Method and apparatus for inflating and deflating balloon catheters

• US 20060122589A1
• Filed: 12/13/2005
• Published: 06/08/2006
• Est. Priority Date: 03/23/2004
• Status: Active Grant

• Current Assignee: Medtronic CryoCath LP (Medtronic Plc)
• Original Assignee: CryoCath Technologies Incorporated (Medtronic Plc)
• Inventors: Mihalik, Teresa, Abboud, Marwan, Harmouche, Chadi, Mahrouche, Rachid, Monger, Eric
• Granted Patent: US 8,545,491 B2
• Time in Patent Office: Days
• US Class Current: 606/21
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/0025 Multiple balloons
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00994 combining two or more different kinds of non-mechanical energy or combining one or more non-mechanical energies with ultrasound
• CPC Class Codes: A61B 2018/0212 using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61B 2018/0262 using a circulating cryogenic fluid
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 25/1018 Balloon inflating or inflation-control devices
• CPC Class Codes: A61M 25/10185 Valves

Abstract

A system and method for controlling the inflation, ablation, and deflation of a balloon catheter. The system includes a balloon catheter, a console, having a pressurized gas or liquid inflation source, and an umbilical system to deliver pressurized coolant to the balloon catheter. The system comprises a PID (Proportional Integral Derivative) controller or other pressure-sensing device that monitors the amount of pressure and volume within the balloon catheter. During inflation, the pressure and/or volume of fluid within the balloon is maintained at a target amount in order to provide sufficient mechanized pressure against the desired target region. The system limits the inflation pressure such that a safe quantity of gas would be released should a leak occur. If the amount falls below a certain threshold level, gas or fluid egress is presumed and the inflation process is halted. In one embodiment, an intermediate console is placed between the console and the balloon catheter and coupled thereto. If a leak is detected, a shut off valve in the intermediate station is activated and the flow of pressurized coolant is interrupted. The balloon catheter can be re-inflated by a separate coolant source in the intermediate station or by a syringe. A further embodiment provides a second balloon to envelope the first balloon and in order to provide a safety vacuum between the two balloons.

Claims

1-11. -11. (canceled)

12. An apparatus for inflating and deflating a catheter having a first expandable membrane, the apparatus comprising:

a first console including means for controlling the inflation and deflation of the first expandable membrane in order to reach a target pressure or volume;

a catheter; and

an umbilical system coupling the console to the catheter and delivering pressurized coolant to the first expandable membrane.

13. The apparatus of claim 12, wherein the first console includes means for determining if the first expandable membrane has reached its target pressure or volume.

14. The apparatus of claim 13, wherein the means for determining if the first expandable membrane has reached its target pressure or volume is a Proportional Integral Derivative controller.

15. The apparatus of claim 12, further comprising an intermediary console located between the first console and the catheter.

16. The apparatus of claim 15, wherein the intermediary console includes means for interrupting the flow of pressurized coolant from the first console to the catheter if the target pressure or volume has been exceeded.

17. The apparatus of claim 16, wherein the means for interrupting the flow of pressurized coolant from the first console to the catheter is a shut-off valve located within the intermediary console.

18. The apparatus of claim 15, wherein the intermediary console includes means for re-inflating the first expandable membrane.

19. The apparatus of claim 18, wherein the means for re-inflating the first expandable membrane is a source of pressurized coolant within the intermediary console.

20. The apparatus of claim 12, wherein the catheter further comprises a second expandable membrane, the first and second expandable membranes defining a safety vacuum space disposed between the first and second expandable membranes.

21. The apparatus of claim 20, further comprising a vacuum umbilical in communication with the safety vacuum space.

22. The apparatus of claim 21, further comprising a flow switch.

23. The apparatus of claim 22, further comprising a flow detector, the flow switch and flow detector being in fluid communication with the safety vacuum space.

24. The apparatus of claim 20, further comprising a pressure sensing element in communication with the safety vacuum space.

25. The apparatus of claim 20, further comprising a leak detection element in communication with the safety vacuum space.

26. The apparatus of claim 20, further comprising a blood detection element in communication with the safety vacuum space.

27. The apparatus of claim 20, further comprising a fluid detection element in communication with the safety vacuum space.

28. The apparatus of claim 12, further comprising a pressure sensing element in communication with a volume within the first expandable membrane.

29. The apparatus of claim 12, further comprising a leak detection element in communication with a volume within the first expandable membrane.

30. The apparatus of claim 12, further comprising a blood detection element in communication with a volume within the first expandable membrane.

31. The apparatus of claim 12, further comprising a fluid detection element in communication with a volume within the first expandable membrane.