CA1052653A - Syringe pump drive system and disposable syringe cartridge - Google Patents
Syringe pump drive system and disposable syringe cartridgeInfo
- Publication number
- CA1052653A CA1052653A CA228,743A CA228743A CA1052653A CA 1052653 A CA1052653 A CA 1052653A CA 228743 A CA228743 A CA 228743A CA 1052653 A CA1052653 A CA 1052653A
- Authority
- CA
- Canada
- Prior art keywords
- syringe
- cylinder
- piston
- piston rod
- cartridge
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
- A61M5/1452—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/14212—Pumping with an aspiration and an expulsion action
- A61M5/14216—Reciprocating piston type
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S128/00—Surgery
- Y10S128/12—Pressure infusion
Abstract
ABSTRACT OF THE DISCLOSURE
This invention relates to a new and improved drive system and syringe for syringe pumps, wherein a disposible syringe cartridge having no valves is reliably and precisely mounted, monitored, and driven through repetitive fill and pump strokes. Prior art disposable syringes are com-plex and expensive and prone to leakage. Additionally, they are difficult to mount and remove. The present invention overcomes these deficiencies by providing a syringe cartridge which has no valves, and the apparatus repetitively and sequentially opens and closes, by means of an external pair of tube pinchers, a pair of intake and output I.V. tubes communicating with the inlet and outlet nipples. The cartridge includes a molded plastic cylinder having inlet and outlet nipples, a plastic piston and piston rod, and a rubber sealing cap defining a conical piston face, a pair of piston sealing rings and a sealing boot.
This invention relates to a new and improved drive system and syringe for syringe pumps, wherein a disposible syringe cartridge having no valves is reliably and precisely mounted, monitored, and driven through repetitive fill and pump strokes. Prior art disposable syringes are com-plex and expensive and prone to leakage. Additionally, they are difficult to mount and remove. The present invention overcomes these deficiencies by providing a syringe cartridge which has no valves, and the apparatus repetitively and sequentially opens and closes, by means of an external pair of tube pinchers, a pair of intake and output I.V. tubes communicating with the inlet and outlet nipples. The cartridge includes a molded plastic cylinder having inlet and outlet nipples, a plastic piston and piston rod, and a rubber sealing cap defining a conical piston face, a pair of piston sealing rings and a sealing boot.
Description
- ioS,~';53 This lnvention relate~ generally to lmprovementa ln ~yringe pumps and, more partlcularly, to a new and im-proved drlve ~y~tem and syrlnge for such pumps, whereln a diflposable ~yrlnge cartrldge havlng no valves i~ reliably and preclsely mounted, monltored, and drlven through repet-itive flll and pump ~trokes.
Ihe usual medlcal procedure for the gradual parenteral adminl~tration o~ liquids lnto the human body, such as liquid nutrlent~, blood or pla~ma, makes u~e of apparatu~ whlch i8 commonly rePerred to in the medical art~
as an intravenous admlnlstratlon set. The lntravenou~
~et usually comprlses a bottle of llquld, normally ~upported ln an inverted posltlon, an intravenous feedlng tube, typi-cally of clear plastlc, and a sultable valve mechanism, ~uch as a roll clamp, whi¢h allows the llquld to drip out of the bottle at a selectively ad~ustable rate into a tran~parent drip chamber below the bottle. The drip chamber serve~
the dual ~unctlon of allowlng a nurse or other attendant to observe the rate at which the liquld drips out o~ the bottle, and also creates a re3ervoir for the llquld at the ; lower end of the drip chamber to lnsure that no air enters the maln feedlng tube leading to the patlent.
Whlle observatlon of the rate of drop flow vla the j drip chamber is a slmple way of controlllng the amount of liquid fed to a patient over a period of tlme, lts ultlmate effectiveness requires that a relatlvely constant vigll be maintalned on the drop flow, le~t it cease entirely due to exhaustlon o~ the liquid ~upplled or become a contlnuous stream and perhap~ increase the rate of llquld introduc-tlon to the patlent to dangerou~ level~.
By way of example, lt ha~ been the general practice in hospltals to have nur~e~ periodlcally monitor drop flow rate at each lntravenous feedlng or parenteral lnfu~lon 105Z~;53 statlon. Such monltoring of drop flow ls a tedious, and time c~n~umlng process, prone to error and assoclated, possibly serious consequences, and resultlng in a substan-tlal reductlon of the available time of quallfied medical per~onnel for other important duties. Typically, the nurse monitoring drop flow rate wlll use a watch to time the number of drops flowlng in an interval of one or more minutes, and she will then mentally perform the mathematics neaessary to convert the observed data to an approprlate fluid flow rate, e.g., in drops per mlnute. If the calcu-lated flow rate is substantially different than the pre- -scribed rate, the nurse must manually ad~ust the roll clamp for a new rate, count drops again, and recalculate to measure the new flow rate.
Obviously, each of the aforede~cribed measure-ments, calculations and flow rate ad~ustments usually take several minutes tlme whlch, when multiplied by the number o~ stations being monitored and the number of times each station should be monitored per day, can result ln a sub-stantial percentage of total personnel time ~vailable. Inaddltion, under the pressure of a heavy schedule, the ob-servatlons and ¢alculations performed by a harried nurse in measuring and ad~ustlng flow rate may not always prove to be reliable and, hence, errors do occur resulting in undesired, pos~ibly dangerous infusion flow rates.
In addition to the a~oredescrlbed difficulties, the parenteral administration of medical liqulds by gravity inducçd hydrostatic pressure infusion of the llquid from a bottle or other container ~uspended above the patlent, is very susceptlble to fluid flow rate variation due to c~anges ln the liquld level in the bottle changes in temperature, changes in the venous or arterial pressure of the patient, patlent movement, and drift in the effective setting of
Ihe usual medlcal procedure for the gradual parenteral adminl~tration o~ liquids lnto the human body, such as liquid nutrlent~, blood or pla~ma, makes u~e of apparatu~ whlch i8 commonly rePerred to in the medical art~
as an intravenous admlnlstratlon set. The lntravenou~
~et usually comprlses a bottle of llquld, normally ~upported ln an inverted posltlon, an intravenous feedlng tube, typi-cally of clear plastlc, and a sultable valve mechanism, ~uch as a roll clamp, whi¢h allows the llquld to drip out of the bottle at a selectively ad~ustable rate into a tran~parent drip chamber below the bottle. The drip chamber serve~
the dual ~unctlon of allowlng a nurse or other attendant to observe the rate at which the liquld drips out o~ the bottle, and also creates a re3ervoir for the llquld at the ; lower end of the drip chamber to lnsure that no air enters the maln feedlng tube leading to the patlent.
Whlle observatlon of the rate of drop flow vla the j drip chamber is a slmple way of controlllng the amount of liquid fed to a patient over a period of tlme, lts ultlmate effectiveness requires that a relatlvely constant vigll be maintalned on the drop flow, le~t it cease entirely due to exhaustlon o~ the liquid ~upplled or become a contlnuous stream and perhap~ increase the rate of llquld introduc-tlon to the patlent to dangerou~ level~.
By way of example, lt ha~ been the general practice in hospltals to have nur~e~ periodlcally monitor drop flow rate at each lntravenous feedlng or parenteral lnfu~lon 105Z~;53 statlon. Such monltoring of drop flow ls a tedious, and time c~n~umlng process, prone to error and assoclated, possibly serious consequences, and resultlng in a substan-tlal reductlon of the available time of quallfied medical per~onnel for other important duties. Typically, the nurse monitoring drop flow rate wlll use a watch to time the number of drops flowlng in an interval of one or more minutes, and she will then mentally perform the mathematics neaessary to convert the observed data to an approprlate fluid flow rate, e.g., in drops per mlnute. If the calcu-lated flow rate is substantially different than the pre- -scribed rate, the nurse must manually ad~ust the roll clamp for a new rate, count drops again, and recalculate to measure the new flow rate.
Obviously, each of the aforede~cribed measure-ments, calculations and flow rate ad~ustments usually take several minutes tlme whlch, when multiplied by the number o~ stations being monitored and the number of times each station should be monitored per day, can result ln a sub-stantial percentage of total personnel time ~vailable. Inaddltion, under the pressure of a heavy schedule, the ob-servatlons and ¢alculations performed by a harried nurse in measuring and ad~ustlng flow rate may not always prove to be reliable and, hence, errors do occur resulting in undesired, pos~ibly dangerous infusion flow rates.
In addition to the a~oredescrlbed difficulties, the parenteral administration of medical liqulds by gravity inducçd hydrostatic pressure infusion of the llquid from a bottle or other container ~uspended above the patlent, is very susceptlble to fluid flow rate variation due to c~anges ln the liquld level in the bottle changes in temperature, changes in the venous or arterial pressure of the patient, patlent movement, and drift in the effective setting of
-2-1~5'~653 the roll clamp or other valve mechanism pin¢hlng the feedlng tube. Moreover, there are a number of situatlons, such as ln intensive care, cardiac and pediatric patients, or where rather potent drugs are belng administered, where the deslred drop flow rate must be capabie of very precise selection.
It wlll be apparent, there~ore, that some of the most crltlcal problems confrontlng hospital personnel faced wlth an overwhelmlng duty schedule and llmited time avail-lO ability are the problems of qulckly, easily, rellably andaccurately controlllng fluld flow ln the parenteral admln-istratlon Or medlcal llqulds.
In recent years, a number of electrlcal monitorlng systems, drop flow controllers and infuslon pumps have been developed to accomplish the various tasks of senslng and regulating drop flow rates. However, while such de-vl¢es have generally served their purpose, they have not always proven entirely satlsfactory from the standpoint of cost, complexity, stablllty, rellablllty or accuracy. In additlon, such systems have sometlmes been sub~ect to drl~t and substantial flow rate variations due to changes ln temperature, ~eedlng tube crimps> variatlons ln venous or arterlal pressure of the patlent~ or variatlons in the height of the bottle or solution level wlthin the bottle.
Even positive pressure pumps of the closed-loop perlstaltic type only serve to malntain accuracy of flow ln terms of stablllzing to a preselected drop flow rate, rather than delivering a preclse preselected volume of fluid, e.g., in cubic centimeters per hour. The reason ~or khis ls that the accuracy of such a system is limlted lnherently to the accuracy of the size of the drops pro-duced by an intravenous administration set, and the actual drop~ produced by the latter apparatus can vary rather 105'~653 ~ubstantially ~rom lts deslgnated drop slze~ e.g., due to drip chamber structural varlations, by a~ much as thirty p ercent.
More recently, posltlve pressure lnfusion pumps o~ the syringe type have also been provlded, whereln a syringe having a very precise displacement volume 18 repeatedly filled and emptied on alternate syrlnge piston stroke~ dùrlng a combined "rill" and "pump" operatlonal cycle, 80 that control of the rate at which the syrlnge 18 10 filled and emptled provldes an accurate means for preclse fluid volume dellvery over a prescribed period o~ tlme.
Such syringe pumps are essentlally lndependent of drop flow lnaccuracies lntroduced by I.V. admlnlstratlon sets and appear to provlde the best overall solution to ao¢urate and stable fluid volume delivery over long perlods of time, at both hlgh and low flow rates.
At the heart of the syrlnge pump 18 the syringe ltself. Such syrlnges must be suffleiently rugged and reliable to enable repetitlve fill and pump strokes over 2Q sustalned perlods of pump operation wlthout leaking, or admlttlng alr or pathogens to the lnterios of the syringe.
Where disposable syrlnges are involved, the syringe should preferably be of relatlvely simple and economical construc-tion, easily handled for insertion into and removal from the remainder of the pumplng apparatus and ~hould be mounted ln su¢h a fashlon as to facilltate removal of air prlor to start-up. ~nfortunately, however, such syringes of the prior art have been relatlvely complex and expensive, have been prone to leakage and have been relatlvely difficult 30 to mount and remove.
In addltlon, syringe pumps -of the prior art prl-marily depend on valving embodled directly withln the syringe it~elf, ~or ~witching from the fill mode to the pumplng mode. Thls not only lncreases the cost and com-plexlty of the ~yrin~e, particularly where di~posable syrlnges are employed, but usually also re~ults ln reduced r~llablllty of operatlon.
Furthermore, lt has been dlfficult at low flow rates, when the syrlnge piston i9 movlng so slowly that lts motion ls not visually dlscernible by the operator, to determlne whether or not the syringe 1~ belng driven at all.
Hence, those concerned wlth the development and - use of parenteral fluld admlnlstratlon systems, and partlcu-larly those concerned wlth the deslgn of syrlnge pumps, have long recognized the need for lmproved, relatlvely ~ -simple, economlcal, reliable, stable and accurate syringes, monitorlng and drive ~ystems for such syringe pumps. The present invention clearly fulfllls this need.
Briefly, and ln general terms, the present inven-tion provldes a new and improved means for accurately con-trolllng fluld flow ln the parenteral admlnistratlon of 20 medical liquids, wherein a disposable, valveless syringe cartridge is easily, rellably and preclsely mounted, lts state of proper lnsertion lnto the pumping apparatus belng monitored; after whlch the syrlnge ls driven through re-petitive fill and pump strokes. Appropriate valving is provlded wlthln the pumplng apparatus external to the ~yringe cartridge, without the need for provlding relative-ly complex, expensive and sometlmes unreliable valve struc-- tures ln the syrlnge itself.
The syringe cartrldge of the present inventlon ls ` 30 o~ strong, lightweight, durable construction and is con-struoted to minimize the possibility of ~luld leakage, enhance the ease and simpllcity of mounting and removal ~rom the pumping apparatus, facilitate the removal of air 105;~653 prior to start-up of the pumping apparatus, and to prevent intake of air or pathogen~ lnto the lnterlor of the syrlnge during repetltive pumping cycles. A running indlcator is provlded to indicate vlsually to the operator that the pump ls oycllng, motion o~ the lndlcator being observable even at low flow rates where syringe operation may not normally be readily dlscernible by the operator. In addl-tlon, a rotation sensor ls provided to monitor the mechan-lcal output of the motor drlvlng the syringe and detect any stalled motor condition.
More particularly, the present inventlon provide~
a new and lmproved syrlnge pu~p operated by a motor to repetltlvely flll and empty a dispo~able ~yrlnge cartridge over a plurallty of operatlonal cycles of successlve ~111 and pump stroke perlods. The dispo~able syringe cartrldge it~elf embodles no valvlng ~tructure, but lncludes a pair of intake and output I.V tubes communicating with the inlet and outlet nipple~, respectively, of the syrlnge.
The remainder of the pumping apparatus drives the syringe and repetitively and sequentlally opens and closes the intake and output I.V tubes by means of a palr of tube plnchers external to the syrlnge cartridge, the I.V tubes alternating thelr opened and ¢losed states, one tube plncher controlling each I.V. tube.
The disposable syringe cartrldge lncludes a molded plastic cylinder havlng lnlet and outlet nlpples and deflnlng an interior chamber adapted to slidingly receive a plastic piston and piston rod. A rubber sealing cap overlies and encases the plastic piston, and deflne~
a conlcal piston face. The sealing cap includes a pair of re~illent annular ribs definlng piston sealing rings, and further includes a limp diaphragm conical seallng boot.
The dual, spaced apart ~ealing rings define two point 105'~653 contact along the longltudinal axis of the syringe to enhance axial alignment and stability oP the plston and pi~ton rod as the piston slldes wlthin the cylinder of the syrlnge, whereas the seallng boot at the base of the cyl-lnder prevents the lntake of alr or pathogens through the bottom of the cyllnder durlng repetitive strokes. All plastlc cross-sections of syringe cartridge components are selected to provlde maximum strength for a mlnimum amount of plastlc materlal.
The lnlet and outlet nipples of the syrlnge cartrldge extend parallel to the longitudinal axls of the 3yringe, on opposlte sldes of the syringe. The interlor surface of the cylinder defines, wlth the piston, a fluid chamber, and the cyllnder surface above the pl~ton ls sloped upwardly tcwards the base of the outlet nlpple, ~o that, when the longitudinal axis of the syrlnge is vertl-cal, gas bubbles will tend to rise to the highest point of the cyllnder and out through the outlet nlpple for easy removal.
The syringe cartrldge and associate~ mounting msans are deslgned to facilitate slmple and easy lnsertlon ~; of the cartridge lnto the pump housing, requlring the use of only one hand by the operator. In this regard, an in-tegral tab extends from the syrlnge cylinder and provides an operator handle for mounting and removlng the syringe from the overall pumping apparatus. In addltion, the end of the piston rod remote from the piston head ls partially - cut-away and provided wlth integral, outwardly extendlng mountlng bosse~. These mountlng bosses are adapted to 30 engage and be retained by a mounting shoe secured to the leadlng end of a linear drive shaft adapted to be coupled to the piston rod for driving the syringe through succes-sive fill and pump strokes. The mounting shoe includes a 105'~53 palr of guide slot~ adapted to engage the piston rod mountlng bosses so that the syringe cartridge can be in-serted into the mounting shoe horizontally, be rotated so thlat lts longltudinal axls i5 vertical, and thereby brlng the lower, cut-away end o~ the syringe piston rod into a retentlon slot within the mounting shoe to prevent the syrlnge cartridge from being dislodged, either horizontal-ly by vlrtue of the retention slot, or vertlcally by means of the lower end of the piston rod and the mounting bosses.
A second pair of outwardly extending mounting bosses, parallel to the first set of mounting bosses on the piston rod, are integral with the syringe cylinder and are adapted to engage a pair of fixed guide and retainlng ~lots provided in opposite walls of a syringe receiving compartment defined in the pump hou~ing. The intake and output I.V. tube~ from the syringe cartridge pas3 ver-tiaally over a palr of tube pincher blades and are clamped ln po~ition by a suitable tubing compartment access door which i8 appropriately latched. ~hus, the syringe car-tridge ls firmly maintained in position during the opera-tional cycles of the pump. The tubing access door must be unlatched and opened to enable the syringe cartridge to be rotated from the vertical position to a horizontal position for removal from the mountlng shoe.
i By controlling the initial location of the mount-ing shoe, relative to the guide and retaining slots in the sldewalls of the syringe compartment, the pumping apparatus can be conditioned to receive the syringe car-tridge only if its pi~ton is in a predetermined position 30 within the syringe cylinder, i.e., in the top dead center position adapted to inltially perform an intake stroke to flll the syringe with fluid. The latter is the proper gtate of the syrlnge for initial start-up of the pumping 105'~53 , apparatus.
A reference light source and photoelectric sensor is provided within the syringe compartment to sense the physical presence of the syringe cartridge, and an appropriate electrical -~ignal is generated whenever the reference light beam is interrupted by one of the syringe nipples, to thereby indicate proper installation of the syringe cartridge for control over pump operation. Another reference light source and photo- `
electric sensor is provided ad~acent one of the syringe nipples as a bubble detector to ensure that all of the air has been removed from the syringe and to prevent air delivery to the patient.
A motor rotation sensor is provided, the rotation sensor typically being in the form of a disc mounted on the motor output shaft for rotation therewith, the di~c having alternate transparent and opaque sectors. A photocell detects light from a reference light source passing through the disc, as it rotates, and generates an output electrical signal capable of indicating any stalled motor condition.
A visual running indicator is also provided, typically in the form of a rotating disc having index lines uniformly spaced along its peripheral edge, so that pump operation is visually discernible by the operator, even at low flow rates where motion of the syringe piston is so slow as to not be readily discernib~e by the eye of the operator.
The new and ~mproved syringe pump drive system and disposable syringe cartridge satisfies a long existing need in the medical arts for improved, relatively simple, economical, reliable, stable and accurate syringe pumping systems.
According to one broad aspect, the invention relates to a syringe for use in a syringe pump, said syringe comprising:
a hollow cylinder having an open end and a closed end, said _g_ 1{)5'~653 cylinder being adapted for normal ~se with its longitudinal axis substantially vertical, said cylinder having a pair of integral, pa,rallel inlet and outlet nipples projecting from said closed end of said cylinder, said nipples being disposed on opposite sides of said cylinder with the axes of said nipples being substantially parallel to said longitudinal axis of said cylinder, there being no valves within said nipples, the uppermost interior surface of said cylinder being sloped upwardly in a single plane, said outlet nipple being located ad~acent the highest point within said cylinder; a piston head within said cylinder and having a sealing relationship therewith:
and a piston rod connected to said piston head and integral therewith for reciprocating said piston head along said ' longitudinal axis of said cylinder.
~he above and other objects and advantages of the .
... .
1, , '- 30 ; -9A-~ 0 5'~ 5 3 present lnvention will become apparent from the followlng more detalled descriptlon, when taken in con~unctlon with the accompanylng drawings of illustrative embodiments.
FIG~RE 1 ls a per~pective vlew showing maln com-~onents of the lnterior structure of a syrlnge pump embody-lng the present inventlon, portions of the outer pump hous-lng belng shown in phantom;
FIGUmE 2 is a fragmentary, plan vlew of a rotatlon sensor ln accordance with the inventlon;
FIG~RE 3 iR a fragmentary, elevational view, por-tlons belng shown in sectlon, through the syringe pump ln the vlcinity of the syringe cartridge compartment, the syrlnge cartrldge being _hown in solld llnes ln lts proper-ly installed po3itlon, the cartridge also being shown in phantom ln an lntermedlate posltlon durlng the installation procedure;
FIGyRE 3A ig a fragmentary Rectional view, taken _ubstantially along the llne 3A-3A in FIG~RE 3, and lllu_-trates the pincher valve_ external to the syringe cartrldge;
FIG~RE 4 iR a fragmentary sectional vlew, taken along the llne 4-4 ln FIGURE 3 and illuRtrates portlons of the drlve system for the syrlnge;
FIGURE 5 ls a perspectlve vlew of the mounting ~: shoe ~or coupling the drive system to the syringe car-tridge;
FIG~RE 6 ls a plan vlew of the mounting shoe ~own ln FIG~RE 5;
FIG~RE 7 is an elevatlonal vlew of an assembled syrlnge cartridge in accordance with the present invention, portions being shown ~n sectlon;
FIGVRE 8 ls a sectional vlew, taken along the : llne 8-8 ln FIG~RE 7;
FIG~RE 9 is an exploded perspectlve vlew o~ the lOS~t;53 main structural components of a syringe cartrld~e con-structed in accordance Wlth the pre~ent lnventionJ a por-tion of the syringe cyllnder being shown ln section;
FIG~RE lO is a fragmentary perspectlve view of the upper portion of a syrlnge cartridge lncorporatlng pro-vi~lons for monltorlng the physlcal posltlon of the car-tridge and the pre3ence of gas bubbles;
FIGURE ll ls a plan view of a syringe nipple embodying the cartrldge posltion monitorlng and bubble detectlon structure of FIGURE lO and further lllustrating the lb¢ation of the reference light ~ources and photocell sensors relatlve to the nlpple; and FIGURE 12 illustrates an alternate arrangement ~or monltoring the physlcal posltion of a syrlnge cartridge.
Referrlng now to the drawings, there i8 shown a syrlnge pump system for fluid flow control, embodying the features of the present invention. In the en~ulng descrip-tion, while reference is made to the term "~.V.", normally connoting ~ntravenous administration, it is to be under-stood that thls is by way of example only, and the ~ystemof the present invention is suitable for other forms of ~renteral adminlstration as well a~ intravenou~ admlnis-tration.
The system shown in FIG~RE 1 depicts a syringe .~-pump 20 embodylng a disposable syringe cartridge 21. The ~yringe cartridge 21 essentially includes a molded plastic cyllnder 22 ln which a piston 23 is slidably recelved and , adapted to be reciprocated back and forth along the axi~
of the cylinder by an integral piston rod 24 which ls re-movably mounted at one end ln a coupling shoe 26 carrled by a linear drive shaft 27 which i8 advanced and retracted by a ~uitable drive system. The drive system lncludes a reversible motor 29 (typically a d.c. stepping motor) and . .
-` 105'~653 approprlate gearlng 31, to advance and retract the sha~t 27 which is, in turn, coupled to the piston rod 24 of the syrlnge cartridge 21. The motor 29 is energized by a pulse traln of motor drlve pul~es generated by an appropriate electrical control system (n~t shown).
The displacement volume of the syringe cartridge 21 is determlned by the volume swept by the piston 23 on eaoh stroke and is identical for the fill stroke and ~or the pump stroke. Therefore, an identlcal number o~ dls-10 ~ete 8tep9 or motor drive pulse3 ~rom the electrical con- -trol system to the motor 29 is required ~or each fill stroke during whlch the syrlnge is filled wlth liquid, and for each pump stroke durlng whl¢h the syringe delivers its precise volume o~ llquld under posltlve pressure to a patient.
The ~yrlnge ¢artridge 21 includes an inlet port 21a and an outlet port 21b. The inlet port 21a communl-cates through a suitable intake I.V tube 33 with any approprlate liquld source (not shown), usually an I.V.
bottle contalning approprlate drugs and/or nutrient~ in liquid form. Typically, the intake I.V. tube 33 is part of an I.V. administratlon set WhiCh lncludes a tran~parent drip ohamber in the llne between the syringe cartridge 21 ` and the llquid source.
A slmllar output I.V. tube 34 is connect~d at one end to the outlet port 21b of the syrlnge cartrldge 21 and ¢onveys ~luid ~rom the syrlnge to a patlent.
A~ be~t observed in FIG~RES 3 and 3A, a pair of `syringe pump valves 36, 37, external to the syrlnge car-;30 tridge 21, are o~ the tube pincher type, and are selec-;tively opened and clo3ed at appropriate tlmes in the overall pumplng cycle, under the control o~ a ~uitable valve control system 40. The valve 36 controls the inlet , ^- lOSi~f~53 p~rt 21a and i~ open during the fill stroke to enable fluld to be drawn from the llquid source, through the in-take llne 33, lnto the syringe cartrldge 21, the valve 36 belng clo9ed dUrlng the pump stroke to prevent ~luld rrOm exitlng the ~yrlnge through the lnlet port. The valve 37 controls the outlet port 21b and ls open during the pump stroke to enable fluld delivery ~rom the syringe carbridge 21 to the patient through the output llne 34 the valve 37 being clo~ed durlng the flll ~troke.
The valve control system 40 ls also drlven, through the gearing 31, by the same motor 29 as ls used to operate the syrlnge cartridge 21. In addltion, the valve control system 40 lncludes means (not shown) for provldlng ln~ormatlon to the electrl¢al ¢ontrol ~y~tem controlling the motor 29, and lndlcatlng that the syrlnge cartrldge 21 ls elther in the flll stroke or the pump stroke. This latter ln~ormatlon, ln turn, enables the electri¢al control system to establlsh the proper direc-tlon of rotation of the motor 29. The electri¢al ¢ontrol 20 sy~tem may be of conventional design for electrlcally energlzlng the motor 29 and controlling its dlrection of rotation.
The motor 29 drlves, through the gearlng 31 and an output camshaft 41, a reversible cam (not shown) ln the valve ¢ontrol system 40, whl¢h cycli¢ally alternates the open and closed posltlons of the syringe pump valves 36~ 37 The syrlnge pump valves 36, 37 typlcally consist o~ a pair o~ plvotal tube pinchers 43, 44 which alter-30 nately plnch off and open the intake and output tubes 33,34 respectively, of the syringe cartridge 21. One face of each o~ the tube pinchers 43, 44 is shaped to define a pincher blade 43a~ 43b, respectively, adapted to cooperate 105'~53 with the confrontlng face of a shoulder 45a deflned on the lnterlor side of a syrlnge pump tublng access door 45 to the syringe compartment. Together, the pincher blades 43a, 44a and the access door shoulder 45a deflne a pair of tube clamps between which the lntake and output I.V. tubes 33, 34 pass. The access door 45 i8 held shut, a~ter the syrlnge cartrldge 21 has been installed, by any sultable latch 45b (FIG. 1).
The tube plnchers 43, 44 are sprlng blased to the lO tube shut-off posltion and are positively drlven open by the valve control system 40, thus allowlng full tube closure regardless of normal variatlons ln I.V. tublng dlameter and wall thlckness.
The valves 36, 37 and valve control system 40 may be of conventional deslgn.
Referrlng now more parti¢ularly to FIGS. 7-9 of the drawings, the new and improved syrlnge cartrldge 21 of the present lnventlon 19 of strong, ilghtweightJ durable ¢onstru¢tlon and ls constructed to mlnimize the possi- -20 blllty of fluld leakage from the lnterior of the æyrlnge, enhance the ease and simpll¢ity of mount lng and removal `~ from the syrlnge ¢ompartment of the pump, fa¢llltate the removal of' alr prlor to actual operatlon of the pumping apparatus, and to prevent lntake of alr or pathogens into the lnterlor o~ the syringe durlng repetitlve pumping cycles.
The dlsposable syringe cartrld~e 21 lnclude~ the molded plastlc cylinder 22 havlng inlet and outlet nipples 51, 52, respectively, at the upper end of the cylinder 3o ~with the longitudinal axi~ of the syringe in the vertical posltlon as is the case followin~s proper lnstallation shown in FIGIJRE l). The cylinder 22 is hollow and thereby defines an interlor chamber adapted to slldingly recelve ~- --14--`- 105'~;53 a plastic piston head 54 which ~9 integral with the piston ~od 24. The cylinder 22, and combined piston rod 24 and piston head 54 are typically ln~ectlon molded of any sultable thermoplastic material, such as polypropylene.
A rubber sealing cap 56 overlle~ and encases the piston head 54 to define the piston 23, the sealing cap provldlng a conical piston ~ace 23a directed towards the lnlet and outlet nlpple~ 51, 52, respectively, of the syringe.
The lnlet and outlet nipples 51, 52 of the syringe cartridge 21, extend parallel to the longltudinal axi9 of the syringe on opposite sides of the ~yringe, dlametrically opposed from each other. The interior surface of the syrlnge cylinder 22 defines, with the piston 23, a fluid aontaining ¢hamber, and the uppermost cyllnder ~urface 22a above the piston is sloped upwardly, typically at an angle o~ approxlmately 10 degrees, towards the base of the ; outlet nipple 52. Hence, when the longitudlnal axis of the syrlnge is vertical, followlng lnstallatlon lnto the pumping apparatus, gas bubbles will tend to rlse to the highest point of the syringe cylinder 22 and pass out through the outlet nlpple 52, ~or easy removal at eome convenient access point in the output I.V. tube 34. In addition, the plston face 23a slopes symmetrlcally down-ward from its apex at an angle of approximately 10 degrees to the horizontal, matching the slope of the interior surface 22a o~ the cylinder 22, to minlmize the residual volume o~ the syringe.
The sealing cap 56, whlch is typically fabricated ; 30 o~ a natural rubber, also lnclu~es a palr Or re~lllent, annular ribs 56a, 56b whlch fit over and are ~upported by correspondlng annular ~langes 54a, 54b ln the plston head 54.
:
- 105;~53 The iealing cap rlbs 56a, 56b provide a pair Or axlally ~paced apart pi~ton sealing rings. The~e dual, sE~aced apart sealing rlngs deflne two polnt contact support along the longitudinal axis of the syringe cartrldge 21 to provlde improved seallng ef~lciency, and to enhance the axial allgnment and stability of the piston and plston rod as~embly withln the cyllnder 22 o~ the syringe a~ the pls~
ton 23 reclprocates back and ~orth within the cylinder durlng repetitlve pump cycles. Hence, the two polnt sup-port along the longltudinal axis of the system prevent~rocking of the piston 23 whlch might otherwise cause the ~ystem to be prone to leakage and might also provlde un- ~-even wear on the seallng rings.
The seallng cap 56 further lncludes a thin walled conical sealing boot 56c integral at its frustrum with the rib 56b and terminating at its base in a thicknned wall portion defining a bead 56d. The seallng boot 56c pro-vides a limp membrane seallng element when the syringe cartridge 21 is assembled, to prevent the lntake of air 20 or pathogens through the bottom of the cylinder 22 as the plston assembly re¢iprocate~ through repetltive strokes wlthin the cylinder.
The use of the seallng cap to encase the plastic plston head 54 and thereby define the outer sur~ace o~ the plston 23, includlng the sealing rlngs 56a, 56b, enables the plston head 54 and piston rod 24 to be fabricated of . ~ .
less expensive materlals than would be required lf the piston head were in direct ~lidlng engagement with the lnterlor walls o~ the cylinder 22.
The material from which the sealing cap 56 is fabrlcated ls chosen because of its material properties, e.g., wear reslstance on the seals~ compresslon set resis-tance so that it will retain lts elastic properties, 105i~53 resistance to tearlng on the boot because of the thin walled membrane, and reslstance to the temperatures norm-ally encountered ln the sterlllzatlon proce~. In con-trast, the plastic materials from whlch the cyllnder 22, piston head 54 and piston rod 24 are fabricated 19 chosen prlmarily for low co~t o~ material, ea~e of manufacture, and reslstance to sterlllzation temperatures.
All plastic cross-sectlons of the various com-ponents of the syrlnge cartrldge 21 are ~elected to pro-1~ vide a maxlmum of strength for a minimum amount of plasticmat~rial. In thi~ regard, while strength i3 required, a thin walled ~tructure is al~o de~irable ln order for plastlc molding to be most effective. Hence, a maximum degree of rigidity with a minlmum amount of plastic, in a convenient cross~sectlon, ls selected for the syrlnge cartrldge 21 o~ the present invention. In thls regard, lt ; will be apparent ln FI~RE 8 that the pi~ton rod 24 ls molded ln an "H" cros~-sectlon, defined by a palr of long-ltudinally extendlng, parallel flanges 24a, 24b Jolned by an lntegral, coextenslve cro~s-bar 24c.
As prevlously polnted out, the plston head ~langes 54a, 54b retain the sealing cap 56 and provide ; adequate support for the plston 23. The parallel flanges 54a, 54b are, in turn, supported by ~our integral ribs 54c whlch intersect at the longitudinal axis of the plston head, the uppermo~t ends of these r~bs belng tapered to provlde aupport for the conlcal face 23a of the sealing cap 56. This prevents the seallng cap 56, which ls not very rigld, from collapsing. The rib structure defined 3Q by the four ribs 54c iæ 3elected, instead of a solid circu-lar cylindrical cross-section, for moldlng purposes, to provlde adequate strength with a mlnlmal amount of plastic materlal required.
~..
-``` lO5Z653 In assembling the cylinder 22, sealing cap 56, and combined plston head 54 and piston rod 24, (the com-ponent~ of FIG~RE 9) intothe syringe cartrldge 21 o~
FIGURE 7, the 3ealing cap 56 is simply pressed over the piston head 54 until the flanges 54a, 54b en~age internal slots in the ~ealing cap ad~acent the rib~ 56a, 56b, whlch re~ults ln the seallng cap and plston head snapplng to-gether. The resulting a~sembly of the seallng cap 56 and piston head 54 (deflning the pi~ton 23) and the plston rod 24, is pushed lnto the openlng in the base of the cylinder 22. A sultable lubricant may be used to facllltate in-sertlon o~ the assembly into the cyllnder 22, as well as ~ubsequent reclprocatlon withln the cyllnder. The base of the seallng boot 56c 18 then folded over the open base of ; the ¢yllnder 22, so that the bead 56d, whlch behaves a~ an ela~tlc 0-rlng, grlps the outer ~urface of the cyllnder and holds the seallng boot 56c in position 80 that lt can't be peeled back easlly or tear. In thls regard, the hoop strength of the bead 56d must be sufflclent to re~lst 20 movement once lt has been positloned to grlp the outer sur~ace o~ the cyllnder 22.
The length of the sklrt portion of the ~ealing boot 56c is such that lt ls not required to stretch at all during any portion of the pumping cycle as the pl~ton 23 re~lprocates back and forth wlthin the cylinder 22. Hence, - the boot 56c provides a limp membrane as a seal a~alnst adml~sion of alr or pathogen~ to the interlor of the cyllnder 22 during repetitlve ~trokes of the ~yrlnge. In thls regard, slnce the llmp membrane seal provlded by the 30 ~ealing boot 56c i3 es~entially unstre~sed, lt ls both rugged and reliable. In addltion, should sufficlent alr be trapped ln the alr gap between the rib 56b and the seal-ing boot 56¢, durlng a~embly into the cylinder 22, the - 105'~653 alr vo~ume mi~ht be compressed durlng ~ill strokes o~ the piston 23 when the piston ls in its l~wermost pasition.
However, the combination of the additional v~lume provided b;y the un~oldlng limp membrane of the sealing boot 56c, together with the anchoring afforded by the bead 56d, reslsts popplng of the sealing boot off the cyllnder 22, even in the event of ballooning of the boot by any such trapped alr.
A~ter the cylinder 22, seallng cap 56 and comblned 10 plston 54 and plston rod 24 have been as~embled in the aforedescribed manner, the lntake I.V. tube 33 and output I.V tube 34 are appropriately secured to the lnlet and outlet nipples 51, 52, respectively, to complete the assembly of the syrlnge cartrldge 21.
~ he syrlnge cartrldge 21 ls con~tructed to cooper-ate wlth assoclated mountlng mean~ withln the syringe com-partment of the pump houslng to facilitate simple and easy lnsertion of the cartridge into the pump housing while requiring the use of only one hand by the operator. In 20 thls regard, an lntegral tab 58 pro~ects from the outer surface of the syrlnge cyllnder 22 near the upper end of the cyllnder, and thereby provldes an operator handle for mountlng and removing the syrlnge cartridge 21 ~rom the pump houslng ln the manner to be hereinafter descrlbed in further detail.
At the end of the piston rod 24 remote from the piston head 54, the longitudinal flanges 24a, 24b are partially cut-away to define surfaces 24d and in order to provide clearance for insertion into the coupling shoe 26.
In addition, this same end of the piston rod 24 is pro-vided with a pair of lntegral, outwardly and oppositely extending, cylindrlcal mounting bosses 59, one boss pro-~ecting perpendicularly outward frcm the outside face of 105;~653 the flange 24a, the other boss llkewise pro~ecting outward from the ~lange 24b.
A ~econd palr of outwardly extending mounting bosses 61, parallel to the first set of mo~ntlng bosses 59 on the piston rod 24, are lntegral wlth the dyringe cylln-der 22 near the upper end o~ the cylinder.
As best observed ln FIG~RES 3, 5 and 6, the piston ;--;
rod mountlng bosses 59 are adapted to engage and be re-talned by the mountlng and coupllng shoe 26 whlah is se-10 ~red to the leading end of the linear drlve sha~t 27 adap_ ;
ted to be coupled to the piston rod 24 for drlvlng the ;~
;syrlnge cartrldge 21 through successlve flll and pump strokes. The coupllng shoe 26 includes a palr of con-fronting, wide mouth gulde slots 63 ln upstandlng flanges 62, dlsposed on opposlte sides of the coupling shoe, and adapted to engage and guide the mountlng bosses 59 80 that the syrlnge cartridge 21 can be inserted lnto the coupllng shoe horizontally.
Hen¢e, during the cartridge installation procedure, the tab 58 of the syringe cartridge 21 is gripped by two flngers of one hand of the operator and, wlth the longi-tudinal axls of the syringe cartrldge held horlzontally, .~
the piston rod 24 and mountlng bosses 59 are lnserted horlæontally into the gulde slots 63 of the coupling shoe 36 (with the cutaway sur~ace3 24d o~ the piston rod direc-.
ted downward) and moved to the rear o~ the coupling shoewhich essentlally de~ines a mounting yoke ~or the bosses 59. The syringe cartrldge 21 ls then rotated upwardly, . ' about an axis o~ rotatlnn through the mounting bosses 59 ~-30 in the coupllng shoe 26, so that the longitudinal axis Or the syringe cartridge is brought into a vertical posltion, as lllustrated by the solld llnes in FIG~RE 3. The latter procedure brlngs the cut-away, lower end of the plston rod ~ .
i 0 S ~ ~ 5 3 24 lnto a retention channel 64 within the coupllng shoe 26. In thl~ regard, the cut-away surfaces 24d of the pls-ton rod are rotated into abutment with a ledge 64a of the r~stention channel 64.
When the syringe cartridge 21 has been thus ln-stalled, the mounting bo6ses 59 in the guide slots 63 prevent the syringe cartrldge ~rom being dislodged ver-tlcally, whereas the cut-away surfaces 24d in the retention channel of the coupling shoe 26 prevent the cartridge from 10 belng dlslodged hor~zontally.
As best observed ln FIGURES 1 and 3, the mounting bosses 61 of the syrlnge cyllnder 22 are adapted to engage ``
a pair of ~ixed guide and retalning slots 66 provided in opposite walls o~ the syringe receiving compartment of the pump houslng. By controlling the initlal location of the coupling shoe 26, relative to the curved, wide mouth guide and retaining slots 66, the pumping apparatus can be con-d itioned to receive the syringe cartridge 21 only if its ; piston 23 is in a predetermined position within the syringe 20 cyllnder 22, i.e., in the top dead center position adapted to initially perform an intake stroke to fill the syringe with liquid. The latter is the proper state of the syrlnge ` for inltial ~tart-up of the pumping apparatus.
J The intake and output I.V. tubes, 33, 34, re-. 9 pectively, ~rom the syringe cartr~dge 21, are then passed vertically over the tube pincher blades 43a, 44a and are clamped in position by the closing of the tubing compart-ment accesQ door 45 which i8 then latched shut by the latch 45b to firmly anchor and maintain the syrlnge cartridge in 30 positlon durlng the operational cycles of the pump. me tubing access door 45 must be unlatched and opened to enable the syringe cartridge 21 to be rotated from the vertical positlon to a hcrlzontal positlon for removal from :' r~
`-- lOS;~t;53 the coupling shoe 26, whenever it ls deslred to replace the cartridge. -The coupling ~hoe 26 i5, aQ prevlously indicated, securèd to the upper end of the linear drive shaft 27 which advances and retract~ the coupling shoe and thereby ad-vances and retract~ the piston rod 24 and plston 23 wlthin the cylinder 22 for repetitlve fill and pump strokes. As best observed ln FIG~RES 3 and 4, the llnear drlve shaft 27 i8 of non-clrcular cross-section and, ln the preferred embodiment show~, is of rectangular cross-section. The drive shaft 27 pasees through and is in slidlng engagement with an antl-rotation bearing 68 havlng an openlng of compllmentary cross-section, and enabling the drive shaft to move along its longitudinal axis while being keyed against rotation about that axls.
A lead screw 70 i3 lntegral wlth, or otherwise appropriately secured to, the drive shaft 27 and ls ad--, uanced and retracted along lts longitudlnal axis, to thereby advance and retract the drive shaft 27, by an lnternally threaded gear 72 ln the gear traln 31 drlven by the motor 29. The gear 72 is approprlateIy supported for rotatlon in a palr o~ statlonary gear carrier3 or thrust bearings 73, 74.
As best observed ln FIG~RES 1 and 3, a visual run-ning lndicator ls provlded ln the ~orm of a rotating disc ;; ~ 76 having a plurality Or visually observable3 preferably ` unlformly spaced, vertical lndex lines 77 located along its entire perlpheral edge. The disc 76 is secured to a central bu~hing 78 (through which the lead screw 70 passes ~reely) and is ~ournaled for rotation in the upper gear carrier 73. ~he bushlng 78 and disc 76 are drlven by the ..
output shaft 29a of the motor 29 via a belt drive ln the orm of a simple O-rlng 79 which passes around the output ;
lOS;~53 ~haft of the motor and around the bushing 78 to provide a simple frictlon drive.
The peripheral lndex llnes 77 are readlly obser-vable through a window 81 ln the pump houslng. Hence, when the pumplng apparatus 1~ operating at a very low pumplng rate, so that no movement of the coupling shoe 26 or pls-ton rod 24 ls visually dlscernlble by the operator, the rotatlon of the running indicator disc 76 will be apparent through the wlndow 81 to assure the operator that the 3ystem is ln operation.
Referrlng now more speclfically to FI~RES 1 and 2, a motor rotation sensor 83 is provlded to insure proper detectlon of a stalled motor 29 so that, in cooperatlon with the electrical control system, an alarm condition can be appropriately generated. Such motor stalling has a greater probability o~ occurrlng when the pump is used wlth a down~tream filter which may clog and lnduce high back pressure on the pumping system.
The rotation sensor 83 comprlses a disc 84 mounted `20 on the output shaft 29a of the motor 29 for rotation therewith, the disc having alternate transparent and opaque sectors 85, 86, respectively. A photocell 87 de-tects light passing through the disc 84 from a reference ;light source 88, as the disc rotates, and generates elec-trical pulses which are appropriately directed to the elec-trlcal control system for monltoring and alarm functlons.
Hence, the rotation sensor 83 is capable of indlcating any stalled motor condition.
;~As best observed in FIG~RES 10 and 11, the pump-30 ing system, includlng the syringe cartrldge 21, may embody appropriate means for lndlcatlng proper installatlon of the syringe cartridge and for detecting the presence of gas bubbles. In thls regard, the inlet nipple 51 of the , 105;~53 syrlnge cartrldge 21 ls surrounded by an integrally m olded, transparent flag member 89. A f~ced llght so~rce 91 and photoelectrlc sensor 92, both located ln flxed p osltlons within the syringe compartment of the pump hous-lng, provide a reference llght beam which i8 selectlvely lnterrupted by the flag~ member 89 whenever the syringe c artridge 21 has been properly positioned ln the syringe compartment o~ the pump houslng. In thi~ regard, the flag 89 prevents the reference l~ght beam from reachlng the lO sen~or 92 by lnterposing a totally reflectlng sur~ace 89a ln the path of the llght beam to deflect the light beam a way from the sensor.
In addltlon, bubble detection ls accompll~hed ln the arrangement of FIGIJRE ll by providlng a fixed light 80urce g4 and photoelectric sensor 95 on opposlte sldes o~ 'che lnlet nipple 51, so that gas bubble~ passlng through the nlpple will lnterrupt the llght beam and generate an appropriate electrlcal ~lgnal. The latter slgnal ls appro-priately transmitted to the electrlcal control system to 20 brlng about the generation of an alsrm ~tate. Hence, the bubble detection system lnsures no air bubbles are entering t he syringe through the lnlet nlpple 51.
An alternatlve embodiment of a suitable system for nDnltoring the proper insertlon of the syrlnge cartrldge 21 wlthln the syringe compartment ls shown ln FIG~RE 12. In this embodiment, a syringe nipple 151 is approprlately provlded with an opaque, typlcally black, outer coating 151a æo that, when the cartrldge has been properly in-stalled, a reference light beam from a ~ixed light source 30 l91 in the pump housing is interrupted. This causes an appropriate electrical slgnal to be gnnerated by a fixed photo~ensor 192 located in the pump houslng on the opposite side of the nipple 151.
105'~f~53 The new and improved syringe pump drlve ~ystem and dispo~able ~yringe cartridge of the present inventlon satis~les a long exi~ting need in the medical arts for improved, relatively simple, economical, rellable, stable and accurate syrlnge pumplng ~y~tem~.
It will be apparent from the foregolng that, while partlcular forms o~ the invention have been illu5-trated and described, varlous modl~ications can be made without departlng ~rom the splrlt and scope of the lnven-tlon. Accordlngly, lt is not intended that the lnventionbe limlted, except as by the appended claim~.
. .
' : '~
It wlll be apparent, there~ore, that some of the most crltlcal problems confrontlng hospital personnel faced wlth an overwhelmlng duty schedule and llmited time avail-lO ability are the problems of qulckly, easily, rellably andaccurately controlllng fluld flow ln the parenteral admln-istratlon Or medlcal llqulds.
In recent years, a number of electrlcal monitorlng systems, drop flow controllers and infuslon pumps have been developed to accomplish the various tasks of senslng and regulating drop flow rates. However, while such de-vl¢es have generally served their purpose, they have not always proven entirely satlsfactory from the standpoint of cost, complexity, stablllty, rellablllty or accuracy. In additlon, such systems have sometlmes been sub~ect to drl~t and substantial flow rate variations due to changes ln temperature, ~eedlng tube crimps> variatlons ln venous or arterlal pressure of the patlent~ or variatlons in the height of the bottle or solution level wlthin the bottle.
Even positive pressure pumps of the closed-loop perlstaltic type only serve to malntain accuracy of flow ln terms of stablllzing to a preselected drop flow rate, rather than delivering a preclse preselected volume of fluid, e.g., in cubic centimeters per hour. The reason ~or khis ls that the accuracy of such a system is limlted lnherently to the accuracy of the size of the drops pro-duced by an intravenous administration set, and the actual drop~ produced by the latter apparatus can vary rather 105'~653 ~ubstantially ~rom lts deslgnated drop slze~ e.g., due to drip chamber structural varlations, by a~ much as thirty p ercent.
More recently, posltlve pressure lnfusion pumps o~ the syringe type have also been provlded, whereln a syringe having a very precise displacement volume 18 repeatedly filled and emptied on alternate syrlnge piston stroke~ dùrlng a combined "rill" and "pump" operatlonal cycle, 80 that control of the rate at which the syrlnge 18 10 filled and emptled provldes an accurate means for preclse fluid volume dellvery over a prescribed period o~ tlme.
Such syringe pumps are essentlally lndependent of drop flow lnaccuracies lntroduced by I.V. admlnlstratlon sets and appear to provlde the best overall solution to ao¢urate and stable fluid volume delivery over long perlods of time, at both hlgh and low flow rates.
At the heart of the syrlnge pump 18 the syringe ltself. Such syrlnges must be suffleiently rugged and reliable to enable repetitlve fill and pump strokes over 2Q sustalned perlods of pump operation wlthout leaking, or admlttlng alr or pathogens to the lnterios of the syringe.
Where disposable syrlnges are involved, the syringe should preferably be of relatlvely simple and economical construc-tion, easily handled for insertion into and removal from the remainder of the pumplng apparatus and ~hould be mounted ln su¢h a fashlon as to facilltate removal of air prlor to start-up. ~nfortunately, however, such syringes of the prior art have been relatlvely complex and expensive, have been prone to leakage and have been relatlvely difficult 30 to mount and remove.
In addltlon, syringe pumps -of the prior art prl-marily depend on valving embodled directly withln the syringe it~elf, ~or ~witching from the fill mode to the pumplng mode. Thls not only lncreases the cost and com-plexlty of the ~yrin~e, particularly where di~posable syrlnges are employed, but usually also re~ults ln reduced r~llablllty of operatlon.
Furthermore, lt has been dlfficult at low flow rates, when the syrlnge piston i9 movlng so slowly that lts motion ls not visually dlscernible by the operator, to determlne whether or not the syringe 1~ belng driven at all.
Hence, those concerned wlth the development and - use of parenteral fluld admlnlstratlon systems, and partlcu-larly those concerned wlth the deslgn of syrlnge pumps, have long recognized the need for lmproved, relatlvely ~ -simple, economlcal, reliable, stable and accurate syringes, monitorlng and drive ~ystems for such syringe pumps. The present invention clearly fulfllls this need.
Briefly, and ln general terms, the present inven-tion provldes a new and improved means for accurately con-trolllng fluld flow ln the parenteral admlnistratlon of 20 medical liquids, wherein a disposable, valveless syringe cartridge is easily, rellably and preclsely mounted, lts state of proper lnsertion lnto the pumping apparatus belng monitored; after whlch the syrlnge ls driven through re-petitive fill and pump strokes. Appropriate valving is provlded wlthln the pumplng apparatus external to the ~yringe cartridge, without the need for provlding relative-ly complex, expensive and sometlmes unreliable valve struc-- tures ln the syrlnge itself.
The syringe cartrldge of the present inventlon ls ` 30 o~ strong, lightweight, durable construction and is con-struoted to minimize the possibility of ~luld leakage, enhance the ease and simpllcity of mounting and removal ~rom the pumping apparatus, facilitate the removal of air 105;~653 prior to start-up of the pumping apparatus, and to prevent intake of air or pathogen~ lnto the lnterlor of the syrlnge during repetltive pumping cycles. A running indlcator is provlded to indicate vlsually to the operator that the pump ls oycllng, motion o~ the lndlcator being observable even at low flow rates where syringe operation may not normally be readily dlscernible by the operator. In addl-tlon, a rotation sensor ls provided to monitor the mechan-lcal output of the motor drlvlng the syringe and detect any stalled motor condition.
More particularly, the present inventlon provide~
a new and lmproved syrlnge pu~p operated by a motor to repetltlvely flll and empty a dispo~able ~yrlnge cartridge over a plurallty of operatlonal cycles of successlve ~111 and pump stroke perlods. The dispo~able syringe cartrldge it~elf embodles no valvlng ~tructure, but lncludes a pair of intake and output I.V tubes communicating with the inlet and outlet nipple~, respectively, of the syrlnge.
The remainder of the pumping apparatus drives the syringe and repetitively and sequentlally opens and closes the intake and output I.V tubes by means of a palr of tube plnchers external to the syrlnge cartridge, the I.V tubes alternating thelr opened and ¢losed states, one tube plncher controlling each I.V. tube.
The disposable syringe cartrldge lncludes a molded plastic cylinder havlng lnlet and outlet nlpples and deflnlng an interior chamber adapted to slidingly receive a plastic piston and piston rod. A rubber sealing cap overlies and encases the plastic piston, and deflne~
a conlcal piston face. The sealing cap includes a pair of re~illent annular ribs definlng piston sealing rings, and further includes a limp diaphragm conical seallng boot.
The dual, spaced apart ~ealing rings define two point 105'~653 contact along the longltudinal axis of the syringe to enhance axial alignment and stability oP the plston and pi~ton rod as the piston slldes wlthin the cylinder of the syrlnge, whereas the seallng boot at the base of the cyl-lnder prevents the lntake of alr or pathogens through the bottom of the cyllnder durlng repetitive strokes. All plastlc cross-sections of syringe cartridge components are selected to provlde maximum strength for a mlnimum amount of plastlc materlal.
The lnlet and outlet nipples of the syrlnge cartrldge extend parallel to the longitudinal axls of the 3yringe, on opposlte sldes of the syringe. The interlor surface of the cylinder defines, wlth the piston, a fluid chamber, and the cyllnder surface above the pl~ton ls sloped upwardly tcwards the base of the outlet nlpple, ~o that, when the longitudinal axis of the syrlnge is vertl-cal, gas bubbles will tend to rise to the highest point of the cyllnder and out through the outlet nlpple for easy removal.
The syringe cartrldge and associate~ mounting msans are deslgned to facilitate slmple and easy lnsertlon ~; of the cartridge lnto the pump housing, requlring the use of only one hand by the operator. In this regard, an in-tegral tab extends from the syrlnge cylinder and provides an operator handle for mounting and removlng the syringe from the overall pumping apparatus. In addltion, the end of the piston rod remote from the piston head ls partially - cut-away and provided wlth integral, outwardly extendlng mountlng bosse~. These mountlng bosses are adapted to 30 engage and be retained by a mounting shoe secured to the leadlng end of a linear drive shaft adapted to be coupled to the piston rod for driving the syringe through succes-sive fill and pump strokes. The mounting shoe includes a 105'~53 palr of guide slot~ adapted to engage the piston rod mountlng bosses so that the syringe cartridge can be in-serted into the mounting shoe horizontally, be rotated so thlat lts longltudinal axls i5 vertical, and thereby brlng the lower, cut-away end o~ the syringe piston rod into a retentlon slot within the mounting shoe to prevent the syrlnge cartridge from being dislodged, either horizontal-ly by vlrtue of the retention slot, or vertlcally by means of the lower end of the piston rod and the mounting bosses.
A second pair of outwardly extending mounting bosses, parallel to the first set of mounting bosses on the piston rod, are integral with the syringe cylinder and are adapted to engage a pair of fixed guide and retainlng ~lots provided in opposite walls of a syringe receiving compartment defined in the pump hou~ing. The intake and output I.V. tube~ from the syringe cartridge pas3 ver-tiaally over a palr of tube pincher blades and are clamped ln po~ition by a suitable tubing compartment access door which i8 appropriately latched. ~hus, the syringe car-tridge ls firmly maintained in position during the opera-tional cycles of the pump. The tubing access door must be unlatched and opened to enable the syringe cartridge to be rotated from the vertical position to a horizontal position for removal from the mountlng shoe.
i By controlling the initial location of the mount-ing shoe, relative to the guide and retaining slots in the sldewalls of the syringe compartment, the pumping apparatus can be conditioned to receive the syringe car-tridge only if its pi~ton is in a predetermined position 30 within the syringe cylinder, i.e., in the top dead center position adapted to inltially perform an intake stroke to flll the syringe with fluid. The latter is the proper gtate of the syrlnge for initial start-up of the pumping 105'~53 , apparatus.
A reference light source and photoelectric sensor is provided within the syringe compartment to sense the physical presence of the syringe cartridge, and an appropriate electrical -~ignal is generated whenever the reference light beam is interrupted by one of the syringe nipples, to thereby indicate proper installation of the syringe cartridge for control over pump operation. Another reference light source and photo- `
electric sensor is provided ad~acent one of the syringe nipples as a bubble detector to ensure that all of the air has been removed from the syringe and to prevent air delivery to the patient.
A motor rotation sensor is provided, the rotation sensor typically being in the form of a disc mounted on the motor output shaft for rotation therewith, the di~c having alternate transparent and opaque sectors. A photocell detects light from a reference light source passing through the disc, as it rotates, and generates an output electrical signal capable of indicating any stalled motor condition.
A visual running indicator is also provided, typically in the form of a rotating disc having index lines uniformly spaced along its peripheral edge, so that pump operation is visually discernible by the operator, even at low flow rates where motion of the syringe piston is so slow as to not be readily discernib~e by the eye of the operator.
The new and ~mproved syringe pump drive system and disposable syringe cartridge satisfies a long existing need in the medical arts for improved, relatively simple, economical, reliable, stable and accurate syringe pumping systems.
According to one broad aspect, the invention relates to a syringe for use in a syringe pump, said syringe comprising:
a hollow cylinder having an open end and a closed end, said _g_ 1{)5'~653 cylinder being adapted for normal ~se with its longitudinal axis substantially vertical, said cylinder having a pair of integral, pa,rallel inlet and outlet nipples projecting from said closed end of said cylinder, said nipples being disposed on opposite sides of said cylinder with the axes of said nipples being substantially parallel to said longitudinal axis of said cylinder, there being no valves within said nipples, the uppermost interior surface of said cylinder being sloped upwardly in a single plane, said outlet nipple being located ad~acent the highest point within said cylinder; a piston head within said cylinder and having a sealing relationship therewith:
and a piston rod connected to said piston head and integral therewith for reciprocating said piston head along said ' longitudinal axis of said cylinder.
~he above and other objects and advantages of the .
... .
1, , '- 30 ; -9A-~ 0 5'~ 5 3 present lnvention will become apparent from the followlng more detalled descriptlon, when taken in con~unctlon with the accompanylng drawings of illustrative embodiments.
FIG~RE 1 ls a per~pective vlew showing maln com-~onents of the lnterior structure of a syrlnge pump embody-lng the present inventlon, portions of the outer pump hous-lng belng shown in phantom;
FIGUmE 2 is a fragmentary, plan vlew of a rotatlon sensor ln accordance with the inventlon;
FIG~RE 3 iR a fragmentary, elevational view, por-tlons belng shown in sectlon, through the syringe pump ln the vlcinity of the syringe cartridge compartment, the syrlnge cartrldge being _hown in solld llnes ln lts proper-ly installed po3itlon, the cartridge also being shown in phantom ln an lntermedlate posltlon durlng the installation procedure;
FIGyRE 3A ig a fragmentary Rectional view, taken _ubstantially along the llne 3A-3A in FIG~RE 3, and lllu_-trates the pincher valve_ external to the syringe cartrldge;
FIG~RE 4 iR a fragmentary sectional vlew, taken along the llne 4-4 ln FIGURE 3 and illuRtrates portlons of the drlve system for the syrlnge;
FIGURE 5 ls a perspectlve vlew of the mounting ~: shoe ~or coupling the drive system to the syringe car-tridge;
FIG~RE 6 ls a plan vlew of the mounting shoe ~own ln FIG~RE 5;
FIG~RE 7 is an elevatlonal vlew of an assembled syrlnge cartridge in accordance with the present invention, portions being shown ~n sectlon;
FIGVRE 8 ls a sectional vlew, taken along the : llne 8-8 ln FIG~RE 7;
FIG~RE 9 is an exploded perspectlve vlew o~ the lOS~t;53 main structural components of a syringe cartrld~e con-structed in accordance Wlth the pre~ent lnventionJ a por-tion of the syringe cyllnder being shown ln section;
FIG~RE lO is a fragmentary perspectlve view of the upper portion of a syrlnge cartridge lncorporatlng pro-vi~lons for monltorlng the physlcal posltlon of the car-tridge and the pre3ence of gas bubbles;
FIGURE ll ls a plan view of a syringe nipple embodying the cartrldge posltion monitorlng and bubble detectlon structure of FIGURE lO and further lllustrating the lb¢ation of the reference light ~ources and photocell sensors relatlve to the nlpple; and FIGURE 12 illustrates an alternate arrangement ~or monltoring the physlcal posltion of a syrlnge cartridge.
Referrlng now to the drawings, there i8 shown a syrlnge pump system for fluid flow control, embodying the features of the present invention. In the en~ulng descrip-tion, while reference is made to the term "~.V.", normally connoting ~ntravenous administration, it is to be under-stood that thls is by way of example only, and the ~ystemof the present invention is suitable for other forms of ~renteral adminlstration as well a~ intravenou~ admlnis-tration.
The system shown in FIG~RE 1 depicts a syringe .~-pump 20 embodylng a disposable syringe cartridge 21. The ~yringe cartridge 21 essentially includes a molded plastic cyllnder 22 ln which a piston 23 is slidably recelved and , adapted to be reciprocated back and forth along the axi~
of the cylinder by an integral piston rod 24 which ls re-movably mounted at one end ln a coupling shoe 26 carrled by a linear drive shaft 27 which i8 advanced and retracted by a ~uitable drive system. The drive system lncludes a reversible motor 29 (typically a d.c. stepping motor) and . .
-` 105'~653 approprlate gearlng 31, to advance and retract the sha~t 27 which is, in turn, coupled to the piston rod 24 of the syrlnge cartridge 21. The motor 29 is energized by a pulse traln of motor drlve pul~es generated by an appropriate electrical control system (n~t shown).
The displacement volume of the syringe cartridge 21 is determlned by the volume swept by the piston 23 on eaoh stroke and is identical for the fill stroke and ~or the pump stroke. Therefore, an identlcal number o~ dls-10 ~ete 8tep9 or motor drive pulse3 ~rom the electrical con- -trol system to the motor 29 is required ~or each fill stroke during whlch the syrlnge is filled wlth liquid, and for each pump stroke durlng whl¢h the syringe delivers its precise volume o~ llquld under posltlve pressure to a patient.
The ~yrlnge ¢artridge 21 includes an inlet port 21a and an outlet port 21b. The inlet port 21a communl-cates through a suitable intake I.V tube 33 with any approprlate liquld source (not shown), usually an I.V.
bottle contalning approprlate drugs and/or nutrient~ in liquid form. Typically, the intake I.V. tube 33 is part of an I.V. administratlon set WhiCh lncludes a tran~parent drip ohamber in the llne between the syringe cartridge 21 ` and the llquid source.
A slmllar output I.V. tube 34 is connect~d at one end to the outlet port 21b of the syrlnge cartrldge 21 and ¢onveys ~luid ~rom the syrlnge to a patlent.
A~ be~t observed in FIG~RES 3 and 3A, a pair of `syringe pump valves 36, 37, external to the syrlnge car-;30 tridge 21, are o~ the tube pincher type, and are selec-;tively opened and clo3ed at appropriate tlmes in the overall pumplng cycle, under the control o~ a ~uitable valve control system 40. The valve 36 controls the inlet , ^- lOSi~f~53 p~rt 21a and i~ open during the fill stroke to enable fluld to be drawn from the llquid source, through the in-take llne 33, lnto the syringe cartrldge 21, the valve 36 belng clo9ed dUrlng the pump stroke to prevent ~luld rrOm exitlng the ~yrlnge through the lnlet port. The valve 37 controls the outlet port 21b and ls open during the pump stroke to enable fluld delivery ~rom the syringe carbridge 21 to the patient through the output llne 34 the valve 37 being clo~ed durlng the flll ~troke.
The valve control system 40 ls also drlven, through the gearing 31, by the same motor 29 as ls used to operate the syrlnge cartridge 21. In addltion, the valve control system 40 lncludes means (not shown) for provldlng ln~ormatlon to the electrl¢al ¢ontrol ~y~tem controlling the motor 29, and lndlcatlng that the syrlnge cartrldge 21 ls elther in the flll stroke or the pump stroke. This latter ln~ormatlon, ln turn, enables the electri¢al control system to establlsh the proper direc-tlon of rotation of the motor 29. The electri¢al ¢ontrol 20 sy~tem may be of conventional design for electrlcally energlzlng the motor 29 and controlling its dlrection of rotation.
The motor 29 drlves, through the gearlng 31 and an output camshaft 41, a reversible cam (not shown) ln the valve ¢ontrol system 40, whl¢h cycli¢ally alternates the open and closed posltlons of the syringe pump valves 36~ 37 The syrlnge pump valves 36, 37 typlcally consist o~ a pair o~ plvotal tube pinchers 43, 44 which alter-30 nately plnch off and open the intake and output tubes 33,34 respectively, of the syringe cartridge 21. One face of each o~ the tube pinchers 43, 44 is shaped to define a pincher blade 43a~ 43b, respectively, adapted to cooperate 105'~53 with the confrontlng face of a shoulder 45a deflned on the lnterlor side of a syrlnge pump tublng access door 45 to the syringe compartment. Together, the pincher blades 43a, 44a and the access door shoulder 45a deflne a pair of tube clamps between which the lntake and output I.V. tubes 33, 34 pass. The access door 45 i8 held shut, a~ter the syrlnge cartrldge 21 has been installed, by any sultable latch 45b (FIG. 1).
The tube plnchers 43, 44 are sprlng blased to the lO tube shut-off posltion and are positively drlven open by the valve control system 40, thus allowlng full tube closure regardless of normal variatlons ln I.V. tublng dlameter and wall thlckness.
The valves 36, 37 and valve control system 40 may be of conventional deslgn.
Referrlng now more parti¢ularly to FIGS. 7-9 of the drawings, the new and improved syrlnge cartrldge 21 of the present lnventlon 19 of strong, ilghtweightJ durable ¢onstru¢tlon and ls constructed to mlnimize the possi- -20 blllty of fluld leakage from the lnterior of the æyrlnge, enhance the ease and simpll¢ity of mount lng and removal `~ from the syrlnge ¢ompartment of the pump, fa¢llltate the removal of' alr prlor to actual operatlon of the pumping apparatus, and to prevent lntake of alr or pathogens into the lnterlor o~ the syringe durlng repetitlve pumping cycles.
The dlsposable syringe cartrld~e 21 lnclude~ the molded plastlc cylinder 22 havlng inlet and outlet nipples 51, 52, respectively, at the upper end of the cylinder 3o ~with the longitudinal axi~ of the syringe in the vertical posltlon as is the case followin~s proper lnstallation shown in FIGIJRE l). The cylinder 22 is hollow and thereby defines an interlor chamber adapted to slldingly recelve ~- --14--`- 105'~;53 a plastic piston head 54 which ~9 integral with the piston ~od 24. The cylinder 22, and combined piston rod 24 and piston head 54 are typically ln~ectlon molded of any sultable thermoplastic material, such as polypropylene.
A rubber sealing cap 56 overlle~ and encases the piston head 54 to define the piston 23, the sealing cap provldlng a conical piston ~ace 23a directed towards the lnlet and outlet nlpple~ 51, 52, respectively, of the syringe.
The lnlet and outlet nipples 51, 52 of the syringe cartridge 21, extend parallel to the longltudinal axi9 of the syringe on opposite sides of the ~yringe, dlametrically opposed from each other. The interior surface of the syrlnge cylinder 22 defines, with the piston 23, a fluid aontaining ¢hamber, and the uppermost cyllnder ~urface 22a above the piston is sloped upwardly, typically at an angle o~ approxlmately 10 degrees, towards the base of the ; outlet nipple 52. Hence, when the longitudlnal axis of the syrlnge is vertical, followlng lnstallatlon lnto the pumping apparatus, gas bubbles will tend to rlse to the highest point of the syringe cylinder 22 and pass out through the outlet nlpple 52, ~or easy removal at eome convenient access point in the output I.V. tube 34. In addition, the plston face 23a slopes symmetrlcally down-ward from its apex at an angle of approximately 10 degrees to the horizontal, matching the slope of the interior surface 22a o~ the cylinder 22, to minlmize the residual volume o~ the syringe.
The sealing cap 56, whlch is typically fabricated ; 30 o~ a natural rubber, also lnclu~es a palr Or re~lllent, annular ribs 56a, 56b whlch fit over and are ~upported by correspondlng annular ~langes 54a, 54b ln the plston head 54.
:
- 105;~53 The iealing cap rlbs 56a, 56b provide a pair Or axlally ~paced apart pi~ton sealing rings. The~e dual, sE~aced apart sealing rlngs deflne two polnt contact support along the longitudinal axis of the syringe cartrldge 21 to provlde improved seallng ef~lciency, and to enhance the axial allgnment and stability of the piston and plston rod as~embly withln the cyllnder 22 o~ the syringe a~ the pls~
ton 23 reclprocates back and ~orth within the cylinder durlng repetitlve pump cycles. Hence, the two polnt sup-port along the longltudinal axis of the system prevent~rocking of the piston 23 whlch might otherwise cause the ~ystem to be prone to leakage and might also provlde un- ~-even wear on the seallng rings.
The seallng cap 56 further lncludes a thin walled conical sealing boot 56c integral at its frustrum with the rib 56b and terminating at its base in a thicknned wall portion defining a bead 56d. The seallng boot 56c pro-vides a limp membrane seallng element when the syringe cartridge 21 is assembled, to prevent the lntake of air 20 or pathogens through the bottom of the cylinder 22 as the plston assembly re¢iprocate~ through repetltive strokes wlthin the cylinder.
The use of the seallng cap to encase the plastic plston head 54 and thereby define the outer sur~ace o~ the plston 23, includlng the sealing rlngs 56a, 56b, enables the plston head 54 and piston rod 24 to be fabricated of . ~ .
less expensive materlals than would be required lf the piston head were in direct ~lidlng engagement with the lnterlor walls o~ the cylinder 22.
The material from which the sealing cap 56 is fabrlcated ls chosen because of its material properties, e.g., wear reslstance on the seals~ compresslon set resis-tance so that it will retain lts elastic properties, 105i~53 resistance to tearlng on the boot because of the thin walled membrane, and reslstance to the temperatures norm-ally encountered ln the sterlllzatlon proce~. In con-trast, the plastic materials from whlch the cyllnder 22, piston head 54 and piston rod 24 are fabricated 19 chosen prlmarily for low co~t o~ material, ea~e of manufacture, and reslstance to sterlllzation temperatures.
All plastic cross-sectlons of the various com-ponents of the syrlnge cartrldge 21 are ~elected to pro-1~ vide a maxlmum of strength for a minimum amount of plasticmat~rial. In thi~ regard, while strength i3 required, a thin walled ~tructure is al~o de~irable ln order for plastlc molding to be most effective. Hence, a maximum degree of rigidity with a minlmum amount of plastic, in a convenient cross~sectlon, ls selected for the syrlnge cartrldge 21 o~ the present invention. In thls regard, lt ; will be apparent ln FI~RE 8 that the pi~ton rod 24 ls molded ln an "H" cros~-sectlon, defined by a palr of long-ltudinally extendlng, parallel flanges 24a, 24b Jolned by an lntegral, coextenslve cro~s-bar 24c.
As prevlously polnted out, the plston head ~langes 54a, 54b retain the sealing cap 56 and provide ; adequate support for the plston 23. The parallel flanges 54a, 54b are, in turn, supported by ~our integral ribs 54c whlch intersect at the longitudinal axis of the plston head, the uppermo~t ends of these r~bs belng tapered to provlde aupport for the conlcal face 23a of the sealing cap 56. This prevents the seallng cap 56, which ls not very rigld, from collapsing. The rib structure defined 3Q by the four ribs 54c iæ 3elected, instead of a solid circu-lar cylindrical cross-section, for moldlng purposes, to provlde adequate strength with a mlnlmal amount of plastic materlal required.
~..
-``` lO5Z653 In assembling the cylinder 22, sealing cap 56, and combined plston head 54 and piston rod 24, (the com-ponent~ of FIG~RE 9) intothe syringe cartrldge 21 o~
FIGURE 7, the 3ealing cap 56 is simply pressed over the piston head 54 until the flanges 54a, 54b en~age internal slots in the ~ealing cap ad~acent the rib~ 56a, 56b, whlch re~ults ln the seallng cap and plston head snapplng to-gether. The resulting a~sembly of the seallng cap 56 and piston head 54 (deflning the pi~ton 23) and the plston rod 24, is pushed lnto the openlng in the base of the cylinder 22. A sultable lubricant may be used to facllltate in-sertlon o~ the assembly into the cyllnder 22, as well as ~ubsequent reclprocatlon withln the cyllnder. The base of the seallng boot 56c 18 then folded over the open base of ; the ¢yllnder 22, so that the bead 56d, whlch behaves a~ an ela~tlc 0-rlng, grlps the outer ~urface of the cyllnder and holds the seallng boot 56c in position 80 that lt can't be peeled back easlly or tear. In thls regard, the hoop strength of the bead 56d must be sufflclent to re~lst 20 movement once lt has been positloned to grlp the outer sur~ace o~ the cyllnder 22.
The length of the sklrt portion of the ~ealing boot 56c is such that lt ls not required to stretch at all during any portion of the pumping cycle as the pl~ton 23 re~lprocates back and forth wlthin the cylinder 22. Hence, - the boot 56c provides a limp membrane as a seal a~alnst adml~sion of alr or pathogen~ to the interlor of the cyllnder 22 during repetitlve ~trokes of the ~yrlnge. In thls regard, slnce the llmp membrane seal provlded by the 30 ~ealing boot 56c i3 es~entially unstre~sed, lt ls both rugged and reliable. In addltion, should sufficlent alr be trapped ln the alr gap between the rib 56b and the seal-ing boot 56¢, durlng a~embly into the cylinder 22, the - 105'~653 alr vo~ume mi~ht be compressed durlng ~ill strokes o~ the piston 23 when the piston ls in its l~wermost pasition.
However, the combination of the additional v~lume provided b;y the un~oldlng limp membrane of the sealing boot 56c, together with the anchoring afforded by the bead 56d, reslsts popplng of the sealing boot off the cyllnder 22, even in the event of ballooning of the boot by any such trapped alr.
A~ter the cylinder 22, seallng cap 56 and comblned 10 plston 54 and plston rod 24 have been as~embled in the aforedescribed manner, the lntake I.V. tube 33 and output I.V tube 34 are appropriately secured to the lnlet and outlet nipples 51, 52, respectively, to complete the assembly of the syrlnge cartrldge 21.
~ he syrlnge cartrldge 21 ls con~tructed to cooper-ate wlth assoclated mountlng mean~ withln the syringe com-partment of the pump houslng to facilitate simple and easy lnsertion of the cartridge into the pump housing while requiring the use of only one hand by the operator. In 20 thls regard, an lntegral tab 58 pro~ects from the outer surface of the syrlnge cyllnder 22 near the upper end of the cyllnder, and thereby provldes an operator handle for mountlng and removing the syrlnge cartridge 21 ~rom the pump houslng ln the manner to be hereinafter descrlbed in further detail.
At the end of the piston rod 24 remote from the piston head 54, the longitudinal flanges 24a, 24b are partially cut-away to define surfaces 24d and in order to provide clearance for insertion into the coupling shoe 26.
In addition, this same end of the piston rod 24 is pro-vided with a pair of lntegral, outwardly and oppositely extending, cylindrlcal mounting bosses 59, one boss pro-~ecting perpendicularly outward frcm the outside face of 105;~653 the flange 24a, the other boss llkewise pro~ecting outward from the ~lange 24b.
A ~econd palr of outwardly extending mounting bosses 61, parallel to the first set of mo~ntlng bosses 59 on the piston rod 24, are lntegral wlth the dyringe cylln-der 22 near the upper end o~ the cylinder.
As best observed ln FIG~RES 3, 5 and 6, the piston ;--;
rod mountlng bosses 59 are adapted to engage and be re-talned by the mountlng and coupllng shoe 26 whlah is se-10 ~red to the leading end of the linear drlve sha~t 27 adap_ ;
ted to be coupled to the piston rod 24 for drlvlng the ;~
;syrlnge cartrldge 21 through successlve flll and pump strokes. The coupllng shoe 26 includes a palr of con-fronting, wide mouth gulde slots 63 ln upstandlng flanges 62, dlsposed on opposlte sides of the coupling shoe, and adapted to engage and guide the mountlng bosses 59 80 that the syrlnge cartridge 21 can be inserted lnto the coupllng shoe horizontally.
Hen¢e, during the cartridge installation procedure, the tab 58 of the syringe cartridge 21 is gripped by two flngers of one hand of the operator and, wlth the longi-tudinal axls of the syringe cartrldge held horlzontally, .~
the piston rod 24 and mountlng bosses 59 are lnserted horlæontally into the gulde slots 63 of the coupling shoe 36 (with the cutaway sur~ace3 24d o~ the piston rod direc-.
ted downward) and moved to the rear o~ the coupling shoewhich essentlally de~ines a mounting yoke ~or the bosses 59. The syringe cartrldge 21 ls then rotated upwardly, . ' about an axis o~ rotatlnn through the mounting bosses 59 ~-30 in the coupllng shoe 26, so that the longitudinal axis Or the syringe cartridge is brought into a vertical posltion, as lllustrated by the solld llnes in FIG~RE 3. The latter procedure brlngs the cut-away, lower end of the plston rod ~ .
i 0 S ~ ~ 5 3 24 lnto a retention channel 64 within the coupllng shoe 26. In thl~ regard, the cut-away surfaces 24d of the pls-ton rod are rotated into abutment with a ledge 64a of the r~stention channel 64.
When the syringe cartridge 21 has been thus ln-stalled, the mounting bo6ses 59 in the guide slots 63 prevent the syringe cartrldge ~rom being dislodged ver-tlcally, whereas the cut-away surfaces 24d in the retention channel of the coupling shoe 26 prevent the cartridge from 10 belng dlslodged hor~zontally.
As best observed ln FIGURES 1 and 3, the mounting bosses 61 of the syrlnge cyllnder 22 are adapted to engage ``
a pair of ~ixed guide and retalning slots 66 provided in opposite walls o~ the syringe receiving compartment of the pump houslng. By controlling the initlal location of the coupling shoe 26, relative to the curved, wide mouth guide and retaining slots 66, the pumping apparatus can be con-d itioned to receive the syringe cartridge 21 only if its ; piston 23 is in a predetermined position within the syringe 20 cyllnder 22, i.e., in the top dead center position adapted to initially perform an intake stroke to fill the syringe with liquid. The latter is the proper state of the syrlnge ` for inltial ~tart-up of the pumping apparatus.
J The intake and output I.V. tubes, 33, 34, re-. 9 pectively, ~rom the syringe cartr~dge 21, are then passed vertically over the tube pincher blades 43a, 44a and are clamped in position by the closing of the tubing compart-ment accesQ door 45 which i8 then latched shut by the latch 45b to firmly anchor and maintain the syrlnge cartridge in 30 positlon durlng the operational cycles of the pump. me tubing access door 45 must be unlatched and opened to enable the syringe cartridge 21 to be rotated from the vertical positlon to a hcrlzontal positlon for removal from :' r~
`-- lOS;~t;53 the coupling shoe 26, whenever it ls deslred to replace the cartridge. -The coupling ~hoe 26 i5, aQ prevlously indicated, securèd to the upper end of the linear drive shaft 27 which advances and retract~ the coupling shoe and thereby ad-vances and retract~ the piston rod 24 and plston 23 wlthin the cylinder 22 for repetitlve fill and pump strokes. As best observed ln FIG~RES 3 and 4, the llnear drlve shaft 27 i8 of non-clrcular cross-section and, ln the preferred embodiment show~, is of rectangular cross-section. The drive shaft 27 pasees through and is in slidlng engagement with an antl-rotation bearing 68 havlng an openlng of compllmentary cross-section, and enabling the drive shaft to move along its longitudinal axis while being keyed against rotation about that axls.
A lead screw 70 i3 lntegral wlth, or otherwise appropriately secured to, the drive shaft 27 and ls ad--, uanced and retracted along lts longitudlnal axis, to thereby advance and retract the drive shaft 27, by an lnternally threaded gear 72 ln the gear traln 31 drlven by the motor 29. The gear 72 is approprlateIy supported for rotatlon in a palr o~ statlonary gear carrier3 or thrust bearings 73, 74.
As best observed ln FIG~RES 1 and 3, a visual run-ning lndicator ls provlded ln the ~orm of a rotating disc ;; ~ 76 having a plurality Or visually observable3 preferably ` unlformly spaced, vertical lndex lines 77 located along its entire perlpheral edge. The disc 76 is secured to a central bu~hing 78 (through which the lead screw 70 passes ~reely) and is ~ournaled for rotation in the upper gear carrier 73. ~he bushlng 78 and disc 76 are drlven by the ..
output shaft 29a of the motor 29 via a belt drive ln the orm of a simple O-rlng 79 which passes around the output ;
lOS;~53 ~haft of the motor and around the bushing 78 to provide a simple frictlon drive.
The peripheral lndex llnes 77 are readlly obser-vable through a window 81 ln the pump houslng. Hence, when the pumplng apparatus 1~ operating at a very low pumplng rate, so that no movement of the coupling shoe 26 or pls-ton rod 24 ls visually dlscernlble by the operator, the rotatlon of the running indicator disc 76 will be apparent through the wlndow 81 to assure the operator that the 3ystem is ln operation.
Referrlng now more speclfically to FI~RES 1 and 2, a motor rotation sensor 83 is provlded to insure proper detectlon of a stalled motor 29 so that, in cooperatlon with the electrical control system, an alarm condition can be appropriately generated. Such motor stalling has a greater probability o~ occurrlng when the pump is used wlth a down~tream filter which may clog and lnduce high back pressure on the pumping system.
The rotation sensor 83 comprlses a disc 84 mounted `20 on the output shaft 29a of the motor 29 for rotation therewith, the disc having alternate transparent and opaque sectors 85, 86, respectively. A photocell 87 de-tects light passing through the disc 84 from a reference ;light source 88, as the disc rotates, and generates elec-trical pulses which are appropriately directed to the elec-trlcal control system for monltoring and alarm functlons.
Hence, the rotation sensor 83 is capable of indlcating any stalled motor condition.
;~As best observed in FIG~RES 10 and 11, the pump-30 ing system, includlng the syringe cartrldge 21, may embody appropriate means for lndlcatlng proper installatlon of the syringe cartridge and for detecting the presence of gas bubbles. In thls regard, the inlet nipple 51 of the , 105;~53 syrlnge cartrldge 21 ls surrounded by an integrally m olded, transparent flag member 89. A f~ced llght so~rce 91 and photoelectrlc sensor 92, both located ln flxed p osltlons within the syringe compartment of the pump hous-lng, provide a reference llght beam which i8 selectlvely lnterrupted by the flag~ member 89 whenever the syringe c artridge 21 has been properly positioned ln the syringe compartment o~ the pump houslng. In thi~ regard, the flag 89 prevents the reference l~ght beam from reachlng the lO sen~or 92 by lnterposing a totally reflectlng sur~ace 89a ln the path of the llght beam to deflect the light beam a way from the sensor.
In addltlon, bubble detection ls accompll~hed ln the arrangement of FIGIJRE ll by providlng a fixed light 80urce g4 and photoelectric sensor 95 on opposlte sldes o~ 'che lnlet nipple 51, so that gas bubble~ passlng through the nlpple will lnterrupt the llght beam and generate an appropriate electrlcal ~lgnal. The latter slgnal ls appro-priately transmitted to the electrlcal control system to 20 brlng about the generation of an alsrm ~tate. Hence, the bubble detection system lnsures no air bubbles are entering t he syringe through the lnlet nlpple 51.
An alternatlve embodiment of a suitable system for nDnltoring the proper insertlon of the syrlnge cartrldge 21 wlthln the syringe compartment ls shown ln FIG~RE 12. In this embodiment, a syringe nipple 151 is approprlately provlded with an opaque, typlcally black, outer coating 151a æo that, when the cartrldge has been properly in-stalled, a reference light beam from a ~ixed light source 30 l91 in the pump housing is interrupted. This causes an appropriate electrical slgnal to be gnnerated by a fixed photo~ensor 192 located in the pump houslng on the opposite side of the nipple 151.
105'~f~53 The new and improved syringe pump drlve ~ystem and dispo~able ~yringe cartridge of the present inventlon satis~les a long exi~ting need in the medical arts for improved, relatively simple, economical, rellable, stable and accurate syrlnge pumplng ~y~tem~.
It will be apparent from the foregolng that, while partlcular forms o~ the invention have been illu5-trated and described, varlous modl~ications can be made without departlng ~rom the splrlt and scope of the lnven-tlon. Accordlngly, lt is not intended that the lnventionbe limlted, except as by the appended claim~.
. .
' : '~
Claims (15)
1. A syringe for use in a syringe pump, said syringe com-prising: a hollow cylinder having an open end and a closed end, said cylinder being adapted for normal use with its longitudinal axis substantially vertical, said cylinder having a pair of integral, parallel inlet and outlet nipples projecting from said closed end of said cylinder, said nipples being disposed on opposite sides of said cylinder with the axes of said nipples being substantially parallel to said longitudinal axis of said cylinder, there being no valves within said nipples, the uppermost interior surface of said cylinder being sloped upwardly in a single plane, said outlet nipple being located adjacent the highest point within said cylinder; a piston head within said cylinder and having a sealing relationship therewith;
and a piston rod connected to said piston head and integral therewith for reciprocating said piston head along said longitudinal axis of said cylinder.
and a piston rod connected to said piston head and integral therewith for reciprocating said piston head along said longitudinal axis of said cylinder.
2. The syringe as claimed in Claim 1, wherein said piston rod has a pair of integral, outwardly extending mounting bosses adapted to engage the mounting means of a piston drive system.
3. The syringe as claimed in Claim 1, wherein said cylinder has a pair of integral, outwardly extending mounting bosses adapted to engage mounting means in a syringe receiving compartment.
4. The syringe as claimed in Claim 1, wherein said piston head has spaced apart annular flanges, and further comprising a flexible sealing cap overlying and encasing said piston head, said cap engaging said annular flanges and defining a piston face, said sealing cap further defining a pair of axially spaced apart sealing rings in engagement with the interior surface of said cylinder.
5. The syringe as claimed in Claim 4, wherein said sealing cap has a limp membrane skirt adapted to seal said open end of said cylinder without stretching at any time during reciprocation of said piston head, said piston rod, and said sealing cap.
6. The syringe as claimed in Claim 5, wherein said skirt terminates in a thickened bead portion adapted to grip the external surface of said cylinder and prevent said sealing cap being being dislodged.
7. The syringe as claimed in Claim 4, wherein said cap defines an upwardly directed conical piston face, the slope of said conical face conforming to the slope of said interior surface of said cylinder.
8. The syringe as claimed in Claim 2, wherein said outwardly extending mounting bosses are positioned adjacent a cut-away portion of said piston rod, said mounting bosses and said cut-away portion being adapted to engage the mounting means of a piston drive system, whereby said syringe can be mounted with the longitudinal axis of said syringe horizontal, said syringe being rotatable about an axis of rotation through said mounting bosses so that its longitudinal axis is positioned vertically and retained by said mounting means for operation of said syringe through repetitive fill and pump cycles.
9. The syringe as claimed in Claim 1, wherein said cylinder, said piston head, and said piston rod are of molded plastic.
10. The syringe as claimed in Claim 8, wherein said piston rod has a substantially H cross-section perpendicular to the longitudinal axis of said piston rod.
11. The syringe as claimed in Claim 10, wherein said piston rod includes a pair of parallel longitudinally extending flanges joined by an integral crossbar.
12. The syringe as claimed in Claim 5, wherein said skirt is conical.
13. The syringe as claimed in Claim 5, wherein said sealing cap is rubber.
14. The syringe as claimed in Claim 7, wherein said annular flanges of said piston head are supported by a plurality of intersecting ribs, said ribs intersecting at the longitudinal axis of said piston head, the uppermost ends of said intersecting ribs being tapered to provide support for said conical face of said sealing cap.
15. The syringe as claimed in Claim 1, wherein said syringe is a disposable syringe cartridge.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CA305,941A CA1059398A (en) | 1975-02-28 | 1978-06-21 | Syringe pump drive system and disposable syringe cartridge |
| CA305,942A CA1054891A (en) | 1975-02-28 | 1978-06-21 | Syringe pump drive system and disposable syringe cartridge |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US05/554,230 US3993061A (en) | 1975-02-28 | 1975-02-28 | Syringe pump drive system and disposable syringe cartridge |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA1052653A true CA1052653A (en) | 1979-04-17 |
Family
ID=24212549
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA228,743A Expired CA1052653A (en) | 1975-02-28 | 1975-06-06 | Syringe pump drive system and disposable syringe cartridge |
Country Status (5)
| Country | Link |
|---|---|
| US (3) | US3993061A (en) |
| JP (1) | JPS51101391A (en) |
| CA (1) | CA1052653A (en) |
| DE (1) | DE2533316A1 (en) |
| GB (3) | GB1510523A (en) |
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| EP3632487A1 (en) | 2018-10-05 | 2020-04-08 | Sorrel Medical Ltd. | Triggering sequence |
| EP3887680B1 (en) | 2018-11-28 | 2022-10-26 | Insulet Corporation | Drug delivery shuttle pump system and valve assembly |
| US11191897B2 (en) | 2019-03-04 | 2021-12-07 | Eitan Medical Ltd. | In cycle pressure measurement |
| US11779699B2 (en) | 2019-09-04 | 2023-10-10 | Lynntech, Inc. | Micropump |
| US11369735B2 (en) | 2019-11-05 | 2022-06-28 | Insulet Corporation | Component positioning of a linear shuttle pump |
Family Cites Families (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US1572075A (en) * | 1924-05-10 | 1926-02-09 | Frank H Nickels | Syringe aspirator |
| US1585628A (en) * | 1924-08-08 | 1926-05-18 | Julius A Pfarre | Syringe or pump |
| FR805611A (en) * | 1935-08-10 | 1936-11-25 | Vacuum pump | |
| US2498672A (en) * | 1947-05-26 | 1950-02-28 | Antonina S Glass | Motor drive for medical syringes |
| US2672866A (en) * | 1951-03-31 | 1954-03-23 | Kater Hermann | Medical syringe |
| US3050059A (en) * | 1959-05-25 | 1962-08-21 | Baxter Don Inc | Hypodermic syringe |
| GB941370A (en) * | 1961-01-31 | 1963-11-13 | Frank Wantoch | Improvements in or relating to hypodermic injection and withdrawal apparatus |
| FR1359200A (en) * | 1963-03-08 | 1964-04-24 | Plastic ampoule with variable internal volume, and device intended to be associated with it for the injection, in particular hypodermic, of liquids | |
| GB1114247A (en) * | 1964-06-01 | 1968-05-22 | Holger Hesse | Infusion apparatus |
| US3335724A (en) * | 1964-07-24 | 1967-08-15 | Erich M Gienapp | Remote control, repeating, variable stroke hypodermic syringe device |
| US3731679A (en) * | 1970-10-19 | 1973-05-08 | Sherwood Medical Ind Inc | Infusion system |
| US3752145A (en) * | 1971-11-01 | 1973-08-14 | Mdt Instr Co | Method for preventing air embolism in a syringe for angiographic power injector |
| US3990444A (en) * | 1972-11-22 | 1976-11-09 | Vial S.A.R.L. | Blood transfusion apparatus |
| US3901231A (en) * | 1974-02-07 | 1975-08-26 | Baxter Laboratories Inc | Infusion pump apparatus |
| US3939078A (en) * | 1974-04-19 | 1976-02-17 | Johnson & Johnson | Extracorporeal filter |
| US3985133A (en) * | 1974-05-28 | 1976-10-12 | Imed Corporation | IV pump |
| US3888239A (en) * | 1974-06-21 | 1975-06-10 | Morton K Rubinstein | Fluid injection system |
-
1975
- 1975-02-28 US US05/554,230 patent/US3993061A/en not_active Expired - Lifetime
- 1975-06-06 CA CA228,743A patent/CA1052653A/en not_active Expired
- 1975-06-11 GB GB24942/75A patent/GB1510523A/en not_active Expired
- 1975-06-11 GB GB49803/77A patent/GB1510525A/en not_active Expired
- 1975-06-11 GB GB49802/77A patent/GB1510524A/en not_active Expired
- 1975-07-15 JP JP50085931A patent/JPS51101391A/ja active Pending
- 1975-07-25 DE DE19752533316 patent/DE2533316A1/en not_active Ceased
-
1976
- 1976-08-25 US US05/717,768 patent/US4080967A/en not_active Expired - Lifetime
- 1976-08-25 US US05/717,769 patent/US4067332A/en not_active Expired - Lifetime
Also Published As
| Publication number | Publication date |
|---|---|
| JPS51101391A (en) | 1976-09-07 |
| GB1510523A (en) | 1978-05-10 |
| US4080967A (en) | 1978-03-28 |
| GB1510524A (en) | 1978-05-10 |
| GB1510525A (en) | 1978-05-10 |
| US3993061A (en) | 1976-11-23 |
| DE2533316A1 (en) | 1976-09-09 |
| US4067332A (en) | 1978-01-10 |
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