WO2021070047A1

WO2021070047A1 - Dressing test fixture for npwt systems

Info

Publication number: WO2021070047A1
Application number: PCT/IB2020/059368
Authority: WO
Inventors: Christopher Brian Locke; Benjamin A. Pratt
Original assignee: Kci Licensing, Inc.
Priority date: 2019-10-08
Filing date: 2020-10-06
Publication date: 2021-04-15

Abstract

A dressing test fixture includes a body and a plurality of recessed areas. The plurality of recessed areas are formed into a first side of the body and extend into the body in a substantially perpendicular orientation relative to the first side. Each of the plurality of recessed areas defines a lower wall of approximately uniform thickness. The lower wall of the dressing test fixture includes a flexible material which allows the lower wall to bend, flex, or otherwise deform in response to an applied negative pressure to the first side of the body.

Description

DRESSING TEST FIXTURE FOR NPWT SYSTEMS

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims the benefit of priority to U.S. Provisional Application No. 62/12,320, filed on October 8, 2019, which is incorporated herein by reference in its entirety.

BACKGROUND

[0002] The present disclosure relates generally to devices used to demonstrate the performance of a medical device. More specifically, the present disclosure relates to a test fixture for demonstrating the performance of a negative pressure wound therapy (NPWT) system.

[0003] NPWT is a therapeutic technique used to promote healing in acute or chronic tissue wounds. NPWT systems are configured to apply a negative pressure to a wound, through a dressing that is connected to the wound (e.g., the skin surrounding the wound). The negative pressure may be utilized to remove infectious materials, and to help promote wound closure and healing. Dressings used by NPWT systems may include absorbent materials to facilitate removal of fluids (e.g., wound exudate) from the wound. The layering and structure of the dressing may vary greatly between different NPWT systems, and may affect the performance of the device. More particularly, the design of the dressing may affect how the NPWT system manifolds negative pressure across the wound. It would be desirable to provide a device that demonstrates the performance of the dressing.

SUMMARY

[0004] One implementation of the present disclosure is a dressing test fixture. The dressing test fixture includes a body and a plurality of recessed areas. The plurality of recessed areas are formed into a first side of the body and extend into the body in a substantially perpendicular orientation relative to the first side. Each of the plurality of recessed areas defines a lower wall of approximately uniform thickness. The lower wall of the dressing test fixture includes a flexible material.

[0005] In some embodiments, the lower wall of each of the plurality of recessed areas is configured to deform in response to a negative pressure applied to the recessed areas from the first side of the body.

[0006] In some embodiments, the plurality of recessed areas is distributed in approximately equal intervals across the first side of the body. Additionally, each of the plurality of recessed areas may have the same cross-sectional shape. For example, each of the plurality of recessed areas may define a substantially cylindrically shaped cavity. [0007] In some embodiments, the body also includes a flexible material. A hardness of the flexible material may be within a range between approximately shore 40 and shore 60. In some embodiments, the body and the lower wall are integrally formed as a single unitary structure. For example, the body and the lower wall may be integrally formed from the same piece of flexible material. In some embodiments, the flexible material may be a cured polyurethane gel.

[0008] In some embodiments, a thickness of the lower wall of each of the plurality of recessed areas is within a range between approximately 0.5 mm and 1 mm.

[0009] In some embodiments, a thickness of the body, between the first side and a second surface of the body opposite the first side is approximately the same across the body. In one implementation, the thickness of the body is within a range between approximately 7 mm and 7.5 mm.

[0010] In some embodiments, each of the plurality of recessed areas is sized to receive a fluid volume of approximately 2 mL.

[0011] In some embodiments, the lower wall of at least one of the plurality of recessed areas is perforated such that air may flow through the lower wall in response to an applied negative pressure. For example, the lower wall may be perforated by a linear cut extending across at least a portion of the lower wall.

[0012] In some embodiments, the dressing test fixture further includes a check valve disposed in the lower wall of at least one of the plurality of recessed areas. The check valve may be configured to selectively permit air to enter the at least one recessed area from a second side of the body opposite the first side.

[0013] In some embodiments, the dressing test fixture further includes a channel formed into the body. For example, the dressing test fixture may include a channel that extends through the body in a partially lateral direction, parallel to the first side of the body.

[0014] Another implementation of the present disclosure is a method of making a dressing test fixture. The method includes providing a curable material and forming the curable material into a body. The body includes a plurality of recessed areas formed into a first side of the body and extending into the body is a substantially perpendicular orientation relative to the first side. Each of the plurality of recessed areas defines a lower wall of approximately uniform thickness.

[0015] In some embodiments, forming the curable material includes providing a mold including a plurality of columns extending outwardly from a surface of the mold. The plurality of columns may be distributed in approximately equal intervals across the surface. Forming the curable material may further include pouring the curable material into the mold and curing the curable material. [0016] In some embodiments, the method further includes perforating the lower wall of at least one of the plurality of recessed areas such that air may flow through the lower wall.

[0017] In some embodiments, the method further includes providing a check valve and joining the check valve with the lower wall of at least one of the plurality of recessed areas. [0018] In some embodiments, the curable material includes a polyurethane gel having a hardness within a range between approximately shore 40 and shore 60.

[0019] Another implementation of the present disclosure is a method of demonstrating an effectiveness of a negative pressure wound therapy dressing. The method includes providing a dressing test fixture. The dressing test fixture includes a body and a plurality of recessed areas formed into a first side of the body and extending into the body in a substantially perpendicular orientation relative to the first side. Each of the plurality of recessed areas defines a lower wall of approximately uniform thickness. The lower wall of the dressing test fixture is made from a flexible material. The method further includes applying a negative pressure to the NPWT dressing and observing a deformation of the lower wall form a second side of the body opposite the first side. [0020] In some embodiments, the method further includes dispensing a liquid into at least one of the plurality of recessed areas.

[0021] In some embodiments, the method further includes forming the body into a radius.

[0022] In some embodiments, the method further includes removing the NPWT dressing from the first side and applying a new NPWT dressing to the first side. [0023] 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 and taken in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS [0024] FIG. 1 is a perspective view of a dressing test fixture and a dressing for an NPWT system, according to an exemplary embodiment.

[0025] FIG. 2 is an exploded view of the dressing test fixture and the dressing of FIG. 1.

[0026] FIG. 3 is a perspective view of the dressing test fixture of FIG. 1.

[0027] FIG. 4 is a top view of the dressing test fixture of FIG. 1. [0028] FIG. 5 is a side cross sectional view of the dressing test fixture of FIG. 1.

[0029] FIG. 6 is a reproduction of FIG. 5 near a recessed area of a body of the dressing test fixture.

[0030] FIG. 7 is a top view of a dressing test fixture for an NPWT system, according to another exemplary embodiment.

[0031] FIG. 8 is a top view of a dressing test fixture for an NPWT system, according to another exemplary embodiment.

[0032] FIG. 9 is a flow diagram of a method of demonstrating an effectiveness of an NPWT system, according to an exemplary embodiment. [0033] FIG. 10 is a side cross sectional view of the dressing test fixture and the NPWT system of

FIG. 1 with the NPWT system in a first state of operation, according to an exemplary embodiment.

[0034] FIG. 11 is a reproduction of FIG. 10 near a recessed area of a body of the dressing test fixture.

[0035] FIG. 12 is a bottom view of the dressing test fixture of FIG. 10. [0036] FIG. 13 is a side cross sectional view of the dressing test fixture and the NPWT system of

FIG. 1 with the NPWT system in a second state of operation, according to an exemplary embodiment.

[0037] FIG. 14 is a reproduction of FIG. 13 near a recessed area of a body of the dressing test fixture.

[0038] FIG. 15 is a bottom view of the dressing test fixture of FIG. 13. [0039] FIG. 16 is a flow diagram of a method of making a dressing test fixture for an NPWT system, according to an exemplary embodiment.

[0040] FIG. 17 is a flow diagram of a method of forming a curable material into a body, according to an exemplary embodiment.

DETAILED DESCRIPTION Overview

[0041] Referring generally to the figures, a dressing test fixture for an NPWT system is shown according to various exemplary embodiments. The dressing test fixture is used to demonstrate the performance that can be achieved by NPWT dressings and can therefore be used to compare the performance of different, competing NPWT systems and dressing designs. In particular, the dressing test fixture provides a visual indication of the pressure manifolding performance that can be achieved by the NPWT dressing across a contact area between the dressing and the dressing test fixture. In other words, the dressing test fixture may be used to demonstrate the distribution of negative pressure across the contact area.

[0042] According to various exemplary embodiments, the dressing test fixture includes a plurality of formations (e.g., recessed areas) that are disposed in a surface of the test fixture to which the NPWT dressing is applied. The formations are spaced apart from one another across the surface of the test fixture such that they are pneumatically isolated from one another by the dressing. The formations are configured to collapse or otherwise distort in such a way that they are detectible by an observer visually. The formations may be filled with a fluid prior to applying the dressing to the dressing test fixture to demonstrate the performance of the NPWT dressing under conditions that simulate application of the NPWT dressing to a wound. Advantageously, the distortion of the formations also provides a visual indication of the reduction in dead volume that can be expected within a wound site via the application of negative pressure by the NPWT dressing. These and other features and advantages of the dressing test fixture are described in detail below.

Dressing Test Fixture Construction

[0043] FIGS. 1-2 show a dressing test fixture, shown as test fixture 100, according to an exemplary embodiment. The test fixture 100 is used to demonstrate the performance (e.g., effectiveness, etc.) of a NWPT dressing 10. In particular, the test fixture 100 is configured to provide a visual indication or representation of negative pressure applied by the NPWT dressing 10 across a surface of the test fixture 100. The NPWT dressing 10 may form part of an NPWT system configured to draw fluids from a wound site, through the NPWT dressing 10, and into a removed fluid canister (not shown).

[0044] As shown in FIGS. 1-2, the test fixture 100 includes a body 102 having a first side 104 (e.g., first surface) and a second side 106 (e.g., second surface) disposed opposite the first side 104. The NPWT dressing 10 is coupled (e.g., adhered, bonded, etc.) to the first side 104 of the body 102 and forms a substantially air tight seal with the first side 104 to minimize the amount of fluid leakage into the NPWT dressing 10 from an environment surrounding the test fixture 100. As shown in FIG.

2, the body 102 additionally includes a plurality of recessed areas 108. FIGS. 3-6 show the body 102 in isolation from the NPWT dressing 10. As shown in FIGS. 3-5, the recessed areas 108 are formed into the first side 104 of the body 102 and extend into the body 102 in a substantially perpendicular orientation relative to the first side 104, such that a central axis through each of the recessed areas 108 is approximately perpendicular to the first side 104. [0045] According to an exemplary embodiment, each of the recessed areas 108 has approximately the same cross-sectional shape, such that the amount of negative pressure required to deform the body 102, proximate to each of the recessed areas 108, is approximately uniform. In the exemplary embodiment of FIGS. 3-5, a cross-sectional shape of each of recessed areas 108, parallel to the first side 104, is substantially circular, such that each recessed area 108 defines a substantially cylindrically shaped cavity (e.g., depression, etc.). In other embodiments, the shape of the recessed areas 108 may be different. For example, a cross-sectional shape of each of the recessed areas 108 may be rectangular, elliptical, or any other suitable shape. Among other benefits, incorporating recessed areas 108 of substantially circular cross-section eliminates sharp comers along a perimeter of the recessed areas 108, which might make visual identification of the therapeutic effect provided by the NPWT dressing 10 (see FIGS. 1-2) more difficult (i.e., removal of any sharp comers reduces the likelihood of non-uniform deformation of the body 102, proximate to the recessed areas 108, as a result of a negative pressure applied to the first side 104 by the NPWT dressing 10).

[0046] As shown in FIG. 4, the recessed areas 108 are arranged in an array across the first side 104 of the body 102. The array is disposed concentrically with respect to an outer perimeter of the body 102, at a central position along the first side 104. As shown in FIG. 4, the recessed areas 108 are spaced apart from one another across the first side 104 of the body 102 such that they are at least partially pneumatically isolated from one another (e.g., such that the recessed areas 108 are pneumatically isolated from one another in a lateral direction, parallel to the first side 104, etc.). In the exemplary embodiment of FIG. 4, the recessed areas 108 are distributed in approximately equal intervals across the first side 104, forming a plurality of rows and columns in a substantially rectangular pattern. In other embodiments, the number, spacing, and/or arrangement of recessed areas 108 within the body 102 may be different. For example, the recessed areas 108 may be arranged in a circular shaped pattern or any other suitable shape.

[0047] The body 102 is configured to deform proximate to each of the recessed areas 108 in response to a negative pressure applied from the first side 104. As shown in FIG. 5, each of the recessed areas 108 defines an upper surface 110 of a lower wall 112 that extends between the recessed areas 108 and the second side 106. The lower walls 112 are configured to deform (e.g., bend, bow, etc.) in response to the negative pressure applied to the recessed areas 108 from the first side 104. In other words, the lower walls 112 are configured to deform to accommodate a removed fluid volume from within a corresponding one of the recessed areas 108.

[0048] In the exemplary embodiment of FIGS. 1-6, the body 102 and the lower wall 112 are integrally formed as a single unitary structure. The body 102 is formed from a flexible material which, advantageously, allows the lower wall 112 to deform in response to an applied negative pressure. Moreover, using a flexible material allows the body 102 to bend to conform/match the shape of the surface upon which the body 102 is placed (or pressed against). In this way, the body 102 may be used to demonstrate application techniques for the NPWT dressing 10 (see also FIG. 1). For example, the body 102 may be bent or otherwise formed into a radius that simulates the radius of a human leg or another body contour. In some embodiments, the test fixture 100 may additionally include straps (e.g., hook and loop fastening straps, a clip strap, or another type of interlocking strap) to secure the body 102 in position around a curved surface. In some embodiments, the flexible material is a cured polyurethane gel, silicone, or another elastomeric material.

[0049] The geometry of the body 102 and the recessed areas 108 depend, at least in part, on the properties of the flexible material and on the range of negative pressures that can be applied to the test fixture 100 by the NPWT dressing 10 (see FIG. 1). For example, FIGS. 1-6 depict an embodiment of a test fixture 100 that has been optimized to demonstrate the effectiveness of an NPWT dressing 10 that is structured to provide negative pressures within a range between approximately 80 mm Hg and 125 mm Hg, and where the test fixture 100 is formed from a material that has a hardness within a range between approximately shore 40 and shore 60 (e.g., shore 40 OO and shore 60 OO). As shown in FIG. 5, a thickness of the body 102, between the first side 104 and the second side 106, is approximately uniform across the body 102, between each of the recessed areas 108, and across an area of contact area between the NPWT dressing 10 and the test fixture 100. As shown in FIG. 6, a thickness 116 of the body is within a range between approximately 7 mm and 7.5 mm. A thickness 118 of the lower wall 112 of each of the plurality of recessed areas 108 is within a range between approximately 0.5 mm and 1 mm. A diameter of each of the recessed areas 108 may be sized to hold a predefined fluid volume (e.g., 90% of the static liquid holding capacity of the NPWT dressing 10, etc.). In the exemplary embodiment of FIG. 6, the diameter of each of the recessed areas 108 is sized to hold a fluid volume (e.g., a volume of saline liquid) of approximately 2 mL, resulting in a test fixture 100 with a combined fluid holding volume of approximately 50 mL within an area of the first side 104 that is covered by the NPWT dressing 10 (e.g., within an approximately 200 mm x 200 mm area across the first side 104). The recessed areas 108 are spaced in approximately equal intervals in both the X-direction and the Y -direction across the first surface to cover a total surface area that is approximately equal to the contact area between the NPWT dressing 10 and the first side 104 of the body 102.

[0050] In other exemplary embodiments, the body 102 may be formed from multiple pieces of material. For example, the body 102 may include a two-piece assembly including an upper portion and a lower portion that is coupled to, and sealably engaged with, the upper portion. The upper portion may include a plurality of openings extending through the upper portion. The lower portion may be sized to at least partially cover the openings across a single side of the upper portion, thereby forming the lower wall. As such, the upper portion and the lower portion may be made from different materials. For example, the upper portion may be made from a substantially rigid material such as polycarbonate or another suitable material. The lower portion may be made from a flexible material to allow for deformation of the lower wall under an applied negative pressure.

[0051] As shown in FIGS. 1-5, the test fixture 100 additionally includes a shallow channel 114 disposed in the first side 104 of the body 102. The shallow channel 114 extends circumferentially around the plurality of recessed areas 108 such that the shallow channel 114 surrounds the recessed areas 108 and the region of contact between the NPWT dressing 10 and the test fixture 100. Among other benefits, the shallow channel 114 frames out the body 102 and provides an appealing overall aesthetic to the test fixture 100.

Additional Configurations

[0052] The combination of features shown in the exemplary embodiment of FIGS. 1-6 should not be considered limiting. Many alternative implementations are possible without departing from the inventive concepts disclosed herein. For example, the size of the test fixture may be modified such that more than one NPWT dressing may be applied to the test fixture simultaneously, for example, to allow for direct comparison between the performance of two or more competing NPWT dressing/system designs.

[0053] In some embodiments, the test fixture may be modified to demonstrate the ability of an NPWT dressing to manage fluid leaks into the NPWT dressing from an environment surrounding a simulated wound site. For example, FIG. 7 shows a test fixture 200 for an NPWT dressing that includes a perforation disposed in a lower wall 212 of each one of the plurality of recessed areas 208 within the test fixture 200. In particular, each lower wall 212 is perforated by a linear cut 216 (e.g., slit, incision, etc.) that extends across a central portion of the lower wall 212. The linear cut 216 is configured to selectively permit air from the environment surrounding the test fixture 200 to enter the recessed areas 208 when the NPWT dressing is coupled to the test fixture 200. More specifically, the linear cut 216 is configured to selectively permit air to enter the recessed areas 208 from the second side of the body 202 of the test fixture 200. At the same time, the linear cuts 216 are small enough to prevent any liquids from leaking out from the recessed areas 108 through the second side. In this way, each of the linear cuts 216 functions as a one way check valve. In other embodiments, an actual one way fluid check valve may be coupled to the lower wall 212 to selectively permit air to enter the recessed areas 208 from the environment surrounding the test fixture 200.

[0054] As another example, FIG. 7 depicts a test fixture 300 that includes a plurality of channels 318 disposed in a first side 304 of a body 302 of the test fixture 300. In particular, the test fixture 300 includes two channels 318, each extending in a substantially lateral direction (e.g., substantially parallel to the first side 304, etc.) across the first side 304 from a corresponding one of the plurality of recessed areas 308. In other embodiments, the test fixture 300 may include a different number of channels 318. As shown in Fig. 7, each of the channels 318 is molded or otherwise formed into the body 302 as a shallow groove and/or depression in the first side 304 that extends laterally outward beyond a contact area 320 between the NPWT dressing and the first side 304. In the embodiment of FIG. 7, each channel 318 is approximately 1-2 mm deep and 5 mm wide. However, the geometry of each of the channels 318 and the number of channels 318 may vary depending on the desired leak rate of air into the NPWT dressing. For example, the channels 318 may be sized such that, together, the channels 318 produce a flow rate of approximately 38 cc/min of air into the NPWT dressing or any other suitable flow rate.

Method of Demonstrating an Effectiveness of an NPWT Dressing [0055] Referring now to FIG. 9, a flow diagram of a method 400 of demonstrating the performance of a NPWT dressing and/or system is shown, according to an exemplary embodiment. In other embodiments, the method 400 may include additional, fewer, and/or different operations. In operation 402, a dressing test fixture is provided. The dressing test fixture may be the same or similar to the dressing test fixtures 100, 200, 300 described with reference to FIGS. 1-6, 7, and 8, respectively. In optional operation 404, a body of the test fixture is formed into a radius. For example, the test fixture may be applied over a curved member (e.g., surface) that simulates a human leg or another body contour. The curved member may include a transparent material so that the effects of the NPWT dressing may be clearly observed through the curved member. Operation 404 may additionally include securing the body of the test fixture in place over the curved member such as by securing a strap around an opposite side of the curved member to which the body is applied.

[0056] In optional operation 406, a liquid is dispensed into at least one of the plurality of recessed areas to demonstrate the ability of the NPWT dressing to manifold pressure across the dressing when the dressing is at least partially saturated with fluid (e.g., to simulate the effects of wound exudate of NPWT dressing performance). Operation 406 may include pouring a saline liquid into at least one of the plurality of recessed areas.

[0057] In operation 408, an NPWT dressing is applied to a first side of the body over at least one of the plurality of recessed areas. Operation 408 may include preparing a patient interface layer of the NPWT dressing and aligning the NPWT dressing with the test fixture such that the NPWT dressing fully covers the plurality of recessed areas (and/or such that a number of recessed areas which can be covered by the NPWT dressing are approximately equidistant from the outer edges of the NPWT dressing). Operation 408 may additionally include pressing the NPWT dressing against the first side of the body to provide an air-tight seal between the NPWT dressing and the first side. FIGS. 10-11 show side cross-sectional views of the NPWT dressing 10 and the test fixture 100 after application of the NPWT dressing 10, but before the application of negative pressure by the NPWT dressing 10 to the first side 104. As shown, the lower wall 112 of each recessed area 108 is approximately coplanar with the second side 106. FIG. 12 shows the second side 106 of the body 102 after application of the NPWT dressing 10 (see also FIGS. 10-11).

[0058] In operation 410, a negative pressure is applied to the NPWT dressing (e.g., to a portion of the first side of the body that is beneath the NPWT dressing). Operation 410 may include activating a pump within an NPWT system to remove air from the dressing (e.g., to remove air from the recessed areas within the test fixture). In operation 412, an observer views the test fixture from the second side of the body to visually assess the amount of deformation of the body proximate to each of the recessed areas. FIGS. 13-14 show side cross-sectional views of the NPWT dressing 10 and the test fixture 100 after the application of negative pressure by the NPWT dressing 10 to the first side 104 of the body 102. As shown, the lower walls 112 are pulled inward toward the recessed areas 108 (e.g., toward the first side 104), thereby forming a plurality of substantially hemispherical shaped depressions in the second side 106. FIG. 15 shows the second side 106 of the body 102 after application of negative pressure to the first side 104 (see also FIGS. 13-14). Operation 412 may additionally include visually assessing a difference in the amount of deformation in at least one direction across the second side to quantify the overall ability of the dressing 10 to manifold negative pressure. For example, a well performing dressing may exhibit a nearly imperceptible difference between an amount of deformation in an area of the test fixture 100 that is centered beneath the dressing 10 and in an area of the test fixture 100 that is proximate to an outer edge of the dressing 10. The deformation of the lower walls 112 also provides a visual indication of the reduction in dead volume that can be achieved between a wound and the NPWT dressing in practice.

Method of Making a Dressing Test Fixture

[0059] Referring now to FIG. 16, a flow diagram of a method 500 of making a dressing test fixture is shown, according to an exemplary embodiment. In other embodiments, the method 500 may include additional, fewer, and/or different operations. As shown in FIG. 16, the method 500 includes providing a curable material (operation 502) such as a polyurethane gel or another curable elastomeric material. In operation 504, the curable material is formed into a body. Operation 504 is further depicted in FIG. 17, according to an exemplary embodiment. In operation 506, a mold is provided suitable for forming a body of the desired geometry. In particular, operation 506 includes providing a mold suitable for forming a body that includes a plurality of recessed areas formed into a first side of the body. The mold may include a hollow cavity or well configured to receive the curable material. The mold may include a plurality of columns extending outwardly from a lower surface of the mold to form the plurality of recessed areas during the molding operation. Each of the plurality of columns may be sized similar to the desired size of the plurality of recessed areas in the body. [0060] In operation 508, the curable material is poured or otherwise deposited (e.g., dispensed, etc.) into the mold. Operation 508 may include providing an amount of curable material to the mold to fully encompass (e.g., surround) each one of the plurality of columns. In operation 510, the curable material is cured within the mold. Operation 510 may include allowing the curable material to dwell within the mold for a predefined time period. Alternatively, or in combination, operation 510 may include heating the mold to expedite the curing operation.

[0061] Returning to FIG. 16, the method 500 may optionally include perforating a lower wall of at least one of the plurality of recessed areas (at operation 512) to provide a simulated leak during testing of the NPWT dressing. Operation 512 may include cutting a linear slit into the at least one lower wall or otherwise piercing the lower wall. Alternatively, or in combination, operation 512 may include providing a check valve (at operation 514) and joining the check valve to the lower wall or to the body at another location proximate to at least one of the recessed areas (at operation 516). The check valve may be joined with the lower wall using glue, epoxy, or another suitable adhesive product.

Configuration of Exemplary Embodiments

[0062] 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 can be reversed or otherwise varied and the nature or number of discrete elements or positions can be altered or varied. Accordingly, all such modifications are intended to be included within the scope of the present disclosure. The order or sequence of any process or method steps can be varied or re sequenced according to alternative embodiments. Other substitutions, modifications, changes, and omissions can be made in the design, operating conditions and arrangement of the exemplary embodiments without departing from the scope of the present disclosure.

Claims

WHAT IS CLAIMED IS:

1. A dressing test fixture, comprising: a body; and a plurality of recessed areas formed into a first side of the body and extending into the body in substantially perpendicular orientation relative to the first side, each of the plurality of recessed areas defining a lower wall of approximately uniform thickness, the lower wall comprising a flexible material.

2. The dressing test fixture of Claim 1, wherein the lower wall of each of the plurality of recessed areas is configured to deform in response to a negative pressure applied to the recessed areas from the first side.

3. The dressing test fixture of Claim 1, wherein the plurality of recessed areas is distributed in approximately equal intervals across the first side, and wherein each of the plurality of recessed areas has the same cross-sectional shape.

4. The dressing test fixture of Claim 3, wherein each of the plurality of recessed areas defines a substantially cylindrically shaped cavity.

5. The dressing test fixture of Claim 1, wherein the body comprises the flexible material, wherein a hardness of the flexible material is within a range between approximately shore 40 and shore 60.

6. The dressing test fixture of Claim 1, wherein the body and the lower wall are integrally formed as a single unitary structure.

7. The dressing test fixture of Claim 1, wherein the flexible material is a cured polyurethane gel.

8. The dressing test fixture of Claim 1, wherein a thickness of the lower wall of each of the plurality of recessed areas is within a range between approximately 0.5 mm and 1 mm.

9. The dressing test fixture of Claim 1, wherein a thickness of the body, between the first side and a second surface of the body opposite the first side is approximately the same across the body.

10. The dressing test fixture of Claim 9, wherein the thickness of the body is within a range between approximately 7 mm and 7.5 mm.

11. The dressing test fixture of Claim 1, wherein each of the plurality of recessed areas is sized to receive a fluid volume of approximately 2 mL.

12. The dressing test fixture of Claim 1, wherein the lower wall of at least one of the plurality of recessed areas is perforated such that air may flow through the lower wall in response to an applied negative pressure.

13. The dressing test fixture of Claim 12, wherein the lower wall is perforated by a linear cut extending across at least a portion of the lower wall.

14. The dressing test fixture of Claim 1, further comprising a check valve disposed in the lower wall of at least one of the plurality of recessed areas, wherein the check valve is configured to selectively permit air to enter the at least one recessed area from a second side of the body opposite the first side.

15. The dressing test fixture of Claim 1, further comprising a channel formed into the body, wherein the channel extends through the body in a partially lateral direction parallel to the first side of the body.

16. A method of making a dressing test fixture, comprising: providing a curable material; and forming the curable material into a body, the body comprising a plurality of recessed areas formed into a first side of the body and extending into the body in substantially perpendicular orientation relative to the first side, each of the plurality of recessed areas defining a lower wall of approximately uniform thickness.

17. The method of Claim 16, wherein forming the curable material comprises: providing a mold, wherein the mold comprises a plurality of columns extending outwardly from a surface of the mold, and wherein the plurality of columns is distributed in approximately equal intervals across the surface; pouring the curable material into the mold; and curing the curable material.

18. The method of Claim 16, further comprising perforating the lower wall of at least one of the plurality of recessed areas such that air may flow through the lower wall.

19. The method of Claim 16, further comprising: providing a check valve; and joining the check valve with the lower wall of at least one of the plurality of recessed areas.

20. The method of Claim 16, wherein the curable material comprises a polyurethane gel, and wherein a hardness of the polyurethane gel is within a range between approximately shore 40 and shore 60.

21. A method of demonstrating an effectiveness of a negative pressure wound therapy (NPWT) dressing, comprising: providing a dressing test fixture, comprising: a body; and a plurality of recessed areas formed into a first side of the body and extending into the body in substantially perpendicular orientation relative to the first side, each of the plurality of recessed areas defining a lower wall of approximately uniform thickness, the lower wall comprising a flexible material; applying the NPWT dressing to the first side of the body over at least one of the plurality of recessed areas; applying a negative pressure to the NPWT dressing; and observing a deformation of the lower wall from a second side of the body opposite the first side.

22. The method of Claim 20, further comprising dispensing a liquid into at least one of the plurality of recessed areas.

23. The method of Claim 20, further comprising forming the body into a radius.

24. The method of Claim 20, further comprising removing the NPWT dressing from the first side and applying a new NPWT dressing to the first side.