U.S. patent number 3,901,231 [Application Number 05/440,410] was granted by the patent office on 1975-08-26 for infusion pump apparatus.
This patent grant is currently assigned to Baxter Laboratories, Inc.. Invention is credited to Raymond G. Olson.
United States Patent |
3,901,231 |
Olson |
August 26, 1975 |
Infusion pump apparatus
Abstract
Infusion pump apparatus for delivering intravenous fluid from a
syringe to a patient so that volume may be accurately controlled
between a small delivery rate and a large delivery rate is
disclosed. The pump is adaptable to adjust the amplitude of the
syringe stroke in order to accurately meter the volume of fluid
delivered to a patient within a given time period. The pump may be
employed in an oxygen atmosphere without creating a potentially
dangerous condition likely to result in an explosion. An an
optional feature a pressure sensitive arrangement which stops the
pump in the event the resistance to flow of fluid becomes greater
than that required for normal operation is also disclosed.
Inventors: |
Olson; Raymond G. (Niles,
IL) |
Assignee: |
Baxter Laboratories, Inc.
(Morton Grove, IL)
|
Family
ID: |
23748655 |
Appl.
No.: |
05/440,410 |
Filed: |
February 7, 1974 |
Current U.S.
Class: |
604/152; 92/13.7;
128/DIG.12; 604/65; D24/111; 128/DIG.1; 128/DIG.13; 604/118 |
Current CPC
Class: |
A61M
5/14216 (20130101); Y10S 128/01 (20130101); Y10S
128/13 (20130101); Y10S 128/12 (20130101) |
Current International
Class: |
A61M
5/142 (20060101); A61m 005/00 () |
Field of
Search: |
;128/214E,214F,218A,218R,218G,DIG.1,DIG.12,DIG.13 ;74/40,48
;92/13.7 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Gaudet; Richard A.
Assistant Examiner: Layton; Henry S.
Claims
I claim:
1. Infusion pump apparatus with an adjustable piston stroke
amplitude for reciprocating a piston within a syringe to deliver
fluid comprising:
a housing;
angulation means pivotally disposed in said housing and operatively
connected to said piston to cause said reciprocation of said piston
in said syringe;
arcuate means pivotally disposed in said housing operatively
connected to said angulation means;
said arcuate means adaptable to adjustably determine said piston
stroke amplitude by varying the displacement of said angulation
means:
motor means connnected to said arcuate means operable to
reciprocate said angulation means through said angular
displacement; and
calibration means cooperable with said operative connection between
said angulation means and said arcuate means,
said calibration means comprising (a) means for pre-selecting the
fluid flow rate of said infusion pump apparatus by adjusting said
displacement of said angulation means, and (b) adjusting means for
establishing the minimum and maximum displacement of said
angulation means.
2. The infusion pump apparatus of claim 1 wherein said adjusting
means comprises a plurality of threadably adjustable screws.
3. The infusion pump apparatus of claim 1 wherein said angulation
means comprises lever means having one end pivotally secured within
said housing, said arcuate means comprising a substantially
U-shaped member having a middle portion shaped to form a portion of
an arc and having grooves formed in said middle portion to define a
curvilinear path, link means connected between a point
substantially intermediate the ends of said lever means and a point
adjustably positioned along said curvilinear path of said U-shaped
member, said point of position of said link means along the
curvilinear path of said U-shaped member being effective to control
the angular distance traveled by said lever and thereby control the
amplitude of the syringe piston.
4. The infusion pump apparatus of claim 1 wherein said motor means
comprises a brushless synchronous electric motor, and magnetic
switch means for controlling said motor means between on and off
positions, said motor means and said magnetic switch means being
adaptable to operate safely in an explosive atmosphere when said
switch controls said motor in an operable condition or causes said
motor to turn on or off.
5. The infusion pump apparatus of claim 3 wherein said motor means
comrises a synchronous motor adaptable to operate safely in an
explosive atmosphere, an eccentric member keyed to a shaft
rotatable by said motor, and a pivot link having one end pivotally
connected to said eccentric member and another end pivotally
connected to the point of position between said arcuate means and
said link means located on the curvilinear path of said U-shaped
member.
Description
The present invention relates to an infusion pump system and more
particularly to a pump having a synchronous motor adaptable to move
a piston of a surgical syringe to deliver to a patient
predetermined accurately measured volumetric amounts of intravenous
fluid.
The use of surgical syringes for injecting intravenous fluid into
the veins of a pateint has long been known. It is common practice
to employ a syringe comprising a cylinder and a piston
reciprocatingly disposed therein to cause fluid to move from a
source of supply to a patient who requires a constant and measured
amount of the fluid for purposes of life sustaining nourishment or
other aspects of medicinal treatment.
Various means may be utilized to operate the piston of a syringe.
The most elementary means for causing movement of a piston would be
pressing by hand against a rod portion of the piston extending
exteriorly of the cylinder, thereby forcing the head of the piston
to move rectilinearly and pump fluid from the supply source to the
patient. Modern technology has developed more advanced and
sophisticated means for delivering fluid from a source of supply by
means of a syringe. In this connection, electromechanical devices
have been created that automatically move a piston or plunger of a
syringe to cause fluid to be pumped to a patient who requires the
adminstering of intravenous fluid to obtain nutrients for
sustaining life.
Illustrative of devices that may be used to pump intravenous fluid
is a so called syringe pump that comprises a pump assembly
adaptable to be either permanently affixed to a syringe or
detachably connected thereto. A detachable syringe pump assembly is
shown by Rosenberg in U.S. Pat. No. 3,447,479. However Rosenberg
discloses a pump driven by the combined efforts of a synchronous
timing motor and an induction drive motor.
There are inherent problems to be overcome combining operating
characteristics of such drive motors. Among the problems
encountered by induction motors are the continual making and
breaking of electrical contact with resultant arcing between
contacts, the disadvantages of which are self-evident when one is
required to operate a motor in an atmosphere wherein free oxygen is
present. Moreover, induction type motors are affected by variances
in voltage and thus it is difficult if not impossible to deliver
with exactitude a constant and closely controlled volume of
intravenous fluid wherein the power services may be irregular;
thus, the supply of energy to the pump may vary greatly with
resultant highly diverse amounts of fluid pumped into a patient's
veins.
BRIEF SUMMARY OF THE INVENTION
In accordance with a major feature of the present invention
infusion pump apparatus is provided for rectilinear pumping and
delivery of fluid, e.g., I.V. solution to a patient, at an average
rate which can be selected within a range of rates. The apparatus
includes a novel rate selecting mechanism which includes means for
defining an arcuate movement path and means for pivotally
reciprocating the arcuate means. A driving linkage is coupled to
reciprocate the pump and also coupled to be moved by the arcuate
means while reciprocating along a range of positions on the arcuate
path thereon. A range of defining member is coupled to the driving
linkage for movement therewith and has a fixed pivot whose position
is selectively variable. At any fixed pivot point the member limits
the range of movement of the driving member along the arcuate path
and thus fixes the stroke and average output of the pump.
In accordance with another feature of the invention means are
provided for sensing the pressure in fluid output and for stopping
the pump or signaling a warning for sensed pressures over a
preselected high value.
This latter feature has the advantage of preventing damage to the
patient should the I.V. capillary be inserted wrongly, e.g. into a
muscle tissue.
These and other features and advantages of the invention will
become apparent from the ensuing description, reference being had
to the accompanying drawings, in which like members are used to
identify like elements in the several views.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a perspective view of a portable stand adaptable to
support a source of supply of intravenous fluid, infusion pump
apparatus including a syringe pump and a motor drive assembly
therefor.
FIG. 2 is a perspective view of the syringe pump and drive assembly
showing more specific details of its exterior construction.
FIG. 3 is a vertical front sectional view through the pump and
drive assembly with the front portion of the housing broken away so
that the working parts of the drive assembly may be seen more
clearly. The component parts of the assembly are shown in two
positions, the solid lines showing the syringe piston fully
extended, the dotted lines showing the syringe piston fully
retracted, and defining a maximum amplitude of syringe stroke.
FIG. 4 is a vertical front sectional view of the pump and drive
assembly similar to FIG. 3 but showing the component parts
operative between a position of complete piston extension and
complete piston retraction, but defining an intermediate amplitude
of syringe stroke.
FIG. 5 is a vertical side sectional view through the drive
assembly, taken along line 5--5 of FIG. 3, a front portion of the
housing broken away to show more clearly the working parts thereof.
The drive assembly is shown secured to a portion of a vertical
column of the stand.
FIG. 6 is a schematic diagram of a control circuit for use with the
subject pump system.
FIG. 7 is a schematic diagram of a control circuit similar to that
shown in FIG. 6 employing a pressure sensitive device for use with
the subject pump system.
DESCRIPTION OF THE PREFERRED EMBODIMENT
Referring to FIG. 1, an infusion pump apparatus 10 is shown mounted
by a clamping arrangement on a vertical rod member 12 of a portable
stand 14 adaptable to support an intravenous fluid storage bottle
16 from a hook member 18 disposed at an upper end of the rod member
12.
As seen more clearly in FIG. 2 pump apparatus 10 comprises a
housing 20 having a front face member 22, side members 24, top 26
and bottom 28 members and a back plate 30. Front face member 22 may
be removably secured to housing 20 as by machine screws 32. Access
to the interior of the housing is accomplished by unthreading the
screws and removing face member 22 from the housing.
Face member 22 has imprinted thereon a scale 34 of incremental
numbers corresponding to a desired parameter of operation for
pumping of fluid by the apparatus. As illustrated, the scale 34
shows a range of numbers from 10 to 300 and refers to milliliters
of fluid pumped per hour. Adjusting knob 36 is keyed in a known
manner to an exterior portion of a shaft 38 FIG. 5) hereinafter
described in detail disposed within the housing. rotation of the
knob 36 serves to set the pump at a predetermined rate of delivery
of fluid for infusion into the veins of a patient and the volume of
fluid flow is indicated by a finger 39 formed integrally with and
extending outwardly from knob 36. Adjusting knob 36 must include a
friction loaded shaft provision or other means (such as a lock
knob) to insure that it will maintain itself in any desired
selected position to have the apparatus pump the required flow of
fluid. The friction shaft or other provisions are needed to
overcome a small tendency of the hereinafter described variable
rate mechanism to shift the setting.
A knurled member 42 is located exteriorly of the face 22 and is
keyed to a portion of a shaft 44 (FIG. 5) extensive exteriorly of
the housing. The knurled member 44 is effective when rotated to
move a magnetic switch 46 assembly (FIGS. 3 and 4) between off and
on positions to activate the pump apparatus. Although the switch is
preferably of the type shown, the present invention, at least in
its broader aspects, contemplates the use of alternative switches
such as the conventional toggle switch.
An operation or "on" light 150 is disposed in face member 22 and
serves to indicate that the apparatus has power connected to and is
turned "on".
A bracket 50 (FIGS. 2-4) is secured to side 24 of the housing and
has formed therein a groove 52 to receive a rectangular flange 54
formed on a cylindrical body 56 of a syringe 58. Extending
outwardly from the body 56 of syringe 58 is a rod member 60 having
a circular flange 62 formed thereon adapted to be securably and
pivotally received by a yoke 64 carved from an exterior end of a
lever member 66 (hereinafter described in detail). The rod member
has an inner end formed to provide a piston (not shown) head or
plunger adaptable to move reciprocatingly within the body 56 of the
syringe 58.
The upper end of syringe 58 is operatively connected as is well
known in the art to a valve arrangement 68 (FIGS. 1 and 2) that
permits flow of fluid therethrough only to the patient and prevents
back flow of solution into the bottle 16 when rod member moves
upwardly to cause pressure to be exerted in valve arrangement 68.
This is preferably a pair of one-way valves permitting flow only
from I.V. bottle 16 to syringe 58 and from syringe 58 to the
patient-connected line.
Referring now to FIGS. 3, 4, and 5, it can be seen that lever 66
extends interiorly into housing 20 and has an inner end 70
pivotally connected to a mounting plate 72 (FIG. 5) secured
substantially intermediate and in parallel relationship with face
member 22 and back plate 30 as by sleeves 74 and bolts 76.
A substantially inverted U-shaped arcuate means or member 78 has
two legs 78A and 78B and a curving middle portion 80 and formed to
provide an arcuate configuration wherein are formed on opposite
sides a pair of arcuate grooves 82. The first leg 78A has its end
84 pivotally connected at 86 to the mounting plate 72.
A first link driving member 90 has a first end 92 pivotally secured
substantially intermediate the ends of lever 66 and has a second
end 94 secured as by pins 96 received in the arcuate grooves 82 of
member 78. It should be noted that the second end 94 of link 90 may
be assumed positions along an arcuate path defined by the grooves
82 formed in the middle portion member 78.
A synchronous electrical motor 98 (FIG. 5) is secured to a back
side of mounting plate 72 and is adaptable to rotate a drive shaft
100 that extends through a mounting plate aperture 102 having a
diameter somewhat larger than the diameter of the drive shaft. The
drive shaft 100 is keyed or otherwise affixed to an eccentric
member 104. The member 104 has an outboard end that pivotally
receives a pin 106 secured in one end of a pivot link 108. Pivot
link 108 has secured in its other end a pin 110 pivotally received
by the aperture formed in the second leg 78B of U-shaped member
78.
A range defining member 112 has one end 114 pivotally secured to
link member 90 and extends to connect its other end in pivotal
engagement at 112P with one end of a rod member 116. The other end
of rod member 116 is secured to shaft 38 and rotates coincidentally
therewith. As hereinbefore described shaft 38 is connected to and
controlled by adjusting knob 36.
Note that the control knob selects or fixes the position of pivot
112P and this in turn controls through range of positions that
pivot 96 can travel on arcuate path 82 (considering the relative
movement between arcuate means 78 and the pivot 96.) This, however,
in accordance with a major feature of the present invention
determines the vertical stroke distance of driving linkage 90 and
thus (through arm 66) of the pump stroke the syringe 58. The rate
of reciprocating of the syringe plunger is determined by the
rotation of the motor 98 which is preferably fixed so that the
position of pivot 112P by fixing the stroke determines the average
pumping rate.
The pump unit as described has been constructed and tested.
Empirical data has established that a near linear relationship can
be made to exist between the setting of knob 36 and the flow rate
and that the average rate of pumping can be precisely controlled
over a satisfactory range.
In order to control the rotation of shaft 38 between minimum and
maximum limit positions, as indicated on scale 34, calibration
means 118 is provided comprising a block 120, a first adjustment
screws 122 threadably receivable therethrough for establishing a
minimum adjustment position and a second adjustment screw 124
threadably receivable by the block for establishing a maximum
adjustment position of the shaft 38. It should be noted that either
screw when threaded inwardly or outawrdly of the block will, upon
rotation of shaft 38, establish a contact point with either edge of
rod member 116 and thereby prevent further rotation of shaft 38.
Thus, it is possible to adjust the rotation of shaft 38 between
minimum and maximum positions so that opposite correspondence is
maintained with scale 34 when knob 36 is turned to rotate shaft 38
and thereby select a desired rate of fluid infusion.
It can be seen that rotation of knurled knob 42 causes a magnetic
arm 126 affixied thereto to rotate therewith throughout an angle of
substantially 90.degree. as defined by limit pin 128 protruding
from the mounting plate and an exterior side of an enclosed
magnetic switch 130 secured as by screws to the mounting plate 72.
The pump assembly is inoperative when magnetic arm 126 is engaged
with pin 128 and becomes operative when magnetic arm 126 is rotated
by knob 42 into contact with magnetic switch 130. Magnetic switch
130 is wired in a known manner to an insulated terminal assembly
132 (FIGS. 6 and 7) secured to the mounting plate 72.
Referring now to FIG. 6, the Unit 10 is designed to be connected to
the commonly available AC power mains (60 hz, 120 v) via a
conventional three prong plug 134 which includes a separate ground
male prong for connection to ground. Of course, other power sources
and double insulation may be employed without departing from the
invention. However, the added ground wiring system is commonly used
in hospitals in the U.S. and provides additional protection against
electrical shock and leakage currents which could be very dangerous
in this environment of use.
The plug 134 has three conductors 134A, 134C and 134G leading to
the unit 10. Conductors 134A and 134C are for the convention AC
power and conductor 134G is connected to the ground prong of plug
134.
The ground wire 134G is connected to a terminal 146 of a terminal
block 132. The terminal 146 is securely electrically and physically
connected to the housing of the unit 10 to ground that housing.
The AC power line 134A is connected through a terminal 133 on block
132 to one side of the switch 130. As best shown in FIG. 6, the
switch 130 comprised an insulated sealed envelope housing 130H and
a pair of switch blades normally mechanically biased apart switch
blades 130B which are made of magnetic material. When the magnet
126 is moved to the horizontal position the magnetic flux causes
the blades to move together and complete the connection through the
switch 130.
The other side of switch 130 is connected via a line 136, terminal
138 and line 140 to the motor 98 of the pump assembly. The other
side of the motor connects by a wire 142 with a post 144 of the
terminal assembly 132 which part is, in turn, connected to the
power input line 134C of the power cord.
The indicator light 150 is connected between wires 140 and 142, and
is lighted to signal when the motor is running and is off when the
motor is shut down.
In FIG. 7 a second preferred embodiment of the invention is
illustrated employing, in accordance with a feature of the present
invention, means 152 for sensing pressure in the I.V. line to the
patient and for automatically shutting off the pump unit 10 in
response to a sensed pressure over a selected level.
This means 152, in this embodiment, includes a closed housing 152H
having a diaphragm 152D which is in pressure communication (via a
noncompressive, non-conductive fluid in zone 152A and a flexible
diaphragm 152F) with the I.V. line to the patent. When the pressure
in the IV chamber 152C rises above a threshold level, it moves
diaphragm 152D to break the contact of a switch 168 and disconnect
the connection between lines 162 and 164.
A two prong plug 160 is adaptable to be received by receptacle 154
and includes the two wires 162; 164 leading from the pressure
sensitive switch 168. A relay switch arrangement 172 is disposed
along the wire 158 of the device and includes an indicator light
174 for warning of an overpressure. It should be noted that in the
event pressure sensor 152 "reads" a pressure considered inimical to
the operation of the system, switch 168 will open, causing the
light 174 to light and, more importantly the interruption of
current flow through switch 172 to shut down motor 98 even though
magnetic switch 130 remains in a closed position.
In the operation of the present invention, a supply of intravenous
fluid is attached to a stand and from the supply conduit means is
connected through the pump apparatus 10 to a vein of a patient as
is well known. The pump apparatus is set to a desired flow of fluid
by rotating adjusting knob 36 to the selected point as indicated on
scale 34. Knob 42 is rotated from the off to on position and the
motor will begin operation to cause the syringe piston to
reciprocate in cylinder 56, alternately drawing fluid into one-way
arrangement means 68 on a retraction stroke and forcing fluid out
of this means 68 into a vein of a patient on an extension
stroke.
The fluid flow setting as accomplished by rotating knob 36 is
translated into a desired volume of fluid flow by varying amplitude
of the syringe piston between positions of full retraction and
extension. Rotation of knob 36 causes rod 116 to turn between the
screws 122, 124 of the calibration means 118 to have indicator arm
39 point to a desired number on scale 34.
Rotational movement of rod 116 to a desired position between
threadably adjustable screws 122 and 124 forces bar member 112, by
virtue of its pinned and articulated relationship with the link 90,
to position the link in a desired position along the curvilinear
path defined by grooves 82 formed in the member 78. The link 90
having one end positioned in grooves 82 and its other end secured
substantially intermediate the ends of lever 66 is effective to
move the lever 66 through an acutate angle about its end 70
pivotally secured to mounting plate 72.
It can be seen that rotation of eccentric 104 by the motor causes
pivot link 108 to urge the free end 88 of member 78 upwardly and
downwardly and thereby define angular displacement about the end 84
of member 78 pivotally secured to the mounting plate. Link 90
positioned in grooves 82 of member 78 and connected to lever 66
causes the lever to rotate about its end 70. The lever in turn
translates its angular movement to the rod 60 of the piston syringe
58 and by virtue of its pivotal connection therewith, causes the
piston to move rectilinearly and reciprocatingly within the
cylinder of the syringe. Thus, it can be seen that the cooperative
construction of the present invention makes it possible by
interrelated structure to combine in a unique arrangement angular
motion with rectilinear motion to establish a desired amplitude of
stroke for a piston syringe. It should be noted that positioning
the end 94 of link 90 at any desired point along the curvilinear
path defined by grooves 82 is effective to change the amplitude of
the piston stroke and thereby deliver to a patient's vein a highly
accurate and closely controlled volume of intravenous fluid.
It is thought that the invention and many of its attendant
advantages will be understood from the foregoing description and it
will be apparent to those skilled in the art that various changes
may be made in the form, construction and arrangement of the
component parts without departing from the spirit and scope of the
invention or sacrificing all its material advantages, the form
hereinbefore described being merely a preferred embodiment
thereof.
* * * * *