CA2229547A1 - Multi-dose syringe driver - Google Patents
Multi-dose syringe driver Download PDFInfo
- Publication number
- CA2229547A1 CA2229547A1 CA002229547A CA2229547A CA2229547A1 CA 2229547 A1 CA2229547 A1 CA 2229547A1 CA 002229547 A CA002229547 A CA 002229547A CA 2229547 A CA2229547 A CA 2229547A CA 2229547 A1 CA2229547 A1 CA 2229547A1
- Authority
- CA
- Canada
- Prior art keywords
- syringe
- carriage
- frame
- proximal
- distal end
- 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.)
- Abandoned
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
- A61M5/1454—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons spring-actuated, e.g. by a clockwork
-
- 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
- A61M5/1456—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons with a replaceable reservoir comprising a piston rod to be moved into the reservoir, e.g. the piston rod is part of the removable reservoir
-
- 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
A syringe driver device is able to effect the controlled, parenteral infusion of a medical fluid using an available disposable syringe. The driver device includes a frame (12) having a movable carriage (14), which houses a force applying element mounted thereto. A disposable syringe (16) mounts upon the frame and a lengthy micro-bore tubing (18) attaches to the outlet tip (22) of the syringe. As a force is applied to the syringe plunger (24), fluid is expelled from the syringe, but its flow rate is dependent upon the diameter of the micro-bore tubing. The driver device enables the delivery of multiple, sequential doses of fluid.
Description
=
CA 02229~47 1998-02-13 W O 97/07838 PCT~US96/13545 MULTI-DOSE SYRINGE DRIVER
R~-~k.~round of the Invention The invention relates to syringe drivers and systems for effecting a controIled infusion of a m~ l fluid from a syringe.
Certain met1i-~1 fluids are ~(1mini~tered by controlled parenteral infusion and require a slow but non-rate critical flow. Infusion of a me-lic~l fluid in this manner has been generally accomplished by use of a drip bag gravity-feed system or an electronic infusion pump. The drip bag provides non-rate critical flow with a simple and relatively inexpensive apparatus.
In certain applic~tion~ particularly those involving small fluid volumes, the use of disposable syringes is preferred to drip bags. The disposable syringe is a commodity item. Syringes may be ~lepa.ed in large qu~ntitie~ and stored for later use, thereby reducing costs and providing greater reliability and repeatability of preparation. Also, a single syringe may be used to provide mllltiple doses, simply by advancing the syringe plunger in fixed increments. For example, it may be desired to fill a 60cc syringe with 40cc of fluid and to then ~f~mini~ter the fluid in lOcc doses, with a flow rate such that a single dose is delivered in twenty to forty minutes.
Doses may then be repeated at fixed intervals, with four doses being delivered from a single disposable syringe.
There exist several advantages to delivering multiple doses from a single dose delivery system. A single large syringe is less expensive than several small syringes or other single dose devices. Significant time savings can be realized in filling, h~ntlling, and ~dmini~tering the syringes since the overall number of operations is greatly recluced. There may also be a decrease in patient risk due to the fact that the intravenous delivery system must be opened fewer times for component changes, and so there are fewer opportunities for c-)nt~min~tion or h~n~llin~ errors.
Arimini~tration of me~ l fluids at a low flow rate using a syringe is generally accompli~hed by the use of a syringe pump. A typical syringe pump is a motorized, programmable device on which a syringe is mounted, and which expels fluid from the syringe by advancing the syringe plunger at a controlled rate. The motorized pump advances the syringe plunger at a predetermined velocity, applying force as required to m~int~in this velocity. The flow rate is therefore independent of fluid resistance unless the resistance becomes so high that the pump cannot sa~ely provide the CA 02229F,47 1998-02-13 corresponding force required. The advantages of using disposable syringes for non-rate critical applications are ~limini~hed by the cost and complexity of ~ ting syringe pumps. Typical pumps are battery powered, microprocessor controlled, provide numerous progr~mming options and ~nnllnci~tors, and require detailed operator tra~ning and ongoing m~int~n~n~e and inspection. Much of the cost and complexityof the syringe pump is directed to the requirements of rate critical appiic~tio~s and is not required for non-rate critical applications. See, U.S. Patent Nos. 4,804,368(Skakoon); 4,544,369 (Skakoon); and 4,943,279 (Samiotes).
Several devices have been developed that are intenfled to provide less complex and expensive means of providing non-rate critical infusion with a disposable syringe.
One option is to replace the electronic components of a typical infusion pump with a spring driven clockwork mPcll~ni~m While this type of device has been described,no actual devices are known to have been commerci~li7Pd. See, U.S. Patent Nos.
4,059,110 (Wuthrich) and 4,676,122 (Szabo).
A second option is based the use of a predetermined force, rather than a predetermined velocity, that is applied to the syringe plunger so that fluid re~i~t~n~e acts to control the flow rate. This force may be applied by a simple mPch~ni~m, such as a weight, or colllyless~d or eYtPn-ied spring of aL~ liate stiffnesc. See, U.S.
Patent No. 4,132,231 (Puccio). By a~l~liate sP~oction of applied force and fluidre~i~t~n-e, the res-lltin~ flow rate can be çn~ineered to a desired level. Fluidresistance may be controlled by varying the length and intçrn~ mptçr of the tubing that connects the syringe to the patient. Appropriate tubing for this application is known as precision microbore tubing because it has a si~nifi~ntly smaller bore m~ter than standard tubing used with drip bags or motorized pumps, and because it is m~n~-f~rtl-red to defined tolerances and specific end points having to do with resistance to fluid flow.
A commercial device based on this ~lt~rn~tive is the "Medifuse" device available from 3M ~lthc~re. In this device, a 'LNeg'ator" rolled spring is used to apply an approximately constant force to a syringe plunger. This is combined with a selection of microbore tubing sizes, each with a different internal rl;~me~çr to provide control of flow rate. A somewhat complicated roller and track mP-~h~ni~m is required to cou~L~ dct the applied torque that is a consequence of the use of the "Neg'ator~
SUBSTITUTE SHEET (RULE 26) CA 02229~47 l998-02-l3 WO 97io7838 ' PCT~US96/1354~
spring. The "Medifuse" device functions as inten~d but its applicability is limited because it does not provide control of multiple doses from a single syringe. TheS "Neg'ator" spring, because of its rolled design, is susceptible to changes in spring force due to cont~min~tion by sticky, abrasive, or particulate m~t~-n~l. Moreover, a spring of this type may be easily damaged by i~ uper h~nflling during cleaning. An additional limit~ion is that the activating mechanism for initi~tin~ a dose on the "Medifuse" device involves pivoting a large cover component, which can be clumsyand which requires additional clearance. Also, a syringe cannot be mounted within a "Medifuse" device without initi~ting fluid delivery from the syringe. U.S. Patent Nos. 4,202,333 ~Thill); 4,298,000 (Thill); 4,430,079 (Thill); and 4,597,754 Cl~hill).
Another commercial device, the UBand-It~ from I-Flow, Inc., described in U.S. Patent No. 5,429,607 (McPhee), employs microbore tubing but applies force to the syringe plunger using an elastomeric element, such as a stretched band of latex rubber. This device is extremely simple but, again, does not enable delivery of multiple doses. Also, it does not provide a constant or nearly constant flow rate because the force applied by the elastomeric elemçnt varies ~ignific~ntly over the range of plunger travel. This device further requires manual ~ tcl~ g of the elastomeric element and provides no r~ech~ni~m to assist in this action. Like the ''Medifuse" device, a syringe cannot be mounted in a "Band-It" unit without causing fluid to be delivered from the syringe.
Other syringe driver systems and described in U.S. Patent Nos. 4,636,197 (Chu); 4,608,042 (Vanderveen); and 5,318,539 (O'Neil).
Known mech~nit~l, predetermined force-applying devices are not well suited to the delivery of multiple doses from a single syringe. Conversion of these devices to achieve multiple dose control might be accomplished using removable stops to limit the range of plunger travel. By sequentially removing the stops, the plunger could move in a series of fixed increments. Such stops, however, are not intrincic~lly safe. It is possible to remove several stops at the same time, or to remove the stops in the wrong order. The result can be an overinfusion conditioninvolving the delivery of two or more doses in a continuous manner.
Another drawback of such devices is that the force applied to the plunger can decrease over the range of travel of the plunger. The result is that successive doses SUBS T ITUTE SHEET (RULE 26) W O 97/07838 PCT~US96/13545 will be delivered from the same syringe at increasingly lower flow rates. Various additional references that describe dose setting include U.S. Patent Nos. 2,632,445 S (~as); 4,498,904 (Turner); 5,232,459 (Hjertman); 5,300,041 (Haber~; 5,328,486 (Woodruff); and 5,092,842 (Bechtold).
Suntmarv of the Invention The present invention overcomes the disadvantages of the prior art by providing a driver device for effecting a controlled, parenteral infusion of a mf~
fluid using an available disposable syringe. The driver device is inten~led for non-rate critical appliç~ticn~, and provides ease of use, intrin~ic safety, robustness, and low cost.
The invention con~i~t~ of two main components: (i) a syringe driver device within which a syringe is removably mountable and which employs a colnpl~ssed spring element to apply a driving force to the syringe plunger, and (ii) a length of microbore tubing having a small inner rli~m~ter through which fluid flows after exiting the syringe, and which provides resi~f~nce to limit the rate of flow. Specific fe~u.~:s of the invention f~cilit~t~ delivery of multiple doses, control of dose volume, easy two-handed opçr~tion, and protection against lmintt-nti~n~l syringe plungertravel.
In particular, the syringe driver device of the invention includes a frame and aselectively positionable carriage that is slidably mounted on the frame, preferably ~d3~ont to the proximal end of the frame. A force applying çlernçnt that is 2~ preferably disposed in or on the carriage is biased to extend from the distal end of the carriage. Preferably, a spring çlçmenf~ disposed within the carriage, applies a biasing force to the force applying Pl(~m~ont Cooperating locking çlçm~ntc are disposed on the frame and carriage to secure the carriage to the frame in a desired position. One or more Pl~m~nt~ for securing and m~int~;ning a syringe within the frame are associated with the frame.
Desired carriage positions include (i) an unlocked, slidable position; ~ii) at least one locked, force applying position in which the force applying elem~nt is at least partially retracted within the carriage; and ~iii) a locked, non-force applying position in which the force applying Plement is fully exten~led ~rom the carriage.
SUBSTITUTE SHEET (RULE 26) W O 97t07838 PCT~US96/1354~
In its operative condition, the syringe driver system constructed according to the present invention inclllcles a syringe, which is secured within the frame, and a S microbore tubing assembly secured to the distal end of the syringe. The microbore tubing assembly has proximal and distal ends with a fluid passageway ~ tPn-ling there between. The proximal end typically inc~ iec a mP-~h~nicm, such as a "Luer Lock,"
to f~ilit~tP ciet~-h~hie coupling to an outlet end of the syringe. Optionally, a family of microbore tubing assemblies is provided. Additionally, each type of microboretubing has an internal passageway with a different inner ~i~mt?tPr and other ~~h~r~cterictics nPcecc~ry to achieve a specified recict~nce to fluid flow. Each type of microbore tubing assembly may have an adapter mech~nicm with a different external geometry and/or flimPncionc coll~onding to a given resistance to fluid flow. Thevarious adapter m~ch~nicms may cooperate selectively with a socket or other engagement means associated with an appl~liate driver device having mP~h~nic~l çh~r~ct~rictirs suitable to the inten~ed fluid delivery app~ tiQ~
The present invention provides a novel driver device that OVt;lCO~ S problems that are ~r~se.lled by the prior art. An ordinary, co."plession type coil spring, or a similar means, is employed to provide the driving force to the syringe. ~owever, the spring must be moved and l.,co.~ ssed for the delivery of each dose. This ".~h~nicm thus enables the m~nit~l~ie of the spring force to be m~int~in~d for sequential doses. The structure of the device that lecu.,.L,resses the spring for each dose is such that it is not possible to set the device to deliver more than one dose contimlously. At the end of the delivery of a dose, any further e~tPncion of thespring, and resulting delivery of fluid, is prevented by a non-removable stop so that continllous, "run away" delivery of fluid is not possible. Acl-lition~lly, at the end of a dose delivery, siphoning or drainage of fluid from the syringe or~ tubing assembly is prevented by non-removable stops which engage the plunger and the syringe barrel, les~e~;Lively, to counteract any hydrostatic force which may tend to bias the plunger towards full insertion when the carriage is in the locked, non-force applying position.
Accordingly, the invention provides a driver device for slowly e~ecting one or more fluid volumes from a specified meAic~l cont~in~r (e.g., a syringe) having a ngid barrel, gr~-iu~t~ci m~rkingc, an outlet port, a gripping flange, and a plunger with tip and disk mech~nicm SUBSTITUTE SHEET (RULE 26) CA 02229~47 1998-02-13 W O 97/07838 PCT~US96/13545 Brief Description of the I~rawinEs Figure 1 is a perspective view of a syringe driver assembly constructed according to the present invention.
Figure 2A is a perspective view from the rear (proximal) end of the syringe driver shown in Figure 1, without the syringe.
Figure 2B is a perspective view from the front (distal) end of the syringe driver shown in Figure 1, without the syringe.
Figures 3A through 3D schem~tic~lly illllctr~te the operation of the syringe driver a~P-mhly shown in Figure 1.
Figure 4 is an eYplo-ie~i view of the syringe driver device shown in Figure 2A.
Figure S is an exploded view of the syringe driver device shown in Figure 2B.
Figure 6 is a side, sectional view of a force-applying el~m~nt used with the syringe driver assembly shown in Figure 1.
Figure 7 is a side view, partially cut away, illll$tr~t~ng the internal mPch~ni~m of the carriage çlem~ont of the driver device.
Figure 8 is a side view of one rail of the track forming the syringe driver assembly of Figure 1.
Figure 9 is a side view of the track shown in Figure 8, rotated 90 in the clockwise direction about the longit~l-lin~l axis of the rail.
Figure 10 is a side view of another embodiment of a syringe driver device constructed according to the present invention, having a folding frame shown in the closed position.
Figure 11 is a side view of the syringe driver device of Figure 10, in the partially opened position.
Figure 12 is a side view of the syringe driver of Figure 10, in the fully openedposition and housing a syringe.
Figure 13 is a side view of another embodiment of the syringe driver device according to the present invention, having a telescoping frame ~c~eml~ly.
Figure 14A i~ tr~t~os a syringe mounted within the front end of the driver device constructed according to one embodiment of the invention.
Figure 14B is a pe.~ecLive view of a front end, partially cut away, of the driver device illustrated in Figure 14A.
SUBSTITUTE SHEET (RULE 26 Figure lSA is a detailed view of a male luer lock fitting.
Figures 15B and C are detailed views of alternative adapter elementc useful with the microbore tubing assembly.
Figure 16 illlT~tr~te~ another embodiment of the driver device of the invention.~ Figure 17 is an exploded view of the driver device of Figure 16.
Detailed Description of the Invention The syringe driver of the invention is useful to f?~ t~te multiple sequential doses of a fluid, such as a mt~ m~nt, from a syringe at a controlled, pre~efP min~d flow rate. The driver device lO, as illll~tr~ted in Figures 1-9, comprises a frame 12, a c~ ge 14, a syringe lo, mounted within the frame, and an outflow tubing assembly 18.
The syringe 16 used with the driver device can be any type of syringe used to dispense me~ l fluids such as me~ m.ontc and the like. The syringe can be of anyone of a variety of sizes, ranging, for example, from Scc to 60cc volume capacity.
The syringe incll~des a barrel (with gr~ t~d markings) 20, an outlet tip 22 at the distal end of the syringe, which connects to outflow tubing assembly 18, a syringe plunger 24, a syringe flange 23, and a plunger disk 26 at a proximal end of the plunger. The plunger is slidable between withdrawn and inserted positions to expel fluid from within the syringe barrel.
As illustrated, the frame 12 has distal 25, and proximal 27 ends, and comprises a track 28, formed of adjacent, parallel rails 30, 32. A carriage 14 is mounted upon the rails 30, 32 of track 28 at the proximal end 27 of the frame, and is able to slide along the track proximally and distally. The distal end 25 of the frame 12 in~ltldes a syringe mounting element 36 which secures the syringe within the frame 12.
Figures 1-5 ilhl5tr~te an embodiment in which the syringe mounting elemPnt 36 is a yoke elPmenr 38 that mates with the syringe flange 23 to help secure thesyringe 20 within the frame 12. The yolce element 38 also acts as an end stop for the carriage motion. The yoke element 38 comprises a longitudinal groove structure 40 for receiving the syringe barrel 24 and plunger assembly. The space separating the eent gri~ping flange 46 and the distal flange 4g forms a transverse slot 50 which SUBS T ITUTE SHEET (RULE 26) W O 97/07838 PCT~US96/13545 is able to engage securely the syringe flange 23, such as through a mech~nic~l fit.
The yoke el~m~nt 38 also serves to prevent movement of the syringe barrel 20, in the proximal or distal directions, relative to the syringe plunger 24.
As illustrated in Figures 12 and 13 the syringe mounting elem~nt 36 can also be in the form of a socket element 54 which cooperatively engages and :iU~Oll'i the distal end 56 of syringe 16 and/or the proximal portion of outflow tubing assembly 18. The socket ~ ment 54 is shaped and ~lim~nci~)ned to cooperatively engage thedistal end 56 of the syringe. Socket 54 ~ feldbly, in~ des an ap~llul~ 58 through which the outlet tip 22 of the syringe, the male luer 67, and the outflow tubing 18 may extend. ~lt~-rn~tively~ as shown in Figures 14A, 14B, 16, and 17, the socketPlemçnt 54 may be flimtoneioned selectively to engage and support an adapter elem~nt 34 of the microbore tubing assembly 18 shown in Figures 15B and 15C.
The proxima} end 27 of the frame 12 includes a stop element 52 for preventing further proximal movement of the carriage 14. Optionally, a hanger device 53 is ~ccot~i~ttod with the stop 52 to enable the apparatus to be sllcrçnde~
As i~ etr~ted in Figures 2A and 4, the carriage 14 inclll~les a structure that enables the carriage to mount and slide upon rails 30, 32 of frame track 28. In one example the carriage may include a longit~-r1in~11y oriented slot 60 on each side of the carriage. The slot 60 mates with a horizontal lip 62 formed on each rail 30, 32.This eng~g~mPnt allows the r~ ge to slide freely on the track 28, while at the same time preventing any vertical, dislodging movement of the c~ e.
The carriage 14 comprises a housing 15 which contains a spring ~l~mpnt 66.
A piston device 68 is displaceably poeitio~ed within and is biased to proiect from an ap~lluie 70 formed in a distal end 72 of the housing. Dual finger grip flanges 74 also extend from the distal end of the housing. Each finger grip flange comprises an outwardly flared finger grip el~ment 76. Further, the interior surface of each finger grip flange incl~lcles an anti-siphon latch or stop element 78 that prevents further distal movement of the syringe plunger (relative to the syringe barrel) independent of movement of the carriage or piston 68.
Cooperating locking elernPnte are associated with the carriage 14 and the frame 12 to secure the carriage to the frame. The coo~e~ ing locking elem~nte enable the carnage to be secured in the following positions~ an unlocked position;
SUBSTITUTE SHEET (~ULE 26) (ii) at least one locked, force applying position in which the piston 68 is at least partially retr~rtçd within the carriage; and (iii) a locked, non-force applying position S in which the piston 68 is fully ext~nded from the carriage.
In one embodiment, illustrated in Figures 1-5, the cooperating locking ~ PlPm~nt~ can comprise the combination of a pawl mech~nicm 80 formed on the carriage and a plurality of detents 82 formed on at least one of rails 30, 32. Detents 82 can be of virtually any useful shape and dimen~ion. Figures 8 and 9 i~ str~te an e~mpl~ry detent shape in which a distal part of detents 82 has a wall 201 which angles outwardly at a gradual rate before reaching a rounded out detent area 203 that it bordered, at its proximal end, by wall 205. By way of example, each detent 82can span a tli~t~nce, from proximal to distal ends, of about 0.2 to 0.4 inch, and have a depth, at its detent area 203, of about 0.1 to 0.2 inch.
1~ Figures 1 through 5 ill~str~t~- that the proximal end of the housing contains a release button 64. The release button, which can be mounted on a side of the housing, is a spring loaded pawl mech~ni~m that eng~es detents or grooves 82 formed in an interior surface of one of rails 30, 32 of the track 28. Co~ res~ion of the release button 64 retracts t~e pawl 80 and allows the carriage to move fu~
(distally) or rearward (proximally) within the traclc 28. Once the pawl 80 is released it is forced (e.g., by spring biasing) against the interior wall 86 of the rail 30. Linear movement of the carriage is possible until the pawl 80 encounters a detent 82.
As i~ st~t~d in Figures 4 through 7, the carriage piston 68 can be in the forrn of a hollow cylinder that is closed at the distal end 88 thereof that projects from the a~el~ule 70 of housing 15. The proximal end of the piston comprises a collar 90 having an increased ~ met~r. The abutment of shoulder 89 of collar 90 with the interior of the wall of the housing, adjacent aperture 70, m~int~in~ the piston 68 within the housing in a displaceable condition.
As illll~tr~tPd in Figure 7, the interior of the housing 15 optionally in~ des adowel 94 which may extend the length of the housing and into the hollow, internal portion of the piston 68. Although not illustrated, the dowel preferably is able to extend through an opening ~not shown) in the proximal wall of the housing. Figure 7 illustrates that a compression spring 66 may be mounted around the dowel 94, which extends from a distal end 98 abutting the interior distal end wall 99 of the piston 68 SUB~TITUTE SHEET (RULE 26) CA 02229~47 1998-02-13 WO 97/07838 PCT~US96il3545 to the interior proximal wall 100 of the housing. As so configured, the piston is biased by the spring ç~emPnt 96 to the extended position.
As previously described, the driver device is intended to be fitted with a spe~ ific syringe and to deliver a single, specific dose of a me~ l fluid following spring ~t~l~tion. Such limitations are mainly enforced by (i) the shape and size of the syringe mounting yoke, (ii) the number and locations of r~t-hçting detents on the track, (iii) the limit of travel of the carriage piston, and (iv) the shape and location of antisiphon stop Pl~mPnt~ 78.
The syringe mounting çlPment 36 preferably is sized such that a syringe smaller than the correct size for a given driver device will immP~i~t~ly fall out of the driver device, and one of too large a diameter cannot be snapped into place within the driver device. .simil~rly~ a differently proportioned syringe, such as one from a different m~nllf~-t~llrer, cannot plop~-ly be fitted within the yoke. The syringe mounting elempnt 36 also serves to contact and restrain a portion of the syringe, such as the syringe flange or the distal end of the syringe, to m~int~in the position of the syringe body longitu~iin~lly when force is applied to the syringe plunger, or hydlo~tic forces (negative yl~s~ ;) are applied to the outlet tip 22 by the action of gravity on the column of fluid in the tubing assembly 18.
One of ordinary skill in the art will readily appreciate that by a~lu~liate design of the device, it is possible to provide adaptations to syringes having specific shapes and ~imPn~ions, and to adapt the device to deliver different dosages of fluids at various fluid flow rates. The syringe mounting elemçnt and the pûrtion of the2~ frame or track co~t~inin~ the detents may be fabricated as se~ le components that areJoined to the rem~inc~çr of the device during assembly. In ~ 1itinl1, a spacer, collar, ûr other ret~ining element may be added to the carriage piston to further limit its travel within the housing. In this way, variations of the device may be created with a minimllm of additional expense.
An example of one modification is to provide 5cc, rather than 10cc, doses for use in pediatric drug delivery. This modification can be accomplished by doubling the number of detents and by adding a collar or other device tû limit the travel of the carriage piston to approximately half of its original range.
CA 02229~47 1998-02-13 W O ~7/07838 PCT~US96/13545 .
Figures 1-5 illustrate an embodiment of the invention in which the syringe mounting elemPnt 36 compri~e~ yoke 38 which engages syringe flange 23. In another S embo~1imPnt illustrated in Figures 12 and 13, the syringe mounting element 36 ~ comprises a socket element 54 formed at a distal end of the frame 12. Socket elPmPnt 54 preferably engages a distal end 56 of the syringe 20 while an aperture 58 in the socket engages an elemPnt, such as a male luer htting 67, on the outflow tubing 18. ~1tern~tively~ as shown in Figures 14A, 14B, 16, and 17, the socket e1emPnt 54 may selectively engage an adapter element 34 of the microbore tubing assembly. It is understood that various other embo-limPnt~ may accomplish the same purpose, which is to engage the distal end of the syringe and/or adapter element 34 of the microbore tubing assembly. For example, an overh~nging lip (not shown) disposed on the distal end of the frame 12 may provide antisiphon protection by preventing proximal movement of the barrel under con-litiQns of negative pressure.
One advantage of this embodiment is that the geometry and/or ~imton~ion~ Of the adapter ~lPmPnt 34, for example, can be spef;fi~11y de~igned to fit a desired driver device. Further, a distal end of frame 12 can include an angled ramp portion 65 which will eject from the driver any syringe that is too large or too small for the driver or any syringe which has mounted to it a tubing assembly with an adapter mPnt 34 which is non-cooperating with socket PlemPnt 54.
As illustrated in Figures 14A and 14B, a syringe can be mounted within frame 12 by angularly inserting the distal end 56 of the syringe into the syringe mounting el~mPnt 36. Next, the syringe is forced downwardly until the syringe plunger is properly positioned adjacent the piston (not shown).
Figures 10-12 illustrate an embodiment of the invention in which frame 12 may include a hinge 106 to facilitate folding of the frame. As illustrated in Figures 10-12 ~he synnge securing element 36 is fQrmed by a socket 54 having an aperture 58 which accommodates a distal end 25 of syringe 16 or a proximal end of the tubingassembly.
Pigure 13 illustrates a similar embodiment in which frame 12 is telescoping - rather than folding. The frame includes a female portion 12A and a male portion 12B. A detent tab 121 is formed in a forward end of frame portion 12A. In the open position the detent 121 extends through an aperture 123 formed in the frame W O 97/07838 P~TAJS9~/13545 portion 12A to lock the frame in the open position. The frame can be closed by simply depressing tab ele~Pnt 121 and sliding frame portion 12B within frame portion 12A.
Figures 3A through 3D sequentially illl-cs~te the manner in which the driver device of the invention may be lltili7~, e.g., to deliver the first of a total of four m~~ fion doses.
Before the syringe 16 is mounted, the carriage 14 is placed in its fully retracted position at the proximal end 27 of the track 28. Proper insertion of the syringe places the syringe plunger disk 26 so that it is adjacent to the eYtt~n-ied carriage piston 68 and contained by the two anti-siphon latches 78. (See Figure 3A).
The extension of the carriage piston 68 is caused by force applied to it by the main spring 66 and is limited by an intPm~l stop ~e.g., the collar 90 of the piston). A
length of miclubol~; tubing 18 of known dimen~ior-c (i.e., length and int~rn~l Ai~mPtpr) and ~lro~ nce (i.e., rtoci~t~n~e to flow of a specified fluid) is cor~n~cte~l to the outlet port 22 of the syringe.
As shown in Figure 3~, to activate the device, initiating flow of the first doseof fluid, the carriage is advanced forwardly (distally) along the track 28 by manual ~Ytern~l force until the pawl 80 engages a desired detent 82 in the track. The carriage piston 68 exerts a force on the syringe plunger 24 and neither the piston nor the plunger can advance due to the presence of fluid in the syringe, the flow of which is restricted by the small diameter of the microbore tubing. This action causes the main spring 66 within the carriage to compress and thereby to apply a driving force to the plunger through the piston. As the carriage piston 68 becomes fully retracted into the carriage, the sliding pawl 80 in the carriage is forced into a detent 82 in the track by an auxiliary pawl biasing spring (not shown), thereby preventing the main spring 66 from forcing the carriage backwards (proximally) when the external force is removed.
As force is now being applied to the disk 26 of syringe plunger 24, fluid will be expelled through the outlet port 22, with a flow rate dependent on the spring force - and the resi~t~nce of the outflow tubing 18. The syringe plunger 24 and the carriage piston 68 will advance together until the piston is in the fully ~tPnded condition in which the collar of the piston contacts the interior distal wall 98 of the carriage. (See CA 02229~47 1998-02-13 WO 97/0783n PCT~US96/13545 , Figure 3C.) Once this condition is achieved, no further force is applied against the syringe plunger and thus fluid flow is stopped. Additional doses are initi~ted in turn by repeating the action of advancing the carriage to the next detent by manual applied force. ~See Figure 3D.) The design of the pawl and the detents in the track, shown in Figures 8 and 9, and the biasing force of the auxiliary pawl biasing spring (now shown) are optimized for several considerations. First, a rearward force of the main spring will not free the pawl from a detent. Second, only a moderate advancing force is needed to lift the pawl out of a detent, such as by a human user advancing the carriage distally to begin meAi-,~tion delivery. Third, the force needed to lift the pawl out of a detent is sllfflcient to resist previously described typical negative ~l~s~llres within the syringe barrel as may act on the locking el~m~nt~ through the plunger disk, anti-siphon stop lPmf~nt~ 78 and carriage housing 1~. Fourth, the detents are so po~itioned that, until a given dose is completed, it is impossible to advance the pawl into the detent corresponding to the following dose. If such an attempt is made, the carriage will advance only a limited ~ t~nee and will spring back to its correct positions as soon as the external force is removed.
If a dose is to be delivered from a partially-filled syringe (e.g., cont~ining, for example, only two of four possible 10-ml doses), the user first observes (using the ~r~ ted markings on the syringe barrel) the fill volume of the syringe, in this inst~nce 20 ml. The carriage is then advanced (by d~lessillg release button 64) distally along the rails of the frame, with a manual sliding motion until the pawl engages the detent corresponding to the locked, non force-applying position for a syringe filled to 20 ml. Preferably, a rail (30)-mounted label (not shown) assists the user in so positioning the carriage. The syringe is then inserted, and the spring is ac.ua-~eu for dose deliverj, as descr,bed above. Confir...atio.l of dose cor..pletio,. is visual by the user, involving observation of device status and plunger tip position with respect to the gr~dll~ted markings on the syringe barrel.
One feature of the driver device of the invention is that it delivers multiple -~ doses of fluid from a single syringe and that delivery of each dose is initi~tPd by recc,~ es~i.lg a drive spring by a simple, individual, manual action such that inadvertent delivery of multiple doses by an individual action is impossible.
W O 97/07838 PCT~US96/13545 Another feature of the driver device of the invention is that one is able to advance the carriage by applying manual force to the two ~ cçnt grip flanges 74 on S the carriage and the two ~di~ent gripping flanges 46 that form part of the syringe mounting elemPnt 36. These el~mPnt~ allow the user to grip the device with the thumb and forefinger of both hands and easily to apply suffici~ont force to advance the carriage. These grips are po~itinnt~d so that they are within the natural range of motion of an ordinaly adult hand. The apparatus does not require additional space or ~clP~r~nce during the operation of advancing the carriage.
An ~d~lition~l feature of the invention relates to removal of the syringe and retraction of the carriage. After all doses have been expelled from the syringe, the syringe may be lifted away from the ~paldtus with a snapping action. The releasebutton 64 on the side of the carriage, connected to the pawl 80, is depressed causing the pawl 80 to retract into the carriage body. While holding the release button down, the user may easily slide the c~rri~ge to its fully retracted position at the proximal end of the frame 12 so that a new syringe may be inserted.
As noted above, and as illustrated in Figures l through S, the driver device of the invention includ~s an anti-siphon element which prevents movement of the plunger independent of movement of the carriage or the force applying Plem~nt This m~nt is intPn~PA to prevent the syringe plunger from being drawn into the syringe barrel if negative pressure is applied to the syringe outlet port via the connecting tubing, causing an inadvertent delivery of additional fluid. In one embodiment, des-rihPd above, the anti-siphon element comprises of a pair of latches 78 formed on the intPrn~l surfAcPs of grip flanges 74 that constrain the syringe plunger disk. The gripping flange 46, in cooperation with the distal flange 48 helps to constrain the syringe flange 23. The combination of these el~mPnt~ prevents the plunger 24 from moving f~ l into the syringe barrel 20 after a dose is completed, and also prevents the syringe barrel 20 from sliding backwards over the plunger.
The shape of the latches 78 is such that if syringe plunger disk 26 is not fullycon~tr~ined by the latches 78 during insertion into the device, a sharp advancing force, m~nn~lly applied, will cause the latches 78 to snap over the plunger disk 26 and to ~e properly engaged by the latches. The first dose cannot be initi~tPf1 until this action has been taken.
WO 97/0783l3 PCTIUS96/1354r, In another embodiment, illustrated in Figures 16 and 17, a pivoting arm 118 has a subst~nti~lly centrally located pivot 120 mounted on a laterally protruding portion 122 of the arm. A proximal end of arm 118 includes a ratcheting pawl 114while a distal end of arm 126 includes a tapered catch 116. The arm 118 mounts within carriage 14, as shown in Figures 18 and 19, such that a spring mPch~ni~m (not shown) biases the pawl 114 into contact with detents ~not shown) in the track 28.
The catch 116 engages the syringe plunger disk 26 whenever the plunger disk 26 is disposed within plunger housing 124 appended to the distal end of carriage 14.
The geometry of the pivoting arm 118 is such that any pulling force on the catch 116 (due to a potential siphoning action) tends to increase the hol~ling force on the detent and thus prevents movement of the carriage. When a user presses the release button 128, which is ~tt~hed to the pawl, both the pawl 114 and the catch 116 are ~1icçng~ged, allowing the carriage 14 to be retracted and the syringe to be released for llnlo~-ling.
One of ordinal~y skill in the art will appreciate that further embo~limPntc having similar geometries involving both pivoting and sliding devices can produce the same combination of ratcheting and anti-siphoning actions.
An additional feature of the invention is that the spring force applied to the syringe plunger 24 does not change ~igni~lc~ntly during the travel required to deliver a dose. Accordingly, the flow rate also does not change significantly during delivery of the dose. This is accomplished by three means. ~irst, as described above, thespace provided for the main compression spring 66 is relatively long, despite the compact ~lim~n~ions of the device. This is partly the result of the use of a hollow carriage piston 68, enabling a portion of the spring to reside within the piston.
Second, the spring is compressed to less than about half of its unstressed length before being assembled into the carriage. The additional compression of the spring required to advance the carriage during use is only a small fraction of the total cc~ s~ion applied to the spring, reslllting in only a small change in reaction force.
~urther, the spring is recompressed for each dose. Because the spring need only be coln~l~,sed sufficiently to deliver a single dose, rather than multiple doses, it must be colll~r~ssed only a small amount for subsequent doses in addition to the colll~lcssion provided during assembly of the apparatus.
W O 97/07838 P~T~US96/13~45 A further advantage of the driver device of the invention is that a simple coil spring is preferably employed as the main spring 66. This spring acts directly in line with the syringe plunger, minimi7ing frictional forces that might act to disturb the force applied to the syringe.
Re~ ce the invention as described depends on the fluid reci~t~nce in the connecting tube to control flow rate, it is important that microbore tubing of proper internal diameter be employed. Many operational strategies, such as co-packaging of pre-filled me~lir~tion cont~ining syringes with ~pioL>-iate microbore tubing, may be employed to ensure safe practice. In some applications it may be ~ o~liate to me~h~nic~lly d~lic~t~ syringe drivers of a particular design to a specific type, or family of types, of precision microbore tubing. In one such embodiment, shown inFigures 14A and 14B, the adapter element 34 of the microbore tubing assembly can1~ have a non-standard geometry and/or dimencions that are adapted to fit only within compl~m~nt~rily si~d and shaped sockets 54 of the syringe mounting elern~nt 36, as described above.
Figure l5A illn~tr~tes a typical male luer fitting 67 which may form a proximal end of the microbore tubing assembly 18 to f~cilit~te connection to thesyringe. Figures 15B and C illustrate different embodiments of an adapter element 34 for a microbore tubing assembly 18. In these embo~1iment~ the adapter is illustrated to be generally oval or circle-shaped, however various other geometries may be used as well. Proximal to adapter 34 is a male Luer lock fitting 67 whichcan mate with outlet tip 22 and female luer components of syringe distal end ~6.In one embo~liment~ filled syringes are distributed with a tubing set ~tt~t he~ or in a combined package. Operating protocol would require that such syringes always be used with the tubing sets with which they are packaged, and that any unused syringes or tube sets must be disposed of or returned to the distributor.
Table 1 illustrates the approximate spring force and length requirements for use of 20cc and 60cc syringes, in which units are in inches and pounds. The smaller syringe requires lower force because of its smaller piston area. By ~ iate choice of spring wire diameter and sprin~ length and pitch, a ratio of maximum to minimllm force can be m~int~in~d comparable to that used with the 60cc syringe, without WO ~7/07838 PCT~US96/13545 greatly t~Ytencling the working spring length. Typically, spring force of about 8 pounds is suitable for use with a 60cc syringe.
S
Table 1: SPRING CALCULATIONS for lOcc doses from 60cc and 20cc syringes (60cc) (20cc) (60cc) (20cc) d (wire ~ ,.)0.048 0.033 plunger diameter 1.05 0.75 10 D (coil diameter) 0.5 0.5 plunger area0.865901 0.441786 n (number of 20 16 F1 (min force) 63.061224 turns) G (shear modulus) 107 107 F2 (max force) 8 4.081633 (302 Staillless) dx (x1-x2) 0.775 1.3265 15 K (spring constant)2.654208 0.741201K (spring const~nt)2.580645 0.769249 (from spIing (from load ~,~.. ,Lly) lc;~lui~ b) xl (df~.fl~ti~n at ~1) 2.325 3.9795 x2 (d~ofl~rti~n at F2) 3.1 5.306 Lfree (n~n. free length)4.156 5.8868 Lstart (length at xl) 1.831 1.9073 pitch at Lfree 0.20780.367925 pitch at xl 0.091550.119206 pitch at x2 0.0528 0.0363 The flow rate through a circular tube under laminar conditions is det~rmin~d by Poi~seuille's law, which can be stated as:
';T7 4 8~LL
where Q is the volumetric flow rate, r is the int~rn~l radius of the tube, ~ is the fluid viscosity, L is the length of the tube, and p is the pressure drop along the tube length. The pressure drop can be expanded as:
_ P = Pi - Po + PgZ
W O 97/07838 PCT~US9G/13545 where Pi is the applied pressure at the inlet end, pO is the applied plessu~e at the outlet end, is the fluid mass density, g is the gravitational conct~nt and z is the S difference in height between the two ends of the tube. In the present case, pO is the venous blood yr~s~ule of the patient (typically less than lOcm H2O), and z is the height of the syringe relative to the patient's body.
The inlet ~les~u~, Pi, is the force, ~, acting on the syringe plunger divided by the plunger surface area, A, and less the friction loss between the plunger and syringe wall, n. The force generated by the compressed spring is known from Hooke's law. In this case Hooke's law may be written as:
F=k(lp+ld) where k is the spring constant (essenti~lly the stiffnPss of thê spring), lp is the pre-1~ load deflection applied during assem~ly, and Id is the additional deflection applied to activate a dose. Mech~ni~l concider~tions require that Ip always be somewhat less than the unlo~lcd spring length, particularly for compression springs. The value of d is at a maximum at the start of a dose, and goes to zero at the completion of a dose. The design of the present invention, as described previously, provides for Id to be small compared to Ip, and, as can be seen from the above equation, this minimi7es the change in force during a dose.
The previous e~uations can ~e combined to obtain:
~77r 4 k(lp+ld) For m~ximllm consistency, the values for k, Ip, and Id should be large enough, ~ relative to A, that the other terms within the brackets have a negligible effect on the flow rate. It should be noted that this analysis is only applicable for certain spring types; Hoolce's law does not apply to "Neg'ator" type springs, and is only .
appro~im~tP- for stretchable rubber springs, which can exhibit highly non-linearbehavior.
S It is understood that various mo Tific~tions can be made to the invention described and cl~imPd herein without departing from the intended scope thereof. All references noted herein are expressly incorporated by reference herein in their entirety.
What is ~l~im~Pd is:
CA 02229~47 1998-02-13 W O 97/07838 PCT~US96/13545 MULTI-DOSE SYRINGE DRIVER
R~-~k.~round of the Invention The invention relates to syringe drivers and systems for effecting a controIled infusion of a m~ l fluid from a syringe.
Certain met1i-~1 fluids are ~(1mini~tered by controlled parenteral infusion and require a slow but non-rate critical flow. Infusion of a me-lic~l fluid in this manner has been generally accomplished by use of a drip bag gravity-feed system or an electronic infusion pump. The drip bag provides non-rate critical flow with a simple and relatively inexpensive apparatus.
In certain applic~tion~ particularly those involving small fluid volumes, the use of disposable syringes is preferred to drip bags. The disposable syringe is a commodity item. Syringes may be ~lepa.ed in large qu~ntitie~ and stored for later use, thereby reducing costs and providing greater reliability and repeatability of preparation. Also, a single syringe may be used to provide mllltiple doses, simply by advancing the syringe plunger in fixed increments. For example, it may be desired to fill a 60cc syringe with 40cc of fluid and to then ~f~mini~ter the fluid in lOcc doses, with a flow rate such that a single dose is delivered in twenty to forty minutes.
Doses may then be repeated at fixed intervals, with four doses being delivered from a single disposable syringe.
There exist several advantages to delivering multiple doses from a single dose delivery system. A single large syringe is less expensive than several small syringes or other single dose devices. Significant time savings can be realized in filling, h~ntlling, and ~dmini~tering the syringes since the overall number of operations is greatly recluced. There may also be a decrease in patient risk due to the fact that the intravenous delivery system must be opened fewer times for component changes, and so there are fewer opportunities for c-)nt~min~tion or h~n~llin~ errors.
Arimini~tration of me~ l fluids at a low flow rate using a syringe is generally accompli~hed by the use of a syringe pump. A typical syringe pump is a motorized, programmable device on which a syringe is mounted, and which expels fluid from the syringe by advancing the syringe plunger at a controlled rate. The motorized pump advances the syringe plunger at a predetermined velocity, applying force as required to m~int~in this velocity. The flow rate is therefore independent of fluid resistance unless the resistance becomes so high that the pump cannot sa~ely provide the CA 02229F,47 1998-02-13 corresponding force required. The advantages of using disposable syringes for non-rate critical applications are ~limini~hed by the cost and complexity of ~ ting syringe pumps. Typical pumps are battery powered, microprocessor controlled, provide numerous progr~mming options and ~nnllnci~tors, and require detailed operator tra~ning and ongoing m~int~n~n~e and inspection. Much of the cost and complexityof the syringe pump is directed to the requirements of rate critical appiic~tio~s and is not required for non-rate critical applications. See, U.S. Patent Nos. 4,804,368(Skakoon); 4,544,369 (Skakoon); and 4,943,279 (Samiotes).
Several devices have been developed that are intenfled to provide less complex and expensive means of providing non-rate critical infusion with a disposable syringe.
One option is to replace the electronic components of a typical infusion pump with a spring driven clockwork mPcll~ni~m While this type of device has been described,no actual devices are known to have been commerci~li7Pd. See, U.S. Patent Nos.
4,059,110 (Wuthrich) and 4,676,122 (Szabo).
A second option is based the use of a predetermined force, rather than a predetermined velocity, that is applied to the syringe plunger so that fluid re~i~t~n~e acts to control the flow rate. This force may be applied by a simple mPch~ni~m, such as a weight, or colllyless~d or eYtPn-ied spring of aL~ liate stiffnesc. See, U.S.
Patent No. 4,132,231 (Puccio). By a~l~liate sP~oction of applied force and fluidre~i~t~n-e, the res-lltin~ flow rate can be çn~ineered to a desired level. Fluidresistance may be controlled by varying the length and intçrn~ mptçr of the tubing that connects the syringe to the patient. Appropriate tubing for this application is known as precision microbore tubing because it has a si~nifi~ntly smaller bore m~ter than standard tubing used with drip bags or motorized pumps, and because it is m~n~-f~rtl-red to defined tolerances and specific end points having to do with resistance to fluid flow.
A commercial device based on this ~lt~rn~tive is the "Medifuse" device available from 3M ~lthc~re. In this device, a 'LNeg'ator" rolled spring is used to apply an approximately constant force to a syringe plunger. This is combined with a selection of microbore tubing sizes, each with a different internal rl;~me~çr to provide control of flow rate. A somewhat complicated roller and track mP-~h~ni~m is required to cou~L~ dct the applied torque that is a consequence of the use of the "Neg'ator~
SUBSTITUTE SHEET (RULE 26) CA 02229~47 l998-02-l3 WO 97io7838 ' PCT~US96/1354~
spring. The "Medifuse" device functions as inten~d but its applicability is limited because it does not provide control of multiple doses from a single syringe. TheS "Neg'ator" spring, because of its rolled design, is susceptible to changes in spring force due to cont~min~tion by sticky, abrasive, or particulate m~t~-n~l. Moreover, a spring of this type may be easily damaged by i~ uper h~nflling during cleaning. An additional limit~ion is that the activating mechanism for initi~tin~ a dose on the "Medifuse" device involves pivoting a large cover component, which can be clumsyand which requires additional clearance. Also, a syringe cannot be mounted within a "Medifuse" device without initi~ting fluid delivery from the syringe. U.S. Patent Nos. 4,202,333 ~Thill); 4,298,000 (Thill); 4,430,079 (Thill); and 4,597,754 Cl~hill).
Another commercial device, the UBand-It~ from I-Flow, Inc., described in U.S. Patent No. 5,429,607 (McPhee), employs microbore tubing but applies force to the syringe plunger using an elastomeric element, such as a stretched band of latex rubber. This device is extremely simple but, again, does not enable delivery of multiple doses. Also, it does not provide a constant or nearly constant flow rate because the force applied by the elastomeric elemçnt varies ~ignific~ntly over the range of plunger travel. This device further requires manual ~ tcl~ g of the elastomeric element and provides no r~ech~ni~m to assist in this action. Like the ''Medifuse" device, a syringe cannot be mounted in a "Band-It" unit without causing fluid to be delivered from the syringe.
Other syringe driver systems and described in U.S. Patent Nos. 4,636,197 (Chu); 4,608,042 (Vanderveen); and 5,318,539 (O'Neil).
Known mech~nit~l, predetermined force-applying devices are not well suited to the delivery of multiple doses from a single syringe. Conversion of these devices to achieve multiple dose control might be accomplished using removable stops to limit the range of plunger travel. By sequentially removing the stops, the plunger could move in a series of fixed increments. Such stops, however, are not intrincic~lly safe. It is possible to remove several stops at the same time, or to remove the stops in the wrong order. The result can be an overinfusion conditioninvolving the delivery of two or more doses in a continuous manner.
Another drawback of such devices is that the force applied to the plunger can decrease over the range of travel of the plunger. The result is that successive doses SUBS T ITUTE SHEET (RULE 26) W O 97/07838 PCT~US96/13545 will be delivered from the same syringe at increasingly lower flow rates. Various additional references that describe dose setting include U.S. Patent Nos. 2,632,445 S (~as); 4,498,904 (Turner); 5,232,459 (Hjertman); 5,300,041 (Haber~; 5,328,486 (Woodruff); and 5,092,842 (Bechtold).
Suntmarv of the Invention The present invention overcomes the disadvantages of the prior art by providing a driver device for effecting a controlled, parenteral infusion of a mf~
fluid using an available disposable syringe. The driver device is inten~led for non-rate critical appliç~ticn~, and provides ease of use, intrin~ic safety, robustness, and low cost.
The invention con~i~t~ of two main components: (i) a syringe driver device within which a syringe is removably mountable and which employs a colnpl~ssed spring element to apply a driving force to the syringe plunger, and (ii) a length of microbore tubing having a small inner rli~m~ter through which fluid flows after exiting the syringe, and which provides resi~f~nce to limit the rate of flow. Specific fe~u.~:s of the invention f~cilit~t~ delivery of multiple doses, control of dose volume, easy two-handed opçr~tion, and protection against lmintt-nti~n~l syringe plungertravel.
In particular, the syringe driver device of the invention includes a frame and aselectively positionable carriage that is slidably mounted on the frame, preferably ~d3~ont to the proximal end of the frame. A force applying çlernçnt that is 2~ preferably disposed in or on the carriage is biased to extend from the distal end of the carriage. Preferably, a spring çlçmenf~ disposed within the carriage, applies a biasing force to the force applying Pl(~m~ont Cooperating locking çlçm~ntc are disposed on the frame and carriage to secure the carriage to the frame in a desired position. One or more Pl~m~nt~ for securing and m~int~;ning a syringe within the frame are associated with the frame.
Desired carriage positions include (i) an unlocked, slidable position; ~ii) at least one locked, force applying position in which the force applying elem~nt is at least partially retracted within the carriage; and ~iii) a locked, non-force applying position in which the force applying Plement is fully exten~led ~rom the carriage.
SUBSTITUTE SHEET (RULE 26) W O 97t07838 PCT~US96/1354~
In its operative condition, the syringe driver system constructed according to the present invention inclllcles a syringe, which is secured within the frame, and a S microbore tubing assembly secured to the distal end of the syringe. The microbore tubing assembly has proximal and distal ends with a fluid passageway ~ tPn-ling there between. The proximal end typically inc~ iec a mP-~h~nicm, such as a "Luer Lock,"
to f~ilit~tP ciet~-h~hie coupling to an outlet end of the syringe. Optionally, a family of microbore tubing assemblies is provided. Additionally, each type of microboretubing has an internal passageway with a different inner ~i~mt?tPr and other ~~h~r~cterictics nPcecc~ry to achieve a specified recict~nce to fluid flow. Each type of microbore tubing assembly may have an adapter mech~nicm with a different external geometry and/or flimPncionc coll~onding to a given resistance to fluid flow. Thevarious adapter m~ch~nicms may cooperate selectively with a socket or other engagement means associated with an appl~liate driver device having mP~h~nic~l çh~r~ct~rictirs suitable to the inten~ed fluid delivery app~ tiQ~
The present invention provides a novel driver device that OVt;lCO~ S problems that are ~r~se.lled by the prior art. An ordinary, co."plession type coil spring, or a similar means, is employed to provide the driving force to the syringe. ~owever, the spring must be moved and l.,co.~ ssed for the delivery of each dose. This ".~h~nicm thus enables the m~nit~l~ie of the spring force to be m~int~in~d for sequential doses. The structure of the device that lecu.,.L,resses the spring for each dose is such that it is not possible to set the device to deliver more than one dose contimlously. At the end of the delivery of a dose, any further e~tPncion of thespring, and resulting delivery of fluid, is prevented by a non-removable stop so that continllous, "run away" delivery of fluid is not possible. Acl-lition~lly, at the end of a dose delivery, siphoning or drainage of fluid from the syringe or~ tubing assembly is prevented by non-removable stops which engage the plunger and the syringe barrel, les~e~;Lively, to counteract any hydrostatic force which may tend to bias the plunger towards full insertion when the carriage is in the locked, non-force applying position.
Accordingly, the invention provides a driver device for slowly e~ecting one or more fluid volumes from a specified meAic~l cont~in~r (e.g., a syringe) having a ngid barrel, gr~-iu~t~ci m~rkingc, an outlet port, a gripping flange, and a plunger with tip and disk mech~nicm SUBSTITUTE SHEET (RULE 26) CA 02229~47 1998-02-13 W O 97/07838 PCT~US96/13545 Brief Description of the I~rawinEs Figure 1 is a perspective view of a syringe driver assembly constructed according to the present invention.
Figure 2A is a perspective view from the rear (proximal) end of the syringe driver shown in Figure 1, without the syringe.
Figure 2B is a perspective view from the front (distal) end of the syringe driver shown in Figure 1, without the syringe.
Figures 3A through 3D schem~tic~lly illllctr~te the operation of the syringe driver a~P-mhly shown in Figure 1.
Figure 4 is an eYplo-ie~i view of the syringe driver device shown in Figure 2A.
Figure S is an exploded view of the syringe driver device shown in Figure 2B.
Figure 6 is a side, sectional view of a force-applying el~m~nt used with the syringe driver assembly shown in Figure 1.
Figure 7 is a side view, partially cut away, illll$tr~t~ng the internal mPch~ni~m of the carriage çlem~ont of the driver device.
Figure 8 is a side view of one rail of the track forming the syringe driver assembly of Figure 1.
Figure 9 is a side view of the track shown in Figure 8, rotated 90 in the clockwise direction about the longit~l-lin~l axis of the rail.
Figure 10 is a side view of another embodiment of a syringe driver device constructed according to the present invention, having a folding frame shown in the closed position.
Figure 11 is a side view of the syringe driver device of Figure 10, in the partially opened position.
Figure 12 is a side view of the syringe driver of Figure 10, in the fully openedposition and housing a syringe.
Figure 13 is a side view of another embodiment of the syringe driver device according to the present invention, having a telescoping frame ~c~eml~ly.
Figure 14A i~ tr~t~os a syringe mounted within the front end of the driver device constructed according to one embodiment of the invention.
Figure 14B is a pe.~ecLive view of a front end, partially cut away, of the driver device illustrated in Figure 14A.
SUBSTITUTE SHEET (RULE 26 Figure lSA is a detailed view of a male luer lock fitting.
Figures 15B and C are detailed views of alternative adapter elementc useful with the microbore tubing assembly.
Figure 16 illlT~tr~te~ another embodiment of the driver device of the invention.~ Figure 17 is an exploded view of the driver device of Figure 16.
Detailed Description of the Invention The syringe driver of the invention is useful to f?~ t~te multiple sequential doses of a fluid, such as a mt~ m~nt, from a syringe at a controlled, pre~efP min~d flow rate. The driver device lO, as illll~tr~ted in Figures 1-9, comprises a frame 12, a c~ ge 14, a syringe lo, mounted within the frame, and an outflow tubing assembly 18.
The syringe 16 used with the driver device can be any type of syringe used to dispense me~ l fluids such as me~ m.ontc and the like. The syringe can be of anyone of a variety of sizes, ranging, for example, from Scc to 60cc volume capacity.
The syringe incll~des a barrel (with gr~ t~d markings) 20, an outlet tip 22 at the distal end of the syringe, which connects to outflow tubing assembly 18, a syringe plunger 24, a syringe flange 23, and a plunger disk 26 at a proximal end of the plunger. The plunger is slidable between withdrawn and inserted positions to expel fluid from within the syringe barrel.
As illustrated, the frame 12 has distal 25, and proximal 27 ends, and comprises a track 28, formed of adjacent, parallel rails 30, 32. A carriage 14 is mounted upon the rails 30, 32 of track 28 at the proximal end 27 of the frame, and is able to slide along the track proximally and distally. The distal end 25 of the frame 12 in~ltldes a syringe mounting element 36 which secures the syringe within the frame 12.
Figures 1-5 ilhl5tr~te an embodiment in which the syringe mounting elemPnt 36 is a yoke elPmenr 38 that mates with the syringe flange 23 to help secure thesyringe 20 within the frame 12. The yolce element 38 also acts as an end stop for the carriage motion. The yoke element 38 comprises a longitudinal groove structure 40 for receiving the syringe barrel 24 and plunger assembly. The space separating the eent gri~ping flange 46 and the distal flange 4g forms a transverse slot 50 which SUBS T ITUTE SHEET (RULE 26) W O 97/07838 PCT~US96/13545 is able to engage securely the syringe flange 23, such as through a mech~nic~l fit.
The yoke el~m~nt 38 also serves to prevent movement of the syringe barrel 20, in the proximal or distal directions, relative to the syringe plunger 24.
As illustrated in Figures 12 and 13 the syringe mounting elem~nt 36 can also be in the form of a socket element 54 which cooperatively engages and :iU~Oll'i the distal end 56 of syringe 16 and/or the proximal portion of outflow tubing assembly 18. The socket ~ ment 54 is shaped and ~lim~nci~)ned to cooperatively engage thedistal end 56 of the syringe. Socket 54 ~ feldbly, in~ des an ap~llul~ 58 through which the outlet tip 22 of the syringe, the male luer 67, and the outflow tubing 18 may extend. ~lt~-rn~tively~ as shown in Figures 14A, 14B, 16, and 17, the socketPlemçnt 54 may be flimtoneioned selectively to engage and support an adapter elem~nt 34 of the microbore tubing assembly 18 shown in Figures 15B and 15C.
The proxima} end 27 of the frame 12 includes a stop element 52 for preventing further proximal movement of the carriage 14. Optionally, a hanger device 53 is ~ccot~i~ttod with the stop 52 to enable the apparatus to be sllcrçnde~
As i~ etr~ted in Figures 2A and 4, the carriage 14 inclll~les a structure that enables the carriage to mount and slide upon rails 30, 32 of frame track 28. In one example the carriage may include a longit~-r1in~11y oriented slot 60 on each side of the carriage. The slot 60 mates with a horizontal lip 62 formed on each rail 30, 32.This eng~g~mPnt allows the r~ ge to slide freely on the track 28, while at the same time preventing any vertical, dislodging movement of the c~ e.
The carriage 14 comprises a housing 15 which contains a spring ~l~mpnt 66.
A piston device 68 is displaceably poeitio~ed within and is biased to proiect from an ap~lluie 70 formed in a distal end 72 of the housing. Dual finger grip flanges 74 also extend from the distal end of the housing. Each finger grip flange comprises an outwardly flared finger grip el~ment 76. Further, the interior surface of each finger grip flange incl~lcles an anti-siphon latch or stop element 78 that prevents further distal movement of the syringe plunger (relative to the syringe barrel) independent of movement of the carriage or piston 68.
Cooperating locking elernPnte are associated with the carriage 14 and the frame 12 to secure the carriage to the frame. The coo~e~ ing locking elem~nte enable the carnage to be secured in the following positions~ an unlocked position;
SUBSTITUTE SHEET (~ULE 26) (ii) at least one locked, force applying position in which the piston 68 is at least partially retr~rtçd within the carriage; and (iii) a locked, non-force applying position S in which the piston 68 is fully ext~nded from the carriage.
In one embodiment, illustrated in Figures 1-5, the cooperating locking ~ PlPm~nt~ can comprise the combination of a pawl mech~nicm 80 formed on the carriage and a plurality of detents 82 formed on at least one of rails 30, 32. Detents 82 can be of virtually any useful shape and dimen~ion. Figures 8 and 9 i~ str~te an e~mpl~ry detent shape in which a distal part of detents 82 has a wall 201 which angles outwardly at a gradual rate before reaching a rounded out detent area 203 that it bordered, at its proximal end, by wall 205. By way of example, each detent 82can span a tli~t~nce, from proximal to distal ends, of about 0.2 to 0.4 inch, and have a depth, at its detent area 203, of about 0.1 to 0.2 inch.
1~ Figures 1 through 5 ill~str~t~- that the proximal end of the housing contains a release button 64. The release button, which can be mounted on a side of the housing, is a spring loaded pawl mech~ni~m that eng~es detents or grooves 82 formed in an interior surface of one of rails 30, 32 of the track 28. Co~ res~ion of the release button 64 retracts t~e pawl 80 and allows the carriage to move fu~
(distally) or rearward (proximally) within the traclc 28. Once the pawl 80 is released it is forced (e.g., by spring biasing) against the interior wall 86 of the rail 30. Linear movement of the carriage is possible until the pawl 80 encounters a detent 82.
As i~ st~t~d in Figures 4 through 7, the carriage piston 68 can be in the forrn of a hollow cylinder that is closed at the distal end 88 thereof that projects from the a~el~ule 70 of housing 15. The proximal end of the piston comprises a collar 90 having an increased ~ met~r. The abutment of shoulder 89 of collar 90 with the interior of the wall of the housing, adjacent aperture 70, m~int~in~ the piston 68 within the housing in a displaceable condition.
As illll~tr~tPd in Figure 7, the interior of the housing 15 optionally in~ des adowel 94 which may extend the length of the housing and into the hollow, internal portion of the piston 68. Although not illustrated, the dowel preferably is able to extend through an opening ~not shown) in the proximal wall of the housing. Figure 7 illustrates that a compression spring 66 may be mounted around the dowel 94, which extends from a distal end 98 abutting the interior distal end wall 99 of the piston 68 SUB~TITUTE SHEET (RULE 26) CA 02229~47 1998-02-13 WO 97/07838 PCT~US96il3545 to the interior proximal wall 100 of the housing. As so configured, the piston is biased by the spring ç~emPnt 96 to the extended position.
As previously described, the driver device is intended to be fitted with a spe~ ific syringe and to deliver a single, specific dose of a me~ l fluid following spring ~t~l~tion. Such limitations are mainly enforced by (i) the shape and size of the syringe mounting yoke, (ii) the number and locations of r~t-hçting detents on the track, (iii) the limit of travel of the carriage piston, and (iv) the shape and location of antisiphon stop Pl~mPnt~ 78.
The syringe mounting çlPment 36 preferably is sized such that a syringe smaller than the correct size for a given driver device will immP~i~t~ly fall out of the driver device, and one of too large a diameter cannot be snapped into place within the driver device. .simil~rly~ a differently proportioned syringe, such as one from a different m~nllf~-t~llrer, cannot plop~-ly be fitted within the yoke. The syringe mounting elempnt 36 also serves to contact and restrain a portion of the syringe, such as the syringe flange or the distal end of the syringe, to m~int~in the position of the syringe body longitu~iin~lly when force is applied to the syringe plunger, or hydlo~tic forces (negative yl~s~ ;) are applied to the outlet tip 22 by the action of gravity on the column of fluid in the tubing assembly 18.
One of ordinary skill in the art will readily appreciate that by a~lu~liate design of the device, it is possible to provide adaptations to syringes having specific shapes and ~imPn~ions, and to adapt the device to deliver different dosages of fluids at various fluid flow rates. The syringe mounting elemçnt and the pûrtion of the2~ frame or track co~t~inin~ the detents may be fabricated as se~ le components that areJoined to the rem~inc~çr of the device during assembly. In ~ 1itinl1, a spacer, collar, ûr other ret~ining element may be added to the carriage piston to further limit its travel within the housing. In this way, variations of the device may be created with a minimllm of additional expense.
An example of one modification is to provide 5cc, rather than 10cc, doses for use in pediatric drug delivery. This modification can be accomplished by doubling the number of detents and by adding a collar or other device tû limit the travel of the carriage piston to approximately half of its original range.
CA 02229~47 1998-02-13 W O ~7/07838 PCT~US96/13545 .
Figures 1-5 illustrate an embodiment of the invention in which the syringe mounting elemPnt 36 compri~e~ yoke 38 which engages syringe flange 23. In another S embo~1imPnt illustrated in Figures 12 and 13, the syringe mounting element 36 ~ comprises a socket element 54 formed at a distal end of the frame 12. Socket elPmPnt 54 preferably engages a distal end 56 of the syringe 20 while an aperture 58 in the socket engages an elemPnt, such as a male luer htting 67, on the outflow tubing 18. ~1tern~tively~ as shown in Figures 14A, 14B, 16, and 17, the socket e1emPnt 54 may selectively engage an adapter element 34 of the microbore tubing assembly. It is understood that various other embo-limPnt~ may accomplish the same purpose, which is to engage the distal end of the syringe and/or adapter element 34 of the microbore tubing assembly. For example, an overh~nging lip (not shown) disposed on the distal end of the frame 12 may provide antisiphon protection by preventing proximal movement of the barrel under con-litiQns of negative pressure.
One advantage of this embodiment is that the geometry and/or ~imton~ion~ Of the adapter ~lPmPnt 34, for example, can be spef;fi~11y de~igned to fit a desired driver device. Further, a distal end of frame 12 can include an angled ramp portion 65 which will eject from the driver any syringe that is too large or too small for the driver or any syringe which has mounted to it a tubing assembly with an adapter mPnt 34 which is non-cooperating with socket PlemPnt 54.
As illustrated in Figures 14A and 14B, a syringe can be mounted within frame 12 by angularly inserting the distal end 56 of the syringe into the syringe mounting el~mPnt 36. Next, the syringe is forced downwardly until the syringe plunger is properly positioned adjacent the piston (not shown).
Figures 10-12 illustrate an embodiment of the invention in which frame 12 may include a hinge 106 to facilitate folding of the frame. As illustrated in Figures 10-12 ~he synnge securing element 36 is fQrmed by a socket 54 having an aperture 58 which accommodates a distal end 25 of syringe 16 or a proximal end of the tubingassembly.
Pigure 13 illustrates a similar embodiment in which frame 12 is telescoping - rather than folding. The frame includes a female portion 12A and a male portion 12B. A detent tab 121 is formed in a forward end of frame portion 12A. In the open position the detent 121 extends through an aperture 123 formed in the frame W O 97/07838 P~TAJS9~/13545 portion 12A to lock the frame in the open position. The frame can be closed by simply depressing tab ele~Pnt 121 and sliding frame portion 12B within frame portion 12A.
Figures 3A through 3D sequentially illl-cs~te the manner in which the driver device of the invention may be lltili7~, e.g., to deliver the first of a total of four m~~ fion doses.
Before the syringe 16 is mounted, the carriage 14 is placed in its fully retracted position at the proximal end 27 of the track 28. Proper insertion of the syringe places the syringe plunger disk 26 so that it is adjacent to the eYtt~n-ied carriage piston 68 and contained by the two anti-siphon latches 78. (See Figure 3A).
The extension of the carriage piston 68 is caused by force applied to it by the main spring 66 and is limited by an intPm~l stop ~e.g., the collar 90 of the piston). A
length of miclubol~; tubing 18 of known dimen~ior-c (i.e., length and int~rn~l Ai~mPtpr) and ~lro~ nce (i.e., rtoci~t~n~e to flow of a specified fluid) is cor~n~cte~l to the outlet port 22 of the syringe.
As shown in Figure 3~, to activate the device, initiating flow of the first doseof fluid, the carriage is advanced forwardly (distally) along the track 28 by manual ~Ytern~l force until the pawl 80 engages a desired detent 82 in the track. The carriage piston 68 exerts a force on the syringe plunger 24 and neither the piston nor the plunger can advance due to the presence of fluid in the syringe, the flow of which is restricted by the small diameter of the microbore tubing. This action causes the main spring 66 within the carriage to compress and thereby to apply a driving force to the plunger through the piston. As the carriage piston 68 becomes fully retracted into the carriage, the sliding pawl 80 in the carriage is forced into a detent 82 in the track by an auxiliary pawl biasing spring (not shown), thereby preventing the main spring 66 from forcing the carriage backwards (proximally) when the external force is removed.
As force is now being applied to the disk 26 of syringe plunger 24, fluid will be expelled through the outlet port 22, with a flow rate dependent on the spring force - and the resi~t~nce of the outflow tubing 18. The syringe plunger 24 and the carriage piston 68 will advance together until the piston is in the fully ~tPnded condition in which the collar of the piston contacts the interior distal wall 98 of the carriage. (See CA 02229~47 1998-02-13 WO 97/0783n PCT~US96/13545 , Figure 3C.) Once this condition is achieved, no further force is applied against the syringe plunger and thus fluid flow is stopped. Additional doses are initi~ted in turn by repeating the action of advancing the carriage to the next detent by manual applied force. ~See Figure 3D.) The design of the pawl and the detents in the track, shown in Figures 8 and 9, and the biasing force of the auxiliary pawl biasing spring (now shown) are optimized for several considerations. First, a rearward force of the main spring will not free the pawl from a detent. Second, only a moderate advancing force is needed to lift the pawl out of a detent, such as by a human user advancing the carriage distally to begin meAi-,~tion delivery. Third, the force needed to lift the pawl out of a detent is sllfflcient to resist previously described typical negative ~l~s~llres within the syringe barrel as may act on the locking el~m~nt~ through the plunger disk, anti-siphon stop lPmf~nt~ 78 and carriage housing 1~. Fourth, the detents are so po~itioned that, until a given dose is completed, it is impossible to advance the pawl into the detent corresponding to the following dose. If such an attempt is made, the carriage will advance only a limited ~ t~nee and will spring back to its correct positions as soon as the external force is removed.
If a dose is to be delivered from a partially-filled syringe (e.g., cont~ining, for example, only two of four possible 10-ml doses), the user first observes (using the ~r~ ted markings on the syringe barrel) the fill volume of the syringe, in this inst~nce 20 ml. The carriage is then advanced (by d~lessillg release button 64) distally along the rails of the frame, with a manual sliding motion until the pawl engages the detent corresponding to the locked, non force-applying position for a syringe filled to 20 ml. Preferably, a rail (30)-mounted label (not shown) assists the user in so positioning the carriage. The syringe is then inserted, and the spring is ac.ua-~eu for dose deliverj, as descr,bed above. Confir...atio.l of dose cor..pletio,. is visual by the user, involving observation of device status and plunger tip position with respect to the gr~dll~ted markings on the syringe barrel.
One feature of the driver device of the invention is that it delivers multiple -~ doses of fluid from a single syringe and that delivery of each dose is initi~tPd by recc,~ es~i.lg a drive spring by a simple, individual, manual action such that inadvertent delivery of multiple doses by an individual action is impossible.
W O 97/07838 PCT~US96/13545 Another feature of the driver device of the invention is that one is able to advance the carriage by applying manual force to the two ~ cçnt grip flanges 74 on S the carriage and the two ~di~ent gripping flanges 46 that form part of the syringe mounting elemPnt 36. These el~mPnt~ allow the user to grip the device with the thumb and forefinger of both hands and easily to apply suffici~ont force to advance the carriage. These grips are po~itinnt~d so that they are within the natural range of motion of an ordinaly adult hand. The apparatus does not require additional space or ~clP~r~nce during the operation of advancing the carriage.
An ~d~lition~l feature of the invention relates to removal of the syringe and retraction of the carriage. After all doses have been expelled from the syringe, the syringe may be lifted away from the ~paldtus with a snapping action. The releasebutton 64 on the side of the carriage, connected to the pawl 80, is depressed causing the pawl 80 to retract into the carriage body. While holding the release button down, the user may easily slide the c~rri~ge to its fully retracted position at the proximal end of the frame 12 so that a new syringe may be inserted.
As noted above, and as illustrated in Figures l through S, the driver device of the invention includ~s an anti-siphon element which prevents movement of the plunger independent of movement of the carriage or the force applying Plem~nt This m~nt is intPn~PA to prevent the syringe plunger from being drawn into the syringe barrel if negative pressure is applied to the syringe outlet port via the connecting tubing, causing an inadvertent delivery of additional fluid. In one embodiment, des-rihPd above, the anti-siphon element comprises of a pair of latches 78 formed on the intPrn~l surfAcPs of grip flanges 74 that constrain the syringe plunger disk. The gripping flange 46, in cooperation with the distal flange 48 helps to constrain the syringe flange 23. The combination of these el~mPnt~ prevents the plunger 24 from moving f~ l into the syringe barrel 20 after a dose is completed, and also prevents the syringe barrel 20 from sliding backwards over the plunger.
The shape of the latches 78 is such that if syringe plunger disk 26 is not fullycon~tr~ined by the latches 78 during insertion into the device, a sharp advancing force, m~nn~lly applied, will cause the latches 78 to snap over the plunger disk 26 and to ~e properly engaged by the latches. The first dose cannot be initi~tPf1 until this action has been taken.
WO 97/0783l3 PCTIUS96/1354r, In another embodiment, illustrated in Figures 16 and 17, a pivoting arm 118 has a subst~nti~lly centrally located pivot 120 mounted on a laterally protruding portion 122 of the arm. A proximal end of arm 118 includes a ratcheting pawl 114while a distal end of arm 126 includes a tapered catch 116. The arm 118 mounts within carriage 14, as shown in Figures 18 and 19, such that a spring mPch~ni~m (not shown) biases the pawl 114 into contact with detents ~not shown) in the track 28.
The catch 116 engages the syringe plunger disk 26 whenever the plunger disk 26 is disposed within plunger housing 124 appended to the distal end of carriage 14.
The geometry of the pivoting arm 118 is such that any pulling force on the catch 116 (due to a potential siphoning action) tends to increase the hol~ling force on the detent and thus prevents movement of the carriage. When a user presses the release button 128, which is ~tt~hed to the pawl, both the pawl 114 and the catch 116 are ~1icçng~ged, allowing the carriage 14 to be retracted and the syringe to be released for llnlo~-ling.
One of ordinal~y skill in the art will appreciate that further embo~limPntc having similar geometries involving both pivoting and sliding devices can produce the same combination of ratcheting and anti-siphoning actions.
An additional feature of the invention is that the spring force applied to the syringe plunger 24 does not change ~igni~lc~ntly during the travel required to deliver a dose. Accordingly, the flow rate also does not change significantly during delivery of the dose. This is accomplished by three means. ~irst, as described above, thespace provided for the main compression spring 66 is relatively long, despite the compact ~lim~n~ions of the device. This is partly the result of the use of a hollow carriage piston 68, enabling a portion of the spring to reside within the piston.
Second, the spring is compressed to less than about half of its unstressed length before being assembled into the carriage. The additional compression of the spring required to advance the carriage during use is only a small fraction of the total cc~ s~ion applied to the spring, reslllting in only a small change in reaction force.
~urther, the spring is recompressed for each dose. Because the spring need only be coln~l~,sed sufficiently to deliver a single dose, rather than multiple doses, it must be colll~r~ssed only a small amount for subsequent doses in addition to the colll~lcssion provided during assembly of the apparatus.
W O 97/07838 P~T~US96/13~45 A further advantage of the driver device of the invention is that a simple coil spring is preferably employed as the main spring 66. This spring acts directly in line with the syringe plunger, minimi7ing frictional forces that might act to disturb the force applied to the syringe.
Re~ ce the invention as described depends on the fluid reci~t~nce in the connecting tube to control flow rate, it is important that microbore tubing of proper internal diameter be employed. Many operational strategies, such as co-packaging of pre-filled me~lir~tion cont~ining syringes with ~pioL>-iate microbore tubing, may be employed to ensure safe practice. In some applications it may be ~ o~liate to me~h~nic~lly d~lic~t~ syringe drivers of a particular design to a specific type, or family of types, of precision microbore tubing. In one such embodiment, shown inFigures 14A and 14B, the adapter element 34 of the microbore tubing assembly can1~ have a non-standard geometry and/or dimencions that are adapted to fit only within compl~m~nt~rily si~d and shaped sockets 54 of the syringe mounting elern~nt 36, as described above.
Figure l5A illn~tr~tes a typical male luer fitting 67 which may form a proximal end of the microbore tubing assembly 18 to f~cilit~te connection to thesyringe. Figures 15B and C illustrate different embodiments of an adapter element 34 for a microbore tubing assembly 18. In these embo~1iment~ the adapter is illustrated to be generally oval or circle-shaped, however various other geometries may be used as well. Proximal to adapter 34 is a male Luer lock fitting 67 whichcan mate with outlet tip 22 and female luer components of syringe distal end ~6.In one embo~liment~ filled syringes are distributed with a tubing set ~tt~t he~ or in a combined package. Operating protocol would require that such syringes always be used with the tubing sets with which they are packaged, and that any unused syringes or tube sets must be disposed of or returned to the distributor.
Table 1 illustrates the approximate spring force and length requirements for use of 20cc and 60cc syringes, in which units are in inches and pounds. The smaller syringe requires lower force because of its smaller piston area. By ~ iate choice of spring wire diameter and sprin~ length and pitch, a ratio of maximum to minimllm force can be m~int~in~d comparable to that used with the 60cc syringe, without WO ~7/07838 PCT~US96/13545 greatly t~Ytencling the working spring length. Typically, spring force of about 8 pounds is suitable for use with a 60cc syringe.
S
Table 1: SPRING CALCULATIONS for lOcc doses from 60cc and 20cc syringes (60cc) (20cc) (60cc) (20cc) d (wire ~ ,.)0.048 0.033 plunger diameter 1.05 0.75 10 D (coil diameter) 0.5 0.5 plunger area0.865901 0.441786 n (number of 20 16 F1 (min force) 63.061224 turns) G (shear modulus) 107 107 F2 (max force) 8 4.081633 (302 Staillless) dx (x1-x2) 0.775 1.3265 15 K (spring constant)2.654208 0.741201K (spring const~nt)2.580645 0.769249 (from spIing (from load ~,~.. ,Lly) lc;~lui~ b) xl (df~.fl~ti~n at ~1) 2.325 3.9795 x2 (d~ofl~rti~n at F2) 3.1 5.306 Lfree (n~n. free length)4.156 5.8868 Lstart (length at xl) 1.831 1.9073 pitch at Lfree 0.20780.367925 pitch at xl 0.091550.119206 pitch at x2 0.0528 0.0363 The flow rate through a circular tube under laminar conditions is det~rmin~d by Poi~seuille's law, which can be stated as:
';T7 4 8~LL
where Q is the volumetric flow rate, r is the int~rn~l radius of the tube, ~ is the fluid viscosity, L is the length of the tube, and p is the pressure drop along the tube length. The pressure drop can be expanded as:
_ P = Pi - Po + PgZ
W O 97/07838 PCT~US9G/13545 where Pi is the applied pressure at the inlet end, pO is the applied plessu~e at the outlet end, is the fluid mass density, g is the gravitational conct~nt and z is the S difference in height between the two ends of the tube. In the present case, pO is the venous blood yr~s~ule of the patient (typically less than lOcm H2O), and z is the height of the syringe relative to the patient's body.
The inlet ~les~u~, Pi, is the force, ~, acting on the syringe plunger divided by the plunger surface area, A, and less the friction loss between the plunger and syringe wall, n. The force generated by the compressed spring is known from Hooke's law. In this case Hooke's law may be written as:
F=k(lp+ld) where k is the spring constant (essenti~lly the stiffnPss of thê spring), lp is the pre-1~ load deflection applied during assem~ly, and Id is the additional deflection applied to activate a dose. Mech~ni~l concider~tions require that Ip always be somewhat less than the unlo~lcd spring length, particularly for compression springs. The value of d is at a maximum at the start of a dose, and goes to zero at the completion of a dose. The design of the present invention, as described previously, provides for Id to be small compared to Ip, and, as can be seen from the above equation, this minimi7es the change in force during a dose.
The previous e~uations can ~e combined to obtain:
~77r 4 k(lp+ld) For m~ximllm consistency, the values for k, Ip, and Id should be large enough, ~ relative to A, that the other terms within the brackets have a negligible effect on the flow rate. It should be noted that this analysis is only applicable for certain spring types; Hoolce's law does not apply to "Neg'ator" type springs, and is only .
appro~im~tP- for stretchable rubber springs, which can exhibit highly non-linearbehavior.
S It is understood that various mo Tific~tions can be made to the invention described and cl~imPd herein without departing from the intended scope thereof. All references noted herein are expressly incorporated by reference herein in their entirety.
What is ~l~im~Pd is:
Claims (25)
1. A syringe driver device, adapted to engage and impart forces to a syringe to dispense fluid from within the syringe, comprising:
a frame having proximal and distal ends;
a selectively positionable carriage element mounted upon the frame adjacent to the proximal end of the frame, the carriage element having proximal and distal ends and being in sliding engagement with the frame;
a syringe, removably mountable within the frame between the distal end of the frame and the distal end of the carriage element, the syringe including a fluid containing barrel with a flange at a proximal end thereof, an outlet tip at a distal end of the barrel and a moveable plunger, including a disk portion at a proximal endthereof and a tip portion at a distal end thereof, slidably disposed within the barrel for movement between withdrawn and fully inserted positions;
a force applying element, associated with the distal end of the carriage, the force applying element being adapted to engage and apply force to the plunger disk;
a spring element disposed substantially internally within the carriage and applying a biasing force to the force applying element;
cooperating locking elements associated with the carriage and the frame to secure the carriage to the frame among (i) an unlocked position, (ii) at least one locked, force applying position in which the force applying element is at least partially retracted within the carriage, and (iii) a locked, non-force applying position in which the force applying element is fully extended from the carriage element; and a syringe securing means for engaging and maintaining the syringe within the frame.
a frame having proximal and distal ends;
a selectively positionable carriage element mounted upon the frame adjacent to the proximal end of the frame, the carriage element having proximal and distal ends and being in sliding engagement with the frame;
a syringe, removably mountable within the frame between the distal end of the frame and the distal end of the carriage element, the syringe including a fluid containing barrel with a flange at a proximal end thereof, an outlet tip at a distal end of the barrel and a moveable plunger, including a disk portion at a proximal endthereof and a tip portion at a distal end thereof, slidably disposed within the barrel for movement between withdrawn and fully inserted positions;
a force applying element, associated with the distal end of the carriage, the force applying element being adapted to engage and apply force to the plunger disk;
a spring element disposed substantially internally within the carriage and applying a biasing force to the force applying element;
cooperating locking elements associated with the carriage and the frame to secure the carriage to the frame among (i) an unlocked position, (ii) at least one locked, force applying position in which the force applying element is at least partially retracted within the carriage, and (iii) a locked, non-force applying position in which the force applying element is fully extended from the carriage element; and a syringe securing means for engaging and maintaining the syringe within the frame.
2. The device of claim 1 wherein the force applying element is biased to extend from the distal end of the carriage.
3. The device of claim 1 further comprising at least one microbore tubing assembly having proximal and distal ends with a fluid passageway extending therebetween, the proximal end including an adapter mechanism to facilitate detachable coupling to the end of the syringe.
4. The device of claim 1 wherein the frame has parallel rails, each being located at opposite, outer edges of the frame, upon which the carriage mounts.
5. The device of claim 4 wherein the locking element comprises:
a plurality of detent elements formed in at least one of the rails, each detent element having a first, ramped surface facing a proximal end of the frame and a second surface, oriented substantially perpendicular to the rails, facing the distal end of the frame; and a pawl element disposed on the carriage and biased to an extended position to engage one of the detent elements such that the biasing force on the pawl must be overcome to slide the carriage with respect to the frame in either the proximal or distal directions.
a plurality of detent elements formed in at least one of the rails, each detent element having a first, ramped surface facing a proximal end of the frame and a second surface, oriented substantially perpendicular to the rails, facing the distal end of the frame; and a pawl element disposed on the carriage and biased to an extended position to engage one of the detent elements such that the biasing force on the pawl must be overcome to slide the carriage with respect to the frame in either the proximal or distal directions.
6. The device of claim 3 wherein the syringe securing means includes a distal securing element and a proximal securing element.
7. The device of claim 6, wherein the proximal element of the syringe securing means comprises at least one grip flange extending distally from a sideportion of the carriage for engaging a portion of the plunger to prevent movement of the plunger independent of movement of the carriage or the force applying element
8. The device of claim 7 wherein the carriage includes two grip flanges, each extending distally from opposite sides of the carriage.
9. The device of claim 6 wherein the distal securing element of the syringe securing means comprises a yoke, including a slot formed therein transverse to a longitudinal axis of the frame, the slot having a size and geometry sufficient to secure and seat a syringe flange.
10. The device of claim 6 wherein the distal securing element of the syringe securing means comprises a socket element at a distal end of the frame, the socket element having an internal geometry of a size and shape to cooperatively engage the distal end of the syringe.
11. The device of claim 6 wherein the distal securing element of the syringe securing means comprises a socket element at a distal end of the frame, the socket element having an internal geometry of a size and shape to cooperatively engage the adapter mechanism of the microbore tubing assembly.
12. The device of claim 6 wherein the proximal securing element of the syringe securing means comprises lateral flanges extending distally from the carriage.
13. The device of claim 1 wherein the force applying means is retractable within the carriage.
14. The device of claim 1 wherein the spring element is a compression spring oriented substantially parallel with a longitudinal axis of the frame.
15. The device of claim 3, further including an antisiphon means for preventing movement of the plunger of the syringe independent of movement of thecarriage or the force applying element.
16. The device of claim 15 wherein the antisiphon means comprises a latch element having a first end appended to the carriage and a second, latching end selectively engageable with a portion of the plunger.
17. The device of claim 6 wherein the adapter mechanism of the microbore tubing assembly includes a Luer lock connection, and further includes an external geometry.
18. The device of claim 17 wherein the microbore tubing assembly includes a plurality of microbore tubing assemblies, each having a fluid passageway with different inner diameters.
19. The device of claim 18 wherein the external geometry of the adapter mechanism varies with the inner diameter of the fluid passageway of the microbore tubing.
20. The device of claim 18 wherein the dimensions of the external geometry of the adapter mechanism vary with the inner diameter of the fluid passageways of the microbore tubing.
21. The device of claim 11 wherein the adapter mechanism is matable with the socket element of the frame.
22. The device of claim 1 wherein the cooperating locking elements enable the carriage to be secured to the frame in a plurality of locked, force applyingpositions, facilitating the delivery of multiple, sequential doses of fluid from the syringe.
23. The device of claim 1, further including at least one ramp which is angled upwardly and distally from a point proximal of the distal end of the frame, the ramp being effective to eject a syringe from the device when the socket and adapter mechanism are non-cooperating.
24. A syringe driver device, adapted to engage and impart forces to a syringe to dispense fluid from within the syringe, comprising:
a frame having proximal and distal ends;
a selectively positionable carriage element, the carriage element being in sliding engagement with the frame and having proximal and distal ends with anaperture formed in the distal end thereof;
a force applying element, extending distally from the aperture in the distal endof the carriage, the force applying element being biased to extend distally from the distal end of the carriage;
a spring element disposed internally within the carriage element and applying a biasing force to the force applying element;
cooperating locking elements associated with the carriage and the frame to secure the carriage to the frame at a desired location between the proximal and distal ends of the frame; and a syringe securing means for engaging and maintaining a syringe within the frame.
a frame having proximal and distal ends;
a selectively positionable carriage element, the carriage element being in sliding engagement with the frame and having proximal and distal ends with anaperture formed in the distal end thereof;
a force applying element, extending distally from the aperture in the distal endof the carriage, the force applying element being biased to extend distally from the distal end of the carriage;
a spring element disposed internally within the carriage element and applying a biasing force to the force applying element;
cooperating locking elements associated with the carriage and the frame to secure the carriage to the frame at a desired location between the proximal and distal ends of the frame; and a syringe securing means for engaging and maintaining a syringe within the frame.
25. A syringe driver system, adapted to engage and impart forces to a syringe to dispense fluid from within the syringe, comprising:
a frame having proximal and distal ends;
a selectively positionable carriage element the carriage element having proximal and distal ends and being in sliding engagement with the frame;
a syringe removably mountable within the frame between the distal end of the frame and the distal end of the carriage element the syringe including a fluid containing barrel with a flange at a proximal end thereof, an outlet tip at a distal end of the barrel and a plunger slidably disposed within the barrel for movement between withdrawn and fully inserted positions;
a force applying element associated with the distal end of the carriage, the force applying element being biased to extend from the distal end of the carriage and being adapted to selectively apply force to the plunger disk;
a spring element disposed substantially internally within the carriage and applying a biasing force to the force applying element;
cooperating locking elements associated with the carriage and the frame to secure the carriage to the frame;
a syringe engaging means for engaging and maintaining the syringe within the frame; and a plurality of microbore tubing assemblies, each having a proximal and a distal end with a fluid passageway extending therebetween, the proximal end including an adapter mechanism to facilitate detachable coupling to the end of the syringe, and each microbore tubing assembly having a different fluid passageway inner diameter and an adapter mechanism external geometry and size specific to the inner diameter of the microbore tubing.
a frame having proximal and distal ends;
a selectively positionable carriage element the carriage element having proximal and distal ends and being in sliding engagement with the frame;
a syringe removably mountable within the frame between the distal end of the frame and the distal end of the carriage element the syringe including a fluid containing barrel with a flange at a proximal end thereof, an outlet tip at a distal end of the barrel and a plunger slidably disposed within the barrel for movement between withdrawn and fully inserted positions;
a force applying element associated with the distal end of the carriage, the force applying element being biased to extend from the distal end of the carriage and being adapted to selectively apply force to the plunger disk;
a spring element disposed substantially internally within the carriage and applying a biasing force to the force applying element;
cooperating locking elements associated with the carriage and the frame to secure the carriage to the frame;
a syringe engaging means for engaging and maintaining the syringe within the frame; and a plurality of microbore tubing assemblies, each having a proximal and a distal end with a fluid passageway extending therebetween, the proximal end including an adapter mechanism to facilitate detachable coupling to the end of the syringe, and each microbore tubing assembly having a different fluid passageway inner diameter and an adapter mechanism external geometry and size specific to the inner diameter of the microbore tubing.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US277195P | 1995-08-24 | 1995-08-24 | |
| US60/002,771 | 1995-08-24 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2229547A1 true CA2229547A1 (en) | 1997-03-06 |
Family
ID=21702429
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002229547A Abandoned CA2229547A1 (en) | 1995-08-24 | 1996-08-23 | Multi-dose syringe driver |
Country Status (10)
| Country | Link |
|---|---|
| US (2) | US5722956A (en) |
| EP (1) | EP0959916B1 (en) |
| JP (1) | JPH11514255A (en) |
| CN (1) | CN1193917A (en) |
| AT (1) | ATE253387T1 (en) |
| AU (1) | AU705032B2 (en) |
| CA (1) | CA2229547A1 (en) |
| DE (1) | DE69630620D1 (en) |
| MX (1) | MX9801372A (en) |
| WO (1) | WO1997007838A1 (en) |
Families Citing this family (76)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5722956A (en) * | 1995-08-24 | 1998-03-03 | The General Hospital Corporation | Multi-dose syringe driver |
| US6110149A (en) * | 1996-09-13 | 2000-08-29 | Novo Nordisk A/S | Syringe |
| JP3874484B2 (en) * | 1997-03-05 | 2007-01-31 | スーガン株式会社 | Medical injector head |
| AU750050B2 (en) | 1998-06-03 | 2002-07-11 | Scott Laboratories, Inc. | Apparatus and method for providing a conscious patient relief from pain and anxiety associated with medical or surgical procedures |
| US5944693A (en) * | 1998-08-17 | 1999-08-31 | Jacobs; Warren A | Syringe assembly and associated syringe biasing device |
| EP1257307A2 (en) | 1999-09-13 | 2002-11-20 | Vitro Diagnostics, Inc. | Multi-dose syringe driver |
| US6382204B1 (en) * | 1999-10-14 | 2002-05-07 | Becton Dickinson And Company | Drug delivery system including holder and drug container |
| JP4593714B2 (en) * | 2000-02-10 | 2010-12-08 | 株式会社根本杏林堂 | Syringe outer cylinder, syringe holder, syringe piston and piston holder |
| US6626862B1 (en) * | 2000-04-04 | 2003-09-30 | Acist Medical Systems, Inc. | Fluid management and component detection system |
| US6471674B1 (en) * | 2000-04-21 | 2002-10-29 | Medrad, Inc. | Fluid delivery systems, injector systems and methods of fluid delivery |
| US6652493B1 (en) * | 2000-07-05 | 2003-11-25 | Animas Corporation | Infusion pump syringe |
| IL156245A0 (en) * | 2000-12-22 | 2004-01-04 | Dca Design Int Ltd | Drive mechanism for an injection device |
| JP4256677B2 (en) * | 2001-01-18 | 2009-04-22 | メドラッド インコーポレーテッド | Syringe interface and adapter used for medical injectors |
| US7041082B2 (en) * | 2002-02-28 | 2006-05-09 | Smiths Medical Md, Inc. | Syringe pump control systems and methods |
| US7033338B2 (en) * | 2002-02-28 | 2006-04-25 | Smiths Medical Md, Inc. | Cartridge and rod for axially loading medication pump |
| US20030236489A1 (en) * | 2002-06-21 | 2003-12-25 | Baxter International, Inc. | Method and apparatus for closed-loop flow control system |
| US7223253B2 (en) * | 2002-07-29 | 2007-05-29 | Gore Enterprise Holdings, Inc. | Blood aspiration system and methods of use |
| FR2845016B1 (en) * | 2002-09-27 | 2004-12-03 | Becton Dickinson France | SPRAYING OR INJECTION DEVICE FOR DELIVERING AT LEAST TWO SPECIFIED DOSES OF PRODUCT |
| AU2003275460A1 (en) | 2002-10-03 | 2004-04-23 | Scott Laboratories, Inc. | Systems and methods for providing trend analysis in a sedation and analgesia system |
| CN101828904A (en) | 2002-10-03 | 2010-09-15 | 斯科特实验室公司 | Be used to provide the system and method for sensor fusion |
| CA2523267C (en) | 2003-04-23 | 2013-09-03 | Biovalve Technologies, Inc. | Hydraulically actuated pump for long duration medicament administration |
| JP2005000203A (en) * | 2003-06-09 | 2005-01-06 | Nemoto Kyorindo:Kk | Liquid medication injection system |
| ATE526052T1 (en) * | 2004-03-30 | 2011-10-15 | Lilly Co Eli | MEDICATION DISPENSING DEVICE HAVING A GEAR SET WITH AN OPENING FOR RECEIVING A DRIVE ELEMENT |
| PT1732629T (en) * | 2004-03-30 | 2019-06-07 | Lilly Co Eli | Medication dispensing apparatus with spring-driven locking feature enabled by administration of final dose |
| WO2006014425A1 (en) | 2004-07-02 | 2006-02-09 | Biovalve Technologies, Inc. | Methods and devices for delivering glp-1 and uses thereof |
| US20060069350A1 (en) * | 2004-09-30 | 2006-03-30 | Buenger David R | Medical syringe injector pen |
| US20060069354A1 (en) * | 2004-09-30 | 2006-03-30 | Buenger David R | Syringe activation device |
| US7905352B2 (en) * | 2004-12-06 | 2011-03-15 | Washington Biotech Corporation | Kits containing medicine injection devices and containers |
| US20110226646A1 (en) * | 2004-12-06 | 2011-09-22 | Wyrick Ronald E | Kits Containing Medicine Injection Devices And Containers |
| US7297136B2 (en) * | 2004-12-06 | 2007-11-20 | Wyrick Ronald E | Medicine injection devices and methods |
| WO2007008257A2 (en) * | 2005-07-06 | 2007-01-18 | Washington Biotech Corp. | Method and apparatus for delivering epinephrine |
| US20060173439A1 (en) | 2005-01-18 | 2006-08-03 | Thorne Gale H Jr | Syringe drive system |
| CA2598700A1 (en) * | 2005-02-24 | 2006-08-31 | Boston Scientific Santa Rosa Corporation | Constant force material delivery system and method |
| DE102005024363B4 (en) * | 2005-05-27 | 2012-09-20 | Fresenius Medical Care Deutschland Gmbh | Apparatus and method for conveying liquids |
| US7632249B2 (en) * | 2005-10-28 | 2009-12-15 | Curlin Medical Inc. | Syringe assist for infusion pump |
| TW200744568A (en) * | 2006-02-28 | 2007-12-16 | Verus Pharmaceuticals Inc | Epinephrine dosing regimens |
| US7867197B2 (en) * | 2006-03-29 | 2011-01-11 | The General Hospital Corporation | Single-dose syringe driver |
| CN103239773B (en) | 2006-03-30 | 2015-08-26 | 瓦莱里塔斯公司 | Multi-cartridge fluid delivery device |
| WO2007143676A2 (en) * | 2006-06-05 | 2007-12-13 | Verus Pharmaceuticals, Inc. | Epinephrine dosing regimens comprising buccal, lingual or sublingual and injectable dosage forms |
| US8968272B2 (en) | 2006-10-06 | 2015-03-03 | Lipocosm Llc | Closed system and method for atraumatic, low pressure, continuous harvesting, processing, and grafting of lipoaspirate |
| EP2085147B1 (en) * | 2008-01-29 | 2012-04-04 | Medmix Systems AG | Device with pressure charged piston for dispensing a multiple syringe or multiple cartridge |
| EP2257323B1 (en) | 2008-01-30 | 2019-05-29 | Becton Dickinson France | Dose dividing delivery device |
| JP2012507357A (en) * | 2008-10-31 | 2012-03-29 | マリンクロッド エルエルシー | Multiple dose injection system |
| US8366682B2 (en) | 2009-03-04 | 2013-02-05 | Washington Biotech Corporation | Medicine injection apparatuses |
| JP5428465B2 (en) * | 2009-03-31 | 2014-02-26 | パナソニック株式会社 | Syringe drive device |
| EP2243505B1 (en) | 2009-04-23 | 2018-02-14 | Bayer Healthcare LLC | Syringe assemblies, methods of forming syringe assemblies |
| US8632511B2 (en) * | 2009-05-06 | 2014-01-21 | Alcon Research, Ltd. | Multiple thermal sensors in a multiple processor environment for temperature control in a drug delivery device |
| WO2011022618A1 (en) * | 2009-08-21 | 2011-02-24 | Becton Dickinson France Sas | Pre-filled active vial having integral plunger assembly |
| US8177747B2 (en) * | 2009-12-22 | 2012-05-15 | Alcon Research, Ltd. | Method and apparatus for drug delivery |
| JP5172866B2 (en) * | 2010-01-05 | 2013-03-27 | 株式会社根本杏林堂 | Syringe, cylinder holder, and chemical injection system |
| CA2736841C (en) * | 2010-04-15 | 2014-02-18 | Teneo Innovations Inc. | Device and electronic controller for syringe piston control |
| CA2799775C (en) | 2010-06-04 | 2020-03-24 | Medrad, Inc. | System and method for planning and monitoring multi-dose radiopharmaceutical usage on radiopharmaceutical injectors |
| US20120071837A1 (en) * | 2010-09-21 | 2012-03-22 | O'connor Sean | Auto injector for medication |
| CN102188764B (en) * | 2011-03-14 | 2015-12-02 | 张亚根 | A kind of pressure injector and adnexa |
| JP5173054B2 (en) * | 2012-07-24 | 2013-03-27 | 株式会社根本杏林堂 | Syringe, cylinder holder, and chemical injection system |
| JP5173055B2 (en) * | 2012-07-24 | 2013-03-27 | 株式会社根本杏林堂 | Syringe, cylinder holder, and chemical injection system |
| WO2014046950A1 (en) | 2012-09-24 | 2014-03-27 | Enable Injections, Llc | Medication vial and injector assemblies and methods of use |
| WO2014204894A2 (en) | 2013-06-18 | 2014-12-24 | Enable Injections, Llc | Vial transfer and injection apparatus and method |
| EP2829290A1 (en) * | 2013-07-25 | 2015-01-28 | Sanofi-Aventis Deutschland GmbH | Drive unit for a drug delivery device |
| US9168562B2 (en) | 2013-10-10 | 2015-10-27 | Ann Gilchrist | Syringe-assist device and method for utilizing the same |
| WO2015085215A1 (en) * | 2013-12-06 | 2015-06-11 | Teleflex Medical Incorporated | Dose divider syringe |
| JP5944451B2 (en) * | 2014-09-04 | 2016-07-05 | 株式会社根本杏林堂 | Syringe, cylinder holder, and chemical injection system |
| CA2966369C (en) | 2014-12-12 | 2023-10-17 | Wake Forest University Health Sciences | Incremental syringe |
| CA3009221A1 (en) | 2014-12-23 | 2016-06-30 | Automed Pty Ltd | Delivery apparatus, system and associated methods |
| TWI688417B (en) * | 2016-06-27 | 2020-03-21 | 美商巴克斯歐塔公司 | Syringe stabilizer |
| CN109550116A (en) * | 2016-12-09 | 2019-04-02 | 王才丰 | Convenient for the needleless injector terminal injecting assembly medicine taking device of operation |
| EP3597235A4 (en) * | 2017-03-16 | 2020-09-02 | Terumo Kabushiki Kaisha | Medicinal liquid administering device |
| US11123494B2 (en) | 2017-08-22 | 2021-09-21 | KB Medical, LLC | Exostructure to assist in accurate syringe injection |
| US10881809B2 (en) | 2017-08-22 | 2021-01-05 | KB Medical, LLC | Exostructure to assist in accurate syringe injection |
| EP3927398A4 (en) * | 2019-02-19 | 2022-11-02 | KB Medical, LLC | Exostructure to assist in accurate syringe injection |
| US11655302B2 (en) | 2019-06-10 | 2023-05-23 | Sanofi | Anti-CD38 antibodies and formulations |
| IL293563A (en) | 2019-12-05 | 2022-08-01 | Sanofi Aventis Us Llc | Formulations of anti-cd38 antibodies for subcutaneous administration |
| WO2021236992A1 (en) * | 2020-05-20 | 2021-11-25 | Betaglue Technologies S.P.A. | Methods and apparatus for controlled delivery of a sealant |
| WO2022235703A1 (en) * | 2021-05-03 | 2022-11-10 | The Children's Hospital Of Philadelphia | Syringes and controllers for the same |
| CN114522298B (en) * | 2022-01-07 | 2024-03-15 | 王奇剑 | Micro-injection pump |
| EP4342508A1 (en) * | 2022-09-21 | 2024-03-27 | Trasis S.A. | Device for coupling a syringe to an actuator |
Family Cites Families (29)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US2632445A (en) * | 1951-10-20 | 1953-03-24 | Sr John L Kas | Dosing hypodermic syringe |
| US4059110A (en) * | 1976-10-07 | 1977-11-22 | Timex Corporation | Clockwork driven hypodermic syringe |
| US4132231A (en) * | 1977-05-20 | 1979-01-02 | Vincent Puccio | Injection device |
| US4202333A (en) * | 1978-11-08 | 1980-05-13 | Minnesota Mining And Manufacturing Company | Fluid dispensing device |
| US4298000A (en) * | 1978-11-08 | 1981-11-03 | Minnesota Mining And Manufacturing Company | Fluid dispensing device |
| US4430079A (en) * | 1978-11-08 | 1984-02-07 | Minnesota Mining And Manufacturing Company | Fluid dispensing device |
| IE52621B1 (en) * | 1981-02-12 | 1988-01-06 | Turner Robert Charles | Dose metering plunger devices for use with syringes |
| US4465478A (en) * | 1982-10-14 | 1984-08-14 | Collagen Corporation | Syringe force amplification device |
| US4544369A (en) * | 1983-11-22 | 1985-10-01 | C. R. Bard, Inc. | Battery operated miniature syringe infusion pump |
| US4547189A (en) * | 1984-03-05 | 1985-10-15 | John A. Long | Insulin syringe injector apparatus with auto-aspirator feature |
| US4676122A (en) * | 1984-06-15 | 1987-06-30 | Daltex Medical Sciences, Inc. | Fail-safe mechanical drive for syringe |
| US4636197A (en) * | 1985-02-15 | 1987-01-13 | Ping Chu | Intravenous fluid infusion device |
| US4652260A (en) * | 1985-03-11 | 1987-03-24 | Strato Medical Corporation | Infusion device |
| US4608042A (en) * | 1985-09-25 | 1986-08-26 | Warner-Lambert Company | Apparatus for sequential infusion of medical solutions |
| US5318539A (en) * | 1986-10-17 | 1994-06-07 | Alexander G. B. O'Neil | Liquid feeding apparatus utilizing capillary tubing, and syringe driver |
| US4804368A (en) * | 1986-12-05 | 1989-02-14 | C. R. Bard, Inc. | Battery operated miniature syringe infusion pump and improved halfnut therefor |
| DE3715258C2 (en) * | 1987-05-08 | 1996-10-31 | Haselmeier Wilhelm Fa | Injection device |
| US4943279A (en) * | 1988-09-30 | 1990-07-24 | C. R. Bard, Inc. | Medical pump with infusion controlled by a detachable coded label |
| US5004124A (en) * | 1988-12-08 | 1991-04-02 | The Trustees Of Columbia In The City Of New York | Method and apparatus for dispensing a fluid substance |
| GB8900763D0 (en) * | 1989-01-13 | 1989-03-08 | Kabi Vitrum Peptide Hormones A | Multi-dose syringe |
| US5140862A (en) * | 1991-02-06 | 1992-08-25 | Pappalardo Joseph T | Injection pump calibration device |
| DE69203472T2 (en) * | 1991-02-07 | 1996-01-04 | Terumo Corp | Dosing device for injector. |
| US5176646A (en) * | 1991-02-19 | 1993-01-05 | Takayuki Kuroda | Motorized syringe pump |
| US5328486A (en) * | 1991-11-19 | 1994-07-12 | American Cyanamid Company | Syringe for dispensing multiple dosages |
| US5300041A (en) * | 1992-06-01 | 1994-04-05 | Habley Medical Technology Corporation | Dose setting and repeating syringe |
| GB9310163D0 (en) * | 1993-05-18 | 1993-06-30 | Owen Mumford Ltd | Improvements relating to injection devices |
| US5429607A (en) * | 1994-03-09 | 1995-07-04 | I-Flow Corporation | Elastomeric syringe actuation device |
| US5722956A (en) * | 1995-08-24 | 1998-03-03 | The General Hospital Corporation | Multi-dose syringe driver |
| US5599315A (en) * | 1995-12-01 | 1997-02-04 | Charles J. McPhee | Syringe actuation device |
-
1996
- 1996-08-14 US US08/696,479 patent/US5722956A/en not_active Expired - Lifetime
- 1996-08-23 AU AU68544/96A patent/AU705032B2/en not_active Ceased
- 1996-08-23 CA CA002229547A patent/CA2229547A1/en not_active Abandoned
- 1996-08-23 AT AT96928975T patent/ATE253387T1/en not_active IP Right Cessation
- 1996-08-23 CN CN96196483A patent/CN1193917A/en active Pending
- 1996-08-23 WO PCT/US1996/013545 patent/WO1997007838A1/en active IP Right Grant
- 1996-08-23 JP JP9510411A patent/JPH11514255A/en active Pending
- 1996-08-23 DE DE69630620T patent/DE69630620D1/en not_active Expired - Lifetime
- 1996-08-23 EP EP96928975A patent/EP0959916B1/en not_active Expired - Lifetime
-
1998
- 1998-02-19 MX MX9801372A patent/MX9801372A/en unknown
- 1998-02-25 US US09/030,093 patent/US5954695A/en not_active Expired - Fee Related
Also Published As
| Publication number | Publication date |
|---|---|
| US5722956A (en) | 1998-03-03 |
| AU6854496A (en) | 1997-03-19 |
| AU705032B2 (en) | 1999-05-13 |
| US5954695A (en) | 1999-09-21 |
| ATE253387T1 (en) | 2003-11-15 |
| EP0959916B1 (en) | 2003-11-05 |
| CN1193917A (en) | 1998-09-23 |
| MX9801372A (en) | 1998-11-29 |
| JPH11514255A (en) | 1999-12-07 |
| EP0959916A4 (en) | 2000-03-08 |
| EP0959916A1 (en) | 1999-12-01 |
| DE69630620D1 (en) | 2003-12-11 |
| WO1997007838A1 (en) | 1997-03-06 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CA2229547A1 (en) | Multi-dose syringe driver | |
| WO1997007838A9 (en) | Multi-dose syringe driver | |
| DE69635167T2 (en) | SUBCUTANEOUS JET INJECTOR | |
| US4813871A (en) | Dental viscous material dispenser | |
| CN100584399C (en) | Medical device with transcutaneous cannula device | |
| AU2002352562B2 (en) | Collapsible syringe cartridge | |
| US4608042A (en) | Apparatus for sequential infusion of medical solutions | |
| US5891096A (en) | Medicament infusion device | |
| WO2000066203A1 (en) | Drug infusion pumping cassette latching mechanism | |
| EP0340899A3 (en) | Syringe | |
| EP3525846B1 (en) | System and method for a syringe micro pump with wave spring | |
| HUE025201T2 (en) | Injection device (adaptable device) | |
| EP0497923A4 (en) | Self-driven pump device | |
| EP0941741A3 (en) | Self-administration device for liquid medicines | |
| JPH04500621A (en) | hypodermic syringe | |
| EP0363338A2 (en) | Dosing/mixing syringe | |
| EP1952837B1 (en) | Device for siphoning a substance | |
| US20210112819A1 (en) | Meat injection device with a self-adjusting position reference and automatic refill | |
| CA2439900A1 (en) | Improvements in and relating to an injection device | |
| WO2010056663A2 (en) | Prefillable constant pressure ambulatory infusion pump | |
| HUE029529T2 (en) | A sharps retraction device | |
| BR112016022349B1 (en) | PUMP COMPARTMENT ASSEMBLY | |
| AU2004267899A1 (en) | System for administering an injectable product | |
| RU2143929C1 (en) | Injection device for unlimited varied dosing and introduction of liquid preparation | |
| EP3328470B1 (en) | Syringe |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FZDE | Discontinued |