IMPLANT TOOL FOR USE WITH A MICROSTIMULATOR

• US 20080132961A1
• Filed: 11/30/2006
• Published: 06/05/2008
• Est. Priority Date: 11/30/2006
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Advanced Bionics Corporation (Sonova Holding AG)
• Inventors: Carbunaru, Rafael, Jaax, Kristen N., Whitehurst, Todd K., Makous, James C., Pianca, Anne M., Anderson, Meredith L.
• Granted Patent: US 7,857,819 B2
• Time in Patent Office: Days
• US Class Current: 607/2
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/36071 Pain

Abstract

A stimulation system is described that includes an implantable microstimulator. A tail may be coupled to a distal end of the implantable microstimulator. In one embodiment, the stimulation system includes an implantation tool that includes an insertion cannula, a handle, a bushing, and a detachable blunt dissector tip. The bushing is situated within the insertion cannula and may position the implantable microstimulator longitudinally within the insertion cannula when the implantable microstimulator is placed within the insertion cannula. The detachable blunt dissector tip may be attached to the tail of the implantable microstimulator. The stimulation system may further comprise an end cap that includes an upper portion and a base portion conformable over at least a portion of curved tissue. An open trough extends through the base upper portions and may be configured to guide the implantation tool through the tissue at various angles.

Claims

1. A stimulation system, comprising:

an implantable microstimulator having a tail that is coupled at a distal end of the implantable microstimulator and is useable to constrain movement of the implantable microstimulator within tissue.

2. The stimulation system of claim 1, further comprising:

an implantation tool comprising;

an insertion cannula;

a handle situated at a proximal end of the insertion cannula useable for grasping the insertion cannula;

a bushing-based advancing mechanism situated within the insertion cannula and arranged to position the implantable microstimulator longitudinally within the insertion cannula when the implantable microstimulator is placed within a lumen of the insertion cannula; and

a detachable blunt dissector tip at the distal end of the cannula and being attached to the tail of the implantable microstimulator.

3. The stimulation system of claim 2, wherein the implantation tool further comprising:

a grasping mechanism attached to a distal end of the bushing-based advancing mechanism for use in grasping the implantable microstimulator.

4. The stimulation system of claim 2, wherein the handle is configured to be moveable along an exterior of the insertion cannula.

5. The stimulation system of claim 2, wherein the bushing-based advancing mechanism further comprises:

a bushing; and

a threaded system situated longitudinally within the lumen of the cannula, the bushing being attached to a distal end of the threaded system, and

wherein the handle further comprises a thumbwheel for moving the threaded system and thereby positioning the bushing longitudinally along the cannula.

6. The stimulation system of claim 2, wherein the bushing-based advancing mechanism further comprises:

a bushing plate;

a plurality of ratcheting teeth situated longitudinally within the lumen of the insertion cannula; and

a plunger that is coupled at a distal end to the bushing plate and is arranged to ratchet the bushing plate longitudinally within the lumen of the insertion cannula and across the plurality of ratcheting teeth.

7. The stimulation system of claim 1, further comprising:

an end cap comprising;

a base portion that is conformable over at least a portion of curved tissue;

an upper portion affixed to the base portion;

an open trough extending through the base portion and the upper portion and configured to guide an implantation tool through the tissue at various angles; and

an optional cleat attached to one or the base portion or the upper portion of the end cap and configured to grip the tail upon removal of a detachable blunt dissector tip and to constrain movement of the implantable microstimulator while the implantation tool is removed from the tissue.

8. The stimulation system of claim 7, wherein the base portion of the end cap is further configured to adhere to the tissue.

9. The stimulation system of claim 7, wherein the curved upper portion of the end cap is shaped in an approximately hemispherical shape.

10. The stimulation system of claim 7, wherein the base portion of the end cap further comprises a silicone material.

11. The stimulation system of claim 1, wherein the tail is threaded through a proximal end of a detachable blunt dissector tip.

12. The stimulation system of claim 1, wherein the tail further comprises at least one of a conductor wire or a suture material.

13. The stimulation system of claim 1, further comprising:

a plate having a cylindrical hollow tube mounted through the plate, the plate being configured to be placed over an implant region of tissue and to minimize a lateral movement of an implantation tool when inserted longitudinally through the cylindrical hollow tube.

14. An tool for insertion of an implantable microstimulator into tissue, comprising:

an insertion cannula;

a handle at a proximal end of the insertion cannula for grasping the insertion cannula;

a bushing-based advancing mechanism situated within the insertion cannula arranged to advance the implantable microstimulator longitudinally within the insertion cannula when the implantable microstimulator is placed within a lumen of the insertion cannula; and

a detachable blunt dissector tip at the distal end of the cannula.

15. The tool of claim 14, wherein the bushing-based advancing mechanism further comprises:

a bushing; and

a threaded system situated longitudinally within the lumen of the cannula, the bushing being attached to a distal end of the threaded system, and

wherein the handle further comprises a mechanism for moving the threaded system and thereby positioning the bushing longitudinally along the cannula.

16. The tool of claim 15, wherein the bushing-based advancing mechanism further comprises a plunger running longitudinally within a lumen of the threaded system and is configured to further position the bushing longitudinally along the cannula.

17. The tool of claim 15, wherein the bushing is keyed.

18. The tool of claim 14, wherein the bushing-based advancing mechanism further comprises:

a bushing plate;

a plurality of ratcheting teeth situated longitudinally within the lumen of the insertion cannula; and

a plunger that is coupled at a distal end to the bushing plate and is arranged to ratchet the bushing plate longitudinally within the lumen of the insertion cannula and across the plurality of ratcheting teeth.

19. The tool of claim 14, wherein a proximal end of the detachable blunt dissector tip is coupled to a distal end of the implantable microstimulator using a tail, wherein the tail is useable to constrain movement of the implantable microstimulator while the tool is removed from the tissue.

20. The tool of claim 19, wherein the tail further comprises a material useable to be sutured to the tissue.

21. A method for implanting an implantable microstimulator into tissue, the implantable microstimulator having an electrode contact and a tail, the tail being coupled at a distal end of the implantable microstimulator, the method comprising:

securing an end cap at an egress site on the tissue, the end cap having an open trough extending through the end cap and being configured to guide an insertion cannula through the tissue at various angles;

placing the implantable microstimulator within the insertion cannula, the tail being attached to a detachable blunt dissector tip situated at a distal end of the insertion cannula;

inserting the insertion cannula through the tissue at an ingress site and through the egress site such that the distal end of the insertion cannula is guided along the open trough of the end cap;

positioning the implantable microstimulator at a desired target location within the tissue using a bushing-based advancing mechanism to advance the implantable microstimulator within the insertion cannula;

attaching the tail to the end cap, in part, by removing the detachable blunt dissector tip upon egress from the tissue; and

removing the insertion cannula from the tissue while the implantable microstimulator remains at the desired target location.

22. The method of claim 21, further comprising:

injecting a stabilizing agent into the tissue to constrain mechanical movement of the tissue during implantation of the implantable micro stimulator.