Method and apparatus for inflating and deflating balloon catheters

• US 7,727,228 B2
• Filed: 03/23/2004
• Issued: 06/01/2010
• Est. Priority Date: 03/23/2004
• Status: Active Grant

• Current Assignee: Medtronic CryoCath LP (Medtronic Plc)
• Original Assignee: Medtronic CryoCath LP (Medtronic Plc)
• Inventors: Harmouche, Chadi, Mihalik, Teresa Ann, Monger, Eric, Mahrouche, Rachid, Abboud, Marwan
• Primary Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US10/806,995
• Publication Number:
  US 20050215989A1
• Time in Patent Office: 2,261 Days
• Field of Search: 606 20- 31, 607101-102
• 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 is provided. 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.

Claims

1. A method of inflating and deflating a catheter having an expandable membrane, the method comprising the steps of:

determining a target pressure for inflation of the expandable membrane;

positioning the expandable membrane within a portion of a cardiovascular system;

controllably inflating the expandable membrane to at least the target pressure;

ablating a desired tissue region, wherein the pressure in the expandable membrane during ablation exceeds the target pressure, and is lower than approximately 20 psi; and

controllably deflating the expandable membrane.

2. The method of claim 1, further comprising keeping the expandable membrane inflated until a region proximate the expandable membrane reaches a predetermined temperature range.

3. The method of claim 1, wherein the step of controllably inflating the expandable membrane to the target pressure is performed by inflation/deflation control means located within a first console.

4. The method of claim 3, wherein the inflation/deflation control means is a Proportional Integral Derivative controller.

5. The method of claim 4, wherein the inflation/deflation control means further includes a pressure switch that controls an on/off valve.

6. The method of claim 3, wherein the inflation/deflation control means is a proportional valve for controlling the delivery of fluid in order to reach and maintain the target pressure in the balloon.

7. The method of claim 3, wherein the inflation/deflation control means is a fixed volume reservoir coupled to a shutoff valve located within the first console.

8. The method of claim 1, wherein, if the target pressure is not reached, further comprising the step of re-inflating the expandable membrane in order to reach the target pressure.

9. The method of claim 1, wherein the step of ablating the desired tissue region is part of a cryoablation process.

10. The method of claim 1, wherein the step of controllably deflating the expandable membrane includes preventing deflation until a temperature in the balloon is higher than a predetermined temperature.

11. The method of claim 1, wherein the step of controllably deflating the expandable membrane includes reducing adhesion between the expandable membrane and the desired tissue region.

12. The method of claim 11 wherein reducing adhesion includes preventing deflation until a temperature in the balloon is higher than a predetermined temperature.

13. A method for inflating and deflating a catheter having an expandable membrane, the catheter being part of a catheter system including a first console, a catheter, and an umbilical system coupling the first console to the catheter, the method comprising the steps of:

evacuating air from the expandable membrane by creating a vacuum in the expandable membrane;

positioning the expandable membrane within a portion of a cardiovascular system;

controllably inflating the expandable membrane proximate a desired tissue region, the expandable membrane being inflated to a preselected target pressure level in order to provide sufficient mechanical force against the desired tissue region;

ablating the desired tissue region, wherein the pressure in the expandable membrane during ablation exceeds the target pressure, and is lower than approximately 20 psi; and

controllably deflating the expandable membrane.