CA1249757A - Linear peristaltic pumping apparatus and disposable cassette therefor - Google Patents

Abstract

ABSTRACT
A disposable casette for use in a linear peristaltic pumping apparatus, comprising a rigid planar frame defining an opening; attachment sleeves provided by the frame on opposite edges of the opening: and a straight section of elastomeric tubing extending across the opening and having end portions secured to the attachment sleeves.

Description

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 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 ~2~

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.

~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 ~2~5~

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.

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 ~2~7~

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 ~Z~P757 -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 * Trade Mark l_ --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.

- ~3 -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 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.

* Trade Mark

Claims

THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE PROPERTY OR PRIVILEGE
IS CLAIMED ARE DEFINED AS FOLLOWS:

1. A disposable casette for use with a linear perstaltic pump having a housing equipped with at least one casette-locating pin disposed in close proximity to a pump mechanism covered by an elastomeric membrane and also having a door equipped with a platen aligned with said membrane when the door is closed, said casette comprising a rigid planar frame having a locating aperture for receiving the casette-locating pin of a pump housing for orienting said casette in relation to such housing, said frame also having an enlarged generally-rectangular opening for registration with the membrane and platen of a pump housing, a pair of rigid attachment sleeves provided by said frame on opposite edges of said opening, and a straight section of transparent elastomeric tubing extending across said opening and having end portions immovably secured to said attachment sleeves, said attachment sleeves each being provided with a pair of outwardly-projecting wing portions permanently secured to said frame adjacent opposite edges of said opening.