Automatic implantable fibrillation preventer

• US 4,750,494 A
• Filed: 06/24/1987
• Issued: 06/14/1988
• Est. Priority Date: 05/12/1981
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: King, Wendell L.
• Primary Examiner(s): Hindenburg, Max
• Application Number:
  US07/063,807
• Time in Patent Office: 356 Days
• Field of Search: 128/419 D, 128/419 P, 128/419 PG, 128/419 R, 128/630, 128/632, 128/635, 128/692, 128/695, 128/699, 128/700, 128/705, 128/732
• US Class Current: 607/14
• CPC Class Codes: A61N 1/3621 for treating or preventing abnormally high heart rate
• 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 1/36557 controlled by chemical substances in blood

Abstract

Apparatus and method for sensing the probable onset of ventricular fibrillation or other harmful tachyarrythmias and delivering electrical cardioverting stimulation pulses in response thereto. The sensing of the onset of the harmful tachyarrhythmia is accomplished using two different types of sensors. The first sensing technique utilizes an intracardiac ECG observed within three dimensional space. Directional changes of the current vector within the intracardiac ECG are used to predict the onset of harmful ventricular tachyarrhythmias. The second sensing technique employs a chemically sensitive semiconductor device which measures the level of ionic potassium found within the intracardiac blood. Rapid changes in ionic potassium level are used to predict the onset of detrimental ventricular tachyarrhythmias. An implantable device uses both types of sensors in a programmable fashion to deliver cardioverting electrical stimulation pulses based upon the predicted onset of ventricular fibrillation.

Claims

1. Apparatus for stimulating the heart through electrodes adapted to be in contact with heart tissue comprising:

pulse generating means for generating stimulation pulses at output terminals adapted to be electrically coupled to heart tissue through electrodes;

first sensing means for measuring the current vectors of electrical depolarization signals of the heart and for producing a first electrical signal representative of the measured current vector;

means for establishing a threshold current vector signal;

second sensing means for measuring the concentration of certain extracellular ions in the blood and producing a second electrical signal representative of the measured ionic concentration; and

triggering means responsive to the measured first and second electrical signals and the threshold current vector signals for causing said pulse generating means to provide a stimulating pulse to the heart.

2. A body implantable apparatus according to claim 1 wherein said certain ion is extracellular ionic potassium.

3. A body implantable apparatus according to claim 1 wherein said certain ion is extracellular ionic sodium.

4. The apparatus of claim 1 further comprising means for establishing a threshold current vector rate of change signal;

and wherein;

said first means further comprises means for determining the rate of change of the current vector and for providing a current vector rate of change signal; and

said triggering means further comprises means responsive to the measured and threshold current vector rate of change signals for causing said pulse generating means to provide a stimulating pulse to the heart.

5. The apparatus of claim 4 wherein said first sensing means further comprises:

three dimensional current sensing means for sensing in three mutually orthogonal directions the electrical depolarization signals of the heart and producing three respective directional electrical signals;

circuit means for developing said first electrical signal and said current vector rate of change signal from the directional signals.

6. The apparatus of claim 5 wherein said three dimensional current sensing means further comprises:

a lead body for introduction into a heart chamber;

three pairs of mutually orthogonal electrodes supported on the lead body;

three pairs of electrical conductors extending within said lead body and electrically connected to said respective three pairs of electrodes;

terminal means electrically connected to said conductors;

body compatible insulating means for covering and electrically insulating said conductors; and

means for connecting said terminal means to said circuit means.

7. The apparatus of claim 1 further comprising means for establishing a threshold current vector rate of change signal;

and wherein;

said first means further comprises means for determining the measured value of the current vector and the rate of change of the current vector and for providing measured value and rate of change current vector signals; and

said triggering means further comprises means responsive to the measured and threshold value signals and the measured and threshold rate of change current vector signals for causing said pulse generating means to provide a stimulating pulse to the heart.

8. The apparatus of claim 7 further comprising:

programmable memory means for storing data representative of a threshold current vector value and a threshold ionic concentration value; and

wherein;

said triggering means further comprises means responsive to said first signal and said threshold current vector value and said second signal and said threshold ionic concentration value for causing said pulse generating means to provide a stimulating pulse to the heart.

9. The apparatus of claim 1 further comprising means for establishing a threshold ionic concentration signal;

and wherein;

said triggering means further comprises means responsive to the measured second electrical signal and the threshold ionic concentration signal for causing said pulse generating means to provide a stimulating pulse to the heart.

10. The apparatus of claim 1 further comprising means for establishing a threshold ionic concentration rate of change signal;

and wherein;

said second means further comprises means for determining the rate of change of the ionic concentration of said certain ion in the blood and for providing an ionic concentration rate of change signal; and

said triggering means further comprises means responsive to the measured and threshold ionic concentration rate of change signals for causing said pulse generating means to provide a stimulating pulse to the heart.

11. The apparatus of claim 1 further comprising means for establishing a threshold ionic concentration signal and rate of change signal;

and wherein;

said second means further comprises means for determining the measured value and the rate of change of the ionic concentration of said certain ion in the blood and for providing ionic concentration measured value and rate of change signals; and

said triggering means further comprises means responsive to the measured value and threshold ionic concentration signals and the measured and threshold ionic concentration rate of change signals for causing said pulse generating means to provide a stimulating pulse to the heart.

12. The apparatus of claim 1 wherein said first sensing means further comprises:

three dimensional current sensing means for sensing in three mutually orthogonal directions the electrical depolarization signals of the heart and producing three respective directional electrical signals; and

circuit means for developing said first electrical signal from the directional signals.

13. The apparatus of claim 12 wherein said three dimensional current sensing means further comprises:

a lead body for introduction into a heart chamber;

three pairs of mutually orthogonal electrodes supported on the lead body;

three pairs of electrical conductors extending within said lead body and electrically connected to said respective three pairs of electrodes;

terminal means electrically connected to said conductors;

body compatible insulating means for covering and electrically insulating said conductors; and

means for connecting said terminal means to said circuit means.

14. A method of cardioverting the heart comprising the steps of:

(a) sensing the intracardiac ECG in three dimensional space;

(b) deriving a current vector signal for the sensed intracardiac ECG;

(c) storing the current vector signal;

(d) repeating steps (a) and (b) to derive a current vector rate of change signal;

(e) storing a threshold rate of change value;

(f) comparing the derived current vector rate of change signal to the threshold rate of change value;

(g) generating stimulating pulses to cardiovert the heart whenever the comparison reveals that the derived current vector differs from the threshold rate of change value by a predetermined amount indicative of fibrillation; and

(h) applying said pulses to the heart.

15. The method of claim 14 further comprising the steps of:

(a) sensing the amount of a certain extracellular ion in the blood;

(b) storing a threshold value for the ionic concentration;

(c) comparing the sensed amount to the threshold value; and

(d) generating said electrical stimulating pulses to cardiovert the heart if said comparisons reveal both that said sensed amount of said threshold value are in a predetermined mathematical relationship and that said derived current vector differs from said threshold rate of change value by said predetermined amount.

16. The method of claim 15 further comprising the steps of:

(a) deriving a signal representative of the rate of change of the sensed ionic concentration;

(b) storing a threshold ionic concentration rate of change value;

(c) comparing the derived ionic concentration rate of change signal to the threshold rate of change; and

(d) generating said electrical stimulating pulses if said comparison reveals that said derived ionic concentration rate of change signal exceeds said threshold ionic concentration rate of change value.

17. Apparatus for cardioverting the heart comprising:

(a) means for sensing the intracardiac ECG in three dimensional space;

(b) means for deriving a current vector signal for the sensed intracardiac ECG;

(c) means for deriving a current vector rate of change signal;

(d) means for storing a threshold rate of change value;

(e) means for comparing the derived current vector rate of change signal to the threshold rate of change value;

(f) means for generating stimulating pulses to cardiovert the heart whenever the comparison reveals that the derived current vector differs from the threshold rate of change value by a predetermined amount indicative of fibrillation; and

(g) means for applying said pulses to the heart.

18. The apparatus of claim 17 further comprising:

(a) means for sensing the amount of a certain extracellular ion in the blood;

(b) means for storing a threshold value for the ionic concentration;

(c) means for comparing the sensed amount to the threshold value; and

(d) means for generating said electrical stimulating pulses to cardiovert the heart if said comparisons reveal both that said sensed amount and said threshold ionic concentration value are in a predetermined mathematical relationship; and

that said derived current vector differs from said threshold rate of change value by said predetermined amount.

19. The apparatus of claim 18 further comprising:

(a) means for deriving a signal representative of the rate of change of the sensed ionic concentration;

(b) means for storing a threshold rate of change value;

(c) means for comparing the derived rate of change signal to the threshold rate of change; and

(d) means for generating said electrical stimulating pulses if said comparison further reveals that said derived rate of change signal exceeds said threshold rate of change value.