U.S. patent number 3,882,861 [Application Number 05/399,904] was granted by the patent office on 1975-05-13 for auxiliary control for a blood pump.
This patent grant is currently assigned to Vital Assists, Inc.. Invention is credited to Morris E. Jones, Donald E. Kettering.
United States Patent |
3,882,861 |
Kettering , et al. |
May 13, 1975 |
Auxiliary control for a blood pump
Abstract
An auxiliary control for a blood pump used in hemodialysis which
acts upon an existing blood pump controller to continuously vary
the pump rate in direct correspondence with changes in flow of a
patient's blood reflected as variations in negative pressure in a
blood line. The auxiliary control regulates the pump rate by
producing an electrical pulse train in which the duration of the
pulses corresponds to changes in negative pressure corresponding to
changes in the blood flow rate. The control presents means for
achieving a rapid response to changes in the flow of the patient's
blood.
Inventors: |
Kettering; Donald E. (Salt Lake
City, UT), Jones; Morris E. (Bountiful, UT) |
Assignee: |
Vital Assists, Inc. (Salt Lake
City, UT)
|
Family
ID: |
23581426 |
Appl.
No.: |
05/399,904 |
Filed: |
September 24, 1973 |
Current U.S.
Class: |
604/66;
128/DIG.12; 417/44.2; 417/44.1; 417/43 |
Current CPC
Class: |
A61M
1/3403 (20140204); A61M 1/3607 (20140204); A61M
1/14 (20130101); A61M 60/50 (20210101); A61M
1/34 (20130101); A61M 1/3639 (20130101); A61M
1/16 (20130101); A61M 60/268 (20210101); A61M
60/43 (20210101); A61M 60/113 (20210101); Y10S
128/12 (20130101); A61M 2205/3334 (20130101); A61M
2205/3331 (20130101) |
Current International
Class: |
A61M
1/10 (20060101); A61M 1/36 (20060101); A61M
1/16 (20060101); A61m 001/03 () |
Field of
Search: |
;128/213,214R,214E,214F,214.2,DIG.12,DIG.13 ;417/44 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Truluck; Dalton L.
Attorney, Agent or Firm: Workman; H. Ross
Claims
What is claimed and desired to be secured by United States Letters
Patent is:
1. A blood pump controller responsive to changes in blood flow
comprising:
a conventional blood pump for displacing blood through an
extracorporeal hemodialysis system including a blood-conducting
conduit;
a conventional power source and means for delivering electrical
power to the blood pump, the pumping capacity of the pump being
proportional to the electrical power delivered to the pump;
means electrically interposed between the power source and the
blood pump said means comprising an attachment site means for
detachably coupling the blood pump to the power source through the
said means; sensing means in said blood-conducting conduit for
monitoring the availability of extracorporeal blood to the pump
upstream from the pump; and means responsive to the sensing means
for selectively and continuously varying the amount of electrical
power delivered to the blood pump from the power source thereby
continuously varying the pumping flow rate of the blood pump, the
magnitude of pumping variation being constantly proportional to
extracorporeal blood flow upstream from the blood pump during the
course of dialysis.
2. A blood pump controller responsive to changes in blood flow
comprising:
a conventional blood pump for displacing blood through an
extracorporeal hemodialysis system;
a blood conduit for conducting blood from a patient to the blood
pump; and
a conventional power source and means for delivering electrical
power to the blood pump;
means electrically interposed between the power source and the
blood pump, said electrically interposed means comprising:
transducer means connected to the blood conduit producing an
electrical signal representing the availability of blood to the
pump;
comparing means for comparing the transducer signal with a
pre-established reference signal and producing a proportional
output signal; and
switching means responsive to the output of the comparing means for
producing a periodic pulse train wherein the duration of each pulse
is pro-proportional to the output signal of the comparing means,
the speed of the blood pump being a direct function of the duration
of the pulse.
3. A blood pump controller as defined in claim 2 wherein said
transducer means comprises averaging means for averaging the
systolic and diastolic blood pressures.
4. A blood pump controller as defined in claim 2 further comprising
means for sensing negative blood pressure upstream from the pump
and wherein the switching means comprises means for (a) producing a
medium duration pulse when the proportional output signal is at an
initial reference level representing a predetermined negative blood
pressure, (b) decreasing the pulse duration when the proportional
output signal indicates reduced patient's blood flow represented by
increased negative value of the blood pressure, and (c) increasing
the pulse duration when the proportional output signal indicates
increased patient's blood flow represented by decreased negative
value of the blood pressure.
5. A blood pump controller as defined in claim 4 wherein said pulse
responsive switching means further comprises means for closing the
circuit between the pump and its corresponding power supply for the
duration of each pulse.
6. A blood pump controller as defined in claim 2 wherein said
comparing means comprises an operational amplifier.
7. A blood pump controller as defined in claim 2, further
comprising means responsive to the transducer means for terminating
the operation of the blood pump when blood flow is reduced below a
predetermined level.
Description
BACKGROUND
1. Field of the Invention
The present invention relates to an improved auxiliary control for
an extracorporeal blood pump used in hemodialysis and more
particularly to novel apparatus for controlling the blood pump rate
in an extracorporeal hemodialysis system.
2. The Prior Art
Historically, kidney diseases have been of critical concern to
human life. Many kinds of kidney diseases interfere with the
function of the kidney such that the kidney ceases to remove waste
and excess water from the blood. When the kidney is sufficiently
impaired that a large portion of the waste products and water are
not removed from the blood, the life of the patient cannot be
preserved unless a way is provided for artificially performing the
functions of the impaired kidney through extracorporeal
hemodialysis.
Many of the presently known hemodialysis apparatus require the use
of a blood pump to provide additional pressure in the withdrawn
blood in order to conduct it through the hemodialysis unit. A major
problem presented by the presently known blood pumps and associated
control apparatus is the inability of such apparatus to provide a
minimum time for dialysis while simultaneously preventing pump
starvation and the resulting collapse of the supply blood lines. It
is well-known that blood should be withdrawn from the patient at a
rapid rate so as to reduce the time for dialysis. However, when the
blood supply at the patient is insufficient to supply the blood
pump, the blood lines and even the patient's blood vessels collapse
which interrupts effective hemodialysis until adequate blood flow
is restored. The collapse of blood lines resulting from
insufficient blood supply to a continuously operating blood pump is
defined herein as "pump starvation." To avoid time consuming and
sometimes dangerous pump starvation, it has conventionally been
necessary to adjust the pump speed well below an optimum rate to a
level which provides a wide safety margin in order to avoid pump
starvation.
Even with this precaution, however, it is common for the patient's
blood flow rate to fluctuate significantly during the course of
dialysis. Accordingly, the attending physician must choose between
(a) lowering the pump rate to accommodate the lowest possible blood
flow rate as a safety margin and thereby significantly extending
the dialysis time or (b) risk collapse of blood lines and premature
interruption of dialysis through pump starvation in the event of a
drop in the patient's blood flow rate.
Several attempts have been made to produce a pump which is able to
compensate for changes in the amount of available blood while the
patient is undergoing dialysis. The prior art shows the use of
step-wise regulation apparatus which only vary the volume of blood
pumped in a series of discrete steps and do not allow for
continuously variable changes in the volume of blood pumped. That
type of pump and control apparatus requires a threshold level of
pressure change before any responsive action is taken. One such
step-wise system is shown in U.S. Pat. No. 3,698,381.
Other types of control apparatus have employed specially designed
pumps which are mechanically capable of increasing the force
applied to a collapsible blood reservoir in order to thereby
increase the pressure of blood supplied from the reservoir. One
such specialized blood pump and associated control is shown in U.S.
Pat. No. 3,592,183.
A major deficiency which is observed in the attempts to solve the
regulation of pump starvation is that the solution involves the
replacement of all existing pump controllers and/or blood pumps.
Until the present invention, it has not been possible to
continuously vary the rate of a continuous flow blood pump in
response to the availability of blood while retaining the existing
conventional blood pump and controller.
BRIEF DESCRIPTION AND OBJECTS OF THE INVENTION
The present invention includes novel apparatus for continuously
varying the pump rate of a blood pump used in hemodialysis in
response to changes in blood flow from the patient so as to
maximize the rate of hemodialysis while avoiding pump starvation.
Furthermore, the invention provides apparatus which can accomplish
the previously described function in combination with existing
conventional blood pumps and control mechanisms.
It is, therefore, a primary object of the present invention to
provide improved extracorporeal hemodialyzing pump control
apparatus.
It is another primary object of the present invention to provide
extracorporeal hemodialysis pump control apparatus which cooperates
with presently known pumps and associated controls to achieve a
continuously variable pump rate responsive to changes in blood
flow.
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
drawing.
BRIEF DESCRIPTION OF THE DRAWING
FIG. 1 is a block diagram illustrating a presently preferred
embodiment of the invention;
FIG. 2 illustrates a waveform taken at point A in FIG. 1, the
waveform particularly showing a signal representation when the
patient's blood flow has increased during the course of dialysis;
and
FIG. 3 illustrates a waveform taken at point A of FIG. 1, the
waveform particularly showing a signal representation when the
patient's blood flow has decreased during the course of
dialysis.
DETAILED DESCRIPTION OF THE INVENTION
Referring particularly to FIG. 1, an improved auxiliary control for
a blood pump generally designated 20 is illustrated within the
broken line. One of the features of the invention is the capability
of use with existing blood pumps and associated controllers.
Accordingly, for ease of illustration, the pump power supply 35,
pump controller 39 and blood pump 37 have been schematically
illustrated in FIG. 1, but do not constitute a part of the
invention.
Blood is continuously forced from the patient to the dialyzer by
blood pump 37. Accordingly, a negative pressure will exist in blood
lines upstream from the pump. If outflow of the patient's blood
should be limited through stricture, clotting, hypotension or any
other of a variety of common circumstances, negative pressure
upstream from the pump will increase proportionately. Conversely,
negative pressure will decrease as blood becomes more available to
the pump.
According to one presently preferred embodiment of the invention, a
conventional pressure transducer 22 provides a direct conversion
between negative pressure in the blood line 24 and electrical
voltage. Blood line 24 connects the pressure transducer to a
conduit (not shown) which carries blood from a blood vessel of a
patient to the blood pump 37. The electrical qualities of the
pressure transducer may be characterized as either a variable
resistance or a variable voltage source. Whichever type of
transducer is employed or whichever electrical characterization is
used, the electrical quantity varies in proportion to the blood
flow as measured by the negative blood pressure in line 24. The
negative pressure is preferably observable on a conventional
readout device 23.
The electrical output signal of the pressure transducer is fed into
an averaging circuit 28. The averaging circuit 28 may be any one of
a wide variety of known discrete or integrated circuits, the most
simplified of which would merely be a capacitor in parallel with
the transducer output conductors to accomplish averaging of the
systolic and diastolic pressure signal from the transducer 22.
Certain types of pressure transducers which maintain a reservoir of
blood and mechanically measure expansion and contraction of a
chamber would not require the averaging circuit since the output
signal from that type of transducer would be averaged
mechanically.
The averaged transducer signal is then conducted to and appears at
one of the inputs to a conventional operational amplifier 31 which
forms part of the comparator 30. The initial reference control 32
provides a reference signal for the second comparing input of the
operational amplifier 31. The initial reference control may be
either a fixed or variable voltage divider which provides a
pre-established signal level at one of at least two operational
amplifier inputs.
The operational amplifier portion 31 of the comparator 30 is used
in the summing mode, where the two inputs are added together to
form an output to the electronic switch 36 which output is
proportional to the sum of the inputs. The electronic switch 36
preferably comprises a conventional threshold trigger circuit
capable of converting the output signal of the operational
amplifier 31 into a pulse of duration proportional to the amplitude
of the output signal of the operational amplifier. A common,
readily available device for performing the function of the
electronic switch would be any suitable type of current controlled
current source such as a unijunction transistor with an external
base to emitter timing capacitance which acts to fire a triac or
the like.
The power supply for the operational amplifier portion of the
comparator is a pulse generator 34 which produces a generally
square wave voltage signal causing the output of the operational
amplifier to turn on and off at a constant rate. Any suitable
conventional pulse generator having sufficient voltage output to
drive the operational amplifier would be acceptable.
It should be recognized that the signal from the operational
amplifier is a periodic pulse having an amplitude proportional to
the sum of the initial reference signal and the averaged transducer
signal. It should be recognized that the higher the output signal
from the comparator, the greater the time increment that switch 36
is on, and conversely the lower the signal from the comparator, the
shorter the time increment that switch 36 is on.
As shown in FIG. 1, the regular power supply line to a conventional
blood pump and controller is diverted through the electronic switch
36. The waveforms shown in FIGS. 2 and 3 are taken at point A in
the diagram of FIG. 1, assuming an alternating current power supply
like that available at a standard utility outlet. The solid
portions of the waveforms represent that portion of the waveforms
during which the electronic switch 36 is off. When the switch 36
turns on, it remains on until the AC cycle goes through zero.
Because the switch 36 is open or off through most of the AC cycle
in FIG. 3, the energy delivered from the pump power supply 35 to
the pump controller 39 is comparatively small. Thus, the blood pump
37 operates slowly. Conversely, when the switch 36 is on through
most of the AC cycle (see FIG. 2), the energy delivered to the
controller 39 is comparatively high and the blood pump 37 will
operate comparatively rapidly.
The existing conventional blood pump controller remains useful for
the purpose of setting upper limits in the speed of the blood pump.
However, the invention 20 provides for immediate and continuous
compensation of the speed of the blood pump in response to changes
in the patient's blood flow. When blood flow decreases, the output
of the comparator 30 is reduced and therefore the electronic switch
36 allows a smaller proportion of the pump power supply signal to
be conducted to the blood pump (see FIG. 3). Also, if the blood
flow of the patient should increase during the course of dialysis,
the amount of power supplied to the blood pump increases thereby
increasing the speed of the pump (see FIG. 2). Accordingly, pump
starvation caused by a vacuum-induced collapse of blood lines and
blood vessels will be avoided because the pump 37 will operate only
at the maximum rate accommodated by the available blood supply.
In using the invention, the patient is connected to the dialyzer in
a method well-known in the art, the supply line 24 being normally
in direct communication with the dialyzer blood circuit upstream
from the pump. In one preferred method embodiment, the auxiliary
control 20 is first switched off so as to have no effect on power
delivered from the supply 35 to the pump controller 39.
Alternatively, the auxiliary control 20 may remain on but the
initial reference control 32 adjusted to the maximum so as not to
interfere with the selection of a desirable maximum flow rate at
the controller 39.
Subsequently, the blood pump 37 is energized and the speed of the
blood pump is increased by adjusting the pump controller 39 to the
desired maximum blood flow. The desired maximum blood flow may be
ascertained by observing the negative pressure read-out 23 and
increasing the speed of the blood pump until the negative pressure
reaches a level prescribed by the attending physician.
Alternatively, the maximum desired flow can be obtained by
increasing the pump speed until the blood line or associated
accumulator collapses and then reducing the speed of the blood pump
37 through the controller 39 slightly until full flow results.
Once the maximum desired flow has been established in the blood
pump 37, the auxiliary controller 20 is activated by adjusting the
initial reference control 32 at least until it appears from the
negative pressure read-out 23 that the auxiliary control 20 is
monitoring blood flow at essentially the maximum desired rate set
by the pump controller 39. It has been found frequently desirable
to set the initial reference control on a specific negative
pressure reading representing a desirable blood flow rate.
When the initial reference control has been set, the auxiliary
control 20 will continuously vary the blood pump speed so as to
maintain the negative pressure reading at the preset level. Thus,
if the patient's blood flow reduces, the auxiliary control 20 will
reduce the speed of the blood pump 37 so that the negative pressure
reading will not significantly change. Conversely, if the patient's
blood flow increases, the auxiliary control 20 will increase the
speed of the blood pump and prevent the negative pressure level
from changing significantly.
The most advantageous physical housing for the invention has been
found to be an enclosure (not shown) which provides an electrical
outlet for the service plug of the conventional blood pump and
controller, a meter for reflecting the negative pressure, and a
dial plate and dial for setting the initial reference control. Of
course, various power switches, pilot lights, or other indicators
may be used in order to monitor the status of the circuit during
operation.
The invention may be embodied in other specific forms without
departing from its spirit or essential characteristics. The
described embodiment is 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.
* * * * *