US5670161A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Biodegradable stent
Assignee: GENERAL VASCULAR DEVICES Ltd
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Filing: 1996-05-28
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Granted: 1997-09-23
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Expires: 2016-05-28
Abstract
Abstract An expandable, biodegradable stent for use within a body lumen comprises a hollow tube made from a copolymer of L-lactide and epsilon -caprolactone that is not plastically expandable at normal body temperatures, and that is expandable using thermo-mechanical means at a temperature between about 38 DEG -55 DEG C. using a balloon catheter. The invention also relates to a method of making such a stent and to a method of deploying such a stent within the body.
Inventors
- 👤 Kevin E. Healy
- 👤 Gary S. Dorfman
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-06 10:47
CPC Classifications
A; A61; A61F; A61F2/00; A61F2/82; A61F2210/00; A61F2210/0004
Claims Analysis
Total Claims: 57
Claim 1
Independent Claim
87 words
An expandable, biodegradable stent for use within a body lumen comprising a hollow tube made from a copolymer of L-lactide and ε-caprolactone that, in unexpanded form, is of a first diameter sufficient to be retained upon a balloon catheter for placement within the body lumen, and that is not plastically expandable at normal body temperatures, and that is expandable using thermo-mechanical means at a temperature between about 38°-55° C. when the balloon catheter is inflated to a second diameter sufficient to be retained within the body lumen.
Claim 2
Dependent Claim
87 words
An expandable, biodegradable stent for use within a body lumen comprising a hollow tube made from a copolymer of L-lactide and ε-caprolactone that, in unexpanded form, is of a first diameter sufficient to be retained upon a balloon catheter for placement within the body lumen, and that is not plastically expandable at normal body temperatures, and that is expandable using thermo-mechanical means at a temperature between about 38°-55° C. when the balloon catheter is inflated to a second diameter sufficient to be retained within the body lumen.
Claim 3
Dependent Claim
23 words
The stent of claim 1, wherein the molar ratio of L-lactide to ε-caprolactone is in the range from about 90:10 to about 98:2.
Claim 4
Dependent Claim
10 words
The stent of claim 1, wherein the tube is imperforate.
Claim 5
Dependent Claim
28 words
The stent of claim 1, wherein the tube is perforated, the perforations placed at a distance relative to each other corresponding to cell ingrowth within the body lumen.
Claim 6
Dependent Claim
10 words
The stent of claim 1, wherein the tube is nonwoven.
Claim 7
Dependent Claim
12 words
The stent of claim 1, wherein the tube incorporates a radio-opaque material.
Claim 8
Dependent Claim
15 words
The stent of claim 1, wherein the tube includes a drug blended with the copolymer.
Claim 9
Dependent Claim
40 words
The stent of claim 7, wherein the drug is selected from the group consisting of antithrombotics, anticoagulants, antimitogens, antimitotoxins, antisense oligonucleotides, gene therapy vehicles, nitric oxide, growth factors and inhibitors, Hirudin, Hirugen, Hirulog, PPACK, D-FPRCH 2 Cl, Heparin, and Warfarin.
Claim 10
Dependent Claim
14 words
The stent of claim 1, wherein the tube is coated with a lubricious material.
Claim 11
Dependent Claim
15 words
The stent of claim 9, wherein the thickness of the coating is about 25 μm.
Claim 12
Dependent Claim
13 words
The stent of claim 9, wherein the coating is blended with a drug.
Claim 13
Dependent Claim
40 words
The stent of claim 11, wherein the drug is selected from the group consisting of antithrombotics, anticoagulants, antimitogens, antimitotoxins, antisense oligonucleotides, gene therapy vehicles, nitric oxide, growth factors and inhibitors, Hirudin, Hirugen, Hirulog, PPACK, D-FPRCH 2 Cl, Heparin, and Warfarin.
Claim 14
Dependent Claim
36 words
The stent of claim 9, wherein the coating is a blend of a biodegradable material with lubricious materials selected from the group consisting of poly(ethylene glycol), poly(vinyl alcohol), poly(vinyl pyrrolidone), poly(acrylic acid), poly(methacrylic acid) and polyacrylamide.
Claim 15
Dependent Claim
39 words
The stent of claim 9, wherein the coating is a copolymer of a biodegradable material with lubricious materials selected from the group consisting of monomer constituents of poly(ethylene glycol), poly(vinyl alcohol), poly(vinyl pyrrolidone), poly(acrylic acid), poly(methacrylic acid) and polyacrylamide.
Claim 16
Dependent Claim
92 words
An expandable, biodegradable stent for use within a body lumen comprising a hollow tube made from a copolymer of L-lactide and ε-caprolactone that, in unexpanded form, is of a first diameter sufficient to be retained upon a balloon catheter for placement within the body lumen, and that is not plastically expandable at normal body temperatures, and that is expandable using thermo-mechanical means at a temperature between about 38°-55° C. when the balloon catheter is inflated to a second diameter sufficient to be retained within the body lumen, further comprising a lubricious coating.
Claim 17
Dependent Claim
92 words
An expandable, biodegradable stent for use within a body lumen comprising a hollow tube made from a copolymer of L-lactide and ε-caprolactone that, in unexpanded form, is of a first diameter sufficient to be retained upon a balloon catheter for placement within the body lumen, and that is not plastically expandable at normal body temperatures, and that is expandable using thermo-mechanical means at a temperature between about 38°-55° C. when the balloon catheter is inflated to a second diameter sufficient to be retained within the body lumen, further comprising a lubricious coating.
Claim 18
Dependent Claim
15 words
The stent of claim 15, wherein the thickness of the coating is about 25 μm.
Claim 19
Dependent Claim
36 words
The stent of claim 15, wherein the coating is a blend of a biodegradable material with lubricious materials selected from the group consisting of poly(ethylene glycol), poly(vinyl alcohol), poly(vinyl pyrrolidone), poly(acrylic acid), poly(methacrylic acid) and polyacrylamide.
Claim 20
Dependent Claim
39 words
The stent of claim 15, wherein the coating is a copolymer of a biodegradable material with lubricious materials selected from the group consisting of monomer constituents of poly(ethylene glycol), poly(vinyl alcohol), poly(vinyl pyrrolidone), poly(acrylic acid), poly(methacrylic acid) and polyacrylamide.
Claim 21
Dependent Claim
13 words
The stent of claim 15, wherein the coating is blended with a drug.
Claim 22
Dependent Claim
40 words
The stent of claim 19, wherein the drug is selected from the group consisting of antithrombotics, anticoagulants, antimitogens, antimitotoxins, antisense oligonucleotides, gene therapy vehicles, nitric oxide, growth factors and inhibitors, Hirudin, Hirugen, Hirulog, PPACK, D-FPRCH 2 Cl, Heparin, and Warfarin.
Claim 23
Independent Claim
80 words
A method for making a stent comprising the steps of: providing a copolymer of L-lactide and ε-caprolactone that is not expandable at normal body temperatures, and that is thermo-mechanically expandable at a temperature between about 38°-55° C.; creating a tube from the copolymer having a diameter sufficient to permit the tube to be retained upon an unexpanded balloon catheter for insertion into a body lumen; and cutting the tube into lengths for use as a stent within the body lumen.
Claim 24
Independent Claim
80 words
A method for making a stent comprising the steps of: providing a copolymer of L-lactide and ε-caprolactone that is not expandable at normal body temperatures, and that is thermo-mechanically expandable at a temperature between about 38°-55° C.; creating a tube from the copolymer having a diameter sufficient to permit the tube to be retained upon an unexpanded balloon catheter for insertion into a body lumen; and cutting the tube into lengths for use as a stent within the body lumen.
Claim 25
Dependent Claim
12 words
The method of claim 21, wherein the tube is created by extrusion.
Claim 26
Dependent Claim
12 words
The method of claim 21, wherein the tube is created by dip-coating.
Claim 27
Dependent Claim
26 words
The method of making a stent of claim 21, wherein the ratio of L-lactide to ε-caprolactone is in the range from about 90:10 to about 98:2.
Claim 28
Dependent Claim
22 words
The method of making a stent of claim 21, further comprising the step of micromachining perforations in the tube using a laser.
Claim 29
Dependent Claim
20 words
The method of making a stent of claim 21, further comprising the step of incorporating radio-opaque material in the tube.
Claim 30
Dependent Claim
20 words
The method of making a stent of claim 21, further comprising the step of blending a drug with the copolymer.
Claim 31
Dependent Claim
44 words
The method of making a stent of claim 27, wherein the drug is selected from the group consisting of antithrombotics, anticoagulants, antimitogens, antimitotoxins, antisense oligonucleotides, gene therapy vehicles, nitric oxide, growth factors and inhibitors, Hirudin, Hirugen, Hirulog, PPACK, D-FPRCH 2 Cl, Heparin, and Warfarin.
Claim 32
Dependent Claim
21 words
The method of making a stent of claim 21, further comprising the step of coating the stent with a lubricious material.
Claim 33
Dependent Claim
20 words
The method of making a stent of claim 29, further comprising the step of blending a drug with the coating.
Claim 34
Dependent Claim
44 words
The method of making a stent of claim 30, wherein the drug is selected from the group consisting of antithrombotics, anticoagulants, antimitogens, antimitotoxins, antisense oligonucleotides, gene therapy vehicles, nitric oxide, growth factors and inhibitors, Hirudin, Hirugen, Hirulog, PPACK, D-FPRCH 2 Cl, Heparin, and Warfarin.
Claim 35
Dependent Claim
39 words
The method of making a stent of claim 29, wherein the coating is a blend of a biodegradable material with a lubricious materials selected from the group consisting of poly(ethylene glycol), poly(vinyl alcohol), poly(vinyl pyrrolidone), poly(methacrylic acid) and polyacrylamide.
Claim 36
Dependent Claim
42 words
The method of making a stent of claim 29, wherein the coating is a copolymer of a biodegradable material with a lubricious materials selected from the group consisting of monomer constituents of poly(ethylene glycol), poly(vinyl alcohol), poly(vinyl pyrrolidone), poly(methacrylic acid) and polyacrylamide.
Claim 37
Independent Claim
106 words
A method for making a stent comprising the steps of: providing a copolymer of L-lactide and ε-caprolactone that is not expandable at normal body temperatures, and that is thermo-mechanically expandable at a temperature between about 38°-55° C.; creating a tube from the copolymer having a diameter sufficient to permit the tube to be retained upon an unexpanded balloon catheter for insertion into a body lumen; cutting the tube into lengths for use as a stent within the body lumen; and, thermo-mechanically expanding the stent within the body lumen to increase the hoop strength of the stent by a sufficient amount to substantially support the body lumen.
Claim 38
Independent Claim
106 words
A method for making a stent comprising the steps of: providing a copolymer of L-lactide and ε-caprolactone that is not expandable at normal body temperatures, and that is thermo-mechanically expandable at a temperature between about 38°-55° C.; creating a tube from the copolymer having a diameter sufficient to permit the tube to be retained upon an unexpanded balloon catheter for insertion into a body lumen; cutting the tube into lengths for use as a stent within the body lumen; and, thermo-mechanically expanding the stent within the body lumen to increase the hoop strength of the stent by a sufficient amount to substantially support the body lumen.
Claim 39
Dependent Claim
28 words
The method of making a stent of claim 34, wherein the stent is thermo-mechanically expanded so that the draw ratio of the expanded stent is greater than 2.0.
Claim 40
Independent Claim
121 words
A method of deploying an expandable, biodegradable stent within a body lumen, comprising the steps of: providing percutaneous access to the body lumen; placing the unexpanded stent, in the form of an unexpanded hollow, nonwoven tube made from a copolymer of L-lactide and ε-caprolactone, upon a balloon portion of a balloon catheter; transporting the stent to a desired location in the body lumen using the catheter; heating the stent to a temperature between 38°-55° C., to permit thermo-mechanical expansion of the stent; expanding the stent to a desired diameter by inflating the balloon catheter; allowing the stent to cool at least below about 38° C. without applying any positive cooling; deflating the balloon portion of the catheter; and, withdrawing the catheter.
Claim 41
Independent Claim
121 words
A method of deploying an expandable, biodegradable stent within a body lumen, comprising the steps of: providing percutaneous access to the body lumen; placing the unexpanded stent, in the form of an unexpanded hollow, nonwoven tube made from a copolymer of L-lactide and ε-caprolactone, upon a balloon portion of a balloon catheter; transporting the stent to a desired location in the body lumen using the catheter; heating the stent to a temperature between 38°-55° C., to permit thermo-mechanical expansion of the stent; expanding the stent to a desired diameter by inflating the balloon catheter; allowing the stent to cool at least below about 38° C. without applying any positive cooling; deflating the balloon portion of the catheter; and, withdrawing the catheter.
Claim 42
Dependent Claim
30 words
The method of deploying a stent of claim 36, wherein the stent is heated by employing a heated material within the catheter to expand the balloon portion of the catheter.
Claim 43
Dependent Claim
35 words
The method of deploying a stent of claim 36, wherein the stent is heated using a heating method selected from the group consisting of microwave heating, DC heating, RF heating, and heating using ultraviolet radiation.
Claim 44
Dependent Claim
33 words
The method of deploying a stent of claim 36, wherein the stent is made from a copolymer having a ratio of L-lactide to ε-caprolactone in the range from about 90:10 to about 98:2.
Claim 45
Dependent Claim
14 words
The method of deploying a stent of claim 36, wherein the stent is imperforate.
Claim 46
Dependent Claim
33 words
The method of deploying a stent of claim 36, wherein the stent is perforated, the perforations placed at a distance relative to each other corresponding to cell ingrowth patterns within the body lumen.
Claim 47
Dependent Claim
14 words
The method of deploying a stent of claim 36, wherein the stent is nonwoven.
Claim 48
Dependent Claim
16 words
The method of deploying a stent of claim 36, wherein the stent includes a radio-opaque material.
Claim 49
Dependent Claim
19 words
The method of deploying a stent of claim 36, wherein the stent includes a drug blended with the copolymer.
Claim 50
Dependent Claim
44 words
The method of deploying a stent of claim 44, wherein the drug is selected from the group consisting of antithrombotics, anticoagulants, antimitogens, antimitotoxins, antisense oligonucleotides, gene therapy vehicles, nitric oxide, growth factors and inhibitors, Hirudin, Hirugen, Himlog, PPACK, D-FPRCH 2 Cl, Heparin, and Warfarin.
Claim 51
Dependent Claim
18 words
The method of deploying a stent of claim 36, wherein the stent is coated with a lubricious material.
Claim 52
Dependent Claim
20 words
The method of making a stent of claim 46, further comprising the step of blending a drug with the coating.
Claim 53
Dependent Claim
44 words
The method of making a stent of claim 47, wherein the drug is selected from the group consisting of antithrombotics, anticoagulants, antimitogens, antimitotoxins, antisense oligonucleotides, gene therapy vehicles, nitric oxide, growth factors and inhibitors, Hirudin, Hirugen, Hirulog, PPACK, D-FPRCH 2 Cl, Heparin, and Warfarin.
Claim 54
Dependent Claim
39 words
The method of deploying a stent of claim 46, wherein the coating is a blend of a biodegradable material with a lubricious materials selected from the group consisting of poly(ethylene glycol), poly(vinyl alcohol), poly(vinyl pyrrolidone), poly(methacrylic acid) and polyacrylamide.
Claim 55
Dependent Claim
42 words
The method of deploying a stent of claim 46, wherein the coating is a copolymer of a biodegradable material with a lubricious materials selected from the group consisting of monomer constituents of poly(ethylene glycol), poly(vinyl alcohol), poly(vinyl pyrrolidone), poly(methacrylic acid) and polyacrylamide.
Claim 56
Independent Claim
129 words
A method of deploying an expandable, biodegradable stent within a body lumen, comprising the steps of: providing percutaneous access to the body lumen; placing the unexpanded stent, in the form of an unexpanded hollow, nonwoven tube made from a copolymer of L-lactide and ε-caprolactone, upon a balloon portion of a balloon catheter; transporting the stent to a desired location in the body lumen using the catheter; heating the stent to a temperature between 38°-55° C., to permit thermo-mechanical expansion of the stent; expanding the stent to a desired diameter by inflating the balloon catheter so that the draw ratio of the expanded stent is greater than 2.0; allowing the stent to cool at least below about 38° C.; deflating the balloon portion of the catheter; and, withdrawing the catheter.
Claim 57
Independent Claim
129 words
A method of deploying an expandable, biodegradable stent within a body lumen, comprising the steps of: providing percutaneous access to the body lumen; placing the unexpanded stent, in the form of an unexpanded hollow, nonwoven tube made from a copolymer of L-lactide and ε-caprolactone, upon a balloon portion of a balloon catheter; transporting the stent to a desired location in the body lumen using the catheter; heating the stent to a temperature between 38°-55° C., to permit thermo-mechanical expansion of the stent; expanding the stent to a desired diameter by inflating the balloon catheter so that the draw ratio of the expanded stent is greater than 2.0; allowing the stent to cool at least below about 38° C.; deflating the balloon portion of the catheter; and, withdrawing the catheter.
References Cited (Backward Citations)
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
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| 3.5 Years (Year 4) | 2000-09-22 | 2001-03-24 | 2001-09-23 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2004-09-22 | 2005-03-24 | 2005-09-23 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2008-09-22 | 2009-03-24 | 2009-09-23 | $7700.00 | Window Closed / Lapsed |