LEAD IDENTIFIER FOR AN IMPLANTABLE ELECTRIC STIMULATION SYSTEM AND METHODS OF MAKING AND USING

• US 20090248124A1
• Filed: 03/26/2009
• Published: 10/01/2009
• Est. Priority Date: 03/27/2008
• Status: Abandoned Application

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Pandit, Aditya Vasudeo, Grandhe, Sarvani, Gifford, Aaron James, Pianca, Anne Margaret, Chinn, Kenny Kinyen
• Application Number:
  US12/412,104
• Publication Number:
  US 20090248124A1
• Time in Patent Office: Days
• US Class Current: 607/116
• 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
• CPC Class Codes: A61N 1/36071 Pain

Abstract

A lead includes a lead body with a distal end and at least one proximal end. The lead includes at least one lead identifier disposed on the lead body. The lead identifier is configured and arranged to visually identify the end of the lead body on which the at least one lead identifier is disposed. The at least one lead identifier includes at least one of a markable-surface-finish region suitable for marking with a pen, at least one laser-ablated identification marking, at least one contrasting band of material formed of a conspicuous color, at least one conspicuously-colored spacer disposed between two adjacent terminals of at least one of the at least one proximal end of the lead body, or a conspicuously-colored proximal tip disposed on at least one of the at least one proximal end of the lead body.

Claims

1. A lead comprising:

a lead body with a distal end and at least one proximal end;

a plurality of electrodes disposed on the distal end of the lead body;

a plurality of terminals disposed on the at least one proximal end of the lead body;

a plurality of conductor wires extending along the lead body to couple the electrodes electrically to the terminals; and

at least one lead identifier disposed on the lead body, the lead identifier configured and arranged to visually identify the end of the lead body on which the at least one lead identifier is disposed, the at least one lead identifier comprising at least one of

a markable-surface-finish region suitable for marking with a pen,

at least one laser-ablated identification marking,

at least one contrasting band of material formed of a conspicuous color,

at least one conspicuously-colored spacer disposed between two adjacent terminals of at least one of the at least one proximal end of the lead body, or

a conspicuously-colored proximal tip disposed on at least one of the at least one proximal end of the lead body.

2. The lead of claim 1, wherein the at least one contrasting band of material is wrapped around at least a portion of a lateral circumference of the at least one proximal end of the lead.

3. The lead of claim 1, wherein the at least one contrasting band of material includes at least one additional marking.

4. The lead of claim 3, wherein the at least one additional marking is at least one of a notch, an aperture, a groove, or a protrusion.

5. The lead of claim 1, wherein the at least one contrasting band of material is inset in a recess disposed in the outer surface of at least one of the at least one proximal end of the lead.

6. The lead of claim 1, wherein the contrasting band of material comprises heat shrink tubing.

7. The lead of claim 1, wherein the contrasting band of material comprises at least one piece of metal.

8. The lead of claim 7, wherein the at least one piece of metal is swaged.

9. The lead of claim 1, wherein the at least one laser-ablated identification marking is at least one of an identification code or a band.

10. The lead of claim 1, wherein the lead identifier is further configured and arranged to identify the location of the distal end of the lead when the distal end of the lead is implanted in a patient.

11. The lead of claim 1, wherein the lead identifier is radiopaque.

12. The lead of claim 1, wherein the markable-surface-finish region is formed by laser ablating a portion of the at least one proximal end of the lead.

13. An electrical stimulating system comprising:

a first lead comprising

a lead body with a distal end and at least one proximal end;

a plurality of electrodes disposed on the distal end of the lead body;

a plurality of terminals disposed on the at least one proximal end of the lead body;

a plurality of conductor wires extending along the lead body to couple the electrodes electrically to the terminals; and

at least one lead identifier disposed on the lead body, the lead identifier configured and arranged to visually identify the end of the lead body on which the at least one lead identifier is disposed, the at least one lead identifier comprising at least one of

a markable-surface-finish region suitable for marking with a pen,

at least one laser-ablated identification marking,

at least one contrasting band of material formed of a conspicuous color,

at least one conspicuously-colored spacer disposed between two adjacent terminals of at least one of the at least one proximal end of the lead body, or

a conspicuously-colored proximal tip disposed on at least one of the at least one proximal end of the lead body;

a control module configured and arranged to electrically couple to the first lead, the control module comprising

a housing,

an electronic subassembly disposed in the housing; and

a connector for receiving the first lead, the connector comprising

a connector housing defining at least one opening for receiving the at least one proximal end of the first lead, and

a plurality of connector contacts disposed in the connector housing, the connector contacts configured and arranged to couple to at least one terminal on the at least one proximal end of the first lead.

14. The electrical stimulating system of claim 13, further comprising a second lead comprising

a lead body with a distal end and at least one proximal end;

a plurality of electrodes disposed on the distal end of the lead body;

a plurality of terminals disposed on the at least one proximal end of the lead body;

a plurality of conductor wires extending along the lead body to couple the electrodes electrically to the terminals; and

at least one lead identifier disposed on the lead body, the lead identifier configured and arranged to visually identify the end of the lead body on which the at least one lead identifier is disposed, the at least one lead identifier comprising at least one of

a markable-surface-finish region suitable for marking with a pen,

at least one laser-ablated identification marking,

at least one contrasting band of material formed of a conspicuous color,

at least one conspicuously-colored spacer disposed between two adjacent terminals of at least one of the at least one proximal end of the lead body, or

a conspicuously-colored proximal tip disposed on at least one of the at least one proximal end of the lead body,

wherein the control module is configured and arranged to electrically couple to the second lead and the at least one lead identifier of the second lead is different from the at least one lead identifier of the first lead.

15. The electrical stimulating system of claim 13, further including a lead extension having a proximal end and a distal end, the connector disposed on the distal end of the lead extension.

16. The electrical stimulating system of claim 15, wherein the proximal end of the lead extension is configured and arranged for insertion into another connector.

17. The electrical stimulating system of claim 13, wherein the connector is disposed on a control module.

18. The electrical stimulating system of claim 13, wherein the connector is disposed on at least one of an operating room cable or an adaptor configured and arranged for electrical coupling to an electronic device.

19. A method for stimulating patient tissue, the method comprising:

implanting at least one lead into a patient, the at least one lead comprising a plurality of electrodes disposed on a distal end of the at least one lead and electrically coupled to a plurality of terminals disposed on each of at least one proximal ends of each of the at least one lead, the lead comprising at least one lead identifier for individually identifying each of the at least one proximal ends of the at least one lead, the at least one lead identifier comprising at least one of

a markable-surface-finish region suitable for marking with a pen,

at least one laser-ablated identification marking,

at least one contrasting band of material formed of a color that is different from the first color,

at least one conspicuously-colored spacer disposed between two adjacent terminals of at least one of the at least one proximal end of the lead body, the at least one conspicuously-colored spacer formed of a color that is different from the first color, or

a conspicuously-colored proximal tip disposed on at least one of the at least one proximal end of the lead body, the at least one conspicuously-colored proximal tip formed of a color that is different from the first color;

disposing each of the at least one proximal ends of the at least one lead into at least one connector, each of the at least one connector defining at least one port for receiving the at least one proximal ends of the at least one lead, each of the at least one port comprising a plurality of connective contacts that electrically couple to at least one of the plurality of terminals disposed on each of at least one proximal ends of each of the at least one lead, each of the at least one the connectors electrically coupled to at least one control module; and

providing electrical signals from at least one of the control modules to electrically stimulate patient tissue using at least one of the electrodes on at least one of the at least one lead.

20. The method of claim 19, wherein implanting at least one lead into a patient comprises implanting a plurality of the leads into the patient, wherein the at least one lead identifier of each of the leads is different.