Implantable cardioverter defibrillator having a smaller displacement volume

• US 5,405,363 A
• Filed: 06/21/1994
• Issued: 04/11/1995
• Est. Priority Date: 03/15/1991
• Status: Expired due to Term

• Current Assignee: Ela Medical S.A. (LivaNova Plc)
• Original Assignee: Angelon Corporation
• Inventors: Kroll, Mark W., Smith, Charles U., Anderson, Kenneth M., Adams, Theodore P.
• Primary Examiner(s): Manuel, George
• Application Number:
  US08/263,257
• Time in Patent Office: 294 Days
• Field of Search: 607/5, 607/34, 607/36
• US Class Current: 607/5
• CPC Class Codes: A61N 1/3758 Packaging of the components within the casing
• CPC Class Codes: A61N 1/3787 from an external energy source
• 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 1/3931 Protecting, e.g. back-up systems
• CPC Class Codes: A61N 1/3956 Implantable devices for applying electric shocks to the heart, e.g. for cardioversion
• CPC Class Codes: A61N 1/3975 Power supply A61N1/378 takes precedence
• CPC Class Codes: H01M 16/00 Structural combinations of different types of electrochemical generators
• CPC Class Codes: H01M 6/5016 Multimode utilisation

Abstract

A capacitor-discharge implantable cardioverter defibrillator (ICD) has a relatively smaller displacement volume of less than about 90 cc. The smaller volume of the ICD is achieved by selecting and arranging the internal components of the ICD to deliver a maximum defibrillation countershock optimized in terms of a minimum physiologically effective current (I_pe), rather than a minimum defibrillation threshold energy (DFT). As a result of the optimization in terms of a minimum effective current I_pe, there is a significant decrease in the maximum electrical charge energy (E_c) that must be stored by the capacitor of the ICD to less than about 30 Joules, even though a higher safety margin is provided for by the device. Due to this decrease in the maximum E_c, as well as corollary decreases in the effective capacitance value required for the capacitor and the net energy storage required of the battery, the overall displacement volume of the ICD is reduced to the point where subcutaneous implantation of the device in the pectoral region of human patients is practical. The size of the capacitor is reduced because the effective capacitance required can be less than about 125 μ F. By optimizing both the charging time and the countershock duration for the smaller maximum E_c, the size of the battery is reduced because the total energy storage capacity can be less than about 1.0 Amp-hours. In the preferred embodiment, the charging time for each defibrillation countershock is reduced to less than about 10 seconds and the pulse duration of the countershock is reduced to less than about 6 milliseconds.

Claims

1. An implantable cardioverter defibrillator for subcutaneous positioning within a human patient comprising:

a sealed housing structure constructed of a biocompatible material and having a displacement volume of less than about 90 cc;

one or more connector port means, each connector port means disposed in a wall of said housing structure for providing electrical connections between an interior space of said housing structure and a corresponding electrode lead within said human patient;

circuit means disposed within said interior space of said housing structure and operably connected to said connector port means for sensing cardiac signals received from one or more of said electrode leads and, in response to the detection of an arrhythmia in said cardiac signals, controlling delivery of one or more high energy electrical cardioversion/defibrillation countershocks of at least 0.5 Joules to the myocardium of said human patient;

capacitor means disposed within said interior space of said housing structure and operably connected to said circuit means for storing electrical energy to generate said electrical cardioversion/defibrillation countershocks and having an effective capacitance value of less than 120 μ

F; and

battery means disposed within said interior space of said housing structure and operably connected to said circuit means and said capacitor means for providing electrical energy to said circuit means and said capacitor means,

wherein said battery means and said capacitor means are selected such that a maximum electrical charge energy stored by said capacitor means for each of said electrical cardioversion/defibrillation countershocks is less than about 30 J and said implantable cardioverter defibrillator is capable of delivering at least five of said electrical cardioversion/defibrillation countershocks in a four minute period.

2. The implantable cardioverter defibrillator of claim 1 wherein said circuit means controls the delivery of said electrical cardioversion/ defibrillation countershocks such that a pulse duration of a monophasic one of said cardioversion/defibrillation countershocks, or of a first phase of a multiphasic one of said cardioversion/defibrillation countershock is less than about 6 milliseconds.

3. The implantable cardioverter defibrillator of claim 2 wherein the duration of each of said electrical cardioversion/defibrillation countershocks is determined by said circuit means to be the sum of:

a first value derived from a first predetermined percentage of an RC time constant, with R being a myocardial tissue resistance value and C being said effective capacitance value of said capacitor means; and

a second value derived from a second predetermined percentage of a cardioversion chronaxie, d_c, value.

4. The implantable cardioverter defibrillator of claim 3 wherein said first and second predetermined percentages are between 0.5 and 0.65.

5. The implantable cardioverter defibrillator of claim 4 wherein said first and second predetermined percentages are both 0.58.

6. The implantable cardioverter defibrillator of claim 3 wherein said first value is determined by comparing an output voltage of said electrical cardioversion/defibrillation countershock with said first predetermined percentage and said second value is determined by providing for a fixed time period equal to said second value.

7. The implantable cardioverter defibrillator of claim 2 wherein at least one of said electrical cardioversion/defibrillation countershocks is a biphasic pulse having a positive phase and negative phase.

8. The implantable cardioverter defibrillator of claim 7 wherein the duration of the positive phase and negative phase are equal and is determined by said circuit means to be the sum of:

a first value derived from a first predetermined percentage of an RC time constant, with R being a myocardial tissue resistance value and C being said effective capacitance value of said capacitor means; and

a second value derived from a second predetermined percentage of a cardioversion chronaxie, d_c, value.

9. The implantable cardioverter defibrillator of claim 1 wherein said battery means is capable of charging said capacitor means to said maximum charge amount in less than about 10 seconds.

10. The implantable cardioverter defibrillator of claim 1 wherein said battery means has an estimated life of five years and a total storage capacity of less than about 1.0 Amp-hours.

11. The implantable cardioverter defibrillator of claim 1 wherein an optimum capacitance value (C) for said effective capacitance value of said capacitor means is determined by the simultaneous solution of the equations:

space="preserve" listing-type="equation">E.sub.c =0.5CV.sub.d.sup.2

space="preserve" listing-type="equation">C=0.8d.sub.c /R

where E_c is said maximum charge amount, V_d is a maximum voltage for each of said electrical cardioversion/defibrillation countershocks, d_c is a cardioversion chronaxie value and R is a myocardial tissue resistance value.

12. The implantable cardioverter defibrillator of claim 1 wherein said battery means comprises:

a first battery means for providing electrical power to said circuit means to monitor said cardiac signals; and

a second battery means, separate from said first battery means and having different energy storage characteristics, for providing electrical power to charge said capacitor means to generate said electrical cardioversion/defibrillation countershocks.

13. The implantable cardioverter defibrillator of claim 12 wherein said second battery means is a rechargeable battery and further include charging circuitry for charging said rechargeable battery from said first battery means or from an external RF power source.

14. The implantable cardioverter defibrillator of claim 1 wherein said battery means comprises:

a low power output primary battery;

a high power output intermediate power intensifying battery; and

switch means connected to said primary battery and said intermediate power intensifying battery for permitting said intermediate power intensifying battery to rapidly charge said capacitor means,

such that said capacitor means discharges in a first pulse an electrical charge derived from said primary battery and discharges one or more subsequent pulses of electrical charge derived from said intermediate power intensifying battery to permit the implantable cardioverter defibrillator to deliver multiple closely spaced cardioversion/defibrillation countershocks.

15. The implantable cardioverter defibrillator of claim 1 wherein said displacement value of said housing structure is greater than about 40cc and less than about 60cc.

16. The implantable cardioverter defibrillator of claim 1 wherein the total weight of said implantable cardioverter defibrillator is less than about 120 grams.

17. The implantable cardioverter defibrillator of claim 1 wherein said housing structure has a length to width to thickness ratio of approximately 5 to 3 to 1.

18. An implantable cardioverter defibrillator for subcutaneous positioning within the pectoral region a human patient comprising:

a sealed housing structure constructed of a biocompatible material and having a displacement volume of less than about 90cc;

one or more connector port means, each connector port means disposed in a wall of said housing structure for providing electrical connections between an interior space of said housing structure and a corresponding electrode lead within said human patient;

circuit means disposed within said interior space of said housing structure and operably connected to said connector port means for sensing cardiac signals received from one or more of said electrode leads and, in response to the detection of an arrhythmia in said cardiac signals, controlling delivery of one or more electrical cardioversion/defibrillation countershocks of at least 0.5 Joules to the myocardium of said human patient;

capacitor means disposed within said interior space of said housing structure and operably connected to said circuit means for storing electrical energy to generate said electrical cardioversion/defibrillation countershocks; and

battery means disposed within said interior space of said housing structure and operably connected to said circuit means and said capacitor means for providing electrical energy to said circuit means and said capacitor means,

wherein said battery means and said capacitor means are selected to maximize a physiologically effective current (I_pe) for a maximum electrical charge energy (E_c) stored by said capacitor means.

19. The implantable cardioverter defibrillator of claim 18 wherein said physiologically effective current (I_pe) is determined by solution of the equation:

space="preserve" listing-type="equation">I.sub.pe =(I.sub.ave *d)/(d.sub.c +d)

where I_ave is an average current of said electrical cardioversion/defibrillation countershocks, d is a duration of said electrical cardioversion/defibrillation countershocks, and d_c is a cardioversion chronaxie value.

20. An implantable cardioverter defibrillator for subcutaneous positioning within the pectoral region of a human patient comprising:

a sealed housing structure constructed of a biocompatible material and having a displacement volume of less than about 90 cc and including one or more connector ports disposed in a wall of said structure for providing electrical connections between an interior space of said structure and electrode leads in said patient;

circuit means within said interior space for sensing cardiac signals received from said electrode leads and, in response to the detection of an arrhythmia in said cardiac signals, controlling delivery of one or more electrical cardioversion/defibrillation countershocks of at least 0.5 Joules to said patient;

capacitor means within said interior space for storing electrical energy to generate said electrical cardioversion/defibrillation countershocks and having an effective capacitance of less than about 120 μ

F; and

battery means within said interior space for providing electrical energy to said circuit means and said capacitor means and capable of charging said capacitor means in less than about 10 seconds to a maximum electrical charge energy of less than about 30 Joules.

21. An implantable cardioverter defibrillator for subcutaneous positioning within a pectoral region of a human patient comprising:

a sealed housing structure constructed of a biocompatible material and having a displacement volume of less than about 90 cc;

one or more connector ports, each connector port disposed in a wall of the housing structure for providing electrical connections between an interior space of the housing structure and a corresponding electrical lead that is implanted within the human patient; and

circuit means disposed within the interior space of the housing structure and operably connected to the connector ports and responsive to a cardiac signal received from the human patient via one or more of the electrical leads for detecting an arrhythmia in the cardiac signal and, in response, controlling delivery of one or more high energy electrical cardioversion/defibrillation countershocks of at least 0.5 joules to the human patient.

22. The implantable cardioverter defibrillator of claim 21 wherein the displacement value of the housing structure is greater than about 40 cc and less than about 60 cc.

23. The implantable cardioverter defibrillator of claim 21 wherein a total weight of the implantable cardioverter defibrillator is less than about 120 grams.

24. The implantable cardioverter defibrillator of claim 21 wherein the housing structure has a length to width to thickness ratio of approximately 5 to 3 to 1.

25. The implantable cardioverter defibrillator of claim 21 wherein the circuit means comprises:

detection means for receiving the cardiac signal and detecting the arrhythmia;

capacitor means for storing electrical energy to generate the electrical cardioversion/defibrillation countershocks;

battery means for providing electrical energy to the detection means, the control means and the capacitor means; and

control means for controlling storing of the electrical energy in the capacitor means and discharging of the electric energy in the capacitor means as the one or more high energy electrical cardioversion/defibrillation countershocks.

26. The implantable cardioverter defibrillator of claim 25 wherein a maximum electrical charge energy stored by the capacitor means for each electrical cardioversion/defibrillation countershocks is less than about 30 joules.

27. The implantable cardioverter defibrillator of claim 26 wherein the battery means charges the capacitor means to the maximum electrical charge energy in less than about 10 seconds.

28. The implantable cardioverter defibrillator of claim 25 wherein the battery means has a total energy storage capacity of less than 1.0 amp-hours.

29. The implantable cardioverter defibrillator of claim 25 wherein the capacitor means has an effective capacitance value of less than 120 μ

F.

30. The implantable cardioverter defibrillator of claim 29 wherein the effective capacitance value of the capacitor means is an optimum capacitance value (C) determined by the simultaneous solution of the equations:

space="preserve" listing-type="equation">E.sub.c =0.5CV.sub.d.sup.2

space="preserve" listing-type="equation">C=0.8d.sub.c /R

where E_c is said maximum charge amount, V_d is a maximum voltage for each electrical cardioversion/defibrillation countershock, d_c is a cardioversion chronaxie value and R is a myocardial tissue resistance value.

31. The implantable cardioverter defibrillator of claim 25 wherein the control means controls the delivery of the electrical cardioversion/defibrillation countershocks such that a pulse duration of a monophasic one of the cardioversion/defibrillation countershocks, or of a first phase of a multiphasic one of the cardioversion/defibrillation countershocks is less than about 6 milliseconds.

32. The implantable cardioverter defibrillator of claim 31 wherein the duration of each electrical cardioversion/defibrillation countershocks is determined by the control means to be the sum of:

a first value derived from a first predetermined percentage of an RC time constant, with R being a myocardial tissue resistance value and C being an effective capacitance value of the capacitor means; and

a second value derived from a second predetermined percentage of a cardioversion chronaxie, d_c, value.

33. The implantable cardioverter defibrillator of claim 32 wherein the first and second predetermined percentages are between 0.5 and 0.65.

34. The implantable cardioverter defibrillator of claim 33 wherein the first and second predetermined percentages are both 0.58.

35. The implantable cardioverter defibrillator of claim 32 wherein the first value is determined by comparing an output voltage of the electrical cardioversion/defibrillation countershock with a first predetermined percentage and the second value is determined by providing for a fixed time period equal to said second value.

36. The implantable cardioverter defibrillator of claim 32 wherein at least one of the electrical cardioversion/defibrillation countershocks is a biphasic pulse having a positive phase and negative phase.

37. The implantable cardioverter defibrillator of claim 36 wherein a duration of the positive phase and negative phase are equal and is determined by the control means to be the sum of:

a first value derived from a first predetermined percentage of an RC time constant, with R being a myocardial tissue resistance value and C being an effective capacitance value of the capacitor means; and

a second value derived from a second predetermined percentage of a cardioversion chronaxie, d_c, value.

38. The implantable defibrillator of claim 25 wherein a ratio of a physiologically effective current (I_pe) to a maximum stored energy charge (E_c) of the capacitor means is at least about 20%.