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-10548705-B2
Publication Date
2020-02-04
Expiration Date
Abstract
A tissue graft 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. In one embodiment, a tissue graft comprises a first layer of material having multiple lugs and a second layer of material having multiple holes, each lug of the first layer being located through a hole in the second layer, the holes and the lugs having dimensions so that the lugs engage with a surface of the second layer and interlock the first layer with the second layer. In further embodiments, a method of preparing a tissue graft by laminating and interlocking two or more layers, the use of a tissue graft for replacing or repairing tissue in a human or animal, and an apparatus comprising a mould, a lug cutting means, a piercing means and a means for pushing lugs through piercings in layers of a tissue graft.
Core Innovation
A laminated tissue graft product is described that is formed from two or more sheets in which each sheet comprises extracellular matrix (ECM) and/or polymeric material. The sheets are laminated together by interlocking portions of one sheet with portions of another sheet, with a first sheet including multiple lugs and a second sheet including multiple holes, each lug located through a hole in the second sheet to interlock the sheets.
Each lug comprises a section of the first sheet that is cut from the first sheet and remains connected to the first sheet. The interlocking lug-and-hole arrangement is used so the sheets are laminated together without requiring sutures or adhesives, and the resulting graft can be presented in wet handling while maintaining integrity. The interlocking structure is described in the context of avoiding delamination in wet presentation.
The laminated product is described as being configurable for different sheet counts and forms, including substantially flat sheets and three-dimensional shaped forms that conform to a grafting location. ECM and polymeric sheet options are described, including ECM from animal tissues such as ruminant forestomach propria-submucosa, and polymeric materials such as polypropylene, PTFE, PGA, PLA, poliglecaprone-25, and polyester.
Claims Coverage
The identified independent claim covers a tissue graft product made from two or more ECM and/or polymeric sheets laminated together via interlocking cut lugs through holes, with the lug remaining connected to its sheet. This independent claim is further refined by multiple dependent claims that specify lug/hole engagement, multi-sheet interlocking configurations, selected polymer materials, total sheet-count ranges, and flat versus three-dimensional graft forms.
Lug-and-hole laminated ECM/polymeric tissue graft product
A tissue graft product comprising two or more sheets of material wherein each sheet comprises extracellular matrix (ECM) or polymeric material and wherein the sheets are laminated together by interlocking portions of one sheet with portions of another sheet, wherein a first sheet has multiple lugs and a second sheet has multiple holes, each lug of the first sheet 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 that is cut from the first sheet and remains connected to the first sheet.
Dimensional lug-and-hole engagement at a second-sheet surface
The tissue graft product wherein the holes and lugs are sized so the lugs engage with a surface of the second sheet.
Three-sheet interlocking with aligned holes
The tissue graft product including a third sheet positioned between the first and second sheets, with the third sheet having multiple holes aligned with holes of the second sheet, and with lugs of the first sheet extending through the holes in the third sheet to interlock the first sheet with the second and third sheets.
Selected synthetic polymeric sheet materials
The tissue graft product wherein the synthetic polymeric material is formed from polypropylene, polytetrafluoroethylene, polyglycolic acid, polylactic acid, poliglecaprone-25, or polyester.
Total sheet-count range for ECM/polymeric laminates
The tissue graft product including a total of 3 to 10 sheets of ECM and/or polymeric material, specifically 3, 4, 5, 6, 7, 8, 9, or 10 sheets.
Flat or three-dimensional conforming graft configuration
The tissue graft product configured either as a substantially flat sheet or as a three-dimensional shaped form that conforms to the grafting location.
Overall, the claim set centers on a laminated ECM/polymeric tissue graft product where cut lugs remain connected to a first sheet and interlock through holes in another sheet (and optionally an added third sheet), with dependent claims further defining lug/hole engagement, specific polymer selections, total sheet counts, and flat versus three-dimensional conforming graft configurations.
Stated Advantages
Avoidance of delamination in wet presentation.
Reduced need for drying and chemical treatments.
Improved tensile strength.
Drainage and perforation benefits, including seroma drainage/perforations.
Ability to form flat or three-dimensional conforming grafts, including large-area grafts.
Documented Applications
Grafting locations for which the tissue graft product is configured as substantially flat or three-dimensional conforming forms.
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