U.S. patent application number 14/246707 was filed with the patent office on 2014-10-09 for system and method for patient preparation.
This patent application is currently assigned to VIKALP, INC. The applicant listed for this patent is VIKALP, INC. Invention is credited to Vijay ARYA.
Application Number | 20140302177 14/246707 |
Document ID | / |
Family ID | 50391768 |
Filed Date | 2014-10-09 |
United States Patent
Application |
20140302177 |
Kind Code |
A1 |
ARYA; Vijay |
October 9, 2014 |
SYSTEM AND METHOD FOR PATIENT PREPARATION
Abstract
A method for preparing the human bowel to undergo colonoscopy. A
salt solution, preferable having a 0.9% w/v concentration of sodium
chloride in water and warmed to 40 C degrees, is utilized. A series
of twisting and maneuvering exercises, such as those used in Yoga,
is also performed. A predetermine quantity of the salt solution is
consumed during predetermined intervals between the exercise steps,
intending to clear and cleanse the colon so as to prepare it to
undergo colonoscopy within about 3 to 24 hours after the completion
of the preparation.
Inventors: |
ARYA; Vijay; (Old
Brookeville, NY) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
VIKALP, INC |
Old Brookeville |
NY |
US |
|
|
Assignee: |
VIKALP, INC
Old Brookeville
NY
|
Family ID: |
50391768 |
Appl. No.: |
14/246707 |
Filed: |
April 7, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12749210 |
Mar 29, 2010 |
8691291 |
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14246707 |
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12101601 |
Apr 11, 2008 |
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12749210 |
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Current U.S.
Class: |
424/680 |
Current CPC
Class: |
A61K 33/14 20130101;
A61P 1/10 20180101 |
Class at
Publication: |
424/680 |
International
Class: |
A61K 33/14 20060101
A61K033/14 |
Claims
1-25. (canceled)
26. A method of cleansing a patient's colon in need of examination
to identify the presence of colon-related diseases or disorders,
comprising: alternating, at least five times, administration of a
predetermined quantity of an oral cleansing solution all at once
following by performing by the patient a predetermined exercise;
wherein the solution comprises sodium chloride mixed with a diluent
and optionally a flavorant to produce a solution comprising from
about 15 to about 20 grams of sodium chloride per 2 liters of the
diluent, wherein each of the at least five predetermined quantities
of the oral cleansing solution total at least about 8-16 ounces,
and wherein each of the at least five predetermined exercises are
different from each other.
27. The method according to claim 26, wherein administering the
first predetermined quantity of the solution occurs at a first
predetermined time, and wherein the first predetermined exercise
occurs at a second predetermined time that is different than the
first predetermined time.
28. The method according to claim 26, further comprising performing
a colonoscopic examination of the patient the same day as the
administration of the solution and following the last performed
predetermined exercise.
29. The method according to claim 26, wherein the solution
comprises a concentration made from 18 grams of sodium chloride per
2 liters of water.
30. The method according to claim 26, wherein the solution is
maintained at about 40 C.
31. The method according to claim 26, wherein performing the first
of the predetermined exercises comprises, with reference to the
patient's body: following a first instruction to stand erect with
both feet together with interlocking fingers and hands on top of
the head with palms facing up; following a second instruction to
inhale while stretching arms upwards as much as possible and
standing on toes; and following a third instruction to exhale and
stand erect with both feet together with interlocking fingers and
hands on top of the head with palms facing up.
32. The method according to claim 26, wherein performing the second
of the predetermined exercises comprises, with reference to the
patient's body: following a fourth instruction to stand with feet
apart with interlocking fingers and arms stretched upwards above
the head; following a fifth instruction to inhale while bending at
the waist and tilt outstretched arms to the right; following a
sixth instruction to exhale and stand with feet apart with
interlocking fingers and arms stretched upwards above the head; and
following a seventh instruction to inhale while bending at the
waist and tilt outstretched arms to the left.
33. The method according to claim 27, wherein performing the third
of the predetermined exercises comprises, with reference to the
patient's body: following an eighth instruction to stand with feet
apart and extend arms out at shoulder level with palms facing down;
following a ninth instruction to inhale while placing left hand on
right shoulder with palm facing down and right hand on left waist
with palm facing out and rotate and twist upper body towards the
right so as to be able to see heel of the left foot; following a
tenth instruction to exhale and stand with feet apart and extend
arms out at shoulder level with palms facing down; and following an
eleventh instruction to inhale while placing right hand on left
shoulder with palm facing down and left hand on right waist with
palm facing out and rotate and twist upper body towards the left so
as to be able to see heel of the right foot.
34. The method according to claim 26, wherein performing the fourth
of the predetermined exercises, with reference to the patient's
body: following a twelfth instruction to lie down flat on stomach
with feet apart with both palms open and flat on the floor as if
preparing to perform a push-up; following a thirteenth instruction
to inhale while twisting upper body towards the right turning the
head to the right until able to see the heels of both feet;
following a fourteenth instruction to exhale and lie down flat on
stomach with feet apart with both palms open and flat on the floor
as if preparing to perform a push-up; and following a fifteenth
instruction to inhale while twisting upper body towards the left
turning the head to the left until able to see the heels of both
feet.
35. The method according to claim 26, wherein performing the fifth
of the predetermined exercises comprises, with reference to the
patient's body: following a sixteenth instruction to squat down
with feet apart and grip with hands just below the knees of each
corresponding knee; following a seventeenth instruction to inhale
while touching right knee to the left toes; following a eighteenth
instruction to exhale and squat down with feet apart and grip with
hands just below the knees of each corresponding knee; and
following a nineteenth instruction to inhale while touching left
knee to the right toes.
36. The method according to claim 26, wherein said colon-related
diseases or disorders include one of gastrointestinal motility
disease, cyclical vomiting syndrome, obesity, improve digestion and
general well being by detoxification, irritable bowel syndrome, gas
and bloating, and allergies.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of and priority date of
U.S. patent application Ser. No. 12/749,210, entitled "System and
Method for Patient Preparation," filed Mar. 29, 2010, which is a
divisional of U.S. patent application Ser. No. 12/101,601, entitled
"System and Method for Patient Preparation," filed Apr. 11, 2008,
the contents of which are incorporated herein by reference.
BACKGROUND OF THE INVENTION
[0002] 1. Field of Invention
[0003] The present invention is generally related to processes for
preparing patients to undergo colonoscopic, endoscopic, or
sigmoidoscopic examination, and for treatment. In particular, the
present invention relates to the administration to a patient in
need of such preparation a salt solution and instructions regarding
performing certain maneuvers or exercises, including those known as
Shankha Prakshalana, with the intention of cleansing the human
bowel in preparation for examination and/or relating to
treatment.
[0004] 2. Description of the Related Art
[0005] Colon cancer is cancer of the large intestine (colon), the
lower part of the human digestive system. Rectal cancer is cancer
of the last six inches of the colon. Together, they are often
referred to as colorectal cancers. About 112,000 people are
diagnosed with colon cancer annually, and about 41,000 new cases of
rectal cancer are diagnosed each year, according to the American
Cancer Society.
[0006] Colon cancer incidence is not much different between males
and females, however colon cancer is slightly more prevalent in
women compared to men (ratio of 1.2:1). Rectal cancer is more
common in males (ratio of 1.7:1). Colon cancer is more common among
elderly persons compared to younger persons. The risk of developing
colon cancer begins to increase from the age of 40 and goes up with
every passing year. The median age of presentation of colon cancer
varies according to the country. In the United States the median
age at presentation is 72 years. Colon cancer is more common in
African Americans compared to the Caucasian population in the
United States. The incidence of colon cancer has been on the
increase in African Americans since 1973 and the incidence in this
ethnic group has gone up by about 30 percent during the last 3
decades. Incidence of colorectal cancer varies widely from country
to country. Countries which are more industrialized like the United
States, Canada, UK, Western Europe, and Australia, have a much
higher incidence of colorectal cancer compared to less
industrialized parts of the world, like Asia, Africa, and South
America.
[0007] Most cases of colon cancer begin as small, noncancerous
(benign) clumps of cells called adenomatous polyps. Over time some
of these polyps become colon cancers. Polyps may be small and
produce few, if any, symptoms. Regular screening tests can help
prevent colon cancer by identifying polyps before they become
cancerous. If signs and symptoms of colon cancer do appear, they
may include changes in bowel habits, blood in the stool, persistent
cramping, gas or abdominal pain. In that event, contemporary
medical practice is that the patient undergo colonoscopic
examination.
[0008] An "endoscopy" is a minimally invasive diagnostic medical
procedure that is used to assess the interior surfaces of an organ
by inserting a tube into the body. The instrument may have a rigid
or flexible tube, and it not only provides an image for visual
inspection and photography, but it also enables taking biopsies and
retrieval of foreign objects.
[0009] A "colonoscopy" is a type of endoscopic examination of the
large colon and the distal part of the small bowel using a CCD
camera or a fiber optic camera on a flexible tube passed through
the anus. It may provide a visual diagnosis (e.g. ulceration,
polyps) and grants the opportunity for biopsy or removal of
suspected lesions. A "sigmoidoscopy" is a type of colonoscopy that
is the minimally invasive medical examination of the large
intestine from the rectum through the last part of the colon.
[0010] A colonoscopy enables a physician to examine the interior of
the entire large intestine, from the lowest part, the rectum, all
the way up through the colon to the lower end of the small
intestine. The procedure is used to diagnose the causes of
unexplained changes in bowel habits. It is also used to look for
early signs of cancer in the colon and rectum. Colonoscopy enables
the physician to see inflamed tissue, abnormal growths, ulcers,
bleeding, and muscle spasms. If anything unusual is in a colon,
like a polyp or inflamed tissue, is found, the physician can remove
a piece of it using tiny instruments passed through the scope, and
then send it for a biopsy examination.
[0011] In preparing to undergo a colonoscopic examination, the
colon must be free of solid matter for the test to be performed
properly. Generally speaking, for one to three days, the patient is
required to follow a low fiber or clear fluid-only diet. Examples
of clear fluids are apple juice, bouillon, artificially flavored
lemon-lime soda or sports drink, and of course water. It is very
important that the patient remains hydrated.
[0012] Use of solutions to cleanse and irrigate (a.k.a. "bowel
preps") are well known in the prior art. U.S. Pat. No. 6,132,767
provides a history of colonic evacuants, their problems, and
various solutions that others have achieved. Currently, various
methods are employed to clear and cleanse the bowel in preparation
for the colonoscopy. Often, a liquid preparation designed to
stimulate bowel movements is given by mouth, which may cause
bloating. Other laxative preparations, such as castor oil, may also
be used. Additional approaches include special diets or the use of
enemas. There are three broad categories, based on pharmacological
mechanism of action, of bowel preparations commonly prescribed by
physicians: (1) isotonic salt solutions, (2) phosphate or magnesium
based solutions, and (3) polyethylene glycol (PEG) based preps.
[0013] Historically, bowel prep products required patients to
ingest isotonic saline. More recently, the day before the
colonoscopy, the patient is either given an osmotic laxative
preparation (such as Bisacodyl, phospho soda, sodium picosulfate,
or sodium phosphate and/or magnesium citrate) and large quantities
of fluid or whole bowel irrigation is performed using a solution of
polyethylene glycol (PEG) and electrolytes (e.g. GoLytely,
NuLytely). In addition, patients are advised to take additional
stool softeners and other medications to assist such as sennakot,
docusate sodium, and psyllium based products.
[0014] U.S. Pat. No. 6,688,497 teaches a method for preparing a pH
balanced saline solution and using the saline solution for rinsing
a nasal passage, but does not discuss combining with exercise or
treating the bowels. U.S. Pat. No. 5,077,048 discloses using a
sodium chloride solution for irrigating the bowels, but does not
discuss combining with exercise nor does it teach an isotonic
concentration. U.S. Pat. No. 7,332,184 discloses using a sodium
chloride solution for irrigating the colon, but does not discuss
combining with exercise not does it teach an isotonic
concentration.
[0015] Thus, while the prior art contains some patents that teach
the use of sodium chloride to irrigate body cavities, and
specifically the bowel and colon, none of these references teach
preparation techniques involving use of exercise or yoga in
combination with irrigation solutions to enhance bowel preparation
efficacy. Likewise, most of the references also do not indicate the
osmolarity or temperature of the specific disclosed solution.
[0016] Adequate colon preparation is essential for successful
visualization of the colon, and essential for the detection of
suspicious lesions. However, studies using large databases of
patients reveal that up to 23% of all colonoscopies have suboptimal
bowel preparation resulting in longer procedural times, poor
intubation rates, and decreased polyp detection. Inadequate
preparation may lead to incomplete visualization of the colon,
resulting in shortened screening intervals due to concerns about
missed lesions.
[0017] In addition, the use of PEG based bowel preparations are
associated with the following adverse side effects: bloating;
nausea; rectal irritation; stomach fullness or cramps; vomiting,
and to a lesser extent, allergic reactions (e.g. rash, hives,
itching, etc.). Phosphate-based preparations are commonly
associated with bloating, nausea, abdominal pain, and vomiting, and
to a lesser extent, cardiac arrhythmias, seizures, and renal
failure.
[0018] Given these side-effects, coupled with the volume and taste
of the fluid in the preparations, patients often complain that
consuming the preparation is worse than undergoing the colonoscopy.
Thus, poor compliance with proper bowel cleansing is often a
significant issue with patients presenting for colonoscopy. In
fact, inadequate bowel preparation is one of the most common
reasons polyps are missed during colonoscopy. Lastly, another
restrictive requirement on all contemporary agents used to prepare
the bowel for colonoscopy is that those agents must be used or
performed on the night before the examination, or at least 12 to 24
hours before.
[0019] The medical and overall health benefits of exercise and
physical activity have been well documented. The merits of exercise
range from preventing chronic health conditions to boosting
confidence and self-esteem. Exercise is known to stimulate various
brain chemicals, lowers cholesterol and plaque build up in the
arteries, improves reuptake of sugar, reduces weight, and promotes
better sleep. More importantly, exercise is known to prevent the
occurrence and recurrence of colorectal cancer.
[0020] Yoga is a group of ancient spiritual practices originating
in India. In the medical context, yoga is a simple, non-athletic
set of movements and stretches that improve health. Shankha
prakshalana is a specific subgroup of Yoga which includes a process
to clean the intestinal tract by removing the impurities with salty
water and set of exercise positions. For example, the website
entitled Yoga Vidya Dham--Yoga Point teaches the performance of the
Shankha Prakshalana exercises, and discloses the use of a solution,
to clean and cleanse the alimentary tract. Similarly, the website
entitled Gandhi Gyan Mandir Yoga Kendra discloses the use of
Shankha Prakshalana technique along with a salt solution of 1%.
However, neither of those references disclose an isotonic
concentration, nor do they discuss the use of the solution and
technique for the specific purpose of preparing a patient for
colonoscopy, or that the outcome of the Shankha Prakshalana
techniques achieves the efficacy necessary for a colonoscopy.
Moreover, both websites state that the procedures should be done
under direct and strict supervision.
[0021] While there is no one uniform approach to Shankha
Prakshalana, the ingredients typically used in the solution are
limited to salt, water, and lemon juice. Given the simple and
natural characteristics of the ingredients, reports of severe
adverse reactions in performing Shankha Prakshalana are uncommon.
However, nausea, dizziness, bloating, diaphoresis, salt and water
retention, general body edema, have been associated with Shankha
Prakshalana. Moreover, patients who suffer from hypertension, salt
sensitiveness, arthritis, and who are pregnant are contraindicated
from performing Shankha Prakshalana.
[0022] Given the compliance problems noted above and the need for
effective and safe alterative to existing bowel preparation
techniques, a better patient preparation method is needed, and one
that involves irrigating, clearing and/or cleansing the colon of a
patient to such a degree that the patient is available to undergo
successful colonoscopy, and one that utilizes natural ingredients
and that has a minimal adverse reaction profile, so as to encourage
compliance among patients. Lastly, what is needed is an inexpensive
and relatively fast method to achieve the cleansing and clearing
such that the colonoscopy procedure could be performed on the same
day as the preparation procedure.
SUMMARY AND OBJECTS OF THE INVENTION
[0023] Accordingly, it is a principal object of the present
invention to provide a method for cleansing and clearing a
patient's bowel.
[0024] It is another object of the present invention to provide a
method that accomplished the cleansing and clearing of a patient's
bowel so as to render the patient prepared and suited to undergo
colonoscopy by endoscope within 24 hours of performing the method.
In particular, an average patient, not suffering from constipation,
may achieve the requisite cleansing and clearing within 2 to 3
hours, if that patient eats only a light meal the night before
examination, and wakes up about 5 AM on the day of the examination
and performs the claimed process, then bowel movements will begin
within 30 to 45 minutes of commencing process. Hence, it is another
an object of the present invention to provide a same-day, faster
alternative to cleansing and clearing a colon in preparation for
colonoscopy compared to the current agents in the prior art.
[0025] It is still another object of the present invention to
provide a method that cleanses and clears a patient's bowels and
prepares it for colonoscopy that utilizes alternative, natural
ingredients without precipitating the side effects typically
associated with conventional prescription and non-prescription
commercially available bowel preparation medical kits.
[0026] It is another object of the present invention to conduct
examinations of a patient's bowel after the patient has completed
the sequence of steps of administering a salt solution followed by
prescribed exercises according to the present invention.
[0027] It is another object of the present invention to provide a
novel approach to preparing the bowel for colonoscopy, which is
relatively quick in that it may be performed on the day of and just
a few hours prior to the exam, and which is relatively inexpensive
as it uses commonly available products.
[0028] Briefly described, those and other objects and features of
the present invention are accomplished, as embodied and fully
described herein, by a method of preparing a patient's colon for a
colonoscopic examination by endoscope or other means, which
involves administering to said patient a treatment regimen, the
treatment regiment including an oral cleansing solution and a
sequential series of exercises. In particular, the treatment
regimen includes administering to the patient a first predetermined
quantity of a salt solution at a first predetermined time period;
and performing by the patient a first exercise at a second
predetermined time period that is different than the first time
period, wherein the administering and performing steps are
intending to effectively prepare a colon of the patient to undergo
the colonoscopic examination. The method further includes the step
of performing the colonoscopic examination of the patient within
about 24 hours of the first and second time periods. Preferably,
the solution contains a concentration made from 15 to 20 grams of
sodium chloride per 2 liters of water, and most preferably the
solution contains from 18 grams of sodium chloride per 2 liters of
water. The solution should be maintained at about 40 C.
[0029] The objects and features of the present invention are also
accomplished, as embodied and fully described herein, by a kit for
colonic cleansing prior to colonoscopic examination, which contains
a package, such as a satchet, comprising sodium chloride and a
flavorant for mixing with a diluent; and an instruction device, the
instruction device containing instructions for performing a
sequential series of exercises. The instruction device may be a
computer-readable medium device containing instructions thereon for
displaying images and audio on a computing device for the patient
to view and follow in order to perform the steps in the correct
sequence.
[0030] With those and other objects, features, and advantages of
the invention that may become hereinafter apparent, the nature of
the invention may be more clearly understood by reference to the
following detailed description of the invention, the appended
claims, and to the several drawings attached herein.
BRIEF DESCRIPTION OF THE DRAWINGS
[0031] Many aspects of the invention can be better understood with
reference to the following drawings.
[0032] FIGS. 1-1, 1-2, and 1-3 show a flow diagram illustrating the
method of the present invention;
[0033] FIGS. 1a through 1c are perspective view drawings of a
patient following a first series of instructions of a first set of
exercises according to the present invention;
[0034] FIGS. 2a through 2c is perspective view drawings of a
patient following a second series of instructions of a second set
of exercises according to the present invention;
[0035] FIGS. 3a through 3c are perspective view drawings of a
patient following a third series of instructions of a third set of
exercises according to the present invention;
[0036] FIGS. 4a through 4c are perspective view drawings of a
patient following a fourth series of instructions of a fourth set
of exercises according to the present invention;
[0037] FIGS. 5a through 5c are perspective view drawings of a
patient following a fifth series of instructions of a fifth set of
exercises according to the present invention; and
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0038] Although preferred embodiments of the invention are
described for illustrative purposes, it should be understood that
the invention may be embodied in other forms not specifically shown
in the drawings. In particular, only a few of the instructional
positions, maneuvers, and exercises according to the present
invention are shown for illustrative purposes. Without limiting the
invention, the terms positions, maneuvers, and exercises are used
interchangeably, although each term also is used according to its
ordinary meaning. The invention is not limited to the specific
instruction discussed herein, but may also involve other positions,
both yoga-based and non-yoga, that is effective in facilitating
movement of fluid and solid matter along the digestive tract,
ultimately leading to an induced defecation.
[0039] The present invention may be used for the examination of a
bowel of a patient in need of such examination, which could be
prescribed based on a patient exhibiting signs and symptoms
associated with gastroparesis, gastroesophageal reflux disease,
intestinal pseudo obstruction, or constipation, among other
diseases, disorders, and conditions. The present invention may be
used in connection with a treatment regimen for such things as
gastrointestinal motility disorders, cyclical vomiting syndrome,
obesity, improve digestion and general well-being by
detoxification, irritable bowel syndrome, gas and bloating, and
allergies.
[0040] Referring to the flow chart in FIGS. 1-1, 1-2 and 1-3, a
patient 102 is prescribed a colonoscopy for examination of his/her
bowel. According to the present invention, the patient 102 receives
or is provided an orally administrable solution (step 94). The
solution should preferably have a concentration of 0.9% w/v (i.e. 9
gm/l; although a solution made from 15 to 20 g/l is also
acceptable), and preferably should have a temperature of about 40
degrees C. A commercially available premixed normal saline solution
suitable for consumption may be used, or the patient 102 may
prepare the solution. The solution is preferably made from purified
water, but tap water, spring water, and well water are also
acceptable. The primary ingredient added to the water is sodium
chloride, in any edible form. This includes table salt, iodized
salt, edible rock salt, sea salt, and any other edible sodium
chloride salt. One to five milliliters of lemon or lime juice may
be added as flavor to the solution. Other flavorings may be added,
including actual or synthetic flavorings of apple, pineapple,
pomegranate, and many others, either alone or in combination with
each other, to the specific preferred taste of the patient being
administered the solution."
[0041] A pre-measured quantity of salt may also be provided to the
patient 102 in the form of a kit (step 96). The kit will contain
one or more packages, such as sachets, pouches, blister packs,
etc., containing the salt with or without the flavorant, each of
which is dissolvable in a diluent, preferably water. The kit
further includes an instruction, which may be in the form of
written instructions on paper or an electronic storage device, such
as digital video disk (DVD) for use with a computing device. The
electronic storage device includes instructions for the computing
device to display images and audio to the patient 102 representing
the steps of performing the method of the present invention.
[0042] Two to 3 or even 4 liters of the solution may be needed to
perform the present invention for a typical patient. Generally
speaking, the average patient 102 can perform the invention and
achieve a clear bowel movement with about 2 liters of the solution.
Eighteen grams of sodium chloride should be completely dissolved in
2 liters of water. The mixing and dissolution of the sodium
chloride may occur after the water is heated, or the saline mixture
may be heated after the fact. Either way, it is preferable that the
fully dissolved solution be heated to approximately 40 degrees C.
at the time of practicing the invention, or at least initially when
the solution is prepared.
[0043] Beginning at approximately 8 hours prior to practicing the
invention, no solid or semi-solid substance should be consumed.
Generally, between 5 and 8 hours prior to performing the invention,
the patient 102 may drink at least 64 fl. oz. of clear liquids, but
this is not a requirement. Examples of "clear liquids" include, but
are not limited to, water, apple juice, white grape juice,
Gatorade.RTM., broth, hard candies, gelatin, and tea. And just
prior to beginning practice of the invention, the patient 102
should prepare by relaxing, turning off all phones, beepers, and
other communication devices for 3 to 4 hours prospectively. They
should also remove all undergarments and wear only loosely fitting,
comfortable clothing, making sure that the pants have an elastic
waistband. The environment for practicing the invention should be
quite and have a hard surface, and be near an available dedicated
bathroom.
[0044] Once the solution has been prepared as described, or after a
previously prepared solution is provided, the patient 102 is
provided with an instruction to administer a portion of the
solution and perform the steps of the invention in the manner
described below. The patient 102 begins by drinking two 8 fl. oz.
glasses of the prepared salt solution; emphasis on "drinking"
continuously rather than "sipping" (step 98). While drinking two 8
fl. oz. glasses is ideal, drinking a lesser amount is also
sufficient, depending on several factors, including the body mass
of the patient 102, age, previous consumption of foods, medical
conditions, and others. Moreover, while the patient 102 may consume
the entire amount all at once, the patient 102 may also drink in
increments, for example every 2 minutes, and/or between exercise
instructions as described below.
[0045] Turning now to FIG. 1a, shown therein is a perspective view
drawing of a patient 102 following a first exercise instruction 104
in the first set of exercises according to the present invention
(step 100). In FIG. 1a, a patient 102 undergoing preparation for
examination or treatment is instructed to begin in the "ready"
position by standing erect with both feet together and both hands
placed on top of the head with the palms facing up and the fingers
of each hand interlocked with each other (step 104).
[0046] Turning now to FIG. 1b, shown therein is a perspective view
drawing of a patient 102 following a second exercise instruction
(step 106) in the first set of exercises according to the present
invention. In FIG. 1b, the patient 102 is instructed to inhale
while stretching the arms upward as much as possible from the
position depicted in FIG. 1a and to stand on the toes of both
feet.
[0047] Turning now to FIG. 1c, shown therein is a perspective view
drawing of a patient 102 following a third exercise instruction
(step 108) in the first set of exercises according to the present
invention. In FIG. 1c, the patient 102 is instructed to exhale
while returning to the "ready" position depicted in FIG. 1a. The
three exercises depicted in FIGS. 1a through 1c represent the first
set of exercises in the present invention and may be repeated
several times, but preferably no more than about 10 times, before
moving onto the second set of exercises.
[0048] Turning now to FIG. 2a, shown therein is a perspective view
drawing of a patient 102 following a first exercise instruction
(step 110) in the second set of exercises according to the present
invention. In FIG. 2a, the patient 102 is instructed to begin in
the "ready" position by standing with the feet apart by about 1 to
2 feet, and the arms should be stretched straight upward with the
palms facing up and both hands interlocked at the fingers.
[0049] Turning now to FIG. 2b, shown therein is a perspective view
drawing of a patient 102 following a second exercise instruction
(step 112) in the second set of exercises according to the present
invention. In FIG. 2b, the patient 102 is instructed to inhale
while bending at the waist to the right to an extent where the
upper body forms an almost 90 degree angle with the right leg at
the hip. The patient 102 is further instructed to maintain the
outward stretched position of both arms while bending. Following
this, the patient 102 is instructed to exhale while returning to
the ready position (step 110) as depicted in FIG. 2a.
[0050] Turning now to FIG. 2c, shown therein is a perspective view
drawing of a patient 102 following a third exercise instruction
(step 113) in the second set of exercises according to the present
invention. In FIG. 2c, the patient 102 is instructed to inhale
while bending at the waist in a similar fashion as that depicted in
FIG. 2b, except to the completely opposite, left side to an extent
where the upper body forms an almost 90 degree angle with the left
leg at the hip. The patient 102 is further instructed to maintain
the outward stretched position of both arms while bending. The
three exercises depicted in FIGS. 2a through 2c represent the
second set of exercises in the present invention and may be
repeated several times, but preferably no more than about 5 times,
before moving onto the third set of exercises.
[0051] Upon completing the second set of exercise, the patient 102
is instructed to drink 2-eight oz. glasses of the prepared salt
solution; emphasis on "drinking" continuously rather than "sipping"
(step 115). As noted above, while drinking two 8 fl. oz. glasses is
ideal, drinking a lesser amount is also sufficient. Moreover, as
also mentioned above, while the patient 102 may consume the entire
amount in one motion, the patient 102 may also drink in increments,
for example every 2 minutes, between exercise instructions as
described below.
[0052] Turning now to FIG. 3a, shown therein is a perspective view
drawing of a patient 102 following a first exercise instruction
(step 116) in the third set of exercises according to the present
invention. In FIG. 3a, the patient 102 is instructed to begin in
the "ready" position by standing with the feet apart by 1 to 2 feet
and the arms stretched outward at the shoulder level, perpendicular
to the body and parallel to the floor, and having the palms facing
down.
[0053] Turning now to FIG. 3b, shown therein is a perspective view
drawing of a patient 102 following a second exercise instruction
(step 118) in the third set of exercises according to the present
invention. In FIG. 3b, the patient 102 is instructed to inhale
while placing left hand on right shoulder with palm facing down,
and right hand on left waist with palm facing out, and rotate and
twist upper body towards the right so as to be able to see heel of
the left foot. Following this, the patient 102 is further
instructed to exhale and return to the ready position (step 119) as
depicted in FIG. 3a.
[0054] Turning now to FIG. 3c, shown therein is a perspective view
drawing of a patient 102 following a third exercise instruction
(step 120) in the third set of exercises according to the present
invention. In FIG. 3c, the patient 102 is instructed to inhale
while placing right hand on left shoulder with palm facing down,
and left hand on right waist with palm facing out and rotate and
twist upper body towards the left so as to be able to see heel of
the right foot. The three exercises depicted in FIGS. 3a through 3c
represent the third set of exercises in the present invention and
may be repeated several times, but preferably no more than about 5
times, before moving onto the fourth set of exercises.
[0055] Turning now to FIG. 4a, shown therein is a perspective view
drawing of a patient 102 following a first exercise instruction
(step 122) in the fourth set of exercises according to the present
invention. In FIG. 4a, the patient 102 is instructed to begin in
the "ready" position by lying down flat on stomach with feet apart
and with both palms open and flat on the floor as if preparing to
perform a push-up.
[0056] Turning now to FIG. 4b, shown therein is a perspective view
drawing of a patient 102 following a second exercise instruction
(step 124) in the fourth set of exercises according to the present
invention. In FIG. 4b, the patient 102 is instructed to inhale
while twisting upper body toward the right turning the head to the
right until able to see the heels of both feet. Ideally, a patient
should twist up to a 90-degree angle, however a greater than or
less attempt would be sufficient. Following this, the patient 102
is further instructed to exhale while returning the body to the
ready position (step 125) as depicted in FIG.
[0057] Turning now to FIG. 4c, shown therein is a perspective view
drawing of a patient 102 following a third exercise instruction
(step 126) in the fourth set of exercises according to the present
invention. In FIG. 4c, the patient 102 is instructed to inhale
while twisting upper body towards the left turning the head to the
left until able to see the heels of both feet. The three exercises
depicted in FIGS. 4a through 4c represent the fourth set of
exercises in the present invention and may be repeated several
times, but preferably no more than about 5 times, before moving
onto the fifth set of exercises.
[0058] Upon completing the fourth set of exercise, the patient 102
is instructed to drink 2-eight oz. glasses of the prepared salt
solution; emphasis on "drinking" continuously rather than "sipping"
(step 127). Again, while drinking two 8 fl. oz. glasses is ideal,
drinking a lesser amount is also sufficient. Moreover, as noted
above, while the patient 102 may consume entire amount in one
motion, the patient 102 may also drink in increments, for example
every 2 minutes, between exercise instructions.
[0059] Turning now to FIG. 5a, shown therein is a perspective view
drawing of a patient 102 following a first exercise instruction
(step 128) in the fifth set of exercises according to the present
invention. In FIG. 5a, the patient 102 is instructed to begin in
the "ready" position by squatting down with feet apart and griping
with both hands just below the knees of each corresponding leg.
[0060] Turning now to FIG. 5b, shown therein is a perspective view
drawing of a patient 102 following a second exercise instruction
(step 130) in the fifth set of exercises according to the present
invention. In FIG. 5b, the patient 102 is instructed to inhale
while touching the right knee to the left toes. The patient 102 is
further instructed to exhale while returning to the ready position
(step 131) as depicted in FIG. 5a.
[0061] Turning now to FIG. 5c, shown therein is a perspective view
drawing of a patient 102 following a third exercise instruction
(step 132) in the fifth set of exercises according to the present
invention. In FIG. 5c, the patient 102 is instructed to inhale
while touching the left knee to the right toes. The three exercises
depicted in FIGS. 5a through 5c represent the fifth set of
exercises in the present invention and may be repeated several
times, but preferably no more than about 5 times.
[0062] The patient 102 is instructed, if at any point when
practicing the invention an urge to defecate arises, to proceed to
the toilet and commence passing the stool (step 140), but patient
102 should not strain. Although step 140 is shown at the end of the
last exercise, it may be performed at any time. After step 140, the
patient 102 should evaluate, with our without assistance from the
patient's healthcare provider, whether a clear, liquid bowel
movement has been achieved (step 142). The patient 102 is further
instructed to perform the above sequence of exercises as shown in
FIGS. 1a through 5c as necessary until a clear, liquid bowel
movement is achieved (step 143). New batches of lukewarm liquid
around 40 degrees C. may need to be prepared for each new cycle of
the exercise sequence, if necessary. Approximately 2 to 3 liters of
the solution and 2 to 3 repetitions of the complete sequence of
exercises shown in FIGS. 1a through 5c are expected for a typical
patient to complete the process sufficient to perform a colonoscopy
(step 146).
[0063] Following the performance of the steps as detailed above,
the patient 102 is instructed to not eat any solid or semi-solid
foods, and to limit consumption to water only until the completion
of the scheduled colonoscopy procedure for early the next morning
or shortly after completion of the exercises described above. No
consumption of substances 3 hours prior to colonoscopy is
recommended.
[0064] Once the above sequence of steps is performed, or at least a
portion of the steps are performed by a patient 102 following the
instructions provided, the patient 102 is further prepared for the
actual colonoscopy examination according to and following well
known clinical or hospital procedures, including those involving
anesthesiology, patient monitoring, and the actual examination
itself (step 146).
[0065] The efficacy and safety of the present invention was
investigated in 42 patients between the ages of 18 and 65 in a
clinical study. The patient population was split into two groups:
Group A was the study group, which consisted of 21 individuals who
practiced the invention, and Group B was the control group, which
consisted of 21 individuals who drank Nulytely.RTM., a prescription
bowel preparation product. All patients were scheduled to undergo
colonoscopy the following day, but Group A had colonoscopies on the
same day. Group A patients were asked to perform a defined set of
light yoga exercises according to the methods described herein,
alternating with drinking lukewarm salt water (40 C) prepared by
dissolving eighteen (18) grams of sodium chloride (NaCl) in two (2)
liters of water. Patients in Group B drank Nulytely as per the
manufacturer's instructions and then presented for colonoscopy the
next day.
[0066] Subsequently, the colonoscopies were performed on the
patient population by a single gastroenterologist. The individual
patient colonoscopy preparation was rated on a four point grading
scale: poor prep (value 1), sub-optimum (value 2), optimum (value
3), and excellent (value 4). The results revealed that 14 out of
the 21 patients in Group A, and 10 out of the 21 patients in Group
B, achieved excellent preparation. Four out of the 21 patients in
Group A, and 9 out of the 21 patients in Group B, achieved optimum
preparation. One patient out of each group achieved sub-optimum
preparation. Two patients in Group A, and 1 patient in Group B,
achieved poor preparation.
[0067] Upon statistical analysis, the grading score means were
found to be 3.43 and 3.34 in Groups A and B, respectively. These
findings, however, were not statistically significant (p-value
>0.05). The results showed that the group using the preparation
technique disclosed in the present invention demonstrated a slight
statistically non-significant improvement over NuLytely, thus
suggesting the two groups to be equal in efficacy. However, the
present preparation method demonstrated a statistically significant
(p-value <0.05) superiority over the national colonoscopic
success rates, which is at 85%. The statistical test used was the
"t test." The study investigators found that using a lukewarm
saline solution and combining it with an exercise routine as
described herein is a safe, simple, and cost effective method for
achieving proper bowel preparation to undergo a colonoscopy
examination by endoscope.
[0068] Although certain presently preferred embodiments of the
disclosed invention have been specifically described herein, it
will be apparent to those skilled in the art to which the invention
pertains that variations and modifications of the various
embodiments shown and described herein may be made without
departing from the spirit and scope of the invention. For example,
other bending and twisting maneuvers or exercises similar to those
described above and shown in the drawings may be used successfully
in cleansing the bowel. Likewise, exercises not similar to those
described above, such as walking on a treadmill at a steady speed
of at least about 5 mph, or brisk walking, and use of step stool
exercises, also are believed to provide successful outcomes in
cleansing the bowel. The specific sequence of the exercises is
important but not critical to the efficacy of the technique for
purposes of colonoscopy and/or treatment. Accordingly, it is
intended that the invention be limited only to the extent required
by the appended claims, prior art, and applicable rules of law.
* * * * *