Reinforced balloon dilatation catheter with slitted exchange sleeve and method

• US 5,496,346 A
• Filed: 05/25/1993
• Issued: 03/05/1996
• Est. Priority Date: 01/06/1987
• Status: Expired due to Term

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Advanced Cardiovascular Systems Incorporated
• Inventors: Horzewski, Michael J., Yock, Paul G.
• Primary Examiner(s): Pellegrino, Stephen C.
• Assistant Examiner(s): Lewis, William W.
• Application Number:
  US08/069,297
• Time in Patent Office: 1,015 Days
• Field of Search: 606/132, 606/134, 606/191-198, 606/207.15, 128/673, 128/675, 128/748, 128/772, 604/96-102, 604/110, 604/111, 604/160, 604/161, 604/164, 604/281, 604/282, 604/280
• US Class Current: 606/194
• 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 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 2025/1063 having only one lumen used for guide wire and inflation, e.g. to minimise the diameter
• CPC Class Codes: A61M 2025/107 having a longitudinal slit in the balloon
• CPC Class Codes: A61M 25/0054 with regions for increasing flexibility
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

Balloon dilatation catheter adapted to be utilized in connection with a guiding catheter and a guide wire. The catheter comprises a flexible elongate tubular member having proximal and distal extremities and having a lumen extending therethrough. An inflatable balloon is mounted on the distal extremity of the tubular member. The interior of the inflatable balloon is in communication with the lumen. A sleeve extends through the balloon and extends rearwardly from the balloon and alongside the lumen. The sleeve has a guidewire lumen extending therethrough. The guidewire lumen is adapted to receive a guide wire extending therethrough and extending rearwardly of the flexible elongate element into a region adjacent the proximal extremity of the proximal elongate element. The sleeve has a slit extending longitudinally of the same from the proximal extremity of the sleeve to a region adjacent the balloon permitting the guide wire to be removed therethrough.

Claims

1. A balloon dilatation catheter adapted to be utilized with a guidewire comprising:

a flexible elongated catheter shaft which has a proximal end and a distal end, a relatively stiff proximal section and a relatively flexible distal section;

a first inner lumen which extends within the proximal and distal sections thereof;

an inflatable balloon at an intermediate location of the distal section of the catheter shaft proximal to the distal end thereof having an interior in fluid communication with the first inner lumen;

a distal guidewire opening in the distal end of the catheter shaft;

a proximal guidewire opening in the distal section of the catheter shaft which is at a location proximal to the inflatable balloon and spaced a substantial distance from the proximal end of the catheter shaft; and

a second inner lumen which extends at least from the proximal guidewire opening to the distal guidewire opening and which is configured to receive a guidewire therein.

2. The balloon dilatation catheter of claim 1 including a stiffening mandrel disposed within the proximal shaft portion to stiffen the proximal section of the catheter shaft.

3. The balloon dilatation catheter of claim 2 wherein the second inner lumen extends proximally from the proximal guidewire opening and the stiffening mandrel is disposed therein.

4. The balloon dilatation catheter of claim 1 wherein the proximal guidewire opening is formed by a notch cut in a wall portion of the catheter shaft which exposes the second inner lumen.

5. The balloon dilatation catheter of claim 1 wherein a ramping means is provided within the second inner lumen to guide a guidewire, advanced proximally through the second inner lumen, out the proximal guidewire opening.

6. The balloon dilatation catheter of claim 1 wherein the proximal guidewire opening includes a slit in the catheter shaft to facilitate removal of the guidewire disposed within the second inner lumen therethrough.

7. The balloon dilatation catheter of claim 6 wherein the slit extends distally to a location proximal to the inflatable member.

8. The balloon dilatation catheter of claim 6 including a stiffening mandrel disposed within the proximal shaft portion.

9. The balloon dilatation catheter of claim 4 wherein the second inner lumen extends proximally from the proximal guidewire opening and the stiffening mandrel is disposed therein.

10. The balloon dilatation catheter of claim 6 wherein the proximal guidewire opening is formed by a notch cut in a wall portion of the catheter shaft which exposes the second inner lumen.

11. The balloon dilatation catheter of claim 6 wherein means is provided within the second inner lumen to guide a guidewire, which is advanced proximally through the second inner lumen, out the proximal guidewire opening.

12. The balloon dilatation catheter of claim 11 wherein the means to guide the guidewire out the proximal guidewire opening is a ramp provided within the second inner lumen adjacent the proximal guidewire opening.

13. A rapid exchange type balloon dilatation catheter adapted to be utilized with a guidewire comprising:

an elongated catheter shaft which has a proximal end, a distal end, a long relatively stiff proximal section and a short relatively flexible distal section;

a first inner lumen which extends within the proximal and distal sections of the catheter shaft;

an inflatable balloon at an intermediate location of the distal section of the tubular shaft proximal to the distal end thereof having an interior in fluid communication with the first inner lumen;

a distal guidewire port in the distal end of the catheter shaft;

a proximal guidewire port in the catheter shaft which is at a location proximal to the inflatable balloon and distal to the relatively stiff proximal section; and

a second inner lumen which is configured to receive a guidewire therein and which extends from the proximal guidewire port to the distal guidewire port and is in fluid communication therewith.

14. A rapid exchange type intravascular catheter assembly adapted to be utilized with a guidewire, comprising:

an elongated catheter shaft which has a proximal end, a distal end, a long relatively stiff proximal shaft section and a short relatively flexible distal shaft section;

means to perform an intravascular procedure at an intermediate location on the distal shaft section proximal to the distal end of the catheter shaft;

a distal guidewire port in the distal end of the catheter shaft;

a proximal guidewire port in the catheter shaft which is at a location a short distance proximal to the distal end of the catheter shaft and distal to the relatively stiff proximal section; and

an inner lumen which is configured to receive a guidewire therein and which extends from the proximal guidewire port to the distal guidewire port and which is in fluid communication therewith.

15. The intravascular catheter assembly of claim 14 wherein a guidewire is disposed within the inner lumen and a portion thereof extends out the proximal guidewire opening and a portion thereof extends out the distal guidewire opening.

16. The intravascular catheter assembly of claim 14 wherein the relatively stiff proximal catheter shaft section is formed at least in part of high density polyethylene.

17. The intravascular catheter assembly of claim 14 wherein the relatively flexible distal catheter shaft section is formed at least in part of low density polyethylene.

18. The intravascular catheter assembly of claim 14 wherein a stiffening mandrel is disposed within the proximal shaft section.