Lead identification system

• US 8,473,074 B2
• Filed: 08/31/2011
• Issued: 06/25/2013
• Est. Priority Date: 08/31/2011
• Status: Active Grant

• Current Assignee: Cirtec Medical Corp.
• Original Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Inventors: North, Richard, Swoyer, John, Kane, Lawrence, Geroy, Jesse, Sage, Shahn, Finley, James, Daglow, Terry, Drees, Scott, Bridgeman, Elliot
• Primary Examiner(s): Gedeon, Brian T
• Application Number:
  US13/222,330
• Publication Number:
  US 20130053927A1
• Time in Patent Office: 664 Days
• Field of Search: 607115-119
• US Class Current: 607/116
• CPC Class Codes: A61B 17/3401 Puncturing needles for the peridural or subarachnoid space or the plexus, e.g. for anaesthesia local anaesthesia A61M19/00
• CPC Class Codes: A61B 90/90 Identification means for patients or instruments, e.g. tags
• CPC Class Codes: A61B 90/92 coded with colour
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system

Abstract

A lead identification system for tracking a plurality of neurostimulation leads during implantation in a patient, and a method of using the same. The lead identification system includes a plurality of lead indicators each adapted to attach to one of a plurality of epidural needles to identify the leads. At least one clip adapted to releasably attach to proximal ends of the leads is provided with corresponding lead indicators. The trial cable for conducting trial stimulation includes connectors with corresponding lead indicators. A plurality of lead indicator stylets are provided for insertion into lumens at the proximal ends of the leads. The pulse generator also has connectors with corresponding lead indicators. The various lead indicators permit a surgeon to track a particular lead to the corresponding connectors on the pulse generator.

Claims

1. A neurostimulation system comprising:

a plurality of therapy delivery elements each comprising a proximal end with a plurality of electrical contacts adapted to electrically couple with an implantable pulse generator and a distal end with a plurality of electrodes electrically coupled to the electrical contacts, each of the plurality of therapy delivery elements being configured to be implanted using one of a plurality of epidural needles;

a plurality of removable lead indicators each adapted to attach to one of the plurality of epidural needles to uniquely identify each of the therapy delivery elements;

at least one clip with corresponding lead indicators adapted to releasably attach to proximal ends of the therapy delivery elements;

a trial cable having connectors with corresponding lead indicators adapted to conduct trial stimulation of the therapy delivery elements;

a plurality of removable lead indicator stylets adapted to be inserted into lumens at proximal ends of each of the therapy delivery elements; and

a pulse generator with connectors having corresponding lead indicators, where the lead indicators permit a surgeon to track electrodes on a particular therapy delivery element to a corresponding connector on the implantable pulse generator.

2. The neurostimulation system of claim 1, wherein each of the lead indicators comprises one or more of color indicators, tactile indicators, alpha-numeric indicators, or a combination thereof.

3. The neurostimulation system of claim 1, wherein the therapy delivery elements comprise one of trial leads or permanent leads.

4. The neurostimulation system of claim 1, wherein the pulse generator comprises one of an external pulse generator for conducting trials or an implantable pulse generator.

5. The lead identification neurostimulation system of claim 1, comprising one or more lead anchors with corresponding lead indicators adapted to attach the therapy delivery elements to the patient.

6. The neurostimulation system of claim 1, wherein the lead indicator stylets comprise a diameter less than, or equal to, a diameter of the therapy delivery elements.

7. The neurostimulation system of claim 1, comprising rotating lead indicators attach attached to each of the epidural needles, wherein a rotational orientation of the rotating lead indicators uniquely identify each of the therapy delivery elements.

8. A lead identification system for tracking a plurality of therapy delivery elements during implantation in a patient using a plurality of epidural needles to corresponding connectors on an implantable pulse generator, each of the plurality of therapy delivery elements being configured to be implanted using one of the plurality of epidural needles, the lead identification system comprising:

a plurality of removable lead indicators each adapted to attach to one of the plurality of epidural needles to uniquely identify each of the therapy delivery elements;

at least one clip with corresponding lead indicators adapted to releasably attach to proximal ends of the therapy delivery elements; and

a plurality of removable lead indicator stylets adapted to be inserted into lumens at proximal ends of each of the therapy delivery elements.

9. The lead identification system of claim 8, comprising at least one clip with corresponding lead indicators adapted to releasably attach to proximal ends of the therapy delivery elements.

10. The lead identification system of claim 8, comprising a trial cable having connectors with corresponding lead indicators adapted to conduct trial stimulation of the therapy delivery elements.

11. The lead identification system of claim 8, comprising a pulse generator with connectors having corresponding lead indicators.

12. The lead identification system of claim 8, wherein the lead indicator stylets comprise a diameter less than, or equal to, a diameter of the therapy delivery elements.

13. The lead identification system of claim 8, comprising rotating lead indicators attachable to each of the epidural needles, wherein a rotational orientation of the rotating lead indicators uniquely identify each of the therapy delivery elements.

14. A lead identification system for tracking at least two therapy delivery elements during implantation in a patient, each of the therapy delivery elements being configured to be implanted using one of at least two epidural needles, the lead identification system comprising:

at least two removable lead indicators, each removable lead indicator adapted to attach to one of the epidural needles to uniquely identify each of the therapy delivery elements;

at least one clip with at least two clip lead indicators corresponding to the at least two removable lead indicators, the clip lead indicators adapted to releasably attach to proximal ends of the therapy delivery elements; and

at least two removable lead indicator stylets corresponding to the at least two removable lead indicators, each removable lead indicator stylet adapted to be inserted into a lumen at a proximal end of each of the therapy delivery elements.

15. The lead identification system of claim 14, wherein each of the removable lead indicators includes a color indicator, the color indicators of each of the removable lead indicators being different from one another.

16. The lead identification system of claim 14, wherein each of the removable lead indicators includes a tactile indicator, the tactile indicators of each of the removable lead indicators being different from one another.

17. The lead identification system of claim 14, wherein each of the removable lead indicators includes an alpha-numeric indicator, the alpha-numeric indicators of each of the removable lead indicators being different from one another.

18. The lead identification system of claim 14, wherein the lead indicator stylets include a diameter less than a diameter of the therapy delivery elements.

19. The lead identification system of claim 14, comprising rotating lead indicators attachable to each of the epidural needles, wherein a rotational orientation of the rotating lead indicators uniquely identify each of the therapy delivery elements.

20. The lead identification system of claim 14, comprising a trial cable configured to conduct trial stimulation of the therapy delivery elements, the trial cable including at least two connectors including at least two connector lead indicators corresponding to the at least two removable lead indicators.

21. The lead identification system of claim 14, comprising a pulse generator including at least two connectors including at least two connector lead indicators corresponding to the at least two removable lead indicators.

22. The lead identification system of claim 14, comprising at least two lead anchors configured to attach the therapy delivery elements to the patient, the lead anchors including at least two anchor lead indicators corresponding to the at least two removable lead indicators.

23. The lead identification system of claim 14, wherein the therapy delivery elements include trial leads.

24. The lead identification system of claim 14, wherein the therapy delivery elements include permanent leads.