Minimally invasive implantable neurostimulation system

Patent metadata

Field	Value
Publication number	US-11957894-B2
Application number	US-202016947947-A
Country	US
Kind code	B2
Filing date	Aug 25, 2020
Priority date	Dec 7, 2012
Publication date	Apr 16, 2024
Grant date	Apr 16, 2024

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.

First claim

The invention claimed is:

1. A low profile implantable medical device configured to lay generally flat beneath skin, muscle or other tissue of a patient for delivering neurostimulation therapy to an acupuncture point for treatment of a symptom associated with the acupuncture point, the implantable medical device comprising:
a hermetically sealed housing formed of a biocompatible metal, the biocompatible metal comprising at least one of a titanium, stainless steel or an alloy thereof, the hermetically sealed housing including:
a top face;
a bottom face; and
a continuous sidewall;

wherein each of the top face and the bottom face has a linear dimension of less than approximately twenty-seven millimeters in length,
wherein the top face and the bottom face are circumscribed by the continuous sidewall defining an internal cavity,
wherein the continuous sidewall extends substantially perpendicular to the top face and is rounded to provide a smooth continuous surface without sharp corners or edges, and
wherein the hermetically sealed housing generally has a flat profile for positioning between tissue layers of a patient;
electronic circuitry positioned within the internal cavity of the hermetically sealed housing, electronic circuitry comprising:
a pulse generator,
a memory, and
a controller configured to cause the pulse generator to deliver a therapy output according to a specified stimulation regimen stored in the memory;
two or more electrodes electrically coupled to the pulse generator and located on an exterior surface of the hermetically sealed housing, the two or more electrodes comprising: a stimulating cathode arranged on the bottom face of the hermetically sealed housing,
the stimulating cathode comprising: an insulator; and an electrically conductive electrode extending through the insulator,
wherein the electrically conductive electrode is configured to be positioned in proximity to a targeted acupuncture point, and an anode, wherein an uninsulated portion of the housing functions as the anode; and

a telemetry module and associated antenna configured to establish a wireless telemetry link between the electronic circuitry and at least one external programming device, wherein the wireless telemetry link enables receipt of a command from the external programming device to adjust an intensity or strength of the therapy up or down,
wherein an established wireless telemetry link between the electronic circuitry and the at least one external programming device is confirmable.

2. The low profile implantable tibial nerve stimulation device of claim 1 , wherein the hermetically sealed housing is configured for implantation in a region of the medial malleolus of a patient for delivering a neurostimulation therapy to the tibial nerve of the patient.

3. The low profile implantable tibial nerve stimulation device of claim 1 , wherein the low profile implantable tibial nerve stimulation device is configured to stimulate a tibial nerve of a patient to treat overactive bladder syndrome.

4. The low profile implantable tibial nerve stimulation device of claim 1 , wherein the low profile implantable tibial nerve stimulation device has a total volume of about 1 cubic centimeter.

5. The low profile implantable tibial nerve stimulation device of claim 1 , wherein the low profile implantable tibial nerve stimulation device has a total volume of between about 1 one cubic centimeter cc and about one tenth of a cubic centimeter.

6. The low profile implantable tibial nerve stimulation device of claim 1 , wherein the controller comprises a microprocessor.

7. The low profile implantable tibial nerve stimulation device of claim 1 , wherein the insulator of the stimulating cathode is comprised of a ceramic material.

8. The low profile implantable tibial nerve stimulation device of claim 1 , wherein an output of the electronic circuitry is selectively adjustable via an external magnetic field.

9. The low profile implantable tibial nerve stimulation device of claim 8 , wherein the external magnetic field is configured to cease the neurostimulation therapy.

10. The low profile implantable tibial nerve stimulation device of claim 1 , wherein the telemetry module is configured to establish a wireless telemetry link over a distance of at least two-feet.

11. The low profile implantable tibial nerve stimulation device of claim 1 , wherein the wireless telemetry link is bidirectional.

12. The low profile implantable tibial nerve stimulation device of claim 1 , wherein the telemetry module is configured to enable a user to control therapy output parameters, including at least one of a pulse amplitude, a pulse width, pulse shape, pulse frequency, duty cycle, or therapy on and off times.

13. The low profile implantable tibial nerve stimulation device of claim 1 , wherein the telemetry module is configured to at least one of transmit or receive at least one of patient data, therapy data or device related data.

14. The low profile implantable tibial nerve stimulation device of claim 1 , wherein the electronic circuitry further includes a power supply comprising at least one of a primary battery cell, rechargeable battery cell, or an inductively couple power source.

15. The low profile implantable tibial nerve stimulation device of claim 14 , wherein the telemetry module is configured to transmit a remaining life of the power supply.

16. The low profile implantable tibial nerve stimulation device of claim 1 , further comprising a user interface configured to enable a user to adjust stimulation control parameters.

17. The low profile implantable tibial nerve stimulation device of claim 16 , wherein the user interface enables the user to enter information relating to at least one of symptoms or events associated with at least one of the delivered neurostimulation therapy or an overactive bladder.

18. The low profile implantable tibial nerve stimulation device of claim 17 , wherein the user interface enables a user to enter at least one of a fluid intake, a voiding time, a wetting event, or a medication taken.

19. The low profile implantable tibial nerve stimulation device of claim 16 , wherein the user interface prompts the user to enter information at regular intervals.

20. The low profile implantable tibial nerve stimulation device of claim 1 , further comprising one or more sensor configured to at least one of detect a need for therapy delivery, monitor a response to therapy delivery, control therapy delivery on/off times, or provide feedback to a user.

21. The low profile implantable tibial nerve stimulation device of claim 20 , wherein the one or more sensor is configured to measure at least one of a electromyogram signal, muscle, or nerve activation due to delivered neurostimulation therapy.

22. The low profile implantable tibial nerve stimulation device of claim 16 , wherein the user interface is configured to receive user input via a touchscreen.

23. The low profile implantable tibial nerve stimulation device of claim 16 , wherein the user interface enables the user to send and receive data over at least one of a local network, wide area network, or cellular network.

24. The low profile implantable tibial nerve stimulation device of claim 16 , wherein the user interface is configured enable interaction with the implantable device to at least one of initiate tibial nerve stimulation, initiate a data communication session or adjust the specified stimulation regim

Assignees

• Medtronic Inc

Inventors

• Chasensky Anthony M
• Li Bernard Q
• Tischendorf Brad C
• Paidosh Chris J
• Nielsen Christian S
• Schmidt Craig L
• Dinsmoor David A
• Bourget Duane L
• Bonde Eric H
• Scott Erik R
• Pape Forrest C M
• Molnar Gabriela C
• Munns Gordon O
• Anderson Joel A
• Kast John E
• Viavattine Joseph J
• Reiterer Markus W
• Ebert Michael J
• Falkner Phillip C
• Tamirisa Prabhakar A
• Roles Randy S
• Robinson Reginald D
• Stone Richard T
• Kelley Shawn C
• Roddy Stephen J
• Miltich Thomas P
• Denison Timothy J
• Smith Todd V
• Wei Xuan K

Classifications

• A61N1/02 Primary

  Details · CPC title

• A61B17/00234

  for minimally invasive surgery (A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence) · CPC title

• A61N1/05

  for implantation or insertion into the body, e.g. heart electrode (A61N1/06 takes precedence) · CPC title

• A61N1/0551

  Spinal or peripheral nerve electrodes · CPC title

• A61N1/36007

  of urogenital or gastrointestinal organs, e.g. for incontinence control · CPC title