Patent Description:
Physicians perform millions of surgical procedures each year around the world. Many of the procedures are performed as open surgery and an increasing number are performed using minimally invasive surgery, such as endoscopic, arthroscopic, and laparoscopic procedures. As one example, the American Society for Aesthetic Plastic Surgery reports that there were more than <NUM>,<NUM> liposuction procedures in the United States in <NUM>.

Surgical procedures involve acute wounds, e.g., an incision, in the skin and related tissue. In many instances, the incision is closed at the conclusion of the procedure using a mechanical apparatus, such as staples or suture, or closed using adhesives. Thereafter, the wound is often merely covered with a dry, sterile bandage. Of course, there is usually more disruption than just at the epidermis.

With many surgical procedures, particularly those done with minimally invasive techniques, much of the disruption or damage is below the epidermis, or at a subcutaneous level. Again, as one example, in one type of liposuction procedure, after the introduction of a tumescent fluid (saline, mild painkiller, and epinephrine), the surgeon will use a trocar and cannula with suction to remove fatty areas. In doing so, it is not uncommon to have subcutaneous voids and other tissue defects formed at tissue sites remote from the incision through which the cannula was placed or other incisions through which equipment was placed. The damaged tissue will need time and care to heal and poses a number of potential complications and risks including edema, seroma, hematoma, further bruising, and ecchymosis to name some.

To facilitate healing after many surgical procedures, such as liposuction, depending on the body part involved, a firm-fitting wrap or elastic compression garment may be used for weeks on the patient. These devices are at times uncomfortable, may apply compression in a non-uniform manner, and can be difficult to take off and put on, In addition, because of edema, a number of different compression garments may be required for a single patient, It would be desirable to address some or all of the shortcomings of post-surgical wound care at the incision and at the undermined subcutaneous tissue. <CIT> concerns an apparatus for cleansing wounds. <CIT> describes a wound dressing comprising a body layer of a resiliently compressible moisture absorbent foam material having an outer surface layer providing a liquid barrier and an inner wound facing surface layer with a wound contacting layer applied to it. The wound contacting layer comprises an attached layer of moisture permeable material and the barrier layer comprises an attached layer of gas permeable material of reduced moisture permeability. Preferably, the foam is of polyether polyurethane and the barrier aid backing layer is <NUM>-<NUM> thick prior to compression.

Shortcomings with aspects of wound care are addressed by the illustrative embodiments herein. The present invention provides a method of manufacturing a shaped dressing bolster according to claim <NUM>. Further optional features are defined by the dependent claims. Also disclosed herein but not part of the claimed invention is a dressing assembly for use with a reduced pressure treatment system includes a shaped dressing bolster, which has a first surface, a second (inward-facing) surface, and an extremity. The shaped dressing bolster is formed from a medical bolster material. The extremity has an oblique surface. The shaped dressing bolster is operable to evenly distribute a compressive force.

Also disclosed herein but not part of the claimed invention is a dressing assembly for use with a reduced-pressure treatment system includes a shaped dressing bolster, which has a first surface, a second (inward-facing) surface, and an extremity. The shaped dressing bolster is formed from a medical bolster material operable to distribute reduced pressure. The dressing assembly further includes an over-drape that is coupled to the first surface of the shaped dressing bolster and the extremity of the shaped dressing bolster. The shaped dressing bolster is operable to evenly distribute a compressive force that results when the shaped dressing bolster is subjected to reduced pressure.

Also disclosed herein but not part of the claimed invention is a dressing assembly for use with a reduced pressure treatment system includes a shaped dressing bolster, which has a shaped extremity, a first surface, and a second (inward-facing) surface. The dressing assembly further includes an over-drape disposed over the first surface of the shaped dressing bolster and that is coupled to a least a portion of the first surface of the shaped dressing bolster. The over-drape may extend beyond the shaped dressing bolster to form a drape extension, which has a first side and a second, inward-facing side. An adhesive perimeter strip may be coupled to the second side of the drape extension to provide a seal between a patient and the over-drape.

Also disclosed herein but not part of the claimed invention is a dressing assembly for use with a reduced-pressure treatment system includes a shaped dressing bolster, which has a shaped extremity, a first surface, and a second (inward-facing) surface. The shaped dressing bolster is operable to evenly distribute a compressive force. The dressing assembly further includes an over-drape disposed over the first surface of the shaped dressing bolster that extends over the shaped dressing bolster beyond the shaped dressing bolster to form a drape extension. The drape extension has a first surface and an inward-facing, second surface. The dressing assembly further includes an inner layer, which has a first surface and a second, inward-facing surface. The first surface of the inner layer is coupled, at least in part, to a portion of the second surface of the shaped dressing bolster. The inner layer is formed with a treatment area aperture. The shaped dressing bolster is formed from a medical bolster material operable to distribute a reduced pressure.

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

A more complete understanding of the present invention may be obtained by reference to the following Detailed Description when taken in conjunction with the accompanying Drawings wherein:.

Referring now to <FIG>, a reduced-pressure system <NUM> for treating tissue, such as subcutaneous tissue in a peri-incisional region or an incision, according to one illustrative embodiment is shown. As used herein, "or" does not require mutual exclusivity. The reduced-pressure system <NUM> is shown in a peri-incisional region around an incision <NUM>, which is through epidermis <NUM>, or skin, and dermis <NUM> and reaching into a hypodermis, or subcutaneous tissue <NUM>. The subcutaneous tissue <NUM> may include numerous tissue types, such as fatty tissue or muscle. A damaged, or undermined or abnormal, subcutaneous tissue site is shown extending from the incision <NUM> and includes, in this instance, a subcutaneous defect, dead space, or void <NUM>.

The damaged subcutaneous tissue <NUM> may have been caused by a surgical procedure, such as liposuction. The damaged subcutaneous tissue <NUM> may include voids, such as the void <NUM>, open spaces, or various defects that can be troublesome for a number of reasons such as allowing fluids to build that may result in edema. The term "fluid" as used herein generally refers to gas or liquid, but may also include any other flowable material, including but not limited to gels, colloids, and foams.

The system <NUM> may help the damaged subcutaneous tissue <NUM> to be approximated-brought together or near-to improve healing while minimizing or eliminating skin irritation. The system <NUM> may also develop a closing force directed toward the incision <NUM> and that may help hold the incision closed or provide support. The system <NUM> may help minimize shear stress on deep wounds, e.g., void <NUM>. The system <NUM> may also help the incision <NUM> remain dry, help avoid dead space formation, improve perfusion, and avoid seroma and hematoma formation. In addition, system <NUM> may help minimize bruising and edema secondary to certain surgical procedures. The system <NUM> may provide comfort for the patient and a relatively shortened duration that the system <NUM> may be required on the patient. With the system <NUM><NUM>, dressing changes may be eliminated or the number of required changes minimized.

The incision <NUM> may be closed using any mechanical closing means such as staples or sutures, or may be closed using an adhesive, but is shown in this illustrative embodiment as being closed with suture <NUM>. The reduced-pressure system <NUM> typically is for treating an area and, in particular, is typically for treating a subcutaneous tissue site <NUM> and the tissue around subcutaneous tissue <NUM>, but the reduced-pressure system <NUM> may also be used to treat a more limited area around the incision <NUM>.

The reduced-pressure system <NUM> includes a dressing assembly <NUM>, which includes a shaped dressing bolster <NUM>, a sealing subsystem <NUM>, and a reduced-pressure subsystem <NUM>. The reduced-pressure system <NUM> develops a force, which may include a vertical force or a closing force. As used in this context and herein, "vertical" means parallel to arrows <NUM> irrespective of orientation but shown vertically in <FIG>. The developed force in the vertical may be a compressive force or a lifting force. In the illustrative embodiment, the net vertical force is presented as a compressive force represented by the arrow <NUM>, and the closing force is shown by arrows <NUM>. The compressive force <NUM> may realized at the subcutaneous tissue <NUM> or deeper, including at an organ. As used herein subcutaneous tissue may include the deeper tissues as well. The compressive force <NUM> may be directed vertically (i.e., generally toward a center line of patient's body or a body portion or with reference to the shaped dressing bolster <NUM> from the first side <NUM> to the second side <NUM>. The compressive force <NUM> may reach subcutaneous tissues. The magnitude of the vertical force <NUM> may be influenced by the size and shape of the shaped dressing bolster <NUM>.

In some situations, it may be desirable to have the shaped dressing bolster <NUM> deliver the vertical force as a lifting force. The density and thickness of the shaped dressing bolster <NUM> are variables for controlling lifting. For example, if the density of a medical bolster material is less than the density of the tissue, e.g., epidermis, at the tissue site, a lifting force may be generated. As a substantially thick portion of a shaped dressing bolster <NUM> experiences reduced pressure, the shaped dressing bolster contracts toward a central portion from all directions. The portion of the shaped dressing bolster <NUM> near the patient's epidermis will pull away from the patient's epidermis since the central portion is above the patient's epidermis. This creates a vertical lifting force. A portion of the shaped dressing bolster may provide a compressive force, while another portion-generally a central portion-provides a lifting force with respect to the patient or the system.

The illustrative embodiment of <FIG> is presented with the vertical force applying a compressive force <NUM>. As described further below, the shaped dressing bolster <NUM> may be shaped and configured to allow the compressive force to be distributed fairly evenly over the patient's epidermis <NUM> and beneath the epidermis <NUM>. Otherwise, if there are areas of substantially increased force as compared to other areas, skin irritation may result The reduced-pressure system <NUM> may also be operable to develop the closing force, i.e. a substantially tangential force towards an interior portion of the dressing assembly <NUM>, represented by the reference numerals <NUM>. The closing force <NUM> remains substantially within the plane of the epidermis <NUM>; in other words, the closing force <NUM> operates mainly within the epidermis <NUM>. In addition, the reduced-pressure system <NUM> is operable to deliver reduced pressure to the incision <NUM> that, depending on the incision and the state of healing, may be realized at the level of the subcutaneous void <NUM> to help approximate-bring together-the tissues in that region as well as to help remove any air or any other fluids or provide reduced-pressure therapy. The compressive force <NUM> may also close or help close the void <NUM>.

As used herein, "reduced pressure" generally refers to a pressure less than the ambient pressure at a tissue site that is being subjected to treatment. In most cases, this reduced pressure will be less than the atmospheric pressure at which the patient is located. Alternatively, the reduced pressure may be less than a hydrostatic pressure at the tissue site. Unless otherwise indicated, values of pressure stated herein are gauge pressures. The reduced pressure delivered 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 the 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, an increase in reduced pressure or vacuum pressure typically refers to a relative reduction in absolute pressure.

The dressing assembly <NUM> includes the shaped dressing bolster <NUM> that has a first side <NUM> and a second, inward (skin-facing or patient-facing) side <NUM>. The shaped dressing bolster <NUM> may be sized and shaped to substantially match the estimated area of damaged subcutaneous tissue <NUM> although a larger or smaller size may be used in different applications. The shaped dressing bolster <NUM> has a peripheral edge <NUM>. The shaped dressing bolster <NUM> may be made of a number of different medical bolster materials, i.e., materials suitable for use in medical applications and that may be made sterile. In one illustrative embodiment, the shaped dressing bolster <NUM> is made from a medical bolster material that is a manifold material. The term "manifold" as used herein generally refers to a substance or structure that is provided to assist in applying reduced pressure to, delivering fluids to, or removing fluids from a tissue site. The manifold material typically includes a plurality of flow channels or pathways that distribute fluids provided to and removed from the tissue site around the manifold material. The flow channels or pathways may be interconnected. The manifold material may be a biocompatible material that is capable of being placed in contact with tissue site and distributing reduced pressure to the tissue site. Examples of manifold materials may include, for example, without limitation, materials that have structural elements arranged to form flow channels, such as, for example, cellular foam, open-cell foam, porous tissue collections, liquids, gels, and foams that include, or cure to include, flow channels.

The manifold material, or medical bolster material, may be porous and may be made from foam, gauze, felted mat, or any other material suited to a particular biological application. In one embodiment, the manifold material is a porous foam and includes a plurality of interconnected cells or pores that act as flow channels. The porous foam may be a polyurethane, open-cell, reticulated foam such as GranuFoam® material manufactured by Kinetic Concepts, Incorporated of San Antonio, Texas. Other embodiments may include "closed cells.

The reticulated pores of the Granufoam® material, that are typically in the range of about <NUM> to <NUM> microns, are helpful in carrying out the manifold function, but other materials may be used. The density of the medical bolster material, e.g., Granufoam® material, is typically in the range of about <NUM> - <NUM> lb/ft<NUM> (<NUM>/m<NUM> - <NUM>/m<NUM>). A material with a higher density (smaller pore size) than Granufoam® material may be desirable in some situations. For example, the Granufoam® material or similar material with a density greater than <NUM> lb/ft<NUM> (<NUM>/m<NUM>) may be used. As another example, the Granufoam® material or similar material with a density greater than <NUM> lb/ft<NUM> (<NUM>/m<NUM>) or <NUM> lb/ft<NUM> (<NUM>/m<NUM>) or even more may be used. The more dense the material is, the higher compressive force that may be generated for a given reduced pressure. If a foam with a density less than the tissue at the tissue site is used as the medical bolster material, a lifting force may be developed.

The medical bolster material may be a reticulated foam that is later felted to thickness of about <NUM>/<NUM> the foam's original thickness. Among the many possible materials, the following materials may be used: Granufoam® material or a Foamex® technical foam (www. In some instances it may be desirable to add ionic silver to the foam in a microbonding process or to add other substances to the medical bolster material such as antimicrobial agents. The medical bolster material may be isotropic or anisotropic depending on the exact orientation of the forces desired during reduced pressure. The medical bolster material could be a bio-absorbable material. A comfort layer of material may be added as well between the medical bolster material and the patient.

The sealing subsystem <NUM> includes an over-drape <NUM>, or drape or sealing member. The over-drape <NUM> may be an elastomeric material or may be any material that provides a fluid seal. "Fluid seal," or "seal," means a seal adequate to hold reduced pressure at a desired site given the particular reduced-pressure subsystem involved. The over-drape <NUM> may, for example, be an impermeable or semi-permeable, elastomeric material. "Elastomeric" means having the properties of an elastomer. Elastomeric material is generally a polymeric material that has rubber-like properties. More specifically, most elastomers have elongation rates greater than <NUM>% and a significant amount of resilience. The resilience of a material refers to the material's ability to recover from an elastic deformation. Examples of elastomers may include, but are not limited to, natural rubbers, polyisoprene, styrene butadiene rubber, chloroprene rubber, polybutadiene, nitrile rubber, butyl rubber, ethylene propylene rubber, ethylene propylene diene monomer, chlorosulfonated polyethylene, polysulfide rubber, polyurethane, EVA film, co-polyester, and silicones. Specific examples of over-drape materials include a silicone drape, <NUM> Tegaderm® drape, acrylic drape such as one available from Avery Dennison, or an incise drape.

The over-drape <NUM> may be coupled to the shaped dressing bolster <NUM>. If coupling is desired, the coupling may occur in many ways. The over-drape <NUM> and shaped dressing bolster <NUM> may be coupled using adhesives, such as an acrylic adhesive, silicone adhesive, hydrogel, hydrocolloid, etc. The over-drape <NUM> and shaped dressing bolster <NUM> may be bonded by using any technique, including without limitation welding (e.g., ultrasonic or RF welding), bonding, adhesives, cements, etc. The over-drape <NUM> and shaped dressing bolster <NUM> may be coupled partially, completely, or not at all. Structure may be added to the bond to make the over-drape <NUM> behave anisotropically in a desired direction, i.e. to make an anisotropic drape material. The anisotropic drape material is configured to move, contract, or expand in a given direction or axis to a greater extent compared to another direction or axis. This behavior is also discussed in connection with <FIG> below. As used herein, the term "coupled" includes coupling via a separate object and includes direct coupling. The term "coupled" also includes two or more components that are continuous with one another by virtue of each of the components being formed from the same piece of material. Also, the term "coupled" may include chemical, such as via a chemical bond, mechanical, thermal, or electrical coupling. Fluid coupling means that fluid is in communication between the designated parts or locations.

In the illustrative embodiment of <FIG>, the over-drape <NUM> may be sized to extend beyond the shaped dressing bolster <NUM> to form a drape extension <NUM>. The drape extension <NUM> has a first surface <NUM> and a second, tissue-facing surface <NUM>. The over-drape <NUM> may be sealed against the epidermis <NUM> of the patient (or against another layer, such as a gasket or an additional sealing member) using a sealing apparatus <NUM> for providing a fluid seal. As used herein, reference to a seal on the patient's epidermis should be deemed to include sealing against another layer, such as a film gasket, which can contact and seal with the patient's epidermis. The fluid seal allows a reduced pressure to be maintained by the reduced-pressure subsystem <NUM>. The sealing apparatus <NUM> may take numerous forms, such as an adhesive <NUM>; a sealing tape, or drape tape or strip; double-side drape tape; paste; hydrocolloid; hydrogel; or other sealing means. If a tape is used, it may be formed of the same material as the over-drape <NUM> with a pre-applied, pressure-sensitive adhesive. The adhesive <NUM> may be applied on the second surface <NUM> of drape extension <NUM>. The adhesive <NUM> provides a substantially fluid seal between the over-drape <NUM> and the epidermis <NUM> of the patient. Before the over-drape <NUM> is secured to the patient, adhesive <NUM> may have removable strips, or releasable backing, covering the adhesive <NUM>. The over-drape <NUM> may be formed as an integral drape or formed by coupled segments or portions.

The reduced-pressure subsystem <NUM> includes a reduced-pressure source <NUM>, or therapy unit. The reduced-pressure source <NUM> may be a vacuum pump, wall suction, or other source. The reduced-pressure source <NUM> provides reduced pressure as a part of the system <NUM>. While the amount and nature of reduced pressure applied to a tissue site will typically vary according to the application, the reduced pressure will typically be between -<NUM> Hg and - <NUM> Hg and more typically between - <NUM> Hg and -<NUM> Hg.

In order to maximize patient mobility and ease, the reduced-pressure source <NUM> may be a battery-powered, single-use reduced-pressure generator. The battery-powered, single-use reduced-pressure generator facilitates application in the operating room and provides mobility and convenience for the patient during the rehabilitation phase. For many procedures, it is believed that the patient would be directed to wear the reduced-pressure system <NUM> for three to five days and may be directed to wear the reduced-pressure system <NUM> for <NUM> days or more. Still, this treatment time can be a time period less than conventional treatments, such as conventional compressive garments, which are often worn for up to six weeks. Accordingly, the battery life or power provisions for such a reduced-pressure source <NUM> may need to accommodate up to <NUM> days of operation. Other sources of reduced pressure may be utilized, such as V. ® therapy unit, which is available from KCI of San Antonio, Texas, or a wall suction unit. The reduced-pressure source <NUM> could also be supplied by a portable mechanical device, such as a piston in a tube, depending on how much leakage there is with the fluid seal between the shaped dressing bolster <NUM> and the epidermis14.

In the illustrative embodiment of <FIG>, the reduced-pressure source <NUM> is shown having a battery compartment <NUM> and a canister region <NUM> with windows <NUM> that allow a visual indication of the level of fluid within canister <NUM>. An interposed membrane filter, such as hydrophobic or oleophobic filter, may be interspersed between a reduced-pressure delivery conduit, or tubing, <NUM> and the reduced-pressure source <NUM>.

The reduced pressure developed by reduced-pressure source <NUM> is delivered through the reduced-pressure delivery conduit <NUM> to a reduced-pressure interface <NUM>, which may be an elbow port <NUM>. In one illustrative embodiment, the elbow port <NUM> is a TRAC® technology port available from KCI of San Antonio, Texas. The reduced-pressure interface <NUM> allows the reduced pressure to be delivered through the sealing subsystem <NUM> and realized within an interior portion of sealing subsystem <NUM>. In this illustrative embodiment, the port <NUM> extends through the over-drape <NUM> and into shaped dressing bolster <NUM>.

In operation, the reduced-pressure system <NUM> may be applied in the operating room after a surgical procedure on the patient or applied elsewhere. The second surface <NUM> of the shaped dressing bolster <NUM>, which may include a comfort layer (see, e.g., <FIG>) would be placed against the patient's epidermis <NUM> with the shaped dressing bolster <NUM> placed over the damaged subcutaneous tissue site <NUM> and with a portion over the incision <NUM>. The dressing assembly <NUM> may be pre-sized for the typical application involved in the procedure performed by a healthcare provider or sized at the time. The dressing assembly <NUM> may be sized, shaped, and configured to work in different anatomical applications such as abdominal, chest, thighs, extremities, etc..

If the over-drape <NUM> has not already been coupled (see other illustrative embodiments) to the shaped dressing bolster <NUM>, the over-drape <NUM> would then be placed over the first surface <NUM> of the shaped dressing bolster <NUM> with an extra portion extending beyond the peripheral edge <NUM> to form the drape extensions <NUM>. The drape extensions <NUM> may then be taped down (see <NUM> in <FIG>) or an adhesive <NUM> (<FIG>) used to form a fluid seal between the over-drape <NUM> and the patient's epidermis <NUM>. The fluid seal need only be adequate to allow the reduced-pressure system <NUM> to hold a reduced pressure at a desired location. The reduced-pressure interface <NUM> would then be applied if not already installed, and the reduced-pressure delivery conduit <NUM> would be coupled at one end. The other end of the reduced-pressure delivery conduit <NUM> would then be coupled to the reduced-pressure source <NUM>. The reduced-pressure source <NUM> may then be activated and a reduced pressure delivered to the shaped dressing bolster <NUM>.

As the pressure is reduced at the shaped dressing bolster <NUM>, the shaped dressing bolster <NUM> compresses and laterally contracts and forms a semi-rigid substrate, or a less-pliable substrate. The reduced pressure is transmitted through the shaped dressing bolster <NUM> so that the reduced pressure is applied to the patient's epidermis <NUM> at the point of the incision <NUM>. At least at the early stages of the healing process and with certain types of wounds, the reduced pressure may be transmitted through the incision <NUM> and into the subcutaneous tissue <NUM> and the reduction of pressure may directly help close defects, such as the subcutaneous void <NUM>, and generally provide stability to the area. The reduced pressure delivered to the shaped dressing bolster <NUM> also develops the compressive force <NUM> that again may provide stability, therapy, and may also close or help close the subcutaneous void <NUM>. The compressive force <NUM> is preferably more than just at the epidermis <NUM>. For example, the compressive force <NUM> can apply a force at the level of the subcutaneous tissue <NUM> or other subdennal anatomy.

As the over-drape <NUM> and shaped dressing bolster <NUM> laterally contract under the influence of the reduced pressure, and as the compressive force acts of the epidermis <NUM>, the net closing force <NUM> develops that may help hold the incision <NUM> closed and may generally provide additional stability to the area. The effective tensile strength of the incision <NUM> may be increased. The closing force <NUM> may rely in part on friction between the shaped dressing bolster <NUM> and the epidermis <NUM> to communicate the closing force to the epidermis <NUM> and may involve force transmission from the drape extension <NUM> to the epidermis <NUM> by way of the adhesive <NUM> or through friction if tape (<NUM> in <FIG>) is used. At the same time, the reduced pressure delivered to and through shaped dressing bolster <NUM> helps to remove any exudates or other fluids from the incision <NUM>. In one aspect, the reduced-pressure system <NUM> inhibits the formation of wrinkles in the epidermis <NUM>. The system <NUM> can deliver an even amount of force to the epidermis <NUM> holding the epidermis <NUM> in a smooth, or non-wrinkled, configuration for healing.

The reduced-pressure system <NUM> may avoid skin irritation, such as blistering of the patient's epidermis <NUM>, which may be due to secondary shear, secondary strain or other effects. To this end, the extremity <NUM> of the shaped dressing bolster <NUM> may be shaped to provide an even distribution of radial, compressive forces. The extremity <NUM> is the outer, shaped portion of the shaped dressing bolster <NUM> and the peripheral edge is generally the most outboard portion of the shaped dressing bolster <NUM> or the most outboard portion that interfaces with patient's skin. The extremity <NUM> may take a number of different shapes to help evenly distribute the compressive forces or otherwise avoid stress risers. The possible shapes for the extremity <NUM> include the following: a chamfered (or angled, beveled, or tapered) surface as shown in <FIG>, an arcuate shape as shown in <FIG>, or other shape that distributes the forces. In contrast, when a bolster with a square-edge is used, a "tent area" may form when an over-drape is applied over the bolster and onto the patient's epidermis. The "tent area" may contribute to skin irritation unless other steps are taken. The shaped dressing bolster <NUM> avoids the "tent area. " The shaped edge, or extremity, of the dressing bolster allows a compressive force to be developed without a big "edge effect"; that is, without causing shear or stress to rise to a level that causes skin irritation, such as erythema or blistering. The shaped portion of the shaped dressing bolster <NUM> gradually distributes the force to avoid irritation. This way of carefully applying the forces to the skin to avoid irritation is generally referred to as "evenly distributing" the compressive force, but is not strictly used in a literal sense. As another precaution against skin irritation, an inner layer may be added between the shaped dressing bolster <NUM> and the patient's epidermis <NUM> (see, e.g., <NUM> in <FIG>) or placed in other locations as explained in connection with other illustrative embodiments further below.

It may be desirable to apply the reduced-pressure system <NUM> in the operating room and allow the reduced-pressure system <NUM> to remain on the patient until adequate healing has taken place. In this regard, it may be desirable to form the over-drape <NUM>, shaped dressing bolster <NUM>, and any other layers from see-through materials to allow the healthcare provider to gain visual cues about the healing of the incision <NUM> and damaged subcutaneous tissue <NUM> without having to remove the dressing assembly <NUM>.

Referring now to <FIG>, another illustrative embodiment of a system <NUM> for treating damaged, or undermined or abnormal, subcutaneous tissue in a patient is presented. The system <NUM> is analogous in most respects to the reduced-pressure system <NUM> and a correlation of parts is generally indicated in this embodiment by indexing the numerals by <NUM> and may not be further referenced. In this particular illustrative embodiment, the system <NUM> is placed over intact epidermis tissue <NUM>, i.e., there is no incision in this instance. There is, however, damaged subcutaneous tissue <NUM> including a subcutaneous void <NUM>. The system <NUM> helps with damaged subcutaneous tissue <NUM> whether or not there is an incision.

While the shaped dressing bolster <NUM> of <FIG> was shown with a trapezoidal cross-section, the shaped dressing bolster <NUM> of <FIG> has a cross-section that is formed with a portion having radiused edges, or having an arcuate cross-section. The arcuate cross-section of the shaped dressing bolster <NUM> is an oval or elliptical shape. The shaped dressing bolster <NUM> may be shaped with a double-beveled cross-section or other shape. As before, the shape of the shaped dressing bolster <NUM> is to facilitate "evenly distributing" the radial, compressive force to an extent that skin irritation is avoided during use of the system <NUM>. An extremity <NUM> of the shaped dressing bolster <NUM> is shown having an elliptical cross section. In the illustrative embodiment of <FIG>, a sealing apparatus <NUM> provides a fluid seal between over-drape <NUM> and epidermis <NUM> of the patient, and, in this instance, is a sealing tape <NUM>.

The developed forces will now be further described. Ambient pressure provides a vertical force <NUM> on a first surface <NUM> of the over-drape <NUM> and contraction of the shaped dressing bolster <NUM> develops a compressive force <NUM> to provide a force that is directed toward the epidermis <NUM> and that reaches to the subcutaneous levels, i.e., to subcutaneous tissue <NUM>. At the same time, a lateral force, or closing force, can be developed. The closing force is transferred to the epidermis through the shaped dressing bolster <NUM>. A force <NUM> is an inward contraction force caused by the shaped dressing bolster <NUM> contracting and compressing. As the shaped dressing bolster <NUM> contracts and compresses, the closing force is transferred to the epidermis <NUM> through the shaped dressing bolster <NUM>. At the same time, for this illustrative embodiment, as the reduced pressure is applied, the over-drape <NUM> is drawn into the area proximate the extremity <NUM> as suggested by arrow <NUM>. Because a drape extension <NUM> is secured to the epidermis <NUM>, the horizontal component of force <NUM> would pull the epidermis inward as is suggested by the inward closing force <NUM>.

Referring now primarily to <FIG>, a system <NUM> for treating tissue, such as damaged subcutaneous tissue <NUM>, is shown on a curved body part <NUM> such as a patient's torso. A dressing assembly <NUM> includes a shaped dressing bolster <NUM>. A sealing subsystem <NUM> includes an over-drape <NUM> and an attachment device <NUM>. A reduced-pressure source (not shown) provides reduced pressure to a reduced-pressure delivery conduit <NUM>, which delivers the reduced pressure to a reduced-pressure interface <NUM>, which in turn delivers the reduced pressure to the shaped dressing bolster <NUM>. As the shaped dressing bolster <NUM> is compressed under the influence of a reduced pressure, a net radial, compressive force <NUM> is developed that is delivered to the subcutaneous tissue <NUM>. The over-drape <NUM> forms a "tent" area around a void <NUM>. Under reduced pressure, the over-drape <NUM> is pulled into the void <NUM> and a force is thereby applied that develops an inward contracting force <NUM>. Alternatively, an extremity of the shaped dressing bolster <NUM> may be shaped to avoid the tent area or the over-drape may be attached to the extremity of the shaped dressing bolster <NUM>.

In the embodiment of <FIG>, the curvature of the shaped dressing bolster <NUM> also helps develop the compressive force. A first surface <NUM> of shaped dressing bolster <NUM> has a greater surface area than a surface area of a second, inward-facing surface <NUM> of the shaped dressing bolster <NUM>, and under reduced pressure this difference in surface area also facilitates the development of the net compressive force <NUM>.

Referring now primarily to <FIG>, an illustrative system <NUM> is presented. The system <NUM> is generally analogous in most respects to that of the system <NUM> of <FIG> and analogous parts are indicated by indexing the reference numerals of <FIG> by <NUM> and may not be further mentioned. The system <NUM> shows a circumferential dressing assembly <NUM>, which in this illustrative embodiment completely extends around a circumference of a torso. Circumferential forces are developed during the application of reduced pressure and combine in the system <NUM> to develop the net radial, compressive force <NUM>. The compressive force <NUM> can be relatively higher than a flat or partial-torso application because there is no off-loading of force to the drape and to the epidermis.

Referring now primarily to <FIG>, another illustrative embodiment of a dressing assembly <NUM> is presented. The dressing assembly <NUM> has a shaped dressing bolster <NUM> with a first surface <NUM> and a second, inward-facing (skin-facing or patient-facing) surface <NUM>. In this illustrative embodiment, the shaped dressing bolster <NUM> has been formed with an oblique extremity <NUM>, and in particular with a trapezoidal cross-section in two orthogonal planes, such as orthogonal planes <NUM> and <NUM>. A cross-section along one such plane of the dressing assembly <NUM> is shown in <FIG>. The peripheral edge <NUM> of the shaped dressing bolster <NUM> is formed with an angle alpha (α) between a vertical (for the orientation shown), or normal, reference line <NUM> and a surface extension line (in cross-section) <NUM>. The angle alpha (α) would typically be between <NUM> degrees and <NUM> degrees, and more typically between <NUM> and <NUM> degrees, and more typically still about <NUM> degrees.

An over-drape <NUM> is placed over the shaped dressing bolster <NUM>. The over-drape <NUM> extends beyond a peripheral edge <NUM> to form drape extensions <NUM>, each having a first side <NUM> and a second, inward-facing surface <NUM>. The over-drape <NUM> may be coupled using any of a number of devices or techniques, such as with adhesives and bonding as previously mentioned. In this illustrative embodiment, the over-drape <NUM> is coupled by a bond <NUM> to an exterior <NUM> of the peripheral edge <NUM>. The over-drape <NUM> may also be coupled to an exterior surface <NUM> of the first surface <NUM> of the shaped dressing bolster <NUM>. In this illustrative embodiment, the over-drape <NUM> may be coupled, at least partially, to substantially all of the exterior surfaces of the shaped dressing bolster <NUM>, except the surface facing the patient. When the over-drape <NUM> is coupled to substantially all the exterior surfaces of the shaped dressing bolster <NUM> except the inward-facing surface, the peripheral edge <NUM> may be shaped to have right angles and yet avoid skin irritation because no "tent area" can form. Otherwise, the edge <NUM> is shaped to be other than at a right angle. Alternatively, a layer may be added to help minimize skin irritation.

As shown in <FIG>, a reduced-pressure delivery conduit <NUM>, which is part of a reduced-pressure subsystem, can be used to supply reduced pressure to a reduced-pressure interface <NUM> that delivers reduced pressure into the shaped dressing bolster <NUM>. The reduced-pressure interface <NUM> may be a port <NUM> or a direct application into the bolster <NUM> or other device.

Referring now primarily to <FIG>, another illustrative embodiment of a dressing assembly <NUM> is presented. The dressing assembly <NUM> has a shaped dressing bolster <NUM> formed to have a rectangular cross-section. In this instance, an over-drape <NUM> is coupled, such as by bonding with bond <NUM>, to an exterior surface <NUM> of a peripheral edge <NUM> and to a first surface <NUM> of the shaped dressing bolster <NUM>. The bond <NUM> may facilitate more even application of the radial, compressive force to the patient even though the shaped dressing bolster <NUM> is shaped with right angles. While the coupling is shown as complete along the exterior <NUM> of the peripheral edge <NUM> and on an exterior surface <NUM> of the first surface <NUM>, the coupled portion may be partial or accomplished with tacking.

Referring now primarily to <FIG>, another illustrative embodiment of a dressing assembly <NUM> is presented. The dressing assembly <NUM> has a shaped dressing bolster <NUM> that is formed to have an arcuate cross-section, which, in this instance, is an elliptical or oval cross-section. As such, the peripheral edge <NUM> has a radius or curved shape. The over-drape <NUM> may be coupled by bonding <NUM> on an exterior surface <NUM> of the peripheral edge <NUM> and on an exterior surface <NUM> of a first surface <NUM> of the shaped dressing bolster <NUM>. The elliptical cross-section may exist in two different orthogonal planes.

Referring now primarily to <FIG>, an illustrative embodiment of a medical bolster material <NUM> is presented with reference to a first axis <NUM>, a second axis <NUM>, and a third axis <NUM>. The medical bolster material <NUM> may be used for any of the shaped dressing bolsters previously mentioned. While in many applications, the medical bolster material <NUM> may be isotropic, in other applications it may be desirable to have an anisotropic material like the medical bolster material <NUM>.

Anisotrophy is generally the property of being directionally dependent, as opposed to isotropy, which means homogeneity in all directions. For example, if it is desirable to produce a stronger force that opposes gravity that is applied to an exterior of a patient, anisotropic material may be used so that when net circumferential force is developed along the first axis <NUM>, a greater movement is developed along the vertical axis-in this instance the third axis <NUM> for the orientation shown. In still other instances, it may be desirable to also have a different performance in the direction of the second axis <NUM>. The anisotropic material may be formed by adding filaments in a first direction. The anisotropic material may also be formed by felting (heat compression) of the material to make lines of differing densities. The anisotropic material may also be formed by using an adhesive that imparts strength in a given direction.

Referring now primarily to <FIG>, a portion of an illustrative embodiment of a system <NUM> for treating tissue, such as damaged subcutaneous tissue, is shown. The system <NUM> includes a shaped dressing bolster <NUM>, a sealing subsystem <NUM>, and a reduced-pressure subsystem <NUM> for which only a portion is shown. The shaped dressing bolster <NUM> may be part of a dressing assembly <NUM> that includes a breathable dry layer <NUM> having a first surface <NUM> and a second, inward-facing surface <NUM>. The dressing assembly <NUM> also may include a non-breathable layer <NUM>, which has a first surface <NUM> and a second, inward-facing surface <NUM>. The sealing subsystem <NUM> includes an over-drape <NUM> similar to the previously discussed embodiments and an attachment device <NUM>.

A number of materials are possible for the various layers <NUM>, <NUM>, <NUM>. The breathable dry layer <NUM> may be formed, for example, from a hydrophilic non-woven material that allows fluids to flow into the shaped dressing bolster <NUM>. The breathable dry layer <NUM> may be a comfort layer that helps avoid skin irritation or otherwise enhances comfort. The shaped dressing bolster <NUM> may be formed from a relatively thin absorbent structure or material that can store relatively large quantities of fluid. For example, the shaped dressing bolster <NUM> may be formed from a superabsorbent polymer (SAP) of the type often referred to as "hydrogels," "super-absorbents," or "hydrocolloids. " The shaped dressing bolster <NUM> may also be formed from any of the previously mentioned manifold materials. The non-breathable layer <NUM> may be formed from a number of different materials, e.g., a polyethylene film that will keep fluids from leaking out. Additional substrates may be added. The various layers <NUM>, <NUM>, <NUM> may be sealed or combined with adhesives such as a hot melt adhesive or heat bonded or coupled using any technique or device.

In operation, as fluid is added to the shaped dressing bolster <NUM>, the shaped dressing bolster <NUM> becomes more rigid (less pliable), and under reduced pressure, this results in an increased radial, compressive force, such as radial force <NUM> in <FIG>. The fluid may come in the form of exudates or other fluids from the wound or may be a supplied fluid such as a saline that is intentionally added through a second port, second lumen, or by injecting through the dressing assembly in an injection port. In this sense, the shaped dressing bolster <NUM> may be regarded as a liquid-controlled bolster since additional liquid can be added to make the shaped dressing bolster <NUM> more rigid (less pliable) and that results in a greater force.

Still referring to <FIG>, an alternative illustrative embodiment of the dressing assembly <NUM> is presented by describing other possible elements. In this illustrative embodiment, the bolster includes two members: a first bolster layer <NUM>, which is formed from a hydrophilic foam, and a second bolster layer <NUM>, which is formed from a hydrophobic foam. The over-drape <NUM> is then placed over a first surface (top surface for orientation shown) of the second bolster layer <NUM>. Other layers of various materials may be added as well.

Referring now primarily to <FIG>, an illustrative embodiment of a dressing assembly <NUM> for use with a system for treating tissue, e.g., damaged subcutaneous tissue, is presented. The dressing assembly <NUM> includes a shaped dressing bolster <NUM> and an over-drape <NUM>, which are generally analogous to those presented in other embodiments herein. A sealing subsystem <NUM> includes the over-drape <NUM> that extends beyond the shaped dressing bolster <NUM> to form drape extensions <NUM>, which have a first surface <NUM> and a second, inward-facing side, <NUM>. A sealing apparatus <NUM> may be used to provide a seal between the drape extension <NUM> and the patient's epidermis <NUM>. In this illustrative embodiment, the sealing apparatus <NUM> is an adhesive <NUM>, which is placed on the surface facing the patient. The adhesive <NUM> may initially be covered with a covering, or releasable backing, that may be peeled off before the dressing assembly <NUM> is applied to a patient's epidermis <NUM>. The dressing assembly <NUM> shows the addition of an inner layer <NUM> having a first surface <NUM> and a second, inward-facing surface <NUM>. The inner layer <NUM> is formed with a treatment-area aperture <NUM>.

The inner layer <NUM> may help reduce or eliminate skin irritation that may result between the shaped dressing bolster <NUM> and the patient's epidermis <NUM>. The inner layer <NUM> may be an acrylic drape material such as an Avery® brand Acrylic drape, a Scapa brand Silicone drape, or another suitable material. The inner layer <NUM> is placed around a perimeter of the second surface <NUM> of the shaped dressing bolster <NUM> where the shaped dressing bolster <NUM> would otherwise interface's with the patient's skin. The inner layer <NUM> and the over-drape <NUM> encapsulate the shaped dressing bolster <NUM>, except for the treatment area aperture <NUM>. An adhesive may be applied on the second surface <NUM> of the inner layer <NUM> to promote a splinting effect over an area where the shaped dressing bolster's <NUM> interaction with the epidermis ends and the over-drape's <NUM> interaction with the epidermis begins. This arrangement may help to prevent blistering due to high concentrations of shear stress and strain when the reduced pressure is applied because the adhesive is believed to help deter the epidermis from rolling or balling up and forming a pressure point or pressure rise.

Referring now primarily to <FIG>, an illustrative embodiment of a dressing assembly <NUM> is shown in an exploded view. The dressing assembly <NUM> has a shaped dressing bolster <NUM>, an inner layer <NUM>, and an over-drape <NUM>. The inner layer <NUM> has a first surface <NUM>, a second, inward-facing surface <NUM>, and is formed with a treatment-area aperture <NUM>. The shaped dressing bolster <NUM> is an example of a shaped dressing bolster <NUM> having an oblique surface (peripheral edge <NUM> is formed with angle to a vertical axis) and thus, in this instance, forms a trapezoidal cross-section in at least two orthogonal planes. The shaped dressing bolster <NUM> has a first surface <NUM> and a second, inward-facing surface <NUM>. The over-drape <NUM> has a first surface <NUM> and a second, inward-facing surface <NUM>.

The inner layer <NUM> may be used in a number of ways to address the potential for skin irritation. In one illustrative embodiment, the second surface <NUM> of the shaped dressing bolster <NUM> is coupled to the first surface <NUM> of the inner layer <NUM>. In another illustrative embodiment, no adhesive or other attachment device is used between the shaped dressing bolster <NUM> and the inner layer <NUM> so as to allow relative movement between the shaped dressing bolster <NUM> and the inner layer <NUM>. Similarly, the second surface <NUM> of the over-drape <NUM> may be coupled to the first surface <NUM> of the shaped dressing bolster <NUM>. In an alternative embodiment, there may be no attachment device between surfaces <NUM> and <NUM>.

Still another illustrative embodiment involves coupling all the exterior surfaces of the shaped dressing bolster <NUM> to the over-drape <NUM>, except the second, inward-facing surface <NUM> of the shaped dressing bolster <NUM>. An adhesive or other attachment device may be used to couple the first surface <NUM> of die inner layer <NUM> to the second surface <NUM> of the shaped dressing bolster <NUM>. No adhesive or attachment device is administered on the second surface <NUM> and so skin irritation may be reduced because the relatively low friction surface of the inner layer <NUM> is allowed to slide relative to the skin. Alternatively, an adhesive or other attachment device may be applied on the second surface <NUM> of the inner layer <NUM> to hold the inner layer <NUM> to the epidermis, but not between the shaped dressing bolster <NUM> and the inner layer <NUM> so as to allow lower-friction movement between the shaped dressing bolster <NUM> and the inner layer <NUM>.

In yet another alternative of this illustrative embodiment, an adhesive or other adhesive device may be applied between the second surface <NUM> of the shaped dressing bolster <NUM> and the first surface <NUM> of the inner layer <NUM> and between the second surface <NUM> of the inner <NUM> and the patient's epidermis. With this alternative, a splinting effect is achieved in the area where the interaction of the shaped dressing bolster <NUM> with the epidermis ends and the inner layer's <NUM> interaction with the epidermis begins. This arrangement helps to prevent blistering due to high concentrations of shear stress and strain placed in that location when reduced pressure is applied. The adhesive or attachment device is believed to prevent the epidermis from rolling or balling up and forming a pressure point or pressure rise. The inner layer <NUM> configurations may be used on any of the illustrative embodiments presented as well as others.

Referring now primarily to <FIG> and <FIG>, an illustrative embodiment of a dressing assembly <NUM> is presented. The dressing assembly <NUM> has a shaped dressing bolster <NUM> with a first surface <NUM> and a second surface <NUM>. An extremity <NUM> of the shaped dressing bolster <NUM> is angled in this illustrative embodiment. An inner layer <NUM> is provided having a first surface <NUM> and a second, inward-facing surface <NUM>, but in this instance, the second surface <NUM> is placed adjacent to the peripheral edge <NUM> of the shaped dressing bolster <NUM>. The inner layer <NUM> is formed with a central aperture <NUM>. The inner layer <NUM> and a portion of shaped dressing bolster <NUM> are covered with an over-drape <NUM>. Adhesive or another attachment device may be used between the first surface <NUM> of the inner layer <NUM> and second surface <NUM> of the over-drape <NUM> or between the second surface <NUM> of the inner drape <NUM> and the first surface <NUM> of the shaped dressing bolster <NUM>.

Referring now primarily to <FIG>, a portion of a system <NUM> for treating a linear wound, area wound, other wound, or graft is presented. The portion of the system <NUM> is presented in <FIG> in a pre-deployment state.

The system <NUM> includes a dressing assembly <NUM>, which includes a shaped dressing bolster <NUM>. The shaped dressing bolster <NUM> has a first side <NUM> and a second, inward-facing side <NUM>. The shaped dressing bolster <NUM> may be formed from any medical bolster material as previously discussed with other embodiments. A comfort layer <NUM>, which has a first side <NUM> and a second, inward-facing side <NUM>, may be coupled, e.g., by a heat bond <NUM> or any other technique, to the second side <NUM> of the shaped dressing bolster <NUM>.

The comfort layer <NUM> may be any material that helps prevent skin irritation and discomfort while allowing fluid transmission through the comfort layer <NUM>. As one non-limiting example, a woven, elastic material may be used or a polyester knit textile substrate. As another non-limiting example, an InterDry™ textile material from Milliken Chemical of Spartanburg, South Carolina, may be used. The comfort layer <NUM> may include anti-microbial substances, such as silver. The comfort layer may be made like the breathable, dry layer <NUM> of <FIG>.

In one embodiment, the shaped dressing bolster <NUM> may include a plurality of flexibility notches <NUM>. The flexibility notches <NUM> may be lateral notches, or lateral cuts, in the shaped dressing bolster <NUM> as shown and, in addition or alternatively, may be one or more longitudinal notches, or longitudinal cuts, or other cuts. The cuts may be made using a saw (or notched blade), a hot knife, or other device. The flexibility notches <NUM> enhance flexibility of the shaped dressing bolster <NUM>. The enhanced flexibility may be particularly useful when the dressing assembly <NUM> is applied over a patient's joint or other area of movement. For example, if the shaped dressing bolster <NUM> is used on a knee, the shaped dressing bolster <NUM> may need to flex or extend as much as <NUM> % or more, and the flexibility notches <NUM> or ridges help provide the desired flexibility. In addition, a plurality of folds <NUM> may be added to facilitate movement as described further below.

In one illustrative embodiment, the shaped dressing bolster <NUM> is manufactured as follows. A block of Granufoam® material, e.g., <NUM> meter x <NUM> meter x <NUM> meter block, is cut to have a <NUM> height, and a saw is used to form lateral grooves, or lateral flexibility notches <NUM>. Then, a dry layer, which may be the comfort layer <NUM>, is laminated onto the second, or bottom, surface. Then, the foam block is cut using a die cut to form the individual shaped dressing bolsters <NUM>.

A sealing subsystem <NUM> provides a fluid seal over the dressing assembly <NUM> and at least a portion of the patient's epidermis. The sealing subsystem <NUM><NUM> includes an over-drape <NUM>, which may be formed with a first over-drape portion <NUM> and a second over-drape portion <NUM>. The first over-drape portion <NUM> extends over the first side <NUM> of the shaped dressing bolster <NUM> and extends further to form a drape flange, or drape extension <NUM>, which has a first side <NUM> and a second, inward-facing side (not explicitly shown). An aperture <NUM> is formed on a portion of the first over-drape <NUM>. The aperture <NUM> is for allowing fluid communication with a reduced-pressure interface (e.g., reduced-pressure interface <NUM> in <FIG>).

The second, inward-facing side of the drape extension <NUM> is placed on a first side <NUM> of the second over-drape portion <NUM> and coupled, such as by an adhesive, bond <NUM>, other coupling technique or device, such as those previously mentioned. The first drape portion <NUM> may include the plurality of folds <NUM>, or bellows. The folds <NUM> allow the first drape portion <NUM> to expand if needed. For example, if the dressing assembly <NUM> is used on a joint, when the joint is flexed, the drape portion <NUM> is extended using the folds <NUM>. Additional drape material may be released from the folds <NUM> to facilitate movement. The second, inward-facing side of the second drape portion <NUM> may have an adhesive on a portion and may have a treatment area aperture (see by analogy treatment area aperture <NUM> in <FIG>). The folds <NUM> may also be formed as ridges that in cross section would appear as accordion-like ridges that flatten out when stretched and thereby provide additional material.

One or more release members <NUM> may be releasably coupled to the first side <NUM> of the second drape portion <NUM>. Four release members <NUM> are shown in the illustrative embodiment of <FIG>. The release members <NUM> provide stiffness and help during deployment of the dressing assembly <NUM>. The release members <NUM> are typically either casting paper or a film held on the first side <NUM> of the second drape portion <NUM>.

Referring now primarily to <FIG>, an exploded perspective view of a portion of a system <NUM> for treating tissue, e.g., subcutaneous tissue, a linear wound, area wound, other wound, or graft is presented. The portion of the system <NUM> presented in <FIG> is shown in a pre-deployment state and in an exploded view. The system <NUM> is analogous in most respects to the system <NUM> of <FIG>, and to indicate corresponding parts, the reference numerals have been indexed by <NUM> and may not be further mentioned. The system <NUM> includes a dressing assembly <NUM>, which includes a shaped dressing bolster <NUM>. The shaped dressing bolster <NUM> is the same as shaped dressing bolster <NUM>, but the flexibility notches <NUM> are both lateral and longitudinal.

The first side <NUM> of the shaped dressing bolster <NUM> is covered by an over-drape <NUM>, which may include a first drape portion <NUM> and a second drape portion <NUM>. The first drape portion <NUM> includes folds <NUM> and an aperture <NUM>. The second drape portion <NUM> is formed with a treatment area aperture <NUM> that provides an opening for at least a portion of the shaped dressing bolster <NUM> (or a comfort layer) to be directly against a patient's epidermis or treatment site. The second drape portion <NUM> has first side <NUM> and has an adhesive <NUM> applied on a portion of the first side <NUM>. The adhesive <NUM> is used primarily during manufacture to hold the shaped dressing bolster <NUM> against the second drape portion <NUM> during assembly and also used to help hold the shaped dressing bolster <NUM> during use. Before applying the shaped dressing bolster <NUM> against the adhesive <NUM>, the adhesive <NUM> is covered by a center releaseable member <NUM>. Outboard of the adhesive <NUM> on the first side <NUM> are releaseable members <NUM> that provides stiffness to the over-drape <NUM> during deployment.

The second, inward-facing side (not explicitly shown but opposite side of the first side <NUM>) of the second drape portion <NUM> may be covered with an adhesive. In the pre-deployment state, this adhesive is covered by a bottom release member <NUM> and side release members <NUM>.

Once assembled, the portion of the system <NUM> resembles the portion of the system <NUM> of <FIG>. The use and design may vary, but in one illustrative embodiment, the portion of the system <NUM> may deployed as will be described. The bottom release liner <NUM> is removed and the exposed adhesive on the second, inward-facing side of the second drape portion <NUM> is placed against a portion of the patient's epidermis beginning at one end and may be placed over a linear wound. After smoothly applying the second drape portion <NUM>, the side release members <NUM> are removed. The release members <NUM> on the first side <NUM> of the over-drape <NUM> are removed. A reduced-pressure interface is coupled to the aperture <NUM> in the first over-drape portion <NUM>. The center release member <NUM> was already removed during manufacture.

With respect to manufacturing the systems and components described above, the components and their assembly have been presented. In applying and coupling an over-drape to the first surface of a shaped dressing bolster, it may be desirable to utilize a press to remove any wrinkles that may otherwise result or remain. The medical bolster material of the shaped dressing assembly may be cut using a die cut or by hand with a router.

According to another illustrative embodiment, a reduced-pressure system for treating a tissue site includes a directed-force member, which has a non-orthogonal edge, e.g., a curved edge, a slanted or angled edged, or an edge with a portion of a drape adhered to the edge, for evenly distributing a force when placed under reduced-pressure. The directed-force member may be formed as a foam member with a plurality of channels for transmitting a fluid. The reduced-pressure system further includes the drape for providing a fluid seal over at least a portion of the directed-force member and a patient's epidermis. The system also may have a reduced-pressure conduit for fluidly coupling a reduced-pressure source and the directed-force member. In one illustrative embodiment, the directed-force member is a foam member with a tapered edge. When reduced-pressure is delivered by the reduced-pressure source to an interior portion through the drape, the reduced pressure causes the directed-force member to exert a force. The force may include a vertical force against a patient's epidermis or other tissue that may penetrate to more than <NUM> millimeter, more than <NUM> millimeters, more than <NUM> millimeters, more than <NUM> millimeters, more than <NUM> millimeters, more than <NUM> millimeters, and even deeper. The vertical force may help approximate dead space and voids. The force may be or include a closing force.

According to another illustrative embodiment, a reduced-pressure, force-generating dressing assembly includes a directed-force member that has an oblique edge for evenly distributing a force when placed under reduced-pressure. The directed-force member has a top side and a bottom side. The directed-force member is formed from a medical bolster material, which has a plurality of channels. The flow channels may be interconnected, e.g., a foam. The dressing assembly may further include a drape for providing a fluid seal over at least a portion of the directed-force member and a patient's epidermis. The directed-force member may have an angled extremity. Alternatively, the directed-force member may have an arcuate extremity. The dressing assembly may also have a comfort layer coupled to the bottom side of the directed-force member. The comfort layer may be a breathable dry layer coupled to the bottom side of the directed-force member or any other material that helps to avoid maceration of the skin or skin irritation of any kind.

Claim 1:
A method of manufacturing a dressing assembly (<NUM>) comprising a shaped dressing bolster (<NUM>) for use with a reduced pressure treatment system (<NUM>), the method comprising the steps of:
providing a medical bolster material;
forming a shaped dressing bolster (<NUM>) having a first surface (<NUM>) and a second, inward-facing surface (<NUM>), wherein the shaped dressing bolster (<NUM>) is formed from the medical bolster material and has a comfort layer (<NUM>) coupled to the second, inward facing surface (<NUM>);
wherein the shaped dressing bolster (<NUM>) is operable to distribute reduced pressure and to evenly distribute a radial, compressive force;
wherein the step of forming the shaped dressing bolster (<NUM>) comprises forming the shaped dressing bolster (<NUM>) with an oblique extremity; and
wherein the step of forming the shaped dressing bolster (<NUM>) comprises:
providing a block of reticulated foam having a density greater than <NUM>/m<NUM>;
cutting the block of reticulated foam to a desired height;
laminating the comfort layer (<NUM>) to the block of reticulated foam; and
cutting the block of reticulated foam with a die or by hand with a router to form the shaped dressing bolster (<NUM>).