U.S. patent number 3,908,653 [Application Number 05/435,908] was granted by the patent office on 1975-09-30 for blood chamber.
This patent grant is currently assigned to Vital Assists, Inc.. Invention is credited to Donald E. Kettering.
United States Patent |
3,908,653 |
Kettering |
September 30, 1975 |
Blood chamber
Abstract
A blood chamber for an arterial line of an extracorporeal blood
system. The chamber is a flow through device for blood with an air
cushion over the blood and access structure for sampling and
treating the blood. A pressure tap in the chamber communicates the
air cushion with a pressure transducer to facilitate measurement of
blood pressure within the chamber. Undesirable obstruction of the
pressure tap by blood foam is reduced by introducing blood into the
chamber through a submerged inlet. The blood chamber may be
situated upstream from a blood pump in a single needle
extracorporeal dialysis system so as to avoid pump starvation.
Inventors: |
Kettering; Donald E. (Salt Lake
City, UT) |
Assignee: |
Vital Assists, Inc. (Salt Lake
City, UT)
|
Family
ID: |
23730320 |
Appl.
No.: |
05/435,908 |
Filed: |
January 23, 1974 |
Current U.S.
Class: |
604/6.05;
604/6.11; 128/DIG.3; 210/90; 604/118 |
Current CPC
Class: |
A61M
1/3627 (20130101); A61M 1/30 (20130101); A61M
1/302 (20140204); A61M 1/306 (20140204); A61M
2205/3351 (20130101); Y10S 128/03 (20130101); A61M
2205/3344 (20130101) |
Current International
Class: |
A61M
1/30 (20060101); A61M 1/36 (20060101); A61M
001/03 () |
Field of
Search: |
;128/214R,214E,214F,214.2,DIG.12,DIG.13,214C,DIG.3,272 ;210/90 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Truluck; Dalton L.
Attorney, Agent or Firm: Workman; H. Ross Young; J.
Winslow
Claims
1. A method for monitoring blood in an arterial line of an
extracorporeal blood handling system comprising venous and arterial
blood lines, a blood pump and a dialyzer, the improvement
comprising:
providing a cylindrical blood chamber, the cylindrical
configuration minimizing blood stagnation in the chamber;
interposing the chamber in an arterial blood line of an
extracorporeal blood handling system upstream of the pump, the
chamber having means for maintaining a vertical orientation of the
chamber;
passing blood through a variable volume pool of blood in the
chamber from a submerged inlet to a submerged outlet while
simultaneously minimizing blood foaming by introducing blood into
the chamber through the submerged inlet;
inhibiting clot formation in the blood and also enhancing mixing
fluids selectively amended to the blood by creating limited
subsurface turbulence in the blood, the turbulence being created by
introducing the blood into the cylindrical chamber below the blood
surface;
maintaining a constant quantity gas cushion above the pool of blood
in the chamber; and
communicating pressure developed in the gas cushion by the blood to
a
2. A method as defined in claim 1 further comprising sampling blood
within
3. A method as defined in claim 1 further comprising delivering
fluids into
4. A blood pressure and blood treatment access device for an
arterial line of a single needle extracorporeal blood handling
system which comprises arterial and venous blood lines, a blood
pump, a dialyzer down stream from the pump and a controller for
determining the direction of blood flow in the single needle,
further, comprising:
an enclosed cylindrical chamber operable to receive a variable
quantity of blood and to maintain a constant quantity gas cushion
above said blood;
means for maintaining a vertical orientation of the cylindrical
chamber;
a blood inlet and a blood outlet through a wall of the chamber,
each located below a minimum blood level, said inlet and outlet
being located upstream from the blood pump of the single needle
system to provide a reservoir of blood from which the blood pump
can draw even when pressure is periodically reduced in the chamber
to thereby avoid pump starvation; and
a plurality of access means into the chamber, at least one of which
is operable to communicate pressure through the gas cushion to a
pressure sensing device, at least one other access means which is
in direct communication with the interior of the chamber for
sampling blood and introducing fluids into the blood within the
chamber.
Description
BACKGROUND
1. Field of the Invention
The present invention relates to method and apparatus for providing
access to and controlling the flow of blood in an extracorporeal
blood handling system.
2. The Prior Art
In extracorporeal blood handling systems, blood access has
historically taken place in the venous line, the venous line being
defined as the extracorporeal blood line which returns blood from a
treatment device to the patient. Blood access, whether for pressure
measurement, sampling or treatment, is more difficult in the
arterial line due to the greater pressures and pressure
fluctuations therein. The arterial line is defined as the
extracorporeal blood line carrying blood away from the body to a
treatment device.
However, blood pressure measurement in an arterial blood line, for
example, in certain methods of hemodialysis, is important because
pressure measurements have been found necessary to control
extracorporeal systems of the single needle type.
Pressure measurement of blood usually entails some form of pressure
transferring medium such as a gas (air, for example) or a flexible
diaphragm. Direct blood contact by a pressure transducer may be
used but often introduces sepsis and is susceptible of fouling. A
flexible diaphragm prevents direct blood contact between the blood
and the pressure transducer; however, similar problems are
encountered when using the flexible diaphragm. An example of a
diaphragm type sensor is found in U.S. Pat. No. 3,713,341. Air, as
a pressure transmitting medium, permits placement of the pressure
transducer at a convenient distance from the blood chamber and
easily accommodates asepsis. However, air over the surface of the
blood often tends to increase the incidence of foam formation which
conventionally has been carried into the pressure transmitting air
line where it interferes with the pressure sensing system. This is
particularly true where the blood is subjected to negative
pressures.
Other prior art devices such as disclosed in U.S. Pat. Nos.
3,690,312 and 3,157,201 employ manifolds wherein a plurality of
access ports are provided to the blood. These devices are limited
in that they are not directly interposed in an extracorporeal
bloodstream but merely provide access thereto. Blood stagnation and
clotting in such devices would, conceivably, become extreme during
long term usage.
In single needle dialysis, pump starvation has been found to be a
serious problem. Pump starvation is defined as the condition that
exists when the availability of blood upstream from the pump is
less than the delivery capacity of the pump. Historically, pump
starvation in single needle dialysis systems results when the
supply of blood from the patient to an operating pump is not
adequate. The action of the pump causes a negative pressure
upstream which tends to collapse the extracorporeal blood lines and
even more importantly frequently collapses the patient's blood
vessel against the indwelling needle or catheter. When the blood
vessel collapses against the needle orifice, blood cannot be
aspirated from the patient.
It is significant that a collapsed blood vessel frequently cannot
be normalized to permit free flow of blood until the pressure
within the blood vessel and the extracorporeal blood line is
equalized. Since essentially all blood pumps are unidirectional,
the blood pressure usually cannot be normalized with at least
partial disassembly of the extracorporeal blood handling
system.
The foregoing problems can be alleviated by providing in the
arterial line of the extracorporeal system a blood chamber which
permits blood flow through with minimum frothing and at the same
time provides a reservoir of blood to avoid pump starvation.
BRIEF SUMMARY AND OBJECTS OF THE INVENTION
The present invention provides a unique apparatus and method for
transmitting blood pressure to a measuring device and providing
access to the blood in an extracorporeal blood handling system. The
apparatus includes a chamber with a gas cushion above the blood.
Access to the blood chamber is provided for coupling a pressure
transducer to the gas cushion and for sampling, treating, amending,
or other such procedures. Foaming of the blood as it passes through
the chamber is significantly reduced by introducing the blood into
the chamber through a submerged inlet. Blood stagnation and
clotting are also significantly reduced by suitably orienting the
inlet and outlet ports to provide for limited subsurface turbulence
and low residence times for the blood in its passage through the
chamber. In one preferred embodiment, pump starvation is avoided by
locating the chamber upstream from the pump.
It is, therefore, a primary object of this invention to provide
improvements in extracorporeal blood handling systems.
It is another object of this invention to provide improvements in
measuring the blood pressure in the arterial line of an
extracorporeal blood handling system.
It is a further object of this invention to reduce foaming of blood
in a blood chamber having a gas cushion above the blood.
It is an even further object of this invention to provide a
plurality of access ports in a blood chamber, giving access to the
blood contained therein.
Another desirable object of the present invention is to alleviate
pump starvation.
It is one still further object of this invention to provide an
improved method for monitoring blood in an extracorporeal blood
system.
These and other objects and features of the present invention will
become more fully apparent from the following description and
appended claims taken in conjunction with the accompanying
drawings.
BRIEF DESCRIPTION OF THE DRAWING
FIG. 1 is a perspective view of one preferred embodiment of the
blood chamber of this invention.
FIG. 2 is a schematic diagram of an extracorporeal hemodialysis
blood system with the blood chamber embodiment of FIG. 1 interposed
therein.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
The invention is best understood by reference to the drawing
wherein like parts are designated with like numerals
throughout.
The Apparatus
The blood chamber of the present invention serves a multiplicity of
purposes, including, for example, blood pressure measurement, a
reservoir to avoid pump starvation, blood sampling, blood
treatment, and fluids addition to the bloodstream. The foregoing
purposes are readily achieved with the blood chamber embodiment of
FIG. 1. In addition, the present invention greatly reduces frothing
and clotting of the blood in the chamber.
Referring to FIG. 1, a blood chamber 10 is molded as a right
cylinder and has a cap 12 sealed thereto. Preferably, chamber 10 is
molded from any commercially available medical grade plastic which
is sterilizable and blood compatible. Visual observation of blood
level 26 and the presence of foam, if any, are also desirable
features and, accordingly, chamber 10 is preferably constructed of
a transparent plastic.
Sufficient rigidity of chamber 10 to resist flexure permits more
accurate pressure readings of the contents of chamber 10. Cap 12
may be opaque but should also resist flexure and has a plurality of
nipples 14, 16 and 18 for providing access to the interior of the
chamber. Clearly, any suitable number of nipples could be used
within the scope of this invention.
A hanger tab 20 with an aperture 22 serves as a hook point for
suspending blood chamber 10 from a suitable I.V. stand or the like
(not shown). Suspension of chamber 10 by tab 20 also serves to
retain chamber 10 in a vertically oriented position.
Nipples 14, 16 and 18 may, for example, serve to receive tubing 15,
17 and 19, respectively, shown in broken lines. Tubing 15, 17 and
19 provide access to the blood, for example, for heparin and saline
infusion and pressure monitoring. Numerous combinations are
possible and, accordingly, only the foregoing representative
example is given.
A blood sample port 34, which is sealed with a rubber cap 36,
permits blood samples to be drawn with conventional techniques. The
rubber constituting cap 36 is preferably latex or like material
which self-seals after penetration. An injection into the blood
with a syringe and a hollow needle may also be made by penetrating
cap 36 in the manner previously described.
Chamber 10 has, for example, in this preferred embodiment, a total
volume of about 30 cc and is adapted to receive a quantity of blood
24 which is less than 30 cc. Accordingly, blood only partially
fills chamber 10 and establishes a blood level 26 with an air
cushion 28 above.
Blood passes through chamber 10 from an inlet 30 to an outlet 32.
Inlet 30 and outlet 32 are interposed serially in an arterial blood
line 48 of an extracorporeal blood handling system (FIG. 2). It
should be particularly noted that inlet 30 is below blood level 26.
This arrangement precludes the high pressure blood entering the
chamber 10 at inlet 30 from squirting into the surface 26 thus
creating excessive quantities of foam. The foam thus produced tends
to intrude into, and even occlude, nipples 14, 16 and 18. Instead,
the inlet 30 is submerged and the relatively high pressure blood
flow is used to create limited subsurface turbulence in blood 24 to
inhibit clot formation and, on occasion, provide mixing when fluids
are amended to the blood through adapters 16 and 18 or sample port
34. Outlet 32 is, of course, submerged to prevent air from being
carried away from chamber 10. While the illustrated embodiment
locates the inlet and outlet normal to the bottom wall of the
chamber 10, any suitable orientation of the inlet and outlet which
locates the interior orifice below the normal blood level is
suitable.
Referring now to FIG. 2, a single needle extracorporeal
hemodialysis system is shown schematically and has the blood
chamber of FIG. 1 interposed therein, preferably upstream from the
pump. With blood chamber 10 located in the arterial line 48 on the
low pressure or upstream side of pump 38, a reservoir of blood is
continuously available to the pump 38 so as to prevent pump
starvation. Of course, if desired, the chamber 10 could be located
downstream from the pump 38 to monitor high pressure, if
desired.
Arrows on the schematic indicate direction of blood flow and a
controller 42 in cooperation with pump 38 controls direction of
blood flow through the extracorporeal system and through a blood
access cannula 40. Blood is alternately withdrawn from and returned
to the patient (not shown) through cannula 40 by controller 42.
Controller 42 may be the commercially available unit from Vital
Assists, Inc., of Salt Lake City, Utah, and sold under their
trademark UNIPUNCTURE.
The blood passes from the patient to the blood chamber 10, thence
to pump 38 and thereafter into a dialyzer 44. A conventional venous
bubble trap 46 may be interposed in venous line 47. Controller 42
routes the blood back to the patient. Although the single needle
hemodialysis system is illustrated herein to demonstrate the
placement and function of the blood chamber of the present
invention, any extracorporeal blood handling system could
beneficially use the blood chamber disclosed herein.
The Method
The presently preferred blood chamber embodiment of this invention
has been advantageously used in single needle hemodialysis systems
such as is disclosed in U.S. Pat. No. 3,756,234.
According to the presently preferred method embodiment of this
invention, the chamber 10 is connected into the arterial line 48
preferably upstream from the pump 38 (FIG. 2). One of the adapters
14, 16 or 18 is selected to communicate directly with a pressure
sensing device. The remaining adapters may be capped or,
alternatively, connected directly to a source of medicament, blood
or other desirable fluid.
The sample port 34 has a cap 36 which prevents inadvertent outflow
of blood 24 from the chamber 10. At the same time, the cap 36 is
penetrable by a hypodermic needle or the like to facilitate
sampling of the blood 24.
In the operation of the system of FIG. 2, the venous line 47 is
clamped and the blood pump 38 draws blood from the needle 40 into
the chamber 10 through the inlet 30 by creating a negative pressure
in the chamber 10. Because the inlet 30 is submerged, turbulence
and thorough mixing of blood in the chamber 10 is possible so as to
inhibit clot formation and at the same time the inrushing blood is
prevented from carrying significant amounts of air into the blood
which would otherwise create bubbles and accumulate excessive
froth. With the reduction of froth, communication between the air
cushion 28 and pressure sensor 49 is maintained clear and free of
solidified blood froth.
As the blood is drawn into the chamber 10, a reservoir of blood
accumulates to provide an adequate supply for the pump 38.
Continued operation of the pump even against a negative pressure in
the chamber 10 has been found to significantly reduce blood vessel
collapse at the patient. When a single needle system is employed,
the low pressure sensor will trigger the controller 42 at a
predetermined level so as to close off the line 48 and allow the
blood 24 to pass through the dialyzer 44 and through the venous
branch 47 to the needle 40. Accordingly, the blood carried by the
system of FIG. 2 is forced to move in the direction of the arrows
shown in the Figure. The volume of blood in the chamber 10 is
alternately reduced and increased responsive to the change in blood
availability and the clamping state of the controller 42.
In view of the foregoing, the present invention provides an
improved method for monitoring extracorporeal pressure, for
alleviating pump starvation, and for providing access to blood in
an arterial bloodstream of an extracorporeal blood handling system
while minimizing foam and clot formation.
The invention may be embodied in other specific forms without
departing from its spirit or essential characteristics. The
described embodiments are to be considered in all respects only as
illustrative and not restrictive and the scope of the invention is,
therefore, indicated by the appended claims rather than by the
foregoing description. All changes which come within the meaning
and range of equivalency of the claims are to be embraced within
their scope.
* * * * *