# US 11,439,728 B2 · Process for coating a biomedical implant with a biocompatible polymer and a biomedical implant therefrom > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,439,728 B2 - Document ID: US11439728B2 - Status: Granted - Kind: B2 - Application number: 16/495,683 - Filed: 2018-03-23 - Published: 2020-02-20 - Granted: 2022-09-13 - Earliest claimed: 2017-03-23 - Assignees: Council of Scientific and Industrial Research - Applicants: Council of Scientific & Industrial Research - Inventors: Abhijit Pravin Shete; Anuya Amol Nisal; Ashish Kishore Lele - Web page: https://patentgrep.com/patent/US11439728B2 ## CPC - A61L 27/34: Macromolecular materials - A61L 27/06: Titanium or titanium alloys - A61L 27/10: Ceramics or glasses - A61L 27/18: obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds - A61L 27/227: {Other specific proteins or polypeptides not covered by A61L27/222, A61L27/225 or A61L27/24} - 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 27/3641: {characterised by the site of application in the body (materials for artificial blood vessels A61L27/507; materials for use in artificial skin A61L27/60)} - A61L 27/40: Composite materials, i.e. containing one material dispersed in a matrix of the same or different material - A61L 27/505: {Stabilizers} - A61L 27/54: Biologically active materials, e.g. therapeutic substances {(A61L27/227 takes precedence)} - A61L 29/005: {Ingredients of undetermined constitution or reaction products thereof} - A61L 29/02: Inorganic materials - A61L 29/048: {Other specific proteins or polypeptides not covered by A61L29/045 - A61L29/047} - A61L 29/06: obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds - A61L 29/085: {Macromolecular materials} - A61L 29/12: Composite materials, i.e. containing one material dispersed in a matrix of the same or different material - A61L 29/143: {Stabilizers} - A61L 29/16: Biologically active materials, e.g. therapeutic substances {(A61L29/048 takes precedence)} - A61L 31/005: {Ingredients of undetermined constitution or reaction products thereof} - A61L 31/022: {Metals or alloys} - A61L 31/026: {Ceramic or ceramic-like structures, e.g. glasses} - A61L 31/047: {Other specific proteins or polypeptides not covered by A61L31/044 - A61L31/046} - A61L 31/06: obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds {(A61L31/041 takes precedence)} - A61L 31/10: Macromolecular materials - A61L 31/12: Composite materials, i.e. containing one material dispersed in a matrix of the same or different material - A61L 31/143: {Stabilizers} - A61L 31/16: Biologically active materials, e.g. therapeutic substances {(A61L31/047 takes precedence)} - D01D 5/0007: {Electro-spinning (non-woven fabrics produced by electro-spinning D04H1/728)} - D01F 4/02: from fibroin - A61L 2420/02: Methods for coating medical devices - A61L 2430/04: for mammary reconstruction - A61L 2430/16: for reconstruction of eye parts, e.g. intraocular lens, cornea - D10B 2509/00: Medical; Hygiene - 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) - D01D: MECHANICAL METHODS OR APPARATUS IN THE MANUFACTURE OF ARTIFICIAL FILAMENTS, THREADS, FIBRES, BRISTLES OR RIBBONS - D01F: CHEMICAL FEATURES IN THE MANUFACTURE OF ARTIFICIAL FILAMENTS, THREADS, FIBRES, BRISTLES OR RIBBONS; APPARATUS SPECIALLY ADAPTED FOR THE MANUFACTURE OF CARBON FILAMENTS - D10B: INDEXING SCHEME ASSOCIATED WITH SUBLASSES OF SECTION D, RELATING TO TEXTILES ## Abstract The present invention disclosed a process to coat the surface of flexible polymeric implant with biocompatible polymer such that the coating does not crack when the implant is subjected to mechanical forces such as tension, torsion or bending while retaining the inherent properties of the coated polymer. ## Claims ### Claim 1 A process for obtaining an implant with a biocompatible polymer coating, said process consisting of: (a) dipping an implant in a solution comprising a first biocompatible polymer to obtain an implant with a wet dip coating comprising the first biocompatible polymer; and (b) electrospinning a second biocompatible polymer onto the implant with the wet dip coating of step (a) to obtain an implant with a biocompatible polymer coating comprising the first biocompatible polymer and electrospun fibers of the second biocompatible polymer; wherein a portion of the fibers of the second biocompatible polymer are embedded into the dip coating and another portion of the fibers of the second biocompatible polymer are not embedded into the dip coating, and the biocompatible polymer coating remains intact, without the formation of cracks or tears after application of a mechanical force selected from the group consisting of bending, tensile stress, compression and torsion. ### Claim 2 (depends on 1) The process as claimed in claim 1, wherein the first biocompatible polymer and the second biocompatible polymer are selected from the group consisting of silk fibroin, polylactic acid (PLA), poly ε-caprolactone (PCL), and collagen. ### Claim 3 (depends on 2) The process as claimed in claim 2, wherein at least one of the first biocompatible polymer and the second biocompatible polymer is silk fibroin. ### Claim 4 (depends on 1) The process as claimed in claim 1, wherein said implant is made up of a material selected from the group consisting of metals, polymers, ceramics, and composites thereof. ### Claim 5 (depends on 4) The process as claimed in claim 4, wherein said implant is made of a metal. ### Claim 6 (depends on 5) The process as claimed in claim 5, wherein the metal is titanium. ### Claim 7 (depends on 4) The process as claimed in claim 4, wherein said implant is made of a polymer. ### Claim 8 (depends on 7) The process as claimed in claim 7, wherein the polymer is polydimethylsiloxane (PDMS) or polyethylene. ### Claim 9 (depends on 4) The process as claimed in claim 4, wherein said implant is made of a ceramic. ### Claim 10 (depends on 9) The process as claimed in claim 9, wherein the ceramic is hydroxyapatite. ### Claim 11 (depends on 1) The process as claimed in claim 1, wherein said implant is selected from the group consisting of a breast implant, an ocular implant, a cardiovascular stent, and a catheter tube. ### Claim 12 (depends on 1) The process as claimed in claim 1, wherein said implant is in a form selected from the group consisting of a tube, a sheet, a film, and a 3D shape. ### Claim 13 (depends on 1) The process as claimed in claim 1, wherein the thickness of said biocompatible polymer coating is in the range of 100 nm to 5 μm. ### Claim 14 (depends on 1) The process as claimed in claim 1, wherein the fiber diameter of the electrospun fibers is in the range of 100 nm to 1000 nm. ### Claim 15 (depends on 1) The process as claimed in claim 1, wherein said biocompatible polymer coating includes at least one of a functional molecule, a drug, a biomolecule, a growth factor and a protein. ### Claim 16 A process for coating the surface of a polydimethylsiloxane (PDMS) implant with a silk fibroin layer, said process consisting of: a) dipping a polydimethylsiloxane (PDMS) implant in a solution comprising regenerated silk fibroin to obtain a wet PDMS implant with a regenerated silk fibroin coating; b) placing the wet PDMS implant with the regenerated silk fibroin coating of step (a) on a collector of an electro-spinning system; c) dissolving lyophilized silk fibroin (SF), and optionally an antibiotic, in Hexafluroisopropanol (HFIP) to obtain a SF-HFIP solution; d) using the SF-HFIP solution of step (c) for electrospinning silk fibroin fibers onto the wet PDMS implant with the regenerated silk fibroin coating of step (b) and; e) randomizing deposition of the electrospun silk fibroin fibers by aid of syringe translation and/or collector translation and/or rotation to obtain the PDMS implant with a silk fibroin layer comprising the regenerated silk fibroin coating and the silk fibroin fibers; wherein a portion of the silk fibroin fibers are embedded into the regenerated silk fibroin coating and another portion of the silk fibroin fibers are not embedded into the silk fibroin coating, and the silk fibroin layer remains intact, without the formation of cracks or tears after application of a mechanical force selected from the group consisting of bending, tensile stress, compression and torsion. ### Claim 17 (depends on 16) The process of claim 16, wherein the lyophilized SF and the antibiotic are dissolved in HFIP to obtain the SF-HFIP solution step (c). ### Claim 18 (depends on 16) The process as claimed in claim 16, wherein said coating includes at least one of a functional molecule, a drug, a biomolecule, a growth factor and a protein. ### Claim 19 (depends on 1) The process of claim 1, wherein the first biocompatible polymer and the second biocompatible polymer are compositionally the same. ### Claim 20 (depends on 1) The process as claimed in claim 1, wherein the first biocompatible polymer is silk fibroin.