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

• US 8,753,352 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, Beerling, Timothy, Downing, Mark, Hoffman, Paul, Orinski, William G.
• Primary Examiner(s): Dowe, Katherine
• Assistant Examiner(s): COLELLO, ERIN L
• Application Number:
  US12/824,119
• Publication Number:
  US 20110319908A1
• Time in Patent Office: 1,453 Days
• Field of Search: 606/129, 607/56, 607/116, 607/136, 607/137, 600/379
• US Class Current: 606/129
• CPC Class Codes: A61B 17/00 Surgical instruments, devices or methods, e.g. tourniquets A61B18/00 takes precedence; contraceptive devices, pessaries, or applicators therefor A61F6/00; eye surgery A61F9/007; ear surgery A61F11/00
• 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: A61F 11/04 Methods or devices for enabling ear patients to achieve auditory perception through physiological senses other than hearing sense, e.g. through the touch sense electronic stimulation of auditory nerves A61N1/36036
• CPC Class Codes: A61F 11/20 Ear surgery
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0541 Cochlear electrodes

Abstract

Exemplary insertion tools, systems, and methods for inserting a pre-curved electrode array portion of a lead into a bodily orifice are described herein. An exemplary insertion tool includes a handle assembly, a slider assembly, an insertion assembly coupled to the handle assembly, and a retractor assembly disposed at least partially within the handle assembly and configured to selectively couple to a straightening member inserted into the pre-curved electrode array portion and at least partially retract the straightening member from the pre-curved electrode array portion in response to actuation by a user of the slider assembly. The retractor assembly may comprise a spring-loaded retractor member configured to move from a distal position to a proximal position in response to actuation by the user of the slider assembly to at least partially retract the straightening member from the pre-curved electrode array portion. Corresponding insertion tools, systems, and methods are also described.

Claims

1. An insertion tool that facilitates insertion of a pre-curved 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 comprising

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

a pusher tube coupled to a distal end of the slider member and that 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;

an insertion assembly coupled to the handle assembly and comprising a holder member configured to removably couple to the lead; and

a retractor assembly disposed at least partially within the handle assembly and that selectively couples to a straightening member inserted into the pre-curved electrode array portion, the retractor assembly comprising a spring-loaded retractor member that moves from a distal position to a proximal position relative to the handle assembly in response to the advancement by the user of the slider member in the distal direction relative to the handle assembly to at least partially retract the straightening member from the pre-curved electrode array portion.

2. The insertion tool of claim 1, further comprising a rocker lever that 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 in response to the advancement by the user of the slider member in the distal direction relative to the handle assembly.

3. The insertion tool of claim 2, wherein the retractor assembly further comprises:

a retractor wire coupled to a distal end of the spring-loaded retractor member and extending at least partially through the slider assembly; and

a collet member coupled to a distal end of the retractor wire and expandable to receive a proximal portion of the straightening member.

4. The insertion tool of claim 3, wherein the collet member is generally tubular and comprises one or more slits extending from a distal end thereof and configured to allow the collet member to expand, the collet member further comprising an internal ledge configured to resist removal of the proximal portion of the straightening member after the proximal portion of the straightening member is received into to collet member.

5. The insertion tool of claim 4, wherein the slider member is slidable relative to the handle assembly between a first position, a second position, and a third position, and wherein when the slider member is in the first position a distal end of the pusher tube is positioned proximal of the collet member to allow the collet member to expand, wherein when the slider member is in the second position a distal portion of the pusher tube covers the collet member to prevent the collet member from expanding, and wherein when the slider member is in the third position the slider member engages a distal end of the rocker lever to release the spring-loaded retractor member.

6. The insertion tool of claim 5, further comprising a detent plate coupled to the handle assembly and defining a first detent configured to provide tactile feedback to the user when the slider member is in the first position and a second detent configured to provide tactile feedback to the user when the slider member is in the second position, and wherein the slider member is configured to engage the first detent when the slider member is in the first position, to engage the second detent when the slider member is in the second position, and to engage the distal end of the rocker lever when the slider member is in the third position.

7. The insertion tool of claim 6, wherein the insertion assembly further comprises an ejection member disposed at least partially within and slidable relative to the holder member, and wherein the holder member comprises a slot in a distal end of the holder member configured to hold a portion of the lead.

8. The insertion tool of claim 7, wherein as the slider member moves from the second position to the third position, the pusher tube engages and advances the ejection member in a distal direction relative to the holder member to push and advance the lead off of the holder member and the pre-curved electrode array portion at least partially off of the straightening member.

9. The insertion tool of claim 8, wherein the ejection member comprises a slot extending along a length thereof and wherein the holder member comprises a tab extending at least partially into the slot of the ejection member to limit relative movement between the holder member and the ejection member.

10. The insertion tool of claim 9, wherein the handle assembly comprises a handle portion configured to at least partially contain the retractor assembly and the slider assembly and a guide tube coupled to a distal end of the handle portion, wherein the handle portion comprises a lumen in communication with a lumen of the guide tube, and wherein the pusher tube of the slider assembly is disposed at least partially through and slidable relative to the guide tube.

11. The insertion tool of claim 10, wherein the guide tube is configured to selectively couple to the holder member.

12. The insertion tool of claim 11, wherein the holder member is configured to be rotatable relative to the guide tube to facilitate selective insertion of the pre-curved electrode array portion in a right cochlea or a left cochlea.

13. The insertion tool of claim 10, wherein the guide tube extends away from the handle portion at a predefined angle.

14. The insertion tool of claim 10, 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 therethrough 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.

15. The insertion tool of claim 14, further comprising a radial spring configured to engage the rocker lever and exert a rotational force on the rocker lever opposite a rotational force exerted on the rocker lever by actuation of the slider member.

16. The insertion tool of claim 1, further comprising an air dampening mechanism configured to dampen movement of the spring-loaded retractor member.

17. The insertion tool of claim 1, wherein the slider assembly comprises a single piece of molded plastic.

18. A system comprising:

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

a straightening member inserted into the pre-curved electrode array portion to retain the pre-curved electrode array portion in a straightened configuration; and

an insertion tool that facilitates insertion of the pre-curved electrode array portion into a cochlea of a patient 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 comprising

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

a pusher tube coupled to a distal end of the slider member and that 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;

an insertion assembly coupled to the handle assembly and comprising a holder member configured to removably couple to the lead; and

a retractor assembly disposed at least partially within the handle assembly and that selectively couples to the straightening member inserted into the pre-curved electrode array portion, the retractor assembly comprising a spring-loaded retractor member that moves from a distal position to a proximal position relative to the handle assembly in response to the advancement by the user of the slider member in the distal direction relative to the handle assembly to at least partially retract the straightening member from the pre-curved electrode array portion.

19. The system of claim 18, wherein the insertion tool further comprises a rocker lever that 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 in response to the advancement by the user of the slider member in the distal direction relative to the handle assembly.

20. The system of claim 19, wherein the retractor assembly further comprises:

a retractor wire coupled to a distal end of the spring-loaded retractor member; and

a collet member coupled to a distal end of the retractor wire and expandable to receive a proximal portion of the straightening member, wherein the collet member is generally tubular and comprises one or more slits extending from a distal end thereof and configured to allow the collet member to expand, the collet member further comprising an internal ledge configured to resist removal of the proximal portion of the straightening member after the proximal portion of the straightening member is received into to collet member.

21. The system of claim 20, wherein the slider member is slidable relative to the handle assembly between a first position, a second position, and a third position, and wherein when the slider member is in the first position a distal end of the pusher tube is positioned proximal of the collet member to allow the collet member to expand, wherein when the slider member is in the second position a distal portion of the pusher tube covers the collet member to prevent the collet member from expanding, and wherein when the slider member is in the third position the slider member engages a distal end of the rocker lever to release the spring-loaded retractor member.

22. A method of inserting a pro-curved electrode array portion of a lead into a bodily orifice, the method comprising:

coupling a proximal portion of a straightening member inserted into the pre-curved electrode array portion 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 comprising

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

a pusher tube coupled to a distal end of the slider member and that 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,

an insertion assembly coupled to the handle assembly and comprising a holder member configured to removably couple to the lead, and

a retractor assembly disposed at least partially within the handle assembly and that selectively couples to the straightening member inserted into the pre-curved electrode array portion, the retractor assembly comprising a spring-loaded retractor member that moves from a distal position to a proximal position relative to the handle assembly in response to the advancement by the user of the slider member in the distal direction relative to the handle assembly to at least partially retract the straightening member from the pre-curved electrode array portion;

moving the slider member in the distal direction relative to the handle assembly from a first position to a second position to retain the straightening member coupled to the retractor assembly;

guiding the pre-curved electrode array portion into a bodily orifice with the insertion tool;

moving the slider member in the distal direction relative to the handle assembly from the second position towards a third position to advance the pre-curved electrode array portion in a distal direction relative to the straightening member; and

moving the slider member in the distal direction relative to the handle assembly to the third position to release the spring-loaded retractor member to move from the distal position to the proximal position to at least partially retract the straightening member from the pre-curved electrode array portion.

23. The method of claim 22, wherein the insertion tool further comprises a plunger assembly configured to reset the spring-loaded retractor member from the proximal position to the distal position, and wherein the method further comprises actuating the plunger assembly to reset the spring-loaded retractor member to the distal position.