IMPROVED SKIN SUBSTITUTE ADHERENCE, STRETCHABILITY, AND COMPLIANCE FOR SKIN SUBSTITUTES

Abstract

An improved dressing is presented which enables quicker wound closure and a lower anesthesia requirement, comprised of an improved prior-art skin-substitute. The improvements consist of variations in the thickness of the woven portion of the dressing, to increase wound adherence.

Claims

1. A bilaminate cured silicone/nylon material, the silicone/nylon material comprised of two layers of material, the first layer of material comprised of a silicone membrane, the second layer comprised of a woven fabric, the two layers combined together with a combination means such that the two layers form a single structure, the preferred combination method is heating, the first layer possessing a plurality of slits in its surface, said slits made after the two layers are combined, said slits in a regular pattern, the regular pattern comprising a parallel vertical orientation, said first layer and said second layer treated with a coating comprised of one or more medicinal or therapeutic substances, the porosity of said skin substitute minimized to essentially zero porosity in the mode where no stretching tension is exerted on the skin substitute, the porosity of said skin substitute variable proportional to the amount of stretching tension and the direction in which said stretching tension is placed on the skin substitute, said second layer of material with a preferred range of thickness of 15/1 denier knitted nylon of an average of 0.0080″ with STDEV of 0.0008″.

2. A bilaminate cured silicone/nylon material as in claim 1 where there is an additional component of salinomycin, native high molecular weight collagen, and Mafenide Acetate in the biological coating.

3. A bilaminate cured silicone/nylon material as in claim 1 using a denier virgin nylon filament of 15/2 or 15/3 with range of thickness 0.0040″ to 0.0095″.

4. A bilaminate cured silicone/nylon material as in claim 1 where said coating is a single layer of biological substances comprised of a. a hypoallergenic BSE free USP Pharmaceutical grade gelatin, b. pure Aloe or Aloesin, c. pure Aloe and BSE free gelatin, or a mixture of pure Aloe, BSE free gelatin and ECM and where said coating interacts with a wound to stimulate the rate of healing while adherent to the wound, the coating deposited directly on the woven fabric, said coating chemically stable for at least three years at room temperature.

Description

BRIEF DESCRIPTION OF THE FIGURES

[0016] FIG. 1—The Biobrane® Glove—fabricated using two sheets of planar Biobrane 1982.

[0017] FIG. 2—AWBAT® Glove, a precision anatomical fit Biosynthetic Glove with three-piece design in 2009. PermeaDerm® Glove is more practical and effective.

[0018] FIG. 3—AWBAT® Bootie, a precision anatomical fit with three-piece design 2009. PermeaDerm® Bootie is more practical and effective.

DETAILED DESCRIPTION

[0019] The present invention is a glove made by gluing two pieces of PermeaDerm® together with the biologically coated 3D Gen 3 nylon structure facing each other and the slitted silicone surface facing out, the 3D coated nylon surface contacts the wound surface inside the glove. For lower cost and efficiency, glue is preferred to seams sewn with thread.

[0020] The present invention is similar in composition to earlier skin substitutes in that they each have a thin silicone component and an underlying 3D thin knitted nylon component. The present invention differs from its ancestors in that it has “variable porosity” controlled by the clinician; the slit width in the thin silicone will be essentially zero (with no stretch, in relaxed mode) to a higher porosity (proportional to the stretch applied).

[0021] In addition, the present invention differs from prior art in the composition of biological coatings applied to both components and how these coatings interact with the wound over time.

[0022] The preferred embodiment of the invention designed for burns, a regular pattern with slits on the silicone surface parallel to each other in the same row is presented. The slits made in the silicone are approximately. 0.125″ long with a space of 0.50″, between the slits; off-set parallel rows of slits are 0.25″ apart.

[0023] In this configuration the silicone/nylon membrane can be stretched in a direction perpendicular to the slit orientation and the slits will open. Porosity therefore increases proportionally to the amount of stretch applied. Obviously, there is a maximum amount of stretching of the preferred embodiment before the dressing fails. IFU (instructions for use) describe a maximum of 20% elongation, well below the breaking point.

[0024] The use of the present invention has a large benefit because it is stable on the wound and possesses biologicals that aid in the healing process.

[0025] The present invention will have a single layer of biologicals comprised of a hypoallergenic BSE free USP Pharmaceutical grade gelatin, pure Aloe or Aloesin, pure Aloe and BSE free gelatin, or a mixture of pure Aloe, BSE free gelatin and ECM interact with the wound to stimulate the rate of healing while adherent to the wound. The layer is deposited directly on the nylon side of the “variable porosity” silicone/nylon surface and is stable for at least three years at room temperature.

[0026] The biologicals are applied to the knitted nylon side of the present embodiment. Optionally, the biologicals can be applied to the silicone layer as well.

[0027] Hand burns represent a small wound area with major potential for disability. The management of hand burns is multidisciplinary, requiring the expertise of surgeons, nurses, and occupational therapists. In addition to surgical excision and autografting, several wound healing modalities are available for the care of hand burns including a bilaminate, biosynthetic glove.

[0028] Motivated and reliable patients with burns limited to the hands can be appropriately managed on an outpatient basis at a burn center, where the requisite expertise in wound care, excision and grafting, and occupational therapy are available. An increase in elongation and compliance (greater 3D structure) of PermeaDerm results in improvements of the following:

3D thickness of cured silicone nylon membrane: Preliminary thickness data of cured silicone/nylon membrane from the manufacturer, Jan. 9, 2019 using micrometer: Gen1—Mean 0.0043″, STDEV 0.0003″, Min 0.0040″, Max 0.0048″. Gen3—Mean 0.0080″, STDEV 0.0008″, Min 0.0070″, Max 0.0095″. 3D structure of Gen3 is about 86% thicker than Gen1. Conclusions on clinically effective adherence relative to thickness of a bilaminate silicone/nylon membrane: [0029] Less than 0.0040″—Inadequate adherence [0030] Current PDB and PDC—Adequate adherence—average thickness 0.0043″ with STDEV 0.0003″ [0031] PDB, PDC and PDG with Gen3 nylon—Optimal Adherence—average thickness 0.0080″ with STDEV of 0.0008″ [0032] Excessive adherence—thickness greater than 0.0095″
The preferred embodiment is the Gen3 PermeaDerm with average thickness of 0.0080″ and STDEV of 0.0008″ which results in Optimal adherence.

TABLE-US-00001 Before Slitting Gen1 Gen3 Gen3/Gen1 Average 0.0043″ 0.0080″ 1.86 STDEV 0.0003″ 0.0008″ 2.67 Max 0.0046″ 0.0095″ Min 0.0040″ 0.0070″
The glove and/or bootie made with an average of 0.008 inch thickness nylon mesh is the preferred embodiment of the invention. The technology to create the invention is listed in the preferred embodiment of this invention, but other methods are possible and are within the contemplation of this patent.