摘要:
This invention is directed to improved blood contact devices such as vascular prostheses rendered substantially nonthrombogenic through addition of a preserved layer of extracellular subendothelial matrix. The preserved subendothelial matrix layer, which serves as the blood interface of the device, is analogous to the subendothelial matrix layer beneath the endothelium of native vascular surfaces. The device consists of a permanent synthetic base material, preferably porous expanded polytetrafluoroethylene, on which this biologic layer of subendothelial matrix is grown in situ. The biologic layer is produced using in vitro tissue culture methods whereby living cells synthesize and deposit extracellular matrix components, after which the cells are killed and/or removed and the subendothelial matrix layer preserved before implantation. A key aspect of this invention is that no living Cells are present in the final configuration, so that the likelihood of recipient immunological response is minimized. This invention results in vascular prostheses that are particularly useful for arterial bypass requiring a diameter of 6 mm or less.
摘要:
This invention relates to improved blood contact devices such as vascular prostheses rendered antithrombotic through the use of recipient endothelial cells grown on an appropriate subendothelial matrix. The subendothelial matrix layer, which serves as the substratum for growing endothelial cells, may be obtained from either natural donor vessels or from in vitro tissue culture sources. This subendothelial matrix is used in situ on the donor vessel, or is grown or applied to a synthetic component, preferably porous expanded polytetrafluoroethylene. Once this subendothelial matrix is prepared, recipient endothelial cells are seeded onto this matrix substratum, which then serves as the immediate blood contact surface. The endothelial cells may be applied as an intra-operative procedure, or grown on the subendothelial matrix substratum in vitro until the cells establish a confluent monolayer. A key aspect of this invention is that living, recipient endothelial cells are grown on the appropriate subendothelial matrix substratum, thereby providing a substantially nonthrombotic blood contact surface. Furthermore, the likelihood of recipient immunological response is minimized. This invention results in vascular prostheses that are particularly useful for arterial bypass requiring a diameter of 6 mm or less.
摘要:
A thin, biocompatible, high-strength, composite material is disclosed that is suitable for use in various implanted configurations. The composite material maintains flexibility in high-cycle flexural applications, making it particularly applicable to high-flex implants such as heart pacing lead or heart valve leaflet. The composite material includes at least one porous expanded fluoropolymer layer and an elastomeric material substantially filling substantially all of the pores of the porous expanded fluoropolymer.
摘要:
Described embodiments are directed toward prosthetic valves. A transcatheter valve has a generally tubular leaflet frame coaxially nested within a generally tubular outer frame. The leaflet frame defines a plurality of leaflet windows and a film defines a plurality leaflets extending therefrom. The outer frame provides frame elements that overlay the leaflet windows to provide structural support.
摘要:
A thin, biocompatible, high-strength, composite material is disclosed that is suitable for use in various implanted configurations. The composite material maintains flexibility in high-cycle flexural applications, making it particularly applicable to high-flex implants such as heart pacing lead or heart valve leaflet. An implantable article for regulating blood flow direction in a human patient, comprises a leaflet comprising more than one layer of the composite material. The composite material has at least one fluoropolymer layer having a plurality of pores and an elastomeric material present in substantially all of the pores of the fluoropolymer layers, less than about 80% fluoropolymer by weight and an additional material layer between the layers of the composite material.
摘要:
A thin, biocompatible, high-strength, composite material is disclosed that is suitable for use in various implanted configurations. In one aspect, the composite material maintains flexibility in high-cycle flexural applications, making it particularly applicable to high-flex implants such as heart pacing lead or heart valve leaflet. The composite material includes a porous expanded fluoropolymer membrane and an elastomer, wherein the elastomer is present in substantially all of the pores of the porous expanded fluoropolymer, and the composite material comprising less than about 80% fluoropolymer by weight.
摘要:
A leaflet for a prosthetic valve formed of at least one layer that includes a composite material containing at least one expanded fluoropolymer membrane and an elastomer. The composite material exhibits an increase in stiffness when elongated to at least about 30% strain. The fluoropolymer may be polytetrafluoroethylene. The elasticity within the leaflets permits, among other things, the leaflets to bend with a reduced occurrence of wrinkles as the valve opens and closes. The elastic properties of the leaflet also, among other things, improve bending properties and reduce closure stresses, thereby extending the life of the leaflet.
摘要:
A thin, biocompatible, high-strength, composite material is disclosed that is suitable for use in various implanted configurations. The composite material maintains flexibility in high-cycle flexural applications, making it particularly applicable to high-flex implants such as heart pacing lead or heart valve leaflet. An implantable article for regulating blood flow direction in a human patient, comprises a leaflet comprising more than one layer of the composite material. The composite material has at least one fluoropolymer layer having a plurality of pores and an elastomeric material present in substantially all of the pores of the fluoropolymer layers, less than about 80% fluoropolymer by weight and an additional material layer between the layers of the composite material.
摘要:
A thin, biocompatible, high-strength, composite material is disclosed that is suitable for use in various implanted configurations. The composite material maintains flexibility in high-cycle flexural applications, making it particularly applicable to high-flex implants such as heart pacing lead or heart valve leaflet. The composite material includes at least one porous expanded fluoropolymer layer and an elastomeric material substantially filling substantially all of the pores of the porous expanded fluoropolymer.