Laminated tissue graft product
Inventors
WARD, Brian Roderick • MAY, Barnaby Charles Hough • CAMPBELL, Andrew Raymond
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Assignees
MemberAroa BiosurgeryAroa BiosurgeryAroa Biosurgery Incorporated is wholly owned by Aroa Biosurgery Limited, a New Zealand-based healthcare company specializing in the development, manufacture, and distribution of advanced bioscaffold devices for soft tissue repair and wound management. Utilizing extracellular matrix (ECM) biomaterials, the company offers solutions for chronic wounds, surgical reconstruction, and dead-space management. Products are distributed internationally and supported by clinical evidence, regulatory approvals in 50+ countries, and a strong commercial presence in the US and Europe. The company maintains ISO 13485:2016 and MDSAP certifications and is publicly listed on the Australian Securities Exchange.
Aroa Biosurgery Incorporated is wholly owned by Aroa Biosurgery Limited, a New Zealand-based healthcare company specializing in the development, manufacture, and distribution of advanced bioscaffold devices for soft tissue repair and wound management. Utilizing extracellular matrix (ECM) biomaterials, the company offers solutions for chronic wounds, surgical reconstruction, and dead-space management. Products are distributed internationally and supported by clinical evidence, regulatory approvals in 50+ countries, and a strong commercial presence in the US and Europe. The company maintains ISO 13485:2016 and MDSAP certifications and is publicly listed on the Australian Securities Exchange.
Publication Number
US-11617639-B2
Publication Date
2023-04-04
Expiration Date
Abstract
A tissue graft product comprising two or more layers of material wherein each layer comprises extracellular matrix (ECM) or polymeric material and wherein the layers are laminated together by interlocking portions of one layer with portions of another layer.
Core Innovation
The invention is directed to a method for replacing or repairing tissue in a human or other animal by applying a laminated tissue graft product. The tissue graft product comprises two or more sheets of material, where each sheet comprises extracellular matrix (ECM) or polymeric material, and the sheets are laminated together by interlocking portions of one sheet with portions of another sheet.
A first sheet includes multiple lugs, and a second sheet includes multiple holes. Each lug of the first sheet is located through a hole in the second sheet to interlock the first sheet with the second sheet, and each lug comprises a section of the first sheet that is cut from the first sheet and remains connected to the first sheet, enabling a laminated connection without sutures or adhesives.
The laminated graft product is described as being constructed with lug sheets, pierced sheets, and optionally polymer layers, and is presented wet or lyophilized. Manufacturing and tooling concepts include cutting lugs, piercing holes, and lugging the sheets together, with optional molding to form planar or 3D shapes.
Claims Coverage
The provided claims include one independent claim covering an interlocking lug-and-hole laminated ECM/polymeric tissue graft applied to a human or other animal. The dependent claims refine the laminate construction by specifying drying, dimensional fit with a surface, and an optional intermediate third sheet with aligned holes for additional interlocking.
Interlocking lug-and-hole laminated tissue graft product with ECM or polymeric sheets
A method for replacing or repairing tissue in a human or other animal by applying a tissue graft product comprising two or more sheets of material, each sheet comprising extracellular matrix (ECM) or polymeric material; the sheets are laminated together by interlocking portions of one sheet with portions of another sheet, where a first sheet has multiple lugs and a second sheet has multiple holes, each lug being located through a hole in the second sheet to interlock the first sheet with the second sheet, and wherein each lug comprises a section of the first sheet cut from the first sheet and remaining connected to the first sheet.
Dryed sheets for the laminated graft product
The method of claim 1, wherein the sheets are dried sheets.
Lug and hole dimensions that engage a surface
The method of claim 1, wherein the holes and the lugs are dimensioned so that the lugs engage with a surface of the second sheet.
Intermediate third sheet with aligned holes for interlocking multiple sheets
The method of claim 1, wherein a third sheet is positioned between the first sheet and the second sheet, with holes aligned to holes of the second sheet, so the lugs extend through the third sheet to interlock the first sheet with the second and third sheets.
Overall, the claim set centers on laminated tissue grafts formed from ECM and/or polymeric sheets joined by a lug-and-hole interlocking mechanism, with refinements regarding drying, dimensional engagement with a surface, and an optional intermediate third sheet to extend interlocking to additional layers.
Stated Advantages
Addresses delamination of laminated ECM.
Avoids inflammation/scarring associated with sutures.
Avoids barrier effects associated with adhesives.
Avoids foreign-body response associated with cross-linked ECM.
Provides wet handling integrity.
Documented Applications
Wound repair and tissue regeneration.
Hernia repair.
Ligament repair and tendon repair.
Replacing or repairing tissue in a human or other animal by applying the laminated tissue graft product.
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