SUBCUTANEOUS IMPLANTABLE LEAD

• US 20100030291A1
• Filed: 07/31/2008
• Published: 02/04/2010
• Est. Priority Date: 07/31/2008
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Lazeroms, Markus J.C., Havel, William J., Smits, Karel F.A.A., Rutten, Jean J.G.
• Granted Patent: US 8,140,171 B2
• Time in Patent Office: Days
• US Class Current: 607/5
• CPC Class Codes: A61N 1/0504 Subcutaneous electrodes
• CPC Class Codes: A61N 1/39622 Pacing therapy

Abstract

A subcutaneous implantable device is provided that includes a defibrillation electrode disposed along a portion of a lead, and a lead tip connected to the lead. The lead tip includes a trailing end coupled to a distal end of the lead, and first and second non-parallel sides extending from the trailing end that converge to a leading end that is configured to wedge between tissue layers as the lead is advanced subcutaneously.

Claims

1. A subcutaneous implantable device comprising:

a defibrillation electrode disposed along a portion of a lead; and

a lead tip comprising;

a trailing end coupled to a distal end of the lead,

first and second non-parallel sides extending from the trailing end, the first and second non-parallel sides converging to a leading end that is configured to wedge between tissue layers as the lead is advanced subcutaneously.

2. The subcutaneous implantable device of claim 1, wherein the trailing end of the lead tip comprises at least one engagement site that is configured to receive a distal end of a subcutaneous implant tool.

3. The subcutaneous implantable device of claim 1, wherein at least a portion of the surface of the lead tip is electrically conductive and configured to reduce impedance shock delivered through the lead.

4. The subcutaneous implantable device of claim 1, wherein the lead and a trailing portion of the lead tip is covered with an electrically non-conductive material such that only a distal apex portion of the lead tip is electrically conductive.

5. The subcutaneous implantable device of claim 1, wherein the first and second non-parallel sides of the lead tip extend between opposing parallel major surfaces of the lead tip.

6. The subcutaneous implantable device of claim 1, wherein the lead tip comprises a substantially triangular periphery defined by the first and second non-parallel sides and the trailing end.

7. The subcutaneous implantable device of claim 1, wherein the leading end of the lead tip comprises an apex of the substantially triangular periphery, the apex having a surface area that is less than a surface area of the trailing end.

8. The subcutaneous implantable device of claim 1, further comprising:

at least one satellite electrode coupled to the trailing end of the lead tip, the at least one satellite electrode electrically coupled with the defibrillation electrode at the lead tip.

9. The subcutaneous implantable device of claim 1, further comprising:

a leading electrode disposed on the leading end of the lead tip, the leading electrode electrically isolated from the defibrillation electrode and configured to sense electrogram signals.

10. The subcutaneous implantable device of claim 1, further comprising:

an implantable cardiodefibrillator (ICD) coupled to a proximal end of the lead.

11. A subcutaneous implantable lead system comprising:

a lead comprising a defibrillation electrode;

a lead tip coupled to a distal end of the lead, the lead tip comprising opposed major surfaces each having a substantially triangular periphery defined by a trailing side and first and second non-parallel sides extending from the trailing side that converge to a leading apex of the lead tip, the trailing side coupled to a distal end of the defibrillation electrode and comprising a tool engagement site; and

a tunneling tool configured to removably couple with the tool engagement site and subcutaneously advance the lead tip and the lead.

12. The lead system of claim 11, wherein the tool engagement site comprises a recess formed in the trailing side of the lead tip, and a distal end of the tunneling tool is insertable into the recess for subcutaneously advancing the lead tip and removable from the recess for removal of the tunneling tool.

13. The lead system of claim 11, wherein the tunneling tool comprises a lead tensioning device that is configured to maintain the lead taut between the lead tip and a proximal end portion of the tunneling tool.

14. The lead system of claim 11, wherein the lead tensioning device comprises a lead clamp coupled to the proximal end portion of the tunneling tool.

15. An implantable medical device comprising:

an implantable cardiodefibrillator (ICD) comprising a first electrode;

a lead comprising a second electrode and a proximal end coupled to the ICD opposite a distal end; and

a lead tip comprising;

a trailing end coupled to the distal end of the lead,

first and second non-parallel sides extending from the trailing end of the lead tip, the first and second non-parallel sides converging to an apex of the lead tip.

16. The implantable medical device of claim 15, wherein the lead tip comprises a third electrode of the device, the third electrode disposed proximal of the apex, electrically isolated from the first and second electrodes, and configured to sense electrogram signals.

17. The implantable medical device of claim 15, further comprising:

at least one satellite electrode coupled to the trailing end of the lead tip and configured to increase electrode surface area of the device.

18. A method of implanting a lead in a patient, the lead attachable to an implantable cardiodefibrillator (ICD), the method comprising:

making a surgical incision in the patient'"'"'s skin;

inserting a lead tip attached to a distal end of the lead directly through the surgical incision; and

advancing the lead tip and pulling the lead through subcutaneous tissue between the patient'"'"'s skin and ribcage with a tunneling tool that is removably attached to the lead tip.

19. The method of claim 18, wherein inserting a lead tip attached to a distal end of the lead directly through the surgical incision comprises inserting an apex of a triangular-shaped lead tip directly through the surgical incision.

20. The method of claim 18, wherein advancing the lead tip and pulling the lead through subcutaneous tissue comprises tensioning the lead between the lead tip and the tunneling tool.

21. The method of claim 20, wherein tensioning the lead between the lead tip and the tunneling tool comprises securing a proximal end portion of the lead against a proximal end portion of the tunneling tool and forcing a distal end of the tunneling tool into the lead tip.

22. The method of claim 18, further comprising:

placing the distal end of the lead in a desired subcutaneous position with the tunneling tool; and

disengaging the tunneling tool from the lead tip.