CA2411232A1 - Variable resistance sterilization process challenge device and method - Google Patents
Variable resistance sterilization process challenge device and method Download PDFInfo
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- CA2411232A1 CA2411232A1 CA002411232A CA2411232A CA2411232A1 CA 2411232 A1 CA2411232 A1 CA 2411232A1 CA 002411232 A CA002411232 A CA 002411232A CA 2411232 A CA2411232 A CA 2411232A CA 2411232 A1 CA2411232 A1 CA 2411232A1
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- sterilization process
- diffusion
- challenge device
- sterilization
- container
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
- A61L2/20—Gaseous substances, e.g. vapours
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/26—Accessories or devices or components used for biocidal treatment
- A61L2/28—Devices for testing the effectiveness or completeness of sterilisation, e.g. indicators which change colour
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
- C12Q1/02—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving viable microorganisms
- C12Q1/22—Testing for sterility conditions
Abstract
A sterilization process challenge device has a sterilization indicator contained within a containers; and a variable diffusion restriction into said container.
Description
VARIABLE RESIST."ANCE STERILIZATION PROCESS CI~iALLENGE
vEVICE AN~~ METHOD
FIELD OF THE INVENTION
The present. in9r~~ntion xelatE~s to a process challenge device and method f~:7~ c~etern~,-ininc, the efficacy of a sterilization proce~:~wsre .
io Medical instruxnent:s area t=virally sterilized prior to use. Many methods are employE~d, including steam sterilization, hyd:r-~,:~ger:~ pero:x.ide, ~,rapor phase sterilization, eit::near with or wit.hc~ut a gas plasma and is ethylene oxide iEtO;. each L~f there methods relates to a certain extent on t:~~e ciiffus.ion crf fluid, primarily gaseous, steriiants into coraact with the instruments and devices to be sterilized.
2o Typically, s~cl.instrumer_ts arid devices are packaged within containers o~~ pauche~~ having a semi-permeable barrier, which allows transmission of the sterilizing fluid but prevents .:~dmrssior~ c~ contaminating organisms.
Packaging of the i.cnstrument.~in ttms fashion creates a z5 diffusion restricti~~n somewhat inhvbiting passage of the sterilizing fluid t~~ the dez~i.ce or instrurnent . In addition, some dez~i:~es and i.rm:zwmer_t.s have diffusion-restricted spaces tlrere.in; f or e:tarnpl e, endoscopes ,SP- 46 __ G _.
typically have lone v:~,~r:,ow l.i.~mer~. ~.'he sterilizing fluid must diffuse into t:l~is 'bong narrow rumen to effect sterilization there:i.r:. In. ada.:it.:ion to diffusion restrictions, the c,ru~~r~tiry o:= devices to be sterilized s during one process, arid the amounl~ of absorbent material in proxim~_ty t: he re a:. c: ~<1:~ affc=cat ht~~w t: he sterilizing fluid travels to and cone:ac°t.s the instruments to: effect sterilization. A :~;af:f:icient_ acrcovru~ must remain in contact with t:.he i4u: t rumenfi: E on a ruf f icient period of io time to ar_hieve a c..W faired :'.ev~e~. ofv sterilization.
To i,zsure tha..: r.>roper ste~:il:~: ation has been achieved, it i-s ty~>ic:vai to i:;caude some indicator of the sterilization proce:~ in proxinv:i.ty nr~ the devices or 15 instrumenvs to be :~t: eri l i zed d~..xr-ing the process . Fox instance, a biolog~.cwl indictor braving a predetermined quantity of micro--:~:~~:~anism:~ ca:: :4c: placed within a sterilization cham~c~f~r° i.f the dwvice is to be sterilized and, after the pro~~.f-~s5 is cccnF~ete, it: can be cultured to 2o determine whether ~.o~~~ cat the macz~c:,-cr;~anisms have survived . Biologi c.-a 3. ~ndi~~ay=or s :nave evolved into designs in whicrr a ~:~:>;.irce of growth media in a frangible container is loc:at~~r3 ac?_jacer..t ~.o a cuantit:y of micro-organisms and after .r.hE~ steril.Az~~tian procedure is 2s completed, the fra.ng:ible corct.a;near is broken to release the growth media ,:~n~.~ cL:lture a~~.y remaining living organisms. Typica.lay, colon iud4cat:ion technology is included to show c. ~d;lor change _~n the presence of living organisms. Alternat~~eiy, ar: enzyme indicative of the organism viability rrt.~l:~ be det c~ct:ec3 . Examples of such.
devices are shown .~.ri ~ . ~> . Patent Nc;; . 5 , 83 ~J , 683 and 5, 418, 167, hereby an.~~-~rporatE~d by reference.
To more accur<:.tel.y repl~c~ate a ~rvia:lienge of diffusing a sterila.r~; fluid :_rlt~~ :=v~ntact with the device during an actual st.:e.ri.lizatic:n pro>cedure, it has sometimes been the ~:aracr.icc~ to "luc~e a biological to indicator inside o: ~x chall.eigE~ device having a diffusion restriction, such ~:asc a long t:ox-t~uous Bath. L1.S. Patent Nos . 5, 89!x, 62'7 and ~: 872, Oo4 i7.. ~.u:~t:.rat.e examples of such challenge devices, ~~Y.d are i=uc<.r-porated herein by reference.
SUMMARY OF THE INVENTION
A sterilizaticaw process challenge device according 2o to the present invention comprise:,s a sterilization indicator contained ~~rithin a ce_:~tztair~.er and a variable diffusion restrict.~c:rm rote tire ccr:ntai.ner.
The sterilizcation indiwc~t:c~r r_an be a biological indicator or a ~chFarr.ca l indi~:at:or indicative of a chemical sterilant:.
iSP--46 _.
The variable chi (fusion ~_e~:triction can comprise a diffusion path intc:~t:he container wh~Ch can comprise an adjustable coverin~:x 1=or the f;~~ttr: r:~~ block or unblock portion of. the= dif l::usion path . In. c:me embodiment of the invention; the contK~~.r~er com~:r i.se;: a f:irat member and second member dispc:~sed in t~e~~esc:o~.~i~y relation with the openings disposed .::>r t_h<=_ fir;:t meni~er and the second member forming the ~:~c~.justable cwv~~rng.
io The di.ffn~~:l~an path e,an cc~r~prlse a plurality of openings, which can be different i:5 size. At least one opening is preferab:l_y covere~~ wit~lr a removable covering.
Rather than, or in :-~c3dition to mu_l:~pl.e openings, the diffusion path can ,omprise a slc~r_, port: ions of which i5 can be covered or .~,u:~overed t.c va~r,~ the diffusion resistance, The diffusion ~:ath can rwmprise a long narrow path, wherein the d.iffusi:~n path can be :~djust.ed by trimming 2o the length of the p~~~th. they tA::fa~_a;s:ion path can comprise two or more mater:ia_l;s ~rloerea.~~ t~ru-~ !nat:eriais have different capab:.l.t.ies to rEytain sterilant. The diffusion path cai:; :comprise a steriiant absorber such that the amount of ~~tez-ilant~ Diffusing tc the indicator 2s can be adjusted bl, ~rrhe type :;~x~ the size of the absorber.
A method for a.;~seasing t~rae :~t~eril.ization efficacy of: a sterilizatiorn process <~cc~or:~ing to the present invention comprises the step's ~>f:: placing a sterilization process c~hal.lE~.~ce ci.e,rice i_n proximity to a device to be ;5ter:i 1 a.:~ec~ duri.:ic; the :;teri.l.ization process, the steri:l i~zation pro~:~e:~s challenge device s comprising a conta.:irrf~r, a ster~l_::at:ion i.zdicator within the container; an ~:~l::~f~n:ing into the cont:ai.ner and an adjustable diffusi.~au restriction at. the opening;
assessing a featur:; ,of a loac:.:f cane or- more deviee:~ to be sterilized in t:.~re st.erili~°_a;,ic>:rr process; adjusting to the amouni~ of diff..z~:,zon restri:.~r_ic7ra provided by the diffusion restrict.i_c.,m based upon the feature of the load; and indi.cati.ruca t:he steer i.iz:,~.t ion efficacy with the indicator.
is The ~otep of adjusting the amount of diffusion restriction ca.n cor~vp:rv ise~ adjusta.nc; ari area of the opening into the container, :such as hey c_overing or uncovering the opening into the cont:~~airxer. '°'h a o ~>E~r~ing can comprise a plurality of aperturf~s ~r, a wai:i caf the container.
The diffusion :restrictic~r~ ;pan comprise a path into the container and t:.;:m..~ step of aca:j u;~t ing the amount of diffusion restriction can comervse adjusting the length of the path.
The step c:f ad:ic.;::~t.ing the ~iif:E'usion restriction can comprise adjusting ara amount ~f absorbent material placed adj acent the ir:dicat:.c::v .
.SP-4n r _. ~~
The indicator .:an indicate whEet.her a reference organism rema.in:; v i,.inie or whet:W .~r a suf f i.cient amount of a sterilizing gas sa;~~ presen,: :_luri:rcg the sterilization s process.
BRIEF DESCRIPTION a~~° THE DRAWINGS
FIG. 1 is a tc~l ~ ~7ian view of ,~ challenge device to according to t:he pt~t~ gent ~nvPnr ~.cn;
FIG. 2 is a f:~~c::~rlt ele~rat is:gin view ref a second embodiments of a prcoc~E~ss chal l enge device according to the present invention;
is FIG. 3 i:_~ a f:c~c::rnt: elevat:ic:rrl view of a third embodiment. of a pr~:::~c: e~ss chal.l eryxe cie~f~ce <:according to the present invention;
2o FIG. 4 is a f:Tvcnt. eleva~:~i<:7z-i view of <~ fourth embodiment. of a prc:owss cha:1-lenge de~.li.ce according to the present invention;
FIG. 5 i~> a teap: plan v~ic_w elf= c ~ fifth embodiment of a z5 process challenge c7ew:icF>_ accai-ell.n~~ lu:o the present invention;
,SP-4E
FIG. 6 is a tcy:r plan view 4of a sixth embodiment of a process chal lenge ~:iF~ ~-x ce acct. rc..~nc~ to the present invention; anti s FIG. 7 is a tt~>f plan ~Tiew of a seventh embodiment of a process challenge: ~~ev:ice ac~cc~rdi.ray t:c~ t:he present invention.
1o DETAILED DESCFtIPTIC~N
Fig. 1 il_lustzwtes a pro::ess challenge device 10 according to the pr e;~ent invE;rlt z crr . l t comprises an enclosure 12 contayn:ing an irzdic,at:or I4 and diffusion restricted passage 1~eadinc lrato t:he enclosure 12. The is enclosure 12 compri sf~s a first opE~n- ended body 18 and a second open-ended b«G:~e~ 4c) d.is~.osed ~n telescoping relation to one anoLtner_ The diffusion restricted passage 16 comprise; a varietX~ ~~f a~>ertures 22 in the first body 18 which are selecti;rely covered and uncovered zc by the second .t~ody a?~,.. as the i.-,-st anu second body 18 and 20 are telescoped iri r°elation to cne another. When all of the apertures 22 <a~ve u.ncoverec~i, .it is much easier :Eor sterilizing fluid t.::> diffuse :.nt_.o t=he enclosure 12 and contact thc: inc~icatr:~x ~.4 than when only a few of the as apertures '?2 are unc~a~fered. ."accordingly, the challenge device 10 provides .-;zr easy anc~3 :~irnFO_e means for providing a process challenge, which cazl be adjusted in accordance with the needs of a f:Fart:icul.a~;tera_lizat:i~~n process.
.SP-4Ei Fig. 2 ia.lustr-ates a sim:i~ar process> challenge device 24 comprising an enclosure 26 with an indicator 28 therein and it has a cover 3C~ st <;~nc~ end, which can be s rotated into var:ioa.is positi.on:: to wary the diffusion restriction into tt:e enc~losuiw ~6. An indicator mark 32 and scale 34 are px:c~ride~d on t.hc c.ovEar for indicating the amount of diffusion v-estriction that: has been selected.
The amount of diffu5:i.~:~n restriction .hould correlate to to the ease or difficult: ~r in di.f fusing the sterilant into devices to be steri:LiLed, and the scale 34 may relate to a feature of the lo,:~t:a. rE>lev~~n~: t..o such, as for instance the quantity of devices or the ier~gth of the most challenging lumen iir. t:he load. ~r~~ferably, detents a:re is provided between th~~ c:c:wc:r 30 aa~d mr:cl:~surE~ 26, or some fr~.ction is provider, t=a keep the cr_wer in the proper position durinc3 the l.~s°oc°edure. i.h<diflusion restricv:.ion in this case can comprise apertures 35 selectively covered and unc.overf::~c:~ by the :o,,~c.r :30 but can comprise=_ ao other rest:rict:ions r~;f a varia.ole nature.
Fig. 3 il:Lustrr:~t::e~;~ :~ thia:d wrr~o<:diment of a process challenge device 40 ac:~c:ording to the present invention.
It comprises a cont~:~ i r~er 42 hav~.ng a l i.d 44 , and ?s containing an indica.t:~or~ 46. ~~ plurality of apertures 48 provide a diffusion-r~PStx-ictec3. ~~ass~age into the container 42. One or more of t:he aper~turE~ ure closed initially but may be opened b~~ punc hing out: ,~ disk 5U . Preferably, .SP-4E>
the disk 50 i:7 forr~~E~d by sha.~~ir~cl ,:he surface of the container 42 i.n the:' :>hape of tine aperture 48 creating a frangible connectit:>r: between tl~c: c~is~, 50 and the remaining material c}f contairo~x- 4~~ .
s The apertures disclosed ir:the first:., second and third embodiments may be the saa i.r~ size; or may vary in size, with the use_~ ~:>x~eaerab.:llr y_:u.~m:~:lng out or uncovering ever larger a~:~ertm:tes t~~ ra.p_.d1 ~;g ~~e~~;i ease the diffusion to restriction. Espec~i.;~ll~.r witr: t.ze f.rst and second embodiments, t:he p~u:ral-~t:y oa~E~:rtlzy~es could be replaced by a single el.ongat.ed slot . '~.'he~ dE~g~~ee to which it i~;
uncovered dete~rminc~s thEs dif2us:lc>n a:-estrio.tion. Such is illustrated in Fig. a . ~ t cls ~>closeu a :process challenge is device 52 similar to the challezzgE~ device 10 comprised of first and second bc~~:ies 54 anti 56 =ir: telescoping relationship a.nd cc~n;~aining t.heze ~rx an indicator 58.
Rather than a plum l :~l pry ~:~f a~>ert u~~e: , a:n elongated slot 59 through the first body 54 i.s fu~~~..y or partially 2o uncovered through tiw te:leec:oi.~izrg relationship of the bodies to determine t:tne diffL.:~i~n restriction.
Fig. 5 il:lustrat:es <~n al t:e.r:nat:Lve concept in which a process challenge de=_~.~.:~::e 60 c~:;rn~rises a container 62 2s having an indicator a';~E therei:~ ;anc1 ~. tortuous path 66 leading to the indz~:<=~~t::or . Pc:r-t i or,~ 68 of the container 62 can be :removed t;:::shorten t:he t ~4,:r t uous path 66 . For instance, if the co:rr°: w~:iner is f~-r~rrrr~=_~o. of mat:ing polymer _ ~ (~
sheets with a chanxie~. formed therein creating the tcyrtuous path 66, ~:u:::~-t:ions o~ t:.:ue ;~heet.s 4~an be cut off with scissors. Alv:_ernativel~,~, ø~he~ comta~ner 62 can be formed of films wi.t:.lb an at lf=<~:;t part:zally rigid lumen s placed therebetweer:~ to form t~ha~ p,~.t.:~ 66. Preferably, cut indicati0I1 lines 7tare provwded rh~~~-eon t:o illdi.Cate particular. location:: t.o cut:. watts <~ :specified degree of diffusion restrict~_on remaining.
lo Not only can the length of the tortuous path 66 be varied; it car. be fo:~-,ned of mate-:real. showing different levels of absorption. Preferably, that portion furthermost away from the ina.icator 64 would be formed of the most absorbent m,-~r.~er~:ial a:ld treat portion closest to is the indicator .formed >>f a low a~sc>:rption or non-absorptive material. Such matee:~ia..l;= include certain polymers known to absorb sterllants such as polyesters, polyurethanes, sili~:~~:>nes, and n';zri~cms, which absorb hydrogen peroxide, :~:r' mane traditional absorbent 2o materials ouch as ct:liulosic prat=erials, lather than form the path entirely ofn ~~uc°h abs~_.jrloent: mater:ia.ls, portions of absorbent material cyan be located in select locations along the path.
z5 Fig. 6 il:l.ustri::ct.~~s a furrhe~x- embodiment of a process challenge device 80 cfomprisi.nca ar~. elongated lumen 82 containing an indicator B4 at: trm~ ~:~losed end 86 thereof .
The length of ~ibsorl~Era rnater:.~~l 8~~ ~:~ put. into the lumen .SP-46 _. i 1 -82 through an oppcs:G.r_e open end t:hFreof 90. Preferably, the absorbent mate:r;~al 88 has markings 92 thereon to indicate places whe:r:°e it: can be coat ar torn to reduce its length and, thus, it:.~a absorpti°ve ~~;~pac.ity" The process s challenge device 8i) ~.;~ dispose~:~ ~:ithi~1 a breathable pouch 94 to provide furt.~~rt.~:- di. f fus i on restriction . Any of the embodiments herein c~~an be en:lc.~sed in a further diffusion restriction to enharce the c..-':a_~lenge they provide.
io Each of t:.he d:i.::c:losed e~nbc;~ciirnents incorporates Nome form of indicator. This indicator is preferably a biological indicatr~r such as descri:~ed in the background thereon but may alo ~4ompri:~c= ~cra ir.:dvcator for the presence c>f a part:a c~ul a:.- stex: i l arm Such as a chemical.
15 indicator for the Fr~~sence of hydrogen peroxide or the like. Such indicators are more ful~.y described in U.S.
Patent Nos . 6 , 218 , 1 8'9 and 6 , :_' ~ r' , 2 9 c incorporated herein by reference. Furt.hear, the indicator may be more active, such as a reacr~ive ~.~:i~o~m:~cal c~c1 a thermal couple to detect zo the presence of a cizemical stc:r ilant as disclosed in pending U.S. Patent= ;:cppLication No. 09/'741,594, filed December 19, 2000, ~a~c..~c~rporatc:d hEar~ein by reference.
Fig. 7 disclosf~, a process ch.a? lenge device 100 ?s comprising a contairie:zr 102 having an indicator 104 therein. Elongated lumens 10E and 108 extend laterally from the container :~i Cite . Each li,:mezn 10E> and 108 has markings 1_0 ttxereor:~ to ind.i.c,~r_f.e it:s length. Preferably, .SP--4t5 1.~
each lumen lCfa and 7.t:~8 lzas ai: i.rat~:zwa1 diameter of similar duamet:er ta: a particular ~~ev::c:e being processed.
For instance, an erudr~scope having a :;.omen of 1.5 meters and an internal di~..rnetea~ of ~_ rru 1.:l:irneter, each of the s lumens 10E> and 108 w~~uld have are :~nt~ernal diameter of 1 mm and a length ap~.:~r;~x:irnately cr~:e-.h~~l f the length of the actual lumen, or 0.7"~~ rn to trrus s:rntalate the sterilant diffusing into the center of the de~fice lumen.
1o In use, an oper<~tor would determine a certain characteristic of t:~c~ toad such a~~ the number of instruments, the mam~>e~r cf wrapped in.strumeint containers, certain types of materials, wiiivh may be absorptive, or the length of an~.~ d:it::ficult-to--:~tex~:ilize lumens. This is would then correlate= t:;::> ~~ part:i~:wlax set=t:irug on a process challenge device. Fc_ar instance, using the process challenge device 10, t:. he user may determine that onl,Y 30 percent of the apert:tares 22 should be uncovered to provide a procr~ss c.m ~ lenge indi t,at:ive of the particular zo load to be ste:rilizl~c~, fhe d~r.:v.it::e:; arnd the process challenge device 10 a~-e then stEeriizzed in the usual manner. For instanc:~e::~, they m~~y be placed into a steam sterilizer and proce::..,:~ed, or i.nt:;~ ci k~ydroc~en peroxide vapor ster~_i i zer . :~r~e Brach e:~cample i s the STERRAD~
as process from AdvancE:~c~ Steril.i ?anon Systems in which t:he devices arE~ placed _nt o a chamber which is evacuated and into which is int:ro<::luc:ed hydr«ge~r; :~e:rr~xidEe vapor to sterilize the art.ic~ e~s . At some p~::m.nt: during the cycle, SP-4Ei __ ;. .3 the hydrogen perox.::..de vapor i~ exc=itred int=o plasma, which has the beneficial effect. of i.eav:inq behind very few residual hydrogen Fierox de mc>l.e~uae~. After the procedure is completed, the process challenge device is s removed ar.,d the inch{~atc>x- exG.rni~aed t. cassess the efficacy of the sterilization orc».-~edur~~.
It should be ::.cued that she present invention is not limited to onl~,~ those em1>oct.rnents described herein.
io Any embodiment. whic:v; retains r~rr~~ :;~;irit: of the present invention should bE° c.onsideread c_o be within its scope.
The invention :is orn.l~.P limited r:~y t:he scope of the following claims.
.SP-4E.
vEVICE AN~~ METHOD
FIELD OF THE INVENTION
The present. in9r~~ntion xelatE~s to a process challenge device and method f~:7~ c~etern~,-ininc, the efficacy of a sterilization proce~:~wsre .
io Medical instruxnent:s area t=virally sterilized prior to use. Many methods are employE~d, including steam sterilization, hyd:r-~,:~ger:~ pero:x.ide, ~,rapor phase sterilization, eit::near with or wit.hc~ut a gas plasma and is ethylene oxide iEtO;. each L~f there methods relates to a certain extent on t:~~e ciiffus.ion crf fluid, primarily gaseous, steriiants into coraact with the instruments and devices to be sterilized.
2o Typically, s~cl.instrumer_ts arid devices are packaged within containers o~~ pauche~~ having a semi-permeable barrier, which allows transmission of the sterilizing fluid but prevents .:~dmrssior~ c~ contaminating organisms.
Packaging of the i.cnstrument.~in ttms fashion creates a z5 diffusion restricti~~n somewhat inhvbiting passage of the sterilizing fluid t~~ the dez~i.ce or instrurnent . In addition, some dez~i:~es and i.rm:zwmer_t.s have diffusion-restricted spaces tlrere.in; f or e:tarnpl e, endoscopes ,SP- 46 __ G _.
typically have lone v:~,~r:,ow l.i.~mer~. ~.'he sterilizing fluid must diffuse into t:l~is 'bong narrow rumen to effect sterilization there:i.r:. In. ada.:it.:ion to diffusion restrictions, the c,ru~~r~tiry o:= devices to be sterilized s during one process, arid the amounl~ of absorbent material in proxim~_ty t: he re a:. c: ~<1:~ affc=cat ht~~w t: he sterilizing fluid travels to and cone:ac°t.s the instruments to: effect sterilization. A :~;af:f:icient_ acrcovru~ must remain in contact with t:.he i4u: t rumenfi: E on a ruf f icient period of io time to ar_hieve a c..W faired :'.ev~e~. ofv sterilization.
To i,zsure tha..: r.>roper ste~:il:~: ation has been achieved, it i-s ty~>ic:vai to i:;caude some indicator of the sterilization proce:~ in proxinv:i.ty nr~ the devices or 15 instrumenvs to be :~t: eri l i zed d~..xr-ing the process . Fox instance, a biolog~.cwl indictor braving a predetermined quantity of micro--:~:~~:~anism:~ ca:: :4c: placed within a sterilization cham~c~f~r° i.f the dwvice is to be sterilized and, after the pro~~.f-~s5 is cccnF~ete, it: can be cultured to 2o determine whether ~.o~~~ cat the macz~c:,-cr;~anisms have survived . Biologi c.-a 3. ~ndi~~ay=or s :nave evolved into designs in whicrr a ~:~:>;.irce of growth media in a frangible container is loc:at~~r3 ac?_jacer..t ~.o a cuantit:y of micro-organisms and after .r.hE~ steril.Az~~tian procedure is 2s completed, the fra.ng:ible corct.a;near is broken to release the growth media ,:~n~.~ cL:lture a~~.y remaining living organisms. Typica.lay, colon iud4cat:ion technology is included to show c. ~d;lor change _~n the presence of living organisms. Alternat~~eiy, ar: enzyme indicative of the organism viability rrt.~l:~ be det c~ct:ec3 . Examples of such.
devices are shown .~.ri ~ . ~> . Patent Nc;; . 5 , 83 ~J , 683 and 5, 418, 167, hereby an.~~-~rporatE~d by reference.
To more accur<:.tel.y repl~c~ate a ~rvia:lienge of diffusing a sterila.r~; fluid :_rlt~~ :=v~ntact with the device during an actual st.:e.ri.lizatic:n pro>cedure, it has sometimes been the ~:aracr.icc~ to "luc~e a biological to indicator inside o: ~x chall.eigE~ device having a diffusion restriction, such ~:asc a long t:ox-t~uous Bath. L1.S. Patent Nos . 5, 89!x, 62'7 and ~: 872, Oo4 i7.. ~.u:~t:.rat.e examples of such challenge devices, ~~Y.d are i=uc<.r-porated herein by reference.
SUMMARY OF THE INVENTION
A sterilizaticaw process challenge device according 2o to the present invention comprise:,s a sterilization indicator contained ~~rithin a ce_:~tztair~.er and a variable diffusion restrict.~c:rm rote tire ccr:ntai.ner.
The sterilizcation indiwc~t:c~r r_an be a biological indicator or a ~chFarr.ca l indi~:at:or indicative of a chemical sterilant:.
iSP--46 _.
The variable chi (fusion ~_e~:triction can comprise a diffusion path intc:~t:he container wh~Ch can comprise an adjustable coverin~:x 1=or the f;~~ttr: r:~~ block or unblock portion of. the= dif l::usion path . In. c:me embodiment of the invention; the contK~~.r~er com~:r i.se;: a f:irat member and second member dispc:~sed in t~e~~esc:o~.~i~y relation with the openings disposed .::>r t_h<=_ fir;:t meni~er and the second member forming the ~:~c~.justable cwv~~rng.
io The di.ffn~~:l~an path e,an cc~r~prlse a plurality of openings, which can be different i:5 size. At least one opening is preferab:l_y covere~~ wit~lr a removable covering.
Rather than, or in :-~c3dition to mu_l:~pl.e openings, the diffusion path can ,omprise a slc~r_, port: ions of which i5 can be covered or .~,u:~overed t.c va~r,~ the diffusion resistance, The diffusion ~:ath can rwmprise a long narrow path, wherein the d.iffusi:~n path can be :~djust.ed by trimming 2o the length of the p~~~th. they tA::fa~_a;s:ion path can comprise two or more mater:ia_l;s ~rloerea.~~ t~ru-~ !nat:eriais have different capab:.l.t.ies to rEytain sterilant. The diffusion path cai:; :comprise a steriiant absorber such that the amount of ~~tez-ilant~ Diffusing tc the indicator 2s can be adjusted bl, ~rrhe type :;~x~ the size of the absorber.
A method for a.;~seasing t~rae :~t~eril.ization efficacy of: a sterilizatiorn process <~cc~or:~ing to the present invention comprises the step's ~>f:: placing a sterilization process c~hal.lE~.~ce ci.e,rice i_n proximity to a device to be ;5ter:i 1 a.:~ec~ duri.:ic; the :;teri.l.ization process, the steri:l i~zation pro~:~e:~s challenge device s comprising a conta.:irrf~r, a ster~l_::at:ion i.zdicator within the container; an ~:~l::~f~n:ing into the cont:ai.ner and an adjustable diffusi.~au restriction at. the opening;
assessing a featur:; ,of a loac:.:f cane or- more deviee:~ to be sterilized in t:.~re st.erili~°_a;,ic>:rr process; adjusting to the amouni~ of diff..z~:,zon restri:.~r_ic7ra provided by the diffusion restrict.i_c.,m based upon the feature of the load; and indi.cati.ruca t:he steer i.iz:,~.t ion efficacy with the indicator.
is The ~otep of adjusting the amount of diffusion restriction ca.n cor~vp:rv ise~ adjusta.nc; ari area of the opening into the container, :such as hey c_overing or uncovering the opening into the cont:~~airxer. '°'h a o ~>E~r~ing can comprise a plurality of aperturf~s ~r, a wai:i caf the container.
The diffusion :restrictic~r~ ;pan comprise a path into the container and t:.;:m..~ step of aca:j u;~t ing the amount of diffusion restriction can comervse adjusting the length of the path.
The step c:f ad:ic.;::~t.ing the ~iif:E'usion restriction can comprise adjusting ara amount ~f absorbent material placed adj acent the ir:dicat:.c::v .
.SP-4n r _. ~~
The indicator .:an indicate whEet.her a reference organism rema.in:; v i,.inie or whet:W .~r a suf f i.cient amount of a sterilizing gas sa;~~ presen,: :_luri:rcg the sterilization s process.
BRIEF DESCRIPTION a~~° THE DRAWINGS
FIG. 1 is a tc~l ~ ~7ian view of ,~ challenge device to according to t:he pt~t~ gent ~nvPnr ~.cn;
FIG. 2 is a f:~~c::~rlt ele~rat is:gin view ref a second embodiments of a prcoc~E~ss chal l enge device according to the present invention;
is FIG. 3 i:_~ a f:c~c::rnt: elevat:ic:rrl view of a third embodiment. of a pr~:::~c: e~ss chal.l eryxe cie~f~ce <:according to the present invention;
2o FIG. 4 is a f:Tvcnt. eleva~:~i<:7z-i view of <~ fourth embodiment. of a prc:owss cha:1-lenge de~.li.ce according to the present invention;
FIG. 5 i~> a teap: plan v~ic_w elf= c ~ fifth embodiment of a z5 process challenge c7ew:icF>_ accai-ell.n~~ lu:o the present invention;
,SP-4E
FIG. 6 is a tcy:r plan view 4of a sixth embodiment of a process chal lenge ~:iF~ ~-x ce acct. rc..~nc~ to the present invention; anti s FIG. 7 is a tt~>f plan ~Tiew of a seventh embodiment of a process challenge: ~~ev:ice ac~cc~rdi.ray t:c~ t:he present invention.
1o DETAILED DESCFtIPTIC~N
Fig. 1 il_lustzwtes a pro::ess challenge device 10 according to the pr e;~ent invE;rlt z crr . l t comprises an enclosure 12 contayn:ing an irzdic,at:or I4 and diffusion restricted passage 1~eadinc lrato t:he enclosure 12. The is enclosure 12 compri sf~s a first opE~n- ended body 18 and a second open-ended b«G:~e~ 4c) d.is~.osed ~n telescoping relation to one anoLtner_ The diffusion restricted passage 16 comprise; a varietX~ ~~f a~>ertures 22 in the first body 18 which are selecti;rely covered and uncovered zc by the second .t~ody a?~,.. as the i.-,-st anu second body 18 and 20 are telescoped iri r°elation to cne another. When all of the apertures 22 <a~ve u.ncoverec~i, .it is much easier :Eor sterilizing fluid t.::> diffuse :.nt_.o t=he enclosure 12 and contact thc: inc~icatr:~x ~.4 than when only a few of the as apertures '?2 are unc~a~fered. ."accordingly, the challenge device 10 provides .-;zr easy anc~3 :~irnFO_e means for providing a process challenge, which cazl be adjusted in accordance with the needs of a f:Fart:icul.a~;tera_lizat:i~~n process.
.SP-4Ei Fig. 2 ia.lustr-ates a sim:i~ar process> challenge device 24 comprising an enclosure 26 with an indicator 28 therein and it has a cover 3C~ st <;~nc~ end, which can be s rotated into var:ioa.is positi.on:: to wary the diffusion restriction into tt:e enc~losuiw ~6. An indicator mark 32 and scale 34 are px:c~ride~d on t.hc c.ovEar for indicating the amount of diffusion v-estriction that: has been selected.
The amount of diffu5:i.~:~n restriction .hould correlate to to the ease or difficult: ~r in di.f fusing the sterilant into devices to be steri:LiLed, and the scale 34 may relate to a feature of the lo,:~t:a. rE>lev~~n~: t..o such, as for instance the quantity of devices or the ier~gth of the most challenging lumen iir. t:he load. ~r~~ferably, detents a:re is provided between th~~ c:c:wc:r 30 aa~d mr:cl:~surE~ 26, or some fr~.ction is provider, t=a keep the cr_wer in the proper position durinc3 the l.~s°oc°edure. i.h<diflusion restricv:.ion in this case can comprise apertures 35 selectively covered and unc.overf::~c:~ by the :o,,~c.r :30 but can comprise=_ ao other rest:rict:ions r~;f a varia.ole nature.
Fig. 3 il:Lustrr:~t::e~;~ :~ thia:d wrr~o<:diment of a process challenge device 40 ac:~c:ording to the present invention.
It comprises a cont~:~ i r~er 42 hav~.ng a l i.d 44 , and ?s containing an indica.t:~or~ 46. ~~ plurality of apertures 48 provide a diffusion-r~PStx-ictec3. ~~ass~age into the container 42. One or more of t:he aper~turE~ ure closed initially but may be opened b~~ punc hing out: ,~ disk 5U . Preferably, .SP-4E>
the disk 50 i:7 forr~~E~d by sha.~~ir~cl ,:he surface of the container 42 i.n the:' :>hape of tine aperture 48 creating a frangible connectit:>r: between tl~c: c~is~, 50 and the remaining material c}f contairo~x- 4~~ .
s The apertures disclosed ir:the first:., second and third embodiments may be the saa i.r~ size; or may vary in size, with the use_~ ~:>x~eaerab.:llr y_:u.~m:~:lng out or uncovering ever larger a~:~ertm:tes t~~ ra.p_.d1 ~;g ~~e~~;i ease the diffusion to restriction. Espec~i.;~ll~.r witr: t.ze f.rst and second embodiments, t:he p~u:ral-~t:y oa~E~:rtlzy~es could be replaced by a single el.ongat.ed slot . '~.'he~ dE~g~~ee to which it i~;
uncovered dete~rminc~s thEs dif2us:lc>n a:-estrio.tion. Such is illustrated in Fig. a . ~ t cls ~>closeu a :process challenge is device 52 similar to the challezzgE~ device 10 comprised of first and second bc~~:ies 54 anti 56 =ir: telescoping relationship a.nd cc~n;~aining t.heze ~rx an indicator 58.
Rather than a plum l :~l pry ~:~f a~>ert u~~e: , a:n elongated slot 59 through the first body 54 i.s fu~~~..y or partially 2o uncovered through tiw te:leec:oi.~izrg relationship of the bodies to determine t:tne diffL.:~i~n restriction.
Fig. 5 il:lustrat:es <~n al t:e.r:nat:Lve concept in which a process challenge de=_~.~.:~::e 60 c~:;rn~rises a container 62 2s having an indicator a';~E therei:~ ;anc1 ~. tortuous path 66 leading to the indz~:<=~~t::or . Pc:r-t i or,~ 68 of the container 62 can be :removed t;:::shorten t:he t ~4,:r t uous path 66 . For instance, if the co:rr°: w~:iner is f~-r~rrrr~=_~o. of mat:ing polymer _ ~ (~
sheets with a chanxie~. formed therein creating the tcyrtuous path 66, ~:u:::~-t:ions o~ t:.:ue ;~heet.s 4~an be cut off with scissors. Alv:_ernativel~,~, ø~he~ comta~ner 62 can be formed of films wi.t:.lb an at lf=<~:;t part:zally rigid lumen s placed therebetweer:~ to form t~ha~ p,~.t.:~ 66. Preferably, cut indicati0I1 lines 7tare provwded rh~~~-eon t:o illdi.Cate particular. location:: t.o cut:. watts <~ :specified degree of diffusion restrict~_on remaining.
lo Not only can the length of the tortuous path 66 be varied; it car. be fo:~-,ned of mate-:real. showing different levels of absorption. Preferably, that portion furthermost away from the ina.icator 64 would be formed of the most absorbent m,-~r.~er~:ial a:ld treat portion closest to is the indicator .formed >>f a low a~sc>:rption or non-absorptive material. Such matee:~ia..l;= include certain polymers known to absorb sterllants such as polyesters, polyurethanes, sili~:~~:>nes, and n';zri~cms, which absorb hydrogen peroxide, :~:r' mane traditional absorbent 2o materials ouch as ct:liulosic prat=erials, lather than form the path entirely ofn ~~uc°h abs~_.jrloent: mater:ia.ls, portions of absorbent material cyan be located in select locations along the path.
z5 Fig. 6 il:l.ustri::ct.~~s a furrhe~x- embodiment of a process challenge device 80 cfomprisi.nca ar~. elongated lumen 82 containing an indicator B4 at: trm~ ~:~losed end 86 thereof .
The length of ~ibsorl~Era rnater:.~~l 8~~ ~:~ put. into the lumen .SP-46 _. i 1 -82 through an oppcs:G.r_e open end t:hFreof 90. Preferably, the absorbent mate:r;~al 88 has markings 92 thereon to indicate places whe:r:°e it: can be coat ar torn to reduce its length and, thus, it:.~a absorpti°ve ~~;~pac.ity" The process s challenge device 8i) ~.;~ dispose~:~ ~:ithi~1 a breathable pouch 94 to provide furt.~~rt.~:- di. f fus i on restriction . Any of the embodiments herein c~~an be en:lc.~sed in a further diffusion restriction to enharce the c..-':a_~lenge they provide.
io Each of t:.he d:i.::c:losed e~nbc;~ciirnents incorporates Nome form of indicator. This indicator is preferably a biological indicatr~r such as descri:~ed in the background thereon but may alo ~4ompri:~c= ~cra ir.:dvcator for the presence c>f a part:a c~ul a:.- stex: i l arm Such as a chemical.
15 indicator for the Fr~~sence of hydrogen peroxide or the like. Such indicators are more ful~.y described in U.S.
Patent Nos . 6 , 218 , 1 8'9 and 6 , :_' ~ r' , 2 9 c incorporated herein by reference. Furt.hear, the indicator may be more active, such as a reacr~ive ~.~:i~o~m:~cal c~c1 a thermal couple to detect zo the presence of a cizemical stc:r ilant as disclosed in pending U.S. Patent= ;:cppLication No. 09/'741,594, filed December 19, 2000, ~a~c..~c~rporatc:d hEar~ein by reference.
Fig. 7 disclosf~, a process ch.a? lenge device 100 ?s comprising a contairie:zr 102 having an indicator 104 therein. Elongated lumens 10E and 108 extend laterally from the container :~i Cite . Each li,:mezn 10E> and 108 has markings 1_0 ttxereor:~ to ind.i.c,~r_f.e it:s length. Preferably, .SP--4t5 1.~
each lumen lCfa and 7.t:~8 lzas ai: i.rat~:zwa1 diameter of similar duamet:er ta: a particular ~~ev::c:e being processed.
For instance, an erudr~scope having a :;.omen of 1.5 meters and an internal di~..rnetea~ of ~_ rru 1.:l:irneter, each of the s lumens 10E> and 108 w~~uld have are :~nt~ernal diameter of 1 mm and a length ap~.:~r;~x:irnately cr~:e-.h~~l f the length of the actual lumen, or 0.7"~~ rn to trrus s:rntalate the sterilant diffusing into the center of the de~fice lumen.
1o In use, an oper<~tor would determine a certain characteristic of t:~c~ toad such a~~ the number of instruments, the mam~>e~r cf wrapped in.strumeint containers, certain types of materials, wiiivh may be absorptive, or the length of an~.~ d:it::ficult-to--:~tex~:ilize lumens. This is would then correlate= t:;::> ~~ part:i~:wlax set=t:irug on a process challenge device. Fc_ar instance, using the process challenge device 10, t:. he user may determine that onl,Y 30 percent of the apert:tares 22 should be uncovered to provide a procr~ss c.m ~ lenge indi t,at:ive of the particular zo load to be ste:rilizl~c~, fhe d~r.:v.it::e:; arnd the process challenge device 10 a~-e then stEeriizzed in the usual manner. For instanc:~e::~, they m~~y be placed into a steam sterilizer and proce::..,:~ed, or i.nt:;~ ci k~ydroc~en peroxide vapor ster~_i i zer . :~r~e Brach e:~cample i s the STERRAD~
as process from AdvancE:~c~ Steril.i ?anon Systems in which t:he devices arE~ placed _nt o a chamber which is evacuated and into which is int:ro<::luc:ed hydr«ge~r; :~e:rr~xidEe vapor to sterilize the art.ic~ e~s . At some p~::m.nt: during the cycle, SP-4Ei __ ;. .3 the hydrogen perox.::..de vapor i~ exc=itred int=o plasma, which has the beneficial effect. of i.eav:inq behind very few residual hydrogen Fierox de mc>l.e~uae~. After the procedure is completed, the process challenge device is s removed ar.,d the inch{~atc>x- exG.rni~aed t. cassess the efficacy of the sterilization orc».-~edur~~.
It should be ::.cued that she present invention is not limited to onl~,~ those em1>oct.rnents described herein.
io Any embodiment. whic:v; retains r~rr~~ :;~;irit: of the present invention should bE° c.onsideread c_o be within its scope.
The invention :is orn.l~.P limited r:~y t:he scope of the following claims.
.SP-4E.
Claims (21)
1. A sterilization princess challenge device comprising:
a sterilization indicator contained within a container; and a variable diffusion restriction into said container.
a sterilization indicator contained within a container; and a variable diffusion restriction into said container.
2. A sterilization process challenge device according to claim 1 wherein the sterilization indicator is a biological indicator.
3. A sterilization process challenge device according to claim 1 wherein the sterilization indicator is a chemical indicator indicative of a chemical sterilant.
4. A sterilization process challenge device according to claim 1 wherein the variable diffusion restriction comprises a diffusion path into said container.
5. A sterilization process challenge device according to claim 4 wherein the diffusion path comprises an adjustable covering for said path to block or unblock portion of said diffusion path.
6. A sterilization process challenge device according to claim 5 wherein the container comprises a first member and second member disposed in telescoping relation with the openings disposed on the first member and the second member forming the adjustable covering.
7. A sterilization process challenge device according to claim 4 wherein the diffusion path comprises a plurality of openings.
8. A sterilization process challenge device according to claim 7 wherein openings are different in size.
9. A sterilization process challenge device according to claim 7 wherein at least one opening is covered with a removable covering.
10. A sterilization process challenge device according to claim 4 wherein the diffusion path comprises a slot.
11. A sterilization process challenge device according to claim 4 wherein the diffusion path comprises a long narrow path, wherein the diffusion path can be adjusted by trimming the length of the path.
12. A sterilization process challenge device according to claim 11 wherein the diffusion path comprises at least two materials wherein said materials have different capabilities to retain sterilant.
13. A sterilization process challenge device according to claim 4 wherein the diffusion path further comprises a sterilant absorber such that the amount of sterilant diffusing to the indicator can be adjusted by the type or the size of the absorber.
14. A method for assessing the sterilization efficacy of a sterilization process comprising the steps of:
placing a sterilization process challenge device in proximity to a device to be sterilized during the sterilization process, the sterilization process challenge device comprising a container, a sterilization indicator within the container, ara opening into said container and an adjustable diffusion restriction at said opening;
assessing a feature of a load of one or more devices to be sterilized in said sterilization process;
adjusting the amount of diffusion restriction provided by said diffusion restriction based upon said feature of said load; and indicating the sterilization efficacy with the indicator.
placing a sterilization process challenge device in proximity to a device to be sterilized during the sterilization process, the sterilization process challenge device comprising a container, a sterilization indicator within the container, ara opening into said container and an adjustable diffusion restriction at said opening;
assessing a feature of a load of one or more devices to be sterilized in said sterilization process;
adjusting the amount of diffusion restriction provided by said diffusion restriction based upon said feature of said load; and indicating the sterilization efficacy with the indicator.
15. A method according to claim 14 wherein the step of adjusting the amount of diffusion restriction comprises adjusting an area of they opening into the container.
16. A method according to claim 15 wherein the area of the opening is adjusted by covering or uncovering the opening into the container.
17. A method according to claim 16 wherein the opening comprises a plurality of apertures in a wall of the container.
18. A method according to claim 14 wherein the diffusion restriction comprises a path into the container and the step of adjusting the amount of diffusion restriction comprises adjusting the length of the path.
19. A method according to claim 14 wherein the step of adjusting the diffusion restriction comprises adjusting an amount of absorbent material placed adjacent the indicator.
20. A method according to claim 14 wherein the indicator indicates whether a reference organism remains viable.
21. A method according to claim 14 wherein the indicator indicates whether a sufficient amount of a sterilizing gas was present during the sterilization process.
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|---|---|---|---|
| US10/002,038 US7091042B2 (en) | 2001-11-02 | 2001-11-02 | Variable resistance sterilization process challenge device and method |
| US10/002,038 | 2001-11-02 |
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| CA2411232A1 true CA2411232A1 (en) | 2003-05-02 |
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| EP (1) | EP1308175B1 (en) |
| JP (1) | JP2003180804A (en) |
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| WO2000055070A1 (en) * | 1999-03-17 | 2000-09-21 | Ethicon, Inc. | Sterilizing agent capsule container and sterilizer |
| US6767509B1 (en) * | 1999-06-16 | 2004-07-27 | Kimberly-Clark Worldwide, Inc. | Self-sterilizing packaging |
| AU5581999A (en) | 1999-08-24 | 2001-03-19 | Process Challenge Devices | Device to assess efficacy of sterilization procedure |
| US7091042B2 (en) * | 2001-11-02 | 2006-08-15 | Ethicon, Inc. | Variable resistance sterilization process challenge device and method |
-
2001
- 2001-11-02 US US10/002,038 patent/US7091042B2/en not_active Expired - Fee Related
-
2002
- 2002-10-31 AU AU2002301748A patent/AU2002301748B2/en not_active Ceased
- 2002-11-01 KR KR1020020067373A patent/KR20030036090A/en not_active Application Discontinuation
- 2002-11-01 ES ES02257597T patent/ES2298333T3/en not_active Expired - Lifetime
- 2002-11-01 DE DE60224345T patent/DE60224345T2/en not_active Expired - Fee Related
- 2002-11-01 JP JP2002320186A patent/JP2003180804A/en not_active Ceased
- 2002-11-01 TW TW091132338A patent/TWI284199B/en not_active IP Right Cessation
- 2002-11-01 EP EP02257597A patent/EP1308175B1/en not_active Expired - Fee Related
- 2002-11-04 CA CA002411232A patent/CA2411232A1/en not_active Abandoned
-
2006
- 2006-06-28 US US11/426,991 patent/US7247482B2/en not_active Expired - Fee Related
Also Published As
| Publication number | Publication date |
|---|---|
| TWI284199B (en) | 2007-07-21 |
| ES2298333T3 (en) | 2008-05-16 |
| DE60224345T2 (en) | 2008-12-11 |
| US20060234330A1 (en) | 2006-10-19 |
| EP1308175B1 (en) | 2008-01-02 |
| US7091042B2 (en) | 2006-08-15 |
| AU2002301748B2 (en) | 2008-12-11 |
| JP2003180804A (en) | 2003-07-02 |
| US20030087441A1 (en) | 2003-05-08 |
| EP1308175A1 (en) | 2003-05-07 |
| DE60224345D1 (en) | 2008-02-14 |
| KR20030036090A (en) | 2003-05-09 |
| TW200302916A (en) | 2003-08-16 |
| US7247482B2 (en) | 2007-07-24 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request | ||
| FZDE | Discontinued |