Programmable human tissue stimulator

• US 4,232,679 A
• Filed: 01/26/1977
• Issued: 11/11/1980
• Est. Priority Date: 01/26/1977
• Status: Expired due to Term

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Systems, Inc. (Abbott Laboratories Incorporated)
• Inventors: Schulman, Joseph H.
• Primary Examiner(s): Michell, Robert W.
• Assistant Examiner(s): Jaworski, Francis J.
• Application Number:
  US05/762,626
• Time in Patent Office: 1,385 Days
• Field of Search: 128/2.1 A, 128/2 P, 128/2.05 R, 128/419 P, 128/419 D, 128/419 E, 128/419 PT, 128/421, 128/422, 128/423, 128/2.1 M, 128/631, 128/668, 128/670 , 128/696-709, 128/731, 128/419 PG
• US Class Current: 607/33
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/37 Monitoring; Protecting
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators
• CPC Class Codes: G05B 19/102 for input of programme steps, i.e. setting up sequence
• CPC Class Codes: G05B 2219/23051 Remote control, enter program remote, detachable programmer

Abstract

An implanted heart and tissue stimulator is provided which is externally programmable so that stimulating signals generated thereby can be changed to meet the changing requirements of the user. Provision is made for verifying and screening control parameter words which are transmitted from an external controller so that only correct parameters will be stored for use by the implanted stimulator. Provision for read out of stimulating signals and of the tissue response thereto is also provided.

Claims

1. A programmable human tissue stimulator system comprising:

an implanted stimulating signal generator for generating body tissue stimulating pulses responsive to control signals,

an implanted memory means for storing control signals for controlling said stimulating signal generator,

external control means for generating a plurality of sets of signals, each set including control signals, and signals which represent a memory address in said memory means,

external means for transmitting said generated sets of signals;

an implanted receiver for receiving said sets of transmitted signals,

implanted means for verifying that the received signals in each set are accurate and for producing an accurate signal when each signal in a set has substantially either a first waveform or a second waveform,

an implanted memory address means for storing the memory address which is represented by the memory address representing signal in the set;

implanted means responsive to said accurate signal for entering selected ones of the received control signals in each set in the memory means at the memory address stored in said memory address means, and

implanted means for controlling said implanted stimulating signal generator with control signals from said memory.

2. A programmable human tissue stimulator system as recited in claim 1 wherein said means for verifying that the received signals in each set are accurate includes:

means for determining that each set of signals includes identification signals at preselected locations within the set and that each identification signal at its preselected location has a predetermined one of said first and second waveforms.

3. A programmable human tissue stimulator system as recited in claim 1 wherein there is included an implanted transmitter means for external transmission of signals applied thereto,

selector means for applying to said implanted transmitter means control signals which are stored in said memory means,

external receiver means for receiving the control signals transmitted by said implanted transmitter means, and

means for determining that the control signals received by said external receiver means correspond to the control signals generated by said means for generating control signals.

4. A programmable human tissue stimulator system as recited in claim 1 wherein said sets of signals comprise digital words, each digital word including identification bits at preselected locations within said word,

said means for verifying includes means for examining said preselected locations to determine the presence or absence of said identification bits.

5. A programmable human tissue stimulator system as recited in claim 1 wherein there is included an implanted transmitter means for external transmission of signals applied thereto,

coupling means connecting said implanted stimulating signal generator to the tissue to be stimulated,

detecting means connected to said coupling means for detecting the stimulating signal applied by said stimulating generator to said tissue, as well as any electrical signal produced by said tissue,

selector means for applying signals detected by said detecting means to said implanted transmitter means,

external receiver means for receiving the detected signals transmitted by said implanted transmitter means, and

means for diplaying the signals received by said external receiver means.

6. A programmable human tissue stimulator system as recited in claim 1 wherein said means for verifying that the received signals are accurate and producing an accurate signal indicative thereof includes,

a second external means for transmitting said generated set of signals,

a second implanted receiver for receiving said second set of signals transmitted by said second means for transmitting, and

means for comparing the set of signals received by said implanted receiver with the set of signals received by said second implanted receiver and producing said accurate signal if they are identical.

7. A programmable human tissue stimulator system as recited in claim 6 wherein said second external means for transmitting is a modulated light source, and

said second implanted receiver is a light to electrical signal transducer.

8. A programmable human tissue stimulator system as recited in claim 1 wherein said external control means includes:

means for generating a first signal for turning off and a second signal for turning on said implanted stimulating signal generator, and

implanted switch means for applying operating potential to said implanted stimulating signal generator responsive to said first signal and for discontinuing the application of said operating potential responsive to said second signal.

9. A programmable human tissue stimulator system as recited in claim 1 wherein said external control means includes means for generating successive sets of signals each of which when applied to said implanted stimulating signal generator causes only a predetermined incremental change in said implanted stimulating signal output.

21. A programmable human tissue stimulator system as recited in claim 4 wherein said external control means includes:

means for generating a first signal for turning off and a second signal for turning on said implanted stimulating signal generator, and

implanted switch means for applying operating potential to said implanted stimulating signal generator responsive to said first signal and for discontinuing the application of said operating potential responsive to said second signal.

10. A programmable human tissue stimulator system comprising:

an implanted stimulating signal generator for generating body tissue stimulating pulses responsive to control signals,

an implanted memory means for storing control signals for controlling said stimulating signal generator,

external control means for generating a plurality of sets of signals, each set including control signals,

external means for transmitting said generated sets of signals,

an implanted receiver for receiving said sets of transmitted signals,

implanted means for verifying that the received signals in each set are accurate and for producing an accurate signal when each signal in a set has substantially either a first waveform or a second waveform,

implanted means responsive to said accurate signal for entering selected ones of the received control signals in each set in a location in said memory means which is defined by other signals in the set,

implanted means for controlling said implanted stimulating signals generator with control signals from said memory, each set of signals comprises a word comprised of binary pulses, each binary pulse rising from a leading edge to a first predetermined amplitude which extends first for a predetermined interval thereafter, then said binary pulse extends for a second predetermined interval at an amplitude level determined by its binary value, and thereafter extends for a third predetermined interval at a second predetermined value,

means for determining that each signal has an acceptable waveform includes,

first means responsive to the leading edge of a binary pulse for generating a reset pulse responsive to a binary value amplitude level change during said second predetermined interval, and

second means responsive to the leading edge of a binary pulse for generating a reset pulse responsive to a change in said first predetermined amplitude during said first predetermined interval,

register means into which a received binary word is transferred from said implanted receiver, and

means for applying said reset signals to said register means to clear said register means.

11. A programmable human tissue stimulator system comprising:

an implanted stimulating signal generator for generatng, responsive to control signals, body tissue stimulating pulse trains having parameters which are determined by said control signals,

an implanted memory means for storing, at different locations, different parameter determining control words for determining the parameters of the pulse train output of said stimulating pulse signal generator,

external control means for generating digital word signals, each word including a first plurality of binary bits representing a parameter for a pulse train, a second plurality of binary bits representing the storage location of said parameter in memory, and a third plurality of binary bits representing patient identifying data,

an external transmitter for transmitting said digital word signals,

an implanted receiver for receiving said transmitted signals,

an implanted temporary storage means for storing word signals received by said receiver,

means for verifying that the waveform of the received binary bits in a word have a predetermined acceptable waveform and clearing said temporary storage if the waveform is not acceptable,

implanted means for storing patient identifying data,

means for comparing the received patient identifying data with stored patient identifying data and producing an acceptance signal if they are the same,

means responsive to said acceptance signal for transferring said first plurality of binary bits, from said temporary storage into the location in memory means indicated by said second plurality of binary bits, and

means responsive to said acceptance signal for clearing said temporary storage.

12. A programmable human tissue stimulator system as recited in claim 11 wherein there is included:

an implanted transmitter means for external transmission of signals applied thereto,

implanted selector means for selecting for application to said implanted transmitter means signals occurring at predetermined locations within the implanted circuits of said programmable human tissue stimulator system specified by selection signals,

said digital word signals generated by said external control means including a fourth plurality of binary bits representative of a selection signal,

means for applying a fourth plurality of binary bits received by said implanted receiver to said implanted selector means whereby said implanted transmitter transmits the signals from the location specified,

an external receiver for receiving the transmitted signals, and

means for utilizing the signals received by said external receiver.

13. A programmable human tissue stimulator system as recited in claim 11 wherein said implanted signal generator includes switch means for applying pulse wavetrains from said stimulating signal generator to tissue at different locations, and

means responsive to stored first pluralities of binary bits in said memory for controlling operation of said switch means.

14. A programmable human tissue stimulator system as recited in claim 11 wherein there is included:

a second external transmitter means for transmitting said generated word signals,

a second implanted receiver for receiving the signals transmitted by said second external transmitter means, and

means for comparing the first and second pluralities of binary bits received by said second implanted receiver, with the first and second pluralities of binary bits in said temporary storage and producing a temporary storage clear signal when they are not alike.

15. A programmable human tissue stimulator system as recited in claim 14 wherein said second external means for transmitting is a modulated light source, and

said second implanted receiver is light to electrical signal transducer.

16. A programmable human tissue stimulator system as recited in claim 14 wherein said second external means for transmitting is a means for generating a modulated sound, and

said second implanted receiver is a sound to electrical signal transducer.

17. A programmable human tissue stimulator system as recited in claim 14 wherein said second external means for transmitting is a means for generating a modulated magnetic field, and

said second implanted receiver is a magnetic field to electrical signal transducer.

18. A programmable human tissue stimulator system as recited in claim 11 wherein said external control means includes means for generating successive control signals each of which when applied to said implanted stimulating signal generator causes only a predetermined incremental change in said implanted stimulating signal output.

19. A programmable human tissue stimulator system as recited in claim 11 wherein each of the pulses of said pulse trains generated by said implanted stimulating signal generator are biphasic pulses.

20. A programmable human tissue stimulator system as recited in claim 11 wherein each of the digital word signals generated by said external control means includes redundant binary bits at predetermined spaced locations in a word, and there is included:

means for verifying the presence of said redundant binary bits at said predetermined locations and preventing said means for comparing producing an acceptance signal when said redundant binary bits are not at said predetermined locations.

22. A programmable human tissue stimulator system as recited in claim 11 wherein there is included an implanted reference level signal source, and

said external means for generating digital word signals includes means to specify a word signal for instructing said implanted digitally responsive switch means to connect to said implanted reference level signal source, whereby the signal received by said external receiver means will be a calibration signal.

33. A programmable human tissue stimulator system as described in claim 20 wherein said manually carriable and operable external control means includes means for generating a set of signals which includes control signals for turning said signal generator on or off.

23. A system for obtaining electrical biophysical signals from electrodes placed at a plurality of different tissue locations within a body comprising:

external means for generating digital word signals specifying a tissue location from which it is desired to obtain electrical biophysical signals,

an external transmitter for transmitting said digital word signals,

an implanted receiver for receiving said digital word signals,

an implanted transmitter for transmitting an electrical biophysical signal,

implanted switch means responsive to said digital word signals for selectively connecting to said implanted transmitter an electrode placed at a tissue location from among a plurality of electrodes placed at different tissue locations within said body, said location being specified by said digital word signal, whereby said implanted transmitter will transmit electrical biophysical signals from said tissue location, and

external receiver means for receiving said transmitted electrical biophysical signals.

24. A programmable human tissue stimulator system comprising:

an implanted stimulating signal generator for generating body tissue stimulating pulses responsive to control signals,

an implanted memory means for storing control signals, for controlling said stimulating signal generator,

external control means for generating a plurality of sets of signals, each set including at least control signals, several of said sets further including memory location signals,

means for transmitting each of said generated sets of signals,

an implanted receiver for receiving each of said transmitted sets of signals,

means for verifying that the received signals in each set are accurate and producing an accurate signal indicative thereof only when each signal in the set has substantially either a first or a second waveform,

means responsive to said accurate signal for entering said received control signals in said memory means, at a location defined by the memory location signals in the set,

means responsive to certain ones of said control signals in said memory means for controlling said generator to establish the frequency of the body tissue stimulating pulses which it generates,

means responsive to others of said control signals in said memory means for controlling said generator to establish the periods of bursts of the body tissue stimulating pulses which it generates, and

means responsive to still others of said control signals in said memory means for controlling said generator to establish the amplitude of the body tissue stimulating pulses which it generates.

25. A programmable human tissue stimulator system as recited in claim 24 wherein said body tissue stimulating pulses are adapted to be applied to more than one body tissue, through plural applicator means,

said means responsive to others of said control signals in said memory for controlling said generator to establish the periods of bursts of the body tissue stimulating pulses includes means for controlling the timing of the application of said periods of bursts to said plural applicator means which are adapted to apply them to each of said more than one body tissue.

35. A programmable human tissue stimulator system as described in claim 24 wherein said manually carriable external control means is adapted to be worn on a patient'"'"'s wrist or attachable to form part of a patient'"'"'s wearable item of jewelry.

26. A programmable human tissue stimulator system comprising

an implanted stimulating signal generator for generating, responsive to control signals, body tissue stimulating pulse trains having parameters which are determined by said control signals,

an implanted memory means for storing, at different locations, different parameter determining control words for determining the parameters of the pulse train output of said stimulating pulse signal generator,

external control means for generating digital word signals, each word including a first plurality of binary bits representing a parameter for a pulse train, a second plurality of binary bits representing the storage location of said parameter in memory, and a third plurality of binary bits representing identifying data,

an external transmitter for transmitting said digital word signals,

an implanted receiver for receiving said transmitted signals,

an implanted temporary storage means for storing word signals received by said receiver,

implanted means for storing identifying data,

means for comparing the received identifying data with stored patient identifying data and producing an acceptance signal if they are the same,

means responsive to said acceptance signal for transferring said first plurality of binary bits, from said temporary storage into the location in memory means indicated by said second plurality of binary bits, and

means responsive to said acceptance signal for clearing said temporary storage.

27. A programmable human tissue stimulator system as recited in claim 26 wherein there is included:

an implanted transmitter means for external transmission of signals applied thereto,

implanted selector means for selecting for application to said implanted transmitter means signals occurring at predetermined locations within the implanted circuits of said programmable human tissue stimulator system specified by selection signals,

said digital word signals generated by said external control means including a fourth plurality of binary bits representative of a selection signal, instructing said selector means to apply the patient identifying word to said implanted transmitter means to be transmitted externally,

an external receiver for receiving the transmission of said implanted transmitter means, and

means for displaying the identifying word received by said external receiver for verification.

28. A programmable human tissue stimulator system comprising:

an implanted stimulating signal generator for generating, responsive to control signals, body tissue stimulating pulse trains having parameters which are determined by said control signals,

an implanted memory means for storing, at different locations, different parameter determining control words for determining the parameters of the pulse train output of said stimulating pulse signal generator,

external control means for generating digital word signals, including a plurality of binary bits representing identifying data,

an external transmitter for transmitting said digital word signals,

an implanted receiver for receiving said transmitted signals, as implanted transmitter,

implanted means for storing identifying data,

means for comparing the received identifying data with the stored identifying data, and

means for selectively connecting said internal transmitter to said implanted means for storing identifying data to selectively transmit said stored identifying data.

29. A programmable human tissue stimulator system comprising:

an implanted stimulating signal generator responsive to different groups of control signals for generating body tissue stimulating pulses having characteristics which are functions of said groups of the control signals;

an implanted memory means for storing in a plurality of locations groups of control signals, for controlling said stimulating signal generator as a function of at least some of said groups of control signals;

external control means for generating any one of a plurality of sets of signals, each set including a group of control signals, some sets further including memory-address-defining signals;

means for transmitting each generated set of signals;

an implanted receiver for receiving said transmitted set of signals;

means for verifying that the received set of signals is accurate and producing an accurate signal indicative thereof, only when each signal in the set has substantially a first or a second waveform;

means responsive to said accurate signal for entering the control signals in the received set in said memory means, at a location, defined by said memory-address-defining signals in said received set, without affecting the control signals located in other locations; and

an implanted battery for continuously applying power to at least said generator and said memory means, independent of external power source means.

30. A programmable human tissue stimulator system as described in claim 29 wherein said external control means includes manually carriable and operable external control means for generating at least one of said sets of signals for transmission to said implanted receiver, said at least one set includes a group of control signals for varying at least one characteristic of said stimulating pulses.

31. A programmable human tissue stimulator system as described in claim 30 wherein said one characteristic is pulse amplitude.

32. A programmable human tissue stimulator system as described in claim 30 wherein said one characteristic is pulse frequency.

34. A programmable human tissue stimulator system as described in claim 30 further including implanted transmitter means for transmitting to said manually carriable external control means signals indicative of the control signals received therefrom.