# Patent

## Title
Negative pressure wound treatment dressing

## Abstract

A wound treatment dressing for applying negative pressure wound therapy to a wound on an extremity, such as on the heel of a foot. The dressing includes a fluid manifold positioned within a fenestrated drape to form a contoured occlusive wrapping. A contoured porous pad is placed adjacent or within the wound, and is covered by the occlusive wrapping. Flexible tubing is attached to or through a port to allow fluid communication of negative pressure to the contoured pad from a source of negative pressure. The negative pressure is communicated from the source, through the tube, through the fluid manifold, and through the fenestrations of the occlusive wrapping, to the wound. The fluid manifold conducts the negative pressure from a position away from the wound site to the contoured pad at the wound site.

## Background
This application claims the benefit under Title 35 U.S.C. §119(e) of U.S. Provisional Patent Application No. 60/489,344 filed under 37 C.F.R. 1.53(b)(2) on Jul. 22, 2003.


FIELD OF THE INVENTION
This invention relates to the treatment of open, chronic wounds, as well as burns and skin grafts. More specifically this invention relates to dressings for the treatment of wounds to the extremities, such as the heel of a human foot, by means of negative pressure wound therapy.
BACKGROUND OF THE INVENTION
Negative pressure wound therapy has been utilized for the treatment of open wounds and has been commercialized by Kinetic Concepts, Inc. of San Antonio, Tex., by its proprietary V.A.C.® product line. In practice, the application to a wound of negative gauge pressure, as commercialized by Kinetic Concepts, Inc. under the designation “VACUUM ASSISTED CLOSURE” (or “V.A.C.”) therapy, typically involves the mechanical-like contraction of the wound with simultaneous removal of excess fluid, which is often accomplished by means of a polymer foam and occlusive drape dressing in fluid communication with a negative pressure source. In this manner, negative pressure wound therapy augments the body's natural inflammatory process while alleviating many of the known intrinsic side effects, such as the production of edema caused by increased blood flow absent the necessary vascular structure for proper venous return. As a result, negative pressure wound therapy has been highly successful in the promotion of wound closure, healing many wounds previously thought largely untreatable.
Many of these wounds include decubitus and venous stasis ulcers to the lower extremities, especially the foot. Closure of these wounds has been difficult and often times impossible using traditional techniques, such as skin grafting, sharp debridement, or combinations thereof. Failure to close these wounds, which have often been present for several years, can lead to necrotizing of the tissue, and in many cases amputation of the extremity. Use of negative pressure wound therapy has proven highly successful in closing these wounds. However, treatment of the lower extremities with negative pressure wound therapy, especially to wounds of the foot and heel can be difficult, especially considering the nature of the location of the wound. Particular concern arises with maintaining the dressing on the extremity, especially in light of the frequent movement of the foot, and friction often associated with foot coverings, including socks, stockings, and shoes. Of particular concern, is the ability to maintain a negative pressure at the wound site when the dressing is in place, as air leaks may occur during movement of the foot, which can adversely affect the therapy being administered.
For the foregoing reasons, there is a need for a negative pressure wound treatment dressing system that is capable of maintaining a negative pressure over an extremity that has heretofore been difficult to treat using traditional negative pressure wound therapy dressings. Additionally, there is a need for a negative pressure wound treatment dressing system that is capable of maintaining a negative pressure over a wound which exists in a highly contoured part of the body, or a portion of the body that undergoes frequent movement or friction against clothing or other outside forces.
It is therefore an object of the present invention to provide a negative pressure wound treatment dressing system that provides a means for maintaining a negative pressure over a contoured extremity, such as the foot, and more specifically the heel of the foot.
SUMMARY
In accordance with the foregoing objects, the present invention generally comprises a fenestrated and contoured occlusive wrapping having a fluid manifold, a receiving site, fluid communicator arms extending from the receiving site, and an occlusive drape enclosing the fluid manifold. The occlusive drape generally includes a wound facing inner drape and an outward facing outer drape, and an aperture substantially aligned with the receiving site. A concave porous pad is placed adjacent or within a wound on an extremity, such as the heel of a foot, and is covered by the occlusive drape. Flexible tubing may be attached to or through the aperture, so as to allow for fluid communication of negative pressure to the porous pad from a source of negative pressure connected to an opposite end of the flexible tubing. The negative gauge pressure is communicated from the source, through the tube, through the fluid manifold in the occlusive drape, and through fenestrations in the occlusive drape, such that negative gauge pressure is applied to the wound. The fluid manifold serves to conduct the negative pressure from a position away from the wound site to the contoured porous pad at the wound site. Such an arrangement allows for the tubing to connect to the occlusive drape of the present invention at a position least likely to be dislodged during normal ambulation of the patient.
Attachment means are formed on the outer edges of the occlusive drape to form an airtight seal over the wound. Such attachment means may be an adhesive coated on the occlusive drape for attachment to an intact area of tissue or skin. The adhesive is coated on the perimeter edge of the occlusive drape such that a pouch is formed when the occlusive drape is secured over the porous pad.
A collection canister is provided between the negative pressure source and the occlusive drape for collecting any effluents that may be drawn from the wound during application of negative pressure.
The tubing is connected to the occlusive wrapping and pad through an aperture in the outer layer of the wrapping, or through a flanged tubing connector as has been described in U.S. Pat. No. 6,345,623, entitled “Surgical drape and suction head for wound treatment,” to Heaton, et al., the disclosure of which is incorporated herein by reference as though fully set forth. Alternative embodiments allow the tubing to be placed within or embedded in the fluid manifold.
The foregoing has outlined some of the more pertinent objects of the present invention. These objects should be construed to be merely illustrative of some of the more prominent features and applications of the invention. Many other beneficial results can be attained by applying the disclosed invention in a different manner or by modifying the invention as will be described. Accordingly, other objects and a fuller understanding of the invention may be had by referring to the following Detailed Description of the Invention, which includes the preferred embodiment.



BRIEF DESCRIPTION OF THE DRAWINGS
These and other features and advantages of the invention will now be described with reference to the drawings of certain preferred embodiments, which are intended to illustrate and not to limit the invention, and wherein like reference numbers refer to like components, and in which:
FIG. 1A, is an exploded view of the occlusive wrapping of the present invention.
FIG. 1B is an orthogonal front view of the assembled occlusive wrapping of FIG. 1A, shown partly in section.
FIG. 2 is an orthogonal front view of a fluid manifold of FIG. 1A.
FIG. 3A is a perspective view of a contoured porous pad of the present invention.
FIGS. 3B and 3C are cross-sectional views of the contoured porous pad of FIG. 3A taken along section lines 3B-3B and 3C-3C, respectively, in FIG. 3D.
FIG. 3D is a top plan view of the contoured porous pad of FIG. 3A.
FIGS. 4A-4G are perspective views of the negative pressure wound treatment dressing system, illustrating the steps of applying the dressing system to a wound on the heel of a foot.
FIG. 5 is an orthogonal side view of the occlusive wrapping of FIG. 1B folded along its center line.



DETAILED DESCRIPTION
Although those of ordinary skill in the art will readily recognize many alternative embodiments, especially in light of the illustrations provided herein, this detailed description is exemplary of the preferred embodiment of the present invention as well as alternate embodiments, the scope of which is limited only by the claims that may be drawn hereto.
The details of the preferred embodiments of present invention are graphically and schematically illustrated in the accompanying drawings. Like elements in the drawings are represented by like numbers, and any similar elements are represented by like numbers with a different lower case suffix.
Referring now to FIGS. 1A and 1B in particular, there is illustrated the primary components of the occlusive wrapping 10 of the negative pressure dressing system that operates in accordance with the present invention. The occlusive wrapping 10 includes of a fluid manifold 14 enclosed within inner drape 16a and an outer drape 16b. Each of these drapes 16a and 16b are preferably made of a clear vapor permeable polyurethane material. The wound facing layer of inner drape 16a and the outward facing layer of outer drape 16b are sealed along their periphery to secure the fluid manifold 14 between the inner drape 16a and the outer drape 16b. Inner drape 16a includes fenestrations 19 in a wound contact region 17, so as to allow for fluid communication through the inner drape 16a to the fluid manifold 14. Outer drape 16b includes an aperture 16c substantially aligned with receiving site 20, through which tubing may fluidly communicate with the receiving site 20 of the fluid manifold 14, so as to allow for fluid communication of negative pressure to a porous pad from a source of negative pressure connected to an opposite end of the tubing (as shown in FIG. 4G). The fluid manifold 14 illustrated in FIG. 1A provides an extension region 21 and fluid communicator arms 22 that allows for attachment of a fluid communication port (not shown) at a position away from the wound site. The type of wounds desired to be treated by the present system are often situated at a position that has, at times, been difficult to maintain a reduced pressure using traditional negative pressure wound therapy techniques described herein. The occlusive wrapping 10 of the present invention overcomes this difficulty by communicating the negative pressure along the fluid manifold 14 of the occlusive wrapping 10. FIG. 1B shows essentially the same components of the occlusive wrapping 10 as shown in FIG. 1A. In this view of FIG. 1B from the wound side of the wrapping, wound contact region 17 on inner drape 16a (shown partly in section) is shown to be bordered by portions of outer drape 16b covered over with removable liner components 35, as well as second removable liner 37. Protective liner 36 (only minimally exposed in this view by partial section of inner drape 16a and outer drape 16b) supports outer drape 16b of occlusive wrapping 10.
FIG. 2 illustrates the fluid manifold 14. As described above, the fluid communication port (not shown) of the overall system is adapted to be attached to a receiving site 20 of the manifold 14. The receiving site 20 is most preferably a circular shaped foam section of the manifold 14 that is approximately the size of the fluid communication port. Fluid communicator arms 22 extend distally from the receiving site 20 area of the fluid manifold 14 into the wound contact regions 17. In the embodiment illustrated in FIG. 2, the extension region 21 is interposed between the receiving site 20 and the fluid communicator arms. The fluid communicator arms 22 in a first embodiment terminate in loops 24, having openings for viewing the wound perimeter when, as in the preferred embodiment, inner and outer drapes 16a and 16b comprise a transparent material. In an alternative embodiment (not shown), fluid communicator arms 22 may terminate in fingers that extend distally from the fluid communicator arms 22 without forming loops.
A contoured pad 26 as illustrated in FIGS. 3A-3D is utilized as a wound contact screen to prevent unwanted adhesions, direct fluid away from the wound through pores within the pad 26, and exert contracting forces on the wound margins as negative pressure is applied through the manifold 14 and to the pad 26. The contoured pad 26 and fluid manifold 14 of the occlusive wrapping 10 are preferably made of a porous polymer foam material, such as polyurethane or polyvinyl alcohol foam. The pad 26 is preferably constructed into an elliptical shape as illustrated in FIG. 3D, but may also be more symmetrically circular to accommodate more uniform wounds.
In practice, the contoured pad 26 is trimmed to the areal dimensions of the wound and is placed in the wound, which may be on the heel of a foot, and between the wound and the fluid manifold 14, as illustrated in FIGS. 4A-4G. The pad 26 may be secured to the wound site by an adhesive strip 28, as shown in FIG. 4A, or by other means known in the art. In the preferred embodiment, the adhesive strip is constructed of the same vapor permeable polyurethane material as the inner and outer drapes 16a and 16b of the occlusive wrapping 10 having an adhesive coated on one side for securing the strip to the pad 26 and the intact skin surrounding the wound.
The occlusive wrapping 10 forms a pouch 30 when it is folded along its centerline and the lower edges 31 are bonded together at 33 as shown in FIG. 5. In practice, the pouch 30 is placed over the wound and contoured pad 26, as illustrated in FIGS. 4B and 4C. A fingerhold 39 is provided as an extension of protective liner 36 to facilitate grasping the pouch 30 and holding it in place as the removable liner components 35 are removed to expose adhesive backing on outer drape 16b. The edges 32a and 32b (shown in FIG. 4B) of the pouch 30 are brought into contact with the intact skin surrounding the wound by means of this adhesive backing. A removable liner 35 (visible through the partial section of protective liner 36) is pulled off, for example, starting at finger tab extension 41 of removable liner 35 (shown bent back for grasping in FIG. 5), exposing the adhesive, as shown in FIG. 4C. The removable liners 35 may be statically adhered to the adhesive backing on outer drape 16b to protect the adhesive during handling.
As illustrated in FIGS. 4D and 4E, a second removable liner 37 is adhered to the wound facing inner drape 16a to protect the adhesive on the wound facing inner drape 16a. The liner 37 is removed prior to adhesion of the wound facing inner drape 16a to a region 40 of intact skin away from the wound site, so as to help prevent dislodgement of the fluid communication port 18 (shown in FIG. 4G) during movement of the patient. Protective liner 36 in a preferred embodiment, is overlaid on the outer drape 16b (as illustrated in FIG. 1), so as to provide partial rigidity to the occlusive wrapping 10 and its fluid manifold 14 during handling. The liner 36 is removed after securing the pouch 30 to the wound site, as shown in FIG. 4F.
Reference is finally made to FIG. 4G which shows how a fluid communication port 18 is positioned over the receiving site 20, and is secured in place also by means of an adhesive contact surface on the communication port 18. As known in the art of negative pressure wound therapy, a fluid communication means 42, such as a flexible silicone tube, communicates negative pressure to the wound from a negative pressure source 44, such as a portable pump. A collection canister 46 is positioned in line between the negative pressure source 44 and the fluid communication means 42 to collect any exudates that may be drawn from the wound.
While the invention has been described herein with reference to certain preferred embodiments, theses embodiments have been presented by way of example only, and not to limit the scope of the invention. Many other variations are possible, which would be obvious to one skilled in the art. Accordingly, the scope of the invention should be identified only in accordance with the claims that follow.

## Claims

1. A wound dressing for use under negative pressure, the wound dressing comprising:
a fluid manifold having a receiving site and fluid communicator arms extending from the receiving site;
a drape formed from an occlusive material and having an inner drape and an outer drape enclosing the fluid manifold, and an aperture formed on the outer drape that is substantially aligned with the receiving site, and wherein the inner drape includes a plurality of fenestrations in a wound contact region substantially aligned with the fluid communicator arms; and
further comprising an extension region interposed between the receiving site and fluid communicator arms.

2. The wound dressing of claim 1, wherein the drape further comprises lower edges bonded together to form a pouch, and further comprising a porous pad positioned in the pouch.

3. The wound dressing of claim 2, wherein the porous pad comprises a concave porous pad formed from polyurethane.

4. The wound dressing of claim 1, wherein said fluid communicator arms terminate in contiguous loops.

5. A wound dressing for use under negative pressure, comprising:
a concave porous pad adapted for placement on a wound;
a fluid manifold having a receiving site and fluid communicator arms extending from the receiving site;
a clear drape formed from an occlusive material and adapted for positioning over and around the concave porous pad, wherein said clear drape encloses said fluid manifold, an adhesive on at least an edge of said clear drape for sealing said at least a portion of said clear drape to an area surrounding the wound, and a plurality of fenestrations formed on the clear drape; and
wherein said fluid communicator arms terminate in loops to allow viewing of the area around the wound through the clear drape.

6. The wound dressing of claim 5, wherein said clear drape is comprised of a wound faceable layer and an outer layer.

7. The wound dressing of claim 6, wherein said plurality of fenestrations are formed on the wound faceable layer for communicating fluid from the wound to said fluid manifold.

8. A wound dressing for use under negative pressure, comprising:
a concave porous pad adapted for placement in a wound;
a wrapping adapted for positioning over and around the concave porous pad, wherein said wrapping comprises a fluid manifold, a clear drape formed from an occlusive material and enclosing said fluid manifold, and an adhesive on at least an edge of said drape for sealing said wrapping to an area surrounding the wound;
said fluid manifold comprising a receiving site, an extension region, and a fluid communicator arm, said receiving site distal to and in flow communication with said fluid communicator arm through said extension region, and wherein said fluid communicator arm is comprised of a plurality of contiguous loops to allow viewing of the area around the wound through the clear drape;
wherein said clear drape is comprised of a wound faceable layer and an outer layer;
wherein said wound faceable layer is fenestrated for communicating fluid from the wound to said fluid manifold; and
wherein the wrapping further comprises lower edges bonded together to form a pouch.