Apparatus and method for treating intravascular disease

• US 7,662,143 B2
• Filed: 07/29/2003
• Issued: 02/16/2010
• Est. Priority Date: 07/29/2003
• Status: Expired due to Fees

• Current Assignee: Stryker European Operations Holdings, LLC (Stryker Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Casados, Jesse E., Carrison, Harold, Abrams, Robert M., Farnholtz, Roger
• Primary Examiner(s): Mendez; Manuel A
• Application Number:
  US10/629,114
• Publication Number:
  US 20050027247A1
• Time in Patent Office: 2,394 Days
• Field of Search: 604/96.01, 60410101-10105, 604/915, 604/916, 60410201-10203, 604/917, 604/919, 606191-194
• US Class Current: 604/509
• CPC Class Codes: A61M 2025/0057 Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters

Abstract

Medical devices and methods of treatment using medical devices, and more particularly, methods of treating a treatment site in a blood vessel and devices or apparatuses for use therewith. In some embodiments, a method and apparatus for treating a treatment site in a blood vessel using fluid movement or agitation adjacent the treatment site is disclosed. In some embodiments, an apparatus is provided including one or more deployable structures adapted to create fluid movement within the vessel. The apparatus is inserted into the vessel, and the deployable structure is positioned adjacent the treatment site. The deployable structure is used to create fluid movement adjacent to the treatment site. In some embodiments, a treatment material, such as a medicine or drug, is introduced into the vessel proximate the treatment site, and the deployable structure is used to create fluid movement or agitation adjacent the treatment site to create a better interface between the treatment site and the medicine, or to move the medicine into the treatment site. In some embodiments, the fluid movement created by the deployable member aids in removal of tissue or other material from the treatment site.

Claims

1. A method of treating a treatment site in a blood vessel, the method comprising:

providing an apparatus including, a first deployable structure and a second deployable structure;

inserting the apparatus into the vessel adjacent the treatment site such that the first deployable structure is disposed adjacent the treatment site, and the second deployable structure is disposed at a location proximal or distal to the treatment site;

introducing a treatment material into the vessel proximate the treatment site;

deploying the second deployable structure within the vessel at the location proximal or distal the treatment site; and

deploying the first deployable structure adjacent the treatment site to create movement of the treatment material adjacent the treatment site.

2. The method of claim 1, further including repeatedly deploying and un-deploying the first deployable structure adjacent the treatment site to create movement of the treatment material adjacent the treatment site.

3. The method of claim 1, wherein the first and second deployable structures each individually comprise a balloon assembly, net assembly, basket assembly, filament assembly, paddle assembly, impeller assembly, or filter assembly.

4. The method of claim 1, wherein the first and second deployable structures each individually comprise a balloon assembly, or filter assembly.

5. The method of claim 1, wherein the treatment material comprises a blood clot dissolving drug.

6. The method of claim 1, wherein the treatment material comprises TpA, urokinase, streptokinase, reteplase, or anistreplase.

7. The method of claim 1, wherein the vessel is a cranial blood vessel, and the treatment site includes a blood clot, and wherein the inserting step includes inserting the apparatus into the cranial vessel and the introducing step includes introducing a blood clot dissolving drug.

8. The method of claim 1, wherein the apparatus comprises a balloon catheter having tubular body, and the first and second deployable structures are inflatable balloon assemblies mounted on the tubular body.

9. The method of claim 1, wherein the first deployable structure comprises an inflatable balloon assembly and the second deployable structure comprises a filter assembly.

10. The method of claim 1, wherein the first deployable structure comprises a filter assembly and the second deployable structure comprises an inflatable balloon assembly.

11. The method of claim 1, wherein the apparatus comprises a balloon catheter including an elongated tubular body defining at least one lumen therein and a balloon assembly mounted thereon, the apparatus further comprising an elongated core member including a distal portion having a filter assembly mounted thereon, the core member being slidably disposed within the lumen of the catheter, and wherein the balloon assembly comprises the first deployable structure and the filter assembly comprises the second deployable structure.

12. The method of claim 11, wherein the elongated tubular body of the catheter includes a distal end, and during the insertion of the apparatus into the vessel, the filter assembly is disposed within the lumen of the catheter proximal of the distal end, and to deploy the filter assembly within the vessel, the filter assembly is advanced distally beyond the distal end of the tubular body of the catheter.

13. The method of claim 1, wherein the second deployable structure is deployed at a location proximal to the treatment site.

14. The method of claim 1, wherein the second deployable structure is deployed at a location distal to the treatment site.

15. The method of claim 1, wherein the apparatus further includes a third deployable structure, and wherein inserting the apparatus into the vessel includes disposing the first deployable structure adjacent the treatment site, disposing the second deployable structure at a location proximal to the treatment site, and disposing the third deployable structure at a location distal to the treatment site, and the method further includes deploying the third deployable structure within the vessel.

16. The method of claim 15, wherein the first, second, and third deployable structures each individually comprise a balloon assembly, a net assembly, a basket assembly, a filament assembly, a paddle assembly, an impeller assembly, or a filter assembly.

17. The method of claim 15, wherein the apparatus comprises a balloon catheter, and the first and second deployable structures each comprise an inflatable balloon assembly, and the third deployable structure comprises a filter assembly.

18. The method of claim 15 wherein the apparatus comprises a balloon catheter having an inner lumen, and the first and second deployable members comprise deployable balloon assemblies, the apparatus further including a distal protection device including a distal filter member, and wherein the distal filter member comprises the third deployable structure.

19. The method of claim 15, wherein the apparatus is a balloon catheter, and the second deployable structures comprises an inflatable balloon assembly, and the third deployable structure comprises a filter assembly.

20. The method of claim 1, wherein the apparatus further includes a delivery catheter, and the treatment material is introduced into the vessel through the delivery catheter.

21. An apparatus for treating a treatment site in a blood vessel, the apparatus comprising:

an elongated tubular member including a distal portion;

a structure for introducing treatment material to the treatment site;

an first deployable structure connected to the distal portion of the tubular member, the first deployable structure adapted to be deployed and engage the blood vessel at a position proximal or distal of the treatment site; and

a second deployable structure connected to the distal portion of the tubular member, the second deployable structure adapted to be deployed adjacent the treatment site to create movement of the treatment material adjacent the treatment site.

22. The apparatus of claim 21, wherein the first and second deployable structures are each individually selected from a balloon assembly, net assembly, basket assembly, filament assembly, paddle assembly, impeller assembly, or filter assembly.

23. The apparatus of claim 21, wherein the first and second deployable structures are each individually selected from a balloon assembly, or a filter assembly.

24. The apparatus of claim 21, wherein the elongated tubular member is adapted to extend within a cranial vessel, and the first and second deployable structures are adapted to be deployed in the cranial vessel.

25. The apparatus of claim 21, wherein the apparatus comprises a balloon catheter having tubular body, and the first and second deployable structures are inflatable balloon assemblies mounted on the tubular body.

26. The apparatus of claim 25, wherein the balloon catheter comprises one of an over-the-wire or a fixed wire balloon catheter.

27. The apparatus of claim 25, wherein the body of the balloon catheter comprises a plurality of lumens disposed in a coaxial arrangement.

28. The apparatus of claim 25, wherein the body of the balloon catheter comprises a plurality of lumens disposed in a side-by-side arrangement.

29. The apparatus of claim 21, wherein the second deployable structure is adapted to be repeatedly deployed and un-deployed adjacent the treatment site.

30. The apparatus of claim 21, wherein the first deployable structure comprises an inflatable balloon assembly and the second deployable structure comprises a filter assembly.

31. The apparatus of claim 21, wherein the first deployable structure comprises a filter assembly and the second deployable structure comprises an inflatable balloon assembly.

32. The apparatus of claim 21, wherein the apparatus comprises a balloon catheter including an elongated tubular body defining at least one lumen therein and a balloon assembly mounted thereon, the apparatus further comprising an elongated core member including a distal portion having a filter assembly mounted thereon, the core member being slidably disposed within the lumen of the catheter, wherein the balloon assembly comprises the first deployable structure and the filter assembly comprises the second deployable structure.

33. The apparatus of claim 32, wherein the elongated tubular body of the catheter includes a distal end, the filter assembly is adapted to in a first, non-expanded configuration when disposed within the lumen of the catheter proximal of the distal end during the insertion of the apparatus into the vessel, the filter assembly further adapted to deploy to a second, expanded configuration when it is advanced distally beyond the distal end of the tubular body of the catheter within the vessel.

34. The apparatus of claim 21, wherein the first deployable structure is adapted to be deployed in a position within the vessel proximal of the treatment site.

35. The apparatus of claim 21, wherein the first deployable structure is adapted to be deployed in a position within the vessel distal of the treatment site.

36. The apparatus of claim 21, wherein the apparatus further includes a third deployable structure, and the first deployable structure is adapted to be deployed at a location proximal to the treatment site, and the third deployable structure is adapted to be deployed at a location distal to the treatment site.

37. The apparatus of claim 36, wherein the first, second, and third deployable structures are each individually selected from a balloon assembly, a net assembly, a basket assembly, a filament assembly, a paddle assembly, an impeller assembly, or a filter assembly.

38. The apparatus of claim 36, wherein the apparatus is a balloon catheter, and the first, second, and third deployable structures each comprise an inflatable balloon assembly.

39. The apparatus of claim 36, wherein the apparatus is a balloon catheter, and the first and second deployable structures each comprise an inflatable balloon assembly, and the third deployable structure comprises a filter assembly.

40. The apparatus of claim 36, wherein the apparatus is a balloon catheter, and the second deployable structures comprises an inflatable balloon assembly, and the third deployable structure comprises a filter assembly.

41. The apparatus of claim 21, wherein the apparatus further includes a delivery catheter.