MINIMALLY INVASIVE IMPLANTABLE NEUROSTIMULATION SYSTEM

• US 20140163580A1
• Filed: 12/06/2013
• Published: 06/12/2014
• Est. Priority Date: 12/07/2012
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Tischendorf, Brad C., Bonde, Eric H., Falkner, Phillip C., Kast, John E., Roles, Randy S., Scott, Erik R., Smith, Todd V., Wei, Xuan K., Chasensky, Anthony M., Ebert, Michael J., Molnar, Gabriela C., Stone, Richard T., Kelley, Shawn C.
• Granted Patent: US 9,931,107 B2
• Time in Patent Office: Days
• US Class Current: 606/129
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61N 1/02 Details
• 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 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: A61N 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence
• CPC Class Codes: A61N 1/36057 adapted for stimulating afferent nerves
• CPC Class Codes: A61N 1/36067 Movement disorders, e.g. tremor or Parkinson disease stimulating motor muscle A61N1/36003
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators
• CPC Class Codes: A61N 1/37223 Circuits for electromagnetic coupling
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: A61N 1/3727 characterised by the modulation technique
• CPC Class Codes: A61N 1/37518 Anchoring of the implants, e.g. fixation
• CPC Class Codes: A61N 1/3754 Feedthroughs
• CPC Class Codes: A61N 1/3756 : Casings with electrodes thereon, e.g. leadless stimulators
• CPC Class Codes: A61N 1/3787 : from an external energy source
• CPC Class Codes: F04C 2270/0421 : Controlled or regulated

Abstract

A neuromodulation therapy is delivered via at least one electrode implanted subcutaneously and superficially to a fascia layer superficial to a nerve of a patient. In one example, an implantable medical device is deployed along a superficial surface of a deep fascia tissue layer superficial to a nerve of a patient. Electrical stimulation energy is delivered to the nerve through the deep fascia tissue layer via implantable medical device electrodes.

Claims

1. A method for delivering a neuromodulation therapy, comprising:

deploying an implantable medical device along a superficial surface of a deep fascia tissue layer superficial to a nerve of a patient, the implantable medical device comprising a plurality of electrodes;

delivering electrical stimulation energy via the plurality of electrodes to stimulate the nerve through the deep fascia tissue layer.

2. The method of claim 1, further comprising:

dissecting a tissue pocket using a first end of a dissection tool; and

delivering test stimulation pulses using an electrode coupled to the first end of the dissection tool and electrically coupled to a pulse generator via a connecter at a second end of the dissection tool to locate the nerve.

3. The method of claim 2, further comprising using a second end of the dissection tool comprising an incising blade for making a skin incision.

4. The method of claim 1, wherein deploying the implantable medical device comprises positioning at least one electrode carried along a face of a housing of the implantable medical device against the tissue layer.

5. The method of claim 1, wherein deploying the implantable medical device comprises advancing an electrical lead carrying at least one electrode along the tissue layer superficial to the nerve.

6. The method of claim 1, further comprising fixating the implantable medical device along the tissue layer using a fixation member.

7. The method of claim 6, wherein fixating the implantable medical device comprises engaging a passive fixation member extending from a housing of the implantable medical device in a surrounding tissue.

8. The method of claim 6, wherein fixating the implantable medical device comprises inserting an active fixation member into the tissue layer to capture the tissue layer between a housing of the implantable medical device and a portion of the active fixation member.

9. The method of claim 8, wherein inserting an active fixation member into the tissue layer comprises advancing the active fixation member through an aperture of a housing of the implantable medical device.

10. The method of claim 1, further comprising transmitting power from an external device positioned cutaneously over the implantable medical device for generating stimulation pulses delivered to the nerve via the plurality of electrodes.

11. A system for delivering a neuromodulation therapy, comprising:

an implantable medical device configured to be deployed along a superficial surface of a deep fascia tissue layer superficial to a nerve of a patient, the implantable medical device comprising;

a housing;

a plurality of electrodes; and

a pulse generating circuit enclosed in the housing for delivering electrical stimulation pulses via the plurality of electrodes to the nerve through the deep fascia tissue layer.

12. The system of claim 11, further comprising:

a dissection tool having a first end for dissecting a tissue pocket and a second end comprising an electrical connector; and

an electrode coupled to the first end of the dissection tool and electrically coupled to the connector , the connector adapted to be coupled to a pulse generator for delivering test stimulation pulses via the electrode coupled to the dissection tool to locate the nerve.

13. The system of claim 12, wherein the second end of the dissection tool comprises an incising blade for making a skin incision.

14. The system of claim 11, wherein the implantable medical device comprises at least one electrode carried along a face of the housing of the implantable medical device configured to be positioned against the superficial surface of the tissue layer.

15. The system of claim 11, wherein the implantable medical device comprises an electrical lead carrying at least one electrode adapted to be advanced along the superficial surface of the tissue layer.

16. The system of claim 11, further comprising a fixation member for fixating the implantable medical device along the superficial surface of the tissue layer.

17. The system of claim 16, wherein the fixation member comprises a passive fixation member extending from a housing of the implantable medical device for engaging a surrounding tissue.

18. The system of claim 16, further comprising an active fixation member adapted to be inserted into the tissue layer for fixating the implantable medical device by capturing the tissue layer between the housing of the implantable medical device and a portion of the active fixation member.

19. The system of claim 18, wherein the housing comprises an aperture for receiving the active fixation member, the active fixation member configured to be advanced through the aperture into the tissue layer.

20. The system of claim 11, further comprising an external device for transmitting power from a cutaneous position over the implantable medical device for powering the pulse generator to generate stimulation pulses delivered to the nerve via the plurality of electrodes.

21. A method for delivering a neurostimulation therapy comprising:

delivering electrical stimulation energy via at least one electrode positioned subcutaneously and superficially to a deep fascia tissue layer superficial to a tibial nerve to stimulate the tibial nerve through the deep fascia tissue layer.