Surgical insertion tool

• US 7,799,037 B1
• Filed: 02/11/2003
• Issued: 09/21/2010
• Est. Priority Date: 02/24/2000
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: He, Tom X, Whitehurst, Todd K, McGivern, James P
• Primary Examiner(s): Erezo; Darwin P
• Application Number:
  US10/364,433
• Time in Patent Office: 2,779 Days
• Field of Search: 606/129, 606/130, 606/108, 606/107, 604/164.01, 604/164.1, 604/164.09, 604/164.12, 604/164.13, 604/60, 604/890.1, 604/891.1, 604/57, 604/59, 623/6.12, 607/1, 607/2, 607/116, 600372-382
• US Class Current: 606/129
• 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 1/0551 Spinal or peripheral nerve electrodes

Abstract

A tool is provided for facilitating determining a proper location for an implantable device or medication, and for then delivering the implant to the precise location determined with the tool. To determine the target location, the tool may include a component for testing target locations, such as a stimulating probe for simulating a miniature implantable stimulator. In one embodiment, the tool is used to test a miniature implantable stimulator prior to depositing the implant precisely at the target location. The components of the tool are configured to maintain the implant at the target location while the tool is withdrawn. In one embodiment, a push rod assembly of the tool keeps the implant in position while it retracts the implant holder from around the implant. The ergonomic and light-weight tool leads to reduced surgical time, number and size of incisions, risk of infection, and likelihood of error.

Claims

1. A surgical system comprising:

an implant comprising an electrode that is biasable to deliver electrical pulses; and

a tool system, comprising;

a cannula;

a stimulating probe configured for being removably retained and secured within the cannula, the stimulating probe comprising an electrode that is biasable to deliver electrical pulses configured to stimulate tissue in a manner that indicates whether a location is suitable as an implant site for the electrode of the implant to deliver the electrical pulses to a nerve; and

an implant holder configured for being removably retained and secured within the cannula;

an implant disengagement assembly configured to disengage the implant from the implant holder;

wherein the electrode of the stimulating probe and the electrode of the implant are located in the same position relative to the cannula when the stimulating probe and implant holder are retained and secured within the cannula.

2. The surgical system of claim 1, wherein the implant holder is configured to allow external activation of the implant to deliver the electrical pulses to the nerve.

3. The surgical system of claim 1, wherein the implant is packaged and provided in the implant holder.

4. The surgical system of claim 1, wherein the implant comprises at least two electrodes that are biasable to deliver electrical pulses to a nerve.

5. The surgical system of claim 1, wherein:

the cannula comprises a retaining mechanism; and

the stimulating probe comprises a member dimensioned to fit with the retaining mechanism and be retained thereby.

6. The surgical system of claim 5, wherein the push rod assembly comprises a member dimensioned to fit with the retaining mechanism and be retained thereby.

7. The surgical system of claim 6, wherein:

the retaining mechanism comprises a receptacle; and

the member of the stimulating probe and the member of the push rod assembly each comprises a tab dimensioned to be received in the receptacle.

8. The surgical system of claim 1, wherein:

the implant holder comprises a tube in which the implant is disposed; and

the implant disengagement assembly comprises a rod insertable within the tube to disengage the implant from the implant holder.

9. The surgical system of claim 8, wherein the tube of the implant holder comprises at least one hole such that interstitial fluids can reach the electrode of the implant through the at least one hole during implantation.

10. The surgical system of claim 9, wherein the at least one hole comprises a collection of holes distributed around the tube of the implant holder.

11. The surgical system of claim 8, wherein the tube of the implant holder comprises a flexible material that is dimensioned to be flexed to engage the implant.

12. The surgical system of claim 8, wherein the implant disengagement assembly further comprises a drive wheel rotatably mounted on the rod to displace the tube of the implant holder in a proximal direction as the rod engages the implant, thereby disengaging the implant from the implant holder.

13. The surgical system of claim 12, wherein:

the implant holder comprises a threaded portion at a proximal end of the tube; and

the drive wheel comprises a mating thread that the threaded portion of the implant holder can engage to displace the tube in the proximal direction.

14. The surgical system of claim 1, wherein the implant further comprises a capsule, and electronic circuitry housed in the capsule and configured to bias the electrode to deliver electrical pulses via an electrical connection thereto.

15. The surgical system of claim 1, further comprising a trocar removably insertable into the cannula.

20. The surgical system of claim 5, further comprising means for allowing external activation of the implant to deliver the electrical pulses to the nerve.

16. A surgical system comprising:

an implant comprising an electrode that is biasable to deliver electrical pulses;

stimulating means comprising an electrode biasable to deliver electrical pulses for locating a proper implant site, wherein the proper implant site allows the implant to deliver the electrical pulses to a nerve;

means for providing access to position the implant at the proper implant site;

means for engaging the implant with the electrode exposed;

means for removably retaining and securing the stimulating means within the means for providing access; and

means for removably retaining and securing the implant engaging means within the means for providing access;

wherein the electrode of the stimulating means and the electrode of the implant are located in the same position relative to the means for providing access when the stimulating means and implant engaging means are retained and secured within the means for providing.

17. The surgical system of claim 16, wherein the implant is packaged and provided in the means for engaging.

18. The surgical system of claim 16, wherein the means for providing access comprises a cannula and a handle attached to the cannula.

19. The surgical system of claim 18, further comprising a trocar removably insertable into the cannula.