Implantable electrodes and insertion methods and tools

• US 8,204,604 B2
• Filed: 02/13/2009
• Issued: 06/19/2012
• Est. Priority Date: 09/30/2005
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Kuzma, Janusz A., Whitehurst, Todd K., Smith, Lani A., Thenuwara, Chuladatta
• Primary Examiner(s): Patel, Niketa
• Assistant Examiner(s): STOKLOSA, JOSEPH A
• Application Number:
  US12/371,276
• Publication Number:
  US 20090149866A1
• Time in Patent Office: 1,222 Days
• Field of Search: 607115-119, 607/130, 606129-130
• US Class Current: 607/116
• 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 first 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, wherein the handle, the first insertion member and the alignment member are configured and arranged so that when the first insertion member and alignment member are coupled to the handle, the alignment member is spaced apart from the first insertion member to remain external to the patient when the first insertion member is inserted into the patient;

a marker that is configured and arranged to be coupled to the alignment member for making a mark on the skin of the patient to mark a position of the first electrode at the distal end of the first insertion member over which the alignment marker is disposed;

a first electrode fixedly attached to the distal end of 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, wherein the insertion kit further comprises a pointer that is configured and arranged to be coupled to the alignment member to find the marked position on the skin of the patient.

6. 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.

7. 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 first 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 first insertion member when the first insertion member is coupled to the handle, wherein the handle, the first insertion member and the alignment member are configured and arranged so that when the first insertion member and alignment member are coupled to the handle, the alignment member is spaced apart from the first insertion member to remain external to the patient when the first insertion member is inserted into the patient; and

a first electrode which is coupleable to the distal end of the first insertion member, the first 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 between the front surface and the back surface;

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

a lead extending from the electrode body and configured and arranged for attachment to a microstimulator; and

a second electrode; and

a second insertion member coupled to the second electrode and configured and arranged for detachably coupling to the handle in place of the first insertion member.

8. The insertion kit of claim 7, wherein the raised rim comprises a non-conducting material.

9. The insertion kit of claim 7, wherein the protrusions comprise a non-conducting material.

10. The insertion kit of claim 7, wherein the first insertion member comprises an electrode holder disposed at a distal end of the first insertion member and the first electrode is disposable in the electrode holder of the first insertion member.

11. The insertion kit of claim 10, wherein the first electrode is detachably disposed in the electrode holder.

12. The insertion kit of claim 10, wherein the electrode holder comprises two opposing rails configured and arranged to hold the first electrode between the opposing rails.

13. 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, wherein the handle, the insertion member and the alignment member are configured and arranged so that when the insertion member and alignment member are coupled to the handle, the alignment member is spaced apart from the insertion member to remain external to the patient when the insertion member is inserted into the patient; and

a stimulating electrode which is coupleable to the distal end of the insertion member, the 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 between the front surface and the back surface;

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

a lead extending from the electrode body and configured and arranged for attachment to a microstimulator; and

a marker that is configured and arranged to be coupled to the alignment member for making a mark on the skin of the patient to mark a position of the electrode at the distal end of the insertion member over which the alignment marker is disposed.

14. The insertion kit of claim 13, wherein the insertion kit further comprises a pointer that is configured and arranged to be coupled to the alignment member to find the marked position on the skin of the patient.

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

providing an insertion tool comprising a handle;

a first insertion member coupled to the handle at a proximal end of the first insertion member;

an alignment member coupled to the handle and disposed over a distal end of the first insertion member;

a marker that is configured and arranged to be coupled to the alignment member for making a mark on the skin of the patient to mark a position of the first electrode at the distal end of the first insertion member over which the alignment marker is disposed; and

a first electrode detachably attached to the first insertion member;

making an incision in the body of the patient;

inserting the first insertion member and the first electrode into the patient through the incision, wherein the alignment member is spaced apart from the first insertion member and remains external to the patient when the first insertion member is inserted into the patient;

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

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

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

16. The method of claim 15, further comprising

coupling the first electrode to a microstimulator unit and

operating the microstimulator unit to stimulate the tissue.

17. The method of claim 15, 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 first electrode and insertion tool through the incision;

using the mapping electrode to determine the placement position;

marking skin over the placement position using the marker; and

withdrawing the mapping electrode from the body of the patient.