Balloon catheters having ultrasonically driven interface surfaces and methods for their use

• US 5,846,218 A
• Filed: 09/05/1996
• Issued: 12/08/1998
• Est. Priority Date: 09/05/1996
• Status: Expired due to Fees

• Current Assignee: PharmaSonics, Inc.
• Original Assignee: PharmaSonics, Inc.
• Inventors: Ghazarossian, Vartan E., Brisken, Axel F.
• Primary Examiner(s): Bockelman, Mark
• Application Number:
  US08/708,589
• Time in Patent Office: 824 Days
• Field of Search: 606/194, 606/1, 606/169, 601/2-3, 604/22, 604/96
• US Class Current: 604/22
• CPC Class Codes: A61B 17/22012 in direct contact with, or very close to, the obstruction or concrement for removing obstructions in blood vessels by laser A61B18/245
• CPC Class Codes: A61B 2017/22065 Functions of balloons dilating A61M29/02
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A catheter comprises a catheter body having an oscillating driver, an interface surface mechanically coupled to the driver, and an inflatable balloon disposed near the interface surface. The balloon may be an angioplasty balloon, in which case the interface surface will deliver ultrasonic or other vibratory energy into a blood vessel as part of an angioplasty or related procedure. Alternatively, the catheter may comprise a pair of axially spaced-apart isolation balloons, in which case the interface surface can deliver ultrasonic or other vibratory energy into a treatment region defined between said balloons. The energy can thus act to mix or enhance penetration of a treatment held between said balloons in performing a vascular treatment procedure.

Claims

1. A catheter comprising:

a catheter body having a proximal end and a distal end;

an oscillating driver disposed in the distal end of the catheter body;

an interface surface mechanically coupled to the driver so that said surface can be oscillated relative to the catheter body; and

an inflatable balloon disposed on the catheter body proximate the interface surface, wherein the balloon is disposed at least partially over the interface surface.

2. A catheter as in claim 1, wherein the interface surface comprises a distal tip which extends laterally over the distal end of the catheter body and further extends over an axial surface of the catheter body.

3. A catheter as in claim 1, wherein the interface surface comprises a cylindrical surface extending over an axial surface of the catheter body.

4. A catheter as in claim 3, wherein the cylindrical surface is disposed at least partly within the balloon.

5. A catheter as in claim 4, wherein at least one end of the balloon is attached circumferentially to the cylindrical surface.

6. A catheter as in claim 4, wherein both ends of the balloon are attached circumferentially to the cylindrical surface.

7. A catheter as in claim 3, wherein the cylindrical surface is disposed entirely within the balloon.

8. A catheter as in claim 1, wherein at least one end of the balloon is attached to the interface surface so that the balloon is oscillated by said surface.

9. A catheter as in claim 8, wherein the balloon is disposed proximally of the interface surface and wherein a distal end of the balloon is attached to the interface surface.

10. A catheter as in claim 9, wherein the interface surface comprises a distal tip which extends laterally over the distal end of the catheter body, wherein the balloon is attached circumferentially about the tip.

11. A catheter as in claim 9, wherein the interface surface comprises a cylindrical surface portion which extends over an axial surface of the catheter body and wherein the balloon is attached circumferentially about the cylindrical interface surface.

12. A catheter as in claim 11, wherein the cylindrical surface portion has a length in the range from 4 mm to 30 mm, and the balloon is attached at the proximal end of the cylindrical surface.

13. A catheter as in claim 1, wherein the balloon is disposed distally of the interface surface and wherein a proximal end of the inflatable balloon is attached to the interface surface.

14. A catheter as in claim 13, wherein the interface surface comprises a cylindrical surface portion which extends over an axial surface of the catheter body and wherein the balloon is attached circumferentially about the cylindrical interface surface.

15. A catheter as in claim 14, further comprising a second inflatable balloon disposed on the catheter body proximally of the interface surface, wherein a distal end of the second balloon is attached circumferentially about the cylindrical interface surface, whereby the two spaced-apart balloons define a treatment region therebetween.

16. A catheter as in claim 15, further comprising a lumen for delivering a liquid medium to the treatment region.

17. A catheter comprising:

a catheter body having a proximal end and a distal end;

an oscillating driver disposed in the distal end of the catheter body;

an interface surface mechanically coupled to the driver so that said surface can be oscillated relative to the catheter body; and

an inflatable balloon disposed on the catheter body proximate the interface surface, wherein the balloon is disposed at least partially over the interface surface, wherein the longitudinally oscillating driver comprises a longitudinally oscillating member and a spring element connecting the interface member to the catheter body, wherein the interface member engages distal ends of the spring element and of the oscillating driver.

18. A catheter as in claim 17, wherein the oscillating driver comprises a longitudinally oscillating member selected from the group consisting of piezoelectric elements and magnetostrictive elements.

19. A catheter as in claim 18, wherein the longitudinally oscillating member comprises a tubular piezoelectric transducer having an inner cylindrical electrode and an outer cylindrical electrode.

20. A catheter as in claim 19, wherein the tubular piezoelectric transducer oscillates at a frequency in the range from 1 kHz to 300 kHz.

21. A catheter as in claim 18, wherein the longitudinally oscillating member comprises a piezoelectric stack including a plurality of ceramic disks having electrodes therebetween.

22. A catheter as in claim 21, wherein the piezoelectric stack oscillate s at a frequency in the range from 1 kHz to 300 kHz.

23. A catheter as in claim 17, wherein the interface member has a mass in the range from 0.3 gm to 4 gm.

24. A catheter as in claim 17, wherein the spring element comprises at least one rod secured at a proximal end to the catheter and/or tail mass and at a distal end to the interface member.

25. A catheter as in claim 24, wherein the spring element consists of a single rod disposed coaxially within the catheter.

26. A catheter as in claim 24, wherein the spring element comprises at least two parallel rod members disposed symmetrically about the axis of the catheter body.

27. A method for dilatating a stenotic lesion in a blood vessel, said method comprising:

providing a catheter having an impermeable angioplasty balloon near a distal end thereof and an interface surface within the angioplasty balloon;

filling the interior of the angioplasty balloon with a liquid inflation medium; and

oscillating the interface surface to pulse the liquid in the balloon and transfer energy through the liquid into the blood vessel wall.

28. A method as in claim 27, wherein at least one end of the balloon is attached to the interface surface, wherein the angioplasty balloon is directly oscillated by the interface surface.

29. A method as in claim 28, wherein both ends of the balloon are attached to the interface surface.

30. A method as in claim 27, wherein the interface member is oscillated at a frequency in the range from about 1 kHz to 300 kHz.

31. A method as in claim 30, wherein the interface member is oscillated to a longitudinal amplitude in the range from 0.05 μ

m to 20 μ

m.

32. A method as in claim 27, wherein the interface surface is cylindrical having a length in the range from 4 mm to 30 mm and a diameter in the range from 2 mm to 5 mm.