Minimally invasive implantable neurostimulation system

Patent metadata

Field	Value
Publication number	US-11730949-B2
Application number	US-202016947949-A
Country	US
Kind code	B2
Filing date	Aug 25, 2020
Priority date	Dec 7, 2012
Publication date	Aug 22, 2023
Grant date	Aug 22, 2023

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 minimally invasive implantable medical device 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 titanium or an alloy thereof,
the hermetically sealed housing having a reduced size for minimally invasive implantation, with a volume of less than approximately one cubic centimeter,
configured for implantation within a body of a patient for delivery of neurostimulation therapy to an acupuncture point for treatment of a symptom associated with the acupuncture point;
electronic circuitry enclosed within the hermetically sealed housing, electronic circuitry comprising:
a power supply,
a pulse generator,
a memory, and
a control unit 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 incorporated into the hermetically sealed housing with externally exposed surfaces capable of being operably positioned in proximity to a targeted nerve and electrically coupled to the pulse generator;
telemetry module and associated antenna configured to establish a wireless telemetry link between the electronic circuitry and at least one external programming device,
wherein communication with the external programming device via the telemetry module enables receipt of a command to adjust an intensity or strength of the therapy up or down,
wherein receipt of a command via the telemetry module is confirmable by the external programming device.

2. The low profile implantable tibial nerve stimulation device of claim 1 , wherein the hermetically sealed housing is configured for implantation along the medial portion of an ankle of a patient for delivery of an electrical stimulation therapy to a 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 between about one cubic centimeter and about one tenth of a cubic centimeter.

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

6. 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.

7. 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.

8. The low profile implantable tibial nerve stimulation device of claim 7 , wherein the external magnetic field is configured to cease the neurostimulation therapy.

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

10. 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, therapy on and off times, electrode selection, or electrode polarity assignments.

11. 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.

12. The low profile implantable tibial nerve stimulation device of claim 1 , wherein the power supply comprises at least one of a primary battery cell, rechargeable battery cell, or an inductively couple power source.

13. The low profile implantable tibial nerve stimulation device of claim 12 , wherein the telemetry module is configured to transmit a remaining life of the power supply.

14. 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.

15. The low profile implantable tibial nerve stimulation device of claim 14 , 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.

16. The low profile implantable tibial nerve stimulation device of claim 15 , 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.

17. The low profile implantable tibial nerve stimulation device of claim 14 , wherein the user interface prompts the user to enter information at regular intervals.

18. 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.

19. The low profile implantable tibial nerve stimulation device of claim 18 , 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.

Assignees

• Medtronic Inc

Inventors

• Scott Erik R
• Kast John E
• Wei Xuan K
• Smith Todd V
• Anderson Joel A
• Pape Forrest C M
• Bourget Duane L
• Denison Timothy J
• Dinsmoor David A
• Roles Randy S
• Roddy Stephen J

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

• A61N1/3605

  Implantable neurostimulators for stimulating central or peripheral nerve system · CPC title