US5578075A
Expired / Lapsed
US
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Minimally invasive bioactivated endoprosthesis for vessel repair
Assignee: Boston Scientific Scimed Inc
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Filing: 1995-06-01
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Granted: 1996-11-26
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Expires: 2015-06-01
Abstract
Abstract A minimally invasive bioactivated endoprosthesis device for vessel repair. The device comprises a stent which is formed from metal or polymers into a predetermined shape which may include a plurality of holes patterned with a desired size, shape and number. The stent is then coated with a polymer or is formed from a polymer which contains a bioactive substance which achieves an equilibrium with the surrounding body tissues or fluids, with the equilibrium being controlled by charge distribution, concentration and molecular weight of the bioactive substance in relation to the pore size of the polymeric carrier for controlled prolonged release of said bioactive substance. The bioactive substance may be selected from the group of heparin, hirudin, prostacyclenes and analogs thereof, antithrombogenic agents, steroids, ibuprofen, antimicrobials, antibiotics, tissue plasma activators, rifamicin, monoclonal antibodies, snake venom protein by-products, antifibrosis agents, hyaluronte, cyclosporine and mixtures of these bioactive substances for simultaneous multiple treatments. The stent itself may take several distinct configurations. Preferred is a stent which comprises a substructure selected from flat sheets, flat sheets having holes therein, meshes and stent frames having a sheath thereon, and the substructure is coated with a polymer embedded with a bioactive substance. The stent may be either self-expandable or mechanically expandable, such as by a balloon or other device.
Inventors
- 👤 Michael P. Dayton
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 18:28
CPC Classifications
A; A61; A61F; A61F2/00; A61F2/82; A61F2/92; A61B; A61B17/00; A61B17/00234; A61F2250/00; A61F2250/0058; A61F2250/0067; Y; Y10; Y10S; Y10S623/00; Y10S623/901
Claims Analysis
Total Claims: 13
Claim 1
Independent Claim
198 words
A minimally invasive bioactivated endoprosthesis device for vessel repair in contact with surrounding body tissues, comprising: a stent formed from a solid non-biodegradable material presenting a substantial surface to said tissues for use with a blood vessel or other body conduit to form an internally unrestricted stent having a diameter of a selected size for said blood vessel or other body conduit; said stent including a plurality of holes sufficiently large to permit rapid endothelialization; and a polymer forming at least the exterior surface of said stent for direct polymer to tissue contact with said tissue, said polymer having a porous structure with a predetermined pore size and further including a bioactive substance within said pores for elution from said pores, said pore size being selected in response to the concentration and molecular weight of said substance to achieve equilibrium between said polymer and said tissue to provide a controlled and prolonged release of said bioactive substance to said surrounding body tissue in an amount sufficient to substantially prevent hyperplasia or therapeutically treat said tissue, said stent having sufficient amount of said substantial surface to support a quantity of said polymer capable of prolonged release of said amount.
Claim 2
Dependent Claim
198 words
A minimally invasive bioactivated endoprosthesis device for vessel repair in contact with surrounding body tissues, comprising: a stent formed from a solid non-biodegradable material presenting a substantial surface to said tissues for use with a blood vessel or other body conduit to form an internally unrestricted stent having a diameter of a selected size for said blood vessel or other body conduit; said stent including a plurality of holes sufficiently large to permit rapid endothelialization; and a polymer forming at least the exterior surface of said stent for direct polymer to tissue contact with said tissue, said polymer having a porous structure with a predetermined pore size and further including a bioactive substance within said pores for elution from said pores, said pore size being selected in response to the concentration and molecular weight of said substance to achieve equilibrium between said polymer and said tissue to provide a controlled and prolonged release of said bioactive substance to said surrounding body tissue in an amount sufficient to substantially prevent hyperplasia or therapeutically treat said tissue, said stent having sufficient amount of said substantial surface to support a quantity of said polymer capable of prolonged release of said amount.
Claim 3
Independent Claim
203 words
A method of making a minimally invasive bioactivated endoprosthesis device for vessel repair in contact with surrounding body tissues, comprising the steps of: forming a stent from a non-biodegradable material sized to present a substantial surface to said tissues for use with a blood vessel or other body conduit and having a diameter of a selected size for said blood vessel or other body conduit; said material including a plurality of holes sufficiently large to permit rapid endothelialization; and forming a polymer on at least the exterior surface of said stent for direct polymer to tissue contact with said tissues, said polymer having a porous structure with a predetermined pore size and further including a bioactive substance within said pores for elution from said pores, said pore size being selected in response to the concentration and molecular weight of said substance to achieve equilibrium between said polymer and said tissues to provide a controlled and prolonged release of said bioactive substance to said surrounding body tissues in an amount sufficient to substantially prevent hyperplasia or therapeutically treat said tissues, said stent having a sufficient amount of said substantial surface to support a quantity of said polymer capable of prolonged release of said amount.
Claim 4
Independent Claim
203 words
A method of making a minimally invasive bioactivated endoprosthesis device for vessel repair in contact with surrounding body tissues, comprising the steps of: forming a stent from a non-biodegradable material sized to present a substantial surface to said tissues for use with a blood vessel or other body conduit and having a diameter of a selected size for said blood vessel or other body conduit; said material including a plurality of holes sufficiently large to permit rapid endothelialization; and forming a polymer on at least the exterior surface of said stent for direct polymer to tissue contact with said tissues, said polymer having a porous structure with a predetermined pore size and further including a bioactive substance within said pores for elution from said pores, said pore size being selected in response to the concentration and molecular weight of said substance to achieve equilibrium between said polymer and said tissues to provide a controlled and prolonged release of said bioactive substance to said surrounding body tissues in an amount sufficient to substantially prevent hyperplasia or therapeutically treat said tissues, said stent having a sufficient amount of said substantial surface to support a quantity of said polymer capable of prolonged release of said amount.
Claim 5
Dependent Claim
44 words
The device of claim 1, wherein said stent comprises a substructure selected from the group consisting of flat sheets, flat sheets having holes therein, meshes and stent flames having a sheath thereon; said structure being coated with said polymer embedded with a bioactive substance.
Claim 6
Dependent Claim
31 words
The device of claim 1, wherein said stent is formed in-situ from said polymer embedded with a bioactive substance wherein the polymer is cured after placement in contact with surrounding tissues.
Claim 7
Dependent Claim
18 words
The device of claim 1, wherein said stent comprises a metallic substructure having said polymer as a coating.
Claim 8
Dependent Claim
38 words
The device of claim 1 wherein said polymer is selected from the group of silicone, polyurethane, polyvinyl alcohol, polyethylene, biodegradable polylactic acid polymers, polyglycolic acid polymers, polyesters, hydrogels, polytetrafluroethylene, fluorosilicone, hyaluronte and combinations, copolymers and blended mixtures thereof.
Claim 9
Dependent Claim
52 words
The device of claim 1, wherein said bioactive substance is selected from the group consisting of heparin, hirudin, prostacyclenes or analogs thereof, antithrombogenic agents, steroids, ibuprofen, antimicrobials, antibiotics, tissue plasma activators, rifamicin, monoclonal antibodies, snake venom protein by-products, antifibrosis agents, hyaluronte, cyclosporine and mixtures of these bioactive substances for simultaneous multiple treatments.
Claim 10
Dependent Claim
24 words
The device of claim 1 wherein said stent is formed solely from said polymer having sufficient structural integrity to be formed into a stent.
Claim 11
Dependent Claim
46 words
The method of claim 2, wherein said stent is formed from a substructure selected from the group consisting of flat sheets, flat sheets having holes therein, meshes and stent frames having a sheath thereon; said structure being coated with said polymer embedded with a bioactive substance.
Claim 12
Dependent Claim
31 words
The method of claim 2, wherein said stent is formed in-situ from a polymer embedded with a bioactive substance wherein the polymer is cured after placement in contact with surrounding tissues.
Claim 13
Dependent Claim
20 words
The method of claim 2, wherein said stent is selected from the group consisting of self-expanding and mechanically expandable stents.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1999-11-26 | 2000-05-27 | 2000-11-26 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2003-11-26 | 2004-05-27 | 2004-11-26 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2007-11-26 | 2008-05-27 | 2008-11-26 | $7700.00 | Window Closed / Lapsed |