U.S. patent number 3,927,980 [Application Number 05/390,567] was granted by the patent office on 1975-12-23 for oxygen overpressure protection system for membrane-type blood oxygenators.
This patent grant is currently assigned to Baxter Laboratories, Inc.. Invention is credited to Ronald James Leonard.
United States Patent |
3,927,980 |
Leonard |
December 23, 1975 |
Oxygen overpressure protection system for membrane-type blood
oxygenators
Abstract
A safety system is provided for a membrane-type blood oxygenator
to prevent the possibility of gas embolism through the membranous
barrier which separates the blood and the oxygen. The safety system
includes a blood reservoir positioned at a higher horizontal level
than the blood inlet of the oxygenator, so that a gravity head is
maintained. In addition, a manometer is provided which has a fluid
level to permit venting of the oxygen if the oxygen pressure
exceeds a predetermined gas pressure, which gas pressure is lower
than the minimum pressure of the blood in the oxygenator.
Inventors: |
Leonard; Ronald James (Elk
Grove Village, IL) |
Assignee: |
Baxter Laboratories, Inc.
(Deerfield, IL)
|
Family
ID: |
23542994 |
Appl.
No.: |
05/390,567 |
Filed: |
August 22, 1973 |
Current U.S.
Class: |
422/48; 422/117;
436/68; 128/DIG.3; 422/112; 435/2; 96/6 |
Current CPC
Class: |
A61M
1/3603 (20140204); A61M 1/3621 (20130101); Y10S
128/03 (20130101); A61M 1/1698 (20130101) |
Current International
Class: |
A61M
1/36 (20060101); A61M 1/16 (20060101); A61M
001/03 () |
Field of
Search: |
;23/258.5 ;128/DIG.3
;55/158 ;195/1.8 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Other References
General Electric DuaLung Instruction Manual, Publication No.
46A209535, Nov. 1972, p. 4.1.1 to 4.1.7. .
C. T. Drake et al., "The Effect . . . During Extracorporeal
Circulation;" J. Thoracic & Cardiovasc. Surgery; Vol. 42, No.
6, 12-61; pp. 735-742. .
Turina et al.; "An Automatic . . . In Infants;" J. Thoracic &
Cardiovasc. Surgery; Vol. 63, No. 2, 2-72; pp. 263-268..
|
Primary Examiner: Richman; Barry S.
Attorney, Agent or Firm: Altman; Louis
Claims
That which is claimed is:
1. In an extracorporeal oxygenator system wherein oxygen and carbon
dioxide are transferred across a porous, hydrophobic membranous
barrier separating the blood and the oxygen, said oxygenator having
a blood inlet, a blood outlet, and an oxygen inlet and outlet; the
improvement comprising, in combination: a blood reservoir coupled
to said blood outlet downstream therefrom, said blood reservoir
being positioned at a higher level than said blood outlet to
provide to blood adjacent the membranous barrier a pre-determined
minimum pressure; and manometer means which comprises an open
liquid container being at least partially filled with a liquid; an
oxygen supply line coupled to said oxygen inlet, venting conduit
means coupled with said oxygen line and communicating with said
liquid within said container and having an outlet therein, said
liquid having a level that is selected to provide a pressure at
said venting conduit means outlet but to permit venting of the
oxygen in order to prevent the pressure of the oxygen from
exceeding said minimum pressure of said blood.
2. An extracorporeal oxygenator system as described in claim 1,
wherein the further improvement comprises said blood reservoir
having an inlet and outlet for blood, and further including a first
pump located downstream of and operatively connected to said outlet
of said blood reservoir for drawing blood from said reservoir, said
blood reservoir being collapsible to prevent a negative pressure
upon the blood side of the oxygenator membranous barrier if the
pumping action is excessive; and a second pump located upstream of
and operatively connected to said blood inlet of said oxygenator
for propelling blood to said blood inlet of said oxygenator said
second pump being operated to pump at a greater flow rate than said
first pump, and means for recirculating the extra flow of blood
from upstream of said first pump to upstream of said second
pump.
3. In an oxygen and blood delivery system for use in conjunction
with a membrane-type blood oxygenator having a blood inlet and
outlet and an oxygen inlet and outlet for diffusion therebetween
across a porous, hydrophobic membrane, the improvement
comprising:
blood and oxygen conduit means for operatively communicating with
said respective blood and oxygen inlets and outlets of said
oxygenator, and for conveying such materials to and from said
oxygenator;
means for carrying a flexible blood reservoir in a position
elevated above the position of said oxygenator,
receptacle means, open to the atmosphere, for containing a
liquid;
an oxygen line having one end thereof disposed within said
receptacle means, for immersion in liquid disposed in said
receptacle means to create a predetermined pressure head at said
one end, said oxygen line communicating with said oxygen conduit
means, whereby the oxygen pressure in said conduit means is limited
in a manner dependent upon said predetermined pressure head.
4. The system of claim 3 in which means are provided for assuring a
continuous minimum blood pressure comprising the further
improvement in said oxygenator.
5. The system of claim 4 comprising the further improvement in
which said oxygen line communicates with said gas conduit means
upstream from said oxygenator.
6. In an extracorporeal oxygenation system in which oxygen and
carbon dioxide are transferred across a membranous barrier
separating the blood and the oxygen, said oxygenator having a blood
inlet, a blood outlet, and an oxygen inlet and outlet; the
improvement comprising, in combination: a blood reservoir coupled
to said blood outlet downstream therefrom, said blood reservoir
being positioned at a higher level than said blood outlet to
provide to blood adjacent the membranous barrier a predetermined
minimum pressure; and manometer means which comprises a liquid
container, open to the atmosphere, being at least partially filled
with a liquid; an oxygen supply line coupled to said oxygen inlet,
venting conduit means coupled with said oxygen line and
communicating with said liquid within said container and having an
outlet therein, said liquid having a level that is selected to
provide a pressure at said venting conduit means outlet but to
permit the venting of the oxygen in order to prevent the pressure
of the oxygen from exceeding said minimum pressure of said blood,
and further including second manometer means coupled to the blood
inlet line, said second manometer means being also operatively
connected to said liquid in the container, and responsive to the
pressure of the blood in said blood inlet line to automatically
adjust the level of said liquid in said container.
Description
BACKGROUND OF THE INVENTION
This invention relates to a safety device for a mass transfer
system, and more particularly, to a system for preventing an
excessive amount of gas from transferring to a liquid on the
opposite side of a membranous barrier.
The system of the present invention is particularly useful as a gas
embolism protection system for extracorporeal oxygenators of blood
in which both oxygen and carbon dioxide are transferred across a
membranous barrier separating the blood and the oxygen. An
exemplary oxygenator with which the present invention can be
effectively utilized is disclosed in the United States patent
application in the name of Ronald J. Leonard, Ser. No. 170,163,
filed Aug. 9, 1971 and now U.S. Pat. No. 3,757,955. It is to be
understood, however, that the present invention may be utilized
with many different types of mass transfer devices, particularly
those using a porous hydrophobic membranous barrier separating a
liquid and a gas.
The advent of controlled pore size, nonwetting, microporous
membranes has made the construction of high transfer rate membrane
oxygenators possible. The membranes have open pores which permit
relatively rapid transfer of oxygen, yet the nonwetting properties
prevent blood loss from the system. During operation of the
oxygenator, it is important that the blood pressures exceed the
oxygen pressures, because accidental reversal of oxygen and blood
pressures might result in large amounts of oxygen rapidly entering
the blood spaces of the oxygenator. In high flow rate oxygenators,
the rapid oxygen accumulation would overwhelm any reservoir or
bubble trap and allow gas to enter the patient. The sizes of
reservoirs or bubble traps are limited as a result of the need to
limit priming volume.
Extracorporeal oxygenators generally require a relatively high gas
volumetric flow rate, and it is important for the gas spaces to be
compact, with good mixing, in order to ensure effective gas
transfer through the microporous membrane. Since this results in
some gas pressure drop in the oxygenator, gas working pressures are
generally greater than atmospheric. It can be seen that if the
blood pressure were reduced to zero, the gas pressure would be
greater than the blood pressure. Such a reversal of gas and blood
pressures could easily occur at idle condition when there is no
blood flow in the oxygenator.
It is extremely difficult, if not impossible, for an operator to
maintain the variable pressures in an oxygenator in the proper
direction. It is thus an object of the present invention to provide
an automatic system of pressure control for a mass transfer system
such as an oxygenator.
It is a further object of the present invention to provide a system
for preventing accidental reversal of gas and liquid pressures in a
mass transfer system without utilizing devices which have moving
parts, springs, small orifices, or diaphragms which can become
disabled or plugged up, thereby causing system failure.
Other objects and advantages of the present invention will become
apparent as the description proceeds.
BRIEF DESCRIPTION OF THE INVENTION
In accordance with the present invention, a safety system is
provided for a mass transfer system of the type wherein a
membranous barrier separates a liquid and a gas, and including a
liquid inlet, a liquid outlet, and a gas inlet and outlet. The
improvement comprises means for maintaining at all times a liquid
pressure which is higher than the gas pressure. A gas pressure
sensing device is coupled to the gas inlet with the gas pressure
sensing device comprising means for venting the gas, to prevent the
pressure of the gas from exceeding the pressure of the liquid.
In the illustrative embodiments of the invention, the liquid
pressure maintaining means comprises a liquid reservoir positioned
at a higher horizontal level than the liquid inlet, whereby gravity
liquid pressure is maintained. A first pump is located downstream
of the reservoir for drawing liquid therefrom, with the reservoir
being collapsible to prevent a negative pressure on the mass
transfer device if the pumping action is excessive.
In the illustrative embodiments of the invention, the gas pressure
sensing device comprises a manometer having a fluid level that
prevents gas from venting unless the gas pressure exceeds a
predetermined maximum gas pressure. The fluid level of the
manometer is such that it permits gas to vent if the gas pressure
exceeds the maximum gas pressure, with the maximum gas pressure
being a pressure that is lower than the minimum pressure of the
liquid in the oxygenator.
In one embodiment of the invention, another manometer is provided,
and is operable in response to a pressure of the liquid for
variably adjusting the first-mentioned manometer.
A more detailed explanation of the invention is provided in the
following description and claims, and is illustrated in the
accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a schematic flow diagram of a safety fluid flow system
for mass transfer devices in accordance with the principles of the
present invention.
FIG. 2 is a schematic flow diagram of a modified safety fluid flow
system for mass transfer devices according to a second embodiment
of the present invention.
DETAILED DESCRIPTION OF THE ILLUSTRATIVE EMBODIMENTS
Referring to FIG. 1, a mass transfer system is shown therein in the
form of an extracorporeal oxygenator system, including a main
console 10 to which a venous reservoir 12 and an arterial reservoir
14 are attached. Console 10 has an oxygen outlet 15 to which a
conduit 16 is connected to feed a regulated flow of oxygen to the
inlet 18 of an oxygenator 20. After passing through oxygenator 20,
the spent gas exits via outlet 19. Main console 10 contains a gas
flow rotometer, an oxygenator shim pressure control, a temperature
readout meter, and the necessary selector buttons and switches, all
as is well-known in the art. Console 10 is located to be within the
operator's easy reach, but out of the way of possible fluid
contamination.
Oxygenator 20 is a typical oxygenator wherein oxygen and carbon
dioxide are transferred in opposite directions across a membranous
barrier separating the blood and the oxygen. Such oxygenators are
disclosed in the United States patent application in the name of
Ronald J. Leonard, Ser. No. 170,163, filed Aug. 3, 1971.
It is to be understood that the system of the present invention is
particularly suitable for use with any oxygenator using a
microporous hydrophobic membrane. A typical suitable membrane
material is polytetrafluoroethylene sheeting having a pore size of
less than 0.5 micron and being about 0.005 inch thick. Another
exemplary membrane is formed of polypropylene sheeting
approximately 0.001 inch thick and having a pore size of about 0.1
micron. The membranes can be laminated to screening for
strengthening support.
A blood conduit 22 is connected from an outlet 24 of venous
reservoir 12 to blood inlet 26 of oxygenator 20. The blood and
oxygen flow through oxygenator 20 on opposite sides of the membrane
contained therewithin and the blood exits via conduit 28 to a heat
exchanger 30, which regulates the blood temperature. A typical heat
exchanger which could be utilized with the system of the present
invention is disclosed in Leonard et al. U.S. Pat. No. 3,640,340,
issued Feb. 8, 1972. The blood is then returned via conduit 32 to
an inlet 34 of arterial reservoir 14.
An arterial pump 36 is utilized to pump oxygenated blood from
arterial reservoir 14 via conduit 38 for flow to the patient's
artery. A venous pump 40 is utilized to pump the blood from venous
reservoir 12 to blood inlet 26. Line 43 provides blood from the
patient's venous supply to venous reservoir 12. The two pumps
(venous pump 40 and arterial pump 36) aid to protect the oxygenator
and heat exchanger from overpressurization. Venous pump 40 draws
blood from venous reservoir 12 and propels it through oxygenator 20
and heat exchanger 30, and into arterial reservoir 14. Arterial
pump 36 draws blood from arterial reservoir 14 and propels it back
to an artery of the perfused subject.
Since the exact matching of the pumping rate of the two pumps is
difficult, if not impossible, the venous pump 40 is set to run at a
slightly greater speed than the arterial pump 14. A recirculation
line 42 between the arterial reservoir 14 and venous reservoir 12
allows the extra flow generated by venous pump 40 to return to the
venous reservoir. This assures that the arterial reservoir 14 has
blood in it at all times while protecting the oxygenator 20 from
over-pressure due to blood accumulation.
Venous reservoir 12 and arterial reservoir 14 are preferably formed
of a medical grade polyvinylchloride plastic, or silicone rubber,
and are collapsible. Thus in the event the output of either venous
pump 40 or arterial pump 36 exceeds the input into a reservoir, the
respective reservoir collapses to restrict outflow, thereby
preventing a reduced pressure from forming upstream of the
reservoir. This is particularly important with respect to arterial
reservoir 14 because it is necessary to maintain a minimum blood
pressure on the oxygenator so long as there is blood in the system
by maintaining a blood pressure head in conduits 22, 32, and
28.
It is important that reservoir 14, and preferably also reservoir
12, is supported so that its lower edges are above the upper port
of the oxygenator generally by at least about 3 inches. In this
manner, a gravity-induced liquid pressure head is always exerted on
the oxygenator by the blood in the reservoir. The gravity head of
the blood is arranged as described below to be always greater than
the gas pressure in the oxygenator, to guard against the
possibility of gas bubbles passing through the microporous
membrane.
A safe, positive, direct method of pressure control is provided by
coupling to oxygen inlet 18 a gas pressure sensing means 60. Gas
pressure sensing means 60 comprises a manometer including an open
container 62 having liquid 64, such as water, filled to a
predetermined level. A venting conduit 66 is coupled from oxygen
inlet 18, to the inside of container 62, passing downwardly through
the top of container 62, to form the manometer construction. Fluid
64 is filled to that level which requires enough back pressure in
venting conduit 66 to thereby prevent the gas from venting unless
the gas pressure exceeds the predetermined maximum gas pressure,
and to permit the gas to vent if the gas pressure exceeds such
maximum gas pressure. The maximum gas pressure is selected to be a
pressure that is lower than a pressure of the blood in the
oxygenator created by the pressure head in line 34, that is, lower
than the pressure of the blood in the oxygenator at the vertically
highest point of the blood flow path therein. Thus, the vertical
distance between outlet 34 of reservoir 14 and oxygen inlet 18 of
oxygenator 20 must be greater than the vertical distance between
lower end 68 of conduit 66 and surface 70 of fluid 64. In that
manner, the gas pressure must always be lower than the blood head,
which typically is about 18-19 inches minimum at inlet 26. Thus gas
cannot bubble through the membrane to enter the blood spaces.
Typically, a 14 inch pressure head of water exists in manometer 60
when the gas pressure is sufficient to cause flow through line 66.
When gas is not flowing, the pressure head is slightly less, since
then water resides within line 66, lowering the liquid level in
container 62.
The system is fail-safe because if the fluid 64 were to evaporate,
the gas would be vented at a lower pressure than before
evaporation. Thus, evaporation of fluid 64 only permits the gas to
vent at a lower pressure, and the oxygenator remains safe from the
possibility of a gas embolism passing through the membrane.
A line 43 connected to the patient's venous blood supply feeds
blood to venous reservoir 12.
The system also may include a cardiotomy reservoir 44, such as is
shown in U.S. Pat. No. 3,507,395, the inlet of which is coupled to
the incision site of the patient via suction line 46. Blood spilled
in the incision site of the patient is sucked by means of a suction
pump 48 to which line 46 is connected. Conduit 50 couples the
outlet of cardiotomy reservoir 44 to venous reservoir 12 through an
optional auxiliary filter 52 which filters out any remaining clots
and other gross particles in the blood, and then passes the blood
to the venous reservoir. The cardiotomy reservoir is usually also
located above the venous and arterial reservoirs to assist in
providing a gravity head of blood.
Where coronary perfusion or other localized perfusion of an organ
is desired, a perfusion conduit 54 is coupled to an outlet of
arterial reservoir 14, and the fluid is pumped through line 54 by
means of a perfusion pump 56.
A modified gas pressure sensing means is illustrated in FIG. 2. As
the remainder of the system may be identical to the FIG. 1 system,
like reference numerals have been used for like structure. The gas
pressure sensing means 60' of FIG. 2 comprises a manometer formed
by container 62' and having an open top and bottom. Container 62'
contains fluid, such as water 64', and has oxygen line 66 inserted
therein in a manner similar to the previous embodiment. The
manometer formed by container 62', fluid 64', and line 66 operates
similarly to gas sensing means 60 of the FIG. 1 embodiment.
However, the gas sensing means 60' of the FIG. 2 embodiment permits
the maximum gas pressure to be raised if the blood pressure is
raised, due to a change in blood flow rate or the like. However, it
is still mandatory that the gas pressure be limited and remain less
than the blood pressure. To this end, a closed blood manometer 70
is provided. Manometer 70 contains an amount of blood 72, which is
dependent on the pressure in line 22, to which it is connected.
This provides a variable gas pressure in the space 74 above blood
72 which also depends on the pressure in line 22. Hence, the height
of fluid 64' is thereby dependent upon the pressure in space 74,
tube 76, and line 22. The outlet of tube 76 communicates with
sealed container 78, into which container 62' is positioned. A
microporous plug 77 prevents blood from entering the control
manometer 60' and provides a sterile barrier through which only the
gas in space 74 and container 78 can pass. Plug 77 can be made of
the same porous, hydrophobic membrane material as can be used in
oxygenator 20.
It can be seen that a shift in the level of blood 72 will cause a
pressure shift in space 74 and tube 76, thereby creating a fluid
shift with respect to fluid 64'. Assuming that the blood pressure
in line 22 is increased by an increased flow rate of other reason,
the level of blood 72 will rise, thereby increasing the pressure in
closed container 78. This will cause fluid 64 to rise in container
62', thereby permitting a higher oxygen pressure before venting
from line 66 will occur. On the other hand, if the blood pressure
in line 22 is decreased, the level of blood 72 in manometer 70 will
be lowered, thereby decreasing the pressure upon fluid 64 and
causing a drop in the height of fluid 64' within container 62'.
Thus the gas will vent at a lower pressure as is required.
The above system provides additional efficiency coupled with
safety, in that higher gas pressures may be used when higher blood
pressures exist, but upon a sudden drop in blood pressure, the
limiting maximum gas pressure will also drop to safe levels.
It is seen that an automatic system of pressure control has been
provided for a mass transfer system, such as an oxygenator. The
system is operative to prevent accidental reversal of gas and
liquid pressures in a mass transfer system, without utilizing
devices having moving parts, springs, small orifices, or
diaphragms. The invention not only provides a safety system, but
also permits effective operation of an oxygenation system at high
altitudes, since manometers 60, 60' permit the safe use of gas
pressures in an oxygenator which may exceed the ambient atmospheric
pressure.
Furthermore, the use of manometers 60, 60' permit the continued
lifesaving oxygenation of a patient even in the event of a gas
delivery pressure valve failure or the like causing excess
pressure, since the excess gas pressure is simply bled off by
manometers 60, 60', while the oxygenator remains exposed to
whatever predetermined maximum gas pressure has been selected.
Although two illustrative embodiments of the invention have been
illustrated and described, it is to be understood that various
modifications and substitutions may be made by those skilled in the
art without departing from the novel spirit and scope of the
present invention .
* * * * *