Digital cardiac pacemaker with threshold margin check

• US 4,273,132 A
• Filed: 11/06/1978
• Issued: 06/16/1981
• Est. Priority Date: 11/06/1978
• Status: Expired due to Term

• Current Assignee: Med-El Incorporated
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Thompson, David L., Hartlaub, Jerome T., McDonald, Ray S.
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US05/958,090
• Time in Patent Office: 953 Days
• Field of Search: 128/419 PG, 128/419 PS, 128/419 PT
• US Class Current: 607/28
• CPC Class Codes: A61N 1/3706 Pacemaker parameters stimulation threshold A61N1/371
• CPC Class Codes: A61N 1/37254 Pacemaker or defibrillator security, e.g. to prevent or inhibit programming alterations by hackers or unauthorised individuals

Abstract

There is disclosed herein 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, accomplished by threshold safety margin means responsive to a programmed test signal for causing a series of stimulating pulses to be provided a rate different than the previously programmed rate with at least one of the stimulating signals having its energy reduced a predetermined amount. Capture at the reduced energy can be monitored by external equipment.

Claims

1. An implantable cardiac pacemaker pulse generator having stimulating signal providing means for generating electrical stimulating pulses having a defined pulse energy and rate adapted to be applied to stimulate the heart, and detecting means for receiving a test signal from an external source and providing a threshold safety margin signal, further comprising safety margin means responsive to said threshold safety margin signal for causing said stimulating signal providing means to provide a test series of stimulating pulses at a rate different than the defined rate when said defined rate is lower than said test rate and at said defined rate where said defined rate exceeds said test rate and to provide one of said stimulating signal having a pulse energy reduced by a predetermined amount from the defined pulse energy, and means for terminating said test series when fixed number of said stimulating pulses is produced following the provision of said threshold safety margin signal.

2. The invention according to claim 1:

wherein said detecting means includes switch means which changes states upon the application of said signal from said external source; and

wherein said threshold margin means responds to the change of states of said switch means.

3. The invention according to claim 2:

wherein said stimulating signal providing means, prior to the time said switch means changes states, generates said stimulating signals as a series of pulses;

wherein said threshold margin means provides a signal to said stimulating signal providing means in response to the change of states of said switch means;

wherein said stimulating signal providing means, in response to said threshold margin means signal, generates said test series of pulses, different from the series of pulses generated prior to the change of states of said switch means, at least one pulse of said test series having an amount of energy which is said predetermined amount less than said defined energy, said test series consisting of a finite number of pulses; and

wherein said stimulating signal providing means generates said initial series of pulses after the generation of said finite number of pulses.

4. A digitally controlled implantable cardiac pacemaker pulse generator comprising:

a pair of output terminals at least one of which is adapted to being connected to a lead to which an output signal to stimulate the heart is provided, said output signal being a series of electrical pulses occurring at a defined rate, with each pulse having a defined pulse width;

digital control means including clock means, counting means and decoding means, said clock means providing a clock signal to said counting means to be counted, and said decoding means providing said output signal to said output terminals in response to said counting means reaching a certain count;

means adapted to respond to an external signal applied to said pulse generator from an external source for providing a test signal;

safety margin means responsive to said test signal for providing a safety margin signal to said digital control means; and

said digital control means comprising means responding to said safety margin signal for providing a test sequence of a given number of the pulses of said output signal at a test rate above the defined rate when said defined rate is less than said test rate and at said defined rate when said defined rate exceeds said test rate and for decreasing the pulse width of at least one pulse of said given number of pulses; and

said safety margin means comprises further means for counting the given number of pulses of said output signal and terminating said test sequence.

5. The invention according to claim 4:

wherein said safety margin signal includes a rate control signal which is at a first or a second logic level; and

wherein said decoding means responds to said rate control signal by providing said pulses at said defined rate in response to said rate control signal being at said first level and by providing said pulses at said test rate above said defined rate in response to said rate control signal being at said second level.

6. The invention according to claim 5 wherein said further means includes second counter means for counting signals related to said output signals and means responsive to said second counter means for providing said rate control signal from a time following the provision of the output signal after said test signal until said given number of output pulses have been provided.

7. The invention according to claim 6:

wherein said digital control means includes means for providing a clocking signal following each pulse of said output signal, said clocking signal being provided to said second counter to be counted; and

wherein said second counter is maintained in a reset state until said test signal is provided and after said given number of pulses of said output signal are provided.

8. The invention according to claim 7 wherein said second counter means includes a plurality of resettable bistable circuits each being one stage of said second counter means, second decoding means for providing said rate control signal as long as at least one of said bistable circuits is not reset and reset means for maintaining each of said bistable circuits reset until said test signal is provided and after said given number of pulses of said output signal are provided.

9. The invention according to claim 8 wherein said reset means includes a resettable bistable circuit and gate means, the output of said gate means being coupled to maintain each of said second counter means bistable circuits reset unless both said test signal is provided and said reset means bistable circuit is reset, said reset means bistable circuit being reset whenever said test signal is not provided and being set after said second counter means has counted to said given number.

10. The invention according to claim 4:

wherein said safety margin signal includes a pulse width control signal which is at one of a first or a second logic level; and

wherein said clock means responds to said pulse width control signal by providing clock signals at a first frequency in response to said pulse width control signal being at said first level and by providing clock signals at a second, higher, frequency in response to said pulse width control signal being at said second level.

11. The invention according to claim 10 wherein said safety margin means includes second counter means for counting signals related to said output signals and means responsive to the count of said second counter means for providing said pulse width control signal at said second level during the time said one of said given number of pulses of said output signal is provided, and for providing said pulse width control signal at said first level at other times.

12. The invention according to claim 11:

wherein said digital control means includes means for providing a clocking signal following the end of said output signal, said clocking signal being provided to said second counter to be counted; and

wherein said second counter is maintained in a reset state until said test signal is provided and after said given number of pulses of said output signal are provided.

13. The invention according to claim 12 wherein said second counter means includes a plurality of resettable bistable circuits, each being one stage of said second counter means, second decoding means for providing said pulse width control signal at the time a pulse of said output signal is provided and said second counter means has counted to a certain value.

14. The invention according to claim 13:

wherein said clock means includes fixed frequency oscillator means for providing a fixed frequency pulse signal and frequency dividing logic means to which said fixed frequency signal is applied, said dividing logic means providing one pulse for each divisor number of pulses applied thereto, said dividing logic means including means responsive to said pulse width signal for varying said divisor number in accordance with the level of the pulse width signal.

15. The invention according to claim 14:

wherein said safety margin signal includes a rate control signal which is at a first or a second logic level; and

wherein said decoding means responds to said rate control signal by providing said pulses at said defined rate in response to said rate control signal being at said first level and by providing said pulses at said rate above said defined test rate in response to said rate control signal being at said second level.

16. The invention according to claim 10:

wherein said clock means includes fixed frequency oscillator means for providing a fixed frequency pulse signal and frequency dividing logic means to which said fixed frequency signal is applied, said dividing logic means providing one pulse for each divisor number of pulses applied thereto, said dividing logic means including means responsive to said pulse width signal for varying said divisor number in accordance with the level of the pulse width signal.

17. The invention according to claim 16:

wherein said safety margin signal includes a rate control signal which is at a first or a second logic level; and

wherein said decoding means responds to said rate control signal by providing said pulses at said defined rate in response to said rate control signal being at said first level and by providing said pulses at said rate above said defined test rate in response to said rate control signal being at said second level.

18. The invention according to claim 17 wherein said further means includes second counter means for counting signals related to said output signals and means responsive to said second counter means for providing said rate control signal from a time following the provision of the output signal after said test signal until said given number of output pulses have been provided.

19. The invention according to claim 18:

wherein said digital control means includes means for providing a clocking signal following the end of said output signal, said clocking signal being provided to said second counter to be counted; and

wherein said second counter is maintained in a reset state until said test signal is provided and after said given number of pulses of said output signal are provided.

20. The invention according to claim 19 wherein said second counter means includes a plurality of resettable bistable circuits each being one stage of said second counter means, second decoding means for providing said rate control signal as long as at least one of said bistable circuits is not reset and reset means for maintaining each of said bistable circuits reset until said test signal is provided and after said given number of pulses of said output signal are provided.

21. The invention according to claim 20 wherein said reset means includes a resettable bistable circuit and gate means, the output of said gate means being coupled to maintain each of said second counter means bistable circuits reset unless both said test signal is provided or said reset means bistable circuit is reset, said reset means bistable circuit being reset whenever said test signal is not provided and being set after said second counter means has counted to said given number.