U.S. patent number 3,739,943 [Application Number 05/112,691] was granted by the patent office on 1973-06-19 for infusion system.
This patent grant is currently assigned to Sherwood Medical Industries Inc.. Invention is credited to Vernon F. Braun, Theodore E. Weichselbaum, Jack L. Wilhelmson.
United States Patent |
3,739,943 |
Wilhelmson , et al. |
June 19, 1973 |
INFUSION SYSTEM
Abstract
A portable infusion system uses a disposable piston-type syringe
and a disposable two-way valve as a positive displacement pump. The
syringe piston is reciprocally driven by a bidirectional DC motor
under control of a battery powered circuit. Different selectable
rates of pumping are maintained by controlling the width of
bidirectional DC pulses coupled to the DC motor and by monitoring
the motor back EMF during the off time of the pulses. Safety
circuits protect against deleterious conditions such as the passage
of an air bubble, an over-pressure condition, or an excess pumping
rate as could be caused by a component failure.
Inventors: |
Wilhelmson; Jack L. (Fenton,
MO), Weichselbaum; Theodore E. (St. Louis, MO), Braun;
Vernon F. (Berkely, MO) |
Assignee: |
Sherwood Medical Industries
Inc. (St. Louis, MO)
|
Family
ID: |
22345341 |
Appl.
No.: |
05/112,691 |
Filed: |
February 4, 1971 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
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81926 |
Oct 19, 1970 |
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Current U.S.
Class: |
222/59; 5/658;
417/417; 128/DIG.13 |
Current CPC
Class: |
A61M
5/1452 (20130101); A61M 5/172 (20130101); A61M
5/365 (20130101); Y10S 128/13 (20130101); A61M
5/1458 (20130101) |
Current International
Class: |
A61M
5/172 (20060101); A61M 5/145 (20060101); A61M
5/168 (20060101); A61M 5/36 (20060101); B67d
005/08 () |
Field of
Search: |
;417/416,417,418
;222/70,76,59 ;128/DIG.13,230 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Freeh; William L.
Assistant Examiner: Winburn; John T.
Parent Case Text
RELATED APPLICATION
This application is a continuation-in-part of our copending
application, Ser. No. 81,926, filed Oct. 19, 1970, entitled
"Infusion System", and assigned to the assignee of this
application.
Claims
We claim:
1. In a system having pump means for pumping fluid from a fluid
source to an outlet, a rate monitor, comprising: control means for
controlling said pump means and for providing a control signal
representative of a selected rate of flow for the fluid; sensing
means for generating a monitor signal representative of the rate of
flow produced by said pump means; first circuit means coupled to
said control means and said sensing means for comparing said
control and said monitor signals for generating an error signal
when a comparison of the control signal and the monitor signal
indicates that the produced rate of flow has varied by a
predetermined amount from the selected rate of flow; and second
circuit means coupled to said first circuit means and responsive to
said error signal for disabling said pump means upon the occurrence
of said error signal.
2. The rate monitor of claim 1 wherein said pump means includes
fluid channel means interconnecting said fluid source and said
outlet and including a pump chamber, and drive means including a
piston slidably mounted within the pump chamber for reciprocation
under control of said control means to pump fluid through said
fluid channel means, said sensing means generating said monitor
signal in response to a predetermined motion of said drive
means.
3. In a system having pump means for pumping fluid from a fluid
source to an outlet, a rate monitor, comprising: control means for
controlling said pump means and for providing a control signal
representative of a selected rate of flow for the fluid; sensing
means for generating a monitor signal representative of the rate of
flow produced by said pump means; circuit means for generating an
error signal when a comparison of the control signal and the
monitor signal indicates that the produced rate of flow has varied
by a predetermined amount from the selected rate of flow, said pump
means including fluid channel means interconnecting said fluid
source and said outlet and including a pump chamber, and drive
means including a piston slidably mounted within the pump chamber
for reciprocation under control of said control means to pump fluid
through said fluid channel means, said drive means including link
means cyclically driven through a path, said sensing means
generating said monitor signal in response to a predetermined
motion of said drive means, said sensing means including position
responsive means for sensing cyclically recurring positions of said
link means whereby said monitor signal is cyclically recurring.
4. The rate monitor of claim 3 wherein said control means provides
a fixed value control signal for a given selected rate of flow,
said circuit means includes time constant means for producing a
time varying signal having a value dependent on the value of said
fixed control signal and the time duration thereof, and means for
time comparing said time varying signal with said cyclically
recurring monitor signal to detect said predetermined amount of
rate variation.
5. The rate monitor of claim 4 wherein said time constant means
includes capacitor means and a charging path therefore coupled to
said fixed value control signal, and said time comparing means
includes gate means for discharging said capacitor means for each
occurrence of said cyclically recurring monitor signal.
6. The rate monitor of claim 3 wherein said sensing means comprises
switch means actuated once for each repetitive cycle of said link
means.
7. The rate monitor of claim 6 wherein said switch means comprises
a magnetically actuable contact means which changes state in the
presence of a magnetic field, and said link means includes magnetic
field generating means carried thereby for actuating the contact
means.
8. In a system having pump means for pumping fluid from a fluid
source to an outlet, a rate monitor, comprising: control means for
controlling said pump means and for providing a control signal
representative of a selected rate of flow for the fluid; said
control means including selector means for selecting different
pumping rates, and motor means responsive to said selector means
for controlling the cyclic rate of driving the pump means; sensing
means for generating a monitor signal representative of the rate of
flow produced by said pump means; and circuit means for generating
an error signal when a comparison of the control signal and the
monitor signal indicates that the produced rate of flow has varied
by a predetermined amount from the selected rate of flow; said
circuit means including means responsive to said selector means for
generating a different value control signal for each selectable
rate, and means for comparing the different value control signals
with the monitor signal.
9. The rate monitor of claim 8 wherein said comparing means
generates the error signal when the rate of flow produced by the
motor means exceeds by a predetermined range the selected rate of
flow, and safety means responsive to said error signal for
disabling said motor means.
10. In an infusion system having pump means for pumping fluid from
a fluid source to a patient, and control means for controlling the
pump means to establish a desired pumping operation, a monitor,
comprising:
sensing means associated with said pump means for providing a
monitor signal representative of the actual pumping operation of
the pump means;
circuit means for generating an analog waveform having a
predetermined relation to the monitor signal when the actual
pumping operation corresponds to the desired pumping operation;
detector means responsive to a change in the predetermined relation
between the monitor signal and the analog waveform for generating
an error signal; and
safety means for disabling the pump means in response to said error
signal.
11. The monitor of claim 10 wherein said pump means comprises a
positive displacement pump having a piston slidably mounted within
a pump chamber for reciprocation along a predetermined path, and
said sensing means generates a recurring monitor signal for at
least each cycle of reciprocation.
12. The monitor of claim 11 wherein said circuit means generates a
recurring analog waveform having a voltage level synchronized with
the occurrence of the monitor signal when the actual rate of
pumping corresponds to the desired rate of pumping, and said
detector means is responsive to a time advance in the occurrence of
the monitor signal for generating said error signal to thereby
prevent an excessive pumping rate.
13. The monitor of claim 10 wherein said control means includes
selector means for selecting different pumping rates for the pump
means, said circuit means includes capacitor means, a plurality of
circuit paths each having a different time constant, and charging
means controlled by said selector means for connecting one of said
circuit paths between a potential source and said capacitor means
to form said analog waveform across said capacitor means, said
detector means includes means for time comparing the charge of the
capacitor means with the occurrence of the monitor signal to detect
for said predetermined relation.
14. The monitor of claim 13 wherein said detector means further
includes discharge means responsive to each occurrence of the
monitor signal for discharging said capacitor means.
Description
This invention relates to an improved pumping system and an
improved control and safety circuit, particularly adapted for use
in an infusion system.
During typical blood transfusions and intravenous injections, a
solution bottle is usually hung about a patient to allow gravity
feed of fluid through disposable venoclysis tubing to a catheter
inserted in the vein of the patient. Transportation of the patient
is difficult because the solution bottle must always be located
above the patient, requiring an attendant to hold the solution
bottle. Even when the patient is located in a hospital, periodic
monitoring of the process is required, utilizing valuable personnel
time. Despite periodic monitoring, certain malfunctions can occur
which may go unattended for lack of a suitable indication of the
malfunction. For example, during an injection, it is possible for a
needle to become displaced from its position in a vein and become
lodged in a muscle.
In our copending application, a novel portable positive
displacement pumping system is disclosed which can replace the
gravity feed system typically used for transfusions and injections.
As a result, the solution bottle can be located at any reasonable
height with regard to the patient. The battery powered control
circuit for the pump system includes a number of safety circuits
which automatically monitors for deleterious conditions, such as
the passage of air bubbles or the dislodgment of the intravenous
needle into a muscle.
In accordance with the present invention, a further safety circuit
is provided which eliminates deleterious conditions which could
otherwise result due to a failure of the control circuit itself. An
electrical analog of the pump is compared with the actual operation
of the pump as indicated by external sensing associated with the
pump drive. When the actual pump produces a rate of pumping in
excess of the pumping rate of the analog circuit, a rate monitor
circuit disables the pump. The analog circuit provides a safety
range of allowable pump rates for each one of the plurality of
pumping rates which are selectable under control of the control
circuit. Desirably, the safety circuit and external pump sensing
means use many parts already existing in the system, providing an
additional safety factor with little increase in cost or number of
components.
One object of this invention is the provision of an infusion system
having improved safety circuits for modifying the operation of a
control circuit for a pump means in accordance with sensed external
and internal conditions.
Further objects and features of the invention will be apparent from
the following specification, and from the drawings, in which:
FIG. 1 is a perspective illustration of an infusion system
incorporating the applicants' pumping system;
FIG. 2 is an exploded view of the pumping system, with the syringe
pump being illustrated for clarity as located on the opposite side
of the pump housing shown in FIG. 1;
FIG. 3 is a schematic diagram of the control circuit for the pump
system;
FIG. 4 is a schematic diagram of a rate monitor circuit for
connection to the control circuit of FIG. 3; and
FIGS. 5A-5E are waveform diagrams illustrating waveforms generated
by the circuit of FIG. 4.
While an illustrative embodiment of the invention is shown in the
drawings, and will be described in detail herein, the invention is
susceptible of embodiment in many different forms and it should be
understood that the present disclosure is to be considered as an
exemplification of the principles of the invention and is not
intended to limit the invention to the embodiment illustrated.
Throughout the specification, values will be given for certain of
the components in order to disclose a complete, operative
embodiment of the invention. However, it should be understood such
values are merely representative and are not critical unless
specifically so stated.
GENERAL DESCRIPTION
FIGS. 1-3 show applicants' novel portable infusion system, as
disclosed in our before identified copending application. For
clarity, the operation of the apparatus and circuits of FIGS. 1-3
which are necessary to an understanding of the invention herein
will be explained. For a more complete description of the operation
of the portable infusion system, and for additional disclosure
concerning the disposable valve assembly for use therewith,
reference should be made to our before identified copending
application, Ser. No. 81,926, filed Oct. 19, 1970, and incorporated
by reference herein.
Turning to FIG. 1, a portable infusion system is illustrated for
pumping fluids such as blood from a solution bottle 20 to a
catheter 21 inserted into the vein of a patient. Fluid transfer is
accomplished by a pumping apparatus 24 held by a caddy assembly 26
mounted to a rail 28 of a bed for the patient. The caddy 26 also
removably holds the solution bottle 20, which can be located at any
reasonable altitude with respect to the patient.
Solution bottle 20 is of conventional construction, and includes a
cap 30 having an air valve 31 and an output port 32 for fluid
transfer. Disposable venoclysis tubing 34 couples the port 32 to an
input port 36 in a disposable two-way valve 40 which forms a part
of the pump apparatus 24.
Pump apparatus 24 uses as a pump chamber a conventional disposable
syringe 42 having a slidable piston 44 which can be reciprocated to
pump fluid within a hollow syringe barrel coupled with the two-way
valve 40 which includes an outlet or output port 46 connected by
venoclysis tubing 50 with a conventional Y connector 52 for
medication introduction. The output of the Y connector 52 is
coupled by additional disposable venoclysis tubing 54 to the
catheter 21.
The control circuit for pump apparatus 24, seen in detail in FIGS.
3 and 4, is completely contained within the housing for the pump
apparatus, and can be either externally or internally powered.
During a back stroke, in which the syringe piston 44 is driven away
from the valve 40, input port 36 admits fluid from solution bottle
20 into the syringe barrel. The valve in output port 46 is closed
at this time. During a forward stroke, in which piston 44 is driven
towards the valve 40, the input port 36 is closed and the output
port 46 is opened, pumping the solution through venoclysis tubing
52 and 54 to the catheter 21.
The novel pumping apparatus 24 is seen in exploded view in FIG. 2.
A sterile, positive displacement pump is economically formed by
using a conventional disposable syringe 42 in combination with a
unique disposable valve 40. Syringe 42 includes a gasket 70 fixedly
mounted to the piston 44 for movement within a hollow barrel 72
which has a single fluid opening terminating in a needle connector
74. The syringe includes extending finger grip arms 76, which in
the present invention are held by base means for the pump apparatus
24.
Syringe 42 and valve 40 are removably held by housing means in
order to allow disposal after use with each patient and replacement
with a new presteriled syringe and valve. A lower molded case 90
includes a pair of upstanding arms 92 each having a slot channel 94
which slidably receives one of the extensions 76 of the syringe.
Lower case 90 also includes an upstanding post 100 having a concave
surface 102 for holding the valve 40 when it is mated to the
syringe 42, and for making electrical contact with electrodes
embedded in the valve. A pair of female electrical sockets 106 in
surface 102 receive air bubble detector electrodes, as will appear,
and a female socket 108 (not illustrated in FIG. 2), which may be
separate from case 90 or similarly molded in a portion thereof,
receives an over-pressure detector electrode. The sockets 106 and
108 are connected by wires to the circuit of FIG. 3 which is
contained within the hollow case 90.
The mechanical drive arrangement for piston 44 consists of a
bidirectional DC motor 120 having an armature shaft 121 with an
integral motor gear 122. The motor gear 122 meshes with an idler
gear 126 rotatable about an idler shaft 128 rigidly attached to a
pinion gear 130. The pinion gear 130 meshes with a drive gear 132
which is fixedly attached to the shaft of a jackscrew 134. A
syringe cylinder carrier 140 includes a gripping head 142 having an
opening therein for slidably receiving the head 45 of piston 44.
The carrier 140 has an internally threaded central opening for
engaging the threads of the jackscrew 134 to cause the carrier to
act as a drive nut on the jackscrew.
When DC motor 120 is energized by voltage of predetermined
polarity, the two-stage spur reduction gears rotate jackscrew 134
and cause the carrier 140 and attached cylinder 44 to be driven in
a forward stroke. Carrier 140 includes a protrusion 150 with a
permanent magnet which extends downward for magnetically actuating
a sealed forward stroke limit switch 154 and a sealed reverse
stroke limit switch 152, mounted to a circuit board 156 which
contains the circuit of FIG. 3. The carrier 140 is driven in a
forward stroke direction until protrusion 150 is directly over
limit switch 154, at which time the circuit of FIG. 3 reverses the
polarity of voltage to DC motor 120 in order to rotate armature 121
in a reverse direction. The carrier 140 and cylinder 44 are now
longitudinally moved through a back stroke until the protrusion 150
is directly over limit switch 152, at which time the circuit of
FIG. 3 again reverses the polarity of voltage to DC motor 120.
While magnetically actuated proximity switches are preferred, a
mechanical switch arrangement could alternately be used, actuated
by mechanical engagement with protrusion 150.
The limit switches 152 and 154, in combination with the protrusion
150, also serve as a sensing means for determining the actual
operation of the pump. As will appear, portions of the circuit of
FIG. 3 which respond to the limit switches are connected to the
rate monitor circuit of FIG. 4 in order to provide an input (at
connectors A and B) representative of the actual operation of the
syringe pump.
Power for the DC motor 120 and the control circuit including the
rate monitor circuit of FIG. 4 is obtained from a self-contained DC
power source, as a pair of series connected DC batteries 160.
Desirably, batteries 160 are rechargeable, sealed nickel-cadmium
batteries which allow the pump apparatus to be powered either from
an external AC source, or internally powered in order to allow the
unit to be completely portable. If the unit is constructed for
portable use only, the batteries 160 may be conventional 1.5 volt
"D" size. The DC batteries 160 are housed within a battery retainer
cylinder 162 molded in lower case 90. Electrical connection is made
through a battery contact spring 164 and a contact on a battery
retainer cap 165 which threads into the battery retainer cylinder
wall to allow replacement of the batteries when necessary.
An upper case 170 mates with the lower case 90 to enclose the drive
train assembly and the batteries 160. Case 170 includes a window
172 through which indicia on a thumbwheel knob 174 may be observed
in order to allow operator selection of different rates of pumping
fluid. Desirably, the indicia on wheel 174 directly indicate pump
rate, such as 1 liter of fluid per 1, 2, 3, etc., hours. A
different range of pump rates may be provided by replacing syringe
42 with a syringe of different capacity, and knob 174 may be so
marked with alternate indicia. A syringe prime switch 176 allows an
operator to override the setting selected by wheel 174 in order to
rapidly reciprocate the piston 44 when first priming the syringe 42
to eliminate air bubbles. During the time the switch 176 is
actuated, the air bubble protector circuit is disabled.
CONTROL CIRCUIT
The control circuit for the pump assembly is illustrated in detail
in FIG. 3. DC power is provided between a DC potential line 248 and
a source of reference potential or ground 250. When external 115
volt AC is available, a plug 256 may be inserted into the external
AC source so as to couple 115 volt AC to a stepdown transformer
258. The transformer is connected through a full wave diode
rectifier to a line 260 connectable through a socket with line 248.
The rechargeable batteries 160 form a filter capacitor for the full
wave rectified AC voltage, reducing the ripple of the voltage on DC
line 248. If desired, an additional filter capacitor 262 may be
provided. The stepdown transformer 258 and full wave rectifier may
be housed within the plug 256, and connected through a two-line
cord to the socket receptacle on the pump assembly. When the pump
assembly is to be used independent of the external AC source, the
line plug is simply removed from the receptacle on the pump
assembly, allowing the previously recharged batteries 160 to
thereafter power the control circuit.
DC motor 120 is a shunt wound permanent magnet motor which rotates
in a forward direction when current flows from a terminal 260 to a
terminal 262, and rotates in a reverse direction when current flows
from terminal 262 to terminal 260. As will appear, the motor is
driven by pulses having a less than 100 percent duty cycle. During
the off-time of the pulses, the motor 120 acts as a generator or
tachometer, and the back EMF across the terminals is sensed and
stored in order to control the duty cycle of the drive pulses.
An electronic reversing switch, including transistors 265, 266,
267, 268, 269 and 270 forms a double-pole, double-throw switch.
Transistors 265 and 268 are synchronously driven conductive to pass
current in a forward direction through motor 120. Alternatively,
transistors 266 and 267 may be synchronously driven conductive to
complete a reverse current path for motor 120 to drive the motor
through its reverse or back stroke. When transistors 265 and 268
are on, current passes from a positive line 275 through transistor
265 to terminal 260 of motor 120, through motor 120 and out
terminal 262 to transistor 268, and thence to ground 250. When the
forward limit of travel is reached, as indicated by the permanent
magnet on protrusion 150 actuating limit switch 154, a reversing
switch driver, to be described, turns transistors 265 and 268 off
and transistors 266 and 267 on. Current then flows from the
positive line 275 through transistor 266 to terminal 262, and
thence through motor 120 and out terminal 260 to transistor 267 and
thence to ground 250.
The reversing switch driver, consisting of transistors 280, 281,
282, and 283, acts as a regenerative bistable switch useful to
obtain the heavy drive capability which is necessary when using low
supply voltage, such as 3.0 volts from the pair of batteries 160.
Transistors 280 and 283 drive each other into saturation when
magnetic protrusion 150 actuates switch 152 at the end of a back
stroke, grounding the base of transistor 282. Alternatively,
transistors 282 and 281 drive each other into saturation when
magnetic protrusion 150 actuates the switch 154, grounding the base
of transistor 283 at the forward stroke limit of travel.
When transistor 281 saturates, current flows from its emitter to
base and through a resistor 290 to the base of transistor 267 to
provide drive for the reversing switch. At the same time, the
voltage at the collector of transistor 281 rises to the potential
of line 275, back biasing transistors 269 and 265. Transistor 282
is also saturated at this time, causing current to flow through the
emitter-base of transistor 266, through a resistor 292 and via a
line 293 to the collector of transistor 282 and thence to ground
250. This provides drive for the other half of the reversing
switch. Since the collector voltage of transistor 282 is at
approximately ground potential, no current flows through a resistor
295 to transistor 270, nor transistor 268. When the opposite stable
state of the bistable is set by magnetic protrusion 150,
transistors 280 and 283 act similar to the above described
operation for transistors 281 and 282, providing drive for
transistors 265 and 269, and transistors 268 and 270, as will be
explained with reference to the bubble detector circuit.
During the forward stroke, transistor 270 is driven on by pulses
having approximately a 25 percent duty cycle. For one circuit which
was constructed, the drive pulses for minimum motor speed had a 4
millisecond on-time out of a sixteen millisecond interval,
producing a 60 hertz frequency. The duty cycle during the forward
stroke is adjustable, as will appear, and is controlled by a
forward stroke control.
The reverse stroke always occurs at maximum speed since transistors
266 and 267 are fully saturated during reverse motor movement. As
the DC voltage from batteries 160 slowly drops with age and use,
lesser voltage is passed through the reverse stroke transistors 266
and 267 to the DC motor 120, resulting in a decreased speed of
movement. A battery voltage variation compensation circuit is
responsive to decreased battery voltage to decrease the off-time of
the pulses controlled by the forward stroke control, thus
increasing speed in the forward stroke in order to maintain the
selected rate of pumping.
The forward stroke control includes transistors 300, 301, 302, 303,
and 304, connected basically as an unsymmetrical astable
multivibrator. To allow selection of different rates of pumping,
thumbwheel knob 174 is connected to the wiper 310 of multi-position
switches 312. Wiper 310 is connected through individual contacts,
labeled 1 through 9, to any one of a plurality of resistors 315
each having a different resistance value. A master OFF switch 316
when actuated connects the wiper 310 to DC line 248, via prime
switch 176. When the thumbwheel 174 is rotated to cause the wiper
310 of switch 312 to contact one particular resistor 315, a path is
formed from DC line 248, through actuated switch 316 and unactuated
switch 176 to wiper 310, and thence through the selected resistor
315 to the emitter of transistor 300. The collector of transistor
300 is connected through a capacitor 317 and thence through the
collector-emitter of transistor 301 to ground 250. The duty cycle
of the pulse coupled to transistor 270 is determined by the
capacitance of capacitor 317, the selected value of resistor 315,
and the voltage at the base of transistor 300 (from the velocity
feedback circuit as will appear).
The on-time of the duty cycle is determined by the time period
transistors 301 and 303 are saturated and transistors 302 and 304
are turned off. Transistor 300 acts as a controlled current source
that discharges capacitor 317 during the time it holds transistor
304 turned off. When transistor 301 turns on, transistor 303 is
turned on by current flowing from its base and through a resistor
320 and conducting transistor 301 to ground 250. Transistor 303
drives transistor 270 of the reversing switch driver through a
resistor 322. Thus, the on-time of the duty cycle which controls
the forward stroke of the motor is determined by saturation of
transistor 303.
The off-time of the duty cycle is controlled by saturation of
transistor 304, at which time transistors 301 and 303 are turned
off. This off-time is determined by the capacitance value of a
capacitor 325, the voltage to which the capacitor 325 is allowed to
charge during the prior on-time, and the resistance values of a
pair of series connected resistors 327 and 328. The allowable
voltage to which capacitor 325 is allowed to charge is set by the
battery voltage variation compensation circuit.
The detailed operation of the forward stroke control circuit is as
follows. Assume transistor 301 has just turned on with capacitor
317 fully charged and capacitor 325 fully discharged. When
transistor 301 saturates, the negative terminal of capacitor 317
has a negative voltage equal to the supply potential. For this
example, it will be assumed that the supply potential from
batteries 160 is at maximum potential, or 3.0 volts. Current now
flows from the +3.0 volt supply and through switches 316, 176 and
310 to the selected resistor 315 and thence through transistor 300
to discharge capacitor 317. When the negative terminal of capacitor
317 reaches 1.2 volts (the base-emitter drop of transistors 302 and
304), transistors 302 and 304 are turned on, turning transistor 301
off and recharging capacitor 317 to supply voltage through a
resistor 330. Capacitor 325 discharges through the series resistors
327 and 328 until the base-emitter voltage of transistor 301 is
reached, at which time transistor 301 turns on and the cycle is
repeated.
During the forward stroke, the pulse coupled to the DC motor has an
approximately 25 percent off-time at the maximum infusion rate
selectable by switch 310. Due to mechanical inertia, the motor
continues to turn and generates a back EMF proportional to the
angular velocity of the armature. This voltage is sensed by a
velocity feedback circuit and stored in order to control transistor
300 and adjust the on-time of the pulses to compensate for
variations in load. Thus, various fluids and syringes may be used
without effecting to any significant extent the calibration of
thumbwheel knob 174.
During the forward stroke, transistor 265 is on, connecting
terminal 260 to the supply voltage at line 275. During the off
portion of the forward stroke pulse, transistor 270 is off,
blocking transistor 268 and disconnecting ground 250 from the motor
terminal 262. The back EMF across the motor terminal is now coupled
through a resistor 335 and a pair of series connected diodes 336
and 337 to a capacitor 340 connected to ground 250. The capacitor
340 charges to a potential that is the sum of the supply voltage
and the voltage generated by the motor.
During the on-time of the forward stroke control, transistor 270 is
driven into conduction, driving transistor 268 into conduction and
hence connecting motor terminal 262 to approximately ground
potential, back biasing the diodes 336 and 337. The voltage charge
across capacitor 340 is now used to control the base drive of
transistors 300, establishing an on-time duration proportional to
the voltage across the capacitor. A resistor 342 allows the voltage
across capacitor 340 to slowly leak off. Since the emitter of
transistor 300 is referenced to the DC supply voltage, the current
through transistor 300 is dependent solely on the back EMF across
the DC motor, eliminating the effect of supply voltage
variations.
The control circuit also includes a number of special safety
circuits, described in the following sections. In addition, the
control circuit includes a battery voltage variation compensation
circuit, including transistors 370 and 371, and described in detail
in the before identified copending application, to which reference
should be made.
BUBBLE DETECTOR
The bubble detector circuit includes the bubble detector electrodes
212 and transistors 350 and 351. When fluids having a conductivity
equal to a salinity of 0.001 percent or greater are present between
electrodes 212 which are spaced 0.25 inches apart, the resistance
therebetween is on the order of 200 kilohms or lower. This causes
current to flow from the supply line 275, through the emitter-base
of transistor 350, through a resistor 352, as 10 kilohms, to one
electrode 212 and thence through the fluid to the other electrode
212 to charge a capacitor 353, as 1.0 microfarads. Capacitor 353 is
discharged by the forward stroke control circuit through a diode
355. The time constants are chosen such that capacitor 353 is never
charged to move than 0.1 volts unless the forward stroke control
circuit fails. If the forward stroke control circuit fails in such
a way that the forward stroke would be at full supply voltage
across the motor 120, capacitor 353 charges to supply voltage and
turns transistor 350 off. This terminates operation. Thus, the
patient is protected from excessive infusion rates which otherwise
might be caused by failure of critical parts in the circuit.
Additional protection is provided by the rate monitor circuit, to
be described.
The current that charges capacitor 353 causes a current of at least
200 times magnitude to flow from the supply, through the
emitter-collector of transistor 350, through a resistor 357 and
into the base of transistor 351. This forward biases transistor
351, creating a path to ground through the transistor 351 and a
resistor 358 connected to the base of transistor 269, thereby
allowing drive for transistor 269 and 265 to flow when the
transistor 269 and 265 are turned on by the reversing switch driver
circuit. When an air bubble or cavity in present between the
electrodes 212, the current path is broken and transistor 351 is
biased off. Therefore, the motor 120 stops on the forward stroke.
Prime switch 176 in the forward stroke control circuit is used to
override this shut-off during syringe priming.
The combination of the bubble detector circuit and the placement of
the electrodes 212 and 220 in the two-way valve assembly 40 creates
a fail safe apparatus which detects air leaks caused by a defect in
the pump assembly itself. For additional disclosure concerning the
placement of the electrodes 212 and 220, reference should be made
to our before mentioned copending application
The bubble detector control circuit serves the dual purposes of
providing a safety device to prevent accidental passage of an air
bubble, and also automatically shuts off the pumping apparatus when
all the fluid in the solution bottle is used up. At the end of the
supply of fluid, air is introduced into the solution bottle and is
pumped to the valve assembly 40. When the air reaches the point
where the two sensing electrodes 212 are placed, the current path
is broken and motor operation is terminated, turning off the
pumping system.
OVER-PRESSURE DETECTOR
This circuit is formed by integrated circuit gates 400, 401 and a
transistor 372. Gates 400 and 401 are connected to form a bistable
multivibrator. During normal operation (no over-pressure
condition), gate 401 is on and transistor 372 is off. To insure
this state, a capacitor 405 is made five times as large as a
capacitor 406. When the control circuit is first energized, the
capacitor 405 holds one input of gate 400 low long enough to set
the bistable with gate 401 saturated and gate 400 off.
When fluid reaches electrodes 220, indicating an overpressure
condition, a circuit path is formed from one input of gate 400 to
the supply voltage line 275 via transistor 350 and the electrode
212 connected through resistor 352 to the base thereof, saturating
gate 400 and turning gate 401 off. This turns transistor 372 on,
turning off transistor 351 which in turn opens the bias path for
transistors 269 and 265. This stops the system on the forward
stroke. The over-pressure detector circuit may be reset by turning
the control circuit off and back on, causing capacitor 405 to again
saturate gate 401.
BUBBLE AND OVER-PRESSURE INDICATOR
This circuit consists of transistors 410 and 411 which control
energization of a visual indicator, such as a light emitting diode
(LED) 413. Desirably, a light emitting diode is used rather than an
incandescent lamp due to its low power consumption. When an air
bubble or an over-pressure condition is detected by the circuits
previously described, transistor 351 is turned off. This in turn
biases off transistor 410, ungrounding a junction formed between a
resistor 415 and a diode 416 connected in series between the anode
of LED 413 and the base of transistor 411. The transistor 411 is
thus forward biased, creating a current path for the LED 413 to
ground through a resistor 420 and the collector-emitter junction of
the conducting transistor 411. The LED 413 is located adjacent a
jewel lens mounted in case 170 in order to give a visual indication
of a circuit shut-off caused by the detection of an air bubble or
an over-pressure condition.
RATE MONITOR CIRCUIT
This circuit, shown in FIG. 4, is connected to the circuit of FIG.
3 through corresponding numbered and lettered connections indicated
within circles. The rate monitor circuit creates an electrical
analog representative of the of the syringe driver, against which
is compared the sensed actions of the actual syringe driver. The
sensed actions are desirably determined using the limit switches
152 and 154 activated by the permanent magnet in protrusion 150,
see FIG. 2. When, for any reason, the actual syringe driver
completes its forward stroke in a predetermined amount of time less
than the analog syringe driver, the rate monitor circuit terminates
the forward stroke, as by activating a portion of the existing
over-pressure detector.
A number of failures might cause the actual syringe driver to have
an excess pumping rate, i.e., a rate substantially in excess of the
rate selected by the rate knob 174. For example, certain
transistors in the circuit of FIG. 3 might fail, or the rate switch
312 might open-circuit. The rate monitor circuit is designed to
protect against all such occurrences, and to cause a shut-down of
the syringe driver in the event that certain portions of the rate
monitor circuit itself should fail.
Considering the circuit in detail, the collectors of transistors
280 and 282 in the reversing switch driver, FIG. 3, are coupled via
connector A to a 47 microfarad capacitor 500, FIG. 4, and through a
3.3 kilohm resistor 502 to the base of a NPN transistor 504. A 10
kilohm resistor 506 is connected in shunt between the base and
emitter electrodes of transistor 504. The transistor serves to
discharge a 470 microfarad capacitor 510 through a 10 ohm resistor
512 connected in series with the collector and emitter electrodes
of the transistor 504.
Capacitor 510 is a part of a selectable time constant means which
serves to generate an analog voltage which can be used to determine
whether the system is operating properly. The capacitor 510 is
charged through a constant current source consisting of a PNP
transistor 516 having a collector directly connected to capacitor
510, an emitter connected to a common line 518, and a base
connected in a voltage divider to the junction between a 220 ohm
resistor 520 and three series connected semiconductor diodes 522.
The voltage divider is connected between a source of positive
voltage on line 248 and ground 250.
The rate of charge of capacitor 510 depends on the position of the
rate switch 312, FIG. 3. Each contact 1 through 9 of the rate
switch is connected through a corresponding diode 530 and a
resistor 532 to the common line 518. Each resistor 532 has a
different resistance value to produce a different time constant for
the analog circuit including capacitor 510, chosen such that the
analog ramp voltage across capacitor 510 will reach +1.2 volts DC
at a time when the syringe driver has completed approximately 60
percent of its forward stroke. For the infusion system which was
constructed, the value of the resistors 532 corresponding to each
of the contacts 1, 2, 3, 4, 5, 6, 7, 8 and 9 was 6.2 kilohms, 20
kilohms, 33 kilohms, 47 kilohms, 62 kilohms, 75 kilohms, 91
kilohms, 100 kilohms and 120 kilohms, respectively.
The analog ramp voltage across capacitor 510 is coupled through a
diode 540 to the base of a NPN transistor 542. The emitter of the
transistor 542 is directly connected to ground 250, and the
collector is connected through a 10 kilohm resistor 544 to the +V
line 248, and also to the base of a NPN transistor 550. The
collector of transistor 550 is connected via connector E with one
input of the gate 401, FIG. 3. The emitter of transistor 550 is
directly connected to the collector of a second NPN transistor 554,
having its emitter directly connected to ground 250. The base and
emitter electrodes thereof are shunted by a 10 kilohm resistor 556.
To control the biasing of transistor 554, the base is also coupled
through a 10 kilohm resistor 560 and via connector B to the series
connected collectors of transistors 281 and 283 in the reversing
switch driver, FIG. 3.
The operation of the rate monitor circuit of FIG. 4 may be
understood with reference to the waveforms shown in FIGS. 5A-5E. At
the termination time of the back stroke of the actual syringe
driver, the syringe cylinder carrier 140, FIG. 2, is in its rear
position at which the permanent magnet on protrusion 150 actuates
the reverse stroke limit switch 152. This external sensing of the
actual piston position is independent of the electrical drive
control, and thus provides actual positioned sensing for the rate
monitor circuit. As reverse limit switch 152 is actuated at the end
of a back stroke, the base of transistor 282, FIG. 3, is grounded.
As previously explained, this drive transistors 280 and 283 into
saturation, producing a positive going voltage at connector A, FIG.
5A, and a negative (or ground) voltage at connector B, FIG. 5B.
This positive voltage occurring at a time 570, FIG. 5A, drives
transistor 504 into saturation, discharging capacitor 510 to
approximately zero volts, as seen in FIG. 5C. Since connector A is
coupled to the base of transistor 504 through a capacitor 500, the
capacitor 500 momentarily charges to the positive voltage, removing
the forward bias from transistor 504. Capacitor 510 now charges
approximately linearly at a rate determined by the particular one
time constant resistor 532 selected by the rate switch. The values
of the resistors 532 are chosen such that the analog ramp voltage,
FIG. 5C, normally reaches +1.2 volts DC level, labeled 572, when
the actual syringe driver has completed approximately 60 percent of
its forward stroke. The +1.2 volts DC level forward biases the
semiconductor diode 540 and the base-emitter junction of transistor
542, thereby reducing the voltage at the base of transistor 550 to
less than 0.1 volts DC, as seen in FIG. 5D.
At the termination time 580 of the actual forward stroke, as sensed
by the closing of switch 154, the voltages at connectors A and B
reverse polarity, FIGS. 5A and B. The positive voltage to
transistor 554 forward biases the same. However, transistor 550 is
still reverse biased by the output. FIG. 5D, of transistor 542,
resulting in an open circuit between connector E and ground 250, as
seen in FIG. 5E. At the end of the back stroke, switch 152 is again
actuated, repeating the cycle previously described.
If for any reason the syringe driver over-speeds so that the
forward stroke is completed before the ramp voltage across
capacitor 510 reaches the +1.2 volt lever 572, a modified operation
results. Assuming that the actual back stroke begins at a time 590
which is well in advance of the selected operation, the voltage at
connector B will rise positively and forward bias transistor 554.
At the same time, the voltage on the base of transistor 550, FIG.
5D, is positive, biasing transistor 550 into conduction. Since both
transistors 550 and 554 are forward biased, the voltage at
connector E drops to ground potential, FIG. 5E, forming a shutdown
or error signal. As seen in FIG. 3, the error signal, i.e., ground,
at the input of the gate 401 switches the bistable multivibrator,
turning gate 401 off and hence turning transistor 372 and
transistor 351 off. As previously explained for the over-pressure
detector, this opens the bias path for transistors 269 and 265,
stopping the syringe driver on the forward stroke.
By different choice of the time constant values of resistors 532,
FIG. 4, and the value of capacitor 510, the safety range which
allows continued normal operation, herein 60% of the selected rate,
can be altered as desired. This range also allows for changes in
consistence of the fluid being pumped, and other factors including
calibration errors.
To increase reliability, the conductors for connecting the
components used in the circuits of FIGS. 3 and 4 may be doubled, as
by being formed on opposite sides of a printed circuit board, and
other conventional redundancy techniques may be utilized. For some
applications, it may be desirable to include less than the number
of individual circuits described above, or to include various
combinations thereof. Other modifications will be apparent to those
skilled in the art.
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