U.S. patent application number 16/109478 was filed with the patent office on 2019-05-23 for devices and methods for treating restless leg syndrome.
This patent application is currently assigned to Sensory Neurostimulation, Inc.. The applicant listed for this patent is Sensory Neurostimulation, Inc.. Invention is credited to Fred H. Burbank, Michael L. Jones, Alvin Memmolo.
Application Number | 20190151190 16/109478 |
Document ID | / |
Family ID | 40637259 |
Filed Date | 2019-05-23 |
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United States Patent
Application |
20190151190 |
Kind Code |
A1 |
Burbank; Fred H. ; et
al. |
May 23, 2019 |
DEVICES AND METHODS FOR TREATING RESTLESS LEG SYNDROME
Abstract
A method and system for treating restless leg syndrome. The
system includes a vibration generator and a controller operable to
provide counter-stimulation vibration to a patient suffering from
restless leg syndrome. The counter-stimulation may be provided at a
frequency of between 1 cycle/minute to 1000 cycles per second and
at an amplitude and duration sufficient to act as a
counter-stimulation vibration to restless leg syndrome but low
enough to allow the patient to sleep.
Inventors: |
Burbank; Fred H.; (San
Clemente, CA) ; Jones; Michael L.; (San Clemente,
CA) ; Memmolo; Alvin; (San Clemente, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Sensory Neurostimulation, Inc. |
San Clemente |
CA |
US |
|
|
Assignee: |
Sensory Neurostimulation,
Inc.
San Clemente
CA
|
Family ID: |
40637259 |
Appl. No.: |
16/109478 |
Filed: |
August 22, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14639627 |
Mar 5, 2015 |
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16109478 |
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12396358 |
Mar 2, 2009 |
9017273 |
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14639627 |
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61032571 |
Feb 29, 2008 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61H 7/004 20130101;
A61H 2201/0242 20130101; A61H 2015/0014 20130101; A61N 2/00
20130101; A61H 23/0263 20130101; A61H 2201/1215 20130101; A61H
2205/108 20130101; A61H 2201/0257 20130101; A61H 2205/106 20130101;
A61F 2007/0071 20130101; A61H 2201/105 20130101; A61H 1/008
20130101; A61H 2201/02 20130101; A61H 2201/1642 20130101; A61H
2201/5005 20130101; A61H 2203/0456 20130101; A61H 2201/1207
20130101; A61H 2201/1676 20130101; A61H 2201/10 20130101; A61H
2201/165 20130101; A61H 2201/0142 20130101; A61H 2205/12 20130101;
A61H 2201/0228 20130101; A61F 2007/0075 20130101; A61H 9/0092
20130101; A61H 1/0255 20130101; A61H 7/001 20130101; A61H 1/0237
20130101; A61H 1/0266 20130101; A61H 2205/10 20130101; A61H
2201/0285 20130101; A61F 2007/0296 20130101; A61N 1/36021 20130101;
A61H 23/02 20130101; A61H 9/0078 20130101; A61H 15/0078 20130101;
A61H 23/0218 20130101 |
International
Class: |
A61H 23/02 20060101
A61H023/02; A61H 1/02 20060101 A61H001/02; A61N 1/36 20060101
A61N001/36; A61H 1/00 20060101 A61H001/00; A61H 7/00 20060101
A61H007/00; A61H 9/00 20060101 A61H009/00; A61H 15/00 20060101
A61H015/00 |
Claims
1. A system for generating a counter-stimulation in a patient
suffering from restless leg syndrome, the system comprising: a
vibration generator configured and arranged to generate a
counter-stimulation vibration in a patient suffering from restless
leg syndrome, the counter-stimulation having a frequency of between
1 cycle/minute to 1000 cycles per second and an amplitude and
duration sufficient to act as a counter-stimulation vibration to
restless leg syndrome but low enough to allow the patient to sleep;
a controller configured and arranged to drive the vibration
generator, said controller operable to terminate vibrations after a
period of vibration; and a base configured and arranged to hold the
vibration generator adjacent to a patient, the vibration generator
attached to the base.
2. The system of claim 1, wherein the controller is configured to
ramp down the counter-stimulation, after a period of vibration, so
as not to waken the patient.
3. The system according to claim 1, wherein the vibration generator
comprises a device selected from the group consisting of a
piezo-chip, a loudspeaker, a motor with an eccentric weight, and a
solenoid.
4. The system according to claim 3, wherein the vibration generator
comprises an electric motor having a shaft, and a weight having a
hole therein, the weight positioned on the shaft, the hole located
at a position offset from a center of mass of the weight.
5. The system according to claim 4, further comprising: a housing
attached to the base; and wherein the weight is located in the
housing.
6. The system according to claim 1, wherein the base comprises a
flexible sheet.
7. The system according to claim 6, wherein the sheet comprises a
foam sheet, the vibration generator positioned in the foam
sheet.
8. The system according to claim 1, wherein the base comprises a
rigid shell having at least one housing, the vibration generator
located in the housing.
9. The system according to claim 8, wherein the vibration generator
comprises a mechanical vibrator.
10. The system according to claim 8, wherein the rigid shell
comprises a hole sized and adapted to receive the kneecap of the
patient.
11. The system according to claim 8, wherein the rigid shell is
shaped to at least in part conformingly fit over the thigh of the
patient.
12. The system according to claim 8, wherein the rigid shell is
shaped to conformingly fit over the calf of the patient.
13. The system according to claim 1, wherein the base comprises a
flexible and elastic sleeve having at least one pocket, the
vibration generator positioned in the at least one pocket.
14. The system according to claim 1, further comprising: a
plurality of vibration generators attached to the base and in
communication with the controller.
15. A method of treating restless leg syndrome, the method
comprising: vibrating a portion of a patient experiencing restless
leg syndrome with a vibration generator at a frequency of between 1
cycle/minute to 1000 cycles per second at an amplitude and duration
sufficient to act as a counter-stimulation vibration to restless
leg syndrome but low enough to allow the patient to sleep; and
performing said stimulating step while (1) the patient is
attempting to sleep and (2) while the patient is experiencing
symptoms of restless leg symptoms.
16. A method of claim 15, the method further comprising the step
of: ramping down the counter-stimulation vibration so as not to
waken or alarm the patient.
17. A method of treating restless leg syndrome, the method
comprising: applying a counter-stimulation generation device to a
leg of a patient experiencing restless leg syndrome, said
counter-stimulation generation device comprising a vibration
generator, a controller operable to drive the counter-stimulation
generation device, and a sleeve or pad for holding the vibration
generator, said vibration generator operable to generate a
counter-stimulation having a frequency of between 1 cycle/minute to
1000 cycles per second of an amplitude, and time duration
sufficient to relieve restless leg syndrome symptoms but low enough
to allow the patient to sleep; operating the counter-stimulation
generation device to provide counter-stimulating vibration to the
legs of the patient, at the onset of a restless leg syndrome
episode.
18. A method of claim 17, the method further comprising the step
of: ramping down the counter-stimulation vibration so as not to
waken or alarm the patient.
19. The method according to claim 15, wherein counter-stimulating
vibration is initiated while the patient is awake; and wherein said
vibrating is insufficient to prevent the patient from falling
asleep.
20. The method according to claim 15, wherein the vibrating step is
accomplished with an amplitude in the range of about 0.002 inches
to about 0.75 inches.
Description
[0001] This application is a continuation of U.S. application Ser.
No. 14/639,627, filed Mar. 5, 2015, pending, which is a
continuation of U.S. application Ser. No. 12/396,358, filed Mar. 2,
2009, now U.S. Pat. No. 9,017,273, which claims priority under 35
U.S.C. .sctn. 119 to U.S. Provisional Application 61/032,571, filed
Feb. 29, 2008, the entirety of which is incorporated by reference
herein.
FIELD OF THE INVENTIONS
[0002] The present invention relates to devices, systems, and
processes useful to treat Restless Leg Syndrome.
BACKGROUND OF THE INVENTIONS
[0003] In 1685 Thomas Willis, an 17th century English physician,
published the first description of what we now term "restless legs
syndrome" ("RLS").(1,2) He characterized patients with this
disorder as, "Wherefore to some, when being a bed they betake
themselves to sleep, presently in the Arms and Legs Leapings and
Contractions of the Tendons, and so great a Restlessness and
Tossing of their Members ensure, that the diseased are no more able
to sleep, than if they were in a Place of greatest Torture." In
1945, Karl Axel Ekbom coined the term "restless legs syndrome" and
suggested a neurological instead of a psychiatric origin to the
disorder.(3) Ekbom focused attention on the abnormal sensory
component of the disease.
[0004] With development of "Sleep Labs" in the 1970's, the
sleep-robbing nature of RLS was objectively characterized.(4) In
1990 the American Sleep Disorders Association defined RLS as (i)
disagreeable touch sensations seemingly originating in the legs,
that (ii) come upon some nights and not other nights, and that
(iii) are relieved almost immediately upon standing or walking. In
1999, a task force of the American Academy of Sleep Medicine
summarized the then current understanding of RLS.(5) Diagnostic
criteria were further expanded in 1995 and 2004 by international
groups to include episodes occurring during the daytime when
drowsy.(6,7)
[0005] Disagreeable touch sensations were cataloged as
"creepy-crawly, ants crawling, jittery, pulling, worms moving, soda
bubbles in veins, electric shock, pain, the gotta moves, burning,
jimmy legs, hebbie jeebies, tearing, throbbing, tight feeling,
grabbing, Elvis legs, itching bones, crazy legs, and fidgets."(7)
With symptom descriptions as bizarre as these, it is no wonder that
early investigators lumped patients with RLS in with patients with
psychiatric hysterical (conversion) disorders. However, clinical
responses to various categories of (8) drugs and to iron therapy
and the presence of at least two genetically identifiable
phenotypes all argue in favor of a physical and not a psychological
origin to RLS.(9)
[0006] RLS is a common disorder: prevalence of symptoms 5 or more
nights per month were reported in 3% of individuals 18-29 years,
10% in 30-79 years, and 19% in those 80 or older.(10) Age adjusted
prevalence in this study was 10%. In a similar study, prevalence
was 11.5% with half of those reporting RLS symptoms causing
moderate to very severe discomfort.(11) Others have described a
rise in prevalence with age but have set peak prevalence at 70-79
years with a slight drop off in people 80 years and older.(12)
Whatever the peak prevalence of RLS, it is more common in older
individuals than younger and it severely affects emotional
well-being in the elderly.(13,14)
[0007] A study of 23,000 individuals conducted in France, Germany,
Spain, and the UK concluded that 11.1% of the general population
have RLS and that in 50% of patients RLS symptoms significantly
disrupted everyday activities and personal relationships.(15) A
companion study of over 15,000 individuals determined that 5% of
the population had RLS attacks at least twice weekly.(16) RLS is
now sufficiently common that in the 2007 issue of Time Magazine it
was featured in "The Year in Medicine from A to Z".(17) Although
quite common, RLS is not commonly recognized by primary-care
physicians even when a diagnostic description is given by the
patient to his doctor.(18) However, when primary-care physicians
are made aware of RLS, they can identify RLS in a high proportion
of patients.(19,20)
[0008] RLS can be early in onset (before the age of 45) with slow
progression of symptoms and run in families, or it can come on
later in life, involving one member of a family with rapid
development of severe symptoms.(12,21-24)
[0009] Because RLS is common, it has been observed in association
with a wide variety of other disorders and diseases. Some have
interpreted these associations as causal links. Such causal
interpretations need to be viewed with great caution. The list
includes metabolic and hormonal abnormalities, pregnancy,
peripheral neuropathies, spinal and brainstem lesions, decreased
serum magnesium and folate levels, anemia, rheumatoid arthritis,
amyloidosis, carcinoma, musculoskeletal disease, anxiety,
depression, multiple sclerosis, cognitive defects, hypertension,
blood donors, heart disease, reduced libido, social isolation,
gastroesophageal reflux, migraine headache, chronic lung disease,
caffeine use, varicose veins, sleep apnea, gastric surgery, drug
withdrawal, hypothyroidism, acute intermittent porphyria,
arborizing telangiectasia, cholesterol microemboli, diabetes,
periodic limb movement disorder in sleep (PLMS), somatoform pain
disorder, being Caucasian, and more.(2,25-40,40-45)
[0010] However, by 2007, only two published studies of patients
selected from the general population accurately measured the
association of RLS with other disorders.(46,47) These two studies
found that diabetes, reduced renal function, and anemia are
significantly associated but make only a small contribution to the
overall prevalence of RLS. Even in the older age groups where the
RLS is most prevalent, secondary disorders and diseases increase
RLS prevalence by only 10-20%.
[0011] Unlike these two general population studies, many small
associative studies have identified patients with specific
disorders or diseases and then compared RLS prevalence in these
selected populations with the general population or with controls.
In a review of 16 publications focused on patients with end-stage
renal disease on dialysis published between 1991-2005, 15 (93.8%)
of the 16 studies demonstrated higher prevalence rates in these
dialysis patients than in the general population.(36) In one study,
84% of patients with end-stage renal disease had RLS. To support
this association, it has been observed that in some patients,
symptoms of RLS dramatically decrease following renal
transplantation.(48) Like RLS in others, in dialysis patients RLS
leads to poor sleep and thereby to a low quality of life.(49)
Patients with RLS suffer from daytime sleepiness, depression, poor
concentration, and even fear of long-distance travel during which
their legs may become restless while awake.(9)
[0012] In a publication examining RLS and pregnancy, four studies
demonstrated prevalence rates higher than the general population,
while one showed rates no different that those observed in the
general population.(36) Others have reported an association of RLS
with pregnancy.(50) This association is further supported by the
observation that the frequency of RLS attacks drops dramatically
following childbirth.(51,52) Goodman et al. present a very
convincing reverse "S" shaped-curve showing a dramatic decrease in
RLS episodes following delivery.(53) In another study of pregnant
women, an association was observed between RLS and parity.(47)
Women who had given birth to three or more children had a three
times greater risk of having RLS compared to nulliparous women or
to men.
[0013] Iron deficiency has been associated with RLS since 1945,
although the connection between the two disorders is not clear-cut.
(3,36,54) Correction of peripheral anemia does not always decrease
RLS symptoms. Furthermore, most patients with RLS are not anemic.
When studied by magnetic resonance imaging, iron abnormalities
associated with RLS were observed in the substantia nigra of the
brainstem.(55) Decreased serum ferritin (below 50 ng/mL) and
cerebral spinal fluid ferritin levels have been associated with
RLS.(2) Patients with RLS appear to have a decreased ability to
transport iron into the central nervous system through the blood
brain barrier.(56)
[0014] A wide variety of peripheral neuropathies have been
connected with RLS including cryoglobulinemia, Charcot-Marie-Tooth
ataxia type 2, diabetic, and amyloid types.(57-60)
[0015] To prospectively evaluate the concomitant occurrence of RLS
and varicose veins in a population seeking treatment for varicose
veins, and to assess the therapeutic response of RLS to
sclerotherapy, 1397 patients with varicose veins were screened for
RLS symptoms by questionnaire and interview. RLS symptoms were
present in 312 (22%) of the 1,397 patients. Sclerotherapy with
sodium tetradecyl sulphate was performed on 113 RLS patients. 111
(98.2%) of 113 treated patients reported initial relief from RLS
symptoms. Follow-up showed recurrence rates of 8% and 28% at 1 and
2 years, respectively.(61)
[0016] And finally, RLS has been associated with the phenomenon of
periodic leg movements in sleep (PLMS).(30) In 1953, Symonds
described an involuntary clonic-like movement of the lower
extremities that occurred during sleep, often waking the patient
over and over again at night.(62) In 1965, Lugaresi et al.
documented the presence of PLMS in patients with RLS.(63) In a
polysomnographic study of 133 individuals with RLS, Montplaisir et
al. observed PLMS in 80.2% of these individuals using a one-night's
sleep PLMS index score of greater than 5 (one of the many
definition of abnormal PLMS).(64) However, PLMS has also been
observed in association with other forms of insomnia such as
narcolepsy, rapid-eye-movement sleep disorder, and obstructive
sleep apnea.(7) It has also been observed in normals.(7) Because
RLMS is associated with many diseases and disorders and with
normals, patients with RLS comprise only a fraction of patients
with PLMS. At best the diagnosis of RLMS is "supportive" of the
diagnosis of RLM; it is not diagnostic.
[0017] If RLS is caused by one of these associated disorder or
disease, and if correction of the associated disorder or disease
can stop the symptoms of RLS, then treatment is straight forward:
treat the associated disorder or disease. Except for pregnancy and
some forms of anemia, these associative disorders or diseases are
not generally amenable to treatment. For most of these patients,
palliation of RLS symptoms is the only treatment available.
[0018] On the other hand, in the vast majority of patients
suffering from RLS, there is no associated disorder or diseases of
the legs.(26) That is, in most individuals, RLS is idiopathic or
primary in nature.(65) Their affected limbs are no different than
limbs of people without RLS. Skin, muscles, bones, nerves, arterial
or venous circulation, spinal reflexes, electromyography, nerve
conduction studies, and imaging examination are all normal in
patients with primary RLS.(12,52)
[0019] In patients with primary RLS, the anatomic site of origin of
RLS appears to be in the central nervous system above the level of
the spinal cord and below the level of the cerebral cortex.(12) The
site of origin may be at the subcortical level, perhaps at the
level of the thalamus and cerebellum.(66)
[0020] FIG. 1 includes an illustration showing a leg and the major
classes of somatic sensory receptors, highly specialized cells
associated with neurons that convert various forms of energy from
physical stimuli into nerve impulses. The hairy skin H (including
free nerve endings, nociceptors, Merkel's disks, and Ruffini's
corpuscles), periosteum and interosseous membrane P (including
Pacinian corpuscles), the gastrocnemius muscle, muscles M including
muscle spindles, glabrous skin G (including free nerve endings,
nociceptors, Merkel's disks, and Ruffini's corpuscles, and
Meissner's corpuscles), joints J (including joint receptors),
tendons and ligaments T (including Ruffini's corpuscles and Golgi
tendon organs), and subcutaneous tissue S (including Pacinian
corpuscles) are illustrated (67).
[0021] Whether secondary or primary, central to RLS is the
nighttime onset of disagreeable somatic sensations that appear to
originate in a leg or in legs. Of our five senses, touch is the
most heterogeneous in character. Touch encompasses the sensation of
pain and temperature, pressure and crude touch, fine or
discriminatory touch, and vibratory sensation. A variety of
specialized microscopic receptors or mechanical-electrical
transducers are present in skin, subcutaneous tissues, muscles,
tendons and ligaments, joints, and periosteum and interosseous
membranes to distinguish different types of touch sensations, as
shown in FIG. 1. These specialized transducers or filters include
Pacinian corpuscles which are encapsulated, onion-like nerve
coverings that sense deep pressure and vibrations in the 250-350 Hz
range; Meissner's corpuscles which are oval structures surrounding
nerve and located between dermal papillae and which detect pressure
and low frequency vibration in the 30-50 Hz range; Merkel's discs
which are spherical collection of cells that identify static
pressure and respond to low frequency vibrations in the 5-15 HZ
range; Ruffini's corpuscles which are elongated structures in the
dermis that detect skin stretching and the sense of slipping; Golgi
tendon organs, joint receptors, and muscle spindles that identify
stretching, and free nerve endings that sense temperature and
pain.(67)
[0022] Three distinct somatic sensory neuronal pathways exist for
the legs. Each pathway begins in the leg and ends with a neuronal
signals reaching the cerebral cortex and, hence, consciousness.
[0023] Pathway No. 1: When painful stimuli or changes in
temperature excite the leg, they cause sensory nerves in skin to
fire. These primary neurons then synapse in the ipsilateral dorsal
horn of the spine with secondary neurons of the contralateral
lateral spinothalamic tract. These lateral spinothalamic nerves
then course up the spine reaching the thalamus on the opposite side
of the stimulus. In the thalamus, these axons synapse with tertiary
neurons that exit the thalamus and ascent in the internal capsule
and terminate in the postcentral or sensory gyrus of the cerebral
cortex.
[0024] Pathway No. 2: Pressure and crude touch nerves follow a
similar pathway with the addition of fibers from the primary neuron
for several spinal segments in the ipsilateral dorsal white matter
column.
[0025] Pathway No. 3: Neurons that transmit the senses of fine or
discriminatory touch, proprioception, and vibratory touch follow a
different pathway to the thalamus. For the legs, the primary
sensory neurons ascend in the ipsilateral fasciculus gracilis of
the dorsal column of the spine to the ipsilateral nucleus gracilis
in the medulla. In the nucleus gracilis these primary neurons
synapse with secondary neurons which then cross the midline to
ascend in the contralateral medial lemniscus to the thalamus.
Tertiary neurons then ascend to the postcentral or sensory cortex,
just as with other touch sensations. Since this wide variety of
somatic leg sensation all reach the thalamus, it makes sense that
the unpleasant leg sensations in patients with RLS are very diverse
in character.
[0026] For patients with primary or secondary RLS, the terribly
unpleasant touch sensations of RLS that often start during sleep
are mapped to their leg or legs (and, much less commonly, to their
arm or arms). Since most patients are not actually being subjected
to bizarre touch sensations in the affected extremity, the
sensations are, in effect, somatic hallucinations. That is, these
sensations are perceived to originate in a limb in which no
corresponding stimulus is present. For example, at the time some
patients with RLS report that a leg feels as though worms are
crawling in it, no worms are actually present to explain the
sensations experienced. The phantom limb syndrome in amputees is a
similar phenomena, where somatic sensations in the brain are mapped
by the individual to a limb that is not present. They are not
usually referred to as "hallucinations," but they are.
[0027] A partial explanation for the hallucinations that begin
during periods of sleepiness and drowsiness or during sleep in
patients with RLS may be found in the neuronal circuit that exists
between the thalamus and the sensory cortex, referred to as the
"thalamocortical loop."(67) Only two stable membrane potential
states exist for thalamocortical neurons. During wakefulness, these
neurons fire tonically which allows them to transmit information
from peripheral somatic stimuli to the cortex or conscious brain
(see Pathways 1-3 above). During sleep, and perhaps during times of
sleepiness or drowsiness, the thalamocortical neurons enter an
oscillatory state, become synchronized with the cortex, and
disconnect the cortex from the outside world. When disconnected,
the conscious brain gets its peripheral somatic sensory input not
from peripheral somatic sensory neurons but from the thalamus and
its varied inputs. The somatosensory brain is no longer looking at
the external world; it is focused internally.
[0028] The primacy of sensory abnormalities in RLS--as opposed to
movement abnormalities--was emphasized in a recent study published
by pulmonary physicians (as opposed to sleep physicians) who noted
that "The endorsement of twitching or frequent body movements in
the current study was so frequent as to render it a nonspecific
finding. We cannot draw any conclusions based on this reported
symptom in this study, other than to suggest that asking about body
twitching may not be useful in the clinical evaluation of
patients."(37) The same authors noted that a consistent diagnosis
of RLS could be obtained using a definition of RLS that requires "
. . . uncomfortable leg sensations a few nights a week or more that
are worse at night." Abnormal brain somatosensory processing in RLS
patients has been described.(68)
[0029] Prior to waking, the unpleasant sensations of RLS lead to
leg movements seemingly as an unconscious attempt to diminish the
amplitude of the disturbing sensations. Dysfunctional leg movements
and their antecedent unpleasant sensations wake the patient who
then seeks relief by doing something, commonly getting out of bed
and standing or walking. However, even though standing and walking
diminish unpleasant limb sensations, they do so at the expense of
sleep. Over half of patients with RLS report waking with symptoms 3
or more times per night on nights they experience attacks.(15) Loss
of sleep is the ultimate price paid by the patients who suffer from
RLS. RLS patients with severe symptoms have the least amount of
sleep of any sleep disorder with the exception of sleep-loss
associated with mania.(66) The sleep-loss of RLS leads to a
generalized decrease in quality of life similar to other forms of
insomnia, such as sleep apnea.(15,69) RLS victims are more likely
than normals to be late to work, miss work, make errors at work,
and miss social events because of sleepiness.(37)
[0030] Two drugs are currently labeled by the Food and Drug
Administration for the treatment of RLS: Mirapex.RTM. (pramipexole
dihydrochloride), a nonergot dopamine agonist, and Requip.RTM.
(ropinirole hydrochloride), a nonergot dopamine agonist. Both
agents have a higher binding affinity with D.sub.3 dopamine
receptor subtypes than for D.sub.2 for D4 receptors. In two
separate blinded studies of ropinirole, very large placebo affects
were observed, suggesting that just the process of focusing
attention on patients with RLS helps them considerably.(70,71)
Off-label drug prescription for RLS is widespread. Many drugs,
including iron preparations, benzodiazepines, opiates, and
anticonvulsants have been used to treat RLS.(8) Some dopaminergic
agents, such as the combination of levodopa/carbidopa, have caused
long-term side effects which include worsening or augmentation of
RLS symptoms.(9) Drugs that influence the central nervous system
commonly effect more than one region of the brain, making drugs
less than desirable as a first line of treatment for RLS. McCrink
et al. studied 16,202 individuals, 7% of which had RLS. They
documented that health-related quality of life was actually
diminished in RLS patients who used prescription medications to
treat RLS symptoms.(72)
[0031] As previously noted, if correction of a patient's secondary
disorder or disease can correct RLS, that disorder or disease
should be treated. However, most patients with RLS have no
secondary disease or disorder to correct or the secondary disorder
or disease is not treatable.
[0032] To relieve the unpleasant tactile sensations of RLS,
patients resort to all sorts of movements and stimulations of the
legs including " . . . walking about, stomping the feet, rubbing,
squeezing or stroking the legs; taking hot showers or baths; or
applying ointment, hot packs, or wraps to the legs."(73) As stated
by Jones and Derodra, "The relief of symptoms produced by movement
or rubbing may be due to the afferent sensory input effect."(25)
Patients are spontaneously applying an overwhelming or swamping
sensory input to serve as a "counterstimulation" to the unpleasant
sensations of RLS. Once up and doing something, RLS symptoms
usually subside. However, the process of getting up and walking
interrupts sleep. And interrupted sleep, over the long haul, leads
to decreased wakeful functioning and diminished
quality-of-life.
[0033] A simple device that could provide a pleasant sensation to
overwhelm or swamp the unpleasant sensations of RLS, without fully
waking the patient, might be a more desirable first line treatment
of RLS than drugs. Counterstimulation is a known medical therapy.
To treat auditory hallucinations, personal stereo music has been
applied as a counterstimulation to overwhelm or swamp auditory
hallucinations.(74) Similarly, to treat a wide variety of chronic
pain syndromes, transcutaneous electrical nerve stimulation has
been applied as a counterstimulation to overwhelm or swamp
pain.(75)
[0034] If a counterstimulus could be applied to a RLS patient at
the onset of an attack while the patient were in bed, and the
counterstimulus could be applied with minimal waking of the
patient, sleep efficiency might be improved. As shown by FIG. 2,
which illustrates a flow chart showing grades of severity of RLS
and types of treatments based upon severity, adapted from
Chaudhuri, many patients with mild forms for RLS spontaneously
apply a counterstimuli of one sort or another to allow themselves
to go back to sleep.(9)
[0035] If the RLS patient's self-treatment proves ineffective or if
it requires a degree of wakefulness incompatible with a good
night's sleep, then a device that applied a counterstimulus without
robbing sleep might be useful.
[0036] FIG. 3 illustrates a cooling pad, embodying principles of
the present invention, applied to a leg, the cooling pad applying
no additional pressure than the patient sheet and mattress pad. In
some patients, therapeutic counterstimulation could be as simple as
making a region of the patients bedding cool, as shown in FIG. 3.
Cooling that does not drop to lower than 17.degree. C. is sensed by
free nerve fibers as a cool sensation and not pain. Below
17.degree. C., the sensation is identified by other free nerve
fibers as pain.(67) (Similarly, above 42.degree. C., heat is no
longer sensed as warmth, but as pain.) If the cooling could be
turned on at the onset of RLS symptoms and set to turn off as the
patient fell back to sleep, a counterstimulation of a single nerve
pathway might be sufficient to overwhelm the central sensations of
RLS.
[0037] FIG. 4 illustrates a hard rubber ball, embodying principles
of the present invention, being pressed against a patient's leg
such that the skin, subcutaneous tissue, muscle, periosteum, and
joints are all effected by the stimulus. In another patient,
therapeutic counterstimulation might require the recruitment of a
host of somatic sensory nerves to overcome the unpleasant
sensations of RLS. FIG. 4 shows a ball pressed against the back of
a patients leg with just enough force not to elicit pain. Free
nerve endings, Merkel's disks, and Ruffini's corpuscles from the
skin, Pacinian corpuscles from subcutaneous tissue, muscle spindles
from the muscle, joint receptors from the knee and ankle, and
Pacinian corpuscles from the interosseous membrane joining the
tibia and the fibula, could all send somatic sensory signals to the
brain from this stimulus. If pressure from a ball, or the like,
could be applied at the onset of RLS symptoms and removed as the
patient fell back to sleep, a counterstimulation from a host nerve
pathways might sufficient to overwhelm the unpleasant central
sensations of RLS. A commercially available boot which diffusely
applies pressure to the foot and calf has been disclosed on the
world wide web
(club-cleo.com/cleo-active-leggings-reflexology.html) and offered
as a means of treating RLS. Similarly, a boot-like device capable
of moving leg fluids to prevent deep vein thrombosis is revealed by
Morgenlander in U.S. Published Patent Application Nos. 2003/0176822
A1, US 2005/0026912 A1, and US 2006/0287621 A1, in which the
affected limb is subjected to " . . . positive pressure to an
extremity" to effect treatment. Additionally, in U.S. Pat. No.
4,149,529, Copeland discloses an apparatus capable of applying
pressure to a leg similar to Morgenlander.
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SUMMARY
[0113] According to a first aspect of the invention, a system for
generating a counter-stimulation in a patient suffering from RLS
comprises a device configured and arranged to generate a
counter-stimulation in a patient suffering from RLS, the
counter-stimulation of an amplitude, intensity, and time duration
lower than that which would wake the patient and higher than that
sufficient to relieve RLS, or sufficient to relieve RLS symptoms
and allow the patient to return to sleep, a controller configured
and arranged to drive the counter-stimulation generation device,
the controller in communication with the counter-stimulation
device, and a base configured and arranged to hold the
counter-stimulation generation device adjacent to a patient, the
counter-stimulation device attached to the base.
[0114] According to another aspect of the present invention, a
method of treating RLS comprises selecting a patient experiencing
RLS, and stimulating a portion of the patient at an amplitude,
intensity, and duration sufficient to act as a counter-stimulation
to RLS.
[0115] Still other aspects, features, and attendant advantages of
the present invention will become apparent to those skilled in the
art from a reading of the following detailed description of
embodiments constructed in accordance therewith, taken in
conjunction with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0116] The invention of the present application will now be
described in more detail with reference to exemplary embodiments of
the apparatus and method, given only by way of example, and with
reference to the accompanying drawings, in which:
[0117] FIG. 1 illustrates a human leg including anatomical
features;
[0118] FIG. 2 illustrates a decision flow chart relating to the
treatment of RLS;
[0119] FIG. 3 illustrates a human leg and the calf thereof;
[0120] FIG. 4 illustrates a human leg with the calf thereof resting
on a ball;
[0121] FIG. 5 illustrates a human leg with a RLS
counter-stimulation device embodying principles of the present
invention positioned on the foot;
[0122] FIG. 6 illustrates a human leg with a RLS
counter-stimulation device embodying principles of the present
invention positioned on the calf;
[0123] FIG. 7 illustrates a human leg with a RLS
counter-stimulation device embodying principles of the present
invention positioned on the thigh;
[0124] FIG. 8 illustrates a human leg with a RLS
counter-stimulation device embodying principles of the present
invention positioned on the foot and calf;
[0125] FIG. 9 illustrates a human leg with a RLS
counter-stimulation device embodying principles of the present
invention positioned on the foot and ankle;
[0126] FIG. 10 illustrates a human leg with a RLS
counter-stimulation device embodying principles of the present
invention positioned on the foot, calf, and thigh;
[0127] FIGS. 11-14 illustrate cross-sectional views, taken a line
A-A in FIG. 10, showing several features of embodiments of the
invention;
[0128] FIG. 15 illustrates a side elevational view of an embodiment
of a device in accordance with the present invention, under a
patient's legs;
[0129] FIG. 16 illustrates a side elevational view of an embodiment
of a device in accordance with the present invention, over a
patient's legs;
[0130] FIGS. 17 and 18 illustrate cross-sectional views, taken a
line A-A in FIG. 10, showing several features of other embodiments
of the invention;
[0131] FIG. 19 illustrates a side elevational view of an embodiment
of a device in accordance with the present invention, under a
patient's legs;
[0132] FIG. 20 illustrates a side elevational view of an embodiment
of a device in accordance with the present invention, over a
patient's legs;
[0133] FIG. 21 schematically illustrates an exemplary device for
producing counter-stimulation by pressure application;
[0134] FIGS. 22-25 illustrate cross-sectional views, taken a line
A-A in FIG. 10, showing several features of other embodiments of
the invention;
[0135] FIGS. 26-28 illustrate side elevational views of embodiments
of a device in accordance with the present invention, under a
patient's legs;
[0136] FIG. 29 schematically illustrates an embodiment of a device
which mechanically produces vibration counter-stimulation;
[0137] FIG. 30a illustrates a side elevational view of an
embodiment of a device in accordance with the present invention,
under a patient's legs;
[0138] FIG. 30b illustrates a side elevational view of an
embodiment of a device in accordance with the present invention,
over a patient's legs;
[0139] FIGS. 31 and 32 illustrate cross-sectional views, taken a
line A-A in FIG. 10, showing several features of other embodiments
of the invention;
[0140] FIG. 33 illustrates a side elevational view of an embodiment
of a device in accordance with the present invention, under a
patient's legs;
[0141] FIG. 34 illustrates a side elevational view of an embodiment
of a device in accordance with the present invention, over a
patient's legs;
[0142] FIGS. 35 and 36 illustrate cross-sectional views, taken a
line A-A in FIG. 10, showing several features of other embodiments
of the invention;
[0143] FIG. 37 illustrates a side elevational view of an embodiment
of a device in accordance with the present invention, under a
patient's legs;
[0144] FIG. 38 illustrates a side elevational view of an embodiment
of a device in accordance with the present invention, over a
patient's legs;
[0145] FIGS. 39 and 40 illustrate cross-sectional views, taken a
line A-A in FIG. 10, showing several features of other embodiments
of the invention;
[0146] FIG. 41 illustrates a side elevational view of an embodiment
of a device in accordance with the present invention, under a
patient's legs;
[0147] FIGS. 42 and 43 illustrate cross-sectional views, taken a
line A-A in FIG. 10, showing several features of other embodiments
of the invention;
[0148] FIG. 44 illustrates a side elevational view of an embodiment
of a device in accordance with the present invention, under a
patient's legs;
[0149] FIG. 45 illustrates a side elevational view of an embodiment
of a device in accordance with the present invention, over a
patient's legs;
[0150] FIGS. 46 and 47 illustrate cross-sectional views, taken a
line A-A in FIG. 10, showing several features of other embodiments
of the invention;
[0151] FIGS. 48 and 49 illustrate yet another embodiment of a
device for RLS counter-stimulation;
[0152] FIGS. 50 and 51 illustrate another embodiment of a device
for RLS counter-stimulation;
[0153] FIGS. 52 and 53 illustrate yet another embodiment of a
device for RLS counter-stimulation;
[0154] FIGS. 54 and 55 illustrate another embodiment of a device
for RLS counter-stimulation;
[0155] FIG. 56 illustrates another embodiment of a device for RLS
counter-stimulation;
[0156] FIG. 57 illustrates a cross-sectional view, taken at line
B-B in FIG. 56;
[0157] FIGS. 58 and 59 illustrate yet another embodiment of a
device for RLS counter-stimulation;
[0158] FIG. 60 illustrates yet another embodiment of a device for
RLS counter-stimulation;
[0159] FIG. 61 illustrates an exemplary system for RLS
counter-stimulation;
[0160] FIGS. 62 and 63 illustrate yet another embodiment of a
device for RLS counter-stimulation;
[0161] FIGS. 64 and 65 illustrate yet another embodiment of a
device for RLS counter-stimulation;
[0162] FIGS. 66-70 illustrate another embodiment of a device for
RLS counter-stimulation; and
[0163] FIGS. 71-73 illustrate another embodiment of a device useful
for producing mechanical vibrations for RLS
counter-stimulation.
DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS
[0164] Referring to the drawing figures, like reference numerals
designate identical or corresponding elements throughout the
several figures.
[0165] It is believed that that most people in the RLS-suffering
population are undiagnosed or symptoms are not sufficient to seek
treatment. Most of those that do seek treatment are adequately
treated by teaching improved sleep hygiene. A few patients may only
be amenable to treatment by dopamine, as the symptoms are so severe
that counter stimulation of the patient does not relieve or prevent
the symptoms. Thus, those falling in a middle group, who do not
benefit from sleep hygiene training and for which neuro-active
drugs are an extreme treatment, can particularly benefit from
additional therapeutic options.
TABLE-US-00001 TABLE 1 Top Level RLS Treatment Matrix RLS symptoms
Mild Symptoms Mild to Severe Severe Patient May be Sleep is Sleep
is nearly Experience undiagnosed occasionally continuously and
untreated interrupted and interrupted patient nearly seeks medical
attention Treatment Sleep Counter Pharmacologic required hygiene
may stimulation to treatment after be sufficient prevent the
failure of lesser therapy sensory seizure therapies provides
adequate relief
[0166] Referring back to FIG. 2, an exemplary process of diagnosing
and treating RLS is illustrated. With reference to Table 1 and FIG.
2, the determination that an RLS-sufferer has mild symptoms, 10,
indicates that sleep hygiene may be sufficient therapy for the
patient. When a determination is made that the patient's RLS is
severe, 14, then other treatment options, such as pharmacologic
treatment after the failure of lesser therapies, is indicated. In
between, when a determination has been made that the patient's RLS
is, thus, mild to severe, 12, counter-stimulation, to prevent the
sensory seizure, can provide adequate relief to the patient, and is
indicated. Particularly advantageous, however, are aspects of the
present invention in which the counter stimulation of the patient
is conducted within a stimulation window, with a level of
stimulation high enough that it acts to counter the "hallucination"
discussed above, while being below a level which will awaken the
patient.
[0167] Turning now to FIG. 5, an exemplary embodiment of a device
100 is illustrated by which stimulation can be applied to the
patient's foot only, but can be applied to the bottom, top, side,
or any combination thereof. With reference to FIG. 6, another
exemplary embodiment of a device 110 is illustrated by which
stimulation can be applied to the patient's calf only, to the shin,
or in combination. With reference to FIG. 7, yet another exemplary
embodiment of a device 120 is illustrated by which stimulation can
be effected to the patient's thigh only, by applying stimulation to
the front, back, side, or in any combination thereof.
[0168] For example, combined stimulation can be applied to the
patient's foot and calf, as illustrated in FIG. 8, either in a
stimulation sequence or in unison. With reference to FIG. 9, the
counter-stimulation can take the form of the application of motion
to part of the patient's body, e.g., a torsion device 130 can be
used to flex the patient's ankle, which may flex unilaterally or
bilaterally. In this exemplary device 130, the device is driven to
produce the flexing of muscles and the sensation of motion to the
patient's brain. The exemplary device 130 can include a portion 132
which, similar to the device 100, is shoe-shaped so that it follows
the contours of the patient's foot, a hinge or pivot 134 to which
the shoe-shaped portion 132, and an ankle cuff 136 also attached to
the pivot. Not illustrated in FIG. 9 is a motor, linear actuator,
or the like which is connected to the shoe-shaped portion 132 and
selectively moves the portion 132 relative to the patient's calf.
With reference to FIG. 10, an embodiment is illustrated which
exemplifies a combined counter-stimulation, in which stimulation of
all three areas (foot, lower leg, thigh) simultaneously, or any two
in combination, is utilized. FIG. 11, which illustrates a
cross-sectional view at line A-A in FIG. 10, illustrates that the
stimulation can be performed around the full circumference of the
thigh or lower leg; FIG. 12, which also illustrates a
cross-sectional view at line A-A in FIG. 10, illustrates how
stimulation can performed over only a portion of the circumference
of the thigh or lower leg; the invention is not limited to
application of counter-stimulation to the calf, as the illustration
of FIG. 12 is merely exemplary.
[0169] FIGS. 13 and 14 illustrate exemplary embodiments, in which
circumferential pressure is applied to a portion of the patient's
body. In an exemplary embodiment illustrated in FIG. 13, a
circumferential bladder 140, which can be pneumatic or hydraulic,
applies low pressure to the patient to stimulate, but not at a
level sufficient to pump blood, as in venous boots; 3-20 mm Hg of
pressure is preferred. With reference to FIG. 14, a
semi-circumferential bladder 142 applies lower pressure to
stimulate the patient, but not pump blood, and similarly 3-20 mm Hg
of pressure can provide counter-stimulation. Not illustrated is a
fluid pump and controller connected to the bladder 140, 142, which
supplies fluid at pressure to the bladders so that the bladder can
stimulate.
[0170] Further embodiments embodying principles of the invention
involve the application of mechanical point pressure to the patient
as a counter stimulation to RLS. With reference to FIG. 15, an
exemplary device 150 includes a single (or array of) pneumatic
cylinders, electric solenoids, inflatable balloons, or similar
mechanical point pressure applicators 152 which can be used to
apply a controlled counter-stimulation to a portion of the
patient's body, here the bottoms of the patient's legs being
illustrated by example; a pillow block 154 can optionally be
provided for comfort, elevation, and to house the mechanisms and
controls which activate the point pressure applicators. Similarly,
with reference to FIG. 16, an exemplary device 160 includes a
single (or array of) pneumatic cylinders, electric solenoids,
inflatable balloons, or similar mechanical point pressure
applicators 162 which can be used to apply a controlled
counter-stimulation to a top portion of the patient's body; a
blanket or pad 164 can optionally be draped over the patient's legs
for comfort, and to mount the devices.
[0171] For embodiments employing pneumatic point pressure
application, with reference to FIGS. 17 and 18, one or more
inflatable balloons 170 can be used for local pressure stimulation.
Advantageously a cuff is not used, because a cuff is prone to cause
blood movement, a treatment associated with venous disorders, which
is too strong of a counter-stimulation for most patients to not be
awoken. The focal pressure applied to the patient, according to
principles of the invention, is sufficient to provide sensory
input, but not so much as to move blood in the patient's venous
systems and particularly advantageously does not wake the
patient.
[0172] FIG. 19 illustrates a system 180 embodying principles of the
invention, in which mechanical touch is utilized to produce
counter-stimulation. By way of a non-limiting example, rollers 182
are provided which spin on their axes and may optionally track
along the patient's leg, optionally housed within a pillow block
184 as discussed above. The roller itself optionally is formed of
or covered with a soft foam which drags on the patient's skin, or
hard rubber. The rollers may be fixed in position and rotate,
causing friction, or, alternately, the rollers may be on a track
186 and move along the patient as they rotate, rolling over the
patient's skin to stimulate an area.
[0173] With reference to FIG. 20, yet another embodiment 190,
complying with principles of the invention, also relies on the
mechanical-touch principle to provide counter-stimulation to RLS.
Soft or hard rollers 192 are used to drag or "roll" on the
patient's skin, in a manner similar to the rollers described with
reference to FIG. 19. A blanket or pad 194 can be provided on top
of the patient's legs, both for comfort and to mount the
devices.
[0174] With reference to FIGS. 21-23, electromechanical or
pneumatic cylinders 200 embodying principles of the invention are
illustrated for providing counter-stimulation to RLS. An electrical
solenoid 202 can be positioned to provide local pressure
stimulation, and can be electrically powered, e.g., 12/24 VDC or
120 VAC, as at 204, to provide a pressure timing mechanism to
control an "on" pressure cycle and an "off" rest cycle. The
pressure can be adjusted to drive the voltage applied to the
solenoid. Additionally, the maximum and minimal travel distances of
the pad/rod 208, and frequency, can be made variable. The cylinder
or cylinders 200 can be mounted to a wrap or other support 210,
similar to such structures described elsewhere herein, with the
pressure pad 206 directed toward the patient.
[0175] With reference to FIG. 23, air pressure can be supplied to
provide hydraulic pressure on a "pancake" cylinder 220 to minimize
the profile of the device. A controller (not illustrated) is
provided to increase pressure to create more force on the cylinder
rod, decrease pressure to reduce the force on cylinder rod, can
ramp or the fluctuate pressure to create a "massage", and/or can
adjust the frequency and/or amplitude to make the stimulation more
vibratory.
[0176] With reference to FIGS. 24 and 25, which are illustrations
of cross-sectional views similar to prior figures, a touch and roll
embodiment is illustrated. As illustrated in FIG. 24,
circumferentially-applied counter-stimulation utilizes powered
rollers 230, which may be solid or foam, and which drag on the skin
or roll along the skin. Optionally, the surfaces of the rollers can
be provided with an extra texture, e.g., dimples, for additional
sensation. With reference to FIG. 25, localized transmission of a
counter-stimulation for treating RLS can be applied by a powered
roller, e.g., on one side of the foot, lower leg, or thigh, which
likewise drags on the skin or rolls along the skin.
[0177] According to yet further principles of the invention,
counter-stimulation for treatment of RLS can be produced by
stretching the patient's muscle(s). With reference to an exemplary
embodiment illustrated in FIG. 26, a device 240 is provided, such
as an air bladder, pneumatic cylinder, or a simple mechanical lift
242, which causes the thigh muscles 244 to flex as the patient's
knee is lifted. Similarly, the calf 246 is flexed as the patient's
knee is lifted. The flexion of either or both of these muscles
provides a counter-stimulation to RLS. With reference to FIG. 27,
an exemplary device includes an air bladder or pneumatic cylinder
252 which can be positioned under the lower legs and feet of the
patient; movement up causes the thigh muscles to flex and stretch,
thus providing a counter-stimulation. With reference to FIG. 28, a
footboard 260 is provided which, upon actuation of an appropriate
mechanism to push the upstanding portion 266 of the footboard,
flexes and stretches the patient's calf muscles, providing a
counter-stimulation to RLS. By way of non-limiting example, the
footboard 260 can include a relatively stationary platform 268 and
a force transmission member 264 connecting the platform to the
upstanding portion 266 at a pivot 262; moving the member 264, e.g.,
by motor or the like (not illustrated) moves the portion 266 and
flexes the patient's foot, causing a counter-stimulation.
[0178] According to yet further principles of the invention,
counter-stimulation for treatment of RLS can be produced by
mechanical vibration. With reference to an exemplary embodiment
illustrated in FIG. 29, an electrical motor 270 provided with an
eccentric weight 274 mounted to the motor shaft 272 can be provided
which, upon actuation, rotates the weight and thus vibrates either
a local region of the patient's body or, e.g., the entire leg of
the patient to create a counter-stimulation to RLS. Another
exemplary embodiment includes a pneumatic cylinder or electric
solenoid which is driven to cause such a vibration, or a
piezo-electric vibrator or speaker. With reference to FIGS. 30a and
30b, the mechanical vibratory device(s) 270 can be positioned on
top of the patient (FIG. 30b), as with other embodiments described
herein, with one or more electrical motors provided with an
eccentric weight, pneumatic cylinder or electric solenoid 282,
and/or a piezo-electric vibrator or speaker 284.
[0179] With respect to using vibration as a counter-stimulation for
RLS, the vibration can be provided with variable frequency and
amplitude, from 1 cycle/minute to 1000 cycles/second. By way of
non-limiting example, numerous devices can be utilized to create
the vibration, including, but not limited to, a piezo-chip, a
loudspeaker, a motor with eccentric weight, an electrical solenoid;
and can be electrically driven (120 VAC, 12 VDC, 24 DC battery
powered, rechargeable, etc.), and/or can be driven by a pneumatic
cylinder. As illustrated in FIG. 31, a series of vibrators 290 can
be provided which wrap around the patient's leg or be applied to
the leg, and can be turned on, run for a predetermined period of
time, and turned off after a specified time. FIG. 32 illustrates an
exemplary embodiment in which the vibrator 290 is localized, rather
than being provided as a series of vibrators.
[0180] According to yet further principles of the invention,
counter-stimulation for treatment of RLS can be produced by
electrical nerve stimulation, muscle stimulation, or both. With
reference to FIGS. 33 and 34, an exemplary embodiment 300 includes
a series of sensors and/or electrodes 302 which are activated for
muscle stimulation, nerve stimulation, or both. When activated for
muscle stimulation, the voltage and frequency of the electrical
energy applied to the patient is sufficient to cause muscular
contraction, which provides the counter-stimulation to RLS; when
activated for nerve stimulation, the electrical energy applied to
the patient is sufficient to cause a patient's nerve to be
stimulated. For either or both of these purposes, the electrodes
and/or sensors are driven by a controller 304, which controls the
application of voltage or current to the electrodes 302, and which
may be a simple timer, a complex controller, or other such device.
With reference to the exemplary embodiments illustrated in FIGS. 35
and 36, multi-circuit (circuits 1, 2; electrodes A, B of each
circuit) stimulation can be applied circumferentially around the,
e.g., leg of the patient, axially, e.g., up and down along the
length of the patient's leg, or both, using sets of electrodes 302.
Alternatively, single circuit (A, B) stimulation can be applied
laterally and/or axially, as suggested in FIG. 36.
[0181] According to yet further principles of the invention,
counter-stimulation for treatment of RLS can be produced by the
application of temperature changes, e.g., hot, cold, and/or
alternating hot and cold, to the patient. With reference to an
exemplary embodiment 310 illustrated in FIG. 37, a resistance
heating element 312, Peltier device 314, and/or a bladder 316
containing heating or chilling fluid is positioned on the skin
surface, below the patient, and an associated (and unillustrated)
control device controls application of heat and/or cold to the
patient's skin. In FIG. 38's embodiment 320, the heat transfer
device 312, 314, 316 is positioned on top of the patient, mounted
to a blanket or the like. FIGS. 39 and 40, which are illustrations
of cross-sectional views similar to other figures herein, show
series of Peltier 314 devices to heat, cool, and/or alternate
hot/cold to the patient around a circumference of a, e.g., limb, or
a single device can be provided. Optionally, a series of fluid
bladders 316 can be provided for holding and/or circulating hot or
cold fluid, e.g., water. Alternately, a series of resistive heating
pads 312 can be provided.
[0182] According to further principles of the invention,
counter-stimulation for treatment of RLS can be produced by
application of a chemical to the patient's skin. With reference to
FIG. 41, an exemplary embodiment 330 includes localized ports 332
or a porous membrane 334 positioned on the patient's skin, to
dispense a preselected chemical, thus causing sensory stimulation.
With reference to FIGS. 42 and 43, one or more chemicals can be
input to a bladder 336 or diffuser, and provided in either a
pulsatile or continuous flow. A bladder/diffuser, when used, can
dispense a chemical such as Bengay.TM., capsaicin, or DMSO, which
provides an exotherm on dissolving into the skin. As indicated in
these figures, the chemical application can be completely
circumferential, or locally, non-circumferentially applied, where
the bladder acts as a manifold for the chemical.
[0183] According to further principles of the invention,
counter-stimulation for treatment of RLS can be produced by
application of magnetic fields to a portion of the patient. With
reference to an exemplary embodiment 340 illustrated in FIGS. 44
and 45, one or more electromagnets 342 are positioned close enough
to the patient for the magnetic field to produce a
counter-stimulation. A controller, not illustrated, is provided to
control the operation of the electromagnets, that is, to turn them
on and off, alternate the current direction, rotating fixed pole
magnets within a housing, or combinations thereof. Electromagnets,
rotating fixed pole magnets, or either of these could be sequenced
to give some vibration or touch sensation, if desired. As
illustrated in the cross-sectional views of FIGS. 46 and 47,
electromagnets 342 can be positioned either circumferentially
around a portion of the patient's body, or only on one side. In
general terms, however, magnets can be provided which are:
electromagnets which are turned on and off to pulse a localized
magnetic field; rotating, fixed pole magnets which are rotated in a
housing; and/or a magnetic button or malleable magnetic rod.
[0184] FIGS. 48 and 49 illustrate yet a further embodiment 350 in
accordance with principles of the present invention. One or
multiple sensory input drivers 352 are positioned in a line on a
wrap 358, sized so that the line of sensors can be positioned along
a predetermined portion of the patient's body. By way of a
non-limiting example, the wrap is sized to fit around an adult
human's calf or thigh, and includes fasteners 356 on respective
portions 354 of the wrap so that the wrap can be held onto the
patient (e.g., hook-and-loop-pile-type fasteners, e.g.,
Velcro-brand fasteners, magnetic strips, hook-and-eye fasteners,
snaps, laces, etc.) with the sensors in sufficient contact with the
patient to perform their respective sensing and/or stimulation
function. Alternatively, as illustrated in FIGS. 50 and 51, another
exemplary embodiment 360 includes two or more lines 362, 364 of
sensors, or the same or different types, can be provided in the
wrap. FIGS. 52 and 53 illustrate an embodiment 370 in which the
stimulator(s)/sensor(s) are positioned in circumferential bands
372, 374, while the exemplary embodiment 380 illustrated in FIGS.
54 and 55 includes axial bands 382, 384 of
stimulator(s)/sensor(s).
[0185] The sensory input drivers described herein are connected to
a controller (not illustrated) which includes logic, either in one
or more electronic circuits, or in a set of logical instructions
which are provided in a memory, and with a processor which can
access the memory and execute the set of instructions based on the
signals received from the sensory input drivers, to drive one or
more of the devices described herein to create a counter-stimulus
for RLS.
[0186] FIGS. 56 and 57 illustrate an example of a device 390
embodying principles of the present invention. A plurality of DC
motors 394 are positioned on or in a foam (e.g., polyurethane foam)
body 392, which is advantageous, yet optionally, flexible,
optionally with an outer jacket 396 of, e.g., neoprene. The motors
are each connected to a relay which receives a control signal from
a suitable controller. The controller provides a signal to the
relay to actuate the motors for a predetermined duty cycle. For
example, the duty cycle could be that the motors are on for between
1 and 180 seconds, and off for between 1 and 18 seconds. As
described above, the motors, when supplied with electricity during
an "on" portion of a cycle, turn to produce a counter-stimulation,
e.g., by having the motor produce mechanical vibration.
[0187] FIGS. 58 and 59 illustrate yet another exemplary embodiment
410, in which an electric motor 414, fed by a voltage source via
leads 419, is encapsulated in a flexible material 412, 418, e.g.,
neoprene, with a hemispherically shaped cover 416 over the motor;
when actuated, as described herein, the motor produces a
counter-stimulation that can be felt by the patient through the
underlying neoprene 418.
[0188] FIG. 60 illustrates yet another exemplary embodiment 400 of
a simple cage or jack device which can be used to produce a
counter-stimulation. An actuator rod 406 extends through a set of
links 402 joined together at pivots 404, with the actuator rod
connected to an end pivot on an end of the device opposite where
the actuator rod extends through a slide pivot 408; alternatively,
the rod can be a screw, and the slide replaced with a nut. Motion
of the rod 406 (suggested by the double-ended arrow) through the
slide 408 pulls the end pivot toward the slide pivot, causing the
links 402 of the cage to move at their pivots 404 and push the
upper link up, relative to the lower link, as suggested by the
arrow. By positioning the cage device 400 adjacent to the skin of a
patient, and connecting the actuator rod 406 to a linear actuator
controlled by a controller (neither illustrated), pressure and/or
vibration can be applied to the patient as a counter-stimulation to
RLS.
[0189] In general terms, mechanical vibration used as a
counter-stimulation to RLS advantageously is in a range of
frequencies between about 50 Hz to 10 per minute, with amplitudes
which can be frequency-dependent, ranging from about 0.002 inches
to about 0.75 inch in amplitude. While other frequencies and
amplitudes can be used, these ranges are preferred. Determining the
best combination of frequency and amplitude of the mechanical
vibration for a particular patient can be easily performed by
simple trial and error.
[0190] In general terms, temperature cycling used as a
counter-stimulation to RLS advantageously is in a range for heating
the pad or sensor from the ambient skin temperature up to about
106.degree. F., although temperatures up to 120.degree. F. can also
be beneficial. For cooling, the pad/sensor is at a temperature from
about ambient skin temperature down to 62.degree. F., although a
temperature as low as 52.degree. F. can also be beneficial. One
exemplary cycle could include the following: from ambient
temperature, heat to skin to a target temperature (e.g.,
106.degree. F.) within 2-20 seconds; hold the temperature at the
target temperature for 2-20 seconds; and then cool, either
passively or actively, down to ambient temperature; and rest for
between 2 seconds and one minute. Another exemplary cycle could
include the following: from ambient temperature, cool to skin to a
target temperature (e.g., 62.degree. F.) within 2-20 seconds; hold
the temperature at the target temperature for 2-20 seconds; and
then heat, either passively or actively, up to ambient temperature;
and rest for between 2 seconds and one minute. The total cycle time
can be between about 6 second to 90 seconds for ramping up the
temperature, maintaining temperature, and ramping down, with a
"rest" period of 2 seconds to one minute.
[0191] In general terms, tissue massaging used as a
counter-stimulation to RLS advantageously is effected with a
contact surface against the skin of the patient which is domed,
e.g., hemispherical, with an outer diameter between about 0.5 inch
and 1.0 inch, and with a linear motion into the patient's skin of
between 0.01 inches and 1.5 inches. While this motion can be
controlled with a stepper motor to control motion and flexibility
of the design, other devices can also be used. The deflection time
of, e.g., the jack illustrated in FIG. 60, should be from 0.5
seconds to 5 seconds, with a hold time of between about 1 and 10
seconds, a relaxation deflection time of 0.5 to 5 seconds, and a
rest time of 1 to 30 seconds.
[0192] More timing functions, particularly for continuous,
low-amplitude vibration, and starting and stopping the vibration
for varied periods of time, is also beneficial. By way of a
non-limiting example, a timing relay can be used to cycle vibrating
motors on and off, with timing cycles ranging from 1 second to 180
seconds on, and "off times" ranging from several seconds to 3
minutes. Typical, however, times for use are 30 seconds on, with a
5 to 10 second off period. The relay cycles in this manner for 5
minutes to relieve symptoms, although up to 20 minutes of cycling
can be used to alleviate RLS symptoms completely through the
night.
[0193] Whether vibration, heat, cold, or massage, a range of
operation from 5 minutes to 30 minutes should be sufficient to act
as a counter-stimulation for many patients. At the end of cycling,
a ramp down in intensity of the stimulation may also be beneficial,
so as not to waken or alarm the patient due to sudden stoppage
which might reawaken the patient if they have fallen back
asleep.
[0194] FIG. 61 illustrates a highly schematic view of a
relationship between one or more sensor(s), one or more
controller(s), and one or more counter-stimulation generators
embodying principles of the invention. As described herein, one or
more sensors are in sufficient proximity to a sufferer of RLS that
it can sense a body condition of the patient indicative of an RLS
episode. The sensor(s) generates and transmits a signal to the
controller(s), which could be wired or wirelessly connected. The
controller includes logic, embodied either in one or more
electronic circuits, or in a set of logical instructions which are
provided in a memory. When provided in a memory, the controller(s)
include a processor which can access the memory and execute the set
of instructions based on the signals received from the sensor(s),
to generate an output signal. The controller(s) are in
communication (wired or wireless) with the counter-stimulation
generators, as described throughout this disclosure, to drive one
or more of the generators to create a counter-stimulus for RLS.
Because the details of the controller's construction are well
within the skill of the ordinary routineer, they are not provided
here so as to not obscure other aspects of the invention.
[0195] FIGS. 62 and 63 illustrate yet another exemplary embodiment
420 of a RLS counter-stimulation device embodying principles of the
present invention. In general terms, the device 420 includes a
removable sleeve to which at least one, and advantageously, yet
optionally, multiple counter-stimulation devices are mounted. The
sleeve is configured so that it can be worn by a RLS-sufferer, and
more particularly on the sufferer's limb. While the exemplary
device 420 is configured to be easily worn around an arm or leg, at
the elbow or knee, respectively, the device 420 is not so limited
and can be differently configured so that it can be worn around
other parts of the sufferer's body so as to bring the
counter-stimulation device(s) into contact with that portion of the
body at which counter-stimulation is most effective against
RLS.
[0196] Turning back to the drawing figures, the exemplary device
420 includes a front shell 422 and a rear shell 424, one or both
formed of a relatively stiff, preferably polymeric material, e.g.,
polyethylene or polypropylene; when only one of the shells is
formed of the stiff material, the other can be formed of a flexible
material, or can be not included at all in the device. The front
shell 422 includes upper 426 and lower 428 portions, while the rear
shell 424 similarly includes upper 430 and lower 432 portions. The
upper and lower portions of the shells are advantageously separated
by openings 434, 436, the front opening 434 being sized to be
capable of receiving an kneecap (patella) or elbow therethrough.
When configured to be worn by a patient's leg or arm, the shells
are formed at an angle (see FIG. 63) between the upper and lower
portions, so that the leg or arm is comfortably bent when wearing
the device 420. The shells 422, 424, when two shells are provided,
are held together and to the patient by at least one, and
preferably a pair of bands 438, 440, positioned at the top and
bottom of the shell(s). The band can be simple elastic bands, or
are more preferably adjustable, e.g., including hook-and-loop-pile
type or other fastener systems (e.g., Velcro), so that the device
420 can be adjusted to the patient.
[0197] At least one, and advantageously several counter-stimulation
devices 442 are attached or mounted to the shells 422, 424. The
counter-stimulation devices 442 can take any of the forms described
herein. In one embodiment, the counter-stimulation device 442 is
one that produces mechanical vibrations, and can either be in
contact with the patient's skin through the inside surface of the
shells 422, 424, or can also vibrate the entire shell 422, 424, to
produce counter-stimulation. The embodiment illustrated in FIGS. 62
and 63 includes devices 442 on both the front 422 and rear 424
shells, and the upper and lower portions thereof; more or fewer
devices 442 can be provided as needed for any particular patient in
order to create an adequate counter-stimulation vibration. The
controllers and energy sources which drive the devices 442 are not
illustrated so as to not obscure aspects of the invention.
[0198] FIGS. 64 and 65 illustrate embodiments 450 similar in many
respects to those illustrated in FIGS. 62 and 63, except that the
devices 442 are mounted to a flexible sleeve 452, e.g., Neoprene,
Lycra, a knit fabric, or the like, which can stretch and confirm to
an arm or leg, with pockets formed in the sleeve in which the
devices 442 are received. The sleeve can be straight or, as
illustrated, preformed at a comfortable angle.
[0199] FIGS. 66-70 illustrate yet another device 460 embodying
principles of the present invention. When the locus of
counter-stimulation for a patient suffering from RLS is
advantageously applied to the patient's calf, the device 460 is
adapted to be worn by the patient on the calf so that
counter-stimulation be applied there. The device 460 includes a
rigid shell 474 which is elongate and concave in the shape of a
person's calf, with a correspondingly shaped flexible liner 462.
The liner 462 and the shell 474 can include structures which allow
the device 460 to be adjustably worn by the patient; in the
embodiment illustrated, slits 464, 480 are provided for the passage
of (unillustrated) straps, however other structures can be used in
addition or instead. The shell 474 includes one or more holes,
cutouts, or windows 476, 478, through which at least one, and
optionally multiple counter-stimulation devices are attached to the
shell. In the exemplary embodiment illustrated, the
counter-stimulation device is a mechanical vibration device, here a
motor and housing 466 are received in the seat 470 of a motor shell
468, with one or more optional spacers or shims 472 positioned
between the housing 466, shell 474, and liner 462. With the shells
468 extending outward through the hole 476, 478, the motor 466
vibrates the device 460 and/or the adjacent patient's skin, causing
a counter-stimulation to RLS. According to another embodiment, the
shell 474 can be formed in the well known shape of a shinguard and
worn one the patient's shin.
[0200] FIGS. 71-73 illustrate an exemplary embodiment of a device
490 which can produce mechanical vibrations suitable for use as a
counter-stimulation to RLS in any of the other embodiments
described herein. The device 490 includes a housing 492 in the open
interior of which an electric motor 494 is received. The motor 494
includes a shaft 504 extending from the motor, which rotates when
the motor is energized. A motor cap 496 is positioned around the
shaft to retain the motor in the housing 492. A counterweight 498
having a throughhole 502 is mounted on the shaft 504; the hole is
offset from the center of mass of the counterweight so that, when
rotated, the counterweight creates a vibration. When the
counterweight is cylindrical, as illustrated, the hole is therefore
offset from the center axis of the cylinder; when the counterweight
has another shape or uneven mass distribution, the hole is offset
from the center of mass of the counterweight.
[0201] For some patients, effective counter-stimulation to RLS
symptoms include mechanical stimulus at low frequencies, for which
a rotating motor with an eccentric weight may not provide adequate
relief. For such patients, the present invention also includes a
solenoid, a geared mechanical actuator, or a cam lobe that are
rotated or otherwise actuated to produce a low frequency, e.g., 1
to 20 Hz. Additionally, a brushless motor may be a requirement for
the medical devices described herein, as the RF emissions for the
brushes and the motor moving within its own magnetic field may be
dangerous for patients with pacemakers or implantable
defibrillators, were a motor with brushes used. Also, the smaller
controllers and drive circuitry are sensitive to induced noise, so
extreme filtering or shielding would be required to produce an
adequately safe device for this purpose.
[0202] In a highly simplified form, systems embodying principles of
the present invention include a simple on/off button or switch (not
illustrated) which can be actuated by the patient when desired to
generate a counter-stimulation to RLS symptoms. When actuated, the
button simply communicates a signal to the controller to begin
generating the counter-stimulation. More complex embodiments
include sensors in addition to or instead of an on/off button,
which sensors are mounted in positions relative to the patient to
sense conditions indicative of RLS symptoms, and to communicate
signals to the controller that the generation of
counter-stimulation is indicated. As such sensors are well known to
those of ordinary skill in the art, a detailed description thereof
will not be presented herein so as to not obscure aspects of the
invention.
[0203] While the invention has been described in detail with
reference to exemplary embodiments thereof, it will be apparent to
one skilled in the art that various changes can be made, and
equivalents employed, without departing from the scope of the
invention. The foregoing description of the preferred embodiments
of the invention has been presented for purposes of illustration
and description. It is not intended to be exhaustive or to limit
the invention to the precise form disclosed, and modifications and
variations are possible in light of the above teachings or may be
acquired from practice of the invention. The embodiments were
chosen and described in order to explain the principles of the
invention and its practical application to enable one skilled in
the art to utilize the invention in various embodiments as are
suited to the particular use contemplated. It is intended that the
scope of the invention be defined by the claims appended hereto,
and their equivalents. The entirety of each of the aforementioned
documents is incorporated by reference herein.
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