METHOD AND APPARATUS FOR REMOTE ISCHEMIC CONDITIONING DURING REVASCULARIZATION

• US 20110224606A1
• Filed: 02/28/2011
• Published: 09/15/2011
• Est. Priority Date: 03/10/2010
• Status: Abandoned Application

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: SHOME, SHIBAJI, SHUROS, ALLAN C., HASTINGS, ROGER, MOKELKE, ERIC A., ESLER, JAMES A.
• Application Number:
  US13/036,941
• Publication Number:
  US 20110224606A1
• Time in Patent Office: Days
• US Class Current: 604/96.01
• CPC Class Codes: A61M 2025/0002 with a pressure sensor at the distal end
• CPC Class Codes: A61M 2025/1015 having two or more independently movable balloons where the distance between the balloons can be adjusted, e.g. two balloon catheters concentric to each other forming an adjustable multiple balloon catheter system
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/1081 having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
• CPC Class Codes: A61M 25/10184 Means for controlling or monitoring inflation or deflation
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

Remote ischemic conditioning is applied during a revascularization procedure to prevent and/or reduce myocardial injury associated with myocardial infarction (MI) and the revascularization procedure such as percutaneous transluminal coronary angioplasty (PTCA). A percutaneous transluminal vascular intervention (PTVI) device used for the revascularization procedure, such as an introducer sheath or a guide catheter, includes an adjustable balloon to be positioned at a vascular site remote from the heart. The remote ischemic conditioning is applied by inflating and deflating the adjustable balloon, thereby causing temporary ischemia in the vascular site to activate the patient'"'"'s intrinsic cardioprotective mechanism.

Claims

1. A percutaneous transluminal vascular intervention (PTVI) device for use with an angioplasty catheter during revascularization of a coronary artery in a body and for placement in one or more arteries through which a distal end of the angioplasty catheter is advanced into the coronary artery, the PTVI device comprising:

a proximal end;

a distal end configured to be placed in the one or more arteries;

an elongate tubular shaft coupled between the proximal end and the distal end,

a lumen extending within the elongate tubular shaft and including a proximal opening at the proximal end and distal opening at the distal end, the lumen configured to accommodate a portion of the angioplasty catheter and allow the distal end of the angioplasty catheter to enter the proximal opening and exit from the distal opening;

an adjustable balloon incorporated onto the elongate tubular shaft and configured to occlude a portion of the one or more arteries, the balloon including a chamber having an adjustable volume; and

an elongate balloon adjustment tube coupled to the adjustable balloon and including a fluid passageway in fluid communication with the chamber to allow inflation and deflation of the adjustable balloon.

2. The PTVI device of claim 1, comprising a distal flow sensor incorporated onto the elongate tubular shaft in a location between the distal end and the adjustable balloon to monitor blood flow.

3. The PTVI device of claim 2, comprising a proximal pressure sensor incorporated onto the elongate tubular shaft in a location between the proximal end and the adjustable balloon to monitor blood pressure.

4. The PTVI device of claim 2, comprising a proximal flow sensor incorporated onto the elongate tubular shaft in a location between the proximal end and the adjustable balloon to monitor blood flow.

5. The PTVI device of claim 1, comprising a sliding balloon assembly over the elongate tubular shaft, the sliding balloon assembly displaceable along a portion of the elongate tubular shaft and including the adjustable balloon.

6. The PTVI device of claim 5, wherein the sliding balloon assembly comprises a positioning member adapted to position the adjustable balloon.

7. The PTVI device of claim 6, wherein a portion of the elongate balloon adjustment tube comprises the positioning member.

8. The PTVI device of claim 6, wherein the sliding balloon assembly comprises a sliding sleeve over the portion of the elongate tubular shaft, the adjustable balloon is constructed on the sleeve, and the positioning member is affixed to the sliding sleeve.

9. The PTVI device of claim 1, comprising an introducer sheath including the proximal end, the distal end, the elongate tubular shaft, the adjustable balloon, and the elongate balloon adjustment tube.

10. The PTVI device of claim 9, wherein the elongate tubular shaft has a length between approximately 7 cm and 25 cm, and the adjustable balloon is affixed onto the elongate tubular shaft at a predetermined location of the elongate tubular shaft.

11. The PTVI device of claim 1, comprising a guide catheter including the proximal end, the distal end, the elongate tubular shaft, the adjustable balloon, and the elongate balloon adjustment tube.

12. The PTVI device of claim 11, wherein the elongate tubular shaft has a length between approximately 90 cm and 130 cm, and a sliding balloon assembly over the elongate tubular shaft, the sliding balloon assembly displaceable along a portion of the elongate tubular shaft and including the adjustable balloon.

13. A method for cardioprotection during revascularization of a coronary artery, the method comprising:

inserting a portion of a percutaneous transluminal vascular intervention (PTVI) device into one or more arteries, the PVTI device including an adjustable balloon;

inserting a portion of an angioplasty catheter into a lumen of the PTVI device;

advancing a distal end of the angioplasty catheter through the PTVI device into the coronary artery; and

occluding a portion of the one or more arteries temporarily by inflating and deflating the adjustable balloon, the occluding timed using parameters selected to create a physiologic stress that is sufficient to trigger an intrinsic myocardial protective mechanism.

14. The method of claim 13, wherein occluding a portion of the one or more arteries temporarily comprises applying an ischemic conditioning sequence including a specified number of cycles of alternating ischemic and non-ischemic periods, the ischemic periods each including an ischemic duration during which the adjustable balloon is inflated to temporarily occlude the portion of the one or more arteries, the ischemic periods each including a non-ischemic duration during which the one or more balloons are deflated.

15. The method of claim 14, comprising programming the number of cycles to a number in a range of approximately 1 cycle to 10 cycles, programming the ischemic period to a time interval in a range of approximately 1 minute to 20 minutes, and programming the non-ischemic period to a time interval in a range of approximately 1 minute to 10 minutes.

16. The method of claim 14, wherein inserting the portion of the PTVI device into the one or more arteries comprising inserting a portion of an introducer sheath into a femoral artery such that the adjustable balloon is placed in the femoral artery.

17. The method of claim 14, wherein the adjustable balloon is displaceable along a portion of the PTVI device, and comprising sliding the adjustable balloon relative to the PTVI device to the portion of the one or more arteries to occlude the portion of the one or more arteries.

18. The method of claim 17, wherein inserting the portion of the PTVI device into the one or more arteries comprising inserting a portion of a guide catheter into the one or more arteries, and sliding the adjustable balloon comprises sliding the adjustable balloon to an iliac artery or a descending aorta.

19. The method of claim 13, comprising sensing blood flow or blood pressure at a vascular location downstream to the portion of the one or more arteries using one or more sensors incorporated onto the PTVI device.

20. The method of claim 13, comprising sensing blood flow or blood pressure at a vascular location upstream to the portion of the one or more arteries using one or more sensors incorporated onto the PTVI device.