# US 11,298,544 B2 · Nerve stimulation systems and methods using an external wireless power source

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- Number: US 11,298,544 B2
- Document ID: US11298544B2
- Status: Granted
- Kind: B2
- Application number: 15/999,427
- Filed: 2017-02-17
- Published: 2020-06-25
- Granted: 2022-04-12
- Earliest claimed: 2016-02-17
- Assignees: Galvani Bioelectronics Limited
- Applicants: Galvani Bioelectronics Limited
- Inventors: Brian Marc Pepin; Brian Otis
- Web page: https://patentgrep.com/patent/US11298544B2

## CPC

- A61N 1/0556: {Cuff electrodes}
- A61B 5/24: Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
- A61B 5/4041: {Evaluating nerves condition}
- A61B 5/686: {Permanently implanted devices, e.g. pacemakers, other stimulators, biochips (A61B5/6861 takes precedence)}
- A61B 5/6877: {Nerve}
- A61N 1/36128: {Control systems}
- A61N 1/36139: {with automatic adjustment}
- A61N 1/3614: {based on impedance measurement}
- A61N 1/36178: {Burst or pulse train parameters}
- A61N 1/36192: {Amplitude modulation}
- A61N 1/37223: {Circuits for electromagnetic coupling}
- A61N 1/37229: {Shape or location of the implanted or external antenna}
- A61N 1/3787: {from an external energy source}
- H02J 7/02: for charging batteries from AC mains by converters
- H02J 7/345: {using capacitors as storage or buffering devices}
- H02J 50/10: using inductive coupling
- H02J 50/20: using microwaves or radio frequency waves
- H02J 50/80: involving the exchange of data, concerning supply or distribution of electric power, between transmitting devices and receiving devices
- A61B 2560/0219: of externally powered implanted units
- A61B 2562/0209: Special features of electrodes classified in A61B5/24, A61B5/25, A61B5/283, A61B5/291, A61B5/296, A61B5/053
- A61B 2562/164: the sensor is mounted in or on a conformable substrate or carrier
- A61N 1/3758: {Packaging of the components within the casing}
- H02J 2105/46: Medical devices, medical implants or life supporting devices
- 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)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- H02J: ELECTRIC POWER NETWORKS; CIRCUIT ARRANGEMENTS OR SYSTEMS FOR SUPPLYING OR DISTRIBUTING ELECTRIC POWER; SYSTEMS FOR STORING ELECTRIC ENERGY

## Abstract

Systems and methods are provided for stimulating one or more nerves with an implantable device. The implantable device may comprise an antenna circuit including a loop antenna and a control circuit including a rectifying diode for rectifying an alternating voltage induced in the antenna circuit by an external electromagnetic field. The implantable device may also include a chargeable storage element for storing energy from the rectified voltage without using a battery. The device may also include an electrode array containing a set of electrodes for emitting an electric field using the stored energy in response to a control signal received from the control circuit. The components of the device may be affixed onto a soft polymer substrate including a linkable peripheral tab on at least two edges of a substantially rectangular body section of the substrate for forming a cuff about the one or more nerves to be stimulated.

## Claims

### Claim 1

A system for stimulating a one or more nerves with an implantable device, the implantable device comprising:
an antenna circuit tunable to a working frequency, the antenna circuit comprising an antenna and configured to detect a modulated data signal received by the antenna;
a control circuit coupled to the antenna circuit, the control circuit comprising a rectifying diode configured to rectify an alternating voltage induced in the antenna circuit by an external electromagnetic field and a demodulation circuit that is configured to extract the modulated data signal and to one or more of process and interpret data from the modulated data signal;
a chargeable storage element, coupled to the control circuit, configured to store energy from the rectified voltage;
an electrode array coupled to the control circuit and the chargeable storage element, the electrode array comprising a set of electrodes and configured to emit an electric field for stimulating the one or more nerves using the stored energy in response to a control signal emitted from the control circuit;
a plurality of sensors coupled to the control circuit and configured to measure an electrical potential associated with the one or more nerves after stimulation, wherein the modulated data signal includes pulse parameters for the electric field based on the measured electrical potential; and
a soft polymer substrate configured to support the antenna circuit, the control circuit, the chargeable storage element, and the electrode array and configured to form a cuff.

### Claim 2 (depends on 1)

The system of claim 1, further comprising a wireless transmitter configured to generate the external electromagnetic field.

### Claim 3 (depends on 2)

The system of claim 2, wherein the wireless transmitter is embedded in an object external to the implantable device.

### Claim 4 (depends on 2)

The system of claim 2, wherein the wireless transmitter comprises an antenna array comprising a plurality of antennas configured to emit the external electromagnetic field.

### Claim 5 (depends on 4)

The system of claim 4, wherein at least two antennas of the plurality of antennas have different orientations.

### Claim 6 (depends on 1)

The system of claim 1, further comprises a plurality of sensors coupled to the control circuit, the plurality of sensors configured to detect an electrical potential within the cuff.

### Claim 7 (depends on 6)

The system of claim 6, wherein:
the antenna circuit comprises at least one input terminal; and the control circuit is configured to:
apply an excitation signal to the input terminal, causing the antenna circuit to generate a second electromagnetic field oscillating at the working frequency; and
modulate the amplitude of the excitation signal based on a measured electrical potential from the plurality of sensors to form a second modulated data signal.

### Claim 8 (depends on 7)

The system of claim 7, further comprising a wireless transmitter configured to generate the external electromagnetic field, wherein the wireless transmitter comprises a second demodulation circuit that is configured to demodulate the second modulated data signal formed in the antenna circuit by the modulated excitation signal.

### Claim 9 (depends on 8)

The system of claim 8, wherein data from the second modulated data signal includes a status of the nerve bundle based on the electrical potential detected by the plurality of sensors.

### Claim 10 (depends on 9)

The system of claim 9, wherein the data in the modulated data signal is based on the status of the nerve bundle.

### Claim 11 (depends on 1)

The system of claim 1, wherein the substrate further comprises a rectangular neck section on which the control circuit is affixed and a circular head section on which the antenna is affixed.

### Claim 12 (depends on 11)

The system of claim 11, wherein the chargeable storage element comprises a capacitive storage element affixed to the circular head section within the antenna circuit, and wherein the implantable device further comprises a plurality of sensors embedded onto the substrate for detecting electrical potentials.

### Claim 13 (depends on 11)

The system of claim 11, wherein the substrate further comprises at least two peripheral tabs includes a first linkable peripheral tab on an edge adjacent to the neck section and a second linkable peripheral tab on an edge opposite the neck section.

### Claim 14 (depends on 11)

The system of claim 11, wherein the chargeable storage element is affixed to the neck section.

### Claim 15 (depends on 1)

The system of claim 1, wherein the chargeable storage element comprises a capacitive storage element.

### Claim 16 (depends on 15)

The system of claim 15, wherein the capacitive storage element has a capacitance of less than 1 nF, preferably less than 75 pF.

### Claim 17 (depends on 15)

The system of claim 15, wherein the control circuit and the capacitive storage element are incorporated on an integrated circuit.

### Claim 18 (depends on 15)

The system of claim 15, wherein the capacitive storage element is external to the control circuit.

### Claim 19 (depends on 1)

The system of claim 1, wherein the electrode array comprises a plurality of electrodes coupled via a high-density, flexible interconnection made of a metal.

### Claim 20 (depends on 1)

The system of claim 1, wherein the control circuit is configured to apply the control signal at a predetermined time to stimulate one or more nerves in proximity to the implantable device.

### Claim 21 (depends on 1)

The system of claim 1, wherein the electrode array is configured to emit the electric field in a plurality of pulses to stimulate the one or more nerves, wherein the plurality of pulses extends for a fixed duration of time.

### Claim 22 (depends on 21)

The system of claim 21, wherein the fixed duration of time is between one and five minutes.

### Claim 23

A method for stimulating a nerve bundle with an implantable device, the implantable device comprising an antenna circuit including one or more input terminals, a control circuit coupled to the antenna circuit, a chargeable storage element coupled to the control circuit, an electrode array coupled to the control circuit and capacitive storage, and a plurality of sensors coupled to the control circuit, the method comprising:
after implantation of the implantable device, rectifying a voltage induced in the antenna circuit from an external electromagnetic field with a rectifying diode in the control circuit;
detecting a modulated data signal received by the antenna circuit;
demodulating the modulated data signal to process a plurality of pulse parameters interpreted from the modulated data signal;
storing the rectified voltage as energy in the chargeable storage element;
applying a control signal from the control circuit to an electrode terminal of the electrode array in accordance with the plurality of pulse parameters;
emitting an electrical pulse from the electrode array using the stored energy to stimulate the nerve bundle, the electrical pulse based on the control signal and the plurality of pulse parameters;
measuring, with the plurality of sensors, an electrical potential associated with the nerve bundle after stimulation; and
applying a modulated excitation signal from the control circuit to an input terminal of the antenna circuit, the excitation signal modulated based on the measured electrical potential.

### Claim 24 (depends on 23)

The method of claim 23, wherein the data of the modulated signal includes pulse parameters for the electrical pulse.

### Claim 25

A method for stimulating a nerve bundle with an implantable device, the implantable device comprising an antenna circuit including one or more input terminals, a control circuit coupled to the antenna circuit, a chargeable storage element coupled to the control circuit, an electrode array coupled to the control circuit and the chargeable storage element, and a plurality of sensors coupled to the control circuit, the method comprising:
measuring, with the plurality of sensors, an electrical potential associated with the nerve bundle after implantation of the implantable device;
applying a modulated excitation signal from the control circuit to an input terminal of the antenna circuit, the excitation signal modulated based on the measured electrical potential;
demodulating a data signal formed in the antenna array from a first external electromagnetic field emitted from a wireless transmitter, the data signal including a plurality of pulse parameters indicative of characteristics of an electrical pulse;
applying a control signal to an electrode terminal of the electrode array, the control signal based on the plurality of pulse parameters; and
emitting an electrical pulse from the electrode array in accordance with the plurality of pulse parameters to stimulate the nerve bundle, the electrical pulse generated from energy stored in the chargeable storage element, wherein the plurality of pulse parameters is based on the measured electrical potential.
