WO2021214608A1

WO2021214608A1 - Incisional dressing for hemispherical anatomy

Info

Publication number: WO2021214608A1
Application number: PCT/IB2021/053129
Authority: WO
Inventors: Luke Perkins; Jonathan G. REHBEIN; Larry Tab Randolph; Richard Marvin Kazala Jr.; Mason HAGGERTY; Archel Ambrosio; Emanuel LANDEZ; Alicia PAPE; Tyler H. Simmons; Mark BIASIOLLI; Enrique SANDOVAL
Original assignee: Kci Licensing, Inc.
Priority date: 2020-04-21
Filing date: 2021-04-15
Publication date: 2021-10-28

Abstract

Some examples of a dressing assembly for treating an incision at a residual limb after an amputation may include a dressing bolster and a sealing member. A portion of the dressing bolster may be configured to face the residual limb and to support both a hemispherical portion and a cylindrical portion of the residual limb. The sealing member may be configured to cover at least the dressing bolster and to create a sealed space containing the dressing bolster. Other dressings, apparatus, systems, and methods are disclosed.

Description

INCISIONAL DRESSING FOR HEMISPHERICAL ANATOMY

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority to U.S. Provisional Application No. 63/013,096, filed on April 21, 2020, which is incorporated herein by reference in its entirety.

TECHNICAL FIELD

[0002] This disclosure relates generally to medical treatment systems and, more particularly, but not by way of limitation, to absorbent dressings, systems, and methods for treating a tissue site with reduced pressure.

BACKGROUND

[0003] Clinical studies and practice have shown that reducing pressure in proximity to a tissue site can augment and accelerate growth of new tissue at the tissue site. The applications of this phenomenon are numerous, but have proven particularly advantageous for treating wounds. Regardless of the etiology of a wound, whether trauma, surgery, or another cause, proper care of a wound is important to the outcome. Treatment of wounds or other tissue with reduced pressure may be commonly referred to as “negative-pressure therapy,” but is also known by other names, including “negative-pressure wound therapy,” “reduced-pressure therapy,” “vacuum therapy,” and “vacuum- assisted closure,” for example. Negative-pressure therapy may provide a number of benefits, including migration of epithelial and subcutaneous tissues, improved blood flow, and micro deformation of tissue at a wound site. Together, these benefits can increase development of granulation tissue and reduce healing times.

[0004] While the clinical benefits of negative-pressure therapy are widely known, the cost and complexity of negative-pressure therapy can be a limiting factor in its application, and the development and operation of negative-pressure systems, components, and processes continues to present significant challenges to manufacturers, healthcare providers, and patients.

SUMMARY

[0005] Shortcomings with certain aspects of tissue treatment dressings, systems, and methods are addressed as shown and described in a variety of illustrative, non-limiting example embodiments herein.

[0006] In some example embodiments, a dressing assembly for treating an incision at a residual limb after an amputation may include a dressing bolster, a tissue interface layer, and a sealing member. The dressing bolster may include a first side and an opposing second side. The second side of the dressing bolster may be configured to face the residual limb and to support both a hemispherical portion and a cylindrical portion of the residual limb. The tissue interface layer may include a first side and an opposing second side. The opposing second side of the tissue interface layer may be configured to be positioned between the residual limb and the second side of the dressing bolster. The sealing member may be configured to cover at least a portion of the first side of the dressing bolster. Further, the sealing member may be configured to create a sealed space containing the dressing bolster between the sealing member and the residual limb.

[0007] In some example embodiments, a dressing assembly configured to treat a residual limb after an amputation may include a dressing bolster, a tissue interface layer, and a sealing member. The dressing bolster may comprise a support hub and at least one support wrap. The support wrap may be fluidly coupled to and may extend outward from the support hub. Further, at least a portion of the support hub may be configured to be positioned proximate to an incision in the residual limb with the support wrap being configured to extend over at least a portion of a cylindrical portion of the residual limb. The tissue interface layer may be configured to be positioned between the residual limb and the dressing bolster. The sealing member may be configured to create a sealed space containing the dressing bolster between the sealing member and the residual limb.

[0008] In some example embodiments, a method for treating a residual limb after an amputation may include providing a dressing bolster. The dressing bolster may comprise a support hub and at least one support wrap. The support wrap may be fluidly coupled to and extend outward from the support hub. Further, the method may include positioning the support hub at an incision in the residual limb. Further, the method may include wrapping one or more of the support wraps around at least a portion of a cylindrical portion of the residual limb. Further, the method may include covering the dressing bolster with a sealing member to form a sealed space containing the dressing bolster. Further, the method may include delivering reduced pressure to the dressing bolster through the sealing member.

[0009] Other features and advantages of the illustrative example embodiments will become apparent with reference to the drawings and detailed description that follow.

BRIEF DESCRIPTION OF THE DRAWINGS

[0010] FIGURE 1 is a perspective view of an illustrative example embodiment of a system for treating a tissue site;

[0011] FIGURE 2 is a cross-section of a portion of an illustrative example embodiment of a dressing assembly depicted in FIGURE 1, taken along line 2-2;

[0012] FIGURE 3 is a perspective view of an illustrative example embodiment of a portion of a treatment system for treating a tissue site;

[0013] FIGURE 4 is a cross-section of an illustrative example embodiment of a dressing assembly depicted in FIGURE 3, taken along line 4-4;

[0014] FIGURE 5 is an exploded, perspective view of the example dressing assembly of FIGURE 4 in a state prior to assembly or deployment at a tissue site; [0015] FIGURES 6A-6C are perspective views, with a portion shown in cross-section, of a portion of an illustrative example embodiment of a treatment system being deployed over a linear wound;

[0016] FIGURE 7A depicts an illustrative example embodiment of a portion of a dressing assembly including an example embodiment of a tissue interface layer that may be configured to treat a limb;

[0017] FIGURE 7B depicts an illustrative example embodiment of a portion of a dressing assembly including another example embodiment of a tissue interface layer that may be configured to treat a limb;

[0018] FIGURE 8A depicts an illustrative example embodiment of a portion of a dressing assembly including an example embodiment of a dressing bolster configured to treat a limb;

[0019] FIGURE 8B depicts the dressing assembly of FIGURE 8A deployed on the limb;

[0020] FIGURE 9A depicts another illustrative example embodiment of a portion of a dressing assembly including another example embodiment of a dressing bolster configured to treat a limb;

[0021] FIGURE 9B depicts the dressing assembly of FIGURE 9A deployed on the limb;

[0022] FIGURE 10A depicts another illustrative example embodiment of a portion of a dressing assembly including another example embodiment of a dressing bolster configured to treat a limb;

[0023] FIGURE 10B depicts the dressing assembly of FIGURE 10A deployed on the limb;

[0024] FIGURE 11 A depicts another illustrative example embodiment of a portion of a dressing assembly including another example embodiment of a dressing bolster configured to treat a limb;

[0025] FIGURE 1 IB depicts the dressing assembly of FIGURE 11 A deployed on the limb;

[0026] FIGURE 12A depicts another illustrative example embodiment of a portion of a dressing assembly including another example embodiment of a dressing bolster configured to treat a limb;

[0027] FIGURE 12B depicts the dressing assembly of FIGURE 12A deployed on the limb;

[0028] FIGURE 13 A depicts another illustrative example embodiment of a portion of a dressing assembly including another example embodiment of a dressing bolster configured to treat a limb;

[0029] FIGURE 13B depicts the dressing assembly of FIGURE 13A deployed on the limb;

[0030] FIGURE 13C is a plan view of the dressing bolster of FIGURE 13A;

[0031] FIGURE 14A depicts another illustrative example embodiment of a portion of a dressing assembly including an example embodiment of a sealing member configured to treat a limb;

[0032] FIGURE 14B depicts the sealing member of FIGURE 14A deployed on the limb; and [0033] FIGURE 15 depicts another illustrative example embodiment of a dressing assembly configured to treat a limb and to be deployed as a pre-assembled unit.

DETAILED DESCRIPTION OF EXAMPLE EMBODIMENTS

[0034] The following description of example embodiments enables a person skilled in the art to make and use the subject matter set forth in the appended claims. Certain details already known in the art may be omitted. Further, the following detailed description is illustrative and non-limiting.

[0035] Referring primarily to FIGURES 1 and 2, presented is an illustrative, non-limiting example embodiment of a treatment system 100 for treating a tissue site 102. The tissue site 102 may be or may include, without limitation, an incision 104, wound, defect, or other tissue or feature. The incision 104 is shown extending through or involving epidermis 106, dermis 108, and subcutaneous tissue 110. The treatment system 100 may also be used with other tissue sites, and may be utilized with or without reduced pressure as described herein. Further, although the tissue site 102 is shown illustratively in FIGURE 2 as having a substantially flat or planar surface, in some examples, the tissue site 102 may include multi -dimensional or three-dimensional surfaces subject to treatment, such as, without limitation, an arm, leg, limb, or other multi-dimensional region of a patient. The tissue site 102 in the form of an example limb, such as a residual limb remaining after an amputation, is shown in FIGURES 7A-15.

[0036] In some embodiments, the treatment system 100 may include a dressing assembly 112 having a dressing bolster 114, which may be referred to as a manifold member 114. In addition, some embodiments of the treatment system 100 may include a sealing member 116 and a reduced- pressure subsystem 118. Some embodiments of the treatment system 100 may also include a reduced- pressure indicator 101. While the treatment system 100 is shown in the context of a reduced-pressure dressing over an incision 104, the treatment system 100 may be used on other tissue sites, including open wounds. Further, features may be optionally added to or omitted from the treatment system 100, and various embodiments thereof, to suit different therapeutic applications, scenarios, or preferences, and thus, features described herein are not to be considered essential unless explicitly stated.

[0037] In some embodiments, the dressing bolster 114 may include a first side 120 and a second side 122 positioned opposite or facing opposite to the first side 120. The first side 120 of the dressing bolster 114 may be configured to face outward from or away from the tissue site 102, and the second side 122 of the dressing bolster 114 may be configured to face inward or toward the tissue site 102. The second side 122 of the dressing bolster 114 may also be referred to as a second, inward facing side 122.

[0038] The dressing bolster 114 may be formed from any bolster material or manifold material that provides a vacuum space, or treatment space. Reduced pressure applied to the dressing bolster 114 may enhance the permeability of the dressing bolster 114. For example, the dressing bolster 114 may be formed from a porous and permeable foam or foam-like material, a member formed with pathways, a graft, a gauze, or any combination thereof. In some embodiments, the dressing bolster 114 may be a reticulated, open-cell polyurethane or polyether foam that may be fluid permeable. One example of a suitable foam material may be a GRANUFOAM™ material available from Kinetic Concepts, Inc. (KCI) of San Antonio, Texas.

[0039] The term “manifold” as used herein may refer to a substance or structure that may assist in applying reduced pressure to, delivering fluids to, or removing fluids from a tissue site. A manifold may include a plurality of flow channels or pathways. The plurality of flow channels may be interconnected to improve distribution of fluids provided to and removed from an area of tissue around the manifold. Examples of manifolds may include, without limitation, devices that have structural elements arranged to form flow channels, cellular foam, such as open-cell foam, porous tissue collections, and liquids, gels, and foams that include or cure to include flow channels.

[0040] The reticulated pores of the GRANUFOAM™ material may be helpful in carrying out the manifold function, but as stated above, other materials may be utilized. A material with a higher or lower density than the GRANUFOAM™ material may be desirable in some embodiments. This material may have, for example, a smaller pore size than the GRANUFOAM™ material.

Among the many possible materials, the following may be used without limitation:

GRANUFOAM™ material, FXI technical foam, gauze, a flexible channel-containing member, a graft, and other similar materials. In some embodiments, ionic silver may be added to the material, such as, for example, by a micro bonding process. Other substances, such as antimicrobial agents, may also be added to the material.

[0041] In some embodiments, a comfort layer 124 may be coupled, for example, by a heat bond 130 or other suitable technique to the second, inward-facing side 122 of the dressing bolster 114. The comfort layer 124 may include a first side 126 and a second side 128 positioned opposite or facing opposite to the first side 126. The first side 126 of the comfort layer 124 may be configured to face outward from or away from the tissue site 102, and the second side 128 of the comfort layer 124 may be configured to face inward or toward the tissue site 102. The first side 126 of the comfort layer 124 may be coupled to the second side 122 of the dressing bolster 114. Herein, the comfort layer 124 may also be referred to as an interfacial layer, a tissue interface layer, or tissue contact layer. Further, the second side 128 of the comfort layer 124 may also be referred to as a second, inward-facing side 128.

[0042] The comfort layer 124 may enhance patient comfort when the dressing bolster 114 is adjacent to or in contact with the epidermis 106 of a patient. The comfort layer 124 may be any material that helps prevent skin irritation and discomfort while allowing fluid transmission through the comfort layer 124. As non-limiting examples, the comfort layer 124 may include or be formed of a woven material, an elastic material, a polyester knit textile substrate, a non-woven material, or a fenestrated film. As another non-limiting example, an INTERDRY™ textile material available from Milliken Chemical, a division of Milliken & Company, Inc. of Spartanburg, South Carolina, may be utilized. In some embodiments, the comfort layer 124 may include antimicrobial substances, such as silver.

[0043] In some embodiments, the dressing bolster 114 may include a plurality of flexibility notches or recesses, analogous to notches 218 shown in FIGURE 4, for example, that may be lateral cuts in the dressing bolster 114 on the first side 120. The dressing bolster 114 may additionally or alternatively include one or more longitudinal cuts or notches, which may intersect the lateral cuts or notches. The flexibility notches may enhance the flexibility of the dressing bolster 114. The enhanced flexibility may be particularly useful when the dressing assembly 112 is applied over a joint or other area of movement on a patient. The flexibility notches may also take various shapes without limitation, such as, for example, hexagons, slits, or squares.

[0044] In some embodiments, the dressing bolster 114 may include lateral edges (not shown) that are orthogonal relative to the second, inward-facing side 122 of the dressing bolster 114. The lateral edges of the dressing bolster 114 may be analogous to lateral edges 205 of dressing bolster 204 depicted in FIGURE 4. The lateral edges of the dressing bolster 114 may also have a beveled edge or angled edge. The angled or beveled edge may help distribute shear stress between the dressing bolster 114 and the epidermis 106 of a patient. The lateral edges of the dressing bolster 114 may substantially correspond to lateral edges (not shown) of the comfort layer 124.

[0045] The sealing member 116 may provide a fluid seal over the dressing bolster 114 and a portion of the epidermis 106 of the patient. As such, the sealing member 116 may be formed from any material that allows for a fluid seal. Herein, the terms “fluid seal,” or “seal,” may be a seal adequate to maintain reduced pressure at a desired site given the particular reduced-pressure source or subsystem involved. The sealing member 116 may be sealed against the epidermis 106, or against a gasket or drape, by a sealing apparatus, such as, for example, a pressure-sensitive adhesive.

[0046] The sealing apparatus may take numerous forms, such as an adhesive sealing tape, drape tape, or strip; double-sided drape tape; pressure-sensitive adhesive; paste; hydrocolloid; hydrogel; or other suitable sealing device. If a tape is used, the tape may be formed of the same material as the sealing member 116 with a pre-applied, pressure-sensitive adhesive. The pressure- sensitive adhesive may be applied on a side of the sealing member 116 adapted to face the epidermis 106, such as an inward-facing side of the sealing member 116. The pressure-sensitive adhesive may provide a fluid seal between the sealing member 116 and the epidermis, and may be utilized in combination with a gasket or drape against the epidermis 106. Before the sealing member 116 is secured to the epidermis 106, removable strips or release liners that cover the pressure -sensitive adhesive may be removed.

[0047] In some embodiments, the sealing member 116 may be an elastomeric material configured to provide a fluid seal. “Elastomeric” may refer to a material having the properties of an elastomer, such as a polymeric material that has rubber-like properties. Some elastomers may have ultimate elongations greater than 100% and a significant amount of resilience. The resilience of a material may refer to the ability of the material to recover from an elastic deformation. Examples of elastomers may include, without limitation, 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. Further, sealing member materials may include a silicone drape, a TEGADERM™ drape available from 3M, an acrylic drape, such as one available from Avery Dennison, or an incise drape.

[0048] In some embodiments, the sealing member 116 may be comprised of a material including a high moisture vapor transmission rate (MVTR). The use of a high MVTR material for the sealing member 116 may permit moisture vapor to pass through the sealing member 116, external to the dressing assembly 112, while maintaining the fluid seal described herein.

[0049] In some embodiments, the sealing member 116 may include a first sealing member portion 132 and a second sealing member portion 134. The first sealing member portion 132 may extend over or cover the first side 120 of the dressing bolster 114. The sealing member 116 may extend further to form a sealing member flange, or sealing member extension 136, which has a first side (not shown) and a second, inward-facing side (not shown). The second, inward-facing side of the sealing member extension 136 may be adapted to face the epidermis 106. An aperture (not shown) may be formed on a portion of the sealing member 116 to allow fluid communication with a conduit interface 138, which may be part of a reduced-pressure assembly 140. The aperture on the sealing member 116 may be analogous to aperture 234 depicted in FIGURE 3.

[0050] The second, inward-facing side of the sealing member extension 136 may be placed on a first side (not shown) of the second sealing member portion 134, and coupled, such as by an adhesive, a bond 135, a weld (e.g., ultrasonic or RF welding), or by cements. The first side of the second sealing member portion 134 may face away or outward from the epidermis 106. In some example embodiments, the second sealing member 134 may be positioned on and extend outward from the second side 122 of the dressing bolster 114 and be coupled to a portion of the first sealing member 132 as described. Further, in some examples, the first sealing member portion 132 and the second sealing member portion 134 may be integrally formed with one another. Further, the first sealing member portion 132 may include a plurality of bellows 142, folds, or stretch zones. The bellows 142 may provide additional drape material when needed to respond to stretching or other movement. For example, if the dressing assembly 112 is used on a joint, when the joint is flexed, the bellows 142 may provide additional drape material to facilitate such movement.

[0051] Prior to application, one or more release members (not shown) may be releasably coupled to the first side of the second sealing member portion 134. The release members may be analogous to release members 242 depicted in FIGURE 5, and may provide stiffness to assist with, for example, deployment of the dressing assembly 112. The release members may be, for example, casting paper or a film held on the first side of the second sealing member portion 134. Each release member may have a release agent disposed on a side of the release member configured to contact a component of the dressing assembly 112, such as the second sealing member portion 134, or other components described herein. In some embodiments, the release agent may be a silicone coating and may have a release factor between about 5 grams per centimeter to about 15 grams per centimeter. In some embodiments, the release factor may be between about 2 grams per centimeter to about 6 grams per centimeter. The release agent may facilitate removal of the release member by hand and without damaging or deforming the dressing assembly 112.

[0052] Release members suitable for use with the embodiments described herein may be, for example and without limitation, polyester release members specified as FRA 301(T-36) and FRA 396-T13, available from Fox River Associates, LLC of Geneva, Illinois. The polyester release members may be a polyethylene terephthalate (PET) release member as described herein. In some embodiments, the release members may have a film thickness between about 30 microns to about 70 microns. In some embodiments, the film thickness may be between about 47 microns to about 53 microns. Further, the release members may have a tensile break strength in a machine direction between about 9 kilograms per square millimeter to about 15 kilograms per square millimeter. In a transverse direction, or direction transverse to the machine direction, the release members may have a tensile break strength between about 15 kilograms per square millimeter to about 23 kilograms per square millimeter. The elongation at break of the release members in both the machine direction and the transverse direction may be between about 40 percent to about 140 percent. The release members may have a shrinkage in the machine direction between about 0.0 percent to about 2.5 percent, and a shrinkage in the transverse direction between about 0.0 percent to about 1.2 percent.

[0053] The reduced-pressure subsystem 118 may include a reduced-pressure source 144. In some example embodiments, the reduced-pressure source 144 may provide reduced pressure as a part of the treatment system 100. Further, in some examples, the reduced-pressure source 144 may be configured to be coupled in fluid communication with the dressing assembly 112. For example, the reduced-pressure source 144 may be fluidly coupled to the conduit interface 138 by a delivery conduit 148.

[0054] As used herein, the term “reduced pressure” may refer to a pressure less than the ambient pressure at a tissue site being subjected to treatment, such as the tissue site 102. The reduced pressure may be less than the atmospheric pressure. The reduced pressure may also be less than a hydrostatic pressure at a tissue site. Unless otherwise indicated, quantitative values of pressure stated herein are gauge pressures.

[0055] The reduced pressure delivered to the dressing bolster 114 may be constant or varied, patterned or random, and may be delivered continuously or intermittently. Although the terms “vacuum” and “negative pressure” may be used to describe the pressure applied to a tissue site, the actual pressure applied to the tissue site may be more than the pressure normally associated with a complete vacuum. Consistent with the use herein, unless otherwise indicated, an increase in reduced pressure or vacuum pressure may refer to a relative reduction in absolute pressure.

[0056] Continuing with FIGURE 1, the reduced-pressure source 144 is shown as having a reservoir region 146, or canister region. An interposed membrane fdter (not shown), such as hydrophobic or oleophobic fdter, may be interspersed between the reduced-pressure delivery conduit 148 and the reduced-pressure source 144. One or more devices, such as a representative device 150, may be fluidly coupled to the reduced-pressure delivery conduit 148. The representative device 150 may be, for example, another fluid reservoir, a collection member to hold exudates and other fluids removed, a pressure-feedback device, a volume detection system, a blood detection system, an infection detection system, a flow monitoring system, or a temperature monitoring system. Multiple representative devices 150 may be included. One or more of the representative devices 150 may be formed integrally with the reduced-pressure source 144.

[0057] The reduced-pressure source 144 may be any device for supplying a reduced pressure, such as a vacuum pump, wall suction, or other source. While the amount and nature of reduced pressure applied to a tissue site may vary according to the application, the reduced pressure may be, for example, between about -5 mm Hg (-667 Pa) to about -500 mm Hg (-66.7 kPa). In some embodiments, the reduced pressure may be between about -75 mm Hg (-9.9 kPa) to about -300 mm Hg (-39.9 kPa).

[0058] The reduced pressure developed by the reduced-pressure source 144 may be delivered through the delivery conduit 148 to the conduit interface 138. The conduit interface 138 may allow the reduced pressure to be delivered through the sealing member 116 to the dressing bolster 114. In some embodiments, the conduit interface 138 may provide fluid communication external to the sealing member 116 without the application of reduced pressure.

[0059] The reduced-pressure indicator 101 may be configured to indicate that a reduced pressure of at least of certain threshold level is being delivered to the tissue site 102. The reduced- pressure indicator 101 may be a separate unit fluidly coupled to the sealing member 116 such that reduced pressure from within the sealed space of the sealing member 116 reaches the reduced- pressure indicator 101. In some embodiments, as shown in FIGURE 1, the reduced-pressure indicator 101 may be associated with the conduit interface 138 as a part of the reduced-pressure assembly 140. When adequate reduced pressure is present, the reduced-pressure indicator 101 may be configured to assume a collapsed position. When inadequate reduced pressure is present, the reduced-pressure indicator 101 may be configured to assume a non-collapsed position.

[0060] Referring primarily to FIGURE 2, the dressing assembly 112 may include a gasket member 117. The gasket member 117 may also be referred to interchangeably as an interface seal or sealing ring 117. For example, features or characteristics of the gasket member 117 may apply to the sealing ring 117, and features or characteristics of the sealing ring 117 may apply to the gasket member 117. The gasket member 117 and the sealing ring 117 may be configured in any suitable shape to enhance or otherwise provide a fluid seal around the tissue site 102, such as the incision 104. For example, the epidermis 106 may have recesses, cracks, wrinkles, or other discontinuities on a surface of the epidermis 106 that may cause leaks. Moreover, folds, buckles, wrinkles, or other discontinuities may form in the sealing member 116 and cause leaks. The gasket member 117 and the sealing ring 117 may help seal any such skin or sealing member discontinuities around the tissue site 102

[0061] The gasket member 117 or the sealing ring 117 may be adapted to be positioned between the dressing assembly 112 and the epidermis 106 and/or the tissue site 102. In some examples, the gasket member 117 may be positioned on, coupled to, or directly coupled to the second side 122 of the dressing bolster 114 or the second side 128 of the comfort layer 124. The gasket member 117 or the sealing ring 117 may be formed, as an illustrative example, by applying or bonding a sealing material around a perimeter or circumference of a portion of the dressing assembly 112. Although the sealing material of the gasket member 117 or the sealing ring 117 may be configured in the shape of a ring in some embodiments, other shapes are suitable, and may include, without limitation, circles, squares, rectangles, discontinuous shapes, continuous shapes, irregular shapes, linear shapes, other shapes or portions that overlap one another, or combinations thereof. The sealing material may include hydrocolloids, hydrogels, silicone polymers (both crosslinked and uncrosslinked gels), and natural gums (xanthan, guar, cellulose). The sealing material may include other soft polymer gels, such as, for example, those based on polyurethanes, polyolefin gels, and acrylics.

[0062] In some embodiments, the gasket member 117 or the sealing ring 117 may be deployed by hand or extruded from an applicator, such as a syringe, to form a ring or other shape prior to application of the dressing assembly 112 to the tissue site 102. Sealing materials suitable for application by extrusion may include, without limitation, water soluble gums such as xanthan, guar, or cellulose, and thick greases, such as silicones. In another embodiment, the sealing ring 117 may be bonded in any suitable manner, such as, for example, by a heat bond, to the second, inward facing side 128 of the comfort layer 124 during manufacture of the dressing assembly 112. In at least this manner, the sealing ring 117 may be adapted to be positioned between the comfort layer 124 and the epidermis 106 and/or the tissue site 102.

[0063] In some embodiments, the gasket member 117 or the sealing ring 117 may include an absorbent. For example, the sealing ring 117 may be a hydrocolloid comprising an absorbent, such as carboxy methyl cellulose (CMC). The absorbent may permit the sealing ring 117 to absorb fluid from the tissue site 102 in addition to enhancing the fluid seal around the tissue site 102. The sealing ring 117 including the absorbent may enhance the ability of the dressing assembly 112 to manage and direct fluid away from the tissue site 102 for keeping the tissue site 102 dry. For example, the dressing bolster 114 may have a thickness between the first side 120 and the second, inward-facing side 122 of the dressing bolster 114. The thickness of the dressing bolster 114 may define at least a portion of a thickness of the dressing assembly 112. The sealing ring 117 may be adapted to be positioned between the dressing assembly 112 and the tissue site 102, as described above, and around or surrounding a circumference of the tissue site 102. Relative to the dressing assembly 112, the sealing ring 117 or the gasket member 117 may be positioned, for example, around, on, or at the lateral edges of the dressing bolster 114 and/or the comfort layer 124. Further, the sealing ring 117 or the gasket member 117 may extend beyond a lateral edge of the dressing bolster 114 and the comfort layer 124. Further, the sealing ring 117 may be positioned around or surrounding a circumference of the dressing bolster 114 and/or the comfort layer 124. Further, the sealing ring 117 may be positioned around at least a portion of the dressing bolster 114 or the comfort layer 124 that is configured to be positioned directly against or in direct contact with the tissue site 102. At least a portion of the dressing bolster 114 and/or the comfort layer 124 may be exposed and configured to be positioned directly against the tissue site 102 when the sealing ring 117 is positioned on the dressing assembly 112. Further, in such embodiments, the sealing ring 117 may surround the exposed portion of the dressing bolster 114 and/or the comfort layer 124.

[0064] The absorbent in the sealing ring 117 may wick or draw fluid in a lateral direction within the dressing assembly 112, normal to the thickness of the dressing bolster 114, and toward the lateral edges of the dressing bolster 114 for absorption in the sealing ring 117. Thus, fluid from the tissue site 102 may be wicked or otherwise drawn in a lateral direction along the surface of the tissue site 102 toward the lateral edges of the dressing bolster 114 and into the sealing ring 117. Further, fluid from the tissue site 102 may also flow through the thickness of the dressing assembly 112 and the dressing bolster 114 at least by operation of the manifold material comprising the dressing bolster 114, described above.

[0065] Referring now primarily to FIGURES 3-5, depicted is a portion of an illustrative embodiment of a treatment system 200 suitable for treating, for example, a linear wound, area wound, a graft, or other wound. FIGURES 3-5 depict the treatment system 200 in a pre -deployment state.

The treatment system 200 may include a dressing assembly 202, and the dressing assembly 202 may include a dressing bolster 204. The dressing bolster 204 has a first side 206 and a second, inward facing side 208. The dressing bolster 204 may be formed from any suitable bolster material, or manifold material, as previously referenced in connection with the dressing bolster 114. A comfort layer 210, which has a first side 212 and a second, inward-facing side 214, may be coupled, such as, for example, by a heat bond 216 or other suitable technique to the second, inward-facing side 208 of the dressing bolster 204.

[0066] The comfort layer 210 may be any material that helps prevent skin irritation and discomfort while allowing fluid transmission through the comfort layer 210. Suitable materials for the comfort layer 210 have been mentioned in connection with the comfort layer 124 of FIGURES 1- 2. In some embodiments, the comfort layer 210 may include antimicrobial substances, such as silver. Further, in some embodiments, the comfort layer 210 may be made as a breathable, dry layer. [0067] In some illustrative embodiments, the dressing bolster 204 may include a plurality of flexibility notches 218. The flexibility notches 218 may extend partially through or completely through the dressing bolster 204. The flexibility notches 218 may be lateral notches, or lateral cuts, in the dressing bolster 204. The flexibility notches 218 may also be one or more longitudinal notches, longitudinal cuts, or other cuts. The cuts may be made using a saw, a notched blade, a hot knife, or other device. The flexibility notches 218 may enhance the flexibility of the dressing bolster 204. The enhanced flexibility may be particularly useful when the dressing assembly 202 is applied over a joint or other area of movement on a patient. For example, if the dressing bolster 204 is used on a knee, the dressing bolster 204 may need to flex or extend as much as 100 % or more. The flexibility notches 218 may provide such flexibility.

[0068] The dressing bolster 204 may have lateral edges 205 that are orthogonal with respect to the second, inward-facing side 208 of the dressing bolster 204. The lateral edges 205 may also have a shape, such as, for example, a beveled, angled, or rounded shape. The lateral edges 205, when angled, may be between about 10 degrees to about 90 degrees with respect to the second, inward facing side 208 of the dressing bolster 204. The shaped lateral edges 205 may reduce shear stress between an epidermis of a patient and the dressing bolster 204. Other dimensions, steps, and processes may be used.

[0069] In some illustrative embodiments, the dressing bolster 204 may be manufactured from a foam block of GRANUFOAM™ material. The GRANUFOAM™ material may be, for example, a foam block having the dimensions of 1.21 meters x 1.8 meters x 0.5 meters. The foam block may be cut to have a 19 millimeter height, and a saw may be used to form lateral grooves, such as the flexibility notches 218, in the foam block. A dry layer, such as the comfort layer 210, may be laminated or otherwise attached to the second, inward facing side 208 of the dressing bolster 204.

The foam block may be cut, for example, utilizing a die cutter to form a plurality of individual dressing bolsters 204.

[0070] A sealing subsystem 222 may provide a fluid seal over the dressing assembly 202 and at least a portion of an epidermis of a patient. The sealing subsystem 222 may include a sealing member 224. The sealing member 224 may be formed with an upper drape portion or first sealing member portion 226 and a lower drape portion or second sealing member portion 228. The first sealing member portion 226 may extend over or cover the first side 206 of the dressing bolster 204 to form a drape flange, or drape extension 230. The drape extension 230 has a first side 232 and a second, inward-facing side 233. The second, inward-facing side 233 of the drape extension 230 may be adapted to face a tissue site of a patient as described above. An aperture 234 may be formed on the first sealing member portion 226. The aperture 234 may provide fluid communication with a conduit interface (not shown). The conduit interface may be analogous to the conduit interface 138 in FIGURE 1. [0071] The second sealing member portion 228 may have a first side 236 and a second, inward-facing side 237 adapted to face a tissue site as described above. The second, inward-facing side 233 of the drape extension 230 may be placed on the first side 236 of the second sealing member portion 228, and may be coupled to the first side 236 by an attachment device 238. The attachment device 238 may be, for example, an adhesive, a bond, a weld (e.g., ultrasonic or RF weld), cements, stitching, staples, or other coupling device. The second sealing member portion 228 may include an attachment apparatus on the second, inward-facing side 237 as described below. The second sealing member portion 228 may also include a treatment area aperture 240, depicted in FIGURE 5, that may be adapted to permit fluid communication through the second sealing member portion 228 and, for example, between a tissue site and the dressing bolster 204. The treatment area aperture 240 may also provide an opening for at least a portion of the dressing bolster 204, or the comfort layer 210, to be positioned directly against an epidermis and/or a tissue site of a patient.

[0072] The first sealing member portion 226 may include a plurality of folds 220 or bellows to facilitate movement as described above. The folds 220 may allow the first sealing member portion 226 to expand. For example, if the dressing assembly 202 is used on a joint, when the joint is flexed, additional drape material from the folds 220 may be released to facilitate movement of the first sealing member portion 226. The folds 220 may also be formed as ridges having the cross-sectional shape of an accordion that provides additional drape material when flattened or stretched, for example.

[0073] One or more release members 242 may be releasably coupled to the first side 236 of the second sealing member portion 228, such as, for example, with an adhesive (not shown) applied on at least a portion of the first side 236. Four of the release members 242 are shown in the illustrative embodiment of FIGURE 3. The release members 242 may provide stiffness to the second sealing member portion 228, and may cover the adhesive or other attachment apparatus to provide a grasping surface during deployment of the dressing assembly 202. The release members 242 may be casting paper or a film held on the first side 236 of the second sealing member portion 228.

[0074] The first side 236 of the second sealing member portion 228 may include an adhesive 244 adapted to retain the second side 208 of the dressing bolster 204 against the second sealing member portion 228 during assembly and usage. A center release member 246 may cover and protect the adhesive 244 prior to assembly. The release members 242 that may provide stiffness to the sealing member 224 during deployment may be positioned outboard of the adhesive 244 on the first side 236 of the second sealing member portion 228.

[0075] The dressing assembly 202 may include a sealing ring 248. Analogous to the sealing ring 117, the sealing ring 248 may help seal any wrinkles or discontinuities in the epidermis or drape that might otherwise cause leaks. Also analogous to the sealing ring 117, the sealing ring 248 may also be referred to interchangeably as an interface seal or a gasket member 248. For example, features or characteristics of the gasket member 248 may apply to the sealing ring 248, and features or characteristics of the sealing ring 248 may apply to the gasket member 248. Further, the previously described features of the sealing ring 117 or the gasket member 117 associated with the dressing assembly 112 may apply by analogy to the sealing ring 248 or the gasket member 248 associated with the dressing assembly 202.

[0076] The sealing ring 248 or the gasket member 248 may be, for example, positioned to cover a portion of the second, inward-facing side 237 of the second sealing member portion 228. The sealing ring 248 or the gasket member 248 may be coupled directly to the dressing assembly 202, or coupled with an optional sealing-ring attachment device 249, such as an acrylic adhesive, cement, or other coupling device. In other embodiments, the sealing ring 248 or the gasket member 248 may be coupled to the second inward-facing side 208 of the dressing bolster 204, and/or to an adjacent layer, such as the comfort layer 210.

[0077] The sealing ring 248 or the gasket member 248 may straddle an edge of the dressing bolster 204, or otherwise extend beyond an edge of the dressing bolster 204, as depicted in FIGURE 4. In some embodiments, the sealing ring 248 or the gasket member 248 may be coupled to a portion of the sealing member 224, such as the first sealing member 226 and/or the second sealing member 228. In some embodiments, the dressing bolster 204 may entirely overlap the sealing ring 248 or the gasket member 248 as suggested in FIGURE 11. While reference is made to a “ring,” discrete members, including linear members, may make up the sealing ring 248 or the gasket member 248.

[0078] The sealing ring 248 may comprise a sealing material, such as, for example, any of the sealing materials previously described in connection with the sealing ring 117, or other material that provides initial tack between the dressing assembly 202 and an epidermis of a patient. Further, the sealing ring 248 may have a durometer, such as a material softness or hardness, between about 20 Shore 00 to about 90 Shore OO. In some embodiments, the durometer of the sealing ring 248 may be between about 70 Shore 00 to about 80 Shore OO. The sealing ring 248 may have a modulus of elasticity that falls between the modulus of elasticity of the second sealing member portion 228 and the modulus of elasticity of a tissue site and/or epidermis of a patient. As shown in FIGURE 4, the sealing ring 248 may have a thickness 250 and a width 252. The thickness 250 of the sealing ring 248 may be between about 0.3 millimeters to about 2.5 millimeters. In some embodiments, the thickness 250 may be between about 0.7 millimeters to about 1.25 millimeters. The width 252 of the sealing ring 248 may be between about 10 millimeters to about 30 millimeters. Other dimensions are possible. In some illustrative embodiments, the thickness 250 may be about 0.7 millimeters and the width 252 may be about 20 millimeters. Further, in some embodiments, the width 252 of the sealing ring 248 may extend beyond an edge of the dressing bolster 204 by about 10 millimeters and overlap the dressing bolster 204 by about 10 millimeters.

[0079] In some embodiments, the second sealing member portion 228 may have a thickness 229 between about 0.178 millimeters to about 0.254 millimeters, or about 7 mils to about 10 mils. The ratio of the sealing ring thickness 250 to the sealing member thickness 229 may be between about 2.75 to about 7.03.

[0080] The sealing ring 248 may include fenestrations or apertures. In some embodiments, the sealing ring 248 may comprise a patterned sealing material on the second, inward-facing side 214 of the comfort layer 210, or on the second, inward-facing side 208 of the dressing bolster 204. The pattern may be, for example, spaced islands, crossing lines of sealing material, or any other suitable pattern.

[0081] The sealing ring 248 may function as a two-sided gasket that may provide a seal between the dressing assembly 202 and a tissue site and/or epidermis of a patient. For example, the sealing ring 248 may provide a seal between the dressing bolster 204, the comfort layer 210, or the second sealing member portion 228 and a tissue site and/or epidermis of a patient. The sealing ring 248 may absorb perspiration or other fluids from a tissue site. Further, the sealing ring 248 may help distribute shear forces created, for example, by the application of reduced pressure at the interface of the dressing bolster 204 and a tissue site and/or epidermis of a patient.

[0082] As shown in FIGURE 4, a portion of the second, inward-facing side 237 of the second sealing member portion 228 may be covered with a sealing apparatus or device 254, such as an adhesive. With reference to FIGURES 4 and 5, when in the pre-deployment state, the sealing device 254 may be covered by a bottom release member 256 and side release members 258.

[0083] The bottom release member 256 may cover and protect, for example, the sealing device 254 and the sealing ring 248. The side release members 258 may also cover and protect the sealing device 254. Similar to the release members 242, the side release members 258 may provide a grasping surface for a user to facilitate deployment of the dressing assembly 202. The release members 242, the bottom release member 256, and /or the side release members 258 may be comprised of a polar semi-crystalline polymer, such as, for example, polyethylene terephthalate (PET). Use of a polar semi-crystalline polymer for the release members 242, the bottom release member 256, and /or the side release members 258 may substantially preclude wrinkling or other deformation of the dressing assembly 202. Any deformation of the release members 242, the bottom release member 256, and/or the side release members 258 may cause wrinkling or deformation of a component of the dressing assembly 202. The polar semi-crystalline polymer is highly orientated and resistant to softening, swelling, or other deformation that may occur when brought into contact with components of the dressing assembly 202, or when subjected to temperature or environmental variations, or sterilization. Thus, for example, when the polar semi-crystalline polymer is used in combination with the hydrocolloid described above for the sealing ring 248, the polar semi-crystalline polymer may not deform when in contact with the compounding ingredients of the hydrocolloid. In some embodiments, the release members 242, the bottom release member 256, and/or the side release members 258 may be configured to resist deformation when exposed to temperature variations between about 40 degrees Celsius to about 60 degrees Celsius, and gamma sterilization doses between about 25kGy to about 45 kGy.

[0084] Continuing with FIGURES 3-5, according to an illustrative embodiment of operation, the bottom release member 256 may be removed to expose the sealing device 254 on the second, inward-facing side 237 of the second sealing member portion 228. Removal of the bottom release member 256 may also expose a second, inward-facing surface 247 of the sealing ring 248. The sealing device 254 and/or the second, inward-facing surface 247 of the sealing ring 248 may be placed against a portion of an epidermis of a patient and around a tissue site that may include a linear wound as described above. The side release members 258 may be removed after applying the second sealing member portion 228. Similarly, the release members 242 on the first side 236 of the second sealing member portion 228 may be removed after applying the second sealing member portion 228. A conduit interface may be coupled to the aperture 234 in the first sealing member portion 226, and reduced pressure may be delivered to the dressing assembly 202.

[0085] Regarding the manufacture of the systems and components described above, in applying and coupling a sealing member to a dressing bolster, a press may be utilized to remove any wrinkles in the sealing member. Further, the medical bolster material of the shaped dressing assembly may be cut using a die cutter, or by hand with a router.

[0086] Referring now primarily to FIGURES 6A-6C, presented is another illustrative embodiment of a portion of a treatment system 300. FIGURES 6A-6C depict the treatment system 300 assembled in stages at a tissue site, such as a linear wound 306. In FIGURE 6A, a closure device 302, such as, for example, stitches 304, close the linear wound 306. Other closure devices 302, such as epoxy or staples may be utilized to close the linear wound 306. The linear wound 306 may include a portion through an epidermis 308, dermis 310, and subcutaneous tissue 312 of a patient.

[0087] Referring now to FIGURE 6B, after the linear wound 306 is closed or prepared as described above, a dressing assembly 314 may be disposed proximate to the linear wound 306. The dressing assembly 314 may include a dressing bolster 316. The dressing bolster 316 may be formed from the bolster or manifold materials previously mentioned. The dressing bolster 316 may include a plurality of lateral notches 318 and one or more longitudinal notches 320. The dressing bolster 316 has a first side 322 and a second, inward-facing side 324. The first side 322 may include an adhesive layer 323. The adhesive layer 323 may help secure a sealing member 340 thereto, as shown in FIGURE 6C.

[0088] The dressing assembly 314 may include a comfort layer 326. The second, inward facing side 324 of the dressing bolster 316 may be covered with the comfort layer 326. The comfort layer 326 has first side 328 and a second, inward-facing side 330. The first side 328 of the comfort layer 326 may be coupled by an attachment device 332, such as, for example, a heat bond, adhesive, weld, or other attachment device, to the second, inward-facing side 324 of the dressing bolster 316. [0089] The dressing assembly 314 may include a sealing ring 334. The sealing ring 334 may be coupled, at least in part, to the second, inward-facing side 330 of the comfort layer 326. The sealing ring 334 may be analogous to the sealing ring 117 of FIGURE 2 and the sealing ring 248 of FIGURES 3-5. Further, the sealing ring 334 may be referred to interchangeably as a gasket member 334 analogous to the gasket member 117 and the gasket member 248.

[0090] The sealing ring 334 may comprise any of the sealing materials previously described in connection with the sealing ring 117 and the sealing ring 248. The sealing ring 334 may adhere directly to the comfort layer 326, or may be coupled with a sealing-ring attachment device 336 to the comfort layer 326. The sealing-ring attachment device 336 may be, for example, acrylic adhesive, cement, or other suitable attachment device. The sealing ring 334 and/or the sealing ring attachment device 336 may be co-extensive with the comfort layer 326, or may extend beyond a lateral edge of the comfort layer 326 and the dressing bolster 316.

[0091] Prior to application, a second, inward-facing surface 338 of the sealing ring 334 may be covered by a release member or release liner (not shown). When the release liner is removed, the sealing ring 334 may be centered about the linear wound 306 for deployment. A release member or release liner (not shown) may also temporarily cover a portion of the sealing ring 334 and/or sealing ring attachment device 336 to provide a grasping surface during deployment of the dressing assembly 314. The release liner or release member covering, for example, the sealing ring 334, the sealing ring attachment device 336, and/or other components of the dressing assembly 314 may be analogous to the release members 242, 256, and 258 of FIGURES 3-5. For example, the release members may be positioned on the dressing assembly 314 analogous to the release members 242, 256, and 258.

Further, the release members on the dressing assembly 314 may be comprised of any of the materials previously described for the release members 242, 256, and 258, such as, for example, a polar semi crystalline polymer or polyethylene terephthalate (PET). As described above, use of a polar semi crystalline polymer such as PET as a release member on the dressing assembly 314 may substantially preclude deformation of the dressing assembly 314. In another embodiment, the sealing ring 334 may be separately applied around the linear wound 306 before the dressing bolster 316 is applied thereto.

[0092] Referring now to FIGURE 6C, a sealing member 340 may be disposed over the dressing assembly 314 and a portion of the epidermis 308 to form a sealed space 342 between the dressing assembly 314 and the linear wound 306. Analogous to the aperture 234 in FIGURE 3, an aperture (not shown) may be formed or preformed in the sealing member 340. A conduit interface (not shown), analogous to conduit interface 138 described above, may be coupled to the sealing member 340 to provide fluid communication with the sealed space 342 through the aperture. Further, a reduced-pressure source (not shown), analogous to the reduced-pressure source 144 in FIGURE 1, may be coupled to the conduit interface to provide reduced pressure to the sealed space 342 to treat the linear wound 306. A delivery conduit (not shown), analogous to the delivery conduit 148 in FIGURE 1, may be utilized for coupling the reduced pressure source to the conduit interface. Reduced pressure may be applied to the tissue site, such as the linear wound 306, and fluid may be extracted from the tissue site and into the dressing assembly 314. The fluid from the tissue site may be absorbed into the sealing ring 334. The fluid from the tissue site may be wicked or otherwise communicated in a lateral direction within the dressing assembly 314 toward the sealing ring 334.

[0093] Referring to FIGURES 7A-15, depicted are various example components and features that may be associated with various example embodiments of a treatment system 400 and a dressing assembly 402 that may be configured to treat a tissue site such as, without limitation, a limb 401, portion of a limb, or a residual limb remaining after an amputation procedure, for example. Some examples of the treatment system 400 may include similar or analogous features as the treatment system 100, 200, and 300. Further, the treatment system 400 may include various example embodiments of the dressing assembly 402, which may include similar or analogous features as the dressing assembly 112, 202, 314. For brevity, features of the treatment system 100, 200, 300 and the dressing assembly 112, 202, 314 not specifically described in connection with the treatment system 400 and the dressing assembly 402 may be applied analogously or included in the treatment system 400 and the dressing assembly 402, respectively. Further, features of the treatment system 400 and the dressing assembly 402 may be added or removed by persons of skill to suit various applications.

[0094] Further, in some examples, separate or individual components of the dressing assembly 402 may be provided, applied, or assembled on-site on the limb 401. In other examples, components of the dressing assembly 402 may be coupled together or provided as an assembly, pre assembled unit, or multi -component unit configured to be collectively applied to the limb 401.

[0095] FIGURES 7A-15 depict various example embodiments of the dressing assembly 402, or features or portions of the dressing assembly 402, that may be associated or included in various examples of the treatment system 400. Referring generally to FIGURES 7A-15, various example components of the dressing assembly 402 are introduced first and later described in specific example embodiments. By way of introduction, in some example embodiments, the dressing assembly 402 may include a dressing bolster 404 and a sealing member 406. Example embodiments of the sealing member 406 are shown in FIGURES 14A-15, but omitted from FIGURES 7A-13C for clarity. However, the example sealing member 406 or the previously described sealing member 116, 224, 340 may be included or associated with the dressing assembly 402 to cover the dressing bolster 404 and other components of FIGURES 7A-13C in a similar or analogous manner. Further, the dressing assembly 402 may optionally, additionally or alternatively include a gasket member 408 similar or analogous to the gasket member 117, 248, 334. Further, the dressing assembly 402 may optionally, additionally or alternatively include a tissue interface layer 410 similar or analogous to the tissue interface layer 124, 210, 326.

[0096] In some examples, the dressing bolster 404 may include similar or analogous features as the previously described dressing bolster 114, 204, and 316. For example, the dressing bolster 404 may include a first side 420 and an opposing second side 422. The second side 422 of the dressing bolster 404 may be configured to face the limb 401, which may include a wound, defect, or target treatment area, such as, without limitation, the previously described incision 104. In some examples, the dressing bolster 404 may be configured to support both a hemispherical portion 403 and a cylindrical portion 405 of the residual limb 401. The second side 422 of the dressing bolster 404 may be configured to be positioned in fluid communication with the limb 401. In some examples, the second side 422 of the dressing bolster 404 may be configured to be positioned in contact with the limb 401. Further, in some examples, the dressing bolster 404 may include or be formed of, without limitation, a porous foam, an open-cell foam, or any of the materials previously described for the dressing bolster 114, 204, and 316.

[0097] In some examples, the sealing member 406 may include similar or analogous features and materials as the previously described sealing member 116, 224, 340. The sealing member 406 may be configured to cover at least a portion of the first side 420 of the dressing bolster 404. Further, the sealing member 406 may be configured to create a sealed space, analogous to the sealed space 342, containing the dressing bolster 404 between the sealing member 406 and the limb 401. Further, in some examples, the sealing member 406 may include or may be formed of a liquid impermeable film or layer or any of the materials previously described for the sealing member 116, 224, 340.

[0098] In some examples, the tissue interface layer 410, which may be similar or analogous to the tissue interface 124, 210, 326, may be coupled to, positioned on, or positioned at the second side 422 of the dressing bolster 404. Further, in some examples, at least a portion of the tissue interface layer 410 may be configured to be positioned in direct contact with the limb 401. The tissue interface layer 410 may include a first side 426 and an opposing second side 428, and may be configured to be positioned between the limb 401 and the second side 422 of the dressing bolster 404. The tissue interface 410 may include or be formed of similar or analogous materials as described for the tissue interface 124, 210, 326, such as, without limitation, one or more of a woven material, a non- woven material, a polyester knit material, an elastic material, a fenestrated film, a felted foam, and a foam skin.

[0099] The optional gasket member 408 may be configured to create or to enhance formation of a sealed space between the sealing member 406 and the limb 401 analogous to the previously described sealed space 342. The dressing bolster 404 may be configured to be positioned in the sealed space at or on the limb 401 when the dressing assembly 402 is deployed at the limb 401. In some examples, the gasket member 408 may be positioned on a portion of the second side 422 of the dressing bolster 404. Further, in some examples, the gasket member 408 may be positioned around a circumference, edge, or periphery of the dressing bolster 404. Further, in some examples, the gasket member 408 may be coupled to a portion of the tissue interface 410, and the portion of the tissue interface 410 may be positioned between the second side 422 of the dressing bolster 404 and the gasket member 408. Further, in some examples, the gasket member 408 may be configured to be positioned between the dressing bolster 404 and the limb 401. Further, in some embodiments, the gasket member 408 may extend beyond an edge of the dressing bolster 404 and may be configured to be coupled to a portion of the sealing member 406. Further, in some embodiments, the gasket member 408 may be configured to be positioned between the limb 401 and a portion of the sealing member 406. Further, in some examples, the gasket member 408 may be a first gasket member coupled to the dressing bolster 404, and the dressing assembly 402 may additionally include a second gasket member 408 coupled to or provided with the sealing member 406 as shown in FIGURES 14A- 14B. Further, in some examples, the gasket member 408 may be coupled to or provided with the sealing member 406 in lieu of or instead of being coupled to, associated with, or provided with the dressing bolster 404. Further, in some examples, the gasket member 408 may include or may be, without limitation, one or more of an adhesive, a hydrocolloid, a hydrogel, a silicone polymer, a natural gum, or any of the previously described materials for the gasket member 117, 248, 334.

[00100] Referring specifically to FIGURES 7A-7B, depicted is an example limb 401 including the incision 104 as an example of a defect or target treatment area on the limb 401. Also depicted is an example embodiment of a tissue interface layer 410 positioned on or covering the incision 104 and an area of tissue around the incision 104 on the limb 401.

[00101] As shown in FIGURES 7A-7B, the hemispherical portion 403 of the limb 401 may be positioned at a distal end of the cylindrical portion 405. At least a portion of the dressing bolster 404 may be configured to be positioned on the hemispherical portion 403 of the limb 401 and on at least a pair of opposing surfaces 407a, 407b on the cylindrical portion 405.

[00102] Further, in some examples, the dressing bolster 404 may be configured to cover at least five dressing contact points 409 on the limb 401. For example, the limb 401 may include a distal contact point 409a, a front contact point 409b, a back contact point 409c opposite the front contact point 409b, a left contact point 409d, and a right contact point 409e opposite the left contact point 409d. The distal contact point 409a may be positioned on the hemispherical portion 403 of the limb 401, the front contact point 409b may be positioned on an opposite side of the cylindrical portion 405 relative to the back contact point 409c, and the left contact point 409d may be positioned on an opposite side of the cylindrical portion 405 relative to the right contact point 409e. In some examples, the front contact point 409b, the left contact point 409d, and the distal contact point 409a may each lie in a plane substantially perpendicular to each other. Further, in some examples, the hemispherical portion 403 and the cylindrical portion 405 of the limb 401 may form a convex three-dimensional surface 411 on the limb 401, and the incision 104 may be positioned proximate to a transition surface 413 between the cylindrical portion 405 and the hemispherical portion 403 of the limb 401.

[00103] Referring specifically to FIGURE 7A, in some examples, the issue interface layer 410 may be a tissue interface layer 410a that may be associated with or included in some example embodiments of the treatment system 400 and the dressing assembly 402 as part of the treatment system 400. As shown in FIGURE 7A, in some examples, the tissue interface layer 410a may include or be formed from a three-dimensional knit material configured to conform to an exterior surface of the limb 401 without seams or wrinkles in the tissue interface layer 410. Further, in some examples, the tissue interface layer 410a may include or be formed as a sock 430 including a cavity configured to receive the hemispherical portion 403 and the cylindrical portion 405 of the limb 401.

[00104] Referring to FIGURE 7B, in some examples, the issue interface layer 410 may be a tissue interface layer 410b that may be associated with or included in some example embodiments of the treatment system 400 and the dressing assembly 402 as part of the treatment system 400. As shown in FIGURE 7B, in some examples, the tissue interface layer 410b may include or be formed as one or more conformable strips 432 configured to conform or wrap around the limb 401. Further, in some examples, the tissue interface layer 410a or the tissue interface layer 410b may be a first tissue interface layer, and the dressing assembly 402 may additionally include a second tissue interface layer coupled to the second side 422 of the dressing bolster 404 similar or analogous to the example tissue interface layer 124, 210, 326 shown in the examples of FIGURES 2, 4, and 6B-6C. Further, in some examples, the tissue interface layer 410a or 410b may be omitted and the tissue interface layer 410 may instead be positioned on or coupled to the second side 422 of the dressing bolster 404 similar or analogous to the example tissue interface layer 124, 210, 326 shown in the examples of FIGURES 2, 4, and 6B-6C.

[00105] Referring to FIGURES 8A-13C and 15, in some examples, the dressing bolster 404 may include a support hub 440 and at least one support wrap 442 fluidly coupled to and extending outward from the support hub 440. A portion of the support hub 440 may be configured to be positioned proximate to the hemispherical portion 403 of the limb 401. In some examples, at least a portion of the support hub 440 may be configured to be positioned at or proximate to the incision 104 in the limb 401. Further, the support wrap 442 may be configured to extend over at least a portion of the cylindrical portion 405 of the limb 401. In some examples, one or more of the support wraps 442 may be configured to extend circumferentially around the cylindrical portion 405 of the limb 401. Further, in some examples, one or more of the support wraps 442 may be configured to extend over at least a portion of both the cylindrical portion 405 and the hemispherical portion 403 of the limb 401.

[00106] Referring FIGURES 11A-12B, in some examples, one or more of the support wraps 442 may be configured to wrap around at least a portion of the cylindrical portion 405 of the limb 401, and one or more of another of the support wraps 442 may be configured to wrap around at least a portion of the hemispherical portion 403 of the limb 401.

[00107] Referring to FIGURES 8A-9B, 11A-13C, and 15, in some examples, one or more of the support wraps 442 may be configured to extend longitudinally along a length of the cylindrical portion 405 of the limb 401.

[00108] Referring to FIGURES 8A-8B and 11A-12B, in some examples, the at least one support wrap 442 may be a plurality of support wraps 442, and one of the plurality of support wraps 442 may be positioned transverse to another of the plurality of support wraps 442. Further, in some examples, the plurality of support wraps 442 may extend radially outward from the support hub 440. Further, in some examples, at least one of the plurality of support wraps 442 may have a length 443 extending from the support hub 440 between about 5 centimeters to about 25 centimeters. Further, in some examples, at least one of the support wraps 442 may have a width 445 transverse to the length between about 2 centimeters to about 10 centimeters.

[00109] Referring to FIGURES 9A-9B, 13A-13C, and 15, in some examples, the dressing bolster 404 and the support hub 440 and the at least one support wrap 442 may be configured to form a cap 444 including a pocket 446 for receiving the hemispherical portion 403 and the cylindrical portion 405 of the limb 401.

[00110] Referring to FIGURES 13A-13C, in some examples, the dressing bolster 404 may include a first half 448 and a second half 450. The first half 448 may include a first pair of edges 452, and the second half 450 may include a second pair of edges 454. In some examples, the first pair of edges 452 may be configured to be coupled to the second pair of edges 454 to form the pocket 446.

In some examples, the pocket 446 may include a base 456 having a diameter between about 10 centimeters to about 18 centimeters and a depth between about 10 centimeters to about 30 centimeters extending to the base 456. Further, in some examples, the dressing assembly 402 may include an optional gathering band 458 configured to slidably secure a portion of the dressing bolster 404 around the cylindrical portion 405 of the limb 401.

[00111] Referring to FIGURES 14A-15, in some examples, the sealing member 406 may include or may be a bag 460 including a closable or a closed volume 462 and an opening 464 defining an entrance into the volume 462. The volume 462 may be configured or sized to receive the limb 401 through the opening 464.

[00112] Referring to FIGURES 14A-14B, the bag 460 may include an internal border 466 and an external border 468 positioned at the opening 464. The internal border 466 may be positioned around an internal surface 470 of the bag 460 at the opening 464, and the external border 468 may be positioned around an exterior surface 472 of the bag 460 at the opening 464. In some examples, the internal border 466 may carry the gasket member 408 or an adhesive 474 and a removable release liner 476 covering the gasket member 408 or the adhesive 474. In some examples, the removable release liner 476 may include a first strip 478 and a second strip 480 configured to be separately removed from the gasket member 408 or the adhesive 474 during deployment of the bag 460 at the limb 401. In some examples, the removable release liner 476 may include or be formed of similar or analogous features and materials as previously described for the release liner 256 shown in FIGURES 4-5. Further, in some examples, the external border 468 may carry a removable stiffening member 482 configured to impart a shape to the entrance of the opening 464 for receiving the limb 401. In some examples, the removable stiffening member 482 may include or be formed of similar or analogous features and materials as previously described for the release members 242 shown in FIGURES 4-5. [00113] The reduced-pressure source 144, previously described and illustrated in FIGURE 1, may be configured to be coupled in fluid communication with the dressing bolster 404 through the sealing member 406 similar or analogous to the previously described sealing member 116, 224, 340.

In some examples, the dressing assembly 402 may include the reduced pressure interface 138 coupled at the first side 420 of the dressing bolster 404 and in fluid communication with the dressing bolster 404 through the sealing member 406. In some examples, the reduced pressure interface 138 may be coupled in fluid communication with the reduced pressure source 144 with the delivery conduit 148 as previously described.

[00114] Referring again generally to FIGURES 7A-15, in some example embodiments, a method for treating the limb 401 may include providing the dressing bolster 404. The dressing bolster 404 may include the support hub 440 and the at least one support wrap 442. The support wrap 442 may be fluidly coupled to and extend outward from the support hub 440. Further, the method may include positioning the support hub 440 at the incision 104 in the limb 401. Further, the method may include wrapping one or more of the support wraps 442 around at least a portion of the cylindrical portion 405 of the limb 401. Further, the method may include covering the dressing bolster 404 with the sealing member 406 to form a sealed space containing the dressing bolster 404. Further, the method may include delivering reduced pressure to the dressing bolster 404 through the sealing member 406.

[00115] In some examples, the method may include wrapping one or more of the support wraps 442 around at least a portion of the hemispherical portion 403 of the limb 401. In such an example, one or more of the support wraps 442 may be configured to extend over at least a portion of both the cylindrical portion 405 and the hemispherical portion 403 of the limb 401.

[00116] In some examples, one or more of the support wraps 442 may extend circumferentially around the cylindrical portion 405 of the limb 401. Further, in some examples, the hemispherical portion 403 of the limb 401 may be positioned at a distal end of the cylindrical portion 405. Further, in some examples, the at least one support wrap 442 may be a plurality of support wraps 442 and one of the plurality of support wraps 442 may be positioned transverse to another of the plurality of support wraps 442.

[00117] The various example configurations of the dressing bolster 404 described herein can conform to complex anatomical geometries, such as, without limitation, the limb 401. As such, the dressing bolster 404 may enhance closure of a treatment target on the limb 401 , such as the incision 104, and additionally support tissue around the treatment target, which may reduce swelling.

[00118] The appended claims set forth novel and inventive aspects of the subject matter in this disclosure. While shown in several illustrative embodiments, a person having ordinary skill in the art will recognize that the systems, apparatuses, and methods described herein are susceptible to various changes and modifications. Features may be emphasized in some example embodiments while being omitted in others, but a person of skill in the art will appreciate that features described in the context of one example embodiment may be readily applicable to other example embodiments. Further, certain features, elements, or aspects may be omitted from this disclosure if not necessary to distinguish the novel and inventive features from what is already known to a person having ordinary skill in the art. Features, elements, and aspects described herein may also be combined or replaced by different or alternative features serving the same, equivalent, or similar purpose without departing from the scope of the invention defined by the appended claims. Moreover, descriptions of various alternatives using terms such as “or” do not require mutual exclusivity unless clearly required by the context, and the indefinite articles "a" or "an" do not limit the subject to a single instance unless clearly required by the context. Further, the benefits and advantages described herein may relate to one embodiment or several embodiments. Even further, the steps of the methods described herein may be carried out in any suitable order, or simultaneously, where appropriate.

Claims

We claim:

1. A dressing assembly for treating an incision at a residual limb after an amputation, comprising: a dressing bolster including a first side and an opposing second side, the second side of the dressing bolster configured to face the residual limb and to support both a hemispherical portion and a cylindrical portion of the residual limb; a tissue interface layer including a first side and an opposing second side configured to be positioned between the residual limb and the second side of the dressing bolster; and a sealing member configured to cover at least a portion of the first side of the dressing bolster and to create a sealed space containing the dressing bolster between the sealing member and the residual limb.

2. The dressing assembly of claim 1, wherein the hemispherical portion of the residual limb is positioned at a distal end of the cylindrical portion, and wherein at least a portion of the dressing bolster is configured to be positioned on the hemispherical portion of the residual limb and on at least a pair of opposing surfaces on the cylindrical portion.

3. The dressing assembly of claim 1, wherein the dressing bolster is configured to cover at least five dressing contact points on the residual limb.

4. The dressing assembly of claim 3, wherein the at least five dressing contact points include a distal contact point, a front contact point, a back contact point opposite the front contact point, a left contact point, and a right contact point opposite the left contact point.

5. The dressing assembly of claim 4, wherein the distal contact point is positioned on the hemispherical portion of the residual limb, wherein the front contact point is positioned on an opposite side of the cylindrical portion relative to the back contact point, and wherein the left contact point is positioned on an opposite side of the cylindrical portion relative to the right contact point.

6. The dressing assembly of claim 4, wherein the front contact point, the left contact point, and the distal contact point each lie in a plane substantially perpendicular to each other.

7. The dressing assembly of claim 1, wherein the dressing bolster comprises a support hub and at least one support wrap fluidly coupled to and extending outward from the support hub, wherein at least a portion of the support hub is configured to be positioned at the incision, and wherein the support wrap is configured to extend over at least a portion of the cylindrical portion of the residual limb.

8. The dressing assembly of claim 7, wherein one or more of the support wraps are configured to wrap around at least a portion of the cylindrical portion of the residual limb, and one or more of another of the support wraps are configured to wrap around at least a portion of the hemispherical portion of the residual limb.

9. The dressing assembly of claim 7, wherein one or more of the support wraps are configured to extend over at least a portion of both the cylindrical portion and the hemispherical portion of the residual limb.

10. The dressing assembly of claim 7, wherein a portion of the support hub is configured to be positioned proximate to the hemispherical portion of the residual limb.

11. The dressing assembly of claim 7, wherein one or more of the support wraps is configured to extend longitudinally along a length of the cylindrical portion of the residual limb.

12. The dressing assembly of claim 7, wherein one or more of the support wraps is configured to extend circumferentially around the cylindrical portion of the residual limb.

13. The dressing assembly of claim 7, wherein the support hub and the at least one support wrap are configured to form a cap including a pocket for receiving the hemispherical portion and the cylindrical portion of the residual limb.

14. The dressing assembly of claim 7, wherein the at least one support wrap is a plurality of support wraps, and wherein one of the plurality of support wraps is positioned transverse to another of the plurality of support wraps.

15. The dressing assembly of claim 7, wherein the at least one support wrap is a plurality of support wraps, and wherein the plurality of support wraps extend radially outward from the support hub.

16. The dressing assembly of claim 7, wherein at least one of the plurality of support wraps has a length extending from the support hub between about 5 centimeters to about 25 centimeters, and wherein at least one of the support wraps has a width transverse to the length between about 2 centimeters to about 10 centimeters.

17. The dressing assembly of claim 1, wherein the dressing bolster includes a pocket configured to receive the hemispherical portion and the cylindrical portion of the residual limb.

18. The dressing assembly of claim 17, wherein the dressing bolster comprises a first half and a second half, wherein the first half includes a first pair of edges and the second half includes a second pair of edges, and wherein the first pair of edges are configured to be coupled to the second pair of edges to form the pocket.

19. The dressing assembly of claim 17, wherein the pocket includes a base having a diameter between about 10 centimeters to about 15 centimeters and a depth between about 10 centimeters to about 30 centimeters extending to the base.

20. The dressing assembly of claim 1, wherein the dressing bolster comprises foam.

21. The dressing assembly of claim 1, further comprising a gathering band configured to slidably secure a portion of the dressing bolster around the cylindrical portion of the residual limb.

22. The dressing assembly of claim 1, wherein the hemispherical portion and the cylindrical portion of the residual limb form a convex three-dimensional surface on the residual limb, and wherein the incision is positioned proximate to a transition surface between the cylindrical portion and the hemispherical portion of the residual limb.

23. The dressing assembly of claim 1, wherein at least a portion of the tissue interface layer is configured to be in direct contact with the residual limb, and wherein the tissue interface layer is selected from one or more elements of a group consisting of: a woven material, a non-woven material, a polyester knit material, an elastic material, and a fenestrated film.

24. The dressing assembly of claim 1, wherein the tissue interface layer comprises a three- dimensional knit material configured to conform to an exterior surface of the residual limb without seams or wrinkles in the tissue interface layer.

25. The dressing assembly of claim 1, wherein the tissue interface layer comprises a sock including a cavity configured to receive the hemispherical portion and the cylindrical portion of the residual limb.

26. The dressing assembly of claim 1, wherein the tissue interface layer comprises a conformable strip configured to conform around the residual limb.

27. The dressing assembly of claim 1, wherein the tissue interface layer is a first tissue interface layer, and wherein the dressing assembly further comprises a second tissue interface layer coupled to the second side of the dressing bolster.

28. The dressing assembly of claim 1, further comprising a gasket member positioned on a portion of the second side of the dressing bolster and configured to be positioned between the dressing bolster and the residual limb.

29. The dressing assembly of claim 28, wherein the gasket member extends beyond an edge of the dressing bolster and is further configured to be coupled to a portion of the sealing member.

30. The dressing assembly of claim 1, further comprising a gasket member configured to be positioned between the residual limb and a portion of the sealing member.

31. The dressing bolster assembly of claims 28 or 30, wherein the gasket member is selected from one or more elements of the group consisting of: an adhesive, hydrocolloid, hydrogel, silicone polymer, and natural gum.

32. The dressing assembly of claim 1, wherein the sealing member comprises a liquid impermeable film layer.

33. The dressing assembly of claim 1, wherein sealing member comprises a bag including a closed volume and an opening defining an entrance into the closed volume, wherein the closed volume is configured to receive the residual limb through the opening.

34. The dressing assembly of claim 33, wherein the bag includes an internal border and an external border positioned at the opening, the internal border being positioned around an internal surface of the bag at the opening, and the external border being positioned around an exterior surface of the bag at the opening.

35. The dressing assembly of claim 34, wherein the internal border carries an adhesive and a removable release liner covering the adhesive, wherein the removable release liner includes a first strip and a second strip configured to be separately removed from the adhesive during deployment of the bag at the residual limb.

36. The dressing assembly of claim 34, wherein the external border carries a removable stiffening member configured to impart a shape the entrance of the opening for receiving the residual limb.

37. A system for treating a tissue site, comprising: the dressing assembly of claim 1; and a reduced-pressure source configured to be coupled in fluid communication with the dressing bolster through the sealing member.

38. A dressing assembly configured to treat a residual limb after an amputation, comprising: a dressing bolster comprising a support hub and at least one support wrap fluidly coupled to and extending outward from the support hub, at least a portion of the support hub configured to be positioned proximate to an incision in the residual limb, the support wrap being configured to extend over at least a portion of a cylindrical portion of the residual limb; a tissue interface layer configured to be positioned between the residual limb and the dressing bolster; and a sealing member configured create a sealed space containing the dressing bolster between the sealing member and the residual limb.

39. The dressing assembly of claim 38, wherein one or more of the support wraps are configured to wrap around at least a portion of the cylindrical portion of the residual limb, and one or more of another of the support wraps are configured to wrap around at least a portion of a hemispherical portion of the residual limb.

40. The dressing assembly of claim 38, wherein one or more of the support wraps are configured to extend over at least a portion of both the cylindrical portion and a hemispherical portion of the residual limb.

41. The dressing assembly of claim 38, wherein a portion of the support hub is configured to be positioned proximate to a hemispherical portion of the residual limb.

42. The dressing assembly of claim 38, wherein one or more of the support wraps is configured to extend circumferentially around the cylindrical portion of the residual limb.

43. The dressing assembly of any one of claims 39-42, wherein the hemispherical portion of the residual limb is positioned at a distal end of the cylindrical portion.

44. The dressing assembly of claim 38, wherein the at least one support wrap is a plurality of support wraps, and wherein one of the plurality of support wraps is positioned transverse to another of the plurality of support wraps.

45. The dressing assembly of claim 38, wherein at least one of the plurality of support wraps has a length extending from the support hub between about 5 centimeters to about 25 centimeters, and wherein at least one of the support wraps has a width transverse to the length between about 2 centimeters to about 10 centimeters.

46. The dressing assembly of claim 38, wherein the dressing bolster comprises foam.

47. The dressing assembly of claim 38, wherein at least a portion of the tissue interface layer is configured to be in direct contact with the residual limb, and wherein the tissue interface layer is selected from one or more elements of a group consisting of: a woven material, a non-woven material, a polyester knit material, an elastic material, and a fenestrated film.

48. The dressing assembly of claim 38, wherein the tissue interface layer comprises a three- dimensional knit material configured to conform to an exterior surface of the residual limb without seams or wrinkles in the tissue interface layer.

49. The dressing assembly of claim 38, wherein the tissue interface layer comprises a sock including a cavity configured to receive both the cylindrical portion of the residual limb and a hemispherical portion of the residual limb positioned at a distal end of the cylindrical portion.

50. The dressing assembly of claim 38, wherein the tissue interface layer is a first tissue interface layer, and wherein the dressing assembly further comprises a second tissue interface layer coupled to a second side of the dressing bolster that is configured to face the residual limb.

51. The dressing assembly of claim 38, further comprising a gasket member configured to be positioned between the residual limb and a portion of the sealing member.

52. The dressing assembly of claim 38, further comprising a gasket member positioned at an edge of the dressing bolster.

53. The dressing bolster assembly of any one of claims 51-52, wherein the gasket member is selected from one or more elements of the group consisting of: a hydrocolloid, hydrogel, silicone polymer, and natural gum.

54. The dressing assembly of claim 38, wherein the sealing member comprises a liquid impermeable film layer.

55. The dressing assembly of claim 38, wherein sealing member comprises a bag including a closed volume and an opening defining an entrance into the closed volume, wherein the closed volume is configured to receive the residual limb through the opening.

56. A method for treating a residual limb after an amputation, comprising: providing a dressing bolster, comprising: a support hub, and at least one support wrap fluidly coupled to and extending outward from the support hub; positioning the support hub at an incision in the residual limb; wrapping one or more of the support wraps around at least a portion of a cylindrical portion of the residual limb; covering the dressing bolster with a sealing member to form a sealed space containing the dressing bolster; and delivering reduced pressure to the dressing bolster through the sealing member.

57. The method of claim 56, further comprising wrapping one or more of the support wraps around at least a portion of a hemispherical portion of the residual limb.

58. The method of claim 57, wherein one or more of the support wraps are configured to extend over at least a portion of both the cylindrical portion and the hemispherical portion of the residual limb.

59. The method of claim 56, wherein one or more of the support wraps extends circumferentially around the cylindrical portion of the residual limb.

60. The method of any one of claims 57-59, wherein the hemispherical portion of the residual limb is positioned at a distal end of the cylindrical portion.

61. The method of claim 56, wherein the at least one support wrap is a plurality of support wraps, and wherein one of the plurality of support wraps is positioned transverse to another of the plurality of support wraps.

62. The apparatus, dressings, systems, and methods as shown and described herein.