Subcutaneous lead implantation

1. A method of implanting a subcutaneous-only defibrillator system in a patient, the system comprising a pulse generator having a lead port and a lead having a proximal end to attach to the pulse generator lead port and a distal end with at least one electrode thereon, the method comprising:

making an axillary incision near the left axilla;

making a xiphoid incision near the xiphoid;

inserting a first introducer tool and first sheath, with the first sheath removably disposed on the first introducer tool, through one of the axilla or xiphoid incisions to create a first tunnel to the other of the xiphoid or axilla incisions;

removing the first introducer tool and leaving the first sheath in place between the axilla and xiphoid incisions;

inserting the proximal end of the lead into the first sheath and advancing the proximal end of the lead from the xiphoid incision to and through the axillary incision through the first sheath;

removing the first sheath while maintaining the lead in a position such that the proximal end of the lead extends out of the axillary incision and the distal end of the lead extends out of the xiphoid incision with a portion of the lead disposed in the first tunnel;

inserting a second introducer tool and second sheath, with the second sheath removably disposed on the second introducer tool, through the xiphoid incision in a generally cephalad direction to create a second tunnel alongside or parallel to the sternum;

removing the second introducer tool and leaving the second sheath in place in the second tunnel;

inserting the distal end of the lead into the second sheath and advancing the distal end of the lead to a desired position; and

removing the second sheath while maintaining a portion of the lead in the second tunnel.

2. The method of claim 1 wherein:

the first introducer tool has a proximal end with a handle and a tunneling shaft extending from the handle to a distal tip;

the first sheath has a proximal end with a hub and a distal end having a length such that, when the first sheath is removably disposed on the first introducer tool, the hub is adjacent the handle and the distal end of the first sheath is proximal of the distal tip of the first introducer tool;

the step of inserting the first introducer tool and the first sheath is performed by inserting the distal end of the first introducer tool into the axillary incision and advancing the distal end of the first introducer tool to and through the xiphoid incision until the distal end of the first sheath extends out of the xiphoid incision; and

the step of inserting the proximal end of the lead into the first sheath is performed by passing the proximal end of the lead through the distal end of the first sheath and advancing the lead therein until the proximal end of the lead extends out of the hub of the first sheath and the axillary incision.

3. The method of claim 1 wherein:

the first introducer tool has a proximal end with a handle and a tunneling shaft extending from the handle to a distal tip;

the first sheath has a proximal end with a hub and a distal end having a length such that, when the first sheath is removably disposed on the first introducer tool, the hub is adjacent the handle and the distal end of the first sheath is proximal of the distal tip of the first introducer tool;

the step of inserting the first introducer tool and the first sheath is performed by inserting the distal end of the first introducer tool into the xiphoid incision and advancing the distal end of the first introducer tool to and through the axillary incision until the distal end of the first sheath extends out of the axillary incision; and

the step of inserting the proximal end of the lead into the first sheath is performed by passing the proximal end of the lead through the hub of the first sheath and advancing the lead therein until the proximal end of the lead extends out of the distal end of the first sheath and the axillary incision.

4. The method of claim 1 further comprising using one or more sutures to secure the lead in place at the xiphoid incision.

5. The method of claim 1 wherein the lead comprises one or more anchoring structures thereon at an intermediate location between the at least one electrode and the proximal end, the anchoring structure configured to anchor the lead in position near the xiphoid incision.

6. The method of claim 5 further comprising applying one or more sutures at the anchoring structure to anchor the lead in position at the xiphoid incision.

7. The method of claim 5 wherein the anchoring structure includes one or more tines or hooks extending therefrom to secure to patient tissue for holding the lead in a desired position.

8. The method of claim 1 wherein the lead comprises one or more anchoring structures at the distal tip thereof, the anchoring structures comprising one or more of a tine or a hook.

9. The method of claim 1 wherein the step of removing the first sheath is performed after the step of inserting the distal end of the lead into the second sheath.

10. A method of implanting a subcutaneous-only defibrillator system in a patient, the system comprising a pulse generator having a lead port and a lead having a proximal end to attach to the pulse generator lead port and a distal end with at least one electrode thereon, the method comprising:

making an axillary incision near the left axilla;

making a xiphoid incision near the xiphoid;

inserting a first introducer tool and first sheath, with the first sheath removably disposed on the first introducer tool, through one of the axilla or xiphoid incisions to create a first tunnel to the other of the xiphoid or axilla incisions;

removing the first introducer tool and leaving the first sheath in place between the axilla and xiphoid incisions;

inserting the distal end of the lead into the first sheath and advancing the distal end of the lead from the axillary incision to and through the xiphoid incision through the first sheath;

removing the first sheath while maintaining the lead in a position such that the proximal end of the lead extends out of the axillary incision and the distal end of the lead extends out of the xiphoid incision with a portion of the lead disposed in the first tunnel;

inserting a second introducer tool and second sheath, with the second sheath removably disposed on the second introducer tool, through the xiphoid incision in a generally cephalad direction to create a second tunnel alongside or parallel to the sternum;

removing the second introducer tool and leaving the second sheath in place in the second tunnel;

inserting the distal end of the lead into the second sheath and advancing the distal end of the lead to a desired position; and

removing the second sheath while maintaining a portion of the lead in the second tunnel.

11. The method of claim 10 wherein:

the first introducer tool has a proximal end with a handle and a tunneling shaft extending from the handle to a distal tip;

the first sheath has a proximal end with a hub and a distal end having a length such that, when the first sheath is removably disposed on the first introducer tool, the hub is adjacent the handle and the distal end of the first sheath is proximal of the distal tip of the first introducer tool;

the step of inserting the first introducer tool and the first sheath is performed by inserting the distal end of the first introducer tool into the axillary incision and advancing the distal end of the first introducer tool to and through the xiphoid incision until the distal end of the first sheath extends out of the xiphoid incision; and

the step of inserting the distal end of the lead into the first sheath is performed by passing the distal end of the lead through the hub of the first sheath and advancing the lead therein until the distal end of the lead extends out of the distal end of the first sheath and the xiphoid incision.

12. The method of claim 10 wherein:

the first introducer tool has a proximal end with a handle and a tunneling shaft extending from the handle to a distal tip;

the first sheath has a proximal end with a hub and a distal end having a length such that, when the first sheath is removably disposed on the first introducer tool, the hub is adjacent the handle and the distal end of the first sheath is proximal of the distal tip of the first introducer tool;

the step of inserting the first introducer tool and the first sheath is performed by inserting the distal end of the first introducer tool into the xiphoid incision and advancing the distal end of the first introducer tool to and through the axillary incision until the distal end of the first sheath extends out of the axillary incision; and

the step of inserting the distal end of the lead into the first sheath is performed by passing the distal end of the lead into the distal end of the first sheath and advancing the lead therein until the distal end of the lead extends out of the hub of the first sheath and the axillary incision.

13. The method of claim 10 further comprising using one or more sutures to secure the lead in place at the xiphoid incision.

14. The method of claim 10 wherein the lead comprises one or more anchoring structures thereon at an intermediate location between the at least one electrode and the proximal end, the anchoring structure configured to anchor the lead in position near the xiphoid incision.

15. The method of claim 14 further comprising applying one or more sutures at the anchoring structure to anchor the lead in position at the xiphoid incision.

16. The method of claim 14 wherein the anchoring structure includes one or more tines or hooks extending therefrom to secure to patient tissue for holding the lead in a desired position.

17. The method of claim 10 wherein the lead comprises one or more anchoring structures at the distal tip thereof, the anchoring structures comprising one or more of a tine or a hook.

18. The method of claim 10 wherein the step of removing the first sheath is performed after the step of inserting the distal end of the lead into the second sheath.

19. An implantation tool kit for implantation of a medical device comprising:

a first introducer tool having a proximal end with a handle and a tunneling shaft extending from the handle to a distal tip, the tunneling shaft having a first length;

a first sheath having a proximal end with a hub and a distal end and having a second length such that, when the first sheath is removably disposed on the first introducer tool, the hub is adjacent the handle and the distal end of the first sheath is proximal of the distal tip of the first introducer tool;

a second introducer tool having a proximal end with a handle and a tunneling shaft extending from the handle to a distal tip, the tunneling shaft having a third length; and

a second sheath having a proximal end with a hub and a distal end and having a fourth length such that, when the second sheath is removably disposed on the second introducer tool, the hub is adjacent the handle and the distal end of the second sheath is proximal of the distal tip of the second introducer tool;

wherein the first length is greater than the second length.

20. The tool kit of claim 19 wherein:

the first length is adapted for use in establishing a first tunnel from a position near the xiphoid to the left axilla of a patient, and the handle of the first introducer tool includes a marking designating that the first introducer tool is for use in establishing the first tunnel; and

the second length is adapted for use in establishing a second tunnel from a position near the xiphoid cephalad within a patient for at least 10 cm, and the handle of the second introducer tool includes a marking designating that the second introducer tool is for use in establishing the second tunnel.