Implantable medical device which may be controlled from central station
First Claim
1. Electronic medical apparatus adapted to be implanted in a human patient, a so-called implantable medical device (IMD), which may be alternatively automatically self-controlled and remotely controlled by a medical expert, said apparatus comprising, in combination:
- (a) a first transmitting/receiving (T/R) device for transmitting medical data sensed from said patient to, and for receiving control signals from, a remote location;
(b) an electronic medical treatment device for treating said patient in response to control signals applied thereto;
(c) a sensor circuit, having a sensor circuit output, for producing at least one sensor circuit output signal at said sensor circuit output in response to the medical data sensed from the patient; and
(d) a logic device coupled to each of(i) said sensor circuit output,(ii) said first T/R device, and(iii) said treatment device,for(i) analysis of said at least one sensor circuit output signal,(ii) generating a remote station notification signal,(iii) generating at least one local treatment device control signal, and(iv) generating at least one remote treatment device control signal;
wherein;
(1) said logic device analyzes said at least one sensor circuit output signal to detect a medical abnormality which requires notification of the medical expert at the remote location, and is operative to generate a notification signal, for consideration by said medical expert when said analysis reveals said medical abnormality;
(2) upon receipt of said notification signal, said first T/R device transmits said notification signal representing at least one medical state of said patient to the remote location;
(3) said logic device analyzes said at least one sensor circuit output signal to detect a medical abnormality which requires treatment and is operative to generate at least one local treatment device control signal, if required; and
(4) said logic device is operative to generate at least one remote treatment device control signal in response to at least one remote control signal received from the remote location by said first T/R device;
wherein said logic device determines whether to issue a notification signal, to issue a local treatment signal, to issue both a notification and a local treatment signal, or to issue neither a notification nor a local treatment signal, based on said analysis,whereby said IMD delivers therapy, if required, in response to one of said at least one local treatment device control signals and said at least one remote treatment device control signals.
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Accused Products
Abstract
An implantable medical device (IMD) comprises a transmitting/receiving (T/R) device for transmitting medical data sensed from a patient to, and for receiving control signals from, a medical expert (a human medical professional and/or a computerized expert system) at a remote location; an electronic medical treatment device for treating the patient in response to control signals applied thereto; and a sensor circuit, having a sensor circuit output, for producing sensor circuit output signal(s) representing medical data sensed from the patient. The IMD also includes logic device which analyzes the sensor circuit output signal(s) to detect a medical abnormality and either sends a notification signal as well as signal(s) representing a medical state of said patient to the medical expert at the remote location or sends a local treatment device control signal to the medical treatment device, or does both.
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Citations
123 Claims
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1. Electronic medical apparatus adapted to be implanted in a human patient, a so-called implantable medical device (IMD), which may be alternatively automatically self-controlled and remotely controlled by a medical expert, said apparatus comprising, in combination:
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(a) a first transmitting/receiving (T/R) device for transmitting medical data sensed from said patient to, and for receiving control signals from, a remote location; (b) an electronic medical treatment device for treating said patient in response to control signals applied thereto; (c) a sensor circuit, having a sensor circuit output, for producing at least one sensor circuit output signal at said sensor circuit output in response to the medical data sensed from the patient; and (d) a logic device coupled to each of (i) said sensor circuit output, (ii) said first T/R device, and (iii) said treatment device, for (i) analysis of said at least one sensor circuit output signal, (ii) generating a remote station notification signal, (iii) generating at least one local treatment device control signal, and (iv) generating at least one remote treatment device control signal; wherein; (1) said logic device analyzes said at least one sensor circuit output signal to detect a medical abnormality which requires notification of the medical expert at the remote location, and is operative to generate a notification signal, for consideration by said medical expert when said analysis reveals said medical abnormality; (2) upon receipt of said notification signal, said first T/R device transmits said notification signal representing at least one medical state of said patient to the remote location; (3) said logic device analyzes said at least one sensor circuit output signal to detect a medical abnormality which requires treatment and is operative to generate at least one local treatment device control signal, if required; and (4) said logic device is operative to generate at least one remote treatment device control signal in response to at least one remote control signal received from the remote location by said first T/R device; wherein said logic device determines whether to issue a notification signal, to issue a local treatment signal, to issue both a notification and a local treatment signal, or to issue neither a notification nor a local treatment signal, based on said analysis, whereby said IMD delivers therapy, if required, in response to one of said at least one local treatment device control signals and said at least one remote treatment device control signals. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 121, 122, 123)
(6) in a second operating mode, said logic device generates at least one remote treatment device control signal in response to at least one remote control signal received from the remote location by said first T/R device; and (7) said logic device selects said operating mode based on at least one signal received from at least one of said first T/R device and said sensor circuit.
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5. The apparatus defined in claim 4, wherein, in response to said remote control signal received from said remote location by said first T/R device said logic device selects said second operating mode.
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6. The apparatus refined in claim 5, wherein said second operating mode is selected following the receipt, from said medical expert at the remote location, of at least one of:
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(a) a second operating state selecting signal; and (b) a remote control signal.
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7. The apparatus defined in claim 4, wherein, in the absence of a signal from said first T/R device, said logic device selects said first operating mode.
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8. The apparatus defined in claim 1, further comprising at least one sensor, coupled to said sensor circuit, for generating at least one electrical signal that represents a medical state of said patient.
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9. The apparatus defined in claim 8, wherein said sensor is selected from the group consisting of:
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(a) a cardiac electrode for sensing cardiac electrical activity; (b) a device for sensing a cardiac QT interval; (c) a device for sensing body motion of said patient, comprising at least one of (a) an accelerometer, and (b) a piezoelectric element; (d) a device for sensing chest ventilation of said patient, said sensor being operable to sense at least one of (1) thoracic impedance, (2) diaphragm motion of said patient, and (3) chest wall motion of said patient; (e) a device for sensing spatial orientation of said patient; (f) a device for sensing blood oxygen saturation; (g) a device for sensing blood oxygen content; (h) a device for sensing blood carbon dioxide content; (i) a device for sensing blood pH; (j) a device for sensing blood lactic acid content; (k) a transducer for sensing blood pressure; (l) a device for sensing blood sugar; (m) a brain electrode for sensing brain electrical activity; (n) a device for sensing a concentration of a pharmacologic agent in said patient; (o) a device for sensing the flow rate from a circulatory heart pump; (p) a device for sensing the rotational speed of a heart pump motor; and (q) a device for sensing cardiac output.
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10. The apparatus defined in claim 9, wherein said spatial orientation sensor (e) is operable to sense at least one of (i) whether a patient has fallen, and (ii) whether a patient is supine.
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11. Apparatus comprising the apparatus (IMD) defined in claim 1, and further comprising a remote station at said remote location including:
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(a) a display device for displaying medical information from said patient for evaluation by said medical expert at the remote station, in response to the receipt of said at least one signal representing a medical state of the patient transmitted by the first T/R device of at least one remotely located IMD; (b) a first input device, responsive to said medical expert, for producing at least one remote control signal for controlling said IMD; and (c) a second T/R device, coupled to said display device and said input device, for electronic communication with the first T/R device of said at least one remotely located IMD; and wherein (1) said medical expert observes and analyzes said at least one signal representing a medical state of said patient via said display device, following said notification signal, (2) based on said analysis, said medical expert may cause said input device to generate at least one remote control signal; (3) said remote control signal is transmitted via said second T/R device and said first T/R device, to the logic device of said at least one remotely located IMD; and (4) said remote control signal causes said logic device to control said treatment device of said at least one remotely located IMD.
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12. The apparatus defined in claim 11, wherein said medical expert is a human medical professional.
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13. The apparatus defined in claim 11, wherein said remote control signal is a remote treatment device control signal which directs the treatment device to administer treatment.
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14. The apparatus defined in claim 11, wherein
(1) in a first operating mode said logic device generates at least one local treatment device control signal based on analysis of said at least one sensor circuit output signal; -
(2) in a second operating mode, said logic device generates at least one remote treatment device control signal in response to at least one remote control signal received from the remote location by said first T/R device; and (3) said logic device selects said operating mode based on at least one signal received from at least one of said first T/R device and said sensor circuit.
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15. The apparatus defined in claim 14, wherein said remote control signal is a mode control signal which directs the logic device to select the operating mode.
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16. The apparatus defined in claim 14, wherein said second operating mode is selected following the receipt, from said medical expert at the remote location, of at least one of:
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(a) a second operating state selecting signal; and (b) a remote control signal.
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17. The apparatus defined in claim 11, wherein said medical expert is a medical expert logic device coupled to said second T/R device for:
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(i) receipt of said notification signal; (ii) receipt and analysis of said signals representing a medical state of a patient; and (iii) generation of medical expert logic device remote control signals; wherein (1) said medical expert logic device analyzes said at least one signal representing a medical state of said patient, following said notification signal, (2) based on said analysis, said medical expert logic device may generate at least one medical expert logic device remote control signal; (3) said at least one medical expert logic device remote control signal is transmitted via said second T/R device and said first T/R device, to the logic device of said at least one IMD; and (4) said at least one medical expert logic device remote control signal causes said IMD logic device to control said treatment device of said at least one IMD.
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18. The apparatus defined in claim 17, wherein
i) said medical expert logic device is further coupled to a first communication device for communication with a human medical expert, ii) said medical expert logic device is operative to perform at least one of: -
a) send a human notification signal to said human medical expert; b) send said signals representing a medical state of a patient to said human medical expert; c) send said a duplicate signal representing said at least one medical expert logic device remote control signal to said human medical expert; and d) receive a human remote control signal; wherein (1) said medical expert logic device analyzes said at least one signal representing a medical state of said patient to detect a medical abnormality which requires notification of the human medical expert, and generates a human notification signal if required; said first communication device transmits said human notification signal and at least one signal representing a medical state of said patient to said human medical expert; (3) said medical expert logic device is operative to generate at least one first type of medical expert logic device remote control signal based on analysis of said at least one signal representing a medical state of said patient; and (4) said medical expert logic device is operative to generate at least one second type of medical expert logic device remote control signal in response to at least one human remote control signal received from said human medical expert by said communication device; whereby said IMD delivers therapy in response to at least one of; i) said at least one local device treatment control signal; ii) said at least one first type of medical expert logic device remote control signal generated by said medical expert logic device; and iii) said at least one second type of medical expert logic device remote control signal, generated by said medical expert logic device in response to said at least one human control signal, generated by said human medical expert.
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19. The apparatus defined in claim 18, wherein a human inhibit command from said human medical professional prevents said electronic medical treatment device from responding to at least one of (a) said at least one local treatment device control signal, and (b) said at least one first type of medical expert logic device remote control signal.
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20. The apparatus defined in claim 18, wherein said at least one human remote control signal causes said electronic medical treatment device to administer therapy prescribed thereby.
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21. A system comprising the apparatus defined in claim 18, and further comprising a human medical expert station at remote human location including:
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(a) a display device for displaying medical information from said patient for evaluation by said human medical expert at said human medical expert station, in response to the receipt of said at least one signal representing a medical state of the patient communicated by said first communication device of said remote station; (b) a human input device, responsive to said human medical expert, for producing at least one human remote control signal for controlling said IMD; and (c) a second communication device, coupled to said display device and said input device, for electronic communication with the first communication device of said at least one remote station; and wherein (1) said human medical expert observes and analyzes said at least one signal representing a medical state of said patient via said display device, following said human notification signal; (2) based on said analysis, said human medical expert may cause said human input device to generate at least one human remote control signal; (3) said human remote control signal is transmitted via said second communication device, said first communication device, said second T/R device and said first T/R device, to the logic device of said at least one remotely located IM; and (4) said human remote control signal causes said logic device to control said treatment device of said at least one remotely located IMD.
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22. The apparatus defined in claim 11, further comprising a plurality of implantable medical devices (IMDs) located at a plurality of sites remote from said remote station, wherein said medical expert at said remote station may control one or more of said plurality of IMDs following the receipt of a notification signal from one of said IMDs.
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23. The apparatus defined in claim 22, wherein
(1) said logic device in each said IMD generates a unique I′ - D identification code for transmission with said notification signal;
(2) remote control signals are transmitted with said unique IMD identification code; and (3) only remote control signals which are received by an IMD which contain the unique IMD identification code for that particular IMD will control that IMD; thereby to assure that said medical expert remote control signals control only the particular IMD for which they were intended.
- D identification code for transmission with said notification signal;
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24. The apparatus defined in claim 15, wherein
(1) said logic device is further operative to determine the presence and the absence of proper communication between said first T/R device and said second T/R device; - and
(2) following the transmission of said notification signal, (i) the absence of said proper communication causes said logic device to select said first operating mode; and (ii) the presence of said proper communication causes said logic device to select one of said first and said second operating modes, in response to said mode control signal from said remote station.
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25. The apparatus defined in claim 14, wherein
(1) said logic device is further operative to determine the presence and the absence of proper communication between said first T/R device and said second T/R device; - and
(2) following the transmission of said notification signal (i) the absence of said proper communication causes said logic device to select said first operating mode; and (ii) the presence of said proper communication causes said logic device to select said second operating mode.
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26. The apparatus defined in claim 11, wherein following the receipt of a first notification signal by said remote station, said medical expert may cause said input device to send a termination signal to said IMD, and wherein, upon receipt of said termination signal, said IMD causes cessation of transmission by said first T/R device until the occurrence of a further medical abnormality which requires a further notification of said medical expert.
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27. The apparatus defined in claim 26, wherein, following the transmission of said termination signal, said logic device is further operative to analyze said at least one sensor circuit output signal to detect a further medical abnormality which requires a second notification of said medical expert at said remote location, and generates a second notification signal if required;
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wherein said further medical abnormality which requires said second notification differs from said medical abnormality which requires said first notification.
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28. The apparatus defined in claim 27, wherein, following said termination signal:
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(a) for a duration of time less than a re-notification time interval, said further medical abnormality causes said second notification; and (b) for a duration of time equal to at least said re-notification time interval, said medical abnormality causes said first notification.
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29. The apparatus defined in claim 28, wherein, said logic device further comprises a clock circuit to measure said re-notification time interval.
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30. The apparatus defined in claim 27, wherein
a) said abnormality which requires a first notification is an abnormality which occurs over a first notification duration of time; -
b) said abnormality which requires said second notification is an abnormality which occurs over a second notification duration of time; and c) said first notification duration of time differs from said second notification duration of time.
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31. The apparatus defined in claim 27, wherein
a) said abnormality which requires a first notification is defined by a first notification frequency of abnormal medical events; -
b) said abnormality which requires said second notification is defined by a second notification frequency of abnormal medical events; and c) said first notification frequency differs from said second notification frequency.
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32. The apparatus defined in claim 27, wherein said further abnormality which requires said second notification is defined by at least one of:
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a) a range of values of a medical parameter of said patient which is greater than a first notification value; and b) a range of values of a medical parameter of said patient which is less than a second notification value; and
said abnormality which requires a first notification is defined by at least one of;a) a range of values of a medical parameter of said patient which is greater than a third notification value; and b) a range of values of a medical parameter of said patient which is less than a fourth notification value; and
and wherein(i) said third notification value is greater than said first notification value; and (ii) said fourth notification value is less than said second notification value; whereby said further abnormality which requires said second notification is a less severe abnormality than said abnormality which requires a first notification.
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33. The apparatus defined in claim 27, wherein said further abnormality which requires said second notification is defined by at least one of:
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a) a range of values of a medical parameter of said patient which is greater than a fifth notification value; and b) a range of values of a medical parameter of said patient which is less than a sixth notification value; and
said abnormality which requires a first notification is defined by at least one of;a) a range of values of a medical parameter of said patient which is greater than a seventh notification value; and b) a range of values of a medical parameter of said patient which is less than an eighth notification value; and
wherein(i) said seventh notification value is less than said fifth notification value; and (ii) said eighth notification value is greater than said sixth notification value; whereby said further abnormality which requires said second notification is a more severe abnormality than said abnormality which requires said first notification.
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34. The apparatus defined in claim 27, wherein said further abnormality which requires said second notification is defined by at least one of:
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a) a range of values of a ninth function of the values of each of a fifth plurality of medical parameters of said patient which is greater than a ninth notification value; and b) a range of values of a ninth function of the values of each of a fifth plurality of medical parameters of said patient which is less than a tenth notification value; and
and said abnormality which requires notification is defined by at least one of;a) a range of values of a ninth function of the values of each of a fifth plurality of medical parameters of said patient which is greater than an eleventh notification value; and b) a range of values of a ninth function of the values of each of a fifth plurality of medical parameters of said patient which is less than a twelfth notification value; and
wherein(i) said eleventh notification value is greater than said ninth notification value; and (ii) said twelfth notification value is less than said tenth notification value.
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35. The apparatus defined in claim 27, wherein said further abnormality which requires said second notification is defined by at least one of:
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a) a range of values of a tenth function of the values of each of a sixth plurality of medical parameters of said patient which is greater than a thirteenth notification value; and b) a range of values of a tenth function of the values of each of a sixth plurality of medical parameters of said patient which is less than a fourteenth notification value; and
said abnormality which requires a first notification is defined by at least one of;a) a range of values of a tenth function of the values of each of a sixth plurality of medical parameters of said patient which is greater than a fifteenth notification value; and b) a range of values of a tenth function of the values of each of a sixth plurality of medical parameters of said patient which is less than a sixteenth notification value; and
wherein(i) said fifteenth notification value is less than said thirteenth notification value; and (ii) said sixteenth notification value is greater than said fourteenth notification value.
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36. The apparatus defined in claim 27, wherein said further abnormality which requires said second notification is defined by at least one of:
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a) a range of values of an eleventh function of (i) the values of each of a seventh plurality of medical parameters of said patient, and (ii) time, which is greater than a seventeenth notification value; and b) a range of values of an eleventh function of (i) the values of each of a seventh plurality of medical parameters of said patient, and (ii) time, which is less than an eighteenth notification value; and said abnormality which requires a first notification is defined by at least one of; a) a range of values of an eleventh function of (i) the values of each of a seventh plurality of medical parameters of said patient, and (ii) time, which is greater than a nineteenth notification value; and b) a range of values of an eleventh function of (i) the values of each of a seventh plurality of medical parameters of said patient, and (ii) time, which is less than a twentieth notification value; and wherein (i) said nineteenth notification value is greater than said seventeenth notification value; and (ii) said twentieth, notification value is less than said eighteenth notification value.
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37. The apparatus defined in claim 27, wherein said further abnormality which requires said second notification is defined by at least one of:
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a) a range of values of a twelfth function of (i) the values of each of an eighth plurality of medical parameters of said patient, and (ii) time, which is greater than a twenty first notification value; and b) a range of values of a twelfth function of (i) the values of each of an eighth plurality of medical parameters of said patient, and (ii) time, which is less than a twenty second notification value; and said abnormality which require a first notification is defined by at least one of; a) a range of values of a twelfth function of (i) the values of each of an eighth plurality of medical parameters of said patient, and (ii) time, which is greater than a twenty third notification value; and b) a range of values of a twelfth function of (i) the values of each of an eighth plurality of medical parameters of said patient, and (ii) time, which is less than a twenty fourth notification value; and wherein (i) said twenty third notification value is less than said twenty first notification critical value; and (ii) said twenty fourth notification value is greater than said twenty second notification critical value.
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38. The apparatus defined in claim 11 wherein said medical expert may cause said input device to send a first programming signal, via said second T/R device and said first T/R device, to said logic device to change a definition of said abnormality which requires notification.
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39. The apparatus defined in claim 27, wherein said medical expert may cause said input device to send a second programming signal, via said second T/R device and said first T/R device, to said logic device to change a definition of said abnormality which requires said second notification.
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40. The apparatus defined in claim 28, wherein said medical expert may cause said input device to send a third programming signal, via said second T/R device and said first T/R device, to said logic device to change the duration of said re-notification time interval.
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41. The apparatus defined in claim 11, wherein,
(a) said electronic medical treatment device is operative to provide a plurality of possible treatments; - and
(b) following receipt of said notification signal, said medical expert may cause said input device to send a fourth programming signal, via said second T/R device and said first T/R device, to said logic device to change at least one of said plurality of possible treatments.
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42. The apparatus defined in claim 41, wherein said treatment change consists of at least one of:
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(a) selecting an alternate type of treatment; (b) causing a repetitive treatment; (c) changing a sequence of treatment steps; and (d) changing a parameter of said treatment.
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43. The apparatus defined by claim 42, wherein said parameter is selected from the group consisting of (1) a stimulating voltage, (2) a stimulating pulse width, (3) a stimulating waveform, (4) a stimulating electrical energy, (5) a rate of stimulation, (6) a choice of a stimulating electrode, (7) a flow rate of a pump, (8) a flow pressure of a pump, (9) an amount of a drug delivered by a pump, and (10) the rate of drug delivery by a pump.
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44. The apparatus defined by claim 42, wherein said type of treatment is selected from the group consisting of a shock, electrical pacing, an administration a drug and a choice of a drug.
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45. The apparatus defined by claim 11, wherein, following receipt of said notification signal, said medical expert may cause said input device to send a fifth programming signal, via said second T/R device and said first T/R device, to said logic device to change the criteria by which said logic device defines a medical abnormality.
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46. The apparatus defined by claim 11, wherein,
(a) said logic device includes a microprocessor capable of running a plurality of algorithms for analysis of said sensor circuit output signals, and (b) following receipt of said notification signal, said medical expert may cause said input device to send a sixth programming signal, via said second T/R device and said first T/R device, to said logic device to change the algorithm by which said logic device analyzes said at least one sensor circuit output signal. -
47. The apparatus defined in claim 11, wherein said treatment device is operative to generate a treatment confirmation signal after administration of treatment to said patient, and wherein said treatment confirmation signal is transmitted to said remote station by said first T/R device.
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48. The apparatus defined in claim 14, wherein, in the absence of a signal from said first T/R device, said logic device selects said first operating mode.
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49. The apparatus defined in claim 11, wherein said logic device is operative to generate at least one logic device analysis signal representing a result of said analysis of said at least one sensor circuit output signal, and wherein said at least one logic device analysis signal is transmitted to said remote station by said first T/R device.
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50. The apparatus defined in claim 1, wherein said at least one local treatment device control signal is transmitted to said remote station by said first T/R device.
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51. The apparatus defined in claim 1, wherein
(a) said logic device is operative to analyze said at least one sensor circuit output signal to detect a medical abnormality which may require treatment; - and
(b) said abnormality which requires notification is the same as said abnormality which may require treatment.
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52. The apparatus defined in claim 1, wherein
(a) said logic device is operative to analyze said at least one sensor circuit output signal to detect a medical abnormality which may require treatment; - and
(b) said abnormality which requires notification is different than said abnormality which may require treatment.
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53. The apparatus defined in claim 52, wherein
a) said abnormality which requires notification is an abnormality which occurs over a first duration of time; -
b) said abnormality which may require treatment is an abnormality which occurs over a second duration of time; and c) said first duration of time differs from said second duration of time.
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54. The apparatus defined in claim 52, wherein
a) said abnormality which requires notification is defined by a first frequency of abnormal medical events; -
b) said abnormality which may require treatment is defined by a second frequency of abnormal medical events; and c) said first frequency differs from said second frequency.
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55. The apparatus defined in claim 52, wherein each said abnormality is determined based on medical data representing at least two medical parameters of said patient.
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56. The apparatus defined in claim 52, wherein said abnormality which requires notification is defined by at least one of:
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a) a range of values of a medical parameter of said patient which is greater than a first critical value; and b) a range of values of a medical parameter of said patient which is less than a second critical value; and
said abnormality which may require treatment is defined by at least one of;a) a range of values of a medical parameter of said patient which is greater than a third critical value; and b) a range of values of a medical parameter of said patient which is less than a fourth critical value; and
wherein(i) said third critical value is greater than said first critical value; and (ii) said fourth critical value is less than said second critical value; whereby said abnormality which requires notification is a less severe abnormality than said abnormality which may require treatment.
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57. The apparatus defined in claim 52, wherein said abnormality which requires notification is defined by at least one of:
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a) a range of values of a medical parameter of said patient which is greater than a fifth critical value; and b) a range of values of a medical parameter of said patient which is less than a sixth critical value; and
said abnormality which may require treatment is defined by at least one of;a) a range of values of a medical parameter of said patient which is greater than a seventh critical value; and b) a range of values of a medical parameter of said patient which is less than an eighth critical value; and
wherein(i) said seventh critical value is less than said fifth critical value; and (ii) said eighth critical value is greater than said sixth critical value; whereby said abnormality which requires notification is a more severe abnormality than said abnormality which may require treatment.
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58. The apparatus defined in claim 52, wherein said abnormality which requires notification is defined by at least one of:
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a) a range of values of a first function of the value of a medical parameter of said patient which is greater than a ninth critical value; and b) a range of values of a first function of the value of a medical parameter of said patient which is less than a tenth critical value; and said abnormality which may require treatment is defined by at least one of; a) a range of values of a first function of the value of a medical parameter of said patient which is greater than an eleventh critical value; and b) a range of values of a first function of the value of a medical parameter of said patient which is less than a twelfth critical value; and wherein (i) said eleventh critical value is greater than said ninth critical value; and (ii) said twelfth critical value is less than said tenth critical value.
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59. The apparatus defined in claim 52, wherein said abnormality which requires notification is defined by at least one of:
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a) a range of values of a second function of the value of a medical parameter of said patient which is greater than a thirteenth critical value; and b) a range of values of a second function of the value of a medical parameter of said patient which is less than a fourteenth critical value; and said abnormality which may require treatment is defined by at least one of; a) a range of values of a second function of the value of a medical parameter of said patient which is greater than an fifteenth critical value; and b) a range of values of a second function of the value of a medical parameter of said patient which is less than a sixteenth critical value; and wherein (i) said fifteenth critical value is less than said thirteenth critical value; and (ii) said sixteenth critical value is greater than said fourteenth critical value.
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60. The apparatus defined in claim 52, wherein said abnormality which requires notification is defined by at least one of:
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a) a range of values of a third function of (i) the value of a medical parameter of said patient, and (ii) time, which is greater than a seventeenth critical value; and b) a range of values of a third function of (i) the value of a medical parameter of said patient, and (ii) time which is less than an eighteenth critical value; and said abnormality which may require treatment is defined by at least one of; a) a range of values of a third function of (i) the value of a medical parameter of said patient, and (ii) time, which is greater than a nineteenth critical value; and b) a range of values of a third function of (i) the value of a medical parameter of said patient, and (ii) time, which is less than a twentieth critical value; and wherein (i) said nineteenth critical value is greater than said seventeenth critical value; and (ii) said twentieth critical value is less than said eighteenth critical value.
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61. The apparatus defined in claim 52, wherein said abnormality which requires notification is defined by at least one of:
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a) a range of values of a fourth function of (i) the value of a medical parameter of said patient, and (ii) time, which is greater than a twenty first critical value; and b) a range of values of a fourth function of (i) the value of a medical parameter of said patient, and (ii) time which is less than a twenty second critical value; and said abnormality which may require treatment is defined by at least one of; a) a range of values of a fourth function of (i) the value of a medical parameter of said patient, and (ii) time, which is greater than a twenty third critical value; and b) a range of values of a fourth function of (i) the value of a medical parameter of said patient, and (ii) time, which is less than a twenty fourth critical value; and wherein (i) said twenty third critical value is less than said twenty first critical value; and (ii) said twenty fourth critical value is greater than said twenty second critical value.
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62. The apparatus defined in claim 52, wherein said abnormality which requires notification is defined by at least one of:
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a) a range of values of a fifth function of the values of each of a first plurality of medical parameters of said patient which is greater than a twenty fifth critical value; and b) a range of values of a fifth function of the values of each of a first plurality of medical parameters of said patient which is less than a twenty sixth critical value; and said abnormality which may require treatment is defined by at least one of; a) a range of values of a fifth function of the values of each of a first plurality of medical parameters of said patient which is greater than a twenty seventh critical value; and b) a range of values of a fifth function of the values of each of a first plurality of medical parameters of said patient which is less than a twenty eighth critical value; and wherein (i) said twenty seventh critical value is greater than said twenty fifth critical value; and (ii) said twenty eighth critical value is less than said twenty sixth critical value.
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63. The apparatus defined in claim 52, wherein said abnormality which requires notification is defined by at least one of:
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a) a range of values of a sixth function of the values of each of a second plurality of medical parameters of said patient which is greater than a twenty ninth critical value; and b) a range of values of a sixth function of the values of each of a second plurality of medical parameters of said patient which is less than a thirtieth critical value; and said abnormality which may require treatment is defined by at least one of; a) a range of values of a sixth function of the values of each of a second plurality of medical parameters of said patient which is greater than a thirty first critical value; and b) a range of values of a sixth function of the values of each of a second plurality of medical parameters of said patient which is less than a thirty second critical value; and wherein (i) said thirty first critical value is less than said twenty ninth critical value; and (ii) said thirty second critical value is greater than said thirtieth critical value.
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64. The apparatus defined in claim 52, wherein said abnormality which requires notification is defined by at least one of:
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a) a range of values of a seventh function of (i) the values of each of a third plurality of medical parameters of said patient, and (ii) time, which is greater than a thirty third critical value; and b) a range of values of a seventh function of (i) the values of each of a third plurality of medical parameters of said patient, and (ii) time, which is less than a thirty fourth critical value; and said abnormality which may require treatment is defined by at least one of; a) a range of values of a seventh function of (i) the values of each of a third plurality of medical parameters of said patient, and (ii) time, which is greater than a thirty fifth critical value; and b) a range of values of a seventh function of (i) the values of each of a third plurality of medical parameters of said patient, and (ii) time, which is less than a thirty sixth critical value; and wherein (i) said thirty fifth critical value is greater than said thirty third critical value; and (ii) said thirty sixth critical value is less than said thirty fourth critical value.
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65. The apparatus defined in claim 52, wherein said abnormality which requires notification is defined by at least one of:
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a) a range of values of an eighth function of (i) the values of each of a fourth plurality of medical parameters of said patient, and (ii) time, which is greater than a thirty seventh critical value; and b) a range of values of an eighth function of (i) the values of each of a fourth plurality of medical parameters of said patient, and (ii) time, which is less than a thirty eighth critical value; and said abnormality which may require treatment is defined by at least one of; a) a range of values of an eighth function of (i) the values of each of a fourth plurality of medical parameters of said patient, and (ii) time, which is greater than a thirty ninth critical value; and b) a range of values of an eighth function of (i) the values of each of a fourth plurality of medical parameters of said patient, and (ii) time, which is less than a fortieth critical value; and wherein (i) said thirty ninth critical value is less than said thirty seventh critical value; and (ii) said fortieth critical value is greater than said thirty eighth critical value.
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66. The apparatus defined in claim 1, wherein said logic device is operative to pass said at least one sensor circuit output signal to said first T/R device for transmission of said at least one sensor circuit output signal to the remote location in addition to said notification signal.
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67. The apparatus defined in claim 1, wherein said sensor circuit output is further coupled to said first T/R device for transmission of said at least one sensor circuit output signal to the remote location in addition to said notification signal.
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68. The apparatus defined in claim 1, further comprising a power supply coupled to a transmitter in said first T/R device, for powering said transmitter, and wherein said logic device is operable to power up said transmitter at the time a notification signal is to be sent, thereby to conserve power during periods when no transmission is required.
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69. The apparatus defined in claim 68, wherein said logic device is operable to power down said transmitter upon the occurrence of an event selected from the group consisting of (i) a specified time following the last transmission, and (ii) receipt of a signal from the remote location.
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70. The apparatus defined in claim 69, further comprising a supplementary power supply coupled to said treatment device, said sensor circuit, said logic device and a receiver in said first T/R device.
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71. The apparatus defined in claim 11, further comprising a power supply coupled to a transmitter in said first T/R device for powering said transmitter, and wherein said transmitter is powered up in response to an activation signal received from at least one of said remote station and said logic device, thereby to conserve power during periods when no transmission is required.
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72. The apparatus defined in claim 71, wherein said transmitter is powered down by at least one of:
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(a) a remote transmitter power reduction signal received from said remote station; and (b) a local transmitter power reduction signal received from said logic device; thereby to reduce the power consumption when said transmitter is not in use.
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73. The apparatus defined in claim 1, wherein said electronic medical treatment device is selected from the group consisting of:
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(a) a cardioverter-defibrillator device comprising; (i) a defibrillator circuit, having a defibrillator circuit output, for producing at least one defibrillation pulse at said defibrillator circuit output; (ii) at least one electrode for application of said defibrillator pulse to said patient; and (iii) a connecting circuit coupling said defibrillator circuit output to said at least one electrode; (b) a pacemaker device comprising; (i) a pacemaker circuit, having a pacemaker circuit output, for producing at least one pacemaker pulse at said pacemaker circuit output; (ii) at least one electrode for application of said pacemaker pulse to said patient; and (iii) a connecting circuit coupling said pacemaker circuit output to said at least one electrode; (a) a carotid receptor stimulator; (d) a brain stimulator; (e) a nerve stimulator; (f) a muscle stimulator; (g) a drug infusion pump; and (h) a circulatory heart pump for pumping the blood of said patient.
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74. The apparatus defined in claim 1, wherein said electronic medical treatment device comprises:
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(a) a defibrillator circuit, having a defibrillator circuit output, for producing at least one defibrillation pulse at said defibrillator circuit output; (b) a pacemaker circuit, having a pacemaker circuit output, for producing at least one pacemaker pulse at said pacemaker circuit output; (c) at least one electrode for application of at least one of (i) said defibrillator pulse; and
(ii) said pacemaker pulse to said patient;(d) a first connecting circuit coupling said defibrillator circuit output to at least one said electrode; and (e) a second connecting circuit coupling said pacemaker circuit output to at least one said electrode.
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75. The apparatus defined in claim 74, wherein at least one of said at least one electrode is selectively coupled to said defibrillator circuit output and said pacing circuit output, thereby serving as both a defibrillator electrode and a pacing electrode.
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76. The apparatus defined in claim 73, wherein said nerve stimulator is operative to stimulate at least one of:
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(1) at least one branch of the vagus nerve; and (2) at least one nerve which conveys nerve signals from a carotid artery baroreceptor.
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77. The apparatus defined in claim 73, wherein said drug infusion pump is selected from the group consisting of:
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(i) a pump which supplies insulin; (ii) a pump which supplies a chemotherapeutic agent; (iii) a pump which supplies an antibiotic; (iv) a pump which supplies an anesthetic agent; and (v) a pump which supplies an analgesic agent, to said patient.
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78. The apparatus defined in claim 11, wherein the IMD comprises a data storage device, coupled to said logic device, for storage of data, said data including at least one of:
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(a) medical data received from said sensor circuit; (b) data representing logic device analysis of medical data (c) data representing logic device control signals for application to said electronic medical treatment device; (c) data representing notification signals for transmission to said remote station; and (d) data representing control signals received from said remote station.
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79. The apparatus defined in claim 78, wherein said data storage device is further coupled to said sensor circuit output for storage of sensor output signal data.
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80. The apparatus defined in claim 78, where said data storage device is operative to provide said stored medical data to said logic device for transmission to said remote station upon receipt of at least one of:
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(1) a command received from said remote station; and (2) a notification signal received from said logic device.
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81. The apparatus defined in claim 11, further comprising:
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(a) at least one battery, coupled to each of said first T/R device, said medical treatment device, said sensor circuit and said logic device, for supplying electrical power thereto; (b) battery monitoring apparatus, coupled to said battery and to said first T/R device, for monitoring battery information selected from the group consisting of (i) battery voltage, (ii) battery current drain, (iii) battery impedance, and (iv) remaining battery energy; wherein said battery monitoring apparatus is operative to send said battery information to said remote station via said first T/R device.
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82. The apparatus defined in claim 81, wherein said first T/R device includes a transmitting device and a receiving device and wherein said transmitting device is operative to reduce its power output in response to a first power reduction signal received by said receiving device from said remote station,
whereby said medical expert, may cause said reduction in transmission power output of said transmitting device to conserve battery function in response to receipt of battery information indicating that battery capacity has declined below a first critical value. -
83. The apparatus defined in claim 81, wherein said first T/R device includes a transmitting device and a receiving device and wherein said transmitting device is operative to switch off, in response to a second power reduction signal received by said receiving device from said remote station,
whereby said medical expert may cause a cessation of transmission by said transmitting device in response to receipt of battery information indicating that battery capacity has declined below a second critical value. -
84. The apparatus defined in claim 1, further comprising at least one battery, coupled to each of said first T/R device, said medical treatment device, said sensor circuit and said logic device, for supplying electrical power thereto;
wherein (a) said first T/R device includes a transmitting device and a receiving device and said transmitting device is operative to reduce its power output in response to a power reduction signal from said logic device; and (b) said logic device is operative to monitor battery information selected from the group consisting of (i) battery voltage, (ii) battery current drain, (iii) battery impedance, and (iv) remaining battery energy; whereby said logic device causes said transmitting device to reduce power output to conserve battery function in response to battery information indicating that battery capacity has declined below a first prescribed value.
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85. The apparatus defined in claim 1, further comprising at least one battery, coupled to each of said first T/R device, said medical treatment device, said sensor circuit and said logic device, for supplying electrical power thereto;
wherein (a) said first T/R device includes a transmitting device and a receiving device and said transmitting device is operative to switch off its power output in response to a power off signal from said logic device; and (b) said logic device is operative to monitor battery information selected from the group consisting of (i) battery voltage, (ii) battery current drain, (iii) battery impedance, and (iv) remaining battery energy; whereby said logic device causes said transmitting device to switch off, to conserve battery function, in response to battery information indicating that battery capacity has declined below a second prescribed value.
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86. The apparatus defined in claim 11, further comprising:
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(a) at least one first battery, coupled to said first T/R device, for supplying power to said first T/R device; (b) at least one second battery coupled to each of said medical treatment device, said sensor circuit and said logic device, for supplying electrical power thereto; and (c) first battery capacity monitoring apparatus, coupled to said first battery and to said first T/R device, for monitoring first battery information selected from the group consisting of (i) first battery voltage, (ii) first battery current drain, (iii) first battery impedance, and (iv) remaining first battery energy; wherein said first battery monitoring apparatus is operative to send said first battery information to said remote station via said first T/R device.
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87. The apparatus defined in claim 86, wherein at least one of said first and second battery is rechargeable.
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88. The apparatus defined in claim 86, wherein said first T/R device includes a transmitting device and a receiving device and wherein said transmitting device is operative to reduce its power output in response to a first power reduction signal received by said receiving device from said remote station,
whereby said medical exert may cause said reduction in transmission power output of said transmitting device to conserve battery function in response to receipt of battery information indicating that the first battery capacity has declined below a first critical value. -
89. The apparatus defined in claim 87, wherein said first T/R device includes a transmitting device and a receiving device and wherein said transmitting device is operative to switch off, in response to a second power reduction signal received by said receiving device from said remote station,
whereby said medical expert may cause a cessation of transmission by said transmitting device in response to receipt of battery information indicating that the first battery capacity has declined below a second critical value. -
90. The apparatus defined in claim 86, wherein said first battery is further coupled to each of said medical treatment device, said sensor circuit and said logic device, for selectively supplying electrical power thereto in response to a battery control signal received by said receiving device from said remote station.
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91. The apparatus defined in claim 86, wherein said second battery is further coupled to said first T/R device, for selectively supplying electrical power thereto in response to a battery control signal received by said receiving device from said remote station.
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92. The apparatus defined in claim 11, further comprising
(a) at least one first battery, coupled to said first T/R device, for supplying power to said first T/R device and coupled to said logic device for supplying battery information to said logic device; -
(b) at least one second battery coupled to each of said medical treatment device, said sensor circuit and said logic device, for supplying electrical power thereto; wherein said logic device is operative to monitor said first battery information selected from the group consisting of (i) first battery voltage, (ii) first battery current drain, (iii) first battery impedance, and (iv) remaining first battery energy; wherein said logic device is operative to cause said transmitting device to reduce power output in response to first battery information indicating that first battery capacity has declined below a first critical value, thereby to conserve first battery function.
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93. The apparatus defined in claim 92, wherein said first T/R device includes a transmitting device and a receiving device and wherein said transmitting device is operative to reduce its power output in response to a first power reduction signal received from said logic device,
whereby said logic device may cause said reduction in transmission power output of said transmitting device to conserve battery function in response to receipt of battery information indicating that the first battery capacity has declined below said first critical value. -
94. The apparatus defined in claim 92, wherein said first T/R device includes a transmitting device and a receiving device and wherein said transmitting device is operative to switch off, in response to a second power reduction signal received from said logic device,
whereby said logic device may cause a cessation of transmission by said transmitting device in response to receipt of battery information indicating that the first battery capacity has declined below a second critical value. -
95. The apparatus defined in claim 1, wherein said logic device is operative to detect faults in the operation of at least one of said first T/R device, said treatment device, said sensor circuit and said logic device itself, and to generate and send a fault detection signal to said remote location via said first T/R device upon detection of a fault.
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96. The apparatus defined in claim 95, wherein said fault detection signal identifies the detected fault.
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97. The apparatus defined in claim 95, further comprising at least one battery and wherein the logic device is operative to determine an unfavorable value of at least one of:
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a) a battery voltage; b) a battery impedance; and c) a charge time and to generate and send said fault detection signal when said unfavorable value is determined.
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121. The apparatus defined in claim 1, wherein said logic device analyzes said at least one sensor circuit output signal and, based on said analysis, is operative to determine whether to issue:
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(i) a notification signal and no local treatment signal, (ii) a local treatment signal and no notification signal, (iii) both a notification signal and a local treatment signal, or (iv) neither a notification signal nor a local treatment signal.
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122. The apparatus defined in claim 1, wherein said notification signal indicates the occurrence of said medical abnormality.
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123. The apparatus defined in claim 1, wherein said notification signal provides information representing said at least one medical state of said patient.
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98. Electronic medical apparatus adapted to be implanted in a human patient, a so-called implantable medical device (IMD), which may be alternatively automatically self-controlled and remotely controlled by a medical expert, said apparatus comprising, in combination:
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(a) a first transmitting/receiving (T/R) device for transmitting medical data sensed from said patient to, and for receiving control signals from, a remote location; (b) an electronic medical treatment device for treating said patient in response to control signals applied thereto; (c) a sensor circuit, having a sensor circuit output, for producing at least one sensor output signal at said sensor circuit output in response to the medical data sensed from the patient; and
(d) a logic device coupled to each of(i) said sensor circuit output, (ii) said first T/R device, and (iii) said treatment device, for (i) analysis of said at least one sensor circuit output signal, (ii) generating a remote station notification signal, (iii) generating at least one local treatment device control signal; and (iv) generating at least one remote treatment device control signal; wherein; (1) said logic device analyzes said at least one sensor circuit output signal to detect a medical abnormality which requires notification of the medical expert at the remote location, and is operative to generate a notification signal, if required; (2) upon receipt of said notification signal, said first T/R device transmits said notification signal signal representing a medical state of said patient to the remote location; (3) said logic device analyzes said at least one sensor circuit output signal to detect a medical abnormality which requires treatment and is operative, in a first operating mode, to generate at least one local treatment device control signal, if required; (4) said logic device is operative, in a second operating mode, to generate at least one remote treatment device control signal in response to at least one remote control signal received from the remote location by said first T/R device; and (5) said logic device selects said operating mode based on at least one signal received from at least one of said first T/R device and said sensor circuit.
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99. A method of controlling an electronic medical apparatus adapted to be implanted in a human patient, a so-called implantable medical device (IMD), which may treat a medical condition in a patient following the detection by said device of an abnormality, which may be alternatively automatically self-controlled and remotely controlled by a medical expert at a remote location, said method comprising the steps of:
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(1) monitoring signals which contain information about at least one medical state in a patient and producing medical condition signals representative of said state; (2) detecting a medical abnormality which may require treatment, based on said signals; (3) upon detection of said medical abnormality, determining by said IMD whether said treatment is to be selected automatically by said IMD or remotely by a medical expert; (4) if said determination is for said IMD-selected automatic treatment, the IMD automatically selecting and administering said treatment, if treatment is warranted; (5) if said determination is for remote selection of treatment; (a) transmitting information concerning said medical abnormality to said medical expert; (b) receiving said information for review by a medical expert; (c) said medical expert selecting the treatment of said medical abnormality, if treatment is warranted, (d) said medical expert transmitting at least one treatment control signal to said IMD, if treatment is warranted; and (e) said IMD administering said medical expert-selected treatment, in response to said at least one treatment control signal. - View Dependent Claims (100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 116)
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117. A method of controlling an electronic medical apparatus adapted to be implanted in a human patient, a so-called implantable medical device (IMD), which may treat a medical condition in a patient following the detection by said device of an abnormality, which may be alternatively automatically self-controlled and remotely controlled by a medical expert at a remote location, said method comprising the steps of:
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(1) at said IMD, monitoring information about at least one medical state in a patient and producing medical condition signals representative of said medical state; (2) at said IMD, detecting a first apparent medical abnormality which may require treatment, based on said medical condition signals; (3) at said IMD, upon detection of said first apparent medical abnormality, transmitting said medical condition signals to a medical expert at a remote location; (4) at said IMD, detecting a second apparent medical abnormality which may require treatment, based on said medical condition signals, and, upon detection of said second apparent medical abnormality generating a local treatment control signal; (5) at said IMD, in the absence of a received remote treatment control signal, administering treatment to said patient specified by said local treatment control signal, if any; (6) at said remote location, making a determination of whether a remote treatment is warranted based on said received medical condition signals, and; if said remote treatment is warranted, transmitting a remote treatment control signal to the IMD from the remote location; (7) at said IMD, determining if the treatment indicated by said remote treatment control signal is different from the treatment indicated by said local treatment control signal; and (8) at said IMD, if the treatment indicated by said remote treatment control signal is different from the treatment indicated by said local treatment control signal, administering treatment to said patient specified by said remote treatment control signals.
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118. A method of controlling an electronic medical apparatus adapted to be implanted in a human patient, a so-called implantable medical device (IMD), which may treat a medical condition in a patient following the detection by said device of an abnormality, which may be alternatively automatically self-controlled and remotely controlled by a medical expert at a remote location, said method comprising the steps of:
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(1) at said IMD, monitoring information about at least one medical state in a patient and producing medical condition signals representative of said medical state; (2) at said IMD, detecting an apparent medical abnormality which may require treatment, based on said medical condition signals; (3) at said IMD, upon detection of said apparent medical abnormality, transmitting said medical condition signals to a medical expert at a remote location; (4) at said remote location, receiving said medical condition signals and determining whether said treatment is warranted based on said medical condition signals; (5) at said remote location, if said treatment is warranted, determining whether said treatment is to be selected automatically by said IMD or remotely by a medical expert; (6) if said determination is for said automatic treatment by said IMD, producing a signal at said remote location for causing said IMD to automatically administer said automatic treatment to said patient; (7) if said determination is for remote treatment by said medical expert; (a) said medical expert selecting the treatment of said medical abnormality; (b) said medical expert transmitting at least one treatment control signal to said IMD; and (c) said IMD administering said medical treatment, in response to said at least one treatment control signal received from said remote location. - View Dependent Claims (119, 120)
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Specification