Method and apparatus for generating biphasic waveforms in an implantable defibrillator

• US 5,534,015 A
• Filed: 10/11/1994
• Issued: 07/09/1996
• Est. Priority Date: 02/18/1992
• Status: Expired due to Fees

• Current Assignee: Angeion Corporation (Niterra Co., Ltd.)
• Original Assignee: Angeion Corporation (Niterra Co., Ltd.)
• Inventors: Kroll, Mark W., Brewer, James E.
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): SCHAETZLE, KENNEDY
• Application Number:
  US08/321,540
• Time in Patent Office: 637 Days
• Field of Search: 607/5, 607/4, 607/7, 607/74, 607/8
• US Class Current: 607/7
• CPC Class Codes: A61N 1/3906 characterised by the form of the shockwave
• CPC Class Codes: A61N 1/3912 Output circuitry therefor, e.g. switches
• CPC Class Codes: A61N 1/3956 Implantable devices for applying electric shocks to the heart, e.g. for cardioversion
• CPC Class Codes: H01M 16/00 Structural combinations of different types of electrochemical generators
• CPC Class Codes: Y02E 60/10 Energy storage using batteries

Abstract

An implantable defibrillator system for generating biphasic waveforms comprises a self-contained human implantable housing containing a capacitor system for storing an electrical charge, a power supply for charging the capacitor system, and a controller for selectively discharging the electrical charge as a biphasic countershock to be delivered through at least two electrodes in response to a sensing of a cardiac dysrhythmia in the human patient. The controller includes a system for controlling a first duration of a first phase of the biphasic countershock such that the discharge of the electrical charge is of a first polarity and the first duration is variable and a system for controlling a second duration of a second phase of the biphasic countershock such that the discharge of the electrical charge is of a second polarity that is opposite from the first polarity and the second duration is fixed.

Claims

1. An implantable defibrillator apparatus electrically connected to at least two electrodes adapted for implantation in a human patient to treat cardiac dysrhythmia by delivering a biphasic countershock, the implantable defibrillator apparatus comprising:

an implantable housing which contains;

sensing means for sensing a cardiac dysrhythmia in the human patient;

capacitor means for storing an electrical charge;

source means for charging the capacitor means to a charging voltage; and

control means for selectively controlling the power source means and the capacitive charge storage means in response to the sensing of the cardiac dysrhythmia to deliver a biphasic countershock to the at least two electrodes including;

means for controlling a first duration of a first phase of the biphasic countershock that has a first polarity such that the first duration is variable; and

means for controlling a second duration of a second phase of the biphasic countershock that has a second polarity that is opposite from the first polarity such that the second duration is fixed.

2. The implantable defibrillator apparatus of claim 1 wherein the means for controlling the first duration dynamically determines a first portion of the first duration based upon a measured tilt of an output voltage of the electrical charge and determines a second portion of the first duration based on a predetermined time value.

3. The implantable defibrillator apparatus of claim 2 wherein the means for controlling the first duration uses a percentage of a system time constant for the implantable defibrillator system to determine the first portion of the first duration and uses a percentage of a predetermined human chronaxie value to determine the second portion of the first duration.

4. The implantable defibrillator apparatus of claim 1 wherein the means for controlling the first duration includes means for dynamically measuring a resistance value across the at least two electrodes that is used to variably control the first duration for the first phase.

5. The implantable defibrillator apparatus of claim 1 wherein the means for controlling the second duration programmably establishes the second duration at a fixed value between 2 to 4 milliseconds.

6. The implantable defibrillator apparatus of claim 1 wherein the means for controlling the second duration is preset to establish the second duration at a constant value of about 2.5 milliseconds.

7. The implantable defibrillator apparatus of claim 1 wherein the control means communicates with a programming device external to the human patient to programmably establish at least one programmable value selected from the set comprising:

a tilt value for the first duration, a tilt value and a fixed value for the first duration, a fixed value for the second duration and any combination thereof.

8. An improved implantable defibrillator system for producing a biphasic capacitive-discharge countershock to be delivered through at least two electrodes adapted for implantation in a human patient, the implantable defibrillator system being a self-contained human implantable housing containing a waveform-generating capacitor means for storing an electrical charge, means for charging the waveform-generating capacitor means, and means for selectively discharging the electrical charge in the waveform-generating capacitor means as a biphasic countershock to be delivered through the at least two electrodes in response to a means for sensing of a cardiac dysrhythmia in the human patient, the improvement comprising:

the means for selectively discharging including;

means for controlling a first duration of a first phase of the biphasic countershock such that the discharge of the electrical charge is of a first polarity and the first duration is variable and increases with an increase of a system time constant for the implantable defibrillator system; and

means for controlling a second duration of a second phase of the biphasic countershock such that the discharge of the electrical charge is of a second polarity that is opposite from the first polarity and the second duration is variable and decreases with an increase of the system time constant for the implantable defibrillator system.

9. The implantable defibrillator system of claim 8 wherein the system time constant is less than about 2 milliseconds.

10. The implantable defibrillator system of claim 8 wherein an effective capacitance of the waveform generating capacitor means is less than about 80 μ

F and an interelectrode resistance between the at least two electrodes is greater than about 25 Ω

.

11. The implantable defibrillator system of claim 8 wherein the means for controlling the second duration determines an optimal second duration (d₂) by solution of the equation:

space="preserve" listing-type="equation">d.sub.2 (opt)=[(τ

.sub.s τ

.sub.m)/(τ

.sub.s -τ

.sub.m)]ln[2-(e.sup.-d.sbsp.1/ τ

.sub.m /e.sup.-d.sbsp.1/ τ

.sub.s)],

where (d₁ ) is the first duration of the first phase of the biphasic waveform, τ

_s is the system time constant for the implantable defibrillator system and τ

_m is a system time constant for a heart cell membrane.

12. The implantable defibrillator system of claim 11 wherein solutions for the equation for the optimal second duration are precalculated for a range of values for d₁, τ

_s, and τ

_m and stored in a memory in the implantable defibrillator, and wherein the means for controlling the second duration selectively chooses among the stored solutions based on determined values for at least d₁ and τ

_s.

13. The implantable defibrillator system of claim 8 wherein the means for controlling the second duration dynamically determines an interelectrode resistance value between the at least two electrodes and uses the interelectrode resistance value to determine an optimal value for the second duration.

14. The implantable defibrillator system of claim 8 wherein the means for controlling the first duration discharges a first portion of the electrical charge based upon a measured tilt of an output voltage of the electrical charge and discharges a second portion of the electrical charge based on a predetermined time value.

15. The implantable defibrillator system of claim 14 wherein the means for controlling the second duration dynamically determines an interelectrode resistance value between the at least two electrodes based on a measured duration of the first portion and uses the interelectrode resistance value to determine an optimal value for the second duration.

16. The implantable defibrillator system of claim 15 wherein the means for controlling the second duration determines the optimal second duration (d₂) by solution of the equation:

space="preserve" listing-type="equation">d.sub.2 (opt)=[(τ

.sub.s τ

.sub.m)/(τ

.sub.s -τ

.sub.m)]ln[2-(e.sup.-d.sbsp.1/ τ

.sub.m /e.sup.-d.sbsp.1/ τ

.sub.s)],

where (d₁) is the first duration of the first phase of the biphasic waveform, τ

_s is the system time constant for the implantable defibrillator system and τ

_m is a system time constant for a heart cell membrane.

17. An improved implantable defibrillator system for producing a biphasic capacitive-discharge countershock to be delivered through at least two electrodes adapted for implantation in a human patient, the implantable defibrillator system being a self-contained human implantable housing containing a waveform-generating capacitor means for storing an electrical charge, means for charging the waveform-generating capacitor means, and means for selectively discharging the electrical charge in the waveform-generating capacitor means as a biphasic countershock to be delivered through the at least two electrodes in response to a means for sensing of a cardiac dysrhythmia in the human patient, the improvement comprising:

the means for selectively discharging including;

means for controlling a first duration of a first phase of the biphasic countershock such that the discharge of the electrical charge is of a first polarity and the first duration is variable; and

means for controlling a second duration of a second phase of the biphasic countershock such that the discharge of the electrical charge is of a second polarity that is opposite from the first polarity and the second duration is fixed.

18. The implantable defibrillator system of claim 17 wherein the means for controlling the first duration discharges a first portion of the electrical charge based upon a measured tilt of an output voltage of the electrical charge and discharges a second portion of the electrical charge based on a predetermined time value.

19. The implantable defibrillator system of claim 18 wherein the means for controlling the first duration uses a percentage of a system time constant for the implantable defibrillator system to determine the first portion of the discharge and uses a percentage of a predetermined human chronaxie value to determine the second portion of the discharge.

20. The implantable defibrillator system of claim 17 wherein the means for controlling the first duration includes means for dynamically measures a resistance value across the at least two electrodes that is used to variably control the first duration for the first phase.

21. The implantable defibrillator system of claim 17 wherein the means for controlling the second duration programmably establishes the second duration at a fixed value between 2 to 4 milliseconds.

22. The implantable defibrillator system of claim 17 wherein the means for controlling the second duration is preset to establish the second duration at a constant value of about 2.5 milliseconds.

23. The implantable defibrillator system of claim 17 wherein the means for selectively discharging communicates with a programming device external to the human patient to programmably establish at least one programmable value selected from the set comprising:

a tilt value for the first duration, a tilt value and a fixed value for the first duration, a fixed value for the second duration and any combination thereof.

24. A method for operating an implantable defibrillator device electrically connected to at least two electrodes adapted for implantation in a human patient to treat cardiac dysrhythmia by delivering a biphasic countershock, the method comprising the device-implemented steps of:

(a) sensing for a cardiac dysrhythmia in a human patient;

(b) in response to sensing the cardiac dysrhythmia, charging a capacitive charge storage system within the implantable defibrillator device to a charge value;

(c) selectively discharging at least a first portion of the charge value stored in the capacitive charge storage system through the at least two electrodes to produce a first phase of the biphasic countershock, the first phase having a first polarity and a first duration that is variable; and

(d) discharging at least a second portion of the charge value stored in the capacitive charge storage system through the at least two electrodes to produce a second phase of the biphasic countershock, the second phase having a second polarity that is opposite from the first polarity and having a second duration that is fixed.

25. The method of claim 24 wherein step (c) comprises:

(c1) discharging a first subportion of the first portion of the charge value based upon a measured tilt of an output voltage of the electrical charge; and

(c2) discharging and second subportion of the first portion of the charge value based on a predetermined time value.

26. The method of claim 25 wherein step (c1) uses a percentage of a system time constant for the implantable defibrillator system to determine the first portion of the charge value, and wherein step (c2) uses a percentage of a predetermined human chronaxie value to determine the second portion of the charge value.

27. The method of claim 26 wherein step (c) further includes the step of dynamically measuring a resistance value across the at least two electrodes that is used to variably control the first duration for the first phase.

28. The method of claim 24 wherein step (d) further includes the step of programmably establishing the second duration at a fixed value between 2 to 4 milliseconds.

29. The method of claim 24 wherein step (d) is accomplished by fixing the second duration at a constant value of about 2.5 milliseconds.

30. The method of claim 24 further comprising the step of:

(e) communicating with a programming device external to the human patient to programmably establish at least one programmable value selected from the set comprising;

a tilt value for the first duration, a tilt value and a fixed value for the first duration, a fixed value for the second duration and any combination thereof.