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Timestamp: 2018-06-24 01:44:28
Document Index: 538642048

Matched Legal Cases: ['artz\n6741886', 'Application No. 13', 'Application No. 13', 'Application No. 11', 'Application No. 11', 'Application No, 11', 'Application No 1', 'Application No. 06836350', 'art.\n5']

Leadless cardiac pacemaker with conducted communication - Pacesetter, Inc.
United States Patent 9168383
Jacobson, Peter M. (Livermore, CA, US)
Ostroff, Alan (Pleasanton, CA, US)
Ciciarelli, Timothy E. (San Jose, CA, US)
13/277151
Pacesetter, Inc. (Sunnyvale, CA, US)
A61N1/00; A61N1/368; A61N1/372; A61N1/375
607/32-33, 607/60
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This application is a continuation-in-part of U.S. application Ser. No. 13/109,728, entitled “PROGRAMMER FOR BIOSTIMULATOR SYSTEM”, filed May 17, 2011; which is a continuation of U.S. application Ser. No. 11/549,605, entitled “PROGRAMMER FOR BIOSTIMULATOR SYSTEM,” filed Oct. 13, 2006, now U.S. Pat. No. 7,945,333; which claims the benefit of priority to U.S. Provisional Application Nos. 60/726,706 entitled “LEADLESS CARDIAC PACEMAKER WITH CONDUCTED COMMUNICATION,” filed Oct. 14, 2005; 60/761,531 entitled “LEADLESS CARDIAC PACEMAKER DELIVERY SYSTEM,” filed Jan. 24, 2006; 60/729,671 entitled “LEADLESS CARDIAC PACEMAKER TRIGGERED BY CONDUCTED COMMUNICATION,” filed Oct. 24, 2005; 60/737,296 entitled “SYSTEM OF LEADLESS CARDIAC PACEMAKERS WITH CONDUCTED COMMUNICATION,” filed Nov. 16, 2005; 60/739,901 entitled “LEADLESS CARDIAC PACEMAKERS WITH CONDUCTED COMMUNICATION FOR USE WITH AN IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR,” filed Nov. 26, 2005; 60/749,017 entitled “LEADLESS CARDIAC PACEMAKER WITH CONDUCTED COMMUNICATION AND RATE RESPONSIVE PACING,” filed Dec. 10, 2005; and 60/761,740 entitled “PROGRAMMER FOR A SYSTEM OF LEADLESS CARDIAC PACEMAKERS WITH CONDUCTED COMMUNICATION,” filed Jan. 24, 2006; all by Peter M. Jacobson, each of which are incorporated herein by reference in their entirety for all purposes.
This application is also a continuation-in-part of U.S. application Ser. No. 13/098,266, entitled “RATE RESPONSIVE LEADLESS CARDIAC PACEMAKER”, filed Apr. 29, 2011; which is a continuation of U.S. patent application Ser. No. 11/549,603, entitled “RATE RESPONSIVE LEADLESS CARDIAC PACEMAKER”, filed Oct. 13, 2006, now U.S. Pat. No. 7,937,148, which claims the benefit of priority to U.S. Provisional Application Nos. 60/726,706, entitled “LEADLESS CARDIAC PACEMAKER WITH CONDUCTED COMMUNICATION,” filed Oct. 14, 2005; 60/761,531, entitled “LEADLESS CARDIAC PACEMAKER DELIVERY SYSTEM,” filed Jan. 24, 2006; 60/729,671, entitled “LEADLESS CARDIAC PACEMAKER TRIGGERED BY CONDUCTED COMMUNICATION,” filed Oct. 24, 2005; 60/737,296, entitled “SYSTEM OF LEADLESS CARDIAC PACEMAKERS WITH CONDUCTED COMMUNICATION,” filed Nov. 16, 2005; 60/739,901, entitled “LEADLESS CARDIAC PACEMAKERS WITH CONDUCTED COMMUNICATION FOR USE WITH AN IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR,” filed Nov. 26, 2005; 60/749,017, entitled “LEADLESS CARDIAC PACEMAKER WITH CONDUCTED COMMUNICATION AND RATE RESPONSIVE PACING,” filed Dec. 10, 2005; and 60/761,740, entitled “PROGRAMMER FOR A SYSTEM OF LEADLESS CARDIAC PACEMAKERS WITH CONDUCTED COMMUNICATION,” filed Jan. 24, 2006; all by Peter M. Jacobson, each of which are incorporated herein by reference in their entirety for all purposes.
1. A leadless pacemaker for pacing a heart of a human comprising: a hermetic housing; at least two electrodes on or near the hermetic housing, the at least two electrodes configured to deliver energy to stimulate the heart and to transfer communication information to or from at least one external device; and a pulse generator in the housing, the pulse generator configured to provide energy to the at least two electrodes and to transfer the communication information through the at least two electrodes to the external device.
2. The leadless pacemaker of claim 1, wherein the external device is a second leadless pacemaker, a defibrillator, a conventional pacemaker, an implanted programmer, or a programmer external to the body of the human.
3. The leadless pacemaker of claim 1, wherein the information is encoded in sub-threshold pulses.
4. The leadless pacemaker of claim 1, wherein the pulse generator further comprises a stimulation pulse generator in the housing, wherein the stimulation pulse generator is configured to provide energy to the at least two electrodes to stimulate the heart.
5. The leadless pacemaker of claim 1, further comprising a controller in the hermetic housing, the controller configured to communicate with the external device by transferring the information through the at least two electrodes.
6. The leadless pacemaker of claim 5, wherein the controller is configured to communicate with the external device by transferring the information through the at least two electrodes during a pacing pulse.
7. The leadless pacemaker of claim 5, wherein controller is configured to communicate with the external device by transferring the information through the at least two electrodes outside of a refractory period or pacing pulse.
8. The leadless pacemaker of claim 5, wherein the controller is configured to communicate with the external device by transferring the information through the at least two electrodes only during an absolute refractory period.
9. The leadless pacemaker of claim 5, wherein the controller is configured to provide charge balancing of the information before the end of a refractory period.
10. The leadless pacemaker of claim 5, wherein the controller is configured to transfer information to or from the external device by sending a bell-ringer signal to the external device and listening for a response from the external device only during a set time period after the bell-ringer signal.
11. The leadless pacemaker of claim 5, wherein the controller is configured to send a synchronization signal through the at least two electrodes to the external device to start transfer of a part of the information.
12. The leadless pacemaker of claim 5, wherein the controller is configured to measure a length of time between encoded information signals received by the at least two electrodes.
13. The leadless pacemaker of claim 12, wherein the controller is configured to use the measured length of time to estimate a clock frequency of the external device and optimize the timing of the transfer of information.
14. The leadless pacemaker of claim 1, further comprising a sensing amplifier to receive and amplify signals received by the, at least two electrodes, wherein the pacemaker is configured to discriminate signals received by the at least two electrodes for noise rejection.
15. A system for pacing a heart of a human comprising: an external device; and a leadless pacemaker comprising a hermetic housing, a pulse generator in the hermetic housing and at least two electrodes on the hermetic housing, the pulse generator configured to provide pacing pulses to the at least two electrodes to stimulate the heart and to transfer communication pulses through the at least two electrodes to provide communication information to the external device, wherein the eternal device is not attached to the leadless pacemaker, and wherein the at least two electrodes are configured to deliver the pacing pulses to stimulate the heart and to transfer the communication pulses to the external device.
16. The system of claim 15, wherein the communication pulses include sub-threshold pulses.
17. The system of claim 15, wherein the external device is a second leadless pacemaker, a defibrillator, a conventional pacemaker, an implanted programmer, or a programmer external to the body of the human.
18. The system of claim 17, wherein the external device is a programmer external to the body of the human, and wherein the programmer comprises at least two skin electrodes configured to attach to skin of the human, the at least two skin electrodes further configured to transfer the communication pulses to or from the leadless pacemaker.
19. The system of claim 18, wherein the external device further comprises a controller, the controller configured to communicate with the leadless pacemaker by transferring the communication pulses through the at least two skin electrodes.
20. The system of claim 19, wherein the controller is configured to transmit the communication pulses through the at least two skin electrodes using a biphasic square wave.
21. The system of claim 20, wherein the biphasic square wave has approximately a 25V peak amplitude.
22. The system of claim 15, wherein the external device further comprises a controller, the controller configured to communicate with the leadless pacemaker by transferring the communication pulses to or from the leadless pacemaker.
23. The system of claim 22, wherein the controller is configured to transfer the communication pulses during a pacing pulse.
24. The system of claim 22, wherein the controller is configured to transfer the communication pulses outside of a refractory period or pacing pulse.
25. The system of claim 22, wherein the controller is configured to transfer the communication pulses only during an absolute refractory period.
26. The system of claim 20, wherein the controller is configured to measure a length of time between the communication pulses transferred from the leadless pacemaker.
27. The system of claim 26, wherein the controller is configured to use the measured length of time to estimate a clock frequency of the leadless pacemaker and optimize the timing of the transfer of the communication pulses.
28. The system of claim 15, wherein the external device further comprising a sensing amplifier to receive and amplify the, communication pulses, and wherein the external device is configured to discriminate the communication pulses transferred from the leadless pacemaker for noise rejection.
29. A method of pacing a heart of a human, comprising: providing a leadless pacemaker comprising a hermetic housing, a pulse generator in the hermetic housing and at least two electrodes on the hermetic housing; configuring the pulse generator to provide pacing pulses and communication pulses to the at least two electrodes; delivering the pacing pulses through the at least two electrodes of the leadless pacemaker to stimulate the heart; and communicating the communication pulses between the at least two electrodes and an external device not attached to the leadless pacemaker.
30. The method of claim 29, wherein communicating occurs only during a refractory period.
31. The method of claim 29, wherein communicating occurs outside of a refractory period the pacing pulses.
32. The method of claim 29, further comprising charge balancing the communication pulses before the end of a refractory period.
33. The method of claim 29, wherein communicating occurs only during predetermined times in one or more pacing cycles.
34. The method of claim 29, further comprising sending a synchronization signal through the at least two electrodes to the external device to start transfer of a part of the communication pulses.
In general, in one aspect, a leadless pacemaker for pacing a heart of a human includes a hermetic housing and at least two electrodes on or near the hermetic housing. The at least two electrodes are configured to deliver energy to stimulate the heart and to transfer information to or from at least one external device.
This and other embodiments can include one or more of the following features.
The external device can be a second leadless pacemaker, a defibrillator, a conventional pacemaker, an implanted programmer, or a programmer external to the body of the human.
The information can be encoded in sub-threshold pulses.
The leadless pacemaker can further include a pulse generator in the housing, and the pulse generator can be configured to provide energy to the at least two electrodes to stimulate the heart. The pulse generator can be further configured to provide energy to the at least two electrodes to transfer the information to the external device. The leadless pacemaker can further include a second pulse generator in the housing, and the second pulse generator can be configured to provide energy to the at least two electrodes to transfer the information signals to the external device.
The leadless pacemaker can further include a controller in the hermetic housing, and the controller can be configured to communicate with the external device by transferring the information through the at least two electrodes. The controller can be configured to communicate with the external device by transferring the information through the at least two electrodes during a pacing pulse. The controller can be configured to communicate with the external device by transferring the information through the at least two electrodes outside of a refractory period or pacing pulse. The controller can be configured to communicate with the external device by transferring the information through the at least two electrodes only during an absolute refractory period. The controller can be configured to provide charge balance of the information before the end of a refractory period. The controller can be configured to transfer information to or from the external device by sending a bell-ringer signal to the external device and listening for a response from the external device only during a set time period after the bell-ringer signal. The controller can be configured to send a synchronization signal through the at least two electrodes to the external device to start transfer of a part of the information. The controller can be configured to measure a length of time between encoded information signals received by the at least two electrodes. The controller can be further configured to use the measured length of time to estimate a clock frequency of the external device and optimize the timing of the transfer of information.
The pacemaker can be configured to discriminate signals received by the at least two electrodes for noise rejection.
In general, in one aspect, a system for pacing a heart of a human includes a leadless pacemaker and an external device not attached to the leadless pacemaker. The leadless pacemaker includes a hermetic housing and at least two electrodes on or near the hermetic housing. The at least two electrodes are configured to delivery energy to stimulate the heart and to transfer information signals to or from the external device.
This and other embodiments can include one or more of the following.
The information can include sub-threshold pulses.
The external device can be a second leadless pacemaker, a defibrillator, a conventional pacemaker, an implanted programmer, or a programmer external to the body of human.
The external device can be a programmer external to the body of the human, and the programmer can include at least two skin electrodes configured to attach to skin of the human, which are further configured to transfer information signals to or from the leadless pacemaker. The external device can further include a controller, and the controller can be configured to communicate with the leadless pacemaker by transferring the information through the at least two skin electrodes. The controller can be configured to transmit the information signals through the at least two skin electrodes using a biphasic square wave. The biphasic square have can have approximately a 25V peak amplitude.
The external device can further include a controller, and the controller can be configured to communicate with the leadless pacemaker by transferring the information signals to or from the leadless pacemaker. The controller can be configured to transfer the information signals during a pacing pulse. The controller can be configured to transfer the information signals outside of a refractory period or pacing pulse. The controller can be configured to transfer the information only during an absolute refractory period. The controller can be configured to measure a length of time between the information signals transferred from the leadless pacemaker. The controller can be further configured to use the measured length to estimate a clock frequency of the leadless pacemaker and optimize the timing of the transfer of information.
The external device can be configured to discriminate signals transferred from the leadless pacemaker for noise rejection.
In general, in one aspect, a method of pacing a heart of a human includes delivering electrical pulses through at least two electrodes of a leadless pacemaker to stimulate the heart and communication information signals between the at least two electrodes and an external device not attached to the leadless pacemaker.
Communicating can occur only during a refractory period. Communicating can occur outside of a refractory period or a pacing pulse. The method can further include charge balancing the information signals before the end of a refractory period. Communicating can occur only during predetermined times in one or more pacing cycles. The method can further include sending a synchronization signal through the at least two electrodes to the external device to start transfer of a part of the information signals.
FIG. 1A is a pictorial diagram showing an embodiment of a cardiac pacing system that includes a leadless cardiac pacemaker;
FIG. 2 is a pictorial diagrams showing the physical location of some elements of an embodiment of a leadless cardiac pacemaker.
FIG. 3 is a pictorial diagram that depicts the physical location of some elements in an alternative embodiment of a leadless cardiac pacemaker;
FIGS. 7A and 7B are pictorial diagrams showing embodiments of pacemaker systems including two leadless cardiac pacemakers secured to internal and to external surfaces of the heart, respectively, and an external programmer and two surface electrodes;
FIG. 8 is a schematic block diagram depicting an embodiment of an external programmer that can be used in a pacemaker system and adapted to communicate via conductive techniques;
FIG. 9 is a time waveform graph showing a sample of modulated communication transmitted from an external programmer to a system of one or more leadless cardiac pacemakers;
FIGS. 10A-10E are schematic flow charts depicting techniques that can be used in various embodiments of methods for communicating in an implantable pacemaker system;
FIG. 11 is a schematic block diagram depicting an embodiment of an external programmer and a pacemaker having two pulse generators.
FIGS. 12 and 13 are charts summarizing international standards applicable to a programmer's body electrode current.
Referring to FIGS. 1A and 1B, a pictorial view which is not shown to scale and a schematic block diagram respectively depict an embodiment of a cardiac pacing system 100 that comprises a leadless cardiac pacemaker 102. The leadless cardiac pacemaker 102 can comprise a housing 110, multiple electrodes 108 coupled to the housing 110, and a pulse delivery system hermetically contained within the housing 110 and electrically coupled to the electrodes 108. The pulse delivery system can be configured for sourcing energy internal to the housing 110, generating and delivering electrical pulses to the electrodes 108. A processor 112 can also be hermetically contained within the housing 110 as part of the pulse delivery system and is communicatively coupled to the electrodes 108. The processor 112 can control electrical pulse delivery at least partly based on the sensed activity.
In various embodiments, the electrodes 108 can be coupled on or within two centimeters of the housing 110. In some arrangements, the electrodes 108 can be formed integrally to an outer surface of the housing 110.
Referring to FIG. 1B, the leadless cardiac pacemaker 102 has functional elements substantially enclosed in a hermetic housing 110. The pacemaker has at least two electrodes 108 located within, on, or near the housing 110, for delivering pacing pulses to and sensing electrical activity from the muscle of the cardiac chamber, and for bidirectional communication with at least one other device within or outside the body. Hermetic feedthroughs 130, 131 can conduct electrode signals through the housing 110. The housing 110 contains a primary battery 114 to provide power for pacing, sensing, and communication. The housing 110 contains circuits 132 for sensing cardiac activity from the electrodes 108; circuits 134 for receiving information from at least one other device via the electrodes 108; and a pulse generator 116 for generating pacing pulses for delivery via the electrodes 108 and also for transmitting information to at least one other device via the electrodes 108. The pacemaker 102 further contains circuits for monitoring device health, for example a battery current monitor 136 and a battery voltage monitor 138. The pacemaker 102 further contains processor or controller circuits 112 for controlling these operations in a predetermined manner.
In accordance with another embodiment of a pacing system, a leadless cardiac pacemaker 102 comprises a housing 110, multiple electrodes 108 coupled to the housing 108, and a pulse generator 116 hermetically contained within the housing 110 and electrically coupled to the electrodes 108. The pulse generator 116 is configured to generate and deliver electrical pulses to the electrodes 108 powered from a source 114 contained entirely within the housing 110. An activity sensor 154 can be hermetically contained within the housing 110 and adapted to sense activity. A logic 112, for example a processor, controller, central processing unit, state machine, programmable logic array, and the like, is hermetically contained within the housing 110 and communicatively coupled to the pulse generator 116, the activity sensor 154, and the electrodes 108. In some embodiments, the logic 112 is configured to control electrical pulse delivery at least partly based on the sensed activity.
In some embodiments, the logic 112 can be a processor that controls electrical pulse delivery and/or application of the activity sensor according to one or more programmable parameters with the processor programmable by communication signals transmitted via the electrodes 108.
In accordance with another embodiment of a pacing system, a leadless cardiac pacemaker 102 comprises a housing 110, multiple electrodes 108 coupled to the housing 110, and a pulse generator 116 hermetically contained within the housing 110 and electrically coupled to the electrodes 108. The pulse generator 116 generates and delivers electrical pulses to the electrodes 108, causing cardiac contractions. The pulse generator 116 also conveys information to one or more devices 106 external to the pacemaker 102, such as another pacemaker or an external programmer. The pacemaker 102 further comprises at least one amplifier 132, 134 hermetically contained within the housing 110 and electrically coupled to the electrodes 108. The amplifier or amplifiers 132, 134 are configured to amplify signals received from the electrodes 108 and to detect cardiac contractions, and further can receive information from the external device or devices 106. The pacemaker 102 further comprises a power supply 114 hermetically contained within the housing 110 and coupled to the pulse generator 116. The power supply 114 sources energy for the electrical pulses from internal to the housing 110. The pacemaker 102 has an activity sensor 154 hermetically contained within the housing 110 that senses activity. A processor 112 is hermetically contained within the housing 110 and communicatively coupled to the pulse generator 116, the amplifiers 132, 134, the activity sensor 154, and the electrodes 108. The processor 112 configured to receive amplifier output signals from the amplifier or amplifiers 132, 134 and control electrical pulse delivery at least partly based on the sensed activity.
In various embodiments, the activity sensor 154 is adapted for controlling rate-responsive pacing and may use any appropriate technology, for the example the activity sensor 154 may be an accelerometer, a temperature sensor, a pressure sensor, or any other suitable sensor. In an illustrative embodiment, the activity sensor 154 can operate with a power requirement of no more than 10 microwatts.
Also shown in FIG. 2, a cylindrical hermetic housing 110 is shown with annular electrodes 108 at housing extremities. In one embodiment, the housing 110 can be composed of alumina ceramic which provides insulation between the electrodes. The electrodes 108 are deposited on the ceramic, and are platinum or platinum-iridium.
A helix 226 and slot 228 enable insertion of the device endocardially or epicardially through a guiding catheter. A screwdriver stylet can be used to rotate the housing 110 and force the helix 226 into muscle 104, thus affixing the electrode 108A in contact with stimulable tissue. Electrode 108B can serve as an indifferent electrode for sensing and pacing. The helix 226 may be coated for electrical insulation, and a steroid-eluting matrix may be included near the helix to minimize fibrotic reaction, as is known in conventional pacing electrode-leads.
In accordance with another embodiment of a pacing system 100, a pacemaker configured as a leadless cardiac pacemaker 102 comprising a housing 110, and multiple electrodes 108 coupled to the housing 110. A pulse generator 116 hermetically contained within the housing 110 and electrically coupled to the electrodes 108 and is configured for generating and delivering electrical pulses to the electrodes 108. In some embodiments, an activity sensor 154 can be is hermetically contained within the housing 110 and adapted to sense activity. A processor 112 is hermetically contained within the housing and communicatively coupled to the pulse generator 116, the activity sensor 154, and/or the electrodes 108. The processor 112 controls electrical pulse delivery, for example at least partly based on the sensed activity, and communicates with one or more devices 106 external to the pacemaker 102 via signals conducted through the same electrodes 108.
The leadless cardiac pacemaker or pacemakers described herein can be configured to detect a natural cardiac depolarization, time a selected delay interval, and deliver an information-encoded pulse to another pacemaker or to an external programmer. Information can be transmitted through the communication channel with no separate antenna or telemetry coil. Communication bandwidth is low with only a small number of bits encoded on each pulse.
In some embodiments, information can be encoded using a technique of gating the pacing pulse for very short periods of time at specific points in the pacing pulse. During the gated sections of the pulse, no current flows through the electrodes of a leadless cardiac pacemaker. Timing of the gated sections can be used to encode information. The specific length of a gated segment depends on the programmer's ability to detect the gated section. A certain amount of smoothing or low-pass filtering of the signal can be expected from capacitance inherent in the electrode/skin interface of the programmer as well as the electrode/tissue interface of the leadless cardiac pacemaker. A gated segment is set sufficiently long in duration to enable accurate detection by the programmer, limiting the amount of information that can be transmitted during a single pacing pulse. Accordingly, a technique for communication can comprise generating stimulation pulses on stimulating electrodes of an implanted pacemaker and encoding information onto generated stimulation pulses. Encoding information onto the pulses can comprise gating the stimulation pulses for selected durations at selected timed sections in the stimulation pulses whereby gating removes current flow through the stimulating electrodes and timing of the gated sections encodes the information.
Another method of encoding information on pacing pulses involves varying the timing between consecutive pacing pulses in a pulse sequence. Pacing pulses, unless inhibited or triggered, occur at predetermined intervals. The interval between any two pulses can be varied slightly to impart information on the pulse series. The amount of information, in bits, is determined by the time resolution of the pulse shift. The steps of pulse shifting are generally on the order of microseconds. Shifting pulses by up to several milliseconds does not have an effect on the pacing therapy and cannot be sensed by the patient, yet significant information can be transmitted by varying pulse intervals within the microsecond range. The method of encoding information in variation of pulses is less effective if many of the pulses are inhibited or triggered. Accordingly, a technique for communication can comprise generating stimulation pulses on stimulating electrodes of an implanted pacemaker and encoding information onto generated stimulation pulses comprising selectively varying timing between consecutive stimulation pulses.
The described methods of encoding information on pacing pulses can use the programmer to distinguish pacing pulses from the patient's normal electrocardiogram, for example by recognition of the specific morphology of the pacing pulse compared to the R-wave generated during the cardiac cycle. For example, the external programmer can be adapted to distinguish a generated cardiac pacing pulse from a natural cardiac depolarization in an electrocardiogram by performing comparative pattern recognition of a pacing pulse an an R-wave produced during a cardiac cycle.
In various embodiments, the pacemaker can transmit and/or receive information such as programmable parameter settings, event counts, power-supply voltage, power-supply current, and rate-response control parameters adapted for converting an activity sensor signal to a rate-responsive pacing parameter.
Information can be transferred between the leadless pacemaker and an external device at various points during the pacing cycle (i.e. the time between heartbeats). For example, the processor 112 of the pacemaker (See, FIG. 2) can be configured to deliver the information during a pacing pulse, during a refractory period, and/or outside of the pacing pulse and the refractory period.
To transfer information outside of both the pacing pulse and the refractory period, the pulse or pulses that transfer the information are configured so as not to stimulate the heart or induce an arrhythmia. To prevent stimulation or arrhythmia induction, the transmitted pulses used to communicate information have a combination of pulse repetition rate, pulse count, and pulse amplitude that keep the transmitted pulses below the stimulation threshold. Further, the transmitted pulses are configured on as to not interfere with the pacemaker's ability to sense natural heartbeats. To avoid such interference, the transmitted pulse or pulses transmitted pulse or pulses used to communicate information can have a combination of pulse duration, pulse repetition rate, pulse count, and pulse amplitude that keeps the pulses below the pacemaker's detection threshold. Alternatively, the pacemaker's sensing amplifier input can be “blanked” or prohibited from sensing. This blanking can be accomplished by disconnecting the sensing amplifier from the electrodes during the transmission of communication pulses, blocking the sensing amplifier's output, or reducing the sensing amplifier's gain.
When a pacemaker is supplying a pacing pulse but is not sending data for communication, the waveform can resemble that shown in FIG. 4.
In some embodiments, configurations, or conditions, the pacemaker is configured to generate and deliver electrical energy with the stimulation pulse interrupted by at least one notch that conveys information to a device external to the pacemaker.
Referring to FIG. 5, a time waveform graph depicts an embodiment of a sample output-pacing pulse waveform adapted for communication. The output-pulse waveform of the illustrative leadless pacemaker is shown during a time when the pacemaker is sending data for communication and also delivering a pacing pulse, using the same pulse generator and electrodes for both functions.
FIG. 5 shows that a pulse generator of a pacemaker has divided the output pulse into shorter pulses 501, 502, 503, 504; separated by notches 505, 506, and 507. The pulse generator times the notches 505, 506, and 507 to fall in timing windows W1, W2, and W4 designated 508, 509, and 511 respectively. Note that the pacemaker does not form a notch in timing window W3 designated 510. The timing windows are each shown separated by a time T1, approximately 100 microseconds in the example.
As controlled by the pacemaker's processor, the pulse generator selectively generates or does not generate a notch in each timing window 508, 509, 510, and 511 so that the pacemaker encodes four bits of information in the pacing pulse. A similar scheme with more timing windows can send more or fewer bits per pacing pulse. The width of the notches is small, for example approximately 15 microseconds, so that the delivered charge and overall pulse width, specifically the sum of the widths of the shorter pulses, in the pacing pulse is substantially unchanged from that shown in FIG. 4. Accordingly, the pulse shown in FIG. 5 can have approximately the same pacing effectiveness as that shown in FIG. 4, according to the law of Lapique which is well known in the art of electrical stimulation.
In some embodiments, configurations, or conditions, a leadless pacemaker configured to generate and deliver electrical energy with the stimulation pulse that conveys information to a device external to the pacemaker in designated codes encoding the information in modulation of off-time between pacing pulses.
In some embodiments, configurations, or conditions, the pacemaker is configured to generate and deliver electrical energy with the stimulation pulse that conveys information to a device external to the pacemaker in designated codes encoding the information in pacing pulse width.
Exemplary Embodiment—External Programmer
In some embodiments, the device that a leadless pacemaker communicates with can be another leadless pacemaker, a conventional leaded pacemaker, a defibrillator, an implanted programmer, or an external programmer.
FIGS. 7A and 7B show a pacemaker system in which the device 106 is an external programmer 1104. The pacemaker systems 1100A, 1100B comprise one or more implantable devices 102 and an external programmer 1104 configured for communicating with the one or more implantable devices 102 via bidirectional communication pathways comprising a receiving pathway that decodes information encoded on stimulation pulses generated by one or more of the implantable devices 102 and conducted through body tissue to the external programmer 1104.
According to the illustrative arrangement, the bidirectional communication pathways can be configured for communication with multiple leadless cardiac pacemakers 102 via two or more electrodes 1106 and conduction through body tissue.
In accordance with various pacemaker system embodiments, an external device or module 1104 is connected by a communication transmission channel and has transmitting and receiving functional elements for a bidirectional exchange of information with one or more implanted medical devices 102. The communication channel includes two or more electrodes 1106 which can be affixed or secured to the surface of the skin. From the point of the skin, the communication transmission channel is wireless, includes the ion medium of the infra- and extra-cellular body liquids, and enables electrolytic-galvanic coupling between the surface electrodes and the implantable modules 1104.
In the pacemaker systems 1100A, 1100B, the bidirectional communication pathways can further comprise a transmitting pathway that passes information from the external programmer 1104 to one or more of the implantable devices 102 by direct conduction through the body tissue by modulation that avoids skeletal muscle stimulation using modulated signals at a frequency in a range from approximately 10 kHz to 500 kHz, for example 100 kHz to 300 kHz, such as approximately 250 kHz.
Information transmitted from the external programmer 1104 to the implanted devices 102 is conveyed by modulated signals at the approximate range of 10 kHz to 100 kHz which is a medium-high frequency. The signals are passed through the communication transmission channel by direct conduction. A modulated signal in the frequency range has a sufficiently high frequency to avoid any depolarization within the living body which would lead to activation of the skeletal muscles and discomfort to the patient. The frequency is also low enough to avoid causing problems with radiation, crosstalk, and excessive attenuation by body tissue. Thus, information may be communicated at any time, without regard to the heart cycle or other bodily processes. No restriction is imposed regarding location of electrode placement on the body because low signal attenuation enables the signal to travel throughout the body and to be received by the implanted devices 102.
In some embodiments, the bidirectional communication pathways can further comprise a receiving pathway including a low-pass filter adapted to separate the electrocardiogram from the information signals. The same surface electrodes 1106 that are used to transmit the information through the communication channel may also be used to detect a patient's electrocardiogram. Electrocardiogram frequencies are generally between 1 and 100 Hz, far lower than the 10 kHz to 100 kHz range of frequencies used to transmit information through the communication transmission channel. Therefore, the electrocardiogram can be separated from the information signal by a low-pass filter and can optionally be displayed by the programmer 1104. In addition to low-pass filtering, blanking techniques that are typical in processing of cardiac signals can be used when the communication channel is active to prevent noise or erroneous signals from the communication channel affecting the electrocardiogram channel.
In various embodiments and applications, the bidirectional communication pathways can further comprise a transmitting pathway that passes information from the programmer 1104 to the one or more implantable devices 102 in a common communication event whereby information is sent to one or more target devices of the implantable devices 102 using a selected technique. For example, information specific to a single implantable device or a subset of implantable devices having a unique address can be assigned to the single implantable device or the subset of implantable devices and encoded in the information. In another technique, information can designate a specific function that is executed by a particular implantable device or a particular subset of implantable devices. The information is passed to one or more implantable devices without sending individual address information for activating execution by the particular implantable device or the particular subset of implantable devices alone. In another technique, information can designate a specific function that is executed by a particular implantable device or a particular subset of implantable devices that have programming specific to the function adapted to recognize the received information is relevant to the function.
In some embodiments, the one or more implantable devices 102 can comprise one or more leadless cardiac pacemakers that generate cardiac pacing pulses and encode information onto the generated cardiac pacing pulses by selective alteration of pacing pulse morphology that is benign to therapeutic effect and energy cost of the pacing pulse. The cardiac pacing pulses conduct into body tissue via the electrodes for antenna-less and telemetry coil-less communication. For information transmitted from the implanted leadless cardiac pacemaker 102 to the external programmer 1104, a communication scheme can be used in which the information is encoded on the pacing pulse. The pulse morphology is altered to contain the encoded information without altering the therapeutic benefits of the pacing pulse. The energy delivered by the pacing pulse remains essentially the same after the information is encoded. The external programmer 1104 receives the pacing pulses through the associated surface electrodes 1106. Encoded information is drawn from the pacing pulses and can contain state information of the implantable leadless cardiac pacemaker, such as battery voltage, lead impedance, sensed electrocardiogram amplitude, pacemaker current drain, programmed parameters, or other parameters.
The illustrative external programmer 1104 and associated operating methods or techniques enable presentation to the user of information gathered from the implanted pacemaker or leadless cardiac pacemakers 102 using conductive communication. Some of the information to be presented may include battery voltage, lead impedance, electrocardiogram amplitude, or current drain of the device. The information can be presented in addition to other information such as parameters to be set and programmed into the leadless cardiac pacemaker. The information can be presented to a user on a display screen. Some embodiments or configurations of an external programmer 1104 can include a secondary link, for example either wireless or through a cable, to another display device, such as a handheld computer or terminal. The secondary link can also include communication over a local area network or the interact for display at a remote terminal.
FIG. 7A depicts a sample configuration involving the external programmer 1104 and two endocardially implanted leadless cardiac pacemakers 102. The external programmer 1104 is physically connected to the skin surface via two electrodes 1106, which serve three functions. First, the electrodes 1106 transmit encoded information from the programmer 1104 to the implanted leadless cardiac pacemakers 102 using a modulated signal at a medium frequency 10 kHz to 100 kHz. Second, the electrodes 1106 receive information from individual leadless cardiac pacemakers 102 by detecting encoded information in the pacing pulses of the leadless cardiac pacemakers 102. Third, the electrodes 1106 receive surface electrocardiogram for display and analysis by the programmer 1104.
In FIG. 7A, the two leadless cardiac pacemakers 102 are implanted endocardially. Thus, in a pacemaker system 1100A or 1100B an implantable device 102 may comprise one or more leadless cardiac pacemakers that can be implanted adjacent to an inside or an outside wall of a cardiac chamber. Referring to FIG. 7B, a similar system is represented with a difference that the two leadless cardiac pacemakers 102 are implanted by affixing to the exterior surface of the heart. The electrodes 1106 and programmer 1104 function similarly in arrangements shown in FIGS. 7A and 7B whether the leadless cardiac pacemakers 102 are implanted endocardially or epicardially (on the external heart surface). No restriction is imposed that the leadless cardiac pacemakers are all implanted inside or all implanted outside the heart. One or more may be implanted endocardially along with others implanted on the outer surface of the heart. The functioning of the programmer 1104 is substantially. the same. Although two electrodes 1106 are shown in FIGS. 7A and 7B, two is generally the minimum number for adequate conductive communication. More electrodes can be used, enabling an electrocardiogram (ECG) to be sensed at multiple vectors for better analysis. More than two electrodes also enable a choice of vectors for conducted communication with the leadless cardiac pacemakers, thereby maximizing the signal to noise ratio of the system. FIGS. 7A and 7B each depict two leadless cardiac pacemakers 102. One, two, or more leadless cardiac pacemakers can be implanted, depending on the number of pacemakers appropriate for effective therapy.
In various embodiments, the external programmer 1104 can be configured to perform one or more operations such as electrocardiogram sensing, retrieving status information from implanted pacemakers, modifying configuration parameters of multiple implanted pacemakers simultaneously in information passed through a common electrode set, displaying electrocardiograms, displaying information received from the at least one implantable device, and others.
In various embodiments, a pacemaker 102 can manage power consumption to draw limited power from an internal battery, thereby reducing device volume. Each circuit in the pacemaker can be designed to avoid large peak currents. For example, cardiac pacing can be achieved by discharging a tank capacitor (not shown) across the pacing electrodes. Recharging of the tank capacitor is typically controlled by a charge pump circuit. In a particular embodiment, the charge pump circuit can be throttled to recharge the tank capacitor at constant power from the battery. The one or more leadless cardiac pacemakers can be configured to charge the tank capacitor in preparation for stimulation pulse generation, time one or more windows between pulse generation, disable charging of the tank capacitor during the one or more timed windows, and enable a receive amplifier in the implanted pacemaker while the tank capacitor is disabled.
In some embodiments, the external programmer 1104 can detect a stimulation pulse from a leadless cardiac pacemaker 102 and transmit data after a selected delay to coincide with a window in which the leadless cardiac pacemaker's receiving amplifier is enabled.
The implantable devices 102 can encode and/or decode information using various techniques such as encoding the information using pacing pulse width, binary-coded notches in a pacing pulse, modulation of off-time between pacing pulses, or other suitable encoding techniques. The external programmer 1104 can encode and/or decode information using on-off keying encoding and modulation techniques depicted in FIG. 9. However, any other appropriate method can be used whereby a modulated bit-stream can be generated at a medium high frequency, for example frequency-shift keying, frequency modulation, or amplitude shift keying.
Referring to FIG. 8, a schematic block diagram shows an embodiment of an external programmer 1204 adapted for communicating with an implanted pacemaker system using conducted communication. The external programmer 1204 comprises an interface 1208 configured for coupling to at least two electrodes 1206 that make electrical contact with body skin for communicating with one or more implanted pacemakers. The external programmer 1204 further comprises bidirectional communication pathways 1210R and 1210T coupled to the interface 1208 and configured for bidirectional communication with the one or more implanted pacemakers. The communication pathways comprise a receiving pathway 1210R that decodes information encoded on stimulation pulses generated by the one or more implanted pacemakers and conducted through body tissue.
The bidirectional communication pathways 1210R and 1210T are configured for communication with one or more leadless cardiac pacemakers via the electrodes 1206 and conduction through body tissue.
The external programmer 1204 can have bidirectional communication pathways 1210R and 1210T that further comprise a transmitting pathway 1210T that passes information from the programmer 1204 to one or more implanted pacemakers by conduction through the body tissue using modulation that avoids skeletal muscle stimulation.
In some arrangements, the bidirectional communication pathways 1210R and 1210T can be further specified to comprise a transmitting pathway that passes information from the programmer 1204 to the one or more implanted pacemakers by direct conduction using modulated signals at a frequency in a range from approximately 10 kHz to 100 kHz. Also in some arrangements, the two or more electrodes 1206 and the bidirectional communication pathways 1210R and 1210T can be configured for bidirectional information signal communication and for sensing an electrocardiogram.
Also in some embodiments, the bidirectional communication pathways 1210R and 1210T can further comprise a transmitting pathway 1210T that passes information from the programmer 1204 to multiple implanted devices in a common communication event. In some embodiments or selected operating conditions, the transmitting pathway 210T can be arranged to pass information from the programmer 1204 to multiple implanted devices in a common communication event whereby information specific to a single implanted device or a subset of implanted devices have a unique address assigned to the single implanted device or the subset of implanted devices and encoded in the information. The transmitting pathway 1210T can also be arranged to pass information from the programmer 1204 to multiple implanted devices in a common communication event whereby information designates a specific function that is executed by a particular implanted device or a particular subset of implanted devices. The information is passed to the multiple implanted devices without individual address information for activating execution by the particular implanted device or the particular subset of implanted devices alone. The transmitting pathway 1210T can also be arranged, either alone or in combination with other techniques, to pass information from the programmer 1204 to multiple implanted devices in a common communication event whereby information designates a specific function that is executed by a particular implanted device or a particular subset of implanted devices that comprise programming specific to the function adapted to recognize the received information is relevant to the function.
In the illustrative embodiment, the bidirectional communication pathways 1210R and 1210T comprise the two or more electrodes 1206 forming a conductive communication path between the programmer 1204 and the skin surface, and a transmitting pathway 1210T. The transmitting pathway 1210T comprises a processor 1212, a command/message encoder 1230, a modulator 1232, and an amplifier 1236. The processor 1212 is configured to communicate information to one or more implanted leadless cardiac pacemakers. The command/message encoder 1230 is coupled to the processor 1212 via a parallel interface and configured to encode and serialize data into a bit stream. Information encoding can be selected from encoding techniques such as on-off keying, frequency-shift keying, frequency modulation, and amplitude shift keying. The modulator 1232 is coupled to the command/message encoder 1230 and receives and modulates the serialized data using a frequency in a range from approximately 10 kHz to approximately 100 kHz. The amplifier 1236 is coupled to the modulator 1232 and increases signal amplitude to a level suitable for robust conducted communication.
The bidirectional communication pathways 1210R and 1210T further comprise a receiving pathway 1210R including a low-pass filter 1214 adapted to separate the electrocardiogram from the information signals.
In various embodiments and arrangements, the bidirectional communication pathways 1210R and 1210T further comprise a receiving pathway 1210R, that receives information at the programmer 1204 from the one or more implanted pacemakers by conduction through the body tissue. The receiving pathway 1210R can decode information, for example by decoding data that is encoded by the pacemakers using pacing pulse width, using binary-coded notches in a pacing pulse, using modulation of off-time between pacing pulses, or other suitable techniques for encoding data in the pacemakers.
In the illustrative embodiment, the bidirectional communication pathways 1210R and 1210T couple to the two or more electrodes 1206 forming a conductive communication path between the programmer 1204 and the skin surface, and a receiving pathway 1210R. The receiving pathway 210R comprises an electrocardiogram (ECG) amplifier/filter 1214, an analog-to-digital converter (ADC) which is not shown in FIG. 8, and the processor 1212. The electrocardiogram (ECG) amplifier/filter 1214 includes a differential band-pass amplifier configured to select and amplify signals in a frequency range from approximately 1 Hz to approximately 100 Hz. The analog-to-digital converter (ADC) is configured to digitize the filtered and amplified signal. The processor 1212 is coupled to the ADC and configured to receive and optionally display ECG data, and configured to decode information encoded into cardiac pacing pulses.
The programmer 1204 may further comprise a processor 1212 coupled to the bidirectional communication pathways and configured to manage communication with one or more pacemakers, for example leadless cardiac pacemakers. Leadless cardiac pacemakers can be implanted adjacent to an inside or an outside wall of a cardiac chamber as depicted in FIGS. 7A and 7B.
As depicted in FIG. 8, external electrodes 1206 enable a conductive communication path between the programmer 1204 and the skin surface. Electrocardiogram (ECG) signals enter an ECG amplifier/filter 1214, which can include a differential band-pass amplifier. In general, an ECG signal has spectral components in a range between 1 Hz and 100 Hz. Band-pass filter poles for the ECG amplifier/filter 1214 can be selected such that sufficient signal energy is passed within the 1 Hz to 100 Hz range, while filtering other signals that are not associated with cardiac activity. The ECG signal can be amplified and digitized using an analog-to-digital converter (ADC). Once digitized, the signal is passed to the processor, for example central processing unit (CPU) 212.
In some embodiments, the electrodes 1206 can be implemented with more than two electrodes to enable an electrocardiogram (ECG) to be sensed at multiple vectors and further to enable selection from among the multiple vectors for conducted communication with implanted leadless cardiac pacemakers so that system signal-to-noise ratio can be improved or maximized.
The CPU 1212 receives and optionally displays ECG data using a display interface 216 and can also display other data acquired from the implanted leadless cardiac pacemaker acquired through the encoded pacing pulses, such as battery voltage, lead impedance, sensed cardiac signal amplitude, or other system status information. The CPU 1212 also can accept input from a user via a keyboard and/or touch-screen interface 1218. Some examples of user input are selected pacing rate or pacing pulse amplitude for implanted leadless cardiac pacemakers. The CPU 1212 can also communicate over a network interface 1220 to other data entry or display units, such as a handheld computer or laptop/desktop unit. The network interface 1220 can be cabled or wireless and can also enable communication to a local area network or the internet for greater connectivity.
The processor 1212 is coupled to the bidirectional communication pathways and configured to perform one or more of various operations such as electrocardiogram sensing, retrieving status information from implanted pacemakers, modifying configuration parameters of multiple implanted pacemakers within a single or multiple cardiac cycles in information passed through a common electrode set, and other operations. A display interface 1216 coupled to the processor 212 can be configured to display an electrocardiogram sensed from the electrodes 1206. In some arrangements or embodiments, a secondary link 1220 can be coupled to the processor 1212 and configured for unidirectional or bidirectional wireless or cable transmission to and/or from a remote display and/or data-entry device to display an electrocardiogram sensed from the at least two electrodes, and/or to control the programmer and/or at least one implanted pacemaker.
The CPU 1212 can execute operations based on firmware stored in non-volatile memory (Hash) 1222. The non-volatile memory 1222 can also be used to store parameters or values that are to be maintained when power is removed. The CPU 1212 uses volatile memory or random access memory (RAM) 1224 as general storage for information such as ECG data, status information, swap memory, and other data. A battery and supply regulator 1226 gives a constant voltage supply to the programmer 1204 during normal operation. A clock module 1228 generates a system clock signal used by the CPU 1212 and by interface blocks for timing.
The CPU 1212, during operation to communicate information to one or more implanted leadless cardiac pacemakers, sends the information over a parallel interface to a command/message encoder 1230, which serializes the data into a bit stream. Serialized data is sent to a modulator 1232. The serialized bit-stream is modulated, for example using a frequency between 10 kHz and 100 kHz. An optional separate modulator clock 1234 supplies a timing signal at a selected carrier frequency that may be used by the modulator 1232. An amplifier 1236 sets signal amplitude to a level that enables robust conducted communication. A sample of a modulated bit-steam is shown in FIG. 9 wherein logic high is shown as a medium high frequency sine wave. An encoding and modulation technique depicted in FIG. 9 is on-off keying. However, any other appropriate method whereby a modulated bit-stream can be generated at a medium high frequency may be used, for example frequency shift keying, frequency modulation, or amplitude shift keying.
Because multiple pacemaker devices can be implanted, communication of information from the programmer 1204 can be detected by all devices, enabling information to be sent to each implanted device without sending the same information multiple times.
If each implanted device or a subset of devices performs a specific function which is different from other implanted devices, then information can be passed to the specific device or subset without the additional overhead of a group or individual address. For example, when the device or subset is responsible for only a specific function. When the programmer 1204 transmits information to the entire group, but the information is relevant to only the device or subset of that group, then any devices that cannot make use of the information may ignore the information as superfluous. The technique presumes that each device have unique programming specific to the associated function, and each device have capability to recognize whether or not received information is relevant to the function. Devices using the illustrative technique are not generic. The function of each device can be defined at the time of manufacture or at the time of implant or thereafter. The devices are labeled or marked such that the associated function can be known upon inspection.
To reduce the peak current for operation of the leadless cardiac pacemakers, a technique can be used in which a window or multiple windows occur between subsequent pacing pulses during which the leadless cardiac pacemaker does not charge pacing tank capacitor in preparation for the next pacing pulse. Instead the pacemaker enables an internal receiving amplifier. Because the programmer 1204 can sense pacing pulses from the implanted devices, the programmer 1204 can time data transmission to coincide with the pre-defined synchronous window or windows. A reduced peak current capability occurs because the charger and receiving amplifier, both power intensive elements, never have to be operated together. Because the data transmission is generally very short compared to the period between pacing pulses, the window technique should not significantly lower the ability of the leadless cardiac pacemaker to charge the pacing tank capacitor effectively between pacing pulses.
Referring again to FIG. 8, data acquired by the programmer 1204 from a specific implanted leadless cardiac pacemaker is received at the surface electrodes 1206 and passes to an amplifier/filter 1240, which functions to remove noise from the incoming signal. Any filtering performed by the amplifier/filter 1240 is designed to leave encoded pulses intact as much as possible. A message decoder 1238 determines whether the received signal is actually a pacing pulse or another signal, such as a cardiac R-wave.
The method of encoding data using modulation of off-time between pacing pulses is less effective if pulses are inhibited, since data can be transmitted using only pacing pulses generated by the pacemaker. When data are encoded in binary-coded notches in the pacing pulse or by varying pacing pulse width, if a therapeutic pacing pulse is inhibited, then the leadless cardiac pacemaker can still generate a non-therapeutic pulse during the refractory period of the heart after the sensed beat, although the pacing pulse has the sole purpose of transmitting data to the programmer or optionally to at least one other implanted pacemaker.
Referring to FIGS. 10A-10E, schematic flow charts depict techniques that can be used in various embodiments of methods for communicating in an implantable pacemaker system. According to FIG. 10A, an illustrative method 700 comprises monitoring 702, at an external programmer, electrical signals conducted through body tissue to body surface electrodes and detecting 704 pulses generated by a body-implanted pacemaker. The external pacemaker decodes 706 information encoded into the generated pulse by the body-implanted pacemaker.
Referring to FIG. 10B, a method 710 can further comprise generating 712 cardiac pacing pulses at an implanted leadless cardiac pacemaker. Information is encoded 714 onto generated cardiac pacing pulses at the implanted leadless cardiac pacemaker by selective alteration of pacing pulse morphology that is benign to therapeutic effect and energy cost of the pacing pulse. In various embodiments, the implanted leadless cardiac pacemaker can encode the information using one or more techniques such as encoding using pacing pulse width, using binary-coded notches in a pacing pulse, and using modulation of off-time between pacing pulses. The cardiac pacing pulses are conducted 716 into body tissue via electrodes for antenna-less and telemetry coil-less communication. The information encoded onto generated cardiac pacing pulses can include pacemaker state information, battery voltage, lead impedance, sensed cardiac signal amplitude, pacemaker current drain, programmed parameters, and the like.
Referring to FIG. 10C, a method 720 can further comprise generating 722 cardiac pacing pulses at an implanted leadless cardiac pacemaker and encoding 724 information onto generated cardiac pacing pulses at the implanted leadless cardiac pacemaker by selective alteration of pacing pulse morphology that is benign to therapeutic effect and energy cost of the pacing pulse. The implanted leadless cardiac pacemaker detects 726 a natural cardiac depolarization and inhibits 728 cardiac pacing pulse delivery with delay for delivery during a refractory period following the natural cardiac depolarization. The cardiac pacing pulses are conducted 730 into body tissue via electrodes for antenna-less and telemetry coil-less communication.
Referring to FIG. 10D, various embodiments of a method 740 can comprise charging 742 a tank capacitor in preparation for stimulation pulse generation. Stimulation pulses are generated 744 on stimulating electrodes of an implanted pacemaker and information encoded 746 onto generated stimulation pulses. One or more windows can be timed 748 between pulse generations. Charging of the tank capacitor is disabled 750 during the one or more timed windows and a receiving amplifier in the implanted pacemaker is enabled 752 while the tank capacitor is disabled. The external programmer senses 754 the stimulation pulses generated by the implanted pacemaker and transmits 756 information from the external programmer to the implanted pacemaker to coincide with the one or more timed windows. For example, the external programmer can detect a stimulation pulse from the implanted pacemaker, time a selected delay interval, and transmit data after the selected delay to coincide with a window that the implanted pacemaker's receive amplifier is enabled.
Referring to FIG. 10E, various embodiments of a method 760 can comprise physically connecting 762 the external programmer to a body surface via two or more body surface electrodes and communicating 764 information among the external programmer and one or more implanted leadless cardiac pacemakers. Encoded information is transmitted 766 from the external programmer to the implanted leadless cardiac pacemakers via the body surface electrodes using a modulated signal at a frequency in orange of approximately 10 kHz to approximately 100 kHz. The external programmer receives 768 the information via the body surface electrodes from one or more of the implanted leadless cardiac pacemakers by detecting information encoded into generated pacing pulses. The external programmer can also receive 770 a surface electrocardiogram via the body surface electrodes for display and analysis.
A person having ordinary skill in the art would understand that the communication mechanisms described herein with respect to communication with an external programmer 1104 can be used when the device 106 is a different type of device as well, for example when the device 106 is another pacemaker, a defibrillator, an implanted programmer, or an external programmer.
FIG. 11 illustrates one embodiment including an external programmer 106 in communication with at least one cardiac pacemakers 102, the pacemaker 102 including a first pulse generator 116 and a second pulse generator 776. The first pulse generator 116 can be used for pacing through the electrodes 108 while the second pulse generator 776 can be used for delivering communication pulses through the electrodes 108 to the external device 106. Thus, the second pulse generator 776 can be uninvolved in the pacing process. The second pulse generator 776 can generate different pulses at different amplitudes from the first pulse generator 112. Advantageously, this allows for the amplitude of the pulses to be optimized for communication or for pacing.
The second pulse generator 776 can be powered from a power supply shared with another function. This power supply can be the lowest-voltage supply already used for another function. For example, the second pulse generator 776 can use the power supply used for analog and digital circuits, which operates at approximately 1.5V. Using a low-voltage supply permits generating more pulses per transmitted signal for the same power consumption, which in turn provides a more narrow-band transmitted frequency spectrum, thereby improving the signal-to-noise ratio at the receiver of the external device 106. By sharing the power supply for the pulse generator 776 with another function, the component count can remain low and the pacemaker size small.
In some embodiments, the pacemaker 102 can transmit communication pulses at the lowest frequency f such that root-mean-square (RMS) transmitted current presents no risk for arrhythmia induction. International standards permit current in cardiac electrodes of up to 10 uArms*f/1 kHz. Therefore, the frequency of the transmitted signal of the cardiac pacemaker 102 can be approximately equal to the current*108 Hz/A. For example, a square wave at 1.5V peak, the voltage discussed above, with a load resistance of 0.6 KΩ, typical for cardiac electrodes, provides 2.5 mArms. Accordingly, to meet international standards, the frequency of the transmitted pulses can be greater than or equal to 0.25 MHz. Thus, in one embodiment, the pacemaker 102 described herein can transmit communication pulses at a frequency close to 0.25 MHz, e.g., between 0.25 MHz and 0.5 MHz. The selection of the lowest frequency signal such that the RMS transmitted current presents no risk for arrhythmia induction, as described herein, provides a design advantage because lower frequencies are less affected by parasitic and intended low pass filters associated with protection and interference suppression circuitry.
Like the pacemaker 102, in some embodiments, the external device 106 can transmit communication pulses to the pacemaker at the lowest frequency f such that the RMS transmitted current presents no risk for arrhythmia induction or sensation. International standards permit current in skin electrodes of 0.1 mArms*f/1 kHz. Therefore, the frequency of the transmitted signal of the external device 106 can be approximately equal to the current*107. In one embodiment, the external device 106 transmits communication pulses to the pacemaker 102 using a biphasic square wave with approximately a 25 Volt peak. Advantageously, 25 Volts provides approximately the largest voltage that can be transmitted through skin electrodes at a 0.25 MHz frequency that is safe. A square wave at 25 V peak with a load resistance of 0.6 KΩ, typical for skin electrodes, provides 25 mArms. Accordingly, to meet international standards, the frequency of the transmitted pulses can be greater than or equal to 0.25 MHz. Therefore, in one embodiment, the external device 106 can transfer the communication signal at around 0.25 MHz, such as between 0.25 and 0.5 MHz. Use of the lower frequency in this range advantageously ensures that the communication signal will be less affected by parasitic and intended low pass filters required for protection and interference suppression circuitry. Further, an amplifier that is responsive to lower frequency signals generally requires less current and enables a longer-lived or smaller pacemaker 102.
In some embodiments, the external device 106 can have a receiving filter centered at the fundamental frequency of transmitted pulses of the pacemaker 102. Accordingly, the external device 106 can reject interference signals outside of this band, such as signals applied to patients by commercial electrocardiographs for confirming surface electrode contact or unintentional radiation from switching power supplies.
Further, referring to FIGS. 12 and 13, a frequency of greater than 200 kHz allows for possible increase in transmission amplitude by providing some additional options for compliance with standards. FIGS. 12 and 13 summarize international standards applicable to the programmer's body electrode current. These figures show that above 200 kHz the hazard presented by the programmer's carrier current, called “patient auxiliary current” by the standards, is limited to thermal considerations rather than arrhythmia induction and sensation that can occur at lower frequencies. Consequently, the limit for body electrode current above 200 kHz can be increased simply by increasing the surface area of the programmer's body electrodes.
Finally, the programmer's transmitted carrier frequency can be selected to be an integral multiple of the implant's clock frequency, on that an integral number of programmer carrier pulses fall within a period of the implant's clock. This allows the programmer to adjust the timing and count of its transmitted pulses for exact alignment to timing windows in the implant, which are set by the implant's clock.
In some embodiments, the pacemaker 102 can transmit communication pulses to the external device 106 during the pacemaker's absolute refractory period. Doing so advantageously ensures that the transmission does not interfere with heartbeat sensing and that the induction of arrhythmias is prevented. Signals can be transmitted only during the absolute refractory period, as the refractory period is sufficiently long to permit full transmission of such signals in place of those encoded in a pacing pulse or in a refractory pulse triggered by sensing. Alternatively, signals can be transmitted during the absolute refractory period in addition to being encoded in a pacing pulse or in a refractory period triggered by sensing, which advantageously increases the data rate of the signal.
Similarly, in some embodiments, the external device 106 can transmit communication pulses to the pacemaker 102 during the pacemaker's absolute refractory period. The external device 106 can transmit communication only during the refractory period. Advantageously, in the case where the programmer is transmitting communication pulses to the pacemaker 102 only during the refractory period, the pacemaker 102 can disconnect its input capacitor used for protection against electromagnetic interference (EMI) during the refractory period only, thereby allowing the pacemaker 102 to more effectively receive the high-frequency communication pulses from the external device 106 while maintaining protection from EMI during the rest of the pacing cycle.
In some embodiments, the pacemaker 102 charge-balances transmitted communication pulses before the end of the pacemaker's absolute refractor period so that the residual unbalanced current does not interfere with heart beat sensing. To do this, the pacemaker 102 can transmit monophasic communication pulses and provide the charge balancing using a fast-discharge circuit already provided for balancing monophasic pacing pulses. Alternatively, the pacemaker 102 can transmit biphasic communication pulses in such a way that each phase balances the other. Charge-balancing biphasic communication signals advantageously permits the pacemaker 102 to transmit more signals in a period of time than when using monophasic communication pulses because it is not necessary to reserve time in the refractory period for an additional balancing pulse.
In some embodiments, when not communicating with the external device 106, the pacemaker 102 can send a “bell-ringer” signal to the external device and listen for a response during at least one window timed from the bell-ringer signal. For example, the implant can send a pulse to the programmer once every five pacing cycles, and then listen for a response in a short window, such as 1 millisecond or less in duration, at a predetermined time, such as 32 milliseconds, after sending the bell-ringer pulse. The pacemaker 102 can send a belt-ringer at the start of every Nth pacing cycle, with N selected in the range from 1 to 20, such as from 3 to 7, to optimize the pacemaker's power consumption (which decreases with N) and the latency for initiating communication (which increases with N). The pacemaker's communication receiving amplifier can then be powered down outside of the window. This infrequent transmission and reception of communication signals can advantageously reduce the amount of power consumption of the pacemaker 102, thereby increasing its longevity and/or reducing the overall size of the pacemaker 102.
In some embodiments, when communicating with the external device 106, the pacemaker 102 can send a synchronization signal to the external device 106 and then send additional signals and/or listen for a response during at least one window timed from the synchronization signal. In addition to signaling the upcoming transfer of information, the synchronization signal can transfer additional information as well, including event markers, event counters, and sensor output. The frequency, number, and duration of these signals and windows can be chosen to optimize the pacemaker's power consumption (which decreases with decreasing frequency, number, and duration) and the communicated data range (which increases with these parameters). For example, the pacemaker can transmit an event marker along with a synchronization pulse for negligible additional power consumption. Further, the message coding can be arranged such that the data most frequently sent requires fewer transmitted pulses and shorter receiving windows. For example, the event marker for a pacing pulse can comprise two bits, both with data value zero and therefore no transmitted pulse, thereby further reducing the pacemaker's power consumption.
In some embodiments, the pacemaker 102 or external device 106 can measure the time between received communication pulses. Measuring the time between received communication pulses can allow the pacemaker 102 or external device 106 to estimate the other devices' clock frequency and therefore optimize the timing of its transmitted pulses and receiving windows accordingly.
In some embodiments, the pacemaker 102 or external device 106 can initiate communication automatically when the user applies skin electrodes and connects them to the external device.
In some embodiments, when communicating, the pacemaker 102 or external device 106 can measure the peak, average, integrated, or filtered amplitude of the received signal to set an automatic discriminating threshold for noise rejection.
Furthermore, the leadless cardiac pacemaker 102 can have a primary battery that exhibits an energy density of at least 0.5 watt-hours per cubic centimeter (W·h/cc), for example at least 1 W·h/cc, such as at least 3 W·h/cc.
Use of conducted communication of information improves over standard methods of communication in several aspects. For example, the illustrative conductive communication also enables power consumption to be reduced due to substantially lower current requirements and eliminating peak power demands currently imposed by existing inductive and radio frequency (RF) systems. Also, the conductive communication technique uses elements generally already existing in the implanted pulse generator, such as the therapeutic electrodes that function as an input-output device, enabling elimination of a coil or antenna that are conventionally used for communication and reducing complexity and component count significantly.
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