IMPLANTABLE ELECTRODES AND INSERTION METHODS AND TOOLS

• US 20090149866A1
• Filed: 02/13/2009
• Published: 06/11/2009
• Est. Priority Date: 09/30/2005
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Whitehurst, Todd K., Thenuwara, Chuladatta, Smith, Lani A., Kuzma, Janusz A.
• Granted Patent: US 8,204,604 B2
• Time in Patent Office: Days
• US Class Current: 606/129
• CPC Class Codes: A61N 1/0529 Electrodes for brain stimulation
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy

Abstract

An insertion kit for implanting an electrode in a patient can include a handle; an insertion member coupled to the handle at a proximal end of the insertion member and configured and arranged to be inserted into a patient; an alignment member coupled to the handle and disposed over the distal end of the insertion member; and an electrode configured and arranged to be inserted into the patient using the insertion member. In some instances, the insertion kit may also include one or more of a marker that cooperates with the alignment member to mark a position of the electrode on the skin of the patient; a pointer that cooperates with the alignment member to find the marked position on the skin of the patient; and a second electrode and a second insertion member configured and arranged for detachably coupling to the handle in place of the insertion member.

Claims

1. An insertion kit for implanting an electrode in a patient, comprising:

a handle;

a first insertion member coupleable to the handle at a proximal end of the insertion member and configured and arranged to be inserted into a patient;

an alignment member coupled to the handle and configured and arranged to be disposed over a distal end of the first insertion member when the first insertion member is coupled to the handle;

a first electrode fixedly attached to the first insertion member and configured and arranged to be inserted into the patient using the first insertion member;

a second insertion member, different from the first insertion member, coupleable to the handle at a proximal end of the insertion member and configured and arranged to be inserted into a patient; and

a second electrode detachably coupleable to a distal end of the second insertion member and configured and arranged to be inserted into the patient using the second insertion member.

2. The insertion kit of claim 1, wherein the second insertion member comprises an electrode holder disposed at a distal end of the second insertion member and the second electrode is disposed in the electrode holder of the second insertion member.

3. The insertion kit of claim 2, wherein the electrode holder comprises two opposing rails configured and arranged to hold the second electrode between the opposing rails.

4. The insertion kit of claim 2, wherein the second electrode comprises a plurality of protrusions disposed on at least one surface of the second electrode and configured and arranged to assist in detaching the second electrode from the electrode holder to implant the second electrode in a body of a patient.

5. The insertion kit of claim 1, further comprising a marker that is configured and arranged to cooperate with the alignment member for making a mark on the skin of the patient to mark a position of the electrode.

6. The insertion kit of claim 5, wherein the insertion kit further comprises a pointer that cooperates with the alignment member to find the marked position on the skin of the patient.

7. The insertion kit of claim 1, wherein the first insertion member defines a hollow tube through which the first electrode can be inserted into the patient.

8. A stimulating electrode, comprising:

an electrode body having a front surface and a back surface opposing the front surface, the electrode body being conductive;

a raised rim disposed around an edge of the electrode body; and

a plurality of protrusions extending from the back surface for engagement with surrounding tissue to assist in retaining the stimulating electrode at a placement position in a body of a patient.

9. The electrode of claim 8, wherein the raised rim comprises a non-conducting material.

10. The electrode of claim 8, wherein the protrusions comprise a non-conducting material.

11. An insertion kit for implanting an electrode in a patient, comprising:

a handle;

an insertion member coupleable to the handle at a proximal end of the insertion member and configured and arranged to be inserted into a patient;

an alignment member coupled to the handle and configured and arranged to be disposed over the distal end of the insertion member when the insertion member is coupled to the handle; and

the electrode of claim 8, which coupleable to the insertion member.

12. The insertion kit of claim 11, further comprising a marker that is configured and arranged to cooperate with the alignment member for making a mark on the skin of the patient to mark a position of the electrode.

13. The insertion kit of claim 12, wherein the insertion kit further comprises a pointer that cooperates with the alignment member to find the marked position on the skin of the patient.

14. The insertion kit of claim 11, wherein the insertion member comprises an electrode holder disposed at a distal end of the insertion member and the electrode is disposable in the electrode holder of the insertion member.

15. The insertion kit of claim 14, wherein the electrode is detachably disposed in the electrode holder.

16. The insertion kit of claim 11, further comprising a second electrode and a second insertion member configured and arranged for detachably coupling to the handle in place of the insertion member.

17. The insertion kit of claim 14, wherein the electrode holder comprises two opposing rails configured and arranged to hold the electrode between the opposing rails.

18. A method of stimulating tissue in a patient, the method comprising:

providing an insertion tool;

making an incision in the body of the patient;

inserting a portion of the insertion tool through the incision;

inserting an electrode into the body using the insertion tool;

determining a placement position for the electrode proximate to the tissue to be stimulated;

detaching the electrode from the insertion tool at the placement position; and

withdrawing the insertion tool from the body of the patient leaving the electrode in the placement position.

19. The method of claim 18, further comprising

coupling the electrode to a microstimulator unit and

operating the microstimulator unit to stimulate the tissue.

20. The method of claim 18, wherein determining a placement position comprises

inserting a mapping electrode into the body using an initial insertion tool through the incision prior to inserting the electrode and insertion tool through the incision;

using the mapping electrode to determine the placement position; and

withdrawing the mapping electrode from the body of the patient.