Systems, apparatuses, and methods for differentiating between multiple leads implanted within a patient

• US 9,289,592 B2
• Filed: 03/09/2009
• Issued: 03/22/2016
• Est. Priority Date: 03/11/2008
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Chinn, Kenny Kinyen, Moffitt, Michael A., Meadows, Paul M.
• Primary Examiner(s): VOORHEES, CATHERINE M
• Application Number:
  US12/400,260
• Publication Number:
  US 20090234427A1
• Time in Patent Office: 2,570 Days
• Field of Search: 607/119, 607/122, 607/36, 607129-131, 607/33, 607/35, 607/37, 607116-117, 606129-130, 606/108
• US Class Current: 1/1
• CPC Class Codes: A61B 2017/320056 Tunnelers
• 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 1/372 Arrangements in connection with the implantation of stimulators
• CPC Class Codes: A61N 1/3752 Details of casing-lead connections

Abstract

Systems, apparatuses, and methods for differentiating between multiple leads that are implanted within a patient include a stimulator configured to be implanted at an implant site within the patient and generate electrical stimulation current, a plurality of leads each comprising one or more electrodes configured to deliver the electrical stimulation current at a stimulation site within the patient, and a shuttle assembly having a plurality of receiving ports each configured to receive a proximal portion of one of the leads and guide the leads from the stimulation site to the implant site of the stimulator. The shuttle assembly is configured to enable a user to differentiate between each of the leads after the leads are guided to the implant site of the stimulator.

Claims

1. A system comprising:

a stimulator configured to be implanted at an implant site within a patient and generate electrical stimulation current;

a plurality of leads each comprising a proximal end, a distal end, and one or more electrodes disposed along the distal end and configured to deliver said electrical stimulation current at a stimulation site within said patient; and

a shuttle assembly comprising a plurality of receiving ports formed as longitudinal grooves on an exterior surface of the shuttle assembly each groove configured to receive the proximal end of one of said leads and Guide said leads from said stimulation site to said implant site of said stimulator;

wherein said shuttle assembly is configured to enable a user to differentiate between each of said leads after said leads are guided to said implant site of said stimulator, wherein said shuttle assembly is configured to be coupled to a tunneling rod, wherein said shuttle assembly comprises a proximal member and a distal member coupled to said proximal member, wherein said distal member comprises a receiving port configured to couple to said tunneling rod, wherein said distal member is configured to rotate freely, with respect to the proximal member, around a central axis.

2. The system of claim 1, wherein said shuttle assembly comprises at least one identifying mark configured to enable said user to differentiate between each of said leads.

3. The system of claim 1, wherein the proximal ends of said leads are configured to snap into said grooves.

4. The system of claim 1, further comprising a tunneling straw configured to receive said shuttle assembly and facilitate said guiding of said leads to said implant site of said stimulator.

5. The system of claim 1, wherein said implant site of said stimulator comprises a subcutaneous pocket formed within a torso of said patient.

6. A method comprising:

providing the system of claim 1;

implanting the stimulator of the system at an implant site within a patient;

positioning said distal ends of said plurality of leads of the system at a stimulation site within said patient;

coupling the proximal end of each of said leads into the longitudinal grooves of the shuttle assembly of the system; and

guiding said shuttle assembly from said stimulation site to said implant site of said stimulator.

7. The method of claim 6, further comprising passing said shuttle assembly through a tunneling straw from said stimulation site to said implant site of said stimulator.

8. The method of claim 6, further comprising coupling said shuttle assembly to a tunneling rod.

9. The method of claim 8, further comprising using said tunneling rod to guide said shuttle assembly from said stimulation site to said implant site of said stimulator.

10. A system comprising:

a stimulator configured to be implanted at an implant site within a patient and generate electrical stimulation current;

a plurality of leads each comprising a proximal end, a distal end, and one or more electrodes disposed along the distal end and configured to deliver said electrical stimulation current at a stimulation site within said patient; and

a shuttle assembly comprising a plurality of receiving ports formed as longitudinal grooves on an exterior surface of the shuttle assembly, each groove configured to receive the proximal end of one of said leads and guide said leads from said stimulation site to said implant site of said stimulator;

a tunneling rod configured to be removably coupleable to said shuttle assembly and create a tunnel between said stimulation site and said implant site; and

a tunneling straw configured to be inserted within said tunnel;

wherein said tunneling rod is configured to guide said shuttle assembly through said tunneling straw from said stimulation site to said implant site of said stimulator;

wherein said shuttle assembly comprises a proximal member and a distal member coli led to said proximal member, wherein said distal member comprises a receiving port configured to couple to said tunneling rod, wherein said distal member is configured to rotate freely, with respect to the proximal member, around a central axis; and

wherein said shuttle assembly is configured to enable a user to differentiate between each of said leads after said shuttle assembly is guided to said implant site of said stimulator.

11. The system of claim 10, wherein said shuttle assembly comprises at least one identifying mark configured to enable said user to differentiate between each of said leads.

12. The system of claim 10, wherein the proximal ends of said leads are configured to snap into said grooves.

13. The system of claim 10, wherein said tunneling rod is further configured to be removably coupleable to a tissue separator tip.

14. The system of claim 10, wherein said tunneling straw comprises a tapered portion configured to increase a diameter of said tunnel as said tunneling straw is inserted within said tunnel.

15. A method comprising:

providing the system of claim 10;

selecting a stimulation site;

selecting an implant site for Hull the stimulator of the system;

creating a tunnel in between said stimulation site and said implant site with the tunneling rod of the system;

inserting the tunneling straw of the system into said tunnel;

coupling the shuttle assembly of the system to said tunneling rod;

coupling the proximal end of each of the plurality of electrode leads of the system to corresponding ports formed as the longitudinal grooves of said shuttle assembly;

guiding said shuttle assembly through said tunneling straw from said stimulation site to said implant site with said tunneling rod;

removing said tunneling straw from said tunnel;

removing said leads from said shuttle assembly in a manner configured to distinguish each of said leads one from another; and

coupling each of said leads to said stimulator.

16. The method of claim 15 wherein said tunneling straw comprises a tapered portion.

17. An apparatus comprising:

an elongated body configured to be Guided from a stimulation site to an implant site of a stimulator within a patient;

a plurality of receiving ports formed as longitudinal grooves on an exterior surface of said elongated body and each groove configured to receive a proximal end of an electrode lead; and

at least one identifying mark configured to enable a user to differentiate between each of said leads after said elongated body is guided from said stimulation site to said implant site, wherein said elongated body is configured to be coupled to a tunneling rod, wherein said elongated body comprises a proximal member and a distal member coupled to said proximal member, wherein said distal member comprises a receiving port configured to couple to said tunneling rod, wherein said distal member is configured to rotate freely, with respect to the proximal member, around a central axis.

18. The apparatus of claim 17, wherein said elongated body is configured to pass through a tunneling straw.

19. The apparatus of claim 17, wherein said implant site of said stimulator comprises a subcutaneous pocket formed within a torso of said patient.

20. The apparatus of claim 17, wherein said identifying mark comprises at least one of a number, a dot, or a stamp.

21. The apparatus of claim 17, wherein the proximal ends of said leads are configured to snap into said grooves.