WO1996009157B1 - Carbon containing vascular graft and method for making same - Google Patents
Carbon containing vascular graft and method for making sameInfo
- Publication number
- WO1996009157B1 WO1996009157B1 PCT/US1995/011731 US9511731W WO9609157B1 WO 1996009157 B1 WO1996009157 B1 WO 1996009157B1 US 9511731 W US9511731 W US 9511731W WO 9609157 B1 WO9609157 B1 WO 9609157B1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- carbon
- polytetrafluoroethylene
- canceled
- cylindrical
- tubular
- Prior art date
Links
- OKTJSMMVPCPJKN-UHFFFAOYSA-N carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 title claims abstract 59
- 229910052799 carbon Inorganic materials 0.000 title claims abstract 34
- 230000002792 vascular Effects 0.000 title claims abstract 16
- 238000001125 extrusion Methods 0.000 claims abstract 10
- 230000000975 bioactive Effects 0.000 claims abstract 6
- 239000000126 substance Substances 0.000 claims abstract 6
- 239000000463 material Substances 0.000 claims abstract 2
- 229940058401 Polytetrafluoroethylene Drugs 0.000 claims 22
- -1 polytetrafluoro-ethylene Polymers 0.000 claims 22
- 229920001343 polytetrafluoroethylene Polymers 0.000 claims 22
- 239000004810 polytetrafluoroethylene Substances 0.000 claims 22
- 229910002804 graphite Inorganic materials 0.000 claims 5
- 239000010439 graphite Substances 0.000 claims 5
- 239000003146 anticoagulant agent Substances 0.000 claims 4
- 238000000465 moulding Methods 0.000 claims 3
- 238000005245 sintering Methods 0.000 claims 3
- 239000007787 solid Substances 0.000 claims 3
- 210000002464 Muscle, Smooth, Vascular Anatomy 0.000 claims 2
- 230000002429 anti-coagulation Effects 0.000 claims 2
- 230000003110 anti-inflammatory Effects 0.000 claims 2
- 230000000702 anti-platelet Effects 0.000 claims 2
- 230000002965 anti-thrombogenic Effects 0.000 claims 2
- 239000004599 antimicrobial Substances 0.000 claims 2
- 239000003795 chemical substances by application Substances 0.000 claims 2
- 239000003527 fibrinolytic agent Substances 0.000 claims 2
- 239000003102 growth factor Substances 0.000 claims 2
- 239000003112 inhibitor Substances 0.000 claims 2
- 230000002401 inhibitory effect Effects 0.000 claims 2
- 239000000314 lubricant Substances 0.000 claims 2
- 239000000041 non-steroidal anti-inflammatory agent Substances 0.000 claims 2
- 229940021182 non-steroidal anti-inflammatory drugs Drugs 0.000 claims 2
- 239000011347 resin Substances 0.000 claims 2
- 229920005989 resin Polymers 0.000 claims 2
- 230000001407 anti-thrombic Effects 0.000 claims 1
- 230000000875 corresponding Effects 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 239000000843 powder Substances 0.000 claims 1
- 150000001875 compounds Chemical class 0.000 abstract 3
- 150000001722 carbon compounds Chemical class 0.000 abstract 2
- 239000010410 layer Substances 0.000 abstract 1
- 239000002365 multiple layer Substances 0.000 abstract 1
Abstract
A method for making a carbon lined vascular graft wherein a polymeric carbon compound and a polymeric compound are co-extruded through a mandrel and die assembly to form a vascular graft having carbon as an integral component of its intraluminal or exterior surface is presented, along with the carbon containing graft which results from the method. A divided preformer comprising two hollow concentrical cylinders is used to form a dual compound billet for extrusion. Alternatively, the polymeric carbon compound may be used to fill both cylinders of the divided preformer to form a single compound billet which is extruded to present a carbon containing polymeric graft having uniform carbon polymeric material throughout the wall of the graft. A preformer having multiple dividers which thereby forms a billet having multiple layers wherein one of the layers contains a carbon element way also be used as part of the inventive method. A time-releasable bioactive substance may be incorporated into the vascular grafts resulting from the inventive method.
Claims
AMENDED CLAIMS
[received by the International Bureau on 25 March 1996 (25.03.96); original claims 7-11, 13 and 16-24 cancelled; original claims 1-3,
12, 14, 15, 25 and 26 amended; remaining claims unchanged (5 pages)] 1. A method for making a tubular carbon-containing vascular graft comprising the steps of:
a) molding a concentrically-plied, cylindrical preform billet having a solid inner cylindrical portion formed of a substantially homogeneous admixture of polytetrafluoro-ethylene and a carbon component selected from activated charcoal or activated carbon and graphite and a solid outer cylindrical portion formed of polytetrafluoroethylene
surrounding said solid inner cylindrical portion;
b) co-extruding the cylindrical preform billet through a die to form a hollow, tubular extrudate having a carbon-containing luminal surface;
c) expanding the tubular co-extrudate; and d) sintering the expanded tubular extrudate.
2. The method of Claim 1 wherein said step cf molding a preform billet comprises the steps of:
a) providing an vertically-oriented cylindrical preform barrel which is divided into inner and outer hollow cylindrical sections by an upright hollow cylindrical divider concentrically positioned within the cylindrical preform barrel;
b) compounding a polytetrafluoroethylene resin, a carbon component selected from activated charcoal or activated charcoal and graphite, and a lubricant to form a substantially homogeneous polytetrafluoroethylene-carbon admixture;
c) pouring an amount of the polytetraflucroethylene- carbon admixture into the inner cylindrical section of said preform barrel such that it fills said inner cylindrical section;
d) pouring a quantity of a polytetrafluoroethylene- lubricant admixture into the outer cylindrical section of the preform barrel such that it fills the outer cylindrical section; e) compacting the inner and outer cylindrical sections within the preform barrel under an applied positive pressure to form a cylindrical extrusion billet having
concentric inner and outer layers; and
f) removing the extrusion billet from the preform barrel.
3. The method of Claim 2 wherein the carbon component is present at approximately 3% to 20% by weight of the
polytetrafluoroethylene resin.
4. The method of Claim 3 wherein said carbon component is an activated charcoal powder.
5. The method of Claim 2 further characterized by the step of incorporating a time-releasable bioactive substance within the carbon containing vascular graft subsequent to the step of sintering the expanded tubular extrudate.
6. The method of Claim 5 wherein said bioactive
substance comprises at least one of an anticoagulant, an anti-microbial agent, an anti-inflammatory, a growth factor, a smooth muscle inhibitor, an antithrombogenic agent, an
antiplatelet agent, and a non-steroidal anti-inflammatory drug.
7. Canceled,
8. Canceled.
9. Canceled.
10. Canceled.
11. Canceled.
12. A tubular vascular graft characterized by concentric luminal and abluminal layers, the luminal layer being composed of a substantially homogenous admixture of a carbon component selected from activated charcoal or activated charcoal and graphite and polytetrafluoroethylene and the abluminal layer being composed of polytetrafluoroethylene, the
polytetrafluoro-ethylene having a microporous microstructure of nodes interconnected by fibrils, with the fibrils being oriented substantially parallel to a longitudinal axis of the tubular vascular graft, and further including a bioactive substance adsorbed within the carbon component and
physiologically releasable therefrom in vivo.
13. Canceled.
14. The vascular graft of Claim 12 wherein said
bioactive substance comprises at least one of an
anticoagulant, an anti-microbial agent, an anti-inflammatory, a growth factor, a smooth muscle inhibitor, an
antithrombogenic agent, an antiplatelet agent, and a non-steroidal anti-inflammatory drug.
15. A tubular carbon-containing vascular graft
comprising:
a first layer forming an interior surface of the tubular vascular graft and defining a flow passage
therethrough, the first layer comprising a substantially homogeneous admixture of polytetrafluoroethylene and carbon; and
a second layer concentrically surrounding the first layer wherein the second layer comprising one of
polytetrafluoroethylene or a substantially homogeneous admixture of polytetrafluoroethylene and carbon, wherein the tubular carbon-containing vascular graft is made in accordance with the method of any of Claims 1 to 6.
16. Canceled.
17. Canceled.
18. Canceled.
19. Canceled.
20. Canceled.
21. Canceled.
22. Canceled.
23. Canceled.
24. Canceled.
25. A method for making a tubular carbon-containing vascular graft comprising the steps of:
a) molding a preform billet by the steps of:
(i) providing an upright, cylindrical preform barrel which is divided into at least two concentric
cylindrical sections;
(ii) pouring a substantially homogeneous admixture of polytetrafluoroethylene, carbon and an extrusion aid into a first one of the at least two cylindrical sections;
(iii) pouring one if an admixture of
polytetrafluoroethylene and an extrusion aid or an admixture of polytetrafluoroethylene, carbon and an extrusion aid into a second one of the at least two cylindrical sections; and
(iv) compacting the admixtures in the first and second of the at least two cylindrical sections to form an extrusion billet having inner and outer concentric layers;
b) extruding the extrusion billet through a die to form a tubular extrudate having plied inner and outer
concentric layers corresponding to the first and second cylindrical layers of the extrusion billet;
c) longitudinally expanding the tubular extrudate; and
d) sintering the longitudinally expanded tubular extrudate.
26. A carbon-containing vascular graft made in
accordance with the method of Claim 25 characterized by an inner layer having a carbon component substantially
homogeneously dispersed in the polytetrafluoroethylene and a polytetrafluoroethylene outer layer. STATEMENT UNDER ARTICLE 19
Claims 1-3 have been amended to specify that the preform billet is formed of concentric plied layers with an inner layer formed from a substantially homogeneous admixture of polytetrafluoroethylene and a carbon component, the carbon component being one of activated charcoal or activated carbon and graphite, and the outer layer being
polytetrafluoroethylene. Claim 2 has been amended to clarify that the preform barrel is vertically-oriented and formed as a hollow cylinder. The method recited in Claims 1-6 has been clarified as a method of making a tubular vascular graft. Claim 6 has been emended to replace "antithrombic" with "antithrombogenic."
Claim 12 has been amended to clarify that the vascular graft is tubular and formed of concentric luminal and abluminal layers of material. The luminal layer is made of a
substantially homogenous admixture of a carbon component, selected from activated charcoal or activated charcoal and graphite and polytetrafluoroethylene. Additionally, the bioactive substance is claimed to be adsorbed within the carbon component and is physiologically releasable therefrom in vivo. Claim 14 has been amended to replace "antrthrombic" with "antithrombogenic."
Claim 15 has been amended to include the claim in its entirety, to specifically claim that the inner layer is made of polytetrafluoroethylene and carbon and that the graft is made in accordance with the method of any of Claims 1-6.
Finally, Claim 25 has been amended to specifically claim polytetrafluoroethylene and an admixture of polytetrafluoroethylene, carbon and an extrusion aid used to form the preform billet using an upright cylindrical preform. Claim 25 further claims that the tubular extrudate is longitudinally expanded. Claim 26 has been amended to clarify that the carbon component is substantially homogeneously dispersed in the polytetrafluoroethylene of the inner layer.
Due to cancellation of many claims, the claims are now presented on fewer pages of the application than in the International Application as originally filed. No change has been made to the Abstract.
Applicant respectfully requests that the Claims as amended herein under Article 19 publish with the International Publication.
Priority Applications (6)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| AU35130/95A AU687248B2 (en) | 1994-09-23 | 1995-09-15 | Carbon containing vascular graft and method for making same |
| AT95931841T ATE202971T1 (en) | 1994-09-23 | 1995-09-15 | CARBON VASCULAR TRANSPLANT AND PRODUCTION METHOD |
| DE69521709T DE69521709T2 (en) | 1994-09-23 | 1995-09-15 | CARBON-BASED VESSEL TRANSPLANT AND MANUFACTURING METHOD |
| JP8510983A JPH10511012A (en) | 1994-09-23 | 1995-09-15 | Carbon-containing vascular graft and method for producing the same |
| CA002200555A CA2200555C (en) | 1994-09-23 | 1995-09-15 | Carbon containing vascular graft and method for making same |
| EP95931841A EP0782497B1 (en) | 1994-09-23 | 1995-09-15 | Vascular graft containing carbon and method for making same |
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US31149794A | 1994-09-23 | 1994-09-23 | |
| US08/311,497 | 1994-09-23 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| WO1996009157A1 WO1996009157A1 (en) | 1996-03-28 |
| WO1996009157B1 true WO1996009157B1 (en) | 1996-06-06 |
Family
ID=23207160
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/US1995/011731 WO1996009157A1 (en) | 1994-09-23 | 1995-09-15 | Carbon containing vascular graft and method for making same |
Country Status (12)
| Country | Link |
|---|---|
| US (1) | US5827327A (en) |
| EP (1) | EP0782497B1 (en) |
| JP (1) | JPH10511012A (en) |
| AT (1) | ATE202971T1 (en) |
| AU (1) | AU687248B2 (en) |
| CA (1) | CA2200555C (en) |
| DE (1) | DE69521709T2 (en) |
| ES (1) | ES2161299T3 (en) |
| IL (1) | IL115400A0 (en) |
| MX (1) | MX9504054A (en) |
| WO (1) | WO1996009157A1 (en) |
| ZA (1) | ZA958035B (en) |
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-
1995
- 1995-09-15 AT AT95931841T patent/ATE202971T1/en not_active IP Right Cessation
- 1995-09-15 CA CA002200555A patent/CA2200555C/en not_active Expired - Lifetime
- 1995-09-15 ES ES95931841T patent/ES2161299T3/en not_active Expired - Lifetime
- 1995-09-15 WO PCT/US1995/011731 patent/WO1996009157A1/en active IP Right Grant
- 1995-09-15 DE DE69521709T patent/DE69521709T2/en not_active Expired - Lifetime
- 1995-09-15 JP JP8510983A patent/JPH10511012A/en active Pending
- 1995-09-15 EP EP95931841A patent/EP0782497B1/en not_active Expired - Lifetime
- 1995-09-15 AU AU35130/95A patent/AU687248B2/en not_active Expired
- 1995-09-22 ZA ZA958035A patent/ZA958035B/en unknown
- 1995-09-22 IL IL11540095A patent/IL115400A0/en unknown
- 1995-09-22 MX MX9504054A patent/MX9504054A/en unknown
-
1997
- 1997-01-03 US US08/777,006 patent/US5827327A/en not_active Expired - Lifetime
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