Component positioning and stress relief for sensor-enabled wound dressings

文档序号：1590333 发布日期：2020-01-03 浏览：24次中文

阅读说明：本技术 用于传感器实现的伤口敷料的部件定位和应力释放 (Component positioning and stress relief for sensor-enabled wound dressings ) 是由艾玛·瑞安·科尔艾伦·肯尼士·弗雷泽·格鲁根·亨特费利克斯·克拉伦斯·昆塔纳丹尼尔·李· 于 2018-04-11 设计创作，主要内容包括：本发明公开了用于部件应力释放的系统和方法。在一些实施例中,伤口敷料包括基本上可伸缩的伤口接触层,该伤口接触层包括面向伤口侧和非面向伤口侧。伤口接触层的面向伤口侧或非面向伤口侧可支承多个电子部件和连接多个电子部件中的至少一些电子部件的多个电子连接。伤口接触层的面向伤口侧或非面向伤口侧可包括基本上不可伸缩材料的区域,该区域支承来自多个电子部件的至少一个电子部件。至少一个电子部件可以用粘合材料附接到伤口接触层。此布置可安全地定位至少一个电子部件且限制由所述区域支承的至少一个电子部件上的机械应变。(Systems and methods for stress relief of components are disclosed. In some embodiments, the wound dressing comprises a substantially stretchable wound contact layer comprising a wound-facing side and a non-wound-facing side. The wound-facing side or the non-wound-facing side of the wound contact layer may support a plurality of electronic components and a plurality of electronic connections connecting at least some of the plurality of electronic components. The wound-facing side or the non-wound-facing side of the wound contact layer may include a region of substantially non-stretchable material supporting at least one electronic component from the plurality of electronic components. The at least one electronic component may be attached to the wound contact layer with an adhesive material. This arrangement may safely position the at least one electronic component and limit mechanical strain on the at least one electronic component supported by the region.)

1. A wound monitoring and/or treatment apparatus comprising:

a wound dressing comprising a substantially stretchable wound contact layer, the wound contact layer comprising a wound-facing side and a non-wound-facing side opposite the wound-facing side, the wound-facing side of the wound contact layer configured to be positioned in contact with a wound,

the wound-facing side or non-wound-facing side of the wound contact layer supports a plurality of electronic components and a plurality of electronic connections connecting at least some of the plurality of electronic components, an

The wound-facing or non-wound-facing side of the wound contact layer supporting the plurality of electronic components and the plurality of electronic connections comprises a first region of substantially non-stretchable material supporting at least one electronic component from the plurality of electronic components, wherein the at least one electronic component is attached to the first region of substantially non-stretchable material with an adhesive material.

2. The apparatus of any one of the preceding claims, wherein a wound-facing side or a non-wound-facing side of the wound contact layer supporting the plurality of electronic components and the plurality of electronic connections comprises a second region of substantially non-stretchable material supporting at least one electronic connection from the plurality of electronic connections.

3. The apparatus of any preceding claim, wherein the wound contact layer comprises a substrate supporting the plurality of electronic components and the plurality of electronic connections, and a conformal coating covering at least the plurality of electronic components and the plurality of electronic connections, the conformal coating configured to prevent fluid from contacting the plurality of electronic components and the plurality of electronic connections.

4. The apparatus of claim 3, wherein the substrate is formed of thermoplastic polyurethane and the conformable coating is formed of urea.

5. The apparatus of any one of the preceding claims, wherein the wound contact layer comprises a plurality of perforations configured to allow fluid to pass through the wound contact layer when negative pressure is applied to a wound.

6. The apparatus of claim 5, wherein the plurality of perforations are further configured to allow a substantially unidirectional flow of fluid through the wound contact layer to prevent fluid removed from the wound from flowing back into the wound.

7. The apparatus of any one of the preceding claims, wherein a wound-facing side of the wound contact layer comprises an area of additional adhesive material configured to position the at least one electronic component in the wound.

8. The apparatus of any one of the preceding claims, wherein a wound-facing side or a non-wound-facing side of the wound contact layer supporting the plurality of electronic components and the plurality of electronic connections comprises a third region of substantially non-stretchable material surrounding the at least one electronic component.

9. The apparatus of any preceding claim, wherein the at least one electronic component comprises one or more of a sensor, a light emitter, a processor, or a communications controller.

10. The apparatus of any of the preceding claims, wherein the plurality of electronic connections comprise a plurality of electrical traces.

11. The apparatus of any one of the preceding claims, further comprising a negative pressure source configured to be fluidly connected to the wound dressing.

12. The apparatus of any one of the preceding claims, wherein the wound dressing further comprises an absorbent layer positioned over the non-wound facing side of the wound contact layer and a backing layer positioned over the absorbent layer.

13. The apparatus of claim 12, wherein the wound contact layer is sealed to the backing layer.

14. The apparatus of claim 12, further comprising a port on the backing layer configured to fluidly connect the wound dressing to a source of negative pressure.

15. The apparatus of any of the preceding claims, wherein at least one of the adhesive material or the additional adhesive material is thermally curable.

16. The apparatus of any one of claims 1-15, wherein at least the wound-facing side of the wound contact layer supports the plurality of electronic components and the plurality of electronic connections.

17. The apparatus of any one of claims 1-15, wherein at least the non-wound facing side of the wound contact layer supports the plurality of electronic components and the plurality of electronic connections.

18. A method of manufacturing a wound dressing, the method comprising:

providing a substantially stretchable wound contact layer comprising a wound-facing side and a non-wound-facing side opposite the wound-facing side, the wound-facing side of the wound contact layer configured to be positioned in contact with a wound;

positioning a first region of substantially non-stretchable material on a wound-facing side or a non-wound-facing side of the wound contact layer;

positioning an adhesive material in at least a portion of the first region; and

positioning a plurality of electronic components and a plurality of electronic connections on a wound-facing side or a non-wound-facing side of the wound contact layer, wherein at least one electronic component from the plurality of electronic components is supported by a first region of substantially non-stretchable material, and wherein at least one electronic component is attached to the first region of substantially non-stretchable material with the adhesive material.

19. The method of claim 18, wherein the wound contact layer comprises a substrate, and wherein the method further comprises:

perforating the substrate around the plurality of electronic components and the plurality of electronic connections; and

applying a conformal coating over at least the plurality of electronic components and the plurality of electronic connections, the conformal coating configured to prevent fluid from contacting the plurality of electronic components and the plurality of electronic connections.

20. The method of claim 19, further comprising identifying a plurality of locations on the substrate for the plurality of electronic components and the plurality of electronic connections prior to perforating the substrate around the plurality of electronic components and the plurality of electronic connections.

21. The method of claim 20, wherein identifying the plurality of locations comprises identifying one or more of: a location of an RFID chip or antenna positioned on the substrate, or a location of an electronic connection configured to connect to an electronic component external to the substrate.

22. The method of any one of claims 19-21, further comprising applying an area of additional adhesive material to a wound-facing side of the wound contact layer, the additional adhesive material configured to position the at least one electronic component in the wound.

23. The method of claim 22, further identifying a location of the at least one electronic component prior to applying the area of additional adhesive material.

24. The method of claim 18, wherein the wound contact layer comprises a substrate, and wherein the method further comprises:

25. The method of claim 24, further comprising:

applying an area of adhesive material to a wound-facing side of the wound contact layer, the adhesive material configured to position the at least one electronic component in the wound; and

perforating the substrate around the plurality of electronic components and the plurality of electronic connections.

26. The method of claim 25, further comprising identifying a plurality of locations on the substrate for the plurality of electronic components and the plurality of electronic connections prior to perforating the substrate around the plurality of electronic components and the plurality of electronic connections.

27. The method of claim 26, further identifying a location of the at least one electronic component prior to applying the area of adhesive material.

28. The method of any one of claims 26 to 27, wherein identifying the plurality of locations comprises identifying one or more of: a location of an RFID chip or antenna positioned on the substrate, or a location of an electronic connection configured to connect to an electronic component external to the substrate.

29. The method of any of claims 18 to 28, further comprising:

positioning a second region of substantially non-stretchable material on a wound-facing side or a non-wound-facing side of the wound contact layer; and

supporting at least one electrical connection from the plurality of electrical connections on the second region.

30. The method of any one of claims 18-29, further comprising enclosing the at least one electronic component by a third region of substantially non-stretchable material positioned on a wound-facing side or a non-wound-facing side of the wound contact layer supporting the plurality of electronic components and the plurality of electronic connections.

31. The method of any of claims 18 to 28, further comprising:

cutting the wound contact layer along at least one cut line to separate an area of the wound contact layer including the plurality of electronic components and the plurality of electronic connections; and

attaching a region of the wound contact layer to one or more of an absorbent layer or a backing layer to form a wound dressing.

32. The method of any one of claims 19 through 21, wherein the substrate is formed of a thermoplastic polyurethane and the conformable coating is formed of urea.

33. The method of any one of claims 18 to 32, further comprising thermally curing at least one of the adhesive material or the additional adhesive material.

34. The method of any one of claims 18-33, further comprising thermally curing the adhesive material during soldering of the at least one electronic component to at least one of the one or more electronic connections.

35. The method of any one of claims 18-34, wherein the plurality of electronic components and the plurality of electronic connections are positioned at least on a wound-facing side of the wound contact layer.

36. The method of any one of claims 18-34, wherein the plurality of electronic components and the plurality of electronic connections are positioned at least on a non-wound facing side of the wound contact layer.

Technical Field

Embodiments of the present disclosure relate to devices, systems, and methods for treating wounds, for example, using a dressing in combination with negative pressure wound therapy or non-negative pressure wound therapy.

Background

Many different types of wound dressings are known for aiding the healing process in humans or animals. These different types of wound dressings include many different types of materials and layers, for example, gauze, pads, foam pads, or multi-layer wound dressings. Topical Negative Pressure (TNP) therapy, sometimes also referred to as vacuum assisted closure, Negative Pressure Wound Therapy (NPWT) or reduced pressure wound therapy, is widely recognized as a beneficial mechanism to increase the rate of wound healing. This therapy is applicable to a wide range of wounds, such as incisions, open wounds, abdominal wounds, and the like.

However, prior art dressings for negative pressure wound therapy or other wound therapy provide little visualization or information about the status of the wound site beneath the dressing. This may require premature dressing changes before a desired level of wound healing has occurred, or for an absorbent dressing, before the full absorbent capacity of the dressing is reached to allow the clinician to check the healing and status of the wound. Some current dressings have limited or unsatisfactory methods or features for providing wound status information.

Disclosure of Invention

In some embodiments, a wound monitoring and/or therapy apparatus includes a wound dressing having a substantially stretchable wound contact layer including a wound-facing side and a non-wound-facing side opposite the wound-facing side, the wound-facing side of the wound contact layer configured to be positioned in contact with a wound, the wound-facing or non-wound-facing side of the wound contact layer supporting a plurality of electronic components and a plurality of electronic connections connecting at least some of the plurality of electronic components, and the wound-facing or non-wound-facing side of the wound contact layer supporting the plurality of electronic components and the plurality of electronic connections includes a first region of substantially non-stretchable material supporting at least one electronic component from the plurality of electronic components. The at least one electronic component may be attached to the first region of substantially non-stretchable material with an adhesive material.

The apparatus described in the preceding paragraph may include one or more of the following features. The wound-facing or non-wound-facing side of the wound contact layer supporting the plurality of electronic components and the plurality of electronic connections may include a second region of substantially non-stretchable material supporting at least one electronic connection from the plurality of electronic connections. The wound contact layer can include a substrate supporting the plurality of electronic components and the plurality of electronic connections, and a conformal coating covering at least the plurality of electronic components and the plurality of electronic connections, the conformal coating configured to prevent fluid from contacting the plurality of electronic components and the plurality of electronic connections. The substrate may be formed of thermoplastic polyurethane and the conformable coating may be formed of urea. The wound contact layer may include a plurality of perforations configured to allow fluid to pass through the wound contact layer when negative pressure is applied to the wound. The plurality of perforations may also be configured to allow substantially one-way flow of fluid through the wound contact layer to prevent fluid removed from the wound from flowing back into the wound.

The apparatus of any of the preceding paragraphs may include one or more of the following features. The wound-facing side of the wound contact layer may include an area of additional adhesive material configured to position the at least one electronic component in the wound. The wound-facing or non-wound-facing side of the wound contact layer supporting the plurality of electronic components and the plurality of electronic connections may include a third region of substantially non-stretchable material surrounding the at least one electronic component. The at least one electronic component may be one or more of a sensor, a light emitter, a processor, or a communications controller. The plurality of electrical connections may include a plurality of electrical traces. The apparatus may include a negative pressure source configured to be fluidly connected to the wound dressing. The wound dressing may also include an absorbent layer positioned over the non-wound facing side of the wound contact layer and a backing layer positioned over the absorbent layer. The wound contact layer may be sealed to the backing layer. The backing layer may include a port configured to fluidly connect the wound dressing to a source of negative pressure. At least one of the adhesive material or the additional adhesive material may be thermally curable. At least the wound facing side of the wound contact layer may support the plurality of electronic components and the plurality of electronic connections. At least the non-wound facing side of the wound contact layer may support the plurality of electronic components and the plurality of electronic connections.

In some embodiments, a method of making a wound dressing comprises: providing a substantially stretchable wound contact layer comprising a wound-facing side and a non-wound-facing side opposite the wound-facing side, the wound-facing side of the wound contact layer configured to be positioned in contact with a wound; positioning a first region of substantially non-stretchable material on a wound-facing side or a non-wound-facing side of the wound contact layer; positioning an adhesive material in at least a portion of the first region; and positioning a plurality of electronic components and a plurality of electronic connections on a wound-facing side or a non-wound-facing side of the wound contact layer. At least one electronic component from the plurality of electronic components may be supported by the first region of substantially non-stretchable material, and the at least one electronic component may be attached to the first region of substantially non-stretchable material with the adhesive material.

The method described in the preceding paragraph may include one or more of the following features. The wound contact layer may include a substrate, and the method may further include: perforating the substrate around the plurality of electronic components and the plurality of electronic connections; and applying a conformal coating over at least the plurality of electronic components and the plurality of electronic connections, the conformal coating configured to prevent fluid from contacting the plurality of electronic components and the plurality of electronic connections. The method may also include identifying a plurality of locations on the substrate for the plurality of electronic components and the plurality of electronic connections prior to perforating the substrate around the plurality of electronic components and the plurality of electronic connections. Identifying the plurality of locations may include identifying one or more of: a location of an RFID chip or antenna positioned on the substrate, or a location of an electronic connection configured to connect to an electronic component external to the substrate. The method may further include applying an area of additional adhesive material to a wound-facing side of the wound contact layer, the additional adhesive material configured to position the at least one electronic component in the wound.

The method of any of the preceding paragraphs may include one or more of the following features. The method may comprise further identifying the location of the at least one electronic component prior to applying the area of additional adhesive material. The wound contact layer may include a substrate, and the method may further include: applying a conformal coating over at least the plurality of electronic components and the plurality of electronic connections, the conformal coating configured to prevent fluid from contacting the plurality of electronic components and the plurality of electronic connections. The method may further include applying an area of adhesive material to the wound-facing side of the wound contact layer, the adhesive material configured to position the at least one electronic component in the wound; and perforating the substrate around the plurality of electronic components and the plurality of electronic connections.

The method of any of the preceding paragraphs may include one or more of the following features. The method may also include identifying a plurality of locations on the substrate for the plurality of electronic components and the plurality of electronic connections prior to perforating the substrate around the plurality of electronic components and the plurality of electronic connections. The method may further include identifying a location of the at least one electronic component prior to applying the area of adhesive material. Identifying the plurality of locations may include identifying one or more of: a location of an RFID chip or antenna positioned on the substrate, or a location of an electronic connection configured to connect to an electronic component external to the substrate. The method may further comprise positioning a second region of substantially non-stretchable material on a wound-facing side or a non-wound-facing side of the wound contact layer; and supporting at least one electrical connection from the plurality of electrical connections on the second region.

The method of any of the preceding paragraphs may include one or more of the following features. The method may further include surrounding the at least one electronic component by a third region of substantially non-stretchable material positioned on a wound-facing side or a non-wound-facing side of the wound contact layer supporting the plurality of electronic components and the plurality of electronic connections. The method may further include cutting the wound contact layer along at least one cut line to separate a region including the plurality of electronic components and the plurality of electronically connected wound contact layers; and attaching an area of the wound contact layer to one or more of the absorbent layer or the backing layer to form the wound dressing. The substrate may be formed of thermoplastic polyurethane and the conformable coating may be formed of urea. The method may also include curing at least one of the adhesive material or the additional adhesive material. The method may further include thermally curing the adhesive material during soldering of the at least one electronic component to at least one of the one or more electronic connections. The plurality of electronic components and the plurality of electronic connections may be positioned on at least a wound-facing side of the wound contact layer. The plurality of electronic components and the plurality of electronic connections may be positioned on at least a non-wound facing side of the wound contact layer.

In some embodiments, a wound treatment apparatus includes a wound dressing including a substantially stretchable wound contact layer including a wound-facing side and a non-wound-facing side opposite the wound-facing side, the wound-facing side of the wound contact layer configured to be positioned in contact with a wound, the non-wound-facing side of the wound contact layer supporting a plurality of electronic components and a plurality of electronic connections connecting at least some of the plurality of electronic components, the non-wound-facing side of the wound contact layer including a first region of substantially non-stretchable material supporting at least one electronic component from the plurality of electronic components.

The apparatus of any of the preceding paragraphs may include one or more of the following features. The non-wound facing side of the wound contact layer may comprise a second region of substantially non-stretchable material supporting at least one electrical connection from the plurality of electrical connections. The wound contact layer can include a substrate supporting the plurality of electronic components and the plurality of electronic connections, and a conformal coating covering at least the plurality of electronic components and the plurality of electronic connections, the conformal coating configured to prevent fluid from contacting the plurality of electronic components and the plurality of electronic connections. The substrate may be formed of thermoplastic polyurethane and the conformable coating may be formed of urea. The wound contact layer may include a plurality of perforations configured to allow fluid to pass through the wound contact layer when negative pressure is applied to the wound. The plurality of perforations may also be configured to allow substantially one-way flow of fluid through the wound contact layer to prevent fluid removed from the wound from flowing back into the wound. The wound-facing side of the wound contact layer may include an area of adhesive material configured to position the at least one electronic component in the wound. The non-wound facing side of the wound contact layer may comprise a third region of substantially non-stretchable material surrounding the at least one electronic component.

The apparatus of any of the preceding paragraphs may include one or more of the following features. The at least one electronic component may include one or more of a sensor, a light emitter, a processor, or a communications controller. The plurality of electrical connections may include a plurality of electrical traces. The apparatus may include a negative pressure source configured to be fluidly connected to the wound dressing. The wound dressing may also include an absorbent layer positioned over the non-wound facing side of the wound contact layer and a backing layer positioned over the absorbent layer. The wound contact layer may be sealed to the backing layer. The apparatus may further include a port on the backing layer configured to fluidly connect the wound dressing to a source of negative pressure.

In some embodiments, a method of making a wound dressing comprises: providing a substantially stretchable wound contact layer comprising a wound-facing side and a non-wound-facing side opposite the wound-facing side, the wound-facing side of the wound contact layer configured to be positioned in contact with a wound; positioning a first region of substantially non-stretchable material on a non-wound facing side of the wound contact layer; and positioning a plurality of electronic components and a plurality of electronic connections on a non-wound facing side of the wound contact layer, wherein at least one electronic component from the plurality of electronic components is supported by a first region of substantially non-stretchable material.

The method of any of the preceding paragraphs may include one or more of the following features. The wound contact layer may include a substrate, and the method may further include: perforating the substrate around the plurality of electronic components and the plurality of electronic connections; and applying a conformal coating over at least the plurality of electronic components and the plurality of electronic connections, the conformal coating configured to prevent fluid from contacting the plurality of electronic components and the plurality of electronic connections. The method may also include identifying a plurality of locations on the substrate for the plurality of electronic components and the plurality of electronic connections prior to perforating the substrate around the plurality of electronic components and the plurality of electronic connections. Identifying the plurality of locations may include identifying one or more of: a location of an RFID chip or antenna positioned on the substrate, or a location of an electronic connection configured to connect to an electronic component external to the substrate. The method may further include applying an area of adhesive material to a wound-facing side of the wound contact layer, the adhesive material configured to position the at least one electronic component in the wound. The method may further include identifying a location of the at least one electronic component prior to applying the area of adhesive material.

The method of any of the preceding paragraphs may include one or more of the following features. The wound contact layer can include a substrate, and wherein the method can further include applying a conformal coating over at least the plurality of electronic components and the plurality of electronic connections, the conformal coating configured to prevent fluid from contacting the plurality of electronic components and the plurality of electronic connections. The method may further include applying an area of adhesive material to the wound-facing side of the wound contact layer, the adhesive material configured to position the at least one electronic component in the wound; and perforating the substrate around the plurality of electronic components and the plurality of electronic connections. The method may also include identifying a plurality of locations on the substrate for the plurality of electronic components and the plurality of electronic connections prior to perforating the substrate around the plurality of electronic components and the plurality of electronic connections. The method may further include identifying a location of the at least one electronic component prior to applying the area of adhesive material.

The method of any of the preceding paragraphs may include one or more of the following features. Identifying the plurality of locations may include identifying one or more of: a location of an RFID chip or antenna positioned on the substrate, or a location of an electronic connection configured to connect to an electronic component external to the substrate. The method may further comprise positioning a second region of substantially non-stretchable material on a non-wound facing side of the wound contact layer; and supporting at least one electrical connection from the plurality of electrical connections on the second region. The method may further comprise surrounding the at least one electronic component with a third region of substantially non-stretchable material positioned on the non-wound facing side of the wound contact layer. The method may further include cutting the wound contact layer along at least one cut line to separate a region including the plurality of electronic components and the plurality of electronically connected wound contact layers; and attaching an area of the wound contact layer to one or more of the absorbent layer or the backing layer to form the wound dressing. The substrate may be formed of thermoplastic polyurethane and the conformable coating may be formed of urea.

In some embodiments, a wound treatment apparatus includes a wound dressing including a substantially stretchable wound contact layer including a wound-facing side and a non-wound-facing side opposite the wound-facing side, the wound-facing side of the wound contact layer configured to be positioned in contact with a wound, the wound-facing side of the wound contact layer supporting a plurality of electronic components and a plurality of electronic connections connecting at least some of the plurality of electronic components, the wound-facing side of the wound contact layer including a first region of substantially non-stretchable material supporting at least one electronic component from the plurality of electronic components.

The apparatus of any of the preceding paragraphs may include one or more of the following features. The wound-facing side of the wound contact layer may include a second region of substantially non-stretchable material supporting at least one electrical connection from the plurality of electrical connections. The wound contact layer can include a substrate supporting the plurality of electronic components and the plurality of electronic connections, and a conformal coating covering at least the plurality of electronic components and the plurality of electronic connections, the conformal coating configured to prevent fluid from contacting the plurality of electronic components and the plurality of electronic connections. The substrate may be formed of thermoplastic polyurethane and the conformable coating may be formed of urea. The wound contact layer may include a plurality of perforations configured to allow fluid to pass through the wound contact layer when negative pressure is applied to the wound. The plurality of perforations may also be configured to allow substantially one-way flow of fluid through the wound contact layer to prevent fluid removed from the wound from flowing back into the wound.

The apparatus of any of the preceding paragraphs may include one or more of the following features. The wound-facing side of the wound contact layer may include an area of adhesive material configured to position the at least one electronic component in the wound. The wound-facing side of the wound contact layer may comprise a third region of substantially non-stretchable material surrounding the at least one electronic component. The at least one electronic component may include one or more of a sensor, a light emitter, a processor, or a communications controller. The plurality of electrical connections may include a plurality of electrical traces. The apparatus may also include a negative pressure source configured to be fluidly connected to the wound dressing. The wound dressing may include an absorbent layer positioned over the non-wound facing side of the wound contact layer and a backing layer positioned over the absorbent layer. The wound contact layer may be sealed to the backing layer. The apparatus may further include a port on the backing layer configured to fluidly connect the wound dressing to a source of negative pressure.

In some embodiments, a method of making a wound dressing comprises: providing a substantially stretchable wound contact layer comprising a wound-facing side and a non-wound-facing side opposite the wound-facing side, the wound-facing side of the wound contact layer configured to be positioned in contact with a wound; positioning a first region of substantially non-stretchable material on a wound-facing side of the wound contact layer; and positioning a plurality of electronic components and a plurality of electronic connections on a wound-facing side of the wound contact layer, wherein at least one electronic component from the plurality of electronic components is supported by a first region of substantially non-stretchable material.

The method of any of the preceding paragraphs may include one or more of the following features. The wound contact layer may include a substrate, and the method may further include: perforating the substrate around the plurality of electronic components and the plurality of electronic connections; and applying a conformal coating over at least the plurality of electronic components and the plurality of electronic connections, the conformal coating configured to prevent fluid from contacting the plurality of electronic components and the plurality of electronic connections. The method may include identifying a plurality of locations on the substrate for the plurality of electronic components and the plurality of electronic connections prior to perforating the substrate around the plurality of electronic components and the plurality of electronic connections. Identifying the plurality of locations may include identifying one or more of: a location of an RFID chip or antenna positioned on the substrate, or a location of an electronic connection configured to connect to an electronic component external to the substrate. The method may include applying an area of adhesive material to a wound-facing side of the wound contact layer, the adhesive material configured to position the at least one electronic component in the wound. The method may include identifying a location of at least one electronic component prior to applying the area of adhesive material.

The method of any of the preceding paragraphs may include one or more of the following features. The wound contact layer may include a substrate, and the method may further include: applying a conformal coating over at least the plurality of electronic components and the plurality of electronic connections, the conformal coating configured to prevent fluid from contacting the plurality of electronic components and the plurality of electronic connections. The method may include applying an area of adhesive material to a wound-facing side of the wound contact layer, the adhesive material configured to position at least one electronic component in the wound; and perforating the substrate around the plurality of electronic components and the plurality of electronic connections. The method may include identifying a plurality of locations on the substrate for the plurality of electronic components and the plurality of electronic connections prior to perforating the substrate around the plurality of electronic components and the plurality of electronic connections. The method may include identifying a location of at least one electronic component prior to applying the area of adhesive material. Identifying the plurality of locations may include identifying one or more of: a location of an RFID chip or antenna positioned on the substrate, or a location of an electronic connection configured to connect to an electronic component external to the substrate.

The method of any of the preceding paragraphs may include one or more of the following features. The method may include positioning a second region of substantially non-stretchable material on a wound-facing side of the wound contact layer; and supporting at least one electrical connection from the plurality of electrical connections on the second region. The method may further include enclosing the at least one electronic component with a third region of substantially non-stretchable material positioned on the wound-facing side of the wound contact layer. The method may include cutting the wound contact layer along at least one cut line to separate a region including a plurality of electronic components and a plurality of electronically connected wound contact layers; and attaching an area of the wound contact layer to one or more of the absorbent layer or the backing layer to form the wound dressing. The substrate may be formed of thermoplastic polyurethane and the conformable coating may be formed of urea.

In some embodiments, a wound treatment apparatus includes a wound dressing including a substantially stretchable wound contact layer including a wound-facing side and a non-wound-facing side opposite the wound-facing side, the wound-facing side of the wound contact layer configured to be positioned in contact with a wound, the wound-facing side of the wound contact layer supporting a plurality of electronic components and a plurality of electronic connections connecting at least some of the plurality of electronic components, the wound-facing side of the wound contact layer including a first region of substantially non-stretchable material supporting at least one electronic component from the plurality of electronic components, wherein the at least one electronic component is attached to the first region of substantially non-stretchable material with an adhesive material.

The apparatus of any of the preceding paragraphs may include one or more of the following features. The wound-facing side of the wound contact layer may include an area of additional adhesive material configured to position the at least one electronic component in the wound. The wound-facing side of the wound contact layer may comprise a third region of substantially non-stretchable material surrounding the at least one electronic component. The at least one electronic component may include one or more of a sensor, a light emitter, a processor, or a communications controller. The plurality of electrical connections may include a plurality of electrical traces. The apparatus may also include a negative pressure source configured to be fluidly connected to the wound dressing. The wound dressing may include an absorbent layer positioned over the non-wound facing side of the wound contact layer and a backing layer positioned over the absorbent layer. The wound contact layer may be sealed to the backing layer. The apparatus may further include a port on the backing layer configured to fluidly connect the wound dressing to a source of negative pressure. The adhesive material may be thermally curable.

In some embodiments, a method of making a wound dressing comprises: providing a substantially stretchable wound contact layer comprising a wound-facing side and a non-wound-facing side opposite the wound-facing side, the wound-facing side of the wound contact layer configured to be positioned in contact with a wound; positioning a first region of substantially non-stretchable material on a wound-facing side of the wound contact layer; and positioning a plurality of electronic components and a plurality of electronic connections on a wound-facing side of the wound contact layer, wherein at least one electronic component from the plurality of electronic components is supported by a first region of substantially non-stretchable material, and wherein the at least one electronic component is attached to the first region of substantially non-stretchable material with an adhesive material.

The method of any of the preceding paragraphs may include one or more of the following features. The wound contact layer may include a substrate, and the method may further include perforating the substrate around the plurality of electronic components and the plurality of electronic connections; and applying a conformal coating over at least the plurality of electronic components and the plurality of electronic connections, the conformal coating configured to prevent fluid from contacting the plurality of electronic components and the plurality of electronic connections. The method may also include identifying a plurality of locations on the substrate for the plurality of electronic components and the plurality of electronic connections prior to perforating the substrate around the plurality of electronic components and the plurality of electronic connections. Identifying the plurality of locations may include identifying one or more of: a location of an RFID chip or antenna positioned on the substrate, or a location of an electronic connection configured to connect to an electronic component external to the substrate.

The method of any of the preceding paragraphs may include one or more of the following features. The method may further include applying an area of additional adhesive material to a wound-facing side of the wound contact layer, the additional adhesive material configured to position the at least one electronic component in the wound. The method may further comprise identifying the location of the at least one electronic component prior to applying the area of additional adhesive material. The wound contact layer may include a substrate, and the method may further include: applying a conformal coating over at least the plurality of electronic components and the plurality of electronic connections, the conformal coating configured to prevent fluid from contacting the plurality of electronic components and the plurality of electronic connections. The method may further include applying an area of adhesive material to the wound-facing side of the wound contact layer, the adhesive material configured to position the at least one electronic component in the wound; and perforating the substrate around the plurality of electronic components and the plurality of electronic connections.

The method of any of the preceding paragraphs may include one or more of the following features. The method may further include positioning a second region of substantially non-stretchable material on the wound-facing side of the wound contact layer, and supporting at least one electrical connection from the plurality of electrical connections on the second region. The method may further include enclosing the at least one electronic component with a third region of substantially non-stretchable material positioned on the wound-facing side of the wound contact layer. The method may further include cutting the wound contact layer along at least one cut line to separate a region including the plurality of electronic components and the plurality of electronically connected wound contact layers; and attaching an area of the wound contact layer to one or more of the absorbent layer or the backing layer to form the wound dressing. The substrate may be formed of thermoplastic polyurethane and the conformable coating may be formed of urea. The adhesive material may be thermally curable.

In some embodiments, a wound monitoring and/or therapy apparatus includes a wound dressing having a substantially stretchable wound contact layer including a wound-facing side and a non-wound-facing side opposite the wound-facing side, the wound-facing side of the wound contact layer configured to be positioned in contact with a wound, at least the wound-facing side of the wound contact layer supporting a plurality of electronic components and a plurality of electronic connections connecting at least some of the plurality of electronic components, the wound-facing side of the wound contact layer including a first region of substantially non-stretchable material supporting at least one electronic component from the plurality of electronic components. The at least one electronic component may be attached to the first region of substantially non-stretchable material with an adhesive material.

The apparatus described in the preceding paragraph may include one or more of the following features. The wound-facing side of the wound contact layer may include a second region of substantially non-stretchable material supporting at least one electrical connection from the plurality of electrical connections. The wound contact layer can include a substrate supporting the plurality of electronic components and the plurality of electronic connections, and a conformal coating covering at least the plurality of electronic components and the plurality of electronic connections, the conformal coating configured to prevent fluid from contacting the plurality of electronic components and the plurality of electronic connections. The substrate may be formed of thermoplastic polyurethane and the conformable coating formed of urea. The wound contact layer may include a plurality of perforations configured to allow fluid to pass through the wound contact layer when negative pressure is applied to the wound. The plurality of perforations may also be configured to allow substantially one-way flow of fluid through the wound contact layer to prevent fluid removed from the wound from flowing back into the wound.

The apparatus of any of the preceding paragraphs may include one or more of the following features. The wound-facing side of the wound contact layer may include an area of additional adhesive material configured to position the at least one electronic component in the wound. The wound-facing side of the wound contact layer may comprise a third region of substantially non-stretchable material surrounding the at least one electronic component. The at least one electronic component may be one or more of a sensor, a light emitter, a processor, or a communications controller. The plurality of electrical connections may include a plurality of electrical traces. The apparatus may include a negative pressure source configured to be fluidly connected to the wound dressing. The wound dressing may also include an absorbent layer positioned over the non-wound facing side of the wound contact layer and a backing layer positioned over the absorbent layer. The wound contact layer may be sealed to the backing layer. The backing layer may include a port configured to fluidly connect the wound dressing to a source of negative pressure. At least one of the adhesive material or the additional adhesive material may be thermally curable.

In some embodiments, a method of making a wound dressing comprises: providing a substantially stretchable wound contact layer comprising a wound-facing side and a non-wound-facing side opposite the wound-facing side, the wound-facing side of the wound contact layer configured to be positioned in contact with a wound; positioning a first region of substantially non-stretchable material on a wound-facing side of the wound contact layer; positioning an adhesive material in at least a portion of the first region; and positioning at least a plurality of electronic components and a plurality of electronic connections on a wound-facing side of the wound contact layer. At least one electronic component from the plurality of electronic components may be supported by the first region of substantially non-stretchable material, and the at least one electronic component may be attached to the first region of substantially non-stretchable material with the adhesive material.

The method of any of the preceding paragraphs may include one or more of the following features. The method may also include identifying a plurality of locations on the substrate for the plurality of electronic components and the plurality of electronic connections prior to perforating the substrate around the plurality of electronic components and the plurality of electronic connections. The method may further include identifying a location of the at least one electronic component prior to applying the area of adhesive material. Identifying the plurality of locations may include identifying one or more of: a location of an RFID chip or antenna positioned on the substrate, or a location of an electronic connection configured to connect to an electronic component external to the substrate. The method may further include positioning a second region of substantially non-stretchable material on the wound-facing side of the wound contact layer, and supporting at least one electrical connection from the plurality of electrical connections on the second region.

The method of any of the preceding paragraphs may include one or more of the following features. The method may further include enclosing the at least one electronic component with a third region of substantially non-stretchable material positioned on the wound-facing side of the wound contact layer. The method may further include cutting the wound contact layer along at least one cut line to separate a region including the plurality of electronic components and the plurality of electronically connected wound contact layers; and attaching an area of the wound contact layer to one or more of the absorbent layer or the backing layer to form the wound dressing. The substrate may be formed of thermoplastic polyurethane and the conformable coating formed of urea. The method may also include curing at least one of the adhesive material or the additional adhesive material. The method may further include thermally curing the adhesive material during soldering of the at least one electronic component to at least one of the one or more electronic connections.

Any features, components, or details of any arrangement or embodiment disclosed in the present application, including but not limited to any of the monitoring and/or therapy system embodiments and/or wound dressing embodiments disclosed below, may be interchangeably combined with any other features, components, or details of any arrangement or embodiment disclosed herein to form new arrangements and embodiments.

Drawings

Embodiments of the present disclosure will now be described, by way of example only, with reference to the accompanying drawings, in which:

fig. 1A illustrates a negative pressure wound treatment system according to some embodiments;

fig. 1B illustrates a wound dressing according to some embodiments;

FIG. 2 illustrates a sensor array showing sensor placement incorporated into a wound dressing, according to some embodiments;

FIG. 3A illustrates a flexible sensor array including a sensor array portion, a tail portion, and connector pad end portions, according to some embodiments;

FIG. 3B illustrates a flexible circuit board with different sensor array geometries according to some embodiments;

FIG. 3C shows a sensor array portion 301B of the sensor array shown in FIG. 3B;

fig. 3D illustrates a flexible sensor array incorporated into a perforated wound contact layer, in accordance with some embodiments;

FIG. 3E illustrates a control module according to some embodiments;

4A-4F illustrate a wound dressing having a plurality of electronic components, according to some embodiments;

5A-5D illustrate a wound dressing having a plurality of electronic components according to some embodiments;

6A-6B and 7A-7B illustrate a process for manufacturing a wound dressing having a plurality of electronic components, according to some embodiments;

FIG. 8 illustrates indexing according to some embodiments.

Detailed Description

Embodiments disclosed herein relate to apparatus and methods for treating wounds with or without reduced pressure, including, for example, negative pressure sources and wound dressing components and apparatus. Devices and components comprising the wound covering and filler material or inner layer (if present) are sometimes referred to herein collectively as dressings. In some embodiments, the wound dressing may be provided for use without reducing pressure.

Some embodiments disclosed herein relate to wound therapy for the human or animal body. Thus, any reference herein to a wound may refer to a wound on a human or animal body, and any reference herein to a body may refer to a human or animal body. Embodiments of the disclosed technology may relate to preventing or minimizing damage to physiological or living tissue, or to the treatment of damaged tissue (e.g., wounds as described herein).

As used herein, the expression "wound" may include damage to living tissue, typically skin that is cut or ruptured, that may result from cutting, pounding, or other impact. The wound may be a chronic or acute injury. Acute wounds occur as a result of surgery or trauma. They undergo various stages of healing within a predicted time frame. Chronic wounds usually begin with acute wounds. Acute wounds may become chronic wounds when they do not follow the healing phase leading to prolonged recovery. It is believed that the transition from acute to chronic wounds may be due to an impaired immune system of the patient.

Chronic wounds may include, for example: venous ulcers (such as those present in the legs), which account for a large portion of chronic wounds and primarily affect the elderly; diabetic ulcers (e.g., foot or ankle ulcers); peripheral arterial disease; pressure ulcers, or Epidermolysis Bullosa (EB).

Examples of such wounds include, but are not limited to, abdominal wounds or other large or incised wounds that result from either surgery, trauma, sternotomy, fasciotomy, or other conditions, dehiscent wounds, acute wounds, chronic wounds, subacute and dehiscent wounds, traumatic wounds, flap and skin grafts, lacerations, abrasions, contusions, burns, diabetic ulcers, pressure ulcers, stomas, surgical wounds, traumatic ulcers, venous ulcers, and the like.

Wounds may also include deep tissue damage. Deep tissue damage is a term proposed by the national pressure sore advisor group (NPUAP) to describe a unique form of pressure ulcer. Clinicians have used these terms to describe these ulcers for many years, such as purple pressure sores, ulcers that may worsen and contused in the bony prominence.

Wounds may also include tissue at risk of becoming a wound as discussed herein. For example, the at-risk tissue may include tissue on a bony protrusion (with risk of deep tissue damage/invasion) or possibly preoperative tissue (e.g., knee tissue) that may be resected (e.g., for joint replacement/surgical alteration/reconstruction).

Some embodiments relate to methods of treating wounds using the techniques disclosed herein in combination with one or more of: advanced footwear, turning the patient, debriding (e.g., debriding a diabetic foot ulcer), treating infection, systemic mixing (systemix), antimicrobial, antibiotic, surgery, removing tissue, affecting blood flow, physiotherapy, exercise, bathing, nutrition, hydration, nerve stimulation, ultrasound, electrical stimulation, oxygen therapy, microwave therapy, the active agent ozone, antibiotic, antimicrobial, and the like.

Alternatively or additionally, the wound may be treated with topical negative pressure and/or traditional advanced wound care, which is not assisted with applied negative pressure (also referred to as non-negative pressure therapy).

Advanced wound care may include the use of absorbent dressings, occlusive dressings, the use of antimicrobial and/or debriding agents in wound dressings or appendages, pads (e.g., cushioning or compression therapy, such as padding or bandages), and the like.

In some embodiments, the treatment of these wounds may be performed using traditional wound care, wherein a dressing may be applied to the wound to facilitate and promote wound healing.

Some embodiments relate to a method of manufacturing a wound dressing, comprising providing a wound dressing as disclosed herein.

Wound dressings that may be used in conjunction with the disclosed techniques include any known in the art. The technique is applicable to negative pressure therapy treatment as well as non-negative pressure therapy treatment.

In some embodiments, the wound dressing includes one or more absorbent layers. The absorbent layer may be a foam or a superabsorbent.

In some embodiments, the wound dressing may include a dressing layer comprising a polysaccharide or modified polysaccharide, polyvinylpyrrolidone, polyvinyl alcohol, polyvinyl ether, polyurethane, polyacrylate, polyacrylamide, collagen, or gelatin or mixtures thereof. Dressing layers comprising the listed polymers are known in the art as being useful for forming wound dressing layers for negative pressure therapy or non-negative pressure therapy.

In some embodiments, the polymer matrix may be a polysaccharide or a modified polysaccharide.

In some embodiments, the polymer matrix may be cellulose. The cellulosic material may comprise a hydrophilically modified cellulose, such as methyl cellulose, carboxymethyl cellulose (CMC), carboxymethyl cellulose (CEC), ethyl cellulose, propyl cellulose, hydroxyethyl cellulose, hydroxypropyl methyl cellulose, carboxyethyl cellulose sulfate, cellulose alkyl sulfonic acid, or mixtures thereof.

In some embodiments, the cellulosic material may be a cellulose alkyl sulfonate. The alkyl moiety of the alkyl sulfonate substituent may have an alkyl group having 1 to 6 carbon atoms, such as methyl, ethyl, propyl, or butyl. The alkyl moiety may be branched or unbranched and thus a suitable propyl sulfonate substituent may be 1-or 2-methyl-ethyl sulfonate. The butyl sulfonate substituent may be 2-ethyl sulfonate, 2, 2-dimethyl-ethyl sulfonate, or 1, 2-dimethyl-ethyl sulfonate. The alkyl sulfonate substituent may be ethyl sulfonate. Cellulose alkyl sulfonates are described in WO10061225, US2016/114074, US2006/0142560 or US 5,703,225, the disclosures of which are hereby incorporated by reference in their entirety.

The cellulose alkyl sulfonate may have varying degrees of substitution, chain length of the cellulose backbone structure, and structure of the alkyl sulfonate substituent. Solubility and absorption depend strongly on the degree of substituents: as the degree of substituents increases, the cellulose alkyl sulfonate becomes more and more soluble. It follows that as the solubility increases, the absorption increases.

In some embodiments, the wound dressing further comprises a top layer or cover layer.

The thickness of the wound dressing disclosed herein may be between 1mm to 20mm, or 2mm to 10mm, or 3mm to 7 mm.

Non-negative pressure wound dressing

In some embodiments, the disclosed techniques may be used in conjunction with non-negative pressure dressings. A non-negative pressure wound dressing suitable for providing protection at a wound site may comprise:

an absorbent layer for absorbing wound exudates and

a masking element for at least partially masking the view of wound exudate absorbed by the absorbent layer in use.

The shading element may be partially translucent.

The masking element may be a masking layer.

The non-negative pressure wound dressing may also include an area in or near the masking element for viewing the absorbent layer. For example, the shading element layer may be disposed over a central region of the absorbing layer and not over a border region of the absorbing layer. In some embodiments, the masking element is provided with or coated with a hydrophilic material.

The shading elements may comprise a three-dimensional knitted spacer fabric. Spacer fabrics are known in the art and may include a knitted spacer fabric layer.

The shading element may further comprise an indicator for indicating that the dressing needs to be changed.

In some embodiments, the shading element is provided as a layer at least partially over the absorbent layer, which layer is further away from the wound site than the absorbent layer in use.

The non-negative pressure wound dressing may also include a plurality of openings in the masking element for movement of fluid therethrough. The masking element may comprise or may be coated with a material having size exclusion properties for selectively allowing or preventing passage of molecules of a predetermined size or weight.

The shading elements may be configured to at least partially mask optical radiation having wavelengths of 600nm and less.

The shading elements may be configured to reduce light absorption by 50% or more.

The shading elements may be configured to produce CIE L values of 50 or more and optionally 70 or more. In some embodiments, the shading elements may be configured to produce CIE L values of 70 or greater.

In some embodiments, the non-negative pressure wound dressing may further comprise at least one of a wound contact layer, a foam layer, an odor control element, a pressure resistant layer, and a cover layer.

In some embodiments, a cover layer is present, and the cover layer is a translucent film. Typically, the translucent film has a moisture vapor transmission rate of 500g/m2/24 hours or greater.

The translucent film may be a bacterial barrier.

In some embodiments, a non-negative pressure wound dressing as disclosed herein comprises a wound contact layer, and an absorbent layer covers the wound contact layer. The wound contact layer carries an adhesive portion for forming a substantially fluid tight seal over the wound site.

A non-negative pressure wound dressing as disclosed herein may comprise a masking element and an absorbent layer, the absorbent layer being provided as a single layer.

In some embodiments, the non-negative pressure wound dressings disclosed herein comprise a foam layer and the masking element is of a material that includes a component that may be displaced or damaged by movement of the masking element.

In some embodiments, the non-negative pressure wound dressing includes an odor control element, and in another embodiment, the dressing does not include an odor control element. When present, the odor control element can be dispersed within or adjacent to the absorbent layer or the masking element. Alternatively, when present, the odour control element may be provided as a layer sandwiched between the foam layer and the absorbent layer.

In some embodiments, the disclosed technology for a non-negative pressure wound dressing includes a method of manufacturing a wound dressing comprising: providing an absorbent layer for absorbing wound exudate; and a masking element for at least partially masking the view of wound exudate absorbed by the absorbent layer in use.

In some embodiments, a non-negative pressure wound dressing may be suitable for providing protection at a wound site, including: an absorbent layer for absorbing wound exudate; and a barrier layer disposed over the absorbent layer and further from the wound-facing side of the wound dressing than the absorbent layer. The shielding layer may be disposed directly over the absorbing layer. In some embodiments, the shielding layer comprises a three-dimensional spacer fabric layer.

The barrier layer increases the area of pressure transmission applied to the dressing by 25% or more or the initial area of application. For example, the barrier layer increases the area of pressure transmission applied to the dressing by 50% or more, and optionally by 100% or more, and optionally by 200% or more.

The shielding layer may include 2 or more sub-layers, wherein a first sub-layer includes a via and another sub-layer includes a via, and the via of the first sub-layer is offset from the via of the other sub-layer.

The non-negative pressure wound dressing as disclosed herein may further comprise a permeable cover layer for allowing gas and vapor transmission therethrough, the cover layer being disposed over the barrier layer, wherein the through holes of the cover layer are offset from the through holes of the barrier layer.

Non-negative pressure wound dressings may be suitable for treating pressure sores.

A more detailed description of the non-negative pressure dressing disclosed above is provided in WO2013007973, the entire content of which is hereby incorporated by reference.

In some embodiments, the non-negative pressure wound dressing may be a multi-layer wound dressing comprising: a fibrous absorbent layer for absorbing exudates from the wound site; and a support layer configured to reduce shrinkage of at least a portion of the wound dressing.

In some embodiments, the multilayer wound dressings disclosed herein further comprise a liquid impermeable film layer, wherein the support layer is positioned between the absorbent layer and the film layer.

The support layer disclosed herein may comprise a mesh. The web may include a geometric structure having a plurality of generally geometric apertures extending therethrough. The geometric structures may, for example, include a plurality of bosses substantially evenly spaced and joined by the polymeric strands to form generally geometric pores between the polymeric strands.

The mesh may be formed of high density polyethylene.

The apertures may have an area of 0.005 to 0.32mm 2.

The support layer may have a tensile strength of 0.05Nm to 0.06 Nm.

The support layer may have a thickness of 50 μm to 150 μm.

In some embodiments, the support layer is located immediately adjacent to the absorbent layer. Typically, the support layer is bonded to the fibers in the top surface of the absorbent layer. The support layer may further comprise a tie layer, wherein the support layer is thermally laminated to the fibers in the absorbent layer through the tie layer. The tie layer may comprise a low melting point adhesive, such as an ethylene vinyl acetate adhesive.

In some embodiments, the multilayer wound dressings disclosed herein further comprise an adhesive layer attaching the film layer to the support layer.

In some embodiments, the multilayer wound dressings disclosed herein further comprise a wound contact layer positioned adjacent to the absorbent layer to be positioned adjacent to the wound. The multilayer wound dressing may further comprise a fluid transport layer between the wound contact layer and the absorbent layer for transporting exudate away from the wound into the absorbent layer.

A more detailed description of the multi-layer wound dressing disclosed above is provided in GB patent application No. GB1618298.2 filed on 28/10/2016, the entire contents of which are hereby incorporated by reference.

In some embodiments, the disclosed techniques may be included in a wound dressing comprising a vertically overlapping material comprising: a first layer of material comprising an absorbent layer and a second layer of material, wherein the first layer is comprised of at least one layer of nonwoven textile fibers folded into a plurality of folds to form a pleated structure. In some embodiments, the wound dressing further comprises a second layer of material that is temporarily or permanently attached to the first layer of material.

Typically, the vertically overlapping material has been cut.

In some embodiments, the first layer has a pleating structure with a depth determined by the pleat depth or by the cut width. The first layer material may be a moldable lightweight fiber-based material, a blend of materials or composite layers.

The first layer material may comprise one or more of fibres made from synthetic, natural or inorganic polymers, natural fibres of cellulose, proteins or mineral sources.

The wound dressing may comprise two or more vertically overlapping material absorbent layers of material stacked one on top of the other, wherein the two or more layers have the same or different densities or compositions.

In some embodiments, the wound dressing may include only one absorbent layer of material that vertically overlaps the material.

The layer of absorbent material is a blend of natural or synthetic, organic or inorganic fibers and binder fibers, or bicomponent fibers, typically PET, having a low melt temperature PET coating to soften at a particular temperature and act as a binder throughout the blend.

In some embodiments, the absorbent material layer may be a blend of 5 to 95% thermoplastic polymer, and 5 to 95% by weight cellulose or a derivative thereof.

In some embodiments, the wound dressings disclosed herein have a second layer comprising a foam or dressing fixative.

The foam may be a polyurethane foam. The polyurethane foam may have an open or closed cell structure.

The dressing fixture may include a bandage, tape, gauze, or backing layer.

In some embodiments, a wound dressing as disclosed herein comprises a layer of absorbent material directly connected to a second layer by lamination or by an adhesive, and the second layer is connected to a dressing anchor layer. The adhesive may be an acrylic adhesive or a silicone adhesive.

In some embodiments, a wound dressing as disclosed herein further comprises a layer of superabsorbent fibers or viscose fibers or polyester fibers.

In some embodiments, a wound dressing as disclosed herein further comprises a backing layer. The backing layer may be a transparent or opaque film. Typically, the backing layer comprises a polyurethane film (typically a transparent polyurethane film).

A more detailed description of the multi-layer wound dressing disclosed above is provided in GB patent applications with application number GB1621057.7 filed on 12/2016 and GB1709987.0 filed on 22/6/2017, the entire contents of which are hereby incorporated by reference.

In some embodiments, a non-negative pressure wound dressing may include an absorbent component for a wound dressing, the component including a wound contact layer comprising gel-forming fibers bonded to a foam layer, wherein the foam layer is directly bonded to the wound contact layer by an adhesive, a polymer-based melt layer, by flame lamination, or by ultrasound.

The absorbent member may be in the form of a sheet.

The wound contact layer may comprise a woven or non-woven or knitted gel-forming fibrous layer.

The foam layer may be an open cell foam or a closed cell foam, typically an open cell foam. The foam layer is a hydrophilic foam.

The wound dressing may include features forming islands in direct contact with the wound surrounded by a perimeter of adhesive adhering the dressing to the wound. The adhesive may be a silicone or acrylic adhesive, typically a silicone adhesive.

The wound dressing may be covered by a film layer on the surface of the dressing furthest from the wound.

A more detailed description of a wound dressing of this type above is provided in EP2498829, the entire content of which is hereby incorporated by reference.

In some embodiments, a non-negative pressure wound dressing may include a multilayer wound dressing for use on a wound that produces high levels of exudate, wherein the dressing comprises: a transmission layer having an MVTR of at least 300gm2/24 hours; an absorbent core comprising gel-forming fibers capable of absorbing and retaining exudates; a wound contact layer comprising gel-forming fibres which transport exudate to an absorbent core and a bonding layer positioned on the absorbent core, the absorbent core and wound contact layer limiting lateral diffusion of exudate from the dressing to the wound area.

The wound dressing is capable of handling at least 6g (or 8g and 15g) of fluid per 10cm2 of dressing over a 24 hour period.

The wound dressing may comprise gel-forming fibres, which are chemically modified cellulose fibres in the form of a fabric. The fibers may include carboxymethyl cellulose fibers, typically sodium carboxymethyl cellulose fibers.

The wound dressing may comprise a wound contact layer, wherein the lateral wicking rate is from 5 mm/min to 40 mm/min. The wound contact layer may have a fibre density of between 25gm2 and 55gm2, for example 35gm 2.

The absorbent core may have an exudate absorbency of at least 10g/g, and typically a lateral wicking rate of less than 20 mm/min.

The absorbent core may have a blend in the range of up to 25% by weight of cellulosic fibers and 75% to 100% by weight of gel-forming fibers.

Alternatively, the absorbent core may have a blend in the range of up to 50% by weight of cellulosic fibres and from 50% to 100% by weight of gel-forming fibres. For example, the blend is in the range of 50% by weight of cellulosic fibers and 50% by weight of gel-forming fibers.

The density of the fibers in the absorbent core may be between 150gm2 and 250gm2, or about 200gm 2.

The wound dressing may have a shrinkage when wetted of less than 25% or 15% of its original size/dimension.

The wound dressing may include a transmission layer, and the layer is a foam. The transfer layer may be a polyurethane foam laminated to a polyurethane film.

The wound dressing may comprise one or more layers selected from the group comprising a dissolvable drug film layer, an odour absorbing layer, a diffusion layer and an additional adhesive layer.

The wound dressing may be 2mm and 4mm thick.

The wound dressing may be characterized by a bonding layer bonding the absorbent core to an adjacent layer. In some embodiments, the bonding layer may be positioned on the wound-facing side of the absorbent core or the non-wound-facing side of the absorbent core. In some embodiments, the bonding layer is positioned between the absorbent core and the wound contact layer. The bonding layer is a polyamide web.

A more detailed description of a wound dressing of this type above is provided in EP1718257, the entire content of which is hereby incorporated by reference.

In some embodiments, the non-negative pressure wound dressing may be a compression bandage. Compression bandages are known for the treatment of edema and other venous and lymphatic disorders such as the lower limbs.

Compression bandage systems typically employ multiple layers, including a filler layer between the skin and one or several compression layers. Compression bandages are useful, for example, in treating wounds such as venous leg ulcers.

In some embodiments, the compression bandage may include a bandage system comprising a skin-facing inner layer comprising a first foam layer and a second layer of an absorbent nonwoven web, and an elastic outer layer, the inner and outer layers being sufficiently long to be capable of wrapping around a limb of a patient. A compression bandage of this type is disclosed in WO99/58090, the entire content of which is hereby incorporated by reference.

In some embodiments, a compression bandage system comprises: a) an inner elongated skin-facing elastic bandage comprising: (i) an elongated elastomeric substrate, and

(ii) an elongate foam layer adhered to one face of the substrate and extending 33% or more across the face of the substrate in a transverse direction and 67% or more across the face of the substrate in a longitudinal direction; and b) an outer elongate self-adhesive elastic bandage; the bandage having a compressive force when extended; wherein, in use, the foam layer of the inner bandage faces the skin and the outer bandage covers the inner bandage. WO2006/110527 discloses a compression bandage of this type, the entire content of which is hereby incorporated by reference.

In some embodiments, other compression bandage systems, such as those disclosed in US 6,759,566 and US 2002/0099318, the entire contents of each of these documents are hereby incorporated by reference.

Negative pressure wound dressing

In some embodiments, such wounds may be treated using negative pressure wound therapy, wherein reduced or negative pressure may be applied to the wound to facilitate and promote healing of the wound. It will also be appreciated that the wound dressings and methods as described herein may be applied to other parts of the body and are not necessarily limited to wound treatment.

It should be understood that embodiments of the present disclosure are generally suitable for use in a topical negative pressure ("TNP") therapy system. Briefly, negative pressure wound therapy helps to close and heal "difficult to heal" wounds of various morphologies by reducing tissue edema, promoting blood flow and granulation tissue formation, removing excess exudate, and may reduce bacterial load (thereby reducing infection risk). In addition, the therapy allows the wound to be less disturbed, resulting in faster healing. TNP therapy systems may also assist in the healing of surgically closed wounds by removing fluid and by helping to stabilize the tissue in close proximity to the closure site. Additional beneficial uses of TNP therapy may be found in grafts and flaps where removal of excess fluid is important and where close proximity of the graft to the tissue is required to ensure tissue viability.

Negative pressure therapy may be used to treat open or chronic wounds that are too large to spontaneously close or otherwise heal by applying negative pressure to the wound site. Topical Negative Pressure (TNP) therapy or Negative Pressure Wound Therapy (NPWT) involves placing a cover that is impermeable or semi-permeable to fluids over the wound, sealing the cover to the patient tissue surrounding the wound using various means, and connecting a source of negative pressure (such as a vacuum pump) to the cover in a manner that causes negative pressure to be created and maintained under the cover. It is believed that this negative pressure promotes wound healing by promoting the formation of granulation tissue at the wound site and assisting the body's normal inflammatory process while removing excess fluid that may contain adverse cytokines or bacteria.

Some of the dressings used in NPWT may include many different types of materials and layers, for example, gauze, pads, foam pads, or multi-layer wound dressings. One example of a multilayer wound dressing is the PICO dressing available from Smith & Nephew, which includes a wound contact layer and a superabsorbent layer beneath a backing layer to provide a can-less system for treating wounds with NPWT. The wound dressing may be sealed to a suction port that provides a connection to a length of tubing that may be used to pump fluid out of the dressing or to transfer negative pressure from the pump to the wound dressing. Additionally, RENASYS-F, RENASYS-G, RENASYS-AB and RENASYS-F/AB, available from Smith & Nephew, are additional examples of NPWT wound dressings and systems. Another example of a multilayer wound dressing is the ALLEVYN Life dressing available from Smith & Nephew, which includes a moist wound environment dressing for treating a wound without the use of negative pressure.

As used herein, a reduced or negative pressure level (e.g., -X mmHg) represents a pressure level relative to normal ambient atmospheric pressure, which may correspond to 760mmHg (or 1atm, 29.93inHg, 101.325kPa, 14.696psi, etc.). Therefore, the negative pressure value-X mmHg reflects an absolute pressure lower than 760mmHg by X mmHg, or in other words, reflects an absolute pressure (760-X) mmHg. Further, a negative pressure "lower" or "less" than X mmHg corresponds to a pressure closer to atmospheric pressure (e.g., -40mmHg is less than-60 mmHg). A negative pressure "higher" or "greater" than-X mmHg corresponds to a pressure further away from atmospheric pressure (e.g., -80mmHg is greater than-60 mmHg). In some embodiments, local ambient atmospheric pressure is used as a reference point, and such local atmospheric pressure may not necessarily be, for example, 760 mmHg.

The negative pressure range of some embodiments of the present disclosure may be about-80 mmHg, or between about-20 mmHg and-200 mmHg. It should be noted that these pressures are based on normal ambient atmospheric pressure (which may be 760 mmHg). Therefore, in practice, about 560mmHg would be about-200 mmHg. In some embodiments, the pressure range may be between about-40 mmHg and-150 mmHg. Alternatively, pressure ranges of up to-75 mmHg, up to-80 mmHg, or above-80 mmHg may be used. In still other embodiments, a pressure range of less than-75 mmHg may be used. Alternatively, the negative pressure device may supply a pressure range in excess of about-100 mmHg, or even-150 mmHg.

In some embodiments of the wound closure devices described herein, increased wound contraction may result in increased tissue expansion in the surrounding wound tissue. This effect may be enhanced by varying the force applied to the tissue (e.g., by varying the negative pressure applied to the wound over time), possibly in combination with increased tension applied to the wound via various embodiments of the wound closure device. In some embodiments, for example, the negative pressure may be varied over time using a sine wave, a square wave, or synchronized with one or more patient physiological indicators (e.g., heart beat). Examples of such applications in which additional disclosure related to the foregoing may be found include U.S. patent No. 8,235,955 entitled "wound treatment apparatus and method" (published 2012, 8, 7); and U.S. patent No. 7,753,894 entitled "Wound cleansing apparatus with stress" published on 7/13/2010. The disclosures of both of these patents are hereby incorporated by reference in their entirety.

Embodiments OF the WOUND dressing, WOUND dressing components, WOUND TREATMENT apparatus AND METHODS described herein may also be used in combination with or in addition to those described in international application No. PCT/IB2013/001469 entitled "apparatus AND METHOD FOR NEGATIVE PRESSURE WOUND TREATMENT" (apparatus AND METHODS FOR achieving PRESSURE in WOUND TREATMENT) "filed on day 11/28 OF 2013, month 5/22 OF 2013, AND U.S. patent application No. 14/418,908 entitled" WOUND dressing AND TREATMENT METHOD (WOUND DRESSING AND METHOD OF tretant) "filed on day 7/9 OF 2015, month 30 OF 2015, entitled" apparatus AND METHOD OF TREATMENT "(WOUND DRESSING AND METHOD OF tretant)" filed on day 7/9 OF 2015, the disclosures OF which are hereby incorporated by reference in their entirety. Embodiments OF the WOUND dressing, WOUND dressing components, WOUND treatment apparatus and METHODs described herein may also be used in combination with or in addition to those described in U.S. patent application No. 13/092,042 entitled "WOUND dressing and METHOD OF USE" (WOUND DRESSING AND METHOD OF USE), filed 2011/0282309, and U.S. patent application No. 14/715,527 entitled "fluid CONNECTOR FOR NEGATIVE PRESSURE WOUND THERAPY" (fluuiconnected CONNECTOR FOR WOUND PRESSURE THERAPY) filed 2016/0339158a1, filed 2016, 24, 18, which is incorporated herein by reference in its entirety, including other details regarding WOUND dressings, WOUND dressing components and principles, and embodiments OF materials FOR WOUND dressings.

Furthermore, some embodiments relating to TNP wound therapy including a wound dressing in combination with a pump AND/or associated electronics as described herein may also be used in combination with or in addition to those described in international application PCT/EP2016/059329 entitled "PRESSURE reduction device AND method" (REDUCED PRESSURE APPARATUS AND METHODS), filed on day 26/4/2016, year 11, year 78, entitled WO 2016/174048, the disclosure of which is hereby incorporated by reference in its entirety.

NPWT System overview

Fig. 1A illustrates one embodiment of a negative or reduced pressure wound therapy (or TNP) system 100 that includes a wound filler 130 disposed within a wound cavity 110 that is sealed by a wound cover 120. The wound filler 130 in combination with the wound cover 120 may be referred to as a wound dressing. A single or multi-lumen tube or conduit 140 is connected to the wound cover 120, wherein the pump assembly 150 is configured to supply reduced pressure. The wound cover 120 may be in fluid communication with the wound cavity 110. In any of the system embodiments disclosed herein, as in the embodiment illustrated in fig. 1A, the pump assembly may be a canister-less pump assembly (meaning exudate is collected in the wound dressing or transferred via tubing 140 to be collected at another location). However, any of the pump assembly embodiments disclosed herein can be configured to include or support a canister. Additionally, in any of the system embodiments disclosed herein, any of the pump assembly embodiments can be mounted to or supported by or adjacent to the dressing.

The wound filler 130 may be of any suitable type, for example, hydrophilic or hydrophobic foam, gauze, inflatable bags, and the like. The wound filler 130 may conform to the wound cavity 110 such that it substantially fills the cavity. The wound cover 120 may provide a substantially fluid impermeable seal over the wound cavity 110. Wound cover 120 may have a top side and a bottom side, with the bottom side adhesively (or in any other suitable manner) sealed with wound cavity 110. The catheter 140 or lumen, or any other catheter or lumen disclosed herein, may be formed of polyurethane, PVC, nylon, polyethylene, silicone, or any other suitable material.

Some embodiments of wound cover 120 may have a port (not shown) configured to receive an end of conduit 140. For example, the Port may be a Renays Soft Port available from Smith & Nephew. In other embodiments, the conduit 140 may otherwise pass through or under the wound cover 120 to supply reduced pressure to the wound cavity 110 in order to maintain a desired reduced pressure level in the wound cavity. The conduit 140 may be any suitable article configured to provide an at least substantially sealed fluid flow path between the pump assembly 150 and the wound cover 120 in order to supply reduced pressure provided by the pump assembly 150 to the wound cavity 110.

The wound cover 120 and wound filler 130 may be provided as a single article or in the form of a unitary, single unit. In some embodiments, no wound filler is provided, and the wound cover itself may be considered a wound dressing. The wound dressing may then be connected to a source of negative pressure, such as a pump assembly 150, via conduit 140. The pump assembly 150 can be miniaturized or portable, but larger conventional pumps can also be used.

Wound cover 120 may be positioned over a wound site to be treated. Wound cover 120 may form a substantially sealed cavity or enclosure over the wound site. In some embodiments, the wound cover 120 may be configured with a membrane having high water vapor permeability to enable evaporation of excess fluid and may have a superabsorbent material contained therein to safely absorb wound exudate. It should be appreciated that throughout this specification, reference is made to a wound. In this sense, it should be understood that the term wound should be interpreted broadly and covers both open and closed wounds in which the skin is torn, cut or punctured or where the wound causes a contusion, or any other superficial or other condition or defect on the patient's skin or is otherwise such that reduced pressure treatment is benefited. Thus, a wound is broadly defined as any damaged tissue area that may or may not produce fluid. Examples of such wounds include, but are not limited to, acute wounds, chronic wounds, surgical and other incisions, subacute and incisional wounds, traumatic wounds, flaps and skin grafts, lacerations, abrasions, contusions, burns, diabetic ulcers, pressure sores, stomas, surgical wounds, venous ulcers, and the like. The components of the TNP system described herein may be particularly suitable for incisional wounds that emit small amounts of wound exudate.

Some embodiments of the system are designed to operate without the use of an exudate canister. Some embodiments may be configured to support an exudate canister. In some embodiments, the pump assembly 150 and tubing 140 are configured such that the tubing 140 can be quickly and easily removed from the pump assembly 150, which can facilitate or improve the process of dressing or pump change (if needed). Any of the pump embodiments disclosed herein can be configured to have any suitable connection between the tubing and the pump.

In some embodiments, the pump assembly 150 can be configured to deliver a negative pressure of about-80 mmHg or between about-20 mmHg and 200 mmHg. It should be noted that these pressures are relative to normal ambient atmospheric pressure, so-200 mmHg would actually be about 560 mmHg. The pressure may range from about-40 mmHg to-150 mmHg. Alternatively, pressure ranges of up to-75 mmHg, up to-80 mmHg, or above-80 mmHg may be used. Additionally, pressure ranges below-75 mmHg may be suitable. Alternatively, the pump assembly 150 can supply a pressure range in excess of about-100 mmHg or even 150 mmHg.

In operation, wound filler 130 is inserted into wound cavity 110 and wound cover 120 is placed to seal wound cavity 110. The pump assembly 150 provides a source of negative pressure to the wound cover 120 that is transmitted to the wound cavity 110 via the wound filler 130. Fluid (e.g., wound exudate) is drawn through the conduit 140 and may be stored in a canister. In some embodiments, the fluid is absorbed by the wound filler 130 or one or more absorbent layers (not shown).

Wound Dressings that may be used with the pump assemblies and other embodiments of the present application include Renasys-F, Renasys-G, Renasys AB, and Pico Dressings available from Smith & Nephew. Other descriptions of such wound dressings and other components of negative pressure wound therapy systems that may be used with pump assemblies and other embodiments of the present application may be found in U.S. patent publication nos. 2011/0213287, 2011/0282309, 2012/0116334, 2012/0136325, and 2013/0110058, which are incorporated by reference herein in their entirety. In other embodiments, other suitable wound dressings may be used.

Overview of wound dressing

Fig. 1B illustrates a cross-section through a wound dressing 155 according to some embodiments. Fig. 1B also illustrates a fluid connector 160 according to some embodiments. Wound dressing 155 may be similar to the wound dressing described in international patent publication WO2013175306a2, which is incorporated herein by reference in its entirety. Alternatively, wound dressing 155 may be any combination of features of any wound dressing embodiment disclosed herein or any number of wound dressing embodiments disclosed herein, which may be positioned over a wound site to be treated. Wound dressing 155 may be placed to form a sealed cavity over a wound, such as wound cavity 110. In some embodiments, wound dressing 155 includes a top layer or cover layer, or backing layer 220 attached to optional wound contact layer 222, both described in more detail below. The two layers 220, 222 are preferably joined or sealed together to define an interior space or chamber. The interior space or chamber may include additional structure that may be adapted to distribute or transmit negative pressure, store wound exudate and other fluids removed from the wound, as well as other functions, which will be explained in more detail below. Examples of such structures described below include the transmission layer 226 and the absorption layer 221.

As used herein, an upper, top or upper layer refers to the layer that is furthest from the skin or surface of the wound when the dressing is in use and positioned over the wound. Thus, a lower surface, layer, sub-layer or layer refers to the layer closest to the skin or surface of the wound when the dressing is in use and positioned over the wound.

The wound contact layer 222 may be a polyurethane or polyethylene layer or other flexible layer that is perforated, such as by a hot-pin process, a laser ablation process, an ultrasonic process, or in some other manner, or otherwise made permeable to liquids and gases. Wound contact layer 222 has a lower surface 224 (e.g., facing the wound) and an upper surface 223 (e.g., facing away from the wound). Perforations 225 preferably include through-holes in wound contact layer 222 that allow fluid to flow through layer 222. Wound contact layer 222 helps prevent tissue ingrowth into the other materials of the wound dressing. In some embodiments, the perforations are small enough to meet this requirement while still allowing fluid to flow therethrough. For example, perforations formed as slits or holes having a size in the range of 0.025mm to 1.2mm are considered to be small enough to help prevent tissue ingrowth into the wound dressing while allowing wound exudate to flow into the dressing. In some configurations, the wound contact layer 222 can help maintain the integrity of the entire dressing 155 while also creating an airtight seal around the absorbent pad to maintain negative pressure at the wound site. In some embodiments, the wound contact layer is configured to allow one-way or substantially one-way or one-way flow of fluid through the wound contact layer when negative pressure is applied to the wound. For example, the wound contact layer may allow fluid to flow through the wound contact layer away from the wound, but not allow fluid to flow back toward the wound. In some cases, the perforations in the wound contact layer are configured to allow such unidirectional or unidirectional fluid flow through the wound contact layer.

Some embodiments of wound contact layer 222 may also serve as a carrier for optional lower and upper adhesive layers (not shown). For example, the lower pressure sensitive adhesive may be provided on the lower surface 224 of the wound dressing 155 and the upper pressure sensitive adhesive layer may be provided on the upper surface 223 of the wound contact layer. The pressure sensitive adhesive may be a silicone, hot melt, hydrocolloid or acrylic based adhesive or other such adhesive, and may be formed on both sides of the wound contact layer, or alternatively on a selected one of the two sides of the wound contact layer, or not formed on both sides. The lower pressure sensitive adhesive layer, when used, can help adhere the wound dressing 155 to the skin surrounding the wound site. In some embodiments, the wound contact layer may comprise a perforated polyurethane film. The lower surface of the membrane may be provided with a silicone pressure sensitive adhesive and the upper surface may be provided with an acrylic pressure sensitive adhesive, which may help the dressing maintain its integrity. In some embodiments, the polyurethane film layer may be provided with adhesive layers on its upper and lower surfaces, and all three layers may be perforated together.

A layer 226 of porous material may be positioned over the wound contact layer 222. This porous or transmission layer 226 allows the transmission of fluids including liquids and gases away from the wound site into the upper layers of the wound dressing. In particular, the transmission layer 226 may ensure that the open air channels maintain a negative pressure delivered over the wound area even when the absorbent layer absorbs large amounts of exudate. The layer 226 may remain open under typical pressures applied during negative pressure wound therapy as described above, such that an equalized negative pressure is seen across the wound site. Layer 226 may be formed of a material having a three-dimensional structure. For example, a knitted or woven spacer fabric (e.g., Baltex 7970 weft knit polyester) or a non-woven fabric may be used.

In some embodiments, the transmission layer 226 comprises a 3D polyester spacer fabric layer comprising a top layer (that is, the layer distal to the wound bed in use) of 84/144 textured polyester, and a bottom layer (that is, the layer proximal to the wound bed in use) of 10 denier flat polyester, and a third layer sandwiched between the two layers, the third layer being the region defined by knitted polyester viscose, cellulose or similar monofilament fibers. Of course, other materials and other linear mass densities of fibers may be used.

Although reference is made throughout this disclosure to monofilament fibers, it should be understood that multiple strand alternatives may of course be used. Thus, the top spacer fabric has a greater number of filaments in the yarns used to form it than the number of filaments that make up the yarns used to form the bottom spacer fabric layer.

This difference between the number of filaments in the spaced apart layers helps to control the flow of moisture through the transfer layer. In particular, by having a greater number of filaments in the top layer, i.e., the top layer is made of yarns having more filaments than the yarns used for the bottom layer, liquid tends to wick more along the top layer than the bottom layer. In use, this difference tends to wick liquid away from the wound bed and into the central region of the dressing where the absorbent layer 221 helps to lock the liquid out or wick the liquid forward on itself toward the liquid-transpirable cover layer.

In some embodiments, to improve the flow of liquid through the transmission layer 226 (that is, perpendicular to the channel region formed between the top and bottom spacer layers), the 3D fabric may be treated with a dry cleaning agent (e.g., without limitation, perchloroethylene) to help remove any manufactured products, such as previously used mineral oils, fats, or waxes, that may interfere with the hydrophilic ability of the transmission layer. Subsequently, an additional manufacturing step may be performed in which the 3D spacer fabric is washed in a hydrophilic agent (such as, but not limited to, Feran Ice 30g/l available from Rudolph Group). This process step helps to ensure that the surface tension on the material is very low so that liquids such as water can enter the 3D knitted fabric once they contact the fabric. This also helps to control the flow of the liquid fouling component of any exudate.

The absorbing material layer 221 may be disposed over the transmission layer 226. Absorbent materials, including foams or non-woven natural or synthetic materials, and optionally super-absorbent materials, form reservoirs for fluids (particularly liquids) removed from the wound site. In some embodiments, layer 221 may also help absorb fluids toward backing layer 220.

The material of the absorbent layer 221 may also prevent liquids collected in the wound dressing 155 from freely flowing within the dressing, and may serve to contain any liquids collected within the dressing. The absorbent layer 221 also helps distribute fluid throughout the layer via wicking for fluid absorption from the wound site and storage throughout the absorbent layer. This helps to prevent accumulation in the area of the absorbent layer. The capacity of the absorbent material must be sufficient to manage the exudate flow rate of the wound when negative pressure is applied. Since in use the absorbing layerA negative pressure is experienced so that the material of the absorption layer is selected to absorb liquid in this case. There are many materials, such as superabsorbent materials, that are capable of absorbing liquid under negative pressure. The absorption layer 221 may be generally composed of ALLEVYN^TMFoam, Freudenberg 114-^TM11C-450. In some embodiments, the absorbent layer 221 can include a composite including a superabsorbent powder, a fibrous material, such as cellulose, and a binding fiber. In some embodiments, the composite is an airlaid thermal bond composite.

In some embodiments, the absorbent layer 221 is a layer of nonwoven cellulosic fibers having superabsorbent material in the form of dry particles dispersed throughout. The use of cellulose fibers introduces a fast wicking element that helps to rapidly and uniformly distribute the liquid absorbed by the dressing. The juxtaposition of the multi-strand fibers results in a strong capillary action in the fiber mat, which helps to distribute the liquid. In this way, the superabsorbent material is effectively supplied with liquid. Wicking also helps to bring liquid into contact with the overlying layer to help increase the transpiration rate of the dressing.

An orifice, hole, or aperture 227 may be provided in the backing layer 220 to allow negative pressure to be applied to the dressing 155. In some embodiments, the fluid connector 160 is attached or sealed to the top of the backing layer 220 over the aperture 227 created in the dressing 155 and transmits negative pressure through the aperture 227. A length of tubing may be coupled at a first end to the fluid connector 160 and at a second end to a pump unit (not shown) to allow fluid to be pumped out of the dressing. Where the fluid connector is adhered to the top layer of the wound dressing, a length of tubing may be coupled at the first end of the fluid connector such that the tubing or conduit extends parallel or substantially to the top surface of the dressing away from the fluid connector. The fluid connector 160 may be adhered and sealed to the backing layer 220 using an adhesive, such as acrylic, cyanoacrylate, epoxy, UV curable, or hot melt adhesive. The fluid connector 160 may be formed from a soft polymer, such as polyethylene, polyvinyl chloride, silicone, or polyurethane, having a shore a durometer of 30 to 90. In some embodiments, the fluid connector 160 may be made of a soft or conformable material.

In some embodiments, the absorbent layer 221 includes at least one through-hole 228 positioned so as to be located below the fluid connector 160. In some embodiments, the through-hole 228 may be the same size as the opening 227 in the backing layer, or may be larger or smaller. As shown in fig. 1B, a single through-hole may be used to create an opening located below fluid connector 160. It will be appreciated that a plurality of openings may alternatively be used. Additionally, if more than one port is used according to certain embodiments of the present disclosure, one or more openings may be created in the absorbent layer and the obscuring layer in registration with each respective fluid connector. Although not necessary for certain embodiments of the present disclosure, the use of through-holes in the superabsorbent layer can provide fluid flow paths that remain unobstructed, particularly when the absorbent layer is near saturation.

As shown in fig. 1B, an aperture or via 228 may be provided in the absorber layer 221 below the aperture 227, such that the aperture is directly connected to the transmission layer 226. This allows the negative pressure applied to the fluid connector 160 to communicate with the transmission layer 226 without passing through the absorbent layer 221. This ensures that the negative pressure applied to the wound site is not inhibited by the absorbent layer when it absorbs wound exudate. In other embodiments, no apertures may be provided in the absorbent layer 221, or a plurality of apertures located below the aperture 227 may be provided. In other alternative embodiments, additional layers (e.g., another transmission layer or a masking layer as described in international patent publication WO2014020440, which is incorporated herein by reference in its entirety) may be provided above the absorbent layer 221 and below the backing layer 220.

The backing layer 220 may be air impermeable, but permeable to water vapor, and may extend across the width of the wound dressing 155. The backing layer 220, which may be, for example, a polyurethane film (e.g., Elastollan SP9109) having a pressure sensitive adhesive on one side, is air impermeable, and this layer thus serves to cover the wound and seal the wound cavity on which the wound dressing is placed. In this way, an effective chamber is created between the backing layer 220 and the wound site, in which chamber a negative pressure can be created. For example, the backing layer 220 may be sealed to the wound contact layer 222 in a border area around the circumference of the dressing by adhesive or welding techniques, ensuring that no air is drawn through the border area. The backing layer 220 protects the wound from external bacterial contamination (bacterial barrier) and allows liquid from wound exudate to be transported through this layer and evaporate from the outer surface of the film. The backing layer 220 may include two layers: a polyurethane film and an adhesive pattern coated on the film. The polyurethane film is permeable to moisture and may be made of a material that has an increased permeability to water when wetted. In some embodiments, the moisture permeability of the backing layer increases when the backing layer becomes wet. The moisture permeability of the wet back liner may be up to about ten times greater than the moisture permeability of the dry back liner.

The absorbent layer 221 may have a larger area than the transmission layer 226 such that the absorbent layer covers the edges of the transmission layer 226, thereby ensuring that the transmission layer does not contact the backing layer 220. This provides an outer channel of the absorbent layer 221 which is in direct contact with the wound contact layer 222, which facilitates a faster absorption of exudate to the absorbent layer. Furthermore, the further channels ensure that no liquid can collect around the perimeter of the wound cavity, which might otherwise penetrate through the seal around the perimeter of the dressing, resulting in the formation of leaks. As shown in fig. 1B, the absorbent layer 221 may define a perimeter that is smaller than the backing layer 220 such that a demarcation or border region is defined between an edge of the absorbent layer 221 and an edge of the backing layer 220.

As shown in fig. 1B, one embodiment of the wound dressing 155 includes an aperture 228 in the absorbent layer 221 below the fluid connector 160. In use, for example when negative pressure is applied to the dressing 155, the wound facing portion of the fluid connector may thus be in contact with the transmission layer 226, which may thus assist in transmitting negative pressure to the wound site even when the absorbent layer 221 is filled with wound fluid. Some embodiments may have the backing layer 220 at least partially adhered to the transmission layer 226. In some embodiments, the aperture 228 is at least 1-2mm larger than the diameter of the wound facing portion or aperture 227 of the fluid connector 11.

For example, in embodiments having a single fluid connector 160 and through-hole, it may be preferable for the fluid connector 160 and through-hole to be located in an off-center position. Such a position may allow the dressing 155 to be positioned on the patient such that the fluid connector 160 is elevated relative to the remainder of the dressing 155. So positioned, the fluid connector 160 and filter 214 are less likely to come into contact with wound fluid that may prematurely occlude the filter 214, such that transmission of negative pressure to the wound site is impaired.

Turning now to fluid connector 160, some embodiments include a sealing surface 216, a bridge 211 having a proximal end (closer to the negative pressure source) and a distal end 140, and a filter 214. The sealing surface 216 may form an applicator that is sealed to the top surface of the wound dressing. In some embodiments, the bottom layer of the fluid connector 160 may include a sealing surface 216. The fluid connector 160 may also include an upper surface vertically spaced from the sealing surface 216, which in some embodiments is defined by a separate upper layer of the fluid connector. In other embodiments, the upper and lower surfaces may be formed from the same piece of material. In some embodiments, the sealing surface 216 may include at least one aperture 229 therein to communicate with the wound dressing. In some embodiments, the filter 214 may be positioned through the opening 229 in the sealing surface, and may span the entire opening 229. The sealing surface 216 may be configured to seal the fluid connector to a cover layer of a wound dressing and may include an adhesive or a weld. In some embodiments, the sealing surface 216 may be placed over an aperture in the cover layer, with an optional spacer element 215 configured to create a gap between the filter 214 and the transmission layer 226. In other embodiments, the sealing surface 216 may be positioned over apertures in the cover layer and apertures in the absorbent layer 220 to allow the fluid connector 160 to provide air flow through the transmission layer 226. In some embodiments, the bridge 211 can include a first fluid passage 212 in communication with a negative pressure source, the first fluid passage 212 including a porous material, e.g., a 3D knitted material, which can be the same as or different from the porous layer 226 described previously. The bridge 211 may be encapsulated by at least one flexible membrane layer 208, 210 having a proximal end and a distal end, and configured to surround the first fluid passageway 212, the distal end of the flexible membrane connecting the sealing surface 216. The filter 214 is configured to substantially prevent wound exudate from entering the bridge, and the spacing element 215 is configured to prevent the fluid connector from contacting the transmission layer 226. These elements will be described in more detail below.

Some embodiments may also include an optional second fluid passageway positioned above the first fluid passageway 212. For example, some embodiments may provide air leakage that may be disposed at a proximal end of a top layer configured to provide an air path into the first flow path 212 and the dressing 155, similar to the suction adapter described in U.S. patent No. 8,801,685, which is incorporated herein by reference in its entirety.

In some embodiments, the fluid pathways 212 are constructed of a compliant material that is flexible and also allows fluid to pass therethrough if the spacers kink or fold. Suitable materials for the fluid pathway 212 include, without limitation, foams, including open foams, such as polyethylene or polyurethane foams, meshes, 3D knitted fabrics, nonwovens, and fluid channels. In some embodiments, the fluid passage 212 may be constructed of materials similar to those described above with respect to the transmission layer 226. Advantageously, such materials used in the fluid pathway 212 not only allow for greater patient comfort, but also provide greater kink resistance so that the fluid pathway 212 is still able to transport fluid from the wound toward the negative pressure source when kinked or bent.

In some embodiments, the fluid pathway 212 may be formed of a wicking fabric, such as a knitted or woven spacer fabric (e.g., knitted polyester 3D fabric, Baltex

Or Gehring

) Or a nonwoven fabric. These materials selected may be suitable for channeling wound exudate away from the wound through the channels and for delivering negative pressure or exhaust air to the wound site, and may also impart a degree of kink or occlusion resistance to the fluid pathway 212. In some embodiments, the wicking fabric may have a three-dimensional structure, which in some cases may help wick fluid or transmit negative pressure. In certain embodiments including wicking fabrics, these materials remain open and are capable of transmitting negative pressure to the wound area at pressures typical for use in negative pressure therapy (e.g., -40 to-150 mmHg). In some embodiments, the wicking fabric may comprise several materials stacked or laminated on each otherA layer that may be used in some cases to prevent the fluid pathway 212 from collapsing under the application of negative pressure. In other embodiments, the wicking fabric used in the fluid pathway 212 may be between 1.5mm to 6 mm; more preferably, the wicking fabric may be 3mm to 6mm thick and may comprise one or several separate layers of wicking fabric. In other embodiments, the fluid passage 212 may be 1.2 to 3mm thick, and preferably thicker than 1.5 mm. Some embodiments (e.g., a suction adapter for a dressing holding a liquid such as wound exudate) may use a hydrophobic layer in the fluid pathway 212, and only gas may travel through the fluid pathway 212. Furthermore, and as previously mentioned, the materials used in the system may be conformable and soft, which may help avoid pressure sores and other complications that may be caused by the wound treatment system pressing against the patient's skin.

In some embodiments, the filter element 214 is liquid impermeable, but gas permeable, and is provided to act as a liquid barrier and ensure that no liquid is able to escape from the wound dressing 155. The filter element 214 may also act as a bacterial barrier. Typically, the pore size is 0.2 μm. Suitable materials for the filter material of the filter element 214 include 0.2 micron Gore from the MMT series^TMExpanded PTFE, PALL Versapore^TM200R and Donaldson^TMTX 6628. Larger pore sizes may also be used, but these may require a secondary filtration layer to ensure complete bioburden containment. Since the wound fluid contains liquid, it is preferred, but not necessary, to use an oleophobic filter membrane, e.g., 1.0 micron MMT-332, before 0.2 micron MMT-323. This prevents the lipid from clogging the hydrophobic filter. The filter element may be attached or sealed to the cover membrane over the port or aperture. For example, the filter element 214 may be molded into the fluid connector 160, or may be adhered to one or both of the top of the cover layer and the bottom of the suction adapter 160 using an adhesive (such as, but not limited to, a UV cured adhesive).

It should be understood that other types of materials may be used for the filter element 214. More generally, microporous films, which are thin flat sheets of polymeric material containing billions of micropores, can be used. Depending on the membrane selected, these pores may range in size from 0.01 to greater than 10 microns. Microporous membranes have both hydrophilic (drainage) and hydrophobic (waterproofing) forms. In some embodiments, the filter element 214 includes a support layer and an acrylic copolymer membrane sheet formed on the support layer. In some embodiments, wound dressing 155 according to certain embodiments uses a Microporous Hydrophobic Membrane (MHM). Many polymers can be used to form MHMs. For example, the MHM may be formed from one or more of PTFE, polypropylene, PVDF, and acrylic copolymers. All of these optional polymers may be treated to obtain specific surface characteristics that may be hydrophobic and oleophobic. Thus, these will reject liquids with low surface tension, such as multi-vitamin infusions, lipids, surfactants, oils and organic solvents.

The MHM blocks liquid while allowing air to flow through the membrane. They are also highly efficient air filters that eliminate potentially infectious aerosols or particles. It is well known that a single piece MHM is an alternative to mechanical valves or vents. Accordingly, configuring the MHM may reduce product assembly costs to improve patient profits and cost/benefit ratios.

The filter element 214 may also include an odor absorbing material such as activated carbon, carbon fiber cloth, or Vitec Carbotec-RT Q2003073 foam, among others. For example, the odor absorbing material may form a layer of the filter element 214, or may be sandwiched between microporous hydrophobic membranes of the filter element. The filter element 214 thus allows gas to vent through the pores. However, the dressing contains liquids, particles and pathogens.

Wound dressing 155 may include a spacer element 215 in combination with fluid connector 160 and filter 214. By adding this spacing element 215, the fluid connector 160 and filter 214 may be supported without direct contact with the absorbent layer 220 or transmission layer 226. The absorptive layer 220 may also serve as an additional spacing element to keep the filter 214 from contacting the transmission layer 226. Thus, with this configuration, contact of the filter 214 with the transmission layer 226 and wound fluid during use may therefore be minimized.

Similar to the embodiments of the wound dressings described above, some wound dressings include a perforated wound contact layer having a silicone adhesive on the skin-contacting side and an acrylic adhesive on the back side. A transmission layer or 3D spacer fabric mat is located above the boundary layer. The absorption layer is located above the transmission layer. The absorbent layer may comprise a super absorbent Nonwoven (NW) mat. The absorbent layer may be about 5mm across the transmission layer at the perimeter. The absorbent layer may have an aperture or through hole towards one end. The orifice may be about 10mm in diameter. The backing layer is positioned over the transmission layer and the absorbent layer. The backing layer may be a high Moisture Vapor Transmission Rate (MVTR) film coated with a pattern of acrylic adhesive. The high MVTR film and wound contact layer encapsulate the transmission layer and the absorbent layer, creating a peripheral boundary of about 20 mm. The backing layer may have a 10mm aperture overlying the aperture in the absorbent layer. A fluid connector may be attached over the well, the fluid connector including a liquid impermeable, gas permeable semi-permeable membrane (SPM) overlying the orifice.

Wound dressing with sensor

A wound dressing comprising a plurality of sensors may be utilized in order to monitor the characteristics of the wound as it heals. Collecting data from both well-healed and non-well-healed wounds may provide useful insight to identify the measured object to indicate whether the wound is on the healing track.

In some embodiments, a number of sensor technologies may be used for the wound dressing or one or more components forming part of the overall wound dressing apparatus. For example, as shown in fig. 2 and 3D, which describe wound dressings 250, 320 having an array of sensors according to some embodiments, one or more sensors may be incorporated onto or into a wound contact layer, which may be a perforated wound contact layer, as shown in fig. 3D. The wound contact layer in fig. 2 and 3D is shown as having a square shape, but it will be appreciated that the wound contact layer may have other shapes, such as rectangular, circular, oval, and the like. In some embodiments, the sensor-integrated wound contact layer may be provided as a separate layer of material that is placed over the wound area and then covered by the wound dressing device or a component of the wound dressing device, e.g., gauze, foam or other wound packing material, a super-absorbent layer, a drape, a fully integrated dressing such as a Pico or Allevyn Life dressing, or the like. In other embodiments, the sensor-integrated wound contact layer may be part of a single unit dressing such as described herein.

The sensor-integrated wound contact layer may be placed in contact with the wound and will allow fluid to pass through the contact layer while causing little or no damage to the tissue in the wound. The sensor-integrated wound contact layer may be made of a flexible material such as silicone and may contain antimicrobial agents or other therapeutic agents known in the art. In some embodiments, the sensor-integrated wound contact layer may comprise an adhesive that adheres to wet or dry tissue. In some embodiments, the sensor or sensor array may be incorporated into or encapsulated in other components of the wound dressing (e.g., the absorbent or spacer layer described above).

As shown in fig. 2 and 3D, five sensors may be used, including, for example, sensors for: temperature (e.g., 25 thermistor sensors in a 5 x5 array, 20mm pitch), oxygen saturation or SpO2 (e.g., 4 or 5 SpO2 sensors in a single line from the center of the wound contact layer to its edge, 10mm pitch), tissue color (e.g., 10 optical sensors in a2 x5 array, 20mm pitch; not all 5 sensors in each row of the array need to be aligned), pH (e.g., by measuring the color of the pH sensitive pad, optionally using the same optical sensor as the tissue color), and conductivity (e.g., 9 conductive contacts in a 3 x3 array, 40mm pitch). As shown in fig. 3A, the SpO2 sensors may be arranged in a single column from the center or near the center of the wound contact layer to the edge of the wound contact layer. The SpO2 sensor column may allow the sensor to measure changes between regions in the middle of a wound, at the edge or wound, or on the intact skin. In some embodiments, the wound contact layer or sensor array may be larger than the size of the wound to cover the entire surface area of the wound as well as the surrounding intact skin. The larger size of the wound contact layer and/or sensor array and plurality of sensors may provide more information about the wound area than if the sensors were placed only in the center of the wound or only in one area at a time.

The sensor may be incorporated onto a flexible circuit board formed from flexible polymers including polyamides, Polyimides (PI), polyesters, polyethylene naphthalate (PEN), Polyetherimides (PEI), along with various Fluoropolymers (FEP) and copolymers, or any material known in the art. The sensor array may be incorporated into a two-layer flex circuit. In some embodiments, the circuit board may be a multilayer flexible printed circuit. In some embodiments, these flexible circuits may be incorporated into any layer of the wound dressing. In some embodiments, the flexible circuit may be incorporated into the wound contact layer. For example, the flexible circuit may be incorporated into a wound contact layer similar to that described with reference to fig. 1B. The wound contact layer may have cuts or slits that allow one or more sensors to protrude from the lower surface of the wound contact layer and directly contact the wound area.

In some embodiments, the sensor-integrated wound contact layer may include first and second wound contact layers with the flexible circuit board sandwiched between the two layers of wound contact layer material. The first wound contact layer has a lower surface intended to be in contact with a wound and an upper surface intended to be in contact with a flexible circuit board. The second wound contact layer has a lower surface intended to be in contact with the flexible circuit board and an upper surface intended to be in contact with the wound dressing or one or more components forming part of the overall wound dressing apparatus. The upper surface of the first wound contact layer and the lower surface of the second wound contact layer may be adhered together by a flexible circuit board sandwiched between the two layers.

In some embodiments, the one or more sensors of the flexible circuit board may be completely encapsulated or covered by the wound contact layer to prevent contact with moisture or fluids in the wound. In some embodiments, the first wound contact layer may have a cut or slit that allows the one or more sensors to protrude from the lower surface and directly contact the wound area. For example, one or more SpO2 sensors as shown in fig. 3D are shown protruding from the bottom surface of the wound contact layer. In some embodiments, the SpO2 sensor may be mounted directly on the lower surface of the first wound contact layer. Some or all of the sensors and electrical or electronic components may be potted or encapsulated (e.g., rendered waterproof or liquidproof) with a polymer (e.g., a silicon or epoxy-based polymer). Encapsulation with a polymer can prevent fluid ingress and leaching of chemicals from the component. In some embodiments, the wound contact layer material may seal the component to prevent water from entering and leaching out chemicals.

In some embodiments, collecting and processing information related to a wound may use three components, including a sensor array, a control or processing module, and software. These components are described in more detail herein.

Fig. 3A illustrates a flexible sensor array circuit board 300 including a sensor array portion 301, a tail portion 302, and a connector pad end portion 303, according to some embodiments. Sensor array portion 301 may include sensors and associated circuitry. Sensor array circuit board 300 may include a long tail 302 extending from a sensor array portion 301. The connector pad end 303 can be connected to a control module or other processing unit to receive data from the sensor array circuitry. The long tail 302 may allow the control module to be placed away from the wound, e.g., in a more convenient location away from the wound.

FIG. 3B illustrates an embodiment of a flexible circuit board having four different sensor array geometries 301A, 301B, 301C, and 301D. The illustrated embodiment includes tails 302A, 302B, 302C, and 302D. In some embodiments, the four different sensor array geometries shown may be implemented in a flex circuit. Although FIG. 3B shows four different sensor array formats and configurations, designs 301B and 302B also include connector pad ends 303 configured to provide electrical or electronic connections between the initiator array 301B and the control module. One or more of the designs 301A, 301C, or 301D may also include connector pad ends, such as portion 303, to allow the flexible circuit board 301A, 301C, or 301D to communicate with a control module or other processing unit. In some embodiments, the sensor array communicates wirelessly with the control module, and the tail may be omitted.

FIG. 3C illustrates in more detail the sensor array portion 301B of the sensor array design shown in FIG. 3B. In any one or more of the embodiments of fig. 2 or fig. 3A-3D, the sensor array portion may include a plurality of portions that extend around the perimeter of the wound dressing member (e.g., wound contact layer) or inward from the outer edge of the wound dressing member. For example, the illustrated embodiment includes a plurality of linearly extending portions that may be parallel to the edges of the wound dressing member and, in some embodiments, follow the entire perimeter of the wound dressing member. In some embodiments, the sensor array portion may include a first plurality of parallel linear extensions that are perpendicular to a second plurality of parallel linear extensions. These linear extensions may also be of different lengths and may extend inwardly to different locations within the wound dressing member. The sensor array portion preferably does not cover the entire wound dressing member, thereby forming a gap between portions of the sensor array. This allows some, and possibly most, of the wound dressing components to be uncovered by the sensor array, as shown in fig. 2. For example, for a perforated wound contact layer as shown in fig. 2 and 3D, the sensor array portion 301 may not block most of the perforations in the wound contact layer. In some embodiments, the sensor array may also be perforated or shaped to match perforations in the wound contact layer, thereby minimizing the resistance of the perforations to fluid flow.

Fig. 3D illustrates a flexible sensor array incorporated into a perforated wound contact layer 320 according to some embodiments. As shown, the sensor array may be sandwiched between two membranes or wound contact layers. The wound contact layer may have perforations formed as slits or holes as described herein that are small enough to help prevent tissue ingrowth into the wound dressing while allowing wound exudate to flow into the dressing. In some embodiments, the wound contact layer may have one or more slits that increase the flexibility of the wound contact layer with the integrated sensor array. In some embodiments, one of the wound contact layers may have additional cutouts to accommodate sensors so that they may directly contact the skin.

The connections of the sensor array may vary depending on the various sensors and sensor array designs used. In some embodiments, for example, as shown in fig. 3B, a total of 79 connections may be used to connect the components of the sensor array. The sensor array may terminate in two parallel 40-way 0.5mm pitch Flat Flex Cable (FFC) contact surfaces with terminals on the top surface designed to connect to an FFC connector, such as Molex 54104-4031.

In some embodiments, one or more of a thermistor, conductivity sensor, SpO2 sensor, or color sensor may be used on the sensor array to provide information related to the status of the wound. The sensor array and individual sensors may assist the clinician in monitoring the healing of the wound. One or more sensors may operate individually or in coordination with one another to provide data relating to the wound and wound healing characteristics.

The temperature sensor may use a thermocouple or a thermistor to measure the temperature. The thermistor may be used to measure or track the temperature of the underlying wound or the thermal environment within the wound dressing. The thermometric sensors may be calibrated, and data obtained from the sensors may be processed to provide information about the wound environment. In some embodiments, an ambient sensor that measures the ambient air temperature may also be used to help eliminate problems associated with ambient temperature excursions.

Optical sensors can be used to measure wound appearance using RGB sensors with illumination sources. In some embodiments, both the RGB sensor and the illumination source may be pressed against the skin such that the light will penetrate into the tissue and present the spectral characteristics of the tissue itself.

Light propagation in tissue can be dominated by two main phenomena (scattering and attenuation). For attenuation, as light passes through tissue, its intensity may be lost due to absorption by various components of the tissue. Blue light tends to be severely attenuated, while light at the red end of the spectrum tends to be minimally attenuated.

The scattering process may be more complex and may have various "regions" (regions) that must be considered. A first aspect of scattering is based on a comparison of the size of the scattering center with the wavelength of the incident light. If the scattering center is much smaller than the wavelength of light, Rayleigh (Rayleigh) scattering can be assumed. If the scattering center is around the wavelength of light, then a more detailed Mie scattering formula must be considered. Another factor involved in scattering light is the distance between the input and output of the scattering medium. Ballistic photon transmission is assumed if the mean free path of light (the distance between scattering events) is much greater than the distance traveled. In the case of tissue, the scattering events are about 100 microns apart, so a path distance of 1mm will effectively randomize the photon direction and the system will enter the diffuse region.

Ultra bright Light Emitting Diodes (LEDs), RGB sensors and polyester optical filters can be used as components of optical sensors to measure by tissue color differentiation. For example, since the surface color can be measured from reflected light, the color can be measured from light that first passes through the tissue for a given geometry. This may include color sensing of diffusely scattered light from an LED in contact with the skin. In some embodiments, LEDs may be used with nearby RGB sensors to detect light that has diffused through tissue. The optical sensor may be imaged with diffuse internal light or surface reflected light.

In addition, optical sensors may be used to measure autofluorescence. Autofluorescence is used because tissue absorbs light at one wavelength and emits light at another wavelength. In addition, dead tissue may not auto-fluoresce, and thus this may be a very strong indication of whether the tissue is healthy or not. Because of the blue light (or even UV light) with such a short penetration depth, UV light with, for example, a red sensitive photodiode (or some other wavelength shift band) in the vicinity can be very useful as a binary test for healthy tissue, which will auto-fluoresce at very specific wavelengths.

Conductivity sensors can be used to determine the difference between live and dead tissue, or to indicate changes in impedance due to opening a wound in diseased tissue. The conductivity sensor may include an Ag/AgCl electrode and an impedance analyzer. The conductivity sensor may be used to measure impedance changes in the wound growth area by measuring the impedance of the surrounding tissue/area. In some embodiments, the sensor array may utilize conductivity sensors to measure changes in conductivity across the peripheral electrodes due to changes in wound size or wound shape. In some embodiments, the conductivity sensor may be used in the wound bed or on the wound periphery.

In some embodiments, a pH change pad may be used as a pH sensor. A spectrometer and a broadband white light source can be used to measure the spectral response of the pH dye. Illumination and imaging may be provided on the surface of the wound dressing in contact with the wound and on the same side as the fluid application (bottom surface). Alternatively, in some embodiments, the illumination and imaging sources may be disposed on the top surface of the dressing opposite the bottom surface and away from the surface to which the fluid is applied.

In some embodiments, a pulse oximetry SpO2 sensor may be used. To measure the degree of oxidation of blood, pulsatile blood flow was observed. Pulse oximetry works by time-resolved measurements of light absorption/transmission in tissue at two different wavelengths of light. When hemoglobin is oxidized, its absorption spectrum changes relative to non-oxygenated blood. By making measurements at two different wavelengths, a ratiometric measure of the degree of blood oxygenation can be obtained.

The components in the sensor array may be connected by a plurality of connections. In some embodiments, the thermistors may be arranged in groups of five. Each thermistor has a nominal value of 10k omega and each group of five has a common ground. There are five groups of thermistors, for a total of 30 connections. In some embodiments, there may be nine conductive terminals. One connection is required for each conductive terminal, providing a total of 9 connections. In some embodiments, there may be five SpO2 sensors. Each SpO2 sensor required three connections, plus power and ground (these were independently covered), for a total of 15 connections. In some embodiments, there may be 10 color sensors. Each color sensor includes an RGB LED and an RGB photodiode. Six connections are required for each color sensor, but five of them are common to each sensor, providing a total of 15 connections. Power and ground are considered separately. In some embodiments, there may be 5 pH sensors. The pH sensor may be a color changing disk and may be sensed using the color sensor described above. Therefore, no additional connections are required for the pH sensor. There may be three power rails and seven ground return signals, providing a total of 10 common connections. In some embodiments, the sensor array may include 25 thermistors (Murata NCP15WB473E03RC), 9 conductive terminals, 5 SpO2(ADPD144RI), 10 RGB LEDs (e.g., KPTF-1616RGBC-13), 10 RGB color sensors, 10 FETs, a Printed Circuit Board (PCB), and components.

The control module may be configured to interface with the sensor array. In some embodiments, the control module may contain a power source, such as a battery, and electronics for driving the sensors. The control module may also record data at appropriate intervals and allow the data to be transferred to an external computing device, such as a Personal Computer (PC). Depending on the sensors used in the sensor array and the data collected by the sensors, the control module may be customized to have various characteristics. In some embodiments, the control module may be comfortable enough and small enough to be worn for several weeks in succession. In some embodiments, the control module may be positioned adjacent to or on the wound dressing. In some embodiments, the control module may be located at a remote location from the wound dressing and accompanying sensor array. The control module may communicate with the sensor array and the wound dressing, whether located on, near, or remote from the wound dressing, via wires or via wireless communication. In some embodiments, the control module may be adapted for use with different sensor arrays, and may enable easy replacement of the sensor arrays.

In some embodiments, the control module may include various combinations of requirements and features including, but not limited to, the features listed in table 1 below.

TABLE 1 optional features of the control Module

FIG. 3E illustrates a block diagram 330 of a control module according to some embodiments. The block diagram of the control module includes a conductivity driver block 391 that displays the characteristics of the conductivity driver. Block 392 shows the characteristics of the thermistor interface and block 393 shows the characteristics of the optical interface. The control module may include a controller or microprocessor having similar features to those shown in block 394. A Real Time Clock (RTC), status LED, USB connector, serial flash, and debug connector may be included as features of the control module, as shown in fig. 3E.

In some embodiments, the microprocessor may have one or more of the following features: 2.4GHz or another suitable frequency radio (integrated or external); a provided Bluetooth software stack; an SPI interface; USB (or UART for external USB drivers); I2C; 3, channel PWM; 32 GPIO; or a 6-channel ADC. In some embodiments, the device may require at least 48I/O pins or possibly more due to stack limitations. The bluetooth stack typically requires-20 kB of onboard flash memory, and thus would require at least 32 kB. In some embodiments, 64kB may be required if complex data processing is considered. The processor core may be an ARMCortex M4 or similar processor core. In some embodiments, the components may include STM32L433LC or STM32F302R8 of ST, which may require external radio, or the Kinetis KW family of NXP that includes integrated radio.

In some embodiments, the control module may include a memory component, wherein the amount of local memory depends on the sampling rate and resolution of the sensor. For example, a serial flash memory device using many manufacturers (Micron, spread) may meet an estimated data requirement of 256Mb (32 Mb).

The control module may use one or more analog switches. In some embodiments, analog switches with good on-resistance and reasonable bandwidth may be used. For example, ADG72 from Analog Device or NX3L4051HR from NXP may be used. Based on the initial system architecture, 8 of these would be needed.

The control module may include a power source, such as a battery. For example, a 300 mWh/day cell may be used. This was 2100mWh for 7 days. This may be provided by: 10 days, non-rechargeable, ER14250(14.5mm diameter × 25mm) LiSOCl2 cell; or 7 days, rechargeable, Li 14500(14.5mm diameter × 500mm) lithium ion battery.

The control module may comprise a Real Time Clock (RTC). The RTC may be selected from any RTC device with a crystal. The control module may also include various resistors, capacitors, connectors, charge controllers, and other power sources.

The PCB of the control module may be 4-layer board, approximately 50mm by 20mm, or 25mm by 40 mm. The type of PCB used depends largely on the connection requirements for the sensor array.

The housing of the control module may be a two-part moulding with a clip feature to allow easy access for replacement of the sensor array or battery.

Data collected by the sensor array may be passed through the control module and processed by host software. The software may be executed on a processing device. The processing device may be a PC, tablet, smartphone or other computer capable of running host software. The processing device executing the software may communicate with the control module via wires or via wireless communication. In some embodiments, the software may be configured to provide access to data stored on the control module, but not to perform big data analysis. The host software may include an interface to the control module via bluetooth or USB. In some embodiments, the host software may read the state of the control module, download logged data from the control module, upload sample rate control to the control module, convert data from the control module into a format suitable for processing by a big data analysis engine, or upload data to the cloud for processing by the analysis engine.

The software may be developed for PCs (Windows/Linux), tablets or smart phones (Android/iOS) or multiple platforms.

In some embodiments, a negative pressure source (e.g., a pump) and some or all of the other components of the local negative pressure system, e.g., power sources, sensors, connectors, user interface components (e.g., buttons, switches, speakers, screens, etc.), etc., may be integral with the wound dressing. In some embodiments, the component may be integrated below, within, on top of, or near the backing layer. In some embodiments, the wound dressing may include a second cover layer or second filter layer for positioning over the layers and any integrated components of the wound dressing. The second cover layer may be the uppermost layer of the dressing or may be a separate envelope enclosing the integrated components of the local negative pressure system.

Component positioning and/or stress relief

In some embodiments, electrical or electronic components (e.g., sensors, connections, etc.) may be placed or positioned on or embedded in one or more wound dressing components that may be placed in or on the wound, skin, or both the wound and skin. For example, one or more electronic components may be positioned on the wound-contacting layer side facing the wound, e.g., lower surface 224 of wound-contacting layer 222 in fig. 1B. As another example, one or more electronic components may be positioned on a wound contact layer side facing away from the wound, e.g., upper surface 223 of wound contact layer 222 in fig. 1B. The wound contact layer may be flexible, elastic or stretchable or substantially flexible, elastic or stretchable to conform to or cover the wound. For example, the wound contact layer may be made of a stretchable or substantially stretchable material, such as one or more of the following: polyurethanes, Thermoplastic Polyurethanes (TPU), silicones, polycarbonates, polyethylenes, polyimides, polyamides, polyesters, polystyrene tetramers (PET), polybutylene terephthalate (PBT), polyethylene naphthalate (PEN), Polyetherimide (PEI), along with various Fluoropolymers (FEP) and copolymers, or other suitable materials. In some cases, one or more electronic components may alternatively or additionally be placed or positioned on or embedded in any one or more of the transmission layer, the absorbent layer, the backing layer, or any other suitable layer of the wound dressing.

In some embodiments, while it may be desirable for the wound contact layer to be stretchable to better fit or cover the wound, at least some of the electronic components may not be stretchable or flexible. In such cases, when the wound is bandaged with the wound dressing and the wound contact layer is located in or over the wound, undesirable or excessive local strains or stresses may be imposed on the one or more electronic components, for example on the support area or mounting of the electronic component. For example, such stress may be due to patient movement, changes in the shape or size of the wound (e.g., due to healing thereof), and the like. Such stress may cause movement, shifting, or failure of one or more electronic components (e.g., disconnection from a pin or another connector creating an open circuit). Alternatively or additionally, it may be desirable to maintain the position of one or more electronic components (e.g., one or more sensors) at the same or substantially the same location or area on the wound contact layer relative to the wound (e.g., in contact with the wound) such that measurements collected by the one or more electronic components accurately capture changes over time in the same or substantially the same location or area of the wound. Although the surface of the retractable wound contact layer may move when, for example, the patient moves, it may be desirable for one or more electronic components to be located in the same location or region relative to the wound.

As described herein, in some embodiments, one or more rigid, rigid or non-stretchable or substantially rigid, rigid or non-stretchable regions, such as one or more non-stretchable or substantially non-stretchable regions of material, may be mounted, positioned or disposed on the wound contact layer (or another suitable wound dressing component) for supporting one or more electronic components. Mounting, positioning, or disposing the one or more electronic components in the one or more non-stretchable or substantially non-stretchable regions may prevent the formation of localized stresses or help maintain the position of the one or more electronic components relative to the wound. In some cases, one or more electronic components may alternatively or additionally be flexible, e.g., mounted or printed on or supported by one or more flexible materials. For example, flexible plastic sheets or substrates such as polyimide, Polyetheretherketone (PEEK), polyester, silicone, and the like may be used.

Fig. 4A-4F illustrate a wound dressing 400 having a plurality of electronic components, according to some embodiments. As shown, the sheet or substrate 430 is configured to support one or more electronic components, including an electronic component or module 402 having a plurality of connectors 404 and a plurality of electronic connections 410, and non-stretchable or substantially non-stretchable regions 422, 424. The substrate 430 may be a stretchable or substantially stretchable wound contact layer as described herein. The electronic module 402 may be any electronic component described herein, such as a sensor, a light source (e.g., LED, temperature sensor, optical sensor, etc.), a controller or processor (such as a communications processor), or the like. The electrical connections 410 may be traces printed on the substrate 430, for example, using conductive copper, conductive inks (e.g., silver ink, silver/silver chloride ink, copper ink, graphite ink, carbon ink, dielectric ink, etc.), and the like. At least some of the electronic connections 410 may be flexible or stretchable or substantially flexible or stretchable. One or more connectors 404 may be configured to electrically connect the electronic module 402 to electronic connections 410 (as shown in fig. 4B), which may in turn be connected to other electronic modules (not shown) positioned on the substrate 430, on or in other components of the wound dressing, or outside the wound dressing. The connectors 404 may be pins, leads, blocks, pads, etc. Additionally or alternatively, a socket may be used to support and electrically connect the electronic module 402.

The electronic module 402 may be held in place on the substrate 430 via one or more connectors 404. For example, the connector 404 may be soldered or otherwise electrically connected to the electrical connection 410. This arrangement may risk the electronic module 402 from being dislodged during use when the wound dressing is placed in a wound. The displacement of the electronic module 402 and its falling into a wound (e.g., a wound cavity) can be detrimental to patient safety, particularly because the electronic module 402 may be small. In some embodiments, an adhesive 406 may be applied to securely adhere or attach the electronic module 402 to the substrate 430. As shown in fig. 4A, adhesive 406 may securely adhere or attach electronic module 402 to region 422. The adhesive 406 may additionally provide mechanical reinforcement for the reinforcement provided by the one or more connectors 404. The adhesive 406 may be an epoxy or any other suitable glue. The adhesive 406 may be thermally curable or curable by any other suitable means.

For example, substrate 430 may include a flexible circuit board as described herein. Prior to soldering the connector 404, the electronic module 402 may be adhered to the circuit board using an adhesive 406 (e.g., a thermally curable epoxy). The adhesive 406 may be cured prior to or at the same time as the welding. For example, if wave soldering is used, the adhesive 406 may cure due to the heat generated by the wave soldering. In some cases, the flexible circuit board may be a two-layer circuit board, and additional electronic modules may be similarly adhered to the other side of the circuit board. In some embodiments, a conductive adhesive may be used in place of or in addition to the connector 404.

Additional electronic components may be similarly attached or adhered. In certain embodiments, one or more electronic traces 410 may also be similarly attached or adhered using an adhesive. In some embodiments, one or more electronic components or traces positioned on the side of the wound dressing 400 facing away from the wound may similarly be attached or adhered using an adhesive.

In some cases, adhering one or more of the electronic components or connectors described herein using an adhesive may help prevent electrostatic discharge (ESD) from damaging the electronics of the wound dressing 400. For example, ESD may be caused by electrical defibrillation and may manifest as an arch between the conductive elements of wound dressing 400. The adhesive may conduct charge away from the electronic component (e.g., to a ground plane) to prevent damage to the electronic device.

Referring to fig. 4A, the regions 422, 424 may comprise a non-stretchable or substantially non-stretchable material, such as one or more of the following: suitable adhesives, epoxies, polyesters, polyimides, polyamides, PET, PBT or another type of material with a high young's modulus. One or more of the regions 422, 424 may be printed on the substrate 430. As used herein, printing a material on a substrate may include one or more of lamination, adhesion, or any other suitable technique. In some embodiments, a flexible circuit board may be positioned on region 422.

Fig. 4B shows the component (shown in fig. 4A) positioned on the substrate 430. As shown, the electronic module 402 is mounted to or supported by the region 422. A portion of electrical connection 410 is mounted to or supported by region 424. Slits, holes, or perforations formed in the substrate 430 according to some embodiments are also illustrated. As described herein, the substrate 430 may be perforated using one or more of cold pin perforation, hot pin perforation, laser ablation perforation, ultrasonic or ultrasonic perforation, or the like, to render the wound contact layer permeable to liquids and gases. In some embodiments, one or more of the utilized perforation processes may create a flat or substantially flat substrate around the hole or uneven surface (e.g., annular surface). Having a flat or substantially flat substrate can help create a uniform layer when a conformable coating is applied (e.g., via a spray, brush, extruded dye, etc., as described herein). In addition, using a perforation process that causes the substrate surface to be non-uniform or substantially non-uniform may result in a greater risk of displacing one or more components (e.g., the electronic connections 410 or the electronic modules 402) when perforating around the components.

In some embodiments, perforations are made or patterned around one or more components (e.g., electrical connections 410, electrical modules 402, or regions 422 or 424) disposed on substrate 430. As explained herein, component indexing may be used to automatically position one or more components on substrate 430 such that the one or more components are not damaged by the perforations. In some embodiments, the substrate may be perforated before one or more of the components shown in fig. 4A are placed on the substrate.

Fig. 4C and 4F illustrate optional application of a coating 440 or one or more of one or more bonding regions 452, 454, 456, according to some embodiments. Fig. 4C illustrates a wound dressing 400 in which one or more electronic modules are positioned on the wound-facing side of substrate 430. Fig. 4F illustrates a wound dressing 400 in which one or more electronic modules are positioned on a side of the substrate 430 facing away from the wound. Coating 440 may be a conformal coating configured to encapsulate or coat one or more of substrate 430 or a component supported by the substrate (e.g., electronic connection 410 or electronic module 402). The coating 440 may provide biocompatibility, shield or protect the electronics from fluid contact, and the like. The coating 440 may be one or more of the following: a suitable polymer; adhesives, for example 1165 or 1072-M UV, light, or heat or cure adhesives, Optimax adhesives (e.g., NovaChem Optimax 8002-LV); parylene (such as parylene C); silicon; an epoxy resin; urea; acrylic urethane; or another suitable biocompatible and stretchable material. The coating 440 may be thin, for example, about 100 microns thick, less than about 100 microns thick, or greater than about 100 microns thick. The coating 440 may be applied and cured using one or more of UV, light, or thermal curing. In some embodiments, the coating 440 may be applied to the component on the other side of the substrate 430 (or the side facing away from the wound), particularly if the substrate is fluid impermeable. In certain embodiments, the coating 440 may be applied on the other side (or wound-facing side) of the substrate 430, particularly if the substrate is rendered fluid-tight. In some embodiments, the coating is optional.

One or more adhesive pads, traces or regions 452, 454, 456 may be applied to the wound-facing side of the substrate 430 or the wound-facing side of the coating 440, as shown in fig. 4C and 4F. Referring to fig. 4C, in some embodiments, the first adhesive region 452 can be shaped, sized, or positioned to adhere the electronic module 402 in contact with or relative to a first particular or specific portion of the wound (e.g., a first particular or specific region, area, or location in contact with or relative to the wound). The adhesive region 452 may be shaped and sized similarly to the region 422 or the electronic module 402 to adhere the module to a specific location in a wound. Referring to fig. 4F, the adhesive region 452 may be shaped and sized similarly to the area 422 or the electronic module 402, however, the area 452 may be positioned to cover the area 422 or the electronic module 402 on the opposite, wound-facing side of the wound contact layer to adhere or position the module to a particular location in a wound. Similarly, second adhesive region 454 can be shaped, sized, or positioned to adhere portions of electrical connection 410 supported by region 424 relative to a second particular or particular portion of the wound (e.g., a second particular or particular region, area, or location in contact with or opposite the wound). Another (third) adhesive region 456 is illustrated that can adhere another portion of the wound contact layer to another (third) particular or specific portion of the wound, such as another (third) particular or specific region, area or location in contact with or opposite the wound. The adhesive material may be one or more of silicone (e.g., two-part silicone, one-part silicone), gel, epoxy, acrylic-based material, or other suitable material. The adhesive may be applied and cured using one or more of UV, light, or thermal curing. For example, the adhesive may be printed, sprayed, coated, etc., and then cured by UV, light, thermal curing, catalysis, water vapor, etc. In some embodiments, the adhesive is optional.

In some embodiments, one or more adhesive regions may be patterned to position or adhere a particular component into a particular region, area or location in contact with or opposite a wound even when substrate 430 is under stress or strain. While the substrate may be strained between the adhesive regions, the electronic module 402 (e.g., sensor) will remain in the same position in contact with or relative to the wound (due to adhesive region 452), thereby maintaining the most repeatable signal, and the portion of the electronic connection 410 will remain in the same position in contact with or relative to the wound, such that the portion of the electronic connection will not be dragged across the wound (due to adhesive region 454) when the substrate 430 is subjected to strain. In addition, because the body (e.g., skin, which may be strained by about 20%) will relieve some of the stress (e.g., due to the wound contact layer being attached to the wound by the one or more adhesive regions) and the substrate will yield around the electronic module, too much stress will not be applied to the support region or mount of the electronic module 402. Similar stress relief may be provided to the portion of electronic connection 410 covered by adhesion region 454. This may prevent failure of one or more electronic components.

In certain embodiments, the pattern of bond regions may be based on the positioning of one or more electronic components, which may be determined using indexing as described herein. As explained herein, it may be desirable to pattern the adhesive to equalize stress or strain on the wound contact layer. The adhesive may be patterned to reinforce or support certain areas or regions, for example, areas where one or more electronic components are placed, while weakening (or reducing rigidity) other areas to distribute stress or avoid straining one or more electrical components. For example, it may be desirable to cover at least 50% or more of the wound-facing surface of the wound-contacting layer with adhesive. In certain embodiments, the adhesive may be applied to cover or substantially cover the entire wound-facing side of the wound-contacting layer.

In some embodiments, the adhesive material used to form the one or more adhesive regions may be non-stretchable or substantially non-stretchable. One or more regions of non-stretchable or substantially non-stretchable material (e.g., regions 422, 424) may not be used or may be sized or shaped differently than one or more bonding regions.

In some embodiments, any or all of the one or more bonding regions may be positioned on coating 440, between coating 440 and substrate 430, between one or more modules 402 and substrate 430 (e.g., to adhere one or more modules to the substrate), or between one or more modules 402 and coating 440.

Fig. 4D-4E illustrate attaching one or more electronic modules 402 to a substrate 430, according to some embodiments. Fig. 4D illustrates the components before attachment to the substrate 430, and fig. 4E illustrates the components after attachment to the substrate 430. As shown, one or more regions 470 may be included or formed on the substrate 430. For example, the region 470 may be formed approximately at the center of the region where the electronic module 402 is intended to be positioned on the substrate 430. The electronic module 402 may then be securely mounted on or supported by the region 470. Region 470 may be formed from an adhesive material, such as one or more of silicone (e.g., two-component silicone, one-component silicone, etc.), a gel, an epoxy, an acrylic-based material, or other suitable material. The adhesive may be applied and cured using one or more of UV, light, or thermal curing. For example, the adhesive may be printed, sprayed, coated, etc., and then cured by UV, light, thermal curing, catalysis, water vapor, etc.

In some embodiments, the region 470 is formed of a thermally curable epoxy, and the epoxy is cured (e.g., in a reflow oven) when the solder (shown as 480 in fig. 4E) melts to connect the connectors 404 of the electronic module to the connectors 480 located on the substrate 430. Connector 480 is configured to provide electrical connections for one or more electrical connections 410.

In some embodiments, one or more regions 470 provide a thermally conductive path from one or more electronic modules 402 to substrate 430 in order to dissipate heat generated by the one or more electronic modules. One or more of the regions 470 may additionally or alternatively act as electrical isolators. The one or more regions 470 may ensure that the one or more electronic modules 402 are properly and securely mounted prior to the addition of the coating 440 as described herein. In some cases, although the coating 440 may be designed to flow under the one or more electronic modules 402 prior to curing, the inclusion of the one or more regions 470 on the substrate 430 may reduce the distance the coating 440 needs to flow and may minimize the possibility of air bubbles being left under the one or more electronic modules 402.

In some embodiments, one or more regions 470 may similarly be used to attach or position part or all of one or more electronic connections 410 on substrate 403. In some cases, one or more of the regions 470 may function similarly and provide similar advantages to the adhesive region 406 shown in fig. 4A and described herein.

Although a single electronic module 402 and a single region 470 are illustrated in fig. 4A-4E, in some embodiments, multiple electronic modules and multiple regions may be used. One or more additional electronic modules or one or more electronic connections 410 interconnecting the electronic module 402 and the additional electronic modules may be disposed on one or more additional non-stretchable or substantially non-stretchable regions. Additionally or alternatively, the adhesive region may be provided to further contact or adhere one or more electronic modules or electronic connections to the wound as described herein.

Fig. 5A illustrates a wound dressing 500A having multiple components according to some embodiments. As shown, wound dressing 500A includes an electronics module 402 and an electronic connection 410. Instead of or in addition to including the region 422 of the support module 402, a non-telescoping or substantially non-telescoping region 550 may be formed around the perimeter of the module 402 to enclose or substantially enclose the module 402. Region 550 may be formed of the same or different material as regions 422 or 424. The region 550 may absorb or maintain strain rather than exposing the module 402 to strain. In some embodiments, the regions 550 may be configured to form a checkerboard or substantially checkerboard shape (e.g., be a single shape, with no or substantially no gaps or overlapping portions). This may help to distribute strain over or across the region 550 while reducing strain on one or more electronic components. For example, for a particular global strain applied to the dressing, the local strain will vary above the global strain value (on or across the region 550) and below the global strain value (on or across one or more electronic components).

Fig. 5B illustrates a cross-sectional view of the wound dressing 500A along line a-a when strain or stress is applied to the dressing. As shown, if the area 550 is separated from the module 402 by a distance d, the substrate 430 may be capable of straining in the z-plane and moving the module 402 (e.g., downward and away from the wound, as indicated by arrow 560) to minimize the pressure exerted by the module 402 on the wound or skin. The module 402 may be pushed away from the wound, but may remain in contact or touching with the wound or skin. This may prevent or limit patient discomfort caused by the module 402 drilling into the wound when the substrate 430 is subjected to strain, while maintaining a desired positioning of the module 402 in the wound.

In some cases, area 550 may not completely surround module 402, e.g., leaving one or more sides of the module uncovered. In some cases, the distance d separating the region 550 from the module 402 may vary around the perimeter of the module 402. In some cases, one or more other regions may be used, such as region 550. For example, another region may be used to surround or substantially surround the portion of electrical connection 410 supported by region 424. This other region may be used in addition to or in place of region 424.

In some embodiments, rather than using a straight electrical connection 410, a concertina type connection may be used. This may allow for a larger global strain of the substrate for a smaller local strain of the individual connecting traces, with a trade-off being that, for example, the traces will occupy a larger proportion of the substrate. In some cases, one or more thinner traces may be used as strain gauges to identify strain between hard points intentionally fixed (e.g., by an adhesive).

In certain embodiments, one or more strain gauges (which may be traces or separate strain gauges) may be used to identify whether the wound dressing has been removed or whether one or more areas of adhesive, such as areas 452, 454, or 456, have failed (e.g., displaced). For example, loss of expected movement and corresponding strain may identify removal or debonding of one or more bond regions. The measured strain may be compared to one or more thresholds corresponding to removal of the dressing (e.g., indicating little or no strain across the dressing), displacement of one or more adhesive regions (e.g., indicating little or no strain across a particular region that has been displaced), and so forth, respectively.

In some embodiments, a semi-elastic conductive adhesive (e.g., epoxy with silver particles), an anisotropic adhesive, or other suitable adhesive may be used to mount one or more electronic components on substrate 430. This may allow some lateral flexibility of the installation when stress is applied to the wound dressing. In some cases, such mounting may be used in addition to or instead of mounting on a non-telescoping or substantially non-telescoping region as described herein.

Fig. 5C-5D illustrate a wound dressing 500B similar to the dressing shown in fig. 5A-5B, but including one or more electronic components on the side of the substrate 430 facing away from the wound. As shown in fig. 5D, if the area 550 is separated from the module 402 by a distance D, the substrate 430 may be capable of straining in the z-plane and moving the module 402 (e.g., up and away from the wound, as indicated by arrow 560) to minimize the pressure exerted by the module 402 on the wound or skin. The module 402 may be pushed away from the wound.

Fig. 6A illustrates a process 600A of manufacturing or fabricating a wound dressing, such as wound dressing 400 or 500A, according to some embodiments. Although a single area of wound contact layer is shown in connection with a single dressing, process 600A may be used to manufacture multiple wound contact layers of multiple dressings in parallel or substantially in parallel (see fig. 8). The process 600A may be performed by an assembly or manufacturing machine.

The process 600A may begin in step or block 602, where a substrate is provided. The substrate may be made of an elastomer (e.g., TPU). In block 604, one or more non-stretchable or substantially non-stretchable regions may be placed or positioned on the substrate. Such one or more regions may be printed on the substrate to provide stress or strain relief for one or more components. In block 606, one or more conductive electronic connections may be positioned or disposed on the substrate (e.g., one or more traces may be printed with conductive ink). In block 608, one or more electronic components may be mounted or positioned on the substrate. One or more electronic components or connections may be securely adhered to a substrate using an adhesive as described herein. As shown, the electronic module may be mounted or positioned on a non-telescoping or substantially non-telescoping region.

In block 610, perforations may be made in the substrate, which may be performed using indexing as described herein. In block 612, a coating may optionally be applied to one or more electronic components (e.g., modules or connections) or other areas of the substrate. The coating may be a conformable coating. For example, the coating may be a urea coating that is applied and cured using one or more of UV, light, or thermal curing. In certain embodiments, perforating the substrate prior to applying the conformable coating allows the conformable coating (which may be about 100 microns thick) to flow through the one or more perforated pores and bond to the interior of the substrate (e.g., during curing of the conformable coating). This may reduce or minimize the likelihood of coating or packaging failure.

In block 614, one or more regions of adhesive are optionally applied, which may be performed using indexing as described herein. For example, the adhesive may be silicone and may be applied and cured using one or more of UV, light, or thermal curing. In block 616, the wound contact layer for an individual dressing (e.g., system) may be cut or separated from a sheet or web of wound contact layers including wound contact layers of a plurality of other dressings. Such cutting may be performed using indexing as described herein.

Fig. 6B illustrates a process 600B of manufacturing or fabricating a wound dressing, such as wound dressing 400 or 500B, according to some embodiments. Process 600B differs from process 600A in that: in block 614, an adhesive is applied to the wound-facing side of the substrate opposite the side of the substrate that supports the one or more electronic components.

Fig. 7A illustrates a process 700A of manufacturing or fabricating a wound dressing, such as wound dressing 400 or 500A, according to some embodiments. Although a single area of wound contact layer is shown in connection with a single dressing, process 700A may be used to fabricate multiple wound contact layers of multiple dressings in parallel or substantially in parallel (see fig. 8). The process 700A may be performed by an assembly or manufacturing machine.

The process 700A may begin in step or block 702, where a substrate is provided. The substrate may be made of an elastomer (e.g., TPU). In block 704, one or more non-stretchable or substantially non-stretchable regions may be placed or positioned on the substrate. Such one or more regions may be printed on the substrate to provide stress or strain relief for one or more components. In block 706, one or more conductive electronic connections may be positioned or placed on the substrate (e.g., one or more traces may be printed with conductive ink). In block 708, one or more electronic components may be mounted or positioned on the substrate. One or more electronic components or connections may be adhered to a substrate using an adhesive as described herein. As shown, the electronic module may be mounted or positioned on a non-telescoping or substantially non-telescoping region.

In block 710, a coating may optionally be applied to one or more electronic components (e.g., modules or connections) or other areas of the substrate. The coating may be a conformable coating. For example, the coating may be a urea coating. In block 712, one or more regions of adhesive are optionally applied, which may be performed using indexing as described herein. For example, the adhesive may be silicone. In block 714, curing may be performed to bond, strengthen, or harden one or more of the coatings or adhesives. For example, one or more of UV, light, or thermal curing may be performed.

In block 716, perforations may be made in the substrate, which may be performed using indexing as described herein. Perforations may be made through the adhesive, as applicable (e.g., where the adhesive does not cover the one or more electronic components). In some cases, perforating the substrate after application of the conformable coating can result in delamination of the coating from the substrate. For example, the use of hot pin perforation can cause delamination. This can be prevented by: creating oversized holes (e.g., by over-drilling during hot pin piercing) to account for the reduction in diameter of the one or more holes caused by the conformal coating in the one or more holes; or use another perforation technique such as ultrasonic or laser perforation that does not result in delamination. In such embodiments, or in any other embodiment described herein, the adhesive coating may be patterned around the individual perforations.

In certain embodiments, applying the adhesive prior to perforation may result in the adhesive coating being over the location of the perforation, which may increase the adhesive area and relax the positional requirements of one or more electronic components in contact with or relative to the wound. In some cases, when perforating with ultrasound, an intermediate or sacrificial layer may be used over the ultrasound transducer or sonotrode (sonotrode). Such a sacrificial layer (which may be PET or another suitable material) may be fused to the substrate that was removed during perforation so that when peeled off, all of the removed substrate will have the sacrificial layer. A first sacrificial layer may be placed between the ultrasound transducer and the wound contact layer and a second sacrificial layer may be placed between the wound contact layer and the anvil. Additionally or alternatively, when ultrasonic or laser perforation is used, the substrate and the conformal coating may be bonded or cauterized together by ultrasonic or laser pulses.

Likewise, in block 716, the wound contact layer for an individual dressing (e.g., system) may be cut or separated from a sheet or web of wound contact layers that includes the wound contact layers of a plurality of other dressings. Such cutting may be performed using indexing as described herein.

Fig. 7B illustrates a process 700B of manufacturing or fabricating a wound dressing, such as wound dressing 400 or 500B, according to some embodiments. Process 700B differs from process 700A in that: in block 712, an adhesive is applied to a wound-facing side of the substrate opposite a side of the substrate supporting the one or more electronic components.

In some embodiments, such as in processes 600A, 600B, 700A, or 700B, processing of the web of wound contact layer may be performed using one or more of a machine tool, a soft roller, a sacrificial, interactive, or recycled soft layer laid as a release liner on the side of the substrate facing or away from the wound, a side mount and slider, or a roller partially removed to line up with the components (e.g., one or more electronic connections, but not an electronic module to line up the contact roller). Alternatively or additionally, lateral handling bars may be used to ensure that the mesh holding these devices is always running on rollers on the base side facing the wound or facing away from the wound, while still maintaining tension.

FIG. 8 illustrates indexing according to some embodiments. A plurality of wound dressings 800, such as dressings 400, 500A or 500B, are shown on the wound contact layer sheet. Vertical and horizontal cut lines 810 separate individual wound contact layers or platforms associated with individual wound dressings. The sheet may be moved or fed in the direction indicated by arrow 840 (or in the opposite direction) through an assembly or manufacturing machine that manufactures the wound dressing. As the sheet is fed through the machine, the machine may cut along cut line 810 to separate the dressing 800.

In some implementations, identification of a location or one or more electronic components (e.g., one or more electronic modules or connections) can be performed automatically using the index. Indexing may be performed by a manufacturing machine, for example, by one or more processors or controllers of the manufacturing machine. For example, a plurality of electronic connections (e.g., connection 820) may be identified and used to determine the boundary of the wound dressing. A plurality of electrical connections 820 may be used to connect electronic components external to the wound contact layer or dressing, such as a controller (e.g., via connector pad end 303 shown in fig. 3). Alternatively or additionally, one or more RFID indicators 830, such as chips or antennas, may be embedded in one or more of the predefined, specific, or known locations of the sheet, and one or more locations of the one or more indicators may be machine-identifiable. Conductive, optical, capacitive, or inductive measurements or methods that identify the location of the plurality of electrical connections 820. An RFID reader may be used to determine the location of the RFID pointer. Using the location information of the plurality of electronic connections 820 or RFID indicators, the location of the single wound dressing 800 and one or more electronic components on the single wound dressing may be determined.

In some embodiments, the positioning information may be used to perforate or apply one or more adhesive zones to the substrate. For example, using the positioning information, the location of one or more electronic components or connections may be determined and perforated around the one or more electronic components or connections as described herein. Additionally or alternatively, one or more adhesive regions may be applied in a pattern according to the location of one or more electronic components or connections as described herein.

In certain embodiments, a patterned adhesive, such as silicone, may be laid down by a programmable patterning drum or robot. The two-part adhesive may be heat cured. Alternatively or additionally, a single part adhesive may be applied to the entire or substantially entire wound-facing side of the wound contact layer, and a mask may be used to apply one or more of UV, light or thermal curing, such that only the location of interest is cured to form the one or more adhesive regions.

Other variants

While certain embodiments are described from the perspective of one or more electronics modules and/or connections being positioned on a wound-facing side of a wound-contacting layer, the techniques described herein are equally applicable to wound dressings and wound-contacting layers in which one or more electronics modules and/or connections are alternatively or additionally positioned on an opposing non-wound-facing side.

Any values of thresholds, limits, durations, etc. provided herein are not intended to be absolute, and thus may be approximate. Further, any thresholds, limits, durations, etc. provided herein may be fixed or changed automatically or by a user. Further, relative terms such as exceeding, greater than, less than, etc., relative to a reference value, as used herein, are intended to also encompass being equal to the reference value. For example, exceeding a positive reference value may include being equal to or greater than the reference value. Further, relative terms such as above, greater than, less than, and the like, as used herein with respect to a reference value, are also intended to encompass the inverse of the disclosed relationship, such as below, less than, greater than, and the like, with respect to the reference value. Further, while blocks of various processes may be described in terms of determining whether a value meets or does not meet a particular threshold, these blocks may be similarly understood, e.g., in terms of values (i) that are below or above the threshold or (ii) that meet or do not meet the threshold.

Features, materials, characteristics, or groups described in connection with a particular aspect, embodiment, or example are understood to apply to any other aspect, embodiment, or example described herein unless incompatible therewith. All of the features disclosed in this specification (including any accompanying claims, abstract and drawings), or all of the steps of any method or process so disclosed, may be combined in any combination, except combinations where at least some of such features or steps are mutually exclusive. The protection is not restricted to the details of any of the foregoing embodiments. Any novel feature or any novel combination of features disclosed in this specification (including any accompanying claims, abstract and drawings), or any novel feature or any novel combination of steps of any method or process so disclosed, is claimed.

While certain embodiments have been described, these embodiments have been presented by way of example only, and are not intended to limit the scope of protection. Indeed, the novel methods and systems described herein may be embodied in a variety of other forms. Furthermore, various omissions, substitutions and changes in the form of the methods and systems described herein may be made. Those of skill in the art will understand that in some embodiments, the actual steps taken in the processes shown or disclosed may differ from those shown in the figures. According to embodiments, some of the steps described above may be eliminated, and other steps may be added. For example, the actual steps or sequence of steps taken in the disclosed processes may differ from those shown in the figures. According to embodiments, some of the steps described above may be eliminated, and other steps may be added. For example, the various components shown in the figures may be implemented as software or firmware on a processor, controller, ASIC, FPGA, or dedicated hardware. Hardware components, such as controllers, processors, ASICs, FPGAs, etc., may comprise logic circuitry. Furthermore, the features and attributes of the specific embodiments disclosed above may be combined in different ways to form additional embodiments, all of which fall within the scope of the present disclosure.

While the present disclosure includes certain embodiments, examples, and applications, it will be understood by those skilled in the art that the present disclosure extends beyond the specifically disclosed embodiments to other alternative embodiments or uses and obvious modifications and equivalents thereof, including embodiments that do not provide all of the features and advantages described herein. Accordingly, the scope of the present disclosure is not intended to be limited by the specific disclosure of the preferred embodiments herein, and may be defined by the claims set forth herein or by claims set forth in the future.

Conditional language, such as "can," "might," or "may," unless expressly stated otherwise or understood otherwise in the context of usage, is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements, or steps. Thus, such conditional language is not generally intended to imply that features, elements, or steps are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without user input or prompting, whether these features, elements, or steps are included or are to be performed in any particular embodiment. The terms "comprising," "including," "having," and the like are synonymous and are used inclusively, in an open-ended fashion, and do not exclude additional elements, features, acts, operations, and the like. Furthermore, the term "or" is used in its inclusive sense (and not in its exclusive sense) so that, when used, e.g., to connect a list of elements, the term "or" means one, some, or all of the elements in the list. Further, the term "each" as used herein may mean any subset of a set of elements to which the term "each" applies, except having its ordinary meaning.

Joint language such as the phrase "X, Y and at least one of Z" is understood in this context to generally mean that an item, term, etc. can be X, Y or Z unless explicitly stated otherwise. Thus, such conjunctive language is not meant to imply that certain embodiments require the presence of at least one of X, at least one of Y, and at least one of Z in general.

The terms "about," "approximately," "substantially," and "approximately" as used herein mean a value, amount, or characteristic that is close to a stated value, amount, or characteristic, that still performs the desired function or achieves the desired result. For example, the terms "about," "substantially," and "substantially" may refer to an amount within less than 10%, within less than 5%, within less than 1%, within less than 0.1%, and within less than 0.01% of the specified amount. As another example, in certain embodiments, the terms "substantially parallel" and "substantially parallel" refer to a value, amount, or characteristic that deviates from exactly parallel by less than or equal to 15 degrees, 10 degrees, 5 degrees, 3 degrees, 1 degree, or 0.1 degrees.

The scope of the present disclosure is not intended to be limited by the particular disclosure of the preferred embodiments in this section or elsewhere in this specification, and may be defined by claims that are presented elsewhere in this or this specification or in the future. The language of the claims is to be construed broadly based on the language employed in the claims and not limited to examples described in the specification or during the prosecution of the application, which examples are to be construed as non-exclusive.

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Component positioning and stress relief for sensor-enabled wound dressings

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