Negative pressure dressing material with preferred lateral shrinkage

Abstract

The present invention provides dressings, systems, and methods for treating tissue sites affected by decompression. [Solution] Some embodiments of the manifold pad may be configured to distribute reduced pressure to a tissue site and to provide lateral contraction to the tissue site. In some embodiments, the manifold pad may comprise a foam having a cellular structure that forms oval or ellipsoidal pores. In some embodiments, the manifold pad may be configured to preferentially contract radially or laterally when negative pressure is applied. For example, the manifold pad may be configured to be more resistant to compression of the thickness of the manifold pad than to collapsing radially or laterally. Other devices, dressings, systems, and methods are disclosed.

Description

[Technical Field]

[0001] Cross-reference of related applications This application claims priority to U.S. Provisional Patent Application No. 63 / 049,866, filed on 9 July 2020, the entirety of which is incorporated herein by reference.

[0002] This disclosure relates, in general, to medical treatment systems, and more specifically, to dressings, systems, and methods for treating tissue sites under decompression. [Background technology]

[0003] Clinical research and practice have shown that reducing pressure near a tissue site can enhance and accelerate the growth of new tissue in that site. While this phenomenon has numerous applications, it has proven particularly advantageous for wound treatment. Regardless of the etiology of the wound—whether trauma, surgery, or another cause—proper wound care is crucial to the outcome. Treatment of wounds or other tissues by decompression can be commonly referred to as "negative pressure therapy," but is also known by other names, including, for example, "negative pressure wound therapy," "decompression therapy," "vacuum therapy," and "vacuum-assisted closure." Negative pressure therapy can offer many benefits, including the transition of epithelial and subcutaneous tissue, improved blood flow, and micro-deformation of tissue at the wound site. These benefits, collectively, can increase granulation tissue development and reduce healing time.

[0004] While the clinical benefits of negative pressure therapy are widely recognized, its cost and complexity can be limiting factors in its application. The development and operation of negative pressure systems, components, and processes continue to present significant challenges for manufacturers, healthcare providers, and patients. [Overview of the project]

[0005] Disadvantages of certain embodiments of tissue treatment dressings, tissue treatment systems, and tissue treatment methods are addressed as illustrated and described in various exemplary and non-limiting embodiments herein.

[0006] For example, in some embodiments, the dressing material may include a manifold pad that can be configured to contract laterally under applied negative pressure, thereby providing a lateral contractile force to the tissue site. For example, the manifold pad may include a felted foam that generates oval-shaped (e.g., with the long axis longer than the short axis) holes or bubbles. In some embodiments, the oval holes may be oriented such that the short axis of the oval hole is oriented parallel to the surface of the manifold pad (e.g., perpendicular to the thickness of the manifold pad) and the long axis of the oval hole is oriented parallel to the thickness (e.g., perpendicular to the surface of the manifold pad). This oval hole configuration may result in a manifold pad that contracts more radially or laterally than in thickness when negative pressure is applied, which may help guide the closure of the incision margin.

[0007] More generally, some embodiments may relate to a foam manifold pad for providing negative pressure therapy to a tissue site, and the manifold pad foam may comprise a first surface, a second surface, and a foam thickness extending between the first and second surfaces, wherein the manifold pad foam may comprise a plurality of oval pores, and the manifold pad and / or oval pores may be configured to contract in a plane substantially or substantially parallel to the first surface and / or substantially perpendicular to the thickness when negative pressure is applied. In some embodiments, the manifold pad and / or oval pores may be configured to contract preferentially in a plane substantially parallel to the first surface. In some embodiments, the manifold pad may be configured to resist shrinkage in thickness, for example, shrinking in thickness less in the lateral or radial directions under negative pressure. In some embodiments, the manifold pad may be configured to contract more in a plane substantially perpendicular to the thickness than in thickness when negative pressure is applied. In some embodiments, the manifold pad may be configured to have substantially no thickness shrinkage in the direction extending from the first surface to the second surface under negative pressure. In some embodiments, the manifold pad may be configured to have no significant thickness shrinkage under the applied negative pressure. In some embodiments, the foam may include open-cell foam. For example, the open-cell foam of the manifold pad may have an open-cell or perforated cellular structure, and oval pores (e.g., open cells) may be formed by the cellular structure.

[0008] In some embodiments, each oval pore may include a major axis and a minor axis, the major axis may be oriented substantially perpendicular to the first surface, the minor axis may be oriented substantially parallel to the first surface, for each oval pore the major axis may be substantially perpendicular to the minor axis, and for each oval pore the length along the major axis may be longer than the length along the minor axis. In some embodiments, the oval pores may be configured to contract more in the minor axis direction than in the major axis direction when negative pressure is applied. In some embodiments, the foam of the manifold pad may comprise a felted foam having a compression axis (e.g., direction), and the minor axis of the oval pores may be substantially parallel to the compression axis. For example, the felted foam may be compressed (e.g., felted) to have a hardness coefficient of 2 to 7. In some embodiments, the ratio of the minor axis contraction of the oval pores to the major axis contraction under applied negative pressure may be greater than 1.

[0009] Some other exemplary embodiments of a manifold pad may include a first surface, a second surface, and a foam thickness extending between the first and second surfaces, where the foam of the manifold pad may include a cellular structure having a plurality of ellipsoidal or elongated cells. In some embodiments, the manifold pad may be configured to preferentially contract in a plane substantially perpendicular to its thickness when negative pressure is applied. In some embodiments, each ellipsoidal cell may have a major axis and a minor axis, the major axis of the ellipsoidal cell may be oriented substantially parallel to the thickness of the manifold pad, the minor axis of the ellipsoidal cell may be oriented substantially perpendicular to the thickness of the manifold pad, and the ellipsoidal cell may be configured to preferentially contract in a plane substantially perpendicular to its thickness when negative pressure is applied. In some embodiments, the major axis of the ellipsoidal cell may be oriented at an angle of 44 degrees or less from parallel to the thickness. In some embodiments, the major axis of the ellipsoidal cell may be oriented at an angle of 25 degrees or less or 20 degrees or less from parallel to the thickness. In some embodiments, the foam of the manifold pad may include a felted foam having a cellular structure with a plurality of ellipsoidal pores, the felted foam of the manifold pad may be configured to be more resistant to thickness shrinkage under applied negative pressure than a similar unfelted foam, to provide greater lateral shrinkage under applied negative pressure than a similar unfelted foam, and / or to transmit a higher lateral closing force under applied negative pressure compared to a similar unfelted foam.

[0010] Some embodiments of dressings for providing negative pressure therapy to a tissue site may include foam manifold pads similar to those described herein. In some embodiments, the dressing may further comprise a therapeutic device which may be configured as a visceral protective layer for providing separation between the abdominal wall and the viscera and protecting the abdominal contents. In some embodiments, the therapeutic device may have a film layer and may be configured to allow fluid to flow radially under applied negative pressure. In some embodiments, the therapeutic device may comprise a central hub and a plurality of elongated members extending outward from the central hub. In some embodiments, the therapeutic device may further comprise a therapeutic manifold which can be attached to the film layer. In some embodiments, the therapeutic manifold may comprise open-cell foam. In some embodiments, the therapeutic manifold may be enclosed or sealed by a film layer which may be a non-adherent drape with a plurality of openings. In some embodiments, the therapeutic manifold may comprise a central connecting manifold member and a plurality of leg manifold members extending outward from the central connecting manifold member. Some embodiments may further include a sealing member configured to cover the manifold pad and the treatment device and to provide a pneumatic seal to the tissue site. In some embodiments, the sealing member may be configured to be positioned above the treatment device and the manifold pad to create a sealing space above the tissue site. In some embodiments, the manifold pad may be configured such that a first surface faces and / or contacts the sealing member, and a second surface faces and / or contacts the treatment device. In some embodiments, the manifold pad may be configured to distribute the applied negative pressure to the treatment device (and thereby to the tissue site).

[0011] System embodiments may include a dressing material similar to those described herein and a negative pressure source fluidly coupled to the dressing material. In some embodiments, the negative pressure source may be fluidly coupled to a sealed space formed by the dressing material. For example, the negative pressure source may be in fluid communication with a manifold pad through a sealing member, and the applied negative pressure may be distributed to the tissue site through the manifold pad and through the treatment device. In some embodiments, the dressing material may be used on a tissue site having an incision, and the application of negative pressure to the manifold pad may bring the incision edges closer together.

[0012] Methods for forming manifold pads or dressing materials are also disclosed, which may include the steps of: providing a foam blank having a plurality of pores; altering the foam blank to form a foam, wherein the altered pores of the foam are oval-shaped with a major axis and a minor axis, and molding the foam to form a manifold pad having a first surface, a second surface, and a thickness of foam extending between the first and second surfaces. In some embodiments, the minor axis may be substantially parallel to the first surface and / or substantially perpendicular to the thickness. In some embodiments, the step of altering the foam blank may include compressing the foam blank along the axis of compression (e.g., the direction) to permanently deform the plurality of pores in order to form a foam having oval-shaped pores with a major axis substantially perpendicular to the axis of compression and a minor axis substantially parallel to the axis of compression. In some embodiments, the foam blank may be heated when compressed. In some embodiments, the step of altering the foam blank may include felting the foam blank to a hardness coefficient of 2 to 7 along the compression axis so that the foam is formed with oval holes having a major axis substantially perpendicular to the compression axis and a minor axis substantially parallel to the compression axis. In some embodiments, the step of forming the foam may include cutting the foam perpendicular to the compression axis. In some embodiments, the step of forming the foam may include cutting the foam to form a first surface substantially parallel to the minor axis and a major axis substantially perpendicular to the first surface. In some embodiments, the step of forming the foam may include rotating the foam by 90 degrees (e.g., rotating the compression axis by 90 degrees after compression) and then cutting the foam in the thickness direction (e.g., perpendicular to the compression axis).

[0013] Methods for treating a tissue site are also disclosed, which may include the steps of applying a treatment device similar to those described herein to the tissue site, applying a manifold pad similar to those described herein above the treatment device, and applying a sealing member above the manifold pad to form a sealed space over the tissue site. In some embodiments, the manifold pad may be applied together with a first surface substantially parallel to a portion of the tissue site beneath the manifold pad, and an oval-shaped hole oriented by a long axis substantially perpendicular to the first surface, a short axis substantially parallel to the first surface, a short axis substantially parallel to a portion of the tissue site beneath the manifold pad, and / or a short axis substantially parallel to a portion of a sealing member positioned above the manifold pad. Some embodiments may further include the steps of applying negative pressure to the manifold pad and shrinking the manifold pad in a plane substantially parallel to the first surface in response to the application of negative pressure without significantly reducing (e.g., decreasing) its thickness. In some embodiments, the step of applying negative pressure may include the step of fluidly coupling a negative pressure source to a manifold pad through a sealing member.

[0014] Other aspects, features, and advantages of exemplary embodiments will become apparent with reference to the following drawings and detailed description. [Brief explanation of the drawing]

[0015] [Figure 1A] This is a schematic diagram showing a portion of a cross-section of an exemplary embodiment of an open cavity decompression therapy device and system. [Figure 1B] Figure 1A is a schematic cross-sectional view of a part of an exemplary therapeutic device. [Figure 1C] This is a schematic cross-sectional view of a portion of the exemplary therapeutic device shown in Figure 1A, along line 1C-1C. [Figure 1D] This is a schematic cross-sectional view of a part of the exemplary system shown in Figure 1A. [Figure 2] Figures 1A to 1D are schematic perspective views of exemplary open cavity decompression therapy devices. [Figure 3A]Schematic plan view of another exemplary embodiment of an open cavity decompression treatment device. [Figure 3B] Schematic plan view of a part of the exemplary treatment device of FIG. 3A. [Figure 3C] Schematic cross-sectional view of a part of the exemplary treatment device of FIG. 3B along line 3C-3C. [Figure 4] Perspective view of an exemplary embodiment of a manifold pad according to the present disclosure. [Figure 5] Schematic view of a part of the dressing material embodiment of FIG. 1A, illustrating additional details regarding an exemplary embodiment of the manifold pad. [Figure 6] Detailed view of an enlarged portion of FIG. 5, showing in more detail the shape and orientation of the pores / bubbles of the foam of the manifold pad. [Figure 7] Schematic view showing compression and / or felting of a foam blank for forming the foam of an exemplary manifold pad similar to FIGS. 5-6.

MODE FOR CARRYING OUT THE INVENTION

[0016] The following description of the exemplary embodiments enables those skilled in the art to make and use the subject matter recited in the appended claims. Certain details that are already known in the art may be omitted. Accordingly, the following detailed description is illustrative and non-limiting.

[0017] Referring to FIGS. 1A-1D, an exemplary embodiment of an open cavity decompression system 100 and a treatment device 102 is shown. The open cavity decompression system 100 and the treatment device 102 are for treating a patient's tissue site 104. The tissue site 104 can be any body tissue of any human, animal or other organism, including bone tissue, adipose tissue, muscle tissue, dermal tissue, tissue, connective tissue, cartilage, tendon, ligament or any other tissue. In this exemplary embodiment, the tissue site 104 includes tissues within a body cavity, particularly within the abdominal cavity, and includes abdominal contents or tissues adjacent to the abdominal cavity. Treatment of the tissue site 104 can include removal of fluid, such as exudate or ascites, protection of the abdominal cavity, or decompression treatment.

[0018] As shown, the therapeutic device 102 is placed in the patient's abdominal cavity to treat a tissue site 104. The therapeutic device 102 in Figures 1A to 1D includes a plurality of enclosed leg members 106 supported by abdominal contents, which constitute the surface on which the plurality of leg members 106 are placed. One or more of the plurality of enclosed leg members 106 may be placed in or near a first paracolonic groove 108, and one or more of the plurality of enclosed leg members 106 may be placed in or near a second paracolonic groove 110. The plurality of enclosed leg members 106 are coupled to a central connecting member 112, and a fluid communication exists between the plurality of enclosed leg members 106 and the central connecting member 112. The plurality of enclosed leg members 106 and / or the central connecting member 112 may be formed with openings 114, 116, 118, 120 that allow intraperitoneal fluid to pass through. The openings 114, 116, 118, and 120 can take any shape, such as a circular opening, a rectangular opening, or a polygon, but in this exemplary embodiment they are shown as slits or straight cuts. One or more of the openings 114, 116, 118, and 120 may be omitted in alternative embodiments.

[0019] The manifold pad 122 distributes decompression to the treatment device 102. The sealing member 124 provides a pneumatic seal above the body cavity opening 126. One or more skin closure devices may be placed on the patient's epidermis 134. Decompression is delivered to the manifold pad 122 through a decompression interface 128 coupled to a decompression delivery conduit 130. The decompression source 132 delivers decompression to the decompression delivery conduit 130.

[0020] Decompression may be applied to tissue site 104 to help facilitate the removal of ascites, exudate, or other fluids from the tissue site 104. In some embodiments, decompression may be applied to stimulate further tissue growth. In some cases, only fluid removal may be desirable. In the case of a wound at tissue site 104, granulation tissue growth, exudate removal, or bacterial removal can help facilitate wound healing. In non-wounded or non-defective tissue situations, decompression may be used to promote the growth of tissue that can be harvested and transplanted to another tissue site.

[0021] As used herein, “decompression” generally refers to a pressure below ambient pressure at the tissue site being treated. Typically, this decompression is below atmospheric pressure. Decompression may also be below hydrostatic pressure at the tissue site. Unless otherwise indicated, the pressure values ​​described herein are gauge pressures. The amount and nature of the decompression applied to the tissue site may generally vary depending on the application, but decompression is typically in the treatment range of -5 mmHg to -500 mmHg, and more typically -100 mmHg to -200 mmHg. For example, treatment decompression may be about -125 mmHg in some applications. Decompression may also be called “negative pressure,” and these terms may be used interchangeably.

[0022] The depressurization delivered may be constant, variable, patterned, or randomized, and may be delivered continuously or intermittently. The terms “vacuum” and “negative pressure” may be used to describe the pressure applied to a tissue site, although the actual pressure applied to a tissue site may exceed the pressure typically associated with a perfect vacuum. Consistently in this specification, an increase in depressurization corresponds to a decrease in pressure (an increase in negative pressure relative to ambient pressure), and a decrease in depressurization corresponds to an increase in pressure (a decrease in negative pressure relative to ambient pressure).

[0023] The depressurization can initially generate fluid flow within the manifold pad 122, within the depressurization conduit 130, and in close proximity to the tissue site 104. As the hydrostatic pressure around the tissue site 104 approaches the desired depressurization, the flow weakens and the depressurization can be maintained.

[0024] The manifold pad 122 is located in close proximity to the central connecting member 112. The manifold pad 122 can take many forms. As used herein, the term “manifold” generally refers to a substance or structure provided to assist in the application of depressurization to a tissue site 104, the delivery of fluid to or from a tissue site 104. The manifold pad 122 typically includes a plurality of channels or pathways around the manifold pad 122, through the central connecting member 112, for distributing fluid to and from the tissue site 104. In one exemplary embodiment, the channels or pathways are interconnected to improve the distribution of fluid to or from the tissue site 104. The manifold pad 122 may be made of a biocompatible material that is positioned in contact with the tissue site 104 and can distribute depressurization to the tissue site 104.

[0025] Examples of materials suitable for the manifold pad 122 include, but are not limited to, devices having structural elements arranged to form channels, cellular foams such as open-cell foams, porous tissue aggregates, and liquids, gels, and foams that contain or harden to contain channels. The manifold pad 122 may be porous and may be made from foam, gauze, felted mat, silicone, polyvinyl alcohol, or any other material suitable for a particular biological application. In one embodiment, the manifold pad 122 is a porous foam and contains a plurality of interconnected bubbles or pores that function as channels or flow paths. The porous foam may be polyurethane or polyether, open-cell, or mesh foam, such as GRANUFOAM® material available from Kinetic Concepts, Incorporated (San Antonio, Texas). Other embodiments may include “closed-cell” foams. These closed-cell portions of the manifold may contain a plurality of bubbles, most of which are not fluidly connected to adjacent bubbles. Closed-cell structures may be selectively placed within the manifold pad 122 to prevent fluid permeation through the surrounding surface of the manifold pad 122. In some situations, the manifold pad 122 may also be used to distribute fluids such as drugs, antimicrobial agents, growth factors, and various solutions to the tissue site 104. Other layers, such as absorbent materials, wicking materials, hydrophobic materials, and hydrophilic materials, may be included within or on the manifold pad 122.

[0026] Materials with a higher or lower density than GRANUFOAM® material may be desirable depending on the application. Among the many possible materials, the following can be used: GRANUFOAM® material, FOAMEX® technology foam, molded base with claw structure, patterned grid materials such as those manufactured by Sercol Industrial Fabrics, 3D fabrics such as those manufactured by Baltex of Derby (United Kingdom), gauze, flexible channel-containing members, grafts, or similar materials. In some cases, silver ions may be added to the manifold pad 122, for example, by a microbonding process. Other substances such as antimicrobial agents may also be added to the manifold 122.

[0027] The sealing member 124 is configured to be positioned over the cavity opening 126 and may be formed from any material capable of providing a sufficient pneumatic or fluid seal for the open cavity decompression system 100 to maintain decompression at the tissue site 104. The sealing member 124 may also be a cover used to secure the manifold pad 122 to the central connecting member 112. The sealing member 124 may be impermeable or semi-permeable. The sealing member 124 can maintain decompression at the tissue site 104 after it has been positioned over the cavity opening 126. The sealing member 124 may be a flexible overdrape or film formed from a silicone-based compound, acrylic, hydrogel or hydrogel-forming material, or any other biocompatible material having impermeable or permeable properties desired for applying decompression to the tissue site 104.

[0028] More specifically, the sealing member 124 may be made from materials such as hydrophilic polyurethane, cellulose derivatives, hydrophilic polyamide, polyvinyl alcohol, polyvinylpyrrolidone, hydrophilic acrylic, or hydrophilic silicone elastomer, for example, 14400 g / m². 2This may include one or more of the following: INSPIRE2301 material from Expopack Advanced Coatings (Wrexham, United Kingdom) with 24-hour MVTR (Inverse Cup Technology) and a thickness of approximately 30 microns; thin, uncoated polymer drapes; natural rubber; polyisoprene; styrene-butadiene rubber; chloroprene rubber; polybutadiene; nitrile rubber; butyl rubber; ethylene-propylene rubber; ethylene-propylene-diene monomer; chlorosulfonated polyethylene; polysulfide rubber; polyurethane (PU); EVA film; copolyester; silicone; silicone drapes; TEGADERM® drapes available from 3M; polyurethane (PU) drapes available from Avery Dennison Corporation (Pasadena, California); for example, polyether-blocked polyamide copolymer (PEBAX) from Arkema (France), EXPOPACK2327; or other suitable materials.

[0029] Furthermore, the sealing member 124 may be vapor permeable and / or liquid impermeable, thereby allowing vapor to escape from the sealed space between the sealing member 124 and the tissue portion 104, while preventing liquid from escaping from that sealed space. In some embodiments, the sealing member 124 is, for example, at least about 250 g / m² per 24 hours. 2 It may be a flexible, breathable film, membrane, or sheet having a high water vapor permeability (MVTR). In other embodiments, a low vapor permeability drape or a vapor-impermeable drape may be used. The sealing member 124 may include a variety of medically appropriate films having a thickness of up to approximately 50 microns (μm).

[0030] The sealing member 124 may further include mounting means 131 for securing the sealing member 124 to the patient's skin 134. The mounting means 131 can take many forms. For example, an adhesive layer 136 may be positioned around the sealing member 124 or along any portion of the sealing member 124 to directly or indirectly provide a pneumatic seal to the patient's skin 134. The adhesive layer 136 may also be covered with a peelable backing or material (not shown) that is pre-applied to the sealing member 124 and removed upon application.

[0031] The decompression interface 128 may, for example, be a port or connector 138 that allows the passage of fluid from the manifold pad 122 to the decompression delivery conduit 130 and vice versa. For example, fluid collected from a tissue site 104 using the manifold pad 122 and the treatment device 102 may enter the decompression delivery conduit 130 via the connector 138. In another embodiment, the open-loop decompression system 100 may omit the connector 138, and the decompression delivery conduit 130 may be directly inserted into the sealing member 124 and the manifold pad 122. The decompression delivery conduit 130 may be a medical conduit or tube, or any other means for decompression and fluid transport. The decompression delivery conduit 130 may be a multi-lumen member for easily delivering decompression and removing fluid. In one embodiment, the decompression delivery conduit 130 is a two-lumen conduit having one lumen for decompression and fluid transport and one lumen for transmitting pressure to a pressure sensor.

[0032] The depressurization source 132 generates and supplies a depressurized state to the depressurization delivery conduit 130. The depressurization source 132 can generate and supply a wide range of depressurization. In one embodiment, the range may include -50 to -300 mmHg, and in another embodiment, the range may include -100 mmHg to -200 mmHg. In an exemplary embodiment, the depressurization source 132 includes a preset selector for -100 mmHg, -125 mmHg, and -150 mmHg. The depressurization source 132 may also include several alarms, such as a blockage alarm, a leak alarm, or a low battery alarm.

[0033] The decompression source 132 may be any suitable device for providing decompression, such as a vacuum pump, wall suction, hand pump, manual pump, electronic pump, micropump, piezoelectric pump, diaphragm pump, or a portable source, wall source, abdominal cavity unit, or other supply source. The decompression source 132 may also include a control circuit and sensors such as a pressure sensor, which can be configured to monitor the decompression in the tissue site 104. The decompression source 132 may also be configured to control the amount of decompression from the decompression source 132 applied to the tissue site 104 according to user input and decompression feedback signals received from the tissue site 104. The decompression source 132 can selectively deliver constant pressure, changing pressure, intermittent pressure, or continuous pressure. The amount of fluid removed from the cavity through the decompression delivery conduit 130 may be more than 5 liters per day.

[0034] Several different devices, for example, device 140, may be added to the inner portion 142 of the depressurization delivery conduit 130. For example, device 140 may be a fluid reservoir or canister collection member, a pressure feedback device, a volume detection system, a blood detection system, an infection detection system, a filter, a filtered port, a flow rate monitoring system, a temperature monitoring system, and the like. Multiple devices 140 may be included. Some of these devices, for example, a fluid collection member, may be formed integrally with the depressurization source 132. For example, a depressurization port 144 on the depressurization source 132 may include a filter member (not shown) containing one or more filters, which may include a hydrophobic filter to prevent liquid from entering the internal space of the depressurization source 132.

[0035] Referring here to Figures 1A, 1C, and 2, the treatment device 102 may include a non-adherent drape 148. The non-adherent drape 148 may be formed from a non-adherent material that inhibits tissue adhesion to the non-adherent drape 148. In one embodiment, the non-adherent drape 148 is formed from a breathable polyurethane film. The non-adherent drape 148 may include a plurality of openings, apertures, or windows 150. The windows may take various shapes, such as circular, rectangular, or polygonal openings, but are shown as slits or straight cuts in Figure 2. Depending on the specific application of the device 102, the desired fluid flow and / or pressure delivery, or other system parameters, the windows may have different sizes.

[0036] Referring to Figures 1A, 1D, and 2, the therapeutic device 102 includes a central connecting member 112 to which a plurality of encapsulated leg members 106 are connected. The central connecting member 112 includes a connecting manifold member 154 enclosed by a first connecting encapsulating member 186, which may be referred to as a first non-adherent drape 186, and a second connecting encapsulating member 192, which may be referred to as a second non-adherent drape 192. A portion of the central connecting member 112 can be fluid-coupled in the leg-connecting region 152 to allow fluid communication between the central connecting member 112 and the plurality of encapsulated leg members 106. The first and second connecting encapsulating members or non-adherent drapes 186, 192 may be defined by a single piece of material or by two or more sheets of material, as shown. For example, the non-adherent drape 148 may be used as a single sheet, or it may include a first non-adherent drape 186 and a second non-adherent drape 192.

[0037] As described above, the central connecting member 112 can be in fluid communication with the manifold pad 122. In one embodiment, the opening 118 can also enable fluid communication in the same manner as the opening described above. In addition, or alternatively, some or more portions of the first connecting sealing member, i.e., the non-adherent drape 186, can be exposed to the manifold pad 122.

[0038] Referring again to Figures 1A to 1D, each of the multiple enclosed leg members 106 may include a leg manifold member 160, which may be a single manifold member extending between the leg module 156 and / or the central connecting member 112, or individual manifold components. The leg manifold member 160 is located within the inner portion 162 of each of the enclosed leg members 106. Each leg manifold member 160 has a first side surface 164 and a second inward-facing (patient-facing) side surface 166.

[0039] In some embodiments, a connecting manifold member 154 and one or more leg manifold members 160 extending from the connecting manifold member 154 may form a therapeutic manifold 167. The therapeutic manifold 167, including the leg manifold members 160 and the connecting manifold member 154, may include or be formed from a foam or manifold material similar to or analogous to the manifold material described herein for the manifold pad 122.

[0040] The non-adherent drape 148 may surround the treatment manifold 167. For example, the non-adherent drape 148 may be coupled around the leg manifold member 160 and the connecting manifold member 154 to provide a plurality of enclosed leg members 106 that are in fluid communication with the central connecting member 112. In some embodiments, the non-adherent drape 148 may include a first non-adherent drape 186 and a second non-adherent drape 192, and the treatment manifold 167 may be positioned as a layer between the first non-adherent drape 186 and the second non-adherent drape 192. The first non-adherent drape 186 can be coupled to the second non-adherent drape 192 to provide a plurality of enclosed leg members 106 that are in fluid communication with the central connecting member 112.

[0041] In one embodiment, one or more of the multiple leg manifold members 160 may have different material properties or structures. For example, different enclosed leg members 106 may require different flow rates. In one embodiment, different manifold materials or manifold properties, different manifold sizes, manifold compression, flow rate limiting material structures, and / or valves can provide different flow rates of fluid through the enclosed leg members and / or central connecting members.

[0042] In one embodiment, a first leg containment member 168, which may be formed by an opening 114, is positioned on a first side surface 164 of the leg manifold member 160. A second leg containment member 170, which may include an opening 116, is positioned on a second inward side surface 166 of the leg manifold member 160. The first leg containment member 168 and the second leg containment member 170 may be part of a non-fixed drape 148. In some embodiments, the first leg containment member 168 may be part of a first non-fixed drape 186, and the second leg containment member 170 may be part of a second non-fixed drape 192. In some embodiments, the contained leg members 106 may be fitted together, for example, via a drape 148. In some embodiments, the contained leg members 106 may be movable independently of each other, except for their proximal ends adjacent to the central connecting member 112. For example, the enclosed leg members 106 do not need to be connected to one another. In another embodiment, a portion of the material connecting the enclosed leg members 106, for example, a non-fixed drape 148 between adjacent enclosed leg members 106, is expandable (e.g., stretchable, flexible, deformable, and / or elastic material) and allows the movement of the individual enclosed leg members 106 relative to one another.

[0043] As indicated by arrow 172 in the longitudinal section of Figure 1B, the fluid can flow from the leg module 156 toward the central connecting member 112. As indicated by arrow 174, the fluid can enter the openings 114 and 116, flow into the leg manifold member 160, and then flow toward the central connecting member 112, as shown by arrow 172.

[0044] In a plan view, the enclosed leg member 106 can take several different shapes, such as an elongated shape, a rectangle, an ellipsoid, etc. In one aspect, the enclosed leg member 106 can include a leg module 156. Adjacent leg modules 156 are fluidly coupled to each other and have an operation zone 158 therebetween. In one aspect, the operation zone includes a weakened area or a perforated area to facilitate sizing the device. For example, a clinician can cut the leg module to change the size of the device. By pulling on the partially cut leg module, the manifold can be peeled off at the next operation zone. In one aspect, the concave shape of the operation zone 158 can prevent accidental removal of additional leg modules. Additionally, or alternatively, the outer portion of the leg module can be fixed to the device to prevent unwanted manifold removal.

[0045] The enclosed leg member 106 can also have various dimensions. For example, the longer dimension of the enclosed leg 106, such as the lengthwise or longitudinal dimension, is L1 and the width is W1 In this case, the aspect ratio is given by L1 / W1 . The aspect ratio can be 8.0, 7.0, 6.0, 5.0, 4.0, 3.0, 2.0, or any number in between. Additionally, other aspect ratios are possible. Generally, the width W1 of the enclosed leg member is greater than the width W2 of the central connecting member 112, that is, W2 > W1 . For example, in an exemplary embodiment, the enclosed leg member 106 has a length of about 270 mm, a width W1 of 60 mm, and a thickness of 10 mm, and the central connecting member has a width W1 parallel to the first width W2 of about 130 mm. Thus, in that exemplary embodiment, the aspect ratio of the enclosed leg 106 is about (270 / 60) or 4.5. In this same exemplary embodiment, the operation zone 158 has a width of about 10 mm.

[0046] Referring to Figure 1C, a cross-sectional view of a portion of the enclosed leg member 106 is shown. As previously noted, the first side surface 164 of the leg manifold member 160 is covered by the first leg encapsulation member 168, and the second inward side surface 166 of the leg manifold member 160 is covered by the second leg encapsulation member 170 (in this case, part of the non-fixable drape 148). Thus, in this exemplary embodiment, the opening 116 may be any of the multiple openings 150 within the non-fixable drape 148. In this exemplary embodiment, the peripheral edge 176 of the leg manifold member 160 is also covered by part of the first leg encapsulation member 168. The peripheral edge 176 includes a first side edge 177 and a second side edge 179. The first leg encapsulation member 168 covers the first side surface 164 and peripheral edge 176 and extends over the first surface 178 of the non-adherent drape 148, forming an extension 180. The extension 180 is joined to the second leg encapsulation member 170 by a weld 182. However, the first leg encapsulation member 168 may be joined to the second leg encapsulation member 170 using any known technique, including welding (e.g., ultrasonic or RF welding), bonding, adhesives, cement, etc.

[0047] In some embodiments, at least a portion of the longitudinal length of at least one of the enclosed leg members 106 is configured to contact the tissue portion 104. Furthermore, in some embodiments, the opening 116 may be positioned along the longitudinal length of at least one of the enclosed leg members 160.

[0048] Referring again to Figures 1D and 2, the central connecting member 112 includes a connecting manifold member 154 enclosed within a first connecting sealing member 186 having an opening 118. The first connecting sealing member 186 is positioned on the first side surface 188 of the connecting manifold member 154. The second connecting sealing member 192 is positioned on the second inward-facing side surface 190 of the connecting manifold member 154. The second connecting sealing member 192 has an opening 120. The first connecting sealing member 186 has a peripheral zone or edge 194, as shown in Figure 2. Similarly, the second connecting sealing member 192 has a peripheral zone or edge (not clearly shown) aligned with the peripheral edge 194. The periphery 194 of the first connecting encapsulating member 186 is coupled to the periphery of the second connecting encapsulating member 192, except for the leg coupling region 152, to allow fluid from within the multiple encapsulated leg members 106 to flow into the connecting manifold member 154, as indicated by arrow 196 in Figure 1D. The fluid may also enter the connecting manifold member 154 directly by flowing through the opening 120, as indicated by arrow 198. The manifold pad 122 is positioned adjacent to the first connecting encapsulating member 186, and when a depressurization is applied to the manifold pad 122, the depressurization causes fluid to flow from the connecting manifold member 154 into the manifold pad 122 through the opening 118, as indicated by arrow 200. The fluid continues to flow in the direction of the depressurization interface 128, through which the fluid is removed to the depressurization delivery conduit 130.

[0049] Referring to Figures 1A to 1D and Figure 2, during operation, the exemplary open-cavity decompression system 100 can be used by first sizing the therapeutic device 102, as will be further described below in relation to Figure 3A. The non-adherent drape 148, having a plurality of enclosed leg members 106, is placed into the abdominal cavity through the body cavity opening 126 and distributed to the abdominal contents. This may include placing at least one enclosed leg member 106 in the first paracolonic groove 108, the second paracolonic groove 110, or behind the liver, or in close proximity to them. Once the therapeutic device 102 is distributed, the manifold pad 122 is positioned adjacent to the first side surface 184 of the first connecting enclosed member 186. The sealing member 124 can then be applied over the body cavity opening 126 to provide a pneumatic seal over the body cavity opening 126.

[0050] In addition to the sealing member 124, the cavity opening 126 may be further closed or reinforced using mechanical closure means, such as staples or tension cords (Derma-close or ABRA (abdominal reapproximation anchor system) surgical skin suture closure), or a decompression closure system. The sealing member 124 can be applied in many ways, but according to one exemplary embodiment, a peelable backing member on the adhesive layer 136 of the sealing member 124 is removed, and the sealing member 124 is then positioned against the patient's epidermis 134 around the cavity opening 126. A decompression interface 128, such as a port 138, is then coupled or attached to the sealing member 124 so that decompression can be delivered by the interface 128 through the sealing member 124 to the manifold pad 122 and central connecting member 154. A decompression delivery conduit 130 is fluidly coupled to the decompression interface 128 and a decompression port 144 on the decompression source 132.

[0051] The decompression source 132 is activated, thereby providing decompression into the decompression delivery conduit 130, and the decompression source 132 delivers decompression to the decompression interface 128, as well as into the manifold pad 122 and the central connecting member 154. The manifold pad 122 distributes the decompression and draws fluid from the connecting manifold member 154 through the opening 118. The connecting manifold member 154 draws fluid from the abdominal cavity through the opening 120 and from the multiple sealed leg members 106, as indicated by arrow 196. The fluid from the abdominal cavity flows into the multiple sealed leg members 106 through the opening 114 on the first leg sealing member 168 and the opening 116 on the second leg sealing member 170, and then flows through the legs toward the connecting manifold member 154, as indicated by arrow 172. The fluid then flows into the decompression delivery conduit 130 through the manifold pad 122 and the decompression interface 128.

[0052] Referring here to Figures 3A to 3C, another exemplary embodiment of the open-cavity decompression therapy device 302 is shown. The open-cavity decompression therapy device 302 is similar in most respects to the therapy device 102 in Figures 1A to 1D. The open-cavity decompression therapy device 302 has a non-adherent drape 304, a plurality of enclosed leg members 306, and a central connecting member 308. In this particular exemplary embodiment, the non-adherent drape 304 is generally formed in an ellipsoidal or arcuate shape. The non-adherent drape 304 has a plurality of openings 305. The non-adherent drape 304 forms a second leg-enclosing member (referring by analogy to the second leg-enclosing member 170 in Figure 1B) and a second connecting enclosing member (referring by analogy to 192 in Figure 1D). Therefore, the multiple openings 305 serve as flow channels for the multiple enclosed leg members 306 and central connecting member 308 on the second inward-facing side surface. The non-adherent drape 304 can also be used on the first side surface of the multiple enclosed leg members 306 and central connecting member 308.

[0053] Each of the enclosed leg members 306 may be formed with a plurality of leg modules 310, having an operating zone 312 between the plurality of leg modules 310. Similar to the operating zone 158 in Figures 1A to 1D, the operating zone 312 can facilitate the movement of the plurality of enclosed leg members 306 within the body cavity and can provide easier locations for cutting the plurality of enclosed leg members 306 when the open cavity decompression therapy device 302 is being sized for a particular application. In this regard, a visual indicator 314 may be added on the non-adherent drape 304 to help healthcare providers know where to cut the non-adherent drape 304 for different size applications within the cavity. The visual indicator 314 may preferably include cutting lines or scales extending through the operating zone 312. In some embodiments, the operating zone 312 may provide a convenient and easy location for cutting the open cavity decompression therapy device 302. In other embodiments, the leg members 306 may be cut anywhere along their length. For example, in some embodiments, the leg member 306 may be cut to fit through the leg module 310, and the foam of the leg member manifold may then be pulled inward against the film or drape to prevent exposure to tissue sites.

[0054] Referring to Figure 3C, a cross-sectional view of a portion of the enclosed leg member 306 is shown. The multiple enclosed leg members 306 are formed by a leg manifold member 318 having a first side surface 320 and a second inward (patient-facing) side surface 322. The first leg encapsulation member 324 covers the first side surface 320 of the leg manifold member 318 and covers the lateral zone or edge 326 of the leg manifold member 318. The second inward side surface 322 of the leg manifold member 318 is covered by a second leg encapsulation member 328, which in this embodiment is part of a non-adherent drape 304. The first leg encapsulation member 324 is bonded to the second leg encapsulation member 328 by any means known in the art, such as welding (e.g., ultrasonic or RF), bonding, adhesive, cement, etc. In this exemplary embodiment, the first leg encapsulation member 324 and the second leg encapsulation member 328 are joined by a weld 330. Referring to Figure 3B, the weld 330 is shown along the perimeter of the multiple leg modules 310. In some embodiments, the weld 330 may be continuous along the perimeter of the leg modules. In other embodiments, the weld 330 may not be continuous. For example, the weld 330 may have small gaps along its length.

[0055] Referring again to Figure 3A, the central connecting member 308 is formed similarly to the central connecting member 112 in Figure 2. The first connecting encapsulating member 334 and the second connecting encapsulating member of the central connecting member 308 are joined along the periphery 332 using a weld 333 or another joining technique such as those described above. However, the periphery 332 is not sealed but is close to each of the encapsulated leg members 306 in order to provide a channel for fluid to flow from the multiple encapsulated leg members 306 into the central connecting member 308.

[0056] According to one exemplary method for constructing an open-cavity decompression therapy device 302, a non-adherent drape 304 having a visual display 314 is provided, with a plurality of openings 305 already formed. A leg manifold member 318 is positioned adjacent to the non-adherent drape 304. A central connecting manifold 308 may be positioned adjacent to the leg manifold member 318 or may be formed integrally with the leg manifold member 318. A first connecting encapsulation member 334 is positioned on the central connecting member 308, and a first leg encapsulation member 324 is positioned above the leg manifold member 318. The first connecting encapsulation member 334 and the first leg encapsulation member 324 may be formed from a single sheet. Welds 330 and 333 are then applied.

[0057] In an alternative embodiment for manufacturing an open-cavity decompression therapy device, a first non-adherent drape 304 including an opening may be provided, and a leg manifold member 318 and a central connecting manifold 308 are positioned on the first non-adherent drape 304. A second non-adherent drape having an opening is positioned across the first non-adherent drape 304, the leg manifold member 318, and the central connecting manifold 308. A number of welds (e.g., thermal or RF or another joining technique used) are then fabricated using a weld 330 or the like. The first non-adherent drape 304 and the second non-adherent drape may be cut to adjust size before or after assembly. By using two drapes, the first non-adherent drape 304 and the second non-adherent drape may provide better distribution of decompression and facilitate the manufacturing process.

[0058] The openings may be formed before or after assembly. The perimeters of the first non-fixed drape 304 and the second non-fixed drape may be welded. Other points may be welded between the drapes to form a single unit. In another alternative embodiment, the drapes may first be positioned and welded without openings, and then openings may be added to the drapes so that the openings are aligned. The openings may also be formed using electrical components that are simultaneously cut and sealed to form "buttonhole" openings aligned through the two drapes.

[0059] Referring to Figures 1A, 1D, and 4, in some exemplary embodiments, the manifold pad 122 may be configured to distribute pressure to the tissue 104 and other components of the system 100, such as the treatment device 102 or the treatment manifold 167. Thus, the manifold pad 122 may be positioned in close proximity to the treatment device 102 or the treatment manifold 167 and in fluid communication with them. In some examples, the manifold pad 122 may be in fluid communication with the treatment manifold 167 through a non-adherent drape 148, such as a first non-adherent drape 186, or a portion of the non-adherent drape 148. Furthermore, in some examples, the manifold pad 122 may be configured to be positioned in direct contact with the non-adherent drape 148 or the first non-adherent drape 186. Furthermore, in some examples, the manifold pad 122 may be positioned close to the connecting manifold member 154 or the central connecting member 112 and be in fluid communication with them. The sealing member 124 may be configured to cover the treatment manifold 167 and the manifold pad 122 at the tissue site 104.

[0060] Referring to Figures 1A and 4, in some exemplary embodiments, the manifold pad 122 may include a transverse width 424 extending from a first edge 426 to a second edge 428 on the opposite side. The transverse width 424 may be configured to extend across the cavity opening 126 in the tissue site 104. Furthermore, the manifold pad 122 may include a longitudinal length 430 extending from a first end 432 to a second end 434 on the opposite side. In some embodiments, the longitudinal length 430 may be greater than the transverse width 424 and perpendicular to the transverse width 424 of the manifold pad 122. The longitudinal length 430 may be configured to be positioned along a closure line that may be formed by both sides of the cavity opening 126 (e.g., an incision, wound edge, or line of staples or sutures). In some embodiments, the incision or cavity opening may be formed by an open wound having a wound margin. In some embodiments, the wound margin of the cavity opening 126 (which may be the abdominal cavity) may extend longitudinally. Furthermore, the manifold pad 122 may include a thickness 436 extending from a first side or surface 438 to a second side or surface 440 on the opposite side of the manifold pad 122. The thickness 436 of the manifold pad 122 may be perpendicular to both the lateral width 424 and the longitudinal length 430 of the manifold pad 122. In some embodiments, the term perpendicular may include orthogonal. In some embodiments, the thickness 436 of the manifold pad 122 may be in the range of about 5–25 mm, about 8–25 mm, about 8–16 mm, or about 5–16 mm. The first surface 438 of the manifold pad 122 may be configured to face outward from or away from the tissue site 104 and, for example, the treatment device 102, the treatment manifold 167, or parts thereof. In some embodiments, the first surface may be configured to face toward the sealing member 124. Furthermore, the second surface 440 of the manifold pad 122 may be configured to face the tissue site 104 and, for example, the treatment device 102, the treatment manifold 167, or parts thereof.In some embodiments, the first surface 438 may reflect the second surface 440 of the manifold pad 122.

[0061] Referring to Figures 5 and 6, some embodiments of the manifold pad 122 may include a foam, such as an open-cell foam, or may consist essentially of a foam, such as an open-cell foam. Some embodiments of the manifold pad 122 may have a first surface 438 and a second surface 440, with the thickness 436 of the foam extending between the first surface 438 and the second surface 440. In some embodiments, the first surface 438 may be configured to face outward away from the tissue site (e.g., toward and / or in contact with the portion of the sealing member 124 above the manifold pad 122), and the second surface 440 may be configured to face toward the tissue site (e.g., toward and / or in contact with the portion of the treatment device 102 beneath the manifold pad 122). In some embodiments, the foam of the manifold pad 122 may have a plurality of elongated, oval or ellipsoidal pores 505 (e.g., bubbles formed by the cellular structure of the foam). In some embodiments, the foam may include an open-cell foam. For example, the open-cell foam of the manifold pad 122 may have an open-cell or perforated cellular structure, and the oval pores 505 may be formed by the cellular structure. In some embodiments (not shown), the manifold pad 122 may also include pores that may provide additional porosity in addition to the oval pores / pores 505 of the foam of the manifold pad 122. In some embodiments, the manifold pad 122 may be configured for use in abdominal wounds and may typically be configured to shrink under the application of negative pressure to laterally close the abdominal wound without significantly reducing the thickness 436 of the manifold pad 122.

[0062] In some embodiments, the manifold pad 122, its foam, and / or the oval-shaped pores 505 may be configured to shrink (e.g., collapse) in a plane substantially parallel to the first surface 438 and / or the second surface 440 (e.g., about + / - 10 degrees) when negative pressure is applied. For example, the manifold pad 122 may be configured to shrink radially or transversely when negative pressure is applied. In some embodiments, the foam and / or the manifold pad 122 may be configured to preferentially shrink in a plane substantially parallel to the first surface 438 and / or the second surface 440 (e.g., radially or transversely) when negative pressure is applied to the manifold pad 122. In some embodiments, the foam of the manifold pad 122 may be configured to preferentially shrink in a plane substantially perpendicular to the thickness 436 when negative pressure is applied to the manifold pad 122, for example, shrinking more in the plane substantially perpendicular to the thickness 436 than at the thickness 436. In some embodiments, the manifold pad 122 may be configured to resist shrinkage of the thickness 436, for example, with less shrinkage of the thickness 436 in the lateral or radial direction under negative pressure. In some embodiments, the foam of the manifold pad 122 may be configured to be more resistant to shrinkage of the thickness 436 than shrinkage in a plane substantially parallel to the first surface 438 and / or the second surface 440 (e.g., radial or lateral direction). In some embodiments, the foam of the manifold 122 may be configured to be more resistant to shrinkage of the thickness 436 than shrinkage in a plane substantially perpendicular to the thickness 436. In some embodiments, the manifold pad 122 may be configured to have substantially no shrinkage of the thickness 436 in the direction extending from the first surface 438 to the second surface 440 under negative pressure. In some embodiments, the manifold pad 122 may be configured to have no significant shrinkage of the thickness 436 of the manifold pad 122 under applied negative pressure.

[0063] As shown in Figure 6, each oval hole 505 may have a major axis 610 and a minor axis 605, where the length of the oval hole 505 along the major axis 610 is longer than the length of the oval hole 505 along the minor axis 605. For example, the major axis 610 of each oval hole 505 may extend longitudinally and to the maximum length of the oval hole 505, and the corresponding minor axis 605 may extend laterally and to the minimum width of the oval hole 505. In some embodiments, for each oval hole 505, the major axis 610 may be oriented substantially perpendicular to the minor axis 605. In some embodiments, the oval holes 505 may be oriented to facilitate preferential lateral or radial contraction of the manifold pad 122. For example, the minor axis 605 may be oriented so as to be 44 degrees or less from parallel to the first surface 438 and / or the second surface 440 (for example, oriented in an arc ranging from 44 degrees above parallel to the first and / or second surface to 44 degrees below parallel to the first and / or second surface), and / or the major axis 610 may be oriented so as to be 44 degrees or less from parallel to the thickness 436. In general, the closer the minor axis 605 of the oval hole 505 is oriented to be parallel to the first surface 438 and / or the second surface 440 (and / or perpendicular to the thickness 436), the more favorable lateral or radial shrinkage will be compared with the shrinkage of the thickness 436 when negative pressure is applied to the manifold pad 122. Similarly, if the long axis 610 is oriented more perpendicular to the first surface 438 and / or the second surface 440 (and / or parallel to the thickness 436), then when negative pressure is applied to the manifold pad 122, a more preferential lateral or radial shrinkage is compared with the shrinkage of the thickness 436. In some embodiments, the short axis 605 may be oriented at an angle of 25 degrees or less, 20 degrees or less, 15 degrees or less, or 10 degrees or less from parallel to the first surface 438 and / or the second surface 440. Preferably, the long axis 610 may be oriented substantially perpendicular to the first surface 438 and / or the second surface 440, the long axis may be oriented substantially parallel to the thickness, the short axis may be oriented substantially perpendicular to the thickness, and / or the short axis 605 may be oriented substantially parallel to the first surface 438 and / or the second surface 440.

[0064] In some embodiments, the oval-shaped holes 505 may be configured to contract along the minor axis 605 (for example, in the direction of the minor axis 605) in response to the application of negative pressure to the manifold pad 122. For example, each of the oval-shaped holes 505 may be configured to contract from an initial relaxed position to a contracted position in response to the application of negative pressure. In some embodiments, the oval-shaped holes 505 may be configured to preferentially contract in a plane substantially parallel to the first surface 438 and / or the second surface 440 (for example, radially or transversely) when negative pressure is applied to the manifold pad 122. In some embodiments, the oval-shaped holes 505 may be configured to preferentially contract in a plane substantially perpendicular to the thickness 436 when negative pressure is applied. For example, each of the oval-shaped holes 505 may be configured to contract more in the direction of the minor axis 605 than in the direction of the major axis 610 when negative pressure is applied. In some embodiments, the oval-shaped holes 505 may be configured to resist contraction along the long axis 610 (e.g., in the direction of the long axis 610) when negative pressure is applied to the manifold pad 122. In some embodiments, the oval-shaped holes 505 may be configured to resist contraction along the long axis 610 (e.g., in the direction of the long axis 610) more than contraction along the short axis 605 (e.g., in that direction). In some embodiments, the oval-shaped holes 505 may be configured not to undergo significant contraction along the long axis 610 (e.g., in the direction of the long axis 610) when negative pressure is applied to the manifold pad 122. In some embodiments, the oval-shaped holes 505 may be configured not to contract substantially along the long axis 610 (e.g., in the direction of the long axis 610) when negative pressure is applied to the manifold pad 122.

[0065] In some embodiments, the foam of the manifold pad 122 may comprise a felted foam that can be formed by a felting process. As described herein, the terms “felting” or “felted” can refer to a porous material, such as the foam of the manifold pad 122, that has been treated or modified to impart desired properties to the porous material. For example, the porous material may be a foam that has been treated or modified to have desired porosity or density. Any porous foam suitable for felting may be used, including the exemplary foams referred herein, such as those found in GRANUFOAM® dressing materials. Generally, felting involves a thermoforming process that permanently compresses the foam to increase its density while maintaining interconnected paths. For example, to produce a felted foam, such as felted polyurethane, a foam blank 705 of an uncompressed material can be heated to an optimal forming temperature and then compressed.

[0066] Felting can be carried out by any known method which may include applying heat and pressure to a porous or foamed material. Such a method may include compressing the porous material for a specific time and at a specific temperature between one or more heated platens or dies (not shown). As shown in Figure 7, the direction of compression 710 (e.g., axis) may be along or parallel to the initial thickness of the foam blank 705 of the porous material. The felting process may alter certain properties of the original material, including pore shape and / or size, elasticity, density, and density distribution. For example, struts defining pores in the foam may be deformed during the felting process, resulting in a flattened pore shape. In some embodiments, the felting process may form oval or ellipsoidal pores or bubbles. Deformed struts may also reduce the elasticity of the foam. The density of the foam generally increases with felting. In some embodiments, contact with a hot-pressed platen in the felting process may also result in a density gradient where density is higher at the surface and pore size is smaller at the surface.

[0067] Felted foams can be characterized by a hardness coefficient that indicates the compression of the foam. The hardness coefficient of a felted foam can be specified as the ratio of the original thickness to the final thickness. Compressed or felted foams may have a hardness coefficient greater than 1. The degree of compression can affect the physical properties of a felted foam. For example, a felted foam may typically have an increased effective density compared to a foam of the same material that has not been felted. The felting process can also affect the interaction between the fluid and the foam. For example, as density increases, compressibility or collapse may decrease in several directions. There is a general linear relationship between hardness level, density, pore size (or pores per inch), and compressibility. For example, a foam found in GRANUFOAM® dressing material felted to a hardness coefficient of 3 shows a 3-fold increase in density and is compressed to about one-third of its original thickness.

[0068] The compression period may range from 10 minutes to 24 hours, but may be longer or shorter depending on the specific type of porous material used. Furthermore, in some examples, the temperature may range between 120°C and 260°C. Generally, the lower the platen temperature, the longer the porous material must be held in a compressed state. After a certain period, the pressure and heat form a felted structure or surface through the porous material or a portion of it. The felted structure may be relatively smoother than any unfinished or unfelted surface or portion of the porous material. Furthermore, the pores in the felted structure may be smaller than the pores throughout any unfinished or unfelted surface or portion of the porous material. In some examples, the felted structure may be applied to all surfaces or portions of the porous material. Furthermore, in some examples, the felted structure may extend throughout the entire thickness of the porous material so that the entire porous material is felted. Typically, the entire manifold pad 122 may be felted to a uniform hardness coefficient throughout, but in other embodiments, the hardness coefficient may vary throughout the manifold pad 122.

[0069] In some embodiments, the felted foam for the manifold pad 122 is approximately 1.3–1.6 lb / ft 3The foam blank 705 may be formed from an open-cell foam such as polyurethane foam having an initial (e.g., pre-felting) density, a free volume of about 90% or more, an average number of pores of about 40 to 50 per inch, an average pore size of about 400 to 600 microns, a 25% compression load deflection of at least 0.35 pounds per square inch, and / or a 65% compression load deflection of at least 0.43 pounds per square inch. The felted foam may have a compression axis (e.g., direction) 710. As shown in Figure 7, the foam blank 705 may be compressed and / or felted in the direction of the compression axis 710 (e.g., parallel to the compression axis 710) to form a foam having oval pores 505. In some embodiments, the minor axis 605 of the oval pores 505 may be substantially parallel to the compression axis 710, and / or the major axis 610 of the oval pores 505 may be substantially perpendicular to the compression axis 710. In some embodiments, the felted foam may be compressed (e.g., felted) to have a hardness coefficient of 2-7, 3-7, 2-5, 3-5, 2-3, or 5-7.

[0070] In some embodiments, the manifold pad 122 has a free volume ranging from about 13% to about 45%, and a volume of about 2.6 to 11.2 lb / ft. 3 The open-cell foam comprises, or may essentially consist of, a density, an average of about 80 to 350 pores per inch (e.g., measured in the compression direction / compression axis 710), and / or an average pore size of about 57 to 300 microns (e.g., measured in the compression direction / compression axis 710). In some embodiments, the foam blank 705 (e.g., similar to those described above) may be felted to obtain a foam having these properties. In some embodiments, the manifold pad 122 has a free volume ranging from about 18% to about 45%, and a volume of about 2.6 to 8.0 lb / ft. 3The open-cell foam comprises, or may essentially consist of, a density, an average of about 80 to 250 pores per inch (e.g., measured in the compression direction / compression axis 710), and / or an average pore size of about 80 to 300 microns (e.g., measured in the compression direction / compression axis 710). In some embodiments, the foam blank 705 (e.g., similar to those described above) may be felted to obtain a foam having these properties. In some embodiments, the manifold pad 122 has a free volume in the range of about 18% to about 30%, and a volume of about 3.9 to 8.0 lb / ft. 3 The open-cell foam comprises, or may essentially consist of, a density, an average of about 120 to 250 pores per inch (e.g., measured in the direction / axis of compression 710), and / or an average pore size of about 80 to 200 microns (e.g., measured in the direction / axis of compression 710). In some embodiments, the foam blank 705 (e.g., similar to those described above) may be felted to obtain a foam having these properties. In some embodiments, the manifold pad 122 has a free volume in the range of about 30% to about 45%, and a volume of about 2.6 to 4.8 lb / ft. 3 The open-cell foam comprises, or may essentially consist of, an open-cell foam having a density of approximately 80 to 150 pores per inch on average (e.g., measured in the direction / axis of compression 710), and / or an average pore size of approximately 133 to 300 microns (e.g., measured in the direction / axis of compression 710). In some embodiments, the foam blank 705 (e.g., similar to those described above) may be felted to obtain a foam having these properties. In some embodiments, the manifold pad 122 has a free volume in the range of approximately 30 to 33%, and a volume of approximately 3.9 to 4.8 lb / ft. 3The foam comprises, or may essentially consist of, an open-cell foam having a density, an average of about 120 to 150 pores per inch (measured in the direction / axis of compression 710), and / or an average pore size of about 133 to 200 microns (measured in the direction / axis of compression 710). In some embodiments, the foam blank 705 (e.g., similar to those described above) may be felted to obtain a foam having these properties.

[0071] In some embodiments, the felted foam may be composed of and / or oriented oval pores 505 having a major axis 610 substantially parallel to the thickness 436, which may result in improved shrinkage properties compared to unfelted foam of the same type and thickness. For example, the felted foam may be more resistant to thickness shrinkage under applied negative pressure and / or may offer greater lateral shrinkage under applied negative pressure than a similar unfelted foam. See, for example, the experimental data below.

[0072] The samples provided were as follows: three unfelted GRANUFOAM® blocks with a starting size of 25 mm (height) x 25 mm (width) and nearly spherical holes; three 3x felted (e.g., hardness coefficient 3) GRANUFOAM® blocks with a starting size of 25 mm (height) x 25 mm (width) and oval holes oriented with a major axis nearly parallel to the thickness (e.g., height); and three 5x felted (e.g., hardness coefficient 5) GRANUFOAM® blocks with a starting size of 25 mm (height) x 25 mm (width) and oval holes oriented with a major axis nearly parallel to the thickness (e.g., height). Negative pressure (e.g., approximately -125 mmHg) was applied to all three samples, and the height and width measurements under the applied negative pressure were recorded as follows.

[0073] TIFF2026076278000002.tif39170

[0074] In some embodiments, a felted foam with oval-shaped holes whose long axes are oriented substantially parallel to the thickness (e.g., height) may shrink in thickness by about half or less under applied negative pressure compared to a similar unfelted foam. For example, a felted foam with oval-shaped holes whose long axes are oriented substantially parallel to the thickness may shrink in thickness by about 1 / 2 to 1 / 5 under applied negative pressure compared to a similar unfelted foam. In some embodiments, a felted foam with oval-shaped holes whose long axes are oriented substantially parallel to the thickness may have a lateral shrinkage of about 16 times or more compared to a similar unfelted foam under applied negative pressure. For example, a felted foam with oval-shaped holes whose long axes are oriented substantially parallel to the thickness may have a lateral shrinkage of about 16 to 24 times greater than that compared to a similar unfelted foam under applied negative pressure.

[0075] In some embodiments, the resistance to thickness shrinkage due to the orientation of the oval pores can maintain a surface area that transmits a higher lateral closing force under applied negative pressure compared to the closing force from a similar unfelted foam. For example, a 3x felted foam with oval pores oriented substantially parallel to its thickness (e.g., a foam with a hardness coefficient of 3) may have about 30–70% better (e.g., greater) lateral closing force than a similar unfelted foam under applied negative pressure. Similarly, if a specific lateral closing force is desired under applied negative pressure, the amount of that lateral closing force can be produced using less negative pressure if a felted foam with oval pores oriented substantially parallel to its thickness is used instead of a similar unfelted foam.

[0076] For example, some embodiments of the dressing material, such as those shown in Figures 5-6, may comprise a foam manifold pad 122 similar to those described herein. In some embodiments, the manifold pad 122 may be configured for use with an abdominal wound and may be configured to contract under the application of negative pressure to laterally close the abdominal wound without significantly reducing the thickness 436 of the manifold pad 122. In some embodiments, the dressing material may further comprise a treatment device 102 which may be configured as a visceral protective layer to provide separation between the abdominal wall and the viscera and to protect the abdominal contents. In some embodiments, the treatment device 102 may have a film layer and may be configured to allow fluid to flow radially under applied negative pressure. In some embodiments, the treatment device 102 may comprise a central hub and a plurality of elongated members extending outward from the central hub. In some embodiments, the plurality of elongated members may comprise 4 to 8 elongated members that can be evenly spaced around the central fluid hub. In some embodiments, each elongated member may be in fluid communication with the central fluid hub. In some embodiments, the film layer may have multiple channels configured to allow radial fluid flow (e.g., flow from an elongated member to a central fluid hub). In some embodiments, the manifold pad 122 may be configured to be positioned in close proximity to and / or in contact with the central fluid hub (e.g., between the central fluid hub of the treatment device 102 and the sealing member 124).

[0077] In some embodiments, the treatment device 102 may further comprise a treatment manifold that can be attached to a film layer. In some embodiments, the treatment manifold may comprise an open-cell foam. In some embodiments, the treatment manifold may be enclosed or sealed by a film layer, which may be a non-adherent drape with multiple openings. In some embodiments, the treatment manifold may comprise a central connecting manifold member and a plurality of leg manifold members extending outward from the central connecting manifold member. In some embodiments, there may be 4 to 8 leg manifold members that can be evenly spaced around the central connecting manifold member. In some embodiments, each of the leg manifold members may be in fluid communication with the central connecting manifold member. Some dressing embodiment may further comprise a sealing member 124 configured to cover the manifold pad 122 and the treatment device 102 and to provide a pneumatic seal to the tissue site. In some embodiments, the sealing member 124 may be positioned above the treatment device 102 and the manifold pad 122 and configured to create a sealing space over the tissue site. In some embodiments, the manifold pad 122 may be configured such that a first surface 438 faces and / or contacts the portion of the sealing member 124 positioned above the manifold pad 122, and a second surface 440 faces and / or contacts the portion of the treatment device 102 below the manifold pad 122. In some embodiments, the manifold pad 122 may be configured to distribute the applied negative pressure to the treatment device 102 (and thereby to the tissue site). In some embodiments, the treatment device 102 may comprise a single film layer, which may be attached to the surface of the treatment manifold. In some embodiments, the film layer may comprise a plurality of openings. In some embodiments, the treatment manifold may comprise a closed-cell foam having multiple channels and / or passages configured for the distribution of applied negative pressure and / or the radial inward draw of fluid (such as exudate). In some embodiments, the treatment device 102 may be similar to those described in more detail with respect to Figures 1A to 4.

[0078] In some embodiments, each of the oval-shaped holes 505 may be configured to be oriented such that its short axis 605 is substantially parallel to a portion of the sealing member 124 above the manifold pad 122. In some embodiments, each of the oval-shaped holes 505 may be configured to be oriented with a short axis 605 substantially parallel to a portion of the treatment device 102 below the manifold pad 122. In some embodiments, each of the oval-shaped holes 505 may be configured to be oriented with a short axis 605 substantially parallel to a portion of the tissue site below the manifold pad 122.

[0079] System embodiments may include a dressing material similar to those described herein and a negative pressure source fluidly coupled to the dressing material. In some embodiments, the negative pressure source may be fluidly coupled to a sealing space formed by the dressing material. For example, the negative pressure source may be in fluid communication with the manifold pad 122 through a sealing member 124, and the applied negative pressure may be distributed to the tissue site through the manifold pad 122 and through the treatment device 102. In some embodiments, the dressing material may be used on a tissue site with an incision, and the application of negative pressure to the manifold pad 122 may bring the incision or wound edge together to facilitate closure of the wound tissue site.

[0080] A method for forming a manifold pad 122 or dressing may include the steps of: providing a foam blank having a plurality of holes; altering the foam blank 705 to form a foam, wherein the altered holes in the foam are oval-shaped, each having a major axis 610 and a minor axis 605, and molding the foam to form a manifold pad 122 having a first surface 438, a second surface 440, and a foam thickness 436 extending between the first surface 438 and the second surface 440. In some embodiments, the minor axis 605 may be substantially parallel to the first surface 438 and / or substantially perpendicular to the thickness. In some embodiments, modifying the foam blank 705 may involve compressing the foam blank 705 along the compression axis (e.g., direction) 710 to permanently deform the multiple holes in order to form a foam having oval holes 505 with a major axis 610 substantially perpendicular to the compression axis 710 and a minor axis 605 substantially parallel to the compression axis 710. Figure 7 shows such a modification of the foam blank 705. In some embodiments, the foam may be heated when compressed.

[0081] In some embodiments, the step of forming the foam may include cutting the foam substantially perpendicular to the compression axis 710. In some embodiments, the step of forming the foam may include cutting the foam to form a first surface 438 substantially parallel to the minor axis 605 and a major axis 610 substantially perpendicular to the first surface 438. In some embodiments, the step of forming the foam may include rotating the foam by at least 46 degrees, at least 65 degrees, at least 70 degrees, or at least 80 degrees before cutting the foam in the thickness direction (e.g., substantially perpendicular to the compression axis). Generally, the closer the angle of rotation of the foam is to 90 degrees, the more preferentially it shrinks in the lateral or radial direction compared to shrinkage in thickness. Therefore, in some embodiments, the step of forming the foam may include rotating the foam by about 90 degrees (e.g., rotating the compression axis 710 by about 90 degrees after compression) and then cutting the foam in the thickness direction (e.g., substantially perpendicular to the rotated compression axis). In some embodiments, the compression axis 710 may be rotated by about 90 degrees before cutting, and the cutting is then performed in the thickness direction and / or substantially perpendicular to the rotated compression axis 710. In some embodiments, the step of modifying the foam blank 705 may include the step of felting the foam blank 705 along the compression axis 710 to a hardness coefficient of 2-7, 2-5, 3-5, or about 3, so that the foam is formed with oval holes 505 having a major axis 610 substantially perpendicular to the compression axis 710 and a minor axis 605 substantially parallel to the compression axis 710. In some embodiments, the foam blank 705 may have its original thickness, and the step of felting the foam blank 705 may include the step of heating and compressing the foam blank 705 to about 1 / 2-1 / 7, 1 / 2-1 / 5, or 1 / 3-1 / 5 of its original thickness. In some embodiments, a plurality of foam blanks are provided, which may be modified (e.g., by felting) to form oval pores, and the plurality of modified foam blanks (e.g., a plurality of foams resulting from the modification process) may then be joined together, for example, by lamination.The step of joining multiple foams together may include the step of oriented the multiple foams such that the oval pores in all of the multiple foams are oriented in substantially the same direction (for example, parallel to each other). In some embodiments, the pre-felted or pre-compressed foam blank 705 has a weight of approximately 1.3 to 1.6 lb / ft. 3 It may have a density of approximately 90% or more free volume, an average number of pores of approximately 40 to 50 per inch, an average pore diameter of approximately 400 to 600 microns, a 25% compression load deflection of at least 0.35 pounds per square inch, and / or at least 0.43 pounds or 65% compression load deflection per square inch.

[0082] In some embodiments, the method may further include the step of providing a treatment device 102 having a film layer and configured to allow a fluid to flow radially under applied negative pressure. In some embodiments, the step of providing the treatment device 102 may include the step of forming a treatment manifold having a central connecting manifold member and a plurality of leg manifold members extending outward from the central connecting manifold member, each of which is in fluid communication with the central connecting manifold member. In some embodiments, the step of providing the treatment device 102 may further include the step of attaching the film layer to the treatment manifold. In some embodiments, the film layer may enclose the treatment manifold.

[0083] For example, to treat a tissue site using a manifold pad 122, treatment device 102, dressing material, and / or system similar to those described herein, exemplary methods may include the steps of applying a treatment device 102 similar to those described herein to the tissue site, applying a manifold pad 122 similar to those described herein above the treatment device 102, and applying a sealing member 124 above the manifold pad 122 to form a sealing space over the tissue site. In some embodiments, the manifold pad 122 may be applied with a first surface 438 substantially parallel to a portion of the tissue site beneath the manifold pad 122, an oval-shaped hole 505 oriented with a major axis 610 substantially perpendicular to the first surface 438, a minor axis 605 substantially parallel to the first surface 438, a minor axis 605 substantially parallel to a portion of the tissue site beneath the manifold pad 122, a minor axis 605 substantially parallel to a portion of the treatment device 102 beneath the manifold pad 122, and / or a minor axis 605 substantially parallel to a portion of the sealing member 124 positioned above the manifold pad 122. Some embodiments may further include the steps of applying negative pressure to the manifold pad 122 and, in response to the application of negative pressure, shrinking the manifold pad 122 in a plane substantially parallel to the first surface 438 without significantly reducing (e.g., decreasing) the thickness 436. In some embodiments, the step of applying negative pressure may include fluid coupling the negative pressure source to the manifold pad 122 through the sealing member 124.

[0084] Next, another exemplary embodiment for using the open cavity decompression treatment device or system according to the present disclosure is presented. The system is particularly suitable for temporary bridging of abdominal wall openings where primary closure may not be readily possible and / or repeated abdominal access is required. The exemplary systems described herein may be used with open abdominal wounds having exposed viscera, including but not limited to abdominal compartment syndrome. Hemostasis should typically be achieved before applying the system.

[0085] When deploying an open-cavity decompression therapy system, the decompression therapy device preferably covers all exposed viscera and preferably completely separates the viscera from contact with the abdominal wall. For example, the underside of a decompression therapy device such as drape 148 can be sized and shaped to allow for covering. The decompression therapy device may be positioned above the omentum or exposed viscera and carefully pressed between the abdominal wall and the viscera. In this way, healthcare providers can use the decompression therapy device to completely separate the abdominal wall from the internal organs.

[0086] To prepare for system deployment, any sharp edges or bone fragments are removed from or covered from the wound area. The abdominal wound is cleansed, and the surrounding area is cleansed. The surrounding tissue in the epidermis is typically dried before further application.

[0087] Next, the decompression therapy device is sized by determining the appropriate size and cutting it. The decompression therapy device is first unfolded in a sterile field. Either side of the decompression therapy device can be positioned over the omentum or viscera. The decompression therapy device is gently placed over the open abdominal cavity. The orientation of the decompression therapy device for a specific application is determined. If the decompression therapy device is positioned around a tube, drain, or sickle ligament, the decompression device is cut only between multiple enclosed leg members. The decompression therapy device is positioned in the appropriate orientation before cutting.

[0088] The decompression device may then be folded to size and used in that manner, or it may be cut. The healthcare provider holds the edge of the decompression device and lifts it slightly. With one hand, the healthcare provider slowly lowers the decompression device into the paracolonic groove, and with the other hand, gently and evenly lowers the decompression device. The healthcare provider folds any excess portion of the decompression device over itself. The healthcare provider continues to position the decompression device between the abdominal wall and the viscera throughout the abdominal compartment. It is preferable that the healthcare provider completely covers all the viscera. The decompression device may then be cut to the size of the outside of the wound, if necessary.

[0089] To adjust the size of the device, the decompression therapy device may be cut using sterile scissors through the center of one of the larger manifold squares or leg modules. In this exemplary embodiment, the cut is made through the leg module rather than through the operating zone. The healthcare provider then pulls the manifold material through the encapsulating member with one hand, grasping the remaining half of the foam square or leg module and the adjacent inner operating zone. The manifold material in the leg module and operating zone will be separated by the next square or leg module. This will ensure that the edges of the decompression therapy device cover the manifold edges that would normally be exposed. The manifold material, such as foam, preferably does not come into contact with the organ.

[0090] Next, a manifold pad is prepared to be placed on the central connecting member. In this embodiment, the manifold pad may be a perforated foam manifold having perforations to help tear the manifold to the desired size. The manifold pad preferably fits directly above the decompression therapy device while still in contact with the wound edge. The manifold pad should generally not be in contact with intact skin. In some cases, two or more manifolds may be used. The sized manifold pad is then gently placed in the wound cavity above the decompression therapy device. It is preferable for the healthcare provider to take care to avoid the manifold pad being below the location of the abdominal incision or wound.

[0091] Next, a drape, overdrape, or sealing member is applied. To apply the drape, the backing is removed from the fixing layer on one side of the drape and the drape is applied. The drape covers the manifold and a portion of the intact epidermis. Preferably, the drape covers at least 8-10 centimeters of the boundary of the intact wound tissue. Additional draping material may be used to seal any difficult areas.

[0092] Next, a decompression interface or interface pad is added. The healthcare provider selects the application site. This site is selected to optimize fluid flow and facilitate the positioning of the tube. The healthcare provider pinches the drape and cuts a 2.5 cm hole (preferably not a slit) in the drape. An interface pad having a central disc and a surrounding outer adhesive peripheral portion is applied. This interface pad is applied by removing the backing layer on the inward surface of the interface pad to expose the adhesive. The interface pad opening in the central disc is positioned directly above the hole in the drape. Gently apply pressure on the central disc and the outer peripheral portion to ensure complete adhesion of the interface pad. Then, one or more stabilizing layers may be removed from the first side of the peripheral portion. The system is now ready for decompression application.

[0093] The systems, apparatus, and methods described herein can offer significant advantages. For example, the manifold pads or dressings disclosed can distribute negative pressure to a tissue site, which can facilitate the removal of fluids such as exudate from the tissue site. Some embodiments of the manifold pads or dressings may be configured to draw the edges of an incision in the tissue site toward each other. For example, applying negative pressure to the manifold pad can provide a lateral closing force to the incision. Some embodiments of the pads may also be configured to resist thickness collapse when negative pressure is applied. These and other advantages may arise from this disclosure.

[0094] When something is described as “exemplary” or “example,” it should be understood that this refers to a non-exclusive example. Terms such as “about” or “approximately,” when used with a number, may mean a range close to that particular number, or a particular number as understood by those skilled in the art (e.g., + / - 10%). The use of broader terms such as “comprises,” “includes,” and “having” should be understood as providing support for narrower terms such as “consisting of,” “consisting essentially of,” and “comprised substantially of.” The use of terms such as “optionally,” “may,” “might,” “possibly,” “could,” “can,” “would,” “should,” “preferably,” “typically,” and “often” relating to any element, component, feature, or characteristic of an embodiment means that the element, component, feature, or characteristic may not be required, or may be required instead, and both options are within the scope of the embodiment. Such elements, components, features, or characteristics may be included or excluded at the discretion of some embodiments (for example, forming alternative embodiments, all of which are within the scope of the disclosure). Section headings used herein are provided for consistency and convenience and do not limit or characterize any invention(s) described in any claim(s) that may be issued from this disclosure. Where a reference number is used to refer to a specific example of a more general term, that reference number may also be used to refer to a general term (and vice versa).

[0095] As shown in several exemplary embodiments, it will be understood by those skilled in the art that the systems, apparatus, and methods described herein are subject to various modifications and alterations within the scope of the appended claims. Furthermore, descriptions of various alternative forms using terms such as “or” do not require mutual exclusivity unless clearly required by context, and the indefinite articles “a” or “an” do not limit the subject to a single case unless clearly required by context. Components may also be combined or excluded in various configurations for the purpose of sale, manufacture, assembly, or use. For example, in some configurations, the therapeutic device, manifold pad, and / or sealing member may be excluded or separated from other components for manufacture or sale. In other exemplary configurations, the controller may also be manufactured, configured, assembled, or sold independently of the other components.

[0096] The attached claims describe the novelty and inventive step of the subject matter described above, but the claims may also include additional subject matter not specifically described in detail. For example, certain features, elements, or embodiments may be omitted from the claims if they are not necessary to distinguish the novel and inventive features from those already known to those skilled in the art. Features, elements, and embodiments described in the context of some embodiments may also be omitted, combined, or replaced by alternative features that serve the same, equivalent, or similar purposes, without departing from the scope of the invention as defined by the attached claims. Furthermore, features, elements, and embodiments described in relation to a particular embodiment may be combined with features, elements, and embodiments described in relation to one or more other embodiments.

Claims

1. A foam manifold pad, The first surface and The second surface and The thickness of the foam extending between the first surface and the second surface is provided, The foam material of the manifold pad has a plurality of egg-shaped holes, The manifold pad is configured to contract in a plane substantially parallel to the first surface when negative pressure is applied. Foam manifold pad.

2. The manifold pad according to claim 1, wherein the oval-shaped holes are configured to contract in a direction substantially parallel to the first surface when negative pressure is applied to the manifold pad.

3. The manifold pad according to claim 1, wherein the manifold pad is configured such that its thickness does not substantially shrink in the direction extending from the first surface to the second surface under negative pressure.

4. The manifold pad according to claim 1, wherein the manifold pad is configured to contract more radially or transversely than in thickness under applied negative pressure.

5. Each of the aforementioned oval-shaped holes is provided with a long axis and a short axis, The aforementioned long axis is oriented substantially perpendicular to the first surface, The short axis is oriented substantially parallel to the first surface, For each oval-shaped pore, the long axis is substantially perpendicular to the short axis. For each oval-shaped pore, the length along the major axis is longer than the length along the minor axis. The manifold pad according to claim 1.

6. The manifold pad according to claim 5, wherein the oval-shaped pore is configured to contract more in the direction of the minor axis than in the direction of the major axis when negative pressure is applied.

7. The manifold pad according to claim 1, wherein the foam includes an open-cell foam.

8. The manifold pad according to claim 5, wherein the foam comprises a felted foam having a compression axis, and the minor axis of the oval-shaped pore is substantially parallel to the compression axis.

9. The manifold pad according to claim 8, wherein the felted foam has a hardness coefficient of 2 to 7.

10. The manifold pad according to claim 9, wherein the ratio of the contraction of the short axis to the contraction of the long axis of the oval-shaped hole is greater than 1 under the applied negative pressure.

11. A dressing material for treating tissue sites, A therapeutic device having a film layer and configured to allow fluid to flow radially under applied negative pressure, In open-cell foam manifold pads, The first surface and The second surface and The thickness of the open-cell foam extending between the first surface and the second surface, The open-cell foam of the manifold pad has a plurality of egg-shaped holes, The manifold pad is configured to contract in a plane substantially parallel to the first surface when negative pressure is applied. The manifold pad is configured to shrink to a thickness less in the radial or transverse direction under the applied negative pressure. Dressing ingredients.

12. The dressing material according to claim 11, further comprising a sealing member configured to cover the manifold pad and the treatment device and to provide an air pressure seal to the tissue site.

13. Each of the aforementioned oval-shaped holes is provided with a long axis and a short axis, The aforementioned long axis is oriented substantially perpendicular to the first surface, The short axis is oriented substantially parallel to the first surface, For each oval-shaped pore, the long axis is substantially perpendicular to the short axis. For each oval-shaped pore, the length along the major axis is longer than the length along the minor axis. The egg-shaped pore is configured such that, when negative pressure is applied, the egg-shaped pore contracts more in the direction of the minor axis than in the direction of the major axis. The dressing material according to claim 11.

14. The foam comprises a felted foam having a compression shaft, The minor axis of the oval-shaped hole is substantially parallel to the compression axis, The felted foam has a hardness coefficient of 2 to 7. The dressing material according to claim 13.

15. A method for forming a dressing material, The steps include providing a foam blank having multiple pores, In the step of forming a foam by changing the foam blank, Each of the altered pores in the foam is oval-shaped, having a long axis and a short axis. In the step of forming the foam to create a manifold pad having a first surface, a second surface, and a thickness of foam extending between the first surface and the second surface, the short axis is substantially parallel to the first surface, method.

16. The method according to claim 15, wherein the step of altering the foam blank includes compressing the foam blank along the compression axis to permanently deform the plurality of holes to form a foam having oval holes having a major axis substantially perpendicular to the compression axis and a minor axis substantially parallel to the compression axis.

17. The method according to claim 16, wherein the step of molding the foam includes the step of cutting the foam perpendicular to the compression axis.

18. The method according to claim 15, wherein the step of forming the foam includes cutting the foam to form a first surface substantially parallel to the short axis and a long axis substantially perpendicular to the first surface.

19. The method according to claim 16, wherein the step of forming the foam includes the step of rotating the foam by 90 degrees after compression, and then cutting the foam in the thickness direction.

20. The method according to claim 15, wherein the step of altering the foam blank includes felting the foam blank along the compression axis to a hardness coefficient of 2 to 7 such that the foam is formed with oval holes having a long axis substantially perpendicular to the compression axis and a short axis substantially parallel to the compression axis.

21. The manifold pad according to claim 1, wherein the foam is configured to preferentially contract in a plane substantially parallel to the first surface when negative pressure is applied to the manifold pad.

22. The manifold pad according to claim 1, wherein the foam is configured so as not to undergo significant shrinkage in thickness when negative pressure is applied to the manifold pad.

23. The manifold pad according to claim 1, wherein the foam is configured to resist shrinkage in thickness.

24. The manifold pad according to claim 1, wherein the foam is configured to be more resistant to shrinkage in thickness than to shrinkage in a plane substantially parallel to the first surface.

25. The manifold pad according to claim 1, wherein the manifold pad is configured to contract radially or laterally under applied negative pressure.

26. The manifold pad according to claim 1, wherein the manifold pad is configured to shrink more in a plane substantially perpendicular to the thickness than in the thickness when negative pressure is applied.

27. The manifold pad according to claim 5, wherein the oval-shaped holes are configured to preferentially contract in a plane substantially parallel to the first surface when negative pressure is applied to the manifold pad.

28. The manifold pad according to claim 5, wherein the oval-shaped holes are configured to contract along the short axis when negative pressure is applied to the manifold pad.

29. The manifold pad according to claim 5, wherein the egg-shaped holes are configured not to undergo significant contraction along the long axis when negative pressure is applied to the manifold pad.

30. The manifold pad according to claim 5, wherein the oval-shaped holes are configured to resist contraction along the long axis when negative pressure is applied to the manifold pad.

31. The manifold pad according to claim 5, wherein the oval-shaped holes are configured not to contract substantially along the long axis when negative pressure is applied to the manifold pad.

32. The manifold pad according to claim 5, wherein the oval-shaped pores are configured to be more resistant to shrinkage along the long axis than to shrinkage along the short axis.

33. The manifold pad according to claim 5, wherein the oval-shaped pore is configured to contract more along the minor axis than along the major axis when negative pressure is applied.

34. The manifold pad according to claim 8, wherein the felted foam contains a hardness coefficient of 3 to 5.

35. The manifold pad according to claim 1, wherein the manifold pad is configured for use on an incision and is configured to shrink under the application of negative pressure to laterally close the incision without significantly reducing the thickness of the manifold pad.

36. The foam has a density of approximately 3.9 to 8.0 lb / ft ３ The manifold pad according to claim 1, having the density of [a certain value].

37. The manifold pad according to claim 1, wherein the foam has a free volume of about 18-30%.

38. The manifold pad according to claim 1, wherein the foam has an average number of holes of about 120 to 250 per inch along the compression axis.

39. The manifold pad according to claim 1, wherein the foam has a pore diameter of about 80 to 200 microns along the compression axis.

40. The felted foam has a density of approximately 1.3 to 1.6 lb / ft ３ The manifold pad according to claim 9, formed from a foam blank having a density of at least 90% free volume, an average number of holes of about 40 to 50 per inch, an average hole size of about 400 to 600 microns, a 25% compression load deflection of at least 0.35 pounds per square inch, and a 65% compression load deflection of at least 0.43 pounds per square inch.

41. The manifold pad according to claim 1, wherein the egg-shaped pores are open bubbles formed by the bubble structure of the foam.

42. The manifold pad according to claim 1, wherein the first surface is configured to face outward away from the tissue area, and the second surface is configured to face toward the tissue area.

43. The dressing material according to claim 13, further comprising a sealing member configured to cover the manifold pad and the treatment device and to provide a pneumatic seal to the tissue site, wherein each of the oval-shaped holes is oriented along the short axis substantially parallel to a portion of the sealing member above the manifold pad.

44. The dressing material according to claim 13, wherein each of the oval-shaped holes is oriented in a short axis substantially parallel to a portion of the treatment device located beneath the manifold pad.

45. The dressing material according to claim 13, wherein each of the oval-shaped holes is oriented along the short axis substantially parallel to a portion of the tissue site beneath the manifold pad.

46. The dressing material according to claim 11, wherein the manifold pad is configured for use on an incision and is configured to shrink under the application of negative pressure to laterally close the incision without significantly reducing the thickness of the manifold pad.

47. The dressing material according to claim 11, wherein the treatment device further comprises a central fluid hub and a plurality of elongated members extending outward from the central fluid hub, each elongated member being in fluid communication with the central fluid hub.

48. The dressing material according to claim 47, wherein the manifold pad is configured to be positioned in close proximity to and / or in contact with the central fluid hub.

49. The dressing according to claim 47, wherein the plurality of elongated members include 4 to 8 elongated members.

50. The dressing material according to claim 47, wherein the plurality of elongated members are evenly spaced around the central fluid hub.

51. The dressing material according to claim 11, wherein the film layer comprises a plurality of channels configured to enable radial fluid flow.

52. The dressing material according to claim 11, wherein the treatment device comprises a treatment manifold having a central connecting manifold member and a plurality of leg manifold members extending outward from the central connecting manifold member, and each of the leg manifold members is in fluid communication with the central connecting manifold member.

53. The dressing material according to claim 52, wherein the treatment manifold includes an open-cell foam.

54. The dressing material according to claim 11, wherein the treatment device comprises a single film layer and a treatment manifold, the single film layer being attached to the surface of the treatment manifold, and the film layer having a plurality of openings.

55. The dressing material according to claim 54, wherein the treatment manifold includes a closed-cell foam.

56. The dressing material according to claim 52, wherein the film layer of the treatment device encloses the treatment manifold, and the film layer has a plurality of openings.

57. The method according to claim 20, wherein the foam blank has an original thickness, and the step of felting the foam blank includes the steps of heating the foam blank to about 1 / 2 to 1 / 7 of its original thickness and compressing it.

58. The foam blank has a yield of approximately 1.3 to 1.6 lb / ft ３ The method according to claim 15, having a density of at least 90% free volume, an average number of holes of about 40 to 50 per inch, an average hole size of about 400 to 600 microns, a 25% compression load deflection of at least 0.35 pounds per square inch, and a 65% compression load deflection of at least 0.43 pounds per square inch.

59. The method according to claim 15, further comprising the step of providing a therapeutic device having a film layer and configured to guide a fluid radially under applied negative pressure.

60. The method according to claim 59, wherein the step of providing the treatment device includes forming a treatment manifold having a central connecting manifold member and a plurality of leg manifold members extending outward from the central connecting manifold member, each of the leg manifold members being in fluid communication with the central connecting manifold member.

61. The method according to claim 60, wherein the step of providing the treatment device further includes the step of attaching the film layer to the treatment manifold.

62. The method according to claim 61, wherein the film layer encloses the treatment manifold.

63. The manifold pad according to claim 5, wherein the oval-shaped holes are configured to contract more in a plane substantially perpendicular to the thickness of the manifold pad than in a plane substantially parallel to the thickness of the manifold pad when negative pressure is applied.

64. The manifold pad according to claim 1, wherein the foam is configured to shrink more in the lateral direction than in the thickness when negative pressure is applied.

65. The manifold pad is configured for use on abdominal wounds, The foam of the manifold pad is configured to pull the edges of the abdominal wounds together laterally when negative pressure is applied to the manifold pad. The manifold pad according to claim 1, wherein the foam of the manifold pad is configured to shrink to a thickness less than that in a plane substantially perpendicular to the thickness when negative pressure is applied to the manifold pad.

66. The manifold pad according to claim 1, wherein the foam is configured such that, under applied negative pressure, the ratio of the contraction of the manifold pad in a direction substantially perpendicular to the thickness to the contraction of the manifold pad in a direction substantially parallel to the thickness is greater than 1.

67. The manifold pad according to claim 1, wherein the foam of the manifold pad is configured such that, under negative pressure, the amount of lateral shrinkage is greater than the amount of thickness shrinkage.

68. The manifold pad according to claim 67, wherein the first surface and the second surface of the manifold pad are configured to extend laterally across the incision in the tissue area.

69. It is a manifold pad, The first surface and The second surface and The thickness of the foam extending between the first surface and the second surface is provided, The foam of the manifold pad has a cellular structure having a plurality of ellipsoidal bubbles, The manifold pad is configured to preferentially contract in a plane substantially perpendicular to its thickness when negative pressure is applied.

70. It is a manifold pad, The first surface and The second surface and The thickness of the foam extending between the first surface and the second surface is provided, The foam material of the manifold pad has a cellular structure with elongated bubbles, A manifold pad configured to preferentially contract in a plane substantially perpendicular to its thickness when negative pressure is applied.

71. It is a manifold pad, The first surface and The second surface and The thickness of the foam extending between the first surface and the second surface is provided, The foam of the manifold pad has a cellular structure having a plurality of ellipsoidal bubbles, Each of the ellipsoidal bubbles has a major axis and a minor axis, The major axis of the ellipsoidal bubble is oriented substantially parallel to the thickness of the manifold pad. The minor axis of the ellipsoidal bubble is oriented substantially perpendicular to the thickness of the manifold pad. A manifold pad in which the ellipsoidal bubbles are configured to preferentially contract in a plane substantially perpendicular to the thickness when negative pressure is applied.

72. It is a manifold pad, The first surface and The second surface and The thickness of the foam extending between the first surface and the second surface is provided, The foam of the manifold pad has a cellular structure having a plurality of egg-shaped bubbles, Each of the aforementioned egg-shaped bubbles has a long axis and a short axis, The long axis of the egg-shaped bubble is oriented substantially parallel to the thickness of the manifold pad. The short axis of the egg-shaped bubble is oriented substantially perpendicular to the thickness of the manifold pad. A manifold pad in which the egg-shaped bubbles are configured to contract preferentially along the short axis, in contrast to the long axis, when negative pressure is applied.

73. It is a manifold pad, The first surface and The second surface and The thickness of the foam extending between the first surface and the second surface is provided, The foam of the manifold pad has a cellular structure having a plurality of ellipsoidal bubbles, Each of the ellipsoidal bubbles has a major axis and a minor axis, A manifold pad in which the major axis of the ellipsoidal bubble is oriented such that it is parallel to the thickness at an angle of 44 degrees or less.

74. It is a manifold pad, The first surface and The second surface and The thickness of the foam extending between the first surface and the second surface is provided, The foam of the manifold pad has a cellular structure having a plurality of ellipsoidal bubbles, Each of the ellipsoidal bubbles has a major axis and a minor axis, A manifold pad in which the major axis of the ellipsoidal bubble is oriented such that it is at an angle of 25 degrees or less from parallel to the thickness.

75. It is a manifold pad, The first surface and The second surface and The thickness of the foam extending between the first surface and the second surface is provided, The foam of the manifold pad has a cellular structure having a plurality of ellipsoidal bubbles, Each of the ellipsoidal bubbles has a major axis and a minor axis, A manifold pad in which the major axis of the ellipsoidal bubble is oriented such that it is at an angle of 20 degrees or less from parallel to the thickness.

76. It is a manifold pad, The first surface and The second surface and In the thickness of the foam extending between the first surface and the second surface, The foam of the manifold pad comprises a felted foam having a cellular structure with a plurality of ellipsoidal bubbles. The felted foam of the manifold pad is Compared to similar unfelted foams, To provide greater lateral contraction under applied negative pressure, and / or to transmit higher lateral closing force under applied negative pressure compared to similar non-felted foams, A manifold pad configured to be more resistant to shrinkage of the thickness under applied negative pressure than a similar non-felted foam.

77. The manifold pad according to claim 1, wherein each of the oval-shaped holes has a long axis and a short axis, and the long axis is oriented such that it is 44 degrees or less from parallel to the thickness.

78. The foam of the manifold pad comprises a felted foam having a cellular structure with a plurality of oval pores, and the felted foam of the manifold pad is configured to be more resistant to shrinkage of the thickness under applied negative pressure than a similar unfelted foam. To provide greater lateral contraction under applied negative pressure compared to similar unfelted foams, and / or to transmit higher lateral closing force under applied negative pressure compared to similar unfelted foams. The manifold pad according to claim 1, including the following:

79. A dressing material for negative pressure therapy on a tissue site, The manifold pad according to any one of claims 1 and 69 to 78, A therapeutic device configured to provide separation between the abdominal wall and the visceral tissue area, and to allow fluid to flow radially under applied negative pressure. Dressing ingredients, including

80. Systems, methods, and apparatus as described and illustrated herein.

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