MULTI-STAGE BALLOON CATHETER

• US 20140277351A1
• Filed: 03/14/2014
• Published: 09/18/2014
• Est. Priority Date: 03/14/2013
• Status: Active Grant

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated)
• Inventors: Koren, Lindsay, Ridgley, Nathan
• Granted Patent: US 9,839,543 B2
• Time in Patent Office: Days
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/821 Ostial stents
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61M 2025/1059 having different inflatable sections mainly depending on the response to the inflation pressure, e.g. due to different material properties
• CPC Class Codes: A61M 2025/1072 having balloons with two or more compartments
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 25/10185 Valves

Abstract

A multistage balloon catheter that uses a single lumen to inflate a balloon in stages is disclosed. A fluid port provides fluid communication from an inflation lumen in the balloon catheter to the inner volume of a distal balloon. The distal balloon expands as fluid in delivered to the inner volume of the distal balloon. Once inflated, the pressure continues to rise until a threshold pressure is exceeded. A pressure sensitive inflation valve provides fluid communication into an inner volume of a second balloon disposed at least partially proximal to the distal balloon. The pressure sensitive valve allows fluid communication into the second balloon once the threshold pressure is reached in the first balloon thereby inflating the second balloon.

Claims

1. A balloon catheter assembly comprising:

a catheter having a proximal end and a distal end;

a first balloon disposed at a distal portion of the catheter, the first balloon having a first interior volume;

a second balloon disposed at least partially proximal to the first balloon, the second balloon having a second interior volume;

a pressure actuated inflation valve operably coupled to the second balloon, the pressure actuated inflation valve providing fluid communication through the inflation valve to the second interior volume when a threshold fluid pressure is exceeded in the first balloon; and

a lumen extending from the proximal end of the catheter to the distal end of the catheter, the lumen being in fluid communication with the first interior volume.

2. The balloon catheter assembly of claim 1 wherein the first balloon has a first balloon wall and the second balloon has a second balloon wall adjacent to the first balloon wall and the pressure actuated inflation valve extends from the first interior volume through the first balloon wall and the second balloon wall into the second interior volume.

3. The balloon catheter assembly of claim 1 wherein the first balloon is disposed within the second interior volume.

4. The balloon catheter assembly of claim 3 wherein the first balloon has a first balloon wall and the second balloon has a second balloon wall, and the pressure actuated inflation valve extends from the first interior volume through the first balloon wall into the second interior volume without passing through the second balloon wall.

5. The balloon catheter assembly of claim 2 wherein the first balloon is disposed entirely distal to the second balloon.

6. The balloon catheter assembly of claim 1 wherein the pressure activated inflation valve is disposed between the catheter and the second balloon and passes from the lumen into the second interior volume.

7. The balloon catheter assembly of claim 1, wherein the pressure activated inflation valve comprises a rupture disk.

8. The balloon catheter assembly of claim 1 wherein the catheter has only one inflation lumen.

9. The balloon catheter assembly of claim 1 wherein the pressure actuated inflation valve is covered by the first balloon when uninflated and the threshold pressure is a pressure sufficient to inflate the first balloon to a point uncovering the pressure actuated inflation valve.

10. The balloon catheter assembly of claim 1, wherein the second balloon has a wall thickness greater than a wall thickness of the first balloon.

11. The balloon catheter assembly of claim 1, wherein the second balloon is formed of a material having a stiffness that is greater than a stiffness of the first balloon.

13. The method of claim 10 wherein guiding a proximal end of the catheter to a treatment site comprises guiding a first portion of the catheter having the stent and the first balloon to the ostial portion of the body lumen.

12. A method for deploying a stent using a multi-phase inflation balloon assembly comprising a catheter, a first balloon, a second balloon, a single inflation lumen, a pressure actuated valve, and a stent, the method comprising the acts of:

guiding a distal end of the catheter to a treatment site having an ostial lesion in a body lumen;

providing fluid to the first balloon to inflate the first balloon in a non-tapered portion of the body lumen, the inflated first balloon securing the catheter within the non-tapered portion of the body lumen;

providing fluid to the first balloon securing the catheter until the fluid pressure in the first balloon exceeds a threshold pressure actuating the pressure actuated inflation valve; and

providing fluid to the second balloon through the pressure actuated inflation valve to inflate the second balloon thereby expanding the stent.