Wound therapy device, kit, and method for improved application to wounds on complex geometries

A negative pressure wound therapy device, kit, and method are provided for improved treatment of wounds on complex three-dimensional anatomies. The device includes a conformable manifold made of a porous and permeable material with a pattern of cuts designed to transform the manifold from a relaxed, planar state to a pliable three-dimensional state when extended along the lateral axis. The kit further may include a wound interface layer, an adhesive, breathable drape, and a pneumatic connection to a negative pressure wound therapy device. Finally, a method for treating wounds using reduced pressure and the presently disclosed kit is provided.

BACKGROUND

The present disclosure relates generally to medical treatment, and more particularly to reduced pressure wound treatment devices, kits, and methods.

Negative pressure wound therapy (NPWT) is a type of wound therapy that involves applying a negative pressure to a wound site to promote wound healing. Some wound treatment systems apply negative pressure to a wound using a pneumatic pump attached to a dressing covering the wound to generate the negative pressure and flow required. However, with NPWT, it is essential that a dressing, bandage or manifold accurately conform to a three-dimensional wound site, since the negative pressure applied to the dressing or bandage compresses the dressing to the wound surface. Thus, sizing and fit are integral elements in the efficacy of a NPWT device, in many instances more so than in standard wound treatments. Many NPWT dressings are improperly sized, ill-fitting, contain imperfections, do not conform to the contours of the anatomy of a three-dimensional wound site, or some combination of all these drawbacks. For example, many NPWT manifolds and dressings are not sized to fit rounded, asymmetric, or non-planar body parts, such as a knee, elbow, foot, shoulder, or breast. Specifically shaped dressings for such geometries, especially when considering variable body-sizes, require a multitude of dressing variants, often leading to an unmanageable number of individual stock-keeping units. Additionally, preformed three-dimensional dressings require larger packaging with increased space for storage and transportation. Accordingly, there is a need for an improved device, kit, and method that more accurately conform NPWT to a wide variety of three-dimensional wound sites and maximize shipping and storage space.

SUMMARY

The present technology overcomes the drawbacks of previous systems by providing a device, kit, and method for improved negative pressure wound therapy to wounds on complex geometries. One implementation of the disclosure is a wound therapy device having a conformable, reticulated manifold made of a porous and permeable material with a pattern of cuts configured to transform the manifold from a planar relaxed state to a pliable three-dimensional state when the manifold is extended along a lateral axis. The manifold further may have a perimeter border substantially free of the pattern of cuts. The manifold may also have at least one tab on at least one side of the lateral axis of the manifold. The tabs further may have an adhesive that adheres to the patient on one side of the device. The tabs may be made of a polymer or a plastic, including, but not limited to, an acrylic. In some embodiments, the manifold includes a reticulated polyurethane foam. In one embodiment, the polyurethane foam may have 40-50 pores per inch for optimal porosity and transfer of wound fluids while under reduced pressure.

In some embodiments, the manifold forms a geodesic dome when extended to the pliable three-dimensional state. The cuts in the manifold may appear in various geometries in both the planar relaxed state and the pliable three-dimensional state. In one embodiment, the cuts appear as a straight line when the manifold is in the planar relaxed state. In another embodiment, the cuts appear as substantially diamond-shaped when the manifold is extended along the lateral axis. In yet another embodiment, the cuts appear as substantially circular when the manifold is extended along the lateral axis. In some embodiments, the cuts substantially appear as one or more geometric shapes. The manifold may be extended along the lateral axis at a midpoint of the manifold.

The manifold of the present technology may be sized to fit a specific anatomy in the three-dimensional state. For example, some specific three-dimensional anatomies with asymmetric or non-planar shapes or sizes include, but are not limited to, a knee, an ankle, a shoulder, a breast, or an elbow.

In one embodiment, the manifold is elliptical in the planar relaxed state. In another embodiment, the manifold is circular in the planar relaxed state.

In an alternative embodiment, the manifold has a first layer with a pattern of cuts and a second layer with a pattern of cuts, where the patterns of cuts on the two layers do not align when both layers are in the pliable three-dimensional state. In another alternative embodiment, the device has an adhesive thermoformed outer polyurethane film that can be peeled away from a non-adhesive, disposable layer immediately prior to administration of the device, otherwise known as a “peel and place” device.

In accordance with another aspect of the present disclosure, a wound therapy kit is described. The kit may include: (i) a conformable, reticulated manifold made of a porous and permeable material, where the manifold has a pattern of cuts configured to transform the manifold from a planar relaxed state to a pliable three-dimensional state when the manifold is extended along a lateral axis, (ii) a wound interface layer, (iii) an adhesive, breathable drape; and (iv) a pneumatic connection to a negative pressure wound therapy device. In certain embodiments of the kit, the wound interface layer is made of a Milliken fabric. In yet another embodiment, the wound interface layer is made of a perforated silicone.

In accordance with yet another aspect of the present disclosure, a method for wound therapy is described. The method may include: (i) extending a conformable, reticulated manifold along a lateral axis of the manifold, wherein the manifold is made of a porous and permeable material and a pattern of cuts designed to transform the manifold from a planar relaxed state to a pliable three-dimensional state as the manifold is extended along the lateral axis; (ii) ceasing extension when the manifold bends to a desired pliable three-dimensional shape adaptable to a contoured wound site; (iii) placing the manifold in the desired pliable three-dimensional shape on the contoured wound site; (iv) placing an adhesive, breathable drape over the manifold on the contoured wound site; (v) attaching a pneumatic connection operatively coupled to a negative pressure wound therapy device to the adhesive, breathable drape; and (vi) activating the negative pressure wound therapy device to apply a negative pressure environment to the wound site.

In one embodiment of the wound therapy method, the pneumatic connection attaches to the adhesive, breathable drape via a T.R.A.C. Pad™. The manifold also may have a perimeter border substantially free of the pattern of cuts. The manifold may also have at least one plastic tab on at least one side of the lateral axis of the manifold. The plastic tabs further may indicate where a user should grip to extend the manifold. The cuts may each appear as a straight line when the manifold is in the planar relaxed state. The cuts also may each appear as substantially diamond-shaped when the manifold is extended along the lateral axis. The cuts also may appear as substantially circular when the manifold is extended along the lateral axis. In some embodiments, the cuts may substantially appear as one or more geometric shapes.

In one embodiment of the method, the manifold has a first layer with a pattern of cuts and a second layer with a pattern of cuts, wherein the pattern of cuts of the first layer do not align with the pattern of cuts of the second layer when both layers are extended to the desired three-dimensional state. The manifold also may be extended along the lateral axis at a midpoint of the manifold.

DETAILED DESCRIPTION

Overview

The wound therapy device, kit, and method of the present invention provides simple dressing administration to three-dimensional anatomy, decreasing kinks and poor adhesion of the device when used in tandem with a negative pressure source. The device and kit are also easily shipped in planar form, alleviating bulk shipments and providing for more efficient transport and storage.

Device

Referring generally to the FIGURES, a wound therapy device, kit, and method and components thereof are shown, according to various exemplary embodiments.

Referring toFIGS. 1-1E, an exemplary device used for wound therapy in accordance with the principles of the present disclosure is described.FIG. 1is a front view of wound therapy device10according to two exemplary embodiments. Device10includes conformable, reticulated manifold100including porous and permeable material102. Manifold100further includes pattern of cuts104designed to transform manifold100from planar relaxed state106, shown inFIG. 7, to pliable three-dimensional state108when manifold100is extended along lateral axis110.

FIG. 1further illustrates that manifold100may include perimeter border112substantially free of the pattern of cuts. Device10further may include at least one plastic tab114on at least one side116of lateral axis110of manifold100. One or more tabs114also may have an adhesive on a side of the device that adheres to a patient. One or more tabs114can also be made of an acrylic, or other exemplary materials used in wound therapy and dressings. In some embodiments, manifold100may be made of a reticulated polyurethane foam with specific porosities, e.g., illustratively 40-50 pores per inch. Porous and permeable material102may be any material that allows for good transfer of wound fluids while under reduced pressure.

FIGS. 1B-1Eillustrate various embodiments where pattern of cuts104on manifold100have different geometries to form different pliable three-dimensional states108when extended along lateral axis110. The various patterns of cuts104create a multitude of arrays or shapes when extended into three dimensional state108.FIG. 1Bis a top view of device10where pattern of cuts104each appear as straight line124when manifold100is in planar relaxed state106.FIG. 1Cis a top view of device10where pattern of cuts104each appear as substantially diamond-shaped126when manifold100is extended along lateral axis110.FIG. 1Dis a top view of device10where pattern of cuts104each appear as substantially circular128when manifold100is extended along lateral axis104.FIG. 1Eis a top view of device10where pattern of cuts104each appear as one or more geometric shapes130. Manifold100may be extended along lateral axis110at midpoint132of manifold100.

Manifold100in pliable three-dimensional state108may be sized to fit a number of specific anatomies. For example,10device may fit a knee, an ankle, a shoulder, a breast, or an elbow when manifold100is extended in pliable three-dimensional state108.

FIG. 2is a top view of device10where, in one embodiment, manifold100′ is elliptical in planar relaxed state106′.

FIG. 3is a top view of device10where manifold100″ is circular in planar relaxed state106″.

FIG. 4depicts a front view of a multiple layer embodiment where manifold100′″ includes first layer400with pattern of cuts402and second layer404with pattern of cuts406, where pattern of cuts402of first layer400does not align with pattern of cuts406of second layer404when both layers are in pliable three-dimensional state108′″. The layers may be arranged such that as manifold100′″ forms a complex curve, the open areas in one layer line up with the closed areas in the second layer. This helps ensure no contact between polyurethane manifold100′″ and the wound bed.

Referring now toFIG. 5, a “peel and place” embodiment of device10is depicted. Here, device10further may include adhesive, thermoformed outer polyurethane film500designed to be peeled away from non-adhesive, disposable layer502immediately prior to administration of device10on a wound bed. The “peel and place” embodiment allows for easy shipment of the device, increased sterility, and usage at any desired time by the patient or medical practitioner.

Referring now toFIG. 6, wound therapy kit20in accordance with the principles of the present disclosure is described. Wound therapy kit20includes: (i) conformable reticulated manifold100including porous, permeable material102where the manifold has pattern of cuts104designed to transform manifold100from planar relaxed state106, shown inFIG. 7, to pliable three-dimensional state108when manifold100is extended along lateral axis110; (ii) wound interface layer600; (iii) adhesive, breathable drape602; and (iv) pneumatic connection604to a negative pressure wound therapy device.

In certain embodiments, wound interface layer600may be made of a Milliken fabric. In other embodiments, wound interface layer may be made of a perforated silicone.

Method

Referring now toFIG. 7, a method for wound therapy in accordance with the principles of the present disclosure is described. This method provides for a more form-fitting and adaptable type of NPWT that can work with anatomies that previously adjusted poorly with NPWT. The method includes: (i) extending conformable, reticulated manifold100along lateral axis110of manifold100, where manifold100may be made of porous and permeable material102and pattern of cuts104designed to transform manifold100from planar relaxed state106to pliable three-dimensional state108as manifold100is extended along lateral axis110; (ii) ceasing extension when manifold100bends to desired pliable three-dimensional shape108adaptable to a contoured wound site; (iii) placing manifold100in desired pliable three-dimensional shape108on the contoured wound site; (iv) placing adhesive, breathable drape602over manifold100on the contoured wound site; (v) attaching pneumatic connection604operatively coupled to a negative pressure wound therapy device to adhesive, breathable drape602; and (vi) activating a negative pressure wound therapy device to apply a negative pressure environment to the wound site.

InFIG. 7, pneumatic connection604may attach to adhesive breathable drape602via a T.R.A.C. Pad™. The method further may include perimeter border112substantially free of pattern of cuts104. Manifold100further may have at least one plastic tab114on at least one side of lateral axis116of manifold100. One or more plastic tab114also may indicate where a user grips to extend manifold100.

Similar to embodiments for device10, cuts104may appear as a straight line when manifold100is in planar relaxed state106. Pattern of cuts104also may appear as substantially diamond-shaped126when manifold100is extended along lateral axis110. Pattern of cuts104also may appear as substantially circular128, as depicted inFIG. 1D, when manifold100is extended along lateral axis110. Also, pattern of cuts104may be one or more geometric shapes130, as depicted inFIG. 1E. Manifold100also may have a first layer400with pattern of cuts402and second layer404with pattern of cuts406, where pattern of cuts402of first layer400do not align with pattern of cuts406of second layer404when both layers400and404are extended to desired pliable three-dimensional state108, as depicted inFIG. 4. Manifold100may extend along lateral axis110at midpoint132of manifold100for improved extension of device10.

Although the figures show a specific order of method steps, the order of the steps may differ from what is depicted. Also two or more steps can be performed concurrently or with partial concurrence. All such variations are within the scope of the disclosure.

Configuration of Exemplary Embodiments