Automatic implantable pulse generator

• US 5,476,485 A
• Filed: 09/21/1993
• Issued: 12/19/1995
• Est. Priority Date: 09/21/1993
• Status: Expired due to Term

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories)
• Inventors: Weinberg, Lisa P., Katz, Samuel M.
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): Getzow, Scott M.
• Application Number:
  US08/124,902
• Time in Patent Office: 819 Days
• Field of Search: 607/27, 607/28, 607/29, 607/35, 607/37, 607/62
• US Class Current: 607/28
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration
• CPC Class Codes: A61N 1/3686 configured for selecting the electrode configuration on a lead A61N1/3688 takes precedence
• CPC Class Codes: A61N 1/3706 Pacemaker parameters stimulation threshold A61N1/371
• CPC Class Codes: A61N 1/3712 Auto-capture, i.e. automatic adjustment of the stimulation threshold

Abstract

The present invention is directed toward a pulse generator for detecting that a pulse generator and an implantable lead are properly implanted so that a plurality of automatic features can be automatically turned ON. The automatic features include: automatic sensitivity adjustment; automatic capture adjustment; automatic rate adjustment, and the automatic adjustment of associated rate-responsive parameters; automatic electrode configuration; and the automatic adjustment of other timing parameters. An impedance detector is used to detect that the electrodes are in contact with the body by determining if the lead impedance is within a prescribed range. Redundant sensors, such as a temperature sensor, a shorting plug, or a resistive load could be used to confirm that the electrodes are in contact with the body.

Claims

1. An automatic implantable pulse generator, the pulse generator having a pair of output terminals, comprising:

pulse generating means for generating stimulation pulses to a patient'"'"'s heart through the pair of output terminals;

a biocompatible housing for housing the pulse generating means;

means for detecting when the housing has been implanted, the detecting means including means for measuring an impedance between the pair of output terminals, the detecting means further including means for determining when the impedance is within a predetermined range of impedances corresponding to normal cardiac tissue;

means for operating the pulse generating means in a storage mode when the detecting means detects that the housing has not been implanted; and

means for operating the pulse generating means in at least one automatic mode when the detecting means detects that the housing has been implanted.

2. The pulse generator recited in claim 1, wherein the range of impedances corresponding to normal cardiac tissue comprises 100-2000 ohms.

3. The pulse generator recited in claim 1, wherein the pulse generator is stored in a sterile package, the detecting means further comprises:

a redundant detecting means for verifying that the housing has been implanted.

4. The pulse generator recited in claim 3, wherein the redundant detecting means comprises:

a load connected between the pair of output terminals prior to storing the pulse generator in the sterile package, the load having a predetermined value; and

wherein the determining means determines when the impedance is outside a range of impedances corresponding to the predetermined value of the load, thereby indicating that the housing has been removed from the sterile package and a physician has removed the load in preparation for implantation.

5. The pulse generator recited in claim 4, wherein:

the load comprises a shorting plug connected between the pair of terminals; and

the predetermined resistive value corresponds to a short.

6. The pulse generator recited in claim 4, wherein:

the load comprises a resistive load connected between the pair of terminals; and

wherein the predetermined range corresponds to the value of the resistive load.

7. The pulse generator recited in claim 3, wherein the redundant detecting means comprises:

means for sensing temperature; and

means for determining when the temperature sensing means detects a temperature within a predetermined range corresponding to body temperature, thereby indicating that the housing is in contact with the body.

8. The pulse generator recited in claim 7, wherein the sensing means comprises a thermistor located in the implanted lead.

9. The pulse generator recited in claim 7, wherein the sensing means comprises a thermistor located in the housing.

10. The pulse generator recited in claim 1, wherein the detecting means comprises at least two detecting means.

11. The pulse generator recited in claim 10, wherein the at least two detecting means are selected from the group of detecting means comprising:

means for detecting that the pulse generating means has been properly connected to an implanted lead in contact with body tissue;

means for detecting that the housing has been prepared for implantation;

means for detecting that the housing is in physical contact with the body; and

means for detecting that an implantable lead is in physical contact with the body.

12. The pulse generator recited in claim 1, wherein the means for operating the pulse generating means in a storage mode comprises:

means for disabling a desired number of pacing functions; and

means for periodically triggering the detecting means to detect if the pulse generating means has been properly connected to an implantable lead in contact with body tissue.

13. The pulse generator recited in claim 12, further comprising:

means for sensing cardiac signals;

wherein the disabling means comprises means for disabling the pulse generating means and the sensing means.

14. The pulse generator recited in claim 12, further comprising:

processing means for controlling a plurality of modes of operations for the pulse generating means; and

wherein the disabling means comprises means for reducing the duty cycle of the processor means.

15. The pulse generator recited in claim 1, wherein:

the pulse generating means includes means for operating in a rate responsive mode, the rate responsive mode being defined by a plurality of rate responsive parameters;

the means for operating the pulse generating means in at least one automatic mode comprises means for automatically determining the plurality of rate responsive parameters so that the pulse generator may operate in the rate-responsive mode.

16. The pulse generator recited in claim 15, wherein the means for operating in the rate-responsive mode comprises:

timing means for generating stimulation pulses at a desired rate;

a physiological sensor for sensing physiological need;

means for measuring the value of the physiological sensor periodically over a predetermined period;

means for automatically determining a plurality of operating parameters based on the value of the physiological sensor measured over the predetermined period;

means for programming the plurality of operating parameters into the pulse generating means; and

means for automatically adjusting at least the rate of stimulation pulses according to the sensed physiological need.

17. The pulse generator recited in claim 1, wherein the means for operating the pulse generating means in at least one automatic mode comprises means for operating in an automatic sensitivity mode.

18. The pulse generator recited in claim 17, wherein the means for operating in the automatic sensitivity mode comprises:

sensing means for sensing cardiac signals, the sensing means having a plurality of sensitivity settings;

means for periodically detecting sensitivity threshold; and

means for automatically adjusting the sensing means to one of the plurality of sensitivity settings based on the detected sensitivity threshold.

19. The pulse generator recited in claim 1, wherein the means for operating the pulse generating means in at least one automatic mode comprises means for operating in an automatic capture mode.

20. The pulse generator recited in claim 19, wherein the means for operating in the automatic capture mode comprises:

means for generating stimulation pulses at a desired energy level;

means for detecting capture following a stimulation pulse generated by the generating means;

means for periodically detecting capture at the lowest energy level; and

means for programming the energy level of the stimulation pulse based on the detected capture threshold.

21. The pulse generator recited in claim 1, wherein the means for operating the pulse generating means in at least one automatic mode comprises means for operating in an automatic electrode configuration mode.

22. The pulse generator recited in claim 21, wherein the pulse generating means is connected to an implantable lead having a tip, a ring, wherein the housing acts as a case electrode, wherein the means for operating in the automatic electrode configuration mode comprises:

means for detecting an operable pair of electrodes in contact with body tissue; and

means for automatically programming an electrode configuration for the pulse generator to the operative pair of electrodes.

23. The pulse generator recited in claim 22, wherein the means for detecting an operable pair of electrodes in contact with body tissue comprises:

means for measuring impedance between a pair of electrodes; and

means for determining when the impedance is within a predetermined range corresponding to normal cardiac tissue.

24. The pulse generator recited in claim 1, wherein the pulse generating means includes sensing means for sensing cardiac activity, and wherein the means for operating the pulse generating means in at least one automatic mode comprises:

means for programming the sensing means in an automatic sensitivity mode; and

means for programming the pulse generating means in an automatic capture mode.

25. The pulse generator recited in claim 24, wherein the sensing means has a plurality of sensitivity settings, further comprising:

means for programming a sensitivity threshold test to determine the optimum sensitivity setting for the sensing means;

means for programming a capture threshold test to determine an optimum output pulse value for the pulse generator;

means for programming the sensing means to the optimum sensitivity setting; and

means for programming the pulse generator to optimum output pulse value.

26. An automatic implantable pulse generator, comprising:

pulse generating means for generating stimulation pulses to a patient'"'"'s heart;

a biocompatible housing for housing the pulse generating means;

means for operating the pulse generating means in a plurality of automatic modes;

means for detecting when the housing has been implanted; and

means for programming the mode of operation to a low current drain mode when the detecting means detects that the housing has not been implanted, and for programming the mode of operation to at least one of the plurality of automatic modes when the detecting means detects that the housing has been implanted.

27. The pulse generator recited in claim 26, wherein the pulse generator includes a pair of output terminals, wherein the detecting means comprises:

means for measuring impedance between the pair of output terminals; and

means for determining when the impedance is within a predetermined range corresponding to normal cardiac tissue.

28. The pulse generator recited in claim 27, wherein the predetermined range comprises 100-2000 ohms.

29. The pulse generator recited in claim 27, wherein the detecting means comprises a redundant detecting means.

30. The pulse generator recited in claim 29, wherein the redundant detecting means comprises:

a shorting plug connected between the pair of output terminals; and

means for determining when the shorting plug has been removed.

31. The pulse generator recited in claim 29, wherein the redundant detecting means comprises:

a resistive load connected between the pair of output terminals; and

means for determining when the resistive load has been removed.

32. The pulse generator recited in claim 29, wherein the redundant detecting means comprises:

means for sensing temperature; and

means for determining when the temperature sensing means detects a temperature within a predetermined range corresponding to body temperature.

33. The pulse generator recited in claim 26, wherein the means for programming the mode of operation to a low current drain mode comprises:

means for disabling a desired number of pulse generator modes of operation; and

means for periodically triggering the detecting means to detect if the pulse generating means has been properly connected to an implantable lead in contact with body tissue.

34. The pulse generator recited in claim 26, wherein the means for operating the pulse generator in a plurality of automatic modes comprises at least one of automatic sensitivity adjustment mode, automatic capture mode, automatic rate adjustment mode, automatic electrode configuration mode.

35. A method of automatically operating an implantable pulse generator, the implantable pulse generator having pulse generating means for generating stimulation pulses, the pulse generating means being enclosed in a biocompatible housing with a pair of output terminals therethrough, the method comprising the steps of:

measuring impedance between the pair of output terminals;

detecting when the housing has been implanted by determining when the impedance is within a predetermined range corresponding to body tissue impedance;

automatically programming the pulse generating means in a storage mode when the detecting means detects that the housing has not been implanted; and

automatically programming the pulse generating means in at least one automatic mode when the detecting means detects that the housing has been implanted.

36. The method recited in claim 35, wherein the detecting step comprises the step of:

verifying that the housing has been implanted using a redundant sensor.

37. The method recited in claim 36, wherein the implantable pulse generator is stored in a sterile package, wherein the verifying step comprises the steps of:

connecting a shorting plug between the pair of output terminals prior to storing the pulse generator in the sterile package; and

determining when the shorting plug has been removed, thereby providing an indication that the housing has been removed from the sterile package in preparation for implantation.

38. The method recited in claim 36, wherein the implantable pulse generator is stored in a sterile package, wherein the confirming step comprises the steps of:

connecting a resistive load between the pair of output terminals prior to storing the pulse generator in the sterile package; and

determining when the resistive load has been removed, thereby providing an indication that the housing has been removed from the sterile package in preparation for implantation.

39. The method recited in claim 36, wherein the verifying step comprises the steps of:

sensing a temperature; and

determining when the temperature is within a predetermined range corresponding to body temperature.

40. The method recited in claim 35, wherein the step of programming the pulse generating means in a storage mode comprises the steps of:

programming a desired number of pacing functions OFF; and

waking-up the pulse generating means periodically to detect if the housing has been properly connected to the lead.

41. The method recited in claim 35, wherein the step of programming the pulse generating means in at least one automatic mode further comprises the steps of programming the pulse generating means into an automatic sensitivity mode.

42. The method recited in claim 35, wherein the step of programming the pulse generating means in at least one automatic mode further comprises the step of programming the pulse generating means into an automatic capture mode.

43. The method recited in claim 35, wherein the pulse generating means includes means for operating in a rate responsive mode, the rate responsive mode being defined by a plurality of rate responsive parameters, wherein:

the step of programming the pulse generating means in at least one automatic mode further comprises the step of automatically determining the plurality of rate responsive parameters so that the pulse generating means may operate in the rate-responsive mode.

44. The method recited in claim 35, wherein the step of programming the pulse generator generating means in at least one automatic mode further comprises the step of programming the pulse generating means into an automatic electrode configuration mode.

45. The method recited in claim 35, wherein the pulse generator includes sensing means for sensing cardiac signals, the sensing means having a plurality of sensitivity settings, further comprising the steps of:

programming a sensitivity threshold test to determine an optimum sensitivity setting for the sensing means;

programming a capture threshold test to determine an optimum output pulse value for the pulse generating means;

programming the sensing means to the optimum sensitivity setting; and

programming the pulse generating means to the optimum output pulse value.

46. A system for detecting when an implantable stimulation device has been properly connected to an implantable lead in contact with body tissue, the system including pulse generating means having a pair of output terminals, the system comprising:

means for measuring impedance between the pair of output terminals;

means for determining when the impedance is within a predetermined range, thereby providing a first indication that the pulse generating means has been properly connected to an implantable lead in contact with body tissue; and

a redundant sensor having means for confirming when the stimulation device has been properly connected to the implantable lead in contact with body tissue.

47. The system recited in claim 46, wherein the predetermined range corresponds to normal cardiac tissue.

48. The system recited in claim 47, wherein the predetermined range comprises 100-2000 ohms.

49. The system recited in claim 46, wherein:

the redundant sensor comprises a shorting plug connected between the output terminals;

the predetermined range corresponds to a short; and

the determining means detects the absence or presence of the shorting plug, thereby indicating that the physician has or has not, respectively, prepared the pulse generator for implant.

50. The system recited in claim 46, wherein:

the redundant sensor comprises a resistive load connected between the output terminals;

the predetermined range corresponds to a value of the resistive load; and

the determining means detects the absence or presence of the resistive load, thereby indicating that the physician has or has not, respectively, prepared the pulse generator for implant.

51. The system recited in claim 46, wherein the redundant sensor comprises:

means for sensing temperature; and

means for determining when the temperature sensing means detects a temperature within a predetermined range corresponding to body temperature, thereby indicating that the stimulation device has been implanted.