Minimally invasive neurostimulation device

Patent metadata

Field	Value
Publication number	US-12257441-B2
Application number	US-202318307385-A
Country	US
Kind code	B2
Filing date	Apr 26, 2023
Priority date	Jul 17, 2019
Publication date	Mar 25, 2025
Grant date	Mar 25, 2025

Abstract

Aspects of the present disclosure are directed to an implantable medical device including a housing containing components therein configured for delivering neurostimulation therapy, and an anchoring feature included with the housing. The implantable medical device also includes a lead having an electrode. In one aspect, the implantable medical device may include a guidewire passageway configured to allow the lead of implantable medical device to be introduced over a guidewire.

First claim

What is claimed is:

1. A method of implanting a tibial nerve stimulation device in an ankle region of a patient, the tibial nerve stimulation device including a housing and an electrical lead coupled to the housing, the electrical lead offset from the housing and including at least one electrode, a longitudinal axis of the housing generally oriented in the same direction as a longitudinal axis of the electrical lead, the method comprising:
creating a first incision, in a skin of a patient superior and posterior to a medial malleolus on an ankle of the patient;
creating a second incision, in a fascia layer in the ankle of the patient, the second incision being smaller than the first incision and the second incision sized to allow passage of the electrical lead therethrough; and
advancing the implantable tibial nerve stimulation device through the first incision downward towards a heel of the patient and inward such that the electrical lead passes through the second incision, such that the housing of the implantable tibial nerve stimulation device is positioned superficial to the fascia layer and such that the at least one electrode is positioned below the fascia.

2. The method of claim 1 , further comprising advancing the implantable tibial nerve stimulation device through the first incision over a guidewire.

3. The method of claim 1 , wherein the electrical lead of the tibial nerve stimulation device includes a guidewire passageway extending from a proximal end of the electrical lead to a distal end of the electrical lead and being open on both ends such that a guidewire can extend outward from each end with the lead coupled to the housing, the method further comprising:
advancing the implantable tibial nerve stimulation device through the first incision over a guidewire via the guidewire passageway in the electrical lead.

4. The method of claim 1 , further comprising implanting the implantable tibial nerve stimulation device such that the electrical lead longitudinal axis is generally oriented in the same direction as the housing longitudinal axis when implanted.

5. The method of claim 1 , wherein advancing the implantable tibial nerve stimulation device is performed using an implant tool including an outer sheath and an inner sheath, the inner sheath including a cradle portion configured to selectively carry the implantable tibial nerve stimulation device, the method further comprising:
advancing the outer sheath of the implant tool toward a target implant location with respect to the inner sheath so as to deliver the implantable tibial nerve stimulation device to the target implant location.

6. The method of claim 1 , further comprising:
performing testing of the implantable tibial nerve stimulation device, the testing including delivering a test stimulation and measuring an indicative patient response to the test stimulation.

Assignees

• Medtronic Inc

Inventors

• Bombeck Charles
• Offutt Sarah
• Bauer Ryan
• Cleland Andrew
• Roles Randy S

Classifications

• A61B2034/252

  indicating steps of a surgical procedure · CPC title

• A61N1/0504

  Subcutaneous electrodes · CPC title

• A61N1/0558

  Anchoring or fixation means therefor · CPC title

• A61N1/378

  Electrical supply · CPC title

• A61N1/0551

  Spinal or peripheral nerve electrodes · CPC title