Method and apparatus for intravascular drug delivery

• US 5,306,250 A
• Filed: 04/02/1992
• Issued: 04/26/1994
• Est. Priority Date: 04/02/1992
• Status: Expired due to Fees

• Current Assignee: ADVANCED RESEARCH & TECHNOLOGY INSTITUTE
• Original Assignee: Indiana University Foundation
• Inventors: Hathaway, David R., Wilensky, Robert L., March, Keith L.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US07/862,075
• Time in Patent Office: 754 Days
• Field of Search: 604/96, 604/104, 604/107, 604/108, 604/53, 604/28, 604/48, 604/49, 604/54, 604/93, 604/265, 604/266, 604/269, 606/191, 606/198
• US Class Current: 604/104
• CPC Class Codes: A61M 16/0445 Special cuff forms, e.g. undulated
• CPC Class Codes: A61M 16/0481 through the cuff wall
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

A drug delivery catheter assembly, including an expandable, porous outer membrane that is insertable into a blood vessel and positioned adjacent a stenotic atherosclerotic lesion on the interior wall of the blood vessel. The membrane is expanded into contact with the lesion, either mechanically or hydraulically. After the membrane is expanded, a drug-containing liquid is caused to flow into the membrane and through the pores in the membrane into contact with the lesion.

Claims

1. A method applying a drug to a localized area on the inner wall of a tubular body vessel comprising the steps of:

providing expandable, porous outer membrane;

inserting membrane into the vessel adjacent the localized area;

expanding the membrane into contact with the localized area of the vessel; and

after the step of expansion causing a drug-containing liquid to flow under pressure through pores in the expanded membrane into contact with the localized area of the vessel;

wherein the step of expanding the membrane occurs independently of the step of causing the drug-containing liquid to flow through the membrane.

2. The method of claim 1, including the step of pumping the drug-containing liquid through a tube and to the expanded membrane to thereby pressurize the membrane with the liquid and cause the liquid to flow through the pores of the membrane.

3. The method of claim 2, wherein the step of expanding the membrane is accomplished by expanding an endoskeletal frame within the membrane, the frame exerting mechanical force on the membrane to expand the membrane.

4. The method of claim 1, wherein the step of expanding the membrane is accomplished by expanding an endoskeletal frame within the membrane, the frame exerting mechanical force on the membrane to expand the membrane.

5. The method of claim 1, wherein the step of expansion comprises pressurizing the membrane with a working fluid that is segregated from the drug-containing liquid.

6. The method of claim 1, wherein the drug is carried by microparticles of a physiologically-compatible, biodegradable polymer.

7. A method of applying a drug to a localized area on the inner wall of a tubular body vessel comprising the steps of:

providing an expandable, porous outer membrane;

inserting the membrane into the vessel adjacent the localized area;

expanding the membrane into contact with the localized area of the vessel; and

causing a drug-containing liquid to flow under pressure into the membrane and through the pores in the membrane into contact with the localized area of the vessel;

the step of expanding the membrane occurring independently of the flow of pressurized drug-containing liquid into the membrane and through the pores in the membrane.

8. The method of claim 7, wherein the step of expanding the membrane is accomplished by expanding an endoskeletal frame within the membrane, the frame exerting mechanical force on the membrane to expand the membrane.

9. A method of treating a stenotic atherosclerotic lesion on the interior wall of a blood vessel comprising the steps of:

providing an expandable, porous outer membrane;

inserting the membrane into the blood vessel adjacent the lesion;

expanding the membrane into contact with the lesion; and

after the step of expansion, causing a drug-containing liquid to flow under pressure through pores in the expanded membrane into contact with the lesion;

wherein the step of expanding the membrane occurs independently of the flow of the drug-containing liquid through the membrane.

10. The method of claim 9, including the step of pumping the drug-containing liquid through a tube into the expanded membrane to thereby pressurize the membrane with the liquid and cause the liquid to flow through the pores of the membrane.

11. The method of claim 10, wherein the step of expanding the membrane is accomplished by expanding an endoskeletal frame within the membrane, the frame exerting mechanical force on the membrane to expand the membrane.

12. The method of claim 9, wherein the step of expanding the membrane is accomplished by expanding an endoskeletal frame within the membrane, the frame exerting mechanical force on the membrane to expand the membrane.

13. The method of claim 9, wherein the step of expansion comprises pressurizing the membrane with a working fluid that is segregated from the drug-containing liquid.

14. The method of claim 9, wherein the drug is carried by microparticles of a physiologically-compatible, biodegradable polymer.

15. A method of treating a stenotic atherosclerotic lesion on the interior wall of a blood vessel comprising the steps of:

providing an expandable, porous outer membrane;

inserting the membrane into the blood vessel adjacent the lesion;

expanding the membrane into contact with the lesion; and

causing a drug-containing liquid to flow under pressure into the membrane and through pores in the membrane into contact with the lesion, the step of expansion occurring independently of the-flow of pressurized drug-containing liquid into the membrane and through the pores in the membrane.

16. The method of claim 15, wherein the step of expanding the membrane is accomplished by expanding an endoskeletal frame within the membrane, the frame exerting mechanical force on the membrane to expand the membrane.

17. Apparatus for applying a drug to a localized area of a tubular body vessel comprising:

an expandable, porous outer membrane;

an elongate flexible tube connected to said membrane;

means for pumping a drug-containing liquid through said tube into said membrane and through pores in said membrane; and

means for mechanically expanding the membrane into contact with the vessel independently of the pumping of the liquid into and through said membrane.

18. The apparatus of claim 17, wherein said means for expanding comprises an endoskeletal frame within said membrane and means for expanding said frame to exert mechanical force on said membrane to thereby expand said membrane.

19. The apparatus of claim 18, including means for contracting said frame.

20. The apparatus of claim 18, wherein said endoskeletal frame comprises a wire mesh cage, and said means for expanding comprises a retractable wire connected to said mesh cage to expand the mesh cage when the wire is retracted.

21. The apparatus of claim 20, wherein said membrane is bonded to said cage.

22. The apparatus of claim 18, wherein said endoskeletal frame is an expandable stent.

23. The apparatus of claim 18, wherein said endoskeletal frame comprises a tubular frame member having a plurality of slots therein forming a plurality of ribs, and said means for expanding comprises a retractable wire connected to the tubular frame member for causing said ribs to expand radially when the wire is retracted.

24. The apparatus of claim 23, wherein said membrane is bonded said ribs.

25. The apparatus of claim 23, wherein said tubular frame member includes a second plurality of slots to form a second plurality of ribs spaced axially from the first mentioned plurality of ribs, wherein said wire expands said second plurality of ribs.

26. The apparatus of claim 25, wherein said porous membrane extends between said first mentioned and second plurality of ribs.

27. The apparatus of claim 24, wherein said tubular frame member extends axially through said flexible tube into said membrane at a proximal end of said membrane, said wire being attached to said tubular frame member at a distal position thereof, and said ribs being disposed intermediate the attachment position of said wire and the proximal end of the membrane.

28. The apparatus of claim 17, wherein said membrane is pleated and said means for expanding comprises means for contracting said membrane axially to thereby cause the pleated membrane to expand radially.

29. The apparatus of claim 28, including pores in said pleats at radially outer peaks thereof.

30. The apparatus of claim 17, including ducts within said membrane connected to said pores, said ducts being in communication with said means for pumping, and wherein said means for expanding comprises means for hydraulically expanding said membrane.

31. The apparatus of claim 30, wherein said means for hydraulically expanding comprises a second flexible tube coextensive with said first mentioned flexible tube and being in communication with said membrane, and means for pumping fluid through said second tube into said membrane to expand said membrane

32. The apparatus of claim 17, wherein said flexible tube is in fluid communication with said membrane.

33. The apparatus of claim 32, wherein said means for expanding comprises an endoskeletal frame within said membrane and means for expanding said frame to exert mechanical force on said membrane to thereby expand said membrane.

34. The apparatus of claim 33, including means for contracting said frame.

35. The apparatus of claim 17, wherein the drug is carried by microparticles of a physiologically-compatible, biodegradable polymer.