# US 10,945,977 B1 · Non-surgical laser treatment for a fibrous mass

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- Number: US 10,945,977 B1
- Document ID: US10945977B1
- Status: Granted
- Kind: B1
- Application number: 16/294,799
- Filed: 2019-03-06
- Granted: 2021-03-16
- Earliest claimed: 2015-07-30
- Applicants: Bbbn, Pllc
- Inventors: Darin Bocian
- Web page: https://patentgrep.com/patent/US10945977B1

## CPC

- A61K 31/192: having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid {(cannabinoids A61K31/658)}
- A61K 31/196: the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil
- A61K 31/277: having a ring, e.g. verapamil
- A61K 31/522: having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
- A61N 5/0613: {Apparatus adapted for a specific treatment}
- A61B 5/4041: {Evaluating nerves condition}
- A61B 8/085: {for locating body or organic structures, e.g. tumours, calculi, blood vessels, nodules}
- A61N 5/0622: {Optical stimulation for exciting neural tissue}
- A61N 5/067: using laser light
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- 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)

## Abstract

Systems and methods for treating a fibrous mass, which is comprised of a Morton's neuroma, are disclosed. In one exemplary implementation, a method may comprise identifying a location of the fibrous mass and non-surgically delivering electromagnetic energy to the fibrous mass. Embodiments may include delivering the energy via a Nd:Yag laser at various specified parameters, such as spot size, power/fluence, frequency, duration, pulse characteristics, and/or tissue depth, among others.

## Claims

### Claim 1

A method for treating a fibrous mass comprised of Morton's neuroma in a human foot, the method comprising:
identifying a location of the fibrous mass in the foot using a medical imaging technique;
determining a size of the fibrous mass located;
non-surgically delivering electromagnetic energy from a lasing device comprising a Nd:Yag laser to the located fibrous mass during a treatment of a plurality of treatments of the foot, each treatment including:
applying a topical medication directly on a skin surface at a location where each treatment of the located fibrous mass is being administered, wherein the topical medication comprises two or more of verapamil, pentoxifylline, and/or tranilast;
emitting electromagnetic energy from a lasing device in a beam having a frequency of 7 Hz;
directing the beam of the laser over a 5 mm diameter spot on a skin surface of the foot such that the beam irradiates the location of the fibrous mass;
adjusting a power of the lasing device up to 15 J/cm2;
delivering at least 1,000 pulses of the laser to the location, per treatment; and
directing the beam onto the location to irradiate the fibrous mass for 10 minutes;
performing 9 of the treatments, and thereby reducing a size of the fibrous mass and softening the fibrous mass to an extent such that the patient is relieved of disability resulting from the Morton's neuroma beyond mere reduction in a pain level-associated with the fibrous mass.

### Claim 2 (depends on 1)

The method of claim 1 wherein using the medical imaging techniques further comprises using magnetic resonance imaging.

### Claim 3 (depends on 1)

The method of claim 1 wherein using the medical imaging techniques further comprises use of ultrasound imaging.

### Claim 4 (depends on 1)

The method of claim 1, further comprising:
directing the beam onto the location for 15 minutes.

### Claim 5 (depends on 1)

The method of claim 1, wherein each of the pulses has an energy of 15 Jcm2 across an area impinged by the laser beam.

### Claim 6 (depends on 1)

The method of claim 1, wherein each of the pulses is applied for a time period of about 6 milliseconds.

### Claim 7 (depends on 1)

The method of claim 1, further comprising:
delivering at least 1,500 pulses of the laser to the location, per treatment.

### Claim 8 (depends on 1)

The method of claim 1, wherein an additional treatment is performed such that the plurality of treatments comprises 10 treatments.

### Claim 9 (depends on 1)

The method claim 1, wherein, as a result of administering the plurality of the treatments, the size of the fibrous masses is reduced between 33% to 66%.

### Claim 10 (depends on 1)

The method of claim 1, further comprising:
delivering at least 2,000 pulses of the laser to the location, per treatment.

### Claim 11 (depends on 1)

The method of claim 1, wherein the topical medication comprises about 15% verapamil by weight or volume, about 3% pentoxifylline by weight or volume, and about 1% tranilast by weight or volume.

### Claim 12 (depends on 1)

The method of claim 1, wherein each of the pulses has an energy of about 15 J/cm2.

### Claim 13 (depends on 1)

The method of claim 1, wherein the delivering electromagnetic energy to the fibrous mass step further comprises:
adjusting a power of the lasing device such that the electromagnetic energy penetrates the patient's flesh to irradiate and thereby soften the fibrous mass at a depth of 6 mm to 8 mm.

### Claim 14 (depends on 1)

The method of claim 1, wherein the delivering electromagnetic energy to the fibrous mass step further comprises:
adjusting a power of to the lasing device such that the electromagnetic energy penetrates tissues to a depth of about 6 mm to about 8 mm.

### Claim 15 (depends on 1)

The method of claim 1 wherein, as a result of administering the plurality of the treatments, size of the fibrous mass is reduced at least 33% in measure in at least one dimension, as determined via comparison of a first image of the fibrous mass obtained via the medical imaging technique before the plurality of treatments are administered and a second image of the fibrous mass taken via the medical imaging technique after the plurality of treatments are administered.

### Claim 16 (depends on 1)

The method of claim 1 wherein the laser comprises a Nd:YAG lasing device that delivers laser energy having a power density of about 15 J/cm2 or less than 15 J/cm2 that is characterized as being less than a fluence at which pre-cooling of the treatment area is utilized in association with each treatment of the plurality of treatments to maintain patient comfort.

### Claim 17

A method for treating a fibrous mass comprised of Morton's Neuroma in a human foot, the method comprising:
identifying a location of the fibrous mass in the foot;
non-surgically delivering electromagnetic energy from a lasing device comprising a Nd:Yag laser to the located fibrous mass during a treatment of a plurality of treatments of the foot, each treatment including:
directing a beam of the laser having a frequency of 7 Hz over a 5 mm diameter spot on a skin surface of the foot such that the beam irradiates the location of the fibrous mass;
adjusting a power of the laser such that the beam has an energy of up to 15 J/cm2 across an area of the skin surface impinged by the beam during irradiation of the fibrous mass;
delivering at least 1,000 pulses of the laser to the location, per treatment;
directing the beam onto the location to irradiate the fibrous mass for 10 minutes;
performing 9 or more of the treatments, and thereby reducing a size of the fibrous mass and softening the fibrous mass to an extent such that the patient is relieved of disability resulting from the Morton's neuroma beyond mere reduction in a pain level-associated with the fibrous mass.

### Claim 18

A method for treating a fibrous mass comprised of Morton's Neuroma in a human foot, the method comprising:
identifying a location of the fibrous mass in the foot;
determining a size of the fibrous mass via a medical imaging technique;
non-surgically delivering electromagnetic energy from a lasing device comprising a Nd:Yag laser to the located fibrous mass during a plurality of treatments to the fibrous mass, each treatment of the plurality of treatments including:
directing a beam of the laser having a frequency of about 7 Hz over a 5 mm diameter spot on a skin surface of the foot such that the beam irradiates the location of the fibrous mass;
adjusting a power of the laser such that the beam has an energy of up to 15 J/cm2 across an area of the skin surface impinged by the beam during irradiation of the fibrous mass, such that the electromagnetic energy penetrates tissue of the foot to a depth of about 6 mm to about 8 mm; and
directing the beam onto the location to irradiate the fibrous mass for 10 minutes;
performing a plurality of the treatments, and thereby reducing a size of the fibrous mass and softening the fibrous mass to an extent such that the patient is relieved of disability resulting from the Morton's neuroma beyond mere reduction in a pain level-associated with the fibrous mass.

### Claim 19 (depends on 18)

The method of claim 18 wherein, as a result of administering the plurality of the treatments, the size of the fibrous mass is reduced at least 33% in measure in at least one dimension, as determined via comparison of a first image of the fibrous mass obtained via the medical imaging technique before the plurality of treatments are administered and a second image of the fibrous mass taken via the medical imaging technique after the plurality of treatments are administered.

### Claim 20 (depends on 18)

The method of claim 18 wherein each said treatment further includes:
applying a topical medication directly on a skin surface at a location where each treatment of the located fibrous mass is being administered, wherein the topical medication comprises two or more of verapamil, pentoxifylline, and/or tranilast.

### Claim 21 (depends on 20)

The method of claim 20, wherein the topical medication comprises two or more of: about 15% verapamil by weight or volume, about 3% pentoxifylline by weight or volume, and about 1% tranilast by weight or volume.

### Claim 22 (depends on 18)

The method of claim 18, wherein the plurality of treatments comprises 9 treatments.

### Claim 23 (depends on 18, 19, 20, 21)

The method of any one of claim 18, 19, 20, 21, or 22, wherein each of the pulses has an energy of about 15 J/cm2 across an area impinged by the laser beam.

### Claim 24 (depends on 23)

The method of claim 23 wherein using the medical imaging techniques further comprises using magnetic resonance imaging.

### Claim 25 (depends on 23)

The method of claim 23 wherein using the medical imaging techniques further comprises using ultrasound imaging.

### Claim 26 (depends on 23)

The method of claim 23, further comprising:
directing the beam onto the location for 15 minutes.

### Claim 27 (depends on 23)

The method of claim 23, further comprising:
delivering at least 1,500 pulses of the laser to the location, per treatment.

### Claim 28 (depends on 23)

The method of claim 23, further comprising:
delivering at least 2,000 pulses of the laser to the location, per treatment.

### Claim 29 (depends on 23)

The method claim 23, wherein, as a result of administering the plurality of the treatments, the size of the fibrous masses is reduced between 33% to 66%.

### Claim 30 (depends on 23)

The method of claim 23 wherein the laser comprises a Nd:YAG lasing device that delivers laser energy having a power density of less than about 15 J/cm2, which is a fluence level below which pre-cooling of the skin surface of the foot is not required to maintain patient comfort.
