Balloon catheter with improved pressure source

• US 5,695,468 A
• Filed: 01/16/1996
• Issued: 12/09/1997
• Est. Priority Date: 09/16/1994
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Kugler, Chad J., Burns, Matthew M., Lafontaine, Daniel M.
• Primary Examiner(s): YASKO JR, JOHN D
• Application Number:
  US08/586,514
• Time in Patent Office: 693 Days
• Field of Search: 604/96, 604/97, 604/99, 604/100, 604/186, 604/101, 606/192-195
• US Class Current: 604/96.01
• 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 2025/1056 having guide wire lumens outside the main shaft, i.e. the guide wire lumen is within or on the surface of the balloon
• 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 25/10186 One-way valves
• CPC Class Codes: A61M 25/10187 Indicators for the level of inflation or deflation
• CPC Class Codes: A61M 25/1025 Connections between catheter tubes and inflation tubes

Abstract

A balloon catheter is disclosed which includes a fluid displacement rod at least partially and slidably disposed in an elongate tubular member with a balloon connected to the distal end of the tubular member. A seal connected to the proximal end of the tubular member creates a liquid tight seal between the inside of the tubular member and the displacement rod. Accordingly, longitudinal actuation of the displacement rod causes the balloon to expand and/or contract. The balloon catheter may be a fixed wire, an over-the-wire or a single-operator exchange type balloon catheter. In addition, a pressure gauge may be connected to the proximal end of the tubular member. A one-way valve is also disclosed which allows the balloon catheter to be prepped via the guide wire lumen. Accordingly, the present invention negates the need for both an inflation device and an inflation lumen which results in a significant improvement in catheter performance and cost savings.

Claims

1. A balloon catheter, comprising:

a. an elongate tubular member having a proximal end and a distal end;

b. a balloon connected to the distal end of the elongate tubular member, the balloon having an interior in fluid communication with the inside of the elongate tubular member;

c. a fluid displacement rod having a portion thereof slidably disposed in the tubular member such that the balloon may be expanded upon longitudinal actuation of the rod; and

d. a seal connected to the proximal end of the tubular member and disposed about the displacement rod to create a liquid seal between the inside of the tubular member and the displacement rod.

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

e. a pressure gauge connected to the proximal end of the elongate tubular member and in fluid communication with the interior of the balloon.

3. A balloon catheter as in claim 2, wherein the seal is an o-ring type seal.

4. A balloon catheter as in claim 2, wherein the seal is a gap tolerance type seal.

5. A balloon catheter as in claim 2, wherein the elongate tubular member contains a guide wire lumen extending at least partially therethrough.

6. A balloon catheter as in claim 5, wherein the guide wire lumen extends the full length of the elongate tubular member.

7. A balloon catheter as in claim 5, wherein the guide wire lumen extends from a point distal of the proximal end of the elongate tubular member to the distal end of the elongate tubular member.

8. A balloon catheter as in claim 5, further comprising;

f. a one-way-valve connected to the distal end of the elongate tubular member, the one-way-valve permitting a pressurized fluid to flow from the guide wire lumen to the interior of the balloon while preventing the pressurized fluid to flow from the interior of the balloon to the guide wire lumen.

9. A balloon catheter as in claim 8, wherein the proximal end of the guide wire lumen is releasable connected to a fluid plug and the distal end of the guide wire lumen is releasable connected to a pressurized fluid source.

10. A balloon catheter as in claim 9, wherein the pressurized liquid source is releasable connected to the distal end of the guide wire lumen with a tubular member disposed about the balloon.

11. A balloon catheter as in claim 10, wherein the tubular member retains the balloon in a contracted state.

12. A balloon catheter as in claim 11, wherein a portion of the elongate tubular member traverses the interior of the balloon.

13. A balloon catheter as in claim 12, wherein the one-way-valve is connected to the portion of the elongate tubular member which traverses the interior of the balloon.

14. A balloon catheter as in claim 13, wherein the one-way-valve includes an elastomer tube disposed about a hole in the portion of the elongate tubular member which traverses the interior of the balloon.

15. A balloon catheter as in claim 2, wherein the elongate tubular member contains a core wire fixed therein, the core wire having a distally mounted spring tip.

16. A method of using a balloon catheter, comprising the steps of:

a. providing a balloon catheter wherein the balloon catheter includes;

i. an elongate tubular member having a proximal end and a distal end;

ii. a balloon connected to the distal end of the elongate tubular member, the balloon having an interior in fluid communication with the inside of the elongate tubular member;

iii. a fluid displacement rod having a portion thereof slidably disposed in the tubular member such that the balloon may be expanded upon longitudinal actuation of the rod; and

iv. a seal connected to the proximal end of the tubular member and disposed about the displacement rod to create a liquid seal between the inside of the tubular member and the displacement rod;

b. inserting the balloon catheter into a vascular system of a patient;

c. positioning the balloon catheter adjacent a treatment site in the vascular system;

d. displacing the rod to at least partially expand the balloon;

e. displacing the rod to at least partially contract the balloon; and

f. withdrawing the balloon catheter from the vascular system.

17. A balloon catheter, comprising:

a. an elongate shaft having a proximal end, a distal end and a lumen disposed therein, the lumen extending from a point distal of the proximal end of the elongate shaft to the distal end of the elongate shaft;

b. a balloon connected to the distal end of the elongate shaft, the balloon having an interior; and

c. a one-way-valve connected to the distal end of the shaft, the one-way-valve permitting a pressurized fluid to flow from the lumen to the interior of the balloon while preventing the pressurized fluid to flow from the interior of the balloon to the lumen.

18. A balloon catheter as in claim 17, wherein one end of the lumen is releasable connected to a fluid plug and the other end of the lumen is releasable connected to a pressurized liquid source.

19. A balloon catheter as in claim 18, wherein a portion of the shaft traverses the interior of the balloon.

20. A balloon catheter as in claim 19, wherein the one-way-valve is connected to the portion of the shaft which traverses the interior of the balloon.

21. A balloon catheter as in claim 20, wherein the one-way-valve includes an elastomer tube disposed about a hole in the portion of the shaft which traverses the interior of the balloon.

22. A balloon catheter as in claim 17, wherein the proximal end of the lumen is releasable connected to a fluid plug and the distal end of the lumen is releasable connected to a pressurized fluid source.

23. A balloon catheter as in claim 22, wherein the pressurized liquid source is releasable connected to the distal end of the lumen with a tubular member disposed about the balloon.

24. A balloon catheter as in claim 23, wherein the tubular member retains the balloon in a contracted state.

25. A balloon catheter as in claim 24, wherein a portion of the shaft traverses the interior of the balloon.

26. A balloon catheter as in claim 25, wherein the one-way-valve is connected to the portion of the shaft which traverses the interior of the balloon.

27. A balloon catheter as in claim 26, wherein the one-way-valve includes an elastomer tube disposed about a hole in the portion of the shaft which traverses the interior of the balloon.

28. A method of prepping a balloon catheter, comprising the steps of:

a. providing a balloon catheter having a proximal end and a distal end, the balloon catheter including;

i. an elongate shaft having a proximal end, a distal end and a lumen disposed therein;

ii. a balloon connected to the distal end of the elongate shaft, the balloon having an interior; and

iii. a one-way-valve connected to the distal end of the shaft, the one-way-valve permitting a pressurized fluid to flow from the lumen to the interior of the balloon while preventing the pressurized fluid to flow from the interior of the balloon to the lumen;

b. providing a pressurized fluid source containing fluid therein;

c. connecting the pressurized fluid source to the distal end of the lumen in the elongate shaft of the balloon catheter;

d. plugging the proximal end of the lumen in the elongate shaft of the balloon catheter; and

e. forcing fluid from the pressurized fluid source into the lumen such that the fluid passes into the lumen, through the one-way-valve and into the interior of the balloon.

29. A balloon catheter, comprising:

a sealed chamber;

a balloon connected to the distal end of the chamber and in fluid communication with the chamber;

and a fluid displacement member disposed at least partially within the sealed chamber to displace fluid into or out of the balloon.