Myostimulator control using metabolic demand and muscle performance

• US 5,807,234 A
• Filed: 06/27/1997
• Issued: 09/15/1998
• Est. Priority Date: 06/27/1997
• Status: Expired due to Fees

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: McConchie, Stuart B., Jacobs, Gordon, Crosby, Peter A., Bui, Tuan
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US08/884,063
• Time in Patent Office: 445 Days
• Field of Search: 600/16, 600/17, 607/17
• US Class Current: 600/17
• CPC Class Codes: A61M 2205/33 Controlling, regulating or measuring
• CPC Class Codes: A61M 2205/3303 Using a biosensor
• CPC Class Codes: A61M 60/161 mechanically acting upon the outside of the patient's blood vessel structure, e.g. compressive structures placed around a vessel
• CPC Class Codes: A61M 60/191 mechanically acting upon the outside of the patient's native heart, e.g. compressive structures placed around the heart
• CPC Class Codes: A61M 60/289 Devices for mechanical circulatory actuation assisting the residual heart function by means mechanically acting upon the patient's native heart or blood vessel structure, e.g. direct cardiac compression [DCC] devices
• CPC Class Codes: A61M 60/515 Regulation using real-time patient data
• CPC Class Codes: A61M 60/878 Electrical connections within the patient's body
• CPC Class Codes: A61M 60/882 Devices powered by the patient, e.g. skeletal muscle powered devices
• CPC Class Codes: A61N 1/36042 of grafted tissue, e.g. skeletal muscle
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
• CPC Class Codes: A61N 1/36514 controlled by a physiological quantity other than heart potential, e.g. blood pressure controlled by two or more physical parameters A61N1/36585
• CPC Class Codes: A61N 1/39622 Pacing therapy

Abstract

In a cardiomyoplasty system, a rate responsive implantable device is disclosed which controls the stimulation of both the heart and a myoplasty muscle. The metabolic demand is used as a rate response parameter and one or both of the heart and the muscle stimulation are increased with metabolic demand. Under certain conditions, for example, if the muscle is tired, its stimulation is maintained constant or reduced and the cardiac stimulation is used to compensate for increased metabolic demand.

Claims

1. A control device for stimulating a patient'"'"'s heart and a muscle arranged to augment cardiac function, said control device comprising:

a cardiac sensor for sensing intrinsic activity in said heart and generating in response cardiac sensed signals

a pace generator for generating pacing signals to said heart in response to pacing commands;

a muscle generator for generating stimulation signals to said muscle in response to stimulation commands;

a metabolic demand sensor for determining a metabolic demand of said patient and generating a metabolic demand parameter; and

a controller receiving said cardiac sensed signals and said metabolic demand parameter and generating in response said pacing and said stimulation commands.

2. The device of claim 1 wherein said controller changes said stimulation commands in response to changes in said metabolic demand parameter while keeping said pacing commands substantially constant.

3. The device of claim 1 wherein said controller changes said pacing commands in response to changes in said metabolic parameter while keeping said stimulation signals substantially constant.

4. The device of claim 1 wherein said controller includes a memory holding a plurality of pacing and stimulation commands and a selector for selecting one of said pacing and one of said stimulation commands in response to said metabolic demand parameter.

5. The device of claim 1 further comprising a muscle sensor for sensing a status of said muscle and generating corresponding muscle status signals.

6. The device of claim 5 wherein said controller receives said muscle status signals and generates one of said stimulation and pacing commands in response to said muscle status signals.

7. An implantable cardiac device for stimulating on demand a patient'"'"'s heart and a muscle arranged and constructed to assist said heart, said device comprising:

a cardiac sensor for sensing intrinsic activity in said heart and generating corresponding sensed cardiac signals;

a pace generator for generating pacing signals for said heart in response to pacing commands;

a muscle generator for generating stimulation signals to said muscle in response to stimulation commands;

a muscle sensor for generating a status of said muscle and generating in response sensed muscle signals; and

a controller receiving said sensed cardiac signals and said sensed muscle signals and generating in response said pacing and said stimulation signals, synchronously.

8. The device of claim 7 wherein sensed muscle signals include a first signal indicative of a normal muscle status and a second muscle signal indicative of a tired muscle status and said controller has a first mode of operation corresponding to said first signal and a second mode of operation corresponding to said second signal.

9. The device of claim 8 wherein said controller generates first stimulation signals to define a first energy level in said fast mode and second stimulation signals defining a second energy level lower than said first energy level.

10. The device of claim 8 wherein said muscle generator generates said stimulation pulses at a stimulation rate.

11. The device of claim 10 wherein said controller defines a first stimulation rate in response to said first signal and a second stimulation rate in response to said second signal, said first stimulation rate being higher than said second stimulation rate.

12. The device of claim 8 wherein said muscle generator generates stimulation pulses having a duration defined by said controller.

13. The device of claim 12 wherein said controller generates a first duration consisting of a first number of pulses in response to said first signal and a second duration consisting of a second number of pulses in response to said second signal, said first number being higher than said second number.

14. The device of claim 7 further comprising a demand sensor for sensing a metabolic demand of said patient and generating a demand parameter, said controller receiving said demand parameter for generating at least one of said pacing and stimulation commands.

15. The device of claim 14 wherein said pacing generator generates said pacing pulses at a pacing rate defined by said pacing command and said muscle generator generates stimulation pulses at a stimulation rate defined by said stimulation command.

16. The device of claim 15 wherein said controller increases at least one of said pacing rate and said stimulation rate when said demand parameter indicates an increase in said metabolic demand.

17. The device of claim 16 wherein said pacing rate is increased with the increase in said metabolic demand while said stimulation command remains constant.

18. The device of claim 17 further comprising a selector for selecting for each demand parameter a corresponding pacing and stimulation command.

19. The device of claim 18 further comprising a memory for storing a pluralist of pacing and stimulation commands, said selector retrieving said corresponding pacing and stimulation commands from said memory.

20. The device of claim 16 wherein said stimulation rate is increased with the increase in said metabolic demand while said pacing rate remains constant.

21. An implantable cardiac device for controlling the simultaneous stimulation of a patient'"'"'s heart and a muscle constructed and arranged to augment the patient'"'"'s cardiac function, said device comprising:

a pacing generator for generating pacing pulses for said heart in response to pacing commands;

a muscle stimulator for generating stimulation pulses for said muscle in response to stimulation commands;

a demand sensor for sensing a metabolic demand of said patient and generating a corresponding demand parameter; and

a controller receiving said metabolic demand and selecting said pacing and stimulation commands to increase said cardiac function when said metabolic demand increases.

22. The device of claim 21 wherein said controller selects said pacing command to increase blood flow in response to an increased metabolic demand by increasing a pacing rate of said heart.

23. The device if claim 22 wherein said controller selects said stimulation command to increase blood flow in response to an increased metabolic demand by increasing the effect the stimulation of said muscle.

24. The device if claim 22 wherein said controller selects said stimulation command to increase blood flow in response to an increased metabolic demand by increasing said stimulation rate.

25. The device of claim 21 further comprising a muscle sensor for sensing a status of said muscle and generating in response a muscle sense signal.

26. The device of claim 25 wherein said controller has a first mode of operation corresponding to a low metabolic demand and a second mode of operation corresponding to a high metabolic demand, and wherein in said second mode, said controller increases the stimulation of said muscle as compared to said first mode.

27. The device of claim 26 wherein said controller has a third mode of operation responsive to a muscle sense signal indicative of a tired muscle status, wherein in said third mode, the stimulation of said muscle is decreased as compared to said second mode and the pacing of said heart is increased.

28. The device of claim 27 wherein said third mode is maintained in the presence of the tired muscle status as indicated by said muscle sense signal.

29. A method of simultaneously stimulating a heart and a muscle constructed and arranged to augment cardiac functions in a patient by using an implantable device, said method comprising the steps of:

generating pacing pulses to the heart at a pacing rate;

generating stimulation pulses to the muscle at a stimulation rate;

sensing a metabolic demand of said patient; and

increasing the stimulation of one of heart and muscle if said metabolic demand increases while maintaining the stimulation of the other of said heart and muscle substantially constant.

30. The method of claim 29 wherein the stimulation of said heart is increased by increasing said pacing rate.

31. The method of claim 29 wherein the stimulation of said muscle is increased.

32. The method of claim 31 wherein the stimulation of said muscle is increased by increasing said stimulation rate.

33. The method of claim 32 further comprising the step of sensing if said muscle is tired.

34. The method of claim 33 further comprising increasing the pacing rate and decreasing said stimulation rate if said muscle is tired.

35. The method of claim 33 further comprising the step of decreasing a duration of the stimulation pulses.

36. An implantable cardiac device for controlling the simultaneous stimulation of a patient'"'"'s heart and a muscle constructed and arranged to augment the patient'"'"'s cardiac function, said device comprising:

a cardiac sensor for sensing intrinsic activity in said heart and generating cardiac sensed signals;

a pacing generator for generating pacing pulses for said heart in response to pacing commands;

a muscle stimulator for generating stimulation pulses for said muscle in response to stimulation commands;

a muscle sensor for sensing a status of the muscle and generating muscle status signals;

a cardiac lead associated with said cardiac sensor and extending to said heart;

a myostimulation lead associated with one of said muscle stimulator and said muscle sensor and extending from said muscle stimulator to said muscle;

a demand detector for sensing a metabolic demand of said patient and generating a corresponding demand parameter, said metabolic demand parameter being generated using said myostimulation lead; and

a controller receiving said cardiac sensed signals, said muscle status signals and said metabolic demand and selecting said pacing and stimulation commands to increase said cardiac function when said metabolic demand increases.

37. The device of claim 36 wherein said demand detector detects a minute volume.

38. The device of claim 36 wherein said demand detector detects said metabolic demand parameter based on a transthoracic impedance.

39. The device of claim 36 wherein said demand detector includes a current generator for generating a current through one of said leads and a voltage sensor for sensing a voltage through the other of said leads, said transthoracic impedance being dependent on said current and said voltage.

40. The device of claim 39 further comprising a switch for switching one of said leads from said demand detector to one of said cardiac and muscle sensors.