System and method for treating heart tissue

• US 9,855,049 B2
• Filed: 12/11/2013
• Issued: 01/02/2018
• Est. Priority Date: 12/11/2013
• Status: Active Grant

• Current Assignee: Miracor Medical Systems Gmbh
• Original Assignee: Miracor Medical Systems Gmbh
• Inventors: Schiemanck, Lars Roman, Haidacher, Martin
• Primary Examiner(s): Nguyen, Victor
• Application Number:
  US14/102,958
• Publication Number:
  US 20150157326A1
• Time in Patent Office: 1,483 Days
• CPC Class Codes: A61B 17/12 for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord specially adapted for vas deferens or fallopian tubes A61F6/20; materials for ligaturing blood vessels A61L17/00
• CPC Class Codes: A61B 17/1204 temporary occlusion
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 2017/00154 pulsed
• 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 2217/005 with suction drainage system
• CPC Class Codes: A61B 2505/05 Surgical care
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/287 Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/6853 with a balloon
• CPC Class Codes: A61B 5/6869 Heart
• CPC Class Codes: A61B 5/7239 using differentiation including higher order derivatives
• CPC Class Codes: A61M 60/135 inside a blood vessel, e.g. using grafting
• 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 60/531 using blood pressure data, e.g. from blood pressure sensors

Abstract

Some embodiments of a system or method for treating heart tissue can include a control system and catheter device operated in a manner to intermittently occlude a heart vessel for controlled periods of time that provide redistribution of blood flow. In particular embodiments, the system can be configured to provide an estimation of the cumulative effects of the treatment. For example, some embodiments of the system or method can treat myocardium that is at risk of infarction by intermittently altering blood flow in a venous system to induce microcirculation within the myocardium, and can output a cumulative dosage value indicative of a measurement of progress of reducing an infarct size.

Claims

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

a coronary sinus occlusion catheter including a distal tip portion comprising an adjustable occlusion device; and

a control system to selectively activate the occlusion device for substantially occluding the coronary sinus during occlusion phases, and to deactivate the occlusion device for substantially non-occluding the coronary sinus during release phases, wherein the control system includes a sensor signal input to receive a pressure sensor data signal indicative of a pressure in the coronary sinus at least during the occlusion phases; and

wherein the control system is configured to determine, in response to stored data points of the pressure sensor data signal during each of the occlusion phases, a cumulative dosage value indicative of cumulative effects of coronary sinus occlusion catheter treatment over two or more successive occlusion phases, wherein the control system comprises a display unit that shows the calculated cumulative dosage value, an estimated amount of salvaged heart muscle tissue based upon the calculated cumulative dosage value, or both.

2. The system of claim 1, wherein the control system stores a computer-executable algorithm that calculates the cumulative dosage value to provide a numerical value indicative of cumulative effects of redistributing blood flow over a series of the occlusion phases.

3. The system of claim 2, wherein the control system is configured to determine the cumulative dosage value having units of (Pressure)²×

(time).

4. The system of claim 1, wherein the control system updates the calculated cumulative dosage value, the estimated amount of salvaged heart muscle tissue, or both after each cycle of one occlusion phase and one release phase.

5. The system of claim 4, wherein the control system includes a touchscreen user interface that contemporaneously displays both the calculated cumulative dosage value and the estimated amount of salvaged heart muscle tissue.

6. The system of claim 5, wherein the touchscreen user interface further contemporaneously displays coronary sinus pressure numerical data and heart rate numerical data.

7. The system of claim 1, wherein the control system is configured to, in response to stored data points of the pressure sensor data signal during at least one of the occlusion phases, output an alert via a user interface of the control system indicating a recommendation to reposition of the occlusion device of the coronary sinus occlusion catheter.

8. The system of claim 7, wherein the control system outputs the alert indicative of the recommendation to reposition the occlusion device in response to detecting that a pulsatile pressure parameter during a sample occlusion phase is less than a minimum threshold value.

9. The system of claim 1, wherein the control system further comprises a control circuit configured to determine the cumulative dosage value based at least on a determined differential between the systolic and diastolic pressures during the occlusion phase.

10. The system of claim 1, wherein the control circuit is configured to determine the cumulative dosage value based at least on a determined differential between a systolic pressure plateau of an occlusion phase and an average non-occluded pressure.

11. The system of claim 1, wherein the control circuitry is configured to determine an inflation hold time based at least in part on pressure measurements, and to determine the cumulative dosage value based in part on the determined inflation hold time.

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

a coronary sinus occlusion catheter including a distal tip portion comprising an adjustable occlusion device; and

a control system to selectively activate the occlusion device for substantially occluding the coronary sinus during occlusion phases, and to deactivate the occlusion device for substantially non-occluding the coronary sinus during release phases, wherein the control system includes a sensor signal input to receive a pressure sensor data signal indicative of a pressure in the coronary sinus at least during the occlusion phases; and

wherein the control system is configured to determine, in response to stored data points of the pressure sensor data signal during each of the occlusion phases, a cumulative dosage value, wherein the control system comprises a display unit that shows the calculated cumulative dosage value, an estimated amount of salvaged heart muscle tissue based upon the calculated cumulative dosage value, or both;

wherein the control system stores a computer-executable algorithm that calculates the cumulative dosage value to provide a numerical value indicative of cumulative effects of redistributing blood flow over a series of the occlusion phases;

wherein the control system is configured to calculate the estimated amount of salvaged heart muscle tissue based upon a predetermined relationship model between the estimated amount of salvaged heart muscle tissue and the calculated cumulative dosage value.

13. The system of claim 12, wherein the estimated amount of salvaged heart muscle tissue displayed by the control system is an estimated myocardial salvage index, and wherein the control system stores a computer-executable algorithm that calculates the estimated myocardial salvage index based upon a linear relationship model with the calculated cumulative dosage value.

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

a coronary sinus occlusion catheter including a distal tip portion comprising an adjustable occlusion device; and

a control system to selectively activate the occlusion device for substantially occluding the coronary sinus during occlusion phases, and to deactivate the occlusion device for substantially non-occluding the coronary sinus during release phases, wherein the control system includes a sensor signal input to receive a pressure sensor data signal indicative of a pressure in the coronary sinus at least during the occlusion phases; and

wherein the control system is configured to determine, in response to stored data points of the pressure sensor data signal during each of the occlusion phases, a cumulative dosage value, wherein the control system comprises a display unit that shows the calculated cumulative dosage value, an estimated amount of salvaged heart muscle tissue based upon the calculated cumulative dosage value, or both;

wherein the control system is configured to calculate the estimated amount of salvaged heart muscle tissue based upon a predetermined relationship model between the estimated amount of salvaged heart muscle tissue and the calculated cumulative dosage value, and wherein the control system comprises a display unit that contemporaneously displays the calculated cumulative dosage value and an estimated amount of salvaged heart muscle tissue based upon the calculated cumulative dosage value; and

wherein the estimated amount of salvaged heart muscle tissue displayed by the control system is an estimated myocardial salvage index, and wherein the control system stores a computer-executable algorithm that calculates the estimated myocardial salvage index based upon a linear relationship model with the calculated cumulative dosage value.

15. The system of claim 14, wherein the control system updates the calculated cumulative dosage value and the estimated amount of salvaged heart muscle tissue after each cycle of one occlusion phase and one release phase.

16. The system of claim 15, wherein the touchscreen user interface further contemporaneously displays coronary sinus pressure numerical data and heart rate numerical data.

17. The system of claim 16, wherein the control circuitry is configured to determine an inflation hold time based at least in part on pressure measurements, and to determine the cumulative dosage value based in part on the determined inflation hold time.

18. The system of claim 14, wherein the control system is configured to, in response to stored data points of the pressure sensor data signal during at least one of the occlusion phases, output an alert via a user interface of the control system indicating a recommendation to reposition of the occlusion device of the coronary sinus occlusion catheter.

19. The system of claim 18, wherein the control system outputs the alert indicative of the recommendation to reposition the occlusion device in response to detecting that a pulsatile pressure parameter during a sample occlusion phase is less than a minimum threshold value.