Patent Description:
Negative pressure wound therapy is a type of wound therapy that involves applying a negative pressure to a wound site to promote wound healing. NPWT applies negative pressure to the wound to drain fluids from the wound as the wound heals. NPWT can be used to treat deep abdominal wounds due to abdominal laparotomies, which are used to gain access to the abdominal cavity for surgery and/or to relieve intra-abdominal pressure by allowing the bowels to expand. Such deep abdominal wounds require cutting of the fascial layer, which is a thin, fibrous layer of tissue located beneath the abdominal muscles that holds the abdominal contents (e.g., internal organs and the bowels) together. In some instances, the laparotomy incision is not immediately closed, resulting in an "open abdomen. " Under such conditions, the fascia can retract laterally toward the patient's paracolic gutters (e.g., open space on the sides of the abdominal cavity), which can make it difficult to secure the cut ends of the fascial layer together (e.g., with staples or sutures) after surgery. Staples and/or sutures are currently used to hold the cut ends of the fascia together under the open abdomen conditions. It may be beneficial to provide an improved wound therapy system for closing deep abdominal incisions. <CIT> discloses a negative pressure treatment system in which an abdominal foam pad can be size in a dimensionally-independent manner. <CIT> discloses a wound shield for exudate management having a conformable frame to circumscribe a wound. <CIT> disclose a wound packing material with frangible regions to allow removal of sections and shaping of the material. <CIT> discloses a negative pressure treatment system in which a wound filler includes a lip to be positioned underneath the fascia.

A selection of optional features is set out in the dependent claims.

Insofar as the term embodiment is used in the following, or features are presented as being optional, this should be interpreted in such a way that the only protection sought is that of the invention claimed (with due regard to Article <NUM> EPC and the protocol thereto).

References to "embodiment(s)" throughout the description which are not under the scope of the appended claims merely represent possible exemplary executions and are not part of the present invention.

Referring generally to the FIGURES, a wound therapy system for treating a deep abdominal wound and/or an open abdomen is shown, according to various embodiments. The phrase "deep abdominal wound" refers to an abdominal incision that includes an incision in the fascial layer to access the abdominal cavity. The fascial layer is a layer of tissue that surrounds and supports the abdominal contents (e.g., the bowels and the internal organs). The phrase "open abdomen" refers to conditions in which a deep abdominal wound is left open (e.g., the abdominal incision is not resealed) for a period of time. For example, the abdomen may be left open to accommodate swelling of the bowels and/or other abdominal contents (e.g., internal organs). The abdomen may also be left open in conditions in which further surgery in the abdominal cavity is required. More specifically, the wound therapy system is for treating open abdominal incisions that include an incision in the fascial layer. The wound therapy system is configured to engage the fascial layer proximate the fascial incision and rejoin the cut ends of the fascial layer, preventing retraction of the cut ends fascial later during the open abdomen conditions.

The wound therapy system includes a plurality of layers, including a visceral protective layer, a compressive component, and a sealing layer. The wound therapy system can be used with a negative pressure wound therapy (NPWT) system and/or an instillation system. The visceral protective layer is positioned within the abdominal cavity and wrapped around the bowels and internal organs. The compressive component is positioned within the abdominal cavity and is configured to contract laterally and/or radially under negative pressure to pull the cut ends of the fascial layer together. The sealing layer is configured to be affixed to a patient's skin surrounding an abdominal incision and to provide a sealed space (e.g., in the open abdomen).

More specifically, the compressive component is configured to overlie a fascial incision formed proximate a bottom of the abdominal incision. The compressive component has a generally elliptical shape to conform to a shape of the open abdominal incision. The compressive component <NUM> can be made from a porous and permeable foam-like material and can be adapted to wick fluid (e.g. exudate) from the wound and can include in-molded manifold structures for distributing negative pressure throughout the wound dressing during NPWT treatments. In some cases, the facial incision is non-uniformly shaped. For example, the fascial incision may have a substantially teardrop shape, in which one end of the incision is wider than another end. In such conditions, it can be desirable to customize the compressive component to provide different amounts of lateral compression, and therefore different amounts of lateral closure forces, to different portions of the fascial incision based on the shape of the fascial incision.

In some embodiments, the compressive component includes a plurality of removable segments that that can be selectively and individually removed from the compressive component to form a plurality of voids. A pattern and/or a position of the plurality of voids can change a compressive profile of the compressive component. For example, the compressive component can have a first compressive profile in which none of the removable portions have been remove is generally uniform over the compressive component. Removing at least one of the removable components changes the compressive profile from the first compressive profile to a second compressive profile, in which at least a portion of the compressive profile is non-uniform.

In some embodiments, the compressive component can be a composite compressive component in which the compressive component is formed from different concentric segments having different densities and/or different material properties that cause the composite compressive component to provide different amounts of lateral compressive forces to the fascial incision under negative pressure conditions.

Additional features and advantages of the wound therapy system are described in detail below.

Referring to <FIG>, a section view of a wound therapy system <NUM> is shown, according to an exemplary embodiment. In the illustrated embodiment, the wound therapy system is configured to treat the abdominal cavity and is discussed in the context of treating an open abdomen. The wound therapy system <NUM> can be used to treat an "open abdomen" condition, in which a deep abdominal wound is left open for a period of time. The components described herein may be used in different configurations of instillation therapy systems and/or negative pressure wound therapy (NPWT) systems. The phrase "negative pressure" means a pressure less than an ambient or atmospheric pressure.

In various embodiments, the wound therapy system <NUM> can be used to treat a deep abdominal incision. The wound therapy system <NUM> includes a wound dressing <NUM>, an instillation system <NUM>, and a NPWT system <NUM>. The wound dressing <NUM> includes an abdominal treatment device <NUM>, a negative pressure manifold or compressive component <NUM>, and a sealing member <NUM>. The wound dressing <NUM> is intended for engagement with a treatment site of a patient, such as an abdominal cavity of a patient. The wound therapy system <NUM> can be used with the NPWT system <NUM> and/or the instillation system <NUM>. The NPWT system <NUM> may include a negative pressure source <NUM>, such as a pump, and a fluid collection chamber <NUM>. The instillation system <NUM> may include an instillation fluid source <NUM>. In some embodiments, the instillation system <NUM> may include an installation pump <NUM>.

The compressive component <NUM> is shaped to be positioned within at least a portion of the abdominal incision, such as an incision formed as part of a vertical laparotomy. The compressive component is configured to overlie a fascial incision formed proximate a bottom of the abdominal incision <NUM>. Accordingly, the compressive component <NUM> is shaped to conform to a shape of the open abdominal incision <NUM>. For example, as shown in the Figures, the compressive component <NUM> has a generally elliptical shape.

Referring to <FIG>, the abdominal treatment device <NUM> is shown to include a first layer <NUM>, a second layer <NUM>, and a foam spacer <NUM>. The second layer <NUM> faces the abdominal contents and is generally opposite the first layer <NUM>. The foam spacer <NUM> includes a first surface <NUM> and a second, abdominal contents-facing surface <NUM>. The foam spacer <NUM> includes a hub <NUM> and a plurality of leg members <NUM> that extend generally radially from the hub <NUM>. The foam spacer <NUM> is generally in fluid communication with a negative pressure conduit <NUM> to receive negative pressure from the negative pressure source <NUM> and to receive fluids flowing from the treatment site towards the negative pressure source <NUM>. The plurality of elongate leg members <NUM> are configured to distribute negative pressure throughout the treatment site. The first layer <NUM> and the second layer <NUM> encapsulate the leg members <NUM>, the hub <NUM>, and the intervening space between adjacent leg members <NUM>. In the illustrated embodiment, the hub <NUM> and the plurality of leg members <NUM> are made of a material that is substantially hydrophobic and configured for fluid flow under substantially atmospheric pressure conditions and under negative pressure conditions. In some embodiments, the hub <NUM> and the plurality of leg members <NUM> are made of a reticulated foam, such as the reticulated foam described below with respect to the compressive component <NUM>. In some embodiments, the leg members <NUM> may be cut to accommodate relatively small wounds. The first layer <NUM> and the second layer <NUM> of the abdominal treatment device <NUM> can made of a material that is fluid-impermeable and intended to not irritate the patient's fascia and internal organs. The abdominal treatment device <NUM> may include a plurality of fenestrations <NUM> (e.g., negative pressure inlets) for distribution of negative pressure by the plurality of leg members <NUM> and/or to permit fluid to flow into the plurality of leg members <NUM> and/or the space between the plurality of leg members <NUM> and the layers <NUM>, <NUM>. The fenestrations <NUM> may include through-holes, slits, or linear cuts. The fenestrations <NUM> may be circular, rectangular, polygonal, or be any other shape in cross-section.

Referring to <FIG>, the compressive component <NUM> is shown to include a first surface <NUM> and a second, abdominal contents-facing surface <NUM> opposite the first surface <NUM>. When the compressive component <NUM> is applied to the treatment site, the first surface <NUM> faces away from the abdominal contents, whereas the second surface <NUM> faces toward the abdominal contents. In some embodiments, the first surface <NUM> of the compressive component <NUM> contacts the second surface <NUM> of the sealing member <NUM>. The compressive component <NUM> is adapted to wick fluid (e.g. exudate) from the wound and includes in-molded manifold structures for distributing negative pressure throughout the compressive component <NUM> during negative pressure wound therapy treatments. The compressive component <NUM> is made from a material that allows fluid and/or negative pressure to pass from between at least a first portion of the compressive component <NUM> and a second portion of the compressive component <NUM>. In some embodiments, the compressive component <NUM> may include in-molded flow channels or pathways that can distribute the fluids provided to and removed around the manifold. In some embodiments, the in-molded flow channels or pathways can be formed by the cells in a porous foam material. The compressive component <NUM> can be a manifold configured to allow fluid to pass from at least a first portion of the compressive component <NUM> to at least a second portion of the compressive component <NUM>.

The compressive component <NUM> can be made from a porous and permeable foam-like material and, more particularly, a reticulated, open-cell polyurethane or polyether foam that allows good permeability of wound fluids while under a reduced pressure. One such foam material that has been used is the VAC® Granufoam® material that is available from Kinetic Concepts, Inc. (KCI) of San Antonio, Tex. Any material or combination of materials might be used for the compressive component <NUM> provided that the compressive component <NUM> is operable to distribute the reduced pressure and provide a distributed compressive force along the treatment site.

The reticulated pores of the Granufoam® material that are in the range from about <NUM> to <NUM> microns, are preferred, but other materials may be used. The density of the absorbent layer material, e.g., Granufoam® material, is typically in the range of about <NUM> lb/ft<NUM>-<NUM> lb/ft<NUM> (<NUM>/m<NUM>-<NUM>/m<NUM>). A material with a higher density (smaller pore size) than Granufoam® material may be desirable in some situations. For example, the Granufoam® material or similar material with a density greater than <NUM> lb/ft<NUM> (<NUM>/m<NUM>) may be used. As another example, the Granufoam® material or similar material with a density greater than <NUM> lb/ft<NUM> (<NUM>/m<NUM>) or <NUM> lb/ft<NUM> (<NUM>/m<NUM>) or even more may be used. The more dense the material is, the higher compressive force that may be generated for a given reduced pressure. If a foam with a density less than the tissue at the tissue site is used as the absorbent layer material, a lifting force may be developed. In one illustrative embodiment, a portion, e.g., the edges, of the wound dressing may exert a compressive force while another portion, e.g., a central portion, may provide a lifting force.

The compressive component <NUM> material may be a reticulated foam that is later felted to thickness of about one third (⅓) of the foam's original thickness. Among the many possible absorbent layer materials, the following may be used: Granufoam® material or a Foamex® technical foam (www. In some instances it may be desirable to add ionic silver to the foam in a microbonding process or to add other substances to the compressive component <NUM> material such as antimicrobial agents. In some instances, it may be desirable to add active and/or time-release therapeutic compounds to the compressive component <NUM> material. The compressive component <NUM> material may be isotropic or anisotropic depending on the exact orientation of the compressive forces that are desired during the application of reduced pressure. The compressive component <NUM> material may also be a bio-absorbable material.

In some embodiments, the compressive component <NUM> can be made of Granufoam ®, felted foam, a three-dimensional textile material such as BallTex, a welded film with hexagonal three-dimensional construction, a non-woven layer, a vacuum-formed structure, layers of vacuum formed film with air bubbles and//or other positive-shaped structures, an injection-molded polymer, or any other material in which the closure force in the lateral direction may be modulated through the selective removal of the material.

In embodiments including the three-dimensional textile material, the thickness, weave pattern, and/or perforation pattern can change the collapse of the material, allowing the force, the shape, and the compressive profile of the three-dimensional textile to be customized.

Referring again to <FIG>, the sealing member <NUM> is shown to include a first surface <NUM> and a second, wound-facing, surface <NUM> opposite the first surface <NUM>. When the wound therapy system <NUM> is applied to a wound, the first surface <NUM> faces away from the wound, whereas the second surface <NUM> faces toward the wound. As is shown in <FIG>, at least a perimeter of the second surface <NUM> includes an adhesive. The adhesive is intended to secure sealing member <NUM> to the patient's skin and to form a fluid-tight seal about the incision. The sealing member <NUM> also provides a barrier to passage of microorganisms through the wound therapy system <NUM>.

In some embodiments, the sealing member <NUM> is an elastomeric material or may be any material that provides a fluid seal. "Fluid seal" means a seal adequate to hold pressure at a desired site given the particular reduced-pressure subsystem involved. The term "elastomeric" means having the properties of an elastomer and generally refers to a polymeric material that has rubber-like properties. Examples of elastomers may include, but are not limited to, natural rubbers, polyisoprene, styrene butadiene rubber, chloroprene rubber, polybutadiene, nitrile rubber, butyl rubber, ethylene propylene rubber, ethylene propylene diene monomer, chlorosulfonated polyethylene, polysulfide rubber, polyurethane, EVA film, co-polyester, thermoplastic polyurethane (TPU), and silicones. As non-limiting examples, the sealing member <NUM> may be formed from materials that include a silicone, <NUM> Tegaderm® drape material, acrylic drape material such as one available from Avery, or an incise drape material. In some embodiments, the sealing member <NUM> may be at least partially transparent to facilitate viewing of the wound therapy system <NUM> through the sealing member <NUM> as described in greater detail below.

The sealing member <NUM> may be substantially impermeable to liquid and substantially permeable to water vapor. In other words, the sealing member <NUM> may be permeable to water vapor, but not permeable to liquid water or wound exudate. This increases the total fluid handling capacity (TFHC) of wound therapy system <NUM> while promoting a moist wound environment. In some embodiments, the sealing member <NUM> is also impermeable to bacteria and other microorganisms. In some embodiments, the sealing member <NUM> is configured to wick moisture from the compressive component <NUM> and distribute the moisture across the first surface <NUM>. In some embodiments, the adhesive applied to the second surface <NUM> of the sealing member <NUM> is moisture vapor transmitting and/or patterned to allow passage of water vapor therethrough.

As shown in <FIG>, the body or compressive component <NUM> is generally symmetrical and elliptical-shaped. The compressive component <NUM> includes a first surface <NUM> and the second, fascia-facing, surface <NUM> opposite the first surface <NUM>. When the compressive component <NUM> is applied to a wound, the first surface <NUM> faces away from the fascia and the second surface faces toward the fascia. In some embodiments, the second surface <NUM> of the compressive component <NUM> contacts the first layer <NUM> of the abdominal treatment device <NUM>. In some embodiments, the first surface of the compressive component <NUM> contacts the sealing member <NUM>. The compressive component <NUM> includes a longitudinal axis <NUM> defining a longitudinal direction, a lateral axis <NUM> defining a lateral direction, and a vertical axis <NUM> defining a vertical direction. The compressive component <NUM> includes a first tapered end <NUM> and a second tapered end <NUM>. The first tapered end <NUM> and the second tapered end <NUM> are spaced part along the longitudinal axis <NUM>. The compressive component <NUM> is configured to collapse in a first direction while resisting collapse in a second direction that is substantially perpendicular to the first direction. For example, in the illustrated embodiment, the compressive component <NUM> is configured to collapse in a lateral direction (e.g., along the lateral axis <NUM>) and/or a radial direction (e.g., along the lateral axis <NUM> and the longitudinal axis <NUM>) under negative pressure while resisting compression in a vertical direction (e. g, along the vertical axis <NUM>) under negative pressure.

The compressive component <NUM> includes a plurality of removable portions <NUM> and a plurality of sizing perforations <NUM>. <FIG> illustrates the compressive component <NUM> in which none of the removable portions <NUM> have been removed. <FIG> illustrates the compressive component <NUM> in which a portion of the removable portions <NUM> has been removed.

The plurality of removable portions <NUM> is oriented in a pattern that is generally symmetric with respect to the lateral axis <NUM> and the longitudinal axis <NUM>. In the illustrated embodiment, the removable portions <NUM> are hexagons. In other embodiments, the removable portions <NUM> can be other geometric shapes. Removal of at least one of the plurality of removable portions <NUM> can increase a lateral and/or a radial force generated as the compressive component <NUM> collapses under negative pressure. The removable portions <NUM> include a marking <NUM> to indicate that the removable portions <NUM> can be removed from the compressive component <NUM>. In some embodiments, the markings <NUM> can be colors and/or patterns. In some embodiments, the marking <NUM> can indicate an increase in the lateral force that is generated upon removal of each of the removable portions <NUM>. The increase in the lateral force that is generated upon removal of each of the removable portions <NUM> is based on the size of the removable portions <NUM>. Removing at least one of the plurality of removable portions <NUM> can change a compression profile of the compressive component <NUM>. As used herein, the phrase "compression profile" refers to a shape of the compressive component <NUM> under negative pressure. Accordingly, removal of a portion of the plurality of removable portions <NUM> can be used to customize the compression profile of the compressive component <NUM> to a shape of the wound being treated. For example, <FIG> illustrates the compressive component <NUM> in which none of the plurality of removable portions <NUM> has been removed. Accordingly, compressive component <NUM> collapses according to the first compression profile" in the compression of the compressive component <NUM> under negative pressure is generally symmetric (e.g., uniform) along the lateral axis <NUM> and the longitudinal axis <NUM>.

By way of non-limiting example, <FIG> illustrates the compressive component <NUM> in which a portion of the removable portions <NUM> has been removed from the compressive component <NUM> to form a plurality of through-openings or voids <NUM> in the compressive component <NUM>. The plurality of voids <NUM> form a pattern of voids <NUM> that generates a second compression profile different than the first compression profile. For example, in the configuration of <FIG>, compression under negative pressure is symmetric with respect to the longitudinal axis <NUM>. Compression under negative pressure is asymmetric with respect to the lateral axis <NUM>. More removable portions <NUM> have been removed from the compressive component <NUM> on the left side of the lateral axis <NUM> than have been on the right side of the lateral axis <NUM>. Accordingly, under negative pressure, the compressive component <NUM> experiences more lateral compression on the left side of the lateral axis <NUM> than on the right side of the lateral axis, as is shown by the dashed lines <NUM>. The pattern of formed by the plurality of voids <NUM> illustrated in <FIG> is optimized for closure of a teardrop-shaped fascial incision that is wider at one end than at another end. Accordingly, the compressive component <NUM> would be oriented on a patient such that the portion of the compressive component <NUM> that has more intact removable portions <NUM> is adjacent the wider portion of the incision and the portion of the compressive component <NUM> that has more voids <NUM> is over the narrow portion of the incision. The voids <NUM> facilitate collapse of the compressive component <NUM> into the teardrop shape under negative pressure, thereby providing uniform closure forces over the fascial incision.

In other configurations, different ones of the plurality of removable portions <NUM> can be selectively and individually removed to generate different compression profiles in the compressive component <NUM>. For example, in some configurations, the compression profile can include a pattern of voids <NUM> oriented such that compressive component <NUM> has a different amount of compression proximate a center of the compressive component than proximate the perimeter of the compressive component <NUM>. The compression profiles can be either be symmetric (e.g., uniform) and/or asymmetric with respect to the longitudinal axis <NUM> and/or the lateral axis <NUM>.

In some embodiments, the plurality of removable portions <NUM> are formed by perforations that extend between the first surface <NUM> and the second surface <NUM> and surround the removable portions <NUM>. In other embodiments, the plurality of removable portions <NUM> are cut into the first surface <NUM> of the compressive component <NUM>. The cuts extend into the compressive component <NUM> in the vertical direction but do not extend through the second surface <NUM> of the compressive component <NUM>. In such an embodiment, the uncut portion of the compressive component <NUM> may extend approximately <NUM> - <NUM> in the vertical direction and approximately <NUM> - <NUM> directions in the lateral and/or longitudinal direction. The perforations and/or the cuts are configured so that a force of less than 5N can be used to remove the removable portions <NUM> from the compressive component <NUM>. In some embodiments, the perforations and/or the cuts can be configured so that there is a higher force required to remove the removable portions from one of the first surface <NUM> and the second surface <NUM>. For example, the removable portions <NUM> may require more force from removal from the second surface <NUM> for compressive components <NUM> configured for treating wounds in which granulation may occur.

In embodiments in which the compressive component <NUM> is a foam material, the compressive component <NUM> may include a welded film layer on one or both of the first surface <NUM> and the second surface <NUM>. In such embodiments, the film layer may include perforations approximately <NUM> long in the shape of the removable portions <NUM> and the removable portions <NUM> may be formed by through-cuts in the compressive component <NUM>, such that the removable portions <NUM> are held in place by the film layer. In some embodiments, the film layer can be a polyurethane film secured to the foam material with an acrylic adhesive. In other embodiments, the film layer can be Miliken fabric.

With continued reference to <FIG>, the pattern of sizing perforations <NUM> includes a plurality of sizing perforations <NUM> extending between the first surface <NUM> and the second surface <NUM>. The pattern of sizing perforations <NUM> includes a first ring of sizing perforations <NUM>, a second ring of sizing perforations <NUM>, and a third ring of sizing perforations <NUM>. The first ring of sizing perforations <NUM>, the second ring of sizing perforations <NUM>, and the third ring of sizing perforations <NUM> are generally elliptical and generally follow a contour of the compressive component <NUM>. The sizing perforations <NUM> facilitate removal of a portion of the compressive component <NUM> to adjust a size of the compressive component <NUM>. The plurality of removable portions <NUM> is spaced from the plurality of sizing perforations <NUM>. The plurality of sizing perforations <NUM> facilitate tool-less resizing of the compressive component <NUM> to conform to a size of the treatment area.

<FIG> illustrates a body or compressive component <NUM> according to another embodiment. The compressive component <NUM> is generally symmetrical and elliptical-shaped. The compressive component <NUM> is shown to include a first surface <NUM> and a second, fascia-facing, surface <NUM> opposite the first surface <NUM>. When the compressive component <NUM> is applied to a wound, the first surface <NUM> faces away from the fascia and the second surface <NUM> faces toward the fascia. In some embodiments, the second surface <NUM> of the compressive component <NUM> contacts the first surface <NUM> of the abdominal treatment device <NUM>. In some embodiments, the first surface of the compressive component <NUM> contacts the sealing member <NUM>. The compressive component <NUM> includes a longitudinal axis <NUM> defining a longitudinal direction, a lateral axis <NUM> defining a lateral direction, and a vertical axis <NUM> defining a vertical direction. The compressive component <NUM> includes a first tapered end <NUM> and a second tapered end <NUM>. The first tapered end <NUM> and the second tapered end <NUM> are spaced part along the longitudinal axis <NUM>. The compressive component <NUM> is configured to collapse in a first direction while resisting collapse in a second direction that is substantially perpendicular to the first direction. For example, in the illustrated embodiment, the compressive component <NUM> is configured to collapse in a lateral direction (e.g., along the lateral axis <NUM>) and/or a radial direction (e.g., along the lateral axis <NUM> and the longitudinal axis <NUM>) while resisting compression in a vertical direction (e.g., along the vertical axis <NUM>) under negative pressure. The compressive component <NUM> can be made of the materials described above with respect to the compressive component <NUM>.

The compressive component <NUM> includes a first plurality of removable portions <NUM>, a second plurality of removable portions <NUM>, a third plurality of removable portions <NUM>, a fourth plurality of removable portions <NUM>. In some embodiments, the compressive component <NUM> includes a plurality of sizing perforations (not shown). The plurality of sizing perforations are substantially similar to the sizing perforations <NUM> of the compressive component <NUM> and will not be described in detail herein for the sake of brevity.

The pluralities of removable portions <NUM>, <NUM>, <NUM>, <NUM> are arranged in concentric rings and are configured for generally radial compression. The first plurality of removable portions <NUM> are generally elongate and spaced close together. The second plurality of removable portions <NUM> are shorter than the first plurality of removable portions <NUM> and spaced apart by a distance longer than their length. The third plurality of removable portions <NUM> are substantially similar to the second plurality of removable portions <NUM> but are spaced close together. The fourth plurality of removable portions <NUM> are thicker and spaced close together. In other embodiments, the removable portions <NUM>, <NUM>, <NUM>, <NUM> can be other geometric shapes. Accordingly, removal of each of the pluralities of removable portions <NUM>, <NUM>, <NUM>, <NUM> can generate a different increase in a lateral and/or a radial force generated as the compressive component <NUM> collapses under negative pressure. Accordingly, the first plurality of removable portions <NUM> can have a first marking <NUM> indicative of a first increase in compressive force, the second plurality of removable portions <NUM> can have a second marking <NUM> indicative of a second increase in compressive force, the third plurality of removable portions <NUM> can have a third marking <NUM> indicative of a third increase in compressive force, and the fourth plurality of removable portions <NUM> can have a fourth marking <NUM> indicative of a fourth increase in compressive force. The markings <NUM>, <NUM>, <NUM>, <NUM> are substantially similar to the markings <NUM> described above with respect to the compressive component <NUM>. However, the markings <NUM>, <NUM>, <NUM>, <NUM> are different from each other to indicate an increase in the lateral force that is generated upon removal of each of the removable portions is different for the first plurality of removable portions <NUM>, the second plurality of removable portions <NUM>, the third plurality of removable portions <NUM>, and the fourth plurality of removable portions <NUM>. As described above with respect to <FIG> and <FIG>, the removable portions <NUM>, <NUM>, <NUM>, <NUM> can be selectively and individually removed to change the compressive component <NUM> from having a first compression profile in which none of the removable portions <NUM>, <NUM>, <NUM>, <NUM> is removed and second compression profile in which at least one of any of the removable portions <NUM>, <NUM>, <NUM>, <NUM> has been removed.

In some embodiments, the pluralities of removable portions <NUM>, <NUM>, <NUM>, <NUM> are formed by perforations that extend between the first surface <NUM> and the second surface <NUM> and surround the pluralities of removable portions <NUM>, <NUM>, <NUM>, <NUM>. In other embodiments, the pluralities of removable portions <NUM>, <NUM>, <NUM>, <NUM> are cut into the first surface <NUM> of the compressive component <NUM>. The perforations and/or cuts are substantially similar to the perforations and/or cuts described above with respect to the compressive component <NUM> and will not be discussed in detail herein for the sake of brevity.

Although the removable portions <NUM> of the compressive component <NUM> and the removable portions <NUM>, <NUM>, <NUM>, <NUM> of the compressive component are configured for tool-less removal, in some embodiments, removal of the removable portions <NUM>, <NUM>, <NUM>, <NUM>, may be facilitated by a tool having a similar cross-sectional shape as the removable portions <NUM>, <NUM>, <NUM>, <NUM>.

While the compressive components <NUM>, <NUM> are described in the context of the wound therapy system <NUM> configured for treatment of deep abdominal wounds, this description is intended to be non-limiting. The compressive components <NUM>, <NUM> can have other shapes and can be used to treat other types of wounds.

In operation, the user selects the compressive component <NUM> and compares a length of the compressive component <NUM> in the generally longitudinal direction to a length of the fascial incision. The user may tear the compressive component <NUM> along the perforations <NUM> to size compressive component <NUM> such that the length of the compressive component <NUM> in the generally longitudinal direction is substantially similar to the length of the fascial incision. Next, the user may remove a portion of the plurality of removable portions <NUM> from the compressive component <NUM> to form the plurality of voids <NUM>. The step of removing at least one of the plurality of removable portions <NUM> from the compressive component <NUM> transforms a compressive profile of the compressive component <NUM> from the first compressive profile to the second compressive profile based on a shape of the fascial incision. The user may determine which of the plurality of removable portions <NUM> to remove from the compressive component <NUM> based on the shape of the fascial incision and/or the marking <NUM> indicative of an increase in lateral force generated by removing each of the removable portions <NUM> including the marking <NUM> from the compressive component <NUM>. In some configurations, the second compressive profile can be symmetric (e.g., uniform) about at least one of the longitudinal axis <NUM> and the lateral axis <NUM>. In other configurations, the second compressive profile can be asymmetric (e.g., non-uniform) with respect to both the longitudinal axis <NUM> and the lateral axis <NUM>. The user then positions the compressive component <NUM> in the abdominal cavity such that the longitudinal axis <NUM> is generally aligned with the fascial incision. The user applies negative pressure to the compressive component <NUM> using the NPWT system <NUM> to provide negative pressure to the wound dressing <NUM> to compress the compressive component <NUM>.

The compressive component <NUM> may be resized as described above with respect to the compressive component <NUM>. The pluralities of removable portions <NUM>, <NUM>, <NUM>, <NUM> may be selectively removed from the compressive component <NUM> to transform the compressive profile of the compressive component <NUM> from the first compressive profile to the second compressive profile as described above with respect to the compressive component <NUM>.

<FIG> illustrates a composite body or compressive component <NUM> according to an exemplary embodiment. The composite compressive component <NUM> is generally symmetrical and elliptical-shaped. The composite compressive component <NUM> includes a first surface <NUM> and a second, fascia-facing, surface <NUM>. In some embodiments, the second surface <NUM> of the composite compressive component <NUM> contacts the first layer <NUM> of the abdominal treatment device <NUM>. In some embodiments, the first surface <NUM> of the composite compressive component <NUM> contacts the sealing member <NUM>. The composite compressive component <NUM> includes a longitudinal axis <NUM> defining a longitudinal direction, a lateral axis <NUM> defining a lateral direction, and a vertical axis <NUM> defining a vertical direction. The composite compressive component <NUM> includes a first tapered end <NUM> and a second tapered end <NUM>. The first tapered end <NUM> and the second tapered end <NUM> are spaced apart along the longitudinal axis <NUM>. The composite compressive component <NUM> is configured to collapse in a first direction while resisting collapse in a second direction that is substantially perpendicular to the first direction. For example, in the illustrated embodiment, the composite compressive component <NUM> is configured to collapse in a lateral direction (e.g., along the lateral axis <NUM>) and/or a radial direction (e.g., along the lateral axis <NUM> and the longitudinal axis <NUM>) while resisting compression in a vertical direction (e.g., along the vertical axis <NUM>) under negative pressure.

The composite compressive component <NUM> includes a first concentric segment <NUM>, a second concentric segment <NUM>, and a third concentric segment <NUM>. The first concentric segment <NUM> forms a central portion of the composite compressive component <NUM>. The second concentric segment <NUM> is substantially ring-shaped and includes a through-opening <NUM> sized to receive the first concentric segment <NUM>. The third concentric segment <NUM> is substantially ring-shaped and includes a through-opening <NUM> for receiving the second concentric segment <NUM>. Accordingly, the first concentric segment <NUM>, the second concentric segment <NUM>, and the third concentric segment <NUM> are arranged in a nested configuration. While the composite compressive component <NUM> illustrated in <FIG> includes three concentric segments, in other embodiments, the compressive component <NUM> can include more or fewer concentric segments.

In the illustrated embodiment, the first concentric segment <NUM>, the second concentric segment <NUM>, and the third concentric segment <NUM> are formed of the same compressive material. The compressive material can be any of the materials discussed above with respect to the compressive component <NUM>. In some embodiments, the compressive material is Granufoam ® or a felted foam material. The first concentric segment <NUM> includes a first plurality of voids <NUM> that generate a first compression ratio. As used herein, "compression ratio" is the ratio of the change in length in a lateral direction under negative pressure to the uncompressed length in the lateral direction. The first plurality of voids <NUM> have a diameter VD1 of approximately <NUM> - <NUM>. The first plurality of voids <NUM> are spaced close together. In the illustrated embodiment, the first plurality of voids <NUM> are generally circular in cross-section. In other embodiments, the first plurality of voids <NUM> can have other cross-sectional shapes, such as oval, hexagonal, rectangular, and any other geometric shape. The second concentric segment <NUM> includes a second plurality of voids <NUM> that generate a second compression ratio that is larger than the first compression ratio. The second plurality of voids <NUM> have a diameter VD2 of approximately <NUM> - <NUM>. The second plurality of voids <NUM> are spaced farther apart than the first plurality of voids <NUM>. In the illustrated embodiment, the second plurality of voids <NUM> are generally circular in cross-section. In other embodiments, the second plurality of voids <NUM> can have other cross-sectional shapes, such as oval, hexagonal, rectangular, and any other geometric shape. The third concentric segment <NUM> includes a third plurality of voids <NUM> that generate a third compression ratio that is larger than the second compression ratio and the first compression ratio. The third plurality of voids <NUM> have a diameter VD3 of approximately <NUM> - <NUM>. The third plurality of voids <NUM> are spaced farther apart than the first plurality of voids <NUM> and the second plurality of voids <NUM>. In the illustrated embodiment, the third plurality of voids <NUM> are generally circular in cross-section. In other embodiments, the third plurality of voids <NUM> can have other cross-sectional shapes, such as oval, hexagonal, rectangular, and any other geometric shape. The first plurality of voids <NUM>, the second plurality of voids <NUM>, and the third plurality of voids <NUM> are configured to change the density of the compressive material. Accordingly, under negative pressure, the third concentric segment <NUM> has high collapse, the second concentric segment <NUM> has intermediate collapse, and the first concentric segment <NUM> has low collapse.

<FIG> illustrates a system <NUM> for forming the composite compressive component <NUM> according to an exemplary embodiment. The system includes a first pad <NUM> of the compressive material including the first plurality of voids <NUM>, a second pad <NUM> of the compressive material including the second plurality of voids <NUM>, and a third pad <NUM> of the compressive material including the third plurality of voids <NUM>. In the illustrated embodiment, the first plurality of voids <NUM>, the second plurality of voids <NUM>, and the third plurality of voids <NUM> are evenly distributed over the first pad <NUM>, the second pad <NUM>, and the third pad <NUM>. In other embodiments, the first plurality of voids <NUM>, the second plurality of voids <NUM>, and the third plurality of voids <NUM> may be arranged in different patterns and /or may be unevenly distributed over the first pad <NUM>, the second pad <NUM>, and the third pad <NUM> to change a compressive profile of the composite compressive component <NUM> formed from at least two of the first pad <NUM>, the second pad <NUM>, and the third pad <NUM>. The first pad <NUM> includes a first plurality of sizing perforations <NUM> that divide the first pad <NUM> into a first plurality of concentric segments <NUM>. The second pad <NUM> includes a second plurality of sizing perforations <NUM> that divide the second pad <NUM> into a second plurality of concentric segments <NUM>. The third pad <NUM> includes a third plurality of sizing perforations <NUM> that divide the third pad <NUM> into a third plurality of concentric segments <NUM>. In the illustrated embodiment, the first plurality of sizing perforations <NUM>, the second plurality of sizing perforations <NUM>, and the third plurality of sizing perforations <NUM> include two generally elliptical rings of perforations that divide the first pad <NUM> into three concentric segments. In other embodiments, the first plurality of sizing perforations <NUM>, the second plurality of sizing perforations <NUM>, and the third plurality of sizing perforations <NUM> may include more or fewer rings of perforations that divide the first pad <NUM>, the second pad <NUM>, and the third pad <NUM> into more or fewer segments. For example, in some embodiments, the first pad <NUM>, the second pad <NUM>, and the third pad <NUM> may include <NUM> concentric segments or <NUM> concentric segments. In the illustrated embodiment, the first plurality of sizing perforations <NUM>, the second plurality of sizing perforations <NUM>, and the third plurality of sizing perforations <NUM> have substantially the same dimensions such that the first plurality of concentric segments <NUM>, the second plurality of concentric segments <NUM>, and the third plurality of concentric segments <NUM> can be used to form the composite compressive component <NUM> in any order. Accordingly, the composite compressive component <NUM> is formed by combining concentric segments from the first pad <NUM>, the second pad <NUM>, and the third pad <NUM>. For any of the pads <NUM>, <NUM>, <NUM> described herein, the prime " ' " symbol refers to a first concentric segment, the double prime " " " symbol refers to a second concentric segment, and the triple prime " ‴ " symbol refers to a third concentric segment. In some embodiments, the first pad <NUM>, the second pad <NUM>, and the third pad <NUM> may have different colors or patterns to indicate that the first pad <NUM>, the second pad <NUM>, and the third pad <NUM> have different compression ratios. The sizing perforations <NUM>, <NUM>, <NUM> are spaced from the pluralities of voids <NUM>, <NUM>, <NUM>.

For example, to form the composite compressive component <NUM> configured for high, rapid compression proximate a perimeter of the composite compressive component <NUM>, an intermediate amount of compression adjacent the high compression portion of the composite compressive component <NUM>, and low compression proximate a center of the composite compressive component <NUM>, a user may remove the smallest concentric segment <NUM>' of the first pad <NUM>. The user may then remove the concentric segment <NUM>" from the second pad <NUM> and remove the concentric segment <NUM>' from the second pad <NUM> to form a through-opening in the second pad <NUM>. Since the first plurality of sizing perforations <NUM> and the second plurality of sizing perforations <NUM> are substantially the same, the user can position the concentric segment <NUM>' from the first pad <NUM> into the through-opening <NUM> in the concentric segment <NUM>" from the second pad <NUM>. The concentric segment <NUM>' may fit in the through-opening <NUM> of the concentric segment <NUM>" in a friction fit. The user may then remove a concentric segment <NUM>‴ from the third pad <NUM> that is larger than the concentric segment <NUM>". The user then may remove the concentric segments <NUM>', <NUM>" from the concentric segment <NUM>‴ to form the through-opening <NUM> in the concentric segment <NUM>‴ of the third pad <NUM>. Since the second plurality of sizing perforations <NUM> and the third plurality of sizing perforations <NUM> are substantially the same, the user can position the concentric segment <NUM>" into the through-opening to form the composite compressive component <NUM>. The concentric segment <NUM>" may fit in the through-opening <NUM> of the concentric segment <NUM>‴ in a friction fit. In some embodiments, concentric segments may be cut to form combined segments made from different pads to form a composite pad having an asymmetrical compressive profile.

<FIG> illustrate a composite body or composite compressive component <NUM> and a system <NUM> for forming the composite compressive component <NUM> according to an exemplary embodiment. The composite compressive component <NUM> is generally symmetrical and elliptical-shaped. The composite compressive component <NUM> includes a first surface <NUM> and a second, fascia-facing, surface <NUM>. In some embodiments, the second surface <NUM> of the composite compressive component <NUM> contacts the first layer <NUM> of the abdominal treatment device <NUM>. In some embodiments, the first surface <NUM> of the composite compressive component <NUM> contacts the sealing member <NUM>. The composite compressive component <NUM> includes a longitudinal axis <NUM> defining a longitudinal direction, a lateral axis <NUM> defining a lateral direction, and a vertical axis <NUM> defining a vertical direction. The composite compressive component <NUM> includes a first tapered end <NUM> and a second tapered end <NUM>. The first tapered end <NUM> and the second tapered end <NUM> are spaced apart along the longitudinal axis <NUM>. The composite compressive component <NUM> is configured to collapse in a first direction while resisting collapse in a second direction that is substantially perpendicular to the first direction. For example, in the illustrated embodiment, the composite compressive component <NUM> is configured to collapse in a lateral direction (e.g., along the lateral axis <NUM>) and/or a radial direction (e.g., along the lateral axis <NUM> and the longitudinal axis <NUM>) while resisting compression in a vertical direction (e.g., along the vertical axis <NUM>) under negative pressure.

<FIG> illustrates a system <NUM> for forming the composite compressive component <NUM> according to an exemplary embodiment. The system includes a first pad <NUM>, a second pad <NUM>, and a third pad <NUM>. The first pad <NUM> is a first compressive material having first material properties that generate a first compression ratio. The second pad <NUM> is a second compressive material having second material properties that generate a second compression ratio that is higher than the first compression ratio. The third pad <NUM> is a third compressive material having third material properties that generate a third compression ratio that is higher than the first compression ratio and the second compression ratio. The first material properties, the second material properties, and the third material properties may be material properties that determine a density of the first compressive material, the second compressive material, and the third compressive material, respectively. The first density is higher than the second density and the second density is higher than the third density. In some embodiments, the first material properties, the second material properties, and the third material properties can include at least one of a concentration of pores per inch ("PPI"), a density, and a percent felting. At least a portion of the first material properties, the second material properties, and third material properties are different. The first compressive material, the second compressive material, and the third compressive material can be any of the materials discussed above with respect to the compressive component <NUM>. In some embodiments, at least one of the first compressive material, the second compressive material, and the third compressive material is Granufoam® or a felted foam material. In some embodiments, at least one of the first compressive material, the second compressive material, and the third compressive material is a three-dimensional textile material such as BallTex.

The first pad <NUM> includes a first plurality of sizing perforations <NUM> that divide the first pad <NUM> into a first plurality of concentric segments <NUM>. The second pad <NUM> includes a second plurality of sizing perforations <NUM> that divide the second pad <NUM> into a second plurality of concentric segments <NUM>. The third pad <NUM> includes a third plurality of sizing perforations <NUM> that divide the third pad <NUM> into a third plurality of concentric segments <NUM>.

In the illustrated embodiment, the first plurality of sizing perforations <NUM>, the second plurality of sizing perforations <NUM>, and the third plurality of sizing perforations <NUM> include two generally elliptical rings of perforations that divide the first pad <NUM>, the second pad <NUM>, and the third pad <NUM> into three concentric segments. In other embodiments, the first plurality of sizing perforations <NUM>, the second plurality of sizing perforations <NUM>, and the third plurality of sizing perforations <NUM> may include more or fewer rings of perforations that divide the first pad <NUM>, the second pad <NUM>, and the third pad <NUM> into more or fewer segments. For example, in some embodiments, the first pad <NUM>, the second pad <NUM>, and the third pad <NUM> may include <NUM> concentric segments or <NUM> concentric segments. In the illustrated embodiment, the first plurality of sizing perforations <NUM>, the second plurality of sizing perforations <NUM>, and the third plurality of sizing perforations <NUM> have substantially the same dimensions such that the first plurality of concentric segments <NUM>, the second plurality of concentric segments <NUM>, and the third plurality of concentric segments <NUM> can be used to form the composite compressive component <NUM> in any order. Accordingly, the composite compressive component <NUM> is formed by combining concentric segments from the first pad <NUM>, the second pad <NUM>, and the third pad <NUM>. For any of the pads <NUM>, <NUM>, <NUM> described herein, the prime " ' " symbol refers to a first concentric segment, the double prime " " " symbol refers to a second concentric segment, and the triple prime " ‴ " symbol refers to a third concentric segment. In some embodiments, the first pad <NUM>, the second pad <NUM>, and the third pad <NUM> may have different colors or patterns to indicate that the first pad <NUM>, the second pad <NUM>, and the third pad <NUM> have different compression ratios.

To form a composite compressive component <NUM> that is configured for high, rapid compression proximate a perimeter of the composite compressive component <NUM>, an intermediate amount of compression adjacent the high compression portion of the composite compressive component <NUM>, and low compression proximate a center of the composite compressive component <NUM>, a user may remove the smallest concentric segment <NUM>' of the first pad <NUM>. The user may then remove the concentric segment <NUM>" from the second pad <NUM> and remove the concentric segment <NUM>' from the second pad <NUM> to form a through-opening <NUM> in the second pad <NUM>. Since the first plurality of sizing perforations <NUM> and the second plurality of sizing perforations <NUM> are substantially the same, the user can position the concentric segment <NUM>' from the first pad <NUM> into the through-opening <NUM> in the concentric segment <NUM>" from the second pad <NUM>. The concentric segment <NUM>' may fit in the through-opening <NUM> of the concentric segment <NUM>" in a friction fit. The user may then remove a concentric segment <NUM>‴ from the third pad <NUM> that is larger than the concentric segment <NUM>". The user then may remove the concentric segments <NUM>', <NUM>" from the concentric segment <NUM>‴ to form a through-opening <NUM> in the concentric segment <NUM>‴ of the third pad <NUM>. Since the second plurality of sizing perforations <NUM> and the third plurality of sizing perforations <NUM> are substantially the same, the user can position the concentric segment <NUM>" (and the concentric segment <NUM>') into the through-opening <NUM> to form the composite compressive component <NUM>. The concentric segment <NUM>" may fit in the through-opening <NUM> of the concentric segment <NUM>‴ in a friction fit.

<FIG> illustrates a perspective view of the composite compressive component <NUM> under ambient pressure conditions and <FIG> is a perspective view of the composite compressive component under negative pressure conditions according to an exemplary embodiment. The composite compressive component <NUM> includes the concentric segment <NUM>' of the first compressive material, the second concentric segment <NUM>" of the second compressive material, and the third concentric segment <NUM>‴ of the third compressive material. The first concentric segment <NUM>' forms a central portion of the composite compressive component <NUM>. The second concentric segment <NUM>" is substantially ring-shaped and includes the through-opening <NUM> sized to receive the first concentric segment <NUM>'. The third concentric segment <NUM>‴ is substantially ring-shaped and includes the through-opening <NUM> for receiving the second concentric segment <NUM>". Accordingly, the first concentric segment <NUM>', the second concentric segment <NUM>", and the third concentric segment <NUM>‴ are arranged in a nested configuration. As is apparent from comparing <FIG>, the composite compressive component <NUM> has compressed in a generally lateral direction and a generally vertical direction as a under negative pressure conditions. As shown in <FIG>, under negative pressure, the third concentric segment <NUM>‴ has high collapse in the generally lateral direction, the second concentric segment <NUM>" has intermediate collapse in the generally lateral direction, and the first concentric segment <NUM>' has low collapse in the generally lateral direction.

Although the system <NUM> for forming the composite compressive component <NUM> and the system <NUM> for forming the composite compressive component <NUM> are illustrated using three pads having three concentric segments, in other embodiments, the system <NUM> and the system <NUM> can include more or fewer pads and/or more or fewer concentric segments. In the illustrated embodiments, the sizing perforations are generally elliptical. In other embodiments, the pluralities of sizing perforations may have different shapes than the sizing perforations illustrated in <FIG>. Although <FIG> illustrate one compressive segment from each of the compressive pads, in some embodiments, more or fewer compressive segments from each of the compressive pads may be used. Furthermore, the compressive segments can be arranged in any order to provide a desired compressive profile based on the wound being treated. While the composite compressive component <NUM> illustrated in <FIG> includes three concentric segments, in other embodiments, the compressive component <NUM> can include more or fewer concentric segments. In some embodiments, concentric segments may be cut to form combined segments made from different pads to form a composite pad having an asymmetrical compressive profile.

While the composite compressive components <NUM>, <NUM> are described in the context of the wound therapy system <NUM> configured for treatment of deep abdominal wounds, this description is intended to be non-limiting. The composite compressive components <NUM>, <NUM> can have other shapes and can be used to treat other types of wounds.

Claim 1:
A system (<NUM>) for forming a composite compressive component (<NUM>) for a negative pressure wound therapy, NPWT, dressing for treating a deep abdominal wound, the system (<NUM>) comprising:
a first compressive material (<NUM>) having a first compression ratio, the first compressive material (<NUM>) including a first pattern of concentric perforations (<NUM>) configured to form at least a first detachable compressive component segment (<NUM>'), wherein the first detachable compressive component segment (<NUM>') has an elliptical shape; and
a second compressive material (<NUM>) having a second compression ratio different than the first compression ratio, the second compressive material (<NUM>) including a second pattern of concentric perforations (<NUM>) configured to form at least a second detachable compressive component segment (<NUM>"), the second detachable compressive component segment (<NUM>") including a through-opening (<NUM>) configured to receive the first detachable compressive component segment (<NUM>') in a friction fit, wherein the second detachable compressive component segment (<NUM>") has an elliptical ring shape;
a third compressive material (<NUM>) having a third compression ratio different than the first compression ratio and the second compression ratio, the third compressive material (<NUM>) including a third pattern of concentric perforations (<NUM>) configured to form at least a third detachable compressive component segment (<NUM>"'), the third detachable compressive component segment (<NUM>‴) including a through-opening (<NUM>) configured to receive the second detachable compressive component segment (<NUM>") in a friction fit to form the composite compressive component (<NUM>), wherein the third detachable compressive component segment (<NUM>‴) has an elliptical ring shape,
wherein the first pattern of concentric perforations (<NUM>), the second pattern of concentric perforations (<NUM>), and the third pattern of concentric perforations (<NUM>) are the same pattern of elliptical concentric perforations, and
wherein the first compressive material (<NUM>), the second compressive material (<NUM>), and the third compressive material (<NUM>) are a felted foam.