CA2677057A1

CA2677057A1 - Methods and devices for treating tissue

Info

Publication number: CA2677057A1
Application number: CA002677057A
Authority: CA
Inventors: Jeffrey A. Saal; Joel S. Saal; Brian R. Dubois
Original assignee: Individual
Current assignee: Laurimed LLC
Priority date: 2007-02-01
Filing date: 2008-02-01
Publication date: 2008-08-07
Also published as: US8088119B2; EP2114494A2; US20110306879A1; WO2008095177A3; AU2008210285A1; WO2008095177A2; US20080188826A1; JP2010517636A; US20080188827A1

Abstract

Device and method are provided for diagnosing and treating diseases and injuries to the spine by injecting drugs into the diseased or injured area. The device and method of the subject invention provide improvements to patient and operator safety, along with ease-of-use and convenience improvements over conventional techniques.

Description

M.E..`['Rt)DS AND DEVIC._~~SFOR TREA'1<"I:`dG TI~SUIs I-oo01] 'f,}Ãis is aÃioÃt-prcrvi,,~,iotiaZ a.pplicatiori of U.S. Provisional Application No.
60/ 898,9y 7 Filed February I,'007, a continuation of US. Application No.
1 l,i838,675 filed AugÃ.ast 44, 2007, aÃid a continuation of U.S. Application No.
I 1 1183 8,69-2 tiled ALÃgust 14, 200 r. rt['h e contents of whic:h are inc:orporated he:r4.in by reference in their entirecy.

FIELD OF THE INVENTION

1-0002] ,I'}ie preseÃit iÃiveÃition is draw-n to devices and Ãiiethods for improved injeetion systems. Vaaaations of the devices and methods of the injection SystCÃns provide at.ra-uÃrÃat.ic: ip,ject.ion cfelivez-y witi7:iÃa a spinal column wlÃile Ã-nin:imrriÃ7g tile likelihood of causing adverse everÃts.

BAC1~r-.t:yROU:1lti'D OF THE INVENTION

100031 Annually, millic.~gis c)t` Americans suffer troÃtÃ ai.;ÃiificaÃit spiiie related pain and discoÃraf-ort. Wbere the cervical, thc7ra.cic, anci ltÃÃnba.r vt;rte.brae asttf discs caÃÃ
be the source of this paiÃi aÃid discomfort, In one estimate, paizy perceived in tlle neck or upper l:iniht tllat iS c.aeÃ:;ecl by irritation in the nerves tlia.t e\it the cervical sliizie tlarcÃtÃgii the fo-~rameii affects a population of approximately i person per 1000 per year. As a res{Ãli, ever~ year pi-ay5acia,t7s in the United States per.forÃ-Ã7 alÃ
esÃ:aÃraatecf 750q000 transf:orarrÃ.ina1 cervical injections to treat tlÃese pat7enÃs.
10004] WIiile the nene iÃ=Ã=itati~.~ÃÃ aricl resultant inflEtmmatiÃ.3n causing this spinal laaiii lias a varietv of etiologies that result in cc.arÃt.act laei:weeÃÃ the Ãierve aÃld -tlie adjac.ent strnÃc:tures in the tipiiie* tra.rlsforaÃninal injectiÃ.3ns of c.urficostt:roids can relieve this irritation and Ã-e<ltice the acco.tnpanv':in<w paiti.
f.()()05:1 Ti-ijectioÃ-Ãs of corticosteroids and or local artesthetic.s into isolated a:reas of tlie epidÃirril space are i::iyiportarit t.reaimeÃ-it a,t7d cfiagnE}siic. Ã-nocJ.allties, toÃ- patyenÃs, sull'erinc, f:rorti spinal Pa.in syntirotaie.s. Isolation of the ir,jei:tion to a specific spinal level is acconipI.ishecl by tisirig a t.raÃ7sfnrarnina.l approach.
'f"llis is t distiziguishdbIe trotii the traditional trans-laminar a.ppr~acEi of spitial epidura:l injections coÃninoiiiy Ã.Ãsed for aÃiesthesia., fOO061 PreseÃÃt.ly, 1?IÃvsia~trists, aÃ7esthes-o(ogists, ra.diE}Io.-.ists-, ÃÃeurologistw, and orthopedic atÃis..roogis perfomi stÃch transforaminal injecti~~s under fltloruscopi~
guidance usittg aC-ArÃii fltÃorcasc~peq a standard spinal sieeclle, and three :?co syringes. Ozie c:urretit teclyaiicltie in p.ro-vidiayg tbe> e injections includes eonsciot.is seciaticstx of ths: patient throLA-h the a.i5e of local a.ne4thctic; a{id anxiolytics. Th. e operator pezfot-m the procedure usiÃ-a¾> multi-plane fluoroscopy to guide the needle iÃÃto positicÃÃi and to -verit:y correct IocatioÃi of the del:iveÃ-v device 1TÃ-ior to :iÃÃ#ecÃioÃÃ
of the substance.
fÃlOÃ17] As shcnvn in Fig, 1, existing delivery devices include a 20 -'?5 ~,~at~ge Itypridertiiic needle .i. tIiat is inserted tliroug1i the skin, muscle and soft ti~ques 1Ø
Using flttsarosc.e~py> the operator positions the distal ciyd cit the needle imme.cliat.-Cly ac~~acent to a portion of a vertebral body 12 at the level of tlle desired injection.
Typically when delivering the injection iz3 a cervical --egioz3 of the spine, this iÃicltÃd~s positiFZning the tip of the needle irziyz7ediately adjaceÃit to a posteÃ ior inferior aspect of a sLÃperior articular process 14 of afac:eÃ iÃiiÃit of the vertebral body 12 tzt aÃi iritlc x foraminal level chosen ~or the illjec::tion. CaÃ-c must be takeÃi to avoid puncturing, t1-ae veztebral arteries or veins 16 extetidiiig tbt-oug}i toramens in t.lÃe vertebral body 12.
100081 To test the initial placement of the Ãieedle it is standard for the operator to iÃÃItially; inject aco-itrast metiia.., scic:la as a.:rad:ic3 opaqÃ~e dye.
"1`iÃis step is tÃsefia1 to ~.~let:eg-iÃiit~e vvlieÃher tlÃe Ã~eedle is Larldeairably located in a blood vessel 16 or irÃ the dural a-iÃeÃiibraric 18 To vc:rit~, whether the noccile is desirably plac>ed, flic operator obser4,es under fluoroscope for negative indication of veÃiec.~tis, arterial, or cerebrospinal a.iptake: of the dve:.. Upon coÃafirmi~i(y the correct location, the needle is left :iÃa pizsi.tÃon. while tNie 5yriÃ7~e ~:c~iitaiÃii~~Ã4~ the rac{io opaqtÃe dye is care.tiÃlly regnt}ved f:roÃn tl-iÃ: needle aÃicl replaced by a syriÃ~ge containing a local aii.estl-ieÃic;
suckÃ as 1idFZcaiÃÃe. As expiaiÃ7ed below, the operator must take -rezit care riot to avoid aÃry inadvertent movemeÃil or aclvaÃ1cemeiit of the iie-eclle especially dtis-iÃ~g ex<:hange of t.lÃ~~ synir~ges, 10009_1 The operator then iiljectti a sma,1l boIcis of lidocaine. (or a l0c:,al m4.sthetic of choice) and waits a suft:~cieÃÃi period (e.g., sixty seconds) to allow tcar the anesthetic to disperse. DuÃ-aÃÃt~ tliis titiae the operator observes the patient for adverse reactions resultitig ftcxzii ac:,ciderafal vascular uptake or injection ilifo t:l~~
dtiral sleeve or thecal sac. A1tbc~ugh pIacement of the needle was observed vs.mg tlic radiopacgue dye, there is 5tili a. risk o.f'acci~efital vz~scalar ir~jccÃions because the needle may [~ave mo-ved during the syrins;c, e?chans;4. ~.~rocc:sss (ir simply because vascular perforation was not detected duri~ig the radiopac~~je ciye itijectsoll.
fooi.oOnce the operator c~o a~iÃ~iys negative adverse reac;t.ic~zys, the operator ~.~ra.iz~
care:fii.Ily exchaa-iges syringes ic) cor~~ect, a syrin4~e containing a cortic:c3stero:id.
Finally, the corticosteroid is iqjected in ati effort to reduce inflammation thereby a.~"o.rding, the patient pairi relief. ,-1.ft.er the thrce injccf.ions i.e.
radior c~par{ue dye, local a}Ãiestlietac, cckrtacosÃcroid are conipleÃc, tlY~ needle is removed from th.-I
paÃiem loot l] A1fhoug1i the current procedure provides bez~efifs to patients having spi~ial rc;l ate;ci pai ii, si gni #icant risk- remai iis with f.Iic current proce.dure.. One itilic.rc.nt ri sk includes breaching a blood vessel aiad the inarlveztent inrjecc:ion of dye., anesthetic, aaie11or corticosteroids into ati artery or ve:iii_ Currently, it is. believed that breach.izi4 a blood vessel occurs in a c.ot7siderable nLirviber of irjecf.itms pertorrriecl (a re;c.eiit cliiiic.al study had venous uptake in over 19% of ir~j1ections performed).
Additional risks iriclude contact bettiueeti t.iic injection sieec11e ~id the nerve root, which may cause paiii along wifl-a damaoe to the dura. Finaltv; there are risks assoc:iated to the operator via ex.l3osiire to ttie X-Ray raciiatioti of the flijc}y-oscope., particularly in view of the cumulative CX}IOsLi.re as tlie operator mrist positican the needle as -well. as etchanee sy-ri-~~~~~s a iiLfltrftaef- of ti.mes, fÃ10121 The actual breaching of fiie blood vessel may occur dziring the irtlit:ial insertion of'tbÃ; needle into f:lie site, ;ubso<lucnt- manipulation of the tiÃ;ecile dttrizig syringe exehaii~~:a, or even ~~~~t~~~~~e~t of the ricedle as a r~.stilÃ of f1~~. force applied by tl~e operator dL7ring actuation of the syrin(ye. In some cases, iz1jectifjn into a blood vess-e1 inay oe~.ur c~~efa if ti-ie iaecdle }-as riot penetrated e}{e vessel wall as tbe force of ttic in jc;ct~.~~t flowing z3tyt- of tbc; di`tal. tip ot'tlie rieed1e can be sufficieti[
cause t?ae .iiijectadit to breaci-i the blood vessel wali atad erite.r irifc) the vessel.
fOO 13] Ct~i-riplicatioÃis from accidental it~jec.tion of tlic anesthefic, ilifo the vessel can include fraiasiegaf paralysis of tl-ie spintaf cr.3rd.. Complications resu1 ltiiig from a.ccitleiital injections of corticosteroids into blood vesse.ls can include permanent paralysis, perinanent b(aiidt7ess (if ir~jecÃcc{ it7tx~ a vertebi-al arter;~), s~~zures., permarient cognitive dvsfutictioii; pbvsical inipairmentõ and/o.r deatli.

1'0014] :1.Ãaotl-aer eori-aplica.irora a.ssocia.ted witEi transfo~r-a.tiiirial ir~~ecticyris, is ma.dverterat corata:c~t beuveen the iieedle arici nerve root which may c;aarse pa.in or-iÃ:ri-1l:ing erriaria.t.i.ng thr~OUgh tlie cipl3er extremities. If the needle perforates tile dtÃraI alee;~~e, spiria[ fluid rnay leak resultirag in a tra.rysicrrÃ headache lasting f:r~n'l several hCiurs to several tiays. If local anesthetic is iqjecÃed itrtc? Ãlie thecal sac, temporary paralysis may c3oe:trr that could result in aceSSatiozi of br-eathin~~, necessitating e:niergeracy intcrb<irion of the patient.
100151 In 'View of the above risks, to ensure pa:tietit safety the ~-perator mu%t reposition the rreedle if I-ae or ;}ie suspects that patierit ha.:rz11 could oecirr. In addition, if arterial uptake is suspected, a commot-i recomrnerida.tion iS.
that Ãlie procedure sliotrld be abandoned to allow itie arterial perforation tc.~ heal and to obviate the risk of jqjc.rry to the spirial cord aesultirig fr-ozYt inadver-terit iqjection of corticosteroid into the raciietrlar artery or vertebral artery.
1'001.61 Eac:h time tl-re iieedle is repositioned, a.tiew X-Ray Ãznage must be ca.ptcrr-ed to verify the iieedle potiition and additioraa.t rea.l tiame fluo:r~~colay i.m-ages, ri3rist be captured willi an a.dciit.ior7al irajectiora of contras't rtied:ia. `i'he additional f1tiorosc:cgpy and associated radiation expc.~stare presents an increased risk to the operator performing the proce;ziLÃ.r-e.To 1-iiiriimize exposure the operator 1.11LFst stc;p toward and away frorii the radiation field to a:ltema.tely manerrver or tiia.riipulate the hypodermic syringe arid allow fliioroscop.ic ii-iiages to be tzikeri.
Tllis exertiOrr Lonibiried ~kllitii the r-epeated cc,nnectÃng, a:rid disconnecting of syringes contributes to operator fa.tigrgC, whieli is riat a trivial eoricideratic:arl for operators performing iiifiltiple proceclLare` in a partieLilar day.

1001 The design of the current devices presents ari additional pi-cgirile2-ii tlia[
cuntribtrte.s to uritlc:sire;tl cle~~icc placer rle.nt. Ctirrer rt devices irlclucie rigid and stra:iaht Iiypcxiemiic iieedieS. Sa.ich a configuration limits the operator to only work within the "line of sight" .fro:in the surface o.l'the skiri along ari axis o.t'the rre.edle. i_r~ i-nany cases, it is desirable to pertc3rni the in,jc:c>tion in a position that is riot directly accessible by a straight, r-igiri neecile, e.g., it is-Frequently desirable to iqjec.t Meciicine in a ~.~oSitÃori "beriÃnt.i>" pc.3rtiorts of the vertebra-, nerves, or blooci ve;;sels, (i.c . around tli e corner frozii the Igiie ~af si~;l~r l~rssititrz1).
[00i81 Devices and methods are pro.ricle:ai herein for aÃra.r rsforaminal epidLrral irijee.tion iieedle systeni that minÃznizes tfie above risks, to :iryipr-ove patient safety.
Ã

ln. additicyii; the beiieits of such devÃc.,e5 reduce operator fatigue and decrease ttie qperator's potential radiation exposure, toolgj The niethoc{s a~~id devices iriay be used foz- trar{wforarninal selective epidural injec.tions tca th~~ cervical, tlyoracic, or ltiinbar s(-'in~..
Fluoroscopically guidc;d, coritra.st-eiihmzt :c;<l iransforaiziinal epidural irkjecÃioÃ~
proced~irÃ;s help to specifically evaluate atid treat ttie precise spinal nerve involved as a source of sp:itia.1 aait( referred extremitv paiia. Although therapeutic a~id diagnostic traiisfoaa:iiiiÃ-aal epici~ira.1 injections have becti perfortt~~d for decades, the equ.ip:~~~ent used f:or these -n,ject.ions has t~~~i-i relatively unchanged during that time.

SUMMARY OF TFl.[:> lNVEIN'I'ION
t0020] The present i~iveiitiogy incorporates features ilyat address cacli of the ri4ks li.stecl above. The devices arid. rnetl7ods described 1-iere:iii include a catheter with a blunt distal tip and an ii1jection port that allow cinigti or other substances to disperse at a tiirge[ site while :minimi:r.ing safety cc3t7c.errtw. The construction oftlle catlieter decreases ttie chances of inadvertent[y iqjectin<,~ substances into a t~~le.~oLl vc;sscl as wÃ;li as inadvertently dai-aiagirig structures becau;e of iiicorrect 131acertieziÃ
of a needle.
10021] The invention it1c.ItidÃ;s an injection systes-ii comprisi~ig a needle c;.inryula havirtf); a sbazp tip ata far eiid of the rieedle n, nnufa., where the sharp tip isaclapÃed Ãc> penetrate tisstae, aiicl a faeecile lumier.i extending ttifc~~l-I1~
~~~edle c>al7.niilil. The ~eviee includes a. sliding mcziil~er slidably affixed withiii the needle lrimen to move between. a re[rac:i~d positiora and a deployed positioti witliiri tlt~ ne-ecile ltir-iiezi. `I'liis s1idi~ig ziie.riiber ri-iay be a plunger, a stop surface, or aÃlsr such siructtire;. In additional variations, the sliding mc:inber car~ be n~.`~n-roÃational {e,g., such as having a f>J-ooLe or lhevvvay} so that ttie irriect.ion zrtbe injection port is always oriciiteci relative to the c:arriitala. [n yet atiother variation, Ã1ic sliding taetitber catt provide itt.formation relating to the orieritatiot3 of tlte, catheter tubing tt) the ph~,rsiciaa-t via t3~ar.~i~~gs, etc. :~ai iz3jecti-~z3 tubing t3av~i~g a[listal portion having a distal end, a proxifz7al i3ortioya, and an irijectiori liirziezi extending l~et-c.~~~~~~
thÃ:. Ãlistal liÃ :ioti and the 13rÃ3ximal po~rtzoay, where the injection lttMctl exits the iiijectioii ttabiÃ-ag at aÃi i~~~ectinii pnÃl located irÃ a sidewall in the dism, l ~~ortion;
where the iniection ta.ÃbiÃig is afflxed to tlie sliditi(x member sÃ.Ãch that when the sliding inenÃber is irÃ ihe proximal posit.iot7, ttÃ~ tiictai portiori is within theneedle cannula aÃici when the slidi~ig meniher advances to the deployed position, the.
distal portion of tiiic; ir~~ectiori tubing exterÃdt out of the far esid of Ã1:1~; Licc.d(~;
canÃiuiGi. Given t:(iat t:lie sliding meanber is a.tYixed to the iÃ~jeetion tubing, the injei:ticsn tubiri.~,F can he, moved a limited distance by advancement or retraction of the sliding assembly. The beÃiefiits Of SLÃ.ch a feature are described below.
An embcxd:iirÃent of the systeni al,-,o iricl des a plurality o.f':iiideper{cierÃt extension Ãtibe 1tianens where a manifold fluidly couples each of tiYe extension tube lumens to Ã1ie itijextion lumen.
100221 T(ic invention further includes ii-aetbods of delivering substances iÃito an c;pi~.~tlral space tflsi~~~ ~~~ie of the -variatiorati of the de-vives cie5cribeÃ.1. In i3ne, viÃ-.iation. tile invention includes methods of cieliveÃ-inc, substances into a q?ine, epidural space, spinal. caÃial or similar region of the body.
100231 l:rÃ one variation, the fa7et}Ãodc ai-elude a fÃcedle car{iitila lia.viiiw a needle ltÃmei7 atid an injection iubi~ig cxteÃiciiÃig through the iic.edle lumen, where the injection tubing comprises asi iniectzc3n lumen, flzr.idly coupling a SOLÃTcO
of a radiopaque nia:teÃ'ial to the iiijectioii lumen aiid independently fluidly ~~uplirtg a sotirce cyt' a first therapecitac :,Libstaiac>e to ttie i~~~ectiorÃ luyiieziõ
where stac}Ã cc}upli~~~.~.
ncLurs prior to irÃsei-tiÃio t[ic xieedle cannula itltt) the patrent, insertino a dism, 1 eÃ~d of the ÃÃeedle ca-irÃÃ.ÃIa so that it is spaced a distance from the op.idci.rai space, advancing the iqjection tubing tlirc.~Ligh the iieedle cannula t~.~ ~~~~~~-ice ati.~.~ of the i-zjc;c:[ioii tubing :f-F=orn the dista.I c;tid of the needle caziÃi.tala to the epidural s~.-~at;e, de;liveritis.r the radiopaque material t1irough the injection ltÃmen to the epidural s~iace to verify piac.emeÃit of the tip of the injection tubing.> arid deliverizit.~ t.l~e first t?Ãer-apeutic substance through the aiÃ~ectioi- 1~~i-iaerÃ to ttÃ~ epidural 5pzic:,e withotiÃ
disconnecting the sotarc:e c3:Ct:lie radi.op4ttltÃe ÃnateÃ-ia1 from ttie tit;edl.c l.wrien.
100241 liÃ yet another variation, the Tzietlaod iricl~~~es providing ati injection System irteltitiÃng a needle camiula liavir~g a rÃeedie ]tamen eateÃldiÃ1g ~ tiicretliÃ-ciLÃg1'.1 aai(i aÃi iiijecÃic~~~ tLabiiig laavizig a curved shape at a distal POrÃ.it}D, Whel-C
thO iqtc;ction tutbe is slidably located in t.Iic neec114. ILtÃiieii to move between a retracted position and a cieplizved position, -whe:re iTi the r-et.~~acted position the injection tubing rerilai~~s within the iieedle luÃtieÃi aiid in the deployeci, position, the injection tubing exÃeiids out of a far etid of the ticedie ca.ÃiÃ-atÃla to cunvte away from an axis of the rieedle ca.nnula, advaÃiciiig a tip of the needle caairiLila into the patient so that the tip is positioned acljaceiÃt to the vertebral body at7ti spaced a distance.f~royzi the foramen of the vertebral body, advancing the distal ~~~id (if the irlj4.ctioÃy tube arutÃnd a foature of the vertebral bc-Ay itato t.lie foramen by advancing the ilsjectiots ttib~;
within the tieed1e catiiiuia. 4uc&y that the distal poÃtion exits the ity,jec;t.ioÃl tube and assua:nes the etirvcti sb.apc;.
100251`l'1ie injJectzon systeii-a ii-aay cieliLer injeetants, iqjecta.(ale substa:nces, and/or inject.able i7tiids. Suc:lÃ szibsiarice; are intended to incl~~tle arÃv iriedicatiori or diagnostic fluid the physician (or oliera:ior) ma.v olioose to admiÃi:isÃer with Ã1ie sysi.cm.
100261 It is iiot.ed cha:t the inveritÃoÃi z~ieiucles comEaitia.tioiis of eiiibodirnents or aspects of the embodiments tliemselvcs. The folicn.o=ing illu5tratiotis are intended to convey an o-vera.ll concept of the inventive methocis, aÃlti devices.

BRIEF DESC;RI_l'T'ION OF THE DRAWINGS
1002 71 The invention is best tiric.ierstc3od firorÃi t:h.e detailed descripÃiorÃ vOlerl Ã~eaci in cf-}t~jÃ:Ãnct.ion witli the acc~.3r~~pai~vÃng, tlra~.On_ga. It is etiipilasizecl tha-t, aecc.~rdil-l~n to ccfmrnon t.-~ractice-, the various feata.ares of the dra.wi.ngs are not Ão-sca.lv. 01-1 the contrary, the tliÃiietisioÃis of the various fea.ttÃrca are arbitrarily expanded cir redLÃce:d for c:lariiy. 1nClUdedin the dra.wirÃgs are the f0ll0Wi11gtigLJTes:
100281FIG. i illustrates a previously li.nnwti procedure for in,iect.ing asubstafice wiÃb:izi a spinal cadiat of a iiatier.it.
~00291FICi. 2A s}iows a cross sectional view of a.ti example aÃi injection svqtem iiic;orpot-at.i:Ãi- tlte coÃicepts discussed i7ereiti.
10030] FIG. 2M :Ãliows a ci-os:Ã sectio;atat view of tlic rqj,ection systerÃl of Fi~.x. 2A
where the catheter or iqjectiÃ.3n tube ~s witlaclrxwn iÃit(i the iieec11e canncÃ1a.
1.0031_1 FICi. 2C sl-aows a cross sectional view of another variation of an iqject.ion systcm without a plun(;er naeclia:Ãxism, t00321 FIG. 21) shows acrcss5 sectional view of the injection System of :[jig.
2c`
w1-tere. the catl-icter or iqjection ttibe is a.dvaa-tccd otit of the needle ca11Ã1t1ia.
1Ã}033] Fi(:rS. :zA to 313 illustrate an exa.rziple ot.'plac:irÃg a~id deploying the iiijectie~~~ svstezns acÃ;orditig to t1it; devices aiid mt;tliotis described herein.

1'0034] FIGS. 4A to 4D sliow additional ~~atia.tioris ofit~jectionsyst.ems where a manifold is located oii a bodv of the device.

DESCRIPTION Ol~ 'I'1:~-1:E INVEN'I'ION
100351 F'i& 1 illustrates a va.ria.tiort of ati iqject:ioÃx cystem 100_ AlthotÃgli the svstc:riis aritl riiethods tlesed.bed I-ic:reiÃi are ot:fcii. described as being LF:seci as a cert ica[ iqjection syste~~i or fcar the cervical region of the spine, the device and r~i.ethotl.s inay be applied in a broader ata(l to various otll.or parts of the spitlÃ; as well as a;na.toÃiiic strLactu.res where the features of tlic systeÃn ma.y provide useful.
1Ã}036] A.s shcavv-:n iti Fig. l, the s;tr`:;teÃii 100 i~icttrde~ a canneÃ.1.Ã
or:needie csa:n.aula.
102 where adi.stz~l tip 104 of the i-ieedle cat7ziiÃla 102 is sharp so that at7 operator may a(lvaaice the ca.nntÃl.a. 102 through ti:styc.~ to reach the itit-entlcacl taigsi,,et- site. The Tieedle cannula 102 may optionally iricltide a latib 1W '1":he li-Lab 106 iiia~~ be a common polymeric litab tha.t is moided, bonded, or otherwise atfixe.cl t(i the rieedle;
cannula .1.02. ?1lteÃ-Ã-ta.tively, lliough Ã-ic.,t shown, the liub 106 Tziay coÃ-iiprise a se;c:tioti of the needle cannula 102 itself. In a.nv ca.se, in some variaticgiis of the syst.eiii I.{)0, the Iiub 106 provides an eÃ-gorioÃrlic surf~ace for the operator to gy ip dfÃ.riiig ifisertio~~ and ~.~ot:etitÃally manipu[a=te with a single hand.
I'lle Rlia-pe of tlie hub (aa-itl device body as desc~abed M additional va.rialions below.) s1i.Esuld enable the operator to hold the litib and/or clc:'vice between their thumb and forefiliger cif t..a.ohhatld, This irriprover the operator's ability to aim aiÃd guide the s~e. odlc: (~wid ultimately t:(ic catheter/iiijection tubing) iÃito position. Additionally, this desil.gr~
shape allows the operator exi:eli~zit, tactile .t'eecikpac:k during, insertion of the clevyce a.zid advancement of the iÃijectioÃi tubing.
1.00371 ln one exad~iple, when the sywteni 100 is ~.'ptit7ii;red -1:oÃ- use in delivering iqjt::c.ÃioÃas in the spirial a.rc;t: the riec:dle a;ta:ÃaDU(ta. can be any sta.Ã-idard zieedle, 1:Ã1 spiiia1 applicatioiis the carmuIa can be 19 to 26 gauge. l:n one variati(iri useful for cervical regioÃi treacziieÃit, a 22 Ga needle having a lengÃb of 2.5 iÃielies was developed. Howe:-,,rer, a1t.e>mativc:: variations of the invention include needles of Val'Yirh,', len_4t11S., i4al.Ã4e5, as well as c-o5s-sect.iozial shape. As shown, tlierÃeedte, canrÃula 102 extends only pa.rtia.llv iiato the htÃb 106. However, Varia.tiesns also inc:lucle a. Ãieettle cannula 102 that extends through the litÃb 106.

1.0038] In a~iv case, t:[i~ ticedle caxitii-tla: 102 itlClU.d.eS a needle lur~~en 108 throcig}i which a. catheter or irjec:tiori ttahing 1:Ct1 extends. Although not illtistrated, the iiijee.iis~ii tLbi.~~g, 110 i.ncludes aii :iiajectioia lL-Ltiieri exteridirig therethrca-ugh and c;xititis.r at an igijection port 112 in a wt~ll at a distal portion 114 of the irl#ee:tion t-L,birig 110. Iti additional vatYat.iosis, the device e;.rrt include an injection port at a distal etid of the injection ttihiiig I 10. In addition, varia.tionS of devices disclosed herein catx include tiiore that7 one inrjection port.
100391`I':[ie iqieeticrn tuhino 110 ea:ty he ~iiade of a. flexible material such as any, poly.ineric or coriiposit.e iyiat.eraal sed t`or medical device applications.
In addition, the catheter tub:ino can bave elastic characteristics #.~.%., flexihle polymers, coil or other rei~lf(irced catlaet.ers, or aupe.r-ctaytic/ shape memory charac;t.eristies), that allow the device to curve Sltgbtly arourid or deflect away, from structures stic li as blood vessels, neri.es; or bone to optimally position the, orifice for the .injJect.ion". 'I'he elastic e.h aracteziscies may eninefizom the properÃies of tlie ttihe, an ela.titie wire tlaa:t is extaa~~eltl witl`tiii the wall of t.he tube, or eve' a.-i elastic sty:ltas that temporarily resides iri the l-uirieTi of the tiibi:n-1.
Iri sonle variaiiot~s of the Systc:iii, the ctÃrve of the distal portion of the catheter h.ihing also enables the operator to ":ste;er" tlie catheter by orietiYsrig the distal tip such that the catheter tezids to follow a particular direction.
100401 Placing the ir~Ject-csn port 112 in a side wa1l and riot at a distal end 120 prevents the likeliliond that tluÃd qjected from the device 100 will cause inad~~eriettt dam.a.ge t~.~ the patiea7t, :ljot- example, even if a d:icÃal.
ti~.~ 120 of the Syst:esii 100 piege.e` avessei or the ciuraw therl the proximal spacing of the iiijectic.~ll pcar-t 112 i-edtÃ.ues the til;elihc.~txd that the izijec;t.ed 11.tiid w+iLil.cl actually c:fiter the structure as the fitÃ.id will be injected proximal to the entry poiiit, ln otlier words, it woLÃld be necessary for the entire distal porxion 114 ol;'the i.r1jeetion tubing I 10 (from the :iiiject:iodi port 112 to the distal tip 120 to cannulate the vessel or dcira.. In the va.i-iatiori tihoivii- tlie ir~jec;tion tubing 11.0 also iric:ludes o2le or m.Egre visualization max:ker(-,) 4.26. For exaiyapie. a single Ã~~7diopa.que i7iar-ker-1.26 c:,arl be placed adjacent to the injection port 112 so that the operator may precisely locate the proxinaiÃy of the. injection port 1.1.2 to avc;ysei or other ytrttc:tu1 .re. Yet a~iother fe.atLire; that improves safety is placement of the injection pc.~~~t 112 on an inteiic.ir radius or aspect o.f'the curved tlict.ii.l portioi- 114 ot`thc iiij ect.ion tubin~ 1t0. As fluid disperses ti'oitt the it1jeetion pon .112, because the injection port 112 is on the d~}

iitt.erior E:,uz-ve of the dista( portion 114 of the irtjectiort tubing lto, the fluid is delivered away froan the dura or other nerve structures (as will be di5ctlsseci belo}v}. [-1ow~~~er., additional variations o.{'the it7vez7tior{ cozite-riipiate piacing an iÃ~jectisan port 112 anywhere along the dista.l l.~urx.i(iri of the iÃ~iec:tiun ttabiiig 110.
1Ã1041] Systems 100 of the present iriveriiioa3 also irtclucle4t sliding member, in this va.riGitioti t;(ie sliding iiiember is a pILi.iitwer 122 slidably affixed ~vitllin a Iuz netl of the ~~~edl.ecannula 102 and ;ec .red totlie anjcctic?ti tubia.-, 110.
Thisc;onstruction perniits movement of the li(uzigez- 122 to advatice or retract the itliect.iotl tubing 110. Since tl-ie p:I{inge:r 122 -s slidably affixed w:it}iiTi the zieeclle cannula 102, the plunger 12:2 can ~~iove be"veeia a. proximal or ret.i-a.cted position (wliere the distal portioii 114 of the iiljectioii tt.abing is retracted within the needle caniitiIa) and a distal c~~, deploved positiora (where the distal portion I.14 of the in,ject.ion tubing 110 is deployed fr~~i-n the needle car~~itala 102 as sh~.~wn iti Fig. 2A), 1'0042] Fi4f. 14B illustrates a distal section of tiie system 100: s1iowiiig the plunger 1,22: in a retracted position causin_ the ~.i,tal 1~oi-t.ii~n 114 ~at the i:t3jectit~:t3 tt~l}i~~T
:140 a.s -wel1. as the inject:ion 13ort 112 witl~idrawt7 into tl~e cziiiilclla 102. As disc.LÃ.sse;cl below, ~~nfiguri~ig the iiijectioii ttiibing 110 tÃi advance in and ottt of the czttirttila 102 irn~~~ovew the ability cYf the operator to ;;.afeIy locate the ti~.~ 104 of the cannula 102 while advaraciiyg t(ic ir~jection ti-ibrtig 110 atid poz-t 112 to a desired lizcatioii for delia~ery- of tlie su(3starices. Tl7:iw 1-eatiire of the syst.eiri 100 i's discussed in ttii-tl~er detail below. Alternate variations of the inventiciti can include p1ongerw that are. rearic3veabie .fr~.'ra7 the ti~edie can-nula. 102. "1"fie p1~~~~~er 1221nay cc~~~~prise a siiiiple ttiibe structure. hi s~.~ty1e variations of the systefii 100, the. fit bet:wet.ii the ii~~ection tubing 11.0 and r~eedlo ca.~~~iula. 102 all~.~w:s a tactile "ft.ei" of the resistanc ~~ as the catheter is advanceai t(i tlic injection tiite. Thiti 1't.ature helps the aperat.or feel whether the tip of the device encounters any structures as it advances to the tarcget s-te.
100431 In the variation shcmi.a in M& 2.A a l.~ruxi.rna.t portion 116 of the injection tubing 1111 extends .fro:Fii the p(un"Ie:r 122 to a nianifoid 126. "I,l~e rtizitiif'oid 126 allows fluid coul.:slif~g of any tit7r-viber of extetisi~.~ii tubes 128 having separate luz~ietis to tlle lur~len of the i==:~~jec;tioii tut?.iiag .l.lfl. Although ihe, vamation show-}
t1ircc separate extetisioii tubes 12S, va iatioiis of thc: device may inclttde a single extension tube w:iili aPl.UralÃtV Of independent luincris. `I'}ie iricleperiderit lc~~~~ens shotaldallow coupling of the systeni 100 to irtdeperttl.ertt fltiid sou.rces 50 (typica.lly I.0 syrin4;es or other s-tich storage ve5se(s,). The number of lumens may be arty artimber greater than 1, However, wheri the system 100 is used for treati-nc:nt of spinal coriditaofrs., the systeni 100 will typically it7c.tude ef{ree separate e:~~ensiorl ltimei7~ so t1iat three separate ~ILtid soLtrces (e.g., a scatirce of a contrast ~geiii, a source of wi atiestbe[ic, mzd a source of ati anti-inf1mlim4ttof), su~stuic.Ã;
st#cb as a corticosteroidl. As shc3~~~ii, the extension tube 128 can irIc:tUde a luer or otlier fitting 130 o.n the proximal end to allow cotrpIitig tt) a fluid soija-cc;.
Moreover, vatiaticyiis of ttie device iiicli-ade Li.se of a valve. fi:rttÃng 130 to prevent retrqgrade flow between syringes.
ges or fluid 1.0044-1 Ot-~e advantage of havin,(~, separate lumens for coupling s.yrin sotÃ.rcc;s is t.~.~ maintain se regition bet-wee.~ the injectable sttbstances.
The ttse of multiple t.itae lu,mews reduces the amount of residual substances that must clear the device dt#-rl~ig sttbsecit#ont iiije;ct.ic?tis. This reduces risk of iRtet=ting ille patrc=nt i~ich all excessive aiiiouiit of am substance or iiiadve-rletic i~ject~~n of an incorrect s~3bsta:r3ce 100451 l:ri ccrtaifi variations of tNie :,ysteiya 100, the lengglifrorn the plunger 122 to the fittings 130 is sufficiciit -sca that tILud scitirc.c.s (e.g, tiyringe~) ca.n be coLil.~led to tlt~ systerii 100 aiid set ztsid~ prior to itist rt:ioti of the ticedle cannula 402 into a patieÃit. In additicrzi, a sufficient leÃ-a¾>tI-a allows the operator to inject the fluids without exccssive exposure to radiatÃr~i-i gener ed b x-~~ay. c)r fluorc}sc:<capic ecluipmeirt. A$thntiawh irot shown, variations of the system 100 iriclude Ãlie uqe of strain relie.{' sleeves or collars to pg~eveiit crinip:ing or ftalding of the :in#ecÃion tubing 110 at or near the ciid of the plLarlger 122.

10046:1 The upÃ;t'a[c.ar prepares the system 100 t:or the pi-ocedure by atl.achistg tlircae ayrÃiiges t.c) the device simultaneously prior tc.~ insertion into the paticiit. Naturally, an opcr~ator ~~ay choose to attach the syziiiges to the system 100 after injection of the caiiriula into tl"ie pat.iciii; }~~~~~ever7 this increases the c.hatice of movenlent ot the cannula subsÃ;qtÃ.c;ni to initial l.-~lacement. The injection tubing 110 is advanced clistal:Iv t~r-ozii the tip of ihc needle (as choNvn in l:Aig. 2.A) atid air is purf.~:ed fz-c~rn the all of f1Liici liiics by actuating the syringes cotitaiiiiii:; tlic sÃ.ibstaiicis to be ia~jectcd (e.o;., cc3rticosteroid, aiie:.t.iictic, Kind. cc3ritra4t ~~iedia}. Natum lly, the i~~jection tutt?e lumen should be charged witli the first stibtit.ancc: to be iRjected into the paÃie.nt.
100471 `Ã'he .indiv:idual syringes c~~i-i cofat.aai- a cotitra5t age-rit sLic.h as a r-adio-n~~que dye, a local atyestlyet7c such as Lidocaine, atit~ a cort;icosteroid.
I.Ã

Alteana:tive[y, a:Ãiy 1aluÃ'alityr of luz~~enS ant1. eXtellSÃOÃl Wbes coÃ.Ãld be use in t}tis anethod were it practical or to the advantage of the operator to have asepa.rate clel.i~~ery of a. l~luÃ-alit.y of- otE-iez- substances%anjectarÃts otl~er than tlÃose, nÃerÃt7orled above.
10048] After the purging atfl<l charging sequences are completed, the iit#ecÃioii tubing 111 is retracted iiitc3 the needle ca:aynula. 102 and the operato.r Ãnay now itxaert the cannula 102 into apatierat to provide treatrne:nt.
1Ã10491Figls. 21(:' a.Ãid 2G illustrate another variation of a diStal section of the systerÃi 100 wlÃea-e the sIid-ng irÃeTzit~er c>oiripri5ew as-to1~ surface 132 tlÃat is entirelyf ~vith.in the liut} :106 of the device 100. F:i -. 2C illustrates the plunger 122 in a retracted position causing the distal portion 114 of t.he iÃyjec:tioÃy tti6ing 110 as well as the i~~~ecti(yii port. 11.2 to be witlidz-a:wtÃ Ãtito the cannula 102. As iltUsÃra:ted, the stop sulface; 132 is affixed to the itijectic.~ii tubing 110 and is %tÃdably=
mÃ.~vea.b1e, ivich.in the hub 106. As s}iown, w}ien ttie stop surface 132 i~; retracted towards a ~.~roxirr-ml portion 107 of the htab :1.06i the internal con-structian of the hub 106 pr~everÃts- .f"urtber withdrawai of the :iiajectaoia tubing 1:1.0 sirÃce the stop suy-ta.ce is, affixed thereto. As noted above, the stop surface 132 can incltide ake~y,'yrc~uve.
interface wifli the inteÃicpr of the liub to prevent rotation oI'tlic injection Ãuibi~ig.
fOO50_1 Fig. '~'D zlli-Ãstrace distal advancement of the stop surface 132 agaiÃist a distal portion 109 of the bzib 106. Agaifa, since tlie stop surface :1.32 is affixed tc) the iilieetion tubiÃig, distal a.dva.iieeriiezit o4'the rÃ~jection tLibin4.;
110 is prevented once the stop gtÃrface 132 encounters the hub 1116. As shown, i:ii the dist.ai niost position, tlle injection tubing, extetids ffi.~m the cannula 102 (and c~fyÃiorrally eur-ve4 as shown).
100511 In those variations, where the irljection ttÃbing 110 dÃics not incltÃ.de a plÃÃnger: the phyrsiciaÃi simply advances the ii~jection tubing, manifold, or exteiÃs:iozi l:ines, to advance a. distal portioia 114 o.1'the iz~jectiozi tubrrÃ~ froziÃ Ã17e cannula.t.[l2. As rioted above, il~o variation shown iti Fig,-,,. 2C aa1cl 2[3 ca.Ãi. irii:lude a single injection or extension tube, or rnay ifÃcltide a. rÃLiriiber of :in#ecÃion Ãu1~es, i1LÃitily coupled to a llÃÃ~ienuf'the iÃ~~ectioÃi ttikle.
100521 As shown M f`ig, A: the iieedle is ptryitiotied. in the patient uzider fluoroscopic guidance in the maiiÃyer described in the cÃ~~w,~enti~.`~nal prc~cedtÃre:, with the exception that the distal tip 104 of the c~~iirÃÃ.ila. is positioned appi'oxiinaiely 5Ãtim proximal to die iiiiettdecf target site {typically t}ie epidural I.2 space or spitia.l foramen). This position keeps the sharp tip 104 away from critical vasculature 16 and nerves 20. As slaowri, the pltinger 122 is in a proximal ot-Ãet.racted pizsi.tion, which maitatains. t.E-ie distal portion of the injection tube 110 within the c arinu[a 102. 'l'1Ãc opcrattar can c(irifirm plaeemetÃt of the c:ariÃtttla 102 by injecting the c:oiitrast a~~ent or dye in the trtanÃter described above or by simply ob serving the ~~inirala 1112 tander fluoroscopy or x-ray.
(0053] The operator cati liold:s tiie htÃb 106 ancl/or the cannula 102 while advartcin~; the device through the skiÃi aaid 5Ofl tisStW, t:3rtce positimting of the cannula is properly deteÃ-Ãyaifaed, tl-ae portion o{'the catÃz7tila .102 nÃ-tlte hcil) 102 ,.rÃitÃ
be secured to tfie exterior skiri or operatiÃt~.~ table in sus:li amatitxer as to stabili2'e it from pe~ietratiÃig deeper or withdrawing fr(im the patictÃt, or moving laterally. A
seccÃÃid method of stabilization riiay be aai adbesÃve liad 18111tb an inte~rated clamp that aelberes to the pat.ie;nts' skin and stabilizes the tÃce.d1e relative to the paticalts' q l:in.
100-54.1 Once the distal tip 1J.04 of the caÃat?Uta 102 Is in position aÃid ilaÃr~pin.8 o--adhesive pads are applied tkie operat.tsr is ready .f6:r advancing the :itÃjectiorÃ ttÃbe.
As shown in Fig. _3 )B: the operator advances the plunger 122 causing itdvanceÃ-n4.nt of the injection tube 110 to the taqge;t site (in one varialÃo~Ãt tlic system 100 allow advazicem~iit of the tip 120 of'the ityjection tube 5 tnrii to the site). As discussed hereÃn. variations of't:he device irtelcACie tti-i aÃ-jectioÃÃ ttÃbe 110 having a slig}Ãi radius (yi- Li-arve at a distal poÃtioti 114 that etial)[es advancement of the distal portion 114 along a curved l.~at:h tfiat is biased toward the posterior aspect tat`the 1'`c}raat7et7 'I'}iis ctarved positioti keeps -tlie iÃÃjectiotÃ t.tibe 110 safely away f-i-t.~til the vasculature and t.lzt; rter-~,e root ulftit;li resitlC in tlle p.rc.~xiz-nity of the iz~~ect.iozi site. AclditiEsÃially, there is a reduced likelihood that the itÃjectiotÃ ttibe 1111 will penetrate vessels if it engages the vessels during advancement due to t.I~~ fe-atÃ.tres of the injection tttbe 110. As Ãtoted above, variatioris o.t't}-e injJection tcÃbe includes a bltatlt tip 120. IrÃ
additit3ti, variations t.Ãf.'the device tÃseti iÃi sfaiÃaal applicati.oÃÃ:s :shz111. be. Ilexible.
100551 `Ã'he injection port 11.2 is located away #roÃvt the distal tip 120 (in orle example tlic injection port is spaced .ÃrtÃ~~ away from tfic tip, bt.it aaiv spat:irtg thaÃ
places the irg'ection pc.3R 112 oÃa ifÃe~ distal portion of the device is coriteiiÃpltited.) This fc;atur~~ prevegit.s inat.i'verÃetÃt va.sUt:tlar tiptake sityce it ut.atild be necessarti, tt.i c~Imlttlate the distal port.iot7 of the :it~jectiota tube within the blood vessel over a distance loÃtg et-tougli to etivelope tfxe ii1jectioÃt port as well.
l~'urther't~iore, in those I.Y

Va.riations w[iere the ilij'ectioi-a port Ãs placed oii an iritet-ior radius or aspect of Ãl~e curved distal portioti, fla.iid delivery occurs towards apottion of the vertebral body 12 ratber tl-ian. agaifisi a vessel or nerve.
100561 Prior tcg delivery of the substanceti, the operator can also observe, Linde;r fluoroscope, the position of t.tie distal portion 114 of the ir~jecti:on t~ibÃ; 110 aric~
even tl~e, placeanent of the iqjection port. 112 by observing the positioi7 of one or 3:nore radicspac~ue ina:rkers on the distal portic?n. As iioied above, sornc variatic~ns, iÃidude placing a. radiopaque mark or iÃ-adin, tnr directly ai~lacent to the iqjeclion poÃt. thereby enabling t}te operator to see ti-c exact positioli wlierc the ittaectaO:t7 occ,ur, fÃ1~57] After verifying the corrcct t.~ositic.~ti of the injection tttbe and injection purt, the operator cc~iiciiiueS M the same seqrtetice as the conventional procedrtre described above;. For example, the operator injects radio-opaque dye into Ã~le site to verify the tip of the iniect:ion tubing :is in the correct location and tliit ablooei vessel wasnot inadvertently brea.el3ed as evideticed by the uptake of radio-opaque dye into the vessel. Next, aTi injection of a test di~~e of local anes-thetic suc1i as licioc:aitic is adtninistered toll~.~wed by asixtv, second waiting p4.riod before a sec;oiid[ lidoc;airic dose zttiz~ or corticosteroid is irijec;tect. The 1Ãdocaisi ~; is injected first a.zid iiati~iit observed to ensure that there has not been intravascular, especially intra-arterial {iptakc.
100581 As noted herein, because all tiiree 5yri~~~es. cati (ae attached to the systern 100, it is not ne.cessar~, to exchange syrit7gec bet.weeri injection.
seqciences. This feature fic.~t oiiIv Ãiiit.~roves ots~r-ator c~.~~iveiiience aaid reduceS
{in<,~c:r iatigue from the tiy ringe exchange, btit nnorc; irnpc.~rtant-ty, it im.proves ptttit;nt safety by reducing the likelihood of inadvertent cannula movement during syringe exchanges. In a(iditiozi, placement of the s-yra.rages outside of the surgical field or away frc}i-n the fluo.rizscopc. Operator sa#:ety is f-ti:rtlaer iyz7prE}ved because tiic pbys-ician administering the injc;cti~.~ns rnay perfortri ttio iz~~ectioti. of c~.~iit.rast ri-iedia safidor away froÃn the injcct:ion site wlaile usai-g real ti~~~~ ttirect t`luoroscopy.
This reduces operator c;LiiiiLgl'ative ex~.~ost7re t.~.~ X-Ray radiatioii fiazards.
100591 After the lr~j'ec;tic3ri se~~luericc; is complc;te<d.. the cannula 102 can ise z-elrioved from the inj'c:ction site with or wit.h~.~tit the irijecti(iri tLibe. 110 retracted iiit.ci the cannu1a. :1.02.

I.4 1.0060]' 'I'he voluii-ae of t`lraid in the cnii-ariiori fluid patb of the catheter systeni 4Ãhe voluiiie of tILiic1 that reiiia.ins hetweeri the nianitold atid the irijeetiozl port of the iiijee:tioÃi tube), is considered irisa~;niticant. In one variation of a system for cervical injectioq, tliis voltime is appr(iximatc:ly .02 ml whereas the typical irtjeÃ:tion voluÃiie of anesthetic is .5 ml (0.4% fltish volusne), and the iqjectlon volume of steroid is 2,0 mI (0. 16% flush Volu.me). Both of these flush volumes are within the ":ncgi;e level '' of oper{~~tors' athiliiy tc} administer a ineasrr:reei dose of iqjeetaÃats. Therefore, it is riot necessary to t`lrish the comnion 1li-:tid path between injecÃi.ons, (e.g. between racliol3ayue dye, anesthetic, ziiid cr}rtiCostero:id).
1UQ6t_1 Although the examples discussed herein, primarily relate to injection syst.enis suited for iqjeetions in the cei:A~ical retsic.~ti o1'thc: spine, the ft.atures uf'the sy'steiii may be used for spinal treatments M the IurnEaar and thor-acic regions as wel l .
1'0062] Fi4fs. 4A-4:I) i.llustrate afiother variation of a systezYi 1110 according to Ãhe u~.~sncepts of the pretieait diticlostire. in. this ti%anatiort, the manifold is tlii-eetly ccaLiplerl to a. device body 1.42.
100631 As shown in Fig. 4A, the components of this variation ine.ltade a c:anlitila needle 102, a ..atlieter or iijjection tube (tiot ;;howti in Fig. 4A) coupled to a plun~;er 122, a device body 140, a manifold 126, extetisioii lines or tubes 1.28, I1-ier connectors 130. As dirsted alic~-ve, in additional ~~ariatioris, ari internal stop surfac:,e 1oeatecl Ik"ithin the hub 106 caii replace the pluii~;ei= 122.
1Ã}0641 Fig,. 413 illustrates a eÃ-c3cs sectional view of'the cysteni ol'4A.
As showii., the body 140 of the iÃljectioti systegYi 100 may be eyli~idt-ical iÃ-i shape for e~ase of r~ixanipu.1a[ion. The rnanifold 126 cari ext.end 1"~-oz-ii the side of the hocly 1.3 to peri-iii[
the flow of injectables (as dise.tÃssed above) from the extension lines 128 iiit.a;i the irtjectiora tÃ.ihe 112. The extension lines 128 may be a single multi¾lumen cross-section or rziav comprise the plurality of :iiad:ividcial tubes showzl. As discussed herein, the rnanif:c.aid 126 combin.e; t.he ffmv of it~jectahles from a plur<Z.li.ty of sotirces (e,g_ syringes) into a sirigle arjection lLiriien 118 for delivery through tlle irtjectiori port 112. NatLgrallv, there will be sealing members 144 (such as oariri:;s) tc) prevent leakage of fluids l~z-c~i-ii the interior ol'the body 140.
fÃ1065_1 In this -vrariation, the pIt:trige:r 122 can have any s:hape, but shall have a portic~~i s-l.irlably at=tixed within the it7terior of the device body :1.3().
Arl iipper portion of the plunger 422 exterids otit of the device body 130 aIlowinc, for an ~.:~

operator to acttaate or slide the i~lj'ectinii tulaitig in and out of the cannula 102. `I`lie plunger 122 is affixed to the injection tÃ.rbing 110 on its lower end with a lumen extending f*roill the Catheter to tlae sealed cavit-s wit}iiri the luyzieti of the bod), cylinder to al[ow t[ic iiijectabie fluids to flow from t1ic manifold into the cathc;ter.
The upper porioti of the pl atigc;r 122 that extcsids out of fop of ÃliÃ; body allows the operator to orip the plt_inger between their forefinger and thumb, thÃ.is providing a tactile "fee1 " of the resistance as the catheter is advanced to the iqjeetioÃa site. :Hc~~~~~~~er, as iiotetl a.bove: the upper poi-tion of the plunger .i.~~ can siÃiip:Iy corTiprise sliniik fubiTig that covers the plunger and exte-ridw over arl it7c17 of so of tlte iqjectio.ttt-Labing 140 to act as a stress reliei` Similar st.t'ess relief strLiCÃuÃ'e can alst.~ be placed over the tip of t.iie:.= manifold tÃi provide stress relieve the catheter ora tlta:t erad as well. inWtants: ia~jecta.ble fluids, and so forth are defined as any ~~ietlicatioti or diagnostic fltÃid the physician may choose to admi tlist-or with the s-y. Cte#11.
100661 I1i. ma.t-ty vanations of tlae device, the plunger has a 1a-n:itecl :strake. 'T'13is liniifed stroke allows .[or a known aiid finite advancezrierit o.f'i}~e distal portic~~i 114 of the ir1ectton tube 110 out of the cannuIa 102. In the variation shown, the pI~ingc;r 122 has a stop on an exterior st.irtace in the for-n of a raised sLirface 124.
A1ternatlveCv , or in combination, a stop surface can Eae located on the iiijectic?fl tu~:be, or evefi on. t.lie plunger port-c~i-i that is ai-~erior to the hiib 106. Nattirally, any, ttiiitiber of eonfiawura.tioiis is cotitegYilalated.
100671 A. flexible catheter or :injeuti.on tube 11Ã1 re;sldes witlilri tlle cannula rieeclle 102 aticl Iias arouiic~ed or b1titit.ec3 tip 120 witli aii lqjeetion port or orifice 112 t.~ti the sside of'tbÃ; catheter :1.10 near the tli,tal pc3rtiori 1.14. As itoted above, catheter ttibing of th~~ present deviU4=~ can be made f'r~~m a flexible material those know'n in medical device applications a~id ma:v lxa.ve slia:ped meniory e~harac.teristic..s that allow it to cur~~e sligbtly around or def:lect away frozn str-Lictiires sticli as blood vessels, nerves, oi- bone to c.~ptiraially positic.~ii. the orif:ict; for t1ic izijictio2i:;. 'I`lic sliape memory cliarac:=tecistae5 iyaay conae t~-oiri the plastic properties of tile catheter, an elastic wire that is t`x-trucled ~vithin the wall of the cat.hetor-, or a,tt elastic styltis that femporaz-ily i`e4islc;s in the 1~~inen of the catheter, fÃ1068_1 Again, the iqjection tL7bing 110 ~~icltides an iqiectiun pt.~rt. 112 located t.iii tlic side of the catNieter t{ib:iii- 110 to.f"urtl~er reduce the likelihood of accidental i11j eC=t1c711s itl.tt3 ait artery.

I.e`~

1.00691:1.Ãav of t:[ic variations discussed hereizi may iticlude a clamp-stabilizer as an acccsson., device that 1iolcls the. system stable relative to the neck.
OÃie efÃibodiÃ-iictit o.f'the clanip-stabilirez- includes a,t7 adbesive pad thzil attaches to the body of the patictit at the point of iÃisertioÃi. WheÃi the neeci1e is in placc, the clamp is activated to hold the needle stable Ã'~.`lative to the patiesiÃ.
f0070_1 One embodiÃ-neiit of the clamp-stahilizer i.ncludes a strtÃctUre that attaches to a clatua:n on the bed or bench where the patient is lying. The needle i~
positicyiiecl at the c,peratiL-e site and the clamp is activated to liold the rieedle st.eady, as long as- the pat:ieaÃt dc~esnot rnove relative to the ciaiuni.
100?tI Ihe flo-,v patli of the i.i1jectable tl-Laids starts in tE-ie syriÃ~g ,es attached to the connector 130. The ttihiÃiÃ~ ~~-tay be muIti-ltiÃnen tubiÃig or individÃ.tal Ãt.~bes. The t7Ã.tid flows froiii the syrftiges througgh their respective individual 1Ã.nnens in the ttihing aiitl iiit.o the ~nanifc.~(d on the side of the device body. Tlic fItÃids theai flow into interior caEZitv of the device body, iÃito the plunger body, throtÃgh the catheter aaie1 otit the injection poa-t on tlae side of th.e catheter near it:, distal end. A.11 aIterrÃate variat:ion irÃcl des a piece ot`ttibit7g that c:orÃiicct.s the manifold directly to the proximal end of the catheter habing thereby hypassiÃig the interior of the dc ; vi c e body.
f0072_1 As zioted above and as shc~vv7~ 4C aaid 4D the system 100 iiiay optionally include as-tylus 1.42. The StVla.Ãs 142 is cari be incorporated izito the .in#ecÃion tube t.lfl to aid in steeritig a trl) of the igyjection tube 11.0 to a desired reÃ;~ian. 111 an alternate variation, the system 1t1() includes tÃ. slj}ius that extends froni it7siclr the ~.~1istal tip of the catlicter tubing through the lutTleri of the cziihcter, through the body of the cylinder ~~id exits the clcvicc throtig1~~ ~rnemhraÃÃc seal oil.
the proximal surface of the l.~It:tÃiger. The styltiis is rÃsed by the operator to ptish the catheter otit of the distal tip of the primary, iieedle aÃid iÃito the injection 5it.e. The stylus c:oLr:ld optionally have a curvature that, t.ranslates its' ctarvziti.irc to tlie cathctt.i- to lielp steer f:lic; tip ol' ttic cathet.or a1c.~ng' a curvcacl path and into a 13osi[ioÃi.
tliat isnizt acc;essihle by a straight, rigicl t7~edle.
f0073] Whcri the cat1ieter tube is in position at the iÃijccti~.~Ãi site, the stylus would be renao-ved [i`otiÃ the catheter to allow. the ir~~ect:ants to llcsv through thc, catheter.
The stylLÃs ti-Ãay be stil.~plic.d in a variety of curvatures to alluw the operator to select the appropriate cairvat rc tcs steer the cathct.er irÃt.c) position based on variations in anatomy or va.ricxus iqject.ioaY ~~~odalities. Alternatively, the sÃyltis jm may be E:,oztstt-tacted of amalleable it-aatet-ial that allows the operator to shape the st"'~l't^ts to a custotit c:tflrvatt.tre, f00741 An a1terdta:~e device et-ithoclit-iterti would irtc:l~~e a bztlloctrt on the tip of tlle cathetc;r. 'I'he; balloott Nvrat.alcl be ittflat~~d via a lumen in the catheter aiid would he.
used to atteltot' the catheter in pIa.ce, tlissctt tissttc, or steer tlic ca:thotet~ by liositictti.izig the ba:llc'c3ti on one side of the c;a.theter sttch that it pus.he5 the orifi~~ of the catheter tc>wat=d a pa:t-t.iea.ilat= injection site.
100751 Before the lit-esetic devices and method of treat.mertt are described, it is to be understood tl-tat this irtverttiot-i is t-iot limited to particular embodiments described, as such may, of course, va.ry, ir is also to be t.trtderstood that Ãhe tcrtnirtralogy used hereigi is for the ptirpose of describing partictilar emboclim4.nt4 ctrtly, aiid is ztot zrtt.encled to be lrÃ-tyitna¾>, since the scope of the present invention will be limited oti(y by the a~.~laerided claims.
1'00761Where a r'aitge ot"E=alrles is, provided, it is understood that each intervening value, to the teiith. of the unit ot''the lower limit urilews the cott:text clearlv dictates cttkterzhise., b~etweest the cil3per aiid lower- limits of that range is aisct s~ecitreztlly disclosod. Each striallet= range betweert at~y stated valttc: or int.erv-enirt~~ value in a stated range a.tid atiy other stated or irttervertitig valitc in that sta.Ãe(l r.-trtge. i~
encompassed within the inventioti. The i-tpper and lower liznits of these st7tallet-rartges tnay irtc~epertderttiy be i.rtc:luded or exte.tt.iclecl in tltc rartge, and eacli mrige wliet-e either, neither nr bot.h limits are Ã.nClU.d.ed in tE~~ smaller ranges is also ettcotiipassed within the invention, subjeet to any ct~ecifi.ca.llv e:xc1rtded litrti.t in the stated range. Whege the stated range itieludes ottc or both of cE-ie litYtits, ranges t.xt-:ludirtg eitbÃ;a' or both of thcasc; iti.clu~ie(1 liz-iti.ts are also irtclucletl itt the i.nvert[i~ll.
100771 Uttless det-itted othe;l-~~ise, all technical and scientific t.omis used herein have the same meatiitig as ctttaxmori1v understood bv otic of ordinary Skill in the art to whic:h. this invention belongs. Although artv zne-thctds and {ztaeerials similar or equivalent to those described herein can be ttted in the t3ra.ctit,e or testing of [tic present invention, sizrt~C Poiertt.iai aiid pret`erred rrtetliE}ds and znaterials are rtow described. All t.tttblÃcatÃorts mentiotied ltereitt at-c incorpttra.ted herein by reference tc) disclose ktrtcl describe the rnethods aga&r.3r.mKitc;ritals izt connection ~Vith which the publications ar~~ cited. It is understood that the present clisclÃ~sure.
st.il.~erc4.de4 artv disclOSLtr-e Of art incorporated t3ubiicaiioft to the extent there is a contradiction.
I.R

1'0078] It. must tae Ãicrteci that as it5ed herein and in the appended claims, the singular tc)rn~s "arr, õara", ~iid "the" iiicl~ide taltÃra1 referents LIn1eSs the context clear1y dictates otherwise. Thus, .for example, reference tt) <<<7:n aerosol"
iÃ7c1Ã.ide5 a plurality of sucli aeroSols aÃict refereÃice to "the drtiag" itÃcltide.s reference to une, or more drtigs ztÃid equiva1eÃits t.tierc;of kÃaourt to those skilled in the art, and so Lc~Ã't}i.
10079_1 The publications discussed lyeÃ=ein are provided solely for their diSCIOSLiÃ-e prior to the filing date of the preSC;Ã7r app1ication. Nothing here-iii is to bc:
constr{aeci asa.n admissiori f[i~t f[i~ preserit invention is ziot entÃded to antedate sucb pub(icatic?Ãl by virtue of Prior iÃiveritÃoii.. Further, ti-ie dates of ptÃb(icatioÃÃ provideci iiÃziv be tl.ift'eaeÃit troni the acttaa[ publicatiort dates which may iieed to be irtdepertderttlv coÃ7firÃncd, I.z>

Claims

1. An epidural injection system comprising:
a needle cannula having a sharp tip at a far end of the needle cannula, where the sharp tip is adapted to penetrate tissue, and a needle lumen extending through needle cannula;
an injection tubing having a distal portion having a distal end, a proximal portion, and an injection lumen extending between the distal portion and the proximal portion, where at least the distal portion is flexible and where the injection lumen exits the injection tubing at an injection port, where the injection tubing is moveable within the needle lumen and limited to extend out of the needle lumen by a fixed distance;
a sliding member affixed to the injection tube such that a sliding movement of the injsection tubing limits a stroke of the injection tubing to the fixed distance such that when the injection tubing is in the proximal position, the distal portion is within the needle cannula and when the injection tubing advances to the deployed position, the distal portion of the injection tubing extends out of the far end of the needle cannula; and a connector on the proximal portion of the injection tube for coupling the injection tube to a fluid source.

2. The epidural injection system of claim 1, further comprising at least one radiopaque marker adjacent to the injection port.

3. The epidural injection system of claim 1, where the sliding member comprises a plunger member.

4. The epidural injection system of claim 1, where the sliding member comprises a stop surface.

5. The epidural injection system of claim 4, where the stop surface is entirely within a hub of the needle assembly.

6. The epidural injection system of claim 1, where the injection port is located in a sidewall of the distal portion of the injection tubing.

7. The epidural injection system of claim 1, where the sliding member is rotatable to less than 360 degrees about the injection tubing.

8. The epdural injection system of claim 1, where a frictional interface between the sliding member and injection tube against the needle lumen is minimized.

9. The epidural injection system of claim 1, the connector comprises a plurality of extension tubes each having a lumen, where each of the extension lumnes are fluidly coupled to the injection port lumen.

10. The epidural injection system of claim 9, where a manifold fluidly couples the extension lumens to the injection port lumen.

11. The epidural injection system of claim 9, where the manifold is located in a hub of the injection tubing.

12. The epidural injection system of claim 9, where a length of the injection tubing between the manifold and plunger member is sufficient to prevent movement of the needle cannula during manipulation of the extension tubes.

13. The epidural injection system of claim 1, where the distal portion of the injection tubing has a curved shape, such that when the distal portion is within the needle connula, the curved shape deforms to straighten and when the distal portion extends out of the far end of the needle cannula, the distal portion deflects away from an axis of the needle cannula.

14. The epidural injection system of claim 13, where the injection port is located on an interior of the curve of the injection tubing.

15. The epidural injection system of claim 1, further comprising a hub located at a near end of the needle cannula, where the hub allows for manipulation of the needle cannula.

16. The epidural injection system of claim 15, where the hub comprises a surface of the needle cannula.

17. The epidural injection system of claim 1, where the distal end of the injection tubing is blunt.

18. The epidural injection system of claim 1, further comprising a radiopaque marker at the distal portion of the injection tubing.

19. The epidural injection system of claim 1, further comprising a plurality of independent extension tube lumens fluidly coupled to the injection lumen.

20. The epidural injection system of claim 19, where the plurality of extension tubes comprise three extension tubes, and where each extension tube is coupled to a syringe.

21.The epidural injection system of claim 19, where a length of each extension tube is sufficient such that the proximal end of the extension tube can be removed from a surgical field.

22. The epidural injection system of claim 1, where a distance between the retracted positon and the deployed position sufficient to advance the distal end of the injection tubing at least 3 mm beyond the far end of the needle cannula.

23. A method of delivering substances into an injection site in an epidural space of a patient, the method comprising:
providing a needle cannula having a needle lumen and an injection tubing extending through the needle lumen, where the injection tubing comprises an injection lumen;
fluidly coupling a source of a radiopaque material to the injection lumen and independently fluidly coupling a source of a first therapeutic substance to the injection humen, where such coupling occurs prior to inserting the needle cannula into the patient;
inserting a distal end of the needle cannula so that it is spaced a distance from the intended injection site;
advancing the injection tubing through the needle cannula to advance a tip of the injection tubing from the distal end of the needle cannula to the injection site;
delivering the radiopaque material through the injection lumen to the epidural space to verify placement of the tip of the injection tubing; and delivering the first therapeutic substance through the injection lumen to the epidural space without disconnection the source of the radiopaque material form the needle lumen.

24. The method of claim 23, where a distal portion of the injection tubing is shaped such that advancing the injection tubing through the needle cannula to advance the tip of the injection tubing form the distal end of the needle cannula to the injection site causes the tip of the injection tubing to move away form an axis to the needle cannula.

25. The method of claim 23, where the injection tubing is coupled to a plunger member having a limited range of movement within the needle cannula, where advancing the injection tubing through the needle cannula comprises advancing the plunger member within the needle cannula.

26. The method of claim 23, further comprising fluidly coupling a source of a second therapeutic substance to the injection lumen and delivering the second therapeutic substance to the epidural space without disconnecting the source of the radiopaque material of the first therapeutic substance form the needle lumen.

27. The method of claim 26, where delivering the second therapeutic substance occurs after observing the patient for adverse reactions form delivering the first therapeutic substance.

28. The method of claim 26, where the first therapeutic substance comprises and anesthetic and the second therapeutic substance comprises a corticosteroid.

29. The method of claim 23, where fluidly coupling the source of the radiopaque material and the source of the first therapeutic substance to the needle lumen comprises placing the sources outside of a surgical field of the patient.

30. The method of claim 23, where the injection lumen is fluidly coupled to a manifold having a plurality of extension lumens, where fluidly coupling the source of the radiopaque material to the injection lumen and independently fluidly coupling the source of the first therapeutic substance to the injection lumen comprises fluidly coupling each source to one of the extension lumens.

31. A method of delivering a substance at an injection site near a vertebral body in a patient, the method comprising;
providing an injection system including a needle cannula having a needle lumen extending therethrough and an injection tubing having a curved shape at a distal portion, where the injection tube is slidably located in the needle lumen to move between a retracted position and a deployed position, where in the retracted position the injection tubing remains within the within the needle lumen and in the deployed position, the injection tubing extends out of a far end of the needle cannula, advancing a tip of the needle cannula into the patient so that the tip is positioned adjuacent to the vertebral body; and advancing the distal end of the injection tube around a feature of the vertebral body into the foramen by advancing the injection tube within the needle cannula such that the distal portion exits the injection tube and assumes the curved shape.

32.The method of claim 31, where advancing the tip of the needle cannula into the patient so that the tip is positioned adjacent to the vertebral body comprises positioning the tip in an epidural space.

33. The method of claim 31, where the injection tubing curves away from an axis of the needle cannula as it extends out of the far end of the needle cannula.

34. The method of claim 31, where advancing the tip of the needle cannula into the patient comprises advancing the tip of the needle cannula through a vertebral foramen.

35. The method of claim 31, further comprising fluidly coupling a plurality of fluid sources to an injection lumen in the injection tube prior to advancing the tip of the needle cannula into the patient.

36. The method of claim 35, where fluidly coupling the plurality of fluid sources comprises placing the fluid sources away from the immediate vicinity of the patient.

37. The method of claim 35, further comprising sequentially delivering fluid in each fluid source thought the injection tube without de-coupling the respective fluid source from the injection lumen.

38. The method of claim 35, where plurality of fluid sources each comprises at least a radiopaque substance, an anesthetic, and an anti-inflammatory substance.

39. The method of claim 35, where the injection lumen is fluidly coupled to a manifold having a plurality of extension lumens, where fluidly coupling the plurality of fluid source to the injection lumen comprises fluidly coupling each source to one of the extension lumens.

40. The method of claim 31, where the injection tubing is coupled to a plunger member having a limited range of movement within the needle cannula, where advancing the tip of the distal end of the injection tubing comprises advancing the plunger member within the needle cannula.