Implantable cardiac function monitor and stimulator for diagnosis and therapy delivery

• US 5,417,717 A
• Filed: 05/16/1994
• Issued: 05/23/1995
• Est. Priority Date: 11/04/1991
• Status: Expired due to Term

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Mower, Morton M., Tockman, Bruce A., Salo, Rodney W.
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): SCHAETZLE, KENNEDY
• Application Number:
  US08/243,069
• Time in Patent Office: 372 Days
• Field of Search: 607/3, 607/2, 607/24, 607/9, 607/17, 607/18, 607/23, 623/3, 600/16, 600/17, 128/734
• US Class Current: 607/18
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• 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 1/36585 controlled by two or more physical parameters

Abstract

An implantable monitor/stimulator is disclosed that monitors and assesses indices of cardiac function, including the strength and timing of cardiac contraction, then automatically executes a physician-selected mode of therapy. It accomplishes this by assessing impedance, electrocardiogram, and/or pressure measurements, then calculating various cardiac parameters. The results of these calculations may be stored within the device, telemetered to an external monitor or display and/or may be used by the physician to determine the mode of therapy to be chosen. If indicated, therapy is administered by the device itself or by telemetering control signals to various peripheral devices for the purpose of enhancing either contraction or relaxation of the heart. The cardiac parameters that are calculated all provide an assessment of level of cardiac function by monitoring changes in ventricular filling and ejection or by calculating isovolumic phase indices of heart contraction. Examples of such parameters are ejection fraction, cardiac output, stroke work, and/or various pressure-volume relationships. These parameters determine the mode of therapy that will be selected by a physician. Choices of therapy include several forms of pacing of cardiac or skeletal muscle, and telemetry to implanted or external units for drug infusion or for monitoring by a central data system.

Claims

1. Apparatus for applying therapy to a patient based upon a contractile state of the patient'"'"'s heart, the apparatus comprising:

(a) intracardiac sensing means for sensing hemodynamic indicators of said contractile state in at least one ventricular chamber of the heart;

(b) signal means coupled to said sensing means for developing a control signal varying as a function of said hemodynamic indicators;

(c) patient therapy means having at least one stimulating electrode for applying stimulating pulses to tissue as a function of said control signal to increase the strength of contraction of the patient'"'"'s heart; and

(d) means for applying said control signal to said patient therapy means for changing said contractile state by increasing the strength of contraction of the heart.

2. The device as in claim 1 wherein said intracardiac sensing means comprises:

pressure sensing means for sensing the pressure in at least one ventricular chamber of the heart and producing a pressure control signal as said control signal, and said pressure control signal varies as a function of said pressure due to the beating action of the heart.

3. The device as in claim 1 wherein said intracardiac sensing means comprises:

(a) volume sensing means for sensing ventricular volume in at least one ventricular chamber of the heart; and

(b) intracardiac pressure sensing means for sensing pressure in at least one ventricular chamber of the heart;

and signal means comprising;

(c) first control signal means coupled to said volume sensing means for developing a first control signal varying as a function of said ventricular volume; and

(d) second control signal means coupled to said intracardiac pressure sensing means for developing a second control signal varying as a function of said pressure, whereby said patient therapy means applies said stimulating pulses to said tissue as a function of said first and second control signals by increasing said contractile state in relation to said changes in said ventricular volume and said pressure.

4. The device as in claim 1 further including calculating means for calculating an ejection fraction, wherein said patient therapy means receives a further control signal varying as a function of the ejection fraction, wherein ejection fraction is computed by said calculating means by dividing a control signal value selected to indicate stroke volume by a control signal value selected to indicated end-diastolic volume.

5. The device as in claim 1 further including means for calculating cardiac output and means for determining heart rate, wherein said patient therapy means receives and responds to a further control signal varying as a function of the cardiac output, wherein cardiac output is calculated as the product of a control signal value selected to indicate the sensed heart rate times a control signal value selected to indicate stroke volume.

6. The device as in claim 2 wherein said signal means includes:

(a) means for producing a time varying signal proportional to pressure measured in one cardiac chamber due to the beating action of the heart;

(b) means for extracting from said time varying signal a modulation signal due to pressure changes in said cardiac chamber; and

(c) means for producing the pressure control signal from said modulation signal which, when applied to said patient therapy means, results in change in the heart'"'"'s contractile state by increasing the strength of contraction of the heart.

7. The device as in claim 1, wherein said signal means is comprised of means for developing an impedance control signal, comprising:

(a) means for producing a time varying signal proportional to impedance measured in one cardiac chamber due to beating action of the heart;

(b) means for extracting from said time varying signal a modulation signal due to impedance changes in said cardiac chamber; and

(c) means for producing the impedance control signal from said modulation signal, whereby said therapy means changes the heart'"'"'s contractile state as a function of said impedance control signal by increasing the strength of contraction of the heart.

8. The device as in claim 3, further including:

(a) a microprocessor for computing the area inside a curve obtained by integration of a plot of the pressure as a function of the ventricular volume, as an indicator of stroke work;

(b) means coupled to said microprocessor for developing a stroke work control signal varying as a function of said stroke work; and

(c) means for applying said stroke work control signal to said patient therapy means, for changing said contractile state.

9. The device in claim 3, further including:

(a) a microprocessor for computing the slope of a regression line plotted through maximal pressure/volume points taken at endsystole of the cardiac cycle, as an indicator of ejection phase contractility;

(b) means coupled to said microprocessor for developing an ejection phase control signal varying as a function of said indicator of ejection phase contractility; and

(c) means for applying said ejection phase control signal to said patient therapy means, for changing said contractile state.

10. The device as in claim 3, further including:

(a) a microprocessor for computing a curve resulting from a plot of minimum diastolic pressure against end-diastolic volume, as an indicator of diastolic function;

(b) means coupled to said microprocessor for developing a diastolic function control signal varying as a function of said curve; and

(c) means for applying said diastolic function control signal to said patient therapy means, for changing said contractile state.

11. The device as in claim 1, wherein said patient therapy means further includes:

(a) means for applying said stimulating pulses from said stimulating electrode to the heart in a predetermined pattern for increasing the strength of contraction of said heart, wherein said predetermined pattern of stimulating pulses includes a pair of pulses, said pair comprising delivery of a first pulse that is either intrinsic or paced, followed by a delay in a range of 150 to 200 msec, then delivery of a second pulse in the form of a pacing pulse, delivered to the right ventricle of the heart, to increase the strength of contraction of said heart.

12. The device as in claim 1, wherein said patient therapy means further includes:

(a) means for applying said stimulating pulses from said stimulating electrode to the heart in a predetermined pattern for increasing the strength of contraction of said heart, wherein said predetermined pattern of said stimulating pulses includes multichamber pacing, said multichamber pacing pattern including delivering either simultaneous or temporarily spaced pacing pulses to two or more sites within the chambers of the heart to increase the strength of contraction or to improve the chamber coordination of said heart.

13. The device as in claim 1 wherein said patient therapy means further includes:

(a) means for applying said stimulating pulses from said stimulating electrode to at least one site in the heart in a predetermined pattern for increasing the strength of contraction of said heart, wherein said predetermined pattern of said stimulating pulses includes a burst pattern, said burst pattern including delivering from 1 to 12 said stimulating pulses at a frequency in the range of from 10 to 130 Hz.

14. The device as in claim 1 wherein said patient therapy means further includes:

(a) means for applying said stimulating pulses from said stimulating electrode to the heart in a predetermined pattern for increasing the strength of contraction of said heart, wherein said predetermined pattern of said stimulating pulses includes a pattern of intercalated pacing, comprising delivery of at least one extrastimulus to the right ventricle;

(b) delay means for calculating a delay of a preset interval after said intracardiac sensing means detects the presence of a conducted heartbeat; and

(c) means for developing an intercalated control signal for causing said patient therapy means to deliver at least one extrastimulus to the right ventricle, thereby extending a relaxation period of the heart to enhance the strength of contraction of said heart.

15. The device as in claim 1 wherein said patient therapy means further includes:

(a) skeletal muscle stimulating means for applying a predetermined pattern of said stimulating pulses from said stimulating electrode to a skeletal muscle that has been surgically attached to the heart, for increasing the strength of contraction of said heart.

16. The device as in claim 1 wherein said means for applying said control signal to said patient therapy means further includes telemetry means for transmitting and receiving radio frequency encoded signals.

17. Apparatus for applying therapy to a patient based upon a contractile state of the patient'"'"'s heart, the apparatus comprising:

(a) intracardiac sensing means for sensing hemodynamic indicators of said contractile state in at least one ventricular chamber of the heart;

(b) signal means coupled to said sensing means for developing a control signal varying as a function of said hemodynamic indicators;

(c) a drug infusion system for administering a drug to the patient as a function of said control signal to increase the strength of contraction of the patient'"'"'s heart; and

(d) means for applying said control signal to said drug infusion system for changing said contractile state by increasing the strength of contraction of the heart.

18. A method of applying therapy to a patient, using an apparatus comprising:

(a) intracardiac sensing means for sensing hemodynamic indicators of a contractile state of a patient'"'"'s heart;

(b) signal means coupled to said sensing means for producing a control signal in response to the sensed hemodynamic indicators; and

(c) patient therapy means comprising either (i) a stimulating electrode for applying stimulating pulses to tissue as a function of said control signal for increasing the strength of contraction of the patient'"'"'s heart, or (ii) a drug infusion system for administering a drug to the patient to increase the contractile strength of the patient'"'"'s heart;

comprising the steps of;

(i) sensing said hemodynamic indicators using said intracardiac sensing means;

(ii) using said signal means to produce a control signal in response to the sensed hemodynamic indicators; and

(iii) applying therapy to the patient using said therapy means by applying said stimulating pulses to said tissue, or using said drug infusion system to administer said drug to said patient, to increase the strength of contraction of the patient'"'"'s heart.