MULTIMODE ICD SYSTEM COMPRISING PHASED ARRAY AMPLIFIERS TO TREAT AND MANAGE CRT, CHF, AND PVC DISORDERS USING VENTRICLE LEVEL-SHIFTING THERAPY TO MINIMIZE VT/VF AND SCA

Abstract

An ICD multimode system comprises a microcontroller or FPGA having a memory, a differentially driven phased array amplifier, one or more sensors, and a wireless transmitter/receiver. Based upon sensor data and demand criteria programmed into the memory, the system provides late systolic impulse (LSI) therapy to treat congestive heart failure (CHF), ventricle level-shifting (VLS) therapy to block unwanted PVCs to prevent VT or VF, and cardiac resynchronization therapy (CRT) that adjusts LV and RV contraction synchronization based upon timing. An integrated echocardiogram and ultrasound system automatically adjusts the therapies administered based upon sensor and demand data in real time to allow a patient's heart to function at a level of improved performance and efficiency.

Claims

1-18. (canceled)

19. An implantable cardioverter defibrillator (ICD) system which comprises: a subcutaneous case capable of being positioned under a patient's skin; a waveform energy control system located within the subcutaneous case, the waveform energy control system comprising: a microcontroller or FPGA having a memory; differentially driven phased array amplifiers having an input and an output; a wireless transmitter/receiver; a battery; and one or more sensors; a bipolar pacing lead; a right ventricular (RV) pacing and defibrillation lead; and a left ventricular (LV) and/or coronary sinus (CS) pacing lead, wherein the LV pacing lead and the RV pacing lead deliver to a heart of a patient cardiac therapy selected from the group consisting of pacing, ventricle level shift (VLS) therapy, premature ventricular contractions (PVC) block therapy, anti-tachycardia pacing (ATP) therapy, congestive heart failure (CHF) therapy, cardiac resynchronization therapy (CRT), late systolic impulse (LSI) therapy, low voltage/medium voltage (LV/MV) therapy, arbitrary waveform ramp shock therapy, biphasic truncated exponential (BTE) defibrillation therapy, and pulseless electrical activity (PEA) asystole rescue, based upon sensor data and demand criteria programmed into the memory of the microcontroller or FPGA.

20. The system of claim 19, wherein the differentially driven phased array amplifier circuits deliver constant current, constant voltage, or constant energy ascending arbitrary ramp waveforms, BTE waveforms, for defibrillation, or cardioversion electrical shocks to the patient's heart which are capable of being driven to deliver medically useful current vectors to the patient's heart using any voltage and/or arbitrary ramp waveforms for a medically useful cardiac therapy.

21. The system of claim 19, wherein the sensors are selected from the group consisting of an O.sub.2 sensor, an ECG, an inclinometer, and an accelerometer, which provide feedback to the microcontroller or FPGA so that delivered voltage and current therapies can be efficiently delivered based on demand.

22. The system of claim 19, wherein the cardiac therapy is delivered using the same phased array amplifiers and is commanded by software algorithms within the memory to pace, cardiovert, defibrillate, or deliver late systolic impulses (LSI) to the ventricles for the treatment of congestive heart failure (CHF) to increase ejection fraction (EF) by increasing the force of LV/RV contractions, based on data from one or more sensors that are translated into commands to deliver therapies.

23. The system of claim 19, wherein ventricle level shifting (VLS) software and hardware within the ICD deliver an atraumatic, sub-threshold, tonic negative bias voltage during vulnerable periods between QRS complexes that blocks or inhibits unwanted premature ventricular contractions (PVCs) from triggering ventricular tachycardia (VT)/ventricular fibrillation (VF) that may cause sudden cardiac arrest (SCA).

24. The system of claim 19, wherein the phased array amplifiers are phase shifted differentially to deliver very accurate cardiac resynchronization therapy (CRT) and pacing pulses that properly synchronize contractions of the right ventricle (RV) and left ventricle (LV) in terms of time difference between the two ventricles to maximize the ejection fraction (EF) and the phased array amplifiers have a unique ability to deliver software regulated and delivered pulses of any shape and amplitude from any stored voltage energy source.

25. The system of claim 19 which comprises a magnetic power supply that uses body motion to assist charging the battery and/or delivers voltage and current on demand as required by the ICD.

26. The system of claim 19 which also comprises a Bluetooth wireless transmitter/receiver external to the patient and there is connectivity between the subcutaneous system and the external transmitter/receiver.

27. The system of claim 19, wherein in a cardiac resynchronization therapy (CRT) mode pacing pulses synchronize the LV and RV with regard to contraction timing, which increases the EF and makes the patient's heart pump more efficiently.

28. The system of claim 19, wherein in a congestive heart failure (CHF)/late systolic impulse (LSI) mode late systolic impulses are provided which are delivered through the RV and LV for the purpose of increasing the ventricle contraction forces, which then increases the ejection fraction (EF) within the patient's heart.

29. The system of claim 19, wherein in a ventricle level shifting (VLS) mode a negative low voltage, low current, steerable, atraumatic sub-threshold electrical field or tonic negative electrical therapy is delivered that level shifts the ventricles' cells from the normal resting voltage of about −90 my to a more negative voltage from about −100 my to about −300 my to prevent and/or block unwanted premature ventricular contractions (PVCs) during vulnerable time periods that may induce VT/VF or SCA.

30. The system of claim 31, wherein the negative voltages may be steady state DC voltages or pulsed or stepped voltages using any arbitrary waveforms to deliver the negative voltage ventricle level shifting (VLS) therapies.

31. The system of claim 19, wherein the waveform energy control system comprises a hot can (HC) that provides another amplifier (A1) as a vector steering surface and wherein the phased array amplifiers comprise three amplifiers (A2), (A3), and (A4) that provide current paths between each other and the (A1) hot can (HC) to deliver cardiac therapies through the entire syncytium of the ventricles.

32. The system of claim 19, wherein inclination and acceleration sensors indicate that there is a posture and/or activity change in real time which may induce an automatic adjustment of the LSI impulses which increases the EF percentage, and physiological changes within the ECG are adjusted for situations that require electrical correction based upon demand to improve heart efficiency.

33. A method of treating a cardiac condition in a patient, which comprises implanting an implantable cardiac system of claim 19 in the patient and applying appropriate treatment to the patient.

34. The method of claim 33, wherein the cardiac condition treated is R on T phenomenon, Long QT Syndrome, congestive heart failure (CHF), low EF, ventricular tachycardia (VT), ventricular fibrillation (VF), Brugada Syndrome, any other idiopathic or genetically aberrant disorder that induces an acceptable number of PVCs per minute that may induce potentially serious or fatal arrythmias, or a benign ventricular disorder such as irrectractable ventricular bigeminy, trigeminy, or another idiopathic cause of excessive PVCs or VT or VF.

35. The method of claim 33, wherein the appropriate treatment is pacing, ventricle level shifting (VLS) therapy, premature ventricular contractions (PVC) block therapy, anti-tachycardia pacing (ATP) therapy, congestive heart failure (CHF) therapy, late systolic impulse (LSI) therapy, cardiac resynchronization therapy (CRT), low voltage/medium voltage (LV/MV) therapy, arbitrary waveform ascending ramp, curved or biphasic truncated exponential (BTE) therapies which deliver cardioversion and/or defibrillation shocks, or pulseless electrical activity (PEA) and asystole rescue.

36. An implantable cardiac system which comprises: a flexible circuit substernal EF module capable of being positioned under a patient's sternum; a waveform energy control system located within the flexible circuit substernal EF module assembly, the waveform energy control system comprising: a microcontroller or FPGA having a memory; differentially driven phased array amplifiers having an input and an output; a wireless transmitter/receiver; a battery; and one or more sensors; a barrel slip ring; a flexible/ridged printed circuit assembly; a bipolar pacing electrode; a right ventricular (RV) pacing and defibrillation electrode; and a left ventricular (LV) and/or coronary sinus (CS) pacing electrode, wherein the LV pacing electrode and the RV pacing electrode deliver to a heart of a patient cardiac therapy selected from the group consisting of pacing, ventricle level shift (VLS) therapy, premature ventricular contractions (PVC) block therapy, anti-tachycardia pacing (ATP) therapy, congestive heart failure (CHF)/late systolic impulse (LSI) therapy, cardiac resynchronization therapy (CRT), low voltage/medium voltage (LV/MV) therapy, arbitrary waveform ascending ramp, curved or biphasic truncated exponential (BTE) therapies which deliver cardioversion or defibrillation shocks, and pulseless electrical activity (PEA), and asystole rescue, based upon sensor data and demand criteria programmed into the memory of the microcontroller or FPGA.

37. The system of claim 36, wherein the sub sternal system uses a flexible circuit assembly or EF module that generates an echocardiogram/ultrasound, four chamber apical view capability with associated electronics to provide a doctor with a real time video of chambers of the heart and their medical significance so that the CRT and EF may be accurately measured and adjusted.

38. The system of claim 36, wherein the sensors are selected from the group consisting of an O.sub.2 sensor, an ECG, an inclinometer, and an accelerometer, which provide feedback to the microcontroller so that delivered voltage and current therapies can be efficiently delivered based on demand.

39. The system of claim 36 which also comprises a Bluetooth wireless transmitter/receiver external to the patient and there is connectivity between the substernal EF module assembly and the external transmitter/receiver.

40. The system of claim 36, wherein in a ventricle level shifting (VLS) mode a negative low voltage, low current, steerable, atraumatic sub-threshold electrical field or tonic negative electrical therapy is delivered that level shifts the ventricles' cells from the normal resting voltage of about −90 my to a more negative voltage from about −100 my to about −300 my to prevent and/or block unwanted premature ventricular contractions (PVCs) during vulnerable time periods that may induce VT/VF or SCA.

41. The system of claim 36, wherein the waveform energy control system comprises an amplifier (A1) as a vector steering surface-electrode and wherein the phased array amplifiers comprise three amplifier electrodes (A2), (A3), and (A4) that provide current paths between each other and the (A1) electrode to deliver the desired cardiac therapies through the entire syncytium of the ventricles.

42. The system of claim 36, wherein inclination and acceleration sensors indicate that there is a posture and/or activity change in real time which may induce an automatic adjustment of the LSI impulses which increases the EF percentage and physiological changes within the ECG are adjusted for situations that require electrical correction based upon demand to improve heart efficiency.

43. The system of claim 36, wherein in a cardiac resynchronization therapy (CRT) mode pacing pulses synchronize the LV and RV with regard to contraction timing, which increases the EF and makes the patient's heart pump more efficiently.

44. A method of treating a cardiac condition in a patient, which comprises implanting an implantable cardiac system of claim 36 in the patient and applying appropriate treatment to the patient.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0089] FIG. 1 is a block diagram that represents one aspect of the invention, showing the delivered functions provided through software algorithms implemented in the ICD hardware;

[0090] FIG. 2 represents the placement positions of a subcutaneous ICD and an optional Echo/ultrasound EF/CRT/CHF/VLS module located substernally in the chest of a patient according to the invention;

[0091] FIG. 3 represents the placement of lead set 30 and electrodes from an ICD-CRT/CHF/VLS module in a patient's heart according to the invention;

[0092] FIG. 4 is a schematic representation of the functional blocks and phased array amplifier circuitry of one aspect of the invention;

[0093] FIG. 5 is a representation of a multi-layer, substernal EF-CHF-CRT-VLS device according to the invention;

[0094] FIG. 6 is a cross-sectional view of a multi-layer, substernal EF-CHF-CRT-VLS device depicting an ultrasound transducer focused at the apex of the heart for the purpose of providing an apical four chamber echocardiogram view on a smart phone, according to the invention.

[0095] FIG. 7A is a representation of a cross-sectional view of a magnetic power supply that uses body motion to assist in charging the battery module and/or that delivers voltage and current on demand as required by the devices according to the invention.

[0096] FIG. 7B is a schematic representation of an AC to DC power supply useful according to the invention.

DETAILED DESCRIPTION OF THE DRAWINGS

[0097] FIG. 1 is a block diagram of an ICD-CRT/CHF/VLS system 2 according to the invention wherein a microprocessor/microcontroller or FPGA 4 receives user commands from electrophysiologists (EP MDs, not shown), where software protocols are selected and delivered using data from sensors such as O.sub.2 sensor 6, inclinometer 8, accelerometer 10, and ECG sensor 12. Command signals are sent through digital-to-analog converters (DACs) 14. The signals are then delivered through or to a patient's heart 16 via differentially driven phased array amplifiers 18 to automatically or manually correct or manage one or more cardiac conditions as shown in the listing 20 of software algorithms for ventricle level shifting (VLS) 20A, PVC blocking 20B, ATP 20C, CHF 20D, CRT 20E, LSI 20F, LV/MV therapy 20G, ramp shock 20H, BTE shock 20I, PEA asystole rescue 20J, and pacing 21, which are programmed for different treatment purposes. A smart phone 22, such as an iPHONE, is connected via Bluetooth technology 24 and/or echo control 11 so that sensor data, including data from ECG 12, ejection fraction (EF) percentage 5 as well as O.sub.2 sensor 6, inclination sensor 8, acceleration sensor 10, and any other desired parameter may be displayed on the screen of smart phone 22 and/or be linked with an EP MD for interpretation and evaluation. Inclination and acceleration sensors 8, 10 indicate that there is a posture and/or activity change in real time which may require an automatic adjustment of the LSI impulses which increases the EF percentage 5. The software algorithms 20 correspond to delivered therapies.

[0098] FIG. 2 represents the substernal placement of an Echo EF/CRT/CHF/VLS module 91 as well as a subcutaneous ICD-CRT/CHF/VLS device 32. Communications between the ICD-CRT/CHF/VLS device 32 and the Echo EF/CRT/CHF/VLS module 91 are encrypted and accomplished by using a Bluetooth bidirectional protocol 24.

[0099] FIG. 3 represents placement of the typical lead set 30 comprising wires for the right atrial (RA) sensor/pacing 34, right ventricle (RV) lead wire 36, sensor band 40, RV pacing tip apex (A4) 42, RV shock coil (A2) 46, and left ventricle (LV) or coronary sinus (CS) (A3) lead wire 38. The lead set wires 30, which are bundled together in CRT/CHF/VLS bipolar pacing RV/LV shock coil lead set 32, provide different modes of electrical therapies using the same lead wires within the heart 16 to manage or correct certain cardiac rhythm disorders: [0100] (1) In the cardiac resynchronization therapy (CRT) mode the pacing pulses synchronize the LV and RV in terms of contraction timing, which increases the EF and makes the heart 16 pump more efficiently. [0101] (2) In the congestive heart failure/late systolic impulses (CHF/LSI) mode late systolic impulses are provided which are delivered through the RV and LV for the purpose of increasing the ventricle contraction forces, which then increases the ejection fraction (EF) within the heart 16. [0102] (3) In the ventricle level shifting (VLS) mode a negative low voltage, low current, steerable, atraumatic sub-threshold electrical field or tonic negative electrical therapy is delivered that level shifts the ventricles' cells from the normal resting voltage of about −90 my to a more negative voltage from about −100 my to about −300 my, for the purpose of preventing and/or blocking unwanted premature ventricular contractions (PVCs) during the vulnerable time periods that may induce VT/VF or SCA. The negative voltages may be steady state DC voltages or pulsed or stepped voltages using any arbitrary waveforms to deliver the negative voltage level shifting (VLS) therapies. [0103] (4) ICD-CRT/CHF/VLS 32 comprises a hot can that provides another amplifier (A1) as a vector steering point wherein the other three amplifiers (A2), (A3), and (A4) may all provide current paths between each other and the (A1) hot can to deliver the many cardiac therapies as required from the sensors 6, 8, 10, 12 and microcontroller circuitry 4.

[0104] FIG. 4 represents a schematic using differentially driven phased array amplifiers 18 wherein all the various cardiac therapies are delivered using the same phased array amplifier circuits 19, 21, 23, 25. The phased array amplifier circuits 19, 21, 23, 25 are commanded by the software algorithms 20 to pace, ventricle level shift (VLS), cardiovert or defibrillate, deliver late systolic impulse (LSI) to the right and left ventricles (RV/LV) or the treatment of congestive heart failure (CHF) by increasing the EF based on several sensors' data as sampled by the O.sub.2 sensor 6, inclinometer 8, accelerometer 10, ECG 12, and other critical measurements that are translated into commands to deliver therapies 50 based on what type of cardiac condition(s) are required. Defibrillation and/or cardioversion shocks are delivered via amplifiers (A1) and (A2) by delivering high, medium, or low voltage shocking waveforms such as ascending ramp or BTE or square waveforms or any ascending curved arbitrary waveform that may be useful to defibrillate or cardiovert successfully.

[0105] In another embodiment of the invention shown in FIGS. 5 and 6, a multi-layer, substernal rigid/flexible circuit EF-CHF-CRT-VLS assembly 91 is surgically installed below the sternum 66 and will traverse toward the upper portion of the heart 16. A flexible circuit assembly 60 will contain one or more ICD-type batteries in a battery module 62 and associated electronics 64. Contacts or electrodes A1 68 and A2 70 will be on the distal side of a flexible circuit 80 and will be in contact with the RV of the heart 16.

[0106] In FIG. 6, a further embodiment of the invention is shown which is a rotated view of FIG. 5. The assembly 91 will project toward the LV through a barrel slip ring 72, with a precise tension adjustment provided within barrel slip ring 72, allowing for flexible circuit 80 and contacts or electrodes A3 74 and A4 76 to form around and be in contact with the LV of the heart 16.

[0107] Between electrode A2 70 and barrel slip ring 72, there is a flexible circuit 90 that folds over the depth of the heart 16 and is in contact with or in close proximity to the apex 78 of the heart 16. Transducer 82, which is part of the flexible circuit 90, transmits and receives ultrasound signals driven by the electronics 64 to produce an echocardiogram/ultrasound image of the four chamber apical view 84. Care should be taken to not interfere with the phrenic nerve 86 by employing a non-conductive isolation pad 88.

[0108] FIGS. 7A and 7B represent embodiments of a magnetic power supply 250 that does not require batteries. The magnetic power supply 250 comprises a case 222 wherein a traversing or flying magnet 212 that, pursuant to Faraday's Law of Electromotive Force (EMF), creates an electrical potential or voltage by moving the traversing magnet 212 through a coil 214 of wire with a specified number of turns. The traversing magnet 212 is captured in a cavity within case 222 between two other magnets which are installed in fixed positions to have their fields aligned as repelling magnets 216, 218 for the traversing magnet 212. On one end of the device the north pole of a fixed magnet 218 will be opposing the north pole of the traversing magnet 212, and on the opposite end of the device the south pole of the fixed magnet 216 will be opposing the south pole of the traversing magnet 212. This arrangement provides a traversing magnet 212 which will traverse or fly between both opposing fields within the device cavities without hitting the internal end walls of the case 222. Magnetic poles or fields which are the same will repel and magnetic poles or fields which are opposites will attract. The traversing magnet 212 shall have a coating of polytetrafluoroethylene or a similar material to reduce friction to near zero within the traversing chamber 224. As the traversing magnet 212 is propelled by any movement, including walking, running or any other motion in the vectored direction of the device, the traversing magnet 212 passes through the wire coil 214 as shown in FIGS. 7A and 76. The repelling magnets 216, 218 aid in the near perpetual motion of the traversing magnet to provide a DC voltage even when a person is at rest but making subtle movements. This action produces an electrical alternating current AC which is then rectified through BR1 230 into a direct current DC. The DC voltage is then filtered by Cl storage capacitor 232 to remove any AC ripple and is also used as a storage device and keeps the DC voltage stable and quiet from noise to power the charging-power supply. Zener diode Z1 234 is used as an electrical clamp to keep the maximum voltage limited to a value expected to be from about +5 VDC to about +12 VDC. These components are housed in the electronics cavity 236. Coil wires 238 extend from wire coil 214 into electronics cavity 236. When the heart is at a resting rate of from about 60 to about 80 beats per minute, any body movement will produce stored energy. These voltages provide energy storage in a “super capacitor” which can be used to either power the LSI therapy and/or charge the batteries associated with the ICD 32 and/or ultrasound echocardiogram device. The positive electrode 240 and negative electrode 241 are shown for reference only. Power supply 250 requires no maintenance and may assist the charging of batteries and/or delivery of voltage and current on demand as required by the devices.

[0109] While the particular invention as herein shown and disclosed in detail is fully capable of obtaining the objects and providing the advantages hereinbefore stated, it is to be understood that this disclosure is merely illustrative of the presently preferred embodiments of the invention and that no limitations are intended other than as described in the appended claims.