U.S. patent application number 11/767414 was filed with the patent office on 2007-10-25 for powered sterile solution device.
This patent application is currently assigned to PRISMEDICAL CORP.. Invention is credited to Tralance O. Addy, Mark L. Sizelove, Michael A. Taylor.
Application Number | 20070248489 11/767414 |
Document ID | / |
Family ID | 23119095 |
Filed Date | 2007-10-25 |
United States Patent
Application |
20070248489 |
Kind Code |
A1 |
Taylor; Michael A. ; et
al. |
October 25, 2007 |
POWERED STERILE SOLUTION DEVICE
Abstract
The disclosure below relates to apparatus and methods for
producing medicament using sub-optimal water sources. One
embodiment of the disclosure is directed to an apparatus comprising
a preliminary purification component, a disinfection component, a
pharmaceutical grade water preparation (PGW) component, and a drug
pack. Another disclosed embodiment relates to a method for
producing a peritoneal dialysis solution, comprising, passing
diluent through a preliminary purification component, passing
diluent through a disinfection component, passing diluent through a
PGW preparation component, passing diluent through a drug pack, and
collecting solute produced by the drug pack.
Inventors: |
Taylor; Michael A.; (Napa,
CA) ; Sizelove; Mark L.; (Napa, CA) ; Addy;
Tralance O.; (Coto de Caza, CA) |
Correspondence
Address: |
KNOBBE MARTENS OLSON & BEAR LLP
2040 MAIN STREET
FOURTEENTH FLOOR
IRVINE
CA
92614
US
|
Assignee: |
PRISMEDICAL CORP.
American Canyon
CA
WATERHEALTH INTERNATIONAL, INC.
Lake Forest
CA
|
Family ID: |
23119095 |
Appl. No.: |
11/767414 |
Filed: |
June 22, 2007 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10478908 |
Jul 14, 2004 |
7250619 |
|
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PCT/US02/15325 |
May 14, 2002 |
|
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11767414 |
Jun 22, 2007 |
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60291155 |
May 14, 2001 |
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Current U.S.
Class: |
422/24 ; 422/1;
422/186.3 |
Current CPC
Class: |
C02F 1/444 20130101;
A61M 1/1674 20140204; A61M 1/287 20130101; B01D 61/145 20130101;
B01D 61/147 20130101; A61M 1/1666 20140204; A61M 1/1656 20130101;
A61M 1/1672 20140204; B01D 61/18 20130101 |
Class at
Publication: |
422/024 ;
422/001; 422/186.3 |
International
Class: |
A61L 2/10 20060101
A61L002/10; A61L 2/00 20060101 A61L002/00 |
Claims
1. A method for producing a peritoneal dialysis solution,
comprising: passing a diluent through a preliminary purification
component; passing the diluent through a disinfection component;
passing the diluent through a PGW preparation component; passing
the diluent through a drug pack; and collecting solute produced by
the drug pack.
2. The method of claim 1, wherein passing diluent through the drug
pack comprises: passing diluent through a dry reagent bed, thereby
consuming reagents in the bed; carrying the consumed reagents with
the diluent out of the bed; and compacting the reagent bed as the
reagents are consumed.
3. The method of claim 1, wherein passing diluent comprises
introducing a diluent to a reagent cartridge housing inlet.
4. The method of claim 2, wherein compacting the reagent bed
comprises exerting pressure upon the reagent bed from two opposite
directions.
5. The method of claim 2, wherein compacting the reagent bed
comprises expanding a compression component adjacent the bed as the
reagents are consumed.
6. The method of claim 5, wherein the compression component
comprises a compressed elastic member continually exerting pressure
upon the reagent bed.
7. The method of claim 5, wherein the compression component
comprises an open-celled foam, and the diluent passes through the
compression component.
8. The method of claim 2, wherein the disinfection component
comprises a UV disinfection component.
9. The method of claim 2, wherein the diluent passes sequentially
in order through the preliminary purification component,
disinfection component, PGW preparation component, and drug
pack.
10. A self-contained apparatus for purifying water and delivering
reagent in a fluid form, comprising: a UV disinfection unit; a
filtration water pack, connected downstream from the UV
disinfection device; and a flow-through drug delivery device
comprising a dry reagent bed in a fluid flow path, the flow-through
drug delivery device being connected downstream of the filtration
water pack.
11. The self-contained apparatus of claim 10, wherein the drug
delivery component comprises a compression component configured to
compact the dry reagent bed during erosion as fluid flows
therethrough.
12. The self-contained apparatus of claim 10, further comprising a
pump and preliminary filtration component upstream of said UV
disinfection unit.
Description
REFERENCE TO RELATED APPLICATIONS
[0001] The present application claims priority under 35 U.S.C.
.sctn. 120 as a divisional of U.S. patent application Ser. No.
10/478,908 filed Jul. 14, 2004, which is a U.S. National Phase
Application of PCT/US02/15325 filed May 14, 2002, which claims
priority to U.S. Provisional Application No. 60/291,155 filed May
14, 2001. All of the priority applications are hereby incorporated
by reference in their entirety.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The apparatus and methods disclosed herein relate to the
preparation of sterile water for various medical uses. An exemplary
medical use is the preparation of peritoneal dialysate solutions or
hydration fluids under sub-optimal conditions.
[0004] 2. Description of the Related Art
[0005] The preparation of medicaments in the field or under
sub-optimal conditions is complicated by the absence of clean water
supplies. Existing water purification devices that produce
pharmaceutical grade water (PGW) in remote locations have limited
production capacity, both by limiting flow rates and by reducing
product life span. The purification capacity of such devices can
become severely limited when used to purify significantly
contaminated water sources. In fact, even potable water quality
standards for municipal water treatment throughout the developed
world allow widely variable levels of contamination that render
such water supplies unsuitable for use in the preparation of
medicaments, without further purification.
[0006] Effective water purification to a level that meets
pharmaceutical-grade water (PGW) quality standards typically
requires extensive mechanical, filtration, chemical, and other
forms of manipulation. Disinfection alone is not adequate to
achieve PGW. Elevated levels of dissociable ions are acceptable in
municipally treated waters for drinking but are potentially
hazardous to health if administered in non-physiologic levels. The
by-products of microbial contamination even following disinfection
are potentially life threatening. Endotoxins derived from gram
negative bacteria represent a life threatening hazard resulting
from pyrogenic shock. A number of common water contaminants are
discussed below.
Particulate Contamination
[0007] PGW have limits that do not apply to maximal potable water
standards for particulate matter which severely limits the capacity
of remote site PGW purification systems.
Organic Contamination
[0008] The acceptable levels of organic contaminants in drinking
water may exceed acceptable levels in a therapeutic PGW due to the
potential toxicity of intravenous administration of these agents.
The toxicology associated with ingested agents is a function of the
blood level reached following absorption into the blood stream.
With therapeutic solutions produced from PGW, the amount of organic
contaminants associated with the PGW is the blood level. Therefore,
exhaustive purification beyond drinking water quality is necessary
to mitigate the potential toxicity. This problem is exacerbated
with the use of available water with uncontrolled organic
contamination. Without preliminary removal of organic contaminants,
a POW system would have severely reduced purification capacity.
Deionization
[0009] Dissolved solids constitute a significant contaminant in
water. These agents include salts, most commonly in the form of
sodium chloride. Dissolved solids also include inorganic
contaminants including heavy metals, such as arsenic, mercury,
lead, and iron. As with removal of organic contaminants, the
toxicology of these agents is markedly increased with direct
administration into the blood stream. The deionization capacity of
a PGW system would be markedly limited without preliminary
deionization of the source water.
Disinfection
[0010] Perhaps the greatest acute hazard to ingestion of available
water results from the potentially infectious agents that may be
present therein. The most effective preventative measure to combat
this hazard involves the disinfection of the source water.
[0011] Among the potentially infectious agents that must be removed
from source water include viruses, bacteriological agents,
spore-forming parasites, and fungal agents. The larger of these
agents are readily filtered from source water. Some microbial
agents, however, have the capacity to grow through filters, thus
rendering them non-sterile. Moreover, viruses pass through
microfilters, therefore requiring the use of ultrafilters or
reverse osmosis filtration. These forms of filtration require
expansive mechanical generation of high pressure and thus entail an
extensive power requirement.
[0012] Drinking water disinfection devices are capable of rendering
viruses and microbes inactive and non-replicative. These devices,
however, do not remove these agents or cell debris from the product
water. In situations where the water is intended for drinking, the
point is not of great importance because generally viruses,
bacteria, bacterial by-products, spores, or other microbiological
materials if killed or rendered non-replicative, do not represent
potential hazards.
[0013] For production of water-based, injectable fluids,
bacterial-by products represent a significant hazard and must be
removed to prevent pyrogenic shock and potential death. The
purification capacity of PGW systems is limited, without a
preliminary filtration of these agents in combination with a
disinfection step, which renders the microbial agents
non-replicative.
SUMMARY OF THE INVENTION
[0014] The disclosure below relates to apparatuses and methods for
producing medicament using sub-optimal water sources. One
embodiment of the disclosure is directed to an apparatus comprising
a preliminary purification component, a disinfection component, PGW
preparation component, and a drug pack. Another disclosed
embodiment relates to a method for producing a peritoneal dialysis
solution, comprising, passing diluent through a preliminary
purification component, passing diluent through a disinfection
component, passing diluent through a PGW preparation component,
passing diluent through a drug pack, and collecting solute produced
by the drug pack.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] FIG. 1 is a flow chart of the medicament preparation
system.
[0016] FIG. 2 is a rear view of a medical fluid delivery
device.
[0017] FIG. 3 is a top view of the device in accordance with FIG.
2.
[0018] FIG. 4 is a side view of the device in accordance with FIG.
2.
[0019] FIG. 5 is a bottom view of the device in accordance with
FIG. 2.
[0020] FIG. 6 is a isometric view of the ultraviolet disinfection
unit, the PGW unit and the PD Pack attached together. A collection
bag is also shown.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0021] While the illustrated embodiments are described in the
context of particular formulations and relative proportions of
reagents, the skilled artisan will find application for the
described methods and devices in a variety of different
formulations and proportions of reagents. Examples of these uses
and solutions include, but would not be limited to, sterile water
for injection or irrigation, sterile solution diluent for
intravenous solutions, vaccines, oral re-hydration solutions,
medical grade drinking water and intravenous drug delivery.
[0022] The apparatus and methods disclosed below provide the means
by which to purify otherwise unpurified water available from the
vast majority of water sources to a level of quality sufficiently
high (pharmaceutical grade) for use in production of medical
therapeutic solutions, then utilizes reagent delivery components to
produce therapeutic solutions. A preferred embodiment consists of a
preliminary filtration component, a purification component, and
disinfection component. Functioning together, each component
renders available fresh water to be purified to produce medical
quality water.
[0023] One novel aspect of the disclosed invention relates to the
range of possible uses of selected components to meet particular
needs. This range includes the preparation of drinking water to the
preparation of patient specific, sterile, therapeutic solution
production. The modular nature of the disclosed components provides
a spectrum of preventative and therapeutic measures for water-born
illnesses and delivery on medicaments under less than optimal
circumstances, such as in a rural setting. Water disinfection and
decontamination for production of delivered fluids such as oral
re-hydration solution, the drug pack can be attached to the
preliminary disinfection component. Such an embodiment enables the
production of electrolyte solutions or nutritional solutions for
infants or immuno-compromised individuals. The additional
purification provided by the PGW maker allows for the production of
highly purified water suitable for immuno-compromised patients and
others particularly sensitive to foreign matter. This highly
purified water can also be used for remote site production of water
of sufficient quality for injectability, including product waters
intended for subsequent production of dialysate solutions or
intravenous solutions. By addition of the drug pack component,
reagents could be added to injectable quality waters to produce
general use therapeutic solutions such as sterile physiologic
saline, Lactated Ringer's, sterile saline with dextrose or other
crystalline or colloid containing resuscitation fluids. The
injectable quality waters could be used as diluents for injectable
drugs or vaccines delivered from drug packs. The drug pack
components could also be used to augment injectable quality water
with combinations of reagents to produce peritoneal or
hemodialysate solutions in remote locations. By additional
combinations of drug packs components to the system, patient
specific therapeutic solutions could be prepared, such as
nutritionals and/or anti-infectives in patient specific doses.
[0024] In particular, medical quality water or other fluid produced
by the illustrated water purification pack 12 exhibits the
following characteristics: a very low level of total organic
carbon, preferably less than about 1 ppm and more preferably less
than about 500 ppb; low conductivity, preferably less than about
5.0 microSiemens (2.5 ppm) and more preferably less than about 2.0
microSiemens (1 ppm TDS); near neutral pH, preferably between about
4.5 and 7.5, and more preferably between about 5.0 and 7.0; very
low particulate concentration, preferably fewer than less than
about 12 particles/mL of particles less than 10 micron, more
preferably less than about 6 particles/mL of such particles, and
preferably less than about 2 particles/mL of particles less than 25
micron, more preferably less than about 1 particle/mL of such
particles; and low endotoxin levels, preferably less than about
0.25 endotoxin units (EU) per mL (0.025 ng/mL), more preferably
less than about 0.125 EU/mL.
[0025] FIG. 1 depicts a therapeutic solution system 10, shown in
three general components. The first component of the system is a
preliminary purification and disinfection component 20. The second
component of the system is typically a PGW production component 30,
which produces pharmaceutical grade water from the water produced
from the preliminary purification and disinfection component. The
third component of the system is typically a therapeutic solution
component or a drug pack 40, which utilizes dry reagent to produce
a medicament solution suitable for therapeutic administration. An
optional collection unit 50 can be included in the system to
provide a means of aseptic/sterile solution collection.
Preliminary Purification and Disinfection Component
[0026] Preferably, the preliminary purification and disinfection
component filters and purifies sea water, brackish water, ordinary
tap water, or fresh water from some other source provides a first
stage of water purification. Typically, this is done using an
optional pump and filtration assembly or by gravity. Additionally,
the preliminary purification and disinfection component
decontaminates the source water to prepare it for passage to the
PGW production component of the system. These components preferably
reduce the load on the downstream PGW unit, discussed below. An
exemplary disinfecting component is described in U.S. Pat. No.
5,780,860, entitled, "UV WATER DISINFECTOR." In this example, the
UV lamp is positioned down stream of the preliminary filtration
device.
[0027] The disinfection unit taught in U.S. Pat. No. 5,780,860
functions as a gravity driven disinfecting apparatus. The presently
described apparatus can use gravity or other means to drive the
fluid past the disinfecting means. Further, although UV
disinfection is a preferred embodiment, other means of germicide
are contemplated for use with in the described apparatus.
[0028] The basic structures of a typical preliminary purification
component provide a continuous stream of purified water. Typically,
a pump provides water to an entry feed trough directing the feed
water into an inlet port. In some embodiments, the inlet port is
about 1.5 cm in diameter when the inlet water flow rate is about 15
liters/minute. In other embodiments, the inlet port is about 3 cm
in diameter when the inlet water flow rate is about 60
liters/minute. The feed water proceeds into the inlet manifold
through a distribution tube. The water flowing through this
assembly is essentially the same pressure throughout the entry
chamber. The feed water then enters the treatment chamber through a
perforated baffle wall, which laminarizes the flow. Angled or
baffled sides ensure uniform UV exposure. A UV lamp suspended above
the flow treats the feed water, and the pure water cascades over an
outlet baffle weir into the outlet manifold and directly into a
collection vessel, or into a holding tank from which the water is
distributed to the users.
[0029] The structure of the entry feed trough provides water to the
UV disinfection device via a pump, at a steady rate which never
exceeds the safe disinfection capacity of the unit. The inlet port
is calibrated so that excess force of feed water will result in
back pressure, resulting in a reduction of flow through the unit.
If there is an interruption in power, causing the UV lamp to
temporarily cease function, a solenoid operated safety valve in the
inlet manifold temporarily blocks the entry of feed water. In a
preferred embodiment, gravity drives the water over the UV
treatment tray. Other safety features have also been built into the
inventive device.
[0030] Preferably, the water flow rate into the UV light
disinfection unit is limited to ensure adequate UV disinfection.
Generally, as the flow rate decreases, the quality of the UV
disinfection is enhanced, due to the fact that the water is exposed
to the light from the UV lamp for a longer duration and thus
receives more UV energy. Therefore, the flow rate is preferably low
enough to ensure that the water receives adequate UV light
exposure. If desired, a flow-restrictor or flow-limiter may be
included upstream of the UV light disinfection unit to ensure that
the flow rate is below a certain level.
[0031] The baffle wall and exit baffle before and after the
treatment chamber provide for steady, predictable treatment of all
portions of the feed water. Angling of the treatment chamber tray,
and positioning of the UV lamp and reflectors, assures that even
water most distant from the lamp receives close to the same UV
dosage as that nearest the lamp.
[0032] To assure the safety of the user, the power to the UV lamp
cuts off if its protective housing is opened, so that there is no
accidental direct exposure to the UV light. While a ground wire is
provided to avoid the potential for shock, there is also a Ground
Fault Circuit Interrupt (GFCI) provided which will cut off power
whenever a short occurs.
[0033] The UV light disinfection unit treats the water stream by
emitting UV light onto the water as it flows through the unit.
Preferably, the unit emits UV light in the wavelength range 240 to
280 nanometers (nm), which is known to be germicidal. The UV
exposure causes adjacent bases in the DNA to covalently bond
together, thus disabling it from replication. Preferably, the unit
includes a low-pressure mercury arc (the same as that used inside
ordinary kitchen fluorescent lamps), which puts out 95% of its
energy at 254 nanometers and is thus an extremely efficient
germicidal UV source.
[0034] In a preferred embodiment, the UV light disinfection unit 36
comprises a UV unit, as described by Gadgil '860. The UV unit
includes a linear UV lamp positioned horizontally below a
semi-cylindrical polished aluminum reflector, suspended above the
free surface of water flowing in a shallow stainless steel tray.
This design innovation circumvents the problem of chemical- and
bio-fouling of the solid surface between the UV source and the
water by eliminating any such surface. Also, since the flow
resistance is small, water with pressure of only a few centimeters
of water column can flow through the device. The UV unit consumes
60 watts of electricity, disinfects just under 1 ton of water per
hour (15 1pm, more than twice the flow rate through an average U.S.
bathtub faucet) by delivering it a UV energy dose of up to 110,000
microwatt-seconds/cm.sup.2 in 10-12 seconds, and accepts
atmospheric-pressure raw water (e.g., poured from a hand-carried
pot). In the emergency relief system, therefore, water is
gravity-driven through the UV disinfection unit, rather than
pressurized.
[0035] FIG. 2 shows a rear view of an exemplary preliminary
purification and disinfection component. This view shows the
preliminary purification portion of the system. Typically, the
preliminary purification of the system 100 comprises a housing 110,
from which an inlet tube 115 extends. Generally, the inlet tube
comprises a connection site for available source water.
[0036] A pump 120 is shown connected to the inlet tube. This water
is propelled into system by the pump. The pump may be eliminated or
left inoperative if a pressurized water source is available. The
pump is a low power requiring device that provides adequate power
to pressurize the system. The pressure derived from this pump
typically ranges from 1to 20 pounds per square inch (PSI),
preferably between 1 and 10 PSI, and more preferably between 2 and
5 PSI.
[0037] The pump is preferably connected to a depth filtration
component 125 by a depth filter tube 130. The depth filtration
component comprises a closed housing 126. Typically, the housing
consists of any chemically inert material, including polymers,
including polypropylene and polyethylene and glass. The housing
contains torturous paths of controlled pore size to retain
insoluble particulate materials greater than 1 micron, while having
sufficient depth to prevent significant pressure increases until
the filter becomes saturated with particulates. This component is
held in place by retention clips that enable rapid removal and
replacement of the deionization component 125. The connection tubes
for this component are sufficiently pliable to enable free
insertion of the inlet and outlet connectors of the organic
chemical reduction component.
[0038] The depth filtration component is connected to an organic
chemical reduction component 140 by a connection tube 135. The
organic chemical reduction component consists of a housing 141, an
organic retention bed 142 and organic retention bed restraints 143.
The organic reduction bed will generally consist of carbon-based
purification materials, which are well known in the art. The
organic retention bed restraints consist of any controlled pored
material that has an absolute pore size of about less than 10
microns. These components can be held in place by retention clips,
grooves, or other means that enable rapid removal and replacement.
As discussed above, the connection tubes for this component are
also sufficiently pliable to enable free insertion of the inlet and
outlet connectors of the organic retention bed into the tubing.
[0039] A deionization component 150 is connected to the organic
chemical reduction component by connection tube 145. The
deionization component will generally consist of a housing 151, the
deionization bed 152 and the resin bed restraints 153, which are
generally composed of chemically inert materials. The deionization
bed consists of a mixed bed of roughly comparable volumes of cation
and anion exchangers. The bed restraints are generally composed of
controlled pored, chemically inert materials that retain resin
beads. The anion and cation components may be contained together or
they may be separately held prior to a organic removal component
followed by a mixed bed deionization component. Water exits through
tube 155.
[0040] FIG. 3 shows a top view of the system 10. This view
illustrates the disinfection component 200 of the system. The
disinfection component will generally comprise a housing 215, the
internal ultraviolet light 220, an inlet 225, a UV light
containment structure 226, an outlet 227, and a light activation
switch. Advantageously, the UV light is of low wattage and serves
to decontaminate water pumped from the preliminary purification
system 100 into the disinfection component through the inlet. By
treating the filtrate produced from the preliminary filtration
system with UV light, any viruses or other microbial agents, are
rendered non-replicative.
[0041] An exemplary disinfecting component is described in U.S.
Pat. No. 5,780,860, entitled, "UV WATER DISINFECTOR."
Pharmaceutical Grade Water (PGW) Production Component
[0042] In a preferred embodiment, the PGW production component of
the described system comprises a portable apparatus for purifying
water to levels suitable for medical applications, including
injection into the human body. In a more preferred embodiment, the
water purified by the PGW production component will have been
preliminarily purified and decontaminated. Such a preliminary step
will increase the useful lifespan of the PGW production component
and further insure the purity of the water produced from the PGW
production component. A suitable PGW production component is
disclosed in U.S. Pat. No. 6,719,745, entitled, "WATER PURIFICATION
PACK."
[0043] The apparatus described herein contemplates the use of fewer
components in the PGW production component since many of its
functions are already performed by the preliminary filtration
component. Alternatively, a complete PGW production component can
be used. The use of a complete PGW component will increase the life
span of the device.
[0044] FIG. 4 shows a side view of the system and illustrates the
PGW production component. Typically, the PGW production component
of the described system includes a housing 310, an inlet 305, fluid
distribution channels 311, a compression component 315, a depth
filtration component 320, a deionization component 325, an organic
contaminant collection component 330, a microfiltration component
335, a microfilter support 340, fluid collection channels 345 and a
housing outlet 350. Typically the microfiltration component will
have a porosity of less than about 0.5 microns and is configured to
retain endotoxins. Ultrafiltration membranes may be included in
addition to or in place of the microfilter.
[0045] As water emerges from the disinfection component of the
system it is passed into the PGW production component. Passage
through the components listed above provides pharmaceutical grade
water for the preparation of medicinal compositions in the
therapeutic solution component.
Therapeutic Solution Component
[0046] Having produced pharmaceutical grade water (PGW) using the
system components described above, the PGW can be used to produce a
variety of medicinal solutions. A variety of medicaments are
contemplated for use with the described system. For example,
solutions suitable for peritoneal dialysis can be prepared using
the described system. An exemplary therapeutic solution component
is described in U.S. Pat. No. 6,274,103, entitled, "APPARATUS AND
METHOD FOR PREPARATION OF A PERITONEAL DIALYSIS SOLUTION."
[0047] Other methods of preparing medicaments are contemplated for
use with the described system. For example, U.S. Pat. No.
6,605,214, entitled, "METHODS AND DEVICES FOR PREPARING
HEMODIALYSIS SOLUTIONS," can also be used as a therapeutic solution
component.
[0048] A preferred embodiment provides an apparatus for producing
dialysis or intravenous solutions from dry reagents immediately
prior to administration. The therapeutic component allows for the
production of physiologically compatible dialysate or intravenous
solutions and minimizes the likelihood of undesirable reactions
among reagents. Moreover, the a typical dialysate producing
component also facilitates separation of incompatible reagents.
Both of these features, independently and in combination, result in
a relatively simple and inexpensive apparatus for storing,
transporting and producing solution from peritoneal dialysis
reagents in dry form. Moreover, the devices and methods expand
options for practically applicable solution formulations.
[0049] One exemplary medicament preparation device comprises a
housing, which defines a fluid flow path through it. The
therapeutic agent component 360 generally consists of a housing
365, an inlet 370, diluent distribution channels 375, agent
compression component 380, agent retention frit 385, therapeutic
agent bed 390, agent restraint bed 395, solution collection
channels 397 and the outlet 399. The compression component 380
assists in the dissolution of the therapeutic agent bed and
facilitates complete dissolution of the reagents contained therein.
Typically, at least one reagent bed is kept within the housing
along the fluid flow path.
[0050] A collection device can also be provided as a component of
the described system. A exemplary collection bag is shown in FIG.
6. The collection component includes the collection bag tubing, the
intermediate microfilter and the collection bag. In one embodiment,
the collection bag can be situated on the exterior of the system
housing on the paired support hooks and a central positioning
bar.
Mechanism of Action
[0051] The system described above comprises an apparatus and a
method for disinfection of source water rendering the viruses and
other microbiological agents non-replicative. This mitigates the
potential for microbiological growth through filtering components.
Non-replicative viruses need not be removed from product water
because they do not represent an infectious hazard. The PGW
capability augments the preliminary purification component
capability and the disinfection component in production of PGW from
available water. The preliminary purification component capability
and the disinfection component produce from potentially
contaminated available water a decontaminated water that is
aliquated for individual patient requirements.
[0052] The PGW further purifies this water to pharmaceutical
quality. The PGW enables removal of agents that represent potential
intravenous hazards. The therapeutic agent component provides a
means of adding the required beneficial reagents to the PGW,
producing the desired therapeutic solution. The method includes a
means to produce intravenous solutions, dialysis solutions,
nutritional solutions or other medicinal solutions in small to
large volumes from any water based fluid, regardless of the quality
of the source water. The collection component provides a collection
reservoir for the prepared therapeutic solution.
[0053] Available water enters the preliminary purification
component via the inlet 115. The system is pressurized by the pump
120. The initial component of the component is the depth filtration
component 126. This component 126 retains insoluble materials
greater than 1 micron. The connection tube 135 provides a means of
conveying particulate free water to be carried to the organic
chemical reduction component 140, which reduces organic materials
in the source water. It also reduces biologicals and biological
by-products, including endotoxin. The connection tube 145 to the
deionization component 150 provides passage of partially
decontaminated water to the next component. The deionization
component retains dissociable ions, biological by-products and any
contaminants containing charged materials. The outlet of
preliminary purification component consists of a connection tube
155 and outlet providing a connection to the disinfection component
200. The preliminary purification component is activated by the
component activation switch located on the component housing.
[0054] The partially purified water is pushed into the disinfection
component. When activated the ultraviolet light within the
disinfection chamber provides a means of rendering the water
passing through the housing decontaminated. A reflective inner
surface 226 within the disinfection chamber enhance the
disinfection capability of the ultraviolet light and minimize the
formation of biofilm on the ultraviolet light housing and the
disinfection chamber. In one embodiment, the internal volume of the
disinfection chamber is approximately 600 milliliters. With a flow
rate of 100 ml/min this provides a 6 minute transit time through
this component, which is more than adequate for
decontamination.
[0055] The partially purified, decontaminated water is then pushed
from the disinfection chamber outlet into the therapeutic agent
component inlet. Within this component water enters the inlet of
the PGW purification component. Water is distributed within the
housing via the fluid distribution channels. Adjacent to this
component is compression component, which constrains the housing
contents. The depth filtration component provides additional
filtration of any particulates not removed by the preliminary
purification component. The deionization component retains
dissociable ions and other charged materials including endotoxin.
The indicator light provides an indication that the water quality
meets or exceeds the desired levels of dissolved solids or
conductivity. The organic contaminant removal component removes
residual organics not removed by the preliminary purification
component. The microfiltration component and the micro filter
support function to prevent penetration of particles greater than
0.2 microns. This includes bacteria and other microbes. Chemical
modification of the microfilter enables additional retention of any
charged materials, including endotoxin. The PGW prepared by this
component collects within the fluid collection channels and exits
the PGW purification component via the housing outlet.
[0056] PGW enters the therapeutic agent component via the inlet.
The PGW is distributed through out the housing via the diluent
distribution channels. The PGW then passes through the porous agent
compression component, which serves to constrain the housing
contents. The agent retention frit has pores of sufficiently small
size to prevent penetration of undissolved particles. Diluent
passes freely through this frit and contacts the therapeutic agent
bed inducing dissolution of this bed. The downstream agent
restraint frit retains the therapeutic agent particles of the
therapeutic agent bed until they are dissolved. The prepared
solution passes through this frit into the solution collection
channels and pass out the outlet, which is continuous with the
collection bag tubing. An intermediate microfilter provides
additional assurance of sterility of the solution exiting the
system. The collection bag provides a means of sterile capture of
the prepared therapeutic solution while maintaining sterility. The
types of therapeutic solutions that can be produced by the system
includes sterile water for injection and irrigation; intravenous
solution including sterile physiologic saline lactated ringer's
solution, saline with dextrose, dialysate solutions including
peritoneal and hemodialysate; nutritional solutions; oral
rehydration solutions; and diluent for vaccines pharmaceuticals and
other medicaments.
[0057] The apparatus provides a system capable of producing a wide
range of injectable quality, therapeutic solutions in any location
from the water available at the location the solution is produced,
regardless of the quality of that source water. Virtually any type
of water-based therapeutic solution can be produced by this system
in any location from any water source.
[0058] Without the preliminary purification component and
disinfection component the extended capability of the PGW component
would be markedly restricted. Through the combination of these
components and full continuum of preventative to therapeutic water
and solution can be produced.
* * * * *