Treating Heart Tissue

• US 20130282042A1
• Filed: 06/24/2013
• Published: 10/24/2013
• 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 11,241,238 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 system for treating heart muscle tissue, comprising:

a coronary sinus occlusion catheter including a distal tip portion, a proximal hub portion, 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 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 intermittently the coronary sinus,

wherein the control system is programmed to activate the inflatable balloon device of the coronary sinus occlusion catheter to intermittently occlude the coronary sinus according to an automated, predetermined pattern of occlusion periods and release periods that is previously stored by the control system and that is independent of the pressure signal indicative of the coronary sinus pressure.

2. The system of claim 1, wherein the automated, predetermined pattern of occlusion periods and release periods stored by the control system comprises predetermined occlusions periods selected from a range of 6 seconds to 20 second and comprises predetermined release periods selected from a range of 3 second to 7 seconds.

3. The system of claim 1, wherein the control system activates the inflatable balloon device of the coronary sinus occlusion catheter to intermittently occlude the coronary sinus according to an automated, predetermined pattern of occlusion periods and release periods during an initial period of operation, and wherein during a second period of operation, the control system activates the inflatable balloon device of the coronary occlusion catheter to intermittently occlude the coronary sinus according to occlusion periods that are dependent at least in part on the pressure signal indicative of the coronary sinus pressure.

4. The system of claim 3, wherein during a third period of operation after the second period of operation, the control system repeats said automated, predetermined pattern of occlusion periods and release periods that is previously stored by the control system and that is independent of the pressure signal indicative of the coronary sinus pressure.

5. The system of claim 4, wherein the control system 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.

6. The system of claim 1, wherein the display device of the control system shows a graph of the pressure signal indicative of the coronary sinus pressure during the intermittent occlusion of the coronary sinus.

7. The system of claim 6, wherein the display device of the control system shows a first time value indicative 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.

8. The system of claim 1, wherein the inflatable balloon device of the coronary sinus occlusion catheter has an outer diameter that is sized to occlude blood flow exiting from the coronary sinus and into a right atrium.

9. The system of claim 1, wherein the distal tip portion of the coronary sinus occlusion catheter includes a plurality of distal ports that are positioned distally forward of the inflatable balloon device.

10. The system of claim 9, wherein the distal ports face in a generally radially outward direction and are substantially uniformly spaced apart from one another along the circumference of the distal tip.

11. The system of claim 9, wherein the distal ports are all in fluid communication with a pressure sensor lumen of the coronary sinus occlusion catheter.

12. The system of claim 1, wherein the display device of the control system provides a graphical user interface that outputs time-sensitive data measurements indicative of a progress of a coronary sinus occlusion procedure.

13. The system of claim 12, wherein the graphical user interface of the display device outputs coronary sinus pressure data in a graph form for monitoring a trend of coronary sinus pressure measurements.

14. The system of claim 13, wherein the graphical user interface of the display device outputs numeric pressure measurements indicative of a maximum coronary sinus pressure and a minimum coronary sinus pressure.

15. The system of claim 11, further comprising one or more ECG sensors connectable to the control system, wherein the graphical user interface of the display device outputs ECG measurement data in a graph form.

16. The system of claim 11, wherein the graphical user interface of the display device outputs a numeric measurement of an occluded time in units of seconds.

17. The system of claim 14, wherein the graphical user interface of the display device outputs a numeric measurement of a non-occluded time in units of seconds.