Method and matrix for tissue regeneration
Inventors
Burhop, Kenneth • Saini, Sunil • Gandhi, Ankur • Kharge, Angana • Johnson, Brandon • BONVALLET, Paul
Assignees
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Publication Number
US-12059509-B1
Publication Date
2024-08-13
Expiration Date
Abstract
Disclosed is a method of regenerating a skin wound using a perforated dermal regeneration matrix combined with autograft in a single-stage procedure. The size of the perforations and the spacing between perforations in the dermal matrix are selected to facilitate drainage, encourage vessel growth and minimize scar tissue formation.
Core Innovation
The invention relates to a method of treating a skin wound of a mammalian subject in need of such treatment. A sheet of biodegradable porous polymeric matrix is provided, the sheet comprising a plurality of channels distributed on the matrix in staggered or aligned rows and penetrating through a thickness of the sheet, thereby creating void areas in the sheet.
The biodegradable porous polymeric matrix sheet further includes a void space percentage of 1% to 10%, where the void space percentage is total void areas represented by the plurality of channels relative to the total area of the sheet without the plurality of channels formed therein. The matrix is placed on a prepared wound bed, a skin graft is placed on top of the sheet, and the wound is closed after the sheet and the skin graft have been placed.
The method is described as single-stage in that it uses the perforated or channeled biodegradable porous polymeric matrix and then places the skin graft on top before closure, rather than using a separate template or silicone removal workflow.
Claims Coverage
The document includes one independent method claim directed to treating a mammalian skin wound using a biodegradable porous polymeric matrix sheet with through-thickness channels that create a defined void space percentage, followed by placing an autologous skin graft and closing the wound. The dependent claims further specify channel and void architecture constraints, matrix material and thickness, and wound types treated.
Through-thickness channels forming void areas on a biodegradable porous polymeric matrix sheet
A sheet of biodegradable porous polymeric matrix comprises a plurality of channels distributed in staggered or aligned rows and penetrating through a thickness of the sheet, thereby creating void areas in the sheet, with each channel having a cross-section shape that is generally circular, elliptical, trapezoidal, rectangular, rhombus, polygonal, star-shaped, custom shaped, or irregular.
Defined void space percentage based on channel-created void areas
The sheet has a void space percentage of 1% to 10%, where the void space percentage is total void areas represented by the plurality of channels relative to the total area of the sheet without the plurality of channels formed therein.
Single-stage placement of the channel matrix on a prepared wound bed with subsequent skin graft placement
The method includes cleaning the skin wound to provide a prepared wound bed, placing the sheet of biodegradable porous polymeric matrix onto the prepared wound bed, removing a skin graft from a healthy area of the subject, placing the skin graft on top of the sheet, and closing the skin wound after the sheet and the skin graft have been placed.
Claim coverage centers on a biodegradable porous polymeric matrix sheet with through-thickness channels arranged in staggered or aligned rows, creating void areas with a specified void space percentage of 1% to 10%, followed by placement of the channel matrix on a prepared wound bed, placement of a skin graft on top, and closure of the skin wound. Dependent claims further constrain void percentage and matrix thickness ranges, specify a collagen-glycosaminoglycan matrix, and narrow the wound categories.
Stated Advantages
Improved autograft take and vascularization compared with solid matrices without channels.
Reduced contraction and scar outcomes compared with solid matrices without channels.
Channel density and diameter are described as affecting graft survival and vascular network characteristics.
Documented Applications
Treatment of deep or full-thickness skin wounds using a single-stage dermal regeneration approach with a biodegradable porous collagen/GAG dermal regeneration matrix and an overlying autologous skin graft.
Preclinical comparative evaluation in porcine full-thickness wound models, with histology and vascular imaging or micro-CT assessments.
Preclinical comparative evaluation in rat models.
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