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(ll)PatentNumber: KE 390
   
(45) Date of grant•. 22/06/20 10   

(51) InlCLA:6 1M 51315, 5150           

(73)0wner:BECTON DICKINSON AND COMPANY of 1 BECTON ORNE,FRANKLIN LUKES, NJ 07417-1880, U.S.A.   

(ll) Application Number:KElP/ 2004/ 000357   
       
(72) Inventor:    SAMUEL, Suresh, P., R.; SMITH. Chad and CAIZZA, Richard,
   
(22) Fillng Date:27/07/2004    James   
           
(74) Agentf,addrrss for correspondence:   

(30) Priority dafa:    Kaplan & Stratton Advocates, P.O. Box 40111-00100, Nairobi 10/838,687  04/0512004    US and 60/490,939 30/0712003  us           

(86) PCTdata PCT/US041024045 27/07/2004 W02005/0 11782 !0/02/2005

(54) Title: SYRINGE ASEMBLY HAVING DISABLING MECHANISM

(57) Abstract: A syringe assembly having passive disabling structure includes a barrel (102) and a plunger rod (108) assembly. The plunger rod assembly includes a phmger rod and a stopper (128) connected by an indexing locking element (130). The number of strokes of the syringe plunger before the stopper is locked into the barrel rendering the syringe assembly unusable is detennined by the number of detents on the plunger rod and stopper which engage the locking mechanism. Upon completion of the final delivery stroke, any attempt to withdraw the plunger rod from the barrel will cause the locking element to engage the barrel and trap the stopper in the barrel preventing further use of the syringe.
 
Syringe Assembly having Disabling Mechanism

Baclqp'ound of the Invention

[0 001]    Tho present invontlon nolatos to syringe asaemhliea and partlcuiarl)' to syringe

assemblies luMng an auloma!ic disabling mechanism.

[0 002] Throughout the world tho multiple use ofhypodcnnic syringe products which are intended for ainglo-use only, is instrumental in drug abuse ODd in the - of colllagious diseases. lnlraV<mOus drug useD who routbu:Jy sbme aud ~e syringes are a high-risk group with respect to the AIDS virus. Alao, the efli:cbi of multiple use are a major

10    O<l!IOem in &oDJll colllllries wbme repeated USB of syringe producbi during IIlllll8 ~oo programs may be respoll9ible for the spread of many diseusas. Re-use ofaingl&-use hypoi:lermic ayringe assemblies ia also instxumonta1 in the spread of drug abuse even in the

abaODCe ofildOctioo or disease.

[0 003]    Many attmnpbi bave baonmede to remeclytbia problem. Moot notable are early

15    contributions wbich miod on a spec;ific act to demoy the syringe after usa elthor bylllliilg a destructive device or providing a syringe assembly with frongible""""' so tba! the syringe could be rondered inoperable by the applicatiOJl of foioa. Other attempts involve the inclusi9n of atructoie which would allow the destruction. or deli:aling ofthe ayrlnge liuwtion to a conscious act by the ayringe n..,. Altbough many oftheBe dovicea wadi: quite well, they

20    do requio:: the apeclfic intent of the naorfollowed by the aaual act to deatroy or render the

syringe inoporable.  Theae devieea are not efli:c6ve with a user beving the speoilio intonl to

,....,. the hypode!mic ayringo. Aomrdingly, thare waa a need for a ainsiiHIBO hypodcmW: syringe which after use will become inoperablo or incapable offurther use automatically without auy additional act on the part of the uaer. The automatic funa!ion is much harder to
25 provide beciDISe the means for rendering the ayringe inoperableiiWSI not preverd its 1llling or use under DOtmal conditions.

[ 0 0 D4] A single-uae syringe wbicb automatically disablea oller injection is tanght in U.S. P-No. 4,973,310 to Kosinski. This syringe contains a locking element positioned in the syringe bam! between the plucger rod ODd the inside sudiu:e of the bam!. 1n use, the

30    syringe allows the user to chaw a pc....;locted amount ofmedieafion into the chamber of the barto! BDd doliver this medication, .. tbrongh mjca!ion, into the patient. Any attempt to withdmw the plunger to use the syringe a second U... willcewe the locking elemem to embed itself into the inside surlilce ofthe ayrlnge bmel to prevent proximal motion of the plunger rod.
 
too o s l    The<o is Blill a need for a siogle-use syringe which will allow a pre-oelected

number ofpluogerrod s1robs before !be automatic dlsahling mechanism activates. For

example, Ibm' strokes of!be pluoger may bo requiml to complete !be illjoction ~""""• Sucb

as when !be syringe assembly is usod 1o clmw • diluoot imo the syringe bono!, dlsponao !be

diluent into a vial oontmning the substmlce Ill bo reconstitl1ted, dmwiDg back the reconstituted

DlOdication into !be syringe and then dellveriDg !be contenlll of the syringe imo !be patimll.

SumiDIIlY of the lnY1111tlon

[ 0 o o6]    An operable syringe assembly having •apassive disabling structure includes a

10    barrel baviag a cylindrical sidewall with an inside surface defining a chamber fur rolahrlng flllid, an open proximal and and a distal oud including a distal wall having a paasagoway therethrough in fluid commuoicatlon with !be chamber. An eloogalo hollow plunger rod having a proximal eod, an opeo distal eod, and an inferior suriBce is provided. A atopper baa

a circular-sbapod sealing olcmout having a podphoml surlhce !brming a seal with. !be inside

IS    sutfacc of!be barrel and a boss mombor projeelh!g proximally from !be aoallng olament. A

looking oleracnt- betwoen !be stopper and the plunger rod. The looking element

includes a centml body portion haviag at least ooe. csntilevorod log oxt.oding diatlllly

outwardiy from !be body portion wberoin the leg includes a sharp free eud - d OlltWaidly

fur eogaging !be inside surlilce of !be bmol. The locking olomeot is movably connootod to

20    the boos of the stopper and movably COllllOOfed to the plunger rod interior surliico. Strudnte fur indexing !be looking oloment distally in the pluoger rod derlng proximal molh!n of!be plunger rod to draw fluid into !be chamber eud fur indexing the looking olamon! distally on

the bosa of the sU>ppcr during distally-directed motion of !be pl.nogor rod fa! dolivedng tluid

from the chamhor through the passageway eud means fur eogaging !be locldng olcmout with

25    the inside surface of tho barrel sidewall fur prevenliDg reuse of !be syringe assembly is provided.
1o o 07] Structure fur eagaglng !be lockhlg olomant with the inside surface of!be bmol

>idewall may include an opeoing in the distal and of!be plunger rod to shorlell tho axial•

length of the interior surfl1ce srea oftho opeaing fur allowing !be sharp free end 1o proje<:t

30    outwordlypasttho plunger rod and.onto tho inside surface of tho barrel.

[ 0 00 8]    The structure fur indexing includes at least one detent on tho inleriDI surface of

!be distal and of tho piJm3er rod, at least one boss- on !be boss and at least one cantilovcrod IIIID on the siDpper baviag an outwmdly extending no near its free and sized to

engage a recess in the inside S!Uliloe of tho plungor rod. The indexing structure further
 
iucludes the locldng element having at least Cli!IO fiogor element oxtending inwardly ftom an aperture in the central body portion of tho locking elemont Tho locking element is positi<mal with its s1wp free end contacting the inlorlor surliu:o of the plunger rod proximally of the at least""" detent and the boss member is posililnlod in the aperture of the locking element wherein the at least one finger element is comaoting the boss member proximally of the at least one boss detent ond the outwardly exteoding rib is pooitioued in tho recess oftho plunger rod.

[ 0 0 o 9] Tho syringe a88embly moy be ccmfigurod so thnt tho at least one deteot in the plunger rod iuclodes two oxially-opaced debmts and the at least""" detent in tho boss
10    iucludes two IOdally-<!paCod boss detenis eo !bet the plunger rod am be moved distally one or two times bofim proximal mntlon of the plunger rod cBilSos the locking element to engage the inside surliu:o of tho bone!, dependlog no tho hdtisl position ~the locking element at the
time ofUBO. Tho two mdally-spaoed detenis in the plunger rod may include two mdally-spacod stcpo eaob bo>ing ablunt snrtilce at its distal end oxtending inwardly ftom the inlerior

IS    snrtilco ofthe plunger rod. Tho two IOdally-<!paCod boss detenta moy eacb include on.inclined

snrtilco extending proxlmally inwerdly and a bhmt surliu:o at a distal end of each oflhe

inclined lllllfaces oxtending radislly inwardly.

[00010] Tho at 1 - one canlilevmed leg of the locking elomootmay iucludo two canlilevmed legs positioned nn opposits sides of the contra! body portion. Tho stopper moy

20    liuthet include two radial caro projectioDs positinood to conta<:.t and foroo the two conlilevmed legs o-ardly wbeo excessive proximally-dh:-d foroo is applied to the
pi - rod in ao illlcmpt to overcome the locking element's ongsgeroent to the inside ll1llfaco oftho barrel.
[00011]'   The at least one canlilovered arm oftho stopper moy inoludo two cantilever arms

25    positioned o.o opposite sides afthe boss and said at. least one recesB in~ inner surface ofthe pl - rod may iucludo two recesses positinoed nn opposita sides of the pi - rod""'' • confignrod to receive the ~y oxtonding ribs of tho two canlilOYered arms.
[000131   Tho syringe bone! may further inolude an olnogate tip extending distally ftom

the distal wall and bo>ing a pwageway thoretbrongb in fluid CODl1llllllieatno with the

30    cbomber of tho syringe bnrrel. The oyriogo assembly may also inoludo aneodle cannola having a distal end, a pmximai end end almnen thoretbrougb, wherein the proximal end of the uodie cannula is c~ to the distal end oftho syringe barrel so thnt tho lumen is in fluid cOIIII!Illllioation with tho passageway ofthe barrel. Tho syringa asoembly may include a
 
locking olemeot made of sheet metal suoh ~ stainless steeL Further, the s!oppellllld all its elements may be imegrally fbmod ofthemoplastic material

Brief Doscripllon of the DrawiDgs

[00013]    Fig. I ia a sio:J&.olevationel view ofthe syringe assembly of the p.....t

invention.

[00014] Fig. 2 is a side-olevallonel end view ofthe proximal end oflbe syringe assembly ofFig.l.
[000151    Fig. 3 is a cross-sectionel vlow ofthe syringe assembly ofFig. I ta1am along Uno

10    3•3.

[O 0016] Fig. 4 is a pempective view ?f'the plunger rod ofthe syringe .,.ombly viewod from its distal end.

[00 0171   F~g. 5 is a poi5pOC!ivo viow of!be locking elemonl of!be syringe assembly

vi<owod from its distal end.

15    [00018] Fig.6 isapOI9pective viewoflbe locking clipvi<owodtromitsproxima1end. [00019] Fig. 7 isapOI9poctivovi<owofthesfllpper of the syringe aasemblyviewed from
il!i distal end.

[00020]    Fig. 8 is a pOI9pOctive view of the slnpper viewod from its proximal one!.

• [ o 0021]   Fig. 9 is an oxplodod sio:J&.olevalionel view of the plunger assembly.

20    [ 00 022]   F~g. 10 is a cro•HeC!ioool view ofthe plunger auombly of Fig. 9 talam along

Uno Hl-10.

[0 0023~ Fig. II i• an enlargedparliol crosHOOt!onel view ofthe syringe assembly of Fig. I Islam along Uno 3-3 showing the syringe assembly before uso.

[00024]    Fig. liAison oolargod partial cro.ss-soctionel view similar to Fig. II but rotated

25    90'.

[ 0 o0 2 5] Fig. 12 is an eclargod partial cros&-Boctionel view of the syrlnge """"'bly of Fig. liabn oloog Uno 3-3 showing tho syringe a99embly after alirat aspiratioo slroko.
[ o o 026]   Fig. 12A is an oolargod partial crosa-sectionel view similar to Fig. 12 but rol!itod

90'.

30 [000271 Fig. 13 is an enlarged partial cross-.sectionel viowofthe syringe assembly of Fig. ll!ikoo oloog Uno 3-3 shewing the syringe asaombly during a first dispensing stroke.

1o 002 Bl Fig. 13A is an eolargod parliol cro......nionel view similar to Fig. 13 but rol!itod goo.


[00029] Fig. 14 is an oolargod partial cross-sectional viow ofthe syringe ......mly of Fig. I t.koo alDII!Ilino 3-3 ohcwing tho syringe OS80Dibly at tho start ofa sec:ond aspiration stroko.
[0003 o]   Pig. 14A is ao cmisrgod partial crosa-sectional viow similorto Fig. 14 but rotated

90".

[00031]    Fig. IS isancmisrgodpartialcroliS-SOdional view of tho syrlngea....,blyof

Fig. 1 t.koo along lino 3-3 ohcwing the syringe OS80D!bly oiler a second dispensing-• (000321 Fig. 15Ais an cmisrgod partial ClDSHoctiooal viow similar to Fig. 15 butiOtated
90".

10 [00033] Fig. 16is anomlargodpartial cros&;,sectional viewofthosytingeasBO!Ilbly of Fig. I t.koo alcmg liDB 3-3 ohcwing a position ofthe interDal oompoMIIIs in tho evaat of an
attempt to witlulraw the plunger mel oiler tho second dispoosing stroko.

[00034]    Fig.16Aisancmisrgodpartialoroao-1110CtiooalviowsimilortoFig.16buttotatod

90".

15 [00035] Fig. 17 is an eolorgod partial cross-sectional viow similar to the syringe.•• asBO!Ilbly of Fig. 16 ohcwing tho iutoraotion of additiooal structure to prevcntiOilaO.
[O 003 61    Pig. 17A is an eolarged partial cross-sectional view similar to F111. 17 but. rotated

90".

[ 0 o o 3 7]   Fig. 18 is an cmisrgod partial cross-sectional viow similar to tho syringe

20    assembly ofFig. 17 ohcwing a disoontiouily in the syringe bam! fur oogsging tho locking alOilllOII.

DeiDllcd Deocriptloa of the Jnveatlon

25    [ o0 0 3 8]   Tho preseo1 invontion is directed to a oyrlnge asBO!Ilbly haviog a pas!live

disablingmeohanism. Tho disabling meohaul.m! oosbles wriable dosages by tho syringe

aaBO!Ilbly and eaables a selected =ber of cycles or strokes by the plunger red baf<>re beiag

automatically disablod. ln one preferred embodimmlt, 1ho diasbling moohaniSID provides two

aspirating and two dispeoaiDg cycles befure being mitomatioally disabled Tho assembly

30    enables tho aspira!ioa and dispoosing of a selected volume of a dlluaat illlo a vial to reoonmtuto a drug, phatmaoeutital agen~ or other substance and thea ospimtiog tho reooostitntod substance back iDtn the syringe. A salocted Volume ofthe recunstitnted substance can be il1jected or delivered to a patient wbere the vollliOC of the substance that is dalivered oan be tho same or di1lerent than tho volmoc ofthe Sllhstanoe ospirlllod. illlo tho

oyrlogo bmel. Tho syringe is -matioally disabled Idler 1bo ID,joction or dolivery stroke by

ro1nding !liB plon~ md, much aoti1'lllosthiO disabling mechanism.

[O o039]   The disabli:ng mechanism is actualed by 1bo Bl<ial mov~ of the pl1lii8or rod

with IOSP•ct to thiO oyrlogo bm:tel and 11l1ho stopper, by mo'liug1bo plunger rod in 1ho

ospiiating direction.  Tho stopper ill coupkd to the pl1112ger rod 1ll allow llmited oxiai

movement of the stnppor with respect to 1bo plpnger rod. Tho diaabliog xnecbanism moves

tbrough a sarles of stages by IOVersing the direotlon of the oxiol movemeut of the pllli!gor rod

with te!!pecl to the stnppor 1ll move the nu:chllllism in a stop-wi.m mazmer to the disabling

positiop. The disabling position of the mechanism is attainod by the relative movement

10    between the phmger rod end the stnppor end is !lOt dopondcnt on the position ofthe slllppor within 1ho syringe barrel or the length oftbo stroke by the stopper. In this llllliUier, tbo oydnge asoomhly is ablo to dispOIISe a desired volume of the dmg or other aubstanco, and the diaabliog mocbaDism can ba acluated ilfter the final dispaosing or iqjection stroke regudless ofthe position ofthe slllppor In the syringe barrel. By llCtuating 1bo disabling mc:ahanism, tbo
IS    atopper cannot be robliO!ed to aspiie1e a substance Into tbe syriugo beael but alloWS" any

subslm:e remaining In tho ll)'rlnge barrel to ba dispensed.

[00040] Rofiltring to 1bo drawings, a syringo IISSOIIlbly 100 bavlnga disabling mechanism includeo a syringe boael10Z and a plunger assembly 10~. llatrol10Z lncludos a cylindrical sidewall106 bavlng an lnsido amfoce 107 do!inlng a cbambar 1091br retaining

20    tluid, an open proximal ODd 113 and a diami end 115 including a distal wallll1 baving a

pas_.,ay 119 theretbrough In :Ouid CO!lllllllllinson with the cbamher. In this ombo<llmenl,

-thowaydistalwall of tho bBn'OI !ncludes an olongote tip oxtonding dis1Dlly therefrom and bav!ng a in fluid communication with the passageway in tbe distal WBlL In this

embodiment l>mei10Z olso !ncludes a~ cannula 170 bav!ng a pmximalond 171, a

2S distal aod 172 and a luman173 therethrough. The prnximalood of the needle cannula is attached~ olongale tip 103 so that tho lumoo ofthe needle cannula is in fluid communi<:ation
with pasesgeway 119 in tho bamL

[00041]    Plunger assembly104 includes an elongate hollow phmgerrod 108, a stopper

Us and a locking elame111130. Plunger rod 108 includes a pmximal end ill, an open distal

30    O!ld 110 acd ao iDterior ll11l'!i!cc 116 end at~ one oper!ll1e or =oss114 in lhe mterior surface at the distal eud ofthe plunger rod. The recess !ncludes a distal face 121. In this embodimOD!, there are two re~ 114 having distal fi>ces lll. Tho intorior surliH:e at the distil eud of the pllll!getrod ineludes at least one datoot. In Ibis embodlmeotthe at least one dotelll on the interior sur:lilce oftbo distal eud oftbo phmgerrod includeolbUT axiliuy spaced

detenls118 with two detenls on eacb side oftho plunger rod. Each pair of detenta is siJaped tn limn oxlally !!pSCod stops 120 with eaoh stoP havillg a blm!t surlilcolll at its distal and oxtonding inwardly fl:om tho iDtorior surlilco of tho phmgor rod.

[000421 Stoppor1281m:ludoa acilcularly-shapodaoalinge!OIIllllll144luMDga peripheral surlilce 145 folllling a seal with tho iDsido surlilce oftho bmel A bosa member 134 extends proximally from tho sealing e!Oillell! and incluclos at least one boas deteot and in this embodiment, oontBina two boss detenls 136. At least one canlileverod 11m1 exteod.s proximally fl:om tho soaJins element and in this ~bodimen! thoro are two CIIDtilever mms

140 oxtODding proximally from the soaJins element Eacb oftho caoti!overod ilmlS includoo

10    .;, ootwardly oxtending rib 14l. Tbe n"b is sized to fit within IOCOOS 114 in tho plunger rod. Tbe axially spaced boss delmltll136 eacb include an incline sudiu:ol37 oxtODding proximally inwardly and a blmtt surlilco 138 at tho distal end ofeaeb of the lnolined sudiu:os. Tho atoppor is preferably integrally limned ofthonnoplastic materta1 sueb as polyethyleoe. Tho

cUoularly-ohaped soeling clomeot and/or tho peripboral soaJins surlilce theroOD may be made

1S   of olastomedc materials sucb ... brmoplnatic alsatomers, natuml rubber, synthoti<>rubber

ood cambinat1una thereof.

[000431    LorJ<ing element 130 inoluclos aceotral body portion 148luMng an aperture 152

thoreth:rougb and at least OJlO cantilevered leg 150 extouding distally outwaxdly fl:om the body

portion and at loast 0110 linger e!emont 154 extoodinginwardly fl:om tho aperture. In this

20    erobodimeot. at loast two cantileverod legs with eaoh of tho cso!!Jevered !ega haYing a shEII]I• free and 1.55 directed outwonlly for oogagingtheiosido smfaco oftho btu:roL Tho configwation ofslwp freo and 155 can be ony configuration capable ofoogaging the inside sudiu:e of the blll7ol, sueb as a sharp edge or one or more pointed teeth and the lib. The locking elemontlllll)' be made of a variety ofmalerials, or combinations ofmnterials,

25    however, it is preferred to haw tho slwp free ends modo ofmetal ood it is olso profomd that the eotire locking elemont be made ofintegrolly funned fl:om siJaot metalsucb as stainless

stool •

. [00044] In this prefoaedembodimentplunger assembly 104 is assembled by inserting locking olemont 13.0 inio the distal end of plunger rod 108. Bou134 ofatopper 1.28 is then

30    inserted into tho distal end oftho plunger rod through aperture 152 ofloc!dng element 130 so !hat cso!!Jevercd legs !SO extend toward cirCui.arly-shsped seoling eleroeot 144 ofthe atopper

.. illustrated in Figa. 9 and 10.

[00 0451 As wiD be oxplained in IIIDre detail hereinsiter, the plunger auembly is then inserted into bmrel1021hrougb open proximo! end 113 to tho initial position illustrated in


Figs. II and 11A. In tbe initial J""ition ofthe syringe elomeot, locldng olomeot 130 is

posiliODed with its slliiip free ends l.SS ctmtacting the intorlor surlilce of the piUDgor rod

proximally of axially speoed steps 120. Boss momber 134 ia positiooed in aporturo 152 of

lccking clocoeat 130 so thet linger clemonb 154 contact boss member proximally of bess dolmll8136. Outwardly extending Iibo 142 ofcantilevorlumo 140 ""'positimu:d in recesses

114 in the pbmger rod. Ribs 142 are cODflgured to complement tbe recessesl14 for allowing

Jlmited axial movement ofthe stopporwith respeot to the piUDgor rod. The stopper 128

:further iDcludes stabilizing mornbor 146 positiooed proodmally with respect to sealing

c1eroont 144 and bes an outer dimeosloo compllmenling 1ho other dim...,;on of the sealing

10    elementos shown in Fig. llA, otabilizing mornbor 146 bes an outer dim...,;on to conlaot the

inner surlilce of1ho syringe bmol and is speoed from oealing clemont144to assist in stabiliziDs stopper 128 to lllllintain the stDppe.r and boss momber l.S4 in on orleoll!ti<Jn
-tially parallel to the axis of tho syringe bmel. In 1ho position lUIJSilUd In Figs. II and II A, syringe assembly 100 iueWly to use :fbr drawing liquid Into the chambm: ofthe
IS    bsrrcl.

[00046] As will nowbo shown, 1ho oporotion of the pi - nssornbly ofthis embodiment includ~s a first aspiration strola: fullowod by a first ~ slroke, a second
aspiration stroke and a final dispaosillg stroke after whicb 1ho syringe is disabled. The

diasblins clemenls prevent orillhibitmovement ofotoppor 128 in a proximal aspirating

20    • diRction tberebrllmitiDg the function of1ho syringe as110111bly to a single use. The maximum number of strolros being llmited by a nombor of axially positioned dolmll8 in 1ho plunger rod
and the number of axially positioned bo.ss dotenb on tbe stopper. Howovor, 1ho actual nombor of strokes the syringe may make will bo cloten!!med by the position of the locldns
clement with respent to 1ho dolmll8 in 1ho plunger rod and.1ho dolmll8 on the stoppor ot 1ho

2S limo of Jirstu.so. For example, a syringe with two plunger dolmll8 and two stopper dotenb •can bo supplied to the end usor as a syringe capable of two strokes ot !bur strokes. This ia an irnpottact fealuro of the present invenlion: since a single syringe nssornbly can be provided with difl'eiOntotroko Jlmitations bo:fbre disabling.

[000471    The syringe ...embly maynowbo used to draw liquid, sucb"as a sterilowster

30    diiUOilt Into 1ho cbamber of the barrel by applying a proximally directed :fbroo to a thumb press U3 on the proximal end of tho pi - rod .milo holding 1ho syringe bmcl. As i1lusiDited in Figs. 12 and 12A, this cau..s the pbmger rod to movo proximally with respect to 1ho stopper until 1ho free end of ceotilovorod logo 150 move• distally along inner surl'acell6 of the plunger rod and snaps pnst biUDt surl'acol22 of the proximo! most axially spaced stapa
 
120, as best illustmled in Fig. 12. A1ao, durlng this mat aspimtion strolce.outwaxdly e>Cimlding nbs 142 engage diata1 surliu:e 121 oftho,.,,. .... 114 in tho plunger rod as best illustraled in Fig. 12A. When ribs 142 engall" diatalsurface Ul tho stopPer is dm"" proximally Wl'lh101p0c! to !be bstre.las tba p!IIDgertodmaves. The stopper is now moved proximelly, tbt<IUgh a<.1ion of tho pl1mgoi rod, UDti1 tbo demed volume of liquid i.s in tho
obambor as dotem>ined by !be usor.

[DO 04&]   Tbe Hquid dilucml in the cbamher JDOYDOW be di.sebarged into a vial of dry

modicotion moh aslyopblllzed modicotion, for reoonslitulloo. Thi.s fiiSt d;.,peosing -ko i.s

acoomplisbecl by moVing tbo p!Wlger rod in a di.stal din:ctioo wbile balding the bane!. A

10    baael flaoll" 124 is provided on tho proximal end oftba bam:! to bclp control motion of!be batm1 during..., of the~ assembly. As best illusimted in Flgs. 13 aod 13A. as tho plunger rod moves distally,lccki"'! eiOIIWlt UO moves with the plunger rod dnlgging !be lockiog elemcml with it so that linger elements 1S4 nn tho lockiog element ll!idell:om !be proximal most to tho di.sta1 most boss doteiitby riding up ioc1ined Bll1face 137 aod fillling into

15    tho second detool. Wheo tba piuoscr rod contacts tho stoppor, tba stopper wiH begio;uwviog in a distal direction along with tho plunger rod to di.sebarll" liquid diluent 1l:om !be obamber • into, for OJqi!DPIO. a vial of1yopbilizedmedioation.

[000491 Wben the diluent and tho lyophilized modicalion oro mixed the $)'rlngeassembly ofthe present invention may now be used to withdmw the =nstituted, Rllldy-to-inject

20 medicsti<m into the cbaml:>or of !he syringe barrel, as best i1lostrated In Flgs. 14 aod 14A. by • applying a proximally directed force to the plD"'IU md wbile holding the•~ barrel. Proixmally din:cted fnrce wiH caase ibe plunger rod to move in a proximal direction wbile lockiDg oi011Wltl30 wiH remain nolalive!y staliOIIIII)I doe to its ooooect!oo to !be boas doteot on tho stopper. Proximal motion of tho pbm&er causes tho locking elem<ml to move distally

25 a1oog the inside sudilce of the•plangor rod so that the sharp free end 155 of the cantilever !ega movcsll:om the proximal-most axially-opaced stops120 in tho plunger md to the second

more diata1 axially-<paced stepa 120. Proximal motion of the pbmgor rod also oauaea outwaidly oxterufuJg rlba 142 of eautilever m:ms 140 to angage diatalsurfaces121 of recesses
114 in tho p!Dnger rod so that lbe stopper DDW moves proximally with lbe plUDgor rod

30    dmv.ing the reconstituted medication i1liD the cbambor of the syringo ban:el to an amount

deremrined by the~• An advantage of the pmcml inveotion is tbat the amount of medication drawn into the chamber, and therefore tb. maxinuno amount of modicalion tbat call be deli mod, is detennined by the user at the time of U!e and oot by !be placemcml of tho componoots at tho time ofm!l!l1ll'acmre.

[ o 0050]   The syringe aasembly of tho present invention is now ready fur a second and

linol dilijiOIISing stroke which is best illustrated in Figs. 15-ISA Tho medication is dolivOR:d

to tho patient by applying a distally directed 1\m:o to the pJunser rod causing tho plunger rod

to move in a distal direction with respeet to tho bmrel. A.o tho pltmger rod ad....., in a

distal direction the engagciDOlll of sbmp free ends 155 ofth!: locking tili:m<mt in wi1h th!:

distal-most blunt surfacos 122 of oxiall:rspacad steps 120 moves th!: locking oleiDOlll disbilly

so thst finger tili:m<mts 154 of tho loc:king element ride over the distal-most inelincd surfilce

137 of!he boas det - distally past tho most distal boss deteatl36. When !he dietally

moving phmger rod contacts the stopper, botb !he stoppor and tho plunger rod move towerd

10    the distal O!ld of the bane! to discharge the contents of the chsmber 1hrough the psssageway. [00051] Tho syringe aasemblyhasDOWbeea used1111d is ready to be discarded. Any

attempt to move !he plunger rod in a proximal direction to refill the oyringe assembly fur

:tiJrthcr 1IBII will cause tholoc:kiDg olement to disable the syringe.  Spocitica!Jy, as best

illwtralod in Figs. 1'6 and 16A, rooving the plunger rod ina proximal direction will allow the

15    pltmger rod to move a short distanoe UDiil the sbmp free ends 155 of the loc:kiDg clip:snap past the and of the plunger rod and eagsgo the inside surfilcel07 of the bmrel side wall.
FurtherproximaliDDtion of the plunger will be resisted by the locking element's '"'8011omcut lo the inside surfilce of the bm:reloidewa!J. In addition, as illustrated in Fig. 17, com surfilce • 125 on the atoppor is positioned to furce sharp free ends 155 :tiJrthcr into tho II)'Iinge•banel

20    wall as m<m> proximally directed force iB wed in an attempt lo improperly """" the syringe.

Accordingly, inere01ed fott:elo pull the plunger rod out ofthe syringe bm:rel results in . inercased force of eogagomODI of the sbmp !i:ee ends of the locking elomODI into tho beael.• Itio destreble to provide a cut-out area 126 in the distol and of the plunger rod along the psth of the sbmp free ends ofthe locking oleaumt for oupporting the locking elemeot aod allowiog

25 it lo engage the inside surfilce of the bmel. Further, the area at the and of the plunger rod on the area around the cutoUt can be conliguicd to support the locking element so !hat ifth!: wer accidauta!Jy withdraws the plunger rod a second time before delivering the final dose of medication the medication may still be doi!"ered oven though the locking element sbmp free ends are toucbing 1he beaelso long u they ore moved in a distal direction and urged not to
30    engssc1he inside surfilce ofthe beael by the cut-out"'"" and the plunger rod. In this case the area around tho cutout supports and liJicits the motion and helps pm><mt defomcation of
1he shorp!i:ee and of the lcckiDg el.,.,m.
[0 0 o52 J It is also within the purview of the Present Invention to provide a discontinuity such "a recess or projection on the intorior surlice of1he bazrel, as illustrated in Fig. IS, to

tinthor improve the engagoment of!he shmp free 11!111 of!he locking eloment with the interior surlB<:e ofthe bmel. In Fig. 18 syringe bmel102 ineludos a di&conlinuity in the fonn of an inwardly diieoled projection 127 oo. inside suriilco107 of the bam!. In this embodimeDI, projeotioo.1271B oo.II!IDlJiar riDs projoctiD.s iiiiD tho bmrelll!lll extending 360' arotmd the inside surface. Tho di&conliDuity may bo in tho futm ofoo.IIIIIllllsr projection, aniiDl!lllsr recess or one or more projections or....,,... sboped to OOSSBOlocking elemeot, all poaitioned within the baaol to eogago shmp tieo 11!111155 of locking olemm!tl30 to farthor increase tho grip oftho locking olomentoo. the banelll!lllinsldo sm:faco.

[O o 053]   The present syrinso assembly provides an improvoment aver prior art devices by

10    allowing a variable dose of dilueot, chaseD. by tho user at tho limo ofUBo, to ba dmwn iiiiD the syringo, dispcosing tho diluent into a vial colllaining a subslanoa to ba reCQIIBtitoted, dmwiDg a aelected OIDOUD.t oftbo reCQilBtitutod !l1lhstaDoe back iiiiD the syringo 11!111 then dolivorins the
collleats oftho syringe. Tho se1octod ammmt of tho recoustitoted subsl!mce muy ba oqual or looo than tho :lbll volmruo reconstitutod at the discretion oftho user. Tho syringo assOmbly Is

IS    autr>matlcally disabled after tho liual illjoctiou stroke by reversing the direotion ofth<>

- oftho pluager rod fiom the dispensing direction to tbo aspiratiog direetion. Aller tho injection strob ofthe syringe plunger tho plUJII!er rod is rotrained to eotivate the disabling nieobauism to preveot axiallliDvameot oftho stopper toward tho proximo! 11!111 of!he syriDge bane! thereby prevenliog the stopper fiom being romovod and preventing rouse of!he

20    syringe.

[000541 Whon tbopreeent•Yrinso assembly bas two or more detoots oo. tho stopper aDd in 1ho pluoger rod, the maximmn DliiDbar of strokes the syringe assembly will allow cao ba varied by tho iDitiol poaitionofthe locking olomoat with respect to the stopper d-11!111 the
plunger rod dstcots.

25 [000551 WbilevoriOIIB~hawbaoochoseotoillustratetheinveotioo, it will ba appreciated !bet cbsoges 11!111 modlficatiollB oan bo msdo without departing from tbo scope

oftb.e invention.

WHATIS CLAIMED IS:

I.    An oporablo syringe assembly having psssive disabling S1I\lCtUro comp:ising: .

a barrel including a cylindrical side wall baving ao Wide Blllface d!!lining a chamber

for rdaluing fluid, an open proximal end and a dislli end including a distal wall bavlng a

]lllllsagewaytbeto1brough in fluid communication with sa>! chamber,

ao el~ hollow plqer rod having a proximal end, an open distal end aod ac

interior 1111l'lhce, at least one recess in said interior sw:filce at said distal end of said phmger

rod, said IOCOSS boving s distBr filco, at loast one detent oa sa>! interior surface at said distal

end of said plunger rod;

10 a stopper including a circular sbapad scaling element having a perlpheml surface fotming a seol with said inside surface of said barrel, a boss member projocting proximally fmm said scaling eleraon~ at least ono boss detent on said boss, at least one cantilevered arm extending proximally fiom said scaling element, said at least ono caotilmredaan bavins an outwardly oxtending no near Its free ODd, said rib being lli2ed to fit within saidrecoss in said
15    plunger rod;

a locking elomcnt including a con!ral body portion bavins an aperture thorethrocgb, at

1oast one cantilevered leg extending disiBlly outwardly from said body porlioo, and at loast oae :ticger element extending proximally inwardly from said apertmo, said at 1oast one log lmvins a s1wp free end directed outwardly fur engaging said inside Blllface of said barrel;
20 said locking el=ent being positioned with said sharp ftoe end coniBcting said interior sudilce of said plungor rod proximally of said at least 0110 delmlt, •,aid boos member being positiOIIOd in said aperture ofsai(llocking element wborain said at least one :ticger elomcnt is coniBcting sold boos proximally of said at least 0110 boos deloDt, and said outwardly extending n"b being positioned in said recess of said phmgor rod, so that applyiDg a proximally dirocted
25    foree to said plunger rod While holding said bmel causes said plongerrod to move proximally with respect to said stopper until said free end of said caotilevored leg moves distally olong said i:Jmer surface of said plunger rod to said at least oae detent and said ourwardly exteudiugn"b on said cuntil.;,.red !UIII engsgos said distal :filca of said recess to

mo.., said stopper in a proximal directl.,; for a selectl!d distaoce, and subsequently applying

30    a_ distally dlreCII!d fon:o to said plunger rod to discborge fluid from said cbambertbrougb said pessageway causes said plunger rod to move in a distal direction olong with said locking elamcnt doe to its engagement with said at lest one detent ontil said :ticger element of said locking element rides over said at least one boss detent and into CODlact with said at lost one boss detont and said plunger rod contacts said stopper to move said stopper disiBlly to


dlscbarge tluid from said chambor, after which applying a proximally directod force to said pbmger rod wm ....., said plUDgOr rod to move prnximally until ooid free end of said

cantilevot<d leg IDOVOII distlllly aloog SBid inner slll&ce post said matal end of ooid plUDger

rod so tbalsaidsbstp end of said at least one CSDtilover leg engage ooid inside of said baael

to help pmoent proximal mo - of said atopporto render said syringe assembly UDusablo.

2.    The II)'Iinge assembly of claim I wherein said at least one deteut in said

pl1JI180f rod includes two axially spaced detmts and said at least one detent on said boas includes two Olci.Uy spaced boos detmts so that said plUDgOr rod con be moved djstolly twa
10 times bef'on: proximal motion of said p!ungor rod callSOs SBid lncking element to engage said inside su:diu:o of SBid bmrol.

3. The syringe assembly of claim 2 whcn:in said two Olci.Uy spaced detent&, in said p!UDgOr rod ineludc two Olcially spaced steps each having ~blunt surlllce at its distal end
IS    oxtcnding inwmlly from said inlerlor surface.

4. 'Ibe syringe aasombly of claim 2 wherein said two axiaUy speced boss detents. oach inclode an inclined surface extending proximally inwmlly end a blunt slll&ce at' a distal end ofoach ofsoid inelined sudllces exllmding radially inwardly.

20
S. 'Ibe BYif'S•IIBBODlbly of claim 2 said at least one clllltilevered leg of said Iookinj! element includes two CIDltilevered lega positioned on oppositlo Bidee of SBid central body portion end two addjtional axiaUy speced dctents ""provided in said p!UDgOr rod opposite said two Olci.Uy-apeoed delmlts.

6. The syringe """"'bly of claim 5 further including two mdja] projections on said stopper positioned to engage and force said two CSDtilevot<d logs outwardly wbon excessive proximally dlreeted force is applied to said plunger rod in an attempt to overcome said J.ncking elomenfs engagement of said inside surface of said bmel.
30

7. Tho syringe assembly of claim I whlliBin said at least one CIDltilevered ann of said stoppor includes two contilevot<d IIIIIlB positioned on opposite Bides of said boos and SBid at l085t one recess in said incer surface of said plunger rod includes two recessee pooitioned
oo opposite sides of said plqer rod aod positiooed to receive said outward extmdiog ribs of

said CBDtile.vered mms.

8.    The syrioge assembly of claim I baviog a disoonlinuity oo said inside sudiu:a of said barrel sidewall poaitiooad to engage said sbmp liee eod of said locking elemaol wbea said alwp free eod ia conlactfug said iuside surfDCe of said bam!.

9.    The syringe assembly of claim I wherein said distal wall Of soid barrel further

ioclodes ao elongate tip cxmodiog distally therefrom baviog a passageway in fluid
10    communication' with said passageway' in said distal wall.

10.    The syringe assembly of claim 1 furtbor im:loding a needle connulahavlng a

distal eod, a proximal eod eod alnmon lheretbrough, said proximal eod of said noedlo

=ula being COIIIIOCtod to said distal eod of said barrel so that said lumen ia in fluid

15    communi calion with said passa8J'Way.

11.    The syringe assembly of claim I whercin said locking elomont ia made of

sboctmstal.

20    12    The syriogo assembly of claim 1 whercin said stopper is iDtogrally farmed of

thermoplastic mlltodal.

13.    All oponhle syrioge assembly baviog passive disabling sl:r1J<:1mo comprising:

a bmol including a cylindrioel side wall baviog an inside surface defiDing a chamber

25    for retaining fluid, an open proximal eod and a distal eod including a distal wall haviog ao elongate tip cxll>ndiDg distally therefrom and a passageway thorotbrougb in lluid communication with sEiid. chamber;

ao '!longate bollowpluoger rod baviog a proximal eod, an open distal eod aad ao

iliterlor SUiface, said interior surface at said distal end of said pbmgor rod lncloding two

30    opposed recesiles and two pairs of axially spaced opposed stJ:ps, osch stop extmding inwardly from said sidewall and baviog a blunt surface at its distal end and oach recess baviog a dialal face;

a stopper including a circularly shaped sosling element baviog a peripheral sudiu:a furming a seal withinsaidinside sor!Bco ofsaid bmel, a boss memberprojootiog proximally

from said sealing elemoa~ two axially spacOd detants on said boss each having an inclined surfiwe oxtending proximally inwardly and a bluot surlilce extending nulially away from said boss, two clll!lilevered """'oxtanding proximally from said sealing elO!IIOII!, eacb cll!!tilevored BIIIl having an outw...Uy extending rib Dellr i1s free eod, said rib being sized to fit willrln said recesses in said pi-rod;

a locking elemeot including a ceotral body portion having an aperture therethrough and two opposed canlllcvmd legs extending distally outwmdly from said body portion, two
:tingcr elements oxtending proximally inwardly from said aperture, said legs having free ends including a book-<~!aped portion, said hook-<~!aped portiou having a ahaJp and direoted
10    proximally outwmdly from engaging said inside sar.l8ce of soid bmol and said bhmt sar.l8ce in said plunger rod;

said loeking elemcot being positioned with said ahaJp ends of said book•shs!led

portions contacting said interior suriico of said plungor rod prnximally of said blont aurliu:e

ofsaid stepa, said boss member baing positioned in said aperture of said locking elamont

15    v.ilerein said fiogor olerocots colllact said boss proximally of said bluot surface of saiO.-doleolB, and said outwmdly extending ribs being positionOd in said recoas of ll>lid plunger rod,< so tbot applying a proximally direoted fot<e to said plunger rod while balding •aid barrel causes said plunger rod to move proximally with respact to said stnppor UIItil said hook• shaped portions of said cantilevered legs move distally along said inner surli!ce of said

20  . plunger rod and moves ou1w11Idly at said blunt ll1llJ8ce of proximal-most of said two steps

and said outwaidly oxtcnding ribs 011 said cantilevered BIIIlB engage said distal J8ce of ll>lid

recesse~s to mova said stopper in a proximal directian for a sW.eoted distance, and

subsequently appl)'ing a distally directed :ftm:e to discharge fiaid from said chambor through said passageway ....... said plungor to move m. distal direetion with said loeking eloment

25    due to said locking olemcot's engagement with the proximal-most of said blunt sarliu:es until said ficger olemcots of said locking element ride ovor said inclined surface ofthe proximal-most said two deteals and into cOJilact with said blunt aurliu:e and said plncgcr rod contacts said stoppor to move ll>lid stnpper distally to discharge fluid from said chamber, an additional

proximal and distal movement of ll>lid plwlgor rod to dmw fluid into ll>lid chamber and to

30    deliver fluid frnm said chamber will..,.. said locking elomcot to be repositioned so that said book-shaped portions of said legs engage tho distal-<DOst of said two steps and said fingor elements engage the distal-most of said blnnt surlilces, a£tar whlcb appl)'ing a proximally directed fot<e to said plunger will call8e said phmgerrod to move proximally until said hook-shaped pnrtions of said cantiloveriod legs move distally alocg said inner surface of

said p!UDger rod psst said distal ODd of llllid plunger rod so that said sharp 011ds ofll!lid hook-

shaped prqjoctions engage said inside surfoco of said bmd 1o holp prevent proximal motion

of ll!lid stopper to render said syringe .....,bly unusable.

14.    An operable syringe assembly havingpossivo disabling strw:1u1e comprising:

a boael including a cylindcicol aidowall having on inaido surfilce defining a chamber

fur retaining fluid, an open proximal ODd and a distal ODd im:ludlng a distal WB1l hovlng a pasaagewaythoretbrough in fluid communication with llllid cbambor;
an elongate hollow phmser rod having a proximal end, an open distal end and an

10    inl!:ri.orsurfilco;

a stopper including a cilouliiHhapod sealing element hovlng o peripheral surface farming a seal with said insida surface of llllid bmd and a boas momborprojeoting proximally fi:om said scoling elcmonl;

alockiDg element including a central body portion bavlng at least ono cantilevered leg

15    oxtending distally oulwludly fi:om said body portion, ll!lid at least one log having a sharp freo end cfuectod outwaldly for engaging said inside surface of said biUiel, llllid locking elomoot movably conoected to llllid boas and said locking elemeot movably conoected to said'phmger rod inmrior smfoce; Bll.d

moaoa fhr indexing said locking element diatally in ll!lid plunger rod during proximal

20    motion of said piUDger rod to dmw fluid into said cbambor and fur indmdng llllid locldng element distally on said boss ofll!lid stopper durihg distally directed motion of said p!UDger ' rod for delivecing llcid fi:om said chamber through said pssssgoway and DlOIIIlll fur engaging
said loolciDg element with said insida surface of said bmd sidaWBII fhr preventing~ of said syrlnge assembly.

25

15. Tho syringo assombly of claim 14 wborein said moans for oogaging said locking element with said insida surlileo of said bmrel aide WB1l im:ludas sn opening in said distal eod ofsaid plunger rod to sbo- tho axially leogth of tho immior surface in~ area of tho openhig and to allow said sbmp froo eod to project outwmdly post tho p1Uil8er rod and
30    into tho io.sida surface of the bmrel

16.    Tho syringe aasombly of claim 14 wlleroin moans fur indexing includes at least

one detent on soid interior surfiloo of said distal eod of said plunger rod, at least one boSB

detent on said boss~ at least ana cantilevered arm on said stopper having an outwardly

extending rib 11011r ils free eod sized to eogage a recesa in imide surface of said plungor rod eod said loc:king olemont including at loast one~ element oxtoDding inwardly from an apertute in said central body portion, aald locking element belog poal!iooed with said lih"'P free eod coataoting said illtarior Blll'1ilceof said plunger rod proximally of said at least ooe

deleD!, said bosa !lll>l!lber beiDa posilitmed iD said aperture of said locking e1entent wbemiD said at least ooe finser elemem is ~tiDg said boas proximally of ;aid at least ooe boss

detent IIQd said outwaltlly extending rib belog positioned in said reo.,. of said plunger rod.  •

17.    Tho syringe assombly of claim 14 wherein said at least one deteDI in said

10    plunger rod includes two axially apaaod detcots and said at least ono detem on said hoss includes two axially spaced boss detellls so tbat said plunger rod can be moved di9!Blly two
timea befoxo proximal motion of said plunaor rod C8llses said locking element to ensegc said ;,;.m. surfaoc of said bonel.

IS    18.    Tho syringe IIIISCIIlbly of claim 17 whciOin said two axially spaced detenls in

said plunger rod include two axially spaced stops eooh beving a blunt sudilce at ill! distal Ond

extendiDg inwardly from said inlericr sw:lilco.

19.    Tho syringe assembly of claim 13 wh=in said two axially spaced hoss

20    detents oaob include an inclined surface extending proximally lnWBitlly aod a blnat surfilce at a distal eod of eooh of said inclined surfuceo extending radiallyinwanily.

20.    Tho syringe assembly of claim 14 said at least ooo cantilevered leg ofsald

1ookillg element includoa two Cllll!ilevored legs pooitioned oo opposite sides of said central

25    body portion eod said at least one detont in said intorior surfilce of said distal ead of said plnogcr rod includes two detents pooitiooed on opposite side of said plunger rod.

21.    Tho syringe ass"?'bly of claim 20 furtbar including two radial cam projections

on said stoppor pooitioood to contact Blld fotce said two cantilevered logs outwcrdly when

30    exc.,.ivo proximally dlrec:tcd fotce is applied to said plunger rod In an attempt to ovoroome said locking element's .;..g.goment to said wide sw:filco of said bane!.

22.    Tho syringe sssorobly of claim 14 whorein said at least one Cllll!ileverad"""

of said stoppor includoa two Cllll!ilovored arms positiooed on opposite sides of said boss aod

said at least Ollll reoess in md inner surlilce ofmd plunger rod includes two rocesses

positinlled on opposite sides ofllllid piUDgOr rod end positioned Ul receive said outward

extonding ribs of said C8Illilovoted arms.

23. The syringe assembly of claim 14 having a discontinuity nn 88id inside surlilce of said bm:rel sidewall positioned to engage said sharp froo end of said looking element when md sharp free end is enntactiDg said inside surface of said barrel.

10 24. Tho syringe assembly of claim 14 wherein said distal wsll of said barrel furthor inelud<:s BD elongate tip extending dislally therefrom having a possageway in fluid communication with 88id passageway in said distal wsll.

25.    • The syringe assembly of olaim 14 furthor including a needle caonula having a

IS    distal end, a proximal end end • lumen tlrerethrough,  said proximal end of said'•nOedJe

- being COilDOOted Ul 88id distal <lid of smd barrel so !bat said lumen is in !laid communication with mdpasllgeWBy.

26.    The syringe assembly of claim 14 wborein said loclciDg element is made of

20    sbeet metal.

27.    The syringeaasembly of claim 14wherein ..;d stepper is integmllyformed of

tbormoplastio tnaterial.

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