CA1327497C - Liquid and gas separation system - Google Patents

Abstract

ABSTRACT OF THE DISCLOSURE

A defoaming device for separating foam and bubbles from a liquid, such as blood, is disclosed. The device can be used in conjunction with a medical device, such as a membrane oxygenator, for separating air from blood while minimizing blood contact with the antifoam agent used in the device. The device includes a reservoir and a filtering material that does not contain any antifoaming agent. This filtering material is positioned in a lower portion of the reservoir to separate foam and bubbles from the liquid. An element containing an antifoaming agent is positioned in the reservoir above the maximum surface fluid level therein and receives the foam and bubbles that rise from the filtering material. Contact of the liquid with the antifoaming agent is substantially avoided.

Description

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This invention relates to a system useful for the j separation of liquid and gas, and more particularly to a q medical device, such as a blood oxygenator or a 10 cardiotomy reservoir, which employs a defoamer system ~ that affords excellent separation of macroscopic and ''~,! ' microscopic air from blood while at the ~ame time ; minimizing blood path contact with the ~illcone containing compounds typically used in the defoamer.
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There are many systems known in the art which are used j to remove gas ~such as air) from fluid~ and which al80 20 employ a defoamer assembly in such systems. For example, in various types o ~urgical procedures, it i8 often necessary to perform a treatment whereby the ~' patients blood is subject to a bypass ~low outside of the patients body, and an apparatus such as an - 25 oxygenator is employed. In many such oxygenators, oxygen i~ transferred to ~he blood via a procedure which -~ forms a foam and therefore requires a defoamer assembly.
, . , These oxygenators are used in open-heart surgery and other operations and treatment# of the body when it is .
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1 3274~7 `~necessary to establish an extracorporeal c~rculation system for temporarily assuming the functions of t~e heart and lungs of the patient. In such a sy8tem, the oxygenator operates to perform the function u~ually performed by the lungs of the patient, i.e., the life-supporting transfer of oxygen into the blood and carbon dioxide out of the blood. The oxygenator is used in association with a pump which perform~ the function of the heart to cause circulation of the blood. Thus, early versions of the oxygenator were often referred to as "heart-lung~ machines. The early heart-lung machines were typically rotating discs which passed through a pool of blood, but were only partially immersed thereln such that tne free surface of the disc exposed the blood to oxygen and accomplished some gas transfer. After this, bag-type oxygenators were introduced which were superior to the disc oxygenators, but which left much to be desired.
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At the present time two principle types of blood oxygenators are used which have proven highly efficient, provide minimal blood trauma, are convenient to set up and operate, are cost effective and have provided excellent clinical results, i.e. bubble oXygenators and `25 membrane oxygenators. In a membrane oxygenator,-a thin, - highly gaæ permeable membrane i8 placed between the gas `~and blood. Venous ~lood flows along one side of the -membrane and gas is on the other side. A pressure ; gradient is established so that when the pa~tial pressure for oxygen is higher in the ventilating ga~
than the partial pressure or oxygen in the venous blood, oxygen will diffuse across the membrane into the . . ~

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1 327~97 :' , _3_ blood. subble oxygenators simply diffu~e gas bubble~
~;into venous blood. The oxygenated blood i8 typ~caliy defoamed before it is ready for delivery to the patient.
-5In medical devices such as the oxygenators as described above, and in other medical devices such as cardiotomies and nardshell venous reservoirs, air or some other ga~
can be introduced into the blood, e.g. oxygen (in an oxygenator), nitrogen, carbon dioxide, etc. Typically, 10 when this occur~ it is medically neces~ary to remove ~;certain ga~ from the blood prior to the blood going to the patient. Separation of the blood f rom the gas requires the medical device to be used in combination qwith a defoaming device which typically incorporates 15 some sort of an agent to assist in breaking the foam down. In medical applications, about the only agent that has proved acceptable is a silicone antifoam agent. ~owever, in the process of the silicone agent performing its job, i.e. remove the gas from tbe blood, 20 a ~mall amount of the silicone actually is transferred into the blood. The problem with th~s i8 that silicone iis not metabolized by the human body, and tberefore silicone accumulates in the body. Even though ~ilicone is an inert material it is undesirable within the human 25 body becau~e it can tend to clog up ~ome of the very small capillaries and arterie~ within the human body.
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As described herein, the features of the présent invention can be employed in ~arious types of medical devices. Examples of the type of so-called membrane oxygenators which can employ the features of the present invention are described in U.S. Patent Numbers 4,094,792 ,. . .

,, 1 3274q7 and 4,196,075 both of which are assigned to Bentley Laboratories, Inc., the assignee of the present invention. In addition Bentley Laboratories, Inc.
products identified as the Bentley BCM-3 and BCM-7 inteqrated membrane oxygenators which are oxygenators having three major components can incorporate the defoamer of the present invention. Examples of the bubble type blood oxygenator that can employ the features of the present invention are described in U.S.
Patent Numbers 3,468,631, 3,488,158 and 3,578,411, the last two of which describe devices which have come to be known as the Bentley Oxyqenator, and also U.S. Pate~t Numbers 4,282,180 and 4,440,723, both assigned to Bentley laboratories, Inc.
Various prior art examples of blood oxygenators and gas-liquid type of transfer apparatus are described in U.S. Patent Numbers 3,065,748; 3,256,883; 3,493,347;
4,073,622; 4,138,288; 4,182,739; 4,203,944; 4,203,945;
4,288,125; 4,231,988; 4,272,373; 4,336,224; 4,370,151;
4,374,088 4,396,584; 4,407,777; 4,440,722; 4,493,692 and 4,533,516.
SUMMARY OF THE INVENTION
It is therefore an object of an aspect of the present invention to provide a device for separating gas from liquid which is substantially devoid of the above-noted disadvantages.
An object of an aspect of the present invention is to provide a defoaming device which has particular use with a medical device such as an oxygenator for the removal of gases, such as oxygen, from blood.
An object of an aspect of the present invention is to provide a defoaming device which employs a silicone antifoam agent to assist in breaking the foam (bubbles) in the blood down, and which at the same time substantially avoids contaminating the blood with undesirable silicone.

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An object of an aspect of the present invention is to provide a defoaming device fox separating gases from , blood which employs a silicone antifoam agent and in ', which the blood contacts the silicone antifoam agent ' 5 only when there is gas in the blood.
An aspect of this invention is as follows:
A blood oxygenator comprising a vertically oriented - housing having an upper and lower end; blood inlet means ~ connected to and communicating with the upper end of the ; 1~ housing; heat exchange means located in the upper end; a blood-oxygen mixing chamber located at the lower end including an oxygen inlet means connected to and communicating with the mixing chamber; and a defoaming ' device located in the upper end, the defoaming device including an antifoaming agent therein being positioned in the oxygenator to selectively expose only foam and ; bubbles from the blood to the antifoaming agent.
By way of added explanation, the foregoing and other objects are accomplished in accordance with the features of the present invention by providing a defoaming device for separating gas in the form of foam from the liquid and then breaking the foam down into a liquid and a gas.
, The device comprises a reservoir and a filtering element that does not contain an antifoaming agent and which is positioned in the lower portion of the reservoir to - first contact the liquid and separate gas foam and bubbles from the liquid. Positioned in the reservoir above the maximum fluid level is an element containing an antifoaming agent which then comes in contact with the foam that rise from the filtering element and breaks down the foam.
Basically, when blood is moving through a medical device it may from time to time have some gas in it. When gas . .

, '`1 3274q7 i8 in the blood, and $t's desired to remove it, an antifoam agent such as a ~ilicone material ~e.g.
simethicone) i~ typically used. ~owever, it is preferred not to nave the blood directly contact the silicone material. The defoamer device in accordance wi~h the features of the present invention i8 unique in that when in operation, blood without gas will not contact the silicone containing material. Foam, macroscopic bubbles, and microscopic bubbles, appearing in the blood will be separated from the blood without contacting the silicone antifoam agent. Then, after separation, the foam and bubbles are allowed to travel to a portion of the defoamer assembly positioned above `~ -the maximum level of blood in the assembly's reservior ~; 15 where the foam and bubbles are then placed in contact with an antifoam dipped material. Thus, the only thing that contacts the antifoam agent is the foam or bubbles that rise up to the area above the blood level where the ~' antifoam agent is located. The present invention is unique because it defines a defoamer which allows selective exposure of only the foam and bubbles to an antifoaming agent.
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2s For a better understanding of the invention a~ well as other objects and further features thereof, reference is made to the following detailed disclosure of this invention taken in coniunction with the accompanying drawings wherein:

~ FIG. 1 is a plan sectional view of a defoaming apparatus ..

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~ -7-,f illustrating the structural feature~ thereof in accordance with the preferred embodiments of the prese;lt inventions and ~; 5 ~IG. 2 is a plan sectional view of a membrane oxygenator ~'f and an enlarged portion thereo~ illustrating how a ~i defoaming apparatus in accordance with the present -~ invention can be used with the oxygenator.
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i~f Broadly speaking, the defoaming device in accordance with the invention can be used for removing a gas, such as air, from various types of fluids, such as blood.
The defoamer system as described herein is particulariy suited for use in any open system device which requires air-blood separation. Excellent opportunities for using this defoamer system thereby exist in such medical devices as, for example, bubble oxygenators, membrane oxygenators, cardiotomies, hardshell venou-~ reservoirs, blood autotransfusion systems and oxygenated blood ~ cardioplegia systems. Thus, although the- unique -~ features of the defoaming device in accordance with the ~, present invention will be described below with regard to its use in an oxygenator for the purpose of removing gas foam and bubbles from blood, it is to be understood that `~ the defoaming device has broader use, does not require the particular ~tructural features of the particular - embodiment described herein and i8 capable of removing ','f 30 various gases ~rom different liquids when used with a medical device and in other environments.

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The basis features of a preferred embodiment of the defoaming device 10 of this invention are shown in ~ Figure l. The device illustrated can be identified as - either the Bentley Laboratories, Inc. BCM-3 or BCM-7 ; 5 defoamer which can be used, for example, in either the Bentley BCM-3 or BCM-7 integrated membrane oxygenator as ! described in commonly assigned U-S- Patent No.
~! 4,698,207, issued October 6, 1987 entitled "Integrated Membrane Oxygenator, Heat Exchanger and Reservoir or in the Bentley BMR-1500 membrane oxygenator reservoir. The defoamer device 10 is a three-piece assembly which affords excellent separation of foam and macroscopic and microscopic air from blood while minimizing blood path contact with the silicone containing antifoam compound that is employed in the device. The three primary components of the defoamer device 10 shown in Figure 1 are as follows: (a) A low antifoam dipped (only on the top portion thereof ll,) polyurethane, thermally reticulated (open cell), foam pre-stage llA constructed, for example, from 1/2 inch thick, 100 ppi (pores per inch) polyurethane; (b) a screen 12 which can be a heparin coated 50 micron (mesh opening in microns) monodur polyester screen having a 36 percent open area (twill weave); and (c) a foam spacer stage 13 which can be a l/8 inch thick, 15 ppi polyurethane, thermally reticulated (open cell) foam spacer stage.
The polyurethane foam pre-stage 11 is the only element of defoamer device 10 which includes an antifoaming agent. In accordance with the features of this invention an antifoam compound (e.g. simethicone) is .

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g applied to the low antifoam defoamer element llA only ~along a relatively narrow border 11, e.g. a two inch border, measured from the top portion of defoamer 10 (Note, 11 and llA are the same piece of foam material).
~ 5 It is this low antifoam design which presents an i antifoam coated surface only to the target blood foam and bubbles which, since being buoyant, move to the top of the blood. Thus contact between the blood and the ,. . .
silicone coating antifoam agent is minimized i.e.
contact occurs with the foam and bubbles and the antifoam agent above the maximum liquid surface level of the blood. When defoaming device 10 is employed in an oxygenator, during normal operation the maximum blood column height within the defoamer remains below the lower margin area of the element 11 which contains the antifoam material. Microbubbles are not significantly affected by the simethicone compound or other - antifoaming agents and exposure of the whole blood path to the antifoaming agents is unnecessary. The defoaming device 10 allows selective exposure of only blood foam ~ to an antifoaming agent.

i~- The 100 ppi polyurethane foam pre-stage llA acts to filter foam, macroscopic air bubbles and microscopic air bubbles appearing in the blood before its presentation to the heparin coated polyester microscreen 12.
Although the microscreen 12 is capable of removing the macroscopic air which is first presented to the pre-stage polyurethane foam 11, doing so cau~es an ` 30 occlusive air film to form on the screen. Exposure of microscreens to large amounts of macroscopic air ' decreases their effective surface area and can impede ,. ..

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their ability to pass fluids, even when treated with , wetting agents such as heparin. A possible consequence of air occlusion of these microscreens is that blood ~, - passing through the diminished screen area is subjected to increased flow resistance and pressure drop. These increases may produce blood formed elements damage.
Placement of a polyurethane foam "filtering stage" prior , to the heparin coated screen significantly improves the , blood air elimination as well as the blood handling ,, lO capability of the defoamer assembly.
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After blood passes through the 100 ppi pre-stage 11, it comes into contact with the 50 micron heparin dipped ~ polyester screen 12. This screen effectively eliminates ,~ 15 microbubbles greater than 50 micron in diameter.
Although polyester microscreen fabrics are available with smaller mesh openings which would provide even greater air filtration, these fabrics would present ;, certain disadvantages. As the fabric's mesh opening 20 size decreases, the percent open area of the fabric (the effective blood passage area) decreases significantly.
As the percent open area decreases, the blood is subjected to greater resistances and shearing forces ~,-, Increased shearing forces are reflected in greatly l 25 increased blood damage. The 50 micron PES twill heparin " ,dipped screen provides excellent microbubble filtration in concert with a relatively high 36 percent open area.
In-vitro evaluation of prolonged blood flow through this screen has clearly demonstrated the excellent blood 30 handling capability of this material.

- As illustrated in Figure 1, the heparin coated , .. - ~ , ~ .
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microscreen 12 does not enclose the upper portion of the polyurethane foam 11. During normal operation of t~e defoaming device 10, the blood level within the defoamer ~; will always be below the margin of tha polyester microscreen. Should the screen 12 become occluded, the blood level within the defoamer will exceed the height of the screen and blood ~low will bypass the screen.
All blood flow will pass through the antlfoam treated section of the polyurethane defoamer 11 and cAscade over the occluded microscreen. Thi~ integral bypass feature of the defoamer assembly 10 is a cruc$al ~afety feature which allows the use of a microscreen in the blood path without the threat of total blood~ path ~i ' occlusion concommitant with æcreen occlusion-The third element of the defoamer assembly 10 i~ a spacer stage 13 which is preferably a 1/8 lnch thick 15 ppi polyurethane, thermally reticulated topen cell) material. This element i8 a spacer stage which prevents the wicking of blood between the polyester microscreen 12 ~or the upper segment of the 100 ppi prestage 11) and the outer containment layer, e.g. a polyester tricot stock, in which the elements of the defoamer assembly are enclosed. A large pore material, such as a 15 ppi polyurethane material 13 is preferably used for t~is spacer stage to limit material surface area for air and - blood remixing.

All three elements llA, 12, and 13 are preferably located in a polyester tricot sock 14 outer layer and the entire defoaming assembly is secured onto a rigid . .
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vented support grid 15. The sock 14 and screen element 12 are connected to straps at positions 16 and 17 in t~e manner as described herein below, i.e. the example given of how the defoaming assembly 10 can be used in a membrane oxygenator.
., In accordance with the features of the particular embodiment of the defoamer assembly that ha~ been described herein above, there are certain critical parameters which will enable the defoamer assembly to operate in the environment of an o~ygenator, particularly a membrane oxygenator, in an efficient manner. In defoamer assembly 10, the polyurethane foam ll,llA and 13 and polyester screen 12 pore ~izes are critical to the efficient functioning of the entire assembly.

; In the polyurethane thermally reticulated foa~ ptestage elements 11 and llA, a preferred pore size for the material i about 100 ppi and this pore ~ize can range from about 80 to 110 ppi. It is preferred not to use foam for element 11 having a pore size less than about 80 ppi because this type of material will not ~i adequately screen macro~copic air. If the pore size of element llA i~ greater than about 110 ppi it may have too high a breakthrough volume thereby bringing the blood path in contact with antifoaming agents. In the monodur polyester screen 12, a preferred pore size for the screen material is about 50 microns and can range from about 50 to 71 microns. It is preferred not to use a screen having less than about S0 mlcron openings because this type of microscreen has an inadequate .
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percent of open area. A low percent of open area may produce unacceptable levels of blood damage. If the ~creen has greater than about 71 micron openings, it will exhibit little affect in reducing microbubble levels. In the polyurethane thermally reticulated foam spacer stage 13, a preferred pore size is about 15 ppi and this can range from about 15 to 25 ppi. It i8 preferred not to use a foam spacer ~tage 13 ha~ing a ppl call out less than about 15 ppi becau~e it i8 difficult to manufacture defoamer material with this low pore ^ size. Polyurethane foam material with a ppi call out greater than about 25 ppi is generally not acceptable because it pre3ents too much material ~urface area for - air/blood remixing.
The operation and use of the defoaming assembly as ~; described herein above will now be described in the - environment of a membrane oxygenator. As lllustrated in ';! Figure 2, there is shown a membrane oxygenator 20 with the circled area 21 illustrating in an enlarged manner ; the structure of a defoaming assembly 22 incorporating '` the unique features of the present invention. In use, blood from a patient is fed into the membrane o~ygenator through a venous inlet connector located at the top portion 23 of the oxygenator. Once in the oxygenator, ~ the blood 810wly trickles in a downward direction onto ;5 the heat exchanger tubes 24, which are preferably in the form of a helically wrapped tube, and then into the defoaming assembly 22. It should be noted that in the - 30 membrane oxygenator the purpose of pas~lng the blood through the defoaming assembly is to separate incidental alr that is ~ed into the oxygenator along with the ' ,;

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-, 1 3274q7 blood.
, The defoaming assembly 22 is structured of an outer layer of a polyester tricot ~ock 25. Located adjacent sock 25 is a layer 26 of a 15 ppi polyurethane foam material. A 50 micron modur polyester screen 27 is positioned between foam material 26 and layer 28 of 100 ppi polyurethane foam material. A strap member ~not shown) is secured to screen 27 at position 29 and used to squeeze foam layer 28 inwardly ~as ~hown) at the approximate location of the maximum blood level within the defoaming assembly. The 100 ppi polyurethane foam material 30 positioned above this indented portion of - the 100 ppi foam ~i.e. positioned above the maximum lS surfacP of the blood level within the defoaming assembly) is the portion of the 100 ppi foam material which includes an antifoaming agent such as, for example, simethicone. The next illustrated layer of defoaming assembly 22 represents a sUppoEt grid 31.
Another strap element is secured to the sock 25 at position 32 and holds the sock onto the support grid.

During use of the membrane oxygenator 20, the blood travels from the heat exchange tubes 24 and is directed into contact with the 100 ppi polyurethane foam pre-stage 28 (that part of the 100 ppi foam without the-antifoaming agent) which acts to filter foam, macro~copic air bubbles, and microscopic air bubbles appearing in the blood. Afterwards the blood travels to the heparin coated polyester microscreen 27 which effectively eliminates the microbubbles of air in the blood greater than S0 microns in diameter. The ., ~ , .

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^` 1 327497 ,~ , ; microbubble~ separated from the blood and any other foam travel to the antifoam area 30 of the 100 ppi polyurethane foam which is located above the maximum - surface level of the blood when the separation of the air from blood occurs. Thus, the defoamer allows selective exposure of only blood foam (bubbles) to the antifoaming agent.

After the blood passes through the defoaming assembly-22, it goes into a venous reservoir 33. Thereafter, the blood passes from the reservoir out of a venous re~ervoir outlet connector 34 to a pump tnot shown) which pumps the blood back to the lower portion of oxygenato~ 20 through an oxygenator inlet connector ;15 (not shown). It is in the lower portion of the membrane oxygenator where oxygen transfer to the blood ` actually occurs. After being pumped back into the oxygenator, the blood flows thru a plurality of vertical hollow fibers 35. The oxygenator includes an oxygen inlet connector 37 which feeds the oxygen to fibers 35 and an oxygen outlet connector 36 wh~ch allow the oxygen to travel out of the oxygenator~
Basically the blood flows through the fibers 35 while the oxygen flows around the hollow fibers whereby the oxygenation takes place.
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The apparatus described in accordance with the pLesent invention can be used to defoam numerous types of liquids. One example of a li~uid is blood, which has been used as a specific example to describe a detailed --embodiment of the present invention.

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'`` 1 327497 While this invention has been described in conjuncti9n : with specific embodiments thereof, it i~ evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, the present invention is intended to embrace all such alternatives, modifications and variations, as fall within the spirit and scope of the appended claims.
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Claims

The embodiments of the invention in which an exclusive property or privilege is claimed are defined as follows:

1. A blood oxygenator comprising a vertically oriented housing having an upper and lower end; blood inlet means connected to and communicating with the upper end of the housing; heat exchange means located in the upper end; a blood-oxygen mixing chamber located at the lower end including an oxygen inlet means connected to and communicating with the mixing chamber; and a defoaming device located in the upper end, the defoaming device including an antifoaming agent therein being positioned in the oxygenator to selectively expose only foam and bubbles from the blood to the antifoaming agent.

2. A blood oxygenator according to Claim 1 further including a venous reservoir containing said heat exchange means and said defoaming device.

3. A blood oxygenator according to Claim 1 wherein said oxygenator is a membrane oxygenator.

4. A blood oxygenator according to Claim 3 wherein said blood-oxygen mixing chamber includes a plurality of vertically oriented hollow fibers, said blood flowing through the fibers while said oxygen flows around the fibers whereby the blood-oxygen transfer occurs.

5. A blood oxygenator according to Claim 1 wherein said heat exchange means comprises a helically wrapped tube.

6. A blood oxygenator according to Claim 1 wherein said defoaming device is supported within said oxygenator by strap means.

7. A blood oxygenator according to Claim 1 wherein said defoaming device separates incidental air that is fed into said oxygenator along with said blood.