Implantable electrodes for accomplishing ventricular defibrillation and pacing and method of electrode implantation and utilization

• US 4,030,509 A
• Filed: 09/30/1975
• Issued: 06/21/1977
• Est. Priority Date: 09/30/1975
• Status: Expired due to Term

• Current Assignee: Mirowski Family Ventures LLC
• Original Assignee: Mieczyslaw Mirowski
• Inventors: Mower, Morton M., Langer, Alois A., Heilman, Marlin S., Mirowski, Mieczyslaw, Reilly, David M.
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US05/620,026
• Time in Patent Office: 630 Days
• Field of Search: 128/404, 128/416, 128/418, 128/419 D, 128/419 P, 128/419 R
• US Class Current: 607/17
• CPC Class Codes: A61N 1/0587 Epicardial electrode systems; Endocardial electrodes piercing the pericardium
• CPC Class Codes: A61N 1/3918 characterised by shock pathway, e.g. by electrode configuration

Abstract

Disclosed are several embodiments of an electrode system for ventricular defibrillation, and the methods of using and implanting the electrode system. In one embodiment, the electrodes are in a generally base-apex configuration having a split conformal base electrode residing above the base of the ventricles (a transecting plane separating the atria from the ventricles) in the region of the atria and a conformal apex electrode in the form of a rotated conic section residing at the apex of the heart. In another embodiment, defibrillation is accomplished by the apex electrode acting against a catheter electrode situated high in the heart or in the superior vena cava.

The electrodes themselves are in the form of planar metallic mesh elements adapted to lie in contact with body tissue on an active surface, insulated on the opposite surface. In another embodiment, the conductive portions of the respective electrodes are developed from metallic plates, exposed on one surface and insulated on the other. The electrodes may be split, or may entirely surround the base and apex of the heart.

The disclosed electrode system is well adapted for easy implantation during an open heart surgery, or in a separate operation which can be performed in the mediastinal space without intrusion of the pleural space. The electrode system may be implanted for immediate stand-by defibrillation, or may be implanted during open heart surgery, used for post-operative monitoring, pacing and defibrillation, should the need arise, and then subcutaneously implanted for future association with an automatic defibrillating pulse generator. When employed after open heart surgery, the electrode system is preferably equipped with independent atrial and ventricular pacer electrodes.

Also disclosed are techniques for fixing the electrode system to the surrounding body tissue, and electrode leads which may be removed after the implanted electrodes have served their desired function, without disturbing the electrodes themselves.

Claims

1. The combination of an implantable cardioverting electrode and pacing electrode, the combination comprising:

conductive base electrode means for associating with the base of the heart;

conductive apex electrode means of substantially frustoconical shape throughout at least a portion thereof, for lying adjacent but exterior to the apex of the heart and conforming to the contours thereof; and

an auxiliary electrode insulated from both said base and said apex electrodes and extending from the surface of one of said base or said apex electrodes in the direction of the heart, said auxiliary electrode serving to deliver pacing energy to the heart.

2. An electrode system for cardiovering a malfunctioning heart, the electrode system comprising:

first conductive electrode means for associating with a heart in the region of its base;

second conductive electrode means for associating with the heart in the region of its apex, said second electrode means having first and second conductive surfaces;

insulation means for insulating the first conductive surface of said second electrode means; and

first and second electrode leads in electrical contact with the respective first and second electrode means, for applying cardioverting electrical energy between said first and second electrode means for discharge through said heart;

the second conductive surface of said second electrode means adapted to lie in contact with the heart, and being in a substantially frustoconical shape throughout at least a portion thereof; and

the insulation means adapted to face away from the heart, and being in a substantially rotated parabola shape.

3. The electrode system recited in claim 2, wherein said first conductive electrode means comprises first and second discrete sections, sized and shaped so that said first and second sections are adapted to reside on opposite sides of the pulmonary artery.

4. The electrode system recited in claim 2, and further comprising an auxiliary electrode on one of said first and second conductive electrode means insulated therefrom and adapted to contact cardiac tissue;

and a third electrode lead associated with said auxiliary electrode for transmitting electrical energy thereto and therefrom.

5. The electrode system recited in claim 2, wherein said first and second conductive electrode means comprise conductive surfaces of metallic mesh for contacting the tissue of the heart.

6. The electrode system recited in claim 2, wherein said first and second conductive electrode means comprise conductive surfaces of metallic plates for contacting the tissiue of the heart.

7. The electrode system recited in claim 2, wherein said first electrode means comprises first and second discrete sections, wherein said first electrode lead has a first component connected to said first section and a second component connected to said second section, and further comprising electrode lead means for joining together said first and second components to form a Y junction.

8. The electrode system recited in claim 2, and further comprising mechanical connector means on at least one of said first or second conductive electrode means for connecting the same to body tissue in the region of the heart.

9. The electrode system recited in claim 2, wherein said first conductive electrode means when relaxed, has a first section of a first radius and a second section of a second and smaller radius, said second section adapted to lie about the pulmonary artery of the heart.

10. The electrode system recited in claim 2, wherein said first conductive electrode means is a catheter electrode adapted to lie high in the heart or in the superior vena cava.

11. The electrode system recited in claim 2, wherein said first and second conductive electrode means are flexible.

12. The electrode system recited in claim 2, wherein said first electrode means is in the shape of a band having a width dimension and a length dimension substantially larger than said width dimension, said band adapted to lie in a circumferential position on the surface of the atrii.

13. The electrode system recited in claim 2, wherein at least one of said first or second conductive electrode means is flexible.

14. An electrode for use in a system for cardioverting a malfunctioning heart, the electrode comprising:

conductive means having first and second conductive surfaces;

insulation means for insulating the first conductive surface;

an electrode lead in electrical connection with said conductive means, for applying cardioverting electrical energy to said conductive means for discharge through a heart;

said second conductive surface adapted to lie in contact with the heart, and being of a substantially frustoconical shape throughout at least a portion thereof; and

said insulation means adapted to face away from the heart, and being of a substantially rotated parabola shape.

15. The electrode recited in claim 14, wherein said conductive means is defined by a metallic mesh.

16. The electrode recited in claim 14, wherein said conductive means is defined by metallic plates.

17. The electrode recited in claim 14, wherein said conductive means and said insulation means are flexible.

18. The electrode recited in claim 14, and further comprising:

an auxiliary electrode insulated from said conductive means and adapted to contact cardiac tissue; and

a further electrode lead connected to said auxiliary electrode for transmitting electrical energy thereto and therefrom.

19. The electrode recited in claim 14, wherein said conductive means and said insulating means are split in at least one portion thereof to permit expansion and contraction with the heart.

20. The electrode recited in claim 14, and further comprising:

mechanical connector means for connecting the electrode to body tissue in the region of the heart.

21. A method of implanting and utilizing an electrode system for cardioverting a malfunctioning heart, the method comprising the steps of:

opening the chest of a patient;

positioning a first electrode in the region of the base of the heart;

positioning a second permanent conformal electrode around the exterior surface of the apex of the heart;

drawing electrical leads from said first and second electrodes outside the body of the patient;

closing the chest of said patient with the proximal ends of said electrical leads lying outside the skin of the patient;

connecting said electrical leads to post-operative defibrillating electronics;

subsequently incising the patient after said post-operative period;

implanting a cardioverting pulse generator;

connecting the pulse generator to the proximal ends of said electrical leads and closing the incision with said electrical leads and said pulse generator beneath the skin of said patient.

22. The method recited in claim 21, and further comprising the step of:

subcutaneously implanting said electrical leads after said post-operative period.

23. The method recited in claim 21, and further comprising the step of:

removing the proximal ends of said electrical leads, leaving only the subcutaneous portions of said leads for subsequent association with said pulse generator.

24. The method recited in claim 21, wherein at leat one of said first and second electrodes includes an auxiliary electrode in the surface thereof but insulated therefrom and wherein said electrical leads include an electrical lead associating with said auxiliary electrode;

and further comprising the step of connecting monitoring and/or pacing instrumentation to the electrical lead of said auxiliary electrode during said post-operative period.

25. The method recited in claim 21, wherein at least a portion of said electrical leads are removed after said post-operative period without assocation with said pulse generator.

26. A method for implanting cardioverting electrodes, the method consisting of the steps of:

forming a first cardioverting electrode adapted to associate with the base of the heart;

forming a second substantially frustoconical cardioverting electrode conforming to the natural shape of the apex of the heart;

positioning said first electrode in association with the heart in the region of the base thereof;

inserting said second electrode through an incision in the pericardium; and

positioning said second electrode around the apex of the heart in the pericardial space.

27. The method recited in claim 26, wherein the approach to the pericardial space is through a sub-xiphoid incision with exposure of and incision through the medial lateral surface of the pericardium.

28. The method recited in claim 27, wherein the first electrode conforms to the apex of the heart and the second electrode conforms to and is positioned on the antero-lateral surface of the artria immediately above the atrio-ventricular notch.

29. The method recited in claim 28, wherein at least the first electrode includes a removable wire stylet for aiding in positioning the electrode.

30. A method for implanting permanent cardioverting electrodes in a patient whose heart may require cardioversion, the method comprising the steps of:

implanting a first permanent cardiac electrode in the vicinity of the base of the heart;

incising the patient to expose the heart;

implanting a second permanent conformal electrode about and in contact with the periphery of the apex of the heart;

implanting a pulse generator capable of delivering cardioverting pulses to the heart through the first and second electrodes;

connecting said first and second electrodes to said pulse generator; and

closing the incision made in the patient.

31. The method recited in claim 30, wherein said second permanent conformal electrode is implanted in the pericardial space.