U.S. patent number 3,774,762 [Application Number 05/108,118] was granted by the patent office on 1973-11-27 for analogue fluid flow programming structures.
Invention is credited to Eric S. Lichtenstein.
United States Patent |
3,774,762 |
Lichtenstein |
November 27, 1973 |
ANALOGUE FLUID FLOW PROGRAMMING STRUCTURES
Abstract
A semi-automatic device for peroforming complex fluid processing
procedures adapted to hemodialysis. The structure includes a
disposable component formed by layers of transparent, flexible
plastic sheets, sealed to each other according to a predetermined
pattern defining between each pair flow paths and pockets which
respectively form fluid passages and reservoirs. The structure also
includes a permanent installation which is to receive the
disposable component in order to form therewith a complete
apparatus for automatically processing fluids, such as treating or
determining the characteristics of a fluid such as human blood,
according to predetermined sequences which may be controlled by
internal and/or external information processing devices.
Inventors: |
Lichtenstein; Eric S. (New
York, NY) |
Family
ID: |
22320418 |
Appl.
No.: |
05/108,118 |
Filed: |
January 20, 1971 |
Current U.S.
Class: |
210/94;
210/321.71; 210/929; 210/96.2 |
Current CPC
Class: |
A61M
1/1668 (20140204); A61M 1/16 (20130101); A61M
2205/123 (20130101); A61M 2205/125 (20130101); A61M
2205/126 (20130101); A61M 2205/6018 (20130101); A61M
1/1696 (20130101); A61M 1/1656 (20130101); Y10S
210/929 (20130101) |
Current International
Class: |
A61M
1/16 (20060101); B01d 031/00 () |
Field of
Search: |
;23/258.5
;210/22,94,96,321,143 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Spear, Jr.; Frank A.
Claims
What is claimed is:
1. For use in the processing of fluids, at least a pair of flexible
plastic sheets sealed to each other according to a predetermined
pattern defining between said sheets fluid passages and pockets
situated inwardly of and spaced from the peripheries of said sheets
and forming predetermined flow paths and reservoirs, respectively,
for the fluid which is to be processed and for containing necessary
active principles of the processing, said sheets having inlet and
discharge connecting portions to be connected with fluid supply and
discharge lines, respectively.
2. The combination of claim 1 and wherein the pattern of sealing of
said sheets to each other defines also valve and pumping mechanisms
adapted for pumping fluid along said passages and into and out of
said reservoirs.
3. The combination of claim 1 and wherein said sheets are
transparent so that fluid between the sheets is visible and can
have characteristics thereof detected by light-signal systems.
4. The combination of claim 1 and wherein said sheets include a
mounting portion for adapting the sheets to be mounted on an
apparatus which coacts with the sheets.
5. In an apparatus for processing fluids, a permanent installation
and a disposable component to be used therewith, said permanent
installation including a control wall having a front surface formed
with recesses and grooves according to a predetermined pattern and
an access wall with similar recesses and grooves located adjacent
said front surface of said control wall for holding a disposable
component in engagement with said front surface of said control
wall, said disposable component including flexible plastic sheets
sealed to each other according to a pattern providing passages and
pockets which are situated inwardly of and spaced from the
peripheries of said plastic sheets and which respectively register
with said grooves and recesses, said passages and pockets providing
predetermined flow paths and reservoirs, respectively, for fluid to
be processed, and for containing necessary active principles, and
said permanent installation including at said control wall thereof
control means communicating with or coacting with said passages and
recesses for controlling the flow of fluid in the passages and
pockets of the disposable component.
6. The combination of claim 5 and wherein the control means carried
by said control wall includes valve plungers for pressing the
sheets of said disposable component together at the passage defined
therebetween and for releasing the sheets from each other at the
passages so as to close and open, respectively, predetermined fluid
passages defined between the sheets.
7. The combination of claim 5 and wherein said sheets are
transparent, and said control means including light-responsive
devices responding to the passage of light through said sheets for
receiving signals indicative of the characteristics of the fluids,
said front wall being transparent so that light can pass through
the sheets to provide visibility of the ongoing processes.
8. The combination of claim 5 and wherein said sheets of said
disposable unit include inlet and outlet connections.
9. The combination of claim 5 and wherein a mounting means forms
part of said permanent installation and coacts with said disposable
component for mounting the latter removably on the permanent
installation.
10. The combination of claim 5 and wherein said disposable
component includes sheets, the area of which is greater than that
of said rear wall, said sheets having portions extending beyond
said walls of said permanent installation and defining additional
pockets and passages for the processed fluid.
11. The combination of claim 5 and wherein said permanent
installation and disposable component form a hemodialysis and
analytic monitoring system, said pockets and passages forming a
flow path for blood and a flow path for dialysate, and all
structures and participant materials necessary for the
procedure.
12. The combination of claim 5 and wherein said control wall
carries pumping means communicating with said recesses, said sheets
defining between themselves pumping chambers communicating with the
latter recess, said pumping means coacting with the disposable
component at said pumping chamber thereof for pumping fluid
therethrough.
13. The combination of claim 1 and wherein said sheets form
portions of active controls and pumping mechanisms by interactions
such as transfer of heat, or pressure relationships between fluid
in adjacent layer flow paths, or via volumetric sizing of the flow
paths and reservoirs.
14. For use in the processing of fluids, at least a pair of
flexible plastic sheets sealed to each other according to a
predetermined pattern defining between said sheets fluid passages
and pockets situated inwardly of and spaced from the peripheries of
said sheets and forming predetermined flow paths and reservoirs,
respectively, for the fluid which is to be processed and for
containing necessary active principles of the processing, said
sheets having inlet and discharge connecting portions to be
connected with fluid supply and discharge lines, respectively, said
sheets defining non-parallel intersections of control paths with
procedural paths functioning as valves by the action of higher
pressure in the control paths to occlude the flow path lumen.
15. The combination of claim 14 and wherein said sheets have series
of pressure activated intersections to function as pumping
mechanism.
16. The combination of claim 13 and wherein said sheets have
proportional resistances within the flow patterns to proportion the
volumes of fluids passing through them.
17. For use in the processing of fluids, at least a pair of
flexible plastic sheets sealed to each other according to a
predetermined pattern defining between said sheets fluid passages
and pockets situated inwardly of and spaced from the peripheries of
said sheets and forming predetermined flow paths and reservoirs,
respectively, for the fluid which is to be processed and for
containing necessary active principles of the processing, said
sheets having inlet and discharge connecting portions to be
connected with fluid supply and discharge lines, respectively, said
sheets defining intersecting control paths with procedural paths
functioning as pressure sensors in procedural path to
proportionally alter resistance characteristics of control path
circuits operating in conjunction with fluidic logic circuits or
other pressure or flow sensing mechanisms to react to significant
changes in the procedural flow paths functions.
Description
BACKGROUND OF THE INVENTION
The present invention relates to fluid processing structures.
In particular, the present invention relates to structures used for
testing or treating fluids as by determining predetermined
characteristics of the fluids or by changing the characteristics of
the fluids. In the case of human blood, for example, various tests
may be carried out in order to determine the characteristics of the
blood, and/or certain treatment may be made in order to change the
characteristics of the blood.
At the present time systems of this type require the services of
highly skilled personnel such as physicians nurses, and technicians
of many different types. The processes involved are fairly complex.
It may be necessary to carry out many different procedures on a
fluid such as human blood during complex treatments such as
hemodialysis. Accomplighing this with conventional processes this
becomes extremely expensive and time consuming. This cost, further
aggravated by the unavailability of skilled personnel even when
funds are available, often makes therapy unavailable to patients
requiring it for maintenance of their lives or well being. The
equipment required for the above purposes is exceedingly delicate
and expensive. A considerable amount of training is required for
proper operation of such equipment and for proper evaluation of
various tests of its effectiveness. This device, embodied
exemplifying almost complete integration of the procedures of
hemodialysis into an automatic system, is suitable for
mass-production and distribution. Similarly designed systems could
app1y to automated monitoring and therapy of shock, or diabetic
keto-acidosis, and other situations frequently encountered is
specialized, hospital intensive care units. They would
significantly improve care in these situations by altering the
balance of personnel time between performance of required
procedures and decision-making based upon repeated evaluation of
the results of therapy. Pertinent information could be made rapidly
and continuously available. Anticipated therapeutic alternatives
could be rapidly instituted. Automated medical systems could also
extend emergency capabilities, for example, providing therapy for
cardiac arrest with rapidly available cardio-pulmonary bypass. With
present methods the costs of these diagnostic and therapeutic
possibilities are prohibitive.
SUMMARY OF THE INVENTION
It is accordingly a primary object of the present invention to
provide fluid processing structures which will avoid the above
drawbacks, to improve the efficiency of existing medical
facilities, and provide extension of servies to additional patients
at reduced cost.
In particular, it is an object of the present invention to provide
a fluid processing structure which can be automated and
computerized to the extent that all the desired test and other
operations of a particular procedure can be carried out by an
extremely small number of operators who need not be particularly
skilled.
Another object of the present invention is to provide, for systems
of this type, a permanent installation which includes the
relatively expensive controls, and a disposable component,
containing the active principles of the procedure in a spatially
ordered configuration which can be manufactured at an extremely low
cost, to be used in conjunction with the permanent installation in
order to carry out the required fluid processing operations.
Another object of the disposable component is to anticipate the
logical relationships of, and provide the fluid flows required for
performing the desired procedures, including sequences of flows,
proportioning of predetermined mixtures, and other such necessary
functions, within the patterns of flow paths and reservoirs formed
by seals between adjacent layers of plastic sheets.
Also, it is an object of the invention to provide a disposable
component with sterile packaging, where necessary, and sealed
functional construction, whereever possible.
The unit is keyed to interact in the prescribed manner with the
external hardward, the operative components consisting of various
non-invasive value and pump mechanisms.
This construction reduces preparation time and complexity. It
anticipates the steps in preparation for a procedure in the
integrated design and automated sequences of function.
Also, it is an object of the invention to improve safety of the
procedures especially when directly involving patient's therapy.
Standardization of design and functions will prevent accidents of
omission, minimizing possible patient errors, and with appropriate
monitoring, control for intrinsic malfunctions. The sealed
construction, and materials used, will provide insulation against
electrical hazards.
A further object of the invention is to include in the disposable
component as many functional control systems as can be compatible
with low cost, affording a reduction to a minimum the size, expense
and complexity of the permanent installation required.
In particular, it is an object of the invention to provide a
disposable component which can be used with a permanent
installation in such a way that relatively complex tests and other
treatment or processing can be carried out in a purely automatic
manner giving readings and the like which can be used with logic
systems of computers in order to determine, with a high degree of
accuracy and at relatively low cost, the information required in
connection with the fluid which is processed.
According to the invention the structure includes a permanent
installation and a disposable component to be used therewith. The
permanent installation includes a wall having a front face formed
with a predetermined pattern of grooves, recesses, and when
necessary inlet and outlet connections. An access door is located
adjacent the front face of the wall to hold a disposable component
between these rigid structures. The disposable component includes
at least a pair of transparent, flexible plastic sheets which are
sealed to each other according to a predetermined pattern which
will define between the sheets predetermined fluid passages and
pockets providing predetermined flow paths and reservoirs,
respectively, for the fluid which is to be processed, and
containing the constituents of the procedure that will be consumed,
contaminated or otherwise rendered ineffective for repeated use.
These passages and reservoirs will register with the grooves and
recesses of the wall of the permanent installation. This latter
installation will have controls in the form of valves, photocells,
pumping units, electrical contacts, and the like, coacting with the
transparent sheets in order to control the flow of the fluids,
perform designated tests, as well as provide predetermined
treatment thereof. There may be inlets and outlets, where
necessary, to perform transportations of aliquots of fluid
automatically removed from the disposable component's fluid flow
flow programming, or to inject functionally active fluids in any of
the preprogrammed layers of the disposable component.
BRIEF DESCRIPTION OF DRAWINGS
The invention is illustrated, by way of example, in the
accompanying drawings, which form part of this application and in
which:
FIG. 1 is a schematic front elevation illustrating the manner in
which the invention is applied to a hemodialysis system;
FIG. 2 is a front elevation of the wall of the permanent
installation, FIG. 2 also schematically illustrating the control
unit and fragmentarily showing access door in an open position;
and
FIG. 3 is a fragmentary sectional plan view, taken along line 3--3
of FIG. 1, in the direction of the arrows, and showing in section,
part of the walls of the permanent installation and part of the
disposable component situated therebetween, FIG. 3 also showing one
type of interface with various valves and pressure-sensing devices,
as well as part of a pumping means.
DESCRIPTION OF PREFERRED EMBODIMENTS
In the drawings, the invention is shown as applied to a
hemodialysis system, but it is to be understood that the principles
of the invention are of general applicability to all types of
systems where relatively complex manipulations of fluids are
required.
Referring to FIG. 1, there is schematically represented therein a
hemodialysis system 10 which includes a permanent installation 12
and a disposable component 14.
The permanent installation 12 of the system 10 includes a pair of
lateral stands 16 which serve to carry the entire system on a
balance apparatus (not shown) and functionally contained in the
permanent installation 12. To the left of rear control wall 18
(FIG. 3) the installation 12 includes a control unit 20. This
control unit has various operating buttons 22 and 24 which can be
used to transmit suitable electrical signals for selecting a
predetermined operation. The entire system is connected to a
suitable source of electrical energy through the cord 25 which has
the grounded plug 26 which can be inserted into any suitable wall
outlet. The assembly 20 also includes devices for transmitting
signals to a computer so that the various items of information can
be automatically obtained and processed. If desired the computer
structure may itself be housed within and form part of the unit
20.
As may be seen from FIG. 3, the rear control wall 18 is formed at
its front surface, which is visible in FIG. 2, with various
recesses 28 and grooves 30 defining a predetermined pattern of the
recesses and grooves for a purpose referred to below. Also, the
rear wall 18 carries at a pair of the recesses 28 suitable pumping
devices 32 communicating with the interior of the recesses and
acting to pump fluids in a manner described in greater detail
below. The illustrated structure also includes various control and
detecting devices such as the schematically represented valves 34
and photocells of conductivity detectors 36.
At its right end the rear wall 18 is connected by a hinge 38 with
the front wall 40 which is transparent, preferably being made of
any suitable clear plastic, with a pattern of grooves and recesses
corresponding to those of the control wall. At its end which is
distant from the hinge 38 the front wall 40 carries a suitable
latch or releasable lock device capable of coacting with a catch 42
for releasably holding the transparent front wall 40 in its closed
position adjacent the front surface of the rear wall 18 which is
visible in FIG. 2. When the front wall 40 is in its closed position
it serves to retain between the wall 40 and the wall 18 a
disposable component 14.
The rear wall 18 also carries a pair of vertical bars 44
respectively terminating at their top ends in eyes 46.
The disposable component 14 is made up of layers of transparent
flexible sheets which are sealed to each other according to a
predetermined pattern. For example in the hemodialysis system to be
described, a pair of these sheets 62 may be made of a clear plastic
such as polyethylene, although other suitable plastics may be used.
The pattern according to which these sheets are sealed to each
other will create fluid passages 48 and pockets 50 which define
flow paths and reservoirs, within the disposable component for the
fluid which is to be processed and to contain necessary reagents or
active principles of the process or procedure.
A mounting means is provided for mounting the disposable component
14 on the permanent installation. This mounting means in the
illustrated example takes the form of a rod 52 which extends
through an open-ended tube 54 which is defined along the top edge
of the component 14 by the sealing of the sheets thereof to each
other. Thus with the rod 52 extending through the tube 54 the
entire disposable component 14 can be mounted on the permanent
installation 12 simply by placing the ends of the rod 52 in the
eyes 46.
The pattern of sealing of the plastic sheets to each other to form
the disposable component 14 is such that the component 14 will have
fluid passages and pockets which register with the grooves and
recesses visible in FIG. 2. In addition it is to be noted that the
area of sheets which form the disposable component 14 is
substantially greater than the area of the front surface of the
rear wall 18 so that these sheets of the component 14 extend a
considerable distance above and below the walls of the permanent
installation 12. At these areas above and below the walls, the
disposable component 14 has additional pockets and passages as well
as connections for fluid-supply and discharge lines, as referred to
in greater detail below.
Referring to FIG. 2, it will be seen that the rear control wall 18
carries at its rear surface a housing 56 in which are housed
various actuating and sensing units with suitable interfaces or
connections incorporated in the structure of the control wall 18.
For example the photocell units 36 actuated by the light which
passes from a source in the control wall, through the disposable
component 14, to be reflected by mirrored surfaces on the inside of
the door to activate a photo detector on the control wall. These
are connected in electrical circuits enabling the photocell units
36 to detect significant air or fluid levels in the fluid flowing
within the pathways of the disposable component. The housing 56
also contains suitable solenoids, or motors capable of displacing
armatures 58 which form valve plungers. As is apparent from FIG. 3
the disposable component 14 is composed of transparent plastic
sheets 60 and 62 which are sealed to each other at their interface
64 so as to define between themselves the passages such as the
passage 66 indicated in FIG. 3. The sheets which form the
disposable component 14 also may be provided with openings through
which locating pins 68 pass for providing a precise positioning of
the disposable component on the permanent installation. It is
furthermore to be noted that the front wall 40 is provided at its
rear surface with recesses and grooves matching those at the front
surface of the rear wall so that the disposable component 14 is
precisely positioned between the walls of the permanent
installation in the manner illustrated in FIG. 3. The various
solenoid motors, or the like housed within the housing 56 are
designed to be actuated in appropriate sequences by the electrical
circuits activated by the operating buttons 22 and 24, with the
result that a plunger such as the plunger 58 of FIG. 3 can be
advanced to the position shown in FIG. 3 for closing a fluid
passage. When this plunger 58 is retracted then the passage will be
opened. In this way suitable valve controls are provided for
determining the pathway and timing of the fluid flows. A second
plunger 68 is shown in its retracted position maintaining the
passage 66 open. Additional active surfaces along the functional
grooves of the control wall 18, such as the plunger 70 shown in
FIG. 3 may through suitable transducers detect pressure changes in
the fluids within flow paths or reservoirs, to provide information
for automatic operation. Furthermore, it is possible to incorporate
elements, such as thermocouples, responsive to temperature changes,
and contact points with conductive properties for electrical
measurements. Appropriate interface manifolds incorporated in the
disposable component will allow spectrophotometric measurements to
be obtained, or access to the internal flow passage for inlet or
outlet of fluids.
At other points along the grooves channels in the control wall 18
pumping means are incorporated, as designated by 32 in FIG. 2,
shown in cross section in FIG. 3. This pumping can be provided by
any suitable means for creating localized pressure differentials,
as for example endless chains 72 driven from any suitable motor and
supported by suitable sprockets 74 so that pumping rollers 76 will
be advanced one after the other across the length of a pocket
defined between the sheets, such as the pocket 80 which is
fragmentarily illustrated in FIG. 3. The result is that each
pumping roller 76 will push a quantity of fluid ahead and suck a
quantity of fluid behind itself, thus bringing about a pumping
action according to which fluid will be pumped from the left toward
the right, as viewed in FIG. 3, with respect to the pocket or
reservoir 80, in accordance with the desired flow characteristics
of the particular circuit involved. Or this pumping means may be
provided by external fluid pumping to provide alternately
increasing or decreasing pressures of fluid contained in a
"pumping" pocket, sealed except for inlet-outlet connections, in
layers of plastic sheets outside the layers providing the primary
passages and reservoirs, in a multiple layer configuration.
Confined within the recesses of the control wall and door,
introductions of fluid under pressure into these pumping means will
transmit this pressure to the inner fluid volume, forcing it to
exit via the passages open to it. These exit passages can be
similarly controlled by higher pressure, non-parallel intersecting
fluid flow circuits forming valves, to provide unidirectional flow.
The introduction of proportional resistances in such pressure
regulates flow paths can, in addition to reservoir and passage
dimensions, provide volumetric controls.
Considering now the specific hemodialysis system which is shown in
the drawings, the sheets which form the disposable component 14
define between themselves a pair of passages 102 and 104
terminating at their left ends, as viewed in FIG. 1, in connections
106 and 108, respectively, adapted to be connected with suitable
liquid-supply lines. Thus, at this part the sheets may have
suitable rigid plastic connecting valves for example, inserted into
the open ends of the passages 102 and 104 sealed to the sheets so
as to form a fluid-tight connection. Flexible tubes may be attached
to the valve connectors 106 and 108 so that sources of water can be
connected with the passages 102 and 104. These sources of water may
be distilled or tap water, for example, or from hot and cold
sources. It will be noted from FIG. 2 that the lower portions of
the passages 102 and 104 register with grooves 110 and 112,
respectively, provided with valves 114 and 116 so that in this way
the source or temperature of liquid can be regulated. The supplied
liquid will flow along the passage 118, part of which registers
with the groove 120 into the water purification reservoir 122
formed by one of the pockets 50 defined between the sheets. This
reservoir 122 communicates through the passage 124, which registers
with the groove 126 into a reservoir 128 which forms a water
reservoir and which registers with the recess 130, at the lower
portion of the reservoir 128. At this part of the apparatus there
is one of the photocell conductivity detectors 36 to transmit a
signal giving information with respect to the level or quantity
water in the reservoir 128. The water purification carried out in
the reservoir 122 will be performed by enclosing within the
reservoir 122 before the sheets are sealed to each other a device
containing filters and suitable chemicals adapted to the particular
nature of the water supplied so as to sterilize and deionize the
water, and provided with characteristics suitable for the purpose
intended. The reservoir 128 communicates through a passage 132 with
a reservoir 134 registering with one of the recesses 28 and adapted
to contain a saline concentrate. The admission of the saline
concentrate, contained in pocked 134 FIG. 1 to the water from
reservoir 128 is controlled by coaction of a value 136 and the
internal structure of the disposable components proportioning
resistances to create uniform mixtures, as will be described
below.
Through this value the reservoir 128 will communicate with a
passage 140 leading to a saline reservoir 142 situated above the
walls of the permanent installation and communicating with an air
trap 144 which in turn communicates through a passage 146 with an
air pressure monitor pocket 148 registering with the recess 150. An
active surface such as the plunger 70 shown in FIG. 3 will sense
the pressure contained within the system reservoir 148 at the
recess 150. It will be noted that part of the passage 146 registers
with the groove 152.
The reservoir 126, at its location above the permanent installation
communicates through a suitable passage with a second air trap 154
defined between the sheets of the disposable component 14 and
communicating through the passage 156, also defined between the
sealed sheets, with the air pressure monitor pocket 148. Through
the combination of these air traps, photocell-conductivity fluid
level detectors 36, and fluid pressure sensitive devices in the
control wall recesses, adequate levels of liquid can be maintained
to supply the functional requirements of the various circuits,
while avoiding the danger of introducing air bubbles into the fluid
circulations.
From the passage 132 purified water flows under hydrostatic
pressure into passage 140 and reservoir 142, and by gravity into a
passage 158 registering with the groove 160. Valves 136 and 164
control the delivery of the purified water to either saline 140, or
dialysate 158, circuits. Valve 164 coacts with the internal
resistance adjustment and predetermined volume of the disposable
component to proportion the mixture of purified water from
reservoir 128 and dialysate concentrate from reservoir 166, under
controlled pressure within recess 168, to form dialysate.
Passage 158 then communicates through the three passages 170, 172,
174, with the dialysate reservoirs 176 and 178. These passages 170,
172, and 174, respectively register with the grooves 180, 182, and
184, which are controlled by the valves 186, 188, and 190, so that
in this way the control of the flow through the various passages
170, 172, and 174 can be regulated to determine the flow of the
dialysate, as it is formed, alternately into the dialysate
reservoirs 176 and 178.
It will be noted that through the passages 172 and 174 the flow can
be controlled to the reservoirs 176 and 178 while through the
passage 170 it is possible to provide for direct flow of the liquid
in this circulation to a waste reservoir 192 in the form of a
pocket defined between the sheets of the disposable component 14.
This waste reservoir 192 has at its left end, as viewed in FIG. 1,
a value 194 through which the contents may be drained.
From the dialysate reservoirs 176 and 178 the liquid can flow
through the passages 192 and 194 into a common passage 196 leading
into a dialyzer 198. It will be noted that the dialyzer 198 can be
a standard device contained between the sheets of disposable
component 14 beneath the wall of the permanent installation. The
passages 192 and 194 respectively register with the grooves 200 and
202. These grooves are respectively provided with control valves
204 and 206. The recesses 208 and 210 respectively register in part
with the dialysate reservoirs 176 and 178 and they are provided
with heating element surfaces 212 and 214 as well as
photocell-conductivity detectors 36 and thermocouples capable of
detecting the nature and level of the dialysate in the reservoirs
176 and 178. In accordance with the characteristics detected in
this way and the programming of the permanent installations to
alternately fill and empty dialysate reservoirs one or the other of
the valves 204 and 206 will be opened to admit the dialysate into
the dialyzer 198. In the dialyzer the blood from the patient will
be treated in a standard manner by dialysis and ultrafiltration
across a suitable membrane. Such a membrane is incorporated into
the dialyzer 198. The dialysate will be pumped by the upper pump
means 32 at the pumping pocket 216 received in the pumping recess
28, so that this liquid will be pumped through the passage 158 back
into the empty dialysate reservoir 176 or 178 thus achieving
recirculation if desired, or to waste. Between the dialyzer 198 and
the pump reservoir 216 is a passage 220 which communicates through
a pocket 222 with the pump reservoir 216. At this pocket 222 is the
recess 224 of the rear wall 18, and at this recess is located a
suitable standard hemoglobin detector carried by the rear housing
56.
A dialysate purification reservior 226 is defined between the
sheets of the disposable component 14 and registers with the recess
228 shown in FIG. 2. The rear wall carries at the connection
between the recess 228 and the recess 224 the valves 230 and 232 so
that in this way the flow from the dialysate purification pocket
along the recirculating passage 234 can be regulated. This passage
234 registers with the groove 236 shown in FIG. 2, and it will be
noted that an additional valve 238 is provided to control the flow
through the passage 234.
Thus, through control of the operation of the valves 232 and 238,
with suitable settings of the operating buttons at the control
panel 20, it is possible to circulate the dialysate through the
dialysate purification reservoir 226, containing suitable exchange
and binding resins, chemicals and reagents to regenerate used
dialysate. These components of the procedure, as well as all the
others such as saline and dialysate concentrates, and the reagents
necessary for appropriate chemical anaylsis within the sealed
analyzer unit 276, are situated at locations destined to form
pockets or reservoirs according to the predesigned patterns and
flows and fluid manipulations necessary to perform the selected
procedure, preliminary to sealing the flexible plastic sheets to
each other to form the disposable component.
All of the above detailed description in connection with the
specific example of a hemodialysis system relates to the features
which are used in connection with obtaining and circulating of
dialysate. It is of course also required to provide an
extracorporeal circuit and suitable safety monitoring, for the
blood of the patient so that the blood can pass through the
dialyzer for treatment, and then be returned to the patient. For
this purpose the sheets which form the component 14 are heated
sealed to define a passage 240 formed with an inlet connection to
receive the flexible line 242 which is connected in standard ways
with the blood system of the patient in the manner shown
schematically in FIG. 1. In this way blood from the patient will
enter into the hemodialysis system. The lower pump means 32 which
has the pumping rollers 76 moving horizontally from the left toward
the right, as viewed in FIGS. 2 and 3, communicates with the
passage 240 through a passage 243 defined between the sheets due to
the sealing thereof. These passages 240 and 242 respectively
register with the vertical and horizontal grooves 244 and 246
formed in front surface of the rear wall 18, as shown in FIG.
2.
The saline reservoir 142 communicates with the passage 243 to allow
saline priming of the extracorporeal circuit, through a vertically
extending passage 248 which registers with the vertical groove 250
formed in the front surface of the rear wall 18. Thus, the blood
will be pumped into the passage 252 formed between the sheets of
disposable component 14, and in this way the blood will reach the
dialyzer 198. This passage 252 which receives the blood registers
in part with a groove 254 provided with an enlarged recess portion
256 where a blood pump pressure monitor is mounted within the
housing 56 so as to detect the pressure of the blood pumped by the
lower pump means 32.
The pumped blood will thus flow through the dialyzer 198 in
countercurrent to the dialysate, with the processing taking place
through a suitable membrane within the dialyzer 198, as is well
known, and then the blood will reach the dialyzer outlet passage
258 defined between the sheets of disposable component 14 through
the sealing pattern. This passage 258 communicates with a reservoir
260 formed by a pocket defined between the sealed sheets, and this
reservoir will register with the recess 262 formed in the front
surface of the rear wall 18. The upper part of the passage 258 will
register with the groove 264. The reservoir 260 forms on the one
hand a bubble trap and on the other hand a blood return line
monitor. For this purpose there are a pair of photocells and
electrical conductivity detectors 266 and 268 carried by the rear
housing 56 and communicating with the interior of the recess 262 so
that the level of the blood returning to the patient in the
reservoir 260 can be detected, thus preventing air embolism from
occurring. The pressure of returning blood is monitored by detector
300. From the blood monitoring reservoir 260 the blood returns to
the patient through a passage 270 defined between the sheets of the
component 14 and placed in communication with a flexible line 272
which again is connected with the patient, as shown schematically
in FIG. 1.
However, part of the blood may be delivered through a passage 274
into a blood analyzer 276 defined between the sheets. The passage
274 registers with a groove 278 in the front surface of the rear
wall 18, and at this point there is a valve 280 which can be
controlled from the panel 20 so as to regulate the flow of blood
into the analyzer portion of the disposable component 276 which
registers with the recess 282 formed in the front surface of the
rear wall 18.
The analyzer component contains fluid passages and reservoirs, as
well as pockets for reagents, and structures suitable to perform
the manipulations necessary for chemical analysis of significant
characteristics of the dialyzed blood. These operations of flow,
mixing, proportioning, filtration, dialysis and so forth, are
performed in a manner similar to the procedures of hemodialysis,
but on a smaller scale, and can be adapted, as well, to function
independently from such large units as the hemodialysis system, as
a means of automating laboratory testing.
The passage 240 communicates also with a reservoir 284 which
contains suitable anticoagulant material to be fed to the passage
242 in order to flow with the blood so as to prevent coagulation
thereof. For example a suitable stabilized heparin composition may
be initially located within the pocket 284 and controlled by a unit
in the housing 56 so as to feed to the blood flowing the dialyzer a
sufficient amount of anticoagulant in order to keep the blood
flowing freely at all times through the apparatus.
It is thus possible with the above structures of the invention to
carry out hemodialysis in a fully automatic manner, achieving
through computer information processing techniques a considerable
amount of precise control in a manner which heretofore required the
operations of skilled personnel and expensive equipment. All of the
relatively expensive components form part of the permanent
installation 12 while the disposable component 14 is quite
inexpensive to manufacture. The sheets are heat sealed to each
other to define the predetermined reservoirs and flow paths and to
contain in certain pockets suitable reagents, and this inexpensive
disposable component 14 can readily be mounted on the permanent
installation in a manner described above. The operator need only
connect the connections 106 and 108 to suitable sources of water,
and after the saline and dialysate have been provided in a suitable
manner between the sheets of component 14 the lines 242 and 272 are
connected with the patient and the hemodialysis can then proceed.
After the operations are completed all of the lines are
disconnected and the component 14 may be removed to replace by
another component to be used with the next patient. The removed
component 14 may be preserved or it may be discarded. With this
system of the invention it is possible for unskilled and relatively
untrained individuals to be given simple instructions for
initiating the sequential operations necessary to perform a complex
procedure such as hemodialysis. These may be reinforced by the
internal programming of the unit, and by indicator lights
associated with the control buttons 22 and 24. The mounting of the
component 14 on the permanent installation becomes fairly
automatic, and the same is true of the connection of the water and
blood lines. Therefore, this system accomplishes its prime
objective, the speeding and simplification of procedures
necessarily performed by human actions in providing complex medical
diagnostic or therapeutic techniques. The invention shown utilizing
this system, is extremely well suited for hemodialysis treatments
to be performed by patients at home, a development that has been
found necessary if all patients requiring this form of treatment
are to have it made available.
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