Method and apparatus for inflating and deflating balloon catheters

• US 8,545,491 B2
• Filed: 12/13/2005
• Issued: 10/01/2013
• Est. Priority Date: 03/23/2004
• Status: Active Grant

• Current Assignee: Medtronic CryoCath LP (Medtronic Plc)
• Original Assignee: Medtronic CryoCath LP (Medtronic Plc)
• Inventors: Abboud, Marwan, Mahrouche, Rachid, Mihalik, Teresa, Harmouche, Chadi, Monger, Eric
• Primary Examiner(s): Peffley, Michael
• Assistant Examiner(s): HUPCZEY, JR, RONALD JAMES
• Application Number:
  US11/301,768
• Publication Number:
  US 20060122589A1
• Time in Patent Office: 2,849 Days
• Field of Search: 606 20- 31, 607101-102
• US Class Current: 606/22
• 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. An apparatus for inflating and deflating a catheter having a first expandable membrane, the apparatus comprising:

a first console including a pressurized coolant supply;

a flow sensor in fluid communication with the pressurized coolant supply, the flow sensor for measuring a fluid flow rate;

a valve in fluid communication with the pressurized coolant supply, wherein the flow sensor and the valve control fluid delivery for inflation and deflation of the first expandable membrane in order to reach a target volume less than a preselected volume threshold;

the first console having a shut-off valve for interrupting the flow of pressurized coolant from the first console to the catheter if the delivered volume exceeds the preselected volume threshold; and

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

2. The apparatus of claim 1, wherein the first console includes a flow switch.

3. The apparatus of claim 1, wherein the first console includes a Proportional Integral Derivative controller for determining if the first expandable membrane has reached its target volume.

4. The apparatus of claim 1, 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.

5. The apparatus of claim 4, further comprising a vacuum umbilical in communication with the safety vacuum space.

6. The apparatus of claim 5, further comprising a flow switch.

7. The apparatus of claim 6, the flow switch and the flow sensor being in fluid communication with the safety vacuum space.

8. The apparatus of claim 4, further comprising a pressure sensing element in communication with the safety vacuum space.

9. The apparatus of claim 4, further comprising a leak detection element in communication with the safety vacuum space.

10. The apparatus of claim 4, further comprising a blood detection element in communication with the safety vacuum space.

11. The apparatus of claim 4, further comprising a fluid detection element in communication with the safety vacuum space.

12. The apparatus of claim 1, further comprising a pressure sensing element in communication with a volume within the first expandable membrane.

13. The apparatus of claim 1, further comprising a leak detection element in communication with an interior of the first expandable membrane.

14. The apparatus of claim 1, further comprising a blood detection element in communication with a volume within the first expandable membrane.

15. The apparatus of claim 1, further comprising a fluid detection element in communication with a volume within the first expandable membrane.