U.S. patent number 3,892,534 [Application Number 05/430,104] was granted by the patent office on 1975-07-01 for rigidly mounted bubble-type blood oxygenator having flexible flow channels.
This patent grant is currently assigned to Baxter Laboratories, Inc.. Invention is credited to Ronald J. Leonard.
United States Patent |
3,892,534 |
Leonard |
July 1, 1975 |
Rigidly mounted bubble-type blood oxygenator having flexible flow
channels
Abstract
A bubble-type blood oxygenator which comprises a flexible
envelope having a blood flow passage with a blood oxygenating
portion and a blood defoaming portion. A stiff backing carries the
oxygenator in flat, stretched-out configuration with the result
that the flow passage, when filled with blood and oxygen, exhibits
reduced outward distension and sagging.
Inventors: |
Leonard; Ronald J. (Elk Grove
Village, IL) |
Assignee: |
Baxter Laboratories, Inc.
(Morton Grove, IL)
|
Family
ID: |
23706079 |
Appl.
No.: |
05/430,104 |
Filed: |
January 2, 1974 |
Current U.S.
Class: |
422/47;
261/DIG.28; 128/DIG.3 |
Current CPC
Class: |
A61M
1/32 (20130101); A61M 1/325 (20140204); Y10S
128/03 (20130101); Y10S 261/28 (20130101) |
Current International
Class: |
A61M
1/32 (20060101); A61m 001/03 () |
Field of
Search: |
;23/258.5 ;128/DIG.3
;195/118 ;261/DIG.28 |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
Chemical & Engineering News; "GM Develops Cheap Plastic Heart
Pump", 6/29/70, page 11. .
Sedlank et al., "Eine Herz-Lungen . . . Zwecke", Chirurg.; Vol. 43,
1972, page 187..
|
Primary Examiner: Richman; Barry S.
Attorney, Agent or Firm: Ellis; Garrettson Altman; Louis
Claims
That which is claimed is:
1. In a bubble-type blood oxygenator which comprises: a flexible
envelope having sealed portions defining in said envelope a flow
passage with a blood oxygenating portion and a blood defoaming
portion, and which has means for introducing a stream of blood and
a stream of oxygen bubbles into one end of said flow passage, and
means for removing blood from the other end of said flow passage,
the improvement comprising: rigid backing means operatively
associated with and carrying and maintaining said envelope in flat,
stretched-out configuration, whereby said flow passage, when filled
with blood, exhibits reduced outward distension and sagging.
2. The oxygenator of claim 1 in which said rigid backing means is
sealed within a second envelope defined by one side of said
flexible envelope and a flexible backing sheet, said flexible
envelope and backing sheet being joined together by a peripheral
seal to tightly enclose said rigid backing means, whereby said
flexible envelope is stretched out along said rigid backing.
3. The oxygenator of claim 2 in which said rigid backing means is
disposed adjacent said blood defoaming portion of the flexible
envelope, but said blood oxygenating portion is laterally spaced
from said rigid backing means.
4. The oxygenator of claim 3 in which means defining a fluid
pressurizable flexible member are positioned along said blood
oxygenating portion to adjust and control the cross sectional area
of the oxygenating portion.
5. The oxygenator of claim 4 in which said blood defoaming portion
comprises an upstream part containing defoaming sponge means, and a
second part comprising a tortuous passage for final gas bubble
removal from the blood, said rigid backing means defining an
aperture adjacent said upstream part to permit increased distension
of said flow passage at said upstream part, to provide space for
said defoaming sponge means, and allow observation of the defoaming
process from both the front and the back of the oxygenator.
6. The oxygenator of claim 5 in which said rigid backing means
comprises a pair of rigid sheets lying against each other, each
sheet comprising a pair of facing sheets separated by a plurality
of parallel reinforcing members, the reinforcing members of each
said rigid sheet defining an angle to the reinforcing members of
the other rigid sheet of said pair, whereby said rigid backing
means exhibits increased resistance to bending.
7. In a bubble-type blood oxygenator which comprises: a flexible
envelope having sealed portions defining in said envelope a flow
passage with a blood oxygenating portion and a blood defoaming
portion, and which has means for introducing a stream of blood and
a stream of oxygen bubbles into one end of said flow passage, and
means for removing blood from the other end of said flow passage,
the improvement comprising: a tubular blood sampling line
communicating at one end with said defoaming portion below the
level of blood in said defoaming portion in normal use and at its
other end with an area which is vertically spaced above said blood
level in normal use, said area being sealed from the exterior by
removable seal means for maintaining a sterile environment about
said other end, and a rigid backing means operatively associated
with and carrying and maintaining said envelope in flat,
stretched-out configuration, whereby said flow passage, when filled
with blood and oxygen, exhibits reduced outward distension and
sagging.
8. The oxygenator of claim 7 in which said rigid backing means is
sealed within a second envelope defined by one side of said
flexible envelope and a flexible backing sheet, said flexible
envelope and backing sheet being joined together by a peripheral
seal to tightly enclosed said rigid backing means whereby said
flexible envelope is stretched out along said rigid backing
means.
9. The oxygenator of claim 8 in which said rigid backing is
disposed adjacent said blood defoaming portion of the flexible
envelope, but said blood oxygenating portion is laterally spaced
from said backing.
Description
BACKGROUND OF THE INVENTION
Flexible, envelope-type blood oxygenators are used during open
heart surgery to take over the function of the lungs while the
heart is stopped during the operation. Blood is artifically pumped
from a body vein through the oxygenator, where it takes up oxygen
and expels carbon dioxide. Thereafter, the blood is artificially
pumped into a body artery, providing a circulation of fresh blood
to the patient throughout the operation.
Examples of commercial, envelope-type blood oxygenators are
described in U.S. Pat. Nos. 3,502,440 and 3,729,377.
The flexible envelope oxygenators have a significant advantage over
the known casing type oxygenators, such as is illustrated in U.S.
Pat. No. 3,488,158 , in that the flexible, collapsible blood flow
channels of the envelope oxygenators reduce the risk that large
amounts of gas can be pumped into a patient's artery, which can
have fatal effect. The flexible flow channels collapse flat when
not filled with liquid or gas. Hence, if by accident the pump
downstream of an envelope oxygenator is not shut off when the
envelope oxygenator empties, little or no gas will be forced into
the patient's artery since the flow channels simply collapse under
suction of the pump as they empty of blood, functioning as a
shut-off valve. Thus, flow into the patient's artery terminates as
the blood supply is exhausted, despite any continued operation of
the downstream, arterial pump.
To the contrary, casing-type oxygenators have blood flow passages
which are rigid and of unvarying volume. Hence, fatal amounts of
gas can easily be pumped into a patient by accident.
In customary use, the envelope oxygenators described above are
stretched flat on a frame, with the top and side edges of the
oxygenator being tied under tension to the frame, which is of
larger dimension than the oxygenator. This inconvenient stretching
and tying operation is important to keep the oxygenator from
sagging when filled with blood, and to keep tubing connections with
the oxygenator straight and unkinked, as well as to prevent
selected portions of the flexible blood flow passage from
distending outwardly to an excessive degree. This latter phenomenon
is undesirable, since it increases the volume of blood retained in
the oxygenator, which in turn reduces the amount of blood available
to the patient at any given time.
Because of the inconvenience of the tying and stretching operation,
the rigid casing-type oxygenators retain substantial popularity,
despite their disadvantages.
The invention of this application provides a device which exhibits
the safety and effectiveness of flexible, envelope-type
oxygenators, yet which also has the convenience of the rigid,
casing-type oxygenators, combined with advantages not found in any
of the prior oxygenators.
DESCRIPTION OF THE INVENTION
In accordance with this invention, a bubble-type blood oxygenator
is disclosed which comprises: a flexible envelope having sealed
portions defining in said envelope a flow passage with a blood
oxygenating portion and a blood defoaming portion, and which has
means for introducing a stream of blood and a stream of oxygen
bubbles into one end of said flow passage, and means for removing
blood from the other end of said flow passage. A rigid backing is
attached to the flexible envelope to carry it in flat, streched-out
configuration. Thus, the desired portions of the flow passage
defined within the envelope are stretched, and exhibit reduced
outward distension and sagging when filled with blood and oxygen
during use.
As a result, the oxygenator of this invention does not need to be
tied and stretched on a frame, as have the previous, flexible
envelope oxygenators. Instead, it can be simply hung up or stood up
for use in a manner similar to the casing-type oxygenators.
Nevertheless, the oxygenator of this invention possesses the
collapsible flow channels which are important for increased safety
of operation.
Furthermore, the flexible flow passage of the oxygenator can
exhibit a restricted capacity to distend with blood by a novel
mechanism, in that the presence of the rigid backing prevents at
all times the side of the flow passage abutting the backing from
distending excessively. Also, as the flow passage begins to
distend, the rigid backing causes the flexible envelope to
encounter increased tension, which additionally restricts the
distension, with the consequent advantages described above.
As a further advantage of this invention, it has not been good
medical practice to tie the prior envelope oxygenators on their
frames for use until shortly before use in an operation. The reason
for this is that the polyvinylchloride plastisol sheeting that is
customarily used to make the envelopes tends to cold-flow or
"creep" slowly under tension, so that, in a day or so, the tension
placed on the envelope tied in a frame is greatly reduced. Thus,
conventionally, the envelope oxygenator must be mounted, or
remounted, on the frame shortly prior to the operation, which of
course is likely to be a most busy and inconvenient time for the
operating room nurse in charge of the oxygenators.
In the oxygenator of this invention, most of the tension needed is
placed on the flow channels in response to their distension with
blood, since the channels are forced away from the rigid backing,
with consequent tension, as they distend. Hence, the oxygenator of
this invention exhibits no undesirable stretching or "creep" prior
to use, and remains available for immediate use without tying and
stretching for an indefinite period of storage.
A second feature of the invention relates to the improvement in
this general type of oxygenator comprising a tubular blood sampling
line which communicates the defoaming portion with a vertically
spaced area above the flow passage which area is sealed by a
removable seal for maintaining a sterile environment.
In the drawings:
FIG. 1 is an elevational view of an oxygenator of this invention
with a portion broken away to show the rigid backing behind the
flexible envelope portion of the oxygenator.
FIG. 2 is an enlarged transverse sectional view taken along Line
2--2 of FIG. 1.
FIG. 3 is an elevational view of the rigid backing of this
invention, with a portion broken away to show a second backing
layer.
Referring to the drawings, an oxygenator of this invention is
shown, having plastic sheet layers 10, 12 and related parts as
shown, which are similar in function to the corresponding parts of
the oxygenator disclosed in FIGS. 1 through 4 of U.S. Pat. No.
3,729,377.
Sheet layers 10, 12, are sealed together in part by peripheral heat
seals 14, 16. Additional heat seals 18, 20 define a flow passage
for blood, which includes a blood oxygenating portion 22 and a
blood defoaming portion 24.
The upstream part of blood defoaming portion 24 contains
conventional defoaming sponge 26, such as spun metal fibers or
porous plastic, generally containing an organosilicon defoaming
agent. A second part of the defoaming portion comprises tortuous
passage 28 to permit the final removal of gas bubbles from the
blood. Access to passage 28 is defining through filter member 30,
having guide funnel 31 to pass the blood to one end of tortuous
passage 28. Gas is carried away from the apparatus through exhaust
ports 32 and 34, which are sealed in sterile manner until time of
use by operable tear seal 35 of conventional design, Pocket 29
provides access for a thermometer or the like.
A stream of blood is introduced through entry ports 36, 38, which
can be sealed in a sterile manner until use by tear seals 37, which
are similar to seal 35. Entry port 36 is connected to a source of
venous blood to provide the main stream of blood being circulated,
while entry port 38 is provided for the optional recycling of blood
as it is removed from an incision site and recycled to the patient.
Exit port 40 at the opposite end of the blood flow passage is
adapted to connect with tubing for passing the blood back into the
patient, and is removably sealed in a manner similar to entry ports
36, 38.
Seals 39 and 41 close off the flow passage around the entry and
exit ports.
Tubular sparger 42 is mounted in the bottom of oxygenating column
22 to provide a wide distribution of fine bubbles of oxygen into
the flowing blood in the column. Sparger 42 is a cup-like member
generally made of porous plastic and typically having an average
pore size of about 90 to 140 microns. The interior of sparger 42 is
connected to oxygen line 44 in a conventional manner, which line is
sealed between sheets 10 and 12 along seal line 18.
Access port 46 is a hole through all layers of the oxygenator, to
permit the running of blood lines and the like through the
oxygenator in convenient manner.
Fluid pressurizable member 59 comprises a pair of plastic sheets
heat sealed together to define a pair of interconnected,
pressurizable chambers, and is folded about oxygenating portion 22
in the manner described in U.S. Pat. No. 3,729,377 for the purpose
of controlling the cross-sectional area of oxygenating portion 22
as desired during the blood oxygenation procedure. Inflation line
80 is provided to add or withdraw pressurizing fluid such as oxygen
gas from pressurizable member 59.
In accordance with this invention, a rigid backing 82 is provided,
which is specifically shown in the present embodiment to be a pair
of corrugated sheets 84, 86 similar in structure to each other and
generally similar to corrugated material used for making shipping
containers. Sheets 84, 86 are preferably made of high density
polyethylene or the like, and each comprise a pair of plastic
facing layers 88, 90 (FIG. 2) separated by a plurality of generally
parallel reinforcing members 92, 94 to space layers 88, 90 and to
strengthen the composite structure.
Sheets 84, 86 are arranged so that their respective reinforcing
members 92, 94 are in angular relation to each other, and generally
perpendicular. This provides the complete backing 82 with a high
degree of bending resistance so the backing is not easily bent or
folded.
In the embodiment shown, backing 82 is positioned against plastic
sheets 10, 12 as indicated in phantom outline in FIG. 1 to hold
sheets 10 and 12 of the envelope oxygenator in stretched-out
configuration without the need for tying to a frame, as has been
the prior art custom. This can be accomplished by sealing, with
heat seals or the like, backing 82 in a second envelope defined by
sheet 12 and a third flexible plastic backing sheet 96 (FIG. 2).
Sheets 10, 12, and 96 are all heat sealed together along seal lines
14, 16 in the manner of FIG. 2 about most of the periphery of
backing 82, with the exception of blood inlet area 100 between
oxygenation portion 22 and defoaming portion 24, and gas vent
outlet area 101, into which vent tube 103, having cotton filter
105, passes to provide a bacteria-proof vent for use during the
sterilization of the oxygenator. Accordingly, the envelope
oxygenator is permanently secured to backing 82 in stretched-out
configuration, to achieve the advantages described above. Also,
area 107 can remain unsealed, for ease of manufacture, up to the
level of outlet 40, but preferably no higher.
In the preferred embodiment shown herein, oxygenation portion 22 of
the blood flow path is not positioned to lie against backing 82,
but is laterally spaced therefrom, since its cross sectional area
is controlled by the operation of pressurizable member 59. However,
in other embodiments of this invention, it may be desirable to
place oxygenation portion 22 against backing 82, especially when no
pressurizable member 59 is present.
Oxygenation portion 22 is desirably partially separable from the
rest of envelope 10 to form an arm-like structure by tearing
portion 22 away along weakened portion 102, which is located
between seal lines 16 and 20.
Rigid backing 82 defines an aperture 104 adjacent that portion of
the blood defoaming passage 24 which carries the defoaming sponge
26. Aperture 104 passes through both layers 84 and 86, and permits
increased distension of the flow passage walls about the defoaming
sponge to provide space for it, and allow observation of the
defoaming process from both front and back of the oxygenator.
Backing 82 also defines other apertures in both layers 84 and 86.
Aperture 106 (FIG. 3) is positioned to allow observation of the
blood level in the reservoir 28 from both front and back of the
oxygenator, while aperture 108 receives outlet port 40.
Oxygenated blood sampling tube or line 110 extends between the area
under seal 35 and the upper end of tortuous passage 28, to permit
the sampling of oxygenated blood after filtering for analysis of
pO.sub.2 levels and the like. Tube 110 is affixed at one end by a
clip 112 which is heat sealed to the envelope oxygenator along seal
line 18. The other, upper end of tube 110, carries a Luer syringe
receiving portion 111, and is exposed upon opening seal 35 so that
a syringe may be connected to the Luer for collecting a blood
sample. The luer-carrying end of tube or line 110 is vertically
spaced above the flow passage 24 in normal use, to prevent blood
from spilling out of the oxygenator through tube 110.
The above has been offered for illustration purposes only, and is
not intended to limit the invention disclosed herein, which is
defined in the claims below.
* * * * *