Crack prevention of implanted prostheses
First Claim
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1. 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 polymeric surface that is elastomeric and susceptible to cracking when subjected to implantation under in vivo conditions for substantial time periods, said in vivo conditions including those that promote crack-forming degradation of said biocompatible polymeric surface, wherein said biocompatible polymeric surface is a polyurethane;
applying a crack preventative composition to said elastomeric biocompatible polymeric surface, said crack preventative composition including a silicone material being a siloxane including ##STR5## groups and, when polymerized, being elastomeric and having a predetermined surface tension, said applying step including efecting adsorption of the silicone material onto the biocompatible polymeric surface and bonding between said elastomeric silicone material and said elastomeric biocompatible polymeric surface so as to effect grafting of said polymerized elastomeric silicone material onto said elastomeric biocompatible polymeric surface; and
said providing step includes selecting said elastomeric biocompatible polymeric surface to have a surface tension that is greater than the predetermined surface tension of said silicone material.
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Abstract
Implantable devices having a biocompatible polymeric surface which is elastomeric and susceptible to cracking under in vivo conditions are provided which have been subjected to treatment with a crack preventative composition that includes an elastomeric silicone such as poly(dimethyl siloxane). This treatment substantially prevents cracking of the implantable device after it is implanted.
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Citations
18 Claims
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1. A method for forming an implantable device for medical use, which device is treated to substantially prevent in vivo cracking thereof, the method comprising:
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providing a non-woven shaped substrate of an implantable medical device having a biocompatible polymeric surface that is elastomeric and susceptible to cracking when subjected to implantation under in vivo conditions for substantial time periods, said in vivo conditions including those that promote crack-forming degradation of said biocompatible polymeric surface, wherein said biocompatible polymeric surface is a polyurethane; applying a crack preventative composition to said elastomeric biocompatible polymeric surface, said crack preventative composition including a silicone material being a siloxane including ##STR5## groups and, when polymerized, being elastomeric and having a predetermined surface tension, said applying step including efecting adsorption of the silicone material onto the biocompatible polymeric surface and bonding between said elastomeric silicone material and said elastomeric biocompatible polymeric surface so as to effect grafting of said polymerized elastomeric silicone material onto said elastomeric biocompatible polymeric surface; and said providing step includes selecting said elastomeric biocompatible polymeric surface to have a surface tension that is greater than the predetermined surface tension of said silicone material. - View Dependent Claims (2, 3, 4, 5, 6)
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7. A method for forming an implantable device for medical use, which device is treated to substantially prevent in vivo cracking thereof, the method comprising:
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providing a non-woven shaped substrate of an implantable medical device having a biocompatible polymeric surface that is elastomeric and susceptible to cracking when subjected to implantation under in vivo conditions for substantial time periods, said in vivo conditions including those that promote crack-forming degradation of said biocompatible polymeric surface, wherein said shaped substrate includes one or more extruded fibers that are shaped by winding over a mandrel; applying a crack preventative composition to said elastomeric biocompatible polymeric surface, said crack preventative composition including a silicone material being a siloxane including ##STR9## groups and, when polymerized, being elastomeric and having a predetermined surface tension, said applying step including effecting adsorption of the silicone material onto the biocompatible polymeric surface and bonding between said elastomeric silicone material and said elastomeric biocompatible polymeric surface so as to effect grafting of said polymerized elastomeric silicone material onto said elastomeric biocompatible polymeric surface; and said providing step includes selecting said elastomeric biocompatible polymeric surface to have a surface tension that is greater than the predetermined surface tension of said silicone material.
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8. A method for forming an implantable device for medical use, which device is treated to substantially prevent in vivo cracking thereof, the method comprising:
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providing a non-woven shaped substrate of an implantable medical device having a biocompatible polymeric surface that is elastomeric and susceptible to cracking when subjected to implantation under in vivo conditions for substantial time periods, said in vivo conditions including those that promote crack-forming degradation of said biocompatible polymeric surface, wherein said shaped substrate includes one or more strands of said biocompatible polymer; applying a crack preventative composition to said elastomeric biocompatible polymeric surface, said crack preventative composition including a silicone material being a siloxane including ##STR10## groups and, when polymerized, being elastomeric and having a predetermined surface tension, said applying step including effecting adsorption of the silicone material onto the biocompatible polymeric surface and bonding between said elastomeric silicone material and said elastomeric biocompatible polymeric surface so as to effect grafting of said polymerized elastomeric silicone material onto said elastomeric biocompatible polymeric surface; and said providing step includes selecting said elastomeric biocompatible polymeric surface to have a surface tension that is greater than the predetermined surface tension of said silicone material.
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9. An implantable device for medical use under in vivo conditions, comprising:
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a shaped substrate of an implantable medical device having a biocompatible polymeric surface that is elastomeric and susceptible to degradation cracking when subjected to implantation under in vivo conditions for substantial time periods; a crack preventative adsorbed to and grafted onto said substrate so that there is bonding between said elastomeric substrate and said crack preventative, said crack preventative being an elastomeric silicone material having a predetermined surface tension, said crack preventative being a siloxane including recurring ##STR11## groups;
said biocompatible polymeric surface has a surface tension greater than the predetermined surface tension of the crack preventative; andsaid elastomeric biocompatible polymeric surface is a polyurethane. - View Dependent Claims (10, 11, 12)
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13. An implantable device for medical use under in vivo conditions, comprising:
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a shaped substrate of an implantable medical device having a biocompatible polymeric surface that is elastomeric and susceptible to degradation cracking when subjected to implantation under in vivo conditions for substantial time periods, wherein said shaped substrate includes one or more strands of said biocompatible polymer; a crack preventative adsorbed to and grafted onto said substrate so that there is bonding between said elastomeric substrate and said crack preventative, said crack preventative being an elastomeric silicone material having a predetermined surface tension, said crack preventative being a siloxane including recurring ##STR13## groups; and
said biocompatible polymeric surface has a surface tension greater than the predetermined surface tension of the crack preventative.
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14. An implantable device for medical use under in vivo conditions, comprising:
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a shaped substrate of an implantable medical device having a biocompatible polymeric surface that is elastomeric and susceptible to degradation cracking when subjected to implantation under in vivo conditions for substantial time periods, wherein said shaped substrate includes one or more extruded fibers that are shaped by winding over a mandrel; a crack preventative adsorbed to and grafted onto said substrate so that there is bonding between said elastomeric substrate and said crack preventative, said crack preventative being an elastomeric silicone material having a predetermined surface tension, said crack preventative being a siloxane including recurring ##STR14## groups; and
said biocompatible polymeric surface has a surface tension greater than the predetermined surface tension of the crack preventative.
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15. An implantable device for medical use under in vivo conditions, comprising:
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a shaped substrate of an implantable medical device having a biocompatible polymeric surface that is elastomeric and susceptible to degradation cracking when subjected to implantation under in vivo conditions for substantial time periods; a crack preventative adsorbed to and grafted onto said substrate so that there is bonding between said elastomeric substrate and said crack preventative, said crack preventative being an elastomeric silicone material having a predetermined surface tension, said crack preventative being a siloxane including recurring ##STR15## groups;
said biocompatible polymeric surface has a surface tension greater than the predetermined surface tension of the crack preventative; andsaid shaped substrate is a graft including wound strands of extruded fiber that overlie and intersect one another, and said extruded fiber is said elastomeric biocompatible polymeric surface having said crack preventative bonded thereto.
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16. An implantable device for medical use under in vivo conditions, comprising:
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a shaped substrate of an implantable medical device having a biocompatible polymeric surface that is elastomeric and susceptible to degradation cracking when subjected to implantation under in vivo conditions for substantial time periods; a crack preventative adsorbed to and grafted onto said substrate so that there is bonding between said elastomeric substrate and said crack preventative, said crack preventative being an elastomeric silicone material having a predetermined surface tension, said crack preventative being a siloxane including recurring ##STR16## groups;
said biocompatible polymeric surface has a surface tension greater than the predetermined surface tension of the crack preventative; andsaid shaped substrate is a suture including an extruded fiber that is composed of said elastomeric biocompatible polymeric surface having said crack preventative bonded thereto.
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17. An implantable device for medical use under in vivo conditions, comprising:
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a shaped substrate of an implantable medical device having a biocompatible polymeric surface that is elastomeric and susceptible to degradation cracking when subjected to implantation under in vivo conditions for substantial time periods; a crack preventative adsorbed to and grafted onto said substrate so that there is bonding between said elastomeric substrate and said crack preventative, said crack preventative being an elastomeric silicone material having a predetermined surface tension, said crack preventative being a siloxane including recurring ##STR17## groups;
said biocompatible polymeric surface has a surface tension greater than the predetermined surface tension of the crack preventative; andsaid elastomeric biocompatible polymeric surface is a polyurethane, and said crack preventative bonded thereto is acetoxy terminated poly(dimethyl siloxane).
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18. A method for forming an implantable device for medical use, which device is treated to substantially prevent in vivo cracking thereof, the method comprising:
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providing a non-woven shaped substrate of an implantable medical device having a biocompatible polymeric surface that is elastomeric and susceptible to cracking when subjected to implantation under in vivo conditions for substantial time periods, said in vivo conditions including those that promote crack-forming degradation of said biocompatible polymeric surface, wherein said elastomeric biocompatible polymeric surface is a polyurethane, and wherein said crack preventative bonded thereto is acetoxy terminated poly(dimethyl siloxane); applying a crack preventative composition to said elastomeric biocompatible polymeric surface, said crack preventative composition including a silicone material being a siloxane including ##STR18## groups and, when polymerized, being elastomeric and having a predetermined surface tension, said applying step including effecting adsorption of the silicone material onto the biocompatible polymeric surface and bonding between said elastomeric silicone material and said elastomeric biocompatible polymeric surface so as to effect grafting of said polymerized elastomeric silicone material onto said elastomeric biocompatible polymeric surface; and said providing step includes selecting said elastomeric biocompatible polymeric surface to have a surface tension that is greater than the predetermined surface tension of said silicone material.
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Specification