阅读说明：本技术 伤口治疗装置和套件 (Wound treatment device and kit ) 是由 科林·J·霍尔 本杰明·A·普拉特 于 2019-08-30 设计创作，主要内容包括：本发明提供了一种负压伤口治疗装置、套件和方法,用于改善对复杂三维解剖结构上的伤口的治疗。该装置包括适形歧管,该适形歧管由具有切口图案的多孔且可渗透的材料制成,该切口图案被设计成当歧管沿着侧向轴线延伸时使歧管从松弛平面状态转变成柔韧三维状态。该套件还可包括伤口界面层、粘合剂、可透气的消毒盖布以及连接到负压伤口治疗装置的气动式连接件。最后,提供了一种使用减压和本发明所公开的套件处理伤口的方法。(The present invention provides a negative pressure wound therapy device, kit and method for improving the treatment of wounds on complex three-dimensional anatomical structures. The device includes a conformable manifold made of a porous and permeable material having a cut pattern designed to transform the manifold from a relaxed planar state to a pliable three-dimensional state as the manifold extends along a lateral axis. The kit may also include a wound interface layer, an adhesive, a breathable drape, and a pneumatic connection to the negative pressure wound therapy device. Finally, a method of treating a wound using reduced pressure and the presently disclosed kit is provided.)

1. A wound treatment apparatus, comprising:

a conformable mesh manifold comprising a porous and permeable material, wherein the manifold further comprises a cut-out pattern configured to transform the manifold from a planar relaxed state to a pliable three-dimensional state when the manifold is extended along a lateral axis.

2. The device of claim 1, wherein the manifold further comprises a perimeter boundary substantially free of the cut-out pattern.

3. The device of claim 1, further comprising at least one plastic tab on at least one side of the lateral axis of the manifold.

4. The device of claim 3, wherein the one or more tabs further comprise an adhesive on one side of the device that adheres to the patient.

5. The device of claim 4, wherein the one or more tabs further comprise acrylic.

6. The device of claim 1, wherein the manifold comprises reticulated polyurethane foam having 40 to 50 pores per inch.

7. The device of claim 1, wherein the manifold forms a cellular dome in the pliable three-dimensional state.

8. The device of claim 1, wherein the cuts each appear as a straight line when the manifold is in the planar relaxed state.

9. The device of claim 1, wherein the cutout appears substantially diamond shaped when the manifold extends along the lateral axis.

10. The device of claim 1, wherein the cutout appears substantially circular when the manifold extends along the lateral axis.

11. The device of claim 1, wherein the incision comprises one or more geometric shapes.

12. The device of claim 1, wherein the manifold extends along the lateral axis at a midpoint of the manifold.

13. The device of claim 1, wherein the manifold in the pliable three-dimensional state is sized to fit a particular anatomical structure.

14. The device of claim 13, wherein the manifold is sized to fit a knee, ankle, shoulder, chest, or elbow in the pliable three-dimensional state.

15. The device of claim 1, wherein the manifold is elliptical in the planar relaxed state.

16. The device of claim 1, wherein the manifold is circular in a two-dimensional planar relaxed state.

17. The device of claim 1, wherein the manifold comprises a first layer having an incision pattern and a second layer having an incision pattern, wherein the incision pattern of the first layer is not aligned with the incision pattern of the second layer when both the first layer and the second layer are in the pliable three-dimensional state.

18. The device of claim 1, wherein the device further comprises a tacky thermoformed outer polyurethane film configured to be peeled from a non-tacky disposable layer just prior to application of the device.

19. A wound treatment kit, comprising:

(i) a conformable mesh manifold comprising a porous and permeable material, wherein the manifold further comprises a cut-out pattern configured to transform the manifold from a planar relaxed state to a pliable three-dimensional state when the manifold is extended along a lateral axis;

(ii) a wound interface layer;

(iii) an adhesive breathable drape; and

(iv) a pneumatic connection to a negative pressure wound therapy device.

20. The kit of claim 19, wherein the wound interface layer comprises a Milliken fabric.

21. The kit of claim 19, wherein the wound interface layer comprises perforated silicone.

22. A method for wound treatment, the method comprising:

(i) extending a conformable mesh manifold along a lateral axis of the manifold, wherein the manifold comprises a porous and permeable material and a cut-out pattern configured to transform the manifold from a planar relaxed state to a pliable three-dimensional state when the manifold is extended along the lateral axis;

(ii) stopping extension when the manifold is bent to a desired pliable three-dimensional shape that can be adapted to a contoured wound site;

(iii) placing the manifold in the desired pliable three-dimensional shape over the contoured wound site;

(iv) placing an adhesive breathable drape over the manifold over the contoured wound site;

(v) attaching a pneumatic connector operatively coupled to a negative pressure wound therapy device to the adhesive breathable drape; and

(vi) activating the negative pressure wound therapy device to apply a negative pressure environment to the wound site.

23. The method of claim 22, wherein the manifold further comprises a perimeter boundary that is substantially free of the cut-out pattern.

24. The method of claim 22, wherein the manifold further comprises at least one plastic tab on at least one side of the lateral axis of the manifold.

25. The method of claim 24, wherein the one or more plastic tabs indicate a position for a user to grasp to extend the manifold.

26. The method of claim 22, wherein the cuts each appear as straight lines when the manifold is in the planar relaxed state.

27. The method of claim 22, wherein the cutouts appear substantially diamond-shaped as the manifold extends along the lateral axis.

28. The method of claim 22, wherein the cutout appears substantially circular when the manifold extends along the lateral axis.

29. The method of claim 22, wherein the cut comprises one or more geometric shapes.

30. The method of claim 22, wherein the manifold comprises a first layer having an incision pattern and a second layer having an incision pattern, wherein the incision pattern of the first layer is not aligned with the incision pattern of the second layer when both the first layer and the second layer are extended to the desired pliable three-dimensional state.

31. The method of claim 22, wherein the manifold extends along the lateral axis at a midpoint of the manifold.

Background

The present disclosure relates generally to medical treatment and, more particularly, to reduced pressure wound treatment devices, kits, and methods.

Negative Pressure Wound Therapy (NPWT) is a type of wound therapy that involves the application of negative pressure to a treatment site to promote wound healing. Some wound treatment systems apply negative pressure to a wound using a pneumatic pump attached to a dressing covering the wound to generate the required negative pressure and flow. However, for NPWT, it is important that the dressing, bandage or manifold conform accurately to the three-dimensional wound site, as the negative pressure applied to the dressing or bandage compresses the dressing to the wound surface. Therefore, sizing and fit are an integral essential element in the efficacy of NPWT devices, and in many cases more important than in standard wound treatment. Many NPWT dressings are improperly sized, poorly fitted, contain defects, are not adapted to the contour of the anatomy of the three-dimensional wound site, or some combination of all of these disadvantages. For example, many NPWT manifolds and dressings are not sized to fit round, asymmetrical, or non-planar body parts, such as the knee, elbow, foot, shoulder, or chest. In particular, shaped dressings for such geometries, especially when considering variable body size, require multiple dressing variants, which often results in unmanageable quantities of individual inventory units. In addition, pre-formed three-dimensional dressings require larger packaging with increased space for storage and shipping. Accordingly, there is a need for improved devices, kits, and methods that more accurately conform NPWT to a wide variety of three-dimensional wound sites and maximize transport and storage space.

Disclosure of Invention

The present technology overcomes the shortcomings of previous systems by providing devices, kits and methods for improved negative pressure wound therapy to wounds on complex geometries. One implementation of the present disclosure is a wound treatment device having a conformable mesh manifold made of a porous and permeable material, the manifold having a cut-out pattern configured to transform the manifold from a planar relaxed state to a pliable three-dimensional state when the manifold is extended along a lateral axis. The manifold may also have a perimeter boundary that is substantially free of a cut-out pattern. The manifold may also have at least one tab on at least one side of a lateral axis of the manifold. The tab may also have an adhesive on one side of the device that adheres to the patient. The tabs may be made of a polymer or plastic (including but not limited to acrylic). In some embodiments, the manifold comprises reticulated polyurethane foam. In one embodiment, the polyurethane foam may have 40 to 50 pores per inch in order to achieve both optimal porosity and transfer of wound fluid under reduced pressure.

In some embodiments, the manifold forms a lattice-like dome when extended to a pliable three-dimensional state. The cuts on the manifold can be present in various geometries in both the planar relaxed state and the pliable three-dimensional state. In one embodiment, the cuts appear as straight lines when the manifold is in a planar relaxed state. In another embodiment, the cutouts appear substantially diamond shaped as the manifold extends along the lateral axis. In another embodiment, the cutout appears substantially circular when the manifold extends along the lateral axis. In some embodiments, the incisions are substantially in the form of one or more geometric shapes. The manifold may extend along the lateral axis at a midpoint of the manifold.

The manifold of the present technology can be sized to fit a particular anatomy in three dimensions. For example, some specific three-dimensional anatomical structures having asymmetrical or non-planar shapes or sizes include, but are not limited to, a knee, an ankle, a shoulder, a chest, or an elbow.

In one embodiment, the manifold is elliptical in a planar relaxed state. In another embodiment, the manifold is circular in a planar relaxed state.

In an alternative embodiment, the manifold has a first layer with a cut-out pattern and a second layer with a cut-out pattern, wherein the cut-out patterns on the two layers are not aligned when both layers are in the pliable three-dimensional state. In another alternative embodiment, the device has an adhesive thermoformed outer polyurethane film that can be peeled off the non-adhesive disposable layer just prior to application of the device, otherwise known as a "peel and place" device.

According to another aspect of the present disclosure, a wound therapy kit is described. The kit may comprise: (i) a conformable mesh manifold made of a porous and permeable material, wherein the manifold has a cut pattern configured to transform the manifold from a planar relaxed state to a pliable three-dimensional state when the manifold is extended along a lateral axis, (ii) a wound interface layer, (iii) an adhesive, gas permeable drape; and (iv) a pneumatic connection to a negative pressure wound therapy device. In certain embodiments of the kit, the wound interface layer is made of a Milliken (Milliken) fabric. In another embodiment, the wound interface layer is made of perforated silicone.

According to yet another aspect of the present disclosure, a method for wound treatment is described. The method can comprise the following steps: (i) extending a conformable reticulated manifold along a lateral axis of the manifold, wherein the manifold is made of a porous and permeable material and a cut-out pattern designed to transform the manifold from a planar relaxed state to a pliable three-dimensional state as the manifold extends along the lateral axis; (ii) stopping extension when the manifold is bent to a desired pliable three-dimensional shape that can be adapted to a contoured wound site; (iii) placing the manifold in the desired pliable three-dimensional shape over a contoured wound site; (iv) placing an adhesive breathable drape over the manifold over the contoured wound site; (v) attaching a pneumatic connector operatively coupled to a negative pressure wound therapy device to an adhesive breathable drape; and (vi) activating the negative pressure wound therapy device to apply a negative pressure environment to the wound site.

In one embodiment of the wound treatment method, the pneumatic connector is via t.r.a.c.pad^TMAttached to an adhesive breathable drape. The manifold may also have a perimeter boundary that is substantially free of a cut-out pattern. The manifold may also have at least one plastic tab on at least one side of a lateral axis of the manifold. The plastic tab may also indicate where the user should grasp to extend the manifold. The cuts may each appear as straight lines when the manifold is in a planar relaxed state. The cutouts may also each appear substantially diamond shaped when the manifold extends along the lateral axis. The cutout may also appear substantially circular when the manifold extends along the lateral axis. In some embodiments, the cuts may be substantially in the form of one or more geometric shapes.

In one embodiment of the method, the manifold has a first layer with a cut-out pattern and a second layer with a cut-out pattern, wherein the cut-out pattern of the first layer is not aligned with the cut-out pattern of the second layer when both layers are extended to the desired three-dimensional state. The manifold may also extend along the lateral axis at a midpoint of the manifold.

Those skilled in the art will appreciate that the summary is illustrative only and is not intended to be in any way limiting. Other aspects, inventive features, and advantages of the devices and/or processes described herein, as defined solely by the claims, will become apparent in the detailed description set forth herein when taken in conjunction with the accompanying drawings.

Drawings

Fig. 1 is a front view of a wound treatment apparatus according to an exemplary embodiment.

FIG. 1A is a top view and a side view, respectively, of a manifold extending from a planar relaxed state to a pliable three-dimensional cellular dome when extended along a lateral axis.

FIG. 1B is a top view of the manifold, wherein the cuts each appear as straight lines when the manifold is in a planar relaxed state.

Fig. 1C is a top view of the device, wherein the cuts each appear substantially diamond shaped as the manifold extends along the lateral axis.

Fig. 1D is a top view of the device, wherein the cutouts each appear substantially circular when the manifold extends along the lateral axis.

FIG. 1E is a top view of a device in which the incisions are each present in one or more geometric shapes.

Fig. 2 is a top view of the device with the manifold elliptical in a planar relaxed state.

Fig. 3 is a top view of the device with the manifold being circular in a planar relaxed state.

FIG. 4 is a front view of a device wherein a manifold has a first layer with an incision pattern and a second layer with an incision pattern, wherein the incision pattern of the first layer is not aligned with the incision pattern of the second layer when both layers are in a pliable three-dimensional state.

Fig. 5 is a perspective view of a device having a tacky thermoformed outer polyurethane film configured to be peeled from a non-tacky disposable layer just prior to application of the device.

Fig. 6 shows an exemplary embodiment of a wound therapy kit comprising: (i) a conformable mesh manifold; (ii) a wound interface layer; (iii) an adhesive breathable drape; and (iv) a pneumatic connection to a negative pressure wound therapy device.

Fig. 7 shows an exemplary embodiment of a method for wound treatment.

Detailed Description

SUMMARY

When used in tandem with a negative pressure source, the wound treatment devices, kits, and methods of the present invention provide for simple dressing application to three-dimensional anatomical structures, thereby reducing kinking and poor adhesion of the device. The device and kit are also easy to transport in a flat form, thereby easing bulk transport and providing more efficient transport and storage.

Device for measuring the position of a moving object

Referring generally to the drawings, wound therapy devices, kits, methods, and components thereof are shown according to various exemplary embodiments.

Referring to fig. 1-1E, an exemplary apparatus for wound treatment according to the principles of the present disclosure is described. Fig. 1 is a front view of a wound treatment apparatus 10 according to two exemplary embodiments. The device 10 includes a conformable mesh manifold 100 that includes a porous and permeable material 102. Manifold 100 also includes a cut-out pattern 104 designed to transition manifold 100 from a planar relaxed state 106, shown in fig. 7, to a pliable three-dimensional state 108 as manifold 100 extends along a lateral axis 110.

Fig. 1 also shows that the manifold 100 may include a perimeter boundary 112 that is substantially free of a cut-out pattern. The device 10 may also include at least one plastic tab 114 on at least one side 116 of the lateral axis 110 of the manifold 100. One or more tabs 114 may also have an adhesive on one side of the device that adheres to the patient. The one or more tabs 114 may also be made of acrylic or other exemplary materials used in wound therapy and dressings. In some embodiments, the manifold 100 may be made of reticulated polyurethane foam having a particular porosity (e.g., illustratively 40 to 50 pores per inch). The porous and permeable material 102 may be any material that allows good transfer of wound fluid under reduced pressure.

Fig. 1A is a top view and a side view, respectively, of a manifold 100 extending from a planar relaxed state 106 to a pliable three-dimensional state 108 when extending along a lateral axis 110. FIG. 1A also shows the manifold 100 in a pliable three-dimensional state 108 forming a grid-like dome 122. The lattice shaped ball top 122 may be shaped to fit a variety of anatomical structures.

Fig. 1B-1E illustrate various embodiments in which the cut-out patterns 104 on the manifold 100 have different geometries to form different pliable three-dimensional states 108 when extended along the lateral axis 110. The various cut patterns 104 form multiple arrays or shapes when extended to the three-dimensional state 108. Fig. 1B is a top view of device 10, wherein cut-out patterns 104 each appear as a straight line 124 when manifold 100 is in a planar relaxed state 106. Fig. 1C is a top view of device 10, wherein cut patterns 104 each appear substantially diamond 126 as manifold 100 extends along lateral axis 110. Fig. 1D is a top view of device 10, wherein cut-out patterns 104 each appear substantially circular 128 as manifold 100 extends along lateral axis 104. FIG. 1E is a top view of device 10, wherein the cut-out patterns 104 are each present in one or more geometric shapes 130. Manifold 100 may extend along lateral axis 110 at a midpoint 132 of manifold 100.

The manifold 100 in the pliable three-dimensional state 108 may be sized to fit a number of specific anatomical structures. For example, the device 10 may fit the knee, ankle, shoulder, chest, or elbow when the manifold 100 is extended in the pliable three-dimensional state 108.

Fig. 2 is a top view of the device 10, wherein in one embodiment, the manifold 100 'is oval in shape in a planar relaxed state 106'.

Fig. 3 is a top view of the device 10, wherein the manifold 100 "is circular in a planar relaxed state 106".

Fig. 4 illustrates a front view of a multi-layer embodiment, wherein the manifold 100 "'includes a first layer 400 having an incision pattern 402 and a second layer 404 having an incision pattern 406, wherein the incision pattern 402 of the first layer 400 is not aligned with the incision pattern 406 of the second layer 404 when both layers are in the pliable three-dimensional state 108"'. The layers may be arranged such that when the manifold 100 "' forms a complex curve, open areas in one layer align with closed areas in a second layer. This helps to ensure that there is no contact between the polyurethane manifold 100 "' and the wound bed.

Referring now to fig. 5, a "peel and place" embodiment of the device 10 is shown. Here, the device 10 may also include an adhesive thermoformed outer polyurethane film 500 designed to be peeled off the non-adhesive disposable layer 502 just prior to application of the device 10 over a wound bed. The "peel and place" embodiment allows for easy transport of the device, increased sterility and use at any desired time by the patient or practitioner.

External member

Referring now to fig. 6, a wound therapy kit 20 according to the principles of the present disclosure is depicted. The wound treatment kit 20 includes: (i) a conformable mesh manifold 100 comprising a porous permeable material 102, wherein the manifold has a cut-out pattern 104 designed to transform the manifold 100 from a planar relaxed state 106 shown in fig. 7 to a pliable three-dimensional state 108 when the manifold 100 is extended along a lateral axis 110; (ii) a wound interface layer 600; (iii) an adhesive breathable drape 602; and (iv) a pneumatic connection 604 connected to the negative pressure wound therapy device.

In certain embodiments, the wound interface layer 600 may be made of a Milliken fabric. In other embodiments, the wound interface layer may be made of perforated silicone.

Method

Referring now to fig. 7, a method for wound treatment according to the principles of the present disclosure is described. The method provides a better and more adaptable type of NPWT that can work with the profile of an NPWT that was previously poorly adjusted with the NPWT. The method comprises the following steps: (i) extending the conformable reticulated manifold 100 along a lateral axis 110 of the manifold 100, wherein the manifold 100 may be made of a porous and permeable material 102 and a cut-out pattern 104 designed to transform the manifold 100 from a planar relaxed state 106 to a pliable three-dimensional state 108 as the manifold 100 extends along the lateral axis 110; (ii) stopping extension when the manifold 100 is bent to the desired pliable three-dimensional shape 108 suitable for a contoured wound site; (iii) placing the manifold 100 in a desired pliable three-dimensional shape 108 over a contoured wound site; (iv) placing an adhesive breathable drape 602 over the manifold 100 over the contoured wound site; (v) attaching a pneumatic connector 604 operatively coupled to a negative pressure wound therapy device to the adhesive breathable drape 602; and (vi) activating the negative pressure wound therapy device to apply a negative pressure environment to the wound site.

In fig. 7, the pneumatic connector 604 may be via a t.r.a.c.pad^TMAttached to an adhesive breathable drape 602. The method may further include a perimeter boundary 112 that is substantially free of the cut-out pattern 104. The manifold 100 may also have at least one plastic tab 114 on at least one side of a lateral axis 116 of the manifold 100. The one or more plastic tabs 114 may also indicate a location for a user to grasp to extend the manifold 100.

Similar to the embodiment of device 10, when manifold 100 is in a planar relaxed state 106, cut 104 may appear as a straight line. The pattern of cuts 104 may also appear as substantially diamond-shaped 126 as the manifold 100 extends along the lateral axis 110. The pattern of cuts 104 may also appear substantially circular 128 as the manifold 100 extends along the lateral axis 110, as shown in FIG. 1D. Additionally, the cut pattern 104 may be one or more geometric shapes 130, as shown in FIG. 1E. The manifold 100 may also have a first layer 400 with an incision pattern 402 and a second layer 404 with an incision pattern 406, where the incision pattern 402 of the first layer 400 is not aligned with the incision pattern 406 of the second layer 404 when both layers 400 and 404 are extended to the desired pliable three-dimensional state 108, as shown in FIG. 4. The manifold 100 may extend along the lateral axis 110 at a midpoint 132 of the manifold 100 to improve the extension of the device 10.

Although the figures show a specific order of method steps, the order of steps may differ from that depicted. Also, two or more steps may be performed simultaneously or partially simultaneously. All such variations are within the scope of the present disclosure.

Configuration of the exemplary embodiment

The construction and arrangement of the systems and methods as shown in the various exemplary embodiments are illustrative only. Although only a few embodiments have been described in detail in this disclosure, many modifications are possible (e.g., variations in sizes, dimensions, structures, shapes and proportions of the various elements, values of parameters, mounting arrangements, use of materials, colors, orientations, etc.). For example, the position of elements may be reversed or otherwise varied, and the nature or number of discrete elements or positions may be altered or varied. Accordingly, all such modifications are intended to be included within the scope of this disclosure. The order or sequence of any process or method steps may be varied or re-sequenced according to alternative embodiments. Other substitutions, modifications, changes and omissions may be made in the design, operating conditions and arrangement of the exemplary embodiments without departing from the scope of the present disclosure.