SYSTEMS AND METHODS FOR MAKING AND USING A TEMPORARY LEAD

• US 20160375238A1
• Filed: 06/24/2016
• Published: 12/29/2016
• Est. Priority Date: 06/26/2015
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Leven, Jacob B., Barker, John M., Pianca, Anne Margaret
• Granted Patent: US 10,130,806 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: A61N 1/37241 providing test stimulations
• CPC Class Codes: A61N 1/3752 Details of casing-lead connections

Abstract

A trial electrical stimulation lead includes a lead body having a distal end portion, a proximal end portion, and a longitudinal length; electrodes disposed along the distal end portion of the lead body; terminals disposed along the proximal end portion of the lead body; conductors electrically coupling the terminals to the electrodes; and a preventer extending proximally from the proximal end portion of the lead body. The preventer has a diameter smaller than a diameter of the lead body. The preventer prevents coupling of the trial electrical stimulation lead to an implantable control module, but permits coupling to an external trial stimulation system.

Claims

1. An electrical stimulation lead, comprising:

a lead body having a distal end portion, a proximal end portion, and a longitudinal length;

a plurality of electrodes disposed along the distal end portion of the lead body;

a plurality of terminals disposed along the proximal end portion of the lead body;

a plurality of conductors electrically coupling the plurality of terminals to the plurality of electrodes; and

a preventer permanently extending proximally from the proximal end portion of the lead body, wherein the preventer has a diameter smaller than a diameter of the lead body.

2. The electrical stimulation lead of claim 1, wherein the lead body defines a central lumen extending from the proximal end portion to the distal end portion, wherein a portion of the preventer is disposed within the central lumen.

3. The electrical stimulation lead of claim 2, wherein the preventer is a tube defining a lumen extending along the tube.

4. The electrical stimulation lead of claim 3, wherein the lumen of the preventer is in communication with the central lumen of the lead body.

5. The electrical stimulation lead of claim 4, further comprising a stylet configured and arranged for insertion through the lumen of the preventer into the central lumen of the lead body.

6. The electrical stimulation lead of claim 2, wherein the preventer comprises a proximal tip that is flared, beveled, or has a radiused inside edge to facilitate insertion of a stylet into the lumen of the preventer.

7. The electrical stimulation lead of claim 2, wherein the portion of the preventer disposed within the central lumen is disposed radially beneath at least one of the terminals.

8. The electrical stimulation lead of claim 2, wherein the portion of the preventer disposed within the central lumen is disposed radially beneath all of the terminals.

9. The electrical stimulation lead of claim 3, wherein the preventer further comprises a polymer jacket disposed over the tube of the preventer to soften an outer surface of the preventer.

10. The electrical stimulation lead of claim 9, wherein the polymer jacket comprises a proximal tip that is flared, beveled, or has a radiused inside edge.

11. An electrical stimulation system, comprising:

the electrical stimulation lead of claim 1; and

an operating room cable for electrically coupling the electrical stimulation lead to a trial stimulator, the operating room cable comprising;

an elongated body having a first end and an opposing second end;

a trial stimulator connector disposed at the first end of the body, and electrically coupleable with the trial stimulator; and

a lead connector disposed at the second end of the body and electrically coupled to the trial stimulator connector, the lead connector configured and arranged to mechanically receive the proximal end portion of the electrical stimulation lead.

12. The electrical stimulation system of claim 11, wherein the lead connector comprises a housing, a first lead aperture in the housing for receiving the proximal end portion of the lead, and a side slit defined along the housing, parallel the first lead aperture, and in communication with the first lead aperture.

13. The electrical stimulation system of claim 12, wherein a width of the side slit is less than a diameter of the lead body of the electrical stimulation lead.

14. The electrical stimulation system of claim 13, wherein the width of the side slit is more than a diameter of the preventer of the electrical stimulation lead.

15. The electrical stimulation system of claim 11, further comprising

a control module comprising

a housing, and

an electronic subassembly disposed in the housing;

and

a connector having a proximal end, a distal end, and a longitudinal length, the connector comprising

a connector housing defining a port at the distal end of the connector, and

a plurality of connector contacts disposed in the connector housing.

16. The electrical stimulation system of claim 15, wherein the control module comprises the connector and the system is configured and arranged so that, when the electrical stimulation lead is inserted into the connector, the terminals of the electrical stimulation lead are prevented from making contact with the connector contacts by the preventer.

17. The electrical stimulation system of claim 15, further comprising a lead extension coupleable to the control module.

18. The electrical stimulation system of claim 17, wherein the lead extension comprises the connector, wherein the system is configured and arranged so that, when the electrical stimulation lead is inserted into the connector, the terminals of the electrical stimulation lead are prevented from making contact with the connector contacts by the preventer.

19. A method of using the electrical stimulation lead of claim 1, the method comprising:

inserting the electrical stimulation lead into a patient; and

coupling the electrical stimulation lead to a cable of an external trial stimulation system.

20. The method of claim 19, further comprising

removing the electrical stimulation lead;

implanting a permanent electrical stimulation lead into the patient; and

coupling the permanent electrical stimulation lead to an implantable control module.