Reinforced balloon dilatation catheter with slitted exchange sleeve and method

• US 4,748,982 A
• Filed: 01/06/1987
• Issued: 06/07/1988
• 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): Rosenbaum, C. Fred
• Assistant Examiner(s): Kartchner, Gene B.
• Application Number:
  US07/000,653
• Time in Patent Office: 518 Days
• Field of Search: 128/344, 128/348.1, 128/325, 128/10, 604/96, 604/102, 604/110, 604/111, 604/160, 604/161
• US Class Current: 606/192
• 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 dilation catheter adapted to be utilized with a guidewire comprising a flexible elongate tubular member having proximal and distal portions, a lumen extending therethrough, an inflatable balloon on the distal portion, the interior of the inflatable balloon being in communication with the lumen and a sleeve-like means having a proximal opening and extending through the balloon to a distal opening in the distal extremity of the tubular member, said sleeve-like means adapted to receive a guidewire therethrough and having a slit extending longitudinally from the proximal opening of the sleeve to a region adjacent the balloon facilitating removal of the guidewire therethrough.

2. A catheter as in claim 1 wherein said sleeve-like means is in the form of an additional lumen provided in the tubular member.

3. A catheter as in claim 1 wherein said tubular member has a portion thereof formed of a higher density material than other portions of the member to provide different stiffnesses for the tubular member.

4. A catheter as in claim 2 including an additional lumen which extends proximally from the proximal opening of the sleeve and wherein a stiffening means is disposed in the additional lumen in the tubular member.

5. A catheter as in claim 4 wherein said stiffening means is in the form of an additional member formed within the tubular member.

6. A catheter as in claim 5 wherein said stiffening means is in the form of a mandrel, at least a portion of which is tapered.

7. A catheter as in claim 1 together with visual marking means carried by the tubular member.

8. A catheter as in claim 6 wherein said marking means is colored.

9. A balloon dilatation catheter for use with a guidewire which is adapted to be inserted in a vessel of a patient comprising, a flexible elongate tubular member having proximal and distal portions and having first and second lumens extending therethrough, a balloon carried by the distal portion of the tubular member and having its interior in communication with the second lumen, the tubular member being provided with a sleeve which extends from a first opening in the exterior of the distal portion of the tubular member through the first lumen to a second opening in the tubular member distally of the balloon, the first opening being positioned proximally of the balloon and adapted to receive a guidewire which extends through the sleeve in the first lumen to the second opening, the said tubular member formed from plastic materials having various densities to provide a decreasing stiffness from the proximal portion to the distal portion.

10. A catheter as in claim 9 together with plug means disposed in the first lumen proximal of the first opening and serving as a ramp to urge the guidewire out of the first opening when the guidewire is threaded through the second opening into the first lumen.

11. A catheter as in claim 9 together with stiffener means disposed in the first lumen from the proximal extremity of the tubular member into a region adjacent the notch.

12. A catheter as in claim 9 wherein the sleeve is provided with a slit extending longitudinally of the tubular member from the first opening through the first lumen to a region adjacent the proximal end of the balloon.

13. A catheter as in claim 9 wherein portions of the tubular member are formed of a plastic of varying densities to provide decreasing stiffness along the length of the tubular member from the proximal portion to the distal portion thereof.

14. A catheter as in claim 13 wherein the proximal portion of the tubular member is formed of 100% high density plastic.

15. A catheter as in claim 14 wherein the tubular member includes an intermediate portion which is formed of a mixture of high density plastic and low density plastic.

16. A catheter as in claim 11 wherein said stiffener is in the form of a mandrel disposed in the first lumen.

17. A catheter as in claim 16 wherein the distal portion of the mandrel is tapered to vary the stiffness provided by the mandrel.

18. A catheter as in claim 17 wherein the mandrel is formed of a metal.

19. A catheter as in claim 9 together with colored visual marker means carried by the tubular member.

21. A method as in claim 10 together with the step of selecting another balloon dilatation catheter and positioning it so that the distal extremity of the sleeve-like means is positioned on the proximal extremity of the guide wire already disposed in the guiding catheter, advancing the selected catheter onto the guide wire until the guide wire exits from the sleeve-like means and then continuing to advance the catheter over the guide wire with the guide wire traveling exteriorally of the tubular member, continuing to advance the catheter until the balloon is near the distal extremity of the guide wire, performing an angioplasty procedure with the balloon dilatation catheter and thereafter removing the balloon dilatation catheter and the guide wire from the guiding catheter.

20. In a method for performing an angioplasty procedure in which a guiding catheter is disposed in the vessel of the patient and in which a balloon dilatation catheter with a guide wire disposed therein is inserted into the guiding catheter, the balloon dilatation catheter having an elongate flexible tubular member with sleeve-like means carried by the flexible tubular member, the sleeve-like means having a guide wire lumen extending therethrough which receives the guide wire, the sleeve-like means having a slit therein extending from the proximal extremity of the sleeve to a region adjacent the proximal extremity of the balloon of the balloon dilation catheter, the method including the steps of taking the proximal extremity of the guide wire, inserting it into the distal extremity of the sleeve-like means and pushing it rearwardly through the sleeve-like means until it exits from the sleeve-like means and then further advancing the guide wire so that the guide wire extends alongside of and exterior of substantially the entire remaining length of the flexible elongate tubular member, inserting the balloon dilatation catheter with the guide wire therein into the guiding catheter, advancing the guide wire into a stenosis, thereafter performing an angioplasty procedure with the balloon dilatation catheter, and removing the balloon dilatation catheter from the guide wire by leaving the guide wire in place by withdrawing the balloon dilatation catheter along the guide wire until the sleeve-like means, becomes visible exteriorally of the guiding catheter, thereafter further withdrawing the balloon dilatation catheter and removing the guide wire through the slit until the portion of the catheter having the slit therein is exposed exteriorally of the guiding catheter and thereafter removing the balloon dilatation catheter from the guide wire.