Treating Heart Tissue

• US 20110295302A1
• Filed: 05/25/2010
• Published: 12/01/2011
• Est. Priority Date: 05/25/2010
• Status: Active Grant

• Current Assignee: Miracor Medical Systems Gmbh
• Original Assignee: Miracor Medical Systems Gmbh
• Inventors: Mohl, Werner
• Granted Patent: US 11,337,707 B2
• Time in Patent Office: Days
• US Class Current: 606/194
• CPC Class Codes: A61B 17/1204 temporary occlusion
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 2017/00199 with a console, e.g. a control panel with a display
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/9583 Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
• CPC Class Codes: A61M 2025/0003 having an additional lumen transmitting fluid pressure to the outside for measurement
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/10184 Means for controlling or monitoring inflation or deflation
• CPC Class Codes: A61M 25/10188 Inflation or deflation data displays
• CPC Class Codes: A61M 60/143 inside the coronary sinus, e.g. for pressure-controlled intermittent coronary sinus occlusion
• CPC Class Codes: A61M 60/295 Balloon pumps for circulatory assistance
• CPC Class Codes: A61M 60/32 of heart muscle tissues, e.g. using coronary sinus occlusion
• CPC Class Codes: A61M 60/515 Regulation using real-time patient data
• CPC Class Codes: A61M 60/531 using blood pressure data, e.g. from blood pressure sensors

Abstract

Some systems and methods for treating heart tissue may include instruments for intermittently occluding the coronary sinus using a coronary sinus occlusion catheter device. In some embodiments, the coronary sinus occlusion catheter can be used before or during a coronary intervention procedure in which a blockage in a heart is repaired or removed.

Claims

1. A method of treating heart tissue, comprising:

detecting a blockage in a coronary artery of the heart;

prior to intervening on the blockage in the coronary artery, advancing distal tip portion of a coronary sinus occlusion catheter through a guide sheath in a right atrium and into the coronary sinus, the coronary sinus occlusion catheter comprising an inflatable balloon device configured to occlude the coronary sinus when inflated;

intermittently occluding the coronary sinus using the inflatable balloon device of the coronary sinus occlusion catheter to redistribute venous blood flow into heart muscle tissue affected by the blockage; and

after intermittently occluding the coronary sinus, delivering a coronary intervention tool via a body artery and to the blockage in the coronary artery of the heart to perform a coronary intervention procedure.

2. The method of claim 1, wherein the coronary sinus is intermittently occluded for periods of time determined by a control system coupled to a proximal portion of the coronary sinus occlusion catheter.

3. The method of claim 2, wherein the control system provides automated control of the inflatable balloon device of the coronary sinus occlusion catheter for providing pressure-controlled intermittent coronary sinus occlusion treatment to the heart, the control system comprising a display device that shows heart sensor data during the intermittent occlusion of the coronary sinus.

4. The method of claim 3, wherein the control system determines the time period for occluding the coronary sinus based at least in part on sensor data received by the control system that is indicative of coronary sinus pressure and electrocardiogram (ECG) information.

5. The method of claim 1, wherein the inflatable balloon device of the coronary sinus occlusion catheter intermittently occludes the coronary sinus so as to pretreat the heart muscle tissue affected by the blockage with venous blood before the blockage is repaired using the coronary intervention tool.

6. The method of claim 1, wherein the coronary intervention tool comprises at least one of an angioplasty balloon catheter and a stent delivery instrument.

7. The method of claim 7, further comprising intermittently occluding the coronary sinus using the inflatable balloon device of the coronary sinus occlusion catheter during repair of the blockage using the angioplasty balloon catheter or the stent delivery instrument.

8. A method of treating heart tissue, comprising:

delivering a distal end of a guide member though a venous system and into a right atrium;

advancing a distal tip portion of a first coronary sinus occlusion catheter slidably along the guide member in the right atrium and into a coronary sinus, the first coronary sinus occlusion catheter comprising an inflatable balloon device configured to occlude the coronary sinus when inflated;

intermittently occluding the coronary sinus using the inflatable balloon device of the first coronary sinus occlusion catheter to redistribute venous blood into heart muscle tissue affected by the blockage;

after intermittently occluding the coronary sinus, withdrawing the first coronary sinus occlusion catheter from a proximal end of the guide member while the distal end of the guide member remains in the right atrium;

monitoring bodily characteristics for a period of time after the first coronary sinus occlusion catheter is withdrawn; and

delivering a distal tip portion of a second coronary sinus occlusion catheter via the guide member remaining in the right atrium and into the coronary sinus, the second coronary sinus occlusion catheter being different from first coronary sinus occlusion catheter.

9. The method of claim 8, wherein the coronary sinus is intermittently occluded for periods of time determined by a control system coupled to a proximal portion of the coronary sinus occlusion catheter.

10. The method of claim 9, wherein the control system provides automated control of the inflatable balloon device of the coronary sinus occlusion catheter for providing pressure-controlled intermittent coronary sinus occlusion treatment to the heart, the control system comprising a display device that shows heart sensor data during the intermittent occlusion of the coronary sinus.

11. The method of claim 10, wherein the control system determines the time period for occluding the coronary sinus based at least in part on sensor data received by the control system that is indicative of coronary sinus pressure and electrocardiogram (ECG) information.

12. The method of claim 8, further comprising, before the step of withdrawing the first coronary sinus occlusion catheter, delivering a coronary intervention tool via a body artery and to the blockage in the coronary artery of the heart to perform a coronary intervention procedure.

13. The method of claim 8, wherein the guide member comprises a steerable distal end to guide the guide member through the venous system.

14. The method of claim 8, wherein the guide member comprises a guide sheath having a lumen extending from the proximal end to the distal end.

15. The method of claim 8, wherein the guide member comprises a guide wire having an outer surface extending from the proximal end to the distal end.

16. A system for treating heart muscle tissue, comprising:

a coronary sinus occlusion catheter including a distal tip portion, a proximal hub portion, a pressure sensor lumen, and a balloon fluid lumen, the distal tip portion of the coronary sinus occlusion catheter comprising an inflatable balloon device configured to occlude a coronary sinus when inflated with fluid via the balloon fluid lumen; and

a control system to control the inflation and deflation of the inflatable balloon device for pressure-controlled intermittent coronary sinus occlusion, the control system comprising a display device, a pressure signal input that receives a pressure signal indicative of coronary sinus pressure, an electrocardiogram (ECG) signal input, and a control circuit that activates a pneumatic subsystem to inflate or deflate the inflatable balloon device of the coronary sinus occlusion catheter for a selected period of time based at least in part on the pressure signal indicative of the coronary sinus pressure,

wherein the control system, during an initial period of operation, activates the inflatable balloon device of the coronary sinus occlusion catheter to intermittently occlude the coronary sinus in a predetermined pattern of occlusion periods and release periods that is independent of the pressure signal indicative of the coronary sinus pressure, and during a second period of operation, activates the inflatable balloon device of the coronary occlusion catheter to intermittently occlude the coronary sinus in a pattern that is dependent in part on the pressure signal indicative of the coronary sinus pressure.

17. The system of claim 16, wherein during a third period of time after the second period of time, the control system repeats the predetermined pattern of occlusion periods and release periods that is independent of the pressure signal indicative of the coronary sinus pressure.

18. The system of claim 17, wherein the controller is configured to compare coronary sinus pressure characteristics resulting from the predetermined pattern of occlusion periods and release periods during the third period of time relative to coronary sinus pressure characteristics resulting from the predetermined pattern of occlusion periods and release periods during the initial period of time.

19. The system of claim 16, wherein the control system provides automated control of the inflatable balloon device of the coronary sinus occlusion catheter for providing pressure-controlled intermittent coronary sinus occlusion treatment to the heart, the control system comprising a display device that shows a graph of the pressure signal indicative of the coronary sinus pressure during the intermittent occlusion of the coronary sinus.

20. The system of claim 19, wherein the display device of the control system shows a first time value indicate of a period of occlusion of the coronary sinus and a second time value indicative of a period of non-occlusion of the coronary sinus, the first and second time values being displayed contemporaneously with the graph of the pressure signal indicative of the coronary sinus pressure.