A system for communicating with a medical device implanted in an ambulatory patient and for locating the patient in order to selectively monitor device function, alter device operating parameters and modes and provide emergency assistance to and communications with a patient. The implanted device includes a telemetry transceiver for communicating data and operating instructions between the implanted device and an external patient communications control device that is either worn by or located in proximity to the patient within the implanted device tranceiving range. The control device preferably includes a communication link with a remote medical support network, a global positioning satellite receiver for receiving positioning data identifying the global position of the control device, and a patient activated link for permitting patient initiated personal communication with the medical support network. A system controller in the control device controls data and voice communications for selectively transmitting patient initiated personal communications and global positioning data to the medical support network, for initiating telemetry out of data and operating commands from the implanted device and transmission of the same to the medical support network, and for receiving and initiating re-programming of the implanted device operating modes and parameters in response to instructions received from the medical support network. The communications link between the medical support network and the patient communications control device may comprise a world wide satellite network, hard-wired telephone network, a cellular telephone network or other personal communications system. Methods and apparatae are also described that enhance the ability of the medical system to find patients and to get reports on patient and medical device status, and even update medical device programming using such facilities, and others described in detail within.

Patent
   RE42934
Priority
Jun 23 1995
Filed
Sep 29 2006
Issued
Nov 15 2011
Expiry
Jun 23 2015
Assg.orig
Entity
Large
28
62
all paid
21. A method of monitoring a patient having a transceiver associated therewith and an implanted medical device in communication with said transceiver comprising;
receiving a command via a medical support network communicatively coupled to said transceiver;
monitoring said implanted medical device in accordance with said command, including monitoring the implanted medical device for an alarm condition associated with either a lack of signal over a predetermined period of time or for an alarm signal generated by said implanted medical device; and
if either said alarm signal is received or if said lack of signal exists over said predetermined period of time,
automatically initiating an emergency telephone call by said transceiver to a node on a telephone network indicating an said alarm condition to said node.
0. 55. A method of monitoring a patient having a transceiver associated therewith and an implanted medical device in communication with the transceiver comprising:
receiving a command via a medical support network communicatively coupled to the transceiver;
monitoring the implanted medical device in accordance with the command, including monitoring the implanted medical device for an alarm condition associated with either a lack of signal over a predetermined period of time or an alarm signal generated by the implanted medical device; and
if either the alarm signal is received or if the lack of signal exists over the predetermined period of time,
automatically initiating an emergency telephone call by the transceiver to a node on a telephone network indicating the alarm condition to the node and transmitting patient data to a medical network.
0. 63. A method of monitoring a patient having a transceiver associated therewith and an implanted medical device in communication with the transceiver comprising:
receiving a command via a medical support network communicatively coupled to the transceiver;
monitoring said implanted medical device in accordance with the command or responsive to a patient activated command, including monitoring the implanted medical device for an alarm condition associated with either a lack of signal over a predetermined period of time or an alarm signal generated by the implanted medical device; and
if either the alarm signal is received or if said lack of signal exists over the predetermined period of time,
automatically initiating an emergency telephone call by said transceiver to a node on a telephone network indicating the alarm condition to said node and transmitting patient data to a medical network.
22. A method of operating an emergency patient location system comprising,
providing said system with patients having implanted medical devices and transceiver units for monitoring communications from said implanted medical devices,
providing said transceiver units with means to receive gps data and to store said gps data,
providing said transceiver units with telecommunications equipment,
awaiting the development of emergency conditions to be reported by said transceiver units to said system across telephonic communications pathways,
dispatching emergency mobile units having receiver means tuned to receive signals from said transceiver unit reporting said emergency condition,
reporting from said transceiver unit location information,
receiving said location information in said emergency mobile unit and
employing said location information by said emergency mobile unit to locate the patient having the reported emergency.
7. Emergency response system for receiving location information from a transceiver unit in proximity to a patient with an implantable medical device in communication with said transceiver unit, said emergency response system comprising;
at least one mobile unit operational on an emergency basis for receiving location information from said transceiver unit and having a gps system and a computer system therein, such that said mobile unit gps system produces data related to a present location of said mobile unit and makes said data related to said present location of said mobile unit available to said computer system and said mobile unit computer system comprises processor means for processing said received location information from said transceiver unit and said data related to the present location of said mobile unit to produce an indication of the relative position of said transceiver unit to said mobile unit, and
a base station for receiving through a telephone system a current location representation from said transceiver unit along with status information related to an implantable device implanted within a patient associated with said transceiver unit.
1. A patient monitoring system comprising:
a transceiver unit to be located in immediate proximity to a patient's body for communicating with a device implanted in the patient's body and with a telephone system outside the patient's body,
the transceiver unit comprising,
a gps location system for receiving satellite transmitted information from a set of earth orbiting satellites,
an imd receiving telemetry circuit means for receiving telemetry from said implanted device,
a memory circuit for storing data relating to data received from said implanted device and from said earth orbital satellite,
telecommunications module for communication through wireless telephonic channels to said telephone system,
real time clock circuit producing an output signal for a real time clock,
transmission initiation processor for generating an automatic transmission over said telecommunications module through said wireless telephonic channels containing information related through said implantable device to said transceiver unit, said automatic transmission to occur at a set of periodically occurring fixed times, and
real time clock circuit update processor for interpreting received satellite transmitted information and providing an update for the real time clock circuit based on said satellite transmitted information so that said transmission initiation processor can operate within an extremely accurately clocked time slice.
8. Method for operation of a transceiver unit for wearing on a person having location means and means for communicating with an implant and with a telephone network comprising:
providing a telemetric communications pathway between an implanted medical device(imd) and a patient word device(PWD) to facilitate the transfer from the imd to the PWD of data relating to any of the following information types: a. Ser. No. or other unique ID data, b. patient Condition, c. device status data, d. device Sensor data, and/or e. coordinating data,
providing a telemetric communications pathway between an imd and a PWD to facilitate the transfer from the PWD to the imd of data relating to any of the following information types: a. commands and /or b. Coordinating data,
providing a telemetric communications pathway between a node on a telephone network and said PWD and between a satellite gps system and said PWD so as to facilitate the transfer of any of the following information types from said node and/or said satellite gps system to said PWD: a. command data and/or coordinating data, and
providing a telemetric communications pathway between a node on a telephone network and said PWD so as to facilitate the transfer of any of the following information types from said PWD to said node: PWD device data including any data received by the PWD from the imd and/or any sensor data that may be developed and stored by the PWD and/or PWD status data and/or Dynamic Relative Reference data from a dead reckoning system associated with said PWD, and gps and DGPS which may be stored by the PWD.
26. A system for communicating with a medical clinic implanted in an ambulatory patient and for locating the patient to selectively monitor the functions of the medical clinic and provide assistance to and communications with the patient, the system comprising:
an implanted device telemetry transceiver within the implanted medical clinic for communicating data and operating instructions to and from the medical device, the implanted medical device telemetry transceiver having a transceiving range extending outside the patient's body, a distance sufficient to receive and transmit such telemetered communication;
a communications network interface means coupled to a system controller and a communications means for selectively enabling to transmit positioning data to a medical support network and for selectively receiving commands from the medical support network wherein an implantable wireless interface including a real time clock and a system for updating said real time clock based on accurate time clock information in signals received from a global positioning system is integrated therewith;
dead reckoning circuit means for determining the relative location of said transceiver over time to any location at a fixed time during which an acceptable fixed location of said transceiver is known, and wherein a circuit means for producing a representation of received location information for presentation to a telecommunications module is configured to also provide a representation of said dead reckoning information to said telecommunications module; and
a distance traveled interpretive processor for receiving an output from said dead reckoning circuit and determining a distance traveled therefrom;
a trigger circuit for triggering the initiation of transmission to a telephone system by said telecommunications module including said communications means when the distance traveled interpretive processor determines a distance traveled is greater than a predetermined trigger distance value.
2. A patient monitoring and emergency location system comprising;
a patient monitoring system as set forth in claim 1 and further comprising;
circuit means for producing a representation of said received satellite information relating the location of said transceiver unit for presentation to said telecommunications module so that said telecommunications module can transmit said representation of said location information to location receiving means in an emergency response system connected to said telephone system.
3. A patient monitoring and emergency location system as set forth in claim 2 said transceiver unit further comprising;
DGPS receiver means for receiving DGPS signals from a base station, and wherein said circuit means for producing a representation of said received location information for presentation to said telecommunications module is configured to also provide DGPS information to said telecommunications module.
4. A patient monitoring and emergency location system as set forth in claim 2 said transceiver unit further comprising;
dead reckoning circuit means for determining the relative location of said transceiver unit over time to any location at a fixed time during which an acceptable fixed location of said transceiver unit is known, and wherein said circuit means for producing a representation of said received location information for presentation to said telecommunications module is configured to also provide a representation of said dead reckoning information to said telecommunications module.
5. A patient monitoring and emergency location system as set forth in claim 2, said transceiver unit further comprising;
a distance traveled interpretive processor for receiving an output from said dead reckoning circuit and determining a distance traveled therefrom,
a trigger circuit for triggering the initiation of transmission to said telephone system by said telecommunications module when the distance traveled interpretive processor determines a distance traveled is greater than a predetermined trigger distance value.
6. A patient monitoring and emergency location system as set forth in claim 2 further comprising a processor adapted for transmitting emergency information from said transceiver unit to an emergency E911 system.
9. A method as set forth in claim 8 and further comprising
determining when said tranceiving unit has traveled a predetermined distance and
upon said determination of having traveled said predetermined distance, initiating a telephonic contact to a node on said telephone network.
10. A method as set forth in claim 8 and further comprising:
awaiting a determination of an emergency condition having occurred,
then initiating a telephonic contact to at least one node on said telephone network when as emergency condition has arisen.
11. A method as set forth in claim 10 and further comprising:
sending coded data regarding-the nature of the emergency to said at least one node.
12. A method as set forth in claim 10 and further comprising:
sending location data regarding the location of the PWD to said at least one node.
13. A method as set forth in claim 8 and further comprising:
awaiting a determination of an emergency condition having occurred,
then initiating a telephonic contact to an emergency system including a system of the two systems, standard emergency system and/or to an E-911 system, on said telephone network when as emergency condition has arisen.
14. A method as set forth in claim 3 and further comprising:
sending coded data regarding nature of the emergency to said emergency system.
15. A method as set forth in claim 13 and further comprising:
sending location data regarding the location of the PWD to said emergency system.
16. A method as set forth in claim 8 and further comprising
providing a real time clock system and a clock updating system for correcting the value of real time clock information based on satellite signals to said transceiver unit,
automatically using the corrected real time clock values to trigger an automatic turn on a communication between said PWD and a node in a narrow time slice, and
reporting to said node by said PWD some or all data facilitated for transfer on that communications pathway.
17. A method as set forth in claim 16 further comprising,
receiving command data from said node by said PWD during an additional narrow time slice.
18. A method as set forth in claim 17 further comprising,
transmitting a representation of said command data to said imd from said PWD.
19. A method as set forth in claim 18 further comprising;
receiving said representation of said command data in said imd,
programming the imd based on said representation of said command data.
0. 20. A method of monitoring a patient having a transceiver associated therewith and an implanted medical device in communication with said transceiver comprising;
monitoring gps and DGPS location data by said transceiver,
interpreting said location data by said transceiver and
if said location data interpreted by said transceiver indicates the patient transceiver is outside a predetermined area,
initiating a telephone call by said transceiver to a telephone node on a telephone network, indicating the present location of said transceiver.
23. Method as set forth in claim 22 further comprising continuously transmitting a signal by said transceiver unit after reporting said emergency condition and wherein said employing step includes triangulation on a signal transmitted by said transceiver unit after said transceiver unit initially reports said emergency condition.
24. Method as set forth in claim 22 wherein said location information transmitted by said transceiver unit includes DGPS information.
25. Method as set forth in claim 22 wherein said location information transmitted by said transceiver unit includes dead reckoning information.
0. 27. The method of claim 21, further including programming said implanted medical device in accordance with said command.
0. 28. The method of claim 27, wherein programming said implanted medical device includes altering an operating mode of said implanted medical device.
0. 29. The method of claim 28, wherein altering an operating mode includes altering a pacing mode of said implanted medical device.
0. 30. The method of claim 27, wherein programming said implanted medical device includes altering a parameter of said implanted medical device.
0. 31. The method of claim 21, wherein said command is an encoded command.
0. 32. The method of claim 21, further including:
generating, via said implanted medical device, patient data; and
transmitting said patient data to said medical support network in accordance with said command.
0. 33. The method of claim 32, wherein transmitting said patient data is performed periodically in accordance with said command.
0. 34. The method of claim 21, further including configuring said transceiver in accordance with said command, wherein said command specifies whether said transceiver is to initiate said emergency telephone call in response to said alarm condition.
0. 35. The method of claim 21, further including specifying said predetermined period of time within said command.
0. 36. The method of claim 21, further including specifying said alarm signal within said command.
0. 37. The method of claim 21, wherein monitoring said implanted medical device further comprises the step of displaying information to the patient.
0. 38. The method of claim 37, wherein monitoring said implanted medical device further comprises receiving information from the patient via a patient activator.
0. 39. The method of claim 21, wherein monitoring said implanted medical device further comprises monitoring said implanted medical device via a monitor worn by the patient.
0. 40. The method of claim 39, wherein monitoring said implanted medical device further comprises monitoring said implanted medical device via the monitor worn by the patient in one of a wrist-worn, belt worn or pocket carried monitor device.
0. 41. The method of claim 21, wherein monitoring said implanted medical device further comprises monitoring said implanted medical device via a monitor positioned within communication range of the implanted medical device.
0. 42. The method of claim 41, wherein monitoring said implanted medical device further comprises monitoring said implanted medical device via the monitor positioned within communication range of the implanted medical device near where the patient sleeps.
0. 43. The method of claim 21, further comprising transmitting patient data to a medical network.
0. 44. The method of claim 21, further comprising transmitting stored ECG histograms of patient data to a medical network.
0. 45. The method of claim 44, further comprising transmitting marker channel information to the medical network.
0. 46. The method of claim 21, further comprising transmitting real-time ECG data of the patient to a medical network.
0. 47. The method of claim 21, further comprising transmitting measured physical parameters of the patient to a medical network.
0. 48. The method of claim 21, wherein automatically initiating an emergency telephone call by said transceiver comprises initiating the emergency telephone call over a hard-wired phone line coupled to a telephone network.
0. 49. The method of claim 21, wherein automatically initiating an emergency telephone call by said transceiver comprises the step of initiating the emergency telephone call over a cellular telephone network.
0. 50. The method of claim 21, wherein automatically initiating an emergency telephone call by said transceiver comprises the step of initiating the emergency telephone call over a cordless telephone network.
0. 51. The method of claim 21, further comprising sending an email message to a medical network.
0. 52. The method of claim 21, further comprising recharging a battery within a monitoring device that monitors the implanted medical device.
0. 53. The method of claim 21, further comprising monitoring the implanted medical device responsive to a command initiated by a patient.
0. 54. The method of claim 21, wherein the command causes at least one of a clock or timer to be at least one of adjusted or reprogrammed.
0. 56. The method of claim 55, wherein transmitting patient data to the medical network includes transmitting stored ECG histograms of patient data to the medical network.
0. 57. The method of claim 55, wherein transmitting patient data to the medical network includes transmitting marker channel information to the medical network.
0. 58. The method of claim 55, wherein transmitting patient data to the medical network includes transmitting real-time ECG data of the patient to the medical network.
0. 59. The method of claim 55, wherein transmitting patient data to the medical network includes transmitting measured physical parameters of the patient to the medical network.
0. 60. The method of claim 55, wherein automatically initiating the emergency telephone call by the transceiver comprises initiating the emergency telephone call over a hard-wired phone line coupled to the telephone network.
0. 61. The method of claim 55, wherein automatically initiating the emergency telephone call by the transceiver comprises initiating the emergency telephone call over a cellular telephone network.
0. 62. The method of claim 55, wherein transmitting the patient data is performed periodically in accordance with the command.
0. 64. The method of claim 63, wherein transmitting patient data to the medical network includes transmitting stored ECG histograms of patient data to the medical network.
0. 65. The method of claim 63, wherein transmitting patient data to the medical network includes transmitting marker channel information to the medical network.
0. 66. The method of claim 63, wherein transmitting patient data to the medical network includes transmitting real-time ECG data of the patient to the medical network.
0. 67. The method of claim 63, wherein transmitting patient data to the medical network includes transmitting measured physical parameters of the patient to the medical network.
0. 68. The method of claim 63, wherein automatically initiating the emergency telephone call by the transceiver comprises initiating the emergency telephone call over a hard-wired phone line in coupled to the telephone network.
0. 69. The method of claim 63, wherein automatically initiating the emergency telephone call by the transceiver comprises initiating the emergency telephone call over a cellular telephone network.
0. 70. The method of claim 63, wherein transmitting the patient data is performed periodically in accordance with the command.

This application is a
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 FIGS. 1 and 2, two communication network interface links with the medical support network 50 are included, although the communication interface links of the second variation of FIGS. 3-5 may be included for optional home use. One non-hard-wired communication interface link is effected through the soon to be deployed, worldwide satellite communications system, called “Iridium”, by Motorola, Inc. of Schaumburg, Ill. This is a PCMCIA card 64 which may be built from common components by one skilled in the art. Another (second) communications link can be effected by the ARDIS (Advanced Radio Data Information Service) pocket radio communications network via PCMCIA link card 66, a Mobidem modem available from Ericsson, Inc. of Raleigh, N.C. Both of the radio links operate as modems with voice and data simultaneously transmitted via adding the CT8020 (DSP Group of Santa Clara, Calif.) to a standard data modem such as a 28.8 Keepintouch™ Express modem from AT & T Corp. of Largo, Fla.

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.

FIG. 2 illustrates the free ranging patient 10 located remotely from the medical support network 50 and from any hard-wired communications link. The patient communications control device 20 is implemented in the belt-worn portable unit 40, although the patient link 26 may be worn separately on the patient's wrist (not shown). Alternatively, the patient communications control device 20 including the patient link 26 may be packaged into a portable telephone configuration and carried in a pocket. In any embodiment, the patient location may be determined by communications with the GPS 62. The voice and data communications link with the medical support network 50 may be effected by a cellular phone link including transceiver 82. Alternatively, the voice and data communications link may be effected using the communications satellite link 80.

The patient communications control device 20 of FIGS. 1 and 2 is powered by a battery power supply 74 that preferably is rechargeable, or alternatively by commonly available batteries of any type. The system controller 24 includes a power control system for powering down the microprocessor and the associated components of the patient communications control device 20 except on receipt of an interrupt in a manner well known in the art.

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 FIGS. 3-5, it should be noted that the system of FIG. 1 may also be used in the home or in the hospital using the cellular communications link card 66. However, the modified patient communications control device 20′ of FIG. 3 is preferably implemented with the voice and data communications network interface 28 having the capability of directly linking with a hard-wired phone line 32 or other communication services, which may include a hospital installed network, e.g. a personal computer interface to a local area network. In either case, the modified patient communications control device 20′ may be implemented in a number of portable or stationary monitor 30 forms.

In the embodiment illustrated in FIG. 4, all of the FIG. 3 components of the modified patient communications control device 20′ are located in the monitor 30. The patient link 26 and the implant wireless interface 22 are hard-wired by voice and data buses 36, 38 and 42 to the system controller 24. In the embodiment of FIG. 5, the patient link 26 and the implant wireless interface 22 are located in the patient-worn communications device 12. The remaining components of the modified patient communications control device 20′ are located in monitor 30, and suitable RF telemetry transceiver links are substituted for the buses 36, 38 and 42. In either embodiment, the power supply 74 of the monitor 30 may be line powered. The modified patient communications control device 20′ within monitor 30 may also be coupled to a wall jack for hard-wired communications through the phone line 32 or other communications service 34 with a medical support network 50 located remotely or within the hospital.

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 FIG. 4 or 5, the patient 10 may communicate with the medical support staff at the medical support network 50 through the voice channel provided in the patient link 26. The patient communications control device 20 or 20′ in either embodiment can retrieve all implanted device stored patient and device operating data on receipt of a command from the medical support network 50, process and temporarily store such data, and transmit it back to the support network 50 for analysis. Moreover, implanted devices 12 . . . 14 may be reprogrammed from the medical support network 50 to alter device operating modes and parameters employing the modified patient communications control device 20′ as a programmer. Finally, the modified patient communications control device 20′ can transmit an alarm to the medical support network should there be problems with the patient or implanted devices 12, 14. For example, the implanted devices 12, 14 may signal a low battery condition or a low drug supply in the case of an implanted drug dispenser or other problems found in self-diagnostic routines periodically conducted within the implanted devices 12 . . . 14.

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 FIGS. 1 and 2, the implanted medical device 12 or 14 would initiate an emergency transmission to the patient communications control device 20 which would contain, but not be limited to, all or some of the following: patient name and mailing address, patient's current location, patient's current medical condition requiring assistance, ongoing “real time physiological variables”, patient medical support team information, and current status (patient and device) and data stored within the implanted medical device. The patient communications control device 20 would obtain the GSS signal and transmit all the information to the medical support network 50. The patient may also transmit voice information if conscious of the event. A similar response to an emergency situation can be initiated and completed in the GCMS of the second variation using the modified patient communications control device 20′. And, as mentioned before, the time slice can be very small for each patient in a local provider network if the system checks its time clock against the atomic clock time signals available from the satellite.

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
Belt Device 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
Device(MD) parameter/value/sequence, interrogate,
request a program or data, etc.)
b. Coordinating data (ex. outside
pressure)
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.)
NOTES:
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 (FIG. 7 ) or in the hospital, or somewhere else in the system, from raw GPS satellite data and thereby saving power for the small devices. Simply turning off the main GPS receiver activities will save power too, as was demonstrated in U.S. Pat. No. 5,592,173, incorporated herein by reference. In this patent as well, a dead reckoning system is also suggested as being useful in the powered down mode.

Referring now to FIG. 7, in which a system 100 in accord with one aspect of this invention is shown, a tower 101 base station, broadcasts its correction data from its known location to the devices located in a clinic/hospital 103, a moving rescue vehicle 105 and the patient system 104. There currently are at least two DGPS systems commercially available, one form Trimble Navigation Limited, Sunnyvale Calif. and Hampshire England, and another from Leica Navigation and Positioning of Torrence California and Leica Inc., Norcross Ga. Both these companies provide base stations for broadcasting and receivers for receiving and correlating GPS and DGPS data that could be useful for the system components shown in FIG. 7, but other similar systems could be used as well. A description of the features providing for DGPS location in the Trimble system are mentioned in the U.S. Pat. Nos. 5,777,580, 5,745,868, 5,731,768, and 5,680,140, all of which are herein incorporated by this reference.

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 FIG. 8, the belt worn device 104 receives satellite data A, broadcast from a set of satellites 102a-n (only one is pictured). It also receives broadcast correction data signals A′ from a base station 101. The finding system in device 106 receives this same data. When alerted to be looking for the location of the patient worn device 104, device 106 will also be looking for information broadcast by device 104 in signal B. Generally this data will include information received from the satellites 102a-n that are in range of the belt worn device 104 in a packet 107a and the correction data received from the DGPS base station 101 in packet 107b. From this data the exact location of device 104, can be computed. By computing this location data itself, device 106 can then compute its own location and produce a vector to the device 104 for display (like display 106a) to the user of device 106. It is believed that the most effective display would be a directional arrow with a numeric display of distance units to the device as illustrated, but any combination of numeric, alpha, and illustrative displays as well as audible signaling including speech (for example, the device could say 20 yards to your left for use by a fire fighter in a smoky building) may be used if desired. There is also no reason not to incorporate a telephone receiver for direct communications with the patient in both the devices 104 and 106 if desired.

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 FIG. 8 can be had using alternate systems already in use.

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 FIG. 7) notes that its wearer has an emergency condition, it could activate a call by a communication to the PMD corn unit 104b to call the 911 or other emergency service (using unit 104d) through the wireless telephone system. An initial location data stream would preferably automatically be sent with the initial call when the call was made, using this new initiative system. This information receiving function could be incorporated into emergency telephone receiving equipment or if the emergency services don't provide it, a voice transmission of the nature of the emergency and perhaps some indication of location could be given by the telecom unit 104d from a bank of recorded message parts to emergency response personnel. If special equipment is incorporated in the emergency telephone communications system, emergency codes could be sent along with the location data or just sent by itself. Also, code data regarding the patient condition, like blood pressure, temperature, battery fault in an implanted device or any other relevant information regarding the patient condition, environment or device status can be reported with the emergency coding.

Time slice updating of the status of a device like that of 104 in FIG. 8, implants 12, 14 etc. and 20 of FIGS. 1, or 12 and 30 of FIG. 2, can be effectively provided to many thousands of patients in a geographic region with little difficulty provided there is accurate keeping of time by all units in a given system.

FIG. 9 illustrates the main internal components needed for keeping track of the patient location if the GPS system is temporarily unavailable, and for using a dead reckoning system to complement the GPS or DGPS systems in any other ways. There should be a real time clock 901, a microprocessor unit 903 and some memory circuits 902 connected by circuit lines or a bus 904 to the position tracking monitoring circuitry 905. This tracking and monitoring circuitry should also be associated with a gyroscope like device, a minimized inertial navigation system, a multi-axis accelerometer system, or some other mechanism useful to track the movement of the patient in three dimensional space. A number of different systems have been worked out that would be satisfactory for this purpose, and any of these could be chosen. The inertial navigation systems used in modern aircraft provide other examples. Alternatively, the pedal impacts based system described in U.S. Pat. No. 5,583,776, hereby incorporated by reference may be used. This will allow for patient location when out of the range of GPS systems and also for rapid restart upon re-entering the GPS or DGPS fields instead of a 10 minute “cold start” which would otherwise be required.

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.

FIG. 10 illustrates the method by which the system of FIG. 9 may be called upon to work. In step A, the real time clock is running, until at step B it is recognized that the real time clock is at the next time value of interest, that is the next day, hour or minute whenever the system needs to check on its location relative to the last good GPS or DGPS fixation reading. Alternatively, whenever the patient system is supposed to report in to the local medical provider system a real time clock setting can be associated with this step B. In any event, in step C, the processing capability of the system needs to be engaged to do whatever is required.

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 FIG. 7, for example. If the time is accurate, then the device can simply process as normal, otherwise it needs to update the real time clock(s) it maintains so as to be able to communicate in its proper time slice within the local provider system.

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.

Thompson, David L.

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