(12) INPERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)
`World Intell
`IP
`ieOrganization CTTAOrganization
`
`International Bureau
`—
`(10) International Publication Number
`(43) International Publication Date —
`WO 201 8/052958 Al
`22 March 2018 (22.03.2018)
`WEPO:I PCT
`
`
`
`(51) International Patent Classification:
`A6IN 1/00 (2006.01)
`A6IN 5/00 (2006.01)
`A6IN 2/00 (2006.01)
`(21) International Application Number:
`
`PCT/US2017/051302
`
`(22) International Filing Date:
`13 September 2017 (13.09.2017)
`English
`English
`
`(25) Filing Language:
`(26) Publication Language:
`.
`(30) Priority Data:
`15 September 2016 (15.09.2016) US
`62/394,907
`(71) Applicant: SENSE TECHNOLOGY INC.
`[US/US];
`1052 Corporate Lane, Export, Pennsylvania 15632 (US).
`
`(72) Inventor: EVANS,Joseph M.; 1052 Corporate Lane, Ex-
`port, Pennsylvania 15632 (US).
`(74) Agent: HOLMAN,John C.; Jacobson Holman PLLC, 400
`Seventh Street, N.W., Suite 700, Washington, District of
`Columbia 20004 (US).
`
`(81) Designated States (unless otherwise indicated, for every
`kind of national protection available): AE, AG, AL, AM,
`AO,
`AT, AU,
`AZ, BA, BB,
`BG,
`BH, BN, BR,
`BW,
`BY, BZ
`0,
`AT,
`AU,
`AZ,
`BA,
`BB,
`BG,BH,
`BN,
`BR,
`BW,BY,
`BZ,
`CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO,
`DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN,
`HR, HU, ID, IL, IN,IR, IS, JO, JP, KE, KG, KH, KN, KP,
`KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, MR,
`MG, MK,MN, MW, MX, MY. MZ, NA, NG, NI, NO, NZ,
`OM,PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA,
`SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN,
`TR,TT,TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW.
`
`(54) Title: METHOD AND APPARATUSFOR INPHASE TREATMENT OF ATRAUMATIC MUSCULOSKELETAL PAIN
`
`i
`
`ATP
`
`f
`
`} raquirad i ae cee ame wee Sry te
`
`
`Actin flaments
`Myosin flauments
`
`FIG.
`
`4
`
`(57) Abstract: Applying at least two separate treatment modalities for the simultaneous and in-phase treatment of atraumatic muscle
`pain consisting of : using an impulse instrument to provide controlled mechanical proprioceptive therapy to the muscle to re-establish
`proprioceptive nervous input from the muscle to the CNS, stimulating drainage of lymph from the muscle tissues; restoring normal
`concentrations of electrolytes within the muscle and stimulating the production of ATP within the muscle mass while applying a pulsed
`light stimulus to generate additional ATP within the muscle; applying a pulsed proprioceptive mechanical stimulus with an impulse
`instrument; attaching a light stimulus between the impulse instrument and the light stimulus; providing a means of powering the light
`stimulus; providing a means of controlling the initiation and duration of the light stimulus to synchronize the proprioceptive and light
`stimulation; electrical stimulation can also include neurochemical support by use ofa lotion.
`
`[Continued on next page]
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`wo2018/052958A1IIINIIINANIMATECCTTT
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`WO 2018/052958 AL [IMITINTIC TA TMATTA AMTATTAATCT
`
`(84) Designated States (unless otherwise indicated, for every
`kind of regional protection available): ARIPO (BW, GH,
`GM,KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ,
`UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ,
`TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK,
`EE, ES, FI, FR, GB, GR, HR, HU,IE, IS, IT, LT, LU, LV,
`MC, MK,MT, NL, NO,PL, PT, RO, RS, SE, SI, SK, SM,
`TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW,
`KM,ML, MR, NE, SN, TD, TG).
`
`Published:
`
`-- with international search report (Art. 21(3))
`
`

`

`WO 2018/052958
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`PCT/US2017/051302
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`~j-
`
`METHOD AND APPARATUS FOR INPHASE
`TREATMENT OF ATRAUMATIC
`MUSCULOSKELETAL PAIN
`
`BACKGROUND OF THE INVENTION
`
`The incidence of low back and other néuromusculoskeletal pain continues to
`
`increase, with low back pain being the leading cause of disability in the worid(Vassilaki &
`
`Hunwitz, 207143Werner & Cote, 2009 see Bibliography).
`
`in addition to the loss of quality of
`
`life for those who experience musculoskeletal pain the cost to both patients and society is
`
`significant and increasing:
`
`CA
`
`10
`
`¢
`
`The annual cost of chronic pain in the United States, including healthcare
`
`expenses (direct medical costs), last income, and fost productivity, is estimated to be
`
`$635billion. This is significanily higher than the estimated annual costs in 2010,
`
`dollars of heart disease ($309 billion), cancer ($243 billion}, and diabetes ($188
`
`billion).
`
`¢
`
`Total estimated medical costs associated with back and neck pain, two of the
`
`commonest presentations of patients with chronic pain, increased by 65% between
`
`1997 and 2005, to about $86 billlon a year. Overall, pharmaceutical expenditures
`
`related to back and neck pain increased by 188%between 1997 and 2005, but casts
`
`asscciated with prescription narcotics rose by an astounding 423%.
`
`° Watlonally, the estimated annual direct medical cost of low back pain is $30
`
`billion. in addition, the impact of back pain is $100-200 billion in decreased wages
`
`and lost productivity.
`
`*
`
`Patients with chronic pain have more hospital admissions, longer haspital
`
`stays, and unnecessary trips io ihe emergency department (Academy, 2011 see
`
`Bibliography)
`
`30
`
`Most back pain encountered by clinicians in their practice is referred to as
`
`nonspecific or as being of “unknown origin.” Musculoskeletal pain resulting from trauma
`
`such as whiplash, repetitive strain injury and heavy lifting is relatively easy to understand;
`
`however, the cause and, therefore, best treatment for acute or chronic nonspecific
`
`musculoskeletal compiainis is elusive.
`
`The response to this problem by the allopathic profession has been to downplay the
`
`potential seriousness of the problem and to educate providers and patients. (Samanta,
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`

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`WO 2018/052958
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`PCT/US2017/051302
`
`Kendall, & Samanta, 2003 see Bibliogrpahy} Other healing aris (referred to hereafter as
`
`“manual therapies”) in the United States and elsewhere have developed terminologyfor the
`
`description of and procedures for treatment that are unique to each profession. Osteopaths
`
`refer to the problem as an “osteopathic lesion,” chiropractors as a “subluxation, physical
`
`therapists as “joint instability,” acupuncturists as “trigger points,” and massage therapists as
`
`“adhesions.” Each of these professions has also developed what they consider to be unique
`7k
`
`approaches to therapy for these conditions,” manipulation,”
`
`“adjustment,” “muscle
`
`strengihening,” “needling anc acupressure.” and “deep massage.”
`
`10
`
`All techniques of manual therapy claim to reduce pain and even te provide a reversal
`
`of the underlying condition causing pain. However, despite numerous clinical iriais
`
`comparing different approaches, there is no single methodology or technique that has
`
`achieved recognition as a primary or “first among equals” treatment.
`
`In fact there exist and
`
`are practiced hundreds of “named techniques” in the manuai professions that have
`
`thousands of advocaies who claim that their approach is superior to all others. This state of
`
`practice is testimonial to the fact that there is no universally recognized “best” treatment
`
`approach because there is no fundamenial understanding of the cause of low back and
`
`other musculoskeletal pain.
`
`bo LA
`
`30
`
`AH manual therapies have at least two features in common. The first is that
`
`individuals seeking treatment have defined themselves as patients. They have accepted
`
`that an authority in the treatment of their complaint can be of help. When they are examined
`
`by that authority, they are further reassured thai they can be helped. This initial and vitally
`
`important step recruits the CNS (central nervous system) to assist in closing the gaie that
`
`modulates the perception of pain, as predicted by the Gate Theory of Pain(Melzack & Wail,
`
`1965 see Bibliography).
`
`The second feature shared by all manual therapies is the application of
`
`proprioceptive afferent inputto the CNS. The acupuncture needie, osteopathic
`
`manipulation, chiropractic adjusiment, physical therapy mobilization and therapisis massage
`
`all provide proprioceptive stimulation by mechanical pressure, impulse, impact, stretching
`
`and active and passive movement. These proprioceptive inputs presumablyelicit responses
`
`from the Goigi tendon complex, muscie spindles and mechanoreceptorsin joints, muscles,
`
`ligaments and fascia which participate in the restoration of proprioception to the CNS. This
`
`increase in proprioceptive input biases the summation of afferent inputs in the substantia
`
`gelatinosa toward domination by large fiber inputs, relieving ihe sympiom of pain.
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`WO 2018/052958
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`- 3.
`
`While all approaches to musculoskeletal therapyincluding simple encouragement
`
`provided to the patient by the allopathic profession are associated with improvement in the
`
`patients’ perception of pain, the iack of a fundamental understanding of the cause of
`
`common low back and neck pain prevents the development of methods of treatment that are
`
`truly effective in reducing or eliminating the cause of pain. This is true whetherthe therapy
`
`consists of the adjustment, mobilization, massage, TENS, micro-current, heat, “laser”
`
`therapy and, perhaps the classic case, trigger point therapy where initially an injection of
`
`anesthetic was used then needling only and finally pressure alone.
`
`10
`
`No prior art for the treatment of the underlying cause of non-specific
`
`musculoskeletal pain exists because the underlying cause of such pain is unknown.
`
`PRIOR ART
`
`The use of mineral supplements in the promotion of general health has a long
`
`history. Examples of the supply of minerals as ionic salutions are to be found in the farm of
`
`trace minerals (http://www traceminerals.com/products/liquid-tablet-minerals/concentrace-
`
`ionic-minerais}) and (hitp-/Avww.ancient-minerals.com). Searching for “mineral supplements”
`
`on the Amazon website returns 542 instances of trace mineral products. However, none of
`
`these products are formulated for the specific purpose of supporting the calcium pump in the
`
`function of muscie relaxation. Whereas the common formulation is elfher specific minerals
`
`like magnesium or a combination of minerals obtained from naturally occurring salt deposits,
`
`the current invention is designed to replicate the composition of electrotytes found in the
`
`tissues of the body with the intent of preferentially replacing any deficiency that may be
`
`found in the body.
`
`The current invention teaches the topical application of a solution of electrolytes for
`
`the purpose of supporting the normal function of the calcium pump in its function of enabling
`muscle relaxation.
`
`US Patent 8883830 teaches the use of topical formulations and methods of treating a
`
`migraines and/or cluster headaches, muscle sprains, muscle spasms, spasticity, tension
`
`headaches, tension related migraines and related conditions associated with muscle tension
`
`and pain with a therapeutically effective amount of an ergot alkaloid, skeletal muscle
`
`relaxant, serotonin agonist, combinations thereof, pharmaceutically acceptable sait thereof,
`
`prodrugs thereof or derivative thereof.
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`WO 2018/052958
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`There is no teaching of the support of the Calcium pump nor of the use of a topical
`
`application of electrolytes for the purpose of enabling muscle relaxation. Although muscle
`
`tension and spasticity are mentioned as being associated with the conditions treated, the
`
`explanation of the underlying cause of muscle tension is cited as:
`
`“Muscle spasm may occur as a result of direct soft tissue trauma with spasm of
`
`injured muscles. it may also arise as a consequence of spinal nerve roat inttation from
`
`musculo-skeletal injury. Para spinal muscles are primarily affected in this situation, so
`
`called "cervical and lumbar sprains.” Muscle spasm can manifest as a sudden
`
`involuntary contraction of one or more muscle groups and is usually an acute condition
`
`10
`
`associated with muscle strain (partial tear of a muscle) or sprain (partial or compiete
`
`rupture of a ligament}. Spasticity is a state of increased muscular tone with exaggeration
`
`of the tendon reflexes from an upper motor neuron (brain or spinal sora) injury in which
`
`spinal inhibitory processes are suppressed or lost. The result is chronic, severe spasm of
`
`the muscles ofthe extremities hindering function and causing pain. Spasticity is often
`
`associated with illnesses such as multiple sclerosis, stroke and spinal cord injury.
`
`Tension headaches and tension-related migraines are a result of over activity of muscles
`
`of the scalp, forenead and neck.”
`
`20
`
`bo LA
`
`30
`
`a a]
`
`This explanation relies on the elevation of nervous activity to initiate and maintain
`
`muscie spasm rather than the opposing view thal the failure of the caicium pump is the true
`
`cause of the muscles inabilily to relax.
`
`This patent may be most valuable as a representation of the thinking and theoretical
`
`basis for the current state of the art for the topical treatment of muscle snasm and
`
`associated pain. The stark differences between this approach and the invention illustrate the
`
`general lack of knowledge of the calcium pump and the role played by the calcium pumpin
`the esseniial function of muscle relaxation.
`
`Another embodiment of the current invention is the systemic application of a saiution
`
`of electrolytes with the purpose of providing a systemic or generalized support of the calcium
`
`pump. Much of the existing art is focused on the ingestion of solutions of electrolytes far
`
`different purposes.
`
`US Pat 4,042,684 teaches the replacement of sugar and electrolytes lost through
`
`vigorous exercise. there is no mention of enhanced muscie relaxation or elimination of pain.
`
`US Pat 4.322,407, teaches the replacement of siectrolytes through use of an electrolytic
`
`drink for the purpose of replacing electroiytes and water. This patent provides a useful
`
`reference for comparing the specific formulas as it teaches that certain compositions are not
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`readily absorbed by the body. The invention does not teach the use of electrolytes in
`
`supporting the calcium pump, ensuring that the environment necessary for the calcium pump
`
`to operate is maintained or supporting the ability of muscles to relax.
`
`US Pat 4,839,347 teaches the treatment of dehydration in swine. No mention of
`
`muscle function etc.
`
`US Pat 4,981,687 teaches the use of a compasition of fluids comprised of water,
`
`sugar, electrolytes, and “non-toxic” substances (glycerol, pyruvate and caffeine) that are
`
`absorbed through the gastrointestinal tract to prevent loss of blood volume (during exercise)
`
`and serve as a source of energy. While containing elecirolytes (metallic ions such as Ca,
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`Mg sic.) the patent does not teach any mechanism for their use nor indicate that their
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`ingestion may support muscie relaxation or muscle function in general.
`
`The primary purpose of this patent appears to be as an enhancement ta the
`
`previously patented solution known as Gatorade.
`
`US Pat 5776952 teaches the application of a local anesthetic using a “carrier system”
`
`which overlies the local anesthetic in the area of pain.
`
`20
`
`The current invention teaches thé use of adjusting instruments in conjunction with the
`
`topical application of a solution of electrolytes to enhance the effect of manual treatment of
`
`musculoskeletal complaints. Adjusting instruments have a history of art in themselves.
`
`US Pai 4,841,955, teaches a method and apparatus for the application of a reproducible
`
`impulse load to the bady of a patient. This teaching is realized through the impulse trigger
`
`mechanism which requires the operator to apply a reproducible and known preload between
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`the instrument and the patient which establishes a known initial farce between the patient
`
`and the insirument prior to ihe application of the energy of the adjusting impulse.
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`In contrasi
`
`to other methods of adjusting patients, the energy of the impulse is precisely contrailed and
`
`30
`
`therefore reproducible.
`
`US Patent 6702836 teaches the use of a manual settable component to select the
`
`frequency of the adjusiment.
`
`[tis not clear from the patent how this is accomplished or what
`
`the desired frequencies may be?
`
`US Pat 7144417 teaches the use of a power supply regulating mechanism that
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`purports to use AC current and voiliage io provide a reproducible impulse io the body of the
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`patient and couples this with a preload indicator and control means to provide indication of
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`proper preload and impulse level.
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`US Pat 8641648 teaches ihe addition of a sensing element to the teaching of the
`
`prior US Pat 7144417.
`
`None of the prior art of adjusting instruments teaches the application of manual
`
`therapy with adjusting instruments in support of the calcium pump or in conjunction with the
`
`topical application of a solution of electrolytes.
`
`US Patent/ 5640978 teaches the treatment of pain due to periosteal-osseous injuries
`
`16
`
`by irradiating the periosteai-osseous injury sites with low power laser energy to open
`
`lymphatic channels and removethe inflammatory substances so that the muscle spasm and
`
`withdrawal are alleviated and the referred pain is reduced. There is no mention of the
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`calcium pump or the generation of ATP denasine triphosphate) which is necessary for the
`
`operation of the calcium pump to enable relaxation of the muscle.
`
`US Pat 8136531 teaches the use of multiple specific optical frequenciesto treat
`
`musculoskeletal pain. While the generation of ATP as a result of laser irradiation is
`
`mentioned, there is no mention of the calcium pump or of muscle relaxation.
`
`US Pat 899613 1ieaches the use of an implanted device for the purpose of exciling
`
`specific nerves through light stimulation and heat. There is no mention of the calcium pump
`or ATP.
`
`“Chronic or recurrent pain affects 20-25% of the U.S. population, and it leads ta
`
`aoproximately $100 billion in health care cosis each year. The fost productivity due to pain is
`
`Na va)
`
`estimated at approximately $50 billion per year in the U.S. dow back pain is alone
`
`responsible for about a third of this figure). Traditional pain treatments include drugs (e.g.,
`
`opioids (the world-wide market size for opioids (e.g., morphine and hydrocodone}is
`
`approximately $36 billion), anti-convulsants, anti-depressants, epidurals/anesthetics),
`
`surgery (e.g., disk surgery, nerve cutting), cognitive/behavioral (e.g., biophsychosocial
`
`fad &
`
`approach, relaxation/biofeedback, placebo), and physical therapy. Other non-traditional
`
`approaches to pain management include acupuncture, ulfrasound, and LLLT dow-level light
`
`therapy). The rule of thumb for leading pain researchers is that almost every major pain
`
`treaiment creates about a 50% reduction in pain for 30-40% ofpatients (ihere is generally no
`
`good way to identify who will respond io a given treatment). Many drugs, particularly opioids,
`
`carry significant side effects and can become addictive. Depending on the study, 10-49% of
`
`back surgery patients are worse after the surgery (“falled back surgery syndrome’).
`
`US Pat 9061135 teaches a refinement of US Pat 8996137.
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`WO 2018/052958
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`PCT/US2017/051302
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`None of the prior ari cited here teaches the use of laser or low level light stimulation to
`
`support the function of the calcium pump or to generate ATP in conjunction with mechanical
`
`stimulation to provide energy to support the function of the calcium pump.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`Figure 1. Siages of Normal Muscle Function: Fig. ta Muscle Fiber Depolarization initiated
`
`10
`
`by Motor Nerve; Fig. 1b. Muscle Fiber Depoiarization Opens Calcium Channels in
`
`Sarcoplasmic Reticulum; Fig ic. Calcium fons Stored in Sarcoptasmic Reticulum Infuse
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`Muscle Fiber Causing Muscle Contraction: Fig 1d. Caicium Pump Returns Caicium lions to
`
`Sarcoplasmic Reticulum Allowing Muscle to Relax (Adapted from “Textbook of Medical
`
`Physiolagy’ Guyton and Hail Edition 12, see Bibliography}
`
`Figure 2. Normal Cycle of Muscle Contraction and Relaxation Produces Lymphatic Flow as
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`well as Prapriaceptive input to the Central Nervous System
`
`Figure 3. Failure of calcium pump results in inability of muscle to relax resulting in
`
`compromise of fymphatic system and perception of pain.
`
`Figure 4 consists of Figures 4A4-4C, Figure 4A shows a perspective view of the Impulse head
`
`(1} without the laser attachment. Figure 4B shows a perspective view of the Laser
`
`attachment (2). Figure 4C shows a perspective view of the impulse head (1} with the Laser
`
`attachment (2) in place.
`
`Figure 5 consists of Figures 54 and 5B. Figure 5A shows a cross section view of the
`
`impulse head with the Laser attachment in place. Figure 5B shows a cross section of the
`laser attachment.
`
`390
`
`Figure 6 consists of Figure GA and 6B. Figure GA shows the top side of the home use
`
`instrument which is desiqned to provide a comfortable and secure handhoid for application
`
`of ihe instrument. Figure 6B shows the underside of the instrument which consists of a sof
`
`transparent material which allows the underside to apply motion therapy as weil as light
`
`therapy to the patient in conjunction with or independently of the application of lotion therapy.
`
`Figure 7 shows a cross-section of the home use instrument.
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`DETAILED DESCRIPTION OF THE INVENTION
`
`In the absence of a fundamental understanding of the true cause of common iow
`
`back and neck pain (usually referred to as “pain of unknown origin) there can be no invention
`
`of improved therapy or methodology for the improved treatment of such pain. Therefore, in
`
`order to create a truly useful invention, one that would be of benefit to therapists by providing
`
`improved patient results through the practice of the invention and benefit the patient through
`
`faster reduction in pain as well as reduction in relapses and improved general health, anew
`
`10
`
`approach to the undersianding of common musculoskeletal pain is required thai identifies
`
`the true cause of such pain. The present invention is dependent on this approach and the
`
`invention cannot exist without this understanding.
`
`In order to develop an understanding of muscle dysfunction that results in pain, itis
`
`necessary to first understand normai pain-free muscle function. Fortunaiely, the
`
`fundamental physiology of normal muscie function is described in current physiology
`
`textis(Hall & Guyton, 2011 see Bibliography} and is generally recognized as an accurate
`
`portrayal of the contraction and, most importantly, the relaxation of muscie fibers. According
`
`to these texis, the cause of muscle fiber contraction is the release of calcium ions from the
`
`20
`
`sarcoplasmic reticulum (@ complex sac that interpenetrates the muscle) causes contraction
`
`of the myofibrils which results in contraction of the muscle fiber. Subsequent relaxation of
`
`the muscie fiber is enabled by the ATP energized caicium pump which returns calcium ions
`
`to the sarcoplasmic reticulum where they are avaitable for the initiation of the next muscle
`contraction.
`
`AS @ result of and coincident with normal muscie contraction and relaxation, sensors
`
`within the muscle (Goigi tendon compiex and muscle spindles) continuously send
`
`information to the central nervous system (CNS) regarding muscte length, speed of
`
`contraction and force. These signals are collectively referred to as proprioception.
`
`in
`
`addition, the contraction and relaxation of the muscies of the body play a significant pari in
`
`the maintenance of lymphatic drainage of the waste products of cellular metabolism from the
`
`body. See Figure 2.
`
`ifthe caicium pump malfunctions, the muscle cannot relax.
`
`Interruption of the normal
`
`contraction and relaxation cycle of the muscle in turn interrupts the normal flow of
`
`proprioceptive input to the CNS as well as the normal flow of lymphatic fluid. Disruption of
`
`proprioceptive input to the CNS is perceived as pain and disruption of the lymphatic flow can
`
`result in metabolic failure at the cellular level. See Figure 3.
`
`30
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`35
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`Therefore the cause of atraumatic muscie pain is:
`
`* An acute siage consisting of an initiating event wherein a portion of muscle mass
`
`in anormal contractile state is prevented from extending or relaxing due to a local
`
`failure of the calcium pump which results in the inability of the muscle to relax.
`
`The inability of the muscle to relax results in the perception of pain.
`
`*
`
`ifthe muscle dysfunction is not immediately corrected, the initial muscle
`
`dysfunction will result in chronic compromise of the lymphatic system resulting in
`
`10
`
`potentially serious and poorly understood consequences for the health of the
`
`individual. Such consequences may inciude but are not limited to: localized
`
`edema, decreased blood flow, production of abnormal producis of cellular
`
`metabolism and other potentially serious health effects.
`
`Calcium ions are the primary mediator of contraction itself and therefore musi be
`
`available in sufficient quantity for normal muscle contraction and relaxation. The release of
`
`caicium into the muscle fiber causes contraction of the myofibrils which results in contraction
`
`ofthe muscle fiber. Subsequent relaxation of the muscle fiber is enabled by the calcium
`
`pump which returns calcium tons to the sarcoplasmic reticulum where they are available for
`
`the initiation of the next muscle contraction. The function of the calcium pump is dependent
`
`upon the availability of adenosine triphosphate (ATP) which suppiies the pumping eneray. A
`
`failure of the calcium pump would account for the inability of a muscle fiber to relax. Such a
`
`failure could be due to a reduction in the synthesis of ATP for continued cycling of the ATP
`
`powered calcium pump.
`
`ATP synthesis can be restricted by @ pH that is eliher too acidic or basic. Other
`
`mechanisms may aiso account for reduced levels of ATP that would compromise the
`
`caicium pump.
`
`itis well known that minimum levels of potassium ion concentration are
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`necessary io allow contracted muscle fo relax(Hall & Guyton, 2011 see Bibliography). Other
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`metallic ions such as sodium, potassium, magnesium, calcium and phosphorous play
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`important roles not only as mediators of membrane depolarization and myofibril contraction,
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`bul as necessary modulators of the of the creation and utilization of ATP. Metallic ion
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`concentrations may exhibit abnormal local concentrations which reduce the availability of
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`ATP leading to the inability of small localized muscle volumes or entire muscles to relax.
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`Therefore, in order to prevent the failure of the calcium pump, an adequate supply of
`Ca*ions as well as ATP must be maintained in the cellular interstitial space as well as the
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`sarcoplasmic reticulum.
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`All techniques of manual therapy claim to successfully reduce pain and even to
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`provide a reversal of the underlying condition causing pain. This is true for the adjustment,
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`mobilization, massage, TENS, micro-current, heat, “laser” therapy and, perhaps the classic
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`case, trigger point therapy where initially an infection of anesthetic was used then needling
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`only and finaily pressure aione. One must specuiate that each and every one of these
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`approaches activates the same or a similar underlying process. Finding that the same
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`neurochemical process is associated with each of these techniques would suggest that each
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`individual iechnique may produce similar therapeutic effects inrough the same mechanism.
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`indeed there appears to be such a process.
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`li has been known for at least thirty years that
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`electrical current stimulates ATP(Cheng ei al., 1982 see Bibliography}. More recently, the
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`existence of a reversible chemomechanical coupling mechanism associated with ATP
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`synthesis that generates rotary motion at the molecular level has been
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`demonstraied.(Montemagno & Bachand, 1999; Noji & Yoshida, 2001; Watanabe & Noi,
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`2013 see Bibliography) Direct evidence for the chemical synthesis of ATP as a result of
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`mechanical action is presented by Itoh et.al.(itoh et al., 2004 see Bibliography) ATP release
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`from masi cells during needling, application of heat and exposure to light stimulation has
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`been demonstraied by Wang et.al. (Wang et al., 2013 see Bibliography)
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`If therapeutic
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`stimulation of all kinds affecis a release of ATP and ATP is necessary for muscle relaxation
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`then the correlation between stimulation of cellular ATP by these various methods and pain
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`relief may be causalin nature. That is, the production of ATP by these methods of therapy
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`may be a primary route leading to pain reduction through the restoration or enhancement of
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`the calcium pump.
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`Assuming that the stimulation of ATP by all types of manual therapyis a primary
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`mechanismfor the restoration of normal neuromuscular function at the cellular level leading
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`to reduction of pain, it would be apparent to one skilled in the art of pain treatment that the
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`simple combination of two or more therapies might be beneficial. That is, rather than
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`applying only one manual therapy, the application of two different tyoes of manual therapy
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`would be expected to provide additional benefits because the recruliment of additional ATP
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`through separate channels would lead io more efficient generation of ATP. Rather than
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`simply combine two therapies additively with the expectation that the combination will result
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`ina more effective pain reduction therapy, the invention utilizes a novel and unique method
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`of combining two or more therapies so that the therapies may be applied simultaneously
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`bo LA
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`35
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`and, more importantly, in phase.
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`A mechanical impulse device such as the multiple impulse adjusting instrument
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`described in US Pat 4,841,955 and 5.662.122 can serve as the foundation for the creation of
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`a new instrument that combines either chotonic (light) or electrical (tens or micro-currend
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`stimulation with proprioceptive Gnechanical impulse) stimulation in a novel way to obtain
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`more effective pain reduction more quickly than the application of these same methods as
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`separate treatment modalities. Simultaneous application of any two or even all of these
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`methods may be achieved by the use of a separate effector head which is attached to and
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`energized by the attachment mechanism itself. Not only can the application of two or more
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`modalities be achieved simultaneously but their application can be synchronized to be “in
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`phase” with one another.
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`In phase means that the initiation, rate of application and peak
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`amplitude of each separate treatment modality may be controlled to coincide to achieve
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`10
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`maximum effect atthe same time in the treatment cycie.
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`in order io create an instrument that is capable of combining the three modes of
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`therapy and control the phase of each, we start with a modification of the holder of the
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`interchangeable patient contact prongs of the multiple impulse adjusting instrument
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`described in US Pat 5,662,122. aciding a positive Voliage and ground connection to this
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`holder to provide power to the patient probe used for the simultaneous application of
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`additional therapeutic light or electrical modalities. A suitably sized and configured
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`mechanism for the connection of the supplied Voltage to the patient probe (such as an audio
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`plug Digikey part no SC1326-ND) will provide a sullable electrical connection between the
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`impulse adjusting instrument and the new patient contact probe. The electrical power
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`provided to the patient contact probe will provide the energy needed for ihe application of the
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`ight or electrical therapy.
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`The timing of the application of the electrical or light therapy or both is controlled to
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`be in phase with the application of proprioceptive therapy provided by the multiple impulse
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`adjusting head by means of a controi mechanism consisting of a means of sensing the
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`resistance between the patient contact probe and the patient (such as a force sensor) or the
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`movement of the patient contact probe (such as an accelerometer). The additional therapy
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`of light or electrical stimulation may be added to the application of proprioceptive therapy at
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`the precise time in the impulsive cycle that wil provide the most effective effect of the
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`combined therapies.
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`While the above procedure will result in pain relief due to muscle relaxation
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`independent of other factors, the preferred embodiment of the invention is to apply the
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`combination of proprioceptive, light and electrical therapies in combination with a solution of
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`metallic ions (see US Provisional Patent Application No. 62/204,622}. The combination of
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`therapies such as massage, manipulation, adjusiment, ultrasound, transcutaneous electrical
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`stimulation, ight stimulation eic. are known to