US4816339A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Multi-layered poly(tetrafluoroethylene)/elastomer materials useful for in vivo implantation
Assignee: Baxter International Inc
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Filing: 1987-04-28
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Granted: 1989-03-28
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Expires: 2007-04-28
Abstract
Abstract Biologically compatible materials capable of being formed into implants, comprising layers of poly(tetrafluoroethylene) and mixtures of poly(tetrafluoroethylene) and elastomer, having excellent compliance, strength, elasticity and suturability are disclosed. The materials are preferably prepared as implants or vascular grafts by co-extruding a relatively thin luminal layer of poly(tetrafluoroethylene) having a distinct fibral nodal microstructure within a layer of a mixture of poly(tetrafluoroethylene) and elastomer to impart elasticity to the implant. A preferred embodiment comprises a radially asymmetric composite vascular graft having a luminal layer of poly(tetrafluoroethylene), a second layer of poly(tetrafluoroethylene)/elastomer mixture, a third layer of elastomer, and a fourth layer of a monomer fibrous elastomer matrix with each layer having a distinctive pore size, pore shape and porosity to promote tissue ingrowth and periprosthetic tissue anchoring.
Inventors
- 👤 Roger H. Tu
- 👤 Edwin Wang
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-22 16:31
CPC Classifications
A; A61; A61L; A61L27/00; A61L27/14; A61L27/26; A61F; A61F2/00; A61F2/02; A61F2/04; A61F2/06; A61L27/16; A61L27/50; A61L27/507; B; B29; B29C; B29C55/00; B29C55/005; A61F2/0077; A61F2250/00; A61F2250/0014; A61F2250/0023; B29K; B29K2027/00; B29K2027/12; B29K2027/18; B29K2105/00; B29K2105/04; Y; Y10; Y10S; Y10S623/00; Y10S623/924; Y10T; Y10T428/00; Y10T428/31504; Y10T428/3154; Y10T428/31544
Claims Analysis
Total Claims: 45
Claim 1
Independent Claim
27 words
A biologically compatible multi-layered in vivo implantation material comprising a porous, luminal layer of poly(tetrafluoroethylene) and a second layer comprising a porous mixture of poly(tetrafluoroethylene) and elastomer.
Claim 2
Dependent Claim
27 words
A biologically compatible multi-layered in vivo implantation material comprising a porous, luminal layer of poly(tetrafluoroethylene) and a second layer comprising a porous mixture of poly(tetrafluoroethylene) and elastomer.
Claim 3
Dependent Claim
43 words
The material in accordance with claim 1 in which the elastomer is selected from the group consisting of polyvinylidene fluoride co-hexafluoropropylene, poly(tetrafluoroethylene-co-perfluoro(methylvinylether)), poly(tetrafluoroethylene-copropylene), poly(vinylidene-co-chlorotrifluoroethylene), silicones, fluorosilicones, fluoroalkoxy phosphazenes, segmented copolyester ether, styrene butadiene block copolymers, polyethers acrylonitrile butadienes, isoprenes, polyurethanes and mixtures thereof.
Claim 4
Dependent Claim
25 words
The material in accordance with claim 1 in which has an elastomer content of from about 5% to about 120% by weight of the poly(tetrafluoroethylene).
Claim 5
Dependent Claim
23 words
The material in accordance with claim 1 in which the luminal layer has a porosity of about 30% to about 90% by volume.
Claim 6
Dependent Claim
26 words
The material in accordance with claim 1 wherein the internodal distance of the pores in the luminal layer ranges between about 20 to about 30 microns.
Claim 7
Dependent Claim
27 words
The material in accordance with claim 1 wherein the elastomer content of the second layer is about 5 to about 20% by weight of the second layer.
Claim 8
Dependent Claim
23 words
The material in accordance with claim 1 in which the second layer has a porosity of about 30% to about 90% by volume.
Claim 9
Dependent Claim
26 words
The material in accordance with claim 1 wherein the internodal distance of the pores in the second layer ranges between about 30 to about 500 microns.
Claim 10
Dependent Claim
27 words
The material in accordance with claim 7 in whioh the internodal distance of the pores in the second layer ranges between about 50 to about 100 microns.
Claim 11
Dependent Claim
31 words
The material in accordance with claim 1 wherein the internodal distance of the pores in the second layer is at least twice the internodal distance of pores in the luminal layer.
Claim 12
Dependent Claim
12 words
The material in accordance with claim 1 which is an asymmetric composite.
Claim 13
Dependent Claim
26 words
The material in accordance with claim 1 in which an elastomer is applied to the exterior surface of the second layer forming a third outer layer.
Claim 14
Dependent Claim
21 words
The material in accordance with claim 12 in which the elastomer is applied by immersing the material into an elastomer bath.
Claim 15
Dependent Claim
20 words
The material in accordance with claim 13 in which the bath comprises about 1 to about 10% by weight elastomer.
Claim 16
Dependent Claim
31 words
The material in accordance with claim 112 in which a solvent is admixed with the elastomer and applied to the exterior surface of the second layer to form a third layer.
Claim 17
Dependent Claim
35 words
The material in accordance with claim 12 in which an effective amount of solvent is admixed with said elastomer to provide for at least the same porosity and pore size as in the second layer.
Claim 18
Dependent Claim
41 words
The material of claim 12 in which the elastomer is selected from the group consisting of polyvinylidene fluoride co-hexafluoropropylene, poly(tetrafluoroethylene-co-perfluoro(methylvinylether)), poly(tetrafluoroethylene-copropylene), poly(vinylidene-co-chlorotrifluoroethylene), silicones, fluorosilicones, fluoroalkoxy phosphazenes, segmented copolyester ether, styrene butadiene block copolymers, polyethers acrylonitrile butadienes, isoprenes, polyurethanes and mixtures thereof.
Claim 19
Dependent Claim
34 words
The material in accordance with claim 13 in which the material is immersed in the bath for an effective amount of time to impregnate the second layer but not migrate with the luminal layer.
Claim 20
Dependent Claim
26 words
The material in accordance with claim 12 in which the third layer has the same porosity and internodal distance of the pores as the second layer.
Claim 21
Dependent Claim
16 words
The material in accordance with claim 12 in which the elastomer provides hydrophillicity to the material.
Claim 22
Dependent Claim
18 words
The material in accordance with claim 1 in which a therapeutically active substance is present in said elastomer.
Claim 23
Dependent Claim
27 words
The material in accordance with claim 12 in which a fibrous polymer elastomer matrix is applied to the exterior of the third layer forming a fourth layer.
Claim 24
Dependent Claim
19 words
The material in accordance with claim 22 in which the fibrous polymer elastomer matrix comprises hydrophilic or hydrophobic polymer.
Claim 25
Dependent Claim
37 words
The material in accordance with claim 23 in which the elastomer is selected from the group consisting of poly(tetrafluoroethylene-co-propylene), silicones, polyurethane, butyl rubber, fluorocarbon elastomer, polyether polyurethane, polyester polyurethane, polyester elastomer, poly(styrene-co-butadiene), and poly(ethylene-propylene-diene), and mixtures thereof.
Claim 26
Dependent Claim
22 words
The material in accordance with claim 24 in which the fibrous polymer elastomer matrix is applied to the outer layer by wrapping.
Claim 27
Dependent Claim
23 words
The material in accordance with claim 24 in which the fourth layer has a porosity of about 30% to about 90% by volume.
Claim 28
Dependent Claim
27 words
The material in accordance with claim 24 in which the internodal distance of the pores in the fourth layer ranges between about 100 to about 2000 microns.
Claim 29
Dependent Claim
28 words
The material in accordance with claim 1 in which the luminal layer comprises a porous mixture of poly(tetrafluoroethylene) and elastomer, and the second outer porous layer is poly(tetrafluoroethylene).
Claim 30
Dependent Claim
10 words
The material of claim 1 shaped as a medical device.
Claim 31
Dependent Claim
15 words
The material of claim 1 shaped as a medical device suitable for in vivo implantation.
Claim 32
Dependent Claim
10 words
The material of claim 1 shaped as a vascular graft.
Claim 33
Dependent Claim
10 words
The material of claim 12 shaped as a medical device.
Claim 34
Dependent Claim
15 words
The material of claim 12 shaped as a medical device suitable for in vivo implantation.
Claim 35
Dependent Claim
10 words
The material of claim 12 shaped as a vascular graft.
Claim 36
Dependent Claim
10 words
The material of claim 22 shaped as a medical device.
Claim 37
Dependent Claim
15 words
The material of claim 22 shaped as a medical device suitable for in vivo implantation.
Claim 38
Dependent Claim
10 words
The material of claim 22 shaped as a vascular graft.
Claim 39
Dependent Claim
42 words
A biologically compatible multi-layered in vivo implantation material comprising a porous, luminal layer of poly(tetrafluoroethylene), a second layer comprising a porous mixture of poly(tetrafluoroethylene and elastomer) and a third layer comprising an elastomer applied to the exterior surface of the second layer.
Claim 40
Dependent Claim
42 words
A biologically compatible multi-layered in vivo implantation material comprising a porous, luminal layer of poly(tetrafluoroethylene), a second layer comprising a porous mixture of poly(tetrafluoroethylene and elastomer) and a third layer comprising an elastomer applied to the exterior surface of the second layer.
Claim 41
Dependent Claim
43 words
The material in accordance with claim 38 in which the elastomer is selected from the group consisting of polyvinylidene fluoride co-hexafluoropropylene, poly(tetrafluoroethyleneco-perfluoro(methylvinylether)), poly(tetrafluoroethylene-copropylene), poly(vinylidene-co-chlorotrifluoroethylene), silicones, fluorosilicones, fluoroalkoxy phosphazenes, segmented copolyester ether, styrene butadiene block copolymers, polyethers acrylonitrile butadienes, isoprenes, polyurethanes and mixtures thereof.
Claim 42
Dependent Claim
58 words
A biologically compatible multi-layered in vivo implantation material comprising a porous, luminal layer of poly(tetrafluoroethylene), a second layer comprising a porous mixture of poly(tetrafluoroethylene) and elastomer, a third layer comprising an elastomer applied to the exterior surface of the second layer and a fourth layer comprising a fibrous monomer matrix applied to the exterior of the third layer.
Claim 43
Dependent Claim
58 words
A biologically compatible multi-layered in vivo implantation material comprising a porous, luminal layer of poly(tetrafluoroethylene), a second layer comprising a porous mixture of poly(tetrafluoroethylene) and elastomer, a third layer comprising an elastomer applied to the exterior surface of the second layer and a fourth layer comprising a fibrous monomer matrix applied to the exterior of the third layer.
Claim 44
Dependent Claim
17 words
The material in accordance with claim 40 in which the fiberous polymer matrix is applied by wrapping.
Claim 45
Dependent Claim
43 words
The material in accordance with claim 40 in which the elastomer is selected from the group consisting of polyvinylidene fluoride co-hexafluoropropylene, poly(tetrafluoroethylene-co-perfluoro(methylvinylether)), poly(tetrafluoroethylene-co-propylene), poly(vinylidene-co-chlorotrifluoroethylene), silicones, fluorosilicones, fluoroalkoxy phosphazenes, segmented copolyester ether, styrene butadiene block copolymers, polyethers acrylonitrile butadienes, isoprenes, polyurethanes and mixtures thereof.
References Cited (Backward Citations)
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1992-03-27 | 1992-09-26 | 1993-03-28 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1996-03-27 | 1996-09-26 | 1997-03-28 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2000-03-27 | 2000-09-26 | 2001-03-28 | $7700.00 | Window Closed / Lapsed |