The present disclosure relates generally to telemetry systems for uplink and/or downlink telemetry transmission between an implantable medical device (IMD) and an external medical device (EMD) such as a programmer or monitor and more specifically to a method for selection of an optimal telemetry communications link.
In the context of programming the operating modes or parameters of an IMD or in receiving information from an IMD, it is helpful to reduce interference and/or fades in the telemetry transmission between an IMD and the EMD. In most currently available systems, the programmer is placed in close proximity to the implanted device, typically by means of a telemetry head in contact with the patient's body. In such applications, there is little likelihood of interference and/or fades in the telemetry transmission.
More recently it has been proposed to provide communication systems for implantable devices in that the telemetry head communication occurs directly between the implanted medical device and a programmer or monitor which, may be located some distance from the patient. Such systems are disclosed in U.S. Pat. No. 5,404,877 issued to Nolan et al, and U.S. Pat. No. 5,113,869 issued to Nappholz. In the Nappholz patent, in particular, broadcasting RF signals from an implanted device to a programmer or monitor that may be located some feet away from the patient is suggested. Such a communication system is also disclosed in U.S. Pat. No. 6,240,317 for a “Telemetry System For Implantable Medical Devices”, filed Apr. 30, 1999 by Villaseca et al., which is incorporated herein by reference in its entirety. In use of such systems, the possibility of interference and/or fades in the telemetry transmission increases as they are frequency and spatially selective.
In some embodiments, a medical device system may include one or more of the following features: (a) an external medical device (EMD), (b) an implantable medical device (IMD) disposed within a hermetically sealed housing adapted for implantation in the body of a patient to provide a therapy delivery and/or monitoring function, (c) two or more transmitters disposed within one of the EMD and the IMD, the two or more transmitters uplinking telemetry transmissions generated by the one of the EMD and IMD, (d) two or more receivers disposed within the other of the one of the EMD and the IMD, the two or more receivers downlinking the telemetry transmissions, and (e) the other of the one of the EMD and the IMD processing the telemetry transmission received by a selected one of the two or more receivers, the selection being based on which receiver is receiving the best quality signal transmission reception.
In some embodiments, a medical device communication system may include one or more of the following features: (a) an external medical device (EMD) having a transmitter and a receiver for downlinking and uplinking telemetry transmissions respectively, and (b) a battery powered implantable medical device (IMD) disposed within a hermetically sealed housing adapted for implantation in the body of a patient to provide a therapy delivery and/or monitoring function, the IMD having a transmitter and a receiver for establishing full duplex communication with the EMD via downlinking and uplinking telemetry transmissions with the EMD over separate communication channels.
In some embodiments, a method of communication in a medical device system may include one or more of the following features: (a) uplinking two or more transmitters telemetry transmissions generated by the one of an EMD and an IMD being hermetically sealed and adapted for implantation in the body of a patient to provide a therapy delivery and/or monitoring function, (b) downliking the telemetry transmissions with two or more receivers within the other of the one of the EMD and the IMD, (c) processing the telemetry transmission received by a selected one of the two or more receivers with the other of the one of the EMD and the IMD, the selection being based on which receiver is receiving the best quality signal transmission reception, (d) checking periodically the signal quality received by the one or more receivers not selected by the other of the one of the EMD and the IMD, and (e) selecting a different receiver based on which receiver is receiving the best quality signal transmission if the signal quality received by the selected receiver deteriorates to beyond a threshold level.
The following disclosure is made to enable a person skilled in the art to make and use the present teachings. Various modifications to the illustrated embodiments will be readily apparent to those skilled in the art, and the generic principles herein may be applied to other embodiments and applications without departing from the present teachings. Thus, the present teachings are not intended to be limited to embodiments shown, but are to be accorded the widest scope consistent with the principles and features disclosed herein. The following detailed description is to be read with reference to the figures, in which like elements in different figures have like reference numerals. The figures, which are not necessarily to scale, depict selected embodiments and are not intended to limit the scope of the present teachings. Skilled artisans will recognize the examples provided herein have many useful alternatives and fall within the scope of the present teachings.
The present teachings relate to a long-range telemetry system of the general type described in the above-referenced Villaseca et al. application wherein an implanted device may be programmed or monitored at a distance from the patient in whom the device is implanted. The system may employ RF transmission in an occupied band of about 402-405 MHz as in the Villaseca et al. application. Within this bandwidth, one or a number of communication channels may be available. Other frequency ranges may be substituted including frequency ranges up to several gigahertz. Each telemetry transmission may be formatted in a frame based format using frequency shift keying or other modulation format. The operating physical distance between the IMD antenna and the external device antenna is 0-2 meters and may be on the order of at 5-10 meters or more. The present teachings are discussed relating to a long range telemetry system, such as a system in compliance with Telemetry C, which permits communication over distances from 0-10 meters or even more as discussed in U.S. Pat. Nos. 6,456,887, 6,169,925, and 5,752,925 herein incorporated by reference in their entirety. However, the present teachings can be utilized with short range telemetry systems, such as Telemetry A or Telemetry B which typically require the telemetry head to be adjacent to or within a few meters of the implanted device as discussed in U.S. Pat. Nos. 6,223,083, 6,295,473, and 5,292,343 herein incorporated by reference in their entirety without departing from the spirit of the present teachings.
Programming commands or data are transmitted between an IPG RF telemetry antenna 28 and an external RF telemetry antenna 24 associated with the external programmer 20. In this configuration, it is not necessary that the external RF telemetry antenna 24 be contained in a programmer RF head of the type described above so that it can be located close to the patient's skin overlying the IPG 10. Instead, the external RF telemetry antenna 24 can be located on the case of the external programmer 20, and the programmer 20 can be located some distance away from the patient 12. For example, the external programmer 20 and external RF telemetry antenna 24 may be on a stand a few meters or so away from the patient 12. Moreover, the patient 12 may be active and could be exercising on a treadmill or the like during an uplink telemetry interrogation of real time ECG or physiologic parameters. The programmer 20 may also be designed to universally program existing IPGs that employ the conventional ferrite core, wire coil, RF telemetry antennas of the prior art and therefore also have a conventional programmer RF head and associated software for selective use with such IPGs. While the present disclosure relates to programmer 20 being some distance away from patient 12, it is fully contemplated the present teachings could be extended to prior programmers requiring a programming head to be in close proximity with the patient without departing from the spirit of the present teachings.
In an uplink telemetry transmission 22, the external RF telemetry antenna 24 operates as a telemetry receiver antenna, and the IPG RF telemetry antenna 28 operates as a telemetry transmitter antenna. Conversely, in a downlink telemetry transmission 26, the external RF telemetry antenna 24 operates as a telemetry transmitter antenna, and the IPG RF telemetry antenna 28 operates as a telemetry receiver antenna. Each RF telemetry antenna is coupled to a respective transmitter and/or receiver system.
In order for the physician or other caregiver or operator to communicate with the programmer 20, a keyboard 65 coupled to CPU 50 is optionally provided. However the primary communication mode may be through graphics display screen 55 of the well known “touch sensitive” type controlled by graphics circuit 53. A user of programmer 20 may interact therewith through the use of a stylus 56, also coupled to graphics circuit 53, which is used to point to various locations on screen 55 which display menu choices for selection by the user or an alphanumeric keyboard for entering text or numbers and other symbols. Various touch-screen assemblies are known and commercially available. The display 55 and or the keyboard 65 comprise means for entering command signals from the operator to initiate transmissions of downlink telemetry and to initiate and control telemetry sessions once a telemetry link with an implanted device has been accomplished. Graphics display screen 55 is also used to display patient related data and menu choices and data entry fields used in entering the data in accordance with the present invention as described below. Graphics display screen 55 also displays a variety of screens of telemetered out data or real time data.
Graphics display screen 55 may also display uplinked event signals as received and thereby serve as a means for enabling the operator of the programmer to correlate the receipt of uplink telemetry from an implanted device with the response-provoking event to the patient's body as disclosed above. Further handshaking functionality may be provided by a device such as microphone 61, which may be used to automatically detect tones generated by the IMD in a manner to be discussed below. Programmer 20 is also provided with a strip chart printer 63 or the like coupled to interface controller module 54 so that a hard copy of a patient's ECG, EGM, marker channel or of graphics displayed on the display screen 55 can be generated.
As will be appreciated by those of ordinary skill in the art, it is often desirable to provide a means for programmer 20 to adapt its mode of operation depending upon the type or generation of implanted medical device to be programmed. Accordingly, it may be desirable to have an expansion cartridge containing EPROMs or the like for storing software programs to control programmer 20 to operate in a particular manner corresponding to a given type or generation of implantable medical device. In addition, in accordance with the present invention, it is desirable to provide the capability through the expansion cartridge or through the floppy disk drive 66 or a CD ROM drive to expand or alter the formal generative grammars stored therein or in hard disk drive 52 as experience dictates the need or opportunity to do so.
The non-isolated analog circuit 59 and the digital circuitry 58 of interface module 57 is coupled to the transmitter/receiver system block 30 which is used to establish the uplink and downlink telemetry links between the IPG 10 and programmer 20. The atrial and ventricular sense amp circuits of IPG 10 may also be provided with (electrogram) EGM amplifiers that produce atrial and ventricular EGM signals. These A EGM and V EGM signals may be digitized and uplink telemetered to programmer 20 on receipt of a suitable interrogation command. The uplink telemetered EGM signals are received in telemetry transmission 22 and provided to non-isolated analog circuit 59. Non-isolated analog circuit 59, in turn, converts the digitized EGM signals to analog EGM signals (as with a digital-to-analog converter, for example) and presents these signals on output lines designated as A EGM OUT and V EGM OUT. These output lines may then be applied to a stripchart recorder 63 to provide a hard-copy printout of the A EGM or V EGM signals transmitted from IPG 10 for viewing by the physician. As these signals are ultimately derived from the intracardiac electrodes, they often provide different information that may not be available in conventional surface ECG signals derived from skin electrodes.
IPG 10 may also be capable of generating so-called marker codes indicative of different cardiac events that it detects. A pacemaker with marker channel capability is described, for example, in U.S. Pat. No. 4,374,382 to Markowitz, which patent is hereby incorporated by reference herein in its entirety. The markers provided by IPG 10 may be received by telemetry transmission 22 and presented on the MARKER CHANNEL output line from non-isolated analog circuit 59.
Isolated analog circuit 60 in interface module 57 is provided to receive external ECG and electrophysiological (EP) stimulation pulse signals. In particular, analog circuit 60 receives ECG signals from patient skin electrodes and processes these signals before providing them to the remainder of the programmer system in a manner well known in the art. Circuit 60 further operates to receive the EP stimulation pulses from an external EP stimulator for the purposes of non-invasive EP studies, as is also known in the art.
The IPG block diagram 300 is divided generally into a microcomputer circuit 302, an input/output circuit 320, and peripheral components including connectors for atrial and ventricular leads 18, the IPG RF telemetry antenna 28, a battery 318, an activity sensor 316 responsive to application of pressure and a magnetic field responsive solid state or reed switch 380. The block diagram 300 is fairly typical of prior art dual chamber pacemaker IPG circuits except for the specific configuration of the RF telemetry antenna, the transceiver 332 and the operating software for practicing the steps of the present invention.
The input/output circuit 320 includes a digital controller/timer circuit 330 coupled with a pulse generator output amplifier circuit 340, sense amplifiers 360, the IPG RF transceiver 332, other circuits and inputs described below and with a data and control bus 306 for communicating with the microcomputer circuit 302. The pulse generator circuit 340 includes a ventricular pulse generator circuit and an atrial pulse generator circuit, and the sense amplifier circuit 360 includes atrial and ventricular sense amplifiers adapted to be coupled to the atrium and ventricle of the patient's heart by means of leads 14. The output circuit 340 and sense amplifier circuit 360 may contain pulse generators and sense amplifiers corresponding to any of those presently employed in commercially marketed cardiac pacemakers.
Crystal oscillator circuit 338 provides the basic timing clock for the circuit, while battery 318 provides power. Power on reset circuit 336 responds to initial connection of the circuit to the battery for defining an initial operating condition and similarly, resets the operative state of the device in response to detection of a low battery condition. Reference and bias circuit 326 generates stable voltage reference and currents for the analog circuits within the input/output circuit 320. Analog to digital converter ADC and multiplexor circuit 328 digitizes analog signals and voltage to provide real time telemetry if a cardiac signals from sense amplifiers 360, for uplink transmission via RF transceiver circuit 332. Voltage reference and bias circuit 326, ADC and multiplexor 328, power on reset circuit 336 and crystal oscillator circuit 338 may correspond to any of those presently used in current marketed implantable cardiac pacemakers. Audio Signal Generator 339 may be provided to generate audible tones in response to telemetry downlink sessions initiated by the EMD.
Control of timing and other functions within the pacemaker circuit is provided by digital controller/timer circuit 330, which includes a set of timers and associated logic. Digital controller/timer circuit 330 defines the basic pacing interval of the IPG 10, which may take the form of an A-A escape interval initiated on atrial sensing or pacing and triggering atrial pacing at the expiration thereof or may take the form of a V-V escape interval, initiated on ventricular sensing or pacing and triggering ventricular pulse pacing at the expiration thereof. Digital controller/timer circuit 330 similarly defines the A-V escape intervals SAV and PAV. The microcomputer circuit 302 via data and control bus 306 controls the specific values of the intervals defined. Sensed atrial depolarization are communicated to the digital controller/timer circuit 330 on A event line 352, with ventricular depolarization communicated to the digital controller/timer circuit 330 on V event line 354. In order to trigger generation of a ventricular pacing pulse, digital controller/timer circuit 330 generates a trigger signal on V trigger line 342. Similarly, in order to trigger an atrial pacing pulse, digital controller/timer circuit 330 generates a trigger pulse on a trigger line 344.
Digital controller/timer circuit 330 also defines time intervals for controlling operation of the sense amplifiers in sense amplifier circuit 360. Typically, digital controller/timer circuit 330 will define an atrial blanking interval following delivery of an atrial pacing pulse, during which atrial sensing is disabled, as well as ventricular blanking intervals following atrial and ventricular pacing pulse delivery, during which ventricular sensing is disabled. Digital controller/timer circuit 330 will also define an atrial refractory period during which atrial sensing is disabled, this refractory period extending from the beginning of the A-V escape interval following either a sensed or paced atrial depolarization, and extending until a predetermined time following sensing of a ventricular depolarization or delivery of a ventricular pacing pulse. Digital controller/timer circuit 330 similarly defines a ventricular refractory period following ventricular sensing or delivery of a ventricular pacing pulse, which is typically shorter than the portion of the atrial refractory period following ventricular sensing or pacing. Digital controller/timer circuit 330 also controls sensitivity settings of the sense amplifiers 360 by means of sensitivity control 350.
Microcomputer circuit 302 controls the operational functions of digital controller/timer 324, specifying which timing intervals are employed, and controlling the duration of the various timing intervals, via data and control bus 306. Microcomputer circuitry contains a microprocessor 304 and associated system clock 308 and on processor RAM circuits 310 and 312, respectively. In addition, microcomputer circuit 302 includes a separate RAM/ROM chip 314. Microprocessor 304 is interrupt driven, operating in a reduced power consumption mode normally, and awakened in response to defined interrupt events, which may include delivery of atrial and ventricular pacing pulses as well as sensed atrial and ventricular depolarization. In addition, if the device operates as a rate responsive pacemaker, a timed interrupt, e.g., every two seconds, may be provided in order to allow the microprocessor to analyze the output of the activity circuit 322 and update the basic rate interval (A-A or V-V) of the device. In addition, the microprocessor 304 may also serve to define fixed or variable A-V escape intervals and atrial and ventricular refractory periods which may also decrease in duration along with decreases in duration of the basic rate interval. Similarly microprocessor 304 may define atrial and/or ventricular refractory periods which decrease in duration as a function of sensed or paced heart rate.
In
In one embodiment of the present invention illustrated in
In
The illustrated circuitry of
With reference to
Transmitters 400 can transmit the telemetry data through antenna 24, however, EMD 20 may be equipped with a compatible antenna or set of antennas that are arranged to avoid nulls or dead spots in reception, for example corresponding generally to that disclosed in the above-cited Villaseca et al. application or in U.S. Pat. No. 6,167,312 titled a “Telemetry System For Implantable Medical Devices” by Geodeke et al., which application is also incorporated herein by reference in its entirety. Transmission can be accomplished through time or phase multiplexing or any other multiplexing communications technology without departing from the spirit of the invention. Further, multiple antennas can be used, one for each transmitter, to avoid having to multiplex the transmissions. Receivers 402 can then receive transmissions 404 through antenna 28. IPG 10 may also employ, for example, an elongated antenna which projects outward from the housing of the IMD, as described in the cited Villaseca et al. application or may employ a coil antenna located external to the device housing as described in U.S. Pat. No. 6,009,350 issued to Renken, incorporated herein by reference in its entirety. Similar to EMD 20, IPG 10 could also use multiple antennas to avoid de-multiplexing of transmissions 404.
Transmitters 400 transmit uplink telemetry data to IPG 10 through transmissions 404. Transmitters 400 can be most any type of transmitter without departing from the spirit of the present teachings. Each transmitter 400 transmits generally the same data at generally the same time. However, each transmitter 400 transmits at a different frequency, which is discussed in more detail below. Receivers 402 receive transmissions 404. In some embodiments, each receiver 402 is paired to a transmitter 400, that is to say that each receiver 402 is adapted to receive the frequency of a transmitter 400. Receivers 402 can be most any type of receiver without departing from the spirit of the present teachings. Receivers 400 can then route the transmission data to microcomputer 302 through control bus 306. Microcomputer 302 then begins to process the transmission data as discussed above. Further, microcomputer 302 also begins to evaluate each incoming telemetry transmission for the transmission quality.
Microcomputer 302 utilizes software algorithms to evaluate the quality of the incoming transmissions 404 so IPG 10 can select an optimal (or best performing) telemetry communication link. In some embodiments, each transmission 404 has its own distinct frequency separated from other transmissions by a channel outside the band to insure no interference with the other transmissions 404. It is also helpful if transmissions 404 cover a wide range of frequencies to insure that any environmental effects or disturbances occurring in one frequency band does not affect any other frequency band due to frequency separation. The transmission quality assurance can be performed in a variety of ways including but not limited to determining the transmission with the largest signal strength, determining the transmission with the lowest data error signal to noise ratio, or utilizing other well known communication statistics. Once microcomputer 302 has made a determination which transmission has the best quality, then microcomputer 302 selects that receiver 402 as the primary input for all downlink telemetry transmissions. Establishing an initial telemetry communication session can happen in many forms including but not limited to simultaneous transmission or paired transmission and reception. Microcomputer 302 continues to monitor all of transmissions 404, continuously evaluating the quality of transmissions 404. If the selected transmission deteriorates in quality, microcomputer can instantly switch to the transmission having the best quality. This helps to insure the highest quality transmission is being received and helps to reduce frequency interference and fades. Additionally, microcomputer 302 could combine multiple receivers 402 and selects the highest frequency of data bits. This could be accomplished utilizing an algorithm such as
to select a predetermined number of receivers 402 and obtain the highest frequency of data bits with an algorithm. This algorithm is generally a voting scheme for microcomputer to choose 2 out of 3, 3 out of 5, or 4 out of 7 receivers.
With reference to
Similar to microcomputer 302, CPU 50 utilizes software algorithms to evaluate the quality of the incoming transmissions 504 so EMD 10 can select an optimal (or best performing) telemetry communication link. Similar to above, each transmission 504 has its own distinct frequency separated from other transmissions by a channel outside the band to insure no interference with the other transmissions 504. The transmission quality assurance can be performed similar to above. Once CPU 50 has made a determination which transmission has the best quality, then CPU 50 can select that receiver 500 as the primary input for all downlink telemetry transmissions 504. CPU 50 continues to monitor all of transmissions 504 continuously evaluating the quality of transmissions 504. If the selected transmission deteriorates in quality, CPU 50 can instantly switch to the transmission having the best quality.
With reference to
With reference to
In an embodiment, each of EMD 20 and IPG 10 could have one transmitter 700 & 706 and one receiver 702 & 704. During initial transmissions each transmitter 700 & 706 would transmit over a plurality of channels each having different frequencies. CPU 50 and microcomputer 302 could then evaluate transmissions 708 and 710 for quality and select a frequency based upon quality. The respective frequency chosen by CPU 50 and microcomputer 302 would then be sent back to IPG 10 and EMD 20. If either EMD 20 or IPG 10 were to have trouble with their selected frequencies then the selection process would be repeated and a new frequency(s) would be selected. In the embodiment shown in
With reference to
Thus, embodiments of the MULTIPLE BAND COMMUNICATIONS FOR AN IMPLANTABLE MEDICAL DEVICE are disclosed. One skilled in the art will appreciate that the present invention can be practiced with embodiments other than those disclosed. The disclosed embodiments are presented for purposes of illustration and not limitation, and the present invention is limited only by the claims that follow.