Innerless dilatation balloon catheter

• US 5,531,689 A
• Filed: 06/06/1995
• Issued: 07/02/1996
• Est. Priority Date: 01/13/1989
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Burns, Matthew M., Lodin, David W.
• Primary Examiner(s): YASKO JR, JOHN D
• Application Number:
  US08/467,749
• Time in Patent Office: 392 Days
• Field of Search: 604/96-103, 604/264, 604/280, 604/282, 606/192-196, 600/18, 128/207.15
• US Class Current: 604/99.04
• CPC Class Codes: A61M 2025/0047 the inner layer having a higher lubricity
• CPC Class Codes: A61M 2025/09125 Device for locking a guide wire in a fixed position with respect to the catheter or the human body
• 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 2025/1079 having radio-opaque markers in the region of the balloon
• CPC Class Codes: A61M 25/0023 by the form of the lumen, e.g. cross-section, variable diameter
• CPC Class Codes: A61M 25/0075 Valve means
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

An "innerless" balloon catheter controls fluid flow past the guide wire at the distal end of the catheter by a combination of flow resistance and a pressure responsive valve. The catheter includes a shaft which carries an inflatable balloon at its distal end. The shaft has a lumen therethrough with the lumen being in fluid communication with the balloon interior for inflating and deflating the balloon via the shaft lumen. The catheter further includes a lumen extension through the balloon, with the lumen extension being in fluid communication with the shaft lumen. A guide wire extends through the shaft lumen and the lumen extension and out the distal end of the balloon. The resistance to fluid flow past the guide wire in the lumen extension is substantially greater than the resistance to fluid flow between the shaft lumen and the balloon interior. A valve member is responsive to the pressure in the balloon interior for blocking fluid flow through the lumen extension during continuing inflation and at least the initial deflation of the balloon.

Claims

1. A balloon catheter assembly comprising:

a. a shaft having a proximal end, a distal end, and a lumen which extends between the proximal end and the distal end;

b. a balloon having a first end and a second end, the first end of the balloon being attached to the shaft near the distal end of the shaft, the second end of the balloon being attached to the shaft proximal of the distal end of the shaft, said balloon being in fluid communication with the lumen to permit inflation and deflation of the balloon;

c. a guide wire disposed within said lumen;

d. a fluid resistance member positioned around the guidewire and carried by the shaft, the fluid resistance member having an inner diameter which permits relative movement of the guide wire with respect to the balloon catheter and also provides a resistance to fluid flow past the guide wire, the resistance to fluid flow provided by the fluid resistance member being greater than the resistance to fluid flow between the lumen and the interior of the balloon; and

e. a valve responsive to inflation pressure operatively mounted with the lumen of the shaft for reducing fluid flow through the lumen.

2. The balloon catheter assembly according to claim 1 wherein the valve comprises a flexible tube which has an outer surface exposed to fluid pressure within the interior of the balloon, the flexible tube having an inner surface which engages the guide wire to reduce fluid flow through the lumen when pressure on the outer surface is greater than on the inner surface.

3. The balloon catheter assembly according to claim 2 wherein the shaft has a break therein thereby forming a gap, the flexible tube being positioned to bridge the gap.

4. A balloon catheter assembly comprising:

a. a shaft having a proximal end, a distal end, and a lumen which extends between the proximal end and the distal end;

b. a balloon having a first end and a second end, the first end of the balloon being attached to the shaft near the distal end of the shaft, the second end of the balloon being attached to the shaft proximal of the distal end of the shaft, said balloon being in fluid communication with the lumen to permit inflation and deflation of the balloon;

c. a guide wire disposed within said lumen;

d. a fluid resistance member positioned around the guidewire and carried by the shaft, the fluid resistance member having an inner diameter which permits relative movement of the guide wire with respect to the balloon catheter and also provides a resistance to fluid flow past the guide wire, the resistance to fluid flow provided by the fluid resistance member being greater than the resistance to fluid flow between the lumen and the interior of the balloon; and

e. valve means responsive to pressure in the interior of the balloon operatively mounted within the lumen of the shaft for reducing fluid flow through the lumen.

5. The balloon catheter assembly according to claim 4 wherein the valve means comprises a flexible tube which has an outer surface exposed to fluid pressure within the interior of the balloon, the flexible tube having an inner surface which engages the guide wire to reduce fluid flow through the lumen when pressure on the outer surface is greater than on the inner surface.

6. The balloon catheter assembly according to claim 5 wherein the shaft has a break therein thereby forming a gap, the flexible tube being positioned to bridge the gap.

7. A balloon catheter assembly comprising:

a. a shaft having a proximal end, a distal end, and a lumen which extends between the proximal end and the distal end, the lumen defined by an inner surface of the shaft;

b. a balloon having a first end and a second end, the first end of the balloon being attached to the shaft near the distal end of the shaft, the second end of the balloon being attached to the shaft proximal of the distal end of the shaft, said balloon catheter having means for fluid communication between the interior of the balloon and the lumen to permit inflation and deflation of the balloon;

c. a guide wire disposed within said lumen;

d. fluid resistance means positioned around the guidewire and carried by the shaft, and cooperating with the inner surface of the shaft, the fluid resistance means being positioned distal of the means for fluid communication, the fluid resistance means having an inner diameter which permits relative movement of the guide wire with respect to the balloon catheter and also provides a resistance to fluid flow past the guide wire, the resistance to fluid flow provided by the fluid resistance means being greater than the resistance to fluid flow between the lumen and the interior of the balloon during at least a part of the inflation of the balloon; and

e. valve means positioned within the lumen of the shaft extending circumferencially around the lumen, said valve means being responsive to pressure in the interior of the balloon for reducing fluid flow through the lumen distal of the means for fluid communication during at least a part of inflation of the balloon.

8. The balloon catheter assembly according to claim 7 wherein the valve means comprises a flexible tube which has an outer surface exposed to fluid pressure within the interior of the balloon, the flexible tube having an inner surface which engages the guide wire to reduce fluid flow through the lumen distal of said means for fluid communication when pressure on the outer surface is greater than on the inner surface.

9. The balloon catheter assembly according to claim 8 wherein the shaft has a break therein thereby forming a gap, the flexible tube being positioned to bridge the gap.