# US 10,307,281 B2 · Foot pressure application method for treatment of identified medical conditions, illnesses, and diseases

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- Number: US 10,307,281 B2
- Document ID: US10307281B2
- Status: Granted
- Kind: B2
- Application number: 14/791,389
- Filed: 2015-07-03
- Published: 2016-01-07
- Granted: 2019-06-04
- Earliest claimed: 2014-07-07
- Assignees: Medi USA, L.P.
- Applicants: medi USA, L.P.
- Inventors: Mary Sorg; Phyllis Kuhn; John Sullivan; Daniel Olson
- Web page: https://patentgrep.com/patent/US10307281B2

## CPC

- A61F 5/01: Orthopaedic devices, e.g. long-term immobilising or pressure directing devices for treating broken or deformed bones such as splints, casts or braces
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)

## Abstract

A method for effecting neuromuscular mechanisms for treatment of specific non-restless leg syndrome, non-restless arms, and non-foot and leg cramps diseases, conditions, and/or illnesses utilizes a device for applying positive pressure to specific areas of the foot. Slight variations to the positioning and/or patient application of the device may be adopted to increase benefits for specific diseases, conditions, or illnesses. Such variations can include frequency or time intervals of use and variations in pressure and positioning of pressure.

## Claims

### Claim 1

A method for effecting neuromuscular mechanisms for treatment of specific non-restless leg syndrome, non-restless arms, and non-foot and leg cramps diseases, conditions, and illnesses, the method comprising:
providing a pressure application pad for providing selective and adjustable pressure to a sole of a foot of an individual, the pressure application pad having a base portion and an upraised portion disposed on the base portion, the upraised portion having a leg and a crosspiece, the leg extending transversely along the sole of the foot, the crosspiece extending about perpendicularly from an end of the leg to extend along the inner side of the foot, the leg being positioned to abut and primarily apply pressure directed to the flexor hallucis brevis muscle at the bottom of the foot, and the crosspiece being positioned to abut and primarily apply pressure directed to the abductor hallucis muscle, the crosspiece being positioned to apply pressure primarily to the inner side of the foot;
applying pressure with the pressure application pad to both feet of the individual;
keeping the individual non-ambulatory only when symptoms occur;
removing the pressure application pad promptly upon the subsidence of symptoms; and
applying pressure to both feet of the individual with the pressure application pad during all sleeping hours regardless of symptoms;
the treatment of specific diseases, conditions, and illnesses including the treatment of at least one of Anxiety Disorder, Attention Deficit Hyperactivity Disorder, Augmentation and Rebound from Dopamine Agonist Therapy, Back Pain and Chronic Back Pain, Dementia, Depression, Dyskinesia, Dystonia, Fibromyalgia, Inherited Neuropsychiatric Disorder, Mental Depressive Disorder, Metatarsalgia, Multiple Sclerosis, Muscle Cramp Disorder, Muscular Dystrophy, Nocturnal Foot and Leg Cramps, Neuroma, Morton's Neuroma, Plantar Neuroma, Traumatic Neuroma, Parkinson's Disease, Periodic Limb Movement Disorder, Peripheral Nerve Disorder, Obsessive Compulsive Disorder, Radiculopathy, Sacroiliac Pain, and Tourette Syndrome.

### Claim 2 (depends on 1)

The method of claim 1 further comprising:
applying and securing the pressure application pad to each foot of the individual and maintaining the individual in a non-ambulatory position for three approximately one hour intervals during daytime and while the individual is awake;
applying and securing the pressure application pad to each foot of the individual while the individual sleeps; and
continuing to apply the pressure application pad each day until symptoms subside.

### Claim 3 (depends on 1)

The method of claim 1 further comprising:
applying pressure with the pressure application pad to both feet at all times the individual is asleep or non-ambulatory up to about 8 to 10 hours;
removing the pressure application pad is in all cases after about 8 to 10 hours of continuous use, even if the individual remains non-ambulatory; and
reapplying pressure with the pressure application pad to both feet if symptoms reappear or until symptoms subside.

### Claim 4 (depends on 1)

The method of claim 1 further comprising:
applying the pressure application pad, tightened only to slight pressure, to both feet of the individual for one hour;
keeping the individual non-ambulatory while the pressure application pad is tightened only to slight pressure; and
after one hour, if symptoms have not yet subsided, applying additional small increments of pressure for additional one-hour intervals until sufficient pressure has been added to relieve symptoms.

### Claim 5 (depends on 1)

The method of claim 1 further comprising:
applying the pressure application pad, tightened only to slight pressure, to both feet of the individual for one hour;
keeping the individual non-ambulatory while the pressure application pad is tightened only to slight pressure;
after one hour, if symptoms have not yet subsided, applying additional small increments of pressure for additional one-hour intervals until sufficient pressure has been added to relieve symptoms; and
also applying pressure with the pressure application pad to both feet of the individual during sleeping hours and removing the pressure application pad when the individual wakes up.

### Claim 6 (depends on 1)

The method of claim 1 further comprising:
applying pressure with the pressure application pad to both feet of the individual whenever the individual is non-ambulatory, and as often as possible for a minimum of 30 minute intervals, regardless of symptoms; and
applying pressure with the pressure application pad to both feet of the individual during all sleeping hours, regardless of symptoms.

### Claim 7 (depends on 1)

The method of claim 1 further comprising:
applying pressure with the pressure application pad to both feet of the individual for two separate, non-ambulatory approximately one-hour intervals during awake hours each day, regardless of symptoms; and
applying pressure with the pressure application pad to both feet of the individual during all sleeping hours, regardless of symptoms.

### Claim 8 (depends on 1)

The method of claim 1 further comprising:
applying pressure with the pressure application pad to both feet of the individual for five to six separate non-ambulatory, approximately one-hour intervals during awake hours each day, regardless of symptoms.

### Claim 9 (depends on 1)

The method of claim 1 further comprising applying pressure with the pressure application pad to only one foot of the individual.

### Claim 10

A method for effecting neuromuscular mechanisms for treatment of specific non-restless leg syndrome, non-restless arms, and non-foot and leg cramps diseases, conditions, and illnesses, the method comprising,:
providing a pressure application pad for providing selective and adjustable pressure to a sole of a foot of an individual, the pressure application pad having a base portion and an upraised portion disposed on the base portion, the upraised portion having a leg and a crosspiece, the leg extending transversely along the sole of the foot, the crosspiece extending about perpendicularly from an end of the leg to extend along the inner side of the foot, the leg being positioned to abut and primarily apply pressure directed to the flexor hallucis brevis muscle at the bottom of the foot, and the crosspiece being positioned to abut and primarily apply pressure directed to the abductor hallucis muscle, the crosspiece being positioned to apply pressure primarily to the inner side of the foot;
applying direct pressure to the abductor hallucis and flexor halluces brevis muscles of the foot of the individual for about five minutes without using the pressure application pad;
applying and securing the pressure application pad to the foot of the individual for about one hour to direct pressure to the abductor hallucis and flexor halluces brevis muscles;
removing the pressure application pad from the foot of the individual;
applying direct pressure to the abductor hallucis and flexor halluces brevis muscles of the foot of the individual for about five additional minutes without using the pressure application pad; and
periodically reapplying and securing the pressure application pad to the foot of the individual whenever symptoms reappear or until symptoms subside;
the treatment of specific diseases, conditions, and illnesses including the treatment of at least one of Anxiety Disorder, Attention Deficit Hyperactivity Disorder, Augmentation and Rebound from Dopamine Agonist therapy, Back Pain and Chronic Back Pain, Dementia, Depression, Dyskinesia, Dystonia, Fibromyalgia, Inherited Neuropsychiatric Disorder, Mental Depressive Disorder, Metatarsalgia, Multiple Sclerosis, Muscle Cramp Disorder, Muscular Dystrophy, Nocturnal Foot and Leg Cramps, Neuroma, Morton's Neuroma, Plantar Neuroma, Traumatic Neuroma, Parkinson's Disease, Periodic Limb Movement Disorder, Peripheral Nerve Disorder, Obsessive Compulsive Disorder, Radiculopathy, Sacroiliac Pain, and Tourette Syndrome.

### Claim 11

A method for effecting neuromuscular mechanisms for treatment of specific non-restless leg syndrome, non-restless arms, and non-foot and leg cramps diseases, conditions, and illnesses, the method comprising:
providing a pressure application pad for providing selective and adjustable pressure to a sole of a foot of an individual, the pressure application pad having a base portion and an upraised portion disposed on the base portion, the upraised portion having a leg and a crosspiece, the leg extending transversely along the sole of the foot, the crosspiece extending about perpendicularly from an end of the leg to extend along the inner side of the foot, the leg being positioned to abut and primarily apply pressure directed to the flexor hallucis brevis muscle at the bottom of the foot, and the crosspiece positioned to abut and primarily apply pressure directed to the abductor hallucis muscle, the crosspiece being positioned to apply pressure primarily to the inner side of the foot;
applying pressure with the pressure application pad to at least one foot of the individual for repeated, predetermined intervals during a period of about four to eight days;
refraining from applying pressure with the pressure application pad to either foot of the individual for a period of about two weeks; and
evaluating the prevalence of symptoms;
the treatment of specific diseases, conditions, and illnesses including the treatment of at least one of Anxiety Disorder, Attention Deficit Hyperactivity Disorder, Augmentation and Rebound from Dopamine Agonist Therapy, Back Pain and Chronic Back pain, Dementia, Depression, Dyskinesia, Dystonia, fibromyalgia, Inherited Neuropsychiatric Disorder, Mental Depressive Disorder, Metatarsalgia, Multiple Sclerosis, Muscle Cramp Disorder, Muscular Dystrophy, Nocturnal Foot and Leg Cramps, Neuroma, Morton's Neuroma, Plantar Neuroma, Traumatic Neuroma, Parkinson's Disease, Periodic Limb Movement Disorder, Peripheral Nerve Disorder, Obsessive Compulsive Disorder, Radiculopathy, Sacroiliac Pain, and Tourette Syndrome.

### Claim 12 (depends on 11)

The method of claim 11,
wherein the period for applying pressure comprises a period of about seven to fourteen days.

### Claim 13

A method for effecting neuromuscular mechanisms for treatment of specific non-restless leg syndrome, non-restless arms, and non-foot and leg cramps diseases, conditions, and illnesses, the method comprising:
applying pressure with a shoe insert to specific areas of a foot of an individual, the shoe insert having a pressure application pad for providing selective and adjustable pressure to a sole of the foot, the insole having an upper surface and being positionable within a shoe, the pressure application pad being positioned on the upper surface of the insole, the pressure application pad having a base portion and an upraised portion disposed on the base portion, the upraised portion having a leg and a crosspiece, the leg extending transversely along the sole of the foot when the foot is inserted in the shoe, the crosspiece extending about perpendicularly from an end of the leg to extend along the inner side of the foot when the foot is inserted in the shoe, the leg being positioned to abut and primarily apply pressure directed to the flexor hallucis brevis muscle at the bottom of the foot, the crosspiece being positioned to abut and primarily apply pressure directed to the abductor hallucis muscle, and the crosspiece being positioned to apply pressure primarily to the inner side of the foot;
applying pressure with the shoe insert to at least one foot of the individual for repeated, predetermined intervals during a period of about four to eight days;
refraining from applying pressure with the shoe insert to either foot or the individual for a period of about two weeks; and
evaluating the prevalence of symptoms:
the treatment of specific diseases, conditions, and illnesses including the treatment of at least one of Anxiety Disorder, Attention Deficit Hyperactivity Disorder, Augmentation and Rebound from Dopamine Agonist Therapy, Back Pain and Chronic Back Pain, Dementia, Depression, Dyskinesia, Dystonia, Fibromyalgia, Inherited Neuropsychiatric Disorder, Mental Depressive Disorder, Metatarsalgia, Multiple Sclerosis, Muscle Cramp Disorder, Muscular Dystrophy, Nocturnal Foot and Leg Cramps, Neuroma, Morton's Neuroma, Plantar Neuroma, Traumatic Neuroma, Parkinson's Disease, Periodic Limb Movement Disorder, Peripheral Nerve Disorder, Obsessive Compulsive Disorder, Radiculopathy, Sacroiliac Pain, and Tourette Syndrome.

### Claim 14 (depends on 13)

The method of claim 13 further comprising:
applying and securing the shoe insert to each foot of the individual and maintaining the individual in a non-ambulatory position for three approximately one hour intervals during daytime and while the individual is awake;
applying and securing the shoe insert to each foot of the individual while the individual sleeps; and
continuing to apply the shoe insert each day until symptoms subside.

### Claim 15 (depends on 13)

The method of claim 13 further comprising:
applying direct pressure to the abductor hallucis and flexor halluces brevis muscles of the foot of the individual for about five minutes without using the shoe insert;
applying and securing the shoe insert to the foot of the individual for about one hour to direct pressure to the abductor hallucis and flexor halluces brevis muscles;
removing the shoe insert from the foot of the individual;
applying direct pressure to the abductor hallucis and flexor halluces brevis muscles of the foot of the individual for about five additional minutes without using the shoe insert; and
periodically reapplying and securing the shoe insert to the foot of the individual whenever symptoms reappear or until symptoms subside.

### Claim 16 (depends on 13)

The method of claim 13 further comprising:
applying pressure with the shoe insert to both feet at all times the individual is asleep or non-ambulatory up to about 8 to 10 hours;
removing the shoe insert is in all cases after about 8 to 10 hours of continuous use, even if the individual remains non-ambulatory; and
reapplying pressure with the shoe insert to both feet if symptoms reappear or until symptoms subside.

### Claim 17 (depends on 13)

The method of claim 13 further comprising:
applying the shoe insert, tightened only to slight pressure, to both feet of the individual for one hour;
keeping the individual non-ambulatory while the shoe insert is tightened only to slight pressure; and
after one hour, if symptoms have not yet subsided, applying additional small increments of pressure for additional one-hour intervals until sufficient pressure has been added to relieve symptoms.

### Claim 18 (depends on 13)

The method of claim 13 further comprising:
applying the shoe insert, tightened only to slight pressure, to both feet of the individual for one hour;
keeping the individual non-ambulatory while the shoe insert is tightened only to slight pressure;
after one hour, if symptoms have not yet subsided, applying additional small increments of pressure for additional one-hour intervals until sufficient pressure has been added to relieve symptoms; and
also applying pressure with the shoe insert to both feet of the individual during sleeping hours and removing the shoe insert when the individual wakes up.

### Claim 19 (depends on 13)

The method of claim 13 further comprising:
applying pressure with the shoe insert to both feet of the individual;
keeping the individual non-ambulatory only when symptoms occur;
removing the shoe insert promptly upon the subsidence of symptoms; and
applying pressure to both feet of the individual with the shoe insert during all sleeping hours regardless of symptoms.

### Claim 20 (depends on 13)

The method of claim 13 further comprising:
applying pressure with the shoe insert to both feet of the individual whenever the individual is non-ambulatory, and as often as possible for a minimum of 30 minute intervals, regardless of symptoms; and
applying pressure with the shoe insert to both feet of the individual during all sleeping hours, regardless of symptoms.

### Claim 21 (depends on 13)

The method of claim 13 further comprising:
applying pressure with the shoe insert to both feet of the individual for two separate, non-ambulatory approximately one-hour intervals during awake hours each day, regardless of symptoms; and
applying pressure with the shoe insert to both feet of the individual during all sleeping hours, regardless of symptoms.

### Claim 22 (depends on 13)

The method of claim 13 further comprising:
applying pressure with the shoe insert to both feet of the individual for five to six separate non-ambulatory, approximately one-hour intervals during awake hours each day, regardless of symptoms.

### Claim 23 (depends on 13)

The method of claim 13,
wherein the period for applying pressure comprises a period of about seven to fourteen days.

### Claim 24 (depends on 13)

The method of claim 13 further comprising applying pressure with the shoe insert to only one foot of the individual.

### Claim 25

A method for effecting neuromuscular mechanisms for treatment of specific non-restless leg syndrome, non-restless arms, and non-foot and leg cramps diseases, conditions, and illnesses, the method comprising:
applying pressure with a pressure application pad to specific areas of a foot of an individual, the pressure application pad having an upraised portion having a leg and crosspiece, and providing a wrapping member for encasing the pressure application pad, the wrapping member also having multiple adjustable straps for securing the wrapping member and the pressure application pad, placing and securing the pressure application pad on the foot of an individual with the wrapping member, the leg of the pressure application pad being positioned to abut and primarily apply pressure directed to the flexor hallucis brevis muscle primarily at the bottom of the foot, the crosspiece of the pressure application pad being positioned to abut and primarily apply pressure directed to the abductor hallucis muscle primarily at the inner side of the foot, and adjusting the multiple adjustable straps to selected magnitudes of tightness to adjustably vary the pressure exerted by the leg against the flexor hallucis brevis muscle and by the crosspiece against the abductor hallucis muscle;
applying pressure with the pressure application pad to both feet of the individual;
keeping the individual non-ambulatory only when symptoms occur:
removing the pressure application pad promptly upon the subsidence of symptoms; and
applying pressure to both feet of the individual with the pressure application pad during all sleeping hours regardless of symptoms;
the treatment of specific diseases, conditions, and illnesses including the treatment of at least one of Anxiety Disorder, Attention Deficit Hyperactivity Disorder, Augmentation and Rebound from Dopamine Agonist Therapy, Back Pain and Chronic Back Pain, Dementia, Depression, Dyskinesia, Dystonia, Fibromyalgia, Inherited Neuropsychiatric Disorder, Mental Depressive Disorder, Metatarsalgia, Multiple Sclerosis, Muscle Cramp Disorder, Muscular Dystrophy, Nocturnal Foot and Leg Cramps, Neuroma, Morton's Neuroma, Plantar Neuroma, Traumatic Neuroma, Parkinson's Disease, Periodic Limb Movement Disorder, Peripheral Nerve Disorder, Obsessive Compulsive Disorder, Radiculopathy, Sacroiliac Pain, and Tourette Syndrome.

### Claim 26 (depends on 25)

The method of claim 25 further comprising:
applying and securing the pressure application pad to each foot of the individual and maintaining the individual in a non-ambulatory position for three approximately one hour intervals during daytime and while the individual is awake;
applying and securing the pressure application pad to each foot of the individual while the individual sleeps; and
continuing to apply the pressure application pad each day until symptoms subside.

### Claim 27 (depends on 25)

The method of claim 25 further comprising:
applying direct pressure to the abductor hallucis and flexor halluces brevis muscles of the foot of the individual for about five minutes without using the pressure application pad;
applying and securing the pressure application pad to the foot of the individual for about one hour to direct pressure to the abductor hallucis and flexor halluces brevis muscles;
removing the pressure application pad from the foot of the individual;
applying direct pressure to the abductor hallucis and flexor halluces brevis muscles of the foot of the individual for about five additional minutes without using the pressure application pad; and
periodically reapplying and securing the pressure application pad to the foot of the individual whenever symptoms reappear or until symptoms subside.

### Claim 28 (depends on 25)

The method of claim 25 further comprising:
applying pressure with the pressure application pad to both feet at all times the individual is asleep or non-ambulatory up to about 8 to 10 hours;
removing the pressure application pad is in all cases after about 8 to 10 hours of continuous use, even if the individual remains non-ambulatory; and
reapplying pressure with the pressure application pad to both feet if symptoms reappear or until symptoms subside.

### Claim 29 (depends on 25)

The method of claim 25 further comprising:
applying the pressure application pad, tightened only to slight pressure, to both feet of the individual for one hour;
keeping the individual non-ambulatory while the pressure application pad is tightened only to slight pressure; and
after one hour, if symptoms have not yet subsided, applying additional small increments of pressure for additional one-hour intervals until sufficient pressure has been added to relieve symptoms.

### Claim 30 (depends on 25)

The method of claim 25 further comprising:
applying the pressure application pad, tightened only to slight pressure, to both feet of the individual for one hour;
keeping the individual non-ambulatory while the pressure application pad is tightened only to slight pressure;
after one hour, if symptoms have not yet subsided, applying additional small increments of pressure for additional one-hour intervals until sufficient pressure has been added to relieve symptoms; and
also applying pressure with the pressure application pad to both feet of the individual during sleeping hours and removing the pressure application pad when the individual wakes up.

### Claim 31 (depends on 25)

The method of claim 25 further comprising:
applying pressure with the pressure application pad to both feet of the individual whenever the individual is non-ambulatory, and as often as possible for a minimum of 30 minute intervals, regardless of symptoms; and
applying pressure with the pressure application pad to both feet of the individual during all sleeping hours, regardless of symptoms.

### Claim 32 (depends on 25)

The method of claim 25 further comprising:
applying pressure with the pressure application pad to both feet of the individual for two separate, non-ambulatory approximately one-hour intervals during awake hours each day, regardless of symptoms; and
applying pressure with the pressure application pad to both feet of the individual during all sleeping hours, regardless of symptoms.

### Claim 33 (depends on 25)

The method of claim 25 further comprising:
applying pressure with the pressure application pad to both feet of the individual for five to six separate non-ambulatory, approximately one-hour intervals during awake hours each day, regardless of symptoms.

### Claim 34 (depends on 25)

The method of claim 25 further comprising applying pressure with the pressure application pad to only one foot of the individual.

### Claim 35

A method for effecting neuromuscular mechanisms for treatment of specific non-restless leg syndrome, non-restless arms, and non-foot and leg cramps diseases, conditions, and illnesses, the method comprising:
applying pressure with a pressure application pad to specific areas of foot of an individual, the pressure application pad having an upraised portion having a leg and crosspiece, and providing a wrapping member for encasing the pressure application pad, the wrapping member also having multiple adjustable straps for securing the wrapping member and the pressure application pad, placing and securing the pressure application pad on the foot of an individual with the wrapping member, the leg of the pressure application pad being positioned to abut and primarily apply pressure directed to the flexor hallucis brevis muscle primarily at the bottom of the foot, the crosspiece of he pressure application pad being positioned to abut and primarily apply pressure directed to the abductor hallucis muscle primarily at the inner side of the foot, and adjusting the multiple adjustable straps to selected magnitudes of tightness to adjustably vary the pressure exerted by the leg against the flexor hallucis brevis muscle and by the crosspiece against the abductor hallucis muscle;
applying pressure with the pressure application pad to at least one foot of the individual for repeated, predetermined intervals during a period of about four to eight days;
refraining from applying pressure with the pressure application pad to either foot of the individual for a period of about two weeks; and
evaluating the prevalence of symptoms;
the treatment of specific diseases, conditions, and illnesses including the treatment of least one of Anxiety Disorder, Attention Deficit Hyperactivity Disorder, Augmentation and Rebound from Dopamine Agonist Therapy, Back Pain and Chronic Back Pain, Dementia, Depression, Dyskinesia, Dystonia, Fibromyalgia, Inherited Neuropsychiatric Disorder, Mental Depressive Disorder, Metatarsalgia, Multiple Sclerosis, Muscle Cramp Disorder, Muscular Dystrophy, Nocturnal Foot and Leg Cramps, Neuroma, Morton's Neuroma, Plantar Neuroma, Traumatic Neuroma, Parkinson's Disease, Periodic Limb Movement Disorder, Peripheral Nerve Disorder, Obsessive Compulsive Disorder, Radiculopathy, Sacroiliac Pain, and Tourette Syndrome.

### Claim 36 (depends on 35)

The method of claim 35,
wherein the period for applying pressure comprises a period of about seven to fourteen days.