# US 2019/0167997 A1 · Spinal Cord Stimulation with Interferential Current

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- Number: US 2019/0167997 A1
- Document ID: US20190167997A1
- Status: Published application
- Kind: A1
- Application number: 16/266,768
- Filed: 2019-02-04
- Published: 2019-06-06
- Earliest claimed: 2003-01-22
- Assignees: Meagan Medical, Inc.
- Applicants: Meagan Medical, Inc.
- Inventors: William J. Carroll
- Web page: https://patentgrep.com/patent/US20190167997A1

## CPC

- A61N 1/36071: {Pain}
- A61N 1/0551: {Spinal or peripheral nerve electrodes}
- A61N 1/0553: {Paddle shaped electrodes, e.g. for laminotomy}
- A61N 1/36171: {Frequency}
- A61N 1/36175: {Pulse width or duty cycle}
- A61N 1/36185: {Selection of the electrode configuration}
- A61N 1/36192: {Amplitude modulation}
- A61N 1/40: Applying electric fields by inductive or capacitive coupling (microwave apparatus A61N5/00); {Applying radio-frequency signals}
- 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

A stimulator and a method for the treatment of intractable pain syndromes by electrical stimulation of the spinal cord is disclosed in which implantable electrodes positioned around a targeted area of the spinal cord transmit an interferential current that has a base medium frequency alternating current between 500 Hz-20 KHz. A digital signal processor generates a sine-wave-like waveform from a pulse generator which after further processing is used to generate at least two circuits for use in producing the beat frequency signal. An effective area of stimulation is controlled by the quantity of electrodes, positioning of the electrodes and electrode cross pattern orientation. Amplitude modulation of electrical circuits created at the electrode placements also augments the effective area of stimulation. The stimulator and method reduce accommodation of the body to the electrical stimulation and provide deeper penetration of the resultant signal.

## Claims

### Claim 1

A method for spinal cord stimulation treatment for treating pain using electrical stimulation of the spinal cord, the method comprising:
positioning a first pair of implantable electrodes to a dura matter in an epidural space proximate to a subject's spinal cord at predetermined locations;
positioning a second pair of implantable electrodes to the dura matter in the epidural space proximate to the subject's spinal cord at predetermined locations;
positioning the first pair of implantable electrodes and the second pair of implantable electrodes so that a first circuit is created between a first electrode of the first pair of implantable electrodes and a first electrode of the second pair of implantable electrodes and so that a second circuit is created between a second electrode of the first pair of implantable electrodes and a second electrode of the second pair of implantable electrodes, wherein the first circuit and the second circuit are arranged to cross one another;
transmitting signals of first and second frequencies through the first and second pairs of implantable electrodes respectively, so that the signals of the first and second frequencies interfere with each other to produce at least one beat signal proximate to the subject's spinal cord; and
altering a targeted area of the subject's spinal cord by modulating amplitudes of the signals of first and second frequencies.

### Claim 2 (depends on 1)

The method of claim 1, further comprising varying a depth of modulation of the at least one beat signal based on an angle of crossing the first and second circuits.

### Claim 3 (depends on 2)

The method of claim 2, wherein a resulting modulation of the at least one beat signal is a deepest level of modulation at about 45° between the first and second circuits.

### Claim 4 (depends on 1)

The method of claim 1, wherein a majority of the at least one beat signal is directionally distributed and controlled, enabling the at least one beat signal to avoid remaining in and shunting through cerebrospinal fluid proximate to the subject's spinal cord, thereby recruiting dorsal column fibers.

### Claim 5 (depends on 1)

The method of claim 1, further comprising:
supplying digital signal pulses to a digital signal processor via a pulse generator;
the digital signal processor processing the digital signal pulses to approximate a sine-wave-like output waveform; and
transmitting the sine-wave-like output waveform as signals of the first and second frequencies through the first and second pairs of implantable electrodes.

### Claim 6 (depends on 1)

The method of claim 1, further comprising varying locations of the first and second pairs of implantable electrodes along the spinal cord.

### Claim 7 (depends on 1)

The method of claim 1, further comprising modulating amplitudes of outputs of the first and second pairs of implantable electrodes.

### Claim 8 (depends on 1)

The method of claim 1, wherein the method includes transmitting signals using a current with a resultant beat frequency of no more than 250 Hz.

### Claim 9 (depends on 1)

The method of claim 1, wherein the method includes transmitting signals using a current with a voltage output of 11 volts maximum.

### Claim 10 (depends on 1)

The method of claim 1, wherein the method includes transmitting signals using a current with a pulse width of 210 microseconds.

### Claim 11 (depends on 1)

The method of claim 1, wherein the method includes transmitting signals using a current with a pulse width comprising a range of at least 10 microseconds but no more than 600 microseconds.

### Claim 12 (depends on 1)

The method of claim 1, wherein the first pair of implantable electrodes and the second pair of implantable electrodes are included on two quadripolar leads.

### Claim 13 (depends on 1)

The method of claim 1, wherein the first circuit and the second circuit interfere to create a resultant signal having a resultant beat frequency that is a difference between the first and second frequencies and an amplitude that is additive and more than an amplitude of the signal of the first frequency.

### Claim 14 (depends on 1)

The method of claim 1, wherein the first and second circuits cross at about 90° resulting in a maximum amplitude of the resultant signal.

### Claim 15 (depends on 1)

The method of claim 1, wherein the first and second circuits cross at about 90° and a resulting modulation of the resultant signal is a deepest level of modulation at about 45° between the first and second circuits.

### Claim 16 (depends on 1)

The method of claim 1, wherein the first and second circuits cross and a resulting modulation of the resultant signal varies in intensity between the first and second circuits.

### Claim 17 (depends on 1)

The method of claim 1, wherein the method includes transmitting signals using a current with a pulse width in a range from 50-600 microseconds.

### Claim 18

An electrical stimulator for the treatment of intractable pain syndromes, comprising:
an interferential current generator which generates an interferential alternating current output comprising first and second signals having different first and second frequencies; and
at least two pairs of implantable electrodes wherein each electrode has a first and a second end, wherein the first ends are connected to said interferential current generator and the second ends are configured to be implanted to a dura matter in an epidural space at predetermined locations proximate to a subject's spinal cord, wherein each pair of said at least two pairs of implantable electrodes transmits one of said first and second signals such that the first and second frequencies interfere with each other to produce at least one beat signal proximate to the subject's spinal cord using a current with a base medium frequency of at least 500 Hz but no more than 20 KHz.

### Claim 19 (depends on 18)

The electrical stimulator of claim 18, wherein said interferential current generator comprises:
a pulse generator that generates digital signal pulses; and
a digital signal processor connected to said pulse generator that processes the digital signal pulses to approximate a sine-wave-like output waveform.

### Claim 20 (depends on 18)

The electrical stimulator of claim 18, wherein said interferential current generator comprises:
a pulse generator that generates digital signal pulses; and
a field-programmable gate array connected to said pulse generator that processes the digital signal pulses to approximate a sine-wave-like output waveform.
