U.S. patent number 3,907,504 [Application Number 05/348,711] was granted by the patent office on 1975-09-23 for blood oxygenation system including automatic means for stabilizing the flow rate of blood therethrough.
This patent grant is currently assigned to General Electric Company. Invention is credited to Gary W. Hammond, Donald R. Ingenito, Gunnar E. Walmet.
United States Patent |
3,907,504 |
Hammond , et al. |
September 23, 1975 |
Blood oxygenation system including automatic means for stabilizing
the flow rate of blood therethrough
Abstract
An apparatus for sensing and signaling changes in the pressure
and volume of a fluid passing therethrough, the apparatus
comprising: (a) a hollow chamber; (b) a compliant reservoir for
holding the fluid, the reservoir being located in the hollow
chamber and being fitted with inlets and outlets for the fluid; and
(c) a motion actuated means in the chamber for signaling changes in
the size of the compliant reservoir. In one embodiment, the
apparatus is used in an extracorporeal circuit to sense changes in
the pressure and volume of blood and to signal the speed controller
on a blood transfer pump in the blood circuit.
Inventors: |
Hammond; Gary W. (Ballston
Lake, NY), Ingenito; Donald R. (Scotia, NY), Walmet;
Gunnar E. (Schenectady, NY) |
Assignee: |
General Electric Company
(Milwaukee, WI)
|
Family
ID: |
23369198 |
Appl.
No.: |
05/348,711 |
Filed: |
April 6, 1973 |
Current U.S.
Class: |
422/46; 417/37;
417/250; 422/111; 128/DIG.3; 417/36; 417/43; 422/48 |
Current CPC
Class: |
A61M
1/3639 (20130101); Y10S 128/03 (20130101) |
Current International
Class: |
A61M
1/36 (20060101); A61M 001/03 () |
Field of
Search: |
;23/258.5 ;128/DIG.3
;417/43,36,37 ;137/565 |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
general Electric Dialing Instruction Manual; Publication No.
46A209535; Nov. 1972; Sections 4.1.1 to 4.1.7. .
C. T. Drake et al.; "The Effect of Low . . . During Extracorporeal
Circulation"; J. Thoracic & Cardiovas. Surg.; Vol. 42; No. 6;
12-61; pp. 735-742. .
F. J. Lewis et al.; "Semiautomatic Control . . . Blood Pump"; J.
Thoracic & Cardiovas. Surg.; Vol. 43; No. 3; 3-62; pp. 392-396.
.
M. Turina et al.; "An automatic . . . Infants"; J. Thoracic &
Cardiovas. Surg.; Vol. 63; No. 2; 2-72; pp. 263-268..
|
Primary Examiner: Richman; Barry S.
Attorney, Agent or Firm: Bird, Jr.; Thomas J. Pine;
Granville M. Hedman; Edward A.
Claims
We claim:
1. An apparatus for extracorporeally oxygenating the blood of a
living patient comprising in combination
i. at least one pumping means for the blood,
ii. oxygenating means for the blood,
iii. means for sensing and signalling changes in the pressure and
volume of blood passing through said apparatus, said sensing and
signalling means comprising:
a. a hollow chamber of a selectively fixed and adjustable volume
and comprising a base piece and a cover piece;
b. a compliant reservoir for holding said blood, said reservoir
being disposed within said hollow chamber and including an inlet
and an outlet port for said blood; said hollow chamber
substantially limiting the maximum expansion volume of said
complaint reservoir and
c. motion activated means in said hollow chamber for generating an
electrical signal proportionate to changes in the size of said
compliant reservoir, and
d. adjusting means movably attaching said cover piece to said base
piece to permit selective adjustment of the volume of said hollow
chamber by movement of said cover piece relative to said base
piece, and
iv. pump speed controlling means being operatively connected to
receive said signal from said motion activated means and to
automatically adjust the operation of said pumping means so as to
move said blood through said apparatus at a flow rate responsive to
said signal.
2. An apparatus as defined in claim 1 wherein two pumping means are
utilized, one being a venous pumping means located upstream of said
oxygenating means and the other being an arterial pumping means
located downstream of said oxygenating means and wherein said pump
speed controlling means is operatively connected to said arterial
pumping means to automatically adjust the flow rate thereof
responsive to said signal.
3. An apparatus as defined in claim 1 wherein said oxygenating
means for the blood is a membrane type blood-gas exchanging
means.
4. An apparatus as defined in claim 1 wherein a single pumping
means is utilized in the apparatus.
5. An apparatus as defined in claim 4 wherein the single pumping
means is a venous pumping means located upstream of said
oxygenating means.
6. An apparatus as defined in claim 1 which also includes a blood
heat exchanging means.
7. An apparatus as defined in claim 6 wherein said oxygenating
means for the blood is a membrane type bood-gas exchanging means
and the blood heat exchanging means is integral therewith.
Description
This invention relates to an apparatus for sensing and signaling
changes in the pressure and volume of fluids passing therethrough.
More particularly, it is concerned with an apparatus which can
sense the amount of liquid in a reservoir, e.g., one used in an
extracorporeal fluid circuit and, using this signal, to modulate
the speed of a pump in the circuit.
BACKGROUND OF THE INVENTION
Various sensors are known which can detect the amount of liquid in
a reservoir used in an extracorporeal circuit and, using this
signal, modulate the speed of a pump in the circuit. If the circuit
is used, for example, to oxygenate blood, such sensor-controllers
operate almost automatically, considerably simplifying the
perfusionist's task. In this way, for example, a two-pump circuit,
generally needed with membrane lungs, is reduced to the operational
simplicity of a one-pump circuit by having an automatically
controlled arterial pump. Also, such an automatic pump speed
controller can be used to sense a venous reservoir being filled by
gravity drainage from the patient and thus control the venous
pump.
Among the prior art sensors are those which are weighing devices.
These suffer serious disadvantages because they have two to four
large tubes and two small tubes connected to a compliant or rigid
reservoir, and the preload due to these tubes adversely affects the
functioning of the weighing mechanism. Another device is based on
the principle of an optical detection of the liquid level in the
reservoir. However, the optical technique is complicated, lacks
reliability, is applicable mainly only to rigid reservoirs, and
generally is adapted to give only on-off rather than modulated pump
control signals.
In a novel way, the device of the present invention can sense the
amount of liquid in a reservoir, e.g., one used in an
extracorporeal circuit and, using this signal, modulate the speed
of a pump in the circuit. The present device provides the stated
advantages simply, reliably, and in a method consistent with
maintaining sterility in the blood.
BRIEF DESCRIPTION OF THE DRAWINGS
In the drawings:
FIG. 1 illustrates a vertical plan view, partially in section, of a
compliant reservoir pressure and volume sensing and signaling
device, which is one embodiment of this invention;
FIGS. 2 a-d illustrate semi-diagramatically, the device of FIG. 1
in which the compliant reservoir is shown to assume typical
configurations under the influence of various fluid pressures and
volumes;
FIG. 3 is a schematic, partial plan view, showing how the device of
FIG. 1 can be used to keep the pump in a gravity drainage, single
pump, extracorporeal circuit at the proper speed;
FIG. 4 is a schematic, partial plan view, showing how the device of
FIG. 1 can be used to keep either the venous pump or the arterial
pump of a two-pump gravity drainage system automatically at proper
speed; and
FIG. 5 is a schematic, partial plan view, showing how the device of
FIG. 1 can automatically control the speed of an arterial pump in a
two-pump venous pump suction circuit.
Although FIGS. 3-5 relate specifically to a membrane lung of the
type described in the copending application of D. R. Ingenito, W.
P. Mathewson, D. R. Ryon and Gunnar E. Walmet, Ser. No. 247,987,
filed on Apr. 21, 1972, now U.S. Pat. No. 3,839,204 issued Oct. 1,
1974, and assigned to the assignee of the present invention, it
will be understood that the device of this invention can be used
equally effectively with other membrane lungs and even different
types of fluid gas-exchanger and/or heat-exhanger.
DESCRIPTION OF THE INVENTION
In its broadest aspects, the invention contemplates a device for
continually sensing changes in reservoir distention/pressure and
for signaling the changes to operate an external controller. In a
preferred feature, the device will include means for varying the
maximum volume of the reservoir. This allows one compliant
reservoir to be used in an extracorporeal circuit for a variety of
patient sizes.
According to the present invention, there is provided an apparatus
for sensing and signaling changes in the pressure and volume of a
fluid passing therethrough, said apparatus comprising:
a. a hollow chamber;
b. a compliant reservoir for holding said fluid, said reservoir
being disposed within said hollow chamber and including an inlet
and an outlet port for said fluid; and
c. motion actuated means in said hollow chamber for signaling
changes in the size of said compliant reservoir.
Referring to FIG. 1, there is shown a preferred embodiment of the
invention, in the form of a compliant reservoir pump speed
controller. The sensor-controller is constructed of hollow chamber
2 comprised of "U" shaped base 4 of metal, plastic or the like and
U shaped cover piece 6 also of metal, plastic or other suitable
material of construction. Preferably, cover piece 6 and/or base 4
will be of transparent material, such as clear plastic to allow the
fluid in compliant reservoir 8 to be visually observed for any
bubbles, clots, suspended foreign matter, and the like. To
facilitate mounting, base 4 can be fitted with holder support 10.
Adjustment slots 12 and lock screws 14 are provided in cover 6 and
base 4 to permit changing the maximum volume of hollow chamber
2.
Compliant reservoir 8 is constructed of any suitable flexible
material, such as metal, plastic and the like, preferably
poly(vinyl chloride), silicone rubber, etc., and is fitted with
inlet 13 and outlet 15, for fluid. It is desirable to provide that
inlet 13 be tubular and that it terminate somewhat high up into the
reservoir so that any bubbles in the fluid will be trapped by
rising to the top of the reservoir instead of being drawn out of
outlet 15. In the embodiment shown in FIG. 1, one or more vents,
16, are provided at the top of reservoir 8, and these can also
serve conveniently as a sample port. For convenience, reservoir
support 18 can be provided to hold the reservoir within the hollow
chamber, e.g. by grasping a ring or other suitable fixture attached
thereto.
Another important element in the device of this invention is the
means for sensing the amount of liquid in reservoir 8. This can
comprise a plate adjacent the reservoir, the plate being movable
with changes in reservoir shape induced by fluid pressure and
volume changes and a transducer actuated by motion from the sensor
plate for supplying a signal to an external recorder or controller.
The sensor plate can be of the linear translating or, preferably, a
pivoting type, and preferably is biased, e.g., with a spring,
against the reservoir. Many different transducers can be used to
convert the motion of the sensor plate to a different form of
signal energy, but when used as a pump controller, it is preferred
to use a linear motion actuated potentiometer or a linear motion
actuated autotransformer.
Referring again to FIG. 1, sensor plate 20 is shown hinged to base
4 at hinge point 22 and is seen to contact compliant reservoir 8
along a fairly substantial area of contact. Leaf spring 24 biases
sensor plate 20 against reservoir 8. The transducer comprises
linear potentiometer 26 having rod 28, of metal, strategically
located to transmit changes in the position of sensor plate 20 to
the potentiometer.
In operation, as compliant reservoir 8 fills up with fluid, sensor
plate 20 deflects against spring 24. Conversely as reservoir 8
empties, sensor plate 20 follows it and moves out. As sensor plate
20 moves, metal rod 28 connected to linear motion actuated
potentiometer 26 has its resistance varied. The resistance is the
speed controlling signal in a suitable pump motor speed controller
(not shown in FIG. 1).
If it is desired to change the maximum volume of the reservoir,
cover plate 6 can be moved with respect to base 4 and locked in the
new position with screws 14. This is shown, along with typical
pressures and volumes in the reservoir (pressures measured near the
top of the reservoir to avoid hydrostatic head contributions), at
various positions in FIG. 2.
For medical use, it is desirable that all parts of the device be
made of plastic. This increases the electrical resistance between
the blood and any electrical components used in the sensor to
insure patient safety in the event of an electrical failure.
Alternately, metal parts, if used, can be covered with an
insulator. The materials in contact with blood should be easily
sterilizable and be biocompatible.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
FIGS. 3-5 show how the device of this invention can be used as a
reservoir sensing pump speed controller in extracorporeal circuits
for oxygenating or otherwise treating body fluids, e.g., blood, and
the like, before their return to the patient.
Referring to FIG. 3, reservoir sensing pump controller 30 is used
in a gravity drainage, single pump, extracorporeal circuit to keep
the pump at the proper speed. Blood from the patient (not shown)
passes by gravity through conduit 32 into inlet port 13 on sensor
device 30. The blood leaves through port 15 and is pumped, e.g.,
with roller type pump 34 (Sarns Corp., Ann Arbor, Mich, or the
like) through conduit 36 past pressure monitoring gauge 38 to the
inlet port of membrane type blood-gas exchanger 40 (GE-DUALUNG,
General Electric Co., Schenectady, N.Y., or the like) which is
fitted with inlet 42 and outlet 44 for heat exchange fluid and
inlet conduit 46 for oxygen. The oxygenated blood exits the
membrane lung through conduit 48 and, after being led to bubble
trap 50, is returned to the patient through conduit 52. Shown
schematically in combination with reservoir 8 are hinged sensor
plate 20 and linear potentiometer 26 which supplies a pump speed
varying signal through conductor 54 to pump 34. As changes in
volume or pressure in the system expand or contract reservoir 8,
the pump speed is varied automatically to compensate.
Referring to FIG. 4, reservoir sensing pump controller 30 is used
to keep either the venous pump or, preferably, the arterial pump of
a two-pump gravity drainage system automatically at proper speed.
Blood from the patient (not shown) passes by gravity through
conduit 56 into inlet port 17 on sensor device 30. The blood leaves
through port 15 and is pumped by roller type venous pump 34 through
conduit 36 past pressure monitoring gauge 38 to an inlet port of
membrane type blood-gas exchanger 40. Oxygenated blood exits the
exchanger through conduit 58 and is split into two streams, one
being recycled to controller 30 through conduit 60 and entrance
port 13. Complaint reservoir 8 is fitted with one vent tube 16 and
a second vent tube includes filter 62 and cardiotomy reservoir 64.
The other oxygenated blood stream is transferred through conduit 66
and pumped by roller type arterial pump 68 to bubble trap 70 before
being returned to the patient. Shown schematically in combination
with reservoir 8 are hinged sensor plate 20 and linear
potentiometer 26 which supplies a pump speed varying signal. If
venous pump 34 is controlled, signal conductor 54 is used.
Alternatively, and preferably, if arterial pump 68 is controlled,
signal conductor 55 is used. In either case the pump speed is
varied automatically to compensate for changes in blood pressure
and volume within reservoir 8.
Referring to FIG. 5, reservoir sensing pump controller 30 is used
to keep the arterial pump in a two-pump venous pump suction circuit
automatically at the proper speed. Blood from the patient (not
shown) flows through conduit 72 into roller type venous pump 34 and
pumped through conduit 36 to an inlet port of membrane type
blood-gas exchanger 40. Oxygenated blood exits the exchanger
through conduit 74 and enters compliant reservoir (arterial) 8
through entrance port 13. Compliant reservoir 8 is fitted with vent
tube 16 and with cardiotomy reservoir 64 coupled to reservoir 8
through filter 62. Part of the oxygenated blood in reservoir 8
exits through port 19 and circulates back through the venous pump
circuit via conduit 76. Another part of the volume of oxygenated
blood in reservoir 8 exits through port 15 to roller type arterial
pump 68 where it is pumped through conduit 78, and, optionally,
bubble trap 70, back to the patient. Shown schematically in
combination with reservoir 8 are hinged sensor plate 20 and linear
potentiometer 26 which supplies a pump speed varying signal through
conductor 55 to pump 68, automatically varying the pump speed to
compensate for changes in blood pressure and volume within
reservoir 8.
Obviously, many other variations are possible in the light of the
above specific embodiments. For example, FIGS. 4 and 5 illustrate
how the sensor can be located in the venous and arterial two-pump
circuits. Several other variations are possible. Illustratively, in
FIG. 5, decoupling conduit 76 between the reservoir and the inlet
to venous pump 34 can be clamped off resulting in coupled pump
speeds, i.e., arterial pump 68 will follow the settings of venous
pump 34. Moreover, the reservoir sensor's control in FIG. 4 can be
moved to run the circuit exactly as shown in FIG. 5 to achieve
automatic operation. In both venous and arterial reservoir
circuits, the venous pump is desirably set somewhat faster than the
anticipated rate of drainage from the patient. Excess flow will
recirculate through a decoupling line (60 in FIG. 4; 76 in FIG. 5).
A sensor controlled arterial pump will return just the venous
drainage back to the patient. This has two major advantages: (i)
lessened manpower drain during partial supports; and (ii) smaller
liquid inventories needed in the reservoir during all cases due to
the ability of the machine to compensate more rapidly than a human
operator. Other variations will include an arterial pump speed
sensor with high and low speed set-point alarms, especially useful
for automatic operation, because a sudden change of speed will
usually indicate a problem with the perfusion. It will be obvious
also that the locations of the cardiotomy reservoir can be changed
from those shown in FIGS. 4 and 5, without departing from the
invention.
The above description demonstrates that the present invention
discloses a reservoir sensing and signaling device which is simple
and offers unique advantages over other pre-existing designs meant
to serve the same function.
Many variations of the present invention are possible without
departing from the spirit or scope of the appended claims.
* * * * *