U.S. patent application number 12/757841 was filed with the patent office on 2010-08-05 for device and method for reducing calorie intake.
This patent application is currently assigned to Paolo Costa. Invention is credited to Amir ALON, Benjamine ALSPECTOR, Abraham J. DOMB, Itzhak KATZ.
Application Number | 20100196470 12/757841 |
Document ID | / |
Family ID | 39303327 |
Filed Date | 2010-08-05 |
United States Patent
Application |
20100196470 |
Kind Code |
A1 |
ALON; Amir ; et al. |
August 5, 2010 |
DEVICE AND METHOD FOR REDUCING CALORIE INTAKE
Abstract
Devices and methods for substantially reducing the caloric
efficiency of the digestive tract by capturing food being digested
in the stomach 10 and/or anywhere else in the gastrointestinal (GI)
tract, absorbing or encapsulating the captured food into multiple
capturing members and moving such multiple capturing members
containing the ingestible encapsulated food down the GI tract,
practically out of reach of the GI absorption organs, thus
excluding the entrapped ingredients from being involved in the
digestion and\or absorption process. The device is designed for
oral delivery. The system can be comprised of liquid, food bars or
a capsule system. The capsule system is comprised of an external
capsule that dissolves in accordance with a temporal or ph
dependent preset, which allows the food intake to be at least
partially fluidic. The capsule system is further comprised of a
mechanism designed to capture and isolate a portion of the food
being digested.
Inventors: |
ALON; Amir; (Hod Hasharon,
IL) ; KATZ; Itzhak; (Petach Tikva, IL) ;
ALSPECTOR; Benjamine; (Mevaseret, IL) ; DOMB; Abraham
J.; (Efrat, IL) |
Correspondence
Address: |
LEVINE BAGADE HAN LLP
2400 GENG ROAD, SUITE 120
PALO ALTO
CA
94303
US
|
Assignee: |
Costa; Paolo
Tiburon
CA
|
Family ID: |
39303327 |
Appl. No.: |
12/757841 |
Filed: |
April 9, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11581175 |
Oct 16, 2006 |
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12757841 |
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PCT/IL2005/000154 |
Feb 8, 2005 |
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11581175 |
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60542843 |
Feb 10, 2004 |
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Current U.S.
Class: |
424/463 ;
128/897 |
Current CPC
Class: |
A61K 9/4808 20130101;
A61K 9/48 20130101 |
Class at
Publication: |
424/463 ;
128/897 |
International
Class: |
A61K 9/48 20060101
A61K009/48 |
Claims
1. A method of malabsorption of food in the GI tract comprising:
containing a volume of chyme within a closed volume, the closed
volume defined by a barrier; placing the barrier between the chyme
and the wall of the GI tract; and moving the barrier with the
closed volume of chyme through the GI tract.
2. The method of claim 1, wherein the barrier comprises a first
partial sphere and a second partial sphere.
3. The method of claim 1, further comprising closing the
barrier,
4. The method of claim 3, wherein the closing comprises closing
with a spring-like element configured to close the barrier.
5. The method of claim 1, wherein moving the barrier comprises
moving the barrier out of the GI tract.
6. The method of claim 1, further comprising sucking the volume of
chyme into the closed volume.
7. A device for containing a volume within the digestive tract
comprising: a first structural element, wherein the first element
has a contracted configuration and an expanded configuration; a
second element wherein the second element has a contracted
configuration and an expanded configuration; and a cover over the
first element and the second element.
8. The device of claim 7, wherein the second element is separate
from the first element.
9. The device of claim 7, wherein the first element is
substantially similar in shape to the second element.
10. The device of claim 7, wherein the first element is
substantially similar in size to the second element.
11. The device of claim 7, wherein the first element and the second
element have contracted and expanded configurations, and wherein in
the expanded configurations the first element and the second
element each have a contained inner volume.
12. The device of claim 7, wherein the cover comprises a
capsule.
13. The device of claim 7, wherein the cover comprises a
coating.
14. The device of claim 7, wherein the cover is dissolvable.
15. The device of claim 7, wherein the first element is spherical
in the expanded configuration.
16. A method for reducing the caloric efficiency of the digestive
tract, comprising: containing and retaining caloric content in the
digestive tract with an element; and dissolving the element within
days in the GI tract.
17. The method of claim 16, further comprising closing the element
until the element is dissolved.
18. The method of claim 16, wherein the element has a closed
configuration, and wherein the closed configuration
19. The method of claim 16, wherein the element has an opened and a
closed configuration, and wherein containing further comprises
closing the element when the element is in the GI tract.
20. The method of claim 16, further comprising exposing the element
to an ingestible liquid when the element is in the GI tract, and
wherein the ingestible liquid is configured to dissolve the element
in the GI tract when the element comes into contact with the
ingestible liquid.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This present application is a continuation of U.S. patent
application Ser. No. 11/581,175, which claims the benefit of PCT
application no. PCT/IL05/00154 filed on Feb. 8, 2005, which claims
the benefit of U.S. provisional application No. 60/542,843 filed on
Feb. 10, 2004 all of which are incorporated herein by reference in
their entireties.
FIELD OF THE INVENTION
[0002] The present invention relates in general to a device and
method for substantially reducing the caloric efficiency of the
digestive tract by capturing food being digested in the stomach
and/or anywhere else in the GI tract, into entrapping members;
moving the entrapping member containing said food down the GI
tract, thus excluding at least part of the food intake from being
absorbed in the small intestine and further down the GI tract.
BACKGROUND OF THE INVENTION
[0003] Obesity is a chronic disease due to excess fat storage, a
genetic predisposition, and strong environmental contributions.
This problem is worldwide, and the incidence is increasing daily.
There are medical, physical, social, economic, and psychological
comorbid conditions associated with obesity. There is no cure for
obesity except possibly prevention. Non-surgical treatment has been
inadequate in providing sustained weight loss. Currently, surgery
offers the only viable treatment option with long-term weight loss
and maintenance for the morbidly obese. Surgeries for weight loss
are called bariatric surgeries. There is no one operation that is
effective for all patients. Gastric bypass operations are the most
common operations currently used. Because there are inherent
complications from surgeries, bariatric surgeries should be
performed in a multidisciplinary setting. The laparoscopic approach
is being used by some surgeons in performing the various
operations. The success rate--usually defined as >50% excess
weight loss that is maintained for at least five years from
bariatric surgery--ranges from 40% in the simple to >70% in the
complex operations. The weight loss from surgical treatment results
in significant improvements and, in some cases, complete resolution
of comorbid conditions associated with obesity. Patients undergoing
surgery for obesity need lifelong nutritional supplements and
medical monitoring.
[0004] It is accepted that patients suffering from obesity are at a
substantially increased risk of medical ailments and a range of
diseases, including: Type II diabetes, heart disease, stroke, high
blood pressure, high cholesterol, certain cancers, and other
disorders. Furthermore, patients suffering morbid obesity have life
expectancy that is significantly reduced, by at least ten to
fifteen years.
[0005] For patients suffering from extremely severe obesity (morbid
obesity), i.e. for patients whose weight exceeds the ideal weight
by at least 50 kilograms, for example, it is absolutely essential
to operate surgically on such patients in order to avoid not only a
series of health problems that stem from such obesity, but also to
avoid certain and imminent death of such patients.
[0006] It has also been observed that treatment based on a severe
diet combined with a series of physical exercises associated with a
change in behavior, in particular eating behavior, are relatively
ineffective in such cases of morbid obesity, even though such
methods of treatment are the most healthy.
[0007] Methods that have been used in the prior art to treat
obesity include gastric bypasses and small-bowel bypasses such as
described in U.S. Pat. No. 6,558,400 and U.S. Pat. No. 6,543,456.
The number of these bariatric surgeries has skyrocketed from 40,000
per year back then to 120,000 in 2002. Many complications are
associated with these procedures. Many patients have suffered
serious side effects and regret having had it.
[0008] Other methods aim at reducing the effective volume of the
stomach to induce a satiety feeling by the patient and hence
reducing the calorie intake per meal.
[0009] One such method is the stapling of portions of the stomach
has also been used to treat obesity, such as described in U.S. Pat.
No. 5,345,949. This includes both vertical and horizontal stapling
and other variations trying to reduce the size of the stomach or
make a small stoma opening. Many problems have been associated with
the use of staples. First, staples are undependable; second, they
may cause perforations; and the pouch or stoma opening formed by
the staples becomes enlarged over time making the procedure
useless.
[0010] Another method that has been developed is the placement of
an inflatable bag or balloon into the stomach causing the recipient
to feel "full". Such a procedure has been described in the patent
to Garren et al U.S. Pat. No. 4,416,267. The balloon is inflated to
approximately 80% of the stomach volume and remains in the stomach
for a period of about three months or more. This procedure,
although simple, has resulted in intestinal blockage, gastric
ulcers, and even in one instance, death and fails to address the
problems of potentially deleterious contact with the gastric mucosa
which can result from leaving an inflated bag in the stomach for an
extended period of time. Moreover, it also failed to produce
significant weight loss for long periods of time.
[0011] Yet another method employs the placement of a band around a
portion of the stomach thereby compressing the stomach and creating
a stoma opening that is less than the normal interior diameter of
the stomach for restricting food intake into the lower digestive
portion of the stomach. Kuzmak et al in U.S. Pat have described
such a band. U.S. Pat. No. 4,592,339. It comprises a substantially
non-extensible belt-like strap, which constrictively encircles the
outside of the stomach thereby preventing the stoma opening from
expanding. Kuzmak et al also describe bands, which include a
balloon-like section that is expandable and deflatable through a
remote injection site. The balloon-like expandable section is used
to adjust the size of the stoma opening both intra-operatively and
post-operatively.
[0012] Complications have been observed with both inflatable and
non-inflatable gastric bands. In particular, obstruction of the
stoma from edema and migration of the band has been observed. Such
edema-caused obstruction of the stoma may be due to excessive
vomiting. In these cases, the stoma must be enlarged either by
deflating the expandable portion of a band or by removing the band
altogether.
[0013] Yet another method is to impose satiety. U.S. Pat. No.
6,677,318, describing a swellable sponge-like structure. These
structures are swallowed by the patient being collapsed inside a
capsule. The capsule dissolves in the stomach and the polymer
structure with super absorbing characteristics; absorb the gastric
juices, which cause the structure to swell considerably. This
patent aims to reduce food intake by causing the recipient to feel
"full", yet the absorbed content of the sponge is finally
digested.
[0014] Lipase inhibition as a mean for reducing lipid intake is
well known in the art, the major draw back is the oily stool as a
side effect. To overcome this side effect, polymers capable of
absorbing lipids where introduce, as in U.S. Pat. No. 4,432,968,
but as the absorption is reversible and shifted backwards as a
result of bile salt emulsifier, the overall entrapment was quite
poor.
[0015] In order to overcome the a forth mentioned drawbacks, the
present invention relates on a lipid absorption polymer having an
prolonged equilibrium period in the range of 4-8 hours so as to
keep the absorption step active during the relevant period in the
digestion tract.
[0016] It is then the object of this invention to overcome these
and other deficiencies described above.
SUMMARY OF THE INVENTION
[0017] The invention seeks to provide a successful and non-invasive
alternative to existing approaches for controlling obesity.
[0018] The invention objective is to substantially reduce the
caloric efficiency of the digestive tract by capturing food being
digested in the stomach and/or anywhere else in the GI tract into
entrapping members; moving the entrapping member containing the
entrapped food ingredients down the gastrointestinal tract, thus
excluding at least part of the entrapped food from being absorbed
in the small intestine.
[0019] Another objective of this invention is to introduce a lipid
absorption polymer having an prolonged equilibrium period in the
range of 4-8 hours so as to keep the absorption step active during
the relevant period in the digestion tract.
[0020] Another objective of this invention is to interfere with the
micelles formation and capture the free lipids contained
within.
[0021] Another objective of this invention is to provide a delivery
system of the material via means of compressing the material so
that it takes less space in the intake, and when the capsule, for
example, opens up or dissolves, the individual particles of the
material expand to accommodate the captured liquids.
[0022] In one embodiment, the device is comprised of a capsule
system for oral delivery. The capsule system is comprised of an
external capsule made of gelatin--as an example that dissolves in
accordance with a temporal preset, which allows the food intake to
be at least partially fluidic. The capsule system is further
comprised of an internal permeable bag having a structure such as
meshed, woven or fibers, made of disintegrable material such as
gelatin for example, which bag contain expandable, super absorbent
beads, which dry beads are larger than the pores of the bag, which
bag is inflatable. When the bag comes in contact with the fluidic
content of the stomach, fluids penetrate into the bag. The fluids
are absorbed by the expandable, hydrogel beads enclosed. These
beads expand partially or until they reach the absorption capacity
limit. Optionally, the internal bag further contains a coating
capsule, which dissolves at this time and coats the expandable
beads, to seals and protects them from disintegration or prevent
leakage of entrapped liquid, throughout their journey out of the GI
tract.
[0023] For the sake of clarity, a capsule is a sealed container and
a bag is a permeable containers.
[0024] In other embodiments, the external capsule contains folded
mechanical structures, which open up to captures some of the
stomach content and protects them from disintegration throughout
their journey through and out of the GI tract.
[0025] Further scope of applicability of the present invention will
become apparent from the detailed description given hereinafter.
However, it should be understood that the detailed description and
specific examples, while indicating preferred embodiments of the
invention, are given by way of illustration only, since various
changes and modifications within the spirit and scope of the
invention will become apparent to those skilled in the art from
this detailed description.
BRIEF DESCRIPTION OF THE DRAWINGS
[0026] The present invention will become more fully understood from
the detailed description given herein below and the accompanying
drawings, which are given by way of illustration only and thus not
limitative of the present invention.
[0027] FIG. 1 is a view of the assembled device.
[0028] FIG. 2a is a view of the external capsule.
[0029] FIG. 2b is a view of the internal bag.
[0030] FIG. 2c is a view of an expandable bead.
[0031] FIG. 2d is a view of a coating capsule.
[0032] FIG. 3 illustrates a basic embodiment of this invention
depicting an outer capsule containing super absorbent expandable
beads.
[0033] FIG. 4a illustrates of the capsule system entering the
stomach at t1.
[0034] FIG. 4b illustrates the external capsule dissolving at
t2.
[0035] FIG. 4c illustrates the expandable beads expanding as they
absorb stomach fluids.
[0036] FIG. 4d illustrates the expandable beads reaching the size
limits of the internal bag at t4.
[0037] FIG. 4e illustrates the rupture of the coating capsule at
t4.
[0038] FIG. 4f illustrates the internal capsule dissolving at
t5.
[0039] FIG. 4g and FIG. 3h illustrate the draining stage of the
coated at t6.
[0040] FIG. 5 is a temporal illustration of a full cycle of the
process.
[0041] FIGS. 6a-d illustrates another embodiment of the
invention.
[0042] FIGS. 7a-c illustrates another embodiment of the
invention.
[0043] FIGS. 8a-c illustrates yet another embodiment of the
invention.
[0044] FIG. 9 illustrates an embodiment for loading the force into
the small structures.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0045] Before explaining embodiments of the invention in detail, it
is to be understood that the invention is not limited in its
application to the details of construction and the arrangement of
the components set forth in the following description or
illustrated in the drawings.
[0046] Unless otherwise defined, all technical and scientific terms
used herein have the same meaning as commonly understood by one of
ordinary skill in the art to which this invention belongs. The
materials, methods, and examples provided herein are illustrative
only and not intended to be limiting.
[0047] In accordance with one basic embodiment of the present
invention, illustrated in FIG. 3, the device is in a form of a pill
comprises an outer capsule 200 made of Gelatin for example, which
capsule 200 is at least partly filled with cross-linked polymer
beads, such as Hydrogels, supper absorbent polymers, cross-linked
polymers, known in the art, which beads having a diameter in the
range of microns to few mm and are made of non toxic and non
digestible polymer and are capable of absorbing fluids at a ratio
of at least 5:1 (W/W), (liquid\bead) by diffusion, osmotic force,
ionic interaction, and\or capillary force, and\or magnetic force,
or other physic-chemical mechanism, such as polyacryl amid
derivatives, which absorbing beads may also act as ion exchanger,
exclusion gel such as a cross-linked polydextran (or possibly
Cellulose Ethers like material), which beads optionally may also
contain functional groups that improves permeability when the
ambient is acidic (low pH--at the stomach), yet the permeability is
reduced when the ambient pH is neutral or basic (small
intestine).
[0048] In practice, the pill is ingested, and the capsule 100
dissolves at a temporal preset, beads 300 which are now in contact
with the content of the food being digested, absorbs caloric
enriched liquid and swells. Next the beads along with content of
the stomach 10 are moved into the small intestine, where the
entrapped content of the beads are practically not involved in the
digestion and absorbing steps in the intestine. It is plausible to
design the beads such that they will continue to absorb digested
food in the small intestine and further down the GI tract.
[0049] In another embodiment, similar to the first embodiment, the
beads are pre coated or pre absorbed by a composition capable of
forming at least a partial nutrient barrier on small intestine. The
composition helps further to reduce the absorption of food in case
of leaking from the bead.
[0050] FIG. 1 is a view of the assembled capsule system. It
comprises an external capsule 100 which can be made of a
biocompatible material such as gelatin, an internal bag 200 which
can be made from gelatin with a net like structure, absorbing beads
300 which can be made from Hydrogels and coating capsule(s)
400.
[0051] FIG. 2a illustrates the opened external capsule, which opens
into two halves 201 and 202 at time t2 (see FIG. 5). It cans also
dissolve with control thickness or any other known technique.
[0052] FIG. 4a illustrates the assembled capsule being swallowed by
the patient at time t1 (see FIG. 5) which is a while after he
started his meal at time t0 (see FIG. 5). FIG. 2b is a view of the
internal bag 200, FIG. 2c is a view of an expandable bead 301 and
FIG. 2d is a view of a coating capsule 400.
[0053] FIG. 4b illustrates the dissolution of the external capsule
in the stomach 10 at time t2. At this time the super absorbing
expandable beads 300 are exposed to the stomach 10 fluids and start
absorbing them, as illustrated in FIG. 4c and continue at time
period t3 (see FIG. 5).
[0054] Optionally, after the expandable beads 300 fill out the
space allowed by the internal bag 200, as illustrated in FIG. 4d,
they press against the coating capsule(s) 400. This triggers at
time t4 (see FIG. 5) the rupture, as illustrated in FIG. 4e, or
dissolution of the coating capsule(s) 400, which contains an agent
that coats and seals (see FIG. 40 all the expandable beads such
that they and their content remains untouched throughout their
migration down the GI tract.
[0055] Once all the expandable beads 300 are coated, at time t5
(see FIG. 5), the internal bag dissolves, all the expandable beads
are free to move about the GI tract, at time period t6 (see FIG.
5), and they are drained untouched through and out of the GI tract,
as illustrated in FIGS. 4g and 4h. The expandable beads 300
dissolve after a preset number of days, in case they were not able
to clear out of the GI tract. In another option, the patient drinks
a liquid that dissolves expandable beads 300.
[0056] Thus the content of the expandable beads 300 which contains
ingested food remains untouched, is not digested and absorbed by
the body and hence reduces the calorie efficiency of the meal.
[0057] In another embodiment of this invention, time t5 (see FIG.
5), when the internal bag 200 dissolves and the expandable beads
300 are free to move about the GI tract, occurs only after the fed
mode of the stomach 10 is finished, and the stomach 10 goes into
its maintenance mode.
[0058] I another embodiment (not shown) the fluids pass on their
way to the super absorbable beads through a filter which is wide on
the outer side and narrow in the inner side. This makes it easy for
the fluids the flow inward the beads and hard to flow back.
[0059] In yet another embodiment of this invention, a polymer
capable of absorbing lipid having an prolonged equilibrium period
in the range of 4-8 hours so as to keep the absorption step active
during the relevant period in the digestion tract, is provided. One
such polymer for example is Polypore, having high absorption ratio
of 13 gr lipid to 1 gr polymer.
[0060] Another embodiment of the present invention is to interfere
with the micelles which are necessary for the lipid digestion
activity. The purpose of the polymer is to disassemble the micelles
and extract the lipids. Such a polymer is, for example, isss
Gantrez.RTM. series, especially Gantrez 225 and Gantrez 425.
[0061] So when a mixture of Polypore and Gantrez are introduced to
the small intestine, the Gantrez will interfere with the micelle
formation equilibrium, and the polypore will absorb the free lipids
without the highly competitive back extraction mechanism.
[0062] Another embodiment of this invention is illustrated in FIGS.
6a-6d in this embodiment the inner bag is in the form of a folded
basket 202 which contains a stack of spheres 500 each of which is
split into to halves 501 and 502 which are connected by a spring
like connection 503 that the force embedded in it will close up the
spheres to the poison 504 in a relaxed mode. When the external
capsule 100 dissolves, the force embedded in the stacked up halve
spheres 500 will cause the optional basket 202 to open up
optionally locked into the position illustrated in FIG. 6d. This
allows the half spheres to close up to position 504 which scoops up
the food being digested while closing up. The sphere 504 is now
small enough to leave the basket 202 through the opening 203, being
pushed by the next pair of half spheres. The last pair of half
spheres in the stack may remain in the basket 202, which dissolves
after a preset time and clears out down the GI tract. The optional
basket 202 is designed to avoid the possibility that the closing
sphere will harm the stomach 10 inner walls. The spheres 500 are of
a size appropriate to be able to travel through the GI tract. The
closed spheres are made of a substantially ingestible biocompatible
material and remain closed and untouched through the journey down
and out of the GI tract. The spheres 500 dissolve after a preset
number of days, in case they were not able to clear out of the GI
tract. In another option, the patient drinks a liquid that
dissolves spheres 500.
[0063] Another embodiment of this invention is illustrated in FIGS.
7a-7c. In this embodiment, the capsule is filled up with number of
folded stent like structures 600. When the external capsule 100
dissolves, a force will cause the stents 600 to open up and lock
into the position illustrated in FIG. 7c. The force can be embedded
in the structures 600, apply via external or internal spring (not
shown) or generated internally or externally via chemical reaction
with the stomach 10 content. While stents 600 open up inside the
stomach 10 they will suck up some of the content into the stents.
The stents 600 are built such that they have entry holes 604
through which the content is sucked up. Optionally, entry holes 604
are equipped with a directional valve such that the stomach 10
content can only enter into the stents but can not escape. The size
of the opened stents 600 is designed to be able to travel through
the GI tract. The stents are made of a substantially ingestible
material and remain closed and untouched throughout their journey
down and out of the GI tract. The folded structures 601, 602, 603
can also be polymer beads and the force applied to them before
delivery to compress the beads substantially so that they open
inside the GI tract to capture various liquids. One such polymer,
for example, is Polypore, having high absorption ratio of 13 gr
lipid to 1 gr polymer and high ratio of its free form volume to its
compressed form volume.
[0064] In another embodiment the force (such as spring force or
elastic force) is being loaded into the small structures 700 before
using the capsule. FIG. 9 shows a device 800 for compressing the
small structures 700 and encapsulating them to form the pill to be
swallowed. Turning the handle 802 in direction 806 moves the bar
804 in direction 808. The capsule half 101 is pushed towards the
second half 102 and the small structures 700 are compressed. This
will overcome the possibility that the force will deteriorate over
time.
[0065] Another embodiment of this invention is illustrated in FIGS.
8a-8c. In this embodiment, the capsule is filled up with a number
of folded structures 700. When the external capsule 100 dissolves,
the force embedded within the structures will cause the structures
700 to open up into the position 702 illustrated in FIG. 8c. The
force can be embedded in the structures 700, in the manufacturing
process by taking a semi rigid structure and forcing it into a
collapsed form by applying pressure. The kinetic energy stored in
the structures 700 will be used to restore the structures into
their natural form once the capsule 100 has opened up. This force
is designed so that it can over come the pressure inside the
stomach 10. While structures 700 open up inside the stomach 10 they
will suck up some of the content into the structures 700. The
structures 700 are made up such that they have entry holes 703
through which the content is sucked up. Optionally, entry holes 703
are equipped with a directional valve such that the stomach 10
content can only enter into the structures 700 but cannot escape.
The size of the opened stents 700 is designed to be able to travel
through the GI tract. The full structures 700 are made of a
substantially ingestible material and remain closed and untouched
throughout the journey down and out of the GI tract.
[0066] In another embodiment the folded structures are polymer
beads and the force applied to them before delivery to compress the
beads substantially so that they take less space on the intake but
open inside the GI tract to capture various liquids. One such
polymer, for example, is Polypore, having high absorption ratio of
13 gr lipid to 1 gr polymer and high ratio of its free form volume
to its compressed form.
[0067] The invention being thus described in terms of several
examples and embodiments, it will be obvious that the same may be
varied in many ways. Such variations are not to be regarded as a
departure from the spirit and scope of the invention, and all such
modifications as would be obvious to one skilled in the art are
intended to be included within the scope of the following
claims.
* * * * *