Method of processing open-celled microcellular polymeric foams with controlled porosity for use as vascular grafts and stent covers

• US 6,702,849 B1
• Filed: 12/13/1999
• Issued: 03/09/2004
• Est. Priority Date: 12/13/1999
• Status: Expired due to Term

• Current Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Rao, Kondapavulur T. V., Dutta, Debashis, Wang, Chicheng
• Primary Examiner(s): Milano, Michael J.
• Assistant Examiner(s): Ho, (Jackie) Tan-Uyen T.
• Application Number:
  US09/460,271
• Time in Patent Office: 1,548 Days
• Field of Search: 606/1, 606/108, 606/194, 606/198, 606/195, 623/1.1, 623/1.11, 623/1.13, 623/1.39, 623/1.4, 623/1.42, 623/1.46, 623/12, 427/2.26, 427/228, 427/2.3
• US Class Current: 623/1.42
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61L 2300/602 Type of release, e.g. controlled, sustained, slow
• CPC Class Codes: A61L 2300/606 Coatings
• CPC Class Codes: A61L 27/40 Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence

Abstract

Porous vascular grafts and stent covers are formed of open-celled microcellular polymeric foams having a porosity that can be modified to be adapted for carrying and delivering different types of therapeutic drugs. A stent cover is formed of a tubular member including at least one layer of a porous, microcellular foam formed from a polymeric material capable of absorbing and releasing therapeutic drugs at predictable rates for delivery of the therapeutic drugs in localized drug therapy in a blood vessel. A composite metal and polymer vascular graft is formed of an interior structural stent member, and an outer layer or coating of the porous, microcellular foam. The method of making the composite metal and polymer vascular graft involves providing an interior structural stent member with an outer layer or coating of the porous, microcellular foam, and can further comprise the step of loading a therapeutic drug into the outer layer of the porous, microcellular foam for delivery of the therapeutic drugs in localized drug therapy in a blood vessel.

Claims

1. A stent cover for use with a stent for controlled release of therapeutic drugs by a stent for delivery of the therapeutic drugs in localized drug therapy in a blood vessel, comprising:

a tubular member formed of at least one layer of a porous, open-celled microcellular foam of a polymeric material formed by dissolving an inert gas in the polymeric material at an initial temperature and pressure and creating microvoids in the polymeric material by changing the pressure or temperature of the polymeric material, said porous open-celled microcellular foam being capable of absorbing and releasing therapeutic drugs at predictable rates.

2. The stent cover of claim 1, wherein the layer of porous, microcellular foam ranges in thickness from about a few nanometers to about a millimeter.

3. The stent cover of claim 1, wherein the size of the pores in the foam and the amount of porosity in the foam is adjusted to accommodate the molecular weight of a desired drug compound.

4. The stent cover of claim 1 wherein the diameter of the pores of the microcellular foam is formed to accommodate a compound having a molecular weight in the range of from about 10 daltons up to about 1,000,000 daltons.

5. The stent cover of claim 1, wherein the microcellular foam is formed from a polymeric material selected from the group consisting of polyurethanes containing carbonate linkages, poly-L-lactic acid, poly-DL-lactic acid, polyglycolic acid, p-dioxanone, and trimethylene carbonate/glycolic acid copolymers.

6. A composite metal and polymer vascular graft for controlled release of therapeutic drugs by a stent for delivery of the therapeutic drugs in localized drug therapy in a blood vessel, comprising:

an inner structural stent member; and

an outer layer formed of at least one layer of a porous, open-celled microcellular foam of a polymeric material formed by dissolving an inert gas in the polymeric material at an initial temperature and pressure and creating microvoids in the polymeric material by changing the pressure or temperature of the polymeric material, said porous open-celled microcellular foam being capable of absorbing and releasing therapeutic drugs at predictable rates for delivery of the therapeutic drugs in localized drug therapy in a blood vessel.

7. The composite metal and polymer vascular graft of claim 6, wherein said inner structural stent member is formed a metal selected from the group consisting of stainless steel, tantalum and gold.

8. The composite metal and polymer vascular graft of claim 6, wherein said inner structural stent member is formed a material selected from the group consisting of polymers and composites.

9. The composite metal and polymer vascular graft of claim 6, wherein said inner structural stent member is formed a composite of tantalum and silicon carbide.

10. The composite metal and polymer vascular graft of claim 6, wherein the layer of porous, open-celled microccllular foam ranges in thickness from about a few nanometers to a millimeter.

11. The composite metal and polymer vascular graft of claim 6, wherein the size of the pores in the foam and the amount of porosity in the foam is adjusted to accommodate the molecular weight of a desired drug compound.

12. The composite metal and polymer vascular graft of claim 6, wherein the diameter of the pores of the porous, open-celled microcellular foam is formed to accommodate a compound having a molecular weight in the range of from about 10 daltons up to about 1,000,000 daltons.

13. The composite metal and polymer vascular graft of claim 6, wherein the porous, open-celled microcellular foam is formed from a polymeric material selected from the group consisting of polyurethanes containing carbonate linkages, poly-L-lactic acid, poly-DL-lactic acid, polyglycolic acid, p-dioxanone, and trimethylene carbonate/glycolic acid copolymers.

14. A method of making a composite metal and polymer vascular graft or coated stent, including an inner structural stent member and an outer layer or coating of a porous, open-celled microccllular foam formed from a polymeric material capable of absorbing and releasing therapeutic drugs at predictable rates for delivery of the therapeutic drugs in localized drug therapy in a blood vessel, comprising the steps of:

providing an inner structural stent member; and

coating the inner structural stent member with at least one outer layer of a polymeric material, wherein microvoids have been formed in the polymeric material by dissolving an inert gas under pressure in the polymeric material and rapidly changing the temperature or pressure of the polymeric material to form a porous, open-celled microcellular foam from the polymeric material, said porous, open-celled microcellular foam being capable of absorbing and releasing therapeutic drugs at predictable rates for delivery of the therapeutic drugs in localized drug therapy in a blood vessel.

15. The method of claim 14, further comprising the step of adjusting the size of the pores in the foam and the amount of porosity in the foam to accommodate the molecular weight of a desired drug compound.

16. The method of claim 14, wherein the layer of porous, open-celled microcellular foam ranges in thickness from about a few nanometers to about a millimeter.

17. The method of claim 15, wherein the diameter of the pores of the porous, open-celled microcellular foam is formed to accommodate a compound having a molecular weight in the range of from about 10 daltons up to about 1,000,000 daltons.

18. The method of claim 14, wherein the porous, open-celled microcellular foam is formed from a polymeric material selected from the group consisting of polyurethanes containing carbonate linkages, poly-L-lactic acid, poly-DL-lactic acid, polyglycolic acid, p-dioxanone, and trimethylene carbonate/glycolic acid copolymers.

19. The method of claim 14, further comprising the step of loading a therapeutic drug into the outer layer of a porous, open-celled microcellular foam for delivery of the therapeutic drugs in localized drug therapy in a blood vessel.

20. The method of claim 14, wherein the therapeutic drug is selected from the group consisting of taxol, aspirin and prostaglandins.

21. A stent cover for use with a stent for controlled release of a therapeutic drug or agent for delivery of the therapeutic drug or agent in drug therapy in a lumen of a body vessel, comprising:

a tubular member formed of at least one layer of a porous, open-celled microcellular foam of a polymeric material formed by dissolving an inert gas in a preform of the polymeric material at an initial temperature and pressure and creating microvoids in the polymeric material by changing the pressure or temperature of the preform of the polymeric material, said porous open-celled microcellular foam being capable of releasing a therapeutic drug or agent.

22. The stent cover of claim 21, wherein the stent cover is adapted for use in delivery of the therapeutic drug or agent in localized drug therapy.

23. The stent cover of claim 21, wherein said at least one layer of a porous, open-celled microccllular foam of a polymeric material is capable of absorbing the therapeutic drug or agent.

24. The stent cover of claim 21, wherein said at least one layer of a porous, open-celled microcellular foam of a polymeric material is capable of releasing the therapeutic drug or agent at predictable rates.

25. A composite metal and polymer vascular graft for controlled release of a therapeutic drug or agent for delivery of the therapeutic drug or agent in drug therapy in a lumen of a body vessel, comprising:

an inner structural stent member; and

an outer layer formed of at least one layer of a porous, open-celled microcellular foam of a polymeric material formed by dissolving an inert gas in a preform of the polymeric material at an initial temperature and pressure and creating microvoids in the preform of the polymeric material by changing the pressure or temperature of the preform of the polymeric material, said porous open-celled microccllular foam being capable of releasing a therapeutic drug or agent.

26. The composite metal and polymer vascular graft of claim 25, wherein the composite metal and polymer vascular graft is adapted for use in delivery of the therapeutic drug or agent in localized drug therapy.

27. The composite metal and polymer vascular graft of claim 25, wherein said at least one layer of a porous, open-celled microcellular foam of a polymeric material is capable of absorbing the therapeutic drug or agent.

28. The composite metal and polymer vascular graft of claim 25, wherein said at least one layer of a porous, open-celled microcellular foam of a polymeric material is capable of releasing the therapeutic drug or agent at predictable rates.

29. A method of making a composite metal and polymer vascular graft or coated stent, including an inner structural stent member and an outer layer or coating of a porous, open-celled microcellular foam formed from a polymeric material capable of releasing a therapeutic drug or agent for delivery of the therapeutic drug or agent in drug therapy in a lumen of a body vessel, comprising the steps of:

providing an inner structural stent member; and

coating the inner structural stent member with at least one outer layer of a polymeric material, wherein microvoids have been formed in a preform of the polymeric material by dissolving an inert gas under pressure in the preform of the polymeric material and rapidly changing the temperature or pressure of the preform of the polymeric material to form a porous, open-celled microcellular foam from the preform of the polymeric material capable of releasing a therapeutic drug or agent.

30. The method of claim 29, wherein the composite metal and polymer vascular graft is adapted for use in delivery of the therapeutic drug or agent in localized drug therapy.

31. The method of claim 29, wherein said at least one layer of a porous, open-celled microcellular foam of a polymeric material is capable of absorbing the therapeutic drug or agent.

32. The method of claim 29, wherein said at least one layer of a porous, open-celled microcellular foam of a polymeric material is capable of releasing the therapeutic drug or agent at predictable rates.

33. A stent cover for use with a stent for controlled release of therapeutic drugs by a stent for delivery of the therapeutic drugs in localized drug therapy in blood vessel, comprising:

a tubular member formed of at least one layer of a porous, microcellular foam with an open-celled reticulated structure;

wherein the microcellular foam is formed by dissolving an inert gas in a preform of a polymeric material at an initial temperature and pressure and creating microvoids in the preform of the polymeric material by changing the pressure or temperature of the preform of the polymeric material, said porous open-celled microcellular foam being capable of absorbing and releasing therapeutic drugs at predictable rates.