Note: Descriptions are shown in the official language in which they were submitted.
~5;~3
APPARATUS AND METHOD FOR RAPID INFUSION
OF CIRCULATORY SVPPORTIVE FLUIDS
Technical Field
This invention relates to an apparatus and method
for the rapid infusion of circulatory supportive fluids
such as blood into a patient. The apparatus includes an
enclosed housing for retaining blood prior to infusion,
means for warming blood within the housing, means for
circulating the blood within the housing prior to
infusion, means for inhibiting cellular damage to the
blood during the circulation, means for permitting oxygen
saturation of the blood, and means for transfusing the
blood from the housing to a patient. Blood can be
transmitted from the apparatus to the internal jugular
vein of the patient, and can be infused at a rate of up to
; a physiological maximum rate.
Backqround of the Invention
During surgery or in the emergency room, it is
often necessary to infuse blood rapidly where massive
blood loss or exsanguination has occurred. Patients
having inadequate blood ~olume can suffer disastrous
consequences.
Many situations give rise to the loss of great
amounts of blood in a short period of time. These
situations include hemorrhagic trauma resulting from
injury to the patient, and a variety of major ~ascular,
orthopedic, thoracic, and abdominal surgeries such as
cancer surgery and liver transplantation.
In the past, surgical teams have had difficulty
rapidly replacing blood lost from a patien~. In a
commonly used method of rapid infusion, several infusion
~ ~ sites are utilized at one time Infusion bags or bags of
; ~ stored banked blood are connected to the sites by
intravenous tubing. Often, four or more personnel are
35 ~required to manage the various infusion sites, manually
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squeezing blood bags or operating direct pressure pumps to
infuse blood through the sites. Nhere warmed blood is
desired for infusion, heating coils are often provided
surrounding the infusion bags, thus requiring more complex
apparatus which is nevertheless inefficient for warming at
rapid infusion rates; this also requires multiple
personnel. These and other similar currently used methods
of rapid infusion have many drawbacks. Often, for
example, where stored banked blood is used directly from
bags, the chemistry of the blood utilized for infusion is
inappropriate for the necessary high infusion rates of 1-
3 liters per minute or more, and can have serious, even
lethal effects on the patient. Further, the presence of
numerous personnel monitoring the infusion sites and
manually squeezing blood bags or operating pumps can
create a chaotic atmosphere and distract others in the
performance of their duties.
Utilizing conventional infusion methods, blood is
often lost faster than it can be given and the patient
goes into shock. In other situations, blood is infused
fast enough but it is cold, acidic, and chemically
imbalanced, leading ko hypothermia and possibly
- cardiovascular instability.
Conventional rapid infusion methods also provide
significant potential for contamination. The presence of
multiple personnel, the use of multiple sites, and the
proce~s of opening numerous blood ~ags and attaching them
ko lines greatly increases the risk of contamination.
This is of particular concern for liver transplant
patients and other critically ill patients where sterile
conditions are of extreme importance.
Further, blood infused by conventional methods is
occasionally inadequately filtered and warmed, which can
lead to severe consequences. It can also lack cost
effec~iveness, in view of the large number of people
required to carry out the infusion and the length of time
the patients generally must remain in intensive care after
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surgery requiring rapid infusion.
Lastly, the morbidity and mortality rates encoun-
~ered with conventional massive trans~usion or infusion
techniques and apparatus are unacceptably high, particu-
larly in liver transplant or resection operations.
Accordingly, a need exists for a rapid blood
infusion apparatus and method which can successfully
infuse large quantities of warmed, processed blood in a
shor~ time, which can be con~eniently operated by one
individual, which eliminates the need for multiple
infusion sites on the patient, and which is easy to set
~` up, operate, and maintain.
Brief Description of the ~nvention
We have invented a rapid blood infusion apparatus
and method which can be easily set up and conveniently
operated by a single individual, and more importantly,
which eliminates the need for multiple infusion sites and
which quickly and safely delivers blood products to the
patient. The apparatus and method can deliver blood up to
a physiological maximum rate which can vary from patient
to patient, the blood having the proper blood chemistry
and temperature for the individual patient's needs. It
can be very quickly set up and xeady for use with trauma
victims where timing is critical. It eliminates the need
~5 for multiple personnel, thereby simplifying rapid infusion
and creating a more orderly environment in the operating
or emergency room. It is simple for use with low birth
weight pediatric patients, as well as adult patients.
A significant advantage of the invention is ~hat
it provides infusion rates which can match exsanguination
rates of severe rapid blood loss. Through use of this
apparatus and method, hemorrhagic shock can be avoided,
and morbidity and mortality rates decreased. Use of the
nvention can also reduce the patient's stay in the
- 35 intensive care unit, thus providing greater cost-effec-
tiveness than csnventional apparatuses and methods.
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The invention also provides for simplified logis-
tics of blood product proces~ing and infusion, because of
the invention's simplicity compared to conventional
techniques.
The inventio~ also serves to optimize sterile
techniques through the design of the apparatu~ and the
simplified infusion procedure. Sterile technique is of
great importance because infection is currently a leading
cause of surgical fatality.
As a further advantage, the apparatus is
compatible with other existing equipment, such as the
Maemonetics Cell Savar~ unit.
The invention can also help oxygen delivery in
patients with gas exchange problems, and can help prevent
respiratory failure. It also allows for a more effective
and direct control of the patient's basic physiological
functions (i.e., temperature, pH, cardiac output, blood
volume, serum electrolytes, etc.).
The invention has made certain radical
operations, such as liver transplants, more successful.
Bleeding can be a serious problem during such operations.
A patient can exsanguinate in a matter of minutes.
Through use of the invention, the patient's blood volume
can be maintained until the vessels can be clamped,
avoiding shock, cardiac arrest, and the need for resusi-
tation.
As used herein, "blood" refers to circulation or
circulatory supportive fluids including, but not limited
to, blood, pla~ma expanders, artificial blood products
such as those comprising Teflon material where for
religious or other reasons a patient cannot receive actual
blood components, and the like. For most situations where
this invention will be used, the circulation supportive
fluids will be whole human blood or packed red cells
resuspended in normal saline, fresh frozen plasma, or
Plasmalyte.
The apparatus of the invention comprises an en-
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closed housing for retain:ing blood prior to infusion. ThP
housing has a top surface, a bo-ttom surface, and a wall
joining the top surface and the bottom surface. The
enclosed housing also has two areas designated generally
as an upper zone and a lower zone.
Positioned within the housing in the lower zone,
the apparatus includes means for warming blood prior to
infusion.
The apparatus further includes means for circu-
lating the blood within the housing prior to infusion.This circulating means is at*ached or connected to the
; housing.
In the upper zone of the housing is provided
means for inhibiting cellular damage during circulation of
the blood.
Located on the housing is a means for providing
oxygen saturation of and CO2 removal from the blood prior
to infusion.
Lastly, the apparatus comprises means for trans-
fusing the blood from the housing to a patient. Thismeans is, of course, connected to the housing.
The in~ention further relates to a method of
rapidly infusing circulation supportive fluid or blood
into a patient. The method comprises providing an
apparatus having an enclosed housing for retaining blood
prior to infusion, means for warming blood prior to
infusion, means for circulating the blood within the
housing prior to infusion, means for inhibiting cellular
damage during blood circulation, means for providing
oxygen saturation of the blood, and means for transfusing
the blood from the housing to a patient, supplying blood
to the apparatus; circulating the blood within the
apparatus while heating the blood to a temperature of
about 36-40C.; and infusing the blood from the apparatus
; 35 to a patient's vein at rates of up to a physiological
maximllm, typically, up to about 3,000 ml. per minute.
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In accordance with a certain aspect of the invention
there is provided an apparatus for rapid infusion o~ circulatory
supportive Eluid into a patient, which comprises:
(a) an enclosed housing for retaining a predetermined
quantity of circulatory supportive fluid prior to infusion, said
housing having a top surface, a bottom surEace, and a surrounding
side wall joining the top surEace and the bottom surface, and
having an upper zone and a lower zone therein,
(b) positioned within the housing in the lower zone, heat
exchanger means Eor warming -the fluid prior to infusion;
(c) attached to the housing, in fluid communication with -the
upper and lower zones therein, means including an exterior pump
- for circulating the fluid within the housing prior to inEusion,
(d) located on the housing, means for permitting oxygen
saturation of the fluid within said housing prior to infusion;
and
(e) connected to the circulating means, means for selectiv-
ely connecting the circulating fluid in fluid communication with
the patient to effect rapid infusion.
In accordance with another aspect of the invention there
is provided an apparatus for rapid infusion of circulatory
supportive fluid into a patient, which comprises:
(a) an enclosed housing for retaining a predetermined quan-
tity~of circula-tory supportive fluid prior to infusion, said hous-
ing having a top surface, a bottom surface, and a surrounding side
wall joining the top surface and the bottom surface, and having an
~ u~er z.one and a lower zone therein;
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(b) posi-tioning within the housing in the lower zone, means
for warming the -fluid prior to infusion;
(c) a-ttached to the housing means -Eor circulating the fluid
; within the housing prior to infusion;
(d) located on the housing, means for permitting oxygen
satura-tion of the fluid prior to infusion; and
(e) connected to the circulating means, means for selectiv-
ely connecting the circulating fluid in fluid communication with
the patient to effect rapid infusion;
said fluid circulating means including a pump e~terior to the
housing, a fluid outlet line at the lower zone o-f the housing
providing fluid communication between the interior of -the housing
. and the pump, and a fluid inlet line at the upper æone of the
hou.sing providing fluid communication between the pump and the
interior o-f the housing such that fluid is circulated from the
interior of the housing through the fluid outlet line, through the
pump, and back into the housing through the fluid inlet line.
In accordance with yet another aspect of the invention
there is provided an apparatus for rapid infusion of circulatory
supportive fluid into a patient, which comprises:
an enclosed housing for retaining fluid prior -to infusion,
having a top surface, a bottom surface, and a wall joining the top
surface and the bottom surface, and having an upper zone and a
.
~; lower zone;
positi.oned within the housing in the lower zone, means for
warming the fluid prior to infusion;
r~ t~ the housinq, means for circulating the fluid
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within the housing prior to inusion;
set within the housing in the upper zone, means for inhibit-
ing cellular damage during circula-tion of the fluid;
located on -the housing, means -for permi-tting oxygen satura-
tion of the fluid prior to infusion:
connected to the housing, means for transfusing -the fluid
from the housing to a patient;
said fluid circulating means including a pump exterior to the
housing, a fluid outlet line at the lower zone of the housing
providing fluid communication between the interior of the housing
and the pump, and a fluid inlet line at the upper zone of the
housing providing fluid communication betwean the pump and the
in-terior of the housing such that fluid is circulated from the
: interior of the housing through the fluid outlet line, through the
pump, and back into the housing through the fluid inlet line; and
sa.id cellular damage inhibiting means including a splash
plate mounted within the housing in the upper zone, cooperatively
placed with respect to the fluid inlet line to reduce cellular
damage of fluid entering the housing from the fluid inlet line.
In accordance with yet another aspect of the invention
there is also provided apparatus for rapid blood in~usion,
comprising:
an enclosed housing for retaining a predetermined quantity of
blood prior to infusion, said housing having upper and lower
zones,.
heat e~changer means positioned in the lower zone of said
housinq for warminq blood therein;
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an external pump with an inlet connected in fluid communica-
tion with the lower zone of said housing, and an outlet connected
in fluid communication with the upper zone of said housing, for
continuously circulating the blood therein; and
means for selectively connecting the ou-tlet of said pump in
fluid communication with a patient for blood infusion at up to a
physiological maximum rate.
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Brief Description of the Drawinqs
Figure 1 is a perspective view generally viewed
as from above and to the side of one embodimen~ of the
- rapid blood infusion apparatus incorporating the present
invention.
Figure 2 is a schematic view of the apparatus and
its use with a patient's circulatory system.
Detailed Description of the Invention
Referring to the drawings~ wherein like reference
numerals represent like parts throughout the several
views, there is generally designated at 5, a rapid blood
or circulation supportive fluid infusion apparatus.
The apparatus 5 comprises enclosed housing or
enclosure 10 having a top surface or wall 12, a bottom
surface or wall 14, and a rigid side wall 16 connecting
the top surface and the bottom surface. Typically,
housing 10 wiil be generally cylindrical in shape. Top
wall 12 and bottom wall 14 will generally be parallel,
with rigid wall 16 being in the form of a curved surface
extending perpendicularly between top 12 and bottom 14 to
create an enclosed housing 10.
Housing 10 is designed for retaining blood prior
to infusion to a patient. The housing will preferably
hold about five liters of blood, in addition to certain
features of the apparatus to be described hereinafter.
five liter housing is large enough to retain sufficient
blood for many rapid infusion situations, and five liters
is sufficient for replacement of the average adult's total
blood volume. In addition, this size is small enough to
permit mobility of the apparatus, and the cylindrical
shape makes it relatively easy to insert into a typical
holder on an IV stand, which will be described
hereinafter. Other sizes and shapes of housings can, of
collrse, be used if desired.
The housing can be formed of any suitable blood
compatible material. Preferably, the material will be a
relatively hard or rigid transparent plastic. Polycar-
bonate materials are preferred because of their light
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weight, strength, and_transparancy which permits vie~ing
the blood level within the housing, and for ease and
economy of manufacture. Other suitable plastics such
as~cellulose acetate butyrate or the like may also be
used.
The housIng includes-an upper zone generally
designated at 18, and a lower zone, generally designated
at 20. Varlous components of the apparatus are located
in either the upper or lower zones, as described herein-
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The apparatus 5 includes a means 30 for warming theblood within the housing. This warming means can be
generally described as a heat exchanger, 32. Prefer-
ably, heat exchanger 32 comprises coiled tubing 34 set
substantially within the lower zone 20 of housing 10.
Tubing 34 is preferably formed of a single length of
tubing, that is, one without joints or ~onnections. Use
of a single length helps prevent the possibility of
water leaking into the blood; such leaks could be
disastrous.
Tubing 34 has a first end 36 and a second end 38.
Connected to first end 36 is an inlet port 40 in housing
wall 16, located in lower zone 20 near bottom wall 14.
Similarly, cooperatively connected to second end 38 is
outlet port 42 in housing wall 16, located near bottom
wall 14. :Inlet and outlet ports 40 and 4~ are designed
for cooperative connection with a warm water supply.
Typically they will be formed of rigid plastic or
aluminum. The warm watex enters or passes into coiled
~0 tubing 34 at first end 36 through inlet port 40, circu-
lates through the coiled tubing and exits the tubing
through second end 38 and outlet port 42.
Commercial units such as the Sarns heater cooler,
Cardio-vascular Instruments, Inc., and Audronics, are
available for supplying water to a heat exchanger.
These units generally consist of a pump, hoses, and a
thermostatically controlled heating element. They are
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:typically.:powe-~ed ~y electricity. A preferred unit for
~se in this~-in~-ention:is the Audronics brand, because of
its smaller.size. -
- Placement'of~the inlet and outlet ports 40 and 42
is not critical, but their location at lower zone 20
near.the bottom wall 14 of the housing tends to
~revent. interference of any hoses, pumps, and the like
.with the ease of oper~tion of the apparatus.
: ..It is.:.preferred that coiled tubing 3~ be formed
Of aluminum because aluminum is light weight, provides
sufficient-heat. transfer, and is blood compatible.
Other types of tubing may be used, for example, certain
: blood compatible rubber or plastic tubing, but such
: tubing gen-erally provides significantly less heat
15 exchange. Stainless steel tubing could also be used,
but is significantly heavier and~ therefore, contributes
greatly .to the weight of the apparatus, decreasing its
ease of mobility.
Where coiled aluminum tubing is used, we suggest
that the temperature of the water supplied to the tubing
be about 42C.
Too high a water temperature in tubing which
. provides good heat transfer may damage the blood.
Generally, it is desirable that the heat exchanger be
capable of warming five liters of blood within about
5-lO minutes, in the context -of this invention.
Rapid blood infusion apparatus lO further includes
means 50 for circulating the blood within the housing
prior to infusion. The blood is circulated to bring it
to the proper temperature, to increase the oxygen
content, if necessary, by way of a gas port to be
: ~ described hereinafter, and to combine it with any
required additives to alter the blood chemistry, or with
: medications required by the patient. In addition, once
the blood has reached the proper temperature, level of
oxygenation,: etc., preferably circulation continues
except'during infusion itself until there is no more
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need for infusion. In this way, the apparat~s and blood
are maintained in a state ready for infusion.
Blood circulating means 50 comprises a pump 52, a
blood outlet line 54, and a blood inlet line 60.
Pu~p 52 is located exterior to housing lOo Any
suitable blood pump, such as a centrifugal, peristaltic,
or rolle~ pump can be utilized. Preferably, the pump
will be calibrated to permit greater precision in its
operation. Suitable pumps can be obtained from many
medical suppliersj such as Sarns and Biomedicus. We
recommend-a pump haying the ability to deliver a minimum
of six liters per minute pumping action. The roller
pump is preferred because of its mechanical simplicity~
safety, relatively low cost, and portability. ~e
currently prefer a Sarns 7000 modular pump available
from Sarns, Inc. -:
Blood outlet line 54 is preferably located in the
lower zone*of housing 10. Blood outlet line 54 includes
port 55 extending through housing wall 16, and coopera-
tively connected thereto, suitable tubing segment 56 orother conduit extending from port 55 providing fluid
communication between the interior of housing 10 and
pump 52. Port 5~ is preferably conventionally adapted
` for connection with_ tubing in various diameters. In
particular, it is preferably adapted for connection with
one-quarter inch by one-sixteenth inch and three-quarter
! inch by one-sixteenth inch tubing, in the nature of a
reducer connector.
The conduit 56 can be any suitable material such as
polyvinyl chloride (pvc) tubing, available commercially
under many marks such as Tygon and Silastic. The cur-
rently preferred conduit is one-quarter inch by one-six-
teenth inch pvc tubing, available from medical suppli-
ers including Norton, the major supplier of Tygon
tubing.
Blood inlet line 60 is located substantially at
upper zone 18 of housing 10. It provides fluid commun-
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ication between pump 52-and the interior of housing 10.
Blood inlet line 60 can comprise port 62 extending into
upper zone 18 of ho~sing 10. Preferably, port 62
extends through top wall 12 of the housing, and
includes a short tubular segment 63 extending, for
exampl~, about one to two inches into the interior of
the-ho~singj parallel to side wall 16. - This extension
63 of port 62 serves to direct blood flow to a splash
p-late-, herein~fter described in detail.
- 10 - Blood-inlet line 60 further comprises blood con-
duits 5qa and -64b.-- The condults~together provide fluid
commùnication between pump~52 and the interior of
housing 10 by way of cooperative connection with a
Y-connector 68 and through port 62.
Conduit 64a preferably comprises pvc tubing segment
64c leading from pump 52 to a rigid plastic tubular
connector 64d. Connector 64d extends into sidewall 16
of housing 10 at point 69a and exits the housin~ at or
near top wall - 12, for example, at 69b. Cooperatively
attached to connector 64d near top surface 12 of housing
10 is an additional conduit such as pvc tubing segment
64e, leading into Y-connector 68 (described hereinafter)
at leg 68c.
Conduit 64b preferably comprises pvc tubing segment
25 64f leading from leg 68a of Y-connector 68 to port 62.
Pbrt 62 is preferably a rigid plastic tubular connector
h~ving-extension 63. Tubing segment 64f is coopera-
tively connected to provide fluid communication between
Y-connector 68 and port 62.
Y-connector 68 connects tubing segments 64e an~ 64f
at a point outside housing 10. Y-connector 68 includes
two outlet legs, or portals 68a and 68b, and one inlet
leg or portal 68c. The term Y-connector as used herein
refers to any connector having two outlet portals and
one inlet portal, it being obvious that a T-connector
would serve the same purpose.
As illustrated in the Figures, conduit 64a extends
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from pump 52 to portal 68c of Y-connector 68, w~ile
conduit 64b extends from portal 68a of Y-connector 68
and includes blood inlet port S2.
- ~s. illustrated, in the preferred embodiment conduit
5 64d enters housing 10 at an aperture 69a and exits
ho~sing 10 at .an~ aperture 69b. This particular config-
uration :aids in maintaining the warmth of the circula
ting blood. Apertures 69a and 69b are, of course,
sealed securely-around condui'c 64d to prevent leakage or
10 contamination. It:is, of course, envisioned that
sev~ral shorter condu~ts:~with conventional fittings at
69a and 69b may be utilized in place of single conduit
64d.
Tubing segment 64c is connected to end 64g of
connector 64d. Like port 55, end 64g is preferably
adapted for attachment to tubing of various diameters.
Preferably, it is adapted in a conventional way for
attachment to one-.quarter and three-eighths inch pvc
.~ tubing. _ .
Blood circulating .means 50 circulates blood re-
tained in housing 10 from the interior of housing 10
through blood .outlet line 54, through pump 52, and back
into housing 10 through the blood inlet line 60. This
permits the blood to be maintained at an even and
constant temperature by way of heat exchanger 32~ and
a.~so provides even distribution of any additives
throughout the blood. It also prevents blood components
: from separating, and allows for faster infusion since
the p~mp will already be operating and the blood already
moving through the pump when infusion becomes necessary
.~ durina surgery.
~ Circulating blood returning to housing 10 via
: blood inlet line 60 (through port 62-) could be subject
to cellular damage if the blood were to fall freely
35 through upper zone 18 and contact with force the blood
-~: already within the housing. Cellular damage could also
occur through the impact of blood falling onto the heat
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exchanger or other components within the housing.
Therefore, means 65 i5 provided within the housing in
upper zone 18 for inhibiting cellular damage during
circulation of the blood.
~` 5 Preferably, means 65 comprises a splash plate 66~
Splash plate 66 directs the flow of blood from port 62 or
extension 63 to wall 16 where it will gently flow down the
wall to lower zone 20 of housing 10.
Splash plate 66 can be of any suitable size and
shape to dir~ct the blood flow from extension 63 to wall
16. In the preferred embodiment, splash plate 66 has a
curved innar surface 67 or through for directing the hlood
flow. The splash plate can be attached directly to
extension 63, or at or near port 62 or extension 63 to
collect the fluid flowing therefrom. It can be formed of
any suitable blood compatible material. Plastic is
preferred due to its light weight and low cost.
The rapid blood infusion apparatus 5 also
comprises means for permitting or providing oxygen
saturation of the blood. The providing means is typically
at least one gas port 70. Generally, one gas port is
sufficient. Gas port 70 is preferably located at top wall
;~ 12 of housing 10. The gas port permits oxygen saturation
of and COz diffusion from the blood prior to infu ion. An
oxygen line, for example, one-quarter inch rubber tubing
connected to an oxygen source can be removably connected
to gas port 70, and oxygen, under pressure, can in this
way be introduced into the interior of housing 10. Oxygen
will then diffuse into the blood into the blood while the
blood is circulated in the housing prior to infusion.
Oxygen saturation of the blood is not always
necessary, depending, for example, upon whether the
hlood has been processed, and whether the patient's lungs
are functioning well, and whether saline used to prime
the apparatus has been supersaturated with oxygen
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gas.
Once the blood has become sufficiently saturated
with oxygen (which can be determined by blood gas
analysis), then the oxygen supply line can be removed
and there is generally no further need for it during the
course of an-operation unless another supply of un-
treated blood is introduced into the apparatus.
'~he gas port 70 i5 preferably supplied with a
conventional fitting or adaptor for connection to an
oxygen line.
The apparatu-s further-includes a means 74 for
transfusing the blood from housing 10 to the patient.
The transfusing means is cooperatively connected to the
housing It comprises hlood outlet line 54, pump 52,
and means 76 for providing fluid communication from the
pump to the patient's circulatory system, which is
represented in ~igure 2 at 77.
The providing means comprises conduit 64a providing
fluid communication between pump 52 to inlet leg or
portal 68c of Y-connector 68, and tubing segment or
; transfusion line 78 providing fluid communication
between outlet leg or port 68b and the patient's circu-
latory system.
- Transfusion line 78 can be any such line as is
known in the art, for example, one-quarter inch pvc
tubing. It i5 connected to an appropriate catheter
which is inserted into a large venous vessel such as the
internal jugular or femoral vein. If necessary, an
.
artery may be used but it is less desirable because of
; 30 increased risk of air embolization.
Preferably, for the most rapid infusion possible in
the context of this invention, the catheter is inserted
into the patient's internal-jugular vein, and advanced
into the right atrium of the heart. Other infusion
.
sites may be used, but they typically will not provide
the level of safety which can be achieved when the
internal jugular is used.
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The catheter can be any suitable catheter. For
an adult, the 12, 14, 16 Bardic is generally preferred.
For a child or larger infant, it is often preferable to
u-tiliz~ a Hickman catheter. For a very small infant, a
2.0 mm internal diameter Hickman catheter or an Angio-
path~ No. 14 catheter can often be utilized successfully.
Mounted on the transfusion line is a first regu
lating means 84. The regulatinq means can open or close
off the transfusion line. Nhen infusion is desired, the
transfusion line is opened. When infusion is no longer
desired, or the rate of infusion is to be slowed, the
regulating means can adjust or stop infusion of blood.
The regulating means can be any suitable con~entional
clamp such as manually operated tubing clamp 88. Such a
clamp provides for ease of operation.
Second regulating means 86 is connected to blood
inlet line 60 at tubing segment 64f. This regulating
means can be used to alter the blood flow back into the
housing 10. It, too, is preferably conventional manually
operated tubing clamp such as tubing clamp 94.
To illustrate the use of clamps 88 and 94, prior
`~ to infusion the blood within housing 10 is circulated
throughout the housing by way of circulating means 50,
including pump 52. First tubing clamp 88 is set to close
off transfusion line 78, while second tubing clamp 94 is
set to allow blood flowage through blood inlet line 60.
~- When infusion is desired, transfusion line 78 is opened to
permit blood flow to the patient by adjusting tubing clamp
88, and second tubing clamp 94 is adjusted to reduce or
eliminate recirculation of blood within the housing.
Rapid infusion apparatus 5 further comprises vent
port 96 to permit the reduc~ion of pressure within the
housing. one or more vent ports may be utilized. In
the preferred embodiment, two conventional vent ports
are placed at opposite sides of top surface 12 of
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housing 10. ~Such ports provide constant pressure
relief.
Apparatus '5 can further comprise one or more
conventional'-' blood'~ilters 98 as a safety precaution.
The blood'::fï'l'ters can-help eliminate the possibility of
-'emboli, clots,~air,'an~' the like entering the'patient's
circulatory system wit'h''the infused fluid. Blood filter
g8 can be any known type, such as-a bubble trap, screen,
or ~epth.''~'~he 'filter can be positioned any convenient
place where tubing 'carries b'lood. Preferably, for
'increased`sa~ety''it will be'positioned near the end of
transfusion line 78 where the blood enters the patient.
For increased safety, it is preferred that at
least three blood filters be provided. They may be
placed in any suitable locations. We suggest that a
filter be used -at the location where blood would enter
cardiotomy 105 (described hereinafter), along ~ubing
segment 64c, and along transfusion line 78 just before
the blood enters the patient. Filters could also be
placed at additional locations, for example, at quick
prime port 106 (described hereinafter).
'~Other safety detectors and sensors known in the art
'can also be utilized to provide increased protection to
the patient. For example, a pressure line (not shown)
can be util:ized to monitor the pressure of the blood
flow entering the patient. Excessive pressure (which
can arise, for example, if the catheter is improperly
placed) can severely injure the patient. A purge line
(not shown) or other safety valve can also be utilized
to permit quick reduction of the pressure when necessary
Rapid infusion apparatus 5 further includes ~ne or
more conventional blood sample ports. The blood sample
ports permit the drawing of samples to test blood
~chemistry levels and obtain other information about the
- 3~ blood, and also provide a site for injecting medication
or other additives to the blood, as needed. The pre-
ferred embodiment includes a first blood sample port 100
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and a second blood sa~lple port 102. They are mounte~ on
housing 10 at upper zone 18, preEerably on or near top
wall 12 for ease of injection and blood drawing. As
is conventional, they are each provided with a stopcock
5 103 to permit opening and closing of the port.
- As shown in Figure l, and as is conventional,
ports lOO.and 102 may be mounted on a flange 102a or
~ other edging piece attached at the top edge of housing
10 to facilitate accessability.- . .
Both sample ports 100 and 102 are in fluid com~uni-
cation with a sample conduit 101. Sample conduit 101
eomprises a narrow semi-rigid plastic tube or other
suitable hollow shaft which extends into housing 10 to a
location near bottom wall 14. Blood can be drawn from
15 lower zone 20 of housing 10, through sample conduit 101
via either of sample ports 100 and 102. Alternatively,
fluids such as medicaments can be injected into the
blood within housing 10 by injecting them into sample
port 100 or 102, from where they will travel into the
~o blood supply via conduit 101.
The rapid infusion apparatus 5 further comprises at
least one cardiotomy port 104. Cardiotomy port 104
permits the conneetion of housing 10 to a cardiotomy
u~nit or blood reservoir 105, so that additional blood
25 can be transferred to housing 10 with ease. Preferably,
; eardiotomy port 104 is located in lower zone 20 of
housing.10 to inhibit cellular damage of blood entering
the housing from cardiotomy unit 105. Cardiotomy unit
105 ean be a simple blood reservoir to house extra
30 blood.
: Prior to placing blood in the cardiotomy, the
blood may be processed, for example, in a unit such as
: the Cell Saver~, an autologous blood reeovery system by
Haemonetics. This is particularly desirable for use
3S with liver transplant or resection patients. If de-
sired, other types of blood processing units sueh as a
hemoconcentrator ean be utili~ed.
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The rapid infusion apparatus of this invention
can further include a rapid or quick prime port 106, pre-
ferably mounted on top sur~ace 12 of housing 10. Quick
prime port 106 is adapted for connection to tubing which
can be used to introduce fluids of various kinds into
housing 10. For example, it is recommended to xun saline
solution through apparatus 5 to purge air from blood
outlet line 54, pump 52, blood inlet line 60, transfusion
line 78, etc., prior to initiating blood flow. The saline
solukion can be added to housing 10 through quick prima
port 106. In addition, in some situations it is desirable
to rapidly add quantities of blood to housing 10, for
example, during infusion when more blood is re~uired.
While blood can be added through cardiotomy port 104 if
another blood reservoir is ready, blood can also be
quickly added from blood bags through quick prime port
106. If desired, a splash plate (not shown) could be
located within housing 10 at the e~trance of quick prime
port 106.
In addition, rapid infusion apparatus 5 can
comprise a temperature probe site llO located on the
housing. The temperature probe site, which can be
designed in any suitable conventional fashion, permits
monitoring of the blood temperature by use o~ a therm-
ister probe. Suitable probes are available from sup-
pliers such as Yellow Springs. The temperature probe site
is preferably located at bottom wall 14 because the blood
products collect at the bottom surface.
Preferably, apparatus 5 will include no defoaming
components. Conventional defoamers, such as silicone
impregnated spongesl can adversely affect the patient and
are generally not needed in the context of this invention.
It is envisioned that apparatus 5 will be used
with a suitable holder (not shown). The holder will
permit its attachment to an IV pole, so that it can be
easily transported and positioned where desired within the
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operating room. Such holders are conventional, and
typically comprise a screw clamp for attachment to the
desired position along the pole, and a support within
which the device can removably rest. The IV pole
typically includes wheels for easy transportation and
maneuverability.
Method of Use
The rapid blood infusion apparatus is easy to
use. It can ba set up within a mat~er of m.inutes. The
preferred method of operating an apparatus having a five
liter capacity is as follows.
First, with second tubing clamp 94 closed and
first tubing clamp 88 open permitting circulation of blood
within the rapid infusion apparatus, about one liter of
0.9 pexcent saline solution or other crystalloid solution
such as Plasmalyte is added to housing 10 through quick
prime port 106~ Heat exchanger 32 is started. Pump 52 is
started and the saline solution is caused to flow through
the system to displace air. Then, second tubing clamp 94
is opened and first tubing clamp 88 is closed off, permit-
ting the solution to pass through the transfusion line to
flush air or other impurities from it. The transfusion
line is then shut o~f by closing second tubing clamp 94
and opening first tubing clamp 88.
The crystalloid solution is removed from the
apparatus, the pump is turned off, and five liters of
blood or other circulatory supportive fluids are added to
~ housing 10 through quick prime port 106 or cardiotomy port
`; 104. The blood can comprise stored banked blood;
filtered, washed, and packed red blood cells suspended in
sterile normal saline; the patient's salvaged shed blood;
or other blood products such as fresh frozen plasma.
Pump 52 is restarted to circulate the bloodwithin apparatus 5. During circulation, if necessary,
oxygen can be provided through gas port 70 until the blood
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reaches its oxygen saturation point or the desired l;~vel
of oxygen saturation is achieved, at which time the
oxygen source is removed. The gas port is left open to
serve as an additional vent site.
With continued circulation, the chemistry and
temperature of the blood is adjusted, as necessary, to
achieve the desired levels for the particular patient
and type of surgery. Some aspects of the blood chemis-
try will generally be adjusted, if necessary, before the
blood is added to cardiotomy 105 or housing 10.
~~ We h-ave found that with this apparatus, excellent
results can be seen in many patients if the blood
chemistry and temperature is adjusted as necessary to
achieve normal or nearly normal physiological values
within the following ranges: hematocrit of about 25-45%
(preferably 30 + 5%); potassium of about 3-6 mEq/L, and
temperature of about 36-40C. (preferably 37 + 1C.).
In addition, it can be desirable to achieve a pH of
about 6.8-7.4 (preferably 7.2 ~ 0.2), a sodium level of
- 20 about 140 + 10 mEq/L (preferably 140 + 5 mEq/L), and a
bicarbonate level of 18 ~ 2 mEq/L.
- It can also be desirable, for example, when a
patient's lungs are functioning poorly, to achieve an
oxygen saturation of 95-99~. The PCO2 Of the blood
will preferably be about 35 + 5 torr.
It is not always necessary, but highly desirable,
that the blood chemistry and température be within the
ranges indicated above. This depends in large part on
how well the patient's lungs, kidneys, liver, and other
organs are functioning, the patient's general health,
the patient's age, and the nature and urgency of the
- need for infusion.
In some instances, for example, where a car acci
dent victim is likely to die without immediate infusion,
it may be acceptable, for a short time, to infuse warm
but otherwise unaltered stored banked blood until
appropriate correction can be made. This blood may fall
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outside all of the ranges except the temperature ra~ge.
For most patients ! as a minimum, the hematocit and
potassium levels and the temperature should fall withi~
the ranges described previously.
Many patients are able to accept blood with a pH
outside the given range, but it is preferable to have
the pH within the given range. This is of particular
importance where the pa~ient lacks the function of a
major organ s~ch as the heart, kidn~ys, or liver.
We have found that the above levels, ta~en to-
gether, are particularly desirable in treating liver
transplant or resection patients, ranging in age from 6
months to 54 years.
The blood chemistry levels can be achieved in
15 various ways known to one skilled in the art. General-
ly, the potassium level of stored banked blood will far
exceed that which is safe at the rapid infusion rates of
the invention. We have found it most advantageous in
the context of this invention to lower the potassium
20 level, when necessary, by blood cell washing prior to
addition of the blood to apparatus 5.
The blood cell washing can be accomplished by
mixing and thereby washing the cells with saline solu-
tionr then utilizing a high speed centrifuge to separate
25 the cells from the saline solution. The washed cells
are then resuspended in a plasma product such as fresh
- frozen plasma. The Cell Saver unit is currently
preferred for the washing process.
The blood- washing process also appears to reduce
30 post-transfusion respiratory failure which is often seen
after conventional blood infusion methods are used. We
theorize that the rernoval of white blood cells in the
washing process relates to the--reduction of such diffi-
culties.
The washin~ process also helps eliminate cell
conglomerates which can for~ in stored, banked blood,
~ reducing the risk of blood clots.
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The pH, pCO2, oxygen saturation level, hemato-
crit, and temp~rature can be adjusted while the blood is
within housing lO. It is also possible to raise the
potassium level, if desired, while the blood is within the
housingO The sodium and bicarbona~e levels can typically
be raised (but not lowered) while the blood is within
housing 10.
As the blood is being prepared, the cathe~er can
be inserted into the desired site. We have found that in
most instances, best results are achieved if the catheter
is inserted into the right atrium of the heart through the
patient's internal jugular vein. Generally a single site
permits sufficiently rapid infusion within the context of
this invention~
When infusion is required, the transfusion line
is opened through use of the second tubing clamp 94, and
blood inlet port 62 and tubing segment 64b can be shut off
utilizing first tubing clamp 88.
With this invention, blood can be infused at a
rate of up to about the physiological maximum for the
individual patient. ~his maximum could be determined or
would be known by one skilled in the art. It varies from
patient to patient and depends largely on the patient's
size. However, currently it would be difficult to obtain
and suitably prepare sufficient blood for rates above
3,000 ml. per minute. It would also be difficult to keep
apparatus 5 supplied with blood at these higher rates.
Generally, in view of the difficulty in obtaining
sufficient blood and keeping apparatus 5 supplied with
prepared blood for rates higher than three liters per
minute, the rate will be up to about three liters per
minute. More typically, the rate will be from about 45 to
2,000 ml. per minute. The desired rate can be determined
.~
by appropriate hemodynamic measurements, e.g., cardiac
output, main pulmonary artery pressures, right atrial
; pressure, and systemic blood pressure. Nechanically, the
rate is adjusted by varying the rpm's of the pump.
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When infusing processed blood, it is generally
necessary to separately infuse cryoprecipitate and
platelets to maintain the desired serum levels of
fibrinogen pl'atelets. Particularly for liver transplant
or resection patients, we have'~ound that their- serum
levels-should~be'maintainèd at-about 0.4 gram percent of
fibrinogen and 250,000 platelets per ml. of blood.
Other fluids-or~ medications may also be indicated in
parti'cu-lar situ'ations.~ - ~ ' ~
Other' modifica~ions-o the invention will be
apparent to 'thosê'''skil'led in the art: in light of the
forégoing description. Accordingly, the invention is
no~ lîmited~tb''the embodiments described herein, or to
the use of elements having specific configurations and
~- 15 shapes as presented herein. All alternative modifica-
tions and variations of the present invention which
follow in the spirit and scope of the appended claims
are included.
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