U.S. patent number 3,864,248 [Application Number 05/243,658] was granted by the patent office on 1975-02-04 for pressure modulator for an artificial blood circuit.
This patent grant is currently assigned to Rhone-Poulenc S.A.. Invention is credited to Alain Granger, Jean Lissot, Andre Sausse.
United States Patent |
3,864,248 |
Granger , et al. |
February 4, 1975 |
Pressure modulator for an artificial blood circuit
Abstract
A pressure modulator for an artificial blood circuit, including
at least one readily deformable wall forming a blood chamber having
inlet and outlet ducts and a pair of substantially rigid plates
arranged one on either side of said blood chamber, pulsation
chambers disposed on the sides of said rigid plates remote from the
blood chamber and a fluid pulse generator connected to the
pulsation chambers, the rigid plates forming part of a rigid plate
exchanger such as a haemodialyser, an artificial lung or a heat
exchanger, the pulses inducing slight flexing of the plates and
thus pulsing of the liquid in the blood chamber.
Inventors: |
Granger; Alain (Seine et Marne,
FR), Lissot; Jean (Seine et Marne, FR),
Sausse; Andre (Hauts-de-Seine, FR) |
Assignee: |
Rhone-Poulenc S.A. (Paris,
FR)
|
Family
ID: |
9075177 |
Appl.
No.: |
05/243,658 |
Filed: |
April 13, 1972 |
Foreign Application Priority Data
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|
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Apr 13, 1971 [FR] |
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71.12959 |
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Current U.S.
Class: |
210/646;
210/321.67; 210/637; 210/136; 210/356 |
Current CPC
Class: |
B01D
63/16 (20130101); F04B 43/073 (20130101); A61M
60/894 (20210101); A61M 1/14 (20130101); A61M
60/562 (20210101); A61M 60/00 (20210101); F04B
43/025 (20130101); A61M 1/3621 (20130101); A61M
60/40 (20210101); A61M 1/267 (20140204); A61M
60/113 (20210101); A61M 60/268 (20210101); A61M
60/50 (20210101); A61M 1/3639 (20130101) |
Current International
Class: |
A61M
1/10 (20060101); A61M 1/36 (20060101); F04B
43/06 (20060101); F04B 43/02 (20060101); F04B
43/073 (20060101); A61M 1/26 (20060101); A61M
1/16 (20060101); B01d 013/00 () |
Field of
Search: |
;210/356,22,321,136,19 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Spear, Jr.; Frank A.
Attorney, Agent or Firm: Cushman, Darby & Cushman
Claims
We claim:
1. A pressure modulator for an artificial blood circuit, said
modulator comprising, in combination:
a. at least one resilient wall defining part of a blood
chamber;
b. an inlet duct and an outlet duct for said blood chamber;
c. a pair of substantially rigid plates arranged one on either side
of said blood chamber, and forming part of said rigid blood
exchanger;
d. at least one pulsation chamber disposed on the side of at least
one of said plates remote from said blood chamber; and
e. a fluid pulse generator connected to said at least one pulsation
chamber, effective to cause slight flexing of said substantially
rigid plates and thereby pulsing of liquid in said blood chamber,
according to a time/pressure curve which is very close to the
physiological curve at a peripheral artery.
2. A pressure modulator as claimed in claim 1, and further
comprising a pump connected to said inlet duct.
3. A pressure modulator as claimed in claim 1, and further
comprising one way valve means in said inlet and outlet ducts
effective to allow inflow into said inlet duct and outflow out of
said outlet duct.
4. A pressure modulator as claimed in claim 1 and including two
resilient walls in the form of semi-permeable membranes.
5. A pressure modulator as claimed in claim 1, wherein said pulse
generator comprises a first and second source of fluid pressure,
said first source being at a substantially higher pressure than
said second source; a three way valve selectively connectable
between either of said two sources and to said pulsation chamber,
and switch means operating said three way valve.
6. A method of use of a fluid exchanger as a blood exchanger,
disposed in an extracorporeal blood circuit, and comprising, in
combination:
a. a plurality of substantially rigid pairs of plates stacked in
overlying relation to one another, each of said plates being
substantially rectangular and symmetrical, and comprising a front
face and a back face, with the front faces of a pair of plates
being in facing relation;
b. a pair of semi-permeable membranes between the front faces of
each pair of plates, whereby each membrane has a plate adjacent
thereto;
c. means defining a first exchange zone between each membrane and
its adjacent plate;
d. means defining a blood exchange zone between the two membranes
of a pair;
e. means to feed a first liquid to and from the first exchange
zone;
f. means to feed blood to and from the blood exchange zone;
g. at least one flexible wall chamber exerting a uniform controlled
pressure on at least a portion of said plates, said flexible wall
chamber defining a pulsation chamber;
h. a plurality of longitudinal, parallel grooves separated by a
plurality of longitudinal parallel ribs defined on said front
faces, the ribs of a pair of plates being in register with one
another;
i. a depression on the back face of each plate of substantially
constant cross-section;
j. diagonally opposite ducts to feed said first liquid to and from
said first exchange zone, said ducts being defined between the back
faces of the plates of adjacent pairs and communicating with said
depression;
k. apertures defined in said plates and communicating said groove
with said depression;
l. recesses on the front face of said plates communicating with
said grooves; and
m. diagonally opposite passages, complementary to said ducts, to
feed said blood to and from said blood exchange zone; said method
comprising varying the pressure of the said at least one flexible
wall chamber according to a time/blood pressure curve which is very
close to the physiological curve at the level of a peripheral
artery.
Description
The subject of the present invention is a pressure modulator for an
artificial blood circuit.
By artificial blood circuit there is meant a blood circuit outside
the body, the two ends of which are connected to a patient, or a
circuit of blood or natural or artificial serum feeding a chamber
for the culture or preservation of living cells.
It has already been proposed to convey the blood by means of
diaphragm pumps comprising on the one hand a blood chamber
interposed in the blood circuit and possessing a deformable wall
and, on the other hand, a pulsation chamber controlling the
deformable wall and connected to a pulse generator (see for example
U.S. Pat. No. 3,513,836).
It is also known to make the blood pass into a plate exchanger,
especially an artificial kidney, by means of a blood pump, usually
of the peristaltic type (see for example U.S. Pat. No.
3,631,986).
According to the present invention we provide a pressure modulator
for an artificial blood circuit, such modulator comprising at least
one readily deformable wall forming a blood chamber, having an
inlet duct and an outlet duct, a pair of substantially rigid plates
arranged one on either side of said blood chamber, and forming part
of a rigid plate exchanger, at least one pulsation chamber disposed
on the side of at least one of said plates remote from said blood
chamber; and fluid pulse producing means connected to said
pulsation chamber or chambers, to cause slight flexing of the
plates and thereby pulsing of liquid in the blood chamber.
The modulator according to the invention allows pulsations of any
nature to be imposed on this circuit, and in particular to
reproduce in it, with great accuracy, the wave of natural
pulsation.
In the text which follows, the description will be simplified by
referring only to the haemodialyser.
The plates of the haemodialysers are usually constructed from
substantially rigid materials such as polystyrene, and the pressure
of the blood between the plates tends to separate them by a very
small, but not negligible, amount. This separation is variable and
is the greater the more the point considered is separated from the
zone of action of the mechanical clamping frame, and so an unequal
distribution of the blood flow in the dialyser is introduced.
The construction of the present invention applies pressure pulses
on the exterior of the plate so that the plates transmit the
variations in pressure produced by the pulse producing means to the
blood.
It thus becomes possible to recreate pulsations in a dialyser and
downstream from the latter, even if it is fed by a pump with a
substantially constant pressure at the outlet.
In the absence of a pump, the slight variations of separation of
the plates of the dialyser can be used profitably to assist the
displacement of the blood. It is then sufficient to equip the
dialyser with suction and delivery valves.
The pulsation chamber may be provided with a rigid external wall or
may be a flexible pouch and can be inflated by liquid (for example,
water), especially if the dialyser is used in an inclined position.
It can be inflated by gas (for example, air or CO.sub.2) and this
simplifies the connection to a gas pressure pulse generator.
The pulse generator can be of any known type. It can be a piston
which compresses the gas in a hermetic chamber connected to the
pulsation chamber or chambers, according to the modulations imposed
by a cam. It can be an assembly of electromagnetic valves
(compressed gas, purging) combined with contact pressure gages by a
programmer or by a cardiac rhythm detector. These examples are
obviously given without implying any limitation.
The modulation by means of the plates imposes only compression
stresses on the readily deformable walls, which may be dialysis
membranes, at the level of the shoulder zones of adjacent plates;
the displacement of the plates are slight and reproducible;
finally, these displacements are perpendicular to the direction of
flow of the blood and thus do not interfere with this flow.
On the other hand, a modulation by means of the dialysis liquid
would impose large and unevenly distributed bending stresses on the
membranes, and would have difficulty in being compatible with a
counter-current operation.
In order that the invention may be more readily understood, the
following description is given, merely by way of example, reference
being made to the accompanying drawings, in which:
FIG. 1 is a schematic view of one embodiment of circuit according
to the invention;
FIG. 2 is an enlarged cross-section through the exchanger of the
circuit of FIG. 1 during the pressure applying stage;
FIG. 3 is a view similar to FIG. 2 during the non-pressure applying
stage; and
FIG. 4 is a schematic cross-section through a modified form of the
exchanger.
With regard to FIG. 1 there is illustrated a pump 1 arranged to
feed blood to a rigid plate exchanger 2 in the form of a dialyser
or diaphragm oxygenator and thence, via an arterial inlet 12 to an
organ, for example, a kidney 3. A venous outlet 13 from the kidney
is connected back to the inlet of the pump 1. A pressure gauge 4 is
connected in parallel across the exchanger 2 and controls the flow
rate of the pump 1 to provide a predetermined mean pressure in the
arterial inlet 12. The pressure gauge also allows the form of the
pressure wave of the perfusion liquid to be recorded.
On either side of the exchanger 2 are arranged pulsation chambers
2a and these are connected by means of a duct 14 to a source of
fluid, in particular air, under controlled pressure, for example
200 mm mercury above atmospheric pressure and to a vacuum source or
atmosphere 6. The connection of these sources to the pulsation
chambers is effected by means of a three way electromagnetic valve
10 which can be controlled by contact pressure gages 7 and 8; the
contact pressure gage 7 senses a predetermined maximum pressure at
which the valve is changed from connecting source 5 to connecting
source 6 to the pulsation chambers. Contact 8 is a minimum pressure
contact which switches valve 10 from connection to source 6 to
connection of source 5. Variable fluid resistances 9 and 11 are
provided between sources 5 and 6 respectively and valve 10.
The above described apparatus was used to perfuse blood into a
pig's kidney. Pump 1 was controlled to maintain an average pressure
of 100 mm of mercury in the arterial inlet. When the pulsation
chambers 2a are connected to atmosphere at 6 the pressure of the
blood separates the support plates 2b (FIG. 2) of the exchanger,
the volume of the blood in the blood chamber 2c increases as is
shown in FIG. 2. When the pressure has reached a minimum value (in
this case 65 mm of mercury) the contact 8 or an electrical signal
given by pressure gauge 4 reverses the direction of the valve 10
and connects the chambers 2a to the pressure source 5. The pressure
introduced in the pulsation chambers causes the support plates 2b
to come closer as shown in FIG. 3 and a certain volume of blood is
ejected into the arterial inlet 12, the pump 1 acting as a
non-return valve. When the predetermined maximum pressure, in this
particular case 140 mm of mercury, is reached, the contact 7 or the
signal from gauge 4 reverses the system again.
The wave form produced can be varied by throttling to a greater or
lesser extent the admission and the escape of the gases through the
resistances 9 and 11 or by modifying the volume of the pulsation
chambers. In particular, it is possible to produce a blood pressure
curve which is very close to the physiological curve at a
peripheral artery, and which comprises, like the physiological
curve, a systolic peak followed by a diastolic decrease.
This arrangement has allowed a living isolated kidney to be kept
for 15 hours in an organ preservation circuit also equipped with an
artificial lung and a thermostat. Working in the same circuit, but
without pulsations, it is not possible to preserve the kidney for
more than 7 hours.
FIG. 4 illustrates a modified form of exchanger used for the
haemodialysis of a patient and having the same system of pneumatic
movement as in FIG. 1 and which can, for example, be connected to a
patient by means of an arterio-venous short circuit or a fistula.
In this construction the blood pump 1 is unnecessary since
non-return valves 15 and 16, such as butterfly valves or ball
valves are included in the inlet or outlet ducts 17 and 18 of the
exchanger 2.
With a dialyser with a diaphragm surface area of 1 m.sup.2 and a
volume of blood of about 200 cm.sup.3 (that is, an average
thickness of blood of 400 .mu.), a pulse frequency of 60 beats per
minute allowed a flow rate of 200 cm.sup.3 /minute, that is to say
3.3 cm.sup.3 per pulse, to be provided.
* * * * *