Temporary and permanent programmable digital cardiac pacemaker

• US 4,253,466 A
• Filed: 11/05/1979
• Issued: 03/03/1981
• Est. Priority Date: 11/06/1978
• Status: Expired due to Term

• Current Assignee: Med-El Incorporated
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Hartlaub, Jerome T., McDonald, Ray S., Shearon, Lawrence W.
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US06/091,606
• Time in Patent Office: 484 Days
• Field of Search: 128/419 PG
• US Class Current: 607/30
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators
• CPC Class Codes: A61N 1/37217 characterised by the communication link, e.g. acoustic or tactile
• CPC Class Codes: A61N 1/37254 Pacemaker or defibrillator security, e.g. to prevent or inhibit programming alterations by hackers or unauthorised individuals

Abstract

A programmable cardiac pacemaker pulse generator utilizing digital circuitry for controlling the provision of cardiac stimulating pulses. The pulse generator is capable of having the rate, the pulse width, the pulse amplitude, the refractory period, the sensitivity and the mode of operation programmed. In addition, the pulse generator can have the output inhibited and can respond to programming signals causing a threshold margin test to be performed, effects of closure of the reed switch overridden, a hysteresis function added and a high rate exceeding the normal upper rate limit programmed. Many of the programmable functions of the pulse generator can either be programmed on a permanent or a temporary basis. The pulse generator further includes means for signaling the acceptance of a programming signal, and means to reset the program acceptance circuit if extraneous signals are detected as programming signals. The program signal acceptance circuit performs several different checks on the detected programming signal including a parity check, an access code check and determining if the proper number of signals were transmitted within a given time. The timing circuit of the pulse generator includes a crystal clock oscillator and counter means for counting the clock pulses therefrom to determine the rate of the pacemaker. The pulse width of each pacemaker pulse is determined by using a voltage controlled oscillator in place of the crystal oscillator to obtain energy compensation due to the battery voltage decreasing with time.

Claims

1. A programmable medical device pulse generator capable of being programmed in either a temporary or a permanent mode in response to a programming signal provided thereto from external means, said programming signal including a first portion of data manifesting that said pulse generator is to be programmed in a certain manner and a second portion of data indicating said certain manner is to be either permanent or temporary, said pulse generator comprising:

detector means for detecting both said first and second portions of data contained in said programming signal; and

means responding to said detector means for permanently programming said pulse generator in said certain manner whenever said second portion of data in said programming signal indicates said certain manner is to be permanent and for temporarily programming said pulse generator in said certain manner whenever said second portion of data in said programming signal indicates said certain manner is to be temporary.

2. The invention according to claim 1 wherein said means for programming includes memory means for storing at least some of said first portion of data whenever said pulse generator is being permanently programmed and for being by-passed by at least some of said first portion of data whenever said pulse generator is being temporarily programmed.

3. The invention according to claim 2 wherein said means for programming further includes second memory means for storing said first portion of data each time said programming signal is provided, and logic means for providing at least some of said data stored in said second memory means to said first memory means for storage in said first memory means if the second portion of said data indicates said certain manner is to be permanent, said logic means further providing at least some of said data stored in said second memory means to control said pulse generator in said certain manner if the second portion of said data indicates said certain manner is to be temporary.

4. The invention according to claim 3 wherein said detector means includes bistable means for being set in response to said second portion of data indicating said certain meanner is to be temporary, said bistable means, when set, controlling said logic means, to provide at least some of the data stored by said second memory means to control said pulse generator in said certain manner.

5. The invention according to claim 4 wherein said pulse generator is controlled to operate in a manner defined by the data stored in said first memory means whenever said bistable means is not set.

6. In a programmable medical device for generating pulses in accordance with a programmed operating condition including detector means responsive to signal manifesting data of an applied programming signal for providing a signal manifesting an operating condition to be changed, first memory means responsive to said detector means signal for storing data manifesting said then permanent programmed operating conditions and oscillator means for providing said pulses in accordance with the data stored in said first memory means, the improvement in which said programming signals further manifest whether the operating condition to be programmably change is to be in a permanent or temporary manner comprising:

decoding means for providing a signal indicating whether the status of said operating condition to be temporarily or permanently changed;

second memory means for storing data related to said operating condition to be changed and for providing signals manifesting the data stored thereby; and

logic means responsive to said decoding means signal for providing certain of said second memory means signals to said first memory means in the event said decoding means signal indicates a permanent operating condition change is to be programmed and for providing said certain signals of said second memory means signals to said oscillator means in place of the signals applied thereto from said first memory means in the event said decoding means signal indicates a temporary operating condition change is to be programmed.

7. The invention according to claim 6 wherein said detector means and said decoding means are responsive to signals manifesting the data contained in a programming signal applied from means external to said medical device.

8. The invention according to claim 7 wherein said detector means includes means for detecting said programming signal and for providing signals means manifesting the data contained in said programming signal.

9. The invention according to claim 6 wherein said logic means includes gate means responsive signal, to signals from said first memory means manifesting the data stored therein and to signals from said second memory means manifesting the data stored therein, for providing signals to said oscillator means in accordance with the manner of programming indicated by said decoding means signal.

10. The invention according to claim 9 wherein said gate means provides said first memory signal applied thereto to said oscillator means whenever said decoding means signal indicates that a permanent operating condition is to be programmed and provides said second memory means signal applied thereto to said oscillator means whenever said decoding means signal indicates that a temporary operating condition is to be programmed.

11. The invention according to claim 6:

wherein said programmable operating conditions include a plurality of different parameters each of which can be programmed to a different value;

wherein each programming signal manifests one parameter to be changed, a value to which said parameter is to be changed and whether such change is to be permanent or temporary; and

wherein said detector means includes input means for detecting and decoding said programming signal and for providing parameter, data and status signals manifesting the parameter to be changed, the value to which that parameter is to be changed and whether that change is to be temporary or permanent, said parameter and data signals being applied to said second memory means and said status signal being applied to said decoding means.

12. The invention according to claim 11 wherein said detector therefore means includes:

parameter decoding means responsive to the parameter signals provided from said second memory means for providing a signal manifesting the one parameter to be changed; and

gate means responding to both said parameter decoding means signal and said status decoding means signals for providing signals to said first memory means to cause the data stored in said second memory means to be either stored in said first memory means or to be provided to said oscillator means.

13. The invention according to claim 12 wherein said logic means further includes second gate means responsive to the data stored in said first memory means, the data stored in said second memory means and the first gate means signals for providing signals to said oscillator means manifesting the data stored in said first memory means whenever said first gate means signals do not indicate a temporary programming change is to occur, for providing signals to said oscillator means manifesting the data stored in said second memory means whenever said first gate means signals indicate a temporary programming change is to occur and for storing the data stored in said second memory means in said first memory means whenever said first gate signals indicate a permanent programming change is to occur.

14. A programmable cardiac pacemaker pulse generator for being programmed to provide cardiac stimulating pulses to output terminals adapted to being electrically coupled to the heart, the operating conditions of said stimulating pulses being changeable in response to a programming signal containing operating data manifesting a defined operation change and mode data manifesting whether said defined parameter is to be permanently or temporarily changed, said pulse generator comprising:

means responsive to said programming signal for detecting said programming signal and for providing signals manifesting said operating data and said mode data;

temporary memory means responsive to said detecting means signal manifesting said operating data for storing data related to said operating data;

mode logic responsive to said detecting means signal manifesting said mode data for providing a signal indicating whether the operation change is to be permanently or temporarily changed;

permanent memory means for storing data and providing signals manifesting said stored data to control the provision of said cardiac stimulating pulses within the defined operating conditions, said permanent memory means being responsive to said temporary memory means data and said mode logic signal for storing the data stored in said temporary memory means in the event said mode logic signal indicates the operation change is to be permanent and for providing signals related to the data stored by said temporary memory means to control the provision of said cardiac stimulating pulses in the event said mode logic signal indicates the operation change is to be temporary.

15. The invention according to claim 14:

wherein said pulse generator is capable of having a plurality of different parameters programmed, at least some of which parameters can be programmed to any of a plurality of different values, said operating data of said programming signal including a parameter portion and a value portion respectively manifesting one parameter to be changed and the value to which that one parameter is to be changed;

wherein said pulse generator further includes decoding means responsive to the parameter portion of the data stored in said temporary memory means and to the mode logic signal for providing a signal manifesting the parameter to be changed and whether said change is to be permanent or temporary; and

wherein said permanent memory means responds to said decoding means signal by either storing the data stored in said temporary memory means or providing signals related to the data stored in said temporary memory means to control the provision of said cardiac stimulating pulses.

16. The invention according to claim 15:

wherein said permanent memory means includes a portion dedicated to storing data for each parameter to be changed;

wherein said decoding means provides a plurality of different signals, each of which manifest one parameter to be changed and one mode of change; and

wherein each parameter portion of said permanent memory means responds to the decoding means signals manifesting the parameter to which that portion is dedicated.

17. The invention according to claim 16 wherein each portion of said memory means includes gate means enabled by said decoding means signals, and responsive to the data in that portion of said permanent memory means and the data in said temporary memory means for providing the proper signals to control the provision of said cardiac stimulating pulses.

18. The invention according to claim 17:

wherein said temporary memory means includes a plurality of stages and each portion of said permanent memory means includes at least one stage; and

wherein said gate means includes first and second gates associated with each stage of said permanent memory means, one of said gates associated with each stage has a signal applied thereto manifesting the data stored in that stage and the other of said gates associated with each stage has a signal applied thereto manifesting the data in a corresponding stage of said temporary memory means, each of said gates further responding to one decoding means signal such that when a temporary mode is being programmed, said other gates are enabled to provide signals manifesting the data in said temporary memory means and at other times, said one gate is enabled to provide signals manifesting the data in said permanent memory means.

19. The invention according to claim 18 wherein each stage of said memory means further includes storage gate means responsive to the data stored in said temporary memory and the signal from said decoding means for being enabled by said decoding means signal to provide said temporary memory means data for storage in permanent memory means.

20. The invention according to claim 19:

wherein said mode logic includes means for providing a continuous signal whenever a temporary change is to occur; and

wherein said decoding logic responds to said continuous signal by providing a continuous signal to enable said other gates in said permanent memory means.

21. The invention according to claim 19:

wherein said mode logic includes means for providing a pulse signal of a duration less than the time between cardiac stimulating pulses whenever a permanent change is to occur; and

wherein said decoding logic responds to said pulse signal to enable said storage gate means in said permanent memory means.

22. The invention according to claim 21:

wherein said mode logic includes means for providing a continuous signal whenever a temporary change is to occur; and

wherein said decoding logic responds to said continuous signal by providing a continuous signal to enable said other gates in said permanent memory means.

23. The invention according to claim 22:

wherein said pulse generator includes switch means which must be reversed to enable said pulse generator to respond to said programming signal; and

wherein said mode logic includes means to discontinue the provision of said continuous signal upon the initialization of said switch means.

24. The invention according to claim 20:

wherein said pulse generator includes switch means which must be reversed to enable said pulse generator to respond to said programming signal; and

wherein said mode logic includes means to discontinue the provision of said continuous signal upon the initialization of said switch means.

25. A programmable cardiac pacemaker pulse generator to which is applied a programming signal including data manifesting a new operating condition which said pulse generator is to assume, said programming signal further including a code manifesting whether said pulse generator is to permanently assume said new operating condition or whether said pulse generator is to temporarily assume said new operating condition, said temporary assumption occurring for a selected time after which time said pulse generator assumes the operating conditions which existed prior to the application of said programming signal, said pulse generator comprising:

cardiac stimulating pulse providing means for providing cardiac stimulating pulses in accordance with operating condition defining signals applied thereto;

temporary memory means for being set to store a code related to data manifested by said programming signal and for providing signals manifesting the code stored thereby;

permanent memory means for being set to store a code related to the code of signals applied thereto and for providing signals manifesting the code stored thereby; and

logic means for detecting whether said programming signal manifests whether said pulse generator is to permamently or temporarily assume said new operating condition and for providing control signals to said temporary and permanent memory means to cause the signals from said temporary memory means to be respectively applied to and stored by said permanent memory means or applied for said selected time to said cardiac stimulating pulse providing means as said operating condition defining signals, said signals provided by said permanent memory means being said operating condition defining signals whenever no signals are applied as operating condition defining signals from said temporary memory means.

26. The invention according to claim 25 wherein said logic means includes gate means for controlling whether said permanent memory means signals or said temporary memory means signals are applied as said operating condition defining signals.

27. The invention according to claim 25 wherein said logic means includes gate means for being enabled to allow the signals from said temporary memory means to be stored in said permanent memory means.

28. The invention according to claim 27 wherein said permanent memory means includes gate means for being disabled in conjunction with said logic means, and gate means to allow said temporary memory means signals to be stored in said permanent memory means.

29. The invention according to claim 26:

wherein said logic means includes;

means for detecting the applied programming signal, means for determining the accuracy of said detected signal, and for providing a signal manifesting determined accuracy, and

means for providing a mode signal not prior to said determined accuracy signal manifesting whether said new operating condition is to be temporary or permanent, said mode signal being provided for said selected time;

wherein said temporary memory means includes gate means which is enabled by said determined accuracy signal to apply signals from said detecting means to be stored in said temporary memory means; and

wherein said permanent memory means includes gate means which is enabled to receive and store signals from said temporary memory means upon the occurrence of said determined accuracy signal and said mode signal manifesting a permanent new operating condition, said gate means further being enabled to provide a signal related to the signal stored by, said temporary memory means to said cardiac stimulating pulse providing means whenever said mode signal manifests a new temporary operating condition and further being enabled to provide a signal related to the signal stored by said permanent memory means to said cardiac stimulating pulse providing means whenever said mode signal does not manifest a new temporary operating condition.

30. The invention according to claim 25:

wherein said pulse generator is capable of having a plurality of operating parameters changed, each programming signal manifesting one parameter to be changed and a multi-bit value code manifesting a value to which said one parameter is to be changed;

wherein said temporary memory means includes a multi-stage register of sufficient size to store each bit of said value code;

wherein said permanent memory means includes a multistage register of greater size than said temporary register and having at least one stage dedicated to each different parameter capable of being changed; and

wherein said logic means includes parameter decoding means responsive to the manifested parameter portion of said programming signal for providing signals coupling appropriate stages of said temporary memory to the stages of said permanent memory dedicated to said manifested parameter.

31. The invention according to claim 30:

wherein said logic means includes;

means for detecting the applied programming signal;

means for determining the accuracy of said detected signal and for providing a signal manifesting determined accuracy, and

means for providing a mode signal not prior to said determined accuracy signal manifesting whether said operating parameter to be changed is to be temporarily or permanently changed, said mode signal being provided for said selected time;

wherein each stage of said temporary memory means includes gate means responsive to a signal from said detecting means representing one bit of said value code and enabled by said determined accuracy signal to apply for storage in that stage a signal related to said signal applied thereto; and

wherein each stage of said permanent memory means includes gate means which enables said parameter decoding means to receive and store a signal from the appropriate stage of said temporary memory means upon the occurrence of said determined accuracy signal and said mode signal manifesting a permanent new parameter change, said gate means further being enabled by said decoding means to provide a signal related to the signal stored by said appropriate stage of said temporary memory means to said cardiac stimulating pulse providing means whenever said mode signal manifests a temporary parameter change and further being enabled by said parameter decoding means to provide a signal related to the signal stored by that stage of said permanent memory means to said cardiac stimulating pulse providing means whenever said mode signal does not manifest a temporary parameter change.

32. The invention according to claim 31 wherein said determined accuracy signal and said mode signal are coupled to said parameter decoding means.

33. A programmable medical device capable of being programmed in a certain manner by a programming signal received from an external source, characterized by:

permanent memory means for storing programming signal data for controlling the operating conditions of the medical device for an indeterminate time period;

temporary memory means for storing programming signal data for controlling the operating conditions of the medical device and a further signal determining whether the medical device is to be permanently or temporarily programmed with the received signal data; and

logic circuit means responsive to the further signal for applying the programming signal data to the permanent or temporary memory means.

34. The programmable medical device according to claim 33:

wherein said programmable operating conditions include a plurality of different parameters each of which can be programmed to a different value;

wherein each programming signal manifests one parameter to be changed, a value to which said parameter is to be changed and whether such change is to be permanent or temporary; and

wherein said logic circuit includes input means for detecting and decoding said programming signal and for providing parameter, data and status signals manifesting the parameter to be changed, the value to which that parameter is to be changed and whether the status of the change is to be temporary or permanent, said parameter and data signals being applied to said temporary memory means.

35. The programmable medical device of claim 33 or 34 wherein:

said logic means responds to said detector means for transferring certain of the signal data in said temporary memory means to said permanent memory means if the status signal indicates a permanent operating condition change is to be programmed and for providing said certain signal data of said temporary memory means to said medical device in place of the signal data applied thereto from said permanent memory means in the event the status signal indicates a temporary operating condition change is programmed.

36. The programmable medical device of claim 35 wherein said logic means further comprises:

switching means for covering the temporary operating conditions to be applied to the medical device for a temporary period related to the period during which the programming signal is detected by said detecting means.

37. The programmable medical device of claim 33 or 34 wherein said medical device is a body stimulator further comprising:

a pulse generator having oscillator means for providing stimulating pulses to body tissue in a mode and having parameters controlled by signal data stored in said permanent or temporary memory means.