Balloon catheter with improved pressure source

• US 5,728,064 A
• Filed: 05/21/1996
• Issued: 03/17/1998
• Est. Priority Date: 09/16/1994
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Burns, Matthew M., Lafontaine, Daniel M.
• Primary Examiner(s): YASKO JR, JOHN D
• Application Number:
  US08/619,375
• Time in Patent Office: 665 Days
• Field of Search: 604/96, 604/97, 604/99, 604/100, 604/101, 604/186, 606/192-195
• US Class Current: 604/100.01
• CPC Class Codes: A61M 2025/0063 having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body
• CPC Class Codes: A61M 2025/0098 having a strain relief at the proximal end, e.g. sleeve
• CPC Class Codes: A61M 2025/102 driven by a solenoid-activated pump
• CPC Class Codes: A61M 2025/1077 having a system for expelling the air out of the balloon before inflation and use
• CPC Class Codes: A61M 25/10187 Indicators for the level of inflation or deflation

Abstract

A balloon catheter having a long shaft with an inflatable balloon connected to its distal end with a pressure source connected to the shaft at an invivo point which operates to inflate and deflate the balloon. The balloon catheter may be a fixed-wire type, an over-the-wire type, or an single-operator-exchange type catheter. The pressure source may include a piston and a chamber with an actuation member attached to the piston. The actuation member may be a solid rod or a hollow robe. In the case where the actuation member is a hollow tube, the tube may be used to introduce inflation fluid into the pressure source and the inflation lumen. A receptacle such as a reel or tubular hoop may be used to contain the actuation member when pulled proximally. A pressure sensor/gauge and a balloon sizing scale may be incorporated into the catheter assembly to assist the treating physician in monitoring the procedure. A longitudinally oscillating drive, such as a solenoid, may be operatively connected to the pressure source.

Claims

1. A balloon catheter insertable into a living body, comprising:

(a) an elongate shaft having a proximal end and a distal end;

(b) an inflatable balloon having a proximal end and a distal end, the proximal end of the balloon connected to the distal end of the shaft; and

(c) a pressure source connected to the shaft, the pressure source including means for limiting balloon over-expansion when the balloon is inflated to dilate a restriction and the restriction yields at a relatively high inflation pressure.

2. A balloon catheter as in claim 1, further comprising:

(d) a spring tip connected to the distal end of the balloon.

3. A balloon catheter as in claim 1, further comprising:

(d) a guide wire lumen extending through at least a portion of the elongate shaft.

4. A balloon catheter as in claim 3, further comprising:

(e) a guide wire lumen access port distal of the proximal end of the elongate shaft.

5. A balloon catheter as in claim 1, further comprising:

(d) a piston disposed in the pressure source.

6. A balloon catheter as in claim 5, further comprising:

(e) an actuation member having a proximal end and a distal end, the distal end of the actuation member connected to the piston.

7. A balloon catheter as in claim 6, wherein the actuation member is a solid rod.

8. A balloon catheter as in claim 6, wherein the actuation member is a tube.

9. A balloon catheter as in claim 8, further comprising:

(f) a valve connected to the proximal end of the actuation member.

10. A balloon catheter as in claim 6, further comprising:

(f) an actuation member receptacle connected to the proximal end of the actuation member.

11. A balloon catheter as in claim 6, further comprising:

(f) a balloon size indicator disposed on either the actuation member or the shaft.

12. A balloon catheter as in claim 6, further comprising:

(f) a pushing member having a proximal end and a distal end, the distal end of the pushing member connected to the pressure source.

13. A balloon catheter as in claim 12, wherein the pushing member is selected from the group consisting of a solid rod, a tube, a braided mesh, and a coil.

14. A balloon catheter as in claim 1, further comprising:

(d) a pressure gauge operatively connected to the pressure source.

15. A balloon catheter as in claim 14, wherein the pressure gauge is fluidic.

16. A balloon catheter as in claim 14, wherein the pressure gauge is electronic.

17. A balloon catheter as in claim 14, wherein the pressure gauge is a spring gauge.

18. A balloon catheter as in claim 1, further comprising:

(d) an inflation fluid disposed inside the pressure source, the inflation fluid being disposed inside the pressure source prior to final packaging.

19. A balloon catheter as in claim 1, further comprising:

(d) an inflation fluid disposed inside the pressure source, the inflation fluid being disposed inside the pressure source just prior to use invivo.

20. A balloon catheter as in claim 5, further comprising:

(e) an oscillating drive operatively connected to the piston.

21. A balloon catheter as in claim 20, wherein the drive is located near the pressure source.

22. A balloon catheter as in claim 20, wherein the drive is located near the proximal end of the shaft.

23. A balloon catheter as in claim 20, wherein the drive is magnetic.

24. A balloon catheter as in claim 23, wherein the drive is a solenoid.

25. A balloon catheter as in claim 6, further comprising:

(f) an oscillating drive operatively connected to the actuation member.

26. A balloon catheter as in claim 25, wherein the drive is located near the proximal end of the shaft.

27. A balloon catheter as in claim 26, wherein the drive is magnetic.

28. A balloon catheter as in claim 25, wherein the drive operates at a subsonic frequency.

29. A balloon catheter as in claim 25, wherein the drive operates at a sonic frequency.

30. A method of using a balloon catheter wherein the catheter includes an elongate shaft having a proximal end and a distal end;

an inflatable balloon having a proximal end and a distal end, the proximal end of the balloon connected to the distal end of the shaft; and

a pressure source connected to the shaft, the method comprising the steps of;

(i) inserting the balloon catheter into a vascular system of a patient;

(ii) positioning the balloon adjacent a treatment site inside the vascular system;

(iii) actuating the pressure source to inflate the balloon to dilate a restriction such that the restriction yields at a relatively high inflation pressure but the balloon does not over-expand thereby reducing the potential for dissection or crack propagation;

(iv) actuating the pressure source to at least partially deflate the balloon; and

(v) withdrawing the balloon catheter from the vascular system.

31. A method of using a balloon catheter as in claim 30 wherein the actuation steps are repeated in rapid succession.

32. A method of using a balloon catheter as in claim 31 wherein the actuation steps are repeated at a frequency substantially within the sonic range.

33. A method of using a balloon catheter as in claim 31 wherein the actuation steps are repeated at various frequencies to find and maintain the natural resonance frequency of the treatment site to facilitate atraumatic dilation.