Durable high strength polymer composite suitable for implant and articles produced therefrom

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 fills substantially all of the pores of the porous expanded fluoropolymer, and the composite material comprising less than about 80% fluoropolymer by weight.

Durable multi-layer high strength polymer composite suitable for implant and articles produced therefrom

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 elastomer substantially filling substantially all of the pores of the porous expanded fluoropolymer.

DURABLE HIGH STRENGTH POLYMER COMPOSITE SUITABLE FOR IMPLANT AND ARTICLES PRODUCED THEREFROM

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 fills substantially all of the pores of the porous expanded fluoropolymer, and the composite material comprising less than about 80% fluoropolymer by weight. 1. An implantable article for regulating blood flow direction in a human patient , said implantable article comprising:a leaflet comprising a composite material having at least one fluoropolymer layer having a plurality of pores and an elastomer present in substantially all of the pores of the at least one fluoropolymer layer, the composite material comprising less than about 80% fluoropolymer by weight.2. The implantable article as set forth in claim 1 , wherein the composite material comprising less than about 70% fluoropolymer by weight.3. The implantable article as set forth in claim 1 , wherein the composite material comprising less than about 60% fluoropolymer by weight.4. The implantable article as set forth in claim 1 , wherein the composite material comprising less than about 50% fluoropolymer by weight.5. The implantable article as set forth in claim 1 , wherein the composite material further includes a layer of the elastomer.6. The implantable article as set forth in claim 5 , wherein the elastomer is a fluoroelastomer.7. The implantable article as set forth in claim 6 , wherein the elastomer is a TFE/PMVE copolymer.8. The implantable article as set forth in claim 7 , wherein the copolymer consists essentially of between about 40 and 80 weight percent perfluoromethyl vinyl ether and complementally 60 and 20 weight percent tetrafluoroethylene.9. The implantable ...

METHODS OF MAKING A DURABLE MULTI-LAYER HIGH STRENGTH POLYMER COMPOSITE SUITABLE FOR PROSTHETIC VALVES

Methods are presented that provide a thin, biocompatible, high-strength, composite material that is suitable for use in prosthetic valves. The composite material maintains flexibility in high-cycle flexural applications, making it particularly applicable to prosthetic valve leaflets. The composite material includes more than one porous expanded fluoropolymer layer and an elastomer present in the pores of the porous expanded fluoropolymer. 1. A method of making a leaflet of a prosthetic valve , the method comprising:providing a composite material having more than one fluoropolymer layer having a plurality of pores and an elastomer present in the pores of the more than one fluoropolymer layer; andbringing more than one layer of the composite material into contact with additional layers of the composite material by wrapping a sheet of the composite material with a starting and ending point adhered to itself at a seam.2. The method of making a leaflet of a prosthetic valve as set forth in claim 1 , further comprising adhering the more than one layer of the composite material to an adjacent layer of the composite material.3. The method of making a leaflet of a prosthetic valve as set forth in claim 2 , further comprising:disposing a layer of the elastomer between the more than one layer of the composite material and the adjacent layer of the composite material; andadhering the more than one layer of the composite material to the adjacent layer of the composite material via the layer of the elastomer.4. The method of making a leaflet of a prosthetic valve as set forth in claim 2 , further comprising:disposing a layer of the elastomer between the more than one fluoropolymer layer; andadhering the more than one fluoropolymer layer to an adjacent fluoropolymer layer via the layer of the elastomer.5. The method of making a leaflet of a prosthetic valve as set forth in claim 3 , further comprising:disposing a layer of the elastomer between the more than one fluoropolymer layer ...

METHODS OF MAKING A PROSTHETIC VALVE WITH A DURABLE HIGH STRENGTH POLYMER COMPOSITE LEAFLET

Methods are provided to make a prosthetic valve having a thin, biocompatible, high-strength, composite material. In one aspect, the composite material maintains flexibility in high-cycle flexural applications, making it particularly applicable to high-flex implants such as a heart valve leaflet. The composite material includes a porous expanded fluoropolymer membrane and an elastomer, wherein the elastomer is present in the pores of the porous expanded fluoropolymer. 1. A method of making a prosthetic valve , comprising:providing a support structure defining a plurality of posts; andcoupling a leaflet to each of the plurality of posts, each leaflet movable between open and closed positions, each leaflet including at least three layers of a composite material, the composite material including a fluoropolymer layer having a plurality of pores and an elastomer present in the pores of the fluoropolymer layer, the at least three layers of composite material being coupled together with a layer of the elastomer between each of the at least three layers of composite material, a method of making the composite material comprising:dissolving an elastomer in a solvent suitable to create a solution to fill the pores of the fluoropolymer layer;filling the pores of the fluoropolymer layer; andallowing the solvent to evaporate so that the elastomer remains in the pores of the fluoropolymer layer.2. The method of claim 1 , further comprising polymerizing the elastomer within the pores of the fluoropolymer layer.3. A method of making a prosthetic valve claim 1 , comprising:providing a support structure defining a plurality of posts; andcoupling a leaflet to each of the plurality of posts, each leaflet movable between open and closed positions, each leaflet including at least three layers of a composite material, the composite material including a fluoropolymer layer having a plurality of pores and an elastomer present in the pores of the fluoropolymer layer, the at least three layers ...

Puncturable and resealable graft

Implantable grafts, particularly for arteriovenous access that may be punctured by an object such as a needle and, following removal of the object, will reseal the resulting hole to the extent of reducing fluid leakage through the graft at the puncture site to an amount less than would be typical for a conventional graft. More particularly, the grafts comprise three layers; an inner layer of implantable graft material such as ePTFE, a middle layer of self sealing elastomeric material such as silicone, and an outer layer of implantable graft material such as ePTFE. Following manufacture, the tubular form of the three-layer graft is everted to put substantially the entire wall thickness of the elastomeric material layer under circumferential compression.

Durable high strength polymer composites suitable for implant and articles produced therefrom

Thin, biocompatible, high-strength, composite materials are disclosed that are suitable for use in a valve for regulating blood flow direction. In one aspect, the composite material maintains flexibility in high-cycle flexural applications, making it particularly applicable to high-flex implants such as a prosthetic heart valve leaflet. The composite material includes a porous polymer membrane and an elastomer, wherein the elastomer fills substantially all of the pores of the porous polymer membrane.

COHERENT SINGLE LAYER HIGH STRENGTH SYNTHETIC POLYMER COMPOSITES FOR PROSTHETIC VALVES

Thin, biocompatible, high-strength, composite materials are disclosed that are suitable for use in a prosthetic valve for regulating blood flow direction. In one aspect, the leaflet material maintains flexibility in high-cycle flexural applications, making it particularly applicable to high-flex implants such as a prosthetic heart valve leaflet. The leaflet material includes a coherent single layer and an elastomer, wherein the elastomer is present in the pores of the porous coherent single layer. 1. A prosthetic valve comprising:a frame; anda leaflet coupled to the frame, the leaflet including at least one coherent single layer and an elastomeric material, wherein the at least one coherent single layer comprises a fluoropolymer and the elastomeric material comprises a TFE/PMVE copolymer.2. The prosthetic valve of claim 1 , wherein the TFE/PMVE copolymer comprises from about 40 to about 80 weight percent perfluoromethyl vinyl ether and from about 60 to about 20 weight percent tetrafluoroethylene and wherein the fluoropolymer is ePTFE.3. The prosthetic valve of claim 2 , wherein the TFE/PMVE copolymer consisting essentially of between about 40 and about 80 weight percent perfluoromethyl vinyl ether and complementally between about 60 and about 20 weight percent tetrafluoroethylene.4. The prosthetic valve of claim 1 , wherein the leaflet has a light transmission of more than 60% at a 550 μm wavelength.5. The prosthetic valve of claim 4 , wherein the leaflet has a light transmission of more than 75% at a 550 μm wavelength.6. The prosthetic valve of claim 5 , wherein the leaflet has a light transmission of more than 90% at a 550 μm wavelength.7. A prosthetic valve of claim 1 , wherein the leaflet has a liquid pickup of less than 10%.8. The prosthetic valve of claim 7 , wherein the leaflet has a liquid pickup of less than 5%.9. The prosthetic valve of claim 8 , wherein the leaflet has a liquid pickup of less than 3%.10. The prosthetic valve of claim 1 , wherein the ...

DURABLE HIGH STRENGTH POLYMER COMPOSITES SUITABLE FOR PROSTHETIC VALVES

Thin, biocompatible, high-strength, composite materials are disclosed that are suitable for use in a valve for regulating blood flow direction. In one aspect, the composite material maintains flexibility in high-cycle flexural applications, making it particularly applicable to high-flex implants such as a prosthetic heart valve leaflet. The composite material includes a porous polymer membrane and an elastomer or elastomeric material, wherein the elastomer or elastomeric material fills substantially all of the pores of the porous polymer membrane. 1. A valve , comprising:at least one leaflet operable to move between open and closed positions, each leaflet including a composite material comprising a synthetic polymer membrane and an elastomer or elastomeric material, the synthetic polymer membrane comprising fibers that define space therebetween defining pores, wherein a diameter of a majority of the fibers is less than about 1 μm, the elastomer or elastomeric material being disposed in substantially all of the pores.2. The valve of claim 1 , wherein the composite material further includes a layer of one of the elastomer or elastomeric material.3. The valve of claim 1 , wherein the composite material comprises elastomer or elastomeric material by weight in a range from about 10% to about 90%.4. The valve of claim 1 , wherein the elastomer or elastomeric material is a TFE/PMVE (tetrafluoroethylene-perfluoromethylvinyl ether) copolymer.5. The valve of claim 4 , wherein the TFE/PMVE copolymer consists essentially of between about 40 and 80 weight percent perfluoromethyl vinyl ether and complementally 60 and 20 weight percent tetrafluoroethylene.6. The valve of claim 1 , wherein the elastomer or elastomeric material is a fluoroelastomer.7. The valve of claim 1 , wherein the elastomer or elastomeric material is selected from the group consisting of TFE/PMVE (tetrafluoroethylene-perfluoromethylvinyl ether) copolymer claim 1 , TFE-PAVE (tetrafluoroethylene-perfluoro (alkyl ...

PUNCTURABLE AND RESEALABLE GRAFT

Implantable grafts, particularly for arteriovenous access that may be punctured by an object such as a needle and, following removal of the object, will reseal the resulting hole to the extent of reducing fluid leakage through the graft at the puncture site to an amount less than would be typical for a conventional graft. More particularly, the grafts comprise three layers; an inner layer of implantable graft material such as ePTFE, a middle layer of self sealing elastomeric material such as silicone, and an outer layer of implantable graft material such as ePTFE. Following manufacture, the tubular form of the three-layer graft is everted to put substantially the entire wall thickness of the elastomeric material layer under circumferential compression. 1. An implantable stent-graft having a diametrically compacted , insertion profile and a diametrically expanded , deployed profile , the stent-graft comprising:a stent having a tubular shape; and an outer tubular member formed of a graft material, the outer tubular member defining an inner surface, an outer surface, and a thickness between the inner and outer surfaces, an entirety of the thickness being under circumferential tension;', 'an inner tubular member formed of a graft material, the inner tubular member defining an inner surface, an outer surface, and a thickness between the inner and outer surfaces, an entirety of the thickness of the inner tubular member being under radial compression by the outer tubular member; and', 'an elastomeric coating between the inner and outer tubular members, an entirety of the thickness of the elastomeric coating being under radial compression by the outer tubular member., 'a graft secured to the stent, the graft including,'}2. The stent-graft of claim 1 , wherein the insertion profile corresponds to a maximum diameter of about 13 French.3. The stent-graft of claim 1 , wherein the stent is configured as a self-expanding stent.4. The stent-graft of claim 1 , wherein the stent is ...

Methods of making durable multi-layer high strength polymer composite suitable for implant and articles produced therefrom

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.

COHERENT SINGLE LAYER HIGH STRENGTH SYNTHETIC POLYMER COMPOSITES FOR PROSTHETIC VALVES

Thin, biocompatible, high-strength, composite materials are disclosed that are suitable for use in a prosthetic valve for regulating blood flow direction. In one aspect, the leaflet material maintains flexibility in high-cycle flexural applications, making it particularly applicable to high-flex implants such as a prosthetic heart valve leaflet. The leaflet material includes a coherent single layer and an elastomer, wherein the elastomer is present in the pores of the porous coherent single layer. 1. A prosthetic valve comprising:a frame; anda leaflet coupled to the frame and movable between open and closed positions, the leaflet comprising at least one coherent single layer comprising an elastomer or elastomeric material and a synthetic polymer, wherein the leaflet is impermeable, and wherein the leaflet has a tensile strength in at least two orthogonal directions greater than about 35 MPa.2. The prosthetic valve of claim 1 , comprising only one coherent single layer.3. The prosthetic valve of claim 2 , wherein the leaflet has a break force of greater than about 1 N/mm.4. The prosthetic valve of claim 2 , wherein the leaflet has a break force of greater than about 2 N/mm.5. The prosthetic valve of claim 2 , wherein the leaflet has a break force of greater than about 3 N/mm.6. The prosthetic valve of claim 1 , wherein the leaflet has a thickness of less than about 1 micron.7. The prosthetic valve of claim 1 , wherein the leaflet comprises elastomer or elastomeric material by weight in a range from about 35% to about 90%.8. The prosthetic valve of claim 1 , wherein the elastomer or elastomeric material is selected from the group consisting of silicones claim 1 , fluoroelastomers claim 1 , urethanes claim 1 , and mixtures thereof.9. The prosthetic valve of claim 1 , wherein the elastomer or elastomeric material is a TFE/PMVE copolymer.10. The prosthetic valve of claim 9 , wherein the TFE/PMVE copolymer comprises from about 40 to about 80 weight percent perfluoromethyl ...

DURABLE MULTI-LAYER HIGH STRENGTH POLYMER COMPOSITE SUITABLE FOR IMPLANT AND ARTICLES PRODUCED THEREFROM

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 a prosthetic heart valve leaflet. The composite material includes at least one porous expanded fluoropolymer layer and an elastomer present in the pores of the porous expanded fluoropolymer. 1. A prosthetic valve , comprising:a leaflet comprising more than one layer of a composite material having at least one fluoropolymer layer having a plurality of pores and TFE/PMVE copolymer substantially filling the pores of the at least one fluoropolymer layer, the composite material comprising less than about 80% fluoropolymer by weight, the more than one layer of composite material being coupled together via the TFE/PMVE copolymer.2. The prosthetic valve as set forth in claim 1 , the leaflet having a ratio of leaflet thickness (μm) to number of fluoropolymer layers of less than about 5.3. The prosthetic valve as set forth in claim 1 , wherein the leaflet has a bending modulus of less than about 100 MPa.4. The prosthetic valve as set forth in claim 1 , wherein the leaflet is operatively coupled to a support frame and movable between closed and open configurations relative to the support frame.5. The prosthetic valve as set forth in claim 4 , wherein the support frame is selectively diametrically adjustable for endovascular delivery and deployment at a treatment site.6. The prosthetic valve as set forth in claim 1 , wherein the composite material comprises less than about 70% fluoropolymer by weight.7. The prosthetic valve as set forth in claim 1 , wherein the TFE/PMVE copolymer comprises essentially of between about 40 and 80 weight percent perfluoromethyl vinyl ether and complementally 60 and 20 weight percent tetrafluoroethylene.8. The prosthetic valve as set forth in claim 1 , wherein the leaflet has ...

COHERENT SINGLE LAYER HIGH STRENGTH SYNTHETIC POLYMER COMPOSITES FOR PROSTHETIC VALVES

Thin, biocompatible, high-strength, composite materials are disclosed that are suitable for use in a prosthetic valve for regulating blood flow direction. In one aspect, the leaflet material maintains flexibility in high-cycle flexural applications, making it particularly applicable to high-flex implants such as a prosthetic heart valve leaflet. The leaflet material includes a coherent single layer and an elastomer, wherein the elastomer is present in the pores of the porous coherent single layer. 1. A prosthetic valve comprising:a frame; anda leaflet coupled to the frame and movable between open and closed positions, the leaflet including at least one coherent single layer and an elastomer, the coherent single layer having pores and is a synthetic polymer, the elastomer present in the pores such that the coherent single layer is impermeable.2. The prosthetic valve of claim 1 , comprising only one coherent single layer.3. The prosthetic valve of claim 1 , wherein the at least one coherent single layer has a microporous structure.4. The prosthetic valve of claim 1 , wherein the at least one coherent single layer is a single ply of porous synthetic polymer membrane.5. The prosthetic valve of claim 4 , wherein the at least one coherent single layer comprises fibers that define space therebetween claim 4 , wherein a diameter of a majority of the fibers is less than 1.0 μm claim 4 , the space between the fibers defining the pores that have a pore size that is less than about 5 μm claim 4 , wherein the leaflet has a tensile strength in at least two orthogonal directions greater than about 35 MPa.6. The prosthetic valve of claim 4 , wherein the at least one coherent single layer comprises fibers that define space therebetween claim 4 , wherein a diameter of a majority of the fibers is less than 1.0 μm claim 4 , the space between the fibers defining the pores that have a pore size that is less than about 5 μm claim 4 , wherein the leaflet has a break force of greater than ...

SUBSTRATE WITH ROTATABLE STRUTS FOR MEDICAL DEVICE

A medical device comprises a substrate () defining a major surface () defining a plane, including a plurality of first struts () along a first direction interconnected with a plurality of second struts () extending along a second direction not parallel with the first direction, wherein widths () of the second struts as measured along the major surface are larger than thicknesses of the second struts as measured perpendicular to the major surface such that when the substrate is stretched in the first direction, intermediate sections () of the second struts () rotate relative to the first struts () and the intermediate sections of the second struts bend out of the plane of the major surface. The medical device is operable to extend and/or retract elements suitable for a particular purpose. The elements are extended and/or retracted in response to a stress applied by way of stretching and/or retracting the device, among other methods. The elements may remain extended and/or retracted or may recoil back to an initial position upon the removal of the force. In various embodiments, the elements are used to treat or deliver treatment to a target site within a body. 1. A medical device comprising:a substrate defining a major surface, the major surface defining a plane, the major surface including a plurality of first struts extending along a first direction that are interconnected with a plurality of second struts extending along a second direction not parallel with the first direction along the major surface,wherein widths of the second struts as measured along the major surface are larger than thicknesses of the second struts as measured perpendicular to the major surface such that when the substrate is stretched in the first direction, intermediate sections of the second struts rotate relative to the first struts and the intermediate sections of the second struts bend out of the plane of the major surface.2. The medical device of claim 1 , wherein the first direction is ...

FRAME WITH INTEGRAL SEWING CUFF FOR PROSTHETIC VALVES

Described embodiments are related to a prosthetic valve for surgical placement with a sewing cuff durably attached to a frame. The durability of the attachment is accomplished by sandwiching a fabric between the frame and a composite material. The fabric extends beyond the frame base to form a sewing cuff that is integral to a frame assembly. The sewing cuff facilitates tissue ingrowth while tissue ingrowth is discouraged elsewhere around the frame. 1. A prosthetic valve frame assembly , comprising:a frame defining a tubular shape;a fabric having fabric pores, the fabric defining a fabric frame portion and a sewing cuff opposite the fabric frame portion, the fabric frame portion having an elastomer present in the fabric pores, the fabric frame portion being coupled to the frame; anda composite material coupled to at least a portion of the fabric frame portion with the fabric frame portion disposed between the frame and the composite material, the sewing cuff extending from the frame.2. The prosthetic valve frame assembly of claim 1 , the frame having a frame inside surface and a frame outside surface opposite the frame inside surface claim 1 , the fabric frame portion being coupled to the frame inside surface claim 1 , the fabric frame portion disposed between the frame inside surface and the composite material.3. The prosthetic valve frame assembly of claim 1 , the frame having a frame inside surface and a frame outside surface opposite the frame inside surface claim 1 , the fabric frame portion being coupled to the frame outside surface claim 1 , the fabric frame portion disposed between the frame outside surface and the composite material.4. The prosthetic valve frame assembly of claim 1 , the frame having a frame inside surface and a frame outside surface opposite the frame inside surface claim 1 , the fabric frame portion being coupled to the frame inside surface and the frame outside surface claim 1 , the fabric frame portion disposed between the frame inside ...

Methods of making durable multi-layer high strength polymer composite suitable for implant and articles produced therefrom

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.

PUNCTURABLE AND RESEALABLE GRAFT

Implantable grafts, particularly for arteriovenous access that may be punctured by an object such as a needle and, following removal of the object, will reseal the resulting hole to the extent of reducing fluid leakage through the graft at the puncture site to an amount less than would be typical for a conventional graft. More particularly, the grafts comprise three layers; an inner layer of implantable graft material such as ePTFE, a middle layer of self sealing elastomeric material such as silicone, and an outer layer of implantable graft material such as ePTFE. Following manufacture, the tubular form of the three-layer graft is everted to put substantially the entire wall thickness of the elastomeric material layer under circumferential compression. 1. An implantable device comprising a tubular structure including a first layer , a second layer , and an elastomeric layer between the first and second layers , an entire thickness of which is under circumferential compression following eversion of the tubular structure , the tubular structure having a first outside diameter prior to eversion , wherein when everted the tubular structure has a second outside diameter that is larger than the first outside diameter , and wherein the tubular structure has a wall thickness and the second outside diameter is larger than the first outside diameter by an amount that is equal to or greater than the wall thickness.2. The implantable device of claim 1 , wherein the implantable device is a vascular graft.3. The implantable device of claim 1 , wherein each of the first and second layers of the tubular structure include graft layers formed of ePTFE.4. The implantable device of claim 1 , wherein the elastomeric layer includes silicone.5. The implantable device of claim 1 , wherein the elastomeric layer includes a fluoroelastomer.6. The implantable device of claim 1 , wherein the elastomeric layer includes a copolymer of tetrafluoroethylene and polyalkylvinylether.7. The implantable ...

DURABLE HIGH STRENGTH POLYMER COMPOSITES SUITABLE FOR IMPLANT AND ARTICLES PRODUCED THEREFROM

Thin, biocompatible, high-strength, composite materials are disclosed that are suitable for use in a valve for regulating blood flow direction. In one aspect, the composite material maintains flexibility in high-cycle flexural applications, making it particularly applicable to high-flex implants such as a prosthetic heart valve leaflet. The composite material includes a porous polymer membrane and an elastomer, wherein the elastomer fills substantially all of the pores of the porous polymer membrane. 1110-. (canceled)111. A valve , comprising:a support structure, andat least one leaflet being supported on the support structure and movable between open and closed positions, each leaflet including a composite material comprising at least one synthetic polymer membrane and an elastomeric material, the at least one synthetic polymer membrane comprising fibers that define space therebetween, wherein a diameter of a majority of the fibers is less than about 1 μm, the space between the fibers defining pores, the elastomeric material being disposed in substantially all of the pores.112. The valve of claim 111 , wherein the composite material further includes a layer of the elastomeric material.113. The valve of claim 111 , wherein the composite material comprises elastomeric material by weight in a range from about 10% to about 90%.114. The valve of claim 111 , wherein the elastomeric material is a TFE/PMVE copolymer.115. The valve of claim 114 , wherein the TFE/PMVE copolymer consists essentially of between about 40 and 80 weight percent perfluoromethyl vinyl ether and complementally 60 and 20 weight percent tetrafluoroethylene.116. The valve of claim 111 , wherein the elastomeric material is a fluoroelastomer.117. The valve of claim 111 , wherein the elastomeric material is a TFE/PMVE (tetrafluoroethylene-perfluoromethylvinyl ether) copolymer.118. The valve of claim 111 , wherein the elastomeric material is selected from the group consisting of TFE/PMVE ( ...

DURABLE HIGH STRENGTH POLYMER COMPOSITE SUITABLE FOR IMPLANT AND ARTICLES PRODUCED THEREFROM

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 a prosthetic heart valve leaflet. The composite material includes a porous expanded fluoropolymer membrane and an elastomer, wherein the elastomer is present in the pores of the porous expanded fluoropolymer. 1. A prosthetic valve , comprising:a frame; anda leaflet coupled to the frame and movable between an open and closed position, the leaflet comprising a composite material having at least one fluoropolymer layer having a plurality of pores and an elastomer present in the pores,wherein the at least one fluoropolymer layer exhibits a ratio of matrix tensile strength in two orthogonal directions of less than 2.2. The prosthetic valve as set forth in claim 1 , wherein the composite material has two or more fluoropolymer layers having a plurality of pores and the elastomer present in the pores claim 1 , wherein the two or more fluoropolymer layers are coupled together via the elastomer.3. The prosthetic valve as set forth in claim 1 , wherein the composite material comprises less than about 80% fluoropolymer by weight.4. The prosthetic valve as set forth in claim 1 , wherein the composite material comprises less than about 70% fluoropolymer by weight.5. The prosthetic valve as set forth in claim 1 , wherein the composite material comprises less than about 60% fluoropolymer by weight.6. The prosthetic valve as set forth in claim 5 , wherein the fluoropolymer is PTFE.7. The prosthetic valve as set forth in claim 6 , wherein the PTFE is ePTFE.8. The prosthetic valve as set forth in claim 7 , wherein the composite material comprises less than about 50% fluoropolymer by weight.9. The prosthetic valve as set forth in claim 1 , wherein the elastomer is a fluoroelastomer.10. The ...

DURABLE MULTI-LAYER HIGH STRENGTH POLYMER COMPOSITE SUITABLE FOR IMPLANT AND ARTICLES PRODUCED THEREFROM

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 a prosthetic heart valve leaflet. The composite material includes at least one porous expanded fluoropolymer layer and an elastomer present in the pores of the porous expanded fluoropolymer. 1. A prosthetic valve , comprising:a leaflet cyclable between a closed configuration for substantially preventing blood flow through the prosthetic valve and an open configuration allowing blood flow through the prosthetic valve, the leaflet having a thickness and formed from a composite material having more than one fluoropolymer layer having a plurality of pores and an elastomer present in the pores of the more than one fluoropolymer layer, the more than one fluoropolymer layer being coupled together via the elastomer, the leaflet having a ratio of leaflet thickness (μm) to number of layers of fluoropolymer of less than about 5.2. The prosthetic valve as set forth in claim 1 , wherein the ratio of leaflet thickness (μm) to number of fluoropolymer layers of less than about 3.3. The prosthetic valve as set forth in claim 1 , wherein the ratio of leaflet thickness (μm) to number of fluoropolymer layers of less than about 1.4. The prosthetic valve as set forth in claim 1 , wherein the ratio of leaflet thickness (μm) to number of fluoropolymer layers of less than about 0.5.5. The prosthetic valve as set forth in claim 1 , wherein the leaflet encompasses a radiopaque element.6. The prosthetic valve as set forth in claim 1 , wherein the leaflet has at least 10 fluoropolymer layers and a composite material comprising less than about 50% fluoropolymer by weight.7. The prosthetic valve as set forth in claim 6 , wherein the leaflet has a thickness less than 100 μm.8. The prosthetic valve as set forth in claim 7 , ...

Frame with integral sewing cuff for prosthetic valves

Described embodiments are related to a prosthetic valve for surgical placement with a sewing cuff durably attached to a frame. The durability of the attachment is accomplished by sandwiching a fabric between the frame and a composite material. The fabric extends beyond the frame base to form a sewing cuff that is integral to a frame assembly. The sewing cuff facilitates tissue ingrowth while tissue ingrowth is discouraged elsewhere around the frame.

DURABLE HIGH STRENGTH COMPOSITE PROSTHETIC VALVE LEAFLETS

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 membrane. 1. A prosthetic valve , comprising:a support structure, andat least one leaflet being supported on the support structure and movable between open and closed positions, each leaflet including at least one composite layer comprising one fluoropolymer membrane having a plurality of pores and an elastomer or elastomeric material present in substantially all of the pores of the fluoropolymer membrane, wherein the fluoropolymer membrane comprises fibrils, wherein a diameter of a majority of the fibrils is less than 1 μm.2. The prosthetic valve of claim 1 , wherein the elastomer or elastomeric material is a fluoroelastomer.3. The prosthetic valve of claim 1 , wherein the elastomer or elastomeric material is a tetrafluoroethylene/perfluoromethyl vinyl ether (TFE/PMVE) copolymer.4. The prosthetic valve of claim 3 , wherein the TFE/PMVE copolymer comprises essentially of between about 40 and 80 weight percent perfluoromethyl vinyl ether and complementally 60 and 20 weight percent tetrafluoroethylene.5. The prosthetic valve of claim 1 , wherein the fluoropolymer membrane is a polytetrafluoroethylene (PTFE) membrane.6. The prosthetic valve of claim 5 , wherein the PTFE membrane is an expanded PTFE (ePTFE) membrane.7. The prosthetic valve of claim 3 , wherein the fluoropolymer membrane is polytetrafluoroethylene (PTFE) membrane.8. The prosthetic valve of claim 7 , wherein the PTFE membrane is an expanded PTFE (ePTFE) membrane.9. The prosthetic valve of claim 8 , wherein the leaflet exhibits a ratio of tensile strength in two orthogonal directions of less than 1.5.10. The prosthetic ...

FLUID HANDLING DETECTORS

Described herein are devices for collecting and analyzing a fluid sample, the devices comprising a fluid-collecting porous material comprising at least one hydrophilic porous layer and one or more sensors adapted to provide a response to the presence of an analyte. The detectors are useful for collecting and analyzing a very small volume of sample and may include features that facilitate and direct flow of the sample through porous material. 1. A detector comprising: wherein the first layer comprises a synthetic porous membrane having a first average pore size,', 'wherein at least a portion of the first layer is hydrophilic, and', 'wherein the first layer is configured to conform to the skin;, 'a first layer having a first side and a second side opposite the first side,'} wherein the second layer is coupled to the first layer such that at least a portion of the first side of the second layer is directly adjacent to at least a portion of the second side of the first layer,', 'wherein the second layer comprises a synthetic porous membrane having a second average pore size that is smaller than the first average pore size, and', 'wherein at least a portion of the second layer is hydrophilic; and, 'a second layer having a first side and a second side opposite the first side,'} 'wherein the at least one sensor is mounted to at least one of (a) the first layer, or (b) the second layer.', 'at least one sensor configured to detect the an analyte in a sample collected on skin of a subject,'}2. (canceled)3. The detector of claim 2 , further comprising a liquid-proof layer overlaying at least a portion of the second side of the second layer so as to cover the at least one sensor.4. The detector of claim 1 , wherein the second layer includes a hydrophilic region and a hydrophobic region.5. The detector of claim 4 , wherein the at least one sensor is mounted to the second side of the second layer so as to be positioned on the hydrophilic region of the second layer.6. The detector ...

Frame with integral sewing cuff for prosthetic valves

A prosthetic valve (100) for surgical placement with a sewing cuff (116) durably attached to a frame (110). The durability of the attachment is accomplished by sandwiching a fabric (112) between the frame (110) and a composite material (118). The fabric(112) extends beyond the frame base (140) to form a sewing cuff (116) that is integral to a frame assembly. The sewing cuff (116) facilitates tissue ingrowth while tissue ingrowth is discouraged elsewhere around the frame.

Flexible and durable printed circuits on stretchable and non-stretchable substrates

The present invention is directed to flexible conductive articles (600) that include a printed circuit (650) and a stretchable or non- stretchable substrate (610). In some embodiments, the substrate has a printed circuit on both sides. The printed circuit contains therein a porous synthetic polymer membrane (660) and an electrically conductive trace (670) as well as a non-conducive region (640). The electrically conductive trace is imbibed or otherwise incorporated into the porous synthetic polymer membrane. In some embodiments, the synthetic polymer membrane is microporous. The printed circuit may be discontinuously bonded to the stretchable or non-stretchable substrate by adhesive dots (620). The printed circuits may be integrated into garments, such as smart apparel or other wearable technology.

Puncturable and resealable graft

Implantable grafts, particularly for arteriovenous access that may be punctured by an object such as a needle and, following removal of the object, will reseal the resulting hole to the extent of reducing fluid leakage through the graft at the puncture site to an amount less than would be typical for a conventional graft. More particularly, the grafts comprise three layers; an inner layer of implantable graft material such as ePTFE, a middle layer of self-sealing elastomeric material such as silicone, and an outer layer of implantable graft material such as ePTFE. Following manufacture, the tubular form of the three-layer graft is everted to put substantially the entire wall thickness of the elastomeric material layer under circumferential compression.

Durable high strength polymer composite suitable for implant and articles produced therefrom

Frame with integral sewing cuff for prosthetic valves

A prosthetic valve (100) for surgical placement with a sewing cuff (116) durably attached to a frame (110). The durability of the attachment is accomplished by sandwiching a fabric (112) between the frame (110) and a composite material (118). The fabric(112) extends beyond the frame base (140) to form a sewing cuff (116) that is integral to a frame assembly. The sewing cuff (116) facilitates tissue ingrowth while tissue ingrowth is discouraged elsewhere around the frame.

Coherent single layer high strength synthetic polymer composites for prosthetic valves

Thin, biocompatible, high-strength, composite materials are disclosed that are suitable for use in a prosthetic valve for regulating blood flow direction. In one aspect, the leaflet material maintains flexibility in high-cycle flexural applications, making it particularly applicable to high-flex implants such as a prosthetic heart valve leaflet. The leaflet material includes a coherent single layer and an elastomer, wherein the elastomer is present in the pores of the porous coherent single layer.

Fluid handling detectors

Described herein are devices for collecting and analyzing a fluid sample, the devices comprising a fluid-collecting porous material comprising at least one hydrophilic porous layer and one or more sensors adapted to provide a response to the presence of an analyte. The detectors are useful for collecting and analyzing a very small volume of sample and may include features that facilitate and direct flow of the sample through porous material.

Flexible and durable printed circuits on stretchable and non-stretchable substrates

The present invention is directed to flexible conductive articles (600) that include a printed circuit (650) and a stretchable or non- stretchable substrate (610). In some embodiments, the substrate has a printed circuit on both sides. The printed circuit contains therein a porous synthetic polymer membrane (660) and an electrically conductive trace (670) as well as a non-conducive region (640). The electrically conductive trace is imbibed or otherwise incorporated into the porous synthetic polymer membrane. In some embodiments, the synthetic polymer membrane is microporous. The printed circuit may be discontinuously bonded to the stretchable or non-stretchable substrate by adhesive dots (620). The printed circuits may be integrated into garments, such as smart apparel or other wearable technology.

Prosthetic heart valve comprising durable, high-strength polymer compounds suitable for implantation

Una válvula, que comprende: una estructura de soporte, y estando soportada al menos una valva sobre la estructura de soporte y móvil entre las posiciones abierta y cerrada, incluyendo cada valva un material compuesto que comprende al menos una membrana de polietileno poroso y un material elastómero, comprendiendo la al menos una membrana de polietileno poroso fibras que definen el espacio entre ellas, definiendo poros el espacio entre las fibras, estando dispuesto el material elastómero sustancialmente en todos los poros, en donde un diámetro de una mayoría de las fibras es menor que 1 μm y/o el tamaño de poro es menor que 5 μm. A valve, comprising: a support structure, and at least one leaflet being supported on the support structure and movable between the open and closed positions, each leaflet including a composite material comprising at least one porous polyethylene membrane and a elastomer, the at least one porous polyethylene membrane comprising fibers that define the space between them, the space between the fibers defining pores, the elastomeric material being arranged in substantially all the pores, where a diameter of a majority of the fibers is smaller that 1 µm and / or the pore size is less than 5 µm.

Coherent single layer high strength synthetic polymer composites for prosthetic valves

Thin, biocompatible, high-strength, composite materials are disclosed that are suitable for use in a prosthetic valve for regulating blood flow direction. In one aspect, the leaflet material maintains flexibility in high-cycle flexural applications, making it particularly applicable to high-flex implants such as a prosthetic heart valve leaflet. The leaflet material includes a coherent single layer and an elastomer, wherein the elastomer is present in the pores of the porous coherent single layer.

Fluid handling detectors

Described herein are devices for collecting and analyzing a fluid sample, the devices comprising a fluid-collecting porous material comprising at least one hydrophilic porous layer and one or more sensors adapted to provide a response to the presence of an analyte. The detectors are useful for collecting and analyzing a very small volume of sample and may include features that facilitate and direct flow of the sample through porous material.

? high strength single layer synthetic polymer composites for prosthetic valves?

são revelados materiais finos, biocompatíveis, de alta resistência e compósitos que são adequados para uso em uma válvula protética para regular a direção do fluxo sanguíneo. em um aspecto, o material do folheto mantém flexibilidade em aplicações de flexão de alto ciclo, tornando-o particularmente aplicável a implantes de alta flexão, como um folheto de válvula cardíaca protética. o material folheto inclui uma camada única aderente e um elastômero, em que o elastômero está presente nos poros da camada única porosa e aderente. Thin, biocompatible, high strength materials and composites are disclosed that are suitable for use in a prosthetic valve to regulate the direction of blood flow. In one aspect, the leaflet material maintains flexibility in high cycle flexion applications, making it particularly applicable to high flexion implants such as a prosthetic heart valve leaflet. The leaflet material includes a single adherent layer and an elastomer, wherein the elastomer is present in the pores of the porous and adherent single layer.

Substrate with rotatable struts for medical device

A medical device comprises a substrate (10) defining a major surface (9) defining a plane, including a plurality of first struts (14) along a first direction interconnected with a plurality of second struts (12) extending along a second direction not parallel with the first direction, wherein widths (11) of the second struts as measured along the major surface are larger than thicknesses of the second struts as measured perpendicular to the major surface such that when the substrate is stretched in the first direction, intermediate sections (15) of the second struts (12) rotate relative to the first struts (14) and the intermediate sections of the second struts bend out of the plane of the major surface. The medical device is operable to extend and/ or retract elements suitable for a particular purpose. The elements are extended and/or retracted in response to a stress applied by way of stretching and/or retracting the device, among other methods. The elements may remain extended and/or retracted or may recoil back to an initial position upon the removal of the force. In various embodiments, the elements are used to treat or deliver treatment to a target site within a body.

Frame with integral sewing cuff for prosthetic valves

A prosthetic valve (100) for surgical placement with a sewing cuff (116) durably attached to a frame (110). The durability of the attachment is accomplished by sandwiching a fabric (112) between the frame (110) and a composite material (118). The fabric(112) extends beyond the frame base (140) to form a sewing cuff (116) that is integral to a frame assembly. The sewing cuff (116) facilitates tissue ingrowth while tissue ingrowth is discouraged elsewhere around the frame.

Durable high strength polymer composite suitable for implant and articles produced therefrom

Durable high strength polymer composite suitable for implant and articles produced therefrom

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.

Flexible and stretchable printed circuits on stretchable substrates

The present disclosure is flexible and stretchable conductive articles that include a printed circuit and a stretchable substrate. The printed circuit contains an electrically conductive trace. The electrically conductive trace may be positioned on the surface of or be imbibed into the pores through the thickness of a synthetic polymer membrane. The synthetic polymer membrane is compressed in the x-y direction such that buckling of the membrane occurs in the z-direction. Additionally, the synthetic polymer membrane may be porous or non-porous. In some embodiments, the synthetic polymer membrane is microporous. The printed circuit may be discontinuously bonded to the stretchable substrate. Advantageously, the flexible, conductive articles retain conductive performance over a range of stretch. In some embodiments, the conductive articles have negligible resistance change when stretched up to 50% strain. The printed circuits may be integrated into garments, such as smart apparel or other wearable technology.

Substrate with rotatable struts for medical device

A medical device suitable for endoluminal delivery, the medical device comprising: a diametrically adjustable tubular substrate defining a tubular major surface including lateral struts and circumferential struts, wherein the lateral struts are operable to rotate when the diametrically adjustable tubular substrate is expanded in a circumferential direction. 38 20286388_1 (GHMatters) P113076.AU.3

Flexible and stretchable printed circuits on stretchable substrates

Fluid handling detectors

Described herein are devices for collecting and analyzing a fluid sample, the devices comprising a fluid-collecting porous material comprising at least one hydrophilic porous layer and one or more sensors adapted to provide a response to the presence of an analyte. The detectors are useful for collecting and analyzing a very small volume of sample and may include features that facilitate and direct flow of the sample through porous material.

Durable high strength polymer composite suitable for implant and articles produced therefrom

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 a prosthetic heart valve leaflet. The composite material includes a porous expanded fluoropolymer membrane and an elastomer, wherein the elastomer is present in the pores of the porous expanded fluoropolymer.

Methods of making a prosthetic valve with a durable high strength polymer composite leaflet

Methods are provided to make a prosthetic valve having a thin, biocompatible, high-strength, composite material. In one aspect, the composite material maintains flexibility in high-cycle flexural applications, making it particularly applicable to high-flex implants such as a heart valve leaflet. The composite material includes a porous expanded fluoropolymer membrane and an elastomer, wherein the elastomer is present in the pores of the porous expanded fluoropolymer.

Durable high strength polymer composites suitable for implant and articles produced therefrom

Thin, biocompatible, high-strength, composite materials are disclosed that are suitable for use in a valve for regulating blood flow direction. In one aspect, the composite material maintains flexibility in high-cycle flexural applications, making it particularly applicable to high-flex implants such as a prosthetic heart valve leaflet. The composite material includes a porous polymer membrane and an elastomer, wherein the elastomer fills substantially all of the pores of the porous polymer membrane.

Puncturable and resealable graft

Implantable grafts, particularly for arteriovenous access that may be punctured by an object such as a needle and, following removal of the object, will reseal the resulting hole to the extent of reducing fluid leakage through the graft at the puncture site to an amount less than would be typical for a conventional graft. More particularly, the grafts comprise three layers; an inner layer of implantable graft material such as ePTFE, a middle layer of self sealing elastomeric material such as silicone, and an outer layer of implantable graft material such as ePTFE. Following manufacture, the tubular form of the three-layer graft is everted to put substantially the entire wall thickness of the elastomeric material layer under circumferential compression.