Tools, systems, and methods for inserting an electrode array portion of a lead into a bodily orifice

• US 8,753,353 B2
• Filed: 06/25/2010
• Issued: 06/17/2014
• Est. Priority Date: 06/25/2010
• Status: Active Grant

• Current Assignee: Advanced Bionics AG (Sonova Holding AG)
• Original Assignee: Advanced Bionics AG (Sonova Holding AG)
• Inventors: Thenuwara, Chuladatta, Gallegos, Rosa, Beerling, Timothy
• Primary Examiner(s): Dowe, Katherine
• Assistant Examiner(s): COLELLO, ERIN L
• Application Number:
  US12/824,120
• Publication Number:
  US 20110319909A1
• Time in Patent Office: 1,453 Days
• Field of Search: 606/129, 607/136, 607/137, 607/56, 607/116, 600/379
• US Class Current: 606/129
• 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: A61B 2017/00787 Surgery of the ear
• CPC Class Codes: A61N 1/0541 Cochlear electrodes

Abstract

Exemplary insertion tools, systems, and methods for inserting an electrode array portion of a lead into a bodily orifice are described herein. An exemplary insertion tool includes a handle assembly, a slider assembly, a retractor assembly disposed at least partially within the handle assembly, and a rocker lever. The retractor assembly may include a stiffening member configured to be inserted into the electrode array portion and a spring-loaded retractor member coupled at a proximal end of the stiffening member. The spring-loaded retractor member may be configured to move from a distal position to a proximal position to at least partially retract the stiffening member from the electrode array portion. The rocker lever may be configured to selectively retain the spring-loaded retractor member in the distal position. Corresponding tools, systems, and methods are also described.

Claims

1. An insertion tool that facilitates insertion of an electrode array portion of a lead into a bodily orifice, the insertion tool comprising:

a handle assembly that facilitates handling of the insertion tool;

a slider assembly disposed at least partially within the handle assembly and that comprises

a slider member configured to be actuated by a user to operate the insertion tool, and

a tubular member coupled to a distal end of the slider member and configured to at least partially contain a stiffening member configured to be inserted into the electrode array portion, wherein the tubular member advances in a distal direction relative to the handle assembly in response to an advancement by the user of the slider member in the distal direction relative to the handle assembly;

a reactor assembly disposed at least partially within the handle assembly and comprising the stiffening member and a spring-loaded reactor member couple at a distal end to the stiffening member, wherein, while the stiffening member is inserted into the electrode array portion, the spring-loaded reactor member moves from a distal position to a proximal position relative to the handle assembly to at least partially retract the stiffening member from the electrode array portion; and

a rocker lever that

pivots about an axle,

selectively retains the spring-loaded retractor member in the distal position, and

releases the spring-loaded retractor member to move from the distal position to the proximal position by pivoting about the axle in response to the advancement by the user of the slider member in the distal direction relative to the handle assembly.

2. The insertion tool of claim 1, wherein the slider member is slidable relative to the handle assembly between a first position and a second position in response to actuation of the slider member by the user.

3. The insertion tool of claim 2, wherein the slider assembly further comprises a spring member configured to return the slider member from the second position to the first position upon release of the slider member by the user.

4. The insertion tool of claim 2, wherein the slider member is configured to engage and pivot the rocker lever about the axle to release the spring-loaded retractor member to move from the distal position to the proximal position as the slider member moves from the first position to the second position.

5. The insertion tool of claim 2, wherein the slider member is configured to prevent inadvertent pivoting of the rocker lever about the axle when the slider member is in the first position and to allow pivoting of the rocker lever by the user about the axle when the slider member is in the second position.

6. The insertion tool of claim 5, wherein the slider member is configured to at least partially cover a distal portion of the rocker lever when the slider member is in the first position and to at least partially expose the distal portion of the rocker lever when the slider member is in the second position.

7. The insertion tool of claim 1, wherein the handle assembly comprises a handle portion configured to at least partially contain the retractor assembly and the slider assembly, a guide tube coupled to a distal end of the handle portion, and a holder member coupled to a distal end of the guide tube and configured to removably couple to the lead.

8. The insertion tool of claim 7, wherein the holder member comprises a slot in a distal end of the holder member, the slot configured to hold a portion of the lead.

9. The insertion tool of claim 7, wherein the holder member is configured to be rotatable relative to the guide tube to facilitate selective insertion of the electrode array portion in a right cochlea or a left cochlea.

10. The insertion tool of claim 1, further comprising a plunger assembly configured to reset the spring-loaded retractor member from the proximal position to the distal position, wherein the plunger assembly comprises:

a plunger housing coupled to a proximal end of the handle portion and defining a lumen extending through the plunger housing in communication with the lumen of the handle portion;

a plunger member disposed at least partially within the lumen of the plunger housing and slidable relative to the plunger housing and handle portion; and

a button member coupled to the plunger member and extending from a proximal end of the plunger housing, wherein the button member is configured to be actuated by the user to move the plunger member in a distal direction to engage the spring-loaded retractor member and return the spring-loaded retractor member from the proximal position to the distal position.

11. The insertion tool of claim 1, further comprising a radial spring configured to engage the rocker lever and exert a constant force on the rocker lever, the constant force configured to move the rocker lever into engagement with the spring-loaded retractor member to retain the spring-loaded retractor member in the distal position.

12. The insertion tool of claim 1, wherein the stiffening member is configured to insert into a lumen that extends along a length of the electrode array portion.

13. A system comprising:

a lead comprising an electrode array portion and configured to be coupled to an implantable cochlear stimulator; and

an insertion tool that facilitates insertion of the electrode array portion into a bodily orifice, the insertion tool comprising

a handle assembly that facilitates handling of the insertion took,

a slider assembly disposed at least partially within the handle assembly and that comprises

a slider member configured to be actuated by a user to operate the insertion tool, and

a tubular member coupled to a distal end of the slider member and configured to at least partially contain a stiffening member configured to be inserted into the electrode array portion, wherein the tubular member advances in a distal direction relative to the handle assembly in response to an advancement by the user of the slider member in the distal direction relative to the handle assembly,

a retractor assembly disposed at least partially within the handle assembly and comprising the stiffening member and a spring-loaded retractor member coupled at a distal end to the stiffening member, wherein, while the stiffening member is inserted into the electrode array portion, the spring-loaded retractor member moves from a distal position to a proximal position relative to the handle assembly to at least partially retract the stiffening member from the electrode array portion, and

a rocker lever that

pivots about an axle,

selectively retains the spring-loaded retractor member in the distal position, and

releases the spring-loaded retractor member to move from the distal position to the proximal position by pivoting about the axle in response to the advancement by the user of the slider member in the distal direction relative to the handle assembly.

14. The system of claim 13, wherein the slider member is slidable relative to the handle assembly between a first position and a second position in response to actuation by the user.

15. The system of claim 14, wherein the slider member is configured to engage and pivot the rocker lever about the axle to release the spring-loaded retractor member to move from the distal position to the proximal position as the slider member moves from the first position to the second position.

16. The system of claim 14, wherein the slider member is configured to prevent inadvertent pivoting of the rocker lever about the axle when the slider member is in the first position and to allow pivoting of the rocker lever by the user about the axle when the slider member is in the second position.

17. A method of inserting an electrode array portion of a lead into a bodily orifice, the method comprising:

coupling the lead to an insertion tool, the insertion tool comprising

a handle assembly that facilitates handling of the insertion tool,

a slider assembly disposed at least partially within the handle assembly and configured to be actuated by a user to operate the insertion tool, the slider assembly comprising a slider member slidable relative to the handle assembly and a tubular member coupled to a distal end of the slider member and configured to at least partially contain a stiffening member configured to be inserted into the electrode array portion, wherein the tubular member advances in a distal direction relative to the handle assembly in response to an advancement by the user of the slider member in the distal direction relative to the handle assembly,

a retractor assembly disposed at least partially within the handle assembly and comprising the stiffening member and a spring-loaded retractor member coupled at a distal end to the stiffening member, wherein, while the stiffening member is inserted into the electrode array portion, the spring-loaded retractor member moves from a distal position to a proximal position relative to the handle assembly to at least partially retract the stiffening member from the electrode array portion, and

a rocker lever configured to

pivots about an axle,

selectively retains the spring-loaded retractor member in the distal position, and

releases the spring-loaded retractor member to move from the distal position to the proximal position by pivoting about the axle in response to the advancement by the user of the slider member in the distal direction relative to the handle assembly;

guiding the electrode array portion into a bodily orifice with the insertion tool; and

moving the slider member from a first position to a second position relative to the handle assembly to facilitate pivoting of the rocker lever about the axle to release the spring-loaded retractor member to move from the distal position to the proximal position to at least partially retract the stiffening member from the electrode array portion.

18. The method of claim 17, wherein as the slider member moves from the first position to the second position, the slider member engages and pivots the rocker lever about the axle to release the spring-loaded retractor member.

19. The method of claim 17, wherein as the slider member moves from the first position to the second position, the slider member at least partially exposes the rocker lever to allow pivoting of the rocker lever about the axle by the user.