Contoured foam dressing shaped for providing negative pressure to incisions in the breast

A negative pressure wound dressing for use with breast incisions. The wound dressing includes a drape layer, a manifold layer, a base layer, and a reduced pressure interface. The drape layer has a first surface and a second, wound-facing, surface. The drape layer is substantially impermeable to liquid and substantially permeable to vapor. The manifold layer has a first surface and a second, wound-facing surface. The manifold layer has a perimeter defined by a first convex curved side surface defining a first lobe, a second convex curved side surface defining a second lobe, and a connecting portion between the first lobe and the second lobe. The base layer is configured to: (i) couple the drape layer to the manifold layer, and (ii) the dressing to a patient's tissue. The reduced pressure interface is integrated with the drape layer.

BACKGROUND

The present disclosure relates generally to a wound therapy system, and more particularly to a wound therapy system contoured to provide negative pressure wound therapy to the site of a breast incision.

Negative pressure wound therapy (NPWT) is a type of wound therapy that involves applying a negative pressure to a wound site to promote wound healing. NPWT can be used to treat wounds in the breast area caused by mastectomies, breast enhancement surgery, breast reconstruction surgery, or breast reduction surgery. Current negative pressure dressings used to treat the breast area are generally shaped in the form of a brassiere and include a first cup and a second cup made from a dressing material connected by a band of material. Such dressings must usually be provided in many sizes and, in the case of mastectomies, may require the use of a prosthetic device in one or both of the cups.

Recent developments in NPWT therapy include the use of adhesive wound dressings that can be positioned over a wound to treat the wound and the surrounding area. However, existing adhesive NPWT dressings are primarily linear dressings designed to treat linear wounds. In most instances, breast surgeries involve two generally perpendicular incisions. A first incision is a generally horizontal incision proximate a base of the breast and a second incision is generally perpendicular to the first incision and extends upward from the first incision and around a top of the nipple. The two incisions form an inverted T-shape. The existing NPWT dressings are configured to treat one of the first incision and the second incision, and must be customized to treat the specific incision pattern, breast size, and/or left breast or right breast of the patient.

SUMMARY

One implementation of the present disclosure is a negative pressure wound therapy system for use with breast incisions. The system includes a wound dressing including a drape layer, a manifold layer, a reduced-pressure interface, a base layer, and an optional wound-interface layer. The drape layer is configured to provide a sealed space over a wound or incision, and has a first surface and a second, wound-facing, surface. The drape layer is substantially impermeable to liquid and substantially permeable to vapor. The manifold layer allows for the transmission of negative pressure to a patient's tissue, and has a first surface and a second, wound-facing surface. In some embodiments, the manifold layer is comprised of a hydrophobic foam, such as an open-cell polyurethane foam. The manifold layer has a perimeter defined by a first convex curved side surface defining a first lobe, a second convex curved side surface defining a second lobe, and a connecting portion between the first lobe and the second lobe. The reduced-pressure interface allows for the fluid communication of negative pressure from a negative pressure source into the dressing (through the drape layer), via a conduit configured to fluidly couple the negative pressure source and the reduced-pressure interface. The reduced-pressure interface is preferably integrated with the drape layer; though alternatively, it can be separate from the drape layer and configured to be coupled to the drape layer by a user. The base layer may comprise polyurethane film coated with an adhesive (such as acrylic or silicone adhesive) on both sides. The base layer may be (i) configured to secure the drape layer to the manifold layer and, if present, the wound-interface layer, and (ii) configured to secure the dressing to a patient's tissue. In some embodiments, the functionality of the base layer is provided by the drape layer, and a separate base layer is not included. In some embodiments, the wound-facing side of the base layer includes a hydrocolloid adhesive. The optional wound interface layer may comprise a wicking material, and may optionally include antimicrobials (such as silver).

Another implementation of the present disclosure is a negative pressure wound dressing for use with breast incisions. The wound dressing includes a drape layer, a manifold layer, a base layer, and a reduced pressure interface. The drape layer has a first surface and a second, wound-facing, surface. The drape layer is substantially impermeable to liquid and substantially permeable to vapor. The manifold layer has a first surface and a second, wound-facing surface. The manifold layer has a perimeter defined by a first convex curved side surface defining a first lobe, a second convex curved side surface defining a second lobe, and a connecting portion between the first lobe and the second lobe. The base layer is (i) configured to secure the drape layer to the manifold layer, and (ii) configured to secure the dressing to a patient's tissue. The reduced pressure interface is integrated with the drape layer.

Another implementation of the present disclosure is a wound dressing for negative pressure wound therapy treatment of breast incisions including a manifold layer and a drape layer that is substantially impermeable to liquid and substantially permeable to vapor. The manifold layer includes a first surface, a second, wound-facing, surface, and a plurality of scores formed in the first surface and extending towards the second surface. The plurality of scores define a geometric scoring pattern. The manifold layer is bendable about the plurality of scores.

Another implementation of the present disclosure is a negative pressure wound dressing for use with breast incisions. The wound dressing includes a drape layer, a manifold layer, a base layer, and a reduced-pressure interface. The drape layer has a first surface and a second, wound-facing, surface. The drape layer is substantially impermeable to liquid and substantially permeable to vapor. The manifold layer has a first surface and a second, wound-facing surface. The manifold layer includes a perimeter defined by a first curved corner having first radius of curvature, a second curved corner having a second radius of curvature, and a third curved corner having a third radius of curvature. The third radius of curvature is smaller than the first radius of curvature and the second radius of curvature. The base layer is (i) configured to secure the drape layer to the manifold layer and (ii) configured to secure the wound dressing to a patient's tissue. The reduced-pressure interface is integrated with the drape layer.

DETAILED DESCRIPTION

Overview

Referring generally to the FIGURES, a wound therapy system for treating wounds of curved body parts is shown, according to various embodiments. More specifically, the wound therapy system is for treating wounds in the breast area, although the wound therapy system can also be deployed on other curved parts of the body, such as the buttocks, harvest sites for skin grafting (e.g. the back of a leg), and the lower back. The wound therapy system includes a wound dressing and a negative pressure wound therapy (NPWT) system. The phrase “negative pressure” means a pressure less than an ambient or atmospheric pressure. While the amount and nature of reduced pressure applied to the wound site can vary according to the application, the reduced pressure typically is between −5 mm Hg and −500 mm Hg and more typically between −100 mm Hg and −300 mm Hg. The wound dressing described herein is shaped to cover the entire breast area (e.g. extend between a side of the patient's rib cage generally beneath the armpit near the lymph node gland to the sternum region and an upper portion of the chest area). In some embodiments, the profile of the wound dressing is generally heart-shaped and includes a curved, slightly concave portion positionable proximate a patient's armpit, a first lobe (e.g. slightly convex) for covering an upper portion of the breast and a second lobe (e.g. slightly convex) for covering a bottom portion of the breast, curving around the ribcage, and extending beneath the armpit. In some embodiments, the profile of the wound dressing is generally shaped like a guitar pick (e.g., generally triangular and having curved sides and corners). The wound dressing described herein can be configured to conform to applications involving two-dimensional and/or three-dimensional contours. For example, when the wound dressing is used to treat a full and/or partial mastectomy, the dressing is configured to conform to a side of the patient's ribcage and a generally flat (e.g. two-dimensional) front portion of the patient's rib cage. In instances where the wound dressing is used to treat a partial mastectomy, a breast enhancement incision, or a breast reduction incision, the wound dressing is configured to conform to a side of the patient's ribcage and a curved (e.g. a three-dimensional) contour formed defined by the breast and the front portion of the ribcage. The profile shape of the wound dressing is generally symmetric to allow placement of the wound dressing on either the left or the right breast.

In the illustrated embodiments, the manifold layer of the wound dressing includes a scoring pattern to allow the manifold layer to bend to conform to three-dimensional curved shapes. The scores extend generally to a partial depth of the thickness (e.g. 7 mm, etc.) into the manifold layer. In some embodiments, the scoring pattern is generally hexagonal. In other embodiments, the scoring pattern is generally quadrilateral. For example, the scores may form squares, parallelograms, or rectangles. In other embodiments, the scoring pattern is concentric scoring following a shape of a perimeter of the manifold layer. The manifold layer is configured to wick fluid (e.g. exudate) from the wound and includes in-molded manifold layer structures for distributing negative pressure throughout the wound dressing during negative pressure wound therapy treatments.

In some embodiments, a portion of the scores in a central area of the manifold layer of the wound include perforations that extend through a width of the manifold layer. The perforations permit selective removal of one or more pieces of the manifold layer to allow visualization of the nipple when the wound dressing is secured to a patient. Visualization of the nipple is intended to allow a healthcare practitioner to observe the health of the wound while leaving the dressing intact.

The wound therapy system may include a removed-fluid container and a pump. The removed-fluid container can be configured to store a fluid removed from the wound site (e.g., wound exudate, etc.). The removed-fluid container can be fluidly coupled to the wound site via a fluid removal line. The NPWT can help reduce the chance of the wounds developing seroma, scaring, infection, or other adverse complications.

In some embodiments, when two wound dressings are used on the same patient, the two wound dressings can be connected using a Y-connection so that the same pump and removed-fluid container can be used to treat the wounds. The pump and/or the Y-connection can include at least one valve so that different amounts of negative pressure can be exerted on each breast if desired.

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

Wound Dressing

Referring now toFIGS.1-4, a wound dressing100is shown, according to an exemplary embodiment.FIG.1is a front view of the wound dressing100.FIG.2is a perspective view of the wound dressing100.FIG.3is an exploded view illustrating several layers120-154of the wound dressing100.FIG.4is a cross-sectional view of the wound dressing100adhered to a surface104, such as a patient's torso.

In various embodiments, the wound dressing100can be formed as a substantially flat sheet for topical application to wounds. The wound dressing100can lie flat for treatment of substantially flat wounds and is also configured to bend to conform to body surfaces having high curvature, such as breasts. The wound dressing100has a profile or a perimeter that is generally heart-shaped and includes a first lobe108(e.g. convex portion) and a second lobe112(e.g. convex portion) that define a concave portion116therebetween. The wound dressing100is generally symmetric about an axis A. It is contemplated that the size of the wound dressing can range from 180 cm2to 1000 cm2. More preferably, the size of the wound dressing can range from 370 cm2to 380 cm2, 485 cm2to 495 cm2, and/or 720 cm2to 740 cm2. However, other shapes and sizes of wound dressing100are also possible depending on the intended use. For example, for some uses, the wound dressing100may have asymmetrically-shaped lobes108,112.

The wound dressing100is shown to include a plurality of layers, including a drape layer120, a manifold layer124, a wound-interface layer128, a rigid support layer142, a first adhesive layer146, a second adhesive layer150, and a patient-contacting layer154. In some embodiments, the wound dressing100includes a removable cover sheet132to cover the manifold layer124, the wound-interface layer128, the second adhesive layer150, and/or the patient-contacting layer154before use.

Drape Layer

The drape layer120is shown to include a first surface136and a second, wound-facing, surface140opposite the first surface136. When the wound dressing100is applied to a wound, the first surface136faces away from the wound, whereas the second surface140faces toward the wound. The drape layer120supports the manifold layer124and the wound-interface layer128and provides a barrier to passage of microorganisms through the wound dressing100. The drape layer120is configured to provide a sealed space over a wound or incision. In some embodiments, the drape layer120is 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, and silicones. As non-limiting examples, the drape layer120may be formed from materials that include a silicone, 3M Tegaderm® drape material, acrylic drape material such as one available from Avery, or an incise drape material.

The drape layer120may be substantially impermeable to liquid and substantially permeable to water vapor. In other words, the drape layer120may be permeable to water vapor, but not permeable to liquid water or wound exudate. This increases the total fluid handling capacity (TFHC) of wound dressing100while promoting a moist wound environment. In some embodiments, the drape layer120is also impermeable to bacteria and other microorganisms. In some embodiments, the drape layer120is configured to wick moisture from the manifold layer124and distribute the moisture across the first surface136.

In the illustrated embodiment, the drape layer120defines a cavity122(FIG.4) for receiving the manifold layer124, the wound-interface layer128, and the first adhesive layer146. As shown inFIG.2, the manifold layer124, the wound-interface layer128, and the first adhesive layer146can have a similar perimeter or profile. In some embodiments, a perimeter of the drape layer120extends beyond (e.g. circumscribes) the perimeter of the manifold layer124to provide a margin144. The first adhesive layer146includes a first surface147and a second, wound-facing surface149. Both first surface147and the second surface149are coated with an adhesive, such as an acrylic adhesive, a silicone adhesive, and/or other adhesives. The first surface147of the first adhesive layer146is secured to the second surface224of the wound-interface layer128. The second surface149of the first adhesive layer146is secured to the second adhesive layer150. The second adhesive layer150includes a first surface151and a second, wound-facing surface153. The second surface149of the first adhesive layer146is secured to the first surface151of the second adhesive layer150. The second surface153of the second adhesive layer150is coated with an acrylic adhesive, a silicone adhesive, and/or other adhesives. The adhesive applied to the second surface153of the second adhesive layer150is intended to ensure that the wound dressing100adheres to the surface104of the patient's skin (as shown inFIGS.4,9, and10) and that the wound dressing100remains in place throughout the wear time. The second adhesive layer150has a perimeter or profile that is similar to a perimeter or profile of the margin144. In the illustrated embodiment, the first surface151of the second adhesive layer150is welded to the margin144. In other embodiments, the first surface151of the second adhesive layer is secured to the margin144using an adhesive, such as an acrylic adhesive, a silicone adhesive, or another type of adhesive. The patient-contacting layer154includes a first surface155and a second, wound-facing surface157. In some embodiments, the patient-contacting layer154can be made of a hydrocolloid material, a silicone material or another similar material. The first surface155of the patient-contacting layer154can be secured to the second adhesive layer150. The patient-contacting layer154follows a perimeter of the manifold layer124. In some embodiments, the patient-contacting layer154can be made of a polyurethane film coated with an acrylic or silicone adhesive on both surfaces155,157. In some embodiments, the patient-contacting layer154can include a hydrocolloid adhesive on the second, wound-facing, surface157. The margin144and/or the second adhesive layer150may extend around all sides of the manifold layer124such that the wound dressing100is a so-called island dressing. In other embodiments, the margin144and/or the second adhesive layer150can be eliminated and the wound dressing100can be adhered to the surface104using other techniques. In some embodiments, the first adhesive layer146, the second adhesive layer150, and the patient-contacting layer154can collectively form a base layer that includes an adhesive on both sides that is (i) configured to secure the drape layer120to the manifold layer124, the optional wound-interface layer128, and (ii) configured to secure the wound dressing100to a patient's tissue. In some embodiments, the base layer can be integrally formed with the drape layer120. In some embodiments, the base layer can be a layer of a polyurethane film having a first surface and a second, wound-facing surface. Both the first surface and the second surface can be coated with an adhesive (such as an acrylic or silicone adhesive). In some embodiments, the wound-facing surface of the base layer can include a hydrocolloid adhesive.

In some embodiments, a reduced-pressure interface158can be integrated with the drape layer120. The reduced-pressure interface158can be in fluid communication with the negative pressure system through a removed fluid conduit268(FIG.4). The reduced-pressure interface158is configured to allow fluid communication between a negative pressure source and the wound dressing100(e.g., through the drape layer120) via a removed fluid conduit coupled between the reduced-pressure interface158and the negative pressure source such that negative pressure generated by the negative pressure source can be applied to the wound dressing100(e.g., through the drape layer120). In some embodiments, the reduced-pressure interface158can be integrated (e.g., integrally formed) with the drape layer120. In other embodiments, the reduced-pressure interface158can be separate from the drape layer120and configured to be coupled to the drape layer120by a user.

With continued reference toFIG.2, the rigid support layer142is positioned above the first surface136of the drape layer120. The rigid support layer142is spaced from but proximate the margin144and the second adhesive layer150. The rigid support layer142is made of a rigid material and helps the wound dressing100maintain rigidity before the wound dressing100is secured to the surface104of the patient. The rigid support layer142is intended to be removed from the drape layer120after the wound dressing100has been secured to the surface104of the patient.

In some embodiments, the second surface140of the drape layer120contacts the manifold layer124. The second surface140of the drape layer120may be adhered to the manifold layer124or may simply contact the manifold layer124without the use of an adhesive.

In some embodiments, the adhesive applied to the second surface140of the drape layer120is moisture vapor transmitting and/or patterned to allow passage of water vapor therethrough. The adhesive may include a continuous moisture vapor transmitting, pressure-sensitive adhesive layer of the type conventionally used for island-type wound dressings (e.g. a polyurethane-based pressure sensitive adhesive).

Manifold Layer

Referring toFIG.5, the manifold layer124is shown to include a first surface148and a second, wound-facing surface152opposite the first surface148. When the wound dressing100is applied to a wound, the first surface148faces away from the wound, whereas the second surface152faces toward the wound. In some embodiments, the first surface148of the manifold layer124contacts the second surface140of the drape layer120. In some embodiments, the second surface152of the manifold layer124contacts the wound-interface layer128. The manifold layer124is configured for transmission of negative pressure to the patient's tissue at and/or proximate a wound and/or incision. The manifold layer124is configured to wick fluid (e.g. exudate) from the wound and includes in-molded manifold layer structures for distributing negative pressure throughout the wound dressing100during negative pressure wound therapy treatments.

The manifold layer124can 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 V.A.C.® 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 manifold layer124provided that the manifold layer124is operable to distribute the reduced pressure and provide a distributed compressive force along the wound site.

The reticulated pores of the Granufoam™ material that are in the range from about 400 to 600 microns, are preferred, but other materials may be used. The density of the manifold layer material, e.g., Granufoam™ material, is typically in the range of about 1.3 lb/ft3-1.6 lb/ft3(20.8 kg/m3-25.6 kg/m3). 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 1.6 lb/ft3(25.6 kg/m3) may be used. As another example, the Granufoam™ material or similar material with a density greater than 2.0 lb/ft3(32 kg/m3) or 5.0 lb/ft3(80.1 kg/m3) 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 manifold layer material, a lifting force may be developed. In one illustrative embodiment, a portion, e.g., the edges, of the wound dressing100may exert a compressive force while another portion, e.g., a central portion, may provide a lifting force.

The manifold layer 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 manifold layer materials, the following may be used: Granufoam™ material or a Foamex® technical foam (www.foamex.com). 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 manifold layer material such as antimicrobial agents. The manifold layer 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 manifold layer material may also be a bio-absorbable material.

As shown inFIGS.1-3and5, the manifold layer124is generally symmetrical, heart-shaped, and includes a first convex curved side156defining a first lobe160, a second convex curved side164defining a second lobe168, and a concave connecting portion172extending therebetween. The manifold layer124can have a width W ranging between 8 cm and 33 cm, and more preferably between 17 cm and 33 cm. The manifold layer124can have a length L ranging between 7 cm and 35 cm, and more preferably between 14 cm and 30 cm. The manifold layer124can have a thickness T ranging between 14 mm and 24 mm, and more preferably 19 mm. The first lobe160and the second lobe168are convex and can have a radius of curvature ranging between 3 cm and 10 cm, and more preferably from 5 cm to 9 cm. The connecting portion172is generally concave and can have a radius of curvature ranging between 20 cm and 33 cm, and more preferably from 22 cm to 28 cm. The first curved side156and the second curved side164form a point174positioned generally opposite the connecting portion172. In the illustrated embodiment, the first curved side156and the second curved side164are generally symmetric about the axis A.

As is best shown inFIG.5, a scoring pattern176is formed in the first surface148of the manifold layer124. The scoring pattern176is shown for example as an arrangement of “slits” or scores (e.g., “mango-cuts”) formed in the manifold layer124(e.g. formed by laser-scoring or other suitable processes). More particularly, the scoring pattern176is cut into the first surface148of the manifold layer124. In the embodiment ofFIG.5, the scoring pattern176extends between the first surface148and the second surface152but does not extend completely to the second surface152. The scoring pattern176can have a depth D that ranges between 5 mm and 12 mm, and more preferably is approximately 7 mm. According to the illustrated embodiment, the scoring pattern176is a generally hexagonal pattern. However, in other embodiments, the scoring pattern176can be a different geometrical pattern. When the wound dressing100is used on a generally flat (e.g. two-dimensional) surface104or portion of a surface104, such as for example a front of a patient's ribcage after a mastectomy or a side of the patient's ribcage, the scores178of the scoring pattern176are generally vertical and are in close proximity to adjacent scores178of the scoring pattern176. In instances when the wound dressing100is secured to a curved (e.g. three-dimensional) surface, such as a breast or a transition portion of the surface that extends between the side of the ribcage and the front of the ribcage, the scores178of the scoring pattern176splay apart to facilitate bending of the manifold layer124so that the manifold layer124closely conforms to the shape of the curved surface104. The scoring pattern176allows the manifold layer124to conform to both substantially flat surfaces and to a wide range of curved surfaces104. The hexagonal scoring pattern176facilitates conforming to highly curved surfaces104by providing six scores178about which the manifold layer124can bend (e.g. the manifold layer124can bend in six different directions proximate each hexagon cut into the first surface148). In implementations where the surface104is the breast or is proximate the breast of a patient, the scoring pattern176allows a single size of manifold layer124to conform to varying sizes of breasts.

FIG.6illustrates a manifold layer180according to another embodiment. The manifold layer180is generally similar to the manifold layer124. The manifold layer180can be incorporated into the wound dressing100as described above with respect to the manifold layer124. Like numbers are indicated by the same number and parts of the manifold layer180are indicated using the prime symbol “′”.

The manifold layer180includes a scoring pattern184formed in the first surface148′. The scoring pattern184is shown for example as an arrangement of “slits” or scores (e.g., “mango-cuts”) formed in the manifold layer180(e.g. formed by laser-scoring or other suitable processes). Preferably, the scoring pattern184is cut into the first surface148′. In the embodiment shown inFIG.6, the scoring pattern184is a hexagonal pattern. In other embodiments, the scoring pattern184can be a different geometrical pattern. The scoring pattern184includes a first portion188of scores proximate a perimeter of the manifold layer180and a second portion192of scores proximate a center of the manifold layer180. The first portion188of scores, which are shown in phantom inFIG.6, extends from the first surface148′ toward the second surface152′, but does not penetrate the second surface152′. The first portion188of scores can have a depth D′ that ranges between 5 mm and 12 mm, and more preferably is approximately 7 mm. The second portion192of scores, which is indicated by the dashed lines inFIG.6, include a cut portion and a perforated portion. The perforations of the perforated portion penetrate through to the second surface152′. The perforations facilitate removal of at least one piece196of the second portion192of the manifold layer124.FIG.6illustrates a piece196of the manifold layer180that has been removed to form a through-opening200in the manifold layer180. The through-opening200allows for visualization of the wound through the manifold layer180when the wound dressing100is secured to the patient. More particularly, when the manifold layer180is used to treat wounds in the breast area, the second portion192is positioned to cover a center of the breast so that at least one piece196of the second portion192can be selectively removed to allow visualization of the nipple. Visual inspection of the color of the nipple is generally understood to be indicative of the health and/or condition of the wounds in the breast area while the dressing remains intact and without interrupting the negative pressure therapy of the wound. To facilitate viewing of the wound through the wound dressing100, the drape layer120is preferably transparent in embodiments of the wound dressing100that include the manifold layer180.

FIG.7illustrates a manifold layer204according to another embodiment. The manifold layer204is generally similar to the manifold layer124. The manifold layer204can be incorporated into the wound dressing100as described above with respect to the manifold layer124. Like numbers are indicated by the same number and parts of the manifold layer204are indicated using the double prime symbol “″”.

The manifold layer204includes a scoring pattern208formed in the first surface148″. The scoring pattern208is shown for example as an arrangement of “slits” or scores (e.g., “mango-cuts”) formed in the manifold layer204(e.g. formed by laser-scoring or other suitable processes). More particularly, the scoring pattern208is cut into the first surface148″. In the embodiment shown inFIG.7, the scoring pattern208is a generally square pattern. In other embodiments, the scoring pattern208can be a different geometrical shape, for example, rectangular, parallelogram, diamond, rhombus, or any other quadrilateral shape. In the embodiment ofFIG.7, the scoring pattern208extends between the first surface148″ and the second surface152″ but does not extend completely through to the second surface152″. The scoring pattern208can have a depth D″ that ranges between 5 mm and 12 mm, and more preferably is 7 mm. In other embodiments, the scoring pattern208can facilitate removal of at least some of a center portion of the manifold layer204as described above with respect toFIG.6. When the wound dressing100is used on a generally flat (e.g. two-dimensional) surface104or portion of a surface104, such as for example a front of a patient's ribcage after a mastectomy or a side of the patient's ribcage, the scores210of the scoring pattern208are generally vertical and are in close proximity to adjacent scores210. In instances when the wound dressing100is secured to a curved (e.g. three-dimensional) surface104, such as a breast or a transition portion of the surface104that extends between the side of the ribcage and the front of the ribcage, the scores210of the scoring pattern208splay apart to facilitate bending of the manifold layer204so that the manifold layer204closely conforms to the shape of the curved surface104. The scoring pattern208allows the manifold layer204to conform to both substantially flat surfaces and to a wide range of curved surfaces104. The square scoring pattern208facilitates conforming to curved surfaces104by providing four scores210about which the manifold layer204can bend (e.g. the manifold layer can bend in four different directions proximate each square cut into the first surface148″). In implementations where the surface104is the breast or is proximate the breast of a patient, the scoring pattern208allows a piece of manifold layer204to conform to varying sizes of breasts.

FIG.8illustrates a manifold layer212according to a different embodiment. The manifold layer212is generally similar to the manifold layer124. The manifold layer212can be incorporated into the wound dressing100as described above with respect to the manifold layer124. Like numbers are indicated by the same number and parts of the manifold layer212are indicated using the triple prime symbol “′″”.

The manifold layer212includes a scoring pattern216formed in the first surface148′″. The scoring pattern is shown for example as an arrangement of “slits” or scores formed in the manifold layer212(e.g. formed by laser-scoring or other suitable processes). Preferably, the scoring pattern216is cut into the first surface148′″. In the embodiment shown inFIG.8, the scoring pattern216includes concentric scores218in a shape of a perimeter of the manifold layer212. In the embodiment ofFIG.8, the scoring pattern216extends between the first surface148′ and the second surface152′″ but does not extend completely through to the second surface152′. The scoring pattern216can have a depth D′″ that ranges between 5 mm and 12 mm, and more preferably is approximately 7 mm. In instances where the wound dressing100is used on a generally flat (e.g. two-dimensional) surface104or portion of a surface104, such as for example a front of a patient's ribcage after a mastectomy or a side of the patient's ribcage, the scores of the scoring pattern216are generally vertical and are in close proximity to adjacent scores. In instances when the wound dressing100is secured to a curved (e.g. three-dimensional) surface104, such as a breast or a transition portion of the surface104that extends between the side of the ribcage and the front of the ribcage, the scores218of the scoring pattern216splay apart to facilitate bending of the manifold layer212so that the manifold layer212closely conform to the shape of the curved surface104. The scoring pattern216allows the manifold layer212to conform to both substantially flat surfaces and a wide range of curved surfaces104. In implementations where the surface104is or is proximate the breast area of a patient, the scoring pattern216allows a single size of manifold layer212to conform to varying sizes of breasts.

Some embodiments may include manifold layers having a first geometric pattern and a second geometric pattern different than the first geometric pattern. In such embodiments, the first geometric pattern may have more sides than the second geometric pattern, and thus be able to conform to a more highly curved shape. In such an embodiment, the first geometric pattern may be positioned proximate a center of the manifold layer and the second geometric pattern may be positioned proximate a perimeter of the manifold layer.

The wound-interface layer128is shown to include a first surface220and a second, wound-facing surface224opposite the first surface220. When the wound dressing100is applied to the wound, the first surface220faces away from the wound, whereas the second surface152faces toward the wound. In some embodiments, the first surface220of the wound-interface layer128contacts the second surface224of the manifold layer124. In some embodiments, the second surface224of the wound-interface layer128contacts the surface104of the patient. In some embodiments, the wound dressing100may not include the wound-interface layer128.

The wound-interface layer128is made of a wicking material that is fluid-permeable and intended to not irritate the patient's skin. In the illustrated embodiment, the wound-interface layer is a polyester pique-knit fabric, such as Milliken Fabric. In other embodiments, other permeable and non-irritating fabrics can be used. The wound-interface layer128can also be treated with antimicrobial materials. In the illustrated embodiment, the wound-interface layer128includes silver ions as an antimicrobial material. Other anti-microbial materials may be used in other embodiments.

Deployment of the Dressing

FIG.9illustrates the manifold layer204positioned proximate a representative model of a woman's torso. While the manifold layer204is shown inFIGS.9and10, the manifold layers124,180, and212can be deployed in a similar manner. Exemplary intersecting incisions used in breast surgeries such as full and/or partial mastectomies, breast enhancements, and/or breast reductions are shown on a left breast of the model. AlthoughFIG.9illustrates the manifold layer204, the wound dressing100is positioned on the patient in a similar manner. A first incision228is positioned proximate the bottom (e.g. towards the feet) of the breast. A second incision232extends upward (e.g. towards the head) from the first incision228, surrounds the nipple, and extends downward toward the first incision228. Such intersecting incisions are typically referred to as T-shaped incisions. Breast surgeries may include further incisions proximate the armpit and/or the lymph node proximate the armpit (not shown). As shown inFIG.9, the manifold layer204(and the wound dressing100) is sized to cover the surface including the entire breast area, including the first incision228, the second incision232, and any incisions proximate the armpit. A further advantage of covering the entire breast area is that the manifold layer204(and the wound dressing100) can provide support to the whole breast area during the negative pressure therapy. In some embodiments, the wound dressing100can be used with topically applied pharmaceutical compounds. For example, the wound dressing100can be used in conjunction with a silicone gel applied proximate the first incision228and the second incision232. The silicone gel can reduce scarring at or near the incisions228,232. In another example, the wound dressing100can be used in conjunction with a nitroglycerin ointment applied at or near the nipple area. The nitroglycerin ointment can increase perfusion at or near the nipple area.

FIG.9illustrates by way of example the manifold layer204positioned above a surface104defined by the right breast for treatment of the right breast area. When the manifold layer204is used to support the right breast, the manifold layer204is positioned so that the connecting portion172″ is positioned proximate the right armpit. The first lobe160″ covers an upper portion of the breast area. The second lobe168″ covers a bottom portion of the breast area and can be curved around the body to cover a portion of a right side of the torso. The point174″ is positioned proximate a bottom of the sternum. By comparison with the incisions228,232shown on the left breast, both the first incision228and the second incision232are positioned beneath the manifold layer204shown inFIG.9. The manifold layer204has not yet been curved to conform to the breast, so the scores of the scoring pattern208are narrow.

FIG.10illustrates the wound dressing100secured to a surface defined by the woman's left breast. The inset shows the manifold layer204. The first lobe160″ covers a lower portion of the breast area and is curved around the ribcage to cover a portion of a left side of the torso proximate the left armpit. The second lobe168″ covers an upper portion of the breast area. The manifold layer204has been curved to conform to the shape of the breast, and the scores of the scoring pattern208have splayed apart to conform to the curvature of the breast. The point174″ is positioned proximate a bottom of the sternum.

Due to the symmetric shape of the manifold layer204, the manifold layer204can be used to treat wounds in both the left breast (FIG.10) and the right breast (FIG.9) without requiring modification. As can best be seen inFIG.10, the wound dressing100is sized so that a wound dressing100can simultaneously be used independently treat each breast.

Wound Dressing

FIG.11illustrates a wound dressing1000having a single lobe according to an exemplary embodiment. The wound dressing1000is substantially similar to the wound dressing100. Like parts between the wound dressings100and1000are indicated by preceding corresponding parts of the wound dressing100with the number1. The wound dressing1000has a profile or a perimeter that is generally shaped like a guitar pick (e.g., generally triangular and having curved sides and corners). It is contemplated that the size of the wound dressing1000can range from 180 cm2to 1000 cm2. More preferably, the size of the wound dressing1000can range from 370 cm2to 380 cm2.

The wound dressing1000is shown to include a plurality of layers, including a drape layer1120, a manifold layer1124, a wound-interface layer1128, a rigid support layer1142, a first adhesive layer1146, and a second adhesive layer1150. In some embodiments, the wound dressing1000includes a removable cover sheet to cover the manifold layer1124, the wound-interface layer128, the second adhesive layer1150, and/or the patient contacting layer1154before use.

Manifold layer

Referring toFIG.11, the manifold layer1124includes a first surface and a second, wound-facing surface opposite the first surface. When the wound dressing1000is applied to a wound, the first surface faces away from the wound, whereas the second surface faces toward the wound. As described above, the manifold layer1124can 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 manifold layer1124provided that the manifold layer1124is operable to distribute the reduced pressure and provide a distributed compressive force along the wound site.

As shown inFIG.11, the manifold layer1124is generally symmetrical and forms defines a single lobe that is generally shaped like a guitar pick (e.g., generally triangular and having curved sides and corners). The manifold layer1124includes a first curved corner1158, a second curved corner1162, and a third curved corner1166. A first side1170extends between the first curved corner1158and the third curved corner1166, a second side1174extends between the second curved corner1162and the third curved corner1166, and a third side1178extends between the first curved corner1158and the second curved corner1162. The manifold layer1124can have a width W ranging between 8 cm and 40 cm, and more preferably between 17 cm and 33 cm. The manifold layer1124can have a length L ranging between 7 cm and 35 cm, and more preferably between 14 cm and 30 cm. The manifold layer1124can have a thickness T ranging between 14 mm and 24 mm, and more preferably 19 mm. Each of the sides1170,1174,1178is generally convex and has a radius of curvature of approximately 42.3 cm. The first curved corner1158and the second curved corner1162are less curved than the third curved corner1166. More specifically, the first curved corner1158, the second curved corner1162, and the third curved corner1166can each have a radius of curvature ranging between 3 cm and 10 cm. More preferably, the first curved corner1158and the second curved corner1162can each have a radius curvature of approximately 4.8 cm. More preferably, the third curved corner1166can have a radius of curvature of approximately 3.5 cm. In the illustrated embodiment, the wound dressing1000is generally symmetric about the axis B.

The manifold layer1124can have any of the scoring patterns176,184,208,216described above. The manifold layer1124can be used in a wound therapy system similar to the wound therapy system described below and illustrated inFIG.4.

The wound dressing1000can be positioned relative to a woman's torso in a manner similar to what is illustrated inFIGS.9and10for the wound dressing100and the manifold layer204. The wound dressing1000is sized to cover the surface including the entire breast area, including the first incision228, the second incision232, and any incisions proximate the armpit as described above. More specifically, the third side1178, extending between the first curved corner1158and the second curved corner1162, is positioned proximate the patient's armpit and the third curved corner1166is oriented towards a bottom portion of the patient's sternum. Due to the symmetric shape of the wound dressing1000, the wound dressing1000can be used to treat wounds in both the left breast and the right breast without requiring modification. For example, when the wound dressing1000is oriented to treat the right breast in a manner similar to what is illustrated with respect to the manifold layer204inFIG.9, the second side1174, which extends between the second curved corner1162and the third curved corner1166, covers an upper portion of the breast area and the first side1170, which extends between the first curved corner1158and the third curved corner1166, covers a lower portion of the breast area. When the wound dressing1000is oriented to treat the left breast in a manner similar to what is illustrated with respect to the wound dressing100and the manifold layer204inFIG.10, the first side1170, which extends between the first curved corner1158and the third curved corner1166, covers an upper portion of the breast area and the second side1174, which extends between the second curved corner1162and the third curved corner1166, covers a lower portion of the breast area.

Wound Therapy System

Referring now toFIG.4, a wound therapy system236is shown engaged with the surface104of a patient to treat a region proximate an incision240, according to an exemplary embodiment. The incision240extends through the epidermis244, or skin, and dermis248, and reaches into a hypodermis252, or subcutaneous tissue. The subcutaneous tissue252may include breast tissue, fatty tissue, or muscle. An undermined subcutaneous tissue site252is shown extending from the incision240, and in the illustrated embodiment, shows a subcutaneous defect or void256that may be caused by surgical procedures, such as full or partial mastectomies, breast enhancements, and/or breast reductions. The incision240can be closed using any closing device such as sutures, staples, or an adhesive. In the illustrated embodiment, the incision240is closed using a suture260.

The wound therapy system236further includes a removed fluid container272and a negative pressure source or pump276that are in fluid communication with the wound dressing100via the removed fluid conduit268. The removed fluid container272can be configured to store a fluid removed from incision240. Removed fluid can include, for example, wound exudate (e.g., bodily fluids), air, or any other type of fluid which can be removed from the incision240during wound treatment.

With continued reference toFIG.4, the wound dressing100is positioned above the incision240. The second adhesive layer150secures the wound dressing100to the patient. The wound-interface layer128contacts the surface104of the patient, and the manifold layer204is positioned above the wound-interface layer128. The drape layer120extends over the manifold layer204to provide a fluid-tight seal of the wound dressing100. The reduced-pressure interface158is engaged with an L-shaped connector264configured to engage a removed fluid conduit268. In the illustrated embodiment, the removed fluid conduit268is a multi-lumen conduit. The removed fluid conduit268includes a first lumen274and a second lumen278. The first lumen274is configured to apply negative pressure to the wound dressing100and to draw exudate into the removed fluid container272. The second lumen278is configured for sensing the pressure of the wound dressing100. One such wound therapy system236including a multi-lumen conduit is the SensaT.R.A.C.™ system that is available from Kinetic Concepts, Inc. (KCI) of San Antonio, Tex.

Negative Pressure Wound Treatment Therapy

FIG.10illustrates a NPWT system engaged with the wound dressing100. The NPWT system includes the pump276configured to apply a negative pressure to the wound site and the removed fluid container272to retain exudate from the wound site. In addition to providing NPWT, the negative pressure caused by the pump276provides support to the breast tissue. The compressive forces caused by the negative pressure hold any remaining breast tissue, reconstructive material, and/or implant material in position as the wound heals.

In embodiments in which both breasts are treated using the wound dressings100, the wound dressings100may be connected to different pumps or the wound dressings100may be connected to the same pump276using a Y connector (not shown). In either configuration, the use of separate wound dressings on each breast allows the NPWT to be customized for each breast. For example, breasts having different sizes of wounds or wounds healing at different rates can have different NPWT requirements. Accordingly, the use of separate wound dressings100on each breast allows the treatment protocol for each wound to be customized.

Configuration of Exemplary Embodiments