Note: Descriptions are shown in the official language in which they were submitted.
P8200CA00
ACOUSTIC SHOCK WAVE THERAPEUTIC METHODS TO PREVENT OR
TREAT OPIOID ADDICTION
Technical Field
[001] The present invention relates to an improved pre-treatment method of
utilizing
acoustic shock waves to reduce pain after a medical procedure and thereby
reduce the
need for prescribing addictive dosages of pain medications and a post
treatment method
to overcome opioid addictions.
Background of the Invention
[002] In US 7,470,240 B2, entitled "Pressure Pulse/Shock Wave Therapy Methods
And
An Apparatus For Conducting The Therapeutic Methods", is disclosed a novel use
of
unfocused shock waves to stimulate a cellular substance. From this patent a
family of
treatment patents evolved. The list includes US 7,841,995; US 7,883,482; US
7,905,845
all divisional applications; and US 7,507,213 entitled "Pressure Pulse/Shock
Wave
Therapy Methods For Organs"; US 7,544,171 B2 entitled "Methods for Promoting
Nerve
Regeneration and Neuronal Growth and Elongation"; US 7,988,648 B2 entitled
"Pancreas
Regeneration Treatment For Diabetics Using Extracorporeal Acoustic Shock
Waves"; all
teaching a new useful way to deliver acoustic shock waves to achieve a healing
response.
Each of these patents are incorporated herein by reference in their entirety.
In addition,
patents US 8,257,282 and 8,535,249 for the device to perform these methods by
delivering
low energy unfocused acoustic shock waves to the cellular tissue being
treated.
[003] During this inventive research, the inventors disclosed the use of
acoustic shock
waves could be beneficial as a disease preventative therapy of at risk
patients to such
ailments as heart disease and other conditions.
[004] While this large volume of research has been rewarded by the granting of
numerous
patents, much new work has been evolving as the understanding of the
technology is being
applied. It is in this latest work that some, heretofore, unknown improvements
and
refinements have been discovered that were hidden from and unappreciated by
scientists
in this field. In particular, the use of acoustic shock waves to regulate and
in some cases
stimulate glandular hormonal secretions or modulate glandular hormonal
secretions.
1
CA 3026905 2018-12-10
P8200CA00
[005] In recently filed co-pending US patent application serial number
15/984,505 filed
May 21, 2018 entitled "Improved Acoustic Shock Wave Therapeutic Methods" which
is
also being incorporated herein by reference in its entirety discloses a method
of modulating
glandular secretions by administering acoustic shock waves to a gland,
includes the steps
of activating acoustic shock waves of an acoustic shock wave generator to emit
acoustic
shock waves and subjecting the gland to acoustic shock waves stimulating the
gland to
have a modulated response. The modulated response is one of an adjustment in
hormonal
release which increases low level output, decreases high level output or
stabilizes erratic
output.
[006] This evolved into a method of modulating glandular secretions by
administering
acoustic shock waves to a reflexology zone or region has been discovered. In
one preferred
embodiment, a treatment method achieves one or more of a) modulating blood
sugar
levels, b) stimulating insulin production levels or c) normalizing A 1 C
levels by using the
step of administering acoustic shock waves to a reflexology zone or region.
This treatment
method, US application 16/009,807 filed on June 15, 2018 entitled "Improved
Acoustic
Shock Wave Therapeutic Methods" is also incorporated herein by reference in
its entirety.
[007] These most recent inventions have recently and quite unexpectedly
discovered an
improved treatment therapy that achieves all the objectives of the earlier
work in a newly
discovered and remarkably efficient way which directs acoustic shock waves to
reflexology regions to achieve a desired response.
[008] The present invention has built upon this large volume of work with a
discovery
that a pre-treatment of acoustic shock wave therapy prior to any medical
procedure or
optionally during such a procedure will reduce the patient's post treatment
requirement for
addictive pain medications such as "opioids" and other addictive pain
medications.
Further, the ability of acoustic shock waves to reduce pain allows this shock
wave therapy
to be used to overcome addictions in patients already addicted as is described
below.
Summary of the Invention
[009] A treatment method to reduce a patient's pain caused by a medical
condition
and/or medical procedure to reduce or eliminate the taking of addictive pain
medication is
disclosed. The treatment has the step of administering acoustic shock waves
directed to
an area near a source of the pain or to a reflexology zone to treat the
medical condition or
2
CA 3026905 2018-12-10
P8200CA00
prior to the medical procedure or during the medical procedure or after the
medical
procedure or any combination thereof. The treatment further has the steps of
activating
acoustic shock waves of an acoustic shock wave generator to emit acoustic
shock waves
and subjecting the area near the source of the pain or the reflexology zone to
acoustic shock
waves stimulating the area near the source of the pain or an area in the
reflexology zone
to have a modulated response wherein the modulated response is one or more of
reducing
patient anxiety or suppressing pain or activating an anesthetic effect over a
period of time.
The emitted acoustic shock waves can be focused or unfocused acoustic shock
waves.
[0010] The reflexology zone underlies the patient's skin in a region of a foot
or hand or
ear. The shock wave generator is acoustically coupled to the patient's skin
using a
coupling gel or liquid. In one embodiment for orthopedic or bone joint pain,
the
reflexology zone for an orthopedic structure is in a region of the foot is
located in an outer
surface of each foot between a toe and a heel. The treatment, when applied to
this
reflexology zone, reduces pain in shoulder joint, upper arm, elbow, forearm,
and at an
ankle reduces pain in the hip, above the ankle reduces pain in the knee. In
another
embodiment, the reflexology zone for an orthopedic structure is in a region of
the foot is
located in an inner surface of each foot progressively between a large toe and
a heel. The
treatment reduces pain at a location adjacent the large toe in the cervical
spine, the thoracic
spine, lumbar spine, the sacral bone, and the tail bone near the heel.
Alternatively, the
reflexology zone for an orthopedic structure can be in a region of the hand.
10011] The stimulating of the area causes a release of nitric oxide, secretion
of digestive
enzymes, hormones and other fluids and can cause a release of growth factors
including,
but not limited to VGEF, can also cause new blood vessels to be created
increasing
vascularization. The treatment method can be repeated one or more times prior
to or
during the medical procedure or after the medical procedure. The emitted
acoustic shock
waves can be low energy soft waves wherein the low energy soft waves have an
energy
density in the range of 0.01 mJ/mm2 to 1.0 mJ/mm2, preferably in the range of
0.04
mJ/mm2 to 0.3 mJ/mm2. Each subjected reflexology zone receives between 100 and
2000
acoustic shock waves per therapy session. The emitted acoustic shock waves are
spherical,
radial, convergent, divergent, planar, near planar, focused or unfocused from
a source with
or without a lens that is one of electrohydraulic, electromagnetic,
piezoelectric, ballistic or
water jets configured to produce an acoustic shock wave and wherein the
acoustic shock
3
CA 3026905 2018-12-10
µ ,
P8200CA00
waves are administered invasively or noninvasively. Ideally, number of
repeated
treatments occur on a schedule over a period of three or more weeks, and
treatments can
be repeated over time as a pain prevention protocol over longer durations of
time between
repeated treatments.
[0012] An important embodiment has a method of treating a patient addicted to
pain
medication. This method has the step of administering acoustic shock waves to
the patient
exhibiting an addiction to pain medications or opioids wherein the
administering of
acoustic shock waves occurs at a location near the source of the pain or at a
location of a
reflexology zone at an extremity of the hands or the feet or the ears. The
method allows
the patient with the addiction to have a reduction in chronic pain. The method
further has
the steps of activating acoustic shock waves of an acoustic shock wave
generator to emit
acoustic shock waves; subjecting the location near the source of the pain or
near the pain
or reflexology zone to acoustic shock waves stimulating an area in the
reflexology zone to
have a modulated response wherein the modulated response is one or more of
reducing
patient anxiety or suppressing pain or activating an anesthetic effect over a
period of time;
and wherein the emitted acoustic shock waves are focused or unfocused acoustic
shock
waves. The administration of emitted shock waves is additionally directed to
an area of
the reflexology zone directed to modulate a response to the pain to suppress
urges to take
the addictive medication or opioids and to minimize withdrawal symptoms. The
treatment
further allows substituting prescribed addictive medications or opioids with
non or less
additive medications.
Definitions
[0013] "Al C level": refers to the Hemoglobin Al c (HbA I c) Test for
Diabetes. The
hemoglobin Alc test measures average blood glucose over the past 2 to 3
months. Ifs also
called HbA I c, glycated hemoglobin test, and glycohemoglobin. People who have
diabetes
need this test regularly to see if their levels are staying within range. It
is used to determine
if there is a need to adjust a person's diabetes medicines. The Al c test is
also used to
diagnose diabetes.
[0014] "Adrenal Gland": The adrenal glands (also known as suprarenal glands)
are
endocrine glands that produce a variety of hormones including adrenaline and
the steroids
4
CA 3026905 2018-12-10
P8200CA00
aldosterone and cortisol. They are found above the kidneys. Each gland has an
outer cortex
which produces steroid hormones and an inner medulla.
[0015] "Adrenaline": Adrenaline, also known as adrenalin or epinephrine, is a
hormone,
neurotransmitter, and medication. Epinephrine is normally produced by both the
adrenal
glands and certain neurons. It plays an important role in the fight-or-flight
response by
increasing blood flow to muscles, output of the heart, pupil dilation, and
blood sugar.
[0016] "Aldosterone": Aldosterone, the main mineralocorticoid hormone, is a
steroid
hormone produced by the zona glomerulosa of the adrenal cortex in the adrenal
gland. It
is essential for sodium conservation in the kidney, salivary glands, sweat
glands and colon.
It plays a central role in the homeostatic regulation of blood pressure,
plasma sodium
(Na+), and potassium (K+) levels. It does so mainly by acting on the
mineralocorticoid
receptors in the distal tubules and collecting ducts of the nephron. It
influences the
reabsorption of sodium and excretion of potassium (from and into the tubular
fluids,
respectively) of the kidney, thereby indirectly influencing water retention or
loss, blood
pressure and blood volume. When dysregulated, aldosterone is pathogenic and
contributes
to the development and progression of cardiovascular and renal disease.
[0017] "Blood sugar level": The blood sugar level, blood sugar concentration,
or blood
glucose level is the amount of glucose present in the blood of humans and
other animals.
Glucose is a simple sugar and approximately 4 grams of glucose are present in
the blood
of a 70-kilogram (150 lb) human at all times. The body tightly regulates blood
glucose
levels as a part of metabolic homeostasis. Glucose is stored in skeletal
muscle and liver
cells in the form of glycogen; in fasted individuals, blood glucose is
maintained at a
constant level at the expense of glycogen stores in the liver and skeletal
muscle. Cellular
glucose uptake is primarily regulated by insulin, a hormone produced in the
pancreas.
Blood sugar levels outside the normal range may be an indicator of a medical
condition.
A persistently high level is referred to as hyperglycemia; low levels are
referred to as
hypoglycemia.
[0018] "Cortisol": Cortisol is a steroid hormone, in the glucocorticoid class
of hormones.
When used as a medication, it is known as hydrocortisone. It is produced in
humans by the
zona fasciculata of the adrenal cortex within the adrenal gland. It is
released in response
to stress and low blood-glucose concentration. It functions to increase blood
sugar through
CA 3026905 2018-12-10
P8200CA00
gluconeogenesis, to suppress the immune system, and to aid in the metabolism
of fat,
protein, and carbohydrates. It also decreases bone formation.
[0019] A "curved emitter" is an emitter having a curved reflecting (or
focusing) or
emitting surface and includes, but is not limited to, emitters having
ellipsoidal, parabolic,
quasi parabolic (general paraboloid) or spherical reflector/reflecting or
emitting elements.
Curved emitters having a curved reflecting or focusing element generally
produce waves
having focused wave fronts, while curved emitters having a curved emitting
surfaces
generally produce wave having divergent wave fronts.
[0020] "Divergent waves" in the context of the present invention are all waves
which are
not focused and are not plane or nearly plane. Divergent waves also include
waves which
only seem to have a focus or source from which the waves are transmitted. The
wave fronts
of divergent waves have divergent characteristics. Divergent waves can be
created in many
different ways, for example: A focused wave will become divergent once it has
passed
through the focal point. Spherical waves are also included in this definition
of divergent
waves and have wave fronts with divergent characteristics.
[0021] "Estrogen": A female steroid hormone that is produced by the ovaries
and, in lesser
amounts, by the adrenal cortex, placenta, and male testes. Estrogen helps
control and guide
sexual development, including the physical changes associated with puberty. It
also
influences the course of ovulation in the monthly menstrual cycle, lactation
after
pregnancy, aspects of mood, and the aging process. Production of estrogen
changes
naturally over the female lifespan, reaching adult levels with the onset of
puberty
(menarche) and decreasing in middle age until the onset of menopause. Estrogen
deficiency can lead to lack of menstruation (amenorrhea), persistent
difficulties associated
with menopause (such as mood swings and vaginal dryness), and osteoporosis in
older
age. In cases of estrogen deficiency, natural and synthetic estrogen
preparations may be
prescribed. Estrogen is also a component of many oral contraceptives. An
overabundance
of estrogen in men causes development of female secondary sexual
characteristics
(feminization), such as enlargement of breast tissue.
[0022] "extracorporeal" means occurring or based outside the living body.
[0023] A "generalized paraboloid" according to the present invention is also a
three-
dimensional bowl. In two dimensions (in Cartesian coordinates, x and y) the
formula
yn=2px [with n being 2, but being greater than about 1.2 and smaller than 2,
or greater
6
CA 3026905 2018-12-10
P8200CA00
than 2 but smaller than about 2.8]. In a generalized paraboloid, the
characteristics of the
wave fronts created by electrodes located within the generalized paraboloid
may be
corrected by the selection of (p (-z,+z)), with z being a measure for the burn
down of an
electrode, and n, so that phenomena including, but not limited to, burn down
of the tip of
an electrode (-z,+z) and/or disturbances caused by diffraction at the aperture
of the
paraboloid are compensated for.
[0024] "Hormone": A hormone is any member of a class of signaling molecules
produced
by glands in multicellular organisms that are transported by the circulatory
system to target
distant organs to regulate physiology and behaviour. Hormones have diverse
chemical
structures, mainly of 3 classes: eicosanoids, steroids, and amino acid/protein
derivatives
(amines, peptides, and proteins). The glands that secrete hormones comprise
the endocrine
signaling system. The term hormone is sometimes extended to include chemicals
produced
by cells that affect the same cell (autocrine or intracrine signalling) or
nearby cells
(paracrine signalling). Hormones are used to communicate between organs and
tissues for
physiological regulation and behavioral activities, such as digestion,
metabolism,
respiration, tissue function, sensory perception, sleep, excretion, lactation,
stress, growth
and development, movement, reproduction, and mood. Hormones affect distant
cells by
binding to specific receptor proteins in the target cell resulting in a change
in cell function.
When a hormone binds to the receptor, it results in the activation of a signal
transduction
pathway that typically activates gene transcription resulting in increased
expression of
target proteins; non-genomic effects are more rapid, and can be synergistic
with genomic
effects. Amino acid¨based hormones (amines and peptide or protein hormones)
are water-
soluble and act on the surface of target cells via second messengers; steroid
hormones,
being lipid-soluble, move through the plasma membranes of target cells (both
cytoplasmic
and nuclear) to act within their nuclei. Hormone secretion may occur in many
tissues.
Endocrine glands are the cardinal example, but specialized cells in various
other organs
also secrete hormones. Hormone secretion occurs in response to specific
biochemical
signals from a wide range of regulatory systems. For instance, serum calcium
concentration affects parathyroid hormone synthesis; blood sugar (serum
glucose
concentration) affects insulin synthesis; and because the outputs of the
stomach and
exocrine pancreas (the amounts of gastric juice and pancreatic juice) become
the input of
the small intestine, the small intestine secretes hormones to stimulate or
inhibit the stomach
7
CA 3026905 2018-12-10
P8200CA00
and pancreas based on how busy it is. Regulation of hormone synthesis of
gonadal
hormones, adrenocortical hormones, and thyroid hormones is often dependent on
complex
sets of direct influence and feedback interactions involving the hypothalamic-
pituitary-
adrenal (HPA), -gonadal (HPG), and -thyroid (HPT) axes. Upon secretion,
certain
hormones, including protein hormones and catecholamines, are water-soluble and
are thus
readily transported through the circulatory system. Other hormones, including
steroid and
thyroid hormones, are lipid-soluble; to allow for their widespread
distribution, these
hormones must bond to carrier plasma glycoproteins (e.g., thyroxine-binding
globulin
(TBG)) to form ligand-protein complexes. Some hormones are completely active
when
released into the bloodstream (as is the case for insulin and growth
hormones), while others
are prohormones that must be activated in specific cells through a series of
activation steps
that are commonly highly regulated. The endocrine system secretes hormones
directly into
the bloodstream typically into fenestrated capillaries, whereas the exocrine
system secretes
its hormones indirectly using ducts. Hormones with paracrine function diffuse
through the
interstitial spaces to nearby target tissue.
[0025] "Hypothalamus": The hypothalamus is a portion of the brain that
contains a
number of small nuclei with a variety of functions. One of the most important
functions of
the hypothalamus is to link the nervous system to the endocrine system via the
pituitary
gland (hypophysis). The hypothalamus is located below the thalamus and is part
of the
limbic system.
[0026] "Insulin": is a hormone made by the pancreas that allows your body to
use sugar,
glucose, from carbohydrates in the food that is eaten for energy or to store
glucose for
future use. Insulin helps keeps blood sugar levels from getting too high
(hyperglycemia)
or too low (hypoglycemia).
[0027] "Melatonin": Melatonin, also known as N-acetyl-5-methoxy tryptamine, is
a
hormone that is produced by the pineal gland in animals and regulates sleep
and
wakefulness. In animals, melatonin is involved in the entrainment
(synchronization) of the
circadian rhythms including sleep-wake timing, blood pressure regulation,
seasonal
reproduction, and many others. Many of its biological effects in animals are
produced
through activation of melatonin receptors, while others are due to its role as
an antioxidant,
with a particular role in the protection of nuclear and mitochondrial DNA.
8
CA 3026905 2018-12-10
P8200CA00
[0028] A "paraboloid" according to the present invention is a three-
dimensional reflecting
bowl. In two dimensions (in Cartesian coordinates, x and y) the formula
y2=2px, wherein
p/2 is the distance of the focal point of the paraboloid from its apex,
defines the paraboloid.
Rotation of the two-dimensional figure defined by this formula around its
longitudinal axis
generates a de facto paraboloid.
[0029] "Parathyroid": Parathyroid glands are small endocrine glands in the
neck of
humans and other tetrapods that produce parathyroid hormone. Humans usually
have four
parathyroid glands, variably located on the back of the thyroid gland.
Parathyroid hormone
and calcitonin (one of the hormones made by the thyroid gland) have key roles
in
regulating the amount of calcium in the blood and within the bones.
[0030] "Parathyroid Hormone": Parathyroid hormone (PTH), also called
parathormone
or parathyrin, is a hormone secreted by the parathyroid glands that is
important in bone
remodeling, which is an ongoing process in which bone tissue is alternately
resorbed and
rebuilt over time. PTH is secreted in response to low blood serum calcium
(Ca2+) levels.
PTH indirectly stimulates osteoclast activity within bone marrow, in an effort
to release
more ionic calcium (Ca2+) into the blood to elevate serum calcium (Ca2+)
levels. The
bones act as a (metaphorical) "bank of calcium" from which the body can make
"withdrawals" as needed to keep the amount of calcium in the blood at
appropriate levels
despite the ever-present challenges of metabolism, stress, and nutritional
variations. PTH
is "a key that unlocks the bank vault" to remove the calcium. In consequence,
PTH is vital
to health, and health problems that yield too little or too much PTH (such as
hypoparathyroidism, hyperparathyroidism, or paraneoplastic syndromes) can
wreak havoc
in the form of bone disease, hypocalcaemia, and hypercalcaemia.
[0031] "Pineal body": Pineal gland, also called conarium, epiphysis cerebri,
pineal organ,
or pineal body, endocrine gland. The pineal gland is a small endocrine gland
in the
vertebrate brain. The pineal gland produces melatonin, a serotonin-derived
hormone which
modulates sleep patterns in both circadian and seasonal cycles. The shape of
the gland
resembles a pine cone, hence its name. The pineal gland is located in the
epithalamus, near
the center of the brain, between the two hemispheres, tucked in a groove where
the two
halves of the thalamus join.
[0032] "Pituitary gland": In vertebrate anatomy, the pituitary gland, or
hypophysis, is an
endocrine gland about the size of a pea and weighing 0.5 grams (0.018 oz) in
humans. It
9
CA 3026905 2018-12-10
P8200CA00
is a protrusion off the bottom of the hypothalamus at the base of the brain.
The hypophysis
rests upon the hypophysial fossa of the sphenoid bone in the center of the
middle cranial
fossa and is surrounded by a small bony cavity (sella turcica) covered by a
dural fold
(diaphragma sellae). The anterior pituitary (or adenohypophysis) is a lobe of
the gland that
regulates several physiological processes (including stress, growth,
reproduction, and
lactation). The intermediate lobe synthesizes and secretes melanocyte-
stimulating
hormone. The posterior pituitary (or neurohypophysis) is a lobe of the gland
that is
functionally connected to the hypothalamus by the median eminence via a small
tube
called the pituitary stalk (also called the infundibular stalk or the
infundibulum). Hormones
secreted from the pituitary gland help control: growth, blood pressure,
management of
energy, all functions of the sex organs, thyroid glands and metabolism as well
as some
aspects of pregnancy, childbirth, nursing, water/salt concentration at the
kidneys,
temperature regulation and pain relief.
= [0033] "Plane waves" are sometimes also called flat or even waves. Their
wave fronts
have plane characteristics (also called even or parallel characteristics). The
amplitude in a
wave front is constant and the "curvature" is flat (that is why these waves
are sometimes
called flat waves). Plane waves do not have a focus to which their fronts move
(focused)
or from which the fronts are emitted (divergent). "Nearly plane waves" also do
not have a
focus to which their fronts move (focused) or from which the fronts are
emitted
(divergent). The amplitude of their wave fronts (having "nearly plane"
characteristics) is
approximating the constancy of plain waves. "Nearly plane" waves can be
emitted by
generators having pressure pulse/ shock wave generating elements with flat
emitters or
curved emitters. Curved emitters may comprise a generalized paraboloid that
allows
waves having nearly plane characteristics to be emitted.
[0034] A "pressure pulse" according to the present invention is an acoustic
pulse which
includes several cycles of positive and negative pressure. The amplitude of
the positive
part of such a cycle should be above about 0.1 MPa and its time duration is
from below a
microsecond to about a second. Rise times of the positive part of the first
pressure cycle
may be in the range of nano-seconds (ns) up to some milli-seconds (ms). Very
fast pressure
pulses are called shock waves. Shock waves used in medical applications do
have
amplitudes above 0.1 MPa and rise times of the amplitude are below 100 ns. The
duration
CA 3026905 2018-12-10
P8200CA00
of a shock wave is typically below 1-3 micro-seconds (j.6) for the positive
part of a cycle
and typically above some micro-seconds for the negative part of a cycle.
[0035] "Reflexology zone" as used herein means an area or pressure point on
the feet or
hands that are access pathways to every organ, gland, muscle, etc. These
pathways between
pressure points and other parts of the body are thought to be connected via
the nervous
system and that a neurological relationship exists between the skin and the
internal organs,
and that the whole nervous system adjusts to a stimulus. According to
reflexology theory,
application of pressure to feet, hands, or ears sends a calming message from
the peripheral
nerves in these extremities to the central nervous system, which in turn
signals the body to
adjust the tension level. This enhances overall relaxation, removes stress,
brings internal
organs and their systems into a state of optimum functioning, and increases
blood supply
which brings additional oxygen and nutrients to cells and enhances waste
removal. It
positively affects the circulatory, respiratory, endocrine, immune, and
neuropeptide
systems in the body.
[0036] "Reproductive glands" include ovaries and testes: A woman's 2 ovaries
are located
on each side of the uterus, just below the opening of the fallopian tubes
(tubes that extend
from the uterus to near the ovaries). The ovaries contain the egg cells needed
for
reproduction. They also make estrogen and progesterone. These affect many of
the female
characteristics and reproductive functions. Estrogens also play an important
role in bone
health and strength. The levels of estrogen and progesterone are controlled by
certain
hormones made by the pituitary gland. The testes are oval-shaped organs that
hang
suspended in a pouch of skin (scrotum) outside the male body. The testes are
the site of
sperm production. They also make testosterone and other hormones. These affect
many of
the male characteristics and support sperm production. Testosterone also plays
an
important role in bone health and strength.
[0037] "Shock Wave": As used herein is defined by Camilo Perez, Hong Chen, and
Thomas J. Matula; Center for Industrial and Medical Ultrasound, Applied
Physics
Laboratory, University of Washington, 1013 NE 40th Street, Seattle, Washington
98105;
Maria Karzova and Vera A. Khokhlovab; Department of Acoustics, Faculty of
Physics,
Moscow State University, Moscow 119991, Russia; (Received 9 October 2012;
revised
16 April 2013; accepted 1 May 2013) in their publication, "Acoustic field
characterization
11
CA 3026905 2018-12-10
P8200CA00
of the Duolith: Measurements and modeling of a clinical shock wave therapy
device";
incorporated by reference herein in its entirety.
[0038] "Testosterone": Testosterone is the primary male sex hormone and an
anabolic
steroid. In male humans, testosterone plays a key role in the development of
male
reproductive tissues such as testes and prostate, as well as promoting
secondary sexual
characteristics such as increased muscle and bone mass, and the growth of body
hair. In
addition, testosterone is involved in health and well-being, and the
prevention of
osteoporosis. Insufficient levels of testosterone in men may lead to
abnormalities including
frailty and bone loss. Testosterone is a steroid from the androstane class
containing a keto
and hydroxyl groups at the three and seventeen positions respectively. It is
biosynthesized
in several steps from cholesterol and is converted in the liver to inactive
metabolites. It
exerts its action through binding to and activation of the androgen receptor.
In humans
and most other vertebrates, testosterone is secreted primarily by the
testicles of males and,
to a lesser extent, the ovaries of females. On average, in adult males, levels
of testosterone
are about 7 to 8 times as great as in adult females. As the metabolism of
testosterone in
males is greater, the daily production is about 20 times greater in men.
Females are also
more sensitive to the hormone.
[0039] "Thymus": The thymus is a specialized primary lymphoid organ of the
immune
system. Within the thymus, T cells mature. T cells are critical to the
adaptive immune
system, where the body adapts specifically to foreign invaders. The thymus is
composed
of two identical lobes and is located anatomically in the anterior superior
mediastinum, in
front of the heart and behind the sternum. Histologically, each lobe of the
thymus can be
divided into a central medulla and a peripheral cortex which is surrounded by
an outer
capsule. The cortex and medulla play different roles in the development of T
cells. Cells
in the thymus can be divided into thymic stromal cells and cells of
hematopoietic origin
(derived from bone marrow resident hematopoietic stem cells). Developing T
cells are
referred to as thymocytes and are of hematopoietic origin. Stromal cells
include epithelial
cells of the thymic cortex and medulla, and dendritic cells. The thymus
provides an
inductive environment for development of T cells from hematopoietic progenitor
cells. In
addition, thymic stromal cells allow for the selection of a functional and
self-tolerant T
cell repertoire. Therefore, one of the most important roles of the thymus is
the induction
of central tolerance. The thymus is largest and most active during the
neonatal and pre-
12
CA 3026905 2018-12-10
P8200CA00
adolescent periods. By the early teens, the thymus begins to atrophy and
thymic stroma is
mostly replaced by adipose (fat) tissue. Nevertheless, residual T
lymphopoiesis continues
throughout adult life.
[0040] "Thyroid": The thyroid gland, or simply the thyroid, is an endocrine
gland in the
neck, consisting of two lobes connected by an isthmus. It is found at the
front of the neck,
below the Adam's apple. The thyroid gland secretes thyroid hormones, which
primarily
influence the metabolic rate and protein synthesis. The hormones also have
many other
effects including those on development. The thyroid hormones triiodothyronine
(T3) and
thyroxine (T4) are created from iodine and tyrosine. The thyroid also produces
the
hormone calcitonin, which plays a role in calcium homeostasis. Hormonal output
from
the thyroid is regulated by thyroid-stimulating hormone (TSH) secreted from
the anterior
pituitary gland, which itself is regulated by thyrotropin-releasing hormone
(TRH)
produced by the hypothalamus. The thyroid may be affected by several diseases.
Hyperthyroidism occurs when the gland produces excessive amounts of thyroid
hormones,
the most common cause being Graves' disease, an autoimmune disorder. In
contrast,
hypothyroidism is a state of insufficient thyroid hormone production.
Worldwide, the most
common cause is iodine deficiency. Thyroid hormones are important for
development, and
hypothyroidism secondary to iodine deficiency remains the leading cause of
preventable
intellectual disability. In iodine-sufficient regions, the most common cause
of
hypothyroidism is Hashimoto's thyroiditis, also an autoimmune disorder. In
addition, the
thyroid gland may also develop several types of nodules and cancer.
[0041] Waves/wave fronts described as being "focused" or "having focusing
characteristics" means in the context of the present invention that the
respective waves or
wave fronts are traveling and increase their amplitude in direction of the
focal point. Per
definition the energy of the wave will be at a maximum in the focal point or,
if there is a
focal shift in this point, the energy is at a maximum near the geometrical
focal point. Both
the maximum energy and the maximal pressure amplitude may be used to define
the focal
point.
Brief Description of the Drawings
[0042] The
invention will be described by way of example and with reference to
the accompanying drawings in which:
13
CA 3026905 2018-12-10
P8200CA00
[0043] Figure 1 is a simplified depiction of a pressure pulse / shock wave
(PP/SW)
generator with focusing wave characteristics.
[0044] Figure 2 is a simplified depiction of a pressure pulse / shock wave
generator with
plane wave characteristics.
[0045] Figure 3 is a simplified depiction of a pressure pulse / shock wave
generator with
divergent wave characteristics.
[0046] Figure 4a is a simplified depiction of a pressure pulse / shock wave
generator
having a focusing element in the form of an ellipsoid. The waves generated are
focused.
[0047] Figure 4b is a simplified depiction of a pressure pulse / shock wave
generator
having a parabolic reflector element and generating waves that are disturbed
plane.
[0048] Figure 4c is a simplified depiction of a pressure pulse / shock wave
generator
having a quasi parabolic reflector element (generalized paraboloid) and
generating waves
that are nearly plane/have nearly plane characteristics.
[0049] Figure 4d is a simplified graphic depiction of a generalized paraboloid
with better
focusing characteristic than a paraboloid in which n=2. The electrode usage is
shown. The
generalized paraboloid, which is an interpolation (optimization) between two
optimized
paraboloids for a new electrode and for a used (burned down) electrode is also
shown.
[0050] Figure 5 is a simplified depiction of a pressure pulse / shock wave
generator being
connected to a control/power supply unit.
[0051] Figure 6 is a simplified depiction of a pressure pulse / shock wave
generator
comprising a flat EMSE (electromagnetic shock wave emitter) coil system to
generate
nearly plane waves as well as an acoustic lens. Convergent wave fronts are
leaving the
housing via an exit window.
[0052] Figure 7 is a simplified depiction of a pressure pulse / shock wave
generator having
a flat EMSE coil system to generate nearly plane waves. The generator has no
reflecting
or focusing element. As a result, the pressure pulse / shock waves are leaving
the housing
via the exit window unfocused having nearly plane wave characteristics.
[0053] Figure 8 is a simplified depiction of a pressure pulse / shock wave
generator having
a flat piezoceramic plate equipped with a single or numerous individual
piezoceramic
elements to generate plane waves without a reflecting or focusing element. As
a result,
the pressure pulse / shock waves are leaving the housing via the exit window
unfocused
having nearly plane wave characteristics.
14
CA 3026905 2018-12-10
. .
P8200CA00
[0054] Figure 9 is a simplified depiction of a pressure pulse / shock wave
generator having
a cylindrical EMSE system and a triangular shaped reflecting element to
generate plane
waves. As a result, the pressure pulse / shock waves are leaving the housing
via the exit
window unfocused having nearly plane wave characteristics.
[0055] Figure 10 shows an exemplary shock wave generator device.
[0056] Figure 11 shows the shock wave generator device directed at a
reflexology zone
on a foot of a patient.
[0057] Figure 12 shows the shock wave generator device directed at a
reflexology zone
on a hand of a patient.
[0058] Figures 13-13C show schematic views showing general reflexology
locations of
the foot and ankle area in the human body.
[0059] Figure 14 shows a schematic view showing general reflexology locations
of the
hand in the human body.
Detailed Description of the Invention
[0060] The present methodology uses an acoustic shock wave form directed to
specific
reflexology zones to stimulate a modulated response. The present invention
described
herein teaches a therapy to reduce the number of opioid addictions following
surgery by
reducing the need for pain medication post-surgery; and, aiding in the
recovery from
addiction of pain medications and opioids by elimination chronic pain in the
addict and
minimizing the withdrawal symptoms in the addict.
[0061] The present inventors have treated hundreds of "addicts", those
individuals
suffering from prescription or opioid addiction, successfully including those
patients who
require pain medication and/or opiates daily to manage their pain such that a
patient can
participate in daily activities. A huge success rate is being achieved as they
only treat
those motivated patients who seek out treatment for their chronic injuries and
want to get
off pain medication or opiates. Two million new addicts are created annually
following
elective surgery in the USA. These people are target patients. Additionally,
the present
invention has had substantial success in treating long term addicts as well.
This is
especially true when an added incentive of a job treating other addicts is
afforded with this
technology upon the successful "kicking" of the addiction. This effort is part
of a Kentucky
project.
CA 3026905 2018-12-10
P8200CA00
[0062] The inventors have also proven the ability to prevent long term chronic
pain not
only in their clinical experiences but in their published skin flap rat model.
By treating
the standardized skin flap of the mouse with shock waves they reduced the area
of necrosis
post-surgery by 75% and accelerated complete healing by 50%. This must
translate into
pain reduction and the need for pain meds. They treated the mouse a day prior
to, or during
surgery to reduce healing time and necrosis. This is the preferred embodiment.
Treat a
patient during surgery to (1) prevent adverse effects and prevent infection
(2) reduce the
recovery time and (3) reduce post-surgical pain. All 3 factor in long term
pain medication
usage. The advantage of treating during surgery is that treating a patient in
the acute injury
phase is painful. During surgery one can increase the energy level and the
number of
shocks to improve outcomes and reduce the amount of future pain medication,
thus
reducing the likelihood of addiction.
[0063] Treating the reflexology points in both hands and feet of the addict
can minimize
the anxiety and pain during the withdrawal period and generally just make the
addict feel
better. The inventors have seen this in numerous cases and this is included in
this patent.
[0064] In the Extracorporeal Shock wave method of treating a patient at a
target site on
the anatomy. In this invention, the term target site refers to a reflexology
location for a
specific orthopedic bone structure, nerve, gland and the tissue of the hand or
foot at the
desired reflexology zone or region being in the path of the shock wave
applicator. The
patient is placed in a convenient orientation to permit the source of the
emitted waves to
most directly send the waves to the target site to initiate shock wave
stimulation of the
target area. Assuming the target area is within a projected area of the wave
transmission,
a single transmission dosage of wave energy may be used. The transmission
dosage can
be from a few seconds to 20 minutes or more dependent on the condition.
Preferably the
waves are generated from an unfocused or focused source. The unfocused waves
can be
divergent or near planar and having a low-pressure amplitude and density in
the range of
0.00001 mJ/mm2 to 1.0 mJ/mm2 or less, most typically below 0.2 mJ/mm2. The
focused
source can use a focused beam of waves or can optionally use a diffusing lens
or have a
far-sight focus to minimize if not eliminate having the localized focus point
within the
tissue. Preferably the focused shock waves are used at a similarly effective
low energy
transmission or alternatively can be at higher energy but wherein the tissue
target site is
disposed pre-convergence inward of the geometric focal point of the emitted
wave
16
CA 3026905 2018-12-10
P8200CA00
transmission. Understanding the higher the energy used, the more sensation of
pain the
patient may experience.
[0065] These shock wave energy transmissions are effective in stimulating a
cellular
response and in some cases, such as unfocused low energy, and even low energy
focused
emissions can be accomplished without creating the localized hemorrhaging
caused by
rupturing cavitation bubbles in the tissue of the target site. This
effectively insures the
patient does not have to experience the sensation of pain so common in the
higher energy
focused wave forms having a focal point at or within the targeted treatment
site. Higher
energy acoustic shock waves including focused ways can be used if the patient
is
adequately sedated such as during a surgical preparation or even during a
surgical
procedure.
[0066] Accordingly, unless for other reasons such as a trauma or immediate
post-operative
shock wave therapy no localized or general anesthesia is required. Post-
operative shock
wave therapy typically will be administered without such sedations at low
energy.
[0067] If the target site is within the body it may be such that the patient
or the generating
source must be reoriented relative to the site and a second, third or more
treatment dosage
can be administered. The fact that the dosage is at a low energy the common
problem of
localized hemorrhaging is reduced making it more practical to administer
multiple dosages
of waves from various orientations to further optimize the treatment and
cellular
stimulation of the target site. Heretofore focused high energy multiple
treatments induced
pain and discomfort to the patient. The use of low energy focused or un-
focused waves at
the target site enables multiple sequential treatments. Alternatively, the
wave source
generators may be deployed in an array wherein the subject patient is
effectively enveloped
or surrounded by a plurality of low energy wave source generators which can be
simultaneously bombarding the target site from multiple directions.
[0068] The goal in such treatments is to provide 100 to 3000 acoustic shock
waves at a
voltage of 14 kV to 28 kV across a spark gap generator in a single treatment
preferably or
one or more adjuvant treatments by targeting the site impinging the emitted
waves on the
desired reflexology target.
[0069] The present method, in many cases, does not rely on precise site
location per se.
The physician's general understanding of the anatomy of the patient should be
sufficient
to locate the reflexology target site to be treated. The treated area can
withstand a far
17
CA 3026905 2018-12-10
P8200CA00
greater number of shock waves based on the selected energy level being
emitted. For
example, at very low energy levels the stimulation exposure can be provided
over
prolonged periods as much as 20 minutes if so desired. At higher energy levels
the
treatment duration can be shortened to less than a minute, less than a second
if so desired.
The limiting factor in the selected treatment dosage is avoidance or
minimization of cell
hemorrhaging and other kinds of damage to the cells or tissue while still
providing a
stimulating cellular release or activation of VEGF and other growth factors
and most
importantly to modulate and regulate hormonal secretions from a specific
targeted gland
by emitting waves to a desired reflexology zone. In other cases where the
precise location
must be known, the use of an applicator acoustic wave emission is directed by
an
ultrasound image, preferably the applicator has a software program coupled to
the imaging
device to allow the doctor to visualize the area being treated. The applicator
can be hand
held or manipulated in a fixture, if so desired, in either way the doctor can
see the
reflexology zone for any gland to be stimulated and the selected reflexology
zone reflects
the path of the wave transmission to modulate that bone structure, nerve or
gland.
[0070] A key advantage of the present inventive methodology is that it is
complimentary
to conventional medical procedures. In the case of any other procedure, the
area of the
patient can be post operatively bombarded with these low energy waves to
stimulate
cellular release of healing agents and growth factors. Most preferably such
patients may
be provided more than one such ESWT treatment with an intervening dwell time
for
cellular relaxation prior to secondary and tertiary treatments.
[0071] The underlying principle of these shock wave therapy methods is to
stimulate the
body's own natural healing capability through the reflexology zone. This is
accomplished
by deploying shock waves to stimulate strong cells in the tissue to activate a
variety of
responses. The acoustic shock waves transmit or trigger what appears to be a
cellular
communication throughout the entire anatomical structure, this activates a
generalized
cellular response at the treatment site, in particular, but more interestingly
a systemic
response in areas more removed from the wave form pattern. This is believed to
be one of
the reasons molecular stimulation can be conducted at threshold energies
heretofore
believed to be well below those commonly accepted as required. Accordingly,
not only
can the energy intensity be reduced but also the number of applied shock wave
impulses
can be lowered from several thousand to as few as one or more pulses and still
yield a
18
CA 3026905 2018-12-10
P8200CA00
beneficial stimulating response. This allows acoustic wave therapies to be
directed to a
specific reflexology zone directed toward, for example, an endocrine gland
being treated
with confidence the signal will be fed back to the entire system via the
pituitary gland
(hypophysis). This use of acoustic wave stimulation allows a therapy to be
given to
modulate and adjust glandular secretions of hormones to be regulated and
adjusted to
achieve a desired adjustment, for example if too low to increase specific
secretions, if too
high to lessen these secretions. Most importantly, the modulation of and
reduction of pain
can be achieved in the bone structure and nerves affected by a medical
condition and/or
medical procedure.
[0072] The biological model motivated the design of sources with low pressure
amplitudes
and energy densities. First: spherical waves generated between two tips of an
electrode;
and second: nearly even waves generated by generated by generalized parabolic
reflectors.
Third: divergent shock front characteristics are generated by an ellipsoid
behind F2.
Unfocused sources are preferably designed for extended two dimensional
areas/volumes
like skin. The unfocused sources can provide a divergent wave pattern or a
nearly planar
wave pattern and can be used in isolation or in combination with focused wave
patterns
yielding to an improved therapeutic treatment capability that is non-invasive
with few if
any disadvantageous contraindications. Alternatively, a focused wave emitting
treatment
may be used wherein the focal point extends to the desired reflexology zone or
site,
preferably at or beyond the target reflexology treatment site within or even
potentially
external to the patient. In any event, the beam of acoustic waves transmitted
needs to
project in a large enough reflexology zone or area to stimulate or modulate
the gland. This
results in the reduction of or elimination of a localized intensity zone with
associated
noticeable pain effect while providing a wide or enlarged treatment volume at
a variety of
depths more closely associated with high energy focused wave treatment. The
utilization
of a diffuser type lens or a shifted far-sighted focal point for the
ellipsoidal reflector
enables the spreading of the wave energy to effectively create a convergent
but off target
focal point. This insures less tissue trauma while insuring cellular
stimulation to enhance
the healing process.
[0073] This method of treatment has the steps of, locating a reflexology
treatment site or
zone, generating either focused shock waves or unfocused shock waves, of
directing these
shock waves to the treatment site; and applying a sufficient number of these
shock waves
19
CA 3026905 2018-12-10
P8200CA00
to induce activation of one or more growth factor thereby inducing or
accelerating a
modulated adjustment to achieve a proper regulated glandular, muscular, bone
or nerve
response.
[0074] The unfocused shock waves can be of a divergent wave pattern or near
planar
pattern preferably of a low peak pressure amplitude and density. Typically,
the energy
density values range as low as 0.000001 mJ/ mm2 and having a high end energy
density of
below 1.0 mJ/ mm2, preferably 0.40 mJ/mm2 or less, more preferably 0.20 mJ/
mm2 or
less. The peak pressure amplitude of the positive part of the cycle should be
above 1.0 and
its duration is below 1-3 microseconds.
[0075] The treatment depth can vary from the surface to the full depth of the
human or
animal torso and the treatment site can be defined by a much larger treatment
area than the
0.10-3.0 cm2 commonly produced by focused waves. The above methodology is
particularly well suited for surface as well as sub-surface soft tissue
treatments in a
reflexology zone.
[0076] An exemplary treatment protocol could have emitted shock waves in a
broad range
of 0.01 mJ/mm2 to 3.0 mJ/mm2 and 200-2500 pulses per treatment with a
treatment
schedule of 1-3 weekly treatments until symptoms reduce. This can be repeated
as
symptoms reoccur or continue weekly as a preventative. The post medical
treatment is
beneficial as a pain suppressor and reduces the need for pain medications and
allows less
addictive medications to be used to prevent addiction.
[0077] The above methodology is valuable in generation of tissue,
vascularization and
may be used in combination with stem cell therapies as well as regeneration of
tissue and
vascularization.
[0078] The following invention description first provides a detailed
explanation of
acoustic shock waves, as illustrated in figures 1 - 9. As used herein an
acoustic shock
wave is an asymmetric wave with an exceptionally rapid peak rise time and
slower return
time from the peak amplitude. Historically, these acoustic shock waves were
first used
medically to destroy kidney stones. The wave patterns were directed to a focal
point with
ah a relatively high energy to blast the concrements into small urinary tract
passable
fragments.
[0079] A whole class of acoustic shock waves for medical treatments were later
discovered that employed low energy acoustic shock waves. These low energy
acoustic
CA 3026905 2018-12-10
P8200CA00
shock waves maintained the asymmetric wave profile, but at much lower energies
as
described in US2006/0100550 which is incorporated herein in its entirety.
[0080] These low energy acoustic shock waves advantageously could stimulate a
substance without requiring a focused beam. The advantage of such an unfocused
beam
was the acoustic wave could be directed to pass through tissue without causing
any cell
rupturing which would be evidenced by a lack of a hematoma or bruising. This
use of
unfocused, low energy acoustic shock waves provided an ability to treat a
large volume of
tissue virtually painlessly. Furthermore, the acoustic energy caused a short
duration
anesthetic sensation that effectively numbs the patient's pain over a period
of days with a
prolonged reduction in pain thereafter.
[0081] The use of low energy acoustic shock waves that employ a focused beam
has been
spurred on as a viable alternative to the unfocused low energy shock waves
because the
focal point being of a small point of energy has little or a small region of
cell damage as
the remaining portions of the wave pattern can provide a stimulating effect
similar to the
unfocused shock waves. Basically, the effect is the same with the users of
focused waves
achieving the benefits of the unfocused waves, but with a focal point of peak
energy in a
tiny localised region. So, for purposes of the present invention, the use of
"soft waves"
those defined by low energy beams will be applicable to both focused and
unfocused
beams o acoustic shock waves for the present invention.
[0082] One last and significant point that the reader must appreciate is that
an "acoustic
shock wave" is not an "ultrasound wave". Sonic or ultrasound waves are
generated with
a uniform and symmetrical wave pattern similar to a sinusoidal wave. This type
of sonic
wave causes a sheer action on tissue as evidenced by a generation of heat
within the tissue,
for this reason, the use of sonic waves of the ultrasonic type are not
considered as efficient
in cell survivability rates.
[0083] The present preferred invention avoids the use of such cell damaging
sonic waves,
most particularly in treating glands, bone structures or nerves via a targeted
reflexology
zone.
[0084] With reference to figures 1 ¨ 9, a variety of schematic views of
acoustic shock
waves are described. The following description of the proper amplitude and
pressure pulse
intensities of the shock waves 200 are provided below along with a description
of how the
shock waves actually function and have been taken from the co-pending
application of the
21
CA 3026905 2018-12-10
P8200CA00
present inventors and replicated herein as described below. For the purpose of
describing
the shock waves 200 were used as exemplary and are intended to include all of
the wave
patterns discussed in the figures as possible treatment patterns.
[0085] Figure 1 is a simplified depiction of a pressure pulse / shock wave
(PP/SW)
generator, such as a shock wave head, showing focusing characteristics of
transmitted
acoustic pressure pulses. Numeral 1 indicates the position of a generalized
pressure pulse
generator, which generates the pressure pulse and, via a focusing element,
focuses it
outside the housing to treat diseases. The affected tissue or organ is
generally located in or
near the focal point which is located in or near position 6. At position 17 a
water cushion
or any other kind of exit window for the acoustical energy is located.
[0086] Figure 2 is a simplified depiction of a pressure pulse / shock wave
generator, such
as a shock wave head, with plane wave characteristics. Numeral 1 indicates the
position
of a pressure pulse generator according to the present invention, which
generates a pressure
pulse which is leaving the housing at the position 17, which may be a water
cushion or any
other kind of exit window. Somewhat even (also referred to herein as
"disturbed") wave
characteristics can be generated, in case a paraboloid is used as a reflecting
element, with
a point source (e.g. electrode) that is located in the focal point of the
paraboloid. The waves
will be transmitted into the patient's body via a coupling media such as,
e.g., ultrasound
gel or oil and their amplitudes will be attenuated with increasing distance
from the exit
window 17.
[0087] Figure 3 is a simplified depiction of a pressure pulse shock wave
generator (shock
wave head) with divergent wave characteristics. The divergent wave fronts may
be leaving
the exit window 17 at point 11 where the amplitude of the wave front is very
high. This
point 17 could be regarded as the source point for the pressure pulses. In Fig
lc the pressure
pulse source may be a point source, that is, the pressure pulse may be
generated by an
electrical discharge of an electrode under water between electrode tips.
However, the
pressure pulse may also be generated, for example, by an explosion, referred
to as a
ballistic pressure pulse. The divergent characteristics of the wave front may
be a
consequence of the mechanical setup.
[0088] This apparatus, in certain embodiments, may be adjusted/modified/or the
complete
shock wave head or part of it may be exchanged so that the desired and/or
optimal acoustic
22
CA 3026905 2018-12-10
P8200CA00
profile such as one having wave fronts with focused, planar, nearly plane,
convergent or
divergent characteristics can be chosen.
[0089] A change of the wave front characteristics may, for example, be
achieved by
changing the distance of the exit acoustic window relative to the reflector,
by changing the
reflector geometry, by introducing certain lenses or by removing elements such
as lenses
that modify the waves produced by a pressure pulse/shock wave generating
element.
Exemplary pressure pulse/shock wave sources that can, for example, be
exchanged for
each other to allow an apparatus to generate waves having different wave front
characteristics are described in detail below.
[0090] In one embodiment, mechanical elements that are exchanged to achieve a
change
in wave front characteristics include the primary pressure pulse generating
element, the
focusing element, the reflecting element, the housing and the membrane. In
another
embodiment, the mechanical elements further include a closed fluid volume
within the
housing in which the pressure pulse is formed and transmitted through the exit
window.
[0091] In one embodiment, the apparatus of the present invention is used in
combination
therapy. Here, the characteristics of waves emitted by the apparatus are
switched from,
for example, focused to divergent or from divergent with lower energy density
to divergent
with higher energy density. Thus, effects of a pressure pulse treatment can be
optimized
by using waves having different characteristics and/or energy densities,
respectively.
[0092] While the above described universal toolbox of the various types of
acoustic shock
waves and types of shock wave generating heads provides versatility, the
person skilled in
the art will appreciate that apparatuses that produce low energy or soft
acoustic shock
waves having, for one example, nearly plane characteristics, are less
mechanically
demanding and fulfill the requirements of many users.
[0093] As the person skilled in the art will also appreciate that embodiments
shown in the
drawings are independent of the generation principle and thus are valid for
not only
electro-hydraulic shock wave generation but also for, but not limited to,
PP/SW generation
based on electromagnetic, piezoceramic and ballistic principles. The pressure
pulse
generators may, in certain embodiments, be equipped with a water cushion that
houses
water which defines the path of pressure pulse waves that is, through which
those waves
are transmitted. In a preferred embodiment, a patient is coupled via
ultrasound gel or oil
23
CA 3026905 2018-12-10
P8200CA00
to the acoustic exit window (17), which can, for example, be an acoustic
transparent
membrane, a water cushion, a plastic plate or a metal plate.
[0094] Figure 4a is a simplified depiction of the pressure pulse / shock wave
generator
(shock wave head) having as focusing element an ellipsoid (30). Thus, the
generated waves
are focused at (6).
[0095] Figure 4b is a simplified depiction of the pressure pulse / shock wave
generator
(shock wave head) having as a focusing element an paraboloid (y2=2px). Thus,
the
characteristics of the wave fronts generated behind the exit window (33, 34,
35, and 36)
are disturbed plane ("parallel"), the disturbance resulting from phenomena
ranging from
electrode burn down, spark ignition spatial variation to diffraction effects.
However, other
phenomena might contribute to the disturbance.
[0096] Figure 4c is a simplified depiction of the pressure pulse / shock wave
generator
(shock wave head) having as a focusing element a generalized paraboloid
(yn=2px, with
1.2<n<2.8 and n 2). Thus, the characteristics of the wave fronts generated
behind the
exit window (37, 38, 39, and 40) are, compared to the wave fronts generated by
a
paraboloid (y2=2px), less disturbed, that is, nearly plane (or nearly parallel
or nearly even
(37, 38, 39, 40)). Thus, conformational adjustments of a regular paraboloid
(y2=2px) to
produce a generalized paraboloid can compensate for disturbances from, e.g.,
electrode
burn down. Thus, in a generalized paraboloid, the characteristics of the wave
front may be
nearly plane due to its ability to compensate for phenomena including, but not
limited to,
burn down of the tips of the electrode and/or for disturbances caused by
diffraction at the
aperture of the paraboloid. For example, in a regular paraboloid (y2=2px) with
p=1.25,
introduction of a new electrode may result in p being about 1.05. If an
electrode is used
that adjusts itself to maintain the distance between the electrode tips
("adjustable
electrode") and assuming that the electrodes burn down is 4 mm (z=4mm), p will
increase
to about 1.45. To compensate for this burn down, and here the change of p, and
to generate
nearly plane wave fronts over the life span of an electrode, a generalized
paraboloid
having, for example n=1.66 or n=2.5 may be used. An adjustable electrode is,
for
example, disclosed in United States Patent 6,217,531.
[0097] Figure 4d shows sectional views of a number of paraboloids. Numeral 62
indicates
a paraboloid of the shape y2=2px with p=0.9 as indicated by numeral 64 at the
x axis which
specifies the p/2 value (focal point of the paraboloid). Two electrode tips of
a new
24
CA 3026905 2018-12-10
P8200CA00
electrode 66 (inner tip) and 67 (outer tip) are also shown in the Figure. If
the electrodes
are fired and the tips are burning down the position of the tips change, for
example, to
position 68 and 69 when using an electrode which adjusts its position to
compensate for
the tip burn down. In order to generate pressure pulse/shock waves having
nearly plane
characteristics, the paraboloid has to be corrected in its p value. The p
value for the burned
down electrode is indicate by 65 as p/2 =1. This value, which constitutes a
slight
exaggeration, was chosen to allow for an easier interpretation of the Figure.
The
corresponding paraboloid has the shape indicated by 61, which is wider than
paraboloid
62 because the value of p is increased. An average paraboloid is indicated by
numeral 60
in which p=1.25 cm. A generalized paraboloid is indicated by dashed line 63
and
constitutes a paraboloid having a shape between paraboloids 61 and 62. This
particular
generalized paraboloid was generated by choosing a value of n 2 and a p value
of about
1.55 cm. The generalized paraboloid compensates for different p values that
result from
the electrode burn down and/or adjustment of the electrode tips.
[0098] Figure 5 is a simplified depiction of a set-up of the pressure pulse /
shock wave
generator (43) (shock wave head) and a control and power supply unit (41) for
the shock
wave head (43) connected via electrical cables (42) which may also include
water hoses
that can be used in the context of the present invention. However, as the
person skilled in
the art will appreciate, other set-ups are possible and within the scope of
the present
invention.
[0099] Figure 6 is a simplified depiction of the pressure pulse / shock wave
generator
(shock wave head) having an electromagnetic flat coil 50 as the generating
element.
Because of the plane surface of the accelerated metal membrane of this
pressure pulse /
shock wave generating element, it emits nearly plane waves which are indicated
by lines
51. In shock wave heads, an acoustic lens 52 is generally used to focus these
waves. The
shape of the lens might vary according to the sound velocity of the material
it is made of.
At the exit window 17 the focused waves emanate from the housing and converge
towards
focal point 6.
[00100]
Figure 7 is a simplified depiction of the pressure pulse / shock wave
generator (shock wave head) having an electromagnetic flat coil 50 as the
generating
element. Because of the plane surface of the accelerated metal membrane of
this generating
element, it emits nearly plane waves which are indicated by lines 51. No
focusing lens or
CA 3026905 2018-12-10
P8200CA00
reflecting lens is used to modify the characteristics of the wave fronts of
these waves, thus
nearly plane waves having nearly plane characteristics are leaving the housing
at exit
window 17.
001011 Fig 8 is a simplified depiction of the pressure pulse /
shock wave generator
(shock wave head) having an piezoceramic flat surface with piezo crystals 55
as the
generating element. Because of the plane surface of this generating element,
it emits nearly
plane waves which are indicated by lines 51. No focusing lens or reflecting
lens is used to
modify the characteristics of the wave fronts of these waves, thus nearly
plane waves are
leaving the housing at exit window 17. Emitting surfaces having other shapes
might be
used, in particular curved emitting surfaces such as those shown in Figs. 4a
to 4c as well
as spherical surfaces. To generate waves having nearly plane or divergent
characteristics,
additional reflecting elements or lenses might be used. The crystals might,
alternatively,
be stimulated via an electronic control circuit at different times, so that
waves having plane
or divergent wave characteristics can be formed even without additional
reflecting
elements or lenses.
[00102] Fig 9 is a simplified depiction of the pressure pulse /
shock wave generator
(shock wave head) comprising a cylindrical electromagnet as a generating
element 53 and
a first reflector having a triangular shape to generate nearly plane waves 54
and 51. Other
shapes of the reflector or additional lenses might be used to generate
divergent waves as
well.
[00103] Figure 10 shows an exemplary shock wave device generator or
source 1
with a control and power supply 41 connected to a hand-held applicator shock
wave head
43 via a flexible hose 42 with fluid conduits. The illustrated shock wave
applicator 43 has
a flexible membrane at an end of the applicator 43 which transmits the
acoustic waves
when coupled to the skin by using a fluid or acoustic gel. As shown, this type
of applicator
43 has a hydraulic spark generator using either focused or unfocused shock
waves,
preferably in a low energy level, less than the range of 0.01 mJ/mm2 to 0.3
mJ/mm2. The
flexible hose 42 is connected to a fluid supply that fills the applicator 43
and expands the
flexible membrane when filled. Alternatively, a ballistic, piezoelectric or
spherical
acoustic shock wave device can be used to generate the desired waves.
[00104] Figure 11 is a perspective view of a foot of a patient whose
reflexology
zone or target 100 is being treated. A shock wave applicator head 43 is
brought into contact
26
CA 3026905 2018-12-10
P8200CA00
with the skin Ps preferably an acoustic gel is used to enhance the
transmission of the shock
waves 200 through the skin Ps. The shock wave applicator head 43 can be hand
held and
manipulated across the skin Ps to drive the shock waves 200 in the direction
the shock
wave head 43 is pointed to activate a stimulating response through the
reflexology zone
100. As illustrated, the device shown is an electrohydraulic acoustic shock
wave
generator, however, other devices that generate acoustic shock waves can be
used.
Ultrasonic devices may be considered, but there is no data to support a
sinusoidal wave
form would work and therefore not considered as effective as the asymmetric
wave
generators. The acoustic shock waves activate a cellular response within the
reflexology
treatment site. This response or stimulation causes an increase of nitric
oxide and a release
of a variety of growth factors such as VEGF. As shown, the flexible membrane
is
protruding outward and the applicator 43 has been filled with fluid, the
transmission or
emission of acoustic shock waves 200 is directed towards the reflexology zone
100. In
order to accomplish a good transmission, it is important the flexible membrane
be pressed
against the patient's skin Ps and as indicated coupling gels may be used. The
zone 100, as
illustrated, is the reflexology zone for a bone structure which is a region of
the foot located
along an outside arch of each foot. By transmitting the shock waves 200 to the
zone 100,
is it believed that a modulation of the pain near the bone structure can be
made. This
modulation or adjustment is achieved by transmitting the acoustic waves 200 at
low energy
directly onto the zone 100. It is believed that a single treatment of the zone
100 will
achieve the desired modulation. However, repeated treatments may be
administered to
help maintain and control this reduced pain level. Having achieved a scheduled
pattern of
treatments, it is possible to achieve regulation of pain without the use of
drugs or other
stimulants.
[00105]
With reference to figure 12, a view of a hand of a patient whose reflexology
zone 100 is being treated with acoustic shock waves 200 is illustrated. In
this illustration,
it is important to note that the applicator 43 presses against the skin Ps of
the hand in the
reflexology zone 100 for the pancreas which is a region of the right hand in
the fatty part
below the index finger and a region of the left hand below the middle finger
close to the
wrist.
27
CA 3026905 2018-12-10
P8200CA00
[00106] With reference to figures 13 -13C, reflexology foot and
ankle area charts
are shown detailing the various zones that correspond to organs, nerves, bones
or glands
of the body.
[00107] With reference to figure 14, a reflexology hand chart is
shown detailing the
various zones that correspond to organs, nerves, bones or glands of the body.
[00108] The transmission of the shock waves 200 is preferred of a
low energy
density of 0.2 mJ/mm2 whether using focused or unfocused shock waves. The
acoustic
shock waves pulse rapidly through the cells penetrating the cell membrane
extremely
rapidly due to the rapid rise to peak time and pass through exiting slower due
to the slower
return from peak amplitude. This asymmetric wave pattern rapidly compresses
each cell
on entry and slow decompresses the cell as it exits. This effective squeezing
of each cell
is believed to cause the release of growth factors such as VEGF and others and
also creates
nitric oxide, all beneficial to new blood vessel formation. This occurs as a
transmission
across the cell membranes without rupturing the native cells.
[00109] Furthermore, such acoustic shock wave forms can be used in
combination
with drugs, chemical treatments, irradiation therapy or even physical therapy
and when so
combined the stimulated cells will more rapidly assist the body's natural
healing response
and thus overcomes the otherwise potentially tissue damaging effects of these
complimentary procedures.
[00110] The present invention provides an apparatus for an effective
treatment of
indications, which benefit from high or low energy pressure pulse/ shock waves
having
focused or unfocused, nearly plane, convergent or even divergent
characteristics. With an
unfocused wave having nearly plane, plane, convergent wave characteristic or
even
divergent wave characteristics, the energy density of the wave may be or may
be adjusted
to be so low that side effects including pain are very minor or even do not
exist at all.
[00111] In certain embodiments, the apparatus of the present
invention is able to
produce waves having energy density values that are below 0.1 mJ/mm2 or even
as low as
0.000 001 mJ/mm2. In a preferred embodiment, those low end values range
between 0.1 -
0.001 mJ/mm2. With these low energy densities, side effects are reduced and
the dose
application is much more uniform. Additionally, the possibility of harming
surface tissue
is reduced when using an apparatus of the present invention that generates
unfocused
waves having planar, nearly plane, convergent or divergent characteristics and
larger
28
CA 3026905 2018-12-10
P8200CA00
transmission areas compared to apparatuses using a focused shock wave source
that need
to be moved around to cover the affected area. The apparatus of the present
invention also
may allow the user to make more precise energy density adjustments than an
apparatus
generating only focused shock waves, which is generally limited in terms of
lowering the
energy output. Nevertheless, in some cases the first use of a high energy
focused shock
wave targeting a treatment zone may be the best approach followed by a
transmission of
lower energy unfocused wave patterns.
[00112] In the use of reflexology zones as the pathway or gate to
control pain
response, the present invention has actual empirical data showing the
effectiveness in the
zone directed to a bone. It is therefore further believed that similar
modulation and
beneficial adjustment can be achieved at other reflexology zones for
stimulating,
modulating or adjusting other glands, bones, nerves or organs such as the
liver, kidney or
any of those indicated in figure 13 for the foot zones and figure 14 for the
hand zones. It
is further believed that the hybrid Eastern medical acupuncture treatments or
massages
historically used are far less effective and less reliable than the results
achieved by the
deeper tissue penetrating transmission that are achieved by acoustic shock
wave therapy
applied to these reflexology zones. Historically, the inventor initially
targeted treatment
locations at the organ as in the patent US 7,988,648 B2, but the present
invention has found
the use of the reflexology zones has achieved unexpected far superior results.
[00113] It will be appreciated that the apparatuses and processes of
the present
invention can have a variety of embodiments, only a few of which are disclosed
herein. It
will be apparent to the artisan that other embodiments exist and do not depart
from the
spirit of the invention. Thus, the described embodiments are illustrative and
should not be
construed as restrictive.
[00114] Variations in the present invention are possible in light of
the description
of it provided herein. While certain representative embodiments and details
have been
shown for the purpose of illustrating the subject invention, it will be
apparent to those
skilled in this art that various changes and modifications can be made therein
without
departing from the scope of the subject invention. It is, therefore, to be
understood that
changes can be made in the particular embodiments described which will be
within the full
intended scope of the invention as defined by the following appended claims.
29
CA 3026905 2018-12-10
