Lead insertion tools

• US 8,452,421 B2
• Filed: 07/08/2010
• Issued: 05/28/2013
• Est. Priority Date: 07/08/2009
• Status: Active Grant

• Current Assignee: Advanced Bionics AG (Sonova Holding AG)
• Original Assignee: Advanced Bionics LLC (Sonova Holding AG)
• Inventors: Thenuwara, Chuladatta, Lenarz, Thomas H. R., Downing, Mark
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Wu, Eugene
• Application Number:
  US12/832,745
• Publication Number:
  US 20110009877A1
• Time in Patent Office: 1,055 Days
• Field of Search: 607 55- 57, 607/137, 607/115, 607/116, 600/379
• US Class Current: 607/137
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61N 1/0541 Cochlear electrodes

Abstract

An exemplary insertion tool configured to facilitate insertion of a lead into a bodily orifice includes a handle assembly configured to facilitate handling of the insertion tool, an insertion assembly coupled to the handle assembly and comprising a rigid holding tube configured to removably couple to a portion of the lead, and a release assembly disposed at least partially within the handle assembly and comprising a release button. The release assembly is configured to release the lead from the holding tube in response to user actuation of the release button. Corresponding insertion tools, systems, and methods are also described.

Claims

1. An insertion tool configured to facilitate insertion of a lead having a plurality of electrodes disposed thereon at least partially into a bodily orifice, the insertion tool comprising:

a handle assembly comprising

a handle portion configured to facilitate handling of the insertion tool by a user and comprising a lumen extending at least partially therethrough, and

a rigid handle tube coupled to a distal end of the handle portion and having a lumen extending therethrough, the lumen of the handle tube being in communication with the lumen of the handle portion;

a release assembly disposed at least partially within the handle assembly and comprising a release button and a plunger disposed within a lumen of the handle portion and coupled to the release button; and

an insertion assembly coupled to the handle assembly and comprising a rigid holding tube configured to removably couple to the lead and a flexible tube coupled to the proximal portion of the holding tube and to a distal portion of the plunger, the flexible tube configured to pass through the lumen of the handle tube;

wherein the release assembly is configured to release the lead from the holding tube of the insertion assembly in response to a user actuation of the release button, the user actuation causing the plunger to retract within the lumen of the handle portion towards a proximal end of the handle portion, wherein the retraction of the plunger causes the flexible tube and the holding tube to retract away from the lead.

2. The insertion tool of claim 1, wherein:

the handle tube comprises a curved portion such that a distal portion of the handle tube extends away from the handle portion at a predefined angle; and

the handle tube is coupled to at least one component of the insertion assembly.

3. The insertion tool of claim 2, wherein the insertion assembly further comprises a rigid guide tube coupled to a proximal portion of the holding tube and to a distal portion of the handle tube, the guide tube configured to rotate to facilitate optimal orientation of the insertion assembly.

4. The insertion tool of claim 3, wherein:

the guide tube comprises a slot partially extending along a length thereof; and

the holding tube comprises an outwardly extending key member configured to fit within the slot of the guide tube;

wherein the key member and slot are configured to facilitate longitudinal movement of the holding tube within the guide tube.

5. The insertion tool of claim 4, wherein the key member and slot are further configured to facilitate concurrent rotation of the guide tube and the holding tube.

6. The insertion tool of claim 3, wherein the guide tube comprises a sleeve configured to be coupled to the handle tube with an interference fit.

7. The insertion tool of claim 1, wherein the release assembly further comprises:

a backstop member configured to be at least partially disposed within a lumen of the holding tube; and

a wire affixed to the backstop member and configured to pass through a lumen of the flexible tube and the lumen of the handle portion, the wire being further affixed to a proximal portion of the handle portion;

wherein the wire is configured to maintain the backstop member in a stationary position; and

wherein the backstop member is configured to facilitate the release of the lead from the holding tube.

8. The insertion tool of claim 7, wherein the wire comprises Nitinol.

9. The insertion tool of claim 1, wherein the flexible tube comprises polytetrafluoroethylene.

10. The insertion tool of claim 1, wherein the plunger is coupled to a spring and configured to assume a non-retracted state upon user release of the release button.

11. The insertion tool of claim 1, wherein the release assembly further comprises a leaf spring configured to release the plunger in response to the user actuation of the release button.

12. The insertion tool of claim 1, wherein the user actuation of the release button comprises an advancing of the release button in a direction substantially parallel to a longitudinal axis of the handle portion.

13. The insertion tool of claim 1, wherein the holding tube comprises a receiving slot configured to facilitate the removable coupling of the holding tube to the lead.

14. A system comprising:

a lead comprising a stimulation portion having a plurality of electrodes disposed thereon, a lead body configured to facilitate handling of the lead, and a jog portion configured to connect the lead body to the stimulation portion; and

an insertion tool comprising

a handle assembly comprising

a handle portion configured to facilitate handling of the insertion tool by a user and comprising a lumen extending at least partially therethrough, and

a rigid handle tube coupled to a distal end of the handle portion and having a lumen extending therethrough, the lumen of the handle tube being in communication with the lumen of the handle portion;

a release assembly disposed at least partially within the handle assembly and comprising a release button and a plunger disposed within the lumen of the handle portion and coupled to the release button;

an insertion assembly coupled to the handle assembly and comprising

a rigid holding tube having a receiving slot disposed therein configured to facilitate passage therethrough of the jog portion of the lead in order to facilitate removable coupling of the jog portion to the holding tube, and

a flexible tube coupled to the proximal portion of the holding tube and to a distal portion of the plunger, the flexible tube configured to pass through the lumen of the handle tube; and

wherein the release assembly is configured to release the lead from the holding tube of the insertion assembly in response to a user actuation of the release button, the user actuation causing the plunger to retract within the lumen of the handle portion towards a proximal end of the handle portion, wherein the retraction of the plunger causes the flexible tube and the holding tube to retract away from the lead.

15. The system of claim 14, wherein:

the handle tube comprises a curved portion such that a distal portion of the handle tube extends away from the handle portion at a predefined angle; and

the handle tube is coupled to at least one component of the insertion assembly.

16. The system of claim 14, wherein the release assembly further comprises:

a backstop member configured to be at least partially disposed within a lumen of the holding tube; and

a wire affixed to the backstop member and configured to pass through a lumen of the flexible tube and the lumen of the handle portion, the wire being further affixed to a proximal portion of the handle portion;

wherein the wire is configured to maintain the backstop member in a stationary position; and

wherein the backstop member is configured to facilitate the release of the lead from the holding tube.

17. The system of claim 14, wherein the user actuation of the release button comprises an advancing of the release button in a direction substantially parallel to a longitudinal axis of the handle portion.

18. The system of claim 17, wherein the advancing of the release button is in a distal direction.

19. A method of inserting a lead into a bodily orifice, the method comprising:

coupling a portion of the lead to a holding tube that is a part of an insertion tool, the insertion tool comprising;

a handle assembly comprising

a handle portion configured to facilitate handling of the insertion tool by a user and comprising a lumen extending at least partially therethrough, and

a rigid handle tube coupled to a distal end of the handle portion and having a lumen extending therethrough, the lumen of the handle tube being in communication with the lumen of the handle portion;

a release assembly disposed at least partially within the handle assembly and comprising a release button and a plunger disposed within a lumen of the handle portion and coupled to the release button; and

an insertion assembly coupled to the handle assembly and comprising the holding tube configured to removably couple to the lead and a flexible tube coupled to the proximal portion of the holding tube and to a distal portion of the plunger, the flexible tube configured to pass through the lumen of the handle tube;

guiding the lead at least partially into the bodily orifice with the insertion tool; and

actuating the release button to release the lead from the holding tube, wherein the actuating causes the plunger to retract within the lumen of the handle portion towards a proximal end of the handle portion, and wherein the retraction of the plunger causes the flexible tube and the holding tube to retract away from the lead.

20. The method of claim 19, wherein the guiding of the lead comprises inserting the lead through a facial recess without allowing the insertion tool to enter the facial recess.