Apparatus and method for discriminating flow of blood in a cardiovascular system

• US 5,782,879 A
• Filed: 06/02/1995
• Issued: 07/21/1998
• Est. Priority Date: 06/02/1995
• Status: Expired due to Term

• Current Assignee: Intermedics Incorporated (Boston Scientific Corporation)
• Original Assignee: Sulzer Intermedics, Inc. (Sulzer AG)
• Inventors: Bonnerup, Chris A., Munshi, M. Zafar A., Rosborough, John P.
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): EVANISKO, GEORGE ROBERT
• Application Number:
  US08/458,952
• Time in Patent Office: 1,145 Days
• Field of Search: 128/691-693, 128/713, 128/734, 607/6, 607/18, 607/24, 607/5, 607/17, 607/23, 600/526, 600/547, 600/504-506
• US Class Current: 607/6
• CPC Class Codes: A61N 1/3918 characterised by shock pathway, e.g. by electrode configuration

Abstract

An implantable cardiac stimulator delivers a first electrical shock via implantable stimulating electrodes at a time when there is substantially no flow of blood. At least one of the stimulating electrodes is disposed in a blood flow path of the cardiovascular system. The first shock is of insufficient energy level to cause defibrillation. An electrical potential is measured as a function of time between the blood-contacting electrode and a reference electrode following delivery of the first shock to obtain a first potential equilibration function under no-flow conditions. A second therapeutic electrical shock, of sufficient energy level to effect defibrillation, is delivered via the stimulating electrodes. A second potential equilibration function is measured following delivery of the second shock. The first and second potential equilibration functions are compared, and if the two functions are sufficiently different in morphology, it is determined that blood is flowing.

Claims

1. An implantable cardiac stimulator, comprising:

a first implantable electrode configured for implanting in a blood flow path of the cardiovascular system of a body;

a second implantable electrode configured for implanting in the body such that an ionically conductive path exists through the body between the first and second electrodes;

a reference implantable electrode configured for implanting in the body such that an ionically conductive path exists through the body between the first and reference electrodes;

means for detecting cardiac fibrillation, whereby, if fibrillation is detected, a state of substantially no flow of blood at said first electrode can be assumed;

means in electrical communication with said first and second electrodes for delivering a reference shock between said first and second electrodes at a time when there is substantially no flow of blood at said first electrode, and for subsequently delivering a defibrillation shock between said first and second electrodes;

means for sensing in the time domain a reference electrical potential between said first electrode and said reference electrode following delivery of said reference shock, and for sensing in the time domain a test electrical potential between said first electrode and said reference electrode following delivery of said defibrillation shock; and

means for analyzing and comparing said sensed reference electrical potential and said sensed test electrical potential, and for determining on the basis of said comparison whether blood is flowing following delivery of said defibrillation shock.

2. The implantable cardiac stimulator of claim 1, in which said second electrode and said reference electrode are electrically common at a common locus.

3. The implantable cardiac stimulator of claim 1, in which said second electrode and said reference electrode are electrically non-common at separate loci.

4. The implantable cardiac stimulator of claim 1, in which said means for analyzing and comparing includes means for performing a regression analysis of each of said sensed reference and test electrical potentials.

5. The implantable cardiac stimulator of claim 4, in which said regression analysis includes determining a damping constant, α

, where the sensed reference and test electrical potentials are expressed as a function of time by the equation

f(t)=Ae.sup.±

α

t, in which A is a constant, e is the base of the natural logarithm, and t is time,

and comparing the damping constants of said sensed reference and test electrical potentials.

6. The implantable cardiac stimulator of claim 4, in which said regression analysis includes determining a coefficient, a, where the sensed reference and test electrical potentials are expressed as a function of time by the equation ##EQU1## representing a general polynomial fit of degree n, and comparing the coefficients of said sensed reference and test electrical potentials.

7. The implantable cardiac stimulator of claim 1, in which said means for analyzing and comparing includes means for performing differentiation of the sensed reference and test electrical potentials, and,

given that the first derivative of the sensed reference and test electrical potential is expressed as a function of time by the equation

f'"'"'(t)=∂

V/∂

t, in which V is the sensed electrical potential and t is time,

comparing the values of f'"'"'(t) for said reference and test electrical potentials.

8. The implantable cardiac stimulator of claim 1, in which said means for analyzing and comparing includes means for performing differentiation of the sensed reference and test electrical potentials, and,

given that the second derivative of the sensed reference and test electrical potentials are expressed as a function of time by the equation

f"(t)=∂

² V/∂

t², in which V is the sensed electrical potential and t is time,

comparing the values of f"(t) for said reference and test electrical potentials.

9. The implantable cardiac stimulator of claim 1, in which said means for analyzing and comparing includes signal processing means for processing said sensed reference and test electrical potentials to generate the first derivative of each of said potentials, and comparing the values of the first derivative for said reference and test electrical potentials.

10. The implantable cardiac stimulator of claim 1, in which said means for analyzing and comparing includes signal processing means for processing said sensed reference and test electrical potentials to generate the second derivative of each of said potentials, and comparing the values of the second derivative for said reference and test electrical potentials.

11. A method for discriminating cardiovascular blood flow, comprising the steps of:

implanting a first electrode in a blood flow path of the cardiovascular system;

implanting a second electrode such that an ionically conductive path exists between said first and second electrodes;

implanting a reference electrode such that an ionically conductive path exists between said first and reference electrodes;

detecting cardiac fibrillation, whereby, if fibrillation is detected, a state of substantially no flow of blood at said first electrode can be assumed;

delivering a reference electrical shock between said first and second electrodes at a time when there is substantially no flow of blood at said first electrode;

subsequently delivering a defibrillating electrical shock between said first and second electrodes;

sensing in the time domain a reference electrical potential between said first and reference electrodes following delivery of said reference electrical shock;

sensing in the time domain a test electrical potential between said first and reference electrodes following delivery of said defibrillation electrical shock;

analyzing and comparing said test electrical potential to said reference electrical potential, and

determining, on the basis of said comparison, whether blood is flowing following delivery of said defibrillation electrical shock.

12. The method of claim 11, in which said step of implanting a second electrode and said step of implanting a reference electrode are performed commonly by implanting a common component comprising both said second electrode and said reference electrode.

13. The method of claim 11, in which said step of implanting a second electrode and said step of implanting a reference electrode are performed independently by implanting separate components comprising said second and reference electrodes, respectively.

14. The method of claim 11, in which said step of analyzing and comparing includes performing a regression analysis of each of said sensed reference and test electrical potentials.

15. The method of claim 14, in which said regression analysis includes determining a damping constant, α

, where the sensed reference and test electrical potentials are expressed as a function of time by the equation

f(t)=Ae.sup.±

α

t, in which A is a constant, e is the base of the natural logarithm, and t is time,

and comparing the damping constants of said sensed reference and test electrical potentials.

16. The method of claim 14, in which said regression analysis includes determining a coefficient, a, where the sensed reference and test electrical potentials are expressed as a function of time by the equation

f(t)=Σ

_j=0ⁿ a_j t^j, in which t is time, representing a general polynomial fit of degree n,

and comparing the coefficients of said sensed reference and test electrical potentials.

17. The method of claim 11, in which said step of analyzing and comparing includes performing differentiation of the sensed reference and test electrical potentials, and,

given that the first derivative of the sensed reference and test electrical potentials are expressed as a function of time by the equation

f'"'"'(t)=∂

V/∂

t, in which V is the sensed electrical potential and t is time,

comparing the values of f'"'"'(t) for said reference and test electrical potentials.

18. The method of claim 11, in which said step of analyzing and comparing includes performing differentiation of the sensed reference and test electrical potentials, and,

given that the second derivative of the sensed reference and test electrical potentials are expressed as a function of time by the equation

f"(t)=∂

² V/∂

t² in which V is the sensed electrical potentia and t is time,

comparing the values of f"(t) for said reference and test electrical potentials.

19. The method of claim 11, in which said step of analyzing and comparing includes signal processing of said sensed reference and test electrical potentials to generate the first derivative of each of said potentials, and comparing the values of the first derivative for said reference and test electrical potentials.

20. The method of claim 11, in which said step of analyzing and comparing includes signal processing of said sensed reference and test electrical potentials to generate the second derivative of each of said potentials, and comparing the values of the second derivative for said reference and test electrical potentials.

21. A method of discriminating flow of blood in a cardiovascular system of a body, comprising the steps of:

disposing a first electrode in a blood flow path of the cardiovascular system;

disposing a second electrode such that an ionically conductive path exists through the body between said first electrode in a blood flow path and said second electrode,

imposing an electrical potential on said first electrode by connecting a voltage source between said first electrode in the blood flow path and said second electrode;

disconnecting said voltage source from said first electrode after said electrical potential has been imposed;

allowing the electrical potential on said first electrode to discharge at least partially;

sensing the discharging electrical potential in the time domain following said step of imposing an electrical potential by

disposing a reference electrode such that an ionically conductive path exists through the body between said first electrode in a blood flow path and said reference electrode, and

sensing the potential of the electrode in a blood flow path relative to the potential of said reference electrode; and

analyzing said sensed electrical potential to discriminate flow of blood, wherein said step of disposing a second electrode and said step of disposing a reference electrode are performed independently by implanting separate components comprising said second and reference electrodes, respectively.

22. An apparatus for discriminating flow of blood in a cardiovascular system, comprising:

a first implantable electrode configured for implanting in a blood flow path of the cardiovascular system;

a second implantable electrode configured for implanting in the body such that an ionically conductive path exists through the body between the first and second electrodes;

a reference implantable electrode configured for implanting in the body such that an ionically conductive path exists through the body between the first and reference electrodes in which said second electrode and said reference electrode are electrically non-common at separate locii;

means for sensing cardiac parameters from which the state of flow of blood at said first electrode can be deduced;

means in electrical communication with said first and second electrodes for delivering a reference shock between said first and second electrodes at a time when the state of flow of blood at said first electrode is known, and for subsequently delivering a test shock between said first and second electrodes;

means for sensing in the time domain a reference electrical potential between said first electrode and said reference electrode following delivery of said reference shock, and for sensing in the time domain a test electrical potential between said first electrode and said reference electrode following delivery of said test shock; and

means for analyzing and comparing said sensed reference electrical potential and said sensed test electrical potential., and for determining on the basis of said comparison the state of flow of blood following delivery of said test shock.