Ultrasonic angioplasty balloon catheter

• US 5,609,606 A
• Filed: 06/07/1995
• Issued: 03/11/1997
• Est. Priority Date: 02/05/1993
• Status: Expired due to Fees

• Current Assignee: The Joe W. & Dorothy Dorsett Brown Foundation
• Original Assignee: The Joe W. & Dorothy Dorsett Brown Foundation
• Inventors: O'Boyle, Matthew
• Primary Examiner(s): Shay, David M.
• Application Number:
  US08/481,184
• Time in Patent Office: 643 Days
• Field of Search: 606/159, 606/169-171, 606/191, 606/192, 606/194, 604/20, 604/22
• US Class Current: 606/194
• CPC Class Codes: A61B 17/2202 the ultrasound transducer being inside patient's body at the distal end of the catheter
• CPC Class Codes: A61B 2017/22021 electric leads passing through the catheter
• CPC Class Codes: A61M 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• CPC Class Codes: A61M 25/1029 Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
• CPC Class Codes: A61M 25/1034 Joining of shaft and balloon
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

An angioplasty balloon catheter particularly adapted for ablation of a stenosis in vivo has a balloon which may be inflated with a conductive contrast fluid injected proximally to the balloon, and is furthermore metalized on the outside of the balloon and catheter shaft. The balloon has piezoelectric properties, and may be excited by application of an ultrasonic signal across the balloon between the metalized surface and the contrast fluid. The catheter is guided by a centrally located guide wire to the site of the stenosis. If the distal tip of the catheter shaft cannot pass through the stenosis, excitation of the piezoelectric balloon in a deflated state at the site of the stenosis causes ultrasonic hammering vibrations at the tip of the catheter shaft which ablate the stenosis. After the tip of the catheter has hammered its way across the stenosis, and while maintaining the ultrasonic excitation signal, the balloon is inflated to keep the vibrating balloon surface in contact with the stenosis. Unlike the case with other inflatable balloon catheters which simply press the stenosis against the blood vessel wall, the stenosis is broken up by ultrasonic vibrations and is carried away by the blood flow, minimizing the risk of re-stenosis.

Claims

1. An angioplasty balloon catheter suitable for use in openings a stenosis in a vascular vessel, said catheter having an inflation lumen which connects with an inflatable balloon fabricated at least partially from a polymeric material having piezoelectric properties, and a means of delivering ultrasonic energy to the inflatable balloon via an ultrasonic electrical excitation signal whereby the inflatable balloon can be excited into ultrasonic vibratory states capable of opening the stenosis in the vascular vessel when the excited and vibrating inflatable balloon is in contact with the stenosis.

2. A catheter according to claim 1, wherein the polymeric material comprises polyvinylidene difluoride.

3. A catheter according to claim 1, wherein the polymeric material comprises a combination of at least one polymer selected from the group consisting of polyvinylidene fluoride, polyvinylidene difluoride (PVDF), PVDF/trifluoroethylene, PVDF/tetrafluoroethylene, and polyvinylidene cyanide, and at least one polymer selected from the group consisting of a polyolefin copolymer.

4. A catheter according to claim 3, wherein the polymer comprises PVDF/trifluoroethylene.

5. A catheter according to claim 4, wherein the polyolefin copolymer is polyethylene terphthalate.

6. A catheter according to claim 3, wherein the polymer comprises PVDF and the polyolefin copolymer is polyethylene terephthalate.

7. A catheter according to claim 3, wherein the polymer comprises polyvinylidene cyanide.

8. A catheter according to claim 1, wherein the ultrasonic electrical excitation signal is applied across the thickness of the polymeric material of the inflatable balloon.

9. A catheter according to claim 8, further including a source of fluid pressure coupled to the inflation lumen for transferring a conductive fluid through the inflation lumen to the interior of the inflatable balloon, whereby the inflatable balloon can be inflated.

10. A catheter according to claim 9, wherein the inflatable balloon includes a contiguous layer of a conductive metal extending over the polymeric material.

11. A catheter according to claim 9 further having a contiguous layer of a conductive metal forming an outer surface of the catheter, including the inflatable balloon.

12. A catheter according to claim 12, wherein the layer of the conductive metal forming the outer surface of the catheter is silver or gold.

13. A catheter according to claim 12 further having a flexible coating of an insulating material surrounding the layer of the conductive metal.

14. An angioplasty balloon catheter suitable for use in opening a stenosis in a human blood vessel, said catheter comprising:

a flexible catheter shaft having at least two lumens, including a first lumen for accommodating a guide wire and a second lumen for transporting a conductive fluid, and having a proximal end and a distal end for insertion into the human blood vessel containing the stenosis,

an inflatable balloon fabricated at least partially from a polymeric material having piezoelectric properties, located at the distal end of the shaft, and attached so as to seal the second lumen at the proximal end of the catheter shaft, such that the balloon is disposed to inflate with conductive fluid transported into the second lumen, and

a continuous layer of a conductive metal forming an outer surface of catheter, including the balloon,

whereby the balloon can be excited into ultrasonic vibratory states capable of opening the stenosis in the human blood vessel when the excited and vibrating balloon is in contact with the stenosis.

15. A catheter according to claim 14 further having a flexible coating of an insulating polymeric material surrounding the continuous layer of the conductive metal.

16. A catheter according to claim 14, wherein the piezoelectric polymeric material has a thickness in a range of about 9 microns to about 56 microns when the balloon is not inflated.

17. A catheter according to claim 14, wherein the balloon has a length in a range of about 20 millimeters to about 25 millimeters.

18. A catheter according to claim 14, wherein the balloon has a burst pressure of at least ten atmospheres.

19. A catheter according to claim 14, wherein the balloon has an inflated profile diameter in the range of about 2 millimeters to about 4 millimeters.

20. A catheter according to claim 19, wherein the catheter shaft has a diameter of less than about 0.050 inches.

21. A catheter according to claim 14, wherein the balloon comprises polyvinylidene difluoride.

22. A catheter according to claim 21, wherein the layer of the conductive metal is silver or gold.

23. A catheter according to claim 22 further having at the proximal end of the shaft a catheter hub having a sealable opening for introducing the conductive fluid into the second lumen and having a conductive lead disposed to intimate conductive contact with the conductive fluid when introduced into the second lumen, for connection to a source of an ultrasonic electrical excitation signal.

24. A catheter according to claim 23 further having a conductive winding wrapped in intimate conductive contact with the layer of conductive metal near the proximal end of the catheter, the winding further having a second conductive lead for connection to the source of the ultrasonic electrical excitation the source of the ultrasonic electrical excitation signal.

25. A catheter according to claim 14, wherein the balloon comprises a combination of at least one polymer selected from the group consisting of polyvinylidene fluoride, polyvinylidene difluoride (PVDF), PVDF/trifluoroethylene, PVDF/tetrafluoroethylene, and polyvinylidene cyanide, and at least one polymer selected from the group consisting of a polyolefin copolymer.

26. A catheter according to claim 25, wherein the balloon comprises a combination of PVDF/trifluoroethylene and the polyolefin copolymer.

27. A catheter according to claim 26, wherein the polyolefin copolymer is polyethylene terephthalate.

28. A catheter according to claim 25, wherein the balloon comprises a combination of PVDF and the polyolefin copolymer and wherein the polyolefin coploymer is polyethylene terephthalate.

29. A catheter according to claim 25, wherein the balloon comprises a combination of polyvinylidene cyanide and the polyolefin copolymer.