Single-lumen balloon catheter having a directional valve

• US 5,304,198 A
• Filed: 11/13/1992
• Issued: 04/19/1994
• Est. Priority Date: 11/13/1992
• Status: Expired due to Term

• Current Assignee: Target Therapeutics, Inc. (Boston Scientific Corporation)
• Original Assignee: Target Therapeutics, Inc. (Boston Scientific Corporation)
• Inventors: Samson, Gene
• Primary Examiner(s): NOT, DEFINED
• Application Number:
  US07/976,197
• Time in Patent Office: 522 Days
• Field of Search: 606/192, 606/194, 604/33, 604/96, 604/99, 604/101-103, 604/246, 604/249, 604/170, 128/772
• US Class Current: 606/194
• CPC Class Codes: A61M 2025/0076 Unidirectional valves
• 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 2025/1093 having particular tip characteristics
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/0075 Valve means
• CPC Class Codes: A61M 25/104 used for angioplasty
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

This invention is a single-lumen balloon catheter having a valve seat on the distal end of the catheter, distal of the balloon, which may be operated by a control wire having a valve plug disposed on the wire. The valve seat may be engaged by the valve plug from either direction, depending on the installation of the control wire. In either event, if the valve plug is installed distally of the valve seat in the catheter lumen, the valve is closed by pulling on the control wire (or moving the control wire in a proximal direction) and introducing fluid through the catheter lumen through the balloon. Alternatively, the guidewire, with its integral valve plug, may be introduced from the proximal end of the catheter and may traverse the body of the balloon to engage the valve seat in the distal end of the catheter. Pushing on the control wire will seat the valve, allowing the introduction of fluid through the catheter lumen to inflate the balloon. The latter arrangement allows the control wire to be interchanged with other guidewires a physician may wish to use. The balloon provided for in this invention is of a single length and does not change its axial length as it is inflated.

Claims

1. A single-lumen balloon catheter assembly comprising a catheter body having proximal and distal ends, a single lumen extending between those proximal and distal ends, an inflatable balloon having proximal and distal ends disposed in the distal region of the catheter body, a valve seat disposed between the distal end of the inflatable balloon and the distal end of the catheter body, which valve seat is formed by a circumferential band cinching a portion of the catheter body forming distal and proximal valve surfaces, and allows passage of a control wire therethrough, and is adapted to engage and seal said lumen, both on its distal and proximal valve surfaces, with a valve plug disposed on a control wire.

2. The catheter assembly of claim 1 also comprising a control wire having distal and proximal ends, having a valve plug disposed near its distal end adapted to engage and seal said lumen by contacting either the distal or proximal valve surfaces by sliding axially through the catheter lumen, and adapted to be introduced into the catheter body either through the proximal or distal ends.

3. The catheter of claim 2 wherein the control wire is a guidewire having a proximal end and a distal tip.

4. The catheter of claim 3 wherein the guidewire additionally comprises a bendable guide tip at its distal tip.

5. The catheter of claim 2 wherein the inflatable balloon additionally comprises a balloon inner member allowing fluid communication between the lumen and the inflatable balloon and extending between the distal

6. The catheter of claim 5 wherein the balloon inner member is additionally adapted to allow axial passage of the valve plug.

7. The catheter of claim 6 wherein the balloon inner member comprises a coil.

8. The catheter of claim 6 wherein the balloon inner member comprises perforated tubing.

9. The catheter of claim 8 wherein the balloon inner member additionally comprises a coil coaxially disposed about the perforated tubing.

10. The catheter of claim 8 wherein the balloon inner member additionally comprises a braided or woven tubing coaxially disposed about the perforated tubing.

11. The catheter of claim 6 wherein the balloon inner member comprises a braided or woven tubing.

12. The catheter of claim 5 wherein the balloon inner member comprises a coil.

13. The catheter of claim 5 wherein the balloon inner member comprises perforated tubing.

14. The catheter of claim 13 wherein the balloon inner member additionally comprises a coil coaxially disposed about the perforated tubing.

15. The catheter of claim 13 wherein the balloon inner member additionally comprises a braided or woven tubing coaxially disposed about the perforated tubing.

16. The catheter of claim 5 wherein the balloon inner member comprises a braided or woven tubing.

17. The catheter of claim 2 wherein the ratio of the diameter of the balloon before inflation and the diameter of the balloon after inflation is less than 1:

6.

18. The catheter of claim 2 wherein the diameter of the balloon before inflation is within 10% of the diameter of the catheter body proximal of the inflatable balloon.

19. The catheter of claim 2 wherein the circumferential band is radiopaque.

20. The catheter of claim 2 wherein the valve plug is spherical.

21. The catheter of claim 2 wherein the catheter body comprises a polyimide tubing coaxially surrounding a lubricious polymeric layer.

22. The catheter of claim 21 wherein the lubricious polymeric layer comprises a fluoroethylene polymer.

23. The catheter of claim 22 wherein the fluoroethylene polymer is selected from polytetrafluoroethylene, fluoroethylene copolymers having perfluoroalkoxy groups, copolymers of tetrafluoroethylene and hexafluoropropylene, and copolymers of ethylene and tetrafluoroethylene.

24. The catheter of claim 23 wherein the fluoroethylene polymer is a copolymer of tetrafluoroethylene and hexafluoropropylene.