Programmable multi-mode cardiac pacemaker

• US 4,562,841 A
• Filed: 08/05/1982
• Issued: 01/07/1986
• Est. Priority Date: 08/05/1982
• Status: Expired due to Term

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Brockway, Brian P., Dreher, Robert D., Mills, Perry A., Morrison, Douglas C., Huntwork, Daniel E., Lindstedt, Brock S.
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US06/405,711
• Time in Patent Office: 1,251 Days
• Field of Search: 128/419 PG, 128/419 PT
• US Class Current: 607/29
• CPC Class Codes: A61N 1/3622 comprising two or more electrodes co-operating with different heart regions
• CPC Class Codes: A61N 1/368 comprising more than one electrode co-operating with different heart regions A61N1/3622, A61N1/3627 take precedence
• CPC Class Codes: A61N 1/3688 configured for switching the pacing mode, e.g. from AAI to DDD
• CPC Class Codes: A61N 1/37223 Circuits for electromagnetic coupling
• 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 that is selectively programmable via a radio frequency communications link into one of a plurality of a single and dual chamber pacing modes. Depending upon the mode selected, an associated plurality of pacing parameters may be programmed, each within a predetermined range of possible magnitudes.

The pacemaker includes a rate smoothing function for preventing the rate interval from changing by more than a predetermined percentage on a cycle-to-cycle basis; and a graceful degradation function for causing the ventricular pacing rate to decay when the atrial rate exceeds a programmed upper rate limit for a predetermined length of time. A graceful degration onset time and rate of decay are also programmable. Additionally, the pacemaker contains a set of pre-programmed alternative pacing parameters for at least one mode and which can be independently reverted to.

The pacemaker control circuitry is organized about a central bus into an I/O controller and a pacing controller. Pacing control is continuous and its I/O communications operate on a prioritized basis. I/O control permits the programming of any register and the interrogation of a variety of analog parameters associated therewith.

Claims

1. An implantable, programmable cardiac pacemaker system comprising:

(a) external programmer means for transmitting and receiving radio frequency encoded signals, said encoded signals defining at least one of a plurality of selectable pacing modes and a plurality of selectable pacing parameters associated with the selected pacing mode;

(b) implantable pulse generator means responsive to ones of said encoded signals for cyclically producing pacing pulses for at least one chamber of the heart, said pulse generator means including;

(1) pulse controller means for performing a plurality of inter-cycle operations associated with the selected pacing mode during the production of pacing pulses for each cardiac cycle and further including;

(i) means for storing ones of said encoded signals,

(ii) means for storing a plurality of inter-cycle instructions, each instruction designating at least one of a plurality of the inter-cycle operations,

(iii) means for sensing a plurality of analog conditions including electrical activity of the heart,

(iiii) means responsive to said stored encoded signals and said inter-cycle instructions for prioritizing the inter-cycle operations of the selected pacing made, and

(2) input/output controller means responsive to received ones of said encoded signals for selectively writing the selected pacing mode and its associated pacing parameters into said encoded signal storage means during a write mode and including means for selectively reading ones of said encoded signal storage means and ones of said analog conditions and further including means for transmitting encoded radio frequency signals corresponding thereto to said external programmer means during a read mode; and

(c) means for coupling said pacing pulses to the appropriate chambers of the heart and said sensed analog conditions to said pulse generator means.

2. A cardiac pacemaker system as set forth in claim 1 wherein said pulse generator means includes rate smoothing means for controlling the rate at which pacing pulses are produced and further including means for preventing the pacing rate from changing by more than a predetermined percentage from one cycle to the next.

3. A cardiac pacemaker system as set forth in claim 2 wherein said pulse generator means includes means responsive to a pacing parameter defining an upper pacing rate limit for enabling said rate smoothing means when sensed naturally occurring heart complexes in one chamber of the heart occur at a rate in excess of the upper pacing rate limit.

4. A cardiac pacemaker system as set forth in claim 3 wherein one of said pacing parameters defines a lower pacing rate limit and includes means for enabling said rate smoothing means when sensed naturally occurring heart complexes in the predetermined one chamber of the heart occur at a rate below the lower pacing rate limit.

5. A cardiac pacemaker system as set forth in claim 1 wherein said pulse generator means includes means responsive to a pacing parameter defining an upper pacing rate limit for reducing the rate at which pacing pulses are produced from one cycle to the next over a number of cardiac cycles from a first pacing rate defined by one of said pacing parameters, upon sensing naturally occurring complexes in one chamber of the heart in excess of the upper pacing rate limit, down to a second lower pacing rate defined by another of said pacing parameters.

6. A cardiac pacemaker system as set forth in claim 5 wherein said rate reducing means includes means responsive to a pacing parameter defining an onset interval for delaying the operation of said rate reducing means, even after sensing heart complexes occurring at a rate in excess of said upper pacing rate limit, until said onset interval times-out.

7. A cardiac pacemaker system as set forth in claim 5 wherein said analog sensing means also senses P-wave complexes and said rate reducing means includes means for periodically recording the occurrence of each P-wave complex over a predetermined amount of time and means for comparing the recorded number of occurrences at the end of each period to said upper pacing rate limit.

8. A cardiac pacemaker system as set forth in claim 7 wherein said periodic recording means includes counter means for positively counting each P-wave complex in excess of said upper rate limit and negatively counting each P wave complex less than said upper rate limit.

9. A cardiac pacemaker system as set forth in claim 5 wherein said rate reducing means includes means for reducing the rate from one cycle to the next in equal incremental steps.

10. A cardiac pacemaker system as set forth in claim 1 wherein said external programmer means includes means for transmitting sync signals and said pulse generator means includes means for monitoring said sync signals for a predetermined sequence thereof, said pulse generator means further including means for transmitting a pulse generator response signal to said external programmer means once said predetermined sequence is detected, thereby synchronizing said external programmer means to said pulse generator means.

11. A cardiac pacemaker system as set forth in claim 1 wherein said pulse generator means includes means for transmitting error identifying signals to said external programmer means, upon detecting errors in said received signals.

12. A cardiac pacemaker system as set forth in claim 1 wherein said pulse generator means and said external programmer means each include means for trasmitting with each transmission an error check word having a mathematical association to each encoded transmission and each also includes means for decoding each received error check word so as to determine whether or not an error occurred during the transmission.

13. A cardiac pacemaker system as set forth in claim 12 wherein said decoding means includes means for producing a cyclic redundancy check generator polynomial and means for dividing portions of each transmission, including the error check word transmitted therewith, by said cyclic redundancy check generator polynomial.

14. A cardiac pacemaker as set forth in claim 13 wherein said cyclic redundancy check generator polynomial comprises a summation including a predetermined portion of each cyclic redundancy check word.

15. A cardiac pacemaker system as set forth in claim 1 wherein said analog sensing means includes:

(a) a plurality of transducer means, each coupled to an analog parameter of interest, for producing an analog signal corresponding thereto;

(b) means for selectively interrogating one of said plurality of transducers; and

(c) means for converting the analog signal of an interrogated transducer to a digital signal, said conversion means comprising;

(i) first counter means coupled to the interrogated analog signal and operable at a first frequency for producing a first count proportional to the magnitude thereof,

(ii) an analog signal of known magnitude,

(iii) second counter means coupled to said analog signal of known magnitude and operable at said first frequency simultaneously with said first counter for producing a second count proportional to the analog signal of known magnitude, and

(iiii) means for producing a digital signal representative of the ratio of said first count to said second count for each analog signal.

16. A cardiac pacemaker system as set forth in claim 1 including a pulse generator power supply and means coupled thereto for interrogating the state of said power supply, said power supply interrogation means comprising:

(a) means for producing a first signal proportional to a selected analog parameter of said power supply means of unknown magnitude;

(b) means operative simultaneously with said first signal producing means for producing a second signal proportional to an analog parameter of known magnitude;

(c) means responsive to said first and second signals for determining a scaled relative value therebetween; and

(d) means for adding said scaled value to one of the pacing parameters of the selected pacing mode so as to reflect the state of said power supply in a changed condition of said pacing pulses.

17. A cardiac pacemaker system as set forth in claim 1 wherein said pulse generator includes:

(a) a pulse generator power supply;

(b) means responsive to the presence of a magnetic field for producing an interrupt request;

(c) means responsive to said interrupt request for sensing the condition of said power supply;

(d) means for scaling the sensed condition of said power supply relative to a known condition; and

(e) means for causing pacing pulses to be produced at a rate related to the scaled condition.

18. A cardiac pacemaker system as set forth in claim 17 including means responsive to at least one of said encoded signals for preventing said pulse generator from producing said interrupt request.

19. A cardiac pacemaker system as set forth in claim 1 wherein said pulse generator means includes an electrically conductive container mounted in surrounding relation thereto and said coupling means includes at least two electrical conductors affixed between said pulse generator means and the heart and wherein said pulse generator means further includes means responsively coupled to ones of said encoded signals for operating said pulse generator means in either a unipolar or a bipolar configuration, a selected one of said conductors being grounded to said container during a unipolar configuration and being ungrounded during a bipolar configuration.

20. A cardiac pacemaker system as set forth in claim 1 wherein said pulse generator means includes means monitoring the occurrence of a pacing event relative to the beginning of each cardiac cycle for controllably varying the rate of delivery of a pacing pulse during the next successive cardiac cycle to a predetermined percentage of the previous cycle'"'"'s rate.

21. A cardiac pacemaker system as set forth in claim 20 including means for varying the amount of permitted variation in pacing rate from one cardiac cycle to the next.

22. A cardiac pacemaker system as set forth in claim 21 wherein one of said pacing parameters defines the amount of cycle to cycle rate variation in a range from zero to fifty percent of the previous cycle'"'"'s rate.

23. A cardiac pacemaker system as set forth in claim 1 wherein said pulse generator means includes means for storing an alternative plurality of pacing parameters for at least one of said plurality of pacing modes and further includes means for reverting from the selected pacing mode to that one of said plurality of pacing modes having said alternative pacing parameters and operating in that other mode relative to the alternative pacing parameters.

24. Improved implantable pulse generator apparatus operable to cyclically produce and couple pacing pulses to at least one chamber of the heart in relation to a selected one of a plurality of pacing modes, a plurality of pacing parameters associated with the selected mode and sensed electrical activity of the heart, the improvement comprising:

(1) means for storing a plurality of operating instructions defining a plurality of operations to be performed between each cycle of the selected pacing mode and wherein ones of said instructions define a plurality of operations; and

(2) means for prioritizing the inter-cycle operations of said pulse generator during the production of pacing pulses for the selected pacing mode.

25. Pulse generator apparatus as set forth in claim 24 including means for storing an alternative plurality of pacing parameters for at least one of said plurality of pacing modes and means for automatically reverting to said one mode and its associated alternative pacing parameters and producing pacing pulses relative thereto and to said one mode'"'"'s operating instructions.

26. Pulse generator apparatus as set forth in claim 24 wherein ones of the selected mode'"'"'s associated pacing parameters define a first pacing rate, a second lower pacing rate and a rate limit, and including means responsive to said sensed electrical activity for comparing the rate of occurrence of the sensed electrical activity to said rate limit and further including means responsive to said comparision means for incrementally reducing the rate at which pacing pulses are produced, if the rate of said sensed activity exceeds said rate limit, from said first pacing rate down to said second pacing rate and thereafter maintaining said second reduced pacing rate so long as the rate of sensed activity exceeds said rate limit.

27. Pulse generator apparatus as set forth in claim 24 including means monitoring the occurrence of a pacing event relative to the beginning of each cardiac cycle for controlling the pacing rate of the next successive cardiac cycle so that the rate of each cardiac cycle does not change by more than a predetermined percentage of the rate of the previous cardiac cycle.