# US 9,433,381 B2 · System and method for treating heart tissue > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 9,433,381 B2 - Document ID: US9433381B2 - Status: Granted - Kind: B2 - Application number: 13/336,769 - Filed: 2011-12-23 - Published: 2013-06-27 - Granted: 2016-09-06 - Earliest claimed: 2011-12-22 - Assignees: Miracor Medical Systems GmbH - Applicants: Werner Mohl; Gregor Neumayr; Alem Jusic - Inventors: Werner Mohl; Gregor Neumayr; Alem Jusic - Web page: https://patentgrep.com/patent/US9433381B2 ## CPC - A61B 17/12122: {within the heart (for closing a cardiac septal defect A61B17/0057)} - A61M 60/135: inside a blood vessel, e.g. using grafting - A61B 5/02028: {Determining haemodynamic parameters not otherwise provided for, e.g. cardiac contractility or left ventricular ejection fraction} - A61B 5/33: specially adapted for cooperation with other devices - A61B 5/6859: {with multiple distal splines} - A61B 5/6869: {Heart} - A61B 5/7239: {using differentiation including higher order derivatives} - A61B 5/742: {using visual displays (displays for heart-related electrical signals, e.g. ECG, A61B5/339)} - A61B 17/1204: {temporary occlusion} - A61B 17/12136: {Balloons} - A61M 25/1018: {Balloon inflating or inflation-control devices} - A61M 60/295: Balloon pumps for circulatory assistance - A61M 60/32: of heart muscle tissues, e.g. using coronary sinus occlusion - A61M 60/515: Regulation using real-time patient data - A61M 60/531: using blood pressure data, e.g. from blood pressure sensors - A61M 25/10184: {Means for controlling or monitoring inflation or deflation} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} ## 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 and methods may be configured to monitor at least one input signal detected at a coronary sinus and thereby execute a process for determining a satisfactory time period for the occlusion of the coronary sinus. In further embodiments, after the occlusion of the coronary sinus is released, the control system can be configured to select the duration of the release phase before the starting the next occlusion cycle. ## Claims ### Claim 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 an occlusion phase, the control system being configured to couple with a proximal portion of the coronary sinus occlusion catheter, and the control system including a sensor signal input to receive a sensor data signal indicative of a hemodynamic performance parameter of a heart; and wherein the control system is configured to determine a calculated release time in response to stored data points of the sensor data signal during the occlusion phase, wherein the control system is configured to determine a filtered release time value that is based at least partially upon the calculated release time and at least one previous release time value for at least one previous occlusion phase. ### Claim 2 (depends on 1) The system of claim 1, wherein the sensor data signal is a pressure signal indicative of coronary sinus pressure, and wherein the control system comprises a control circuit that activates a pneumatic subsystem to activate the occlusion 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. ### Claim 3 (depends on 2) The system of claim 2, wherein the occlusion device comprises an inflatable balloon device configured to occlude the coronary sinus, wherein the coronary sinus occlusion catheter includes a plurality of lumens extending to the distal tip portion carrying the inflatable balloon, wherein the control system is configured to selectively activate the inflatable balloon device for providing pressure-controlled intermittent coronary sinus occlusion treatment to the heart, and wherein the control system comprises a display device configured to show a graph of the pressure signal indicative of the coronary sinus pressure during the intermittent occlusion of the coronary sinus. ### Claim 4 (depends on 1) The system of claim 1, wherein the control system is configured to deactivate the occlusion device for substantially non-occluding the coronary sinus during a release phase, and to randomly select a duration time for the release phase from a predefined bracketed range of about 2 seconds to about 15 seconds. ### Claim 5 (depends on 4) The system of claim 4, wherein the sensor data signal is a pressure signal indicative of coronary sinus pressure, and wherein the control system comprises a control circuit configured to activate a pneumatic subsystem to activate the occlusion 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. ### Claim 6 (depends on 5) The system of claim 5, wherein the occlusion device comprises and inflatable balloon device configured to occlude the coronary sinus, wherein the control system is configured to selectively activate the inflatable balloon device for providing pressure-controlled intermittent coronary sinus occlusion treatment to the heart, and wherein the control system comprises a display device configured to show a graph of the pressure signal indicative of the coronary sinus pressure during the intermittent occlusion of the coronary sinus. ### Claim 7 (depends on 4) The system of claim 4, wherein the control system is configured to detect and store a series of local maxima or minima of the sensor data signal during the occlusion phase, generate a curve fit function representing an envelope curve for said series of local maxima or minima, and determine a calculated release time for the occlusion phase based upon a time derivative of the curve fit function. ### Claim 8 (depends on 7) The system of claim 7, wherein the control system is configured to determine a weighted average time value that is based upon the calculated release time and at least one previous release time value for at least one previous occlusion phase. ### Claim 9 (depends on 8) The system of claim 8, wherein the first time value represents an elapsed time since a start of the occlusion phase, and the second time value is the weighted average time value, wherein the control system is configured to release the occlusion phase in response to a determination that said elapsed time is greater than said weighted average time value. ### Claim 10 (depends on 4) The system of claim 4, wherein the sensor data signal communicated to the control system is indicative of the hemodynamic performance parameter selected from the group consisting of: coronary sinus pressure, fluid temperature in the coronary sinus, blood volume or mass flow rate in the coronary sinus, rate of change of the blood volume or mass flow rate in the coronary sinus, acceleration of a vessel wall of the coronary sinus, displacement of the coronary sinus vessel, intra coronary sinus ECG; and contractility of the heart. ### Claim 11 (depends on 1) The system of claim 1, wherein the control system is configured to detect and store a series of local maxima or minima of the sensor data signal during the occlusion phase, wherein the series of local maxima or minima comprise said data points. ### Claim 12 (depends on 11) The system of claim 11, wherein the control system is configured to generate a curve fit function based at least partially upon said data points of the sensor data signal, the curve fit function representing an envelope curve for said series of local maxima or minima, and wherein the control system is further configured to determine a calculated release time for the occlusion phase based upon a time derivative of the curve fit function. ### Claim 13 (depends on 12) The system of claim 12, wherein said filtered time value is generated by the control system using a weighted average value of a set including the calculated release time and said at least one previous release time value for said at least one previous occlusion phase. ### Claim 14 (depends on 13) The system of claim 13, wherein the first time value represents an elapsed time since a start of the occlusion phase, and the second time value is the weighted average time value, wherein the control system is configured to release the occlusion phase in response to a determination that said elapsed time is greater than said weighted average time value. ### Claim 15 (depends on 12) The system of claim 12, wherein the sensor data signal is a pressure signal indicative of coronary sinus pressure, and wherein the control system comprises a control circuit configured to activate a pneumatic subsystem to activate the occlusion 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. ### Claim 16 (depends on 15) The system of claim 15, wherein the occlusion device comprises and inflatable balloon device configured to occlude the coronary sinus, wherein the coronary sinus occlusion catheter includes a plurality of lumens extending to the distal tip portion carrying the inflatable balloon, wherein the control system is configured to selectively activate the inflatable balloon device for providing pressure-controlled intermittent coronary sinus occlusion treatment to the heart, and wherein the control system comprises a display device configured to show a graph of the pressure signal indicative of the coronary sinus pressure during the intermittent occlusion of the coronary sinus. ### Claim 17 (depends on 12) The system of claim 12, wherein the control system is configured to deactivate the occlusion device for substantially non-occluding the coronary sinus during a release phase, and to randomly select a duration time for the release phase from a predefined bracketed range of about 2 seconds to about 15 seconds. ### Claim 18 (depends on 12) The system of claim 12, wherein the control system is configured to release the occlusion phase in response to a comparison of a first time value to a second time value. ### Claim 19 (depends on 12) The system of claim 12, wherein the sensor data signal communicated to the control system is indicative of the hemodynamic performance parameter selected from the group consisting of: coronary sinus pressure, fluid temperature in the coronary sinus, blood volume or mass flow rate in the coronary sinus, rate of change of the blood volume or mass flow rate in the coronary sinus, acceleration of a vessel wall of the coronary sinus, displacement of the coronary sinus vessel, intra coronary sinus ECG; and contractility of the heart. ### Claim 20 (depends on 1) The system of claim 1, wherein the control system is configured to release the occlusion phase in response to a determination that an elapsed time since a start of the occlusion phase is greater than said filtered release time. ### Claim 21 (depends on 1) The system of claim 1, wherein the sensor data signal communicated to the control system is indicative of the hemodynamic performance parameter selected from the group consisting of: coronary sinus pressure, fluid temperature in the coronary sinus, blood volume or mass flow rate in the coronary sinus, rate of change of the blood volume or mass flow rate in the coronary sinus, acceleration of a vessel wall of the coronary sinus, displacement of the coronary sinus vessel, intra coronary sinus ECG; and contractility of the heart. ### Claim 22 (depends on 1) The system of claim 1, wherein the control system is configured to deactivate the occlusion device for substantially non-occluding the coronary sinus during a release phase, and, wherein the control system is configured to end the release phase after a release phase duration time that is from a predefined pattern of release phase duration times in a range about 2 seconds to about 6 seconds, the control system storing said predefined pattern of release phase duration times. ### Claim 23 (depends on 22) The system of claim 22, wherein the sensor data signal comprises a pressure signal indicative of coronary sinus pressure, and the control system comprises a control circuit configured to activate a pneumatic subsystem to activate the occlusion 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. ### Claim 24 (depends on 23) The system of claim 23, wherein the occlusion device comprises an inflatable balloon device configured to occlude the coronary sinus, wherein the control system is configured to selectively activate the inflatable balloon device for providing pressure-controlled intermittent coronary sinus occlusion treatment to the heart, and the control system comprises a display device configured to show a graph of the pressure signal indicative of the coronary sinus pressure during the intermittent occlusion of the coronary sinus. ### Claim 25 (depends on 23) The system of claim 23, wherein the control system is configured to detect and store a series of local maxima or minima of the sensor data signal during the occlusion phase, generate a curve fit function representing an envelope curve for said series of local maxima or minima, and determine a calculated release time for the occlusion phase based upon a time derivative of the curve fit function. ### Claim 26 (depends on 22) The system of claim 22, wherein the sensor data signal communicated to the control system is indicative of the hemodynamic performance parameter selected from the group consisting of: coronary sinus pressure, fluid temperature in the coronary sinus, blood volume or mass flow rate in the coronary sinus, rate of change of the blood volume or mass flow rate in the coronary sinus, acceleration of a vessel wall of the coronary sinus, displacement of the coronary sinus vessel, intra coronary sinus ECG, and contractility of the heart. ### Claim 27 (depends on 1) The system of claim 1, wherein the control system includes a computer-readable memory storage device having computer-readable instructions stored thereon that, when executed by at least one processor, cause the following operations to occur: monitor a sensor data signal indicative of a hemodynamic performance parameter of a heart; selectively activate of the occlusion device for substantially occluding the coronary sinus during an occlusion phase; and deactivate the occlusion device for substantially non-occluding the coronary sinus during a release phase. ### Claim 28 (depends on 27) The system of claim 27, wherein the computer-readable instructions stored on the control system further cause the following operation to occur: release the occlusion phase in response to a comparison of a first time value to a second time value, the second time value being determined at least in part from data points of the sensor data signal during the occlusion phase. ### Claim 29 (depends on 27) The system of claim 27, wherein the computer-readable instructions stored on the control system further cause the following operation to occur: determine the filtered release time value that is based at least partially upon the calculated release time and said at least one previous release time value for said at least one previous occlusion phase. ### Claim 30 (depends on 27) The system of claim 27, wherein the computer-readable instructions stored on the control system further cause the following operations to occur: generate a curve fit function representing an envelope curve for said series of local maxima or minima, and determine a calculated release time for the occlusion phase based upon a time derivative of the curve fit function. ### Claim 31 (depends on 27) The system of claim 27, wherein the computer-readable instructions stored on the control system further cause the following operation to occur: randomly select a duration time for the release phase from a predefined bracketed range of about 2 seconds to about 6 seconds. ### Claim 32 (depends on 27) The system of claim 27, wherein the computer-readable instructions stored on the control system further cause the following operation to occur: end the release phase after a release phase duration time that is from a predefined pattern of release phase duration times stored on the memory device, each of the release phase duration times in the predefined pattern being in a range about 2 seconds to about 6 seconds.