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EP0331774A1 Expired / Lapsed EP ⏱️ 0.0 years remaining

Crack prevention of implanted prostheses

Assignee: Corvita Corp
•
Filing: 1988-03-08
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Granted: —
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Expires: 2008-03-08
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Abstract

Abstract Implantable devices for medical use are provided which have been subjected to treatment with a crack preventa­tive composition that include a silicone rubber such as poly(dimethyl siloxane). This treatment substantially prevents cracking of the implantable device after it is implanted.

Inventors

  • 👤 Leonard Pinchuk

Bibliographic Details

Application Number —
Jurisdiction EP
Data Source google_patents
Last Synchronized 2026-11-01 18:17
CPC Classifications
A; A61; A61L; A61L17/00; A61L17/14; A61L17/145; A61L27/00; A61L27/28; A61L27/34

Claims Analysis

Total Claims: 19
Claim 1
Independent Claim 161 words
A method for forming an implantable device for me­dical use, which device is treated to substantially prevent in vivo cracking thereof, the method com­prising: providing a non-woven shaped substrate of an im­plantable medical device having a biocompatible polymer surface that is susceptible to cracking when subjected to implantation under in vivo con­ditions for substantial time periods, said in vivo conditions including those that promote crackfor­ming biodegration of said biocompatible polymeric surface, said non-woven shaped substrate including wound strands of extrude fiber that overlie and intersect one another; applying a crack preventative composition to said biocompatible polymeric surface, said crack pre­ventative compostion including a silicone rubber material being a siloxane including -O-Si-O- groups and having a predetermined surface tension, said applying step including effecting adsorption of the silicone rubber material onto biocompatible polyme­ric surface; and said providing step includes selecting said bio­compatible polymeric surface to have a surface tension that is greater than the predetermined ten­ sion of said silicone rubber material.
Claim 2
Independent Claim 161 words
A method for forming an implantable device for me­dical use, which device is treated to substantially prevent in vivo cracking thereof, the method com­prising: providing a non-woven shaped substrate of an im­plantable medical device having a biocompatible polymer surface that is susceptible to cracking when subjected to implantation under in vivo con­ditions for substantial time periods, said in vivo conditions including those that promote crackfor­ming biodegration of said biocompatible polymeric surface, said non-woven shaped substrate including wound strands of extrude fiber that overlie and intersect one another; applying a crack preventative composition to said biocompatible polymeric surface, said crack pre­ventative compostion including a silicone rubber material being a siloxane including -O-Si-O- groups and having a predetermined surface tension, said applying step including effecting adsorption of the silicone rubber material onto biocompatible polyme­ric surface; and said providing step includes selecting said bio­compatible polymeric surface to have a surface tension that is greater than the predetermined ten­ sion of said silicone rubber material.
Claim 3
Dependent Claim 63 words
The treatment method according to claim 1 wherein said silicone rubber material of the crack preven­tative composition is a siloxane condensation reaction product of reactants including: a) a silicone moiety of the formula: wherein n has an average value of greater than 100; and b) an acetoxy silane crosslinker of the formula: R-Si O- -CH₃) p wherein p is 1, 2 or 3.
Claim 4
Dependent Claim 24 words
The treatment method according to claim 1 wherein said crack preventative composition includes a solvent that does not detrimentally affect said biocompatible polymeric surface.
Claim 5
Dependent Claim 25 words
The treatment method according to claim 1 wherein said shaped substrate includes one or more extruded fibers that are shaped by winding over a mandrel.
Claim 6
Dependent Claim 20 words
The treatment method according to claim 1, wherein said applying step includes imparing lubricating properties to the biocompatible polymeric surface.
Claim 7
Dependent Claim 15 words
The treatment method according to claim 1, wherein said biocompatible polymeric surface is a poly­urethane.
Claim 8
Dependent Claim 119 words
The forming method according to claim 1, wherein said silicone rubber material of the crack pre­ventative composition is a siloxane which, prior to curing, has the formula: wherein each group is an organic moiety selected from the group consisting of one or more ester moieties, acetoxy moieties, acrylic moieties and alcohol moieties, wherein each R₃ and R₄ group is an organic group selected from the group consisting of aliphatic groups and substituted aliphatic groups having from 1 to about 12 carbon atoms, and aromatic groups and substituted aromatic groups having from 6 to about 20 carbon atoms, and wherein each R₁ group and R₂ group is an organic component selected from the group consisting of R, R₃ and R₄.
Claim 9
Dependent Claim 20 words
The forming method according to claim 1, wherein said silicone rubber material of the crack preven­tative composition is poly(dimethyl siloxane).
Claim 10
Dependent Claim 20 words
The treatment method according to claim 1, wherein said shaped substrate includes one or more strands of said biocompatible polymer.
Claim 11
Dependent Claim 106 words
An implantable device for medical use under in vivo conditions, comprising: a shaped substrate of an implantable medical device having a biocompatible polymeric surface that is suspectible to biodegradation cracking when sub­jected to implantation under in vivo conditions for substantial time periods, said shaped substrate including wound strands of extruded fiber that overlie and intersect one another; a crack preventative adsorbed to said substrate, said crack preventative being a silicone rubber material having a predetermined surface tension, said crack preventative being a siloxane including recurring -O-Si-O- groups; and said biocompatible polymer surface has a surface tension greater than the predetermined surface tension of the crack preventative.
Claim 12
Dependent Claim 106 words
An implantable device for medical use under in vivo conditions, comprising: a shaped substrate of an implantable medical device having a biocompatible polymeric surface that is suspectible to biodegradation cracking when sub­jected to implantation under in vivo conditions for substantial time periods, said shaped substrate including wound strands of extruded fiber that overlie and intersect one another; a crack preventative adsorbed to said substrate, said crack preventative being a silicone rubber material having a predetermined surface tension, said crack preventative being a siloxane including recurring -O-Si-O- groups; and said biocompatible polymer surface has a surface tension greater than the predetermined surface tension of the crack preventative.
Claim 13
Dependent Claim 114 words
The implantable device according to claim 10 where­in said crack preventative is a siloxane which, prior to curing, has the formula: wherein each R group is an organic moiety selected from the group consisting of one or more ester moieties, acetoxy moieties, acrylic moieties and alcohol moieties, wherein each R₃ and R₄ group is an organic group selected from the group consisting of aliphatic groups and substituted aliphatic groups having from 1 to 12 carbon atoms, and aro­matic groups and substituted aromatic groups having from 6 to about 20 carbon atoms, and wherein each R₁ group and R₂ group is an organic component se­ lected from the group consisting of R, R₃ and R₄.
Claim 14
Dependent Claim 19 words
The implantable device according to claim 10 where­in said siliconerubber material of the crack pre­ventative compostion is poly(dimethyl siloxane).
Claim 15
Dependent Claim 20 words
The implantable device according to claim 10 where­in said shaped substrate includes one or more strands of said biocompatible polymer.
Claim 16
Dependent Claim 25 words
The implantable device according to claim 10 where­in said shaped substrate includes one or more ex­truded fibers that are shaped by winding over a mandrel.
Claim 17
Dependent Claim 44 words
The implantable device according to claim 10 where­in said biocompatible polymeric surface is a poly­mer selected from the group consisting of a poly­urethane, a poly(fluorosilicone urethane) copoly­mer, a polypropylene, an acrylate polymer, and other polymers having a surface tension greater than about 18 Dynes/cm.
Claim 18
Dependent Claim 15 words
The implantable device according to claim 10 where­in said shaped substrate is a vascular graft.
Claim 19
Dependent Claim 14 words
The implantable device according to claim 10 where­in said shaped substrate is a suture.

References Cited (Backward Citations)

GB913158A Cited
DE2556665A1 Cited
GB2033234A Cited
US4475972A Cited
US4678468A Cited
US4731080A Cited

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