Epicardial and myocardial leads for implanting in the heart by thoracotomy or port access surgeries with detachable electrode tip

• US 7,212,871 B1
• Filed: 12/24/2003
• Issued: 05/01/2007
• Est. Priority Date: 12/24/2003
• Status: Expired due to Fees

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Morgan, Kevin L.
• Primary Examiner(s): Getzow; Scott M.
• Application Number:
  US10/745,839
• Time in Patent Office: 1,224 Days
• Field of Search: 607129-131
• US Class Current: 607/129
• CPC Class Codes: A61N 1/0587 Epicardial electrode systems; Endocardial electrodes piercing the pericardium
• CPC Class Codes: A61N 1/059 Anchoring means

Abstract

A medical electrical lead to conduct electrical stimulation and/or signals between an electrical stimulator and a heart site includes an elongated lead body extending to a proximal connector for attachment to the electrical stimulator. An electrode head at the distal end includes an electrode tip member for fixation to the heart and an electrode backing member fixed to the lead body is releasably attachable to the electrode tip member for transmission of electrical signals between the heart and the electrical stimulator. The electrode tip member may include a first non-conductive base with an outwardly projecting tip electrode and a first mounting member projecting oppositely away from the non-conductive base. The electrode backing member includes a second non-conductive base and a second mounting member thereon adapted for mounting engagement with the first mounting member for selectively releasably but firmly integrating the electrode tip member and the electrode backing member.

Claims

1. An implantable, epicardial lead adapted to conduct electrical stimulation from an electrical stimulator to an epicardial site of the heart and to conduct electrical signals of the heart from the epicardial site to the electrical stimulator, the implantable epicardial lead comprising:

an elongated lead body defining a lead body distal end and a lead body proximal end, and comprising a connector at the lead body proximal end for mechanical and electrical attachment to the electrical stimulator, and further comprising a conductor extending between the lead body distal end and lead body proximal end; and

an electrode head provided at the lead body distal end including an electrode tip member adapted to be fixated to the outside of the heart and an electrode backing member fixed to the distal end of the lead body and releasably attachable to the electrode tip member to establish electrical contact between the electrode tip member and the lead body, a planar surface at a distal end of the electrode tip member to establish contact with the outside of the heart;

a tip electrode disposed at the planar surface of the electrode tip member, the elongated lead body being coupled to the electrode head such that the lead body distal end is moveable from a first position wherein a longitudinal axis of the lead body distal end is substantially perpendicular to the planar surface to a second position wherein the longitudinal axis of the lead body distal end is substantially parallel to the planar surface when the tip electrode is in electrical contact with the outside of the heart;

wherein the electrode tip member comprises;

a first non-conductive and disc-shaped base;

the tip electrode mounted on and projecting away from the first base in one direction; and

the first base having a first mounting member directed away from the tip electrode; and

wherein the electrode backing member comprises;

a second non-conductive and disc-shaped base; and

a second mounting member cooperatively received on the second base and adapted for mounting engagement with the first mounting member for releasably but firmly integrating the electrode tip member and the electrode backing member as a unit.

2. The implantable lead as set forth in claim 1:

wherein the first mounting member includes a centrally located tapped bore in the first base;

wherein the second base has a central smooth bore nearest the electrode tip member, an enlarged counterbore in communication with the central bore and extending farther away from the electrode tip member, and an annular shelf intermediate the central bore and the enlarged counterbore; and

wherein the second mounting member includes a screw member attached to the lead body and including a head, a threaded shank, and a shoulder intermediate the head and the threaded shank; and

wherein the threaded shank is slidably received through the central bore with the shoulder of the screw member engageably received on the annular shelf, the threaded shank being threadedly engaged with the tapped bore of the first base and rotated about its axis until firm integration of the electrode tip member and of the electrode backing member has occurred.

3. The implantable lead as set forth in claim 2:

wherein the first base has the planar surface facing the second base;

wherein the second base has an additional planar surface facing the planar surface, the planar surface and the additional planar surface being contiguously engaged when the electrode tip member and the electrode backing member are firmly integrated as a unit.

4. The implantable lead as set forth in claim 3 including:

a ring electrode mounted on and projecting away from the first base in one direction, the ring electrode disposed at the planar surface of the electrode tip member and being spaced from the tip electrode to form a bipolar electrode configuration;

a ring contact mounted on the planar surface;

a connection branch received in a bore through the first base electrically connecting the ring electrode and the ring contact;

wherein the lead body includes a first lead attached to the screw member for connection with the tip electrode; and

wherein the lead body includes a second lead attached through a bore in the second base to a second contact on the additional planar surface for connection with the ring contact when the electrode tip member and the electrode backing member are firmly integrated as a unit.

5. The implantable lead as set forth in claim 1, wherein the tip electrode is a passive fixation electrode.

6. The implantable lead as set forth in claim 1, wherein the tip electrode is an active fixation electrode.

7. The implantable lead as set forth in claim 1 including a non-conductive cap member proximally overlying the electrode backing member.

8. The implantable lead as set forth in claim 1:

wherein the first base has the planar surface;

wherein the first mounting member includes a post having a contoured peripheral outer surface upstanding from the planar surface and extending to an outwardly projecting annular rim;

wherein the second non-conductive base has an additional planar surface and a contoured central bore extending away from the additional planar surface and generally configured congruently to the upstanding post, having an intermediate annular ridge and terminating beyond the annular ridge at an annular valley region distant from the additional planar surface;

such that the upstanding post may be slidably but fittingly received through the central bore until the annular rim engages the annular ridge, momentarily enlarging the diameter of the annular ridge, then be contiguously received by the annular valley region and, simultaneously, the planar surface and the additional planar surface become contiguously engaged whereupon firm integration of the electrode tip member and of the electrode backing member occurs.

9. The implantable lead as set forth in claim 1:

wherein the first base has the planar surface;

wherein the first mounting member includes a post having an extreme end and an outer peripheral surface with a first annular groove positioned intermediate the extreme end and the planar surface; and

wherein an annular coil spring is fittingly received in the second annular groove;

wherein the second base has an additional planar surface and a central bore extending away from the additional planar surface and a second annular groove spaced from the additional planar surface; and

wherein an annular coil spring is fittingly received in the second annular groove;

such that the upstanding post may be slidably received through the central bore until the extreme end engages the coil spring and, with continued movement of the post relative to the coil spring, the first annular groove engageably receives the annular coil spring and, simultaneously, the planar surface and the additional planar surface become contiguously engaged whereupon firm integration of the electrode tip member and of the electrode backing member occurs.

10. An implantable, epicardial lead adapted to conduct electrical stimulation from an electrical stimulator to an epicardial site of the heart and to conduct electrical signals of the heart from the epicardial site to the electrical stimulator, the implantable epicardial lead comprising:

an elongated lead body defining a lead body distal end and a lead body proximal end, and comprising a connector at the lead body proximal end for mechanical and electrical attachment to the electrical stimulator, and further comprising a conductor extending between the lead body distal end and lead body proximal end; and

an electrode head provided at the lead body distal end including an electrode tip member adapted to be fixated to the outside of the heart and an electrode backing member fixed to the distal end of the lead body and releasably attachable to the electrode tip member to establish electrical contact between the electrode tip member and the lead body, a planar surface at a distal end of the electrode tip member to establish contact with the outside of the heart;

a tip electrode disposed at the planar surface of the electrode tip member, the elongated lead body being coupled to the electrode head such that the lead body distal end is moveable from a first position wherein a longitudinal axis of the lead body distal end is substantially perpendicular to the planar surface to a second position wherein the longitudinal axis of the lead body distal end is substantially parallel to the planar surface when the tip electrode is in electrical contact with the outside of the heart;

wherein the electrode tip member comprises;

a first non-conductive base;

the tip electrode mounted on and projecting away from the first non-conductive base in one direction; and

the first base having a first mounting member directed away from the tip electrode, a longitudinal axis of the first mounting member being parallel to a longitudinal axis of the tip electrode; and

wherein the electrode backing member comprises;

a second non-conductive base; and

a second mounting member cooperatively received on the second non-conductive base and adapted for mounting engagement with the first mounting member for releasably but firmly integrating the electrode tip member and the electrode backing member as a unit, a longitudinal axis of the second mounting member being parallel to the longitudinal axis of the first mounting member and the longitudinal axis of the tip electrode.

11. The implantable lead as set forth in claim 10:

wherein the first mounting member includes a centrally located tapped bore in the first non-conductive base;

wherein the second non-conductive base has a central smooth bore nearest the electrode tip member, an enlarged counterbore in communication with the central bore and extending farther away from the electrode tip member, and an annular shelf intermediate the central bore and the enlarged counterbore; and

wherein the second mounting member includes a screw member attached to the lead body and including a head, a threaded shank, and a shoulder intermediate the head and the threaded shank; and

wherein the threaded shank is slidably received through the central bore with the shoulder of the screw member engageably received on the annular shelf, the threaded shank being threadedly engaged with the tapped bore of the first non-conductive base and rotated about its axis until firm integration of the electrode tip member and of the electrode backing member has occurred.

12. The implantable lead as set forth in claim 11:

wherein the first non-conductive base has the planar surface facing the second non-conductive base;

wherein the second non-conductive base has an additional planar surface facing the planar surface, the planar surface and the additional planar surface being contiguously engaged when the electrode tip member and the electrode backing member are firmly integrated as a unit.

13. The implantable lead as set forth in claim 12 including:

a ring electrode mounted on and projecting away from the first non-conductive base in one direction, the ring electrode disposed at the planar surface of the electrode tip member and being spaced from the tip electrode to form a bipolar electrode configuration;

a ring contact mounted on the planar surface;

a connection branch received in a bore through the first base electrically connecting the ring electrode and the ring contact;

wherein the lead body includes a first lead attached to the screw member for connection with the tip electrode; and

wherein the lead body includes a second lead attached through a bore in the second non-conductive base to a second contact on the additional planar surface for connection with the ring contact when the electrode tip member and the electrode backing member are firmly integrated as a unit.

14. The implantable lead as set forth in claim 10, wherein the tip electrode is a passive fixation electrode.

15. The implantable lead as set forth in claim 10, wherein the tip electrode is an active fixation electrode.

16. The implantable lead as set forth in claim 10:

wherein the first base has the planar surface;

wherein the first mounting member includes a post having a contoured peripheral outer surface upstanding from the planar surface and extending to an outwardly projecting annular rim;

wherein the second non-conductive base has an additional planar surface and a contoured central bore extending away from the additional planar surface and generally configured congruently to the upstanding post, having an intermediate annular ridge and terminating beyond the annular ridge at an annular valley region distant from the additional planar surface;

such that the upstanding post may be slidably but fittingly received through the central bore until the annular rim engages the annular ridge, momentarily enlarging the diameter of the annular ridge, then be contiguously received by the annular valley region and, simultaneously, the planar surface and the additional planar surface become contiguously engaged whereupon firm integration of the electrode tip member and of the electrode backing member occurs.