Programmable digital cardiac pacemaker with means to override effects of reed switch closure

• US 4,273,133 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: Rossing, Martin A., Hartlaub, Jerome T., McDonald, Ray S.
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US05/958,325
• Time in Patent Office: 953 Days
• Field of Search: 128/419 PG, 128/419 PS, 128/419 PT
• US Class Current: 607/30
• CPC Class Codes: A61N 1/362 Heart stimulators heart defibrillators A61N1/39
• 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. The programmable medical device having operating modes or parameters adapted to be programmed by the application thereto of first and second programming signals which include the program data manifesting the desired operating mode or parameter values for the medical device to assume, comprising:

means responsive to the first programming signal for receiving and storing the second programming signal;

switching means responsive to the first programming signal for switching the operating mode of the medical device from a normal operating mode to a different operating mode; and

disabling means responsive to the program data manifesting certain parameters for disabling said switching means so that the medical device is maintained in its normal operating mode while the medical device is programmed to the certain parameter value.

2. The medical device of claim 1 wherein said medical device comprises a cardiac pacemaker pulse generator having operating modes and parameter values which may be programmed by applying the first and second signals thereto, said pulse generator further comprising:

timing means for providing cardiac stimulating pulses having programmable parameters at programmable pacing rates and intervals; and

resetting means for resetting said timing means to restart the pacing interval upon the occurrence of natural heart activity; and

wherein

said switching means is responsive to said first programming signal for causing said timing means to operate independently of said resetting means; and

said disabling means is responsive to the program data manifesting certain parameters for disabling said switching means for certain parameters which affect said sensing means.

3. The medical device of claim 2 wherein said second programming signal further comprises program data manifesting permanent or temporary operating modes or parameter values, and wherein:

said receiving and storing means further comprises permanent and temporary program data storage means for receiving the permanent and temporary program data; and

said disabling means is responsive to temporary program data in said temporary program data storage means relating to the certain parameter.

4. The medical device of claim 3 wherein said certain parameters includes programming the refractory time of said pulse generator.

5. The medical device of claim 3 wherein said certain parameters includes programming the sensitivity of said sensing means.

6. The medical device of claim 3 wherein said certain parameter includes programming the operating mode of said pulse generator to be ventricular synchronous.

7. The invention according to claim 3 wherein said pulse generator can be permanently programmed to allow said sensing means signal to be applied to said oscillator means whenever said switch means is in said disable position.

8. The medical device of claim 2 further comprising switching means for switching from a first state to a second state in response to the first programming signal;

and wherein said resetting means further comprises;

sensing means responsive to natural cardiac activity for providing a sense signal; and

interface means coupled between said sensing means and said timing means and responsive to the switching means for coupling said sense signal to said timing means while said switching means is in said first state.

9. The medical device of claim 3 or 8 wherein said interface means further comprises means responsive to the second state of said switching means and said certain parameters for coupling said sense signal to said timing means.

10. A programmable cardiac pacemaker pulse generator which is programmed by applying first and second programming signal thereto having normally enabled switch means disabled in response to said first programming signal, said second programming signal including data manifesting desired operating conditions for said pulse generator to assume, said pulse generator comprising:

oscillator means for providing cardiac stimulating pulses;

sensing means responsive to the occurrence of natural activity for providing a signal to said oscillator means to inhibit the provision of said cardiac stimulating pulses;

inhibiting means responsive to said switch means being disabled for preventing the provision of said sensing means signal to said oscillator means; and

means for applying a selected signal to the inhibiting means in response to a certain second programming signal for overriding the inhibiting means and enabling the provision of the sensing means signal to the oscillator means during the programming of certain parameters of said pulse generator which interact with said sensing means.

11. A pacemaker pulse generator as claimed in claim 10 having means for programming said pulse generator in either a permanent mode or a temporary mode responsive to said selected signal for permanently or temporarily overriding the inhibiting means.

12. A pacemaker pulse generator as claimed in claim 11 wherein said selected signal is applied during the temporary mode programming of certain parameters of said pulse generator which interact with said sensing means.

13. A pacemaker pulse generator as claimed in claim 11 wherein said pulse generator can be permanently programmed to allow said sensing means signal to be applied to said oscillator means when said switch means is disabled.

14. A pacemaker pulse generator as claimed in claim 10 or 12 wherein said certain parameters include programming the refractory time of said pulse generator.

15. A pacemaker pulse generator as claimed in claim 10 or 12 wherein said certain parameters include programming the sensitivity of said sensing means.

16. A pacemaker pulse generator as claimed in claim 10 or 12 wherein said certain parameters include programming the operating mode of said pulse generator to be ventricular synchronous.

17. A pacemaker pulse generator as claimed in claim 10 wherein said inhibiting means includes interface means including a gate to which said sensing means signal is applied, said inhibiting means providing a signal to said gate for disabling said gate.

18. A pacemaker pulse generator as claimed in claim 17 wherein said switch means includes means for providing a switch signal manifesting the state of said switch means;

and wherein said inhibiting means includes gate means responsive to said switch signal and said selected signals for providing said inhibiting means signal to enable said interface means gate whenever said switch signal manifests said switch means is in said first state or whenever one of said selected signals is provided thereto and to disable said interface means gate whenever said switch signal manifests said switch means is in said second state and none of said selected signals are provided thereto.

19. A pacemaker pulse generator as claimed in claim 18 wherein said inhibiting means further includes bistable means responsive to said switch signal manifesting said switch means is in said second state for being held in one state and further responsive to a selected signal manifesting that said inhibiting means is not to provide a signal inhibiting said interface means for being triggered to the other state, said inhibiting means gate responding to said bistable means being in said other state by providing a signal to enable said interface means gate.