# US 9,433,490 B2 · Multilayered implant materials derived from amniotic membrane, methods of making the multilayered implant materials, and method of using multilayered implant materials > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 9,433,490 B2 - Document ID: US9433490B2 - Status: Granted - Kind: B2 - Application number: 13/994,915 - Filed: 2011-12-22 - Published: 2013-10-31 - Granted: 2016-09-06 - Earliest claimed: 2010-12-22 - Assignees: University of Florida Research Foundation, Inc. - Applicants: Peter McFetridge - Inventors: Peter McFetridge - Web page: https://patentgrep.com/patent/US9433490B2 ## CPC - A61F 2/02: Prostheses implantable into the body - A61L 27/3604: {characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel} - A61L 27/3804: {characterised by specific cells or progenitors thereof, e.g. fibroblasts, connective tissue cells, kidney cells} - A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C) - A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K) ## Abstract Exemplary embodiments of the present disclosure provide for multi-layered implantation materials, methods of making a multi-layered implantation material, methods of forming a multi-layered implantation material, methods of forming a multi-layered implantation material having a spiral roll cross-section, and the like. ## Claims ### Claim 1 A method of forming a multi-layered implantation material, comprising the steps of: obtaining an amniotic membrane; decellularizing the amniotic membrane to produce a decellularized amniotic membrane; forming a multi-layered implantation material by wrapping the amniotic membrane around itself to form a multi-layered structure having a spiral roll cross-section with two or more spiral layers; freeze drying the multi-layered implantation material; and after forming the multi-layered implantation material, culturing the multi-layered implantation material under conditions whereby the membrane is colonized by a population of cells. ### Claim 2 (depends on 1) The method of claim 1, wherein the decellularized amniotic membrane is substantially free of non-amniotic tissue. ### Claim 3 (depends on 1) The method of claim 1, wherein the amniotic membrane is decellularized by contact with sodium dodecyl sulphate or sodium chloride. ### Claim 4 (depends on 1) The method of claim 1, wherein the amniotic membrane is decellularized by contact with sodium chloride. ### Claim 5 (depends on 1) The method of claim 1, wherein the multi-layered implantation material is an implant for a subject human or animal. ### Claim 6 (depends on 1) The method of claim 1, further comprising: disposing the multi-layered implantation material onto a second multi-layered implantation material to form a structure; and freeze drying the structure. ### Claim 7 (depends on 6) The method of claim 6, further comprising: drilling a plurality of drilled holes in the amniotic membrane. ### Claim 8 (depends on 6) The method of claim 6, wherein the drilled holes can have a diameter of about 1 to 500 micrometers and wherein one or more pairs of drilled holes are spaced by about 1 micrometer to 10 millimeters. ### Claim 9 (depends on 1) The method of claim 1, further comprising: drilling a plurality of holes in the multi-layered amniotic membrane before wrapping the amniotic membrane around itself. ### Claim 10 (depends on 9) The method of claim 9, wherein the drilled holes can have a diameter of about 1 to 500 micrometers and wherein one or more pairs of drilled holes are spaced by about 1 micrometer to 10 millimeters. ### Claim 11 (depends on 9) The method of claim 9, further comprising: freeze drying the amniotic membrane before drilling the plurality of holes. ### Claim 12 (depends on 11) The method of claim 11, further comprising: cross-linking the multi-layered amniotic membrane. ### Claim 13 (depends on 1) The method of claim 1, wherein wrapping includes wrapping the multi-layered implantation material around a structure to form the multi-layered implantation structure having the spiral roll cross-section, wherein removal of the structure provides a lumen oriented along the longitudinal axis of the multi-layered implantation structure. ### Claim 14 (depends on 13) The method of claim 13, wherein the lumen has a substantially circular cross-section. ### Claim 15 (depends on 13) The method of claim 13, wherein the lumen has a diameter of about 0.2 mm to 30 mm and wherein the multi-layered implant has a diameter of about 1 mm to 30 mm. ### Claim 16 (depends on 1) The method of claim 1, wherein the population of cells is selected from the group consisting of: a stem cell, an endothelial cell, a smooth muscle cell, a fibroblast, and a combination thereof. ### Claim 17 (depends on 1) The method of claim 1, wherein the population of cells is a homogeneous population of cells. ### Claim 18 (depends on 1) The method of claim 1, wherein the population of cells is a heterogeneous population of cells. ### Claim 19 A method of forming a multi-layered implantation material having a spiral roll cross-section, comprising the steps of: wrapping an amniotic membrane around itself to form a multi-layered structure having the spiral roll cross-section, wherein the multi-layered implant has two or more spiral layers; and freeze drying the multi-layered structure. ### Claim 20 (depends on 19) The method of claim 19, wherein the multi-layered implantation material has an inner edge, an outer edge, and a longitudinal axis along the length of the multi-layered implant. ### Claim 21 (depends on 19) The method of claim 19, wherein the multi-layered structure has a plurality of holes. ### Claim 22 (depends on 19) The method of claim 19, further comprising: cross-linking the multi-layered structure. ### Claim 23 (depends on 19) The method of claim 19, further comprising: drilling a plurality of holes in the multi-layered structure. ### Claim 24 (depends on 19) The method of claim 19, further comprising disposing a population of cells on said amniotic membrane before wrapping. ### Claim 25 (depends on 24) The method of claim 24, further comprising decellularizing the amniotic membrane before disposing the population of cells on the amniotic membrane. ### Claim 26 (depends on 24) The method of claim 24, wherein the lumen has a diameter of about 0.2 mm to 30 mm and wherein the multi-layered implant has a outside diameter of about 1 mm to 30 mm. ### Claim 27 (depends on 19) The method of claim 19, further comprising decellularizing the amniotic membrane before wrapping. ### Claim 28 (depends on 19) The method of claim 19, wherein each spiral layer has a thickness of about 45 μm to 2000 μm. ### Claim 29 (depends on 19) The method of claim 19, wherein the multi-layered implantation material has a width along the longitudinal axis of about 0.01 mm to 1200 mm. ### Claim 30 A method of forming a non-synthetic, multi-layered implantation tubular scaffold, the method comprising: wrapping an amniotic membrane around itself to form a multi-layered implantation tubular scaffold having a spiral roll cross-section with two or more spiral layers; optionally freeze drying the multi-layered implantation tubular scaffold; and optionally culturing the multi-layered implantation tubular scaffold under conditions whereby the membrane is colonized by a populations of cells; wherein the multi-layered implantation tubular scaffold does not comprise synthetic materials.