SYSTEMS AND METHODS FOR MAKING AND USING A TRIAL STIMULATION SYSTEM HAVING AN ELECTRICAL CONNECTOR DISPOSED ON A TRIAL STIMULATION LEAD

• US 20110218549A1
• Filed: 03/04/2011
• Published: 09/08/2011
• Est. Priority Date: 03/05/2010
• Status: Abandoned Application

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Barker, John Michael
• Application Number:
  US13/040,760
• Publication Number:
  US 20110218549A1
• Time in Patent Office: Days
• US Class Current: 606/129
• CPC Class Codes: A61B 2562/225 Connectors or couplings
• CPC Class Codes: A61B 90/00 Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges protective face masks A41D13/11; surgeon's or patient's gowns or dresses A41D13/12; devices for carrying-off, for treatment of, or for carrying-over, body liquids A61M1/00
• 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 1/37241 providing test stimulations
• CPC Class Codes: H01R 13/005 Electrical coupling combined with fluidic coupling
• CPC Class Codes: H01R 13/621 Bolt, set screw or screw clamp
• CPC Class Codes: H01R 2107/00 Four or more poles
• CPC Class Codes: H01R 2201/12 for medicine and surgery
• CPC Class Codes: H01R 24/58 Contacts spaced along longitudinal axis of engagement

Abstract

A trial stimulation lead assembly for providing electrical stimulation of patient tissue during a trial stimulation includes a trial stimulation lead for insertion into a patient. The trial stimulation lead includes an elongated lead body having a length and a longitudinal axis. A plurality of electrodes are disposed at a distal end of the lead body. An electrical connector is disposed at a proximal end of the lead body. The electrical connector includes an outer case and a contact array disposed along the outer case. The contact array extends transversely to the longitudinal axis of the lead body. A plurality of electrical conductors extend along the length of the lead body and couple each of the plurality of electrodes to at least one of the plurality of contacts. A lumen extends along at least a portion of the length of the lead body.

Claims

1. A trial stimulation lead assembly for providing electrical stimulation of patient tissue during a trial stimulation, the trial stimulation lead assembly comprising:

a trial stimulation lead configured and arranged for insertion into a patient, the trial stimulation lead comprising

an elongated lead body having a length, a circumference, and a longitudinal axis defined by a proximal end and a distal end,

a plurality of electrodes disposed at the distal end of the lead body,

an electrical connector disposed at the proximal end of the lead body, the electrical connector comprising an outer case and a contact array disposed along the outer case, wherein the contact array extends transversely to the longitudinal axis of the lead body,

a plurality of electrical conductors extending along the length of the lead body and coupling each of the plurality of electrodes to at least one of the plurality of contacts, and

a lumen extending along at least a portion of the length of the lead body.

2. The trial stimulation lead assembly of claim 1, wherein the electrical connector has a circumference that is larger than the circumference of the lead body.

3. The trial stimulation lead assembly of claim 1, wherein the electrical connector further comprises a connector lumen defined in the electrical connector from a location adjacent the lumen of the lead body to an access port defined in the electrical connector, and wherein the lumen, connector lumen, and access port are configured and arranged for receiving a stylet.

4. The trial stimulation lead assembly of claim 3, wherein the access port is defined on the outer case of the electrical connector.

5. The trial stimulation lead assembly of claim 3, wherein the access port is defined within the contact array.

6. The trial stimulation lead assembly of claim 3, further comprising a self-sealing element disposed over the access port.

7. The trial stimulation lead assembly of claim 1, wherein the contact array is arranged into one of a rectangular configuration or a round configuration.

8. The trial stimulation lead assembly of claim 1, wherein the contact array comprises at least one of a plurality of pins or a plurality of pin receptacles.

9. The trial stimulation lead assembly of claim 1, wherein the contact array is one of a high definition multimedia interface connector or a LEMO connector.

10. The trial stimulation lead assembly of claim 1, wherein the number of contacts is no fewer than the number of electrodes.

11. The trial stimulation lead assembly of claim 1, wherein the contact array is configured and arranged to couple directly to an external trial stimulator.

12. The trial stimulation lead assembly of claim 1, wherein the contact array is configured and arranged to couple to an external trial stimulator via one or more operating room cables.

13. A kit for providing electrical stimulation of patient tissue during a trial stimulation, the kit comprising:

the trial stimulation lead assembly of claim 1; and

a lead introducer for facilitating insertion of the trial stimulation lead into the patient, the lead introducer comprising

an outer member configured and arranged for insertion into the patient, and

an insertion needle configured and arranged for insertion into the outer member, the insertion needle also configured and arranged to receive the distal end of the trial stimulation lead.

14. The kit of claim 13, further comprising a stylet for facilitating guidance of the electrodes to a target stimulation region within the patient, the stylet configured and arranged for insertion into the access port of the connector lumen of the trial stimulation lead assembly.

15. The kit of claim 13, wherein the outer member is configured and arranged to divide into at least two parts for removal of the outer member from the trial stimulation lead upon insertion of the trial stimulation lead into the patient.

16. The kit of claim 13, wherein the insertion needle defines an open channel configured and arranged to receive at least a portion of the trial stimulation lead.

17. The kit of claim 13, wherein the insertion needle comprises a plurality of body elements configured and arranged to at least partially separate from one another upon removal of the outer member.

18. A method for implanting a trial electrical stimulation into a patient, the method comprising:

inserting an insertion needle into an outer member;

guiding a distal end of the outer member to a target stimulation region within the patient;

inserting the distal end of the trial stimulation lead of claim 1 into the insertion needle;

removing the outer member from the patient while leaving the trial stimulation lead within the patient such that the plurality of electrodes are at the target stimulation region;

separating the trial stimulation lead from the insertion needle; and

removing the insertion needle from the trial stimulation lead while leaving the trial stimulation lead within the patient such that the plurality of electrodes are at the target stimulation region.

19. The method of claim 18, wherein removing the outer member from the patient comprises separating the outer member into at least two parts along a length of a lumen of the outer member and removing the outer member from the patient.

20. The method of claim 18, wherein removing the insertion needle from the trial stimulation lead comprises passing the trial stimulation lead laterally through an open channel of the insertion needle and removing the insertion needle from the patient.

21. The method of claim 18, wherein removing the insertion needle from the trial stimulation lead comprises at least partially separating at least two of a plurality of body elements from one another along a longitudinal axis of the insertion needle.

22. The method of claim 18, wherein removing the outer member from the patient comprises at least one of rolling up or sliding the outer member proximally along the longitudinal axis of the insertion needle.