Myocardial lead and lead system

• US 7,369,901 B1
• Filed: 02/10/2005
• Issued: 05/06/2008
• Est. Priority Date: 02/11/2004
• Status: Active Grant

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Schimke, Kerwyn, Patel, Jnyan, Chitre, Yougandh, Morgan, Kevin L., Salys, Scott, Fleck, Christopher, Williams, Sheldon, Helland, John R., McGarvey, Andrew W.
• Primary Examiner(s): Layno; Carl
• Assistant Examiner(s): Patel; Natasha
• Application Number:
  US11/056,666
• Time in Patent Office: 1,181 Days
• Field of Search: 607/116, 607/119, 607122- 3, 607126- 7, 607129- 31, 600373- 75, 600/37
• US Class Current: 607/127
• CPC Class Codes: A61N 1/059 Anchoring means

Abstract

An implantable myocardial stimulation lead comprises a lead body having a distal end and a proximal end, and an electrical connector carried by the proximal end of the lead body. An electrode header carried by the distal end of the lead body has an axis and includes a helical fixation element extending along the axis, the electrode header having a surface configured to receive a driver for rotating the electrode header to screw the helical fixation element into the tissue of the heart. The lead body carries along its length a strain relief member resisting excessive bending of the lead body.

Claims

1. An implantable epicardial stimulation lead comprising:

a lead body having a distal end and a proximal end;

an electrical connector carried by the proximal end of the lead body; and

an electrode header carried by the distal end of the lead body, the electrode header having a header body with a substantially planar distal tip surface, the electrode header having an axis and including a helical fixation element extending along said axis and extending distally from the planar distal tip surface, the electrode header having a ring electrode disposed at the planar distal tip surface, the electrode header having an outer surface configured to receive a driver for rotating the electrode header to screw the helical fixation element into heart tissue, the lead body carrying along its length a strain relief member resisting excessive bending of the lead body;

wherein a plurality of pins project radially outwardly from the outer surface of the electrode header, the plurality of pins engaging with the driver to rotate the electrode header to screw the helical fixation element into the heart tissue; and

wherein said strain relief member comprises a longitudinally disposed strain relief coil extending proximally of the distal end of the lead body, and wherein the strain relief coil is disposed within the lead body and permanently fixated to the lead body.

2. The lead of claim 1, wherein:

the strain relief coil extends between the distal and proximal ends of the lead body.

3. The lead of claim 1, wherein:

the strain relief coil is made of metal but is not connected to conduct electrical current.

4. The lead of claim 1, wherein:

the lead body further comprises an outer, tubular, insulating housing overlying the strain relief coil and extending from the distal end of the lead body to the proximal end of the lead body, and the outer, tubular, insulating housing is not part of an introducer.

5. The lead of claim 4, wherein:

at the junction of the outer, tubular, insulating housing and the electrode header, the outer, tubular, insulating housing extends away from the electrode header in a direction that falls between the axis of the electrode header and a radial direction perpendicular to the axis of the electrode header such that the outer, tubular, insulating housing conforms to an outer surface of the heart after implantation.

6. The lead of claim 1, wherein:

the driver has longitudinally extending slots to receive the plurality of pins, and the driver is a portion of an introducer.

7. The lead of claim 1, wherein:

at a junction of the lead body and the electrode header, the lead body extends away from the electrode header in a direction that falls between the axis of the electrode header and a radial direction perpendicular to the axis of the electrode header such that the lead body conforms to an outer surface of the heart after implantation.

8. The lead of claim 1, wherein:

an outer diameter of the electrode header is at least three times greater than an outer diameter of the lead body.

9. An implantable epicardial stimulation lead system comprising:

an introducer comprising;

an introducer body having an inner sheath extending from a proximal portion to a distal portion of the introducer body;

a handle at the proximal end of the introducer body;

an electrode header driver at the distal portion of the introducer body, the electrode header driver having a matable surface; and

an implantable epicardial stimulation lead comprising;

a lead body having a distal end and a proximal end, the lead body configured to be received within the inner sheath of the introducer body;

an electrical connector carried by the proximal end of the lead body;

an electrode header carried by the distal end of the lead body and having an outer surface and a planar distal tip surface, the electrode header having an axis and including a helical fixation element extending along the axis and extending distally from the planar distal surface, the electrode header having a ring electrode disposed at the planar distal tip surface, the electrode header driver configured to receive the electrode header; and

a plurality of pins projecting radially outwardly from the outer surface of the electrode header, the plurality of pins engaging with the matable surface of the electrode header driver to rotate the electrode header to screw the helical fixation element into heart tissue;

wherein an outer diameter of the electrode header is at least three times greater than an outer diameter of the lead body;

a strain relief member carried along the length of the lead body, the strain relief member disposed within the lead body and permanently fixated to the lead body the strain relief member configured to resist excessive bending of the lead body.

10. The lead system of claim 9, wherein:

said strain relief member comprises a longitudinally disposed strain relief coil extending proximally of the distal end of the lead body.

11. The lead of claim 9, wherein:

the strain relief coil extends between the distal and proximal ends of the lead body.

12. The lead of claim 9, wherein:

the strain relief coil is made of metal but is not connected to conduct electrical current.

13. The lead of claim 9, wherein:

the lead body further comprises an outer, tubular, insulating housing overlying the strain relief coil and extending from the distal end of the lead body to the proximal end of the lead body, and the outer, tubular, insulating housing is not part of the introducer.

14. The lead of claim 13, wherein:

at the junction of the outer, tubular, insulating housing and the electrode header, the outer, tubular, insulating housing extends away from the electrode header in a direction that falls between the axis of the electrode header and a radial direction perpendicular to the axis of the electrode header such that the outer, tubular, insulating housing conforms to an outer surface of the heart after implantation.

15. The lead of claim 9, wherein:

the electrode header driver has longitudinally extending slots to receive the plurality of pins.

16. The lead of claim 9, wherein:

at the junction of the lead body and the electrode header, the lead body extends away from the electrode header in a direction that falls between the axis of the electrode header and a radial direction perpendicular to the axis of the electrode header such that the lead body conforms to an outer surface of the heart after implantation.