U.S. patent number 3,620,215 [Application Number 05/041,312] was granted by the patent office on 1971-11-16 for apparatus for peritoneal dialysis.
This patent grant is currently assigned to LKB Medical AB, Bromma, SE. Invention is credited to Jan Erik Tysk, Nils Bertil Jacobson, Sven Olofsson.
United States Patent |
3,620,215 |
|
November 16, 1971 |
APPARATUS FOR PERITONEAL DIALYSIS
Abstract
An apparatus for peritoneal dialysis treatment of a patient
operating automatically in accordance with a predetermined program
comprising a plurality of successive dialysis cycles each
consisting of a fill-phase during which fresh dialysis fluid is
introduced into the peritoneal cavity of the patient, a
dialysis-phase during which the dialysis fluid remains in the
peritoneal cavity, and a drain-phase during which the used dialysis
fluid is withdrawn from the peritoneal cavity of the patient. The
apparatus comprises two identical measuring vessels having lower
fluid connections, which through fluid valve means can be connected
alternatively to a supply conduit for fresh dialysis fluid, a
discharge conduit for used dialysis fluid and a patient conduit
connected to the patient being treated, and upper air connections,
which can be connected alternatively to the delivery side and the
suction side of an air pump. During the fill-phase, when fresh
dialysis fluid is introduced into the patient, fresh dialysis fluid
is sucked under vacuum into one of the measuring vessels from the
supply conduit at the same time as fresh dialysis fluid is
discharged under pressure from the other measuring vessel into the
patient conduit and this takes place alternatingly for the two
measuring vessels. During the drain-phase, when used dialysis fluid
is withdrawn from the patient, used dialysis fluid is sucked under
vacuum into one of the measuring vessels from the patient conduit
at the same time as used dialysis fluid is discharged under
pressure from the other measuring vessel into the discharge conduit
and this takes place alternatingly for the two measuring
vessels.
Inventors: |
Jan Erik Tysk (Stockholm,
SE), Sven Olofsson (Skalby, SE), Nils Bertil Jacobson
(Solna, SE) |
Assignee: |
LKB Medical AB, Bromma, SE
(N/A)
|
Family
ID: |
20272584 |
Appl.
No.: |
05/041,312 |
Filed: |
May 28, 1970 |
Foreign Application Priority Data
Current U.S.
Class: |
604/29 |
Current CPC
Class: |
A61M
1/28 (20130101); A61M 1/282 (20140204) |
Current International
Class: |
A61M
1/28 (20060101); A61m 005/00 () |
Field of
Search: |
;128/1,213,214R,214B,214.2,348,350,230 |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
Boen et al., Trans. Amer. Soc. Art. Inter. Orgs. Vol. VIII, 1962
pp. .
256-262 (copy in Gp. 335).
|
Primary Examiner: Dalton L. Truluck
Attorney, Agent or Firm: Waters, Roditi, Schwartz &
Nissen
Claims
What we claim is:
1. An apparatus for peritoneal dialysis comprising two identical
measuring vessels (M1,M2) each vessel being provided with a lower
fluid connection (1,3) at its lower end and an upper air connection
(2,4) at its upper end each vessel further having a lower fluid
level detector (E1,D1,E3,D3) adjacent said lower fluid connection
and an upper fluid level detector (E2,D2,E4,D4) adjacent said upper
air connection; an air pump (16) having a delivery side and a
suction side; air valve means (V7,V8) alternatingly connecting the
delivery side (15) of said air pump to said upper air connection of
one of said measuring vessels and at the same time the suction side
(17) of said air pump to said upper air connection of the other
measuring vessel or vice versa respectively; a patient conduit (L3)
provided for connection to a patient to be treated; first fluid
valve means (V5,V6) for connecting said patient conduit to said
lower fluid connection (1,3) of alternatingly the one or the other
measuring vessel respectively; a supply conduit (L1) for fresh
dialysis fluid and a discharge conduit (L2) for used dialysis
fluid; second fluid valve means (V1,V2,V3,V4) for connecting
alternatingly said supply conduit or said discharge conduit to said
lower fluid connection (1,3) of alternatingly the one or the other
measuring vessel respectively; and a programmed control unit (S)
responsive to said fluid level detectors (D1 to D4) for operating
said air valve means and said first and second fluid valve means in
such a manner that to introduce fresh dialysis fluid to the patient
being treated, fresh dialysis fluid is sucked into one of said
measuring vessels from said supply conduit through said second
fluid valve means until said upper fluid level detector of said
measuring vessel indicates that the vessel is filled and at the
same time dialysis fluid is discharged under pressure from the
other measuring vessel to said patient conduit through said first
fluid valve means until said lower fluid level detector of said
other vessel indicates that said other vessel is emptied,
whereafter fresh dialysis fluid is sucked into said emptied
measuring vessel from said supply conduit through said second fluid
valve means and at the same time dialysis fluid is discharged under
pressure from the filled measuring vessel to said patient conduit
through said first fluid valve means, and so on in alternating
sequences, whereas to withdraw used dialysis fluid from the patient
being treated used dialysis fluid is sucked into one of said
measuring vessels from said patient conduit through said first
fluid valve means until said upper fluid level detector of said
vessel indicates that said vessel is filled and at the same time
dialysis fluid is discharged under pressure from the other
measuring vessel to said discharge conduit through said second
fluid valve means until said lower fluid level detector of said
other vessel indicates that said other vessel is emptied,
whereafter used dialysis fluid is sucked into the emptied measuring
vessel from said patient conduit through said first fluid valve
means and at the same time dialysis fluid is discharged under
pressure from the filled measuring vessel to said discharge conduit
through said second fluid valve means, and so on in alternating
sequences.
2. An apparatus as claimed in claim 1, comprising a first
reversible counter (R2) responsive to said fluid level detectors
(D2,D4) for counting in its one direction, when fresh dialysis
fluid is being introduced to the patient, the number of measuring
vessels filled with fresh dialysis fluid being discharged under
pressure into said patient conduit and for counting in its opposite
direction, when used dialysis fluid is being withdrawn from the
patient, the number of measuring vessels filled with used dialysis
fluid being sucked out from said patient conduit.
3. An apparatus as claimed in claim 2, comprising storing means
(ST) and gating means (G) controlled by said control unit (S) for
transferring the count in said first counter (R2) to said storing
means after used dialysis fluid has been withdrawn from the patient
and before fresh dialysis fluid is once more introduced into the
patient.
4. An apparatus as claimed in claim 3, comprising display means
(I2) for displaying the count stored in said storing means
(ST).
5. An apparatus as claimed in claim 2, comprising display means for
displaying the instantaneous count in said first counter (R2).
6. An apparatus as claimed in claim 1, comprising a second counter
(R1) being presetable to a predetermined variable count and
responsive to said fluid level detectors (D2,D4) when fresh
dialysis fluid is being introduced into the patient to count the
number of measuring vessels filled with dialysis fluid being
introduced into the patient and connected to said control unit (S)
to cause said control unit to interrupt the introduction of fresh
dialysis fluid into the patient when it reaches said predetermined
count.
7. An apparatus as claimed in claim 6, wherein said second counter
(R1) is responsive to said fluid level detectors (D2,D4) also when
used dialysis fluid is being withdrawn from the patient to count
the number of measuring vessels filled with used dialysis fluid
being withdrawn from the patient and is provided to prevent said
control unit (S) from interrupting the withdrawal of used dialysis
fluid from the patient before it has counted a number of measuring
vessels equal to said predetermined count.
8. An apparatus as claimed in claim 2, wherein said control unit
(S) is provided to interrupt the introduction of fresh dialysis
fluid to the patient at a stage when both measuring vessels (M1,M2)
are empty.
9. An apparatus as claimed in claim 1, comprising first presetable
timing means (T1) connected to said control unit (S) for
determining a time interval between an introduction of fresh
dialysis fluid into the patient and a subsequent draining of said
dialysis fluid from the patient.
10. An apparatus as claimed in claim 1, comprising second
presetable timing means (T2) connected to said control unit (S) for
determining a minimum duration of the draining of used dialysis
fluid from the patient.
11. An apparatus as claimed in claim 1, wherein said upper air
connections (2,4) of said measuring vessels (M1,M2) are connected
to said air valve means (V7,V8) through moisture traps (11,12) and
germ filters (13,14).
12. An apparatus as claimed in claim 1, comprising a heating device
for heating fresh dialysis fluid flowing through said supply
conduit (L1) to a predetermined temperature, said heating device
including a metal pipe (6) forming a portion of said supply
conduit, a controlled electric current source (7) having its output
terminals connected to opposite ends of said metal pipe, and a
temperature transducer (10) for measuring the temperature of said
metal pipe at a point adjacent the downstream end of the pipe and
for controlling the output current of said current source.
13. An apparatus as claimed in claim 1, wherein said two measuring
vessels (M1,M2), said patient conduit (L3), said supply conduit
(L1), said discharge conduit (L2) and any connecting conduits (L4
to L8) between said conduits and said measuring vessels form a
dispensable assembly intended only for one-time use, said
dispensable assembly being removably mounted in a predetermined
position on an apparatus panel (31) provided with a number of tube
clamps operated by said control unit (S) for clamping said conduits
mounted on said apparatus panels so as to form said first and
second fluid valve means, said conduits consisting of flexibly
compressible tubes at least opposite to said tube clamps.
14. An apparatus as claimed in claim 13, wherein said lower fluid
connections (1,3) of said two measuring vessels (M1,M2) are
connected to said patient conduit (L3) through a first branch
conduit (L4,L5) each, said first branch conduits including each one
stop valve (V6,V5) forming said first fluid valve means, and are
connected to a junction (L8) through a second branch conduit (L6,
L7) each, said second branch conduits including each one stop valve
(V4,V3), and said supply conduit (L1) and said discharge conduit
(L2) are connected through each one stop valve (V1,V2) to said
junction (L8), said last mentioned stop valves together with said
stop valves in said second branch conduits forming said second
fluid valve means.
Description
The present invention is related to an apparatus for peritoneal
dialysis.
The purpose of a peritoneal dialysis as of any other dialysis
method is to remove from a patient having an insufficient renal
function the excess water and the waste products that would
normally be removed from the body due to the renal function of the
patient. At a peritoneal dialysis this is obtained in that a
dialysis fluid, essentially consisting of a solution of various
salts, is introduced into the peritoneal cavity of the patient,
where it remains for a predetermined time. The peritoneum of the
patient functions then as a semipermeable membrane which permits
the passage of waste products and also some water to the dialysis
fluid. Thereafter the used dialysis fluid, now containing waste
products and some excess water from the patient, is drained from
the peritoneal cavity. Thus, a complete dialysis cycle comprises a
fill-phase during which fresh dialysis fluid is introduced into the
peritoneal cavity of the patient, a dialysis-phase during which the
dialysis fluid remains in the peritoneal cavity, and a drain-phase
during which the used dialysis fluid is drained from the patient.
Each such complete dialysis cycle requires a time of about 15 to 75
minutes and the volume of dialysis fluid introduced into the
patient during the fill-phase is of the magnitude 0.5 to 2 liters.
For a complete dialysis treatment a total volume of dialysis fluid
of the magnitude of 60 liters must be supplied to the patient,
wherefore it is obvious that a complete dialysis treatment takes a
considerable time. Therefore, if peritoneal dialysis treatments are
to be used in any considerable extent, an apparatus is necessary by
means of which the dialysis treatment can be carried out
substantially completely automatically according to a preset
program, while full safety for the patient is maintained, so that
the dialysis treatment does not require any constant supervision of
the patient from the hospital staff. However, several comparatively
severe demands are imposed upon such an automatically operating
apparatus for peritoneal dialysis. Thus, the dialysis fluid
introduced into the patient must be heated to body temperature and
de-aired. Further, during each fill-phase an accurately
predetermined volume of dialysis fluid must be introduced and
during the subsequent drain-phase it must be safeguarded that at
least an equally large volume of fluid is drained from the patient
before a new fill-phase is started. Furthermore, during the
complete dialysis treatment it must be possible to check the fluid
balance of the patient, that is the difference between the total
volume of fluid that has been introduced into the patient and the
total volume of fluid that has been drained from the patient during
the completed portion of the dialysis treatment. For a complete
dialysis treatment, during which as mentioned above totally about
60 liters of dialysis fluid are introduced into the patient, said
difference volume amounts to some liters and it is required that
this volume can be determined with an error less than one-tenth of
a liter. Consequently, it is appreciated that it must be possible
to measure very accurately the fluid volumes introduced into and
drained from the patient respectively. Further, it must be
safeguarded that no infectious matter can be transferred from one
patient to another through the dialysis apparatus. However, it
should be possible to safeguard this without any time- and
work-consuming cleaning and sterilization steps between different
dialysis treatments.
All the requirements discussed above are satisfied in a very
efficient way by means of an apparatus for peritoneal dialysis
according to the present invention.
The apparatus according to the invention is characterized in that
it comprises two identical measuring vessels each provided with a
lower fluid connection at its lower end and an upper air connection
at its upper end and with a lower fluid level detector adjacent
said lower fluid connection and an upper fluid level detector
adjacent said upper air connection; an air pump with a delivery
side and a suction side; air valve means for connecting
alternatingly the delivery side of said air pump to said upper air
connection of the one measuring vessel and simultaneously the
suction side of said air pump to said upper air connection of the
other measuring vessel and vice versa; a patient conduit provided
for connection to a patient to be treated; first fluid valve means
for connecting said patient conduit to said lower fluid connection
of alternatingly the one and the other measuring vessel; a supply
conduit for fresh dialysis fluid and a discharge conduit for used
dialysis fluid; second fluid valve means for connecting
alternatingly said supply conduit and said discharge conduit to
said lower fluid connection of alternatingly the one or the other
measuring vessel; and programmed control means responsive to said
fluid level detectors for controlling said air valve means and said
first and second fluid valve means in such a way that
to introduce fresh dialysis fluid into the patient fresh dialysis
fluid is sucked into one of said measuring vessels from said supply
conduit through said second fluid valve means until said upper
fluid level detector of said measuring vessel indicates that the
vessel is full and at the same time dialysis fluid is discharged
under pressure from the other measuring vessel to said patient
conduit through said first fluid valve means until said lower fluid
level detector of said other vessel indicates that the vessel is
empty, whereafter fresh dialysis fluid is sucked into the emptied
measuring vessel from said supply conduit through said second fluid
valve means and at the same time dialysis fluid is discharged under
pressure from the filled measuring vessel to said patient conduit
through said first fluid valve means, and so on in alternating
sequences,
whereas to drain used dialysis fluid from the patient used dialysis
fluid is sucked into one of said measuring vessels from said
patient conduit through said first fluid valve means until said
upper fluid level detector of said vessel indicates that the vessel
is full and at the same time dialysis fluid is discharged under
pressure from the other vessel to said discharge conduit through
said second fluid valve means until said lower fluid level detector
of said other vessel indicates that the vessel is emptied,
whereafter used dialysis fluid is sucked into the emptied vessel
from said patient conduit through said first fluid valve means and
at the same time the dialysis fluid in said filled vessel is
discharged under pressure into said discharge conduit through said
second fluid valve means and so on in alternating sequences.
As the apparatus according to the invention comprises two identical
measuring vessels and the introduction of fresh dialysis fluid into
the patient during the fill-phase of a dialysis cycle as well as
the draining of the used dialysis fluid from the patient during the
drain-phase of the dialysis cycle is carried out in that the
dialysis fluid is sucked by means of a vacuum into one of the
measuring vessels and subsequently by means of overpressure is
discharged again from the measuring vessel and this takes place
simultaneously and alternatingly for both measuring vessels, it
becomes possible during the fill-phase as well as the drain-phase
to determine in a simple and in spite of this accurate manner the
volume of fresh dialysis fluid being introduced into the patient
and the volume of used dialysis fluid being drained from the
patient respectively by quite simply counting the number of
measuring vessels filled with fluid that are being supplied to or
drained from the patient respectively. As the same measuring
vessels and the same "pumping operation" is used both during the
fill-phase and the drain-phase and additionally the volume of the
measuring vessels can be small as compared with the total volume of
fluid being pumped during a complete dialysis treatment, the
measuring errors can be kept very small. By using two measuring
vessels it is also obtained that the supply of dialysis fluid to
the patient during the fill-phase as well as the draining of used
dialysis fluid from the patient during the drain-phase is
continuous.
The automatization of the operation of the apparatus is also
comparatively easy in that each measuring vessel is provided with
an upper fluid level detector indicating when the vessel is filled
and a lower fluid level detector indicating when the vessel is
emptied; the signals from these fluid level detectors being usable
as control signals for a preprogrammed logic control unit which
controls the fluid valves determining the fluid flow between the
measuring vessels, the patient conduit, the supply conduit for
fresh dialysis fluid and the discharge conduit for used dialysis
fluid as well as the air valves determining the connection of the
air pump to the measuring vessels.
As in an apparatus according to the invention the dialysis fluid
comes into contact only with the two measuring vessels, the patient
conduit, the supply conduit for fresh dialysis fluid, the discharge
conduit for the used dialysis fluid and the pipe connections
between these fluid conduits and as the fluid valves controlling
the fluid flow between the different conduits and the measuring
vessels may preferably consist of tube clamps, which from the
outside pinch the conduits which consist of resiliently
compressible tubes at least opposite said tube clamps, those parts
of the apparatus that are brought in contact with the dialysis
fluid may without any technical or economical difficulties be
constructed and manufactured as a dispensable set for "one-time"
use only, which is readily mounted on an apparatus panel provided
with the controlled tube clamps and necessary electrical contacts,
for instance for the fluid level detectors of the measuring
vessels, and which after each dialysis treatment is discarded and
replaced with a new set. In this way a full guarantee is obtained
against a transfer of infectious matter from one patient to another
without any cleaning or sterilization of complicated apparatus
components being necessary.
In the following the invention will be further described with
reference to the accompanying drawing in which
FIG. 1 is a simplified diagram illustrating an apparatus for
peritoneal dialysis according to the invention;
FIG. 2 is a schematic perspective view of the control and
instrument panel of the dialysis apparatus with a dispensable
one-time-use set mounted thereon; and
FIG. 3 illustrates a modification of the apparatus illustrated in
FIG. 1.
In the diagram of FIG. 1 fluid conduits are illustrated with double
lines, air conduits with single solid lines, electrical signal
conductors with broken lines and electrical power conductors with
dash-and-dot lines.
The dialysis apparatus according to the invention illustrated in
FIG. 1 comprises two identical measuring vessels M1 and M2. Each
vessel is provided with a lower conduit or tube connection 1 and 3
respectively and an upper conduit or tube connection 2 and 4
respectively. Preferably the vessels are shaped to have a
relatively small cross-sectional area close to said tube
connections. At its lower tube connection 1 each vessel is provided
with an annular electric electrode E1 and E3 respectively. In a
similar manner an annular electric electrode E2 and E4 respectively
is provided at the upper tube connection of each vessel. A third
electric electrode E5 and E6 projects from above into each vessel
so that the lower tip of this electrode is positioned close to the
lower annular electrode E1 or E3 respectively. The electrodes E1,
E2 and E5 in the measuring vessel M1 are connected to two detector
units D1 and D2, which sense the resistance between the electrodes
E1 and E5 and the resistance between the electrodes E2 and E5
respectively. The detector D1 is designed to provide a signal on
its output when the resistance between the electrodes E1 and E5
displays a stepwise increase, that is when the electrically
conducting dialysis fluid sinks so far in the measuring vessel M1
that the fluid surface reaches the annular electrode E1. The
detector D2 is designed to provide a signal on its output when the
resistance between the electrodes E2 and E5 displays a stepwise
decrease, that is when the dialysis fluid rises so high in the
measuring vessel M1 that the fluid surface reaches the annular
electrode E2. Thus the fluid level detector D1 indicates when the
measuring vessel M1 is empty, whereas the fluid level detector D2
indicates when the measuring vessel M1 is filled. In the same way
the electrodes E3, E4 and E6 in the other measuring vessel M2 are
connected to two fluid level detectors D3 and D4, of which the
detector D3 provides an output signal when the measuring vessel M2
is emptied, whereas the detector D4 provides an output signal when
the measuring vessel M2 is filled.
The dialysis apparatus comprises additionally a supply conduit L1
for fresh dialysis fluid from a source of dialysis fluid not shown
in the drawing, a discharge conduit L2 for used dialysis fluid that
has been drained from the patient and a patient conduit L3 provided
to be connected to the patient to be treated, for instance by means
of a catheter inserted into the peritoneal cavity of the patient.
The lower connections 1 and 3 of the measuring vessels M1 and M2
respectively are through branch conduits L4 and L5 respectively
connected to the patient conduit L3 and through additional branch
conduits L6 and L7 respectively to a conduit junction L8, to which
also the supply conduit L1 and the discharge conduit L2 are
connected. The two branch conduits L4 and L5 from the patient
conduit L3 are provided with a stop valve V6 and V5 respectively
illustrated only schematically in the drawing but consisting of
electrically controlled tube clamps which can clamp their
associated conduits from the outside and interrupt the fluid flow
through the conduits, which consist of resiliently compressible
tubes or hoses at least opposite these tube clamps. In the same way
the branch conduits L6 and L7 are provided with stop valves V4 and
V3 respectively consisting of electrically controlled tube clamps.
Also the supply conduit L1 and the discharge conduit L2 are
provided with such electrically controlled tube clamps V1 and V2
respectively.
For the heating of the fresh dialysis fluid supplied through the
conduit L1 to a predetermined desired temperature a heating device
is provided, which includes a metal pipe 6, as for instance of
stainless steel, forming a portion of the supply conduit L1. The
heating device includes also a controlled electric current source 7
having a power output which can be connected to opposite ends of
the metal pipe 6 by means of electrical terminals 8 and 9. Thus,
the fresh dialysis fluid flowing through the metal pipe 6 is heated
by the electric current from the current source 7 passing through
the metal pipe 6. The temperature of the dialysis fluid is measured
at the downstream end of the metal tube 6 by means of a suitable
temperature transducer 10, for instance consisting of thermocouple,
which measures the temperature of the metal tube 6 and which is
connected to the controlled current source 7 so as to control the
output power of the current source, whereby the fresh dialysis
fluid supplied to the apparatus is maintained on a predetermined
desired temperature.
The upper connections 2 and 4 of the measuring vessels M1 and M2
respectively are through moisture traps 11 and 12 respectively and
germ filters 13 and 14 respectively connected to two electrically
operated valves V7 and V8 respectively. The valve V7 is connected
through a pipe 15 to the delivery side of an air pump 16, whereas
the valve V8 is connected through a pipe 17 to the suction side of
the pump 16. An expansion tank 18 and a variable relief valve 19
are connected to the pressure pipe 15. In a similar manner an
expansion tank 20 is connected to the vacuum pipe 17. A variable
vacuum regulator 21 and a pressure gauge 22 are also connected to
the vacuum pipe 17 through an electrically operated valve V9. The
vacuum pipe 17 communicates also with the ambient atmosphere
through a throttle passage 36 which is adjusted to determine the
maximum vacuum in the pipe 17.
All the fluid valves V1 to V6 as well as all the air valves V7, V8
and V9 are controlled from a programmed control unit S. For the
sake of simplicity the control signal connections between the
various valves and the control signal outputs 23 of the control
unit are not shown in the drawing. The control unit S can be
constructed with the use of conventional components and
conventional technique, wherefore it is not illustrated in detail
in the drawing.
The control unit S is primarily responsive to and controlled by the
output signals from the fluid level detectors D1, D2, D3 and D4.
Additionally the control unit S receives control signals from a
counter R1 and two variable timers T1 and T2. The counter R1 is a
reversible counter which can count in both directions and is
provided with a first input 24 for drive pulses when counting in
the one direction and a second input 25 for drive pulses when
counting in the opposite direction. As described in the foregoing,
the upper fluid level detector D2 of the measuring vessel M1
provides an output signal each time the measuring vessel M1 has
been filled with dialysis fluid. In the same way the upper fluid
level detector D4 for the other measuring vessel M2 provides an
output signal each time this measuring vessel M2 has been filled
with dialysis fluid. The output signals from these two fluid level
detectors D2 and D4 can be supplied through a switch S1
alternatively to the first input 24 or the second input 25 of the
counter R1. The switch S1 is operated by the control unit S so as
to be in the position illustrated in the drawing during the
fill-phase of a dialysis cycle, that is when fresh dialysis fluid
is pumped into the patient, whereas it is in the opposite position
during the drain-phase of the dialysis cycle, that is when the used
dialysis fluid is drained from the patient. Consequently, it is
appreciated that during the fill-phase of a dialysis cycle the
counter R1 will count in its one direction the number of measuring
vessels being filled with fresh dialysis fluid to be pumped into
the patient, whereas during the drain-phase of the dialysis cycle
the counter counts in its opposite direction the number of
measuring vessels being filled with used dialysis fluid drained
from the patient. The counter R1 is provided with a manually
presetable output 26 on which an output signal is provided when the
counter R1 during the fill-phase of a dialysis cycle reaches the
count, i.e. has counted the number of filled measuring vessels,
corresponding to the presetting of the output 26. This output
signal from the counter output 26 activates the control unit S to
interrupt the fill-phase of the dialysis cycle, that is the supply
of fresh dialysis fluid to the patient. The counter R1 is also
provided with an output 27 from its O-stage, on which output a
signal is provided when the counter R1 during the drain-phase of a
dialysis cycle has counted the same number of filled measuring
vessels as during the preceding fill-phase of the same dialysis
cycle. The control unit S is designed not to be able to interrupt
the drain-phase of the dialysis cycle, that is the draining of used
dialysis fluid from the patient, until it has received a signal
from the output 27 of the counter R1. In this way it is safeguarded
that at least an equal number of measuring vessels with used
dialysis fluid is drained from the patient during the drain-phase
as the number of measuring vessels with fresh dialysis fluid that
has been pumped into the patient during the preceding
fill-phase.
The length or duration of the fill-phase is consequently determined
by the presetting of the counter R1, that is by the number of
measuring vessels with dialysis fluid one wishes to pump into the
patient during each dialysis cycle. The length or duration of the
dialysis-phase subsequent to the fill-phase is determined by the
setting of the timer T1, whereas the length of the drain-phase is
determined by the setting of the timer T2. However, as mentioned
above, the drain-phase cannot be interrupted until a signal is
provided on the output 27 of the counter R1 even if the time preset
in the timer T2 should run out before said signal has been
provided. For determining the length of the dialysis-phase and the
drain-phase respectively the control unit S may for instance
include a pulse counter provided to count a predetermined number of
pulses during the dialysis-phase and a predetermined number of
pulses during the drain-phase, in which case the two presetable
timers T1 and T2 consist of pulse generators with variable pulse
frequency, the output pulses of which are used for driving the
pulse counter in the control unit S during the dialysis-phase and
the drain-phase respectively. An indicating instrument I1 is
connected to the control unit S for indicating the stage of the
program, that is the dialysis cycle, in which the apparatus is
currently operating.
The output signals from the fluid level detectors D2 and D4
counting the number of filled measuring vessels during the
fill-phase and the drain-phase can also be connected through a
switch S2 alternatively to the one input 28 and the second input 29
respectively of a reversible counter R2. The switch S2 is operated
by the control unit S so as to be in the position shown in the
drawing during the fill-phase of a dialysis cycle and in its
opposite position during the drain-phase. Consequently, the count
in this counter R2 will continuously correspond to the difference
between the total number of measuring vessels filled with fresh
dialysis fluid that has been supplied to the patient and the total
number of measuring vessels filled with used dialysis fluid that
has been drained from the patient during the completed portion of a
dialysis treatment. Thus, the count in the counter R2 represents
the instantaneous fluid balance of the patient. The count in the
counter R2 can be transferred through a gate G to a store ST. The
gate G is controlled by the control unit S so as to open after the
drain-phase of each dialysis cycle before the fill-phase of the
next dialysis cycle. Consequently, the count stored in the store S2
represents the accumulated fluid balance of the patient before the
beginning of the current dialysis cycle. An indicating instrument
I2 is connected to the store ST for indicating this accumulated
fluid balance. By means of a manually operated switch S3 the
instrument I2 may be temporarily connected to the output of the
counter R2 for indicating the instantaneous fluid balance of the
patient during the current dialysis cycle.
FIG. 1 shows the apparatus during a fill-phase, that is when fresh
dialysis fluid is pumped into the patient, when fresh dialysis
fluid is being sucked into the measuring vessel M1 from the supply
conduit L1 at the same time as fresh dialysis fluid is being
discharged under pressure from the other measuring vessel M2
through the patient conduit L3 to the patient.
When the apparatus is started for the fill-phase of the first
dialysis cycle of a dialysis treatment, both measuring vessels M1
and M2 as well as all conduits L1 to L8 are empty. The valves V7,
V8 and V9 are in the positions illustrated in FIG. 1 so that a
vacuum exists in the measuring vessel M1, whereas an overpressure
exists in the measuring vessel M2. The overpressure in the pressure
pipe 15 is determined by the relief valve 19, whereas the vacuum in
the vacuum pipe 17 is as low as the pump 16 can make it. The tube
clamps V2, V3, V5 and V6 are closed, whereas the tube clamps V1 and
V4 are open, whereby the supply conduit L1 for fresh dialysis fluid
communicates with the lower connection 1 of the measuring vessel
M1. Consequently, fresh dialysis fluid is sucked from the supply
conduit L1 into the measuring vessel M1 by the vacuum in this
measuring vessel. When the fluid surface in the measuring vessel M1
reaches the upper electrode E2, the upper fluid level detector D2
provides a signal as described in the foregoing indicating that the
measuring vessel M1 is filled. This output signal is supplied to
both counters R1 and R2, which consequently count one filled
measuring vessel, and also to the control unit S, which closes the
tube clamp V4 so that the communication between the filled
measuring vessel M1 and the supply conduit L1 is interrupted, opens
the tube clamp V6 so that the filled measuring vessel M1 is instead
connected to the patient conduit L3, and opens the tube clamp V3 so
that the other measuring vessel M2 is connected to the supply
conduit L1. At the same time the air valves V7 and V8 are switched
to their opposite positions so that the measuring vessel M2 is put
under vacuum, whereas the measuring vessel M1 is put under
overpressure. Therefore, fresh dialysis fluid from the supply
conduit L1 will now be sucked into the empty measuring vessel M2,
whereas the dialysis fluid in the previously filled measuring
vessel M1 is discharged into the patient conduit L3 to the patient.
The overpressure in the pressure pipe 15 and the vacuum in the
vacuum pipe 17 are such that the filling of the measuring vessel M2
requires less time than the discharging of the measuring vessel M1.
When the measuring vessel M2 is filled with fresh dialysis fluid up
to its upper electrode E4, the upper fluid level detector D4
provides an output signal, whereby the counters R1 and R2 count one
more filled measuring vessel at the same time as the control unit S
is caused to close the tube clamp V3 so that the connection between
the supply conduit L1 and the now filled measuring vessel M2 is
interrupted. When somewhat later the measuring vessel M1 has been
emptied to such an extent that the fluid level in the vessel has
reached the lower electrode E1, the lower fluid level detector D1
provides a signal to the control unit S indicating that the
measuring vessel M1 is emptied. The control unit S closes then the
tube clamp V6 so that the connection between the measuring vessel
M1 and the patient conduit L3 is interrupted, opens the tube clamp
V5 so that instead the filled measuring vessel M2 is connected to
the patient conduit L3, and opens the tube clamp V4 so that the
emptied measuring vessel M1 is connected to the supply conduit L1.
Simultaneously the two valves V7 and V8 are returned to the
positions shown in the drawing so that the measuring vessel M1 is
once more put under vacuum, whereas the measuring vessel M2 is put
under overpressure. Thus, the dialysis fluid in the filled
measuring vessel M2 will be discharged under pressure into the
patient conduit L3, whereas fresh dialysis fluid from the supply
conduit L1 is sucked into the empty measuring vessel M1. This
alternating sequence with fresh dialysis fluid from the conduit L1
being sucked into one of the measuring vessels while at the same
time dialysis fluid is discharged under pressure from the other
measuring vessel through the patient conduit L3 to the patient
continues until the counter R1 reaches the preset count of the
output 26, which corresponds to the number of measuring vessels
with fresh dialysis fluid one wishes to introduce into the patient
during each fill-phase. The output signal provided on the output 26
of the counter R1 causes the control unit S to operate the valves
V1 to V8 in such a way that the dialysis fluid in the filled
measuring vessel is discharged under pressure through the patient
conduit L3 without any fresh dialysis fluid from the supply conduit
L1 being simultaneously sucked into the other measuring vessel.
Consequently, the fill-phase ends with both measuring vessels M1
and M2 emptied and with the fluid levels located at the lower
electrodes E1 and E3 respectively in both vessels. At the end of
the fill-phase all tube clamps V1 to V6 are closed, whereas the
valves V7 and V8 remain in their last positions. It is appreciated
that at the end of the first fill-phase of the dialysis treatment
also the counter R2 contains a count corresponding to the number of
measuring vessels with fresh dialysis fluid that has been
introduced into the patient during this fill-phase.
The length or duration of the dialysis-phase following the
fill-phase is, as described in the foregoing, determined by the
setting of the timer T1. When the preset time for the
dialysis-phase runs out, the control unit S is activated to
initiate the drain-phase, that is the withdrawal of the used
dialysis fluid from the patient.
As obvious from the foregoing, the drain-phase starts with both
measuring vessels M1 and M2 empty. If it is assumed that at the
beginning of the drain-phase the two air valves V7 and V8 are in
the positions shown in the drawing so that there is vacuum in the
measuring vessel M1 and overpressure in the measuring vessel M2,
the control unit S initiates the drain-phase by opening the tube
clamp V6 so that the measuring vessel M1 is connected to the
patient conduit L3. The other tube clamps remain closed. At the
beginning of the drain-phase the valve V9 is also switched to its
open position so that the vacuum regulator 21 is connected to the
vacuum pipe 17. In this way the vacuum in the vacuum pipe 17 will
be maintained on the value determined by the preset vacuum
regulator 21. This vacuum is indicated by the pressure gauge 22.
Thus, used dialysis fluid will be sucked out from the patient under
the action of a predetermined variable vacuum. With the different
valves in these new positions used dialysis fluid is sucked out
from the patient through the patient conduit L3 into the measuring
vessel M1, until this is filled and the fluid level detector D2
provides a signal. This output signal is transferred on the one
hand through the switch S1, which is now in its opposite position,
to the input 25 of the counter R1 and on the other hand through the
switch S2, which is also in its opposite position, to the input 29
of the counter R2. Consequently, both counters R1 and R2 are now
counting in their opposite direction, that is reduce their counts.
The output signal from the fluid level detector D2 influences also
the control unit S, whereby this closes the tube clamp V6 so that
the connection between the measuring vessel M1 and the patient
conduit L3 is interrupted, opens the tube clamps V4 and V2 so that
the filled measuring vessel M1 is connected to the discharge
conduit L2, and opens the tube clamp V5 so that the empty measuring
vessel M2 is connected to the patient conduit L3. At the same time
the two air valves V7 and V8 are switched to their opposite
positions so that the measuring vessel M2 is put under vacuum and
the measuring vessel M1 is put under overpressure. Consequently,
used dialysis fluid is now sucked out from the patient through the
patient conduit L3 into the measuring vessel M2, whereas the used
dialysis fluid in the filled measuring vessel M1 is discharged
under pressure from the vessel through the discharge conduit L2.
The vacuum in the vacuum pipe 17 and the overpressure in the
pressure pipe 15 are such that the discharging of dialysis fluid
from the measuring vessel M1 requires less time than the filling of
the measuring vessel M2 with used dialysis fluid. When the
measuring vessel M1 is emptied down to its lower electrode E1, the
fluid level detector D1 provides a signal to the control unit S,
which closes the tube clamp V4 so that the connection between the
vessel M1 and the discharge conduit L2 is interrupted. When
somewhat later the vessel M1 is filled up to the upper electrode
E4, the fluid level detector D4 provides a signal on the one hand
to the two counters R1 and R2, which counts one more vessel of used
dialysis fluid drained from the patient, and on the other hand to
the control unit S, which then closes the tube clamp V5, opens the
tube clamps V3 and V6 and returns the air valves V7 and V8 to their
original positions, whereby the measuring vessel M1 is once more
put under vacuum and the vessel M2 once more under overpressure.
Consequently, used dialysis fluid is once more sucked from the
patient through the patient conduit L3 into the empty vessel M1,
whereas the used dialysis fluid in the filled vessel M2 is
discharged under pressure into the discharge conduit L2. This
alternating sequence with used dialysis fluid being sucked out from
the patient through the patient conduit L3 into one of the
measuring vessels and at the same time used dialysis fluid being
discharged under pressure from the other measuring vessel through
the discharge conduit L2 continues, until the time for the
drain-phase as determined by the timer T2 runs out. However, as
mentioned in the foregoing, the drain-phase cannot be interrupted
until the control unit S has received signal from the output 27 of
the counter R1, which signal indicates that during the drain-phase
an equal number of measuring vessels filled with used dialysis
fluid has been withdrawn from the patient as has been introduced
into the patient during the preceding fill-phase. If the time
determined by the timer T2 runs out before signal is provided on
the output 27 of the counter R2, the drain-phase continues until
said signal is provided. This means that the preset duration of the
drain-phase is too short and preferably some sort of alarm should
be generated so that a longer duration of the drain-phase can be
set by means of the timer T2. In this connection it should be
remembered that normally a somewhat larger fluid volume shall be
withdrawn during the drain-phase than the fluid volume that has
been introduced into the patient during the preceding fill-phase,
as the object of the dialysis treatment is inter alia to remove
excess water from the patient. If a larger number of measuring
vessels filled with dialysis fluid is withdrawn from the patient
during the drain-phase than was introduced into the patient during
the preceding fill-phase, this difference will be indicated by the
count in the counter R2 at the end of the drain-phase. At the end
of the drain-phase the control unit S opens the gate G so that the
count in the counter R2 is transferred to the store ST.
The drain-phase is always terminated with one of the two measuring
vessels completely emptied down to its lower electrode El or E3
respectively. It can occur, however, that at the end of the
drain-phase the other measuring vessel is only partially filled
with used dialysis fluid withdrawn from the patient, as there is no
more dialysis fluid in the patient to be withdrawn. This measuring
vessel only partially filled with used dialysis fluid drained from
the patient is not counted and is not discharged through the
discharge conduit L2 but will instead at the beginning of the next
fill-phase be pumped back into the patient through the patient
conduit L3, also in this case without being counted. In this way it
is obtained that at the end of the complete dialysis treatment the
total error in the measured difference volume between the total
volume of dialysis fluid pumped into the patient and the total
volume of dialysis fluid withdrawn from the patient can at a
maximum correspond to a portion of the volume of one measuring
vessel.
The controlled electric current source 7 in the heating device for
the heating of the fresh dialysis fluid being supplied through the
supply conduit L1 is preferably controlled from the control unit S
so as to supply a heating current to the pipe S only when the tube
clamp V1 and one of the tube clamps V3 and V4 are open, that is
only when dialysis fluid flows through the supply conduit L1. In
this way overheating of the dialysis fluid is prevented. The
temperature variations of the supplied dialysis fluid caused by the
mode of operation of the heating device are equalized in that the
dialysis fluid is mixed in the measuring vessel before it is
supplied to the patient. As the dialysis fluid supplied through the
conduit L1 is sucked into the measuring vessel under the action of
a vacuum, an efficient de-airing of the fluid is also obtained.
As obvious from the foregoing, only the two measuring vessels M1
and M2 and the fluid conduits L1 to L8 together with the heating
pipe 6 will come into contact with the dialysis fluid. As these
components of the dialysis apparatus are very simple and
inexpensive, they may preferably be designed as a dispensable set
intended for "one-time" use only, which set is discarded after each
completed dialysis treatment and replaced with a new set for the
next dialysis treatment. In this way it is safeguarded against any
infectious matter being transferred from one patient to another
patient via the dialysis apparatus.
A dialysis apparatus according to the invention with the features
described above may for instance be constructed as schematically
illustrated in FIG. 2. This apparatus consists of a casing 30
enclosing the major portion of the electrical and mechanical
components of the dialysis apparatus and having its topside
designed as a control panel 31. Thus, this panel includes for
instance the pressure gauge 22 indicating the draining vacuum
during the drain-phase, the instrument I2 indicating the fluid
balance of the patient and the instrument I1 indicating the stage
of the current dialysis cycle in which the apparatus is operating.
The panel 31 is also provided with a setting knob K1 for the vacuum
regulator 21 determining the draining vacuum used during the
drain-phase, a knob K2 for the setting of the counter R1, that is
for presetting the volume of fresh dialysis fluid that is
introduced into the patient during each fill-phase, a knob K3 for
the setting of the timer T1, that is the duration of the
dialysis-phase, and a knob K4 for the presetting of the timer T2,
that is the minimum duration of the drain-phase. The control panel
31 includes also a number of pushbuttons B for various control
functions as for instance start, stop etc. One of these pushbuttons
operates the switch S3 mentioned in the foregoing, by means of
which the instrument I2 may be temporarily connected to the counter
R2.
The control panel 31 supports also the dispensable "one-time-use"
set consisting of the two measuring vessels M1 and M2, the supply
conduit L1 with its heating pipe 6, the discharge conduit L2, the
patient conduit L3 and the branch conduits L4 to L8. For this
purpose the control panel is provided with a holder 32 for the
branch conduits L4 to L8. This holder cooperates also with
pivotable hook-shaped arms or levers mounted on the control panel
31 and forming the tube clamps V1 to V6. For the heating pipe 6 two
contact clamps are provided, which on the one hand support and fix
the pipe and on the other hand form the electrical terminals 8 and
9 for the heating current source. The thermocouple 10 controlling
this current source consists of two pins between which the pipe 6
has a tight fit and one of which consists of the same material as
the pipe 6, whereas the other pin consists of another material
which together with the material in the pipe 6 forms a
thermocouple. For supporting the two measuring vessels M1 and M2
two support brackets 34 and 35 are provided on a column 33. These
two brackets 34 and 35 can be opened and closed around the upper
tube connections 2 and 4 and the lower tube connections 1 and 3
respectively of the measuring vessels. These support brackets 34
and 35 are also provided with necessary electrical terminals for
the electrodes E1 to E6 of the measuring vessels so that these
electrodes are automatically connected to the fluid level detectors
D1 to D4 when the brackets 35 and 34 are closed. The column 33
supports also the moisture traps 11 and 12 and the germ filters 13
and 14. As can be seen from the drawing, the moisture trap 11 and
the germ filter 13 for the measuring vessel M1 on the one hand and
the moisture trap 12 and the germ filter 14 for the measuring
vessel M2 on the other hand are combined to two assemblies, which
can easily be removed and replaced with new sterilized assemblies
before a new dialysis treatment.
In the embodiment of the invention described above there exists a
certain danger that air might be forced into the peritoneal cavity
of the patient. This may occur, if during a fill-phase the lower
fluid level detector in the measuring vessel, which is currently
under overpressure and from which dialysis fluid is being forced
into the patient, fails to give indication when the measuring
vessel is emptied. In this case also the dialysis fluid in the
patient conduit will be forced into the patient and when also the
patient conduit is emptied air will be forced into the patient.
However, this can be prevented by means of a comparatively simple
modification of the dialysis apparatus according to the invention
described in the foregoing.
FIG. 3 illustrates schematically this modification, which concerns
the connection between the two measuring vessels M1 and M2 on the
one hand and the pressure pipe 15 and the vacuum pipe 17 on the
other hand. With this modification only a predetermined limited air
volume can be pumped into the measuring vessel which is currently
under overpressure and this air volume is determined to be only
slightly larger than the volume of the measuring vessel. The
modification comprises an additional air valve V10 which is
operated by the control unit S in the same manner as the valves V7
and V8 so as to change its state simultaneously with these valves.
Further, the pressure pipe 15 is connected to the two valves V7 and
V10 through a tank 37, the interior of which is divided by means of
two bellows 38 and 39 into three separate chambers 37a, 37b and
37c. The two bellows 38 and 39 are resilient so that each bellow
tends to assume its most expanded state when the same pressure
exists on both sides of the bellow.
In the operating position of the valves V7, V8 and V10 illustrated
in FIG. 3 the measuring vessel M1 is connected to the vacuum pipe
17 through the valve V8. The other measuring vessel M2 is connected
to the chamber 37a in the tank 37 through the valve V7. The middle
chamber 37b in the tank 37 is as always connected directly to the
pressure pipe 15. Also the third chamber 37c is connected to the
pressure pipe 15 through the valve V10 and the middle chamber 37b
in the tank 37. Thus, in this state air is sucked out from the
measuring vessel M1, whereas air is forced under pressure into the
measuring vessel M2 from the chamber 37a, as the bellow 38 is
compressed by the pressure in the chamber 37b. The bellow 39
expands to its most expanded state so that the chamber 37c expands,
as the same air pressure exists in both chambers 37b and 37c on
both sides of the bellow 39. It is appreciated that the largest air
volume that can be forced into the measuring vessel M2 corresponds
to the initial maximum volume of the chamber 37a. The flow of air
under pressure into the measuring vessel M2 will consequently be
automatically interrupted even if the lower fluid level detector in
this measuring vessel should fail to provide an output signal.
In the opposite operating state of the valves V7, V8 and V10 the
measuring vessel M2 is connected to the vacuum pipe 17 through the
valve V8, whereas the measuring vessel M1 is connected to the
chamber 37c in the tank 37 through the valve V10. The chamber 37a
is connected to the pressure pipe 17 through the valve V7 and the
middle chamber 37b in the tank 37. In this state consequently the
bellow 39 and thus also the chamber 37c are being compressed,
whereas the bellow 38 and thus also the chamber 37a are expanded to
the maximum volume.
* * * * *