Balloon catheter having an external guidewire

• US 7,300,415 B2
• Filed: 12/20/2002
• Issued: 11/27/2007
• Est. Priority Date: 12/20/2002
• Status: Active Grant

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Advanced Cardiovascular Systems Incorporated
• Inventors: Lee, Jeong S., McMurtry, Christopher, Wantink, Kenneth L.
• Primary Examiner(s): Hayes; Michael J.
• Assistant Examiner(s): NGUYEN, VI X
• Application Number:
  US10/326,359
• Publication Number:
  US 20040122465A1
• Time in Patent Office: 1,803 Days
• Field of Search: 606191-199, 604/95.03, 604/96.01, 604/101.01, 604/101.02, 604/101.03, 604/102.01, 604/95.3, 604/96.1, 604/101.1, 604/101.2, 604/101.3, 604/102.1
• US Class Current: 604/96.01
• CPC Class Codes: A61M 2025/0004 having two or more concentrically arranged tubes for forming a concentric catheter system
• CPC Class Codes: A61M 2025/0034 characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores making of catheters A61M25/0009
• CPC Class Codes: A61M 2025/0037 characterized by lumina being arranged side-by-side
• CPC Class Codes: A61M 2025/0039 characterized by lumina being arranged coaxially
• 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 25/0029 characterized by features relating to least one lumen located at the middle part of the catheter, e.g. slots, flaps, valves, cuffs, apertures, notches, grooves or rapid exchange ports catheter shaft surface irregularities A61M2025/006
• CPC Class Codes: A61M 25/003 characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves catheter tips A61M25/0067
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A catheter having an elongated shaft with an inflation lumen and a guidewire lumen, a balloon on a distal shaft section, and a proximal intermediate port proximal to the balloon and a distal intermediate port distal to the balloon, the intermediate ports being in communication with the guidewire lumen and being configured to slidably receive a guidewire therethrough so that the guidewire extends into or out of a proximal section of the guidewire lumen through the proximal intermediate port, extends along an outer surface of the balloon, and extends into or out of a distal section of the guidewire lumen through the distal intermediate port. The balloon is inflated in a patient'"'"'s blood vessel to perform a medical procedure, with the section of the guidewire extending along an outer surface of the balloon providing improved balloon retention at the desired location in the blood vessel during inflation of the balloon.

Claims

1. A balloon catheter, comprising:

a) an elongated tubular shaft having a proximal end, a distal end, an inflation lumen, a guidewire lumen, a guidewire proximal port, and a guidewire distal port at the distal end of the shaft;

b) a balloon on a distal shaft section, having a proximal end, a distal end, and an inflatable section having a proximal end, a distal end, and an interior in fluid communication with the inflation lumen, with a portion of the tubular shaft extended through the balloon interior and bonded to a distal skirt of the balloon; and

c) a proximal intermediate port in communication with the guidewire lumen and located proximal to the inflatable section of the balloon and distal to the guidewire proximal port, and a distal intermediate port in communication with the guidewire lumen and located distal to the distal end of the inflatable section of the balloon and proximal to the guidewire distal port, the intermediate ports being configured to slidably receive a guidewire therethrough so that the guidewire extends into or out of a proximal section of the guidewire lumen through the proximal intermediate port and extends into or out of a distal section of the guidewire lumen through the distal intermediate port, and the proximal section of the guidewire lumen located proximal to the proximal intermediate port is not in communication with the portion of the tubular shaft extending through the interior of the balloon.

2. The balloon catheter of claim 1 wherein the distal portion of the guidewire lumen located distal to the distal intermediate port is not in communication with the portion of the tubular shaft extending in the interior of the balloon.

3. The balloon catheter of claim 1 wherein the guidewire lumen at the intermediate ports is oriented to open outwardly in a direction pointing toward the balloon.

4. The balloon catheter of claim 1 wherein the guidewire proximal port is distal to the proximal end of the shaft.

5. The balloon catheter of claim 1 having a support member in at least a part of the guidewire lumen located between the proximal and distal intermediate ports.

6. The balloon catheter of claim 1 wherein the shaft comprises an outer tubular member defining at least a section of the inflation lumen, and an inner tubular member defining at least a section of the guidewire lumen and disposed at least in part in the inflation lumen, and the balloon has a proximal end secured to the outer tubular member and a distal end secured to the inner tubular member so that the portion of the tubular shaft extending in the balloon interior is formed by a distal portion of the inner tubular member.

7. The balloon catheter of claim 6 wherein the inner tubular member has a support member with a proximal end located at the proximal intermediate port and a distal end located at the distal intermediate port, so that the support member extends between the proximal and distal intermediate ports.

8. A balloon catheter, comprising:

a) an elongated shaft comprising an outer tubular member defining an inflation lumen, and an inner tubular member disposed at least in part in the inflation lumen and defining at least a section of the guidewire lumen, the inner tubular member having a proximal guidewire port, and a distal guidewire port at a distal end of the shaft;

b) an inflatable balloon on a distal shaft section having inflatable section with an interior in fluid communication with the inflation lumen, and having a distal portion of the inner tubular member extending in the balloon interior;

c) a proximal intermediate port proximal to the inflatable section of the balloon and distal to the guidewire proximal port, and a distal intermediate port distal to the inflatable section of the balloon and proximal to the guidewire distal port, the intermediate ports being in communication with the guidewire lumen and being configured to slidably receive a guidewire therethrough; and

d) a support member in the guidewire lumen between the proximal and distal intermediate ports, which at least partially occludes the guidewire lumen, and which has a wedge-shaped proximal end surface at least a portion thereof being located at the proximal intermediate port.

9. The balloon catheter of claim 8 wherein the support member fully occludes the guidewire lumen, so that a section of the guidewire lumen located proximal to the proximal intermediate port is not in fluid communication with the section of the guidewire lumen extending in the interior of the balloon.

10. The balloon catheter of claim 8 wherein the support member comprises a mandrel.

11. The balloon catheter of claim 8 wherein the support member has a wedge-shaped distal end surface at least a portion thereof being located at the distal intermediate port.

12. The balloon catheter of claim 8 wherein the inner tubular member has a first section coaxially disposed in the outer tubular member lumen, and a second section longitudinally adjacent to the first section and bonded to the outer tubular member at the proximal intermediate port.

13. A balloon catheter, comprising:

a) an elongated tubular shaft having a proximal end, a distal end, an inflation lumen, a guidewire lumen, a guidewire proximal port, and a guidewire distal port at the distal end of the shaft;

b) a balloon on a distal shaft section, having a proximal end, a distal end, and an inflatable section having an interior in fluid communication with the inflation lumen;

c) a proximal intermediate port in communication with the guidewire lumen and located proximal to the inflatable section of the balloon and distal to the guidewire proximal port, and a distal intermediate port in communication with the guidewire lumen and located distal to the inflatable section of the balloon and proximal to the guidewire distal port, the intermediate ports being configured to slidably receive a guidewire therethrough; and

d) a support member between the proximal and distal intermediate ports and extending through the interior of the balloon and having a proximal end which is not proximal to the proximal intermediate port, and a distal end which is not distal to the distal intermediate port.

14. A balloon catheter system, comprising:

a) a balloon catheter, comprising;

i) an elongated shaft having a proximal end, a distal end, an inflation lumen, a guidewire lumen, a guidewire proximal port, and a guidewire distal port at the distal end of the shaft;

ii) a balloon on a distal shaft section, having a proximal end, a distal end, and an inflatable section having a proximal end, a distal end, and an interior in fluid communication with the inflation lumen, with a portion of the tubular shaft extending in the balloon interior; and

iii) a proximal intermediate port proximal to the inflatable section of the balloon and distal to the guidewire proximal port, and a distal intermediate port distal to the distal end of the inflatable section of the balloon and proximal to the guidewire distal port, the intermediate ports being in communication with the guidewire lumen and being configured to slidably receive the guidewire therethrough; and

b) a guidewire in the guidewire lumen proximal and distal to the balloon, and extending through the proximal and distal intermediate ports so that a section of the guidewire extends along an outer surface of the balloon.

15. The balloon catheter system of claim 14 wherein the balloon outer surface has an exposed section in a noninflated configuration prior to being inflated to an inflated configuration, and the section of the guidewire extending along the outer surface of the balloon extends along the outer surface exposed section of the balloon in the noninflated configuration.

16. The catheter system of claim 14 wherein the guidewire has a coiled distal tip having a length sufficiently long so that a proximal end of the coiled distal tip is proximal to the distal end of the balloon and a distal end of the coiled distal tip is distal to the distal end of the catheter, so that at least a section of the coiled distal tip extends along the outer surface of the balloon and through the guidewire distal port.

17. The catheter system of claim 14 having a support member in at least a portion of the guidewire lumen located between the proximal and distal intermediate ports.