# US 10,441,807 B2 · Treatment of conditions susceptible to pulsed electromagnetic field therapy

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- Number: US 10,441,807 B2
- Document ID: US10441807B2
- Status: Granted
- Kind: B2
- Application number: 15/527,977
- Filed: 2015-11-23
- Published: 2017-12-14
- Granted: 2019-10-15
- Earliest claimed: 2014-11-21
- Assignees: Regenesis Biomedical, Inc.
- Applicants: Regenesis Biomedical, Inc.
- Inventors: John Moffett
- Web page: https://patentgrep.com/patent/US10441807B2

## CPC

- A61N 2/008: {for pain treatment or analgesia}
- A61N 2/004: {specially adapted for a specific therapy}
- A61N 2/006: {for magnetic stimulation of nerve tissue}
- 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

The present disclosure relates to methods for treating diseases or conditions with pulsed electromagnetic field therapy, where the disease or condition treated is one susceptible to modulation of gene expression by pulsed electromagnetic field therapy. The present disclosure generally relates to methods of modulating gene expression and biological regulatory pathways with pulsed electromagnetic field therapy for treating diseases or conditions associated with such gene expression or regulatory pathways that are susceptible to modulation by pulsed electromagnetic therapy, including diseases or conditions associated with inflammation, nerve pain and wound repair.

## Claims

### Claim 1

A method of modulating one of a peroneal nerve and a tibial nerve function in a patient in need thereof comprising:
administering a PEMF treatment to the patient, the PEMF treatment comprising applying the PEMF treatment to a treated foot of the patient with a pulse frequency of about 1000 Hz and a pulse width of about 42 μs;
producing one of an increase in sympathetic skin response (SSR) waveform amplitude, a decrease in SSR time-to-onset, and an increase in nerve conduction velocity in the treated foot by administering the PEMF treatment; and
producing an increase in expression of one of IL-5, IL-6, IL-10, IL-12b, IL-21 and NGF genes in a neuronal cell in the treated foot by administering the PEMF treatment;
wherein the one of the peroneal nerve and the tibial nerve function is susceptible to the increase in expression of the one of IL-5, IL-6, IL-10, IL-12b, IL-21 and NGF genes in the neuronal cell in the treated foot.

### Claim 2 (depends on 1)

The method of claim 1, wherein administering the PEMF treatment does not modulate expression of one of IL-la and IL-1B in the neuronal cell in the treated foot.

### Claim 3 (depends on 1)

The method of claim 1, wherein the method comprises modulating one of an A-fiber and a C-fiber function associated with the one of the peroneal nerve and the tibial nerve function.

### Claim 4 (depends on 1)

The method of claim 1, wherein the patient has a condition of painful peripheral diabetic neuropathy (PPDN).

### Claim 5

A method of treating painful peripheral diabetic neuropathy (PPDN) in a patient in need thereof comprising:
administering a plurality of PEMF treatments to the patient over a treatment period, each of the plurality of PEMF treatment comprising applying the PEMF treatment to a treated foot of the patient with a pulse frequency of about 1000 Hz and a pulse width of about 42 μs;
promoting an increased nerve density in the treated foot over the treatment period by administering the PEMF treatment;
modulating nerve function in the treated foot over the treatment period by administering the PEMF treatment; and
producing a decrease in a pain score reported by the patient over the treatment period, by administering the PEMF treatment.

### Claim 6 (depends on 5)

The method of claim 5, wherein modulation of nerve function comprises producing one of an increase in sympathetic skin response (SSR) waveform amplitude, a decrease in SSR time-to-onset, and an increase in nerve conduction velocity in the treated foot.

### Claim 7

A method of modulating wound healing in a cell of a treated tissue of a patient in need thereof comprising:
applying a PEMF treatment to the treated tissue of the patient, the PEMF treatment comprising a pulse frequency of about 1000 Hz and a pulse width of about 42 μs; and
modulating expression of one of an HO-1, COX-2, ALOX-12, ALOX-15, PTGDS, PTGES, PTGIS, NOX, CAT, GSR, PRDX-6, and SOD-3 gene in the cell of the treated tissue; and
measuring a first wound volume at a first time and a second wound volume at a second time;
wherein the cell is one of a dermal fibroblast cell, an epidermal keratinocyte cell, and a human monocyte cell;
wherein expression of one of the HO-1, COX-2, ALOX-12, ALOX-15, PTGDS, PTGES, PTGIS, NOX, CAT, GSR, PRDX-6, and SOD-3 genes in the cell of the treated tissue is susceptible to the PEMF treatment; and
wherein the PEMF treatment produces a decrease in a wound volume between the first wound volume and the second wound volume.

### Claim 8 (depends on 7)

The method of claim 7, further comprising modulating expression for PENK, PDYN, and POMC genes of an IMR-32 cell.

### Claim 9 (depends on 7)

The method of claim 7, further comprising modulating one of the peroneal nerve and the tibial nerve function in the patient by applying the PEMF treatment to a foot of the patient.

### Claim 10 (depends on 9)

The method of claim 9, wherein modulating the one of the peroneal nerve and the tibial nerve function comprises producing one of an increase in sympathetic skin response (SSR) waveform amplitude, a decrease in SSR time-to-onset, and an increase in nerve conduction velocity in the treated foot.

### Claim 11 (depends on 7)

The method of claim 7, wherein the PEMF treatment is applied to a foot of the patient and comprises promoting an increased nerve density in the treated foot.

### Claim 12 (depends on 1)

The method of claim 1, further comprising promoting an increased nerve density in the treated foot over a treatment period by administering the PEMF treatment.

### Claim 13 (depends on 1)

The method of claim 1, further comprising modulating expression of one of an HO-1, COX-2, ALOX-12, ALOX-15, PTGDS, PTGES, PTGIS, NOX, CAT, GSR, PRDX-6, and SOD-3 gene in a cell of the treated foot.

### Claim 14 (depends on 1)

The method of claim 1, further comprising measuring a first wound volume at a first time and a second wound volume at a second time.

### Claim 15 (depends on 1)

The method of claim 1, further comprising promoting an increased nerve density in the treated foot.

### Claim 16 (depends on 1)

The method of claim 1, further comprising producing a decrease in a pain score reported by the patient over a treatment period by administering the PEMF treatment.

### Claim 17 (depends on 5)

The method of claim 5, further comprising modulating expression of one of an HO-1, COX-2, ALOX-12, ALOX-15, PTGDS, PTGES, PTGIS, NOX, CAT, GSR, PRDX-6, and SOD-3 gene in a cell of the treated foot.

### Claim 18 (depends on 5)

The method of claim 5, further comprising modulating one of the peroneal nerve and the tibial nerve function in the patient by applying the PEMF treatment to a foot of the patient.

### Claim 19 (depends on 18)

The method of claim 18, wherein modulating the one of the peroneal nerve and the tibial nerve function comprises producing one of an increase in sympathetic skin response (SSR) waveform amplitude, a decrease in SSR time-to-onset, and an increase in nerve conduction velocity in the treated foot.