Programmable pacer

• US 4,124,031 A
• Filed: 06/09/1977
• Issued: 11/07/1978
• Est. Priority Date: 06/09/1977
• Status: Expired due to Term

• Current Assignee: Vitatron Medical BV
• Original Assignee: Vitatron Medical BV
• Inventors: Mensink, K. A., Renirie, A. C. M., Wittkampf, F. H. M.
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US05/805,037
• Time in Patent Office: 516 Days
• Field of Search: 128/419 P, 128/419 PG, 128/419 PS, 128/419 PT
• US Class Current: 607/31
• CPC Class Codes: A61N 1/365 controlled by a physiological parameter, e.g. heart potential evoked response A61N1/371
• CPC Class Codes: A61N 1/37217 characterised by the communication link, e.g. acoustic or tactile

Abstract

An implantable programmable pacer is disclosed which incorporates a program logic system for receiving magnetic signals from a simple magnet source applied external to the patient, and for translating the simple magnetic signals into logic signals for re-programming selected pacer parameters. The circuitry of the programming system is adapted to react to predetermined timed sequences of application of the external magnetic signal, which timed sequences are correlated with successive intervals of the pacer stimulus generator. The programming system is adapted to interpret predetermined patterns of external application of a magnetic field as instructions for re-programming respective operating parameters.

Claims

1. A demand cardiac pacer having a pulse generator operating at a pulse interval determined by the programming of said pacer when it is in the asynchronous mode and by received QRS signals when it is in the demand mode, and comprising:

a. means for sensing the presence and absence of an externally applied magnetic signal;

b. first means for counting said pulse intervals when said external magnetic signal is sensed;

c. second means for counting said pulse intervals when the absence of said external magnetic signal is sensed;

d. control signal means for generating control signals as a function of the counts of said first and second counting means; and

e. control means for controlling at least one predetermined pacer parameter with said generated control signals.

2. The pacer as described in claim 1, wherein said first means counts consecutive ones of said pulse intervals while said external magnetic signal is sensed and said second means counts consecutive ones of said pulse intervals following a sensed magnetic signal.

3. The pacer as described in claim 1, wherein said control signal means comprises logic means for determining the occurrence of a predetermined pattern of said externally applied magnetic field defined in terms of successive ones of said pulse intervals, and for generating a respective control signal in response to such determination.

4. The pacer as described in claim 3, wherein said control means is adapted to control the pulse rate of said pulse generator in response to a first control signal generated in response to a first predetermined pattern of said externally applied magnetic field.

5. The pacer as described in claim 3 wherein said control means is adapted to control the pulse output level of said pulse generator in response to a second control signal generated in response to a second predetermined pattern of said externally applied magnetic field.

6. A cardiac pacer having a stimulus generator circuit which continuously operates with successive time intervals which may vary within a predetermined internal range, comprising:

a. means for sensing the presence of an externally applied magnetic signal;

b. counting means for counting the total number of such stimulus generator time intervals which occur during the time period that a continuous magnetic signal is sensed by said sensing means;

c. control signal means for generating a predetermined control signal when said total count of said counting means is within a predetermined range; and

d. means for controlling a predetermined pacer operating parameter with said control signal.

7. The pacer as described in claim 6, wherein said control signal means generates said control signal only after more than one of said time intervals following a count within a predetermined range.

8. The pacer as described in claim 7, wherein said control signal means generates respective control signals following counts within respective predetermined ranges, and said controlling means controls respective pacer parameters with said respective control signals.

9. The pacer as described in claim 6, comprising second means for counting such time intervals following a sensed magnetic signal, and wherein said control signal means generates control signals as a function of the count of said counting means and of said second counting means.

10. A demand pacer adapted to operate with an electrode for communicating pacer stimulus signals to the patient'"'"'s heart and for communicating sensed heartbeat signals from said heart to the pacer, comprising:

a. oscillator means, operating in demand mode, in combination with amplifier and on demand logic circuitry, for operating at a fixed programmed rate in the absence of detected natural heartbeat signals and in an inhibited mode in the presence of detected natural heartbeat signals, and with a pulse interval defined by the programmed state of said pacer during said fixed operation and by the received heartbeat rates during said demand mode;

b. sensing means for sensing predetermined sequences of an external magnetic field wherein said magnetic field is present and absent in predetermined time coincidence with consecutive ones of said pulse intervals, and for generating program control signals corresponding to said sensed predetermined sequences; and

c. means for controlling at least one selected operating parameter of said pacer with said control signals.

11. The pacer as described in claim 10, wherein said oscillator means comprises a digital oscillator.

12. The pacer as described in claim 10, wherein said oscillator means comprises an analog oscillator.

13. The pacer as described in claim 10, wherein said sensing means generates a magnet rate control signal corresponding to such a sensed predetermined sequence, and said controlling means controls said oscillator means with said magnet rate control signal to operate at a fixed magnet rate.

14. The pacer as described in claim 10, wherein said sensing means generates a rate step up control signal corresponding to such a sensed predetermined sequence, and said controlling means controls said oscillator means with said rate step up control signal to operate at a higher rate.

15. The pacer as described in claim 10, wherein said sensing means generates a rate step down control signal corresponding to such a sensed predetermined sequence, and said controlling means controls said oscillator means with said rate step down control signal to operate at a lower rate.

16. The pacer as described in claim 10, wherein said sensing means generates a program cycle control signal corresponding to such a sensed predetermined sequence, and said controlling means controls the operation of said pacer so that one of its operating parameters is cycled through a programmed cycle.

17. The pacer as described in claim 16, wherein said one operating parameter is the pulse output of said oscillator means.

18. The pacer as described in claim 17, wherein said sensing means generates a signal for terminating said cycle upon sensing a predetermined change of said magnetic field which occurs during said cycle.

19. The pacer as described in claim 10, wherein said sensing means comprises key means for enabling said generating program control signals only following sensing of a predetermined magnetic key signal.

20. A cardiac pacer for use in connection with a catheter for delivery of stimulus signals to a patient'"'"'s heart, comprising:

a. pulse generating means for delivering stimulus pulses to said catheter;

b. means for detecting an externally generated time-varying signal;

c. means for determining when said detected time-varying signal has one of a plurality of predetermined time relations to the operation of said pulse generation means, and for generating a predetermined program signal upon determining said time relation;

d. means for controlling a preselected operating parameter of said pacer in a predetermined manner with said predetermined program signal.

21. The pacer as described in claim 20, wherein said detecting means is adapted to detect an externally generated magnetic signal.

22. The pacer as described in claim 21, comprising a sealed housing containing said pulse generating means, said detecting means and said adjusting means, said housing being of a metal having the characteristic of permitting passage therethrough of magnetic signals, and having only one feedthrough element therethrough, which element connects said stimulus pulse generator means to said catheter.

23. The pacer as described in claim 22, wherein said housing is made of titanium.

24. The pacer as described in claim 23, wherein said feedthrough element is made of tantalum.

25. A cardiac pacer for use in connection with a catheter adapted to be positioned in a patient'"'"'s heart, comprising:

a. a sealed metallic housing having only one feedthrough element, said element being adapted for connection to said catheter;

b. demand pacer circuitry, including a pulse generator, contained within said housing and connected to said feedthrough element, said circuitry continuously generating parameter signals representative of a pacer operating parameter;

c. means for detecting time-varying programming signals generated outside of said housing and for generating therefrom program signals, said detecting means being contained within said housing;

d. control signal means connected to said detecting means and said pacer circuitry for generating control signals derived from said parameter signals and said program signals; and

e. program control means for controlling a preselected operating parameter as a function of said control signals.

26. The pacer as described in claim 25, wherein said parameter signals are pulses from said pulse generator.

27. The pacer as described in claim 26, wherein said control signal means contains circuitry for counting the number of said pulses corresponding to a continuous detected outside signal.

28. The pacer as described in claim 27, wherein said outside signal is a magnetic signal, said housing is made of titanium, and said detecting means comprises a reed switch.

29. The pacer as described in claim 25 wherein said control signal means comprises a key circuit for enabling said generating of control signals only after detecting of a predetermined key program signal.

30. Apparatus adapted to be implanted in a body and for generating output signals suitable for transmission to a predetermined location within said body, comprising:

a. means for receiving time-varying external signals from outside of said apparatus;

b. means for generating internal signals independent of said external signals;

c. logic means connected to receive said external signals and said internal signals for generating a program control signal upon a predetermined time coincidence of the receipt of said external signal and the generation of said internal signal;

d. power means for providing power to said apparatus;

e. generating means for generating said output signals; and

f. control means for controlling the operation of said generating means with said control signal.

31. The apparatus as described in claim 30, wherein said logic means comprises electronic circuitry, and comprising switching means connected to said receiving means for connecting power to at least a portion of said logic means only following receipt of an external signal.

32. The apparatus as described in claim 31, wherein said switching means connects power to said portion of said logic means for a predetermined time interval following the termination of a received external signal, and disconnects said power thereafter until receipt of another external signal.

33. The apparatus as described in claim 30, wherein said coincidence is in real time.

34. The apparatus as described in claim 30, wherein said logic means is adapted for generating a plurality of different program control signals corresponding to respective predetermined coincidences, and said control means controls respective operating parameters of said generating means with said different program control signals.

35. The apparatus as described in claim 30, wherein said internal signal generating means is continuously operative to generate said internal signals.

36. The apparatus as described in claim 35, wherein said apparatus is a cardiac pacer, and said internal signals represent the time interval of said pacer output signals.

37. The apparatus as described in claim 36, wherein said generating means is a pulse generator which is reset when it delivers a pulse in the asynchronous mode of operation.

38. The apparatus as described in claim 37, wherein said control means causes a change of said operation only during the interval between pulse generator resets.

39. The apparatus as described in claim 37, wherein said pulse generator is reset by a signal from said body in the demand mode of operation, and said control means causes a change of said operation only during the interval between pulse generator resets.

40. The apparatus as described in claim 30, wherein said external signals are magnetic signals, said receiving means comprises a magnetic field operated switch, and said apparatus is contained in a sealed titanium housing.

41. The apparatus as described in claim 40, wherein said housing has only one feedthrough element through it, said feedthrough element being connected within said housing to a first output of said generating means, and said housing being connected on its inside to a second output of said generating means.

42. The apparatus as described in claim 41, wherein said feedthrough element has a portion outside of said housing which is adapted for direct connection to means for delivering output signals to said predetermined body location.

43. The apparatus as described in claim 30, wherein said logic means comprises logic key means for generating an enabling signal only upon receipt of a predetermined external key signal, and means for enabling said logic means with said enabling signal to generate a program control signal only following generation of said enabling signal.

44. A programmable cardiac pacer for generation of output signals suitable for delivery to a patient'"'"'s heart, having receiving means for receiving externally generated program signals and signal generating circuitry for generating said output signals, said signal generating circuitry continuously providing timing signals representative of the timing of said circuitry, characterized by:

programmer means for generating control signals as a function of the time relationship of said program signals and said timing signals, and control means for controlling at least one operating parameter of said pacer with said program signals.

45. The pacer as described in claim 44, wherein said pacer is a demand pacer and said externally generated program signals are magnetic signals.

46. The pacer as described in claim 44, comprising a sealed housing containing said signal generating circuitry, said receiving means, said programmer means and said control means, said housing shielding passage therethrough of electromagnetic signals and permitting passage therethrough of magnetic signals, and having only one feedthrough element therethrough, which element connects the output of said signal generating circuitry to a terminal outside of said housing.

47. The pacer as described in claim 46, wherein said housing is made of titanium.

48. The pacer as described in claim 47, wherein said feedthrough element is made of tantalum.