Method and apparatus for inflating and deflating balloon catheters

• US 8,900,222 B2
• Filed: 01/25/2013
• Issued: 12/02/2014
• 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, Harmouche, Chadi, Mihalik, Teresa Ann, Desrochers, Giles
• Primary Examiner(s): DELLA, JAYMI E
• Application Number:
  US13/749,795
• Publication Number:
  US 20130172866A1
• Time in Patent Office: 676 Days
• Field of Search: 606 20- 26, 607104-105, 607/113
• 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, 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 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, the second coolant reservoir, and the vacuum source are in fluid communication with the expandable element of the medical device;

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

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

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

evacuating the coolant from the expandable element with the vacuum source,

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

2. The method according to claim 1, further comprising the steps of:

terminating the transferring of the coolant from the first coolant reservoir to the expandable element;

wherein the pressure is maintained in the expandable element at the level substantially equal to or greater than the target pressure until the expandable element achieves a predetermined temperature.

3. The method according to claim 1, wherein the step of transferring the coolant from the first coolant reservoir to the expandable element includes a stepped increase of coolant transfer.

4. The method according to claim 1, wherein the coolant transferred from the second coolant reservoir to the expandable element is in a gaseous state.

5. The method according to claim 4, wherein the coolant transferred from the first coolant reservoir to the expandable element is in a liquid state.

6. The method according to claim 1, wherein the target coolant flow rate is greater than approximately 2500 sccm.

7. The method according to claim 1, wherein the target pressure is greater than approximately atmospheric pressure.

8. 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.

9. The method according to claim 8, wherein the volumetric capacity of the second coolant reservoir is less than approximately twenty cubic centimeters.

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

11. The method according to claim 1, further comprising a step of placing both the supply and the exhaust lumen in fluid communication with the atmosphere upon an indication of medical device malfunction.