阅读说明：本技术 具有施用拉伸的混合粘合剂组织覆盖件 (Hybrid adhesive tissue cover with applied stretch ) 是由 克里斯多佛·布赖恩·洛克 蒂莫西·马克·罗宾逊 于 2020-03-20 设计创作，主要内容包括：本发明提供了一种用于保护组织部位的覆盖件,该覆盖件可包括：外壳层；粘合剂,该粘合剂设置在该外壳层上；和接触层,该接触层与该粘合剂相邻设置。该接触层可具有第一图案的开孔和桥接件,并且该外壳层可具有覆盖该桥接件的第二图案的开孔。在一些示例中,该粘合剂可具有大于该外壳层的拉伸模量的粘结强度。该接触层可具有该接触层的总面积的约40％至约50％的开放面积。剥离衬件可与该接触层相邻设置。穿过该外壳层和该接触层的穿孔可限定牺牲段,该牺牲段被配置为与该外壳层和该接触层分开。抓握条可联接到该牺牲段。(The present invention provides a cover for protecting a tissue site, the cover may include: an outer shell layer; an adhesive disposed on the outer shell layer; and a contact layer disposed adjacent to the adhesive. The contact layer may have a first pattern of apertures and a bridge, and the shell layer may have a second pattern of apertures overlying the bridge. In some examples, the adhesive may have a bond strength greater than the tensile modulus of the outer shell layer. The contact layer may have an open area of about 40% to about 50% of the total area of the contact layer. A release liner may be disposed adjacent to the contact layer. The perforations through the housing layer and the contact layer may define sacrificial segments configured to be separated from the housing layer and the contact layer. A grip bar may be coupled to the sacrificial segment.)

1. A device for covering a tissue site, the device comprising:

a contact layer having a first pattern of apertures and bridges;

an outer shell layer having an aperture covering the second pattern of the bridge member; and

an adhesive disposed on the housing layer and exposed through the first pattern of openings in the contact layer.

2. The device of claim 1, wherein the adhesive has a bond strength greater than a tensile modulus of the outer shell layer.

3. The device of any preceding claim, wherein the contact layer has an open area in the range of about 40% to about 50%.

4. The device of claim 3, wherein the contact layer has an open area of about 45%.

5. A device according to any preceding claim, wherein the apertures of the second pattern comprise elongate holes.

6. The device of any preceding claim, wherein the apertures of the second pattern comprise elongated holes having a length in a range of about 2 millimeters to about 5 millimeters.

7. The device of claim 6, wherein the apertures of the second pattern comprise end bridges between the elongated holes, the end bridges having a length in a range of about 2 millimeters to about 5 millimeters.

8. The device of any preceding claim, wherein the apertures of the first pattern comprise staggered rows.

9. The device of any preceding claim, wherein the apertures of the first pattern comprise staggered rows of circular apertures.

10. The apparatus of any preceding claim, wherein:

the apertures of the first pattern comprise staggered rows of circular apertures; and is

The second pattern of openings includes a diamond pattern of elongated openings.

11. The apparatus of any preceding claim, wherein:

the contact layer has a first modulus of elasticity;

the outer shell layer has a second modulus of elasticity; and is

The first elastic modulus is less than the second elastic modulus.

12. The apparatus of any preceding claim, wherein the second pattern of openings is configured to maintain the structural integrity of the outer shell layer.

13. The apparatus of any preceding claim, wherein the outer shell layer is configured to maintain a seal around a tissue site.

14. The device of any preceding claim, wherein the contact layer is a silicone gel.

15. The device of any preceding claim, wherein the outer shell layer is a polymer film.

16. The device of any preceding claim, wherein the adhesive is an acrylic adhesive.

17. A device for covering a tissue site, the device comprising:

a contact layer having a first pattern of holes;

a housing layer coupled to the contact layer; and

an adhesive disposed on the casing layer and exposed through the first pattern of apertures in the contact layer, the adhesive having a bond strength greater than a yield strength of the casing layer.

18. The apparatus of claim 17, wherein the outer shell layer is configured to be stretched and released without causing failure of the adhesive.

19. The apparatus of claim 18, wherein the outer shell layer is configured to plastically deform.

20. The apparatus of any one of claims 17 to 19, wherein:

the adhesive is an acrylic adhesive; and is

The outer shell layer is a film comprising or consisting essentially of polypropylene, polyester, polyamide or high density polyethylene.

21. The apparatus of any of claims 17 to 20, wherein the outer shell layer is configured to thin under tension.

22. The apparatus of any one of claims 17 to 21, wherein the pores of the contact layer are configured to open under tension.

23. The device of any one of claims 17 to 22, wherein the outer shell layer comprises microperforations.

24. Use of a device according to any preceding claim for treating a tissue site with negative pressure.

25. A dressing for treating a tissue site with negative pressure, the dressing comprising:

a manifold; and

the device of any one of claims 1 to 23, for covering the tissue site and the manifold.

26. A system for treating a tissue site with negative pressure, the system comprising:

the dressing of claim 25; and

a negative pressure source fluidly coupled to the dressing.

27. A method of treating a tissue site with negative pressure, the method comprising:

applying a tissue interface to the tissue site;

stretching a cover over the tissue interface;

sealing the cover to an attachment surface peripheral to the tissue site;

fluidly coupling a source of negative pressure to the tissue interface through the cover; and

applying a therapeutic level of negative pressure from the negative pressure source to the tissue interface.

28. The method of claim 27, wherein the cover comprises or consists essentially of the device of any one of claims 1 to 23.

29. A method of treating a tissue site with negative pressure, the method comprising:

stretching a cover over the tissue site;

sealing the cover to an attachment surface peripheral to the tissue site; and

fluidly coupling a negative pressure source to the tissue site through the cover.

30. The method of claim 29, wherein the step of stretching the cover comprises plastically deforming the cover.

31. The method of any of claims 29-30, wherein the step of stretching the cover comprises thinning the cover.

32. The method of any of claims 29-31, wherein the cover does not elastically recover after stretching.

33. The method of any one of claims 29 to 32, wherein:

the cover comprises a shell layer and a contact layer having an aperture; and is

The step of stretching the cover comprises opening the apertures in the contact layer.

34. A system, apparatus and method substantially as described herein.

Technical Field

The present invention set forth in the appended claims relates generally to tissue treatment systems and more particularly, but not by way of limitation, to systems, devices and methods for covering a tissue site.

Background

Dressings are generally considered for many types of tissue treatment, particularly for standard care for treating wounds. Regardless of the etiology of the wound, whether trauma, surgery, or another cause, proper care of the wound is important to the outcome. Dressings can provide a number of functions beneficial to wound healing, including controlling the wound environment and protecting wounds from bacteria and further physical trauma.

While the benefits of dressings are well known, improvements in dressing technology can benefit healthcare providers and patients.

Disclosure of Invention

Novel and useful systems, devices and methods for treating tissue are set forth in the appended claims. The illustrative embodiments are also provided to enable any person skilled in the art to make and use the claimed subject matter.

For example, in some embodiments, a dressing and cover for treating tissue may be configured to stretch and deform during application without the inherent spring force of the dressing or cover overcoming the adhesive system. In some examples, a suitable cover may include a silicone layer having perforations and a polymer film having a pattern of fenestrations aligned between the perforations in the silicone layer. The length of the fenestrations may be between about 2 millimeters and about 5 millimeters, and the spacing between the fenestrations may be between 2 millimeters and 5 millimeters. The fenestrations may be arranged to maintain the structural integrity of the membrane when fenestrated. The laminate film and silicone structure may be deformable, with the silicone layer stretching and thinning as it elongates. The polymer film may also allow stretching with low force, and the fenestrations may move and open as the structure moves and stretches.

In some embodiments, the polymer film may be very thin and not fenestrated. The film retains a very low level of elasticity and can be bonded to perforated and windowed silicone layers. Thus, the elasticity in the silicone layer can be reduced or removed, leaving the polymer film as the sole source of elasticity in the structure.

In some embodiments, the polymer film may have an elastic limit that is lower than the bond strength of the weakest adhesive in the system. The membrane may be selected to have a low elastic limit such that higher forces cause the material to exceed its elastic limit and permanently deform while maintaining its integrity.

Additionally or alternatively, the film may be slightly embossed, which may provide for storage of the film, which may become available in a low elastic form if stretched.

More generally, a cover for protecting a tissue site may include: an outer shell layer; an adhesive disposed on the outer shell layer; and a contact layer disposed adjacent to the adhesive. The contact layer may have a first pattern of apertures and bridge members, and the shell layer may have a second pattern of apertures overlying the bridge members. In some examples, the adhesive may have a bond strength greater than the tensile modulus of the outer shell layer.

In some embodiments, the contact layer may have an open area of about 40% to about 50% of the total area of the contact layer. The perforations through the housing layer and the contact layer may define sacrificial segments configured to be separated from the housing layer and the contact layer. A grip bar may be coupled to the sacrificial segment. A release liner may be disposed adjacent to the contact layer.

In some examples, the open area may be formed by a plurality of apertures through the contact layer, and at least some of the plurality of apertures may be arranged in a row having a midline substantially aligned with the perforations. In some examples, the perforations may have a cut length of about 2 millimeters and a tie length (tie length) of about 1 millimeter. Additionally or alternatively, some embodiments of the grip strip may be disposed at least partially between the outer shell layer and the contact layer. For example, the grip strip may be at least partially disposed between the outer shell layer and the contact layer, outside of the perforations.

The outer shell layer may include a polymer film, such as a drape. In a more specific example, the outer shell layer may include a polyurethane film. In some examples, the contact layer may include a silicone gel.

In other examples, an apparatus for protecting a tissue site may include a contact layer, a drape, and a release liner. The contact layer may generally have a first edge and a second edge parallel to the first edge. The contact layer may additionally have a plurality of openings, which may be arranged in a first row having a first midline parallel to the first edge and a second row having a second midline parallel to the second edge. The drape may have an adhesive on one side, wherein at least a portion of the adhesive is disposed adjacent to the plurality of apertures. In some examples, the drape may be coextensive with the contact layer. The drape and the contact layer may have a first perforation line, and the first perforation line may be aligned with a first midline. The drape and the contact layer may additionally have a second perforation line, and the second perforation line may be aligned with the second midline. The first grip strip may be partially disposed between the contact layer and the drape outside the first perforation line, and the second grip strip is partially disposed between the contact layer and the outer shell layer outside the second perforation line. In some examples, the apparatus may additionally include a release liner adjacent to the contact layer.

A method of manufacturing a cover for a tissue site is also described herein. In some examples, the method may include: perforating the contact layer; arranging a gripping strip on the contact layer; disposing a barrier layer having an adhesive over the grip strip on the contact layer; perforating the barrier layer and the contact layer along the inner edge of the grip strip; and disposing a release liner on the contact layer.

The objects, advantages and preferred modes of making and using the claimed subject matter are best understood by reference to the following detailed description of illustrative embodiments when read in conjunction with the accompanying drawings.

Drawings

FIG. 1 is an assembled view of a cover that may be applied to a tissue site;

fig. 2 is a top view of an example of a contact layer that may be associated with some embodiments of the cover of fig. 1;

FIG. 3 is a detail view of the contact layer of FIG. 2;

fig. 4 is a perspective view of an example of the cover of fig. 1, illustrating additional details that may be associated with some embodiments;

FIG. 5 is an assembly view of another example of a cover that may be applied to a tissue site;

FIG. 6 is a perspective view of the assembled cover of FIG. 5;

FIG. 7 is a top view of the cover of FIG. 6;

FIG. 8 is a schematic diagram illustrating an example of the cover of FIG. 1 for use with a treatment system that may provide negative pressure therapy to a tissue site; and is

Fig. 9 is a detail view of the cover of fig. 8.

Detailed Description

The following description of exemplary embodiments provides information that enables one of ordinary skill in the art to make and use the subject matter recited in the appended claims, but may omit certain details that are well known in the art. The following detailed description is, therefore, to be regarded as illustrative rather than restrictive.

Example embodiments may also be described herein with reference to the spatial relationships between various elements or the spatial orientations of the various elements depicted in the figures. Generally, such relationships or orientations assume a frame of reference that is consistent with or relative to the patient in the location to be treated. However, as will be appreciated by those skilled in the art, this frame of reference is merely descriptive convenience and is not strictly required.

Fig. 1 is an assembly view of an example of a cover 100 that may be applied to a tissue site. In this context, the term "tissue site" broadly refers to a wound, defect, or other therapeutic target located on or within a tissue, including but not limited to bone tissue, adipose tissue, muscle tissue, neural tissue, dermal tissue, vascular tissue, connective tissue, cartilage, tendons, or ligaments. Wounds may include, for example, chronic wounds, acute wounds, traumatic wounds, subacute wounds and dehiscent wounds, partial cortical burns, ulcers (such as diabetic ulcers, pressure ulcers or venous insufficiency ulcers), flaps, and grafts. The term "tissue site" may also refer to an area of any tissue that is not necessarily wounded or defective, but rather an area in which it may be desirable to add or promote the growth of additional tissue. For example, the tissue site may be used to grow additional tissue, which may be harvested and transplanted.

The cover 100 of fig. 1 generally includes a contact layer 105 and a shell layer 110. As shown in the example of fig. 1, the cover 100 may additionally include one or more grip strips 115 and a release liner 120. As shown in the example of fig. 1, the contact layer 105 and the shell layer 110 may have openings. For example, the contact layer 105 of FIG. 1 has a plurality of openings 125 and the shell layer 110 has a plurality of openings 130. The area between the apertures in the contact layer 105, the outer shell layer 110, or both may be characterized as a bridge or a ligament. For example, the contact layer 105 may have bridges 135 between the openings 125.

In some embodiments, the contact layer 105 may comprise or consist essentially of a suitable soft pliable material. The contact layer 105 may also have an adhesive or tacky surface. For example, the contact layer 105 may include or consist essentially of an adhesive gel having a peel strength of about 0.2N/cm to 0.3N/cm (180 degree peel on stainless steel). The contact layer 105 may include, but is not limited to, silicone gels, soft silicones, hydrocolloids, hydrogels, polyurethane gels, polyolefin gels, hydrogenated styrene copolymer gels, foamed gels, soft closed cell foams (such as adhesive coated polyurethanes and polyolefins), polyurethanes, polyolefins, or hydrogenated styrene copolymers. In some embodiments, contact layer 105 may have a thickness between about 200 micrometers (μm) and about 1000 micrometers (μm). In some embodiments, the contact layer 105 may have a hardness between about 5 shore OO and about 80 shore OO. In addition, the contact layer 105 may be composed of a hydrophobic material or a hydrophilic material.

In some embodiments, the contact layer 105 may be a coated material. For example, the contact layer may be formed by coating a porous material (such as, for example, a woven, nonwoven, or extruded mesh) with a hydrophobic material. The hydrophobic material used for coating may be, for example, a soft silicone.

In some embodiments, the outer shell layer 110 can provide a bacterial barrier and protection from physical trauma. The outer shell layer 110 can also be constructed of a material that can reduce evaporative losses and provide a fluid seal between two components or two environments, such as between a therapeutic environment and a local external environment. The outer shell layer 110 can include or consist of, for example, an elastomeric film or membrane that can provide a seal sufficient to maintain negative pressure at the tissue site for a given source of negative pressure. In some applications, the outer shell layer 110 may have a high Moisture Vapor Transmission Rate (MVTR). For example, in some embodiments, the MVTR can be at least 250 grams per square meter per 24hours (g/m)²24hours), measured according to the ASTM E96/E96M positive cup method at 38 ℃ and 10% Relative Humidity (RH) using the upright cup technique. In some embodiments, up to 5000g/m²MVTR of 24hours provides effective breathability and mechanical properties.

In some exemplary embodiments, the outer shell layer 110 may be a polymeric drape, such as a polyurethane film, that is permeable to water vapor but not liquid. Such drapes typically have a thickness in the range of 25 to 50 microns. For permeable materials, the permeability should generally be low enough so that the desired negative pressure can be maintained. The outer shell layer 110 may include, for example, one or more of the following materials: polyurethanes (PU), such as hydrophilic polyurethanes; cellulose; a hydrophilic polyamide; polyvinyl alcohol; polyvinylpyrrolidone; a hydrophilic acrylic resin; silicones, e.g. hydrophilic siliconesA body; natural rubber; a polyisoprene; styrene-butadiene rubber; chloroprene rubber; polybutadiene; nitrile rubber; butyl rubber; ethylene propylene rubber; ethylene propylene diene monomer; chlorosulfonated polyethylene; polysulfide rubber; ethylene Vinyl Acetate (EVA); a copolyester; and polyether block polyamide copolymers. Such materials are commercially available, for example: commercially available from 3M Company (3M Company, Minneapolis Minnesota) of Minneapolis, MinnesotaA drape; polyurethane (PU) drapes commercially available from Avery Dennison Corporation (Avery Dennison Corporation, Pasadena, California); polyether block polyamide copolymers (PEBAX) obtainable, for example, from Arkema s.a. company (Arkema s.a., Colombes, France) of cobb, France; and Inspire 2301 and Inpsire 2327 polyurethane films commercially available from expack Advanced Coatings, Wrexham, United Kingdom, rawrechslem, england, uk. In some embodiments, the outer shell layer 110 can include a polymer having a molecular weight of 2600g/m²MVTR (vertical cup technique) at 24hours and INSPIRE 2301 at a thickness of about 30 microns.

The attachment device may be disposed on one side of the outer shell layer 110. The attachment device may take a variety of forms. For example, the attachment device may be a medically acceptable pressure sensitive adhesive disposed on a side of the outer shell layer 110 facing the contact layer 105. At least a portion of the adhesive may be disposed adjacent to the aperture 125. For example, in some embodiments, a portion or all of one side of the outer shell layer 110 can be coated with an adhesive, such as an acrylic adhesive, that can be applied at a coating weight of about 25 to 65 grams per square meter (g.s.m.). Other exemplary embodiments of the attachment device may include double-sided tape, paste, hydrocolloid, hydrogel, silicone gel, or organogel.

In some configurations, additional layers (not shown) may be disposed between the outer shell layer 110 and the contact layer. For example, a scrim layer may be used with an adhesive to facilitate manufacturing, or an absorbent may be disposed between portions of the contact layer 105 and the outer shell layer 110.

The release liner 120 may be configured to protect the contact layer 105 and any adhesive prior to use. In some examples, the release liner may be embossed. In some embodiments, the release liner 120 may include two or more release sheets. For example, the release liner 120 may include one or more tabs that may be positioned along opposing edges of the contact layer 105. In some embodiments, the first release sheet may overlap or otherwise extend over a portion of the second release sheet. In other embodiments, the release liner 120 may additionally have a third release sheet that may overlap or otherwise extend over a portion of at least one of the other release sheets. In some embodiments, the release liner 120 may have the same dimensions as the contact layer 105. The release liner 120 may also have one or more release tabs, which in some embodiments may be integral with or otherwise coupled to one or more release sheets.

The release liner 120 (or release sheet (s)) may comprise or consist essentially of, for example, cast paper or a polymeric film. In some embodiments, the release liner 120 may comprise or consist essentially of a polyethylene film. Further, in some embodiments, the release liner 120 may be a polyester material, such as polyethylene terephthalate (PET) or similar polar semi-crystalline polymers. The use of a polar semi-crystalline polymer for the release liner 120 may substantially eliminate wrinkles or other distortions of the cover 100. For example, the polar semi-crystalline polymer may be highly oriented and resistant to softening, swelling, or other deformation that may occur when in contact with components of cover 100, or when subjected to temperature or environmental changes or sterilization. Further, a release agent may be disposed on a side of the release liner 120 configured to contact the contact layer 105. For example, the release agent may be a silicone coating and may have a release coefficient suitable to facilitate removal of the release liner 120 by hand without damaging or deforming the cover 100. In some embodiments, the release agent may be, for example, a fluorocarbon or fluorosilicone. In other embodiments, the release liner 120 may be uncoated or otherwise used without a release agent.

Fig. 2 is a top view of an example of contact layer 105, illustrating additional details that may be associated with some embodiments. Fig. 3 is a detail view of the contact layer 105 in the example of fig. 2, illustrating additional details that may be associated with some embodiments. In the example of fig. 2, the contact layer 105 is rectangular, having an edge 205, a width W, and a length L. The apertures 125 may be characterized by various characteristics, such as aperture shape, aperture size, aperture pattern, and pattern orientation.

The aperture 125 may have a number of shapes including circular, square, star, oval, polygonal, slit, complex curve, rectilinear shape, triangular, or some combination of such shapes.

In some examples, the size of the aperture 125 may be specified by a single dimension (such as the width of a circle or square). In some examples, the size may be specified by a length (the longer of the two dimensions) and a width (the shorter of the two dimensions). In some embodiments, each of the apertures 125 may have a width of about 1 millimeter to about 50 millimeters. For some embodiments, a width of about 6 millimeters to about 8 millimeters may be suitable. Each of the apertures 125 may have a uniform or similar size. For example, in some embodiments, each of the apertures 125 may have substantially the same width. In other embodiments, the geometric characteristics of the apertures 125 may vary. For example, the width of the opening 125 may vary depending on the location of the opening 125 in the contact layer 105. In some embodiments, the width of the opening 125 may be greater in the peripheral region than in the interior region of the contact layer 105. At least some of the apertures 125 may be positioned on one or more of the edges 205 of the contact layer 105 and may have an open or exposed internal cut at the edges 205.

The apertures 125 may be arranged in a pattern. For example, the apertures 125 may have a uniform distribution pattern (such as a row arrangement), or may be randomly distributed in the contact layer 105. In some examples, the rows may be staggered. The staggering may be characterized by orientation relative to an edge or other reference line associated with the contact layer 105. For example, staggering may be characterized by the angle a between the midline 210 of the contact layer 105 and a line through the midpoints of the apertures 125 in adjacent rows parallel to the edge 205. The angle a may vary. For example, for some embodiments, an interleaving of about 45 degrees or about 60 degrees may be suitable. The pattern may also be characterized by a pitch P, which indicates the spacing between the centers of the apertures. Some patterns may be characterized by a single pitch value; other patterns may be characterized by at least two pitch values. For example, if the spacing between the centers of the apertures 125 is the same in all orientations, the pitch P may be characterized by a single value indicating the diagonal spacing between the centers of the apertures 125 in adjacent rows.

The contact layer 105 may also be characterized by an open area, which may be formed by the openings 125. The open area may be expressed as a percentage of the area defined by the edges of the contact layer 105, such as the area defined by the edges 205 in the example of fig. 2. For some examples, an open area of about 40% to about 50% of the area of the contact layer 105 may be suitable.

As shown in the example of fig. 2, some embodiments of the contact layer 105 may additionally have a plurality of openings 215. The apertures 215 may be characterized by various characteristics, such as aperture shape, aperture size, aperture pattern, and pattern orientation. For example, in fig. 2, aperture 215 may be characterized as a slot. The size of the slot is typically characterized by a length, which may be designated as a "cut length". For some examples, a cut length of about 2 millimeters may be suitable. The apertures 215 of fig. 2 are arranged in a linear pattern, wherein all of the apertures 215 are aligned parallel to one of the edges 205. The linear pattern may be characterized by the spacing between the apertures 215, which may be referred to as a bridge or ligament. For some examples, a tether length of about 1 millimeter may be suitable. As shown in the example of fig. 2, the centerlines of the apertures 215 may be aligned with the centerlines of the rows of apertures 125. More specifically, in some examples, a midline of aperture 215 may be aligned with a row of peripheral apertures 125 that is parallel to a shorter one of edges 205. The peripheral rows are generally characterized as the rows of apertures 125 closest to the edge 205, excluding rows in which some or all of the apertures 125 are exposed or partially open on the edge 205. In some embodiments, the midline of the aperture 215 may be aligned with the inner row, which is located inside the peripheral row.

As shown in the example of fig. 3, the apertures 125 may be circular holes having a width D. For some examples, a width D of about 7 millimeters may be suitable. FIG. 3 further illustrates an example in which the pitch is specified by two values p1 and p2 indicating the center-to-center pitch of apertures 125 in aligned rows orthogonal to edge 205. If p1 and p2 are not equal, p1 indicates a shorter pitch. In the example of fig. 3, p1 may be about 9.8 millimeters, and p2 may be about 17 millimeters. D. Exemplary values for p1 and p2 form an open area of about 46% of the area defined by edge 205 of fig. 2.

Fig. 4 is a perspective view of an example of a cover 100, illustrating additional details that may be associated with some embodiments. In fig. 4, the apertures 130 in the housing layer 110 and the apertures 215 (not visible in fig. 4) in the contact layer 105 are aligned and define one or more sacrificial segments 405. Each of the grip strips 115 may be coupled to one of the sacrificial segments 405. For example, each of the grip strips 115 may be at least partially laminated or otherwise disposed between the contact layer 105 and the shell layer 110. In some examples, the inner edge of the grip bar 115 may be located outside of the apertures 130 and 215, and the grip bar 115 may extend past the edges of the contact layer 105 and the outer shell layer 110.

In some embodiments, the outer shell layer 110 and the contact layer 105 may be coextensive. The release liner 120 may be coextensive with the contact layer 105 and may extend through the contact layer 105 to coincide with the outer edges of the grip strip 115.

Fig. 5 is an assembly view of another example of cover 100, showing additional details that may be associated with some embodiments. For example, the outer shell layer 110 may include a plurality of apertures 505.

Fig. 6 is an assembled view of the cover 100 of fig. 5. As shown in the example of fig. 6, the aperture 505 may be offset from the aperture 125.

Fig. 7 is a top view of the cover 100 of fig. 6, illustrating additional details that may be associated with some examples. As shown in the example of fig. 7, the openings 505 may be aligned with one or more bridges 135 between the openings 125 in the contact layer 105.

In some embodiments, the apertures 505 can be characterized as slots or slots with end bridges between the holes. A cut length of about 2 mm to about 5mm may be suitable for some examples. The apertures 505 may be arranged to maintain the structural integrity of the outer shell layer 110. For example, the openings 505 of fig. 7 are arranged in a linear pattern that may intersect to form a diamond pattern in the outer shell layer 110. A tether length of about 2 millimeters to about 5 millimeters may be suitable for some examples.

The method of some embodiments of manufacturing the cover 100 may include perforating the contact layer 105 to form the opening 125 in the contact layer 105. The opening 125 may be formed by: cutting, or applying, for example, topical RF or ultrasonic energy; or other suitable technique for forming holes in the contact layer 105. In some embodiments, the apertures 125 may be arranged in rows. For example, the contact layer 105 may have a first edge and a second edge parallel to the first edge, and the apertures 125 may be arranged such that at least one row has a midline parallel to the first edge. The second row may also have a midline parallel to the second edge.

At least one grip strip may be disposed at least partially on the contact layer 105, and the outer shell layer 110 may be disposed on the contact layer 105 at least partially overlapping the grip strip.

The outer shell layer 110 can have an adhesive that can be configured such that at least some of the adhesive is disposed adjacent to at least some of the apertures 125 in the contact layer 105. The adhesive may bond the casing layer 110 to the contact layer 105, thereby securing the grip strip to the casing layer 110 and the contact layer 105.

The outer shell layer 110 and the contact layer 105 may be perforated in a linear pattern along the inner edge of the grip strip to form a sacrificial section. The linear perforations are preferably aligned with the midline of the outermost row of openings 125 in the contact layer 105 (within acceptable tolerances), which may improve the separation of the sacrificial segments and reduce jagged edges. Tolerances between the linear perforations and the edges of the contact layer 105 may additionally or alternatively facilitate alignment between the midline and the edges, which may minimize alignment with the tangent of the rows of apertures 125 in the contact layer 105.

Additionally or alternatively, the outer shell layer 110 can be perforated to form apertures 505 that can cover bridges in the contact layer 105, as shown in the example of fig. 7.

In some examples, a release liner may then be disposed on the contact layer 105. Alternatively, a release liner may be disposed on the contact layer 105 prior to perforating the outer shell layer 110. For example, suitable pressure may be applied to the roller die to cut through the outer shell layer 110 and the contact layer 105 without perforating the release liner. In some embodiments, pressures in the range of about 750 psig to about 1000 psig may be suitable.

In use, the release liner 120 can be removed to expose the contact layer 105, which can be placed within, over, on, or otherwise proximate to the tissue site. For example, the contact layer 105 may be centered over the tissue site, and a peripheral portion of the contact layer may be applied to an attachment surface adjacent or proximate to the tissue site. The contact layer 105 may be sufficiently tacky to hold the cover 100 in place while also allowing the cover 100 to be removed or repositioned without significant trauma to the tissue site.

The grip strip 115 may facilitate gripping the cover 100 until the cover is placed, and then the grip strip 115 may be removed. For example, the grip strip 115 of FIG. 4 may be removed by separating the sacrificial segment 405, which may be separated by tearing the contact layer 105 and the shell layer 110 along the cut 215 and the cut 130, respectively.

Removing the release liner 120 may also expose the adhesive on the outer shell layer 110 through at least some of the apertures 125. Once the cover 100 is in the desired position, an adhesive may be pressed through the aperture 125 to bond the outer shell layer 110 to the attachment surface. The apertures 125 at the edge 205 may allow adhesive to flow around the edge 205, which may enhance adhesion to the attachment surface.

In some embodiments, the apertures 125 may be sized to control the amount of adhesive exposed through the contact layer 105. In some embodiments, the bond strength of the adhesive may vary at different locations of the cover 100. For example, the adhesive may have a lower bond strength adjacent to relatively larger apertures and may have a higher bond strength where the apertures are smaller. Adhesives with lower bond strengths in combination with larger apertures may provide a bond comparable to adhesives with higher bond strengths at locations with smaller apertures.

In some applications, the contact layer 105, the shell layer 110, or both may have some elasticity, and the cover 100 may be stretched, intentionally or unintentionally, before or after placement on the tissue site. Tension in either the contact layer 105 or the outer shell layer 110 may cause shear on the adhesive and tension on the tissue site. Some embodiments of the cover 100 may provide a means for reducing shear and tension. For example, some embodiments of the outer shell layer 110 may have a higher elastic modulus than the bond strength of the adhesive, and the apertures 505 may provide a means for reducing the tensile modulus of the outer shell layer 110 such that the bond strength is greater than the tensile modulus. More specifically, if the outer shell layer 110 is stretched or elongated, the apertures 505 may move and open, which may reduce shear on the adhesive and any strain on the tissue site. Openings 505 may also be provided between openings 125 to prevent a leak path through contact layer 105 and outer shell layer 110. In other embodiments, the outer shell layer 110 can have a lower modulus of elasticity than the contact layer 105, and the contact layer 105 can include an aperture disposed in the bridge 135 that is similar or analogous to the aperture 505.

The outer shell layer 110 may additionally or alternatively have a yield strength that is less than the bond strength of the adhesive. Thus, the outer shell layer 110 may be stretched beyond its yield strength to plastically deform, and may be released without causing adhesive failure or traumatic tension on the tissue site. For example, the outer shell layer 110 may be configured to thin if stretched beyond its yield strength. In some embodiments, the outer shell layer 110 may comprise or consist essentially of polypropylene, polyester, polyamide, or higher density polyethylene. Polyurethanes with relatively low elasticity may also be suitable for some examples. In some configurations, the outer shell layer 110 may also be micro-perforated to increase breathability.

In other examples, the outer shell layer 110 may additionally or alternatively be treated to produce a pattern having variable elasticity. For example, the outer shell layer 110 may include or consist of a polyurethane film heat-treated to form a pattern of thick and thin regions. The thick section may have a yield strength greater than the bond strength of the adhesive, and the thin section may have a yield strength less than the bond strength of the adhesive. For example, a film having a nominal thickness of about 150 microns may be treated to produce a pattern of areas having a nominal thickness of about 50%.

In some embodiments, the outer shell layer 110 may comprise or consist essentially of a film that has been pre-stretched during the extrusion process to remove most of the elasticity from the film prior to cooling. The film may additionally or alternatively be formed of a hydrophobic polymer to reduce moisture induced plastication changes.

Strain indicators may be printed or otherwise disposed on some embodiments of the outer shell layer 110 to indicate an acceptable level of stretch, to indicate plastic deformation, or both. In some examples, printing ink that disintegrates as it deforms may be disposed on the outer shell layer 110. If the outer shell layer 110 is stretched, the printed ink may appear thinner, which may indicate the level of force being applied or caused by motion (such as motion of a joint).

The cover 100 may provide a sealed treatment environment substantially isolated from the external environment proximate the tissue site. The contact layer 105 may provide an effective and reliable seal against challenging anatomical surfaces, such as the elbow or heel, at and around the tissue site. Further, in some embodiments, the cover 100 may be reapplied or repositioned, for example, to eliminate wrinkles and other discontinuities in the cover 100 or tissue site.

Fig. 8 is a schematic diagram illustrating an example of a cover 100 for use with a treatment system 800 that may reduce pressure proximate a tissue site. Clinical studies and practice have shown that reducing pressure proximate to a tissue site can enhance and accelerate the growth of new tissue at the tissue site. The applications of this phenomenon are numerous, but it has proven to be particularly advantageous for treating wounds. Treatment of wounds or other tissues by reduced pressure may be generally referred to as "negative pressure therapy," but also by other names, including, for example, "negative pressure wound therapy," reduced pressure therapy, "" vacuum assisted closure, "and" partial negative pressure. Negative pressure therapy can provide a number of benefits, including migration of epithelial and subcutaneous tissue, improved blood flow, and micro-deformation of tissue at the wound site. Together, these benefits may increase the development of granulation tissue and reduce healing time.

The treatment system 800 may include a source or supply of negative pressure, such as negative pressure source 805, and one or more dispensing components, such as dressings and fluid containers. The dispensing part is preferably removable and may be disposable, reusable or recyclable. Dressings such as dressing 810 and fluid containers such as container 815 are examples of dispensing components that may be associated with some examples of treatment system 800. As shown in the example of fig. 8, the dressing 810 may include or consist essentially of the cover 100 and the tissue interface 820.

Fluid conductor 825 is another illustrative example of a distribution component. In this context, "fluid conductor" broadly includes a tube, pipe, hose, conduit, or other structure having one or more lumens or open paths suitable for conveying fluid between two ends. Typically, the tube is an elongated cylindrical structure with some flexibility, but the geometry and stiffness may vary. Further, some fluid conductors may be molded into or otherwise integrally combined with other components. The dispensing component may also include or include an interface or fluid port to facilitate coupling and decoupling of other components. For example, in some embodiments, the dressing interface 828 can facilitate coupling the fluid conductor 825 to the dressing 810. For example, such dressing interfaces may be Kinetic Conse available from St.Antonio, TexasSensat.r.a.c. from pts (Kinetic Concepts, inc., San Antonio, Texas).^TMA pad.

The therapy system 800 may also include a regulator or controller and sensors to measure operating parameters and provide feedback signals indicative of the operating parameters to the controller. Some components of treatment system 800 may be housed within or used in conjunction with other components, such as sensors, processing units, alarm indicators, memory, databases, software, display devices, or user interfaces that further facilitate treatment. For example, in some embodiments, the negative pressure source 805 may be combined with a controller and other components into a therapy unit.

In general, the components of treatment system 800 may be coupled directly or indirectly. For example, the negative pressure source 805 may be directly coupled to the container 815 and may be indirectly coupled to the dressing 810 through the container 815. Coupling may include fluidic coupling, mechanical coupling, thermal coupling, electrical coupling, or chemical coupling (such as chemical bonding), or in some cases, some combination of couplings. For example, the negative pressure source 805 can be electrically coupled to a controller and can be fluidly coupled to one or more dispensing components to provide a fluid path to the tissue site. In some embodiments, components may also be coupled by physical proximity, be integral with a single structure, or be formed from the same piece of material.

For example, a negative pressure supply source such as negative pressure source 805 may be a reservoir of air at negative pressure, or may be a manual or electrically powered device such as a vacuum pump, suction pump, wall suction port or micro-pump available at many healthcare facilities. "negative pressure" generally refers to a pressure less than the local ambient pressure, such as the ambient pressure in the local environment outside the sealed treatment environment. In many cases, the local ambient pressure may also be the atmospheric pressure at which the tissue site is located. Alternatively, the pressure may be less than a hydrostatic pressure associated with tissue at the tissue site. Unless otherwise indicated, the pressure values described herein are gauge pressures. References to an increase in negative pressure generally refer to a decrease in absolute pressure, while a decrease in negative pressure generally refers to an increase in absolute pressure. While the amount and nature of the negative pressure provided by the negative pressure source 805 may vary depending on the treatment requirements, the pressure is typically a low vacuum (also commonly referred to as a rough vacuum) between-5 mmHg (-667Pa) and-500 mmHg (-66.7 kPa). A common treatment range is between-50 mm Hg (-6.7kPa) and-300 mm Hg (-39.9 kPa).

The container 815 represents a container, canister, pouch, or other storage component that may be used to manage exudates and other fluids drawn from the tissue site. In many environments, a rigid container may be preferable or desirable for collecting, storing, and disposing of fluids. In other environments, the fluid may be properly disposed of without a rigid container storage device, and the reusable container may reduce waste and costs associated with negative pressure therapy.

The tissue interface 820 may generally be adapted to partially or fully contact the tissue site. The tissue interface 820 may take a variety of forms and may have a variety of sizes, shapes, or thicknesses depending on various factors, such as the type of treatment being administered or the nature and size of the tissue site. For example, the size and shape of the tissue interface 820 may be adapted to the contour of deeper and irregularly shaped tissue sites. Any or all of the surfaces of tissue interface 820 may have a non-flat, rough, or jagged profile.

In some embodiments, the tissue interface 820 may include or consist essentially of a manifold. In this context, a manifold may comprise or consist essentially of means for collecting or distributing fluid under pressure across the tissue interface 820. For example, the manifold may be adapted to receive negative pressure from a source and distribute the negative pressure across the tissue interface 820 through the plurality of apertures, which may have the effect of collecting fluid across the tissue site and drawing the fluid toward the source. In some embodiments, the fluid path may be reversed or an auxiliary fluid path may be provided to facilitate delivery of fluid over the tissue site.

In some exemplary embodiments, the manifold may include a plurality of passages that may be interconnected to improve distribution or collection of fluids. In some exemplary embodiments, the manifold may comprise or consist essentially of a porous material having interconnected fluid passages. Examples of suitable porous materials that may be suitable for forming interconnected fluid passages (e.g., channels) may include honeycomb foams, including open-cell foams such as reticulated foams; collecting porous tissues; and other porous materials, such as gauze or felt pads, that typically include pores, edges, and/or walls. Liquids, gels, and other foams may also include or be cured to include open cells and fluid pathways. In some embodiments, the manifold may additionally or alternatively include protrusions that form interconnected fluid passages. For example, the manifold may be molded to provide surface protrusions defining interconnected fluid passages.

In some embodiments, the tissue interface 820 may comprise or consist essentially of reticulated foam having pore sizes and free volumes that may vary according to the needs of a given treatment. For example, reticulated foam having a free volume of at least 90% may be suitable for many therapeutic applications, and foams having an average pore size in the range of 400 to 600 microns (40 to 50 pores per inch) may be particularly suitable for some types of therapy. The tensile strength of the tissue interface 820 may also vary according to the needs of a given treatment. For example, the tensile strength of the foam can be increased for instillation of a topical treatment solution. The tissue interface 820 may have a 25% compressive load deflection of at least 0.35 psi and a 65% compressive load deflection of at least 0.43 psi. In some embodiments, the tissue interface 820 may have a tensile strength of at least 10 psi. The tissue interface 820 may have a tear strength of at least 2.5 lbs/inch. In some embodiments, tissue interface 820 may be a foam composed of a polyol (such as a polyester or polyether), an isocyanate (such as toluene diisocyanate), and a polymerization modifier (such as an amine and a tin compound). In some examples, the tissue interface 820 may be a reticulated polyurethane foam, such as that present in GRANUFOAM^TMDressing or v.a.c.veraflo^TMThe reticulated polyurethane foam in the dressing, both available from Kinetic Concepts, san antoino, texas.

The thickness of the tissue interface 820 may also vary as needed for a given treatment. For example, the thickness of the tissue interface 820 may be reduced to reduce the tension on the surrounding tissue. The thickness of the tissue interface 820 may also affect the conformability of the tissue interface 820. In some embodiments, a thickness in the range of about 5 millimeters to about 10 millimeters may be suitable.

The tissue interface 820 may be hydrophobic or hydrophilic. In examples where the tissue interface 820 may be hydrophilic, the tissue interface 820 may also wick fluid away from the tissue site while continuing to distribute negative pressure to the tissue site. The wicking properties of the tissue interface 820 may draw fluid away from the tissue site via capillary flow or other wicking mechanisms. An example of a potentially suitable hydrophilic material is a polyvinyl alcohol open cell foam, such as white foam available from Kinetic Concepts, san antoino, texas^TMA dressing is provided. Other hydrophilic foams may include those made from polyethers. Other foams that may exhibit hydrophilic properties include hydrophobic foams that have been treated or coated to provide hydrophilicity.

In some embodiments, the tissue interface 820 may be constructed of a bioabsorbable material. Suitable bioabsorbable materials can include, but are not limited to, polymer blends of polylactic acid (PLA) and polyglycolic acid (PGA). The polymer blend may also include, but is not limited to, polycarbonate, polyfumarate, and caprolactone. The tissue interface 820 may also serve as a scaffold for new cell growth, or a scaffold material may be used in conjunction with the tissue interface 820 to promote cell growth. A scaffold is generally a substance or structure used to enhance or promote the growth of cells or the formation of tissue, such as a three-dimensional porous structure that provides a template for cell growth. Illustrative examples of scaffold materials include calcium phosphate, collagen, PLA/PGA, coral hydroxyapatite, carbonate, or processed allograft material.

In operation, the tissue interface 820 may be placed within, over, on, or otherwise proximate to a tissue site. For example, if the tissue site is a wound, the tissue interface 820 may partially or completely fill the wound, or it may be placed over the wound. The cover 100 may be placed over the tissue interface 820 and sealed to the attachment surface near the tissue site. For example, in fig. 8, the cover 100 may be placed over the epidermis 830 peripheral to the tissue interface 820 and the tissue site 835 extending through the dermis 840 and into the subcutaneous tissue 845. The contact layer 105 may hold the cover 100 in place and, as shown in the detail view of fig. 9, pressure may be applied to the outer shell layer 110 to press the adhesive 905 on the outer shell layer 110 into contact with the skin 830 through the opening 125 in the contact layer 105. In some embodiments, another adhesive may be disposed between the outer shell layer 110 and the adhesive 905. For example, an adhesive with a lower shear resistance than the adhesive 905 may disengage any elasticity in the outer shell layer 110 from the adhesive 905. Thus, the cover 100 may provide a sealed treatment environment 850 proximate the tissue site 835 that is substantially isolated from the external environment, and the negative pressure source 805 may reduce the pressure in the sealed treatment environment 850.

The hydrodynamics of using a negative pressure source to reduce pressure in another component or location, such as within a sealed treatment environment, can be mathematically complex. However, the basic principles of hydrodynamics applicable to negative pressure therapy are generally well known to those skilled in the art, and the process of reducing pressure may be illustratively described herein as "delivering", "dispensing", or "generating" negative pressure, for example.

The negative pressure applied across the tissue site by sealing the tissue interface 820 in the treatment environment may cause macro-and micro-strains in the tissue site. The negative pressure may also remove exudates and other fluids from the tissue site, which may be collected in a container 815.

The systems, devices, and methods described herein may provide significant advantages. For example, the cover 100 may provide a high seal around and over the tissue site while substantially reducing or eliminating trauma upon removal. Additionally or alternatively, the cover 100 may facilitate treatment and application to the tissue site. In some examples, the cover 100 may be stretched prior to or during application while maintaining a seal without significantly increasing the tension or decreasing flexibility on the surrounding tissue. These properties may be particularly advantageous for treating wounds with negative pressure therapy.

While shown in several exemplary embodiments, one of ordinary skill in the art will recognize that the systems, devices, and methods herein are susceptible to various changes and modifications, and such changes and modifications fall within the scope of the appended claims. Moreover, descriptions of various alternatives using terms such as "or" are not required to be mutually exclusive, unless the context clearly requires otherwise, and the indefinite article "a" or "an" does not limit the subject matter to a single instance, unless the context clearly requires otherwise. It is also possible to combine or eliminate components in various configurations for purposes of sale, manufacture, assembly, or use. For example, in some configurations, cover 100 may be separate from other components for manufacture or sale.

The following claims set forth novel and inventive aspects of the above-described subject matter, but the claims may also cover additional subject matter not specifically recited. For example, if it is not necessary to distinguish between novel and inventive features and features known to those of ordinary skill in the art, certain features, elements or aspects may be omitted from the claims. Features, elements, and aspects described herein in the context of certain embodiments may also be omitted, combined, or substituted with alternative features for the same, equivalent, or similar purpose, without departing from the scope of the invention, which is defined by the claims.