Note: Descriptions are shown in the official language in which they were submitted.
This is a divisional application of Canadian application serial
number 43~,420 filed August 11, 1983 and although the pumping
apparatus and casette are disclosed, the invention is related
solely to the disposal casette.
sackground
Peristaltic pumps of the type known for use for
the infusion of medical fluids, or for the removal of
body fluids, are generally characterized by a length of
flexible tubing which is disposed within an arc between a
stator-like member and a rotor assembly. The rotGr assembly
is provided with a plurality of rollers which, upon
rotation of the rotor assembly, successively pinch-off
the tube and advance the location of the pinch-off so as
lo to progressively advance the fluid within the tube at a
rate determined by the rate of rotation of the rotor.
Such pumps have the advantage of having a disposable el~ment
in the fluid flow path, in that the length of tubing in the
pump may be replaced after each use, and casettes have been
provided to facilitate the insertion and removal of such
lengths of tubing. U-S. Patents illustrative of such constructions
are 3,927,955, 4,256,437, and 4,187,057. Despite their
advantages, such systems are also known to exhibit poor
accuracy and reproducibility, re~uire substantial power
for operation (thereby making them relatively expensive and
inappropriate for battery operation), berelatively complex
and bulky in construction, and require a casette which,
because it must support the tube along an arcuate path, is
relatively elaborate, complex, and expensive.
U.S. Patents 4,199,307 and 4,273,121 disclose linear
casettes for medical infusion systems, the casettes
comprising tubes having flexible portions which are engaged
by movable bar members at three different locations to
control flow of fluid through the tubes. The use of
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5~
pressure bars is also disclosed in patent 3,083,647.
Other u.s. patents such as 3,229,643, 3,981,633, and
3,233,553 disclose pumps in which shafts and eccentrics are
disposed inter~ally rather than externally in relation to
the flexible tubes. Other U.S. patents generally illustrative of
the state of the art are 3,067,692, 2,722,893, 1,8?4,667,
2,414,355, and 2,249,806.
Summary of the Invention
~ his invention is directed to a linear peristaltic
lo pump system in which a casette having a rigid, planax perimetric
frame and a tensioned linear section of elastomeric tubing
bridging the opening of that frame coacts with the other
elements of the system to deliver fluid at accurate, pre-
selected, and reproducible flow rates. In addition, the
casette has the advantages of being relatively simple and
inexpensive in construction, and is easily and quic~ly inserted
and removed from the pump housing. In the operation of the
pump, the tensioned section of tubing that spans the opening
of the casette frame is interposed between a platen and an
elastomeric membrane, both of which are provided by the pump
housing. The elastomeric membrane engages the outer members or
races of a series of bearing assemblies eccentrically mounted
upon a po~er-driven shaft, the membrane engaging the bearing
assemblies along a first band or linear zone of contact lying
in the same plane as the rotational axis of the shaft. The
elastomeric tubing of the casette engages the opposite side of
the membrane along a second band or linear zone of contac~
lying in the same plane and parallel wi~h the first line
of contact. Replacement of a casette may be achieved simply
by withdrawing ~he platen, which may be carried by
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a door of ~he housing assembly, and withdrawing the casette
and its elastomeric tubing from contact with the mem~rane
that overlies the bearinq assemblies.
In a preferred embodiment particularly suitable
for the administration of parenteral fluids, the casette
takes the form of a generally rectangular perimetric frame
having an elongated rectangular opening. Attachment sleeves
face each other from opposite edges of that opening, and the
section of tensioned elastomeric tubing has its ends secured
to the attachment sleeves so that the tubing section bridges
the full length of the opening. The casette may include
other tubing sections secured to and communicating with ~he
attachment sleeves, the other sections being provided at
their free ends with suitable coupling elements for connecting
the casette to a patient and a source of parenteral fluid.
Other features, advantages, and objects of the
invention will become apparent from the specification and
drawings.
Drawings
Fi~ure 1 is a perspective view of a system
utilizing the peristaltic fluid-pumping apparatus of
the invention for metered intravenous (IV) administration.
Figure 2 is a side elevation taken partly in
section showing the pump apparatus.
Figure 3 is an enlarged vertical sectional Yiew
showing details of the apparatus.
Figure 4 is a s~:ill further enlarged horizontal
sectional view taken along line 4-4 of Figure 3 and showing
the eccentric bearing assembly in an extreme position
compressing and occluding the elastomeric tube.
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~917~7
Figure S is a horizontal sectional view similar
to Figure 4 but showing the bearing assembly in its outer
extreme posi~ion with theelastomeric tube nearly fully expanded.
Figures 6-9 are schematic views showing the sequence
of operation of a modified fluid-pumping apparatus.
Figure 10 is a fragmentary perspective view of the
apparatus modified to include a membrane preferentially
reinforced against stretohing ln directionstransverse to the
axis of the tube.
lo Figure 11 is a fragmentary perspective view of a
pump appara~us modified to utilize a replaceable casette
for supporting the fluid delivery tube.
Figure 12 is a perspective view showing the opposite
side of the casette depicted in Figure 10.
Figure 13 is an enlarged cross sectional view
taken along line 13-13 of ~igure 12.
Figure 14 is an enlarged sectional view along
line 14 14 of ~igure 12.
Figure 15 is an enlarged longitudinal sectional
view along line 15-15 of Figure 12.
Detailed Description
Referring to the drawings, and particularly to
Figures 1-9, the numeral 10 generally designates an apparatus
including a metering pump 11, a fluid delivery tube 12,
coupling means 13 for coupling one end of the tube to a
suitable container 14, in this case a parenteral solution
container supported by a c:onventional IV stand 1;. The
coupling means takes the form of a spike 13a formed as part
of drip charnber housing 13b and received within the opening of
a vent-providing stopper at the mouth of the container. A
suitable valve or clamp 16 may be provided for controllins or
interrupting the flow of fluid through tube 12.
The opposite end of the tube 12 leads to a suitable
connector 17 represented diagramatically in Figures 1 and 2.
In the case of a fluid administration system, the connector
would ordinarily take the form of a hypodermic needle or
cannula. Excluding metering pump 11, the elements of the
system shown in Figures 1-2 are conventional and well known
and, therefore, further discussion of such elements is
believed unnecessary herein.
The metering pump 11 includes a housing 18 equipped
with a handle 19 andadoororremovable panel 20. Attachment
of ~he housing to IV stand 15 is achieved by thumb screw 21
which can be tightened against the poie of the stand when the
pole extends between a pair of ears 22, 23 projecting from the
rear of the housing. An electric stepping motor 24 drives the
pump and a power pack 25 composed of one or more batteries or
power cells (5 are shown) is located within the housing to
sup~ly power for the motor and other components. The electrical
controls for the operation of the motor may be simple or complex
depending on the requirements and use of the system. In the
illustration given, a plurali~y of finger buttons 26 are
provided at the face of the housing and a digital display
window 27 reveals information con~erning selected delivery rates
as controlled by motor speed for a ~ube 12 of selected cross
sectional dimensions.
The pump mechanisrR 28 includes a series of bearing
assemblies 29 each having inner and outer bearing members 30
and 31, respectively. Preferably the inner member 30 takes
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the form of an inner bearing race, the outer member 31
constitutes an outer race, and anti-friction bearing elements
32 are disposed therebetween. Such anti~friction bearing
elements would normally consist of ball bearings; however,
the use of various types of roller bearings is possible.
Furthermore, other types of bearing assemblies, such as
self-lubricating sleeve bearings, might be advantageously used.
Each inner race (or member) is mo-~nted eccentrically
upon a drive shaft 33. 'Journalling means in the form of
hangers 34 and bearings 35 (preferably ball bearings) support
the ends of drive shaf~ 33 as shown in ~igures 2 an~ 3. One
end of the shaft (the lower end in the embodiment illustrated)
is operatively connected to motor 24. A flexible coupling 36
is shown for that purpose, but other connecting means may be
used. Also, while the drive shaft 33 is illustrated with its
longitudinal axis oriented vertically, it is to be understood
that the action of the pump is independent of such orientation
as long as fluid is available to tl~e pump through line or tube 12.
Each inner race (or member) 30 is eccentrically mounted
upon shaft 33 with the centers of all such races beins equidistant
from the axis w of the drive shaft and with the angular spacing
between all of such centers being essentially the same and the
sum of the angular spacing being 360. ~7here a series of seven
bearing assemblies is provided as shown, the incremental angular
distanoe between the centers ofthe inner races should be 360
divided by seven, or approximately 51.43. A greater or smaller
number of bearing assemblies may be provided, although the
preferred range isbelieved to be 3 to 3~ such assemblles. Of
particular importance is the fact that the series of bearing
assemblies must be mounted upon the drive shaft 33 so that the
centers x of ~he inner races describe a spiral or helix of at
360 about drive shaft axis ~1.
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The inner races 30 may be secured upon the shaft 33
in any suitable manner . In the.embodiment illustrated in the
drawings, shaft 33 has a central portion of non-circular
(heptagonal) cross sec~ional outline and the eccentrically-
disposed openings 30a in the respective inner races 30 are of
the same configuration so that the eccentric bearings may be
incrementally p~sitioned upon the shaft with thelr centers
helically orien~ed. The inner races are thereby secured
against independent relative rotation with respect to shaft
lo 33, and locking elements 38 are secured to the shaft at
opposite ends of the series of beaxing assemblies 29 to
hold the series against axial displacement.
The central portion of elastomeric tube 12 is
supported with its longitudinal axis parallel with the
rotational axis of the shaft 33 and with a linear zone of the
outer surface of a membrane 40 in contact with the outer surfaces
of outer races 31. Ideally tne tube is stre~ched so that it is
under slight axial tension, thereby assurinc that the portion of
the tube opposite the bearing assemblies will be straight or
linear in the absence of lateral distorting forces. For purposes
of such ~ensioning, and to insure parallel alignment of the
tube with the axis w of the drive sha~t, mounting straps or
brackets may be located at 39 to immobilize those portions of
the tube with respect to housing 18. Alternatively, such
portions of the tube may be secured to the housing by adhesives
~r by any other suitable means.
The elastomeric imper'orate membrane 40 is interposed
between tube 12 and the cylindrical surfaces of outer bearing
members or races 31, as shown most clearly in Figures 3-5. The
membrane is planar in an untensioned state and assumes the
configuration shown in ~i~ure 3 because of the distortions
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developed by bear.ing assemblies 29 and tubing 12. It bridges
the space in which ~he series of bearing assemblies is located
and separates that mechanism from tube 12. Any suitable means
may be used to secure the periphery of the membrane to casing
or housing 18; in the embodiment illustrated, a frame 41 is
secured to the housing by screws 42 and clamps the perimeter
of the membrane tightly in place.
A rigid platen 43 braces tube 12 and not only main-
tains the tube in contact with one surface of the membrane
lo 40 but also maintains the opposite surface of the membrane
in contact with the outer races of the bearing assemblies 29.
More specifically, as shown in Figures 4 and ;, the outer races
tangentially engage the membrane 40 along a first linear zone
or band of contact y, and the elastomeric tube engages the
opposite side of the membrane along a second linear zone or band
of con~act z directly behind or opposi~e from the firs~ band
of contact. Also, the two bands of contact y and z lie in the
same plane as the rotational axis w of drive shaft 33.
Each bearing assembly 29 has its inner race 30
eccentrically mounted so that its center x moves between one
extreme position in which center x is spaced maximally from
the platen and the lumen 12a of the tube is substantially fully
open ~Figure 5) and the other extreme position in which center x
is spaced minimally ~rom platen 43 and the lumen of the tube
is closed (Pigure 4). To reduce torque peaks that develop as
each bearing assembly sweeps through the tube-occluding position
of Figure 4, especially when two such assemblies (the first and
last of the series) simultaneously compress and substantially
close the tube, platen 43 may be provided with a resilient
facing 44 engaging and supporting tube 12. The facing must not
7~7
be so compliant that it will allow outward displacement of
~he tube in preference to complete occlusion of that tube.
The tube should close as sho~n in Figùre 4 with the resilience of
facing 40 serving the primary purpose of reducing the torque
peak once such occlusion has taXen place. Additionally, the
resilient facing may perform the secondary function of providin~
additional resi~tance to lateral or transverse displacement of
the portion of the tube 12 extending alonside the series of
bearing assemblies 29 and membrane 40. In general, a facing
material having a durometer of about 60 to 80 has been found
effective.
Lateral displacement of the tube during pump operation
is prevented primarily by membrane 40 and by the effectiveness
of anti-friction bearing elements 32. A slight frictional
resistance is necessarily inherent in the operation of each
bearing assembly 29, but that resistance is substantially less
than the frictional resistance between the outer surface of outer
race 31 and the surface of membrane 40 in contact therewith.
Tangential sliding movement between the outer races of the bearing
assemblies and membrane 40 is therefore avoided. Since the
membrane's resistance to stretching is substantial in relation
to the frictional resistance inherent in the operation of the
bearing assembly, rotational forces that might otherwise be
transmitted to tube 12 are isolated by membrane 40.
In the form of the invention depicted in Figures 2-5,
each outer race 31 remains in continuous contact with membrane 40
even when the center x of bearing assembly 29 is spaced maximally
from the platen and the lumen Oc tube 12 is substantially fully
open (Figure ;). Alternatively, the appara~us may be adjusted
ox constructed so that it is structurally and functionally
identical to what has already been described except that the
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outer race of each bearing assembly is momentarily drawn out
of contact with the membrane when the shaft has rotated to
space center x its maximum distance from the platen, in which
case the outer race will be free to rotate a limited angular
distance ~i.e., 360 divided by the number of assemblies)
until it is again brought into contact with the membrane.
Such an embodiment not only provides the advantages of allowing
the tube to expand to a fully open position ~in which the cross
section of the lumen is circular in outline) but also, by
lo permitting incremental rotation of the outer race, tends to
?roduce more uni~orm bearing wear and thereby increase the
operating life of the apparatus.
The operation of such a modified version of the pump
is schematically illustrated in Figures 6-9. The two concentric
circles represent a bearing assembly 29 with the inner circle
indicating the inner race or member 30 and the outer circle
representins the outer race or member 31. The inner race is
eccentrically mounted with the extent of eccentricity beins the
distance between the center x of the inner race and the
rotational axis w of the mounting shaft.
The linear zone or band of contact z between tube 12
and membrane 40 is clearly shown in Figures 6 9. Similarly,
the linear zone or band of contact y between the membrane and
the outer race is revealed in Figures 6-~; however, when the
inner race of the bearinq assembly has rotated into a position
where its center x approaches maximum spacing from platen 43,
a gap or spacing 45 develops between outer race ~1 and membrane 40
(Pigure 9). The gap assures that tubing 12 will not be restrained
by the bearing assembly from assuming a condition of maximum
lumen cross sectional area, and also allows incremental angular
.
advancement of the outer race 31.
The incremental angular advancement may be observed
by noting the relative positions of reference points ~1 and P2
along the outer and inner races. In Figure 6, such points are
shown to be in radial alignment. As the drive shaft rotates
90 about axis w, reference point P2 has shifted 90 in a
counterclockwise direction while Pl retains its original
position because rotation of the outer race is resisted by
contact with membrane 40. In Figure 8, points Pl and P2 are
lo 180 apart with Pl still remaining in its ori~inal posit~on.
However, as the inner race rotates from the position depicted
in Figure 8 towards the position of Fiyure 9, the outer race 31
moves out of contact with me~brane 40 and the slight frictional
resistance inherent in the operation of assembly 29 causes
outer race 31 to rotate along with inner race 30. Point Pl
therefore shifts a limited angular distance from its original
position and will continue such movement until the outer race
again contacts membrane 40 in approaching the position of Figure 6.
When the Figure 6 position is again assumed, however, reference
?oints Pl and P2 will no longer be in radial alignment but will
be separated a limited angular distance from each other.
Figure 10 illustrates a construction which is identical
to those already described except that membrane 40' has a
multiplicity of flexible but non-stretchable reinforcing elements
45 extending along the plane of the membrane in a direction
perpendicular to bands of contact y and 2. The embedded
filaments may be formed of Dacron, wire, or any other suitable
material, and prevent lateral stretching of the membrane without
apprecia~ly affecting expansion and contraction of the membrane
in the general direction of the lines of contact. The
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preferential reinforcement of the membrane insures that
frictional resis~ance inherent in the construction of bearing
assemblies will not in any case be transmitted through the
membrane to cause lateral displacement of tube 12 and Dossible
variation in the delivery rate of the pump apparatus. Such
reinforcement, while generally unnecessary, may become important
in pumps of larger capacity in which the tubing is relatively
large (e.g., more than 1 cm. OD) and of substantial wall thickness.
In the operation of the embodiments of Figures 1-10,
lo rotation of shaft 33 causes a progressive occlusion of the tube
12 in a downward direction as each bearing assembly in downward
sequence assumes the tube-collapsing position depicted in Figure 4.
(It will be understood that if the direction of shaft ro~ation
were reversed, the progressive action o~ the bearing assemblies
would similarly be reversed to drive a segment of flu~d upwardly
rather than downwardly.) Figure 3 shows the uppermost bearing
assembly of the series in the tube-occluding position of ~igure 4.
The next tube bearing assembly directly below it is advancing
into occluding positions, the middle assembly is in its maximally
open position of Pigure 5, and the remaining three bearins
assemblies therebelow are progressing towards their maximally
open positions. A metered segment of fluid is thereby forced
downwardly through the tube in the direction of peristaltic action.
Figures 11-15 depict a preferred embodiment o the
invention similar to the embodiments already describe~
except that tube 112 is part of a replaceable casette 100.
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If the apparatus is to be used or the adm~nistration of
parenteral fluids, then the casette may include ~ suitable
coupli~g 113 at one end of the tube, the coupling being
equipped with a spL~e and drip chamber as previously
indicated, ænd the upper portlon of the tube also being
equipped (~f deslred) with a control device 116 si~lar to
device 16. The~,opposite end of the tube is provided with
a sui~able connector 117 which, if the apparatus is to be
used for parenteral administration, would take the ~onm of
a needle or cannula.
The mud-portion of tube 112 is stretched slightly
across the opening 150 of a rigid perimetric frame 151.
The fræme is gene~ally planar a~d may be provided with inner
and outer flanges 152 and 153 for increased rigidity. To
facilitate mounting the tube 112 upon the Crame lSl, ~he
tube ~ay be .ormed in sections, wi-h ~d-section 112a having
i~5 ends secu_ed to rigid mountins sleeves 154 znd l;j. The
sleeves are provid~d with wing por~ions 156 .hat zre
permanen~ly secured by heat sealing, fusion bondins, or
any other suitable means to the portions of rrame 151 above
and below windo~ openins 150. The upper section 112~ of the
elastomeric tubing has its lower end secured to the rigid
sleeve 154, and the lower section of the tube has its upper
end simllarly secured to lower sleeve 155.
As shown in Figure 11, platen 43 and facing ~4 are
mounted on door panel 20 and are dimensioned ~o extend
through opening lS0 of casette frame 151 when the casette is
in operative position and the door is latched closed. When
the casette is ino~erating position, locating pin 157 of the
housing extends through aperture 158 in the upper portion of
f~ 37~
the frame 151. Tube section 112a engages membrane 28 and is
supported or braced by planar platen 43 and its resilient
facing 44 in the same manner as shown and described with
respect to Figures 3-1~. However, the casette 100 ~reatly
facilitates use of the apparatus, particularly in medical
applications, because it may be discarded in its entirety
after it has se~ved its purpose, and a new sterile casette
may be inserted into position for use by the same patient
or a different patient, without risks of cross contamination
lo and without need to clean and sterilize the used casette or
the pump housing and mechanism.
The ease and speed with which a casette may be
removed and replaced is of course of considerable importance,
especially ln medical applications where time may be critical.
The casette also insures accurate alignment of the tensioned
section 112a of the tube with respect to the rotational axis
w of the drive shaft, a critical relationship as previously
described in connection with Figures 3-10. Furthermore, the
casette 100 allows precise tensioning or stretching of the
linear tube section 112a during manufacture of the casette.
Since the extent of tensioning of the linear tube section
affects the internal diameter of that section, reproducibility
of flow rates may be assured.
In assembling the casette of this inv~ntion it has
been found advantayeous to perform the following steps to
assure uniform stretching of tube section ll'a. The tubing is
first connected to sleeves 156 ~efore the sleeves are attached
to perimetric frame lSl. The frame is mounted on a jig
(not shown) utilizing the alignment aperture 158. The jig
accommodates two conventional ultrasonic welding horns, and
~2~'7~'7
one of the horns is operated to weld one of the sleeves 156
to the frame. ~ weight capable of exerting a predetermined
stretching force is attached to the other end of the tubing
and the tubing is freely stretched by the weight. The other
attachment sleeve 1S6, which has been connected to the tubing
but has been allowed to float freely with regard to the frame,
is then secured`.to the frame by the second ultrasonic welder.
Accurate "inline" measurement of tubing inside and outside
diameters is possible by means of laser micrometers, air
lo gauges, or tne li~e. If a deviation is detected then the
extent of stretching may be readily adjusted by varyi~g the
weight used to produce such stretching. By such a procedure,
stretching, tubing size, and pumping action may be accurately
controlled. While ultrasonic welding has been found particularly
effec~ive, other means of attachment such as cementing, solvent
bonding, or mechanical fastening may be used.
Should production operations result in variations
in the inside diameters of the tensioned tube sections 112a
of the casettes and not be corrected by stretching adjustment
as described above, each casette may be coded with suitable
indicia, colors, or indentations on the frame 1~1 or elsewhere
to indicate the average ID of the tensioned tubular pumping
section 112a of tha~ particular casette, and the microprocessor
of the pump mechanism may then be programmed accordingly to
correct the pump speed to achieve the required delivery rate.
If desired, the pump may be equipped with mechanical or electro-
optical transducers for reading such codin~ automatically.
The frame 15l of the casette includes a tab portion
159 which projects beyond the door 20 when the door is closed
and the casette is in operative position, thereby providing
a clear visual indica~ion that a casette is in place. In
~ddition, tab poxtion 159 is easily gripped by a user to
facilitate insertion and removal of a casette.
Depending on its intended use, the system may
include safety functions to insure that unintended interruptions
or changes in pump operation will not occur or at least will
not pass undetected. For such purposes, the opening 150 in the
casette frame, and the tensioned pump section 112a of the tube,
are substantially lonyer than the series of bearing assemblies
lo 29. When the casette is in place, the lower portion of tube
section 112a bridges a pair of guides 160, 161 and ext.ends
between the eMitter 162 and receiver 163 of an ultrasonic
or ?hotoptic bu~ble detector. Also, an occlusion detector 164
may contact a portion of the tube directly below, or on the
discharge side, of the series of rotor bearing pump assemblies
29 to sense increases in back pressure that might be caused ~y
kinking of the outlet section 112c of the tube, obstruction
of needle 117, or any other reason. Since bubble detectors
and pressure sensors are well known in the art and do not
cons~itute elements of this invention, further discussion is
believed unnecessary herein.
The rigid platen 43, resilient facincJ 44, and
elastomeric tube 12 and 112a are all preferably formed of
materials that have suffficient transparency to permit a user
or operator to view the peristalsis of the tube and the movement
of fluid therethrough through the platen. For that purpose,
the platen 43 may be formed of glass or any rigid and adequately
transparent polymeric material such as polyme~hyl methacrylate,
polymethyl alphachloro acrylate, cyclohexyl methacrylate, and
the like. The facing layer 44 and tube 12 and 112a are
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75;~
preferably formed of silicone rubber or polyurethane rubber,
but any elastomeric material having similar properties may
be used. The elastomeric material of membranes 40 and 40'
may also be silicone rubber or polyurethane rubber but, since
transparency of the membrane is not necessary, a variety of
other elastomeric materials such as Neoprene may be utilized.
While in the foregoing we have disclosed embodiments
of the invention in considerable detail for purposes of
illustration, it will be understood by those skilled in the
art that many of these details may be varied without
departing from the spirit and scope of the invention.
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