Dilation catheter

• US 5,882,336 A
• Filed: 02/28/1997
• Issued: 03/16/1999
• Est. Priority Date: 12/30/1994
• Status: Expired due to Fees

• Current Assignee: Jaroslav Janacek
• Original Assignee: Jaroslav Janacek
• Inventors: Janacek, Jaroslav
• Primary Examiner(s): Coggins, Wynn Wood
• Assistant Examiner(s): GRING, NOELLE K
• Application Number:
  US08/807,546
• Time in Patent Office: 746 Days
• Field of Search: 604/49, 604/51-3, 604/96, 604/102, 604/103, 604/104, 604/280, 604/282
• US Class Current: 604/164.13
• 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 2025/1095 with perfusion means for enabling blood circulation while the balloon is in an inflated state or in a deflated state, e.g. permanent by-pass within catheter shaft
• CPC Class Codes: A61M 25/1034 Joining of shaft and balloon
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A dilation catheter for use in performing angioplasty procedures. The catheter includes a relatively long catheter shaft which has two lumens. A relatively short guidewire receiving tube is thermally bonded to the distal end of the shaft, with its lumen approximately aligned with one of the lumens of the catheter shaft and a stiffening wire positioned therein. A dilation balloon, preformed with a shape that enables it to be used in an offset configuration, is thermally bonded to the distal and proximal ends of the tube, with its lumen aligned with the remaining lumen of the catheter shaft. The balloon and tube together define channels for the perfusion of blood past the balloon, which channels remain open even when the balloon bears against the tube during the inflation thereof.

Claims

1. A process for manufacturing a catheter including an inflatable balloon, the process comprising steps of:

a) providing an elongated tubular member including proximal and distal ends, the tubular member including an inflation lumen and a guidewire lumen, the guidewire lumen extending proximally from the tubular member distal end and adapted to receive a guidewire;

b) providing a balloon located adjacent the tubular member distal end, the inflation lumen in fluid communication with the balloon for inflating the balloon;

c) positioning a stiffening wire in the tubular member, the stiffening wire extending over a portion of the length of the catheter and having a distal end;

d) forming a guidewire port in the tubular member intermediate the tubular member proximal and distal ends to provide an opening into the guidewire lumen for feeding a guidewire into the guidewire lumen of the tubular member in sliding relationship, wherein the distal end of the stiffening wire is disposed at the guidewire port such that the stiffening wire extends proximally from the guidewire port and stiffens a portion of the catheter extending proximally to said guidewire port and inserting a guidewire into the guidewire lumen stiffens a portion of the catheter extending distally of said guidewire port.

2. A process according to claim 1, further comprising the step of inserting a guidewire into the guidewire lumen, wherein the stiffening wire is secured within the tubular member so as to be collinear with the guidewire.

3. A process according to claim 1, wherein the step of providing an elongated tubular member includes forming the tubular member with a stiffening wire lumen, positioning the stiffening wire in the stiffening wire lumen and wherein a portion of the tubular member defining the guidewire lumen comprises a separate guidewire tube extending distally from a portion of the tubular member including the stiffening wire lumen a proximal end of the guidewire tube attached to a distal end of the portion of the tubular member including the stiffening wire such that the guidewire lumen is longitudinally aligned with the stiffening wire lumen.

4. A process according to claim 3, wherein the distal end of the portion of the tubular member including the stiffening wire has a stepped portion and the proximal end of the guidewire tube is attached to the stepped portion such that the guidewire tube extends beyond the stepped portion and said guidewire port is formed in said proximal end of the guidewire tube.

5. A process according to claim 4, wherein the stepped portion at the distal end of the portion of the tubular member including the guidewire tube includes a trough and the proximal end of the guidewire tube is disposed in said trough.

6. A process according to claim 3, wherein a proximal end of the balloon is secured to a distal end of a portion of the tubular member defining the inflation lumen in an overlapping manner.

7. A process according to claim 3, wherein a proximal end of the balloon is secured to a distal end of a portion of the tubular member defining the inflation lumen in an abutting manner.

8. A process according to claim 3, wherein a proximal end of the balloon is secured to a distal end of a portion of the tubular member defining the inflation lumen and the proximal end of the guidewire tube overlaps at least portions of the distal end of the portion of the tubular member defining the inflation lumen and the proximal end of the balloon.

9. A process according to claim 3, wherein a distal end of the stiffening wire is sealed within the stiffening wire lumen of the tubular member.

10. The process according to claim 3 wherein a proximal end and a distal end the balloon are thermally bonded to the guidewire tube and a central section of the balloon is unattached to the guidewire tube and further wherein the balloon is shaped such that the central section of the balloon contacts the guidewire tube when the balloon is inflated within a patient, but bows away from the guidewire tube when the balloon is inflated outside the patient.

11. A process for producing a catheter comprising steps of:

a) providing an elongated shaft including a first lumen and a second lumen, each of the first and second lumens having a proximal end and a distal end;

b) providing a balloon having a proximal end, a distal end and an inflatable portion;

c) securing the balloon to the shaft such that the first lumen of the shaft communicates with the inflatable portion of the balloon;

d) providing a stiffening wire having a proximal end and a distal end;

e) securing the stiffening wire within the second lumen;

f) providing a guidewire-receiving tube defining a guidewire lumen extending proximally from a distal end of the tube, the tube further having a port leading to the guidewire lumen for receiving a guidewire;

g) securing the guidewire-receiving tube to the shaft such that the distal end of the stiffening wire is disposed at the port of the guidewire-receiving tube and extends proximally therefrom.

12. A process according to claim 11, wherein the stiffening wire is generally collinear with the guidewire lumen of the guidewire-receiving tube.

13. A process according to claim 11, wherein the proximal and distal ends of the balloon are thermally bonded to the guidewire-receiving tube.

14. A process according to claim 13, wherein a central section of the balloon is unattached to the guidewire-receiving tube.

15. The process according to claim 14 wherein the balloon is shaped such that the central section of the balloon contacts the guidewire-receiving tube when the balloon is inflated within a patient, but bows away from the guidewire-receiving tube when the balloon is inflated outside the patient.

16. A process according to claim 11, wherein at least one end of the shaft is formed with a stepped configuration with said first lumen being longer than said second lumen.

17. A process according to claim 11, wherein the balloon and the guidewire-receiving tube are thermally bonded to the shaft and to each other.