U.S. patent number 3,853,479 [Application Number 05/265,864] was granted by the patent office on 1974-12-10 for blood oxygenating device with heat exchanger.
This patent grant is currently assigned to Sherwood Medical Industries, Inc.. Invention is credited to Denton A. Cooley, Daniel A. Talonn.
United States Patent |
3,853,479 |
Talonn , et al. |
December 10, 1974 |
BLOOD OXYGENATING DEVICE WITH HEAT EXCHANGER
Abstract
A blood oxygenation device with a heat exchanger that includes a
pair of plates disposed against the opposite sides of a flexible
blood containing chamber of the device. The plates are relatively
movable to selectively vary the volume of the chamber and the blood
priming volume of the device. One or both of the plates are used as
a heat exchange member to raise or lower the temperature of the
blood flowing in the oxygenation device.
Inventors: |
Talonn; Daniel A. (University
City, MO), Cooley; Denton A. (Houston, TX) |
Assignee: |
Sherwood Medical Industries,
Inc. (St. Louis, MO)
|
Family
ID: |
23012173 |
Appl.
No.: |
05/265,864 |
Filed: |
June 23, 1972 |
Current U.S.
Class: |
422/46; 165/46;
422/47; 128/DIG.3; 261/DIG.28 |
Current CPC
Class: |
A61M
5/44 (20130101); A61M 2205/366 (20130101); Y10S
128/03 (20130101); Y10S 261/28 (20130101) |
Current International
Class: |
A61M
5/44 (20060101); A61m 001/03 () |
Field of
Search: |
;23/258.5 ;128/DIG.3
;261/DIG.28 ;165/46 ;195/1.8 |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
Galletti et al., "Temperature Regulating Devices and Heat
Exchangers," Heart-Lung By-Pass; 2nd Printing; 2/66; Grune &
Stratton; pp. 164-170..
|
Primary Examiner: Richman; Barry S.
Attorney, Agent or Firm: Garber; Stanley N. O'Meara; William
R.
Claims
What is claimed is:
1. In combination, a blood oxygenation device including an
oxygenator chamber, means for introducing venous blood and
oxygenation gas to said oxygenator chamber for producing gas
bubbles in the blood to oxygenate the blood, a defoaming chamber
connected to receive blood from said oxygenator chamber and having
anti-foam means therein for assisting in the removal of excess gas
and vent means for venting excess gas to atmosphere, and a supple
plastic blood settling reservoir chamber connected to receive blood
from said defoaming chamber, said reservoir chamber having an
outlet for discharging oxygenated blood, and blood temperature
control means including a heat exchanger having a pair of
relatively movable plates disposed respectively on opposite sides
of said reservoir chamber, adjustment means for adjustably
effecting relative movement between said plates to clamp at least a
portion of said reservoir chamber therebetween to selectively vary
the volume of said reservoir chamber, and means for varying the
temperature of at least one of said plates to control the
temperature of the blood.
2. The combination according to claim 1 wherein said adjustment
means includes indicia to indicate the relative positions of said
plates.
3. The combination according to claim 1 wherein said reservoir
chamber and the other of said plates are transparent.
4. The combination according to claim 1 wherein said reservoir
chamber portion comprises the major surface area of said reservoir
chamber.
5. The combination according to claim 1 wherein said plates are
adjustable to compress a main portion of said reservoir chamber and
effect an upper reservoir chamber portion having a greater width
than the portion of the reservoir chamber between said plates when
blood is disposed in said reservoir chamber.
6. The combination according to claim 1 wherein at least one of
said plates has a chamber therein, and said temperature varying
means includes means for circulating heat exchange fluid through
said chamber.
7. The combination according to claim 6 wherein said fluid is
water.
8. The combination according to claim 1 further including
upstanding frame means, and means hingedly connecting one of said
plates to said frame means for pivotal movement toward and away
from the other of said plates.
9. The combination according to claim 8 including means for
connecting said oxygenation device to said frame means to support
said oxygenation device between said plates.
Description
BACKGROUND OF THE INVENTION
This invention relates to blood oxygenation apparatus and more
particularly to an improved temperature control device for an
oxygenation device.
Blood oxygenation devices are generally provided with blood
temperature control devices which may include heat exchangers
interposed in series in the extracorporeal circulating system.
Various types of heat exchange devices have been proposed, however,
they have not been entirely satisfactory for one reason or another.
Some heat exchangers, for example, result in an increase in
extracorporeal blood volume due to the blood priming requirement of
the exchanger, and an increase in the length of the blood flow path
thereby increasing the danger of damage to the bood. With some
devices there exists the danger that, should any heat exchange
fluid leak from the exchanger, the blood would be subjected to
contamination by such fluid. Some proposed devices are lacking in
other aspects such as heat transfer efficiency, and high cost.
In some cases, it is desired to change the blood volume or capacity
of the oxygenation device in order to alter the priming volume of
blood, for example, to minimize the priming volume for given
patients. It is also desirable or necessary to maintain the blood
in the reservoir chamber of an oxygenation device at its designed
normal operating level so that the device functions in a manner
consistent with its designed characteristics. While the blood
capacity or level in the reservoir chamber can be varied by
pinching off a portion of the chamber, such a method is not
satisfactory because it affects the normal blood flow path through
the device which may damage the blood, and it is an inaccurate way
to vary the capacity.
SUMMARY OF THE PRESENT INVENTION
It is therefore an object of the present invention to provide an
improved blood oxygenation device with a blood temperature control
wherein the above-mentioned disadvantages are substantially
obviated.
Another object is to provide an improved blood oxygenation device
and blood temperature control in which the priming volume of blood
may be readily and accurately varied and the temperature of the
blooc efficiently controlled.
Another object is to provide a novel heat exchanger in combination
with a blood oxygenation device which is highly efficient in
operation to either heat or cool the blood, and which is capable of
varying the bood capacity of the oxygenation device.
Another object is to provide a novel blood oxygenation device
having a blood reservoir compartment of plastic material, and a
heat exchange device which provides efficient heat transfer
characteristics, is capable of adjusting the blood level, and
wherein the danger of blood contamination from the heat exchanger
device is eliminated.
Still another object is to provide improved blood oxygenation
apparatus having a disposable blood oxygenation device with a
reusable heat exchanger wherein blood does not come in contact with
the heat exchanger and the danger of cross-infection is
eliminated.
In accordance with one form of the present invention, blood
oxygenation apparatus is provided which includes a compartment for
containing blood, and a heat exchanger disposed in contact with the
exterior of the blood compartment. In accordance with another
aspect, the heat exchanger includes a pair of plates positioned
respectively on opposite sides of a flexible blood compartment and
are relatively movable to vary the volume of the compartment and
effect heat transfer therewith.
These and other objects and advantages of the present invention
will be apparent from the following detailed description and
accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is an elevational view of an oxygenation device and a blood
temperature control in accordance with a preferred embodiment of
the present invention;
FIG. 2 is a cross-sectional view taken along the line 2--2 of FIG.
1;
FIG. 3 is a cross-sectional view taken along the line 3--3 of FIG.
1;
FIG. 4 is a perspective view of the heat exchanger of FIG. 1;
and
FIG. 5 is a perspective view of a modified form of heat
exchanger.
DESCRIPTION OF THE PREFERRED EMBODIMENT
Referring now to the drawings, and particularly to FIG. 1, there is
shown blood oxygenation apparatus including an oxygenation device
10 supported by a frame 12 connected to a standard 14, and a
temperature control device, indicated generally at 16, which is
also supported by the standard 14. The device 10 is shown connected
to frame 12 by a plurality of supporting rings 15.
Oxygenation device 10 is of the plastic bag type which is generally
formed by uniting a pair of supple plastic sheets 17 and 18, such
as by predeterminately located heat seals, to form a number of
chambers or compartments such as a defoaming compartment 20, and a
settling reservoir compartment or chamber 22. An oxygenator 24 is
connected at the upper end thereof to the defoaming chamber 20.
Oxygenator 24 is similar to the oxygenator shown and described in
copending application Ser. No. 263,049, filed June 15, 1972, by N.
W. Burlis and assigned to the same assignee as this application and
now, U.S. Pat. No. 3,827,860, issued Aug. 8, 1974.
Oxygenator 24 includes a hollow member 26 having interior walls
forming an oxygenator column or chamber 27 which receives a movable
oxygenating gas disperser and venous blood delivery member 28 shown
in phantom in FIG. 1 and described in detail in the above copending
application. The member 28 is provided with three tubes 29, 30 and
31, two of which, such as tubes 29 and 30, may be connected to a
source of venous blood while the tube 31 is connected to a source
of oxygenating gas. The member 26 is cylindrical and may be of
plastic material and formed by cutting it to size from plastic
tubing. Member 26 is connected, such as by heat sealing, to the
interior of the defoaming chamber 20. The disperser member 28 is
provided with an upper plate and a plurality of small holes for
dispersing gas into the blood in the chamber 27. It also has
connections for connecting the tubes 29 and 30 through the member
28 to pass blood into chamber 27, the blood flowing over the plate
with the holes and being subjected to the gas bubbles, as described
in the above mentioned copending application. A releasable clamp 32
is shown clamping the movable member 28 in a desired location in
member 26 in sealing engagement with the walls of the chamber 27.
The member 28 is movable after releasing clamp 32, by pulling on
the tubes 29, 30 and 31 or by working the member externally through
the tube 26 where the tube 26 is sufficiently supple, or a plunger
rod (not shown) may be used to engage and connect with the member
28 to move it in one or both directions within the chamber 27 as
desired. In this way the oxygenator 24 can be selectively adjusted
to subject the venous blood to oxygenating gas for different
lengths of time so that the same oxygenation device can be used to
efficiently oxygenate venous blood for different flow rates and for
patients of various sizes.
When the oxygenation device 10 is connected for operation and
provided with a suitable amount of priming blood, venous blood
flows in tubes 29 and/or 30 into the oxygenator chamber 27, and
oxygenating gas bubbles through the blood generating a blood foam
which moves upwardly into defoaming chamber 20. An anti-foam member
40, such as formed of plastic or metal fibers, is shown in phantom
disposed in the defoaming chamber 20 and extending into the
settling reservoir chamber 22 below the designed blood level,
indicated at 39 in FIG. 1. The defoaming member 40 may be enclosed
in a filter (not shown) such as a nylon woven stocking-like member.
Blood flows into the settling chamber 22 with the excess oxygen gas
and carbon dioxide leaving the defoaming chamber and settling
chamber and passing to atmosphere by way of a vent indicated at 42.
The oxygenated blood flows through an outlet 44 at the bottom of
chamber 22, and, by means of a pump, into the arterial system of
the patient to which it is connected.
The blood temperature control device 16 includes a heat exchanger
50 including front and rear heat exchange members 52 and 54 that
engage the external sides of settling reservoir chamber 22 of
device 10. The members 52 and 54, as also seen in FIG. 2, are shown
as hollow plates, for example, of stainless steel, having heat
transfer fluid inlet conduits 56 and 58 connected to a suitable
fluid temperature control device 60, and a pair of outlet conduits
62 and 64 for discharging fluid from within the members 52 and 54
for returning it to the heat exchange system. The heat exchange
members 52 and 54 are hinged together for pivotal movement relative
to each other such as by hinges 70 and 72 connected to a vertical
supporting member 74 of the standard 14. The heat exchange members
may be opened or moved away from each other, such as shown in FIG.
4, to allow insertion of the oxygenation device 10.
As seen more fully in FIGS. 3 and 4, heat exchange members 52 and
54 are shown mounted for adjusting movement relative to each other
by connecting the hinges 70 and 72 for movement relative to the
supporting member 74 by rivets 75 and 76 slidable in slots 77 and
78 in member 74. The space between the members 52 and 54 is
accurately adjusted by a pair of threaded adjusting screws 80 and
81 provided with handles. The screws 80 and 81 are shown connected
for rotation on member 52 and threadedly coupled to the member
54.
The heat exchange members 52 and 54 are shown in FIG. 2 engaging
the external, opposed sides of the blood reservoir compartment 22
for effecting a relatively narrow reservoir chamber main portion
22a therebetween which connects at its upper end with a relatively
wide, shallow reservoir chamber portion 22b at the top. It will be
apparent that by varying the distance between the heat exchange
members 52 and 54 by means of screws 80 and 81, the shape and
volume of the reservoir chamber portion 22a can be varied and the
total capacity of the chamber 22 changed. Also, the heat exchange
members 52 and 54 intimately engage opposed sides of chamber 22
and, since chamber 22 is resilient or supple, compress and cause
the chamber walls to conform in shape to the shape of the facing
sides of the heat exchange members to maximize the areas of contact
between the chamber of blood and heat exchange members for
efficient heat transfer. The facing surfaces of the heat exchange
members in the illustrated embodiment are planar and parallel to
each other and contact the entire surface area of chamber portion
22a which constitutes the major surface area of the chamber 22.
While the temperature of the plates 52 and 54 may be varied by
various means other than fluids, for example, electronically, the
temperature control device 16 may employ a liquid, such as water,
flowing into the inlet tubes 56 and 58 and out the outlet tubes 62
and 64 to control the temperature of the heat exchange members. The
temperature of the water is controlled by any suitable temperature
monitoring and control means well known in the art to either heat
or cool the water. Each of the heat exchange members 52 and 54 may
be provided with internal baffling such as indicated at 79 and 79'
in FIG. 2. The cooling or heating liquid flowing in the heat
exchanger system may be used to cool or heat the blood as desired
or required, and with the blood containing chamber 22 and heat
exchanger disposed in the atmosphere of the operating room where
they may be continuously viewed.
Because of the relatively shallow, relatively wide upper chamber
portion 22b as a result of the clamping forces applied by the heat
exchanger 50, bubbles entering this portion readily rise and pass
upwardly and out vent 42 to atmosphere, the relatively large
surface of blood in portion 22b providing an efficient pool for the
escape of such bubbles.
A pair of turn counters 82 and 83 are shown connected to heat
exchange member 52 respectively adjacent the screws 80 and 81. The
counters may be of the well known tumbler type and geared to the
screws to provide an indication of the number of turns that the
screws have been rotated and the relative positions or spacing of
the members 52 and 54. By correlating the turns with the spacing
between the members and the volume of the portions of reservoir
chamber 22, the counters give an accurate indication of the volume
or blood capacity of the chamber 22 for any given setting of the
screws 80 and 81. Thus, the volume of the chamber 22 is readily
adjusted to a desired value and can be readjusted or reset
accurately by use of counters 82 and 83 which serve as volume
indicating devices.
In FIG. 5, there is shown a modification of the heat exchanger at
84. Heat exchanger 84 includes a rear hollow heat exchange plate
member 85 connected, such as by screws (not shown), to a vertical
support 74'. Member 85 has fluid inlet and outlet tubes 87 and 87'
for controlling the temperature of member 85. A front plate member
or panel 86 is hinged to support 74' or to member 85 if desired.
The members 85 and 86 are relatively movable toward and away from
each other by means such as the sliding hinge shown and a pair of
threaded adjustment screws 88 and 89. In this case, the panel or
front plate member 86 is formed of a transparent material such as
glass or plastic, for the purpose of permitting the technician or
surgeon to visually observe substantially the total blood flow in
the oxygenation device, such as device 10, that is to be inserted
between members 84 and 85 during use. For example, it may be
desirable to continuously observe the blood in the reservoir
chamber, such as reservoir chamber 22 of device 10, during surgery
to ensure against the flow of a bubble into the outlet 44. The heat
exchanger 84 is capable of varying the blood carrying capacity of a
supple or resilient plastic compartment, such as a settling
reservoir chamber 22, in the same manner as described herein in
connection with the heat exchanger 50 of FIG. 1. The chamber to be
disposed between members 85 and 86, such as the supple chamber 22
of oxygenation device 10, has its facing sides conform to the
surfaces of these members. In this illustrated arrangement, only
member 85 is connected to a source of heat transfer fluid.
It will now be apparent that all of the objects and advantages of
the present invention hereinbefore mentioned, as well as others,
are provided by the present invention. It should be understood that
although this invention has been described with reference to the
illustrated preferred embodiments, modifications thereto may be
made without departing from the true spirit and scope of the
invention.
* * * * *