TUNNELING TOOL FOR IMPLANTABLE LEADS

• US 20120016377A1
• Filed: 03/11/2011
• Published: 01/19/2012
• Est. Priority Date: 07/15/2010
• Status: Active Grant

• Current Assignee: Cirtec Medical Corp.
• Original Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Inventors: Geroy, Jesse
• Granted Patent: US 9,381,030 B2
• Time in Patent Office: Days
• US Class Current: 606/129
• CPC Class Codes: A61B 17/320016 Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes A61B10/0233, A61B17/29, A61B17/3207 take precedence
• CPC Class Codes: A61B 2017/00946 malleable
• CPC Class Codes: A61B 2017/320056 Tunnelers
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy

Abstract

A tunneling tool for creating a pathway for implanting a therapy delivery element in a living body. The tunneling tool includes a malleable elongated shaft having a distal end. A sheath having a lumen is slidably positioned over a portion of the shaft. A primary handle secured to proximal end of the shaft permits a user to advance and manipulate the shaft and the sheath in the living body. A secondary handle with an opening is slidably positioned on the shaft between the primary handle and the sheath. The opening has a diameter less than an outside diameter of a proximal end of the sheath. A locking mechanism releasably engages the secondary handle to the primary handle. The sheath is retained in a desired location within the living body by securing the secondary handle relative to the living body as the primary handle is used to remove the shaft from the sheath.

Claims

1. A tunneling tool for creating a pathway for implanting a therapy delivery element in a living body, the tunneling tool comprising:

a malleable elongated shaft having a distal end;

a sheath having a lumen slidably positioned over a portion of the shaft;

a primary handle secured to proximal end of the shaft that permits a user to advance and manipulate the shaft and the sheath in the living body; and

a secondary handle with an opening slidably positioned on the shaft between the primary handle and the sheath, the opening having a diameter less than an outside diameter of a proximal end of the sheath so that the secondary handle abuts, but is not attached to, the sheath.

2. The tunneling tool of claim 1 comprising a locking mechanism releasably engaging the secondary handle to the primary handle, wherein the sheath is retained in a desired location within the living body by retaining the secondary handle relative to the living body, as the primary handle is used to remove the shaft from the sheath.

3. The tunneling tool of claim 1 wherein locking mechanism comprises:

a protrusion formed at a distal end of the primary handle, the protrusion including at least one recess in the protrusion; and

a recess in a proximal end of the secondary handle sized to fit over the protrusion, the recess including at least one tab sized to releasably engage with a recess in the protrusion in a locked position.

4. The tunneling tool of claim 3 wherein the tabs engage with the recess on the protrusion with a twisting motion.

5. The tunneling tool of claim 1 wherein the shaft comprises a non-linear configuration.

6. A neurostimulation system comprising:

an implantable pulse generator;

a therapy delivery element comprising a proximal end adapted to electrically couple with the implantable pulse generator and a distal end with a plurality of electrodes electrically coupled to the implantable pulse generator;

an anchor for securing the therapy delivery element in a desired location within a living body;

a tunneling tool for creating a pathway for implanting the therapy delivery element in a living body, the tunneling tool comprising;

a malleable elongated shaft having a distal end;

a sheath having a lumen slidably positioned over a portion of the shaft;

a primary handle secured to proximal end of the shaft that permits a user to advance and manipulate the shaft and the sheath in the living body;

a secondary handle with an opening slidably positioned on the shaft between the primary handle and the sheath, the opening having a diameter less than an outside diameter of a proximal end of the sheath, so that the secondary handle abuts, but is not attached to, the sheath; and

a locking mechanism releasably engaging the secondary handle to the primary handle, wherein the sheath is retained in a desired location within the living body by retaining the secondary handle relative to the living body, as the primary handle is used to remove the shaft from the sheath.

7. A method of creating a pathway for implanting a therapy delivery element in a living body, the method comprising the steps of:

inserting a distal end of a tunneling tool between skin and muscle tissue in the living body to create the pathway;

disengaging a primary handle from a secondary handle of the tunneling tool, the secondary handle engaging a proximal end of a flexible sheath positioned on a shaft of the tunneling tool;

holding the secondary handle relative to the living body to secure the flexible sheath located in the pathway;

grasping the primary handle to remove the shaft of tunneling tool from the flexible sheath;

separating the secondary handle from the flexible sheath;

passing the therapy delivery element through the flexible sheath; and

removing the flexible sheath from the pathway.

8. The method of claim 7 comprising the step of disengaging a locking mechanism releasably engaging the secondary handle to the primary handle.

9. The method of claim 7 comprising the step of shaping the shaft before inserting into the living body.

10. The method of claim 7 wherein proximal end of the sheath is releasably attached to the secondary handle.

11. The method of claim 7 wherein proximal end of the sheath is located in a recess in the secondary handle.

12. The method of claim 7 comprising the step of sliding an opening in the secondary handle along the shaft as the shaft is removed from the sheath.

13. A method of implanting a neurostimulation system within a living body, the method comprising the steps of:

positioning electrodes at a distal end of a therapy delivery element through a first incision site to a target location within the living body;

accessing a proximal end of the therapy delivery elements at the first incision site;

attaching the therapy delivery element to the living body;

forming a subcutaneous pocket for implanting an implantable pulse generator within the living body through a second incision site;

inserting a distal end of a tunneling tool between skin and muscle tissue in the living body to create the pathway between the first and second incisions;

disengaging a primary handle from a secondary handle of the tunneling tool, the secondary handle engaged with a proximal end of a flexible sheath positioned on a shaft of the tunneling tool;

holding the secondary handle relative to the living body to secure the flexible sheath along the pathway;

grasping the primary handle to remove the shaft of the tunneling tool from the flexible sheath;

separating the secondary handle from the flexible sheath;

passing the therapy delivery element through the flexible sheath;

removing the flexible sheath from the pathway; and

electrically coupling the proximal end of the therapy delivery element to the implantable pulse generator.