Innerless dilatation balloon catheter

• US 5,221,260 A
• Filed: 08/21/1991
• Issued: 06/22/1993
• 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, John D.
• Assistant Examiner(s): CERMAK, ADAM
• Application Number:
  US07/748,255
• Time in Patent Office: 671 Days
• Field of Search: 604/96-103, 604/264, 604/280, 604/282, 606/192, 606/194
• US Class Current: 604/99.04
• CPC Class Codes: A61M 2025/0047 the inner layer having a higher lubricity
• 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 shaft having a proximal end, a distal end, and a lumen which extends between the proximal end and the distal end;

a balloon carried at the distal end of the shaft, the balloon having an interior which is in fluid communication with the lumen to permit inflation and deflation of the balloon;

a guide wire;

a lumen extension through the interior of the balloon, the lumen extension being fixed to the distal end of the shaft to provide a passage for the guide wire to extend through the shaft and the balloon, the lumen extension having an inner diameter which permits relative movement of the guide wire and the balloon catheter and which provides a resistance to fluid flow past the guide wire in the lumen extension which is greater than 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

valve means responsive to pressure in the interior of the balloon for blocking fluid flow through the lumen extension during at least a part of inflation and deflation of the balloon.

2. The balloon catheter assembly of claim 1 wherein the valve means comprises a flexible tube positioned within the interior of the balloon which has an outer surface exposed to fluid pressure within the interior of the balloon, the flexible tube having an inner surface which defines a portion of the lumen extension and which engages the guide wire to block fluid flow through the lumen extension when pressure on the outer surface is greater than the threshold value.

3. The balloon catheter assembly of claim 2 wherein the lumen extension includes a proximal portion connected to the shaft and a distal portion connected to a distal end of the balloon.

4. The balloon catheter assembly of claim 3 wherein the flexible tube extends between the proximal portion and the distal portion.

5. The balloon catheter assembly of claim 4 wherein the proximal portion has a first pocket at a distal end and the distal portion has a second pocket at a proximal end, and wherein the flexible tube has a first end positioned in the first pocket and a second end positioned in the second pocket.

6. A balloon catheter assembly comprising:

an inflatable balloon;

a shaft which carries the inflatable balloon at a distal end of the shaft, the shaft having a lumen therethrough with the lumen being in fluid communication with an interior of the balloon for inflation and deflation of the balloon via the lumen;

a lumen extension through the balloon, the lumen extension being in fluid communication with the lumen;

a guide wire movably extending through the lumen and the lumen extension, wherein resistance to fluid flow past the guide wire in the lumen extension is greater than 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

valve means responsive to the pressure in the interior of the balloon for limiting fluid flow through the lumen extension during at least a part of the inflation and deflation of the balloon.

7. The balloon catheter assembly of claim 6 wherein the valve means comprises resilient means within the lumen extension and surrounding the guide wire within the lumen extension.

8. The balloon catheter assembly of claim 7 wherein the lumen extension includes a tubular portion having an annular break, the resilient means comprising a flexible ring generally coaxial with the lumen extension and spanning said break.

9. The balloon catheter assembly of claim 6 wherein the lumen extension includes a tubular portion having an annular break;

and the valve means is located at the break.

10. An over-the-wire angioplasty balloon catheter assembly comprising:

a shaft having a proximal end and a distal end, and having a lumen extending therethrough from the proximal end to the distal end;

an inflatable balloon at the distal end of the shaft with its interior in fluid communication with the lumen, and with the balloon having a proximal segment, an intermediate expandable segment and a distal segment;

a guide wire movably extending through the lumen of the shaft and the balloon interior;

a lumen extension fixed to the distal end of the shaft and the distal segment of the balloon for defining a path for the guide wire through the balloon and out of the balloon through the distal segment thereof; and

valve means, positioned across the path, which permits movement of the guide wire freely therethrough for providing a fluid restriction around the guide wire and across the path during at least a part of inflation and deflation of the inflatable balloon.

11. An over-the-wire angioplasty balloon catheter assembly comprising:

a shaft having a proximal end and a distal end, and having a lumen extending therethrough from the proximal end to the distal end;

an inflatable balloon at the distal end of the shaft with its interior in fluid communication with the lumen, and with the balloon having a proximal segment, an intermediate expandable segment and a distal segment;

a guide wire movably extending through the lumen of the shaft and the balloon interior;

a lumen extension connected to the distal end of the shaft and the distal segment of the balloon for defining a path for the guide wire through the balloon and out of the balloon through the distal segment thereof, the lumen extension having an inner diameter which is greater than an outer diameter of the guide wire to permit relative axial movement of the guide wire and the lumen extension and to define a passage around the guide wire in the lumen extension which has a resistance to fluid flow that is substantially greater than resistance to fluid flow between the lumen and the interior of the balloon during at least part of the inflation of the balloon; and

valve means, positioned across the path, which permits movement of the guide wire freely therethrough for providing a fluid restriction around the guide wire and across the path only when positive fluid pressure is applied through the lumen to the interior of the balloon.

12. A balloon catheter assembly comprising:

a shaft having a proximal end and a distal end, and having an inflation lumen extending therethrough from the proximal end to the distal end;

a lumen extension having a proximal end fixed to the distal end of the shaft, and a distal end, the lumen extension extending distally from the shaft;

a guide wire movably extending through the inflation lumen and the lumen extension;

an inflatable balloon at the distal end of the shaft with an interior in fluid communication with the inflation lumen, the balloon surrounding the lumen extension and being connected to the distal end of the lumen extension;

valve means responsive to fluid pressure in the interior of the balloon for providing an essentially fluid-tight seal around the guide wire during inflation and deflation of the balloon; and

wherein the lumen extension has an inner diameter which permits relative movement of the guide wire and the balloon catheter and which provides a resistance to fluid flow past the guide wire in the lumen extension which is greater than resistance to fluid flow between the lumen and the interior of the balloon during at least a part of the inflation of the balloon.

13. The catheter assembly of claim 12 wherein the lumen extension has a port communicating between the lumen and the interior of the balloon.

14. The catheter assembly of claim 12 wherein the balloon member has a proximal segment, and intermediate balloon segment, and a distal segment.

15. The catheter assembly of claim 14 wherein the valve means is located within the intermediate balloon segment.

16. The catheter assembly of claim 12 wherein the valve means comprises a flexible tube which surrounds the guide wire and which deforms radially inwardly in response to fluid pressure in the interior of the balloon.