Method and apparatus for inflating and deflating balloon catheters

• US 20070032783A1
• Filed: 10/16/2006
• Published: 02/08/2007
• 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, Desrochers, Gilles, Mahrouche, Rachid
• Granted Patent: US 8,491,636 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 2018/0212 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 25/10184 Means for controlling or monitoring inflation or deflation

Abstract

A system and method for controlling the inflation, ablation, and deflation of a balloon catheter. The system includes a balloon catheter, a console, a pressurized gas or liquid inflation source, and an umbilical system to deliver pressurized coolant to the balloon catheter. The system may include controller 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.

Claims

1. A method of providing coolant to a medical device, the method comprising the steps of:

providing a first coolant reservoir and a second coolant reservoir, wherein the first and second coolant reservoirs are in fluid communication with the medical device;

transferring coolant from the first coolant reservoir to the second coolant reservoir; and

transferring coolant from the second coolant reservoir to the medical device.

2. The method according to claim 1, wherein the step of transferring coolant from the second coolant reservoir to the medical device pressurizes at the medical device to a predetermined target pressure.

3. The method according to claim 2, further comprising monitoring a pressure level within at least a portion of the medical device.

4. The method according to claim 3, further comprising evacuating coolant from the medical device when the monitored pressure level varies from the predetermined target pressure.

5. The method according to claim 1, wherein the second coolant reservoir defines a volumetric capacity substantially less than a volumetric capacity of the first coolant reservoir.

6. The method according to claim 2, wherein the second coolant reservoir has a volumetric capacity less than approximately twenty cubic centimeters.

7. The method according to claim 1, wherein the medical device defines an injection lumen and an exhaust lumen, and wherein the step of transferring coolant from the second coolant reservoir to the medical device includes transferring coolant into the exhaust lumen.

8. The method according to claim 1, wherein the coolant transferred from the second reservoir to the medical device is in a gaseous state.

9. The method according to claim 1, wherein the medical device includes an expandable element.

10. The method according to claim 1, wherein the second coolant reservoir is defined by a length of tubing defining a lumen therein.

11. A method of providing coolant to a medical device having an expandable element, the method comprising the steps of:

providing a coolant reservoir and a vacuum source, wherein the coolant reservoir and vacuum source are in fluid communication with the expandable element of the medical device;

inflating the expandable element to a target pressure;

transferring coolant from the coolant reservoir to the expandable element;

evacuating coolant from the expandable element with the vacuum source;

wherein the steps of transferring and evacuating coolant are regulated to achieve a target coolant flow rate while maintaining the pressure in the expandable element at a level substantially equal to or greater than the target pressure.

12. The method according to claim 11, further comprising the steps of:

terminating coolant transfer from the reservoir to the expandable element;

controllably evacuating coolant from the expandable element with the vacuum source such that the pressure in the expandable element is maintained at a level substantially equal to or greater than the target pressure until the expandable element achieves a predetermined temperature.

13. The method according to claim 12, wherein the predetermined temperature is greater than approximately −

10°

C.

14. The method according to claim 11, further comprising monitoring a pressure level within the expandable element.

15. The method according to claim 14, further comprising evacuating coolant from the medical device when the monitored pressure level varies from the predetermined target pressure.

16. The method according to claim 11, wherein the target coolant flow rate is greater than approximately 2500 sccm.

17. The method according to claim 11, wherein the target pressure is greater than approximately atmospheric pressure.

18. A method of operating a medical device having an expandable element in fluid communication with a supply lumen and an exhaust lumen, the method comprising the steps of:

providing a first coolant reservoir, a second coolant reservoir and a vacuum source, wherein the first coolant reservoir, second coolant reservoir and vacuum source are in fluid communication with the expandable element of the medical device;

transferring coolant from the first reservoir to the second reservoir; and

transferring coolant from the second coolant reservoir to the expandable element through the exhaust lumen, wherein the expandable element is inflated to a target pressure.

19. The method according to claim 18, further comprising the steps of:

transferring coolant from the first coolant reservoir to the expandable element through the supply lumen; and

evacuating coolant from the expandable element with the vacuum source;

wherein the steps of transferring coolant from the first coolant reservoir to the expandable element and evacuating coolant from the expandable element are regulated to achieve a target coolant flow rate, while maintaining the pressure in the expandable element at a level substantially equal to or greater than the target pressure.

20. The method according to claim 19, further comprising the steps of:

terminating coolant transfer from the reservoir to the expandable element;

controllably evacuating coolant from the expandable element with the vacuum source such that the pressure in the expandable element is maintained at a level substantially equal to or greater than the target pressure until the expandable element achieves a predetermined temperature.

21. The method according to claim 19, wherein the step of transferring coolant from the first coolant reservoir to the expandable element includes a stepped increase of coolant transfer.

22. The method according to claim 18, wherein the coolant transferred from the second coolant reservoir to the expandable element is in a gaseous state.

23. The method according to claim 22, wherein the coolant transferred from the first coolant reservoir to the expandable element is in a liquid state.

24. The method according to claim 18, wherein the target coolant flow rate is greater than approximately 2500 sccm.

25. The method according to claim 18, wherein the target pressure is greater than approximately atmospheric pressure.

26. The method according to claim 18, wherein the second coolant reservoir defines a volumetric capacity substantially less than a volumetric capacity of the first coolant reservoir.

27. The method according to claim 26, wherein the second coolant reservoir has a volumetric capacity less than approximately twenty cubic centimeters.

28. The method according to claim 18, wherein the second coolant reservoir is defined by a length of tubing defining a lumen therein.

29. The method according to claim 18, further comprising the step of placing both the supply lumen and exhaust lumen in fluid communication with the atmosphere upon an indication of medical device malfunction.

30. A medical system, comprising:

a supply lumen and an exhaust lumen;

a first coolant reservoir; and

a second coolant reservoir, wherein the first coolant reservoir is selectively switchable from being in fluid communication with either the supply lumen or the second coolant reservoir.

31. The medical system according to claim 30, further comprising a vacuum source, wherein the exhaust lumen is selectively switchable from being in fluid communication with either the second coolant reservoir or the vacuum source.

32. The medical system according to claim 31, further comprising:

a first valve in fluid communication with the supply lumen; and

a first controller coupled to the valve for varying fluid flow therethrough.

33. The medical system according to claim 32, further comprising:

a second valve in fluid communication with the vacuum source; and

a second controller coupled to the valve for varying fluid flow therethrough.

34. The medical system according to claim 30, wherein the second coolant reservoir defines a volumetric capacity substantially less than a volumetric capacity of the first coolant reservoir.

35. The medical system according to claim 34, wherein the second coolant reservoir has a volumetric capacity less than approximately twenty cubic centimeters.

36. The medical system according to claim 30, wherein the second coolant reservoir is defined by a length of tubing defining a lumen therein.

37. The medical system according to claim 30, further comprising a valve in fluid communication with both the supply lumen and exhaust lumen for preventing siphoning of bodily fluids.

38. A coolant system for a medical device, comprising:

a first coolant reservoir;

a first proportional valve in fluid communication with the first coolant reservoir;

a first controller coupled to the first proportional valve;

a coolant supply line in fluid communication with the first proportional valve;

a vacuum source;

a second proportional valve in fluid communication with the vacuum source;

a second controller coupled to the second proportional valve; and

a coolant exhaust line in fluid communication with the second proportional valve.

39. The coolant system according to claim 38, further comprising a second coolant reservoir in fluid communication with the first coolant reservoir.

40. The coolant system according to claim 38, wherein the second coolant reservoir is defined by a length of tubing defining a lumen therein.