Controllable pressure cryogenic balloon treatment system and method

• US 8,177,779 B2
• Filed: 12/02/2005
• Issued: 05/15/2012
• Est. Priority Date: 06/02/2004
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Joye, James, Williams, Richard S., Reuschling, Glen
• Primary Examiner(s): Gibson, Roy
• Assistant Examiner(s): SMITH, KAITLYN ELIZABETH
• Application Number:
  US11/292,855
• Publication Number:
  US 20060084962A1
• Time in Patent Office: 2,356 Days
• Field of Search: 606/21, 606/23
• 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 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: A61F 2007/126 for invasive application, e.g. for introducing into blood vessels
• CPC Class Codes: A61F 7/123 using a flexible balloon containing the thermal element

Abstract

Devices, systems, and methods controllably cool blood vessels and other body lumens. The blood vessel will often be treated for atherosclerotic or other diseases by inflating a balloon so as to engage the surrounding luminal wall. Controlled cooling of the balloon effected by a change in phase of a cryogenic fluid within the balloon typically a change from a liquid phase to a gas phase can be provided with a controlled, gradual inflation of the balloon. A single control system can be used for any of a variety of alternative selectable balloon catheters having significantly differing cooling fluid flow characteristics.

Claims

1. A method for treating a region of a blood vessel, the method comprising:

positioning a balloon within the blood vessel and adjacent the region while the balloon is in a first configuration;

inflating the balloon from the first configuration to the second configuration by cycling delivery valve and a vent valve, the vent valve disposed along a cooling fluid path upstream of the balloon, the inflating between the first configuration and the second configuration extending over a period of time from about 0.25 seconds to 10 seconds; and

cooling the region to a treatment temperature with the balloon in a second configuration at a treatment pressure by changing a cooling fluid from a liquid phase to a gas phase within the balloon so as to urge the balloon radially outwardly and treat the vessel.

2. The method of claim 1, wherein the inflating between the first configuration and the second configuration occurs by increasing a pressure within the balloon throughout the period of time.

3. The method of claim 2 further comprising controlling the pressure so that the balloon inflates gradually over the period of time.

4. The method of claim 2 wherein the step of inflating occurs by applying a plurality of successive pressure increase steps which increase the pressure over the period of time.

5. The method of claim 1, wherein the first configuration comprises a non-inflated state and the second configuration comprises a maximum inflated state.

6. The method of claim 1, wherein the period of time is from about 0.5 seconds to 7 seconds.

7. The method of claim 1, wherein the period of time is at least about 1 second.

8. The method of claim 1, wherein the period of time is at least about 7 seconds.

9. The method of claim 1 further comprising:

selecting the balloon catheter from among a plurality of differing alternative balloon catheters having differing cooling fluid flow characteristics,

controlling a rate of change of pressure within the balloon between the first configuration and the second configuration step so as to compensate for the alternative cooling fluid flow characteristics and provide the pressure change rate within a desired range.

10. The method of claim 1, wherein the inflating step comprises an intermediate balloon pressure, the intermediate pressure being greater than a first configuration balloon pressure and less than a second configuration balloon pressure.

11. The method of claim 1, further comprising

coupling a fluid supply to a supply lumen of the balloon catheter so as to provide a fluid path extending from the fluid supply, distally along the supply lumen, into the balloon, and proximally along an exhaust lumen of the balloon catheter.

12. The method of claim 11, wherein the inflating step further comprises periodic opening and closing of a vent valve coupled to the fluid path upstream of the balloon.

13. A catheter system for cooling a region of a blood vessel, the system comprising:

a balloon catheter having a catheter body with a proximal end, a distal end, and a balloon disposed near the distal end, the catheter body having a supply lumen and an exhaust lumen in fluid communication with the balloon;

a fluid supply coupleable to the proximal end of the catheter body so as to define a cooling fluid path extending distally along the supply lumen, through the balloon, and returning proximally along the exhaust lumen, the fluid supply having a cooling fluid which changes phase from a liquid to a gas so as to effect cooling;

a vent valve disposed along the cooling fluid path upstream of the balloon;

a delivery valve disposed between the fluid supply and the vent valve; and

a cooling fluid control system coupled to the fluid path, the fluid control system having at least one of controller software or controller hardware configured to implement a first configuration in which the balloon is uninflated, a second configuration in which the balloon is inflated to a treatment pressure and cools the region to a treatment temperature, and an inflation of the balloon from the first configuration to the second configuration over a period of time lasting about 0.25 seconds to 10 seconds, wherein the controller software or controller hardware is further configured to actuate the vent valve and delivery valve.

14. The catheter system of claim 13, wherein the period of time is from about 0.5 seconds to 7 seconds.

15. The catheter system of claim 13, wherein the period of time is at least about 1 second.

16. The catheter system of claim 13, wherein the cooling fluid comprises nitrous oxide, and wherein the treatment pressure is in a range from about 7 to about 11 atmospheres.

17. The catheter system of claim 13, wherein the inflation of the balloon includes a plurality of increasing pressure steps.

18. The catheter system of claim 13, further comprising a plurality of alternatively selectable balloon catheters having differing cooling fluid flow characteristics, each alternative balloon catheter being coupleable to the fluid supply so as to define an associated alternative fluid path, wherein the controller software or controller hardware of the fluid control system is configured to compensate for the differing flow characteristics so as to provide at least one of a treatment temperature in a desired temperature range, a treatment pressure in a desired treatment pressure range, and an inflation time period in a desired inflation time period range.

19. The catheter system of claim 13, wherein the control system is configured to adjust the vent valve to inflate the balloon over the period of time.

20. The catheter system of claim 19, further comprising a timer adapted for periodically cycling the vent valve open and closed to inflate the balloon over the period of time.