|Publication number||USRE42934 E1|
|Application number||US 11/541,521|
|Publication date||15 Nov 2011|
|Filing date||29 Sep 2006|
|Priority date||23 Jun 1995|
|Also published as||EP1133255A1, US6083248, WO2000030529A1, WO2000030529A9|
|Publication number||11541521, 541521, US RE42934 E1, US RE42934E1, US-E1-RE42934, USRE42934 E1, USRE42934E1|
|Inventors||David L. Thompson|
|Original Assignee||Medtronic, Inc.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (62), Referenced by (17), Classifications (16), Legal Events (3)|
|External Links: USPTO, USPTO Assignment, Espacenet|
This application is a CIP continuation-in-part of 09/045,275, filed Mar. 20, 1998, now abandoned U.S. Pat. No. 6,292,698, and which is a CON continuation of 08/494,218, filed Jun. 23, 1995, now U.S. Pat. No. 5,752,976.
The present invention relates to communication systems for communicating with an implanted medical device or device system, and more particularly, such a communication system that may function on a world wide basis at any time to communicate patient location, device monitoring data, device re-programming data and to allow for effective response to emergency conditions.
The following references were cited in commonly assigned, U.S. Pat. No. 5,683,432 for ADAPTIVE, PERFORMANCE-OPTIMIZING COMMUNICATION SYSTEM FOR COMMUNICATING WITH AN IMPLANTABLE DEVICE by S. Goedeke et al. to indicate the prior state of the art in such matters. In particular, in reed switch use U.S. Pat. No. 3,311,111 to Bowers, U.S. Pat. No, 3,518,997 to Sessions, U.S. Pat. No. 3,623,486 to Berkovits, U.S. Pat. No, 3,631,860 to Lopin, U.S. Pat. No. , 3,738,369 to Adams et al., U.S. Pat. No. 3,805,796 to Terry, Jr., U.S. Pat. No. 4,066,086 to Alferness et al.; informational type U.S. Pat. No. 4,374,382 to Markowitz, U.S. Pat. No, 4,601,291 to Boute et al.; and system U.S. Pat. No. 4,539,992 to Calfee et al., U.S. Pat. No. 4,550,732 to Batty Jr., et al., U.S. Pat. No, 4,571,589 to Slocum et al., U.S. Pat. No. 4,676,248 to Berntson, U.S. Pat. No. 5,127,404 to Wyborny et al., U.S. Pat. No. No. 4,211,235 to Keller, Jr. et al., U.S. patents to Hartlaub et al., U.S. Pat. No. 4,250,884, U.S. Pat. No. 4,273,132, U.S. Pat. No. 4,273,133, U.S. Pat. No. 4,233,985, U.S. Pat. No. 4,253,466, U.S. Pat. No. 4,401,120, U.S. Pat. No. 4,208,008, U.S. Pat. No. 4,236,524, U.S. Pat. No. 4,223,679 to Schulman et al., U.S. Pat. No. 4,542,532 to McQuilkin, and U.S. Pat. No. 4,531,523 to Anderson.
Over the years, many implantable devices have been developed to monitor medical conditions and deliver therapy to a patient. Such devices included electrical stimulation devices for stimulating body organs and tissue to evoke a response for enhancing a body function or to control pain, and drug delivery devices for releasing a drug bolus at a selected site. Other more passive implantable and wearable medical devices have been developed for monitoring a patient's condition.
We will refer to devices that are implantable as IMD's or simply MD's to indicate that they may be implantable or wearable. We will occasionally also refer to the device having GPS and transmitter for keeping in touch with the medical network or satellites as a belt worn device or simply a belt device, although it is understood that the requirement for the device is proximity to the patient with the medical device, (the IMD or MD), meaning it can be worn as a pendent, on the neck, wrist, ankle, or the like.
Chronically implanted cardiovascular devices for monitoring cardiovascular conditions and providing therapies for treating cardiac arrhythmias have vastly improved patients quality of life as well as reduced mortality in patients susceptible to sudden death due to intractable, life threatening tachyarrhythmias. As implanted device technology has grown more sophisticated with capabilities to discover, monitor and affect more patient conditions (including otherwise life threatening conditions) patients have enjoyed freedom from hospital or home confinement or bed rest. However, the improved mobility brings with it the need to maintain communications with the patient and the implanted device.
Early in the development of cardiac pacemakers, patient follow-up to monitor pacemaker operation was facilitated by telephonic transmissions of skin surface ECGs in real time to a physician's office employing such systems as the MEDTRONIC® TeleTrace® ECG transmitter. Over time, various patient worn, ambulatory ECG and device monitors have been developed for providing ECG data for remote analysis of cardiac arrhythmias. Also, the remotely programmable modes of operation of implantable medical devices increased, and programming methods improved.
In current arrhythmia control devices, (e.g. cardiac pacemakers, and pacemaker-cardioverter-defibrillators) a relatively wide range of device operating modes and parameters are remotely programmable to condition the device to diagnose one or more cardiac arrhythmia and deliver an appropriate therapy. In cardiac pacemakers, the pacing rate in one or both heart chambers is governed by algorithms that process the underlying cardiac rhythm as well as physiologic conditions, e.g. patient activity level and other measured variables, to arrive at a suitable pacing rate. The pacemaker operating modes and the algorithm for calculation of the appropriate pacing rate are programmed or reprogrammed into internal memory by accessing the implanted pacemaker's telemetry transceiver with an external programmer. Even the diagnosis of a tachyrhythmia requiring delivery of a treatment therapy and the therapies to be delivered may now be governed by operating modes and algorithm parameters that can be programmed into and changed using such a programmer.
Such implanted devices can also process the patient's electrogram and any measured physiological conditions employed in the diagnosis and store the data, for subsequent telemetry out on interrogation by the external programmer. The telemetered out data is analyzed and may be employed to establish or refine the operating modes and parameters by a doctor to adjust the therapies the device can deliver. In general, the manner of communicating between the transceivers of the external programmer and the implanted device during programming and interrogating is referred to as telemetry.
Initially, when programming techniques were first devised, the paramount concern addressed related to patient safety. Safeguards addressed the concern that the patient could be put at risk of inadvertent mis-programming of the implanted device, e.g. by stray electromagnetic fields. For this reason, and in order to avoid high current consumption that would shorten the implanted device battery life, telemetry operating range was extremely limited. In systems continuing to the present time, telemetry has required application of a magnetic field at the patient's skin over the implanted device to close a reed switch while RF programming or interrogating commands are generated to be received by the implanted device transceiver. The programming or interrogating commands are decoded and stored in memory or used to trigger telemetry out of stored data and operating modes and parameters by the implanted device transceiver.
As stated at the outset, one of the rationales and attributes of implanted medical devices of the type described, is that the patient is allowed to be ambulatory while his medical condition is monitored and/or treated by the implanted medical device. As a further safety precaution, “programmers” (devices capable of programming all the operating modes or functions of the implanted device and for initiating interrogation through the telemetry system) are generally not provided to the patients. Patients are periodically examined and device interrogation is conducted by the physician using the external “programmer” during follow-up visits to the physicians office or clinic. This limits the frequency of monitoring and may require certain patients to remain close to the physician's office, and/or limit their life style options (i.e., remain in or near their home).
Emergency conditions (device failure, physiologic variable changes resulting in inappropriate therapy, transient conditions/problems) may require additional monitoring or follow-up.
The short range of conventional device telemetry is itself viewed as unduly limiting of a patient's mobility. In the medical monitoring field, longer range, continuously accessible telemetry has been sought and systems for doing so have been proposed. In U.S. Pat. No. 5,113,869 for example, an implanted ambulatory ECG patient monitor is described that is provided with longer range telemetry communication with a variety of external accessory devices to telemeter out alarm signals and ECG data and to receive programming signals. The high frequency RF signals are encoded, including the implanted device serial number, to ensure that the communication is realized only with the proper implanted device and that it is not mis-programmed.
Telemetry communication with other implanted devices, particularly drug infusion pumps or pacemaker-cardioverter-defibrillator devices, to initiate or control their operation is also disclosed. Communication between the implanted AECG monitor and an external defibrillator is also suggested through low current pulses transmitted from the defibrillator paddles through the body link in order to condition the implanted AECG monitor to provide telemetry signals to the external defibrillator.
One of the external devices disclosed in the 869 patent is a wrist worn, personal communicator alarm for responding to a telemetered out signal and emitting a warning to the patient when the implanted AECG monitor has detected an arrhythmia. The patient is thereby advised to take medications or contact the physician or to initiate external cardioversion. The personal communicator alarm also includes a transceiver and may also be used to control certain functions of the implanted AECG monitor. A further, belt worn “full disclosure recorder” is disclosed with high capacity memory for receiving and storing data telemetered out of the implanted AECG monitor when its memory capacity is exhausted.
A remote, external programmer and analyzer as well as a remote telephonic communicator are also described that may be used in addition to or alternately to the personal communicator alarm and/or the full disclosure recorder. The programmer and analyzer may operate at a distance to the implanted AECG monitor to perform programming and interrogation functions. Apparently, the implanted AECG may automatically transmit a beacon signal to the programmer and analyzer to initiate an interrogation function to transmit data to the programmer and analyzer on detection of an arrhythmia or a malfunction of the implanted AECG monitor detected in a self-diagnostic test. Or by setting a timer in the personal communicator alarm, the implanted AECG monitor may be automatically interrogated at preset times of day to telemeter out accumulated data to the telephonic communicator or the full disclosure recorder. The remote telephonic communicator may be part of the external programmer and analyzer and is automatically triggered by the alarm or data transmission from the implanted AECG monitor to establish a telephonic communication link and transmit the accumulated data or alarm and associated data to a previously designated clinic or physician's office through a modem.
The combination of external devices provided to a given patient is at the discretion of the physician. It is preferred that at least the patient be provided with the external programmer and analyzer including a communications link.
A similar programmer/interrogator for an implanted pacemaker-cardioverter-defibrillator device is disclosed in U.S. Pat. No. 5,336,245, wherein the data accumulated in the limited capacity memory implanted device is telemetered out to a larger capacity, external data recorder. The accumulated data is also forwarded to a clinic employing an auto-dialer and FAX modem resident in a personal computer-based, programmer/interrogator.
In each of these disclosed systems, presumably, the patient is able to communicate with the physician's office or clinic contemporaneously with the transmission of data by modem. In all such telemetry systems for programming an operating mode or parameter or interrogating accumulated patient data or device operating modes and parameters, the patient is located within a short range, typically within sight, of the remote devices, particularly the remote programmer. If the patient is out of range of the programmer and an attached telephone system, the security of the patient is diminished. Consequently, at risk patients are advised to remain close by to the programmer and telephone for their safety.
The performance over time of implanted medical devices in the implant population is informally monitored by the periodic patient follow-ups employing the telemetry system conducted by the physician and the reporting of device malfunctions from the physician to the device manufacturer. Moreover, operating algorithm improvements developed over time to counter adverse device performance reports or to simply improve device function are provided to physicians to employ in re-programming the implanted devices at the next patient follow-up.
Although significant advances have been made in allowing patient's who are dependent on implanted medical devices to be ambulatory and still allow for monitoring of the device operation or the patient's underlying condition, a need remains to expand patient security while allowing the ambulatory patient to range widely. Telemetry systems in current use require prepositioning of the telemetry head over the implanted medical device, although the telemetry systems described above may offer the possibility of telemetry at a distance of several meters. In any case, such telemetry systems cannot communicate patient device information (uplink telemetry) or accept re-programming (downlink telemetry) when the patient is in remote or unknown locations vis-a-vis the physician of medical support network. In certain patient conditions, the inability to communicate with the medical implant can significantly increase patient mortality or cause serious irreversible physical damage.
It is therefore an object of the present invention to provide a patient data communication system for world wide patient location and data and re-programming telemetry with a medical device implanted in the patient.
It is a further object of the present invention to address the above described problems by providing such a communication system allowing the device and/or patient to communicate with support personnel at any time and from any place.
It is a still further object of the invention to allow the medical device and patient to be accurately and automatically located enabling prompt medical assistance if necessary.
These and other objects of the invention are realized in a first aspect of the invention in a system for communicating patient device information to and from a medical device implanted in an ambulatory patient and with a remote medical support network comprising: an implanted device telemetry transceiver within the implanted medical device for communicating data and operating instructions to and from the medical device in a coded communication, the implanted device telemetry transceiver having a transceiving range extending outside the patient's body a predetermined distance sufficient to receive and transmit coded telemetry communications at a distance from the patient's body; and an external patient communications control device adapted to be located in relation to the patient within the device transceiving range having a system controller for facilitating communications, an implant wireless interface including a control device telemetry transceiver for receiving and transmitting coded communications between the system controller and the implant device telemetry transceiver, a global positioning system coupled to said system controller for providing positioning data identifying the global position of the patient to the system controller; communications means for communicating with the remote medical support network; and communications network interface means coupled to the system controller and the communications means for selectively enabling the communications means for transmitting the positioning data to the medical support network and for selectively receiving commands from the medical support network.
Preferably the system further comprises an external patient communications device adapted to be located in relation to the patient within the device transceiving range for providing patient voice and data communications with the system controller, so that patient voice communications may be effected through the communications interface means and the communications means with the remote medical support network.
Furthermore, the communications interface means may effect two-way communication of voice and/or data between the remote medical support network and the patient communications device and implanted device telemetry transceiver by inclusion of cards for accessing one or all of the communications means including a cellular telephone network and a satellite-based telecommunication network, a hard-wired telephone communications system and/or a hard-wired interface for computer based system for local area and for modem-based e-mail communications systems. The cards are preferably interchangeable to fit the application needed by the particular patient.
The communications interface means preferably include two-way voice communications between the patient and the medical support network and two-way data communications for selectively receiving interrogation or programming commands from the medical support network to interrogate or program the operation of the device operation and to interrogate patient location.
The present invention allows the residential, hospital or ambulatory monitoring of at-risk patients and their implanted medical devices at any time and anywhere in the world. The medical support staff at a remote medical support center may initiate and read telemetry from the implanted medical device and reprogram its operation while the patient is at very remote or even unknown locations anywhere. Two-way voice communications with the patient and data/programming communications with the implanted medical device may be initiated by the patient or the medical support staff. The location of the patient and the implanted medical device may be determined and communicated to the medical support network in an emergency. Emergency response teams can be dispatched to the determined patient location with the necessary information to prepare for treatment and provide support after arrival on the scene.
Enhancements available due to technological improvement are included to provide additional benefits to what was available in U.S. Pat. No. 5,752,976 from which these stem.
These improvements include enhancements to the ability to locate the user of the inventive device by dynamic relative location (also called dynamic relative navigation), time slicing of patient device signals to the provider network to improve the normal, non-emergency communications features, clock updating in the patient devices using high accuracy clock signals available from the satellite systems used in GPS which can enhance the fine granularity of available time slicing of patient device communications signals, the use of Enhanced 911 (called E-911, which will permit triangulation on the cell phone callers location through the E-9 11 system) or other emergency telephone systems (including current 911 systems), dead reckoning , improved GPS systems like DGPS, reporting changed location if a larger than some predetermined distance is traversed by the patient device, cell phone triangulation and emergency location, all to supplement contact location information, and the transmission of raw data to be position calculated at remote or emergency vehicle locations.
These and other objects, advantages and features of the present invention will be more readily understood from the following detailed description of the preferred embodiments thereof, when considered in conjunction with the drawings, in which like reference numerals indicate identical structures throughout the several views, and wherein:
The Global Communications and Monitoring System (GCMS) of the present invention provides a means for exchanging information with and exercising control over one or more medical devices implanted within the body of a patient employing the patient communications control device. The GCMS in its most comprehensive form of
Improvements in technology are now available since the filing of the parent applications hereto that allow for enhancement of the features first described. Also, some additional problems and opportunities have been identified and addressed in this application. The improvement in GPS accuracy provided by DGPS systems and the development of cell phone location techniques have provided new opportunities to enhance patient location. The fact that behind some barriers, like trees, buildings, and so forth block some GPS signals has provided the inventor to improve the original disclosure. Likewise, some new thinking about how to improve the ability to find patients, including dead reckoning intelligence being added to the patient devices and use of time slice updates to the medical provider system have increased the usefulness of the invention.
The system is not intended to be limited to such remote use by a free ranging patient and is intended to also be used when the patient is less mobile. In the sub-system or second variation illustrated in
At least one implanted medical device 12 possesses a transceiver of the type known in the art for providing two-way communication with an external programmer. The encoded communication may be by the RF transmission system such as is described in the above-referenced '869 patent or by using spread spectrum telemetry techniques described in U.S. Pat. No. 5,381,798 to Burrows or by the system disclosed in the above-referenced U.S. Pat. No. 5,683,432 or any of the known substitutes. The telemetry technique employed and the transceiver of the implanted medical device 12 have enough range to communicate between the transceiver in the implant wireless interface 22 in the remote patient communications control device 20 and the implant (12 . . . 14). The system disclosed in the above-referenced U.S. Pat. No. 5,683,432 may be employed to increase the accuracy and efficiency of the uplink and downlink telemetry.
The IPG circuit 300 of
Sensed atrial depolarizations or P-waves that are confirmed by the atrial sense amplifier (ASE) in response to an A-sense are communicated to the digital controller/timer circuit 330 on ASE line 352. Similarly, ventricular depolarizations or R-waves that are confirmed by the ventricular sense amplifier in response to a V-sense are communicated to the digital controller/timer circuit 330 on VSE line 354.
In order to trigger generation of a ventricular pacing or VPE pulse, digital controller/timer circuit 330 generates a trigger signal on V-trig line 342. Similarly, in order to trigger an atrial pacing or APE pulse, digital controller/timer circuit 330 generates a trigger pulse on A-trig line 344.
Crystal oscillator circuit 338 provides basic timing clock for the pacing circuit 320, 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 may reset the operative state of the device in response to a low battery condition. Reference mode circuit 326 generates stable voltage and current references for the analog circuits within the pacing circuit 320. Analog to digital converter (ADC) and multiplexor circuit 328 digitizes analog signals. When required, the controller circuit will cause transceiver circuit 332 to provide real time telemetry of cardiac signals from sense amplifiers 360. Of course, these circuits 326, 328, 336, and 338 may employ any circuitry similar to those presently used in current marketed implantable cardiac pacemakers.
Data transmission to and from the external programmer of the patient communications control device of the preferred embodiment of the invention is accomplished by means of the telemetry antenna 334 and an associated RF transmitter and receiver 332, which serves both to demodulate received downlink telemetry and to transmit uplink telemetry. Uplink telemetry capabilities will typically include the ability to transmit stored digital information, e.g. operating modes and parameters, EGM histograms, and other events, as well as real time EGMs of atrial and/or ventricular electrical activity and Marker Channel pulses indicating the occurrence of sensed and paced depolarization in the atrium and ventricle, as is well known in the pacing art. The IPG transceiver system disclosed in the above-referenced U.S. Pat. No. 5,638,432 may be employed to provide the uplink and downlink telemetry from and to the implanted medical device in the practice of the present invention.
Control of timing and other functions within the pacing circuit 320 is provided by digital controller/timer circuit 330 which includes a set of timers and associated logic circuits connected with the microcomputer 302. Microcomputer 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 302 contains a microprocessor 304 and associated system clock 308 and on-processor RAM and ROM chips 310 and 312, respectively. In addition, microcomputer circuit 302 includes a separate RAM/ROM chip 314 to provide additional memory capacity. Microprocessor 304 is interrupt driven, operating in a reduced power consumption mode normally, and awakened in response to defined interrupt events, which may include the A-trig, V-trig, ASE and VSE signals. The specific values of the intervals defined are controlled by the microcomputer circuit 302 by means of data and control bus 306 from programmed-in parameter values and operating modes.
If the IPG is programmed to a rate responsive mode, the patient's activity level is monitored periodically, and the sensor derived V-A escape interval is adjusted proportionally. A timed interrupt, e.g., every two seconds, may be provided in order to allow the microprocessor 304 to analyze the output of the activity circuit (PAS) 322 and update the basic V-A escape interval employed in the pacing cycle. The microprocessor 304 may also define variable A-V intervals and variable ARPs and VRPs which vary with the V-A escape interval established in response to patient activity.
Digital controller/timer circuit 330 thus defines the basic pacing or escape interval over a pacing cycle which corresponds to a successive A-V interval and V-A interval. As a further variation, digital controller/timer circuit 330 defines the A-V delay intervals as a SAV that commence following a sensed ASE and a PAV that commences following a delivered APE, respectively.
Digital controller/timer circuit 330 also starts and times out intervals for controlling operation of the atrial and ventricular sense amplifiers in sense amplifier circuit 360 and the atrial and ventricular amplifiers in output amplifier circuit 340. Typically, digital controller/timer circuit 330 defines an atrial blanking interval following delivery of an APE 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 also defines an atrial refractory period (ARP) during which atrial sensing is disabled or the ASE is ignored for the purpose of resetting the V-A escape interval. The ARP extends from the beginning of the SAV or PAV interval following either an ASE or an A-trig and until a predetermined time following sensing of a ventricular depolarization or triggering the delivery of a VPE pulse as a post-ventricular atrial refractory period (PVARP). A ventricular refractory period (VRP) may also be timed out after a VSE or V-trig. The durations of the ARP, PVARP and VRP may also be selected as a programmable parameter stored in the microcomputer 302. Digital controller/timer circuit 330 also controls sensitivity settings of the sense amplifiers 360 by means of sensitivity control 350.
The illustrated IPG block diagram of
At the medical support network 50, a base station is provided to be in the communication link with the monitor 30 or the patient-worn communications device 40. The base station is preferably a microprocessor-based system that includes the software and hardware needed for voice communication with the patients to locate the patient and to interrogate and program the implanted medical devices using the communications interface links incorporated into the GCMS. Alternatively, a system can employ a device similar to the base station as a mobile unit in an emergency vehicle like an ambulance or helicopter as illustrated in
Patient link 26 is a custom designed circuit that preferably has a microphone and speaker, associated drivers, a visual indicator (i.e. light or LCD display), and a patient activator. In the embodiment where the patient link 26 is physically part of the patient communications control device 20, the patient link also includes interface circuitry to buses 36 and 38 as shown in
Much improved location finder systems are available from Trimble Navigation and Leica as described below, and these could of course be used to effectuate the improved location of and contacting of the patient system. For most situations basing the receiver on the DGPS in the AgGPS 132 from Trimbal would be sufficient, but including the signal interference capabilities of the 400 rsi and Dsi devices may prove advantageous. By incorporating or using these or even the Leica systems now available to determine location to a claimed 1 cm accuracy, sending the location information from the patient to the emergency locator vehicle could aid in locating a patient more quickly by indicating the direction and distance to that location in the emergency vehicle's base/mobile station display(one example illustrated in
Continuing specifically with the first variation of
In accordance with one aspect of the invention, the system controller 24 is coupled to a GPS receiver 60 via bus 58 for receiving patient positioning data from an earth satellite 62. The GPS receiver 60 may use current systems such as the Mobile GPS™ (PCMCIA GPS Sensor) provided by Trimble Navigation, Inc. of Sunnyvale, California or Retki GPS Land Navigation System provided by Liikkura Systems International, Inc. of Cameron Park, Calif., or other similar systems. The GPS receiver 60 may be actuated by a command received through the system controller 24 from the medical support network, in the case of an emergency response. In the case of a non-emergency, periodic follow-up, the GPS receiver 60 may be enabled once an hour or once a day or any other chosen interval to verify patient location. The determined location may be transmitted to the medical support network and/or stored in RAM in the system controller 24. To maintain patient location information in the absence of GPS signals (such as inside metal buildings), a three-axis accelerometer 72 or other position/motion determining device can be incorporated into the system. By knowing original position (from the last valid GPS point), time (from the internal clock) and acceleration (motion), patient position can be calculated from the three axis coordinates realized from each accelerometer output calculated in each case from:
where x(0) is the initial position stored in memory for each axis, t is time, a is acceleration and v is velocity.
In the free ranging embodiment of
Either or both PCMCIA cards 64 and 66 may be provided and they are coupled with the voice and communications network 28 via buses 68 and 70, respectively. When both are provided, access to the communications satellite link 80 is automatically obtained when a link to a cellular transceiver 82 is not possible.
It should be noted that “Iridium” manages cellular location of each subscriber in the network at all times. The subscriber unit, which in this invention would be incorporated into the device 20 (or communicatively connected to it) identifies itself and its location on a periodic basis to the system manager. In any system chosen it is expected that the control and communications device will have to report in to a management system regarding its location on a periodic or at least on a changed location basis or both. The implanted device need not be concerned about this activity and need not use any of its battery power to accomplish it since only the external device 20 (in the preferred embodiments) needs to be involved in such location communication. Only by knowing the patient location can the medical system 50 communicate to the implanted device at any time it wants or needs to. Accordingly, if emergency communications are expected short intervals between reporting in are recommended.
By checking in, the patient's external communications device would act like a cellular phone, answering incoming medical system messages broadcast into the cell in which it is located.
For patient convenience, a personal communicating device may incorporate the controller/communicator that communicates between implanted device(s) and the external world. In this way it could look like and operate as a personal communicator or cellular phone and reduce patient psychological discomfort. It should also be recognized that if the cellular telephone system manages all communication functions between the outside-the-patient-system and the medical community system, the implanted device need only be able to communicate with the cellular communications product.
The patient communications control device 20 of
Power consumption can be significantly reduced by powering up the communication and satellite circuitry periodically for a short period of time to re-acquire a GPS location and/or look for requests for data or status from the medical support network 50. This system power consumption reduction can greatly enhance battery lifetime requiring less frequent battery replacement or recharging, in the case of a rechargeable battery configuration. As an alternate to using a management system to maintain a patient location data based on patient's device periodic check-in each GCMS system for each patient could have a specific time slot (for example, 30 seconds) non-overlapping with other GCMS systems to power up, acquire location coordinates from the GPS system and be alert for a call from the medical support network 50. Periodically (for example, once per day), the medical support network 50 would reset/recalibrate the system clock in system controller 24 from the atomic clock in the GPS satellite system. This would ensure that no specific GCMS system clock would drift out of range of its allotted time slot and be unavailable for reception or drift into an adjacent time slot. Other time dividing schemes used in other arts may also be employed to maximize battery life for any system.
Time slicing the power up communications can increase the number of available time slots in a local system if the time slices are small and accurately maintained. To do this, the patient's system would simply update it's internal clock with reference to the atomic clock signal broadcast via the satellite to maintain accurate timekeeping for itself.
Turning to the second variation of the invention illustrated in
In the embodiment illustrated in
As described above, implantable devices such as 12 . . . 14 include telemetry transceivers with range suitable for communicating over a short range to the implant wireless interface 22 of the modified patient communications control device 20′ within stand alone monitor 30. This remote link offers advantages over patient-worn electrodes or programming heads required in the standard skin contact telemetry and monitoring used at present. Skin contact is difficult to maintain, as the adhesive for the electrodes or heads fails in time, skin irritation is often a problem and inadvertent removal of electrodes is also prevalent. Moreover, the EGM and other body condition monitoring capabilities of advanced implanted medical devices can be taken advantage of to substitute for in-hospital monitoring, e.g. Holter monitoring of the patient's electrogram. The electrogram and/or other sensor derived data, e.g. pressure, temperature, blood gases or the like, stored by the implanted device can be transmitted out continuously or on periodic automatic telemetry command and sent by the communications link to the remote or hospital medical support network 50.
In either environment of
The variations and embodiments of the GCMS of the present invention provides comprehensive monitoring of implanted medical devices independent of the geographic mobility of the patient using the devices, obviating the need for the patient to return to a designated follow-up monitoring site or clinic. Moreover, it allows determination of the patient's geographic location via the GSS 62 while providing simultaneous two-way communication with devices and the patient when desired. In addition to emergency response and routine patient management, the GCMS facilitates medical device clinical studies, providing data collection at one central site from all study patients without requiring their active involvement or clinic visits. This is especially useful for conducting government-mandated post-market surveillance studies. Should there be need to upgrade or change the behavior of implanted devices the global system allows a central monitoring site to revise all involved implants anywhere in the world by transmitting new programming instructions to every device (assuming appropriate governmental authorities and the patients' physicians have agreed to the need for such changes). The patient need not be directly involved in this updating and need not be aware of the actual process.
A continuous and automatic medical monitoring service could be implemented to shorten response time for emergency medical situations or device events signifying patient difficulty. For example, a patient having an implanted cardioverter/defibrillator may be subjected to multiple defibrillation shocks, due to an underlying arrhythmia that cannot be converted by the shocks. To achieve this in the first variation of
Moreover, patient follow-up and periodic monitoring (i.e. monthly, quarterly, etc.) of the medical implant's stored data and status could be done automatically and be completely transparent to the patient. The medical support team would even have the capability of changing the implanted device settings or programming with complete transparency to the patient (or alternatively, voice or warning signals may be used to identify impending programming).
Interactions with the implanted device and patient may be totally transparent to the patient, e.g., routine location checks to determine if the patient is in proximity sufficiently with the patient communications device to interrogate the implanted device or for follow-up data collection from the implanted device's monitoring memory or reprogramming of operations of the device effected at night while the patient sleeps. Or the patient may be included in the process, even to the extent that voice communications from the staff at the support network to instruct or reassure the patient are received in the patient communications control device.
The following chart details the communications pathways and the data that can travel over them are detailed in the following chart.
Medical Device(MD) Data to
a. Serial No. or other unique ID data
b. Patient Condition
c. Device status data
d. Device Sensor data
e. Coordinating data
Belt Device to Medical
a. Commands to MD(change a program
request a program or data, etc.)
b. Coordinating data (ex. outside
Network Data to Belt Device
a. Commands to Belt Device or MD
b. Coordinating data(ex. DGPS)
Belt Device to Network
a. Belt Device data (which includes all
data from the MD and Belt Device
generated data including Dynamic
Relative Reference, and GPS and DGPS
as required or requested.)
Wake-ups, acknowledgments, protocol, error correcting, and handshaking all as designed for each component to component communication. It should be noted that Network includes for example any number of nodes in a telephone system that are part of the health care provider network, or any specific one of such nodes.
Using these communications features we can enhance the functionality available to the medical community for using these devices, while at the same time providing enhanced location of patients in emergency situations.
In particular, we use the enhancements of the GPS system called DGPS to more accurately identify the patient location. We also use on-board automatic dead reckoning facilities in the belt worn or in the IMD itself to provide update control and location information relative to a last DGPS or GPS location. We also can provide interaction with cellular telephony systems that can now be used to provide location information as well.
To reduce the amount of information processing that has to be done in the belt worn or IMD, we can take advantage of the nature of the GPS data itself. This data can be represented as follows. The table illustrates a variable length data transmission from the patient communications control device 20 (or 20′) to the remote medical support network 50, for example.
DATA TABLE: Byte Label Description 0 Sync flag A hex value to identify the start to receiver (usually FF) 1-2 Length of Data integer indication of number of bytes to follow 3-6 Patient ID code Unsigned long integer value 7-8 GPS FOM Figure Of Merit, calculated by GPS (integer value, depends on number of satellites in view) 9-10 GPS GDOP Geometric Dilution of Precision calculated by GPS (integer value, includes the time correction data based on the satellite broadcast atomic clock data) 11-18 GPS Latitude IEEE double precision format 19-26 GPS Longitude IEEE double precision format 27-n ECG/physiologic number of bits dependent on digitization signal/device status, rate and what data is being sent etc. n + 1 LRC Longitudinal Redundancy Check data and ECC data to correct errors in transmission.
When using the system to locate patients, the Contact Patient software module contains two identical arrays that form the binary data packets. While one packet is collecting real time data from the ADC 328 of implantable device 300 and the result of a GPS calculation, the other is communicating to the base station. Once every second the packets change function (commonly called double buffering). Real time displayed data is delayed by one second. The actual data transmission time depends on the amount of data, which is set by the digitization rate and the baud rate achieved over the wireless link between devices. Typically the table full of data would be transferred in a third of a second.
Alternatively, to save power in the patient worn belt and IMD devices, the use of the GPS Latitude and Longitude calculations need not be made. These could be calculated in a computer in a rescue vehicle (
Referring now to
The satellite 102 could be any of the GPS satellites, and the hospital or clinic 103 could be any medical facility. The personal system of the patient 104, may be worn for example on a belt or pendant or by other means kept near his body, as preferably two parts, the medical device MD (104a) and the belt worn device consisting of the programmer type communicating module PMD 104b for communicating with the medical device 104a, the telecom unit 104d for communicating with local telephony systems through wireless cell phone type technologies, and the DGPS or GPS unit 104c, which receives the satellite data and data from fixed base stations like station 101.
Referring now to
The data in the interchange between the mobile finding device 106 and the patient belt worn device 104 can be in many forms, but preferably we would use a data format like in the DATA TABLE, above.
Improvements in the flexibility of how to access a patient in distress or for location of any other person using a device such as 140 in
For example, in the United States, there is a new FCC proposed rule for broadband personal communications services carriers to comply with section 103 of the Communications Assistance for Law Enforcement Act, so many competing systems for location of cell phones will be available to supplement the finding features of this invention. It is believed that nearly all cell phone systems will be able to locate their users within 15 meters under this initiative. While this initiative is related to law enforcement activities primarily, it's use for medical emergencies should not be proscribed. There is also an initiative to have emergency calls to the Emergency 911 (E911) system from cell phones activate location information for the emergency response services to be more effective. Finally, if the medical device (104a of
Time slice updating of the status of a device like that of 104 in
An additional feature this inertial navigation system can provide is to initiate a transmission to the provider system in the event the patient moves greater than a set distance, say 100 yards. The supplementation of a dead reckoning system beyond the DGPS or GPS provides for a second source for checking whether the patient has moved so the device should function through a GPS outage. Such a system could keep track of Alzheimer's patients with minimal supervision, for example.
Because of its current level of accuracy, wherever we can we would prefer to rely on the data from the modern DGPS systems for dynamic relative navigation. Examples of systems currently taught include those described in U.S. Pat. No. 5,689,431, and U.S. Pat. No. 5,680,140, and U.S. Pat. No. 5,583,517, all incorporated herein by this reference. Triangulation techniques of U.S. Pat. No. 5,784,339, and spread spectrum techniques of U.S. Pat. No. 5,583,517, both also incorporated by reference, may also be used if desired.
Step D has the system checking the high accuracy clock for comparison to the running real time clock in the patient local device or devices, such as the system 104 of
In Step E, the system on the patient needs to check to see if the time from the properly updated real time clock is appropriate for it to send data, and if so, to activate the part of the system that communicates the data to the medical provider system. Otherwise if the time is not right, it can go back to Step A, and let the processor power stay off until the next value of interest is seen from the real time clock. (A description of power cycling to save battery life is found in U.S. Patent No. 5,592,173, incorporated by this reference, and a description of use of this in a vehicle location GPS system is in U.S. Pat. No. 5,777,580, also incorporated by this reference).
For communication between an implanted device and an externally worn patient device, common telemetry techniques presently used by any pacemaker manufacturer may be employed, as well as less evident techniques such as is described in the Funke Body Bus of U.S. Pat. No. 4,987,897, or his acoustic bus, in U.S. Pat. No. 5,113,859, both incorporated herein by this reference.
Variations and modifications to the present invention may be possible given the above disclosure. Although the present invention is described in conjunction with a microprocessor-based architecture, it will be understood that it could be implemented in other technology such as digital logic-based, custom integrated circuit (IC) architecture, if desired.
While there has been shown what are considered to be the preferred embodiments of the invention, it will be manifest that many changes and modifications may be made therein without departing from the essential spirit of the invention. It is intended, therefore, in the following claims to cover all such changes and modifications as may fall within the true scope of the invention.
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|U.S. Classification||607/30, 607/32, 607/60|
|International Classification||A61N1/36, A61B5/00, A61N1/372|
|Cooperative Classification||A61B5/0031, A61B2560/0295, A61B2505/07, A61B5/686, G06F19/3418, A61B5/1112, A61N1/37282|
|European Classification||A61B5/11M, G06F19/34C, A61B5/00B9|
|4 Jan 2012||FPAY||Fee payment|
Year of fee payment: 12
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