Source: https://patents.google.com/patent/US6993385B1/en
Timestamp: 2019-03-23 05:22:54
Document Index: 374828409

Matched Legal Cases: ['art 2', 'art 2', 'art 2', 'art 2', 'art 2', 'art.\n6', 'art.\n7', 'art.\n8', 'art.\n24', 'art.\n25', 'art.\n31', 'art.\n41', 'art.\n42', 'art.\n43', 'art.\n51']

US6993385B1 - Cardiac contractility modulation device having anti-arrhythmic capabilities and a method of operating thereof - Google Patents
Cardiac contractility modulation device having anti-arrhythmic capabilities and a method of operating thereof Download PDF
US6993385B1
US6993385B1 US10/111,515 US11151502A US6993385B1 US 6993385 B1 US6993385 B1 US 6993385B1 US 11151502 A US11151502 A US 11151502A US 6993385 B1 US6993385 B1 US 6993385B1
US10/111,515
1999-10-25 Priority to US16132899P priority Critical
1999-10-27 Priority to US16189999P priority
1999-10-27 Priority to US16190099P priority
2000-10-24 Priority to PCT/IL2000/000676 priority patent/WO2001030445A1/en
2000-10-24 Application filed by Impulse Dynamics NV filed Critical Impulse Dynamics NV
2000-10-24 Priority to US10/111,515 priority patent/US6993385B1/en
2002-10-30 Assigned to IMPULSE DYNAMICS N.V. reassignment IMPULSE DYNAMICS N.V. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: BELSKY, ZIV, DARVISH, NISSIM, HALUSKA, EDWARD, PRUTCHI, DAVID, ROUTH, ANDRE G.
2003-09-17 Assigned to IMPULSE DYNAMICS N.V. reassignment IMPULSE DYNAMICS N.V. CORRECTION OF ASSIGNEE'S ADDRESS PREVIOUSLY RECORDED AT REEL 013443 FRAME 0909. Assignors: BELSKY, ZIV, DARVISH, NISSIM, HALUSKA, EDWARD, PRUTCHI, DAVID, ROUTH, ANDRE G.
2006-01-31 Publication of US6993385B1 publication Critical patent/US6993385B1/en
2007-06-12 Assigned to DRUMBEAT LIMITED reassignment DRUMBEAT LIMITED SECURITY INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: IMPULSE DYNAMICS N.V.
2007-08-30 Assigned to BANK HAPOALIM B.M. reassignment BANK HAPOALIM B.M. SECURITY AGREEMENT Assignors: IMPULSE DYNAMICS N.V.
2007-09-10 Assigned to JOHNSON & JOHNSON DEVELOPMENT CORPORATION reassignment JOHNSON & JOHNSON DEVELOPMENT CORPORATION SECURITY AGREEMENT Assignors: IMPULSE DYNAMICS N.V.
2009-03-18 Assigned to MEDINVEST CAPITAL S.A R.L. reassignment MEDINVEST CAPITAL S.A R.L. SECURITY AGREEMENT Assignors: IMPULSE DYNAMICS N.V.
2015-04-08 Assigned to SANDLEFORD PARK LIMITED, AS SECURITY AGENT reassignment SANDLEFORD PARK LIMITED, AS SECURITY AGENT ASSIGNMENT OF TRADEMARK AND PATENT SECURITY AGREEMENT Assignors: MEDINVEST CAPITAL S.A.R.L., MORGAN STANLEY BANK INTERNATIONAL LIMITED
2022-03-04 Adjusted expiration legal-status Critical
A cardiac contractility modulating (CCM) device includes an anti-arrhythmic therapy unit for detecting a cardiac arrhythmia in a heart of a patient based on processing electrical signals related to cardiac activity sensed at the heart, and for delivering anti-arrhythmic therapy to the heart. The device includes a cardiac contractility modulating unit capable of delivering cardiac contractility modulating signals to the heart for modulating the contractility of a portion of the heart. The device may provide to the anti-arrhythmic therapy unit control signals associated with the delivery of the CCM signals to the heart. The control signals may be used to prevent interference of the CCM signals with the detecting of the cardiac arrhythmia. The device includes a power source. The device may be an implantable device or a non-implantable device. The device may also include a pacing unit.
This Patent Application is related to and claims priority from commonly owned U.S. Provisional Patent application Ser. No. 60/161,328, filed Oct. 25, 1999 entitled “CARDIAC CONTRACTILITY MODULATION DEVICE HAVING ANTI-ARRHYTHMIC CAPABILITIES AND A METHOD OF OPERATING THEREOF”, Ser. No. 60/161,899 filed Oct. 27, 1999 entitled “DEVICE FOR CARDIAC THERAPY”, and Ser. No. 60/161,900 filed Oct. 27, 1999 entitled “ANTI-ARRHYTHMIC DEVICE AND A METHOD OF DELIVERING ANTI-ARRHYTHMIC CARDIAC THERAPY”, all three Provisional Patent Applications are incorporated herein by reference in their entirety.
U.S. Pat. No. 4,403,614 to Engle et al., titled “IMPLANTABLE CARDIOVERTER”, incorporated herein by reference, discloses an implantable cardioverter/defibrillator device capable of delivering cardioversion therapy pulses having an energy level lower than necessary for defibrillation as well as defibrillating pulses.
ETC devices modulate the activity of excitable tissues by application of non-excitatory electrical signals to the heart (or other excitable tissues) through suitable electrodes in contact with the tissue. For example, ETC devices may be used, inter alia, to increase or decrease the contractility of cardiac muscle in vitro, in vivo and in situ., as disclosed in detail in PCT application, International Publication Number WO 97125098 to Ben-Haim et al., titled “ELECTRICAL MUSCLE CONTROLLER”, incorporated herein by reference. Other methods and applications of ETC devices are disclosed in PCT applications commonly-assigned to the assignee of the present application, International Publication Number WO 98/10828, titled “APPARATUS AND METHOD FOR CONTROLLING THE CONTRACTILITY OF MUSCLES” to Ben Haim et al., incorporated herein by reference, International Publication Number WO 98/10829, titled “DRUG-DEVICE COMBINATION FOR CONTROLLING THE CONTRACTILITY OF MUSCLES” to Ben Haim et al., incorporated herein by reference and International Publication Number WO 98/10830, titled “FENCING OF CARDIAC MUSCLES” to Ben Haim et al., incorporated herein by reference, International Publications Number WO 98/10831 to Ben Haim et al., titled “CARDIAC OUTPUT CONTROLLER”, incorporated herein by reference.
Co-pending U.S. patent application Ser. No. 09/328,068 to Mika et al., titled “APPARATUS AND METHOD FOR COLLECTING DATA USEFUL FOR DETERMINING THE PARAMETERS OF AN ALERT WINDOW FOR TIMING DELIVERY OF ETC SIGNALS TO A HEART UNDER VARYING CARDIAC CONDITIONS”, filed Jun. 8, 1999, now U.S. Pat. No. 6,223,072, the entire specification of which is incorporated herein by reference, and the corresponding PCT application, International Application No. PCT/IL00/00310, disclose devices and methods for collecting patient data which is usable for the operation of a device for timing of delivery of ETC signals to the heart using, inter alia, a dynamically varying alert window period for event sensing.
Co-pending U.S. patent application Ser. No. 09/338,649 to Mika et al., titled “APPARATUS AND METHOD FOR SETTING THE PARAMETERS OF AN ALERT WINDOW USED FOR TIMING THE DELIVERY OF ETC SIGNALS TO A HEART UNDER VARYING CARDIAC CONDITIONS”, filed Jun. 23, 1999, now U.S. Pat. No. 6,233,487, the entire specification of which is incorporated herein by reference, and the corresponding PCT application, International Application No. PCT/IL00/00321, disclose devices and methods for timing of delivery of ETC signals to the heart using, inter alia, a dynamically varying alert window period for event sensing.
Application of ETC therapy to the heart may enhance the cardiac output without increasing the heart rate. Such therapy may be advantageously applied, inter alia, to patients having no diagnosed cardiac rhythm abnormalities as well as to patients such as congestive heart failure (CHF) patients which are particularly prone to episodes of VT or VF. Since cardiac patients such as, inter alia, CHF patients may benefit from the use of implantable or non-implantable anti-arrhythmic devices, such as defibrillators, Defibrillator/cardioverter devices and the like, it may be advantageous to implement a single device which is capable of delivering anti-arrhythmic therapy and ETC therapy to a cardiac patient. For example, such a device may be capable of delivering ETC therapy and defibrillating shock therapy to a patient, when a need for such therapy is detected.
While the various methods of timing the delivery of ETC signals to the heart disclosed in the above co-pending U.S. patent application Ser. Nos. 09/276,460, 09/328,068 and 09/338,649 to Mika et al., and in the corresponding PCT applications, greatly reduce the probability of inducing arrhythmias due to delivery of ETC signals to the heart at a vulnerable time, it may be desirable to include anti-arrhythmia capabilities in ETC or CCM devices as a safety device in case of occurrence of tachy-arrhythmia episodes such as VT or VF, either due to a delivered ETC signal or spontaneously.
Another problem which may result from delivering of ETC signals to the heart of a patient which is monitored by an anti-arrhythmic device such as, inter alia, a defibrillator/cardioverter device, is the possible interference of ETC induced electrical artifacts with the operation of detection circuitry utilizing automatic gain control (AGC) or automatic threshold control (ATC). AGC methods and ATC methods are well known in the art. For example, AGC and ATC methods are disclosed by Dennis A. Brumwell et al. in Chapter 14 titled “THE AMPLIFIER: SENSING THE DEPOLARIZATION” in the book titled “IMPLANTABLE CARDIOVERTER DEFIBRILLATOR THERAPY: THE ENGINEERING-CLINICAL INTERFACE”, pp. 275–302, Eds. Mark W. Kroll and Michael H. Lehmann, Kluwer Academic Publishers, USA, 1997.
ETC signal induced artifacts sensed by the defibrillator amplification circuits may cause an undesirable decrease in the gain of the amplifier circuits in defibriliators using AGC based algorithms which may lead to failure to detect VF signal. ETC signal induced artifacts sensed by the defibrillator amplification circuits may also cause an undesirable increase in the threshold level in defibrillators using ATC based algorithms which may also lead to failure to detect VF signal.
Furthermore, in accordance with another preferred embodiment of the present invention, the device includes a look up table, the look up table includes data associating different parameters of the refractory period with different cardiac contractility modulating signals deliverable to the heart. The data included in the look up table is determined in a data collection session performed in the patient.
Furthermore, in accordance with another preferred embodiment of the present invention, the processing includes processing the data to determine the heart rate of the heart, classifying the determined heart rate according to a classification method adapted to determine the suspected occurrence of different types of arrhythmias based on the determined heart rate, and controlling the delivery of a selected type of anti-arrhythmic-therapy to the heart in response to detection of a suspected arrhythmia type.
The sensing unit 8 may include amplification circuitry for amplifying the filtered electrical signals. The output of the sensing unit 8 is suitably connected to a detecting circuit which performs the detection of electrical depolarization events representing cardiac activation. The detecting unit may be any analog or digital unit which is capable of detecting cardiac depolarization events by comparing it to a detection threshold as is known in the art or by any other event detection method which is known in the art. For example, the sensing unit 8 and the detecting unit 10 may be implemented using analog circuitry as disclosed by Dennis A. Brumwell et al. in Chapter 14 titled “THE AMPLIFIER: SENSING THE DEPOLARIZATION” of the book titled “IMPLANTABLE CARDIOVERTER DEFIBRILLATOR THERAPY: THE ENGINEERING-CLINICAL INTERFACE”, pp. 275–302, Eds. Mark W. Kroll and Michael H. Lehmann, Kluwer Academic Publishers, USA, 1997, incorporated herein by reference. However, The sensing unit 8 and the detecting unit 10 may also be implemented by other different analog or digital circuits or any combinations thereof as is known in the art of defibrillators.
The microprocessor 12 is also connected to a defibrillating unit 18 which is controlled by the microprocessor unit 12. The defibrillating shock unit 18 is designed to deliver electrical defibrillating shocks to the heart 2 through suitable defibrillating electrodes 6A and 6B disposed in or about the heart 2. The defibrillating shock unit 18 may typically include a current source such as a battery (not shown), a charging circuit (not shown), and high voltage output switches (not shown) as is known in the art. For example, the defibrillating shock unit 18 may be implemented as disclosed by C. G. Supino in Chapter 8. titled “THE SYSTEM”, pp. 163–172 of the book titled “IMPLANTABLE CARDIOVERTER DEFIBRILLATOR THERAPY: THE ENGINEERING-CLINICAL INTERFACE”, Eds. Mark W. Kroll and Michael H. Lehmann, Kluwer Academic Publishers, USA, 1997, incorporated herein by reference. However, the defibrillator unit 18 may be implemented using any design or circuit for delivering defibrillation shocks to the heart which is known in the art.
The defibrillator device 1 also includes a power source 13 for providing power to the various components of the device 1. The power source 13 is suitably operatively connected (connections not shown for the sake of clarity of illustration) to provide electrical energy the components of the defibrillator device 1 as is known in the art. The power source 13 may be an electrochemical cell or a battery (primary or rechargeable), or the like but may be any other suitable power source for providing electrical power which is known in the art. It is noted that while the power source 13 is shown as included within the defibrillator device 1, the power source 13 may be also disposed externally to the device 1. For example, the power source 13 may be a power source such as, but not limited to, a conditioned or regulated DC or AC power supply, operatively connected to the mains power supply (not shown) as is known in the art. Such mains powered external defibrillator devices are well known in the art.
In operation, the sensing unit 8 amplifies the filtered electrical signals sensed by the sensing electrodes 4A and 4B, the detecting unit 10 receives the amplified filtered signals and detects depolarization events, the detection may employ various methods such as threshold crossing detection methods as disclosed by Brumwell et al., including, but not limited to, AGC methods and ATC methods. However any other suitable event detection methods known in the art may also be used for event detection. The detecting unit 10 provides to the microprocessor unit 12 detection signals representative of the detection of an event in the sensed amplified signal provided by the sensing unit 8. The microprocessor unit 12 processes the detection signals using suitable processing programs embedded in the microprocessor unit 12 or in the memory unit(s) 16 connected thereto. The various processing algorithms are generally referred to as classification algorithms or classification programs. The classification programs process the temporal data of the time of occurrence of the detection signals and classify the sensed cardiac rhythm as belonging to one of a plurality of possible cardiac rhythm categories. In a non-limiting example, the categories may include a range of heart rates defined as normal cardiac rate for a particular patient, an elevated heart rate range classified as a ventricular tachycardia (VT), and another elevated heart rate range classified as a ventricular fibrillation (VF). The various classification methods and algorithms are well known in the art are not the subject matter of the present invention and will therefore; not be disclosed in detail hereinafter. Some exemplary methods of tachy-arrhythmia detection methods are disclosed by Stan M. Bach et al. in Chapter 15, titled “TACHYARRHYTHMIA DETECTION”, pp. 303–323, of the book titled “IMPLANTABLE CARDIOVERTER DEFIBRILLATOR THERAPY: THE ENGINEERING-CLINICAL INTERFACE”, Eds. Mark W. Kroll and Michael H. Lehmann, Kluwer Academic Publishers, USA, 1997, incorporated herein by reference.
Some prior art defibrillator/cardioverter devices are also capable of delivering Anti-tachycardia pacing (ATP) and cardioversion therapy after detection of VT, as is well known in the art. For example, such devices and methods of delivering ATP and cardioversion therapy are disclosed in Chapter 16, titled “ANTI-TACHYCARDIA PACING AND CARDIOVERSION” pp. 325–342, of the book titled “IMPLANTABLE CARDIOVERTER DEFIBRILLATOR THERAPY: THE ENGINEERING-CLINICAL INTERFACE”, Eds. Mark W. Kroll and Michael H. Lehmann, Kluwer Academic Publishers, USA, 1997, incorporated herein by reference. Such devices may utilize pacing circuitry (not shown in FIG. 1 for the sake of clarity of illustration) to deliver various pacing and shock signals to the heart for treating the ventricular tachycardia.
It is noted that while the anti-arrhythmic therapy unit 38, is illustrated as being connected to a single pair of sensing electrodes 34A and 34B, a single pair of electrodes 32A and 32B for delivering anti-tachycardia therapy to the heart 2, and a single pair of CCM electrodes for delivery of CCM signals to the heart 2, many other electrode configurations and combinations are possible which are all considered to be within the scope of the present invention. For example, the anti-arrhythmic therapy unit 38 may be connected to more than one CCM delivering electrode pair or electrodes (not shown) for delivering CCM signals to more than one cardiac region. In another example, more than one pair of sensing electrodes or a plurality of single sensing electrodes (not shown) may be used for enabling multi chamber sensing and/or pacing, such multi-electrode configurations are disclosed in the above referenced, PCT publications to Ben Haim et al. and in co-pending U.S. patent application Ser. Nos. 09/276,460, 09/328,068 and 09/338,649 to Mika et al., and in the corresponding PCT applications.
Preferably, the anti-arrhythmic therapy unit 38 and the CCM unit are both in communication with a common microprocessor unit (not shown in FIG. 2, for the sake of clarity of illustration). In such a case, the microprocessor unit (not shown) controls the delivery of CCM signals by the CCM unit 40 and also sends control signals to the anti-arrhythmic therapy unit 38. The control signals sent from the microprocessor unit (not shown) control the anti-arrhythmic therapy unit 38 to prevent the CCM signal induced electrical artifacts from interfering with the detection of cardiac arrhythmias as is disclosed in detail hereinafter. Alternatively, the anti-arrhythmic therapy unit 38 and the CCM unit 40 may each include a dedicated microprocessor unit (the microprocessor units are not shown in FIG. 2, for the sake of clarity of illustration). In the latter case the microprocessor unit (not shown) of the anti-arrhythmic therapy unit 38 is in communication with the microprocessor unit (not shown) of the CCM unit 40 to provide the microprocessor unit of the anti-arrhythmic therapy unit 38 with data representative of the time of delivery of CCM signals by the CCM unit 40. This data is processed by the microprocessor of the anti-arrhythmic therapy unit 38, or by the microprocessor of the CCM unit 40 or by both of these microprocessors to prevent the interference of the CCM signal induced electrical artifacts from interfering with the detection of cardiac arrhythmias as is disclosed in detail hereinafter.
The prevention of interference of the sensed CCM signal induced electrical artifacts may be implemented in various ways. In accordance with one preferred embodiment of the present invention, the prevention of interference is implemented at the sensing level. In this implementation, suitable control signals are sent to the sensing unit 58 prior to the delivery of each CCM signal to the heart 2. These control signals are represented by the dashed arrow 70. Each of the received control signals causes the sensing unit 58 to become refractory to incoming input signals from the filtering and voltage protecting unit 53. The timing and duration of the control signals are such that the sensing unit 58 becomes refractory to incoming input signals before the delivery of the CCM signal to the heart and stays refractory for a refractory period having a duration that is sufficient to prevent the CCM induced electrical artifact from being detected as an event by the detection unit 60. Thus, the refractory period of the sensing unit 58 may last longer than the duration of the CCM signal delivered to the heart, to accommodate for the precise shape, amplitude, polarity and duration of the CCM induced artifact as it is sensed by the sensing unit 58. The duration of the refractory period may be a fixed duration, or may be a preset duration, that may be programmed, telemetrically or non-telemetrically, into the memory (not shown) of the CCM device 51 based on actual determination of the artifact parameters obtained from each individual patient in a recording and measurement session taking place after implantation of the electrodes in the patient.
It is noted that, while the method of triggering or inducing a refractory period in one or more of the sensing unit 58, the filtering and voltage protection unit 53 and the detecting unit 60 may provide an adequate solution to the problem of erroneous CCM induced artifact detection, care must be taken to ensure that the blanking of one or more of the sensing unit 58, the filtering and voltage protection unit 53 and the detecting unit 60 during the imposed refractory period will not by itself produce undesirable errors in the estimation of the heart rate due to the cessation of detection of any electrical events within the imposed refractory period duration. Typically, the CCM signal duration may vary between approximately 20–50 milliseconds (although lower or higher duration values may also be used). Some VT episodes in human cardiac patients may exhibit R—R intervals of approximately 250–300 millisecond duration, Therefore, when the above disclosed refractory period method is used, the blanking or refractory period may occupy approximately 20% of the total beat cycle. Thus, there is a possibility that a true event may occur within the refractory period and will therefore not be detected, which may cause errors in the determination of the heart rate. Such errors may eventually lead to wrong classification of the heart rate by the classification methods or classification algorithms used and may also undesirably delay or in extreme cases even prevent the delivery of the proper anti-arrhythmic therapy by the anti-arrhythmic module 50 of the device 51. For example, under such circumstances, an episode of VT may be missed of misclassified as allowable tachycardia, and VF may be misclassified as VT leading to delay in delivery of the proper type of anti-arrhythmic therapy or to failure to deliver any tachy-arrhythmic therapy.
The device 100 also includes a power source 165 for providing power to the various components of the device 100. The power source 165 is suitably operatively connected (connections not shown for the sake of clarity of illustration) to provide electrical energy the components of the device 100 as is known in the art. The power source 165 may be an electrochemical cell or a battery (primary or rechargeable), or the like, but may also be any other suitable power source for providing electrical power which is known in the art. It is noted that while the power source 165 is shown as included within the device 100, the power source 165 may be also disposed externally to the device 100. For example, the power source 165 may be a power source such as, but not limited to, a conditioned or regulated DC or AC power supply, operatively connected to the mains power supply (not shown) as is known in the art.
In operation, the delivery of CCM signals to the heart by the CCM unit 108 is controlled based on the output of the detecting units 112 to the microprocessor unit 106, as disclosed in detail in the above referenced co-pending U.S. patent application Ser. Nos. 09/276,460, 09/328,068 and 09/338,649 to Mika et al., and in the corresponding PCT applications.
It is noted that, the sensing units 112 may include a plurality of sensing units operative for providing sensing at different sites of the heart, such as but not limited to, the right atrium, the right ventricle, the left ventricle of the heart and other different cardiac sites in order to provide the various sensing configurations required for the operation of any of the specific type or configuration of the anti-tachyarrhythmic unit 118 which is implemented in the device 100, any of the specific configurations or modes of anti-bradycardia pacing therapy which may be implemented on the pacing unit 102, and any of the specific sensing configurations required for operating the CCM unit 108, including but not limited to, the sensing methods and configurations disclosed in the PCT publications to Ben Haim et al. and in the co-pending U.S. patent application Ser. Nos. 09/276,460, 09/328,068 and 09/338,649 to Mika et al. referenced hereinabove, and in the corresponding PCT applications.
Typically, the heart rate is determined by determining the R—R interval as is known in the art, but other methods may also be used.
It is noted that the CCM devices 30, 51 and 100 of FIGS. 2, 3 and 4, respectively, may be adapted for acute implantation in a patient for short term patient monitoring and therapy treatment such as for temporary use in intensive care hospitalized patients. Alternatively, the CCM devices 30, 51 and 100 of FIGS. 2,3 and 4, respectively, may be adapted for used as implantable devices for chronic implantation.
at least one power source for energizing said anti-arrhythmic therapy unit and said cardiac contractility modulating unit.
2. The cardiac contractility modulating device according to claim 1 wherein said anti-arrhythmic therapy unit is configured for providing said cardiac contractility modulating unit with second control signals associated with the delivery of said antiarrhythmic therapy to said heart to control the operation of said cardiac contractility modulating unit.
3. The cardiac contractility modulating device according to claim 2 wherein said second control signals comprise control signals for disabling the delivery of cardiac contractility modulating signals to said heart by said cardiac contractility modulating unit, and control signals for enabling the delivery of cardiac contractility modulating signals to said heart by said cardiac contractility modulating unit.
4. The cardiac contractility modulating device according to claim 1 wherein said anti-arrhythmic therapy unit is configured for delivering to said heart an anti-arrhythmic therapy selected from a defibrillating shock therapy, a cardioverting shock therapy, anti-tachycardia pacing therapy, anti-bradycardia pacing therapy, variable energy shock therapy, and any combination thereof.
5. The cardiac contractility modulating device according to claim 1 further including electrodes operatively connected to said cardiac contractility modulating unit and to said anti-arrhythmic therapy unit for sensing said electrical signals, for delivering said cardiac contractility modulating signals to said heart, and for delivering said anti-arrhythmic therapy to said heart.
6. The cardiac contractility modulating device according to claim 1 further including a pacing unit for pacing at least one cardiac chamber of said heart.
7. The cardiac contractility modulating device according to claim 6 wherein said pacing unit is connectable to one or more pacing electrodes to provide anti-bradycardia therapy to said heart.
8. The cardiac contractility modulating device according to claim 1 wherein said device is configured for preventing or modifying the sensing of said electrical signals in response to receiving one of said first control signals.
9. The cardiac contractility modulating device according to claim 8 wherein said device comprises a sensing unit for sensing said electrical signals, said sensing unit is configured for stopping said sensing of said electrical signals within a refractory time period in response to receiving one of said first control signals.
10. The cardiac contractility modulating device according to claim 9 wherein said refractory period is a preset refractory period.
11. The cardiac contractility modulating device according to claim 9 wherein the duration of said refractory period is set to prevent the erroneous detection of electrical artifacts associated with said cardiac contractility modulating signals.
12. The cardiac contractility modulating device according to claim 9 wherein the duration of said refractory period is set to prevent erroneous detection of any of the cardiac contractility modulating signal associated electrical artifacts recorded in a recording session in said patient.
13. The cardiac contractility modulating device according to claim 9 wherein said device is configured for controllably varying the parameters of the cardiac contractility modulating signals delivered to said heart, said refractory period is a variable refractory period, and said device is configured for determining the parameters of said variable refractory period in accordance with the parameters of the cardiac contractility modulating signal delivered to said heart in each cardiac beat cycle.
14. The cardiac contractility modulating device according to claim 13 wherein said device comprises a look up table, said look up table includes data associating different parameters of said refractory period with different cardiac contractility modulating signals deliverable to said heart, wherein the data included in said look up table is determined in a data collection session performed in said patient.
15. The cardiac contractility modulating device according to claim 8 wherein said device comprises a detecting unit for detecting cardiac activity related events in said electrical signals, said detecting unit is configured for stopping said detecting of said cardiac activity related events within a refractory time period in response to receiving one of said first control signals.
16. The cardiac contractility modulating device according to claim 15 wherein said refractory period is a preset refractory period.
17. The cardiac contractility modulating device according to claim 15 wherein the duration of said refractory period is set to prevent the erroneous detection of electrical artifacts associated with said cardiac contractility modulating signals.
18. The cardiac contractility modulating device according to claim 15 wherein the duration of said refractory period is set to prevent erroneous detection of any of the cardiac contractility modulating signal associated electrical artifacts recorded in a recording session in said patient.
19. The cardiac contractility modulating device according to claim 15 wherein said device is configured for controllably varying the parameters of the cardiac contractility modulating signals delivered to said heart, said refractory period is a variable refractory period, and said device is configured for determining the parameters of said variable refractory period in accordance with the parameters of the cardiac contractility modulating signal delivered to said heart in each cardiac beat cycle.
20. The cardiac contractility modulating device according to claim 19 wherein said device comprises a look up table, said look up table includes data associating different parameters of said refractory period with different cardiac contractility modulating signals deliverable to said heart, wherein the data included in said look up table is determined in a data collection session performed in said patient.
21. The cardiac contractility modulating device according to claim 8 wherein said device comprises a voltage protection unit electrically coupled to sensing electrodes disposed at or about said heart, said voltage protection unit is connected to a sensing or a detecting unit included in said device, said voltage protection unit protects the circuitry of said device from high voltages applied by said anti-arrhythmic unit to said heart, said voltage protection unit is configured for modifying said electrical signals prior to passing said electrical signals to said sensing unit or said detecting unit, in response to receiving one of said first control signals.
22. The cardiac contractility modulating device according to claim 21 wherein said voltage protection unit comprises a controllable filter unit for controllably attenuating said electrical signals in response to receiving one of said first control signals.
23. The cardiac contractility modulating device according to claim 1 further comprising a matched filter unit configured for rejecting electrical artifact signals included in said electrical signals, said electrical artifact signals are associated with the delivery of said cardiac contractility modulating signals to said heart.
24. The cardiac contractility modulating device according to claim 1 further comprising a processor unit in communication with said cardiac contractility modulating unit and with said anti-arrhythmic therapy unit, and a classification program operative on said processor unit to control the delivery of said anti-arrhythmic therapy to said heart in response to detection of arrhythmia types based on the classification of the determined heart rate of said heart.
25. The cardiac contractility modulating device according to claim 24 wherein said program is adapted to correct or compensate errors in said classification of arrhythmia types.
26. The cardiac contractility modulating device according to claim 25 wherein said errors comprise the erroneous detection of electrical artifact signals as events associated with cardiac beats, said electrical artifact signals are associated with the delivery of said of cardiac contractility modulating signals to said heart, and wherein said program is adapted to correct or compensate said errors by subtracting the number of cardiac contractility modulating signals delivered to said heart within a time period comprising a number of cardiac beat cycles from the number of events detected within the duration of said time period.
27. The cardiac contractility modulating device according to claim 25 wherein said errors comprise errors due to stopping of the sensing or of the detecting of cardiac events within a refractory time period comprising a portion of the cardiac beat cycle of said heart, and wherein said errors are corrected by stopping the delivery of said cardiac contractility modulating signals when the heart rate of said heart exceeds a threshold value, and performing said classification of arrhythmia types in the absence of said cardiac contractility modulating signals.
28. The cardiac contractility modulating device according to claim 1 wherein said device is an implantable device and wherein said cardiac contractility modulating unit, said anti-arrhythmic therapy unit and said power source are disposed within an implantable housing.
29. The cardiac contractility modulating device according to claim 24 further comprising a telemetry unit operatively coupled to said at least one processing unit, for telemetrically communicating with a telemetry transceiver.
30. The cardiac contractility modulating device according to claim 1 wherein said device is disposed outside said patient and is operatively connectable to electrodes for sensing said electrical signals, for delivering said cardiac contractility modulating signals to said heart, and for delivering said anti-arrhythmic therapy to said heart.
31. The cardiac contractility modulating device according to claim 1 further comprising at least one processing unit operatively coupled to said cardiac contractility modulating unit and to said anti-arrhythmic therapy unit for controlling the operation of said cardiac contractility modulating unit and said anti-arrhythmic therapy unit.
32. The cardiac contractility modulating device according to claim 31 further comprising a memory unit operatively coupled to said processing unit, said processing unit is capable of storing data in said memory unit and of retrieving data stored in said memory unit.
33. The cardiac contractility modulating device according to claim 31 further comprising at least one timing unit operatively coupled to said processing unit, for providing timing signals to said processing unit.
34. The cardiac contractility modulating device according to claim 1 wherein at least one of said cardiac contractility modulating unit and said anti-arrhythmic therapy unit comprises a processing unit therewithin, for controlling the operation of said cardiac contractility modulating unit and said anti-arrhythmic therapy unit.
35. A method for operating an anti-arrhythmic therapy device in a patient undergoing cardiac contractility modulation therapy by a cardiac contractility modulating device, the method comprising the steps of:
providing an anti-arrhythmic therapy device for sensing electrical signals related to cardiac activity of said patient, for processing said electrical signals to detect a cardiac arrhythmia, and for delivering anti-arrhythmic therapy to the heart of said patient in response to the detecting of said cardiac arrhythmia;
providing a cardiac contractility modulating device for applying cardiac contractility modulating signals to the heart of said patient; and
providing said anti-arrhythmic therapy device with control signals associated with the delivery of said cardiac contractility modulating signals to said heart, and modifying said sensing or said processing in response to said control signals to prevent the interference of electrical artifact signals associated with said cardiac contractility modulating signals with the detecting of cardiac arrhythmia by said anti-arrhythmic therapy device.
36. A method for applying anti-arrhythmic therapy to a heart of a patient undergoing cardiac contractility modulation therapy by a cardiac therapy device, the method comprising the steps of:
applying cardiac contractility modulating signals to said heart;
sensing an electrical signal associated with cardiac activity of said patient;
detecting in said electrical signal cardiac events associated with said cardiac activity to provide data related to the heart rate of said heart;
processing said data to detect a cardiac arrhythmia;
delivering anti-arrhythmic therapy to the heart of said patient if an arrhythmia is detected;
providing said anti-arrhythmic therapy device with control signals associated with the delivery of said cardiac contractility modulating signals to said heart; and
using said control signals to prevent electrical artifact signals associated with the delivery of said cardiac contractility modulating signals to said heart from interfering with the detecting of said cardiac arrhythmia.
37. The method according to claim 36 wherein said step of using comprises disabling the sensing of said electrical signal in response to a control signal associated with the delivery of a cardiac contractility modulating signal to said heart, said disabling is performed within a refractory time period, said refractory time period comprises a portion of the cardiac beat cycle, said cardiac contractility modulating signal is delivered to said heart within said refractory time period.
38. The method according to claim 36 wherein said step of using comprises disabling said detecting of said cardiac events in said electrical signal in response to a control signal associated with the delivery of a cardiac contractility modulating signal to said heart, said disabling is performed within a refractory time period, said refractory time period comprises a portion of the cardiac beat cycle, said cardiac contractility modulating signal is delivered to said heart within said refractory time period.
39. The method according to claim 37 wherein said step of using comprises modifying said electrical signal in response to a control signal associated with the delivery of a cardiac contractility modulating signal to said heart, said disabling is performed within a refractory time period, said refractory time period comprises a portion of the cardiac beat cycle, said cardiac contractility modulating signal is delivered to said heart within said refractory time period.
40. The method according to claim 39 wherein said modifying comprises controllably filtering said electrical signal within said refractory time period to prevent detection of the electrical artifact signal associated with the delivery of said cardiac contractility modulating signal to said heart.
41. The method according to claim 36 wherein said step of using comprises filtering said electrical signal to prevent detection of said electrical artifact signals associated with the delivery of said cardiac contractility modulating signals to said heart.
42. The method according to claim 41 wherein said filtering comprises using a matched filter adapted for favoring detection of said cardiac events representing the beating of said heart and for rejecting frequencies characteristic to said electrical artifacts associated with the delivering of said cardiac contractility modulating signals to said heart.
43. The method according to claim 36 wherein said processing comprises processing said data to determine the heart rate of said heart, classifying the determined heart rate according to a classification method adapted to determine the suspected occurrence of different types of arrhythmias based on said determined heart rate, and controlling the delivery of a selected type of anti-arrhythmic therapy to said heart in response to detection of a suspected arrhythmia type.
44. The method according to claim 43 wherein said processing further comprises correcting or compensating for errors in said classifying of said heart rate.
45. The method according to claim 44 wherein said errors comprise the erroneous detection of electrical artifact signals as cardiac events associated with cardiac beats, said electrical artifact signals are associated with the delivery of said of cardiac contractility modulating signals to said heart, and wherein said correcting or compensating for said errors comprises subtracting the number of cardiac contractility modulating signals delivered to said heart within a time period comprising a number of cardiac beat cycles from the number of cardiac events detected within the duration of said time period.
46. The method according to claim 44 wherein said errors comprise errors due to stopping of said sensing or stopping of said detecting of cardiac events within a refractory time period comprising a portion of the cardiac beat cycle of said heart, and wherein said errors are corrected by stopping the delivery of said cardiac contractility modulating signals to said heart when the heart rate of said heart exceeds a threshold value, and performing said classifying using said classification method in the absence of said cardiac contractility modulating signals.
47. The method according to claim 36 wherein said anti-arrhythmic therapy is selected from a defibrillating shock therapy, a cardioverting shock therapy, anti-tachycardia pacing therapy, anti-bradycardia pacing therapy, variable energy shock therapy, and combinations thereof.
48. The method according to claim 36 wherein said applying of cardiac contractility modulating signals to said heart is terminated prior to or upon said delivering of said anti-arrhythmic therapy to the heart of said patient.
49. The method according to claim 48 wherein said applying of cardiac contractility modulating signals to said heart is renewed after the delivering of said anti-arrhythmic therapy to the heart of said patient is terminated.
50. The method according to claim 36 further including protecting the electronic circuitry of said cardiac therapy device from high voltages generated during said applying of said anti-arrhythmic therapy to said heart.
51. The method according to claim 36 further including pacing at least one chamber of said heart of said patient.
52. A cardiac contractility modulating device comprising:
anti-arrhythmic therapy means for detecting a cardiac arrhythmia in a heart of a patient based on processing electrical signals related to cardiac activity of said heart and for delivering anti-arrhythmic therapy to said heart in response to detecting of said cardiac arrhythmia;
cardiac contractility modulating means configured for delivering cardiac contractility modulating signals to said heart for modulating the contractility of at least a portion of said heart, said cardiac contractility modulating means is operatively connected to said anti-arrhythmic therapy means for providing said anti-arrhythmic therapy means with first control signals associated with the delivery of said cardiac contractility modulating signals to said heart to prevent interference of said cardiac contractility modulating signals with said detecting of said cardiac arrhythmia by said anti-arrhythmic device; and
energizing means for providing power to said anti-arrhythmic therapy means and said cardiac contractility modulating means.
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