# US 2024/0198103 A1 · System, Method, and Apparatus for Neurostimulation

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- Number: US 2024/0198103 A1
- Document ID: US20240198103A1
- Status: Published application
- Kind: A1
- Application number: 18/591,326
- Filed: 2024-02-29
- Published: 2024-06-20
- Earliest claimed: 2017-12-28
- Assignees: Realeve, LLC
- Applicants: Realeve, LLC
- Inventors: William Hsu; Ian Welsford; Mark Van Kerkwyk; Vimal Ganesan; Bruce Levin
- Web page: https://patentgrep.com/patent/US20240198103A1

## CPC

- A61N 1/36075: {Headache or migraine}
- A61N 1/0546: {Nasal electrodes}
- A61N 1/36146: {specified by the stimulation parameters}
- A61N 1/37241: {providing test stimulations}
- A61N 1/3787: {from an external energy source}
- A61N 1/0476: {Array electrodes (including any electrode arrangement with more than one electrode for at least one of the polarities)}
- A61N 1/0526: {Head electrodes (A61N1/0551 takes precedence)}
- A61N 1/36057: {adapted for stimulating afferent nerves}
- A61N 1/37205: {Microstimulators, e.g. implantable through a cannula}
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)

## Abstract

An implantable neurostimulator includes a lead comprising a plurality of electrodes at a distal end, and an implant body including electronics for controlling operation of the electrodes. An electrical connector establishes an electrical connection between the electronics and the electrodes. The implant body includes a first portion of the electrical connector, and the proximal end of the lead includes a second portion of the electrical connector. The first and second portions of the electrical connector are connectable to establish the electrical connection between the electronics and the electrodes. The lead is configured for initial implantation in the patient and the implant body is configured for subsequent implantation in the patient. The electrical connector is configured so that the connection of the first and second portions can be performed with the implant body and the lead positioned at a surgical site in the patient.

## Claims

### Claim 1

An implantable neurostimulator comprising:
a lead comprising a plurality of electrodes at a distal end;
an implant body comprising electronics for controlling operation of the electrodes; and
an electrical connector for establishing an electrical connection between the electronics and the electrodes;
wherein the implant body comprises a first portion of the electrical connector and the proximal end of the lead comprises a second portion of the electrical connector, the first and second portions of the electrical connector being connectable to establish the electrical connection between the electronics and the electrodes; and
wherein the lead is configured for initial implantation in the patient and the implant body is configured for subsequent implantation in the patient, and wherein the electrical connector is configured so that the connection of the first and second portions can be performed with the implant body and the lead positioned at a surgical site in the patient.

### Claim 2 (depends on 1)

The implantable neurostimulator recited in claim 1, wherein the electrical connector is a plug-in connector configured so that the electrical connection can be made by pressing together the first and second portions.

### Claim 3 (depends on 2)

The implantable neurostimulator recited in claim 2, wherein the first portion of the electrical connector has a stepped female configuration and the second portion of the electrical connector has a stepped male configuration.

### Claim 4 (depends on 1)

The implantable neurostimulator recited in claim 1, wherein the second portion of the connector is configured for a connection via wires to an external controller, wherein the external controller is configured to energize the electrodes during implantation in order to obtain feedback for use in positioning the electrodes.

### Claim 5 (depends on 4)

The implantable neurostimulator recited in claim 4, wherein the feedback is feedback indicative of sensing paresthesia induced by the electrodes.

### Claim 6 (depends on 1)

The implantable neurostimulator recited in claim 1, wherein the lead is configured to pass through an 18 gauge surgical needle.

### Claim 7 (depends on 1)

The implantable neurostimulator recited in claim 1, wherein the implant body is configured to pass through a 14 gauge surgical needle.

### Claim 8 (depends on 1)

The implantable neurostimulator recited in claim 1, further comprising a remote transducer for providing a wireless signal for powering the stimulator, the remote transducer comprising at least one of a patch, headset, earpiece, extended earpiece, handheld remote controller, headband, and eyeglasses.

### Claim 9 (depends on 8)

The implantable neurostimulator recited in claim 8, further comprising a remote controller for controlling operation of the remote transducer, the remote controller comprising a foot pedal or a key fob that communicates wirelessly with the remote transducer.

### Claim 10

A method for implanting a two-piece neurostimulator comprising an electrode lead and an implant body connectable with the lead to supply power for energizing the electrodes to apply stimulation therapy, the method comprising:
implanting the lead using a Seldinger technique; and
implanting the implant body; and
connecting the implant body to the lead.

### Claim 11 (depends on 10)

The method of claim 10, wherein the neurostimulator is implanted via a gingival-buccal approach, a transoral approach, a trans-nasal a lateral approach through an infratemporal fossa of the patient, or an infrazygomatic approach in which the entry site of the neurostimulator is inferior to the zygoma and anterior to the mandible.

### Claim 12

A method for implanting a two-piece neurostimulator comprising an electrode lead and an implant body connectable with the lead to supply power for energizing the electrodes to apply stimulation therapy to a patient, the method comprising:
attaching a guidewire to the lead;
implanting the lead using the guidewire to navigate through the patient's anatomy and position the electrodes at a desired site in the patient;
removing the guidewire, leaving the lead implanted;
implanting the implant body; and
connecting the implant body to the lead.

### Claim 13 (depends on 12)

The method of claim 12, wherein the neurostimulator is implanted via a gingival-buccal approach, a transoral approach, a trans-nasal a lateral approach through an infratemporal fossa of the patient, or an infrazygomatic approach in which the entry site of the neurostimulator is inferior to the zygoma and anterior to the mandible.

### Claim 14

A method for implanting a neurostimulator comprising an electrode lead and an implant body for supplying power for energizing the electrodes to apply stimulation therapy to a patient, the method comprising:
attaching a guidewire to the neurostimulator;
implanting the stimulator using the guidewire to navigate through the patient's anatomy and position the electrodes at a desired site in the patient; and
removing the guidewire, leaving the stimulator.

### Claim 15 (depends on 14)

The method of claim 14, wherein the neurostimulator is implanted via a gingival-buccal approach, a transoral approach, a trans-nasal a lateral approach through an infratemporal fossa of the patient, or an infrazygomatic approach in which the entry site of the neurostimulator is inferior to the zygoma and anterior to the mandible.

### Claim 16

A method for implanting a two-piece neurostimulator comprising an electrode lead and an implant body connectable with the lead to supply power for energizing the electrodes to apply stimulation therapy to a patient, the method comprising:
anesthetizing the patient using an anesthesia solution that is sufficient for controlling pain but allows the patient to perceive paresthesia from stimulation;
connecting the lead to an external controller that is operable to energize the electrodes to apply stimulation;
surgically implanting the lead while applying stimulation via the electrodes;
querying the patient for feedback regarding perceived paresthesia during while implanting the lead;
using the feedback from the patient to assist in determining a proper position for the lead;
securing the lead in the proper position;
disconnecting the lead from the external controller; and
surgically implanting the implant body and connecting the implant body to the lead.

### Claim 17 (depends on 16)

The method of claim 16, wherein the neurostimulator is implanted via a gingival-buccal approach, a transoral approach, a trans-nasal a lateral approach through an infratemporal fossa of the patient, or an infrazygomatic approach in which the entry site of the neurostimulator is inferior to the zygoma and anterior to the mandible.

### Claim 18

A method for treating a migraine headache in a patient using an implantable neurostimulator, comprising:
programming stimulation parameters into the neurostimulator so that patient does not perceive paresthesia from electrical stimulation of the sphenopalatine ganglion (SPG);
implanting the neurostimulator so that a lead of the stimulator having at least one electrode is at a target position proximate to the SPG of the patient;
delivering a non-paresthesia stimulation waveform to the at least one electrode based on a therapy parameter set (TPS), the stimulation waveform including a series of pulses configured to excite at least one of A-delta fibers or C-fibers of the SPG of the patient;
sensing sensory action potential (SAP) signals of the patient;
iterating the steps of delivering the non-paresthesia stimulation waveform and sensing the SAP signals while changing at least one parameter from the TPS;
analyzing the SAP signals to obtain SAP activity data associated with the TPS for at least one of an SAP C-fiber component or an SAP A-delta fiber component to obtain a collection of SAP activity data associated with multiple therapy parameter set;
selecting one or more parameters for the TPS based on the collection of SAP activity data;
programming a pulse generator of the neurostimulator to deliver electrical stimulation to the SPG according to the TPS; and
activating the neurostimulator so that the pulse generator delivers electrical stimulation to the patient according to the programmed TPS.