Note: Descriptions are shown in the official language in which they were submitted.
CA 02622476 2008-03-13
SYSTEM, METHOD AND COMPOSITION FOR DIALYSIS AND SHOCK TREATMENT
This application is a division of Canadian Application Serial
Number 2,279,348, which is the national phase application of PCT
International Application PCT/US97/19768 filed 31 October 1997.
Background of the Invention
The present invention is directed to a dialysis system, method
and composition especially useful for removing toxic matter from
the serum of the large intestine, and to a system, method and
composition for shock treatment.
Summary of the Invention
It is an object of the present invention to replace normal
hemodialysis in the filtration of toxic substances in the serum.
It is another object of the present invention to provide a
dialysis system and method for a patient which will result in
substantially no blood loss during dialysis treatment.
It is yet another objection of the present invention to provide a
dialysis system and method which substantially eliminates the
risk of infection.
It is a further object of the present invention to provide a
dialysis system and method using components which are relatively
low in cost so that each patient should be able to afford his or
her own individual system, which will further allow for increased
time available for dialysis, therefore increasing treatment
proficiency, and also reduce or substantially eliminate the risk
of cross infection.
It is a yet further object of the present invention to provide a
dialysis system and method having components which are of simple
design and easy to use, thereby obviating the need for specially
trained medical technicians.
It is a yet further object of the present invention to provide a
system, method and composition for treating shock.
In accordance with the present invention, a dialysis system for
removing toxic matter from the serum of the large intestine is
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provided, comprising means for introducing a dialysis filtrate
solution to the large intestine of a patient at a first location,
said filtrate providing a vehicle for removing toxic matter from
the serum of the large intestine, said means for introducing
compr'ising a flexible input tube having a distal end for
insertion into the large intestine and having a first inflatable
balloon at the distal end of said input tube, means for removing
waste filtrate from the large intestine at a second location
spaced from the first location after the filtrate removes toxic
matter from the serum, said means for removing comprising a
flexible output tube having a distal end for insertion into the
large intestine and having a second inflatable balloon at the
distal end of said output tube, said first and second balloons
being spaced from each other for sealing off a portion of the
descending colon of the large intestine, a third inflatable
balloon between said first and second inflatable balloons, and
means for providing fluid to said first, second and third
inflatable balloons to thereby inflate said balloons, said means
for providing fluid being independent from said means for
introducing a dialysis filtrate solution.
The invention also provides a dialysis method for removing toxic
matter from the serum of the large intestine of a patient,
comprising the steps of introducing into the large intestine of
a patient a tube having a distal end with first and second
inflatable balloons spaced from each other at the distal end
thereof , and a third inf latable balloon between the f irst and
second inflatable balloons, inflating the first and second
inflatable balloons, to seal off a portion of the large intestine
of the patient, and the third inflatable balloon, introducing a
dialysis filtrate solution to the large intestine of the patient
from the third inflatable balloon at a first location adjacent
the first inflatable balloon independently after said inflating
step, said dialysis filtrate solution providing a vehicle for
removing toxic matter from the perum of the large intestine, and
removing waste filtrate from the large intestine through the
third inflatable balloon at a second location which is spaced
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from the first location and adjacent the second inflatable
balloon to remove toxic matter from the serum between the
first location and second location.
The invention also provides a system and method for treating
shock.
The invention also provides a filtrate composition for use in
dialysis, comprising a vasodilator, a high molecular weight
protein to effect osmotic pressure to achieve diffusion of
element across the large intestine membrane into the filtrate,
and mineral constituents for maintaining proper serum levels
in the large intestine.
The dialysis filtrate composition may comprise electrolyte
ingredients, buffers and a high molecular weight osmotic agent
for removing nitrogenous waste.
The invention also provides a system and method for treating
shock, which can be adapted from the same system and method
for dialysis. The composition for treating shock may comprise
electrolyte ingredients, buffers and a rehydrating agent.
In another aspect, the present invention provides use of the
system of the present invention for treating shock.
In another aspect, the present invention provides use of the
system of the present invention for removing toxic matter from
the serum of the large intestine of a patient.
In another aspect, the present invention provides a dialysis
system for removing toxic matter from the serumt of the large
intestine, comprising: input means for introducing a dialysis
filtrate solution to the large intestine of a patient at a
first location, said dialysis filtrate solution providing a
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vehicle for removing toxic matter from the serum of the large
intestine, said input means comprising: an input pump having a
pump input port and an output-port, a flexible input tube
having one end connected to the output port of the input pump
and having a distal end for insertion into the large
intestine, and a first inflatable balloon at the distal end of
said flexible input tube; means for removing waste dialysis
filtrate solution from the large intestine at a second
location spaced from the first location after the dialysis
filtrate solution removes toxic matter from the serum, said
means for removing comprising: a flexible output tube having a
distal end for insertion into the large intestine, and a
second inflatable balloon at the distal end of said flexible
output tube; a third inflatable balloon between said first and
second inflatable balloons; means for providing fluid to said
first, second and third inflatable balloons to thereby inflate
said balloons, said means for providing fluid being
independent from said means for introducing a dialysis
filtrate solution; and an input tank connected to an input
pump, said input tank containing dialysis filtrate solution
and having a float switch for de-energizing said input pump in
response to the dialysis filtrate solution level in the input
tank falling below a predetermined level.
Brief Description of the Drawing
Fig. 1 is a block diagram of a system according to the present
invention;
Fig. 2 is an elevational view of a balloon donut design for
the system according to the invention; and
Fig. 3 is an elevational view of a balloon donut design having
an inflatable central cylinder.
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Detailed Description of the Preferred Embodiment
As shown in Fig. 1, the dialysis system 10 according to the
present invention comprises an input pump 12 connected to an
input dialysis solution container 14.The input pump 12 has its
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output 16 connected in line with two pressure gauges, the first
one being a 75mm Hg pressure gauge 18 and the second one being
a 45mm Hg pressure gauge 20. To the out;put of input pump 12 is
connected a flexible plastic input tube 22 which is fed through
the sidewall of an output tube 24 also being made of flexible
plastic. The input and output tubes 22, 24 are concentric, with
the input tube having a distal end 26 about 14-22 inches longer
than the distal end 28 of the output tube 24. The differential
in the lengths of the two tubes will be determined according to
patient size, and of course may be outside of this range.
Adjacent the distal end 26 of the input tube are a plurality of
openings 29 for introducing the dialysis fluid into the large
intestine at a first location. The fluid is removed at a second
location as shown by the arrow at the distal end 28 of the output
tube 24.
Also shown in the Fig. 1 is an output suction pump 30 connected
to an output container 32. The output container 32 has a
capacity of about 8 liters and has a float switch 34 to detect
when the level of fluid in the output container 32 is greater
than about 105% of its capacity, i.e. about 8.4 liters. When the
float switch 34 detects that the fluid level exceeds 8.4 liters,
the output pump 30 is disabled or de-energized. This action
guards against the patient becoming dehydrated. However, if the
patient does become dehydrated, he or she may have to drink a
small quantity of water or juice to return to normal osmotic
balance.
The capacity of the input container 14 is also about S liters and
also has a float switch 36 disposed close to its bottom. When
the level of fluid in the input container 14 is less than a
predetermined level of perhaps 1 liter or less, the input pump
12 is disabled.
The 45mRa Hg pressure gauge 20 is connected to the output suction
pump 30 so that the output suction pump 30 is enabled or
energized when the input pressure is greater than about 45mm Hg.
CA 02622476 2008-03-13
Of course, the pressure may be different as determined by various
clinical trials. The input pump 12 is connected to the 75 mm Hg
pressure gauge 18, so that the input pump 12 is disabled when the
input pressure exceeds 75mm Hg. Of course, this value inay also
5 be changed depending upon clinical trials.
The pumps 12 and 30 may be operated by AC or DC power. If AC
electricity is not available because of power outage or other
reasons, a gravity and pressure valve arrangement may be
employed.
The length of the concentric tubes is on the order of 36-48
inches. Its outer dimension is about 5/8 inches and its inner
dimension is about 3/8 inches. The tubes may be made of flexible
plastic to allow for flexibility and ease of cleaning and
disinfecting. These may be available as either pre-sterilized
and disposable, or reusable after proper sterilization. The ends
of the tubes should preferably be rounded and free of sharp
angles so as not to perforate the bowel wall of the patient.
In cases where the ileo-cecal has been damaged through disease
or surgery, it may be necessary or desirable to incorporate
inflatable doughnut-shaped balloons 40, 42 at the end of the
tubes, as shown. The balloons are connected to an air line 44
embedded in the input tube, which air line 44 is connected to a
balloon pump 46, of conventional design, for inflating and
controlling the deflating of the balloons 40, 42.
A wire 48 encased in the input tube may also be provided which
carries a low voltage current, for controlling ion flow and
increasing osmotic effect of the filtrate solution. The wire 48
is connected to a DC voltage.source 50, which is grounded to the
patient by a skin electrode, for example.
Fig. 2 shows a balloon donut design having balloons 40, 42
particularly suited to limit movement from peristalsis, thereby
assuring the sealing off of a segment of the large intestine in
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an area suitable for rapid diffusion. The cellular make-up of
the approximately 25 cm of colon proximal to the rectum is
stratified, leaving no available diffusible surface area. The
balloon 42 is located preferably at least 25 cm from the rectum
and is formed of two spaced donut portions 42A and 42B. Each
donut portion is inflatable to a 150 mm maximum diameter. The
inner or middle portion 42C is inflatable to maximum diameter of
75 mm. The width of the inner portion 42C is about 20 mm, and
the width of the outer portions 42A, 42B are each about 10 mm,
these dimensions being exemplary and not limiting. Balloon 40
is similarly arranged. Leaving a 20 mm gap (between the portions
42A, 42B) in which the myenteric plexus will not be activated by
distention should eliminate/reduce peristalsis and thereby
maintain ideal position of the sealed off segment in an area
richly supplied with cells with great diffusion capability as
well as greatly expanded surface area.
Fig. 3 shows a balloon donut design similar to that of Fig. 2,
while also including an inflatable central balloon cylinder 52
disposed between donuts 40 and 42 and surrounding the input and
output tubes 22, 24. The inflatable cylinder 52 is, during
insertion and removal of the device, in a deflated condition like
the donuts 40 and 42. The cylinder is in fluid communication
with the donuts 40 and 42 through ports 54 and will thus inflate
and deflate with the donuts 40 and 42. Actually, during
inflation, donut 42 will inflate first, followed by cylinder 52,
and then donut 40. The cylinder 52 insures maximal interface of
the dialysate and the large intestine semi-permeable membrane 58
in the dialysis region 56 between the cylinder 52 and membrane
58. The dialysate will flow in the direction of the arrows
through openings 29 at the distal end 26 of the input tube 22,
through connecting input tubes 60 into the region 56, then
through connecting output tubes 62 to openings 28 into the output
tube 24.
The large intestine is a semi-permeable membrane allowing
transport or diffusion or water soluble elements. The purpose
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of the filtrate solution according to the invention is to provide
a vehicle in which undesirable elements or toxins may be removed
from the serum of the large intestine without affecting the basic
homeostatic mechanisms and iinportant mineral and pH balances.
The filtrate composition preferably consists of the following
components:
Table A
Sodium Chloride 120 mEq/liter
Potassium Gluconate 5.0 mEq/liter
Magnesium Citrate 2.4 mEq/liter
Calcium Lactate 18 mEq/liter
Ferrous Citrate 220 mg./liter
Zinc Citrate 205 mcg./liter
Vitamin C (Ascorbic Acid) 400 mg./liter
Lemon bioflavinoids 15 mg./liter
Rutin 15 mg./liter
Hesperidin 15 mg./liter
Acerola 15 mg./liter
Niacin 20 mg./liter
Casein (to achieve a filtrate osmolality of 450 mosm/kg)
Sodium Bicarbonate (min. of 40 mEq/liter) and Glucoronic Acid to
produce a highly buffered pH of about 7.38 pH.
The mineral constituents serve to maintain proper serum levels
of the associated minerals. Niacin is provided for its
vasodilator effect and the concomitant effect to increase blood
supply to the_area, thereby shorting time for serum filtration.
Casein is provided to introduce a high molecular weight protein
that is not available to transport through the membrane wall,
i.e. to effect the osmotic pressure that will achieve diffusion
of elements across the membrane into the filtrate. The filtrate
is in a water base and is buffered preferably to a pH of about
7.38. It should of course be understood that the concentration
values given may be adjusted or changed after clinical test. The
make up of the components may be modified to adjust to
individual, metabolic distortions or to sensitivities to the
components of the patient.
The present invention provides another embodiment of a dialysis
filtrate composition. The objective is to remove about 24 grams
of urea daily. The dialysis filtrate composition has as its
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goals: (1) the re-establishment of proper electrolyte
concentrations, (2) maintaining proper acid-base equilibrium, and
(3) removal of nitrogenous and other associated waste. The
dialysis filtrate composition according to this embodiment
preferably comprises the following ingredients with the preferred
values and ranges indicated:
Table B
Electrolytes: Sodium 135 mmol/1, range 134-147 mmol/1
Potassium 4 rtmol/1, range 3-5 mmol/1
Magnesium 1 mrol/1, range 0.75-2.3 mmol/1
Calcium 2 cmnol/l, range 1-3.5 mmol/1
Chloride 105 msol/1, range 95-110 mmol/l
Buffer: Bicarbonate 37 mmol/1, range 35-45 mmol/l
Lactate 8 nmol/1, range 0-9 mmol/1
High Mol. Weight Osmotic Agent: range 3-16%
The lactate could be reduced or eliminated, in which case it
would preferably be replaced on almost a mmol/1 per mmol/l basis
by bicarbonate, which could then be increased up to 45 mmol/l if
no lactate is used. The bicarbonate is an ideal physiological
buffer. The lactate also serves as a buffer, and as a
vasodilator.
The high molecular weight osmotic agent can be any medium weight
(eg. about 200 Daltons) to high molecular weight polymer, protein
or amino acid, or combination thereof, that is non-irritating and
not readily absorbed in the colonic mucosa. Such examples are
maltodextrin (having a molecular weight of 16k Daltons), and
casein.
If necessary or desirable another vasodilator such as niacin in
an amount of about 0.25 mg/1 may be added to promote increased
local/systemic vasodilation.
If necessary or desirable, an ingredient to promote increased
ammonium binding may be added to lessen the time necessary for
treatment. Such ingredient could be activated charcoal or'other
synthetic sorbent in an amount of about 15 g/l.
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If necessary or desirable, an ingredient may be added to promote
increased creatinine binding and removal, such as zirconium
phosphate in an amount of about 2 g/1.
To increase the effective removal of cholesterol and
triglycerides, the concentration of the osmotic agent can be
increased to thereby increase the osmotic pressure, at only a
slight increase in risk of irritation, which should be tolerable.
Through the use of the iontophoretic component, antigen/antibody
complexes should be removable with or without addition of binding
agents.
The present invention also provides an apparatus, method and
composition for treating shock. The same apparatus and method
described for dialysis could be adapted for treating shock. The
composition would be more tailored to treating shock.
in treating shock the invention has three goals: (1) the
correction of any electrolyte composition deviations, (2) the
maintenance of proper acid-base equilibrium, and (3) rehydration
as well as increased serum osmotic pressure to curtail capillary
leakage. The shock treatment composition according to the
invention prelerably comprises the following ingredients:
Electrolytes: Sodium 135 mmol/1, range 134-147 mmol/l
Potassium 4 mmol/1, range 3-5 mmol/l
Magnesium 1 mmol/1, range 0.75-2.3 mmol/l
Calcium 2 mmol/1, range 1-3.5 mmol/1
Chloride 105 mmol/1, range 95-110 mmol/1
Buffer: Bicarbonate 37 mmol/1, range 35-45 mmol/l
Lactate 8 mmol/1, range 0-9 mmol/1
Rehydrating Agent: 3-6% by weight
The lactate could be reduced or eliminated, in which case it
would preferably be replaced by bicarbonate, which could then be
increased almost on a mmol/l per rmnol/1 basis with the amount of
lactate reduced, or up to 45 mmol/1 of bicarbonate if no lactate
is used.
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The rehydrating agent is preferably a non-irritating readily
absorbed saccride diaaccride, e.g. sorbitol, which would increase
the serum osmotic pressure. I
5 While all the above percentages and concentrations described are
believed to be appropriate and efficacious, these values may be
increased or decreased as the need arises or as may be dictated
by clinical trials.
10 Although one or more preferred embodiments of the system, method
and composition according to the present invention have been
shown and described, it will be understood that numerous
variations and modifications may be effected without departing
from the true novel concept and spirit of the present invention.
Accordingly, the present invention is not limited to the
preferred embodiments disclosed, and is defined by the appended
claims.
