CA2253801A1 - Oval cannula assembly - Google Patents
Oval cannula assembly Download PDFInfo
- Publication number
- CA2253801A1 CA2253801A1 CA002253801A CA2253801A CA2253801A1 CA 2253801 A1 CA2253801 A1 CA 2253801A1 CA 002253801 A CA002253801 A CA 002253801A CA 2253801 A CA2253801 A CA 2253801A CA 2253801 A1 CA2253801 A1 CA 2253801A1
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- CA
- Canada
- Prior art keywords
- obturator
- oval
- bore
- disc
- elongated member
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3403—Needle locating or guiding means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
- A61B17/3421—Cannulas
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
- A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
- A61B2017/00238—Type of minimally invasive operation
- A61B2017/00261—Discectomy
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
- A61B17/3421—Cannulas
- A61B2017/3445—Cannulas used as instrument channel for multiple instruments
Abstract
The present invention is the apparatus and method for performing percutaneous surgical disc procedures. The apparatus comprises an oval cannula (110) having a bore and an oval transverse cross section. The apparatus is used with an obturator and an elongate member.
Description
OV~I CANNUI ~ ASSEME~LY
This invention relates to sur~ery and specifically to an apparatus and a method for ~ccessing herniated inter~ertebral discs ,.
5 in a human patient.
Low back pain syndrome with sciatica secondary to herniated intervertebral disc~i represent~i ~ major t~ealth pro~lem An intervertebral disc is a ~itructute which occupies the space between 10 the vertebrae and acts, amon~ other things, as a shock absorbin~
cushion. A normal disc COIISiStii of two parts; a centr~l part known as the "nucleus" and a ~iurroundin~ part known as the "annulus" or "annulus fibrosis". The annulus degenerates with a~e as does the nucleus. Degeneration of the disc is characterized by collaçlenation, 5 in which some of the fluid content of the nl~cleus is lost and fragments of colla~enized hbrous tissue are formed which float in the tissue fluid. At this sta~e of de~eneration, external force:s can readily increase the hydfo~talic pressure on the nucleus, caL~sing the fibers of the annulus to rupture. Nucleus fraglr,~l~ts protrude.
20 This, in turn. may cause pressure on the adjacent nerve root with re~iultant pain. De~eneration of the disc may also be caus~~d by other factors, for ~xample, by accidental injury.
Several methods of treatment already exist. One method, 25 usually rc:fel~d to as "laminectomy" involves the sur~ical excision of the sy,~,p~oi~lic portion of the ~,er~liat~d disc. This method of treatment has been used for many years, however, typical hospitalization time in nine days. Microsurgery has also bee~n used in the treatment of herniated discs, in a procedure known a~i 30 "microlumbar disoe~lolny." This rnicrosur~ical procedure, althouah less invasive, nevertheless carries with it many of the complications ~ssoci~t~d with the older procedure, including injury tn the nerYe W O 97/40878 PCT~US97/07435 root and dural sac perineural scar formation reherniatlon ol the site of the su~ery and instabiilty due to exGess bone removal Another method of tleal"lent is known as chemonucleolysis winich i~i carried out by injection of the enzyme chymopapain into the disc structure.
5 This procedure has many complications including severe pain and spasm, which may last up to several weeks foilowing injection.
Sensitivity r~a~tio, 15 and anaphylactic shock occur in limited but si3nific~nt numbers of patients.
A further ~,etl~od of l~al,nent, aulG,n~t~d percutanecus iumbar discectomy, utilizes a specially designed needle whioh is inse~ed into ~ ruptured disc space. The nucleus of the disc is removed by suction instead of open sur~ery.
Anothe~ method of treatment is di~cussed in U.S. Patent 4,573,448 and involves the percutaneous evacuation of fragments of the herniated disc throug~ an ~ccess cannula positioned against the annulus of the herniated disc A measure of safet~ and accuracy is added to this operative procedure by the arthroscopic 20 visué~ tion of the annulus and other important structures which lie in the path of the instruments such as the spinal nerve:. While a considerable improvement over the existin3 proGedures, nevertheless this procedure does not enable the surgeon to directly view the resection of posterior nuclear rlag"~ents That is, the 25 internal diameter of the access Gannula as described in U.S. Patent 4 573 448 limits the design of an operatin3 discosoope and limits the type and size of instrurnents that would allow for the visualization and simultan~ous suction ir, i~ation and resection of the nuclear material.
W O 97/40878 PCTrUS97/07435 The introcluction of a second portal to the annulus from the opposite side of a first portal has been reported by Schreiber and his co-workers in Clinical Orthopaedics and Rstated Re~earch, Number 238, pa3e 36, January 1989 However, this bilateral, biportal 5 procedure increases the operatin~ room time, exposure to r~diation by physician, patient and operatin3 room per~onnel and also increaa~ post-operative morbidity by involving both sides of the back and m~y cause excessive removai of nuclear mat~rial which i"cr~a~cs the possibility for stenosis of the for~n,en and nerve root 10 comp, ~35ion.
Thus, there is a need in the art for a percutaneous procedure to create an unilateral portal in the annulus c~a~in~ minimal exposure of the patient, physician and operatin3 room staff to 15 rd~i~tiOn and without unduly prolonging time spent in the operatin~
room. A unilat~ral approach which will allow for continuous visualization, id~r~liricalio" and e~l,a~ion of nuclear fra~msnts from the disc under gi6~0sG~pic control is required Large central herniations and partially extruded ~r~9r~,~nts may be visualized and 20 evacuated. Such a unilat~rdl approach to place a percutaneous portal in, for example, the L5-S1 vertebral joint, is ~Iso hi~hly desirable bec~lse this procedure requires deficction of the patient's spine to enable access on the one side, causing a cor~esponding ,esl,i.;tion of access on the opposite side. Moreo~er, ~y usin3 a 25 unilateral approach, instruments do not need to traver~;e across the dlsc nucleus frorn a second po~al remote from the sy",ptornatic side. Therefore, the a~ount of non-symptomatic nuclear material removed by the unilateral approach is decreased as compared to the bilateral biportal approach ~his is important in preventir~g 30 collapse of disc approach. This is important in preventing collapse of disc space, which reaults in nerve compression and stenosis of .
W 097140878 PCTrUS97/0743S
the spinal canal. Also, another si~nificant benefit of the unilatsral approach is that the musculature and soft tissue and disc are traumatized on only one side of the back.
Accorciing to the present inYention there is provided an apparatus hr use in a percutaneous sur~ical disc procedure wherein the disc has an annulus, comprisin~:
a) an oval cannula having an elG"~ated tube with an inner bore, an outer surface, and a transverse CrOS5 section that ia d~ined by an X axis and a Y axis, wherein the X axis dimen~ion is greater that the Y axis dimension so that the bore has a generally ovoid shape, the elo~ ted tube havin~ proximal and distal 13nds;
b) the inner bore bein3 sized and shaped to allow ~n obturator and an elon~ated member to fit insid~ the inner bore when the obturator and elon3ated member ~re ~dj~c~nt to cne another and form an a~e~bly with an ovai cross-section;
c) the oYal shaped bore of the oval cannul3 enabling a u~er to insert more than one instrument at a time into the bore when the obturator and elongated member have been removed from the oval shaped bore.
Thus in the present invention a single oval cannula throu~h which both the procedure and the viewin3 can be pe,rul,,,ed, is provided.
The pre~ent invention further provides an apparatus f~r use in a percutaneous sur~ical disc procedure wherein the disc has an annulus, c~")pri~ing:
a) an oval cannula having an elon~ ed t~be with an inner bore, an outer surface, and a transverse cross sect;on that is ciefined by an X axis and a Y axis. wherein the X axis dimension is ~reabr that the Y axis dimension so th~t th~ bore has n gener~lly ovoid shape, the elonyaled tubc h~vin~ proxi~nal and distal ends;
b) a collar portion with a lon~itudinal axis, a transverse axis, and upper and lower surfaces, lon~itudinal opposing ~id~ walls positioned between the upper and lower surfaces along the longitudinal axis, and transverse opl,o~in~ side walls positioned ~ehr~_on the upp~r and lower surfaces along the transverss axis, th~ collar portion having first and second ends;
d) th~ ~longated tube eft~ lg throu~h the coilar portion from the lowsr surhce to the upper surface proxil)~al to the first end of the collar portion;
e) an elevated cylindsr ~xtendin~ from the upper surface of the collar portion in alignment with the elongated tube forming a first openin~ and ~ continuous ch~"n~l from the op~ning of th~ ebvated cylinder throu~h the dishl end of th~ elongat~d tube;
and fl a valve ~e~cnd;n~ outwardly from the trsnsverse opposin~ side wall at the first ~nd of the collar portion the valve formin~ cond op~nin~ communicating with the continuous chann~l of the elongated tube.
In a,~otl,er ~mbo~l;.nent of the present invontion thsre is provid~d an ~pp~r~lus for percutaneously ~, Forn~ing &ur~;cal proc~dures on the spinal re~ion of a patient, comprisin~:
a) a obturator for adv~n~i"g through a ~ percutaneously c~t~d fenes~r~liur, of the annulus of the disc of a p~tienl;
b) an elon~éat~d memb~r;
c) the combination of the cl~nyate~ ,emb~r and the obturator havin~ a generally oYal shape upon assembly when the obturator is placed ~j~cent to ~longabd ",ei"bcr;
W O 97/40878 PCTrUS97/07435 d) a guide for ~uidin~ th~ obturator and eton~ated member togeth~r in an adiacPnt ~ositiG";
~ ) an oval cannula havin~ a ~ener~lly oval shaped bore th#t can remov~bly r~c~ivo the obturator and el~ ..IeJ
5 .n~ sr assembly, the oval sh..pLd bore e.,a~l;.,~ a user to insert moro th~n ons instrumont st a time into the bore when the obturator and the ~lon~dt~d ~ n)ber have been removed from the oval sha~ed bore.
In yet another embodiment of the pr~~c~l~ invention ther~ i8 provided ~n ~pparat-l6 for percubneously pe,f~""~ng ~urgical procedures on the spinal rsoion of a patient, comprbin~;
a) moan~, includin~ Qn obturator havin~ a ~umsn and an outer su~ace for fo~ and adv~ncing into a f~n~tr~lion 16 fo~ d In a pati~n~s back and spinal disc;
b) ~n &lon~a~l msmber havin~ a lon~itudinal groove that is sized and shaped to l~:CCiYe: a portion of th~ out~r surfac~ of the obturator, the ~roove bein~ so shaped in tranfiverse cross-section that a lon~itudinally extending portion of the obturator 20 can occupy and nest in the gro~
c) the combination o~ ths elon~atsd n)gn~bar ~nd the obturator havin~ a ~eneraliy oval shape upon ~sser,l~ly when the obturator clos~ly fits into the ~roove; and d) tn oval cannula that has a generally oval 25 ~hap~d bore that can remoYably receive the combination of the clor,~alecl In&,nber and the obturator, the ov~l si,~t boro enabling a user to insc~ sur~ical instruments into the bore durin~ disc sur~ery.
The present inv~ntion aiso provides a percutaneous 8U~
disc procedure, oG~ risi~ the 8teps of percutaneously enterin~ the WO 97/408~8 PCT/US97tO7435 back of the patient in a poster~lal~r~l dir~clion wlth an ~cce~;s cannula, ad~anci,~ id acces~ cannula throu~h a first percutaneoualy crcatsd f~n~st,~tion of the annulus of the di~c, percuS~neously ~SnteSrin~ the bac~ of the patient in a posterol~teral 5 L~irc~liGIl with an aGcessory cannula, ~nd ~dYancing said ~ 5501'y cannula throu~h a second percutaneously ~re~kd f~,lesl,~tion of the annulus ~ ~nt to and on the same side of the disc as the first fcncslrdtion.
Th~refore accordin~ to the present invsntion there is al80 provided a percut~neous surgical di~c procedure, using the apparatus as herein before described comprisin~ the steps of:
a) percutaneously enterin~ the back of a patient in a posterolateral position with an obturator havin~ a lumen;
b) advancin~ th~ obturator throu~h a percut3neously cr~ted fenestl~tion of the annulus of the di~ic;
c) placiny a guide containing a generally oval shsped bore over the obturator;
d) insertin~ an ~lon~ated m~mber through the 20 bore o~ the ~uide and into the back Gf the patient into the percutaneously created fenestr~tion of the annulus of l:he disc, the elongated member havin~ a cross-sectional shape suc:h thal when placed adjacent to the obturator, forrns an assembly having an oval cro~s-section;
e) removins the ~uide from the obturaSor and elon~ated member assembly;
f) slidin~ an oval cannula having a bore with an oval transverse cross-section and proximal and distal ends, ~ dDwnwardly over the obturator and elongated member asse~bly;
~) jrl~E, ~ the distal end of the oYal cannula into the disc;
W O 97/40878 PCTnJS97/07435 h) removin~ the obturator and elongated ",er"ber assembly from the bore of the oval cannula and the disc; and i) introducin3 multiple sur~ical instr~ments into the oval cannula to per~orm the surgi~al procedure.
The present invention also provides a IlletllG~l ~or the percutaneous decGmpression of a hsrniated inte~ertebral disc in a humsn patient, which comprises percutaneously sntering the back of the patient in a posterolateral direction with an access cannula, 10 adYancin~ the access cannula into the disc through a first percutaneously created fene~il,dlion of the annulus of the di~.c, percutaneously ent~ri"~ the back of the patient in a poster~i~ter~l direction with an aGGe~s~ cannuia, adv~ncin~ the ~ce~sory cann~la into the disc throu3h a ccGnd percutaneously ~re~ed 15 fenestration of the annulus adjacent to and on the same side~ of the dis~ as the first fenestration, removing nuclear malerial thro~lgh one of the cannulae and observin~ the removal with an endoscope through the other.
The method of the present invention requires only a small incision to place the Gannula, this a~ruaeh utilizing unilateral placement. The unilateral approach allows for continuous discoscopic control and ~ U~Ii7~tion and pro~ides adequate channels for fluid management, which significantly enhances the visual identification of the posterior annulus. The met~.od in accordance with the invention may be carried out under loca,l anesthesia, thus avoidin~ the risk of general anesthetics~
A better understandin~ of the invention can be obtained whPn 3~ the detailed description of exemplar~ embodiments s~i forth below is re~iewed in conjunction with the acc~",yanying dr~ings, in which:
W O 97/40878 PCTrUS97/07435 FIGURE t is a plan view of a ~uide wire useful in the pr~sent invention;
FIGURE 2 is a plan view, partly in section, of a cannul~t~d obturator useful in the plesent i,.v_,~t~n, FIGURE 3 i8 a phn view, partly in ~eetion, of an access cannula useful in the present invention;
FIGURE 4 is a plan view of a trephine useful in th~ pr~cnt invcnffon;
FiGURE 5 is a s~ . "dti~ Yiew of two cannulae i..6e . t~ into 10 the hemiat~d di~c;
FIGURE ~ is a scl.~ L~. vi~w of an oval cannula ;.l~c.~d over the two ¢annulae ~hown in Fig. 5;
FIGURE 7 is a viel,v in section, bk~n slon~ ths lin~ of 20 -20 in Fi~. Bi ~5 FIGURE 8 b a p~r6p~liv~ view of an attemate . nLo.li",_,~
of the subjed invention illu~tratin~ an oval cannula appuatus;
FIGURE 9 ~ide pl~n vi~w of ~n ~Item~t~ 6..1b~di,..~nt of the subject invention illustratin~ a half-moon r~il;
FIGURE 10 is a side plan view in partial cross section of the 20 oval cannub appQrQtus of Fi~
FIGURE 10A b a cro6a ~ec~ional vi~w of the oval bore of the oval cannula appar~tus of Fb. 8 along the lines of 10A-10A of Fi~.
10;
FIGURE 11 i~ Q p~ vi~w of Qn Qltsmab ~ bG~i,..~nt 25 of the subjeGt ;n~ ., illustratin~ a ~uide ,,,..,,~c~, FIGURE 12 is a side plsn view of the ~uide .,.~ I.er of Fi~.
11;
FIGURE 13 is a top plan view of the ~uide r..e..Ler of Fi~. 11;
FIGURE 14 is a ~J_.a~Jc ~re view of an assembly of the 30 altomato ~n~bo~ nt of th~ subjcct i--n.~
FIGURE 15 is a top pC~L_ti~_ view of an a~emate ernbodiment o~e subject il-J_.ltion IIIL-~at~ a sealin~ ll.chlLcr, FIGURE 1~.is a bottom pc.a~e ~ view of the sealin~
I,~.t~L~r of Fi~. 15;
FIGURE 17 is a ~Ide pbn view in partial cross ~e~on of th~
sealin~ L_- of Fi~. 15;
FIGURE 18 is a bide pbn view in pJrtialCro85 ~ection of the ~alin~ ."c."bEr of Fi~. 15 in place on the oval c~nnula appsratus of Fi~. 8;
FIGURE 1g is a s~h~.~ic view of the cannulated obturator of Fi~. 2 Insertcd into a hemiated di~c;
FIGURE 2Q i~ a ~chsmatic vi~w of the cannulated obturator of Fi~. 2 and the rail of Fi~ el~t~d hto ffle disc Illustrating the use of ~e ~uide ll~n~L er of Fi~. 11;
FIGURE 21 is a schematic view of an ~ bly of the oval cannula apparatus of Fi~. 8, the ~:annulated obturator of Fi~. 2 and the rall of Fi~. 9 ins~rted in~o ths disc; and FIGURE ~2 h a ~hellldli~ view of a wr~ l plu~J~lre bein~
pe.h.llll~ throu~h the oval cannub apparatus of Fi~. 8.i,l~rtLd into 20 ths l~G.~ ed disc.
In the d~cri~Gn that follows, instrument2l are generally made out of suitable austenitic stainless steel, unles~ otherwise ~,e~ qd. While the sur~ical ~ru~dure desc,i~cd hsrein r~f~rs to 25 d~co,~ r~ss;on of intL.~uLkr~l lumbar discs. it is to be u.-d~.~t~
that th~ ~r~,c~durc is not limitcd to lumbsr disc~.. ,~ snd may be used in any proc~d~lre for p~rcut~ncous~ pbcin~ at Icast two cannulae in a patbnt, such as an int~ I disc proc~Jur~ or operation.
W O 97/40878 PCTrUS97/07435 Ac~ordin~ to the ,.,_lhod of the ~.~s~ i"1l_ntiu,., the pati~nt is positioned on a radioluoent table in the ap,~.u~.,i~e pron~ or bt~r~l position snd a 9uidewire 10 (Fi~. 1), sui~ably of about O.OgO
in. (0.127cm) diamebr, i5 advancsd throu~h ~e ~kin of the b~ck 5 po~brobt~rally under fluo,- scopic obsonrntion until the ~uidewire 10 contacts the _~k..;or s~ Jtol~ side of the nnn~dus fibrosis of ths h~miat~d di~c. Thcr~al~r, a cannulatcd obturator 20 (Fb. 2), havin~ a lumen with a dismeter sU~htly lar~er than that of the ~uid~wire 10, is passed over the gu~ewire 10 unUI the c~nnulated 10 obtu~#tor 20 CGI~b r.ts the e~emal surhce o~the annulus flbrosi~ of tho hemiated disc The ,~ ~' of the ~uidewire t O at this point is ~"~on~l An access cannula 30a IFi~ 3), suitably of about 0 25 in (0.~35crn) outer diameter and ha~nn~ extemal ~radations 31 of 10 mm, is then passed oYer the cannulated obturator 20 and advanoed 15 to th~ ext~mal sur~ace of the annulus fibrosis At this point, the ~uidswirs 10 ic rernov~d if not pr~viously ~_r"o~d, The inn~r diam~t~r of the acc~ss cannula 30a i8 siz~d to dO8BIy M over the cannulabd obturator 20 ThB cannulated obturator 2û i8 then removed, ~nd a 3 mm or 5 mm t~ephine 40 (Fi~ 4) i8 illtrOdVOed 20 thr~u~h the acces~ cannu~a 30a The ~ ,Jhi, ~ 40 has a plurality of saw tee~ 40~ or o~er cu~n~ L- ~D. The trephine 40 i~
ad~Janccd into thB ~nnulu~ of th~ di~c, wXh rotaffon, uedSI,~ an ~nnular fenestr~tion (that 18,a bore) throu~h the annul~ls flbrosis Into the nucleu~ The trephine 40 i8 then ~~ ,.u~_ The canmllated obturator 20 i8 rei~ociua~d into ~ access cannula 30a and pa~sed into ~e h c~ation of the annulus ~luoroscopic ~uidsncs may bs utiliz~d. Th~ ¢annula 30a is then adv~nced irno the fenestration of ~e annulus, wi~ rotary 30 "ov_ ..e ~l Afbr the acces8 cannula 30a is in th~ proper posfflon, th~ cannulated obtu~tor20 i~ - uv~d Thc ~,u.~imal ~n~ of W O 97/40878 PCT~US97/07435 cannula 30~ projscts b~yond the su~aoe of the patier~s baclc (not shown) whils th~ dkt~l ~nd i8 in position in the nucleufi. The pr~urs d~;liL~d for plaosmont of cannula 30a into the annulus of the disc follows the p~c~dure des~ribed in U.S. Patent 5 4,573,448. As i~ l~own, suit~ble locd arie~tt,ebc i8 u~ed a8 appr "~
Accordir~ to the pr~W~ ntiu., the sur~ roudurs and viewin~ can be done throu~h a sin~le oval cannula 110 r~ther than 10 ~o cannula~ 30a ~nd 30b. The oval csnnula 110 provid~s a l" uJor access to the int~Nertobral diw and is particularly useful for a, Ihr~opic decortation of the v~.rt. ~r_l plates in prepa~tion for p~rcutaneous i,-t~rb~y fusion. Furthor, when p~ ,r"~ing pGat~rior or ~,G~rolat~ral fr~n~nt~_t~ ia an intradiscal access, the oval 15 cannul~ 110 allous forfurthsr angulatlon of th~ insert~d instrumerts and proYid~s a b~tt~r ~ 8~a to ~e posbrior hembtions.
If thi~ IhGJ i8 used hHo cannulated obturators 20 or cannulas ~Oa, 30b are inserkd into the disc 101 usin~ a ji~ 70 to align ~e obt~Jrator8 20 or cann~lae 30a, 30b in parallel ali~.",lent as 20 shown in Fi~. ~. The ji~ 70i5 removed and the oval cannula 110, sli~hffy lar~er in diarneter than the ~No obturators 20a, 20b or cannulae 30a, 30b, i5slid downwardly over the obturators 20a, 20b or cannube 30a, 30b and i,- e~L.J into the annulus ~I,r -'- (Fbs. 6 and n. The obturators 20a, 20b or cannulas 3Qa, 30b are remo~red 25 and the sur~ ,,uoclure and viewin~ are pe.f~,."_~ throu~h the sin~b ovsl cannulae 1 10. The oval cannula 1 1 0 has a unHorrn inner and o~ter dbm~t~r ond 8 tran~ver~ cross section that is d~;,.cd by an X axis D~ and a Y a~tis D2 (F4 7). The Y a~ds D2 has a dimension ~n~rally b~t Neen about 3 to 11 millimebrs ~nd the X
30 axis D1 has a di~ n~;o" of g~r~rally b~tw~sn about 5 to 22 millimeter~ and ~ longitudinal bngth of g~nerally bsh~n about SO
.
W O 97/40878 PCT~US97/07435 250 millim~ter~. Th~c din,Gr sicns will ~ccG~ G~ate the variety of obturaton~ 20 ant eannula~ 30 ussd in tl~ In~thod of the Lon.
If the surgical prucedure is ~,E.h,.. ,led on ~ p~tient havin~ a small di~c space, a half circle cannula of a type known in the indû~try can be used wKh an altemab Ib 120 havin~ a oentral bore 121 and a ~~nd bor~ 122 in th~ shspe of a half circle. An oval cannul~ 110 wi~ a smaller ~i.. ~t r can then be slid oYer the 10 cannulae to provlds a working channd ~hich will m into ths ~m~ller disc spaoe.
An altemate embodin~nt of th~ oval cannula 110 i~ sn ov~l cannula assembly 200 (Fi~. 14) The oval cannula assembly 200 15 includss ths cannulat~d obturator 20, ~ ~uide 300, an clon~
..._.,lber 350, and an oval cannula apparstu~ 400. Guid~ 30Q i~
forrned fr~m a solid cyiinder 302 havin~ opposin~ sides 304, 30~
and a centrally locatsd throu~h bor~ 30~ (Fi~s. 11 13). Bors 308 is generally ovoid in shap~ and is sh~psd to allow ths c~nnlJlatsd 20 obturator 20 and an elon~ated ~n,.lL.,. 350 to ne~t in relation to each other when the cannulated obturator 20 and elon~
,.._..,~r 350 are i"~ d through guide 300. Opposing side8 304, 30B of the cylinder 302 can indude indenbffons 310 that enabk a sur~son'~ fin~ers to firmly ~rip the ~uide 300 durin~ the sur~ical 25 ~ cod~r~. Cylindsr 302 has cn outsr surfsce 311 that cQn includ~
~srrations 312 over a portion of the outer surfaoe 311 (Fi~. 12). The indent~ffons 310 hav~ an outer surf~ 314 that is smooth In a preferred e..~L~d;..~o,r~l. ~e indentations 310 are gener~l~ circu~r and conoav~ in shape -W O 97/40878 rCT~US97/07435 The slon~ated ",~ r 350 h~s a cro~6 8g ~ional shape such that when plac~d ~djac~, It to ~e cannulated obturator 20, the elon~ated ."- -.nbGr 350 and the obturator 20 form ~n ~semb~
havin~ an oYal crws~ction. An example of such a cra~ ~e_tiulldl 5 ~hape is a half moon rail that includes ~n elon~ted groov~d ",_n~L~r 352 haYin~ a ~en~rally ~oac~t ~hapsd cros~ ~ection 354 (Fig ~). Other~lon~ d .)~raLe,~ ~rith different cros~ tio,..~l shapes could be used to form tne oval ~,,u~_ sectional assemb~.
Elongat~d ,.,~n~b~r 352 has a pr~,--al snd po~ion 35~ and a distal 10 enq portion 358. The pr~iu.al end portion 356 has a ~enerally flat surfaoe. The distal end portion 358 includes 8 taper 362 to allow insertion of the elon~ted "..,..,L_r 352 into the back of the pabient and into the percutaneously c.~t~ .J hnes~tiG.. of the annulus of the disc. Elon~ated ..b_."L_r 3~2 includes a lon~itudinal ~roove 3B0 15 that i~ aked and shaped to cradb the cannulated obturator 20.
Lon~itudinal ~roove 350 of the elon~ated ...e..lLer 3B0 allows the cannula1ed obturstor 20 and elG,-~d I~lE.l.eb_r 350 to be nested togsth~r and form a ~cnsrally oval shape which ~i~ throu~h ~8 oval bore 30~ of guide 300.
Oval cannula apparatus 400, as iOustrated in Fi~s. 8 and 10, inehldes an Blon9ated tub~ 402 w th an inner bors 404 having a tran~ e C~BB Bection that ~s J~ ed by en X axi8 D1 and ~ Y axis D2 that fonns a ~enerally ovoid shape (Fi~. 1 OA). The X axis D1 25 has a dimension ~enerally between about 5 to 22 millimeters and th~ Y axis D2 has a dlmension ~enelally between about 3 to 11 millimeters. The elon~abd tube 402 has a lon~itudinal len~th of generally beh~een ~bout 50 to 250 millirneters. Cl~n~..t~J tube 402 has sn outer ~uf~aoe 406, a PIUAI~Ial end 408 and a di6tal end 410.
W O 97/40878 PCTrUS97/07435 A Gollar portion 412 i~ athch~d to ~lon~at~d tube 402 at Its proxim~l end 408. Collar portion 412 has a lon~udin~l BXi~; LA (Fi~.
10), a tr~na~ TA (Fi~. 8), an upper surface 414, and a lower surfaoe 416. In a pr~nsd ~mbodim~nt, oollar portion 412 has 8 5 ~ener~lly recbn~ular shup~ with longitudinal opposin~ side walls 418 posWoned between the upper and lower surfaces 414, 416 along the longitudin~l axis LA snd transver~e o,~osin~ side walls 420 po~ ncJ b~en the upper and lower sur~aGes 414, 416 alon~ the transvc~ a~ti5 TA. Prefera~ly, collar por~ion 412 18 10 fo"..c.l from a solid piece of material ~h a rounded flrst end 4~
and rounded a #cond end 424. The ~lo,.~d~d tube 402 extends through the collar portion 412 l~om ds Iow~r sur~a~ 41~ to its upper surfacc. In o pr.,F~ ,J embodiment, elong~ted tube 402 ext~nds through collar po~tion 412 ~ener~lly proximal to the first end 422 of 15 collar portion 412. The elon~ated tube 402 cre~tes a continuous ch~nnel 417 ~rom the upper su~ce 414 to the lower surhce 41~ of collar portion 412 throu~h the distal end 410 of elon~ated tube 402.
An devat~d cylindrical ~6..lbsr 426 ~xt~nds from the upper surbce 414 of collar portion 4~2 in ali~nment with Ule elon~ted hbe 402.
20 Cylindrical ~ bsr 42~ fcrm~ a fir~t openin~ 428 with the continuous cl,_nnal 417 of ~longatsd n.~n)t~ar 402 th~t 6~t,nd~
through the distal end 410 of elongnted tube 4~2. Cyllndrical ...e..l~er 42~ h~s a an outer surf~ce 427 thut includes one or more annulsr ~ 42~ (F4 10).
Collar portion 412 includes a second u~en~ 430 that communicates with ~ continuous channel 4t7 of elon~ated tube 402. The o~cor)d op~nin~ 430 is preferably plaoed ~rough the transve~e oppo~ing slde wall 420 ~t thc first ~nd 422 of collar 30 por~on 412 ~.~,~ndicular to and communicatin~ with the continuous channcl 417 of eion~sted tu~e 402. A valv~ 432 i~ conn~ct~d to the .
W O 97/40878 PCT~US97/07435 s~cond openin~ 430 of ¢ollar portion 412, with valve 432 extendin~
euhYardly from th~ transverse opposin~ side wall 420 at ~ first end 422 of collar portion 412. Valv~ 432 can b~ o~r~J and clo~d by ~e user to allow wntrollsd outRow of ~ fluid ~nd is of a bpe known 5 by thos~ skilled in ~e 8rt- In ~-~f,.-~d anbodiment, valv~ 432 i~ a manually op~rabb typ~ v~lv~ with a stop cock mechanism 431 for openin~ and closln~ ~e valve 432.
Ov~l cannula assembly 200 can also indude a sealin~ means 10 or cap 4~0 for sealin~ the first openin~ 42B d the oval cannula appara~ 400 ~or us~ wKh an irn~tion sy4t~m ~not sho Yn)~ Th~
~ealing cap 480 pr~wnb t~ outflow of fluids throu~h ffl~ fir~t openin~ 428 when ~n in Igation device i8 inserted th~ou~h the cap 4OO. Cap 4~0 i~ ~ener~lly cylindricd in shape and jB forrned ~f a 15 plhbl~ m~terial such as silicon rubber which allows an irri~affon device to ~e inserbd ~u~h a small openin~ in cap 460 but ~r~ uS ttle oufflow of tluid ttlmu~h the cap 4~0. Sealin~ cap 4~0 has a top portion 4~2 and ~ botk~m portion 4~4, with top po~ion 4B2 having a c~ntrally lo~t~ opsnin~ 4~B for the ins~rtion of th~
20 ;~ ltiGn device. Bottom porbon 4B4 of c~p 4~0 includ~s ~ lip 4~8 that i~ sked and shaped to en~a~e the annular ~.oo~a 42~ of the cylindrical n.~."~er 42B in order to securely fasten cap 4~0 to the cylindrical ".~.ub~,~ 462 of the oval cannula apparatu~ 400. Cap 480 contains interior wall6 470 that form an interior openin~ 472 in cap 25 4~0. The interio~ openin~ 472 includes 8 barrier w~ll 474 plac~d ~G.~u,l~ally to ~nd ~pacecl apart from the top portion 4B~ of csp 4~0.
Barrier wall 474 is co~-r~ d to and is part of th~ inbrior w~lb 470 of cap 460 and creabs an upper ~ be~ 476 w~hin ~ in~ or openin~ 472 of cap 460. Th~ barri~r wall 474 1,.~-. ts the outfbw 30 of fluid throu~h the fir8t openln~ 428 wl~n ttl~ irri~ation d~ce ~s placed through openin~ 466 in the top portion 4~2 of ths cap 4~0.
W O 97/40878 PCT~US97/07435 In a pr~ferred ~rnbo~ nl, bamer wall 474 can contain ~ small l-o,~orltal cut for ca~e in ins~rtin~ the i..is~on device through the c~p 4~0. When a clo#d i,-~tion ~yst~m i~ desir~d, the ir~-~tiul, device i8 in~rt~d throu~h openin~ 4~6 and bsrrier wall 474 of cap 5 460 and i6 plao~d into ~e continuou~ channel 417 of elon~a~d tube 402. A su~tion devioe, known to one skilled in the art, is connc ted to valve 432 for suctionins fluid out of the sccond openin~ 428 and throu~h valve 432. Thus, when c~p 4~0 is attached to the cylindrical "-e.,ll~_r 426, the oYal cannula apparatus 400 allows for a 10 closed i-,~hi~r, system wherein ffle fluid is int~ d into the first openin~ 4~8 ~nd circulate~ ~rou~ll tho conffnuous d~ann~l 417, out the distal end 410 of ebngat~d tub~ 402 and into ~e o~rdtin~ s~e and up and out the ~econd openin~ 430 and the valve 432 by means of the suction de~i~ce connected to valve 432. When the 15 irri~ation sy~tem i~ not required, the sealin~ cap 4B0 is ._h.~.v~.d from the cylindricsl .,.~ Lcr 42~ and the sur~ical instrumerts and vi~An~ de~ are in~erted throu~h th~ hr~t opening 42B and down the elongated tube 402 h order to p~ffDrn~ the sur~ical di~c ~ruc The ~uide 300, th~ elo"y..t-_d ".~ I,er 350 and the oval cannula apparatus 400 are p~ferably formed from a biocon~tible m~brial 8uch a~ stainless 8teel or ~ustinitic stainless steel.
Wnen ~e oval cannula 110 or the oval cannula assembly 200 25 is used in a percubnoous sur~ical disc procedure, uniportal access to the intervertebral disc space i~ established by ~dYancin~ a ~uidewire 10 throu~h the skin of a ~atic~,t'~ back posterolaterally underflou~scopic ob~enration unffl th~ ~uid~wir~ 10 contac~
ea~_. ior ~ ddo of the annulus fibrosis of th~ hemiatsd 30 disc. The cannulated obtur~tor 20 is pass~d o~er thc ~uideHllre 10 until th~ distal end of ~e cannulated obtu~tor 20 wllh_b the W O 97/40878 PCT~US97/07435 l su~ace of the annulu~ fibrosis of the hemiated disc (Fi~.
19). Therea~br, ~ c~nntJlatBd obturator 20 (Fb. 2), havin~ a lumen with a diameler 51i~ ~ lar9er than that ~ the ouidewire 10, 18 pa~sed over the ~uidowirs 10 until the cannulated obtur~tor 20 S ~, ~b the extemd ~;urf8ce ~f the annulu~ fibrosis of the hemi~t~d d~c. The remov~l of the guid~wire 10 at this point is opffonal. An acoes~ cannul~ ~Oa (Fb. 3), ~uibbiy of sbout 0.2~ in. (O~OS~n) oubr dbmet~r snd having ~ dd~ons 31 of 10 mm, i~ then ps~cd ove~ the csnnulated obturator 20 and ~ nced to th~
10 extem81 surfaoe of the annulus fibro6is. At this point, the ~uid~wire 10 is remov~d if not prev oudy remov~d. The inner diameter of thQ
acoes~ cannula 30a 18 sked to closely M over the cannulatsd obturator 20. The cannulsted ob~rator 20 is then remoYed, and a 3 mm or 5 mm trephine 0,0 (Fi~. 4) is introduc~d throu~h the access 15 c~nnula 30a. The trephine 40 has a pluralit~ of ~aw te~th 40a or other cuttin~ IllC..~ . The ~ephine 40 is advanced into the annulu~ af t~e disc, with rotation, creatin~ an annular f~nes~ation (that i8, a bore) through the annulu~ fib~osis into the nucleus. The trephine 40 is then removed.
Thc cannulated obturator 20 is .~ uduced into ths acce~
cannuls 30a and passed into the f~no~t,lation of the annulus.
Fluoroscopic ~uidsnc~ may b~ utilized. The acoeas cannula 30a is then removed. Guide 300 is placsd o~r the cannulated o~turator 25 20 with the o~Jal bor~ 308 of guide 300 sllowing for th~ insertion of the elongahd .,~ernber 350 through guide 300 and pbcin~ the ~longsted ~ bu 350 in n~n~ rehtionship with the cannulshd obtur~tor 20 (Fi~. 20). The nesbd cannulste obtu~tor 20 and elongated memb-r 350 fill the openln~ of ~e oYal bore 308 of guide 30 300 and create ~n a~sembly that has a generally oval cr~ection.
The bpered end 3~2 of the ehngat~d ",~.,lber 350 ~llow~ X to be easily in~d into th~ back of the patient and lo be easily wed~d into th~ dlse, alon~ the side of the obturator 20.
The ~uide 300 is removed from thc ns~t~d cannul~bd 5 obturator 20 and elon~abd ll~~ ar 350 and thQ ov~ nnul~ 110 or oval csnnula ~pparatus 400 is slid down~rdly ov~r ths nesbd cannulated obturator 20 and the elon~abd l~r.lb0r 350 tFig. 21) with the distal end 410 of the oval cannula appar~tus 400 or ~ oval canula 110 bein~ inserbd into the annulus of the disc. Th~
10 c~nnulaS~ obturator 20 and elon~ated n~a..~ber 350 are r~ G~_d from the oval c~nnula 110 or oYal cannula ~ ,z.~ 400 and the dbG and the sur~ical procedure is prefonned by introducing both the sur~ical instruments and/or the viewin~ apparatus into th~ oval Gannula 110 or oval cannula apparatus 400 (Fi~. 22). If a clo~d 15 ;.~ dt;~ll system is desired, the se~ling cap 460 can be plaoed over the ~rlindrical m~ ber 426 wi~ the i~ig~tion device bein~ plaoed throu~h the cap 4~0. A suc~on devic~ Is appli~d to valYe 432 which ~ill provide for a continuous flow of fluid fr~m the fir~t openin~ 42~, throu~h the c1~ ~J tube 402 and out the second openin~ 430 20 and valvc 432.
It should be U~ .s~DG~I that thue can be impro~ements and .,-Gdifications made to the embodiment~ of th~ invenUon described in detail above without dep~rtin~ from the spirit or scope o~ the 2~ invention. a~ set hrth in the ~,..~anyin~ claims.
.
This invention relates to sur~ery and specifically to an apparatus and a method for ~ccessing herniated inter~ertebral discs ,.
5 in a human patient.
Low back pain syndrome with sciatica secondary to herniated intervertebral disc~i represent~i ~ major t~ealth pro~lem An intervertebral disc is a ~itructute which occupies the space between 10 the vertebrae and acts, amon~ other things, as a shock absorbin~
cushion. A normal disc COIISiStii of two parts; a centr~l part known as the "nucleus" and a ~iurroundin~ part known as the "annulus" or "annulus fibrosis". The annulus degenerates with a~e as does the nucleus. Degeneration of the disc is characterized by collaçlenation, 5 in which some of the fluid content of the nl~cleus is lost and fragments of colla~enized hbrous tissue are formed which float in the tissue fluid. At this sta~e of de~eneration, external force:s can readily increase the hydfo~talic pressure on the nucleus, caL~sing the fibers of the annulus to rupture. Nucleus fraglr,~l~ts protrude.
20 This, in turn. may cause pressure on the adjacent nerve root with re~iultant pain. De~eneration of the disc may also be caus~~d by other factors, for ~xample, by accidental injury.
Several methods of treatment already exist. One method, 25 usually rc:fel~d to as "laminectomy" involves the sur~ical excision of the sy,~,p~oi~lic portion of the ~,er~liat~d disc. This method of treatment has been used for many years, however, typical hospitalization time in nine days. Microsurgery has also bee~n used in the treatment of herniated discs, in a procedure known a~i 30 "microlumbar disoe~lolny." This rnicrosur~ical procedure, althouah less invasive, nevertheless carries with it many of the complications ~ssoci~t~d with the older procedure, including injury tn the nerYe W O 97/40878 PCT~US97/07435 root and dural sac perineural scar formation reherniatlon ol the site of the su~ery and instabiilty due to exGess bone removal Another method of tleal"lent is known as chemonucleolysis winich i~i carried out by injection of the enzyme chymopapain into the disc structure.
5 This procedure has many complications including severe pain and spasm, which may last up to several weeks foilowing injection.
Sensitivity r~a~tio, 15 and anaphylactic shock occur in limited but si3nific~nt numbers of patients.
A further ~,etl~od of l~al,nent, aulG,n~t~d percutanecus iumbar discectomy, utilizes a specially designed needle whioh is inse~ed into ~ ruptured disc space. The nucleus of the disc is removed by suction instead of open sur~ery.
Anothe~ method of treatment is di~cussed in U.S. Patent 4,573,448 and involves the percutaneous evacuation of fragments of the herniated disc throug~ an ~ccess cannula positioned against the annulus of the herniated disc A measure of safet~ and accuracy is added to this operative procedure by the arthroscopic 20 visué~ tion of the annulus and other important structures which lie in the path of the instruments such as the spinal nerve:. While a considerable improvement over the existin3 proGedures, nevertheless this procedure does not enable the surgeon to directly view the resection of posterior nuclear rlag"~ents That is, the 25 internal diameter of the access Gannula as described in U.S. Patent 4 573 448 limits the design of an operatin3 discosoope and limits the type and size of instrurnents that would allow for the visualization and simultan~ous suction ir, i~ation and resection of the nuclear material.
W O 97/40878 PCTrUS97/07435 The introcluction of a second portal to the annulus from the opposite side of a first portal has been reported by Schreiber and his co-workers in Clinical Orthopaedics and Rstated Re~earch, Number 238, pa3e 36, January 1989 However, this bilateral, biportal 5 procedure increases the operatin~ room time, exposure to r~diation by physician, patient and operatin3 room per~onnel and also increaa~ post-operative morbidity by involving both sides of the back and m~y cause excessive removai of nuclear mat~rial which i"cr~a~cs the possibility for stenosis of the for~n,en and nerve root 10 comp, ~35ion.
Thus, there is a need in the art for a percutaneous procedure to create an unilateral portal in the annulus c~a~in~ minimal exposure of the patient, physician and operatin3 room staff to 15 rd~i~tiOn and without unduly prolonging time spent in the operatin~
room. A unilat~ral approach which will allow for continuous visualization, id~r~liricalio" and e~l,a~ion of nuclear fra~msnts from the disc under gi6~0sG~pic control is required Large central herniations and partially extruded ~r~9r~,~nts may be visualized and 20 evacuated. Such a unilat~rdl approach to place a percutaneous portal in, for example, the L5-S1 vertebral joint, is ~Iso hi~hly desirable bec~lse this procedure requires deficction of the patient's spine to enable access on the one side, causing a cor~esponding ,esl,i.;tion of access on the opposite side. Moreo~er, ~y usin3 a 25 unilateral approach, instruments do not need to traver~;e across the dlsc nucleus frorn a second po~al remote from the sy",ptornatic side. Therefore, the a~ount of non-symptomatic nuclear material removed by the unilateral approach is decreased as compared to the bilateral biportal approach ~his is important in preventir~g 30 collapse of disc approach. This is important in preventing collapse of disc space, which reaults in nerve compression and stenosis of .
W 097140878 PCTrUS97/0743S
the spinal canal. Also, another si~nificant benefit of the unilatsral approach is that the musculature and soft tissue and disc are traumatized on only one side of the back.
Accorciing to the present inYention there is provided an apparatus hr use in a percutaneous sur~ical disc procedure wherein the disc has an annulus, comprisin~:
a) an oval cannula having an elG"~ated tube with an inner bore, an outer surface, and a transverse CrOS5 section that ia d~ined by an X axis and a Y axis, wherein the X axis dimen~ion is greater that the Y axis dimension so that the bore has a generally ovoid shape, the elo~ ted tube havin~ proximal and distal 13nds;
b) the inner bore bein3 sized and shaped to allow ~n obturator and an elon~ated member to fit insid~ the inner bore when the obturator and elon3ated member ~re ~dj~c~nt to cne another and form an a~e~bly with an ovai cross-section;
c) the oYal shaped bore of the oval cannul3 enabling a u~er to insert more than one instrument at a time into the bore when the obturator and elongated member have been removed from the oval shaped bore.
Thus in the present invention a single oval cannula throu~h which both the procedure and the viewin3 can be pe,rul,,,ed, is provided.
The pre~ent invention further provides an apparatus f~r use in a percutaneous sur~ical disc procedure wherein the disc has an annulus, c~")pri~ing:
a) an oval cannula having an elon~ ed t~be with an inner bore, an outer surface, and a transverse cross sect;on that is ciefined by an X axis and a Y axis. wherein the X axis dimension is ~reabr that the Y axis dimension so th~t th~ bore has n gener~lly ovoid shape, the elonyaled tubc h~vin~ proxi~nal and distal ends;
b) a collar portion with a lon~itudinal axis, a transverse axis, and upper and lower surfaces, lon~itudinal opposing ~id~ walls positioned between the upper and lower surfaces along the longitudinal axis, and transverse opl,o~in~ side walls positioned ~ehr~_on the upp~r and lower surfaces along the transverss axis, th~ collar portion having first and second ends;
d) th~ ~longated tube eft~ lg throu~h the coilar portion from the lowsr surhce to the upper surface proxil)~al to the first end of the collar portion;
e) an elevated cylindsr ~xtendin~ from the upper surface of the collar portion in alignment with the elongated tube forming a first openin~ and ~ continuous ch~"n~l from the op~ning of th~ ebvated cylinder throu~h the dishl end of th~ elongat~d tube;
and fl a valve ~e~cnd;n~ outwardly from the trsnsverse opposin~ side wall at the first ~nd of the collar portion the valve formin~ cond op~nin~ communicating with the continuous chann~l of the elongated tube.
In a,~otl,er ~mbo~l;.nent of the present invontion thsre is provid~d an ~pp~r~lus for percutaneously ~, Forn~ing &ur~;cal proc~dures on the spinal re~ion of a patient, comprisin~:
a) a obturator for adv~n~i"g through a ~ percutaneously c~t~d fenes~r~liur, of the annulus of the disc of a p~tienl;
b) an elon~éat~d memb~r;
c) the combination of the cl~nyate~ ,emb~r and the obturator havin~ a generally oYal shape upon assembly when the obturator is placed ~j~cent to ~longabd ",ei"bcr;
W O 97/40878 PCTrUS97/07435 d) a guide for ~uidin~ th~ obturator and eton~ated member togeth~r in an adiacPnt ~ositiG";
~ ) an oval cannula havin~ a ~ener~lly oval shaped bore th#t can remov~bly r~c~ivo the obturator and el~ ..IeJ
5 .n~ sr assembly, the oval sh..pLd bore e.,a~l;.,~ a user to insert moro th~n ons instrumont st a time into the bore when the obturator and the ~lon~dt~d ~ n)ber have been removed from the oval sha~ed bore.
In yet another embodiment of the pr~~c~l~ invention ther~ i8 provided ~n ~pparat-l6 for percubneously pe,f~""~ng ~urgical procedures on the spinal rsoion of a patient, comprbin~;
a) moan~, includin~ Qn obturator havin~ a ~umsn and an outer su~ace for fo~ and adv~ncing into a f~n~tr~lion 16 fo~ d In a pati~n~s back and spinal disc;
b) ~n &lon~a~l msmber havin~ a lon~itudinal groove that is sized and shaped to l~:CCiYe: a portion of th~ out~r surfac~ of the obturator, the ~roove bein~ so shaped in tranfiverse cross-section that a lon~itudinally extending portion of the obturator 20 can occupy and nest in the gro~
c) the combination o~ ths elon~atsd n)gn~bar ~nd the obturator havin~ a ~eneraliy oval shape upon ~sser,l~ly when the obturator clos~ly fits into the ~roove; and d) tn oval cannula that has a generally oval 25 ~hap~d bore that can remoYably receive the combination of the clor,~alecl In&,nber and the obturator, the ov~l si,~t boro enabling a user to insc~ sur~ical instruments into the bore durin~ disc sur~ery.
The present inv~ntion aiso provides a percutaneous 8U~
disc procedure, oG~ risi~ the 8teps of percutaneously enterin~ the WO 97/408~8 PCT/US97tO7435 back of the patient in a poster~lal~r~l dir~clion wlth an ~cce~;s cannula, ad~anci,~ id acces~ cannula throu~h a first percutaneoualy crcatsd f~n~st,~tion of the annulus of the di~c, percuS~neously ~SnteSrin~ the bac~ of the patient in a posterol~teral 5 L~irc~liGIl with an aGcessory cannula, ~nd ~dYancing said ~ 5501'y cannula throu~h a second percutaneously ~re~kd f~,lesl,~tion of the annulus ~ ~nt to and on the same side of the disc as the first fcncslrdtion.
Th~refore accordin~ to the present invsntion there is al80 provided a percut~neous surgical di~c procedure, using the apparatus as herein before described comprisin~ the steps of:
a) percutaneously enterin~ the back of a patient in a posterolateral position with an obturator havin~ a lumen;
b) advancin~ th~ obturator throu~h a percut3neously cr~ted fenestl~tion of the annulus of the di~ic;
c) placiny a guide containing a generally oval shsped bore over the obturator;
d) insertin~ an ~lon~ated m~mber through the 20 bore o~ the ~uide and into the back Gf the patient into the percutaneously created fenestr~tion of the annulus of l:he disc, the elongated member havin~ a cross-sectional shape suc:h thal when placed adjacent to the obturator, forrns an assembly having an oval cro~s-section;
e) removins the ~uide from the obturaSor and elon~ated member assembly;
f) slidin~ an oval cannula having a bore with an oval transverse cross-section and proximal and distal ends, ~ dDwnwardly over the obturator and elongated member asse~bly;
~) jrl~E, ~ the distal end of the oYal cannula into the disc;
W O 97/40878 PCTnJS97/07435 h) removin~ the obturator and elongated ",er"ber assembly from the bore of the oval cannula and the disc; and i) introducin3 multiple sur~ical instr~ments into the oval cannula to per~orm the surgi~al procedure.
The present invention also provides a IlletllG~l ~or the percutaneous decGmpression of a hsrniated inte~ertebral disc in a humsn patient, which comprises percutaneously sntering the back of the patient in a posterolateral direction with an access cannula, 10 adYancin~ the access cannula into the disc through a first percutaneously created fene~il,dlion of the annulus of the di~.c, percutaneously ent~ri"~ the back of the patient in a poster~i~ter~l direction with an aGGe~s~ cannuia, adv~ncin~ the ~ce~sory cann~la into the disc throu3h a ccGnd percutaneously ~re~ed 15 fenestration of the annulus adjacent to and on the same side~ of the dis~ as the first fenestration, removing nuclear malerial thro~lgh one of the cannulae and observin~ the removal with an endoscope through the other.
The method of the present invention requires only a small incision to place the Gannula, this a~ruaeh utilizing unilateral placement. The unilateral approach allows for continuous discoscopic control and ~ U~Ii7~tion and pro~ides adequate channels for fluid management, which significantly enhances the visual identification of the posterior annulus. The met~.od in accordance with the invention may be carried out under loca,l anesthesia, thus avoidin~ the risk of general anesthetics~
A better understandin~ of the invention can be obtained whPn 3~ the detailed description of exemplar~ embodiments s~i forth below is re~iewed in conjunction with the acc~",yanying dr~ings, in which:
W O 97/40878 PCTrUS97/07435 FIGURE t is a plan view of a ~uide wire useful in the pr~sent invention;
FIGURE 2 is a plan view, partly in section, of a cannul~t~d obturator useful in the plesent i,.v_,~t~n, FIGURE 3 i8 a phn view, partly in ~eetion, of an access cannula useful in the present invention;
FIGURE 4 is a plan view of a trephine useful in th~ pr~cnt invcnffon;
FiGURE 5 is a s~ . "dti~ Yiew of two cannulae i..6e . t~ into 10 the hemiat~d di~c;
FIGURE ~ is a scl.~ L~. vi~w of an oval cannula ;.l~c.~d over the two ¢annulae ~hown in Fig. 5;
FIGURE 7 is a viel,v in section, bk~n slon~ ths lin~ of 20 -20 in Fi~. Bi ~5 FIGURE 8 b a p~r6p~liv~ view of an attemate . nLo.li",_,~
of the subjed invention illu~tratin~ an oval cannula appuatus;
FIGURE 9 ~ide pl~n vi~w of ~n ~Item~t~ 6..1b~di,..~nt of the subject invention illustratin~ a half-moon r~il;
FIGURE 10 is a side plan view in partial cross section of the 20 oval cannub appQrQtus of Fi~
FIGURE 10A b a cro6a ~ec~ional vi~w of the oval bore of the oval cannula appar~tus of Fb. 8 along the lines of 10A-10A of Fi~.
10;
FIGURE 11 i~ Q p~ vi~w of Qn Qltsmab ~ bG~i,..~nt 25 of the subjeGt ;n~ ., illustratin~ a ~uide ,,,..,,~c~, FIGURE 12 is a side plsn view of the ~uide .,.~ I.er of Fi~.
11;
FIGURE 13 is a top plan view of the ~uide r..e..Ler of Fi~. 11;
FIGURE 14 is a ~J_.a~Jc ~re view of an assembly of the 30 altomato ~n~bo~ nt of th~ subjcct i--n.~
FIGURE 15 is a top pC~L_ti~_ view of an a~emate ernbodiment o~e subject il-J_.ltion IIIL-~at~ a sealin~ ll.chlLcr, FIGURE 1~.is a bottom pc.a~e ~ view of the sealin~
I,~.t~L~r of Fi~. 15;
FIGURE 17 is a ~Ide pbn view in partial cross ~e~on of th~
sealin~ L_- of Fi~. 15;
FIGURE 18 is a bide pbn view in pJrtialCro85 ~ection of the ~alin~ ."c."bEr of Fi~. 15 in place on the oval c~nnula appsratus of Fi~. 8;
FIGURE 1g is a s~h~.~ic view of the cannulated obturator of Fi~. 2 Insertcd into a hemiated di~c;
FIGURE 2Q i~ a ~chsmatic vi~w of the cannulated obturator of Fi~. 2 and the rail of Fi~ el~t~d hto ffle disc Illustrating the use of ~e ~uide ll~n~L er of Fi~. 11;
FIGURE 21 is a schematic view of an ~ bly of the oval cannula apparatus of Fi~. 8, the ~:annulated obturator of Fi~. 2 and the rall of Fi~. 9 ins~rted in~o ths disc; and FIGURE ~2 h a ~hellldli~ view of a wr~ l plu~J~lre bein~
pe.h.llll~ throu~h the oval cannub apparatus of Fi~. 8.i,l~rtLd into 20 ths l~G.~ ed disc.
In the d~cri~Gn that follows, instrument2l are generally made out of suitable austenitic stainless steel, unles~ otherwise ~,e~ qd. While the sur~ical ~ru~dure desc,i~cd hsrein r~f~rs to 25 d~co,~ r~ss;on of intL.~uLkr~l lumbar discs. it is to be u.-d~.~t~
that th~ ~r~,c~durc is not limitcd to lumbsr disc~.. ,~ snd may be used in any proc~d~lre for p~rcut~ncous~ pbcin~ at Icast two cannulae in a patbnt, such as an int~ I disc proc~Jur~ or operation.
W O 97/40878 PCTrUS97/07435 Ac~ordin~ to the ,.,_lhod of the ~.~s~ i"1l_ntiu,., the pati~nt is positioned on a radioluoent table in the ap,~.u~.,i~e pron~ or bt~r~l position snd a 9uidewire 10 (Fi~. 1), sui~ably of about O.OgO
in. (0.127cm) diamebr, i5 advancsd throu~h ~e ~kin of the b~ck 5 po~brobt~rally under fluo,- scopic obsonrntion until the ~uidewire 10 contacts the _~k..;or s~ Jtol~ side of the nnn~dus fibrosis of ths h~miat~d di~c. Thcr~al~r, a cannulatcd obturator 20 (Fb. 2), havin~ a lumen with a dismeter sU~htly lar~er than that of the ~uid~wire 10, is passed over the gu~ewire 10 unUI the c~nnulated 10 obtu~#tor 20 CGI~b r.ts the e~emal surhce o~the annulus flbrosi~ of tho hemiated disc The ,~ ~' of the ~uidewire t O at this point is ~"~on~l An access cannula 30a IFi~ 3), suitably of about 0 25 in (0.~35crn) outer diameter and ha~nn~ extemal ~radations 31 of 10 mm, is then passed oYer the cannulated obturator 20 and advanoed 15 to th~ ext~mal sur~ace of the annulus fibrosis At this point, the ~uidswirs 10 ic rernov~d if not pr~viously ~_r"o~d, The inn~r diam~t~r of the acc~ss cannula 30a i8 siz~d to dO8BIy M over the cannulabd obturator 20 ThB cannulated obturator 2û i8 then removed, ~nd a 3 mm or 5 mm t~ephine 40 (Fi~ 4) i8 illtrOdVOed 20 thr~u~h the acces~ cannu~a 30a The ~ ,Jhi, ~ 40 has a plurality of saw tee~ 40~ or o~er cu~n~ L- ~D. The trephine 40 i~
ad~Janccd into thB ~nnulu~ of th~ di~c, wXh rotaffon, uedSI,~ an ~nnular fenestr~tion (that 18,a bore) throu~h the annul~ls flbrosis Into the nucleu~ The trephine 40 i8 then ~~ ,.u~_ The canmllated obturator 20 i8 rei~ociua~d into ~ access cannula 30a and pa~sed into ~e h c~ation of the annulus ~luoroscopic ~uidsncs may bs utiliz~d. Th~ ¢annula 30a is then adv~nced irno the fenestration of ~e annulus, wi~ rotary 30 "ov_ ..e ~l Afbr the acces8 cannula 30a is in th~ proper posfflon, th~ cannulated obtu~tor20 i~ - uv~d Thc ~,u.~imal ~n~ of W O 97/40878 PCT~US97/07435 cannula 30~ projscts b~yond the su~aoe of the patier~s baclc (not shown) whils th~ dkt~l ~nd i8 in position in the nucleufi. The pr~urs d~;liL~d for plaosmont of cannula 30a into the annulus of the disc follows the p~c~dure des~ribed in U.S. Patent 5 4,573,448. As i~ l~own, suit~ble locd arie~tt,ebc i8 u~ed a8 appr "~
Accordir~ to the pr~W~ ntiu., the sur~ roudurs and viewin~ can be done throu~h a sin~le oval cannula 110 r~ther than 10 ~o cannula~ 30a ~nd 30b. The oval csnnula 110 provid~s a l" uJor access to the int~Nertobral diw and is particularly useful for a, Ihr~opic decortation of the v~.rt. ~r_l plates in prepa~tion for p~rcutaneous i,-t~rb~y fusion. Furthor, when p~ ,r"~ing pGat~rior or ~,G~rolat~ral fr~n~nt~_t~ ia an intradiscal access, the oval 15 cannul~ 110 allous forfurthsr angulatlon of th~ insert~d instrumerts and proYid~s a b~tt~r ~ 8~a to ~e posbrior hembtions.
If thi~ IhGJ i8 used hHo cannulated obturators 20 or cannulas ~Oa, 30b are inserkd into the disc 101 usin~ a ji~ 70 to align ~e obt~Jrator8 20 or cann~lae 30a, 30b in parallel ali~.",lent as 20 shown in Fi~. ~. The ji~ 70i5 removed and the oval cannula 110, sli~hffy lar~er in diarneter than the ~No obturators 20a, 20b or cannulae 30a, 30b, i5slid downwardly over the obturators 20a, 20b or cannube 30a, 30b and i,- e~L.J into the annulus ~I,r -'- (Fbs. 6 and n. The obturators 20a, 20b or cannulas 3Qa, 30b are remo~red 25 and the sur~ ,,uoclure and viewin~ are pe.f~,."_~ throu~h the sin~b ovsl cannulae 1 10. The oval cannula 1 1 0 has a unHorrn inner and o~ter dbm~t~r ond 8 tran~ver~ cross section that is d~;,.cd by an X axis D~ and a Y a~tis D2 (F4 7). The Y a~ds D2 has a dimension ~n~rally b~t Neen about 3 to 11 millimebrs ~nd the X
30 axis D1 has a di~ n~;o" of g~r~rally b~tw~sn about 5 to 22 millimeter~ and ~ longitudinal bngth of g~nerally bsh~n about SO
.
W O 97/40878 PCT~US97/07435 250 millim~ter~. Th~c din,Gr sicns will ~ccG~ G~ate the variety of obturaton~ 20 ant eannula~ 30 ussd in tl~ In~thod of the Lon.
If the surgical prucedure is ~,E.h,.. ,led on ~ p~tient havin~ a small di~c space, a half circle cannula of a type known in the indû~try can be used wKh an altemab Ib 120 havin~ a oentral bore 121 and a ~~nd bor~ 122 in th~ shspe of a half circle. An oval cannul~ 110 wi~ a smaller ~i.. ~t r can then be slid oYer the 10 cannulae to provlds a working channd ~hich will m into ths ~m~ller disc spaoe.
An altemate embodin~nt of th~ oval cannula 110 i~ sn ov~l cannula assembly 200 (Fi~. 14) The oval cannula assembly 200 15 includss ths cannulat~d obturator 20, ~ ~uide 300, an clon~
..._.,lber 350, and an oval cannula apparstu~ 400. Guid~ 30Q i~
forrned fr~m a solid cyiinder 302 havin~ opposin~ sides 304, 30~
and a centrally locatsd throu~h bor~ 30~ (Fi~s. 11 13). Bors 308 is generally ovoid in shap~ and is sh~psd to allow ths c~nnlJlatsd 20 obturator 20 and an elon~ated ~n,.lL.,. 350 to ne~t in relation to each other when the cannulated obturator 20 and elon~
,.._..,~r 350 are i"~ d through guide 300. Opposing side8 304, 30B of the cylinder 302 can indude indenbffons 310 that enabk a sur~son'~ fin~ers to firmly ~rip the ~uide 300 durin~ the sur~ical 25 ~ cod~r~. Cylindsr 302 has cn outsr surfsce 311 that cQn includ~
~srrations 312 over a portion of the outer surfaoe 311 (Fi~. 12). The indent~ffons 310 hav~ an outer surf~ 314 that is smooth In a preferred e..~L~d;..~o,r~l. ~e indentations 310 are gener~l~ circu~r and conoav~ in shape -W O 97/40878 rCT~US97/07435 The slon~ated ",~ r 350 h~s a cro~6 8g ~ional shape such that when plac~d ~djac~, It to ~e cannulated obturator 20, the elon~ated ."- -.nbGr 350 and the obturator 20 form ~n ~semb~
havin~ an oYal crws~ction. An example of such a cra~ ~e_tiulldl 5 ~hape is a half moon rail that includes ~n elon~ted groov~d ",_n~L~r 352 haYin~ a ~en~rally ~oac~t ~hapsd cros~ ~ection 354 (Fig ~). Other~lon~ d .)~raLe,~ ~rith different cros~ tio,..~l shapes could be used to form tne oval ~,,u~_ sectional assemb~.
Elongat~d ,.,~n~b~r 352 has a pr~,--al snd po~ion 35~ and a distal 10 enq portion 358. The pr~iu.al end portion 356 has a ~enerally flat surfaoe. The distal end portion 358 includes 8 taper 362 to allow insertion of the elon~ted "..,..,L_r 352 into the back of the pabient and into the percutaneously c.~t~ .J hnes~tiG.. of the annulus of the disc. Elon~ated ..b_."L_r 3~2 includes a lon~itudinal ~roove 3B0 15 that i~ aked and shaped to cradb the cannulated obturator 20.
Lon~itudinal ~roove 350 of the elon~ated ...e..lLer 3B0 allows the cannula1ed obturstor 20 and elG,-~d I~lE.l.eb_r 350 to be nested togsth~r and form a ~cnsrally oval shape which ~i~ throu~h ~8 oval bore 30~ of guide 300.
Oval cannula apparatus 400, as iOustrated in Fi~s. 8 and 10, inehldes an Blon9ated tub~ 402 w th an inner bors 404 having a tran~ e C~BB Bection that ~s J~ ed by en X axi8 D1 and ~ Y axis D2 that fonns a ~enerally ovoid shape (Fi~. 1 OA). The X axis D1 25 has a dimension ~enerally between about 5 to 22 millimeters and th~ Y axis D2 has a dlmension ~enelally between about 3 to 11 millimeters. The elon~abd tube 402 has a lon~itudinal len~th of generally beh~een ~bout 50 to 250 millirneters. Cl~n~..t~J tube 402 has sn outer ~uf~aoe 406, a PIUAI~Ial end 408 and a di6tal end 410.
W O 97/40878 PCTrUS97/07435 A Gollar portion 412 i~ athch~d to ~lon~at~d tube 402 at Its proxim~l end 408. Collar portion 412 has a lon~udin~l BXi~; LA (Fi~.
10), a tr~na~ TA (Fi~. 8), an upper surface 414, and a lower surfaoe 416. In a pr~nsd ~mbodim~nt, oollar portion 412 has 8 5 ~ener~lly recbn~ular shup~ with longitudinal opposin~ side walls 418 posWoned between the upper and lower surfaces 414, 416 along the longitudin~l axis LA snd transver~e o,~osin~ side walls 420 po~ ncJ b~en the upper and lower sur~aGes 414, 416 alon~ the transvc~ a~ti5 TA. Prefera~ly, collar por~ion 412 18 10 fo"..c.l from a solid piece of material ~h a rounded flrst end 4~
and rounded a #cond end 424. The ~lo,.~d~d tube 402 extends through the collar portion 412 l~om ds Iow~r sur~a~ 41~ to its upper surfacc. In o pr.,F~ ,J embodiment, elong~ted tube 402 ext~nds through collar po~tion 412 ~ener~lly proximal to the first end 422 of 15 collar portion 412. The elon~ated tube 402 cre~tes a continuous ch~nnel 417 ~rom the upper su~ce 414 to the lower surhce 41~ of collar portion 412 throu~h the distal end 410 of elon~ated tube 402.
An devat~d cylindrical ~6..lbsr 426 ~xt~nds from the upper surbce 414 of collar portion 4~2 in ali~nment with Ule elon~ted hbe 402.
20 Cylindrical ~ bsr 42~ fcrm~ a fir~t openin~ 428 with the continuous cl,_nnal 417 of ~longatsd n.~n)t~ar 402 th~t 6~t,nd~
through the distal end 410 of elongnted tube 4~2. Cyllndrical ...e..l~er 42~ h~s a an outer surf~ce 427 thut includes one or more annulsr ~ 42~ (F4 10).
Collar portion 412 includes a second u~en~ 430 that communicates with ~ continuous channel 4t7 of elon~ated tube 402. The o~cor)d op~nin~ 430 is preferably plaoed ~rough the transve~e oppo~ing slde wall 420 ~t thc first ~nd 422 of collar 30 por~on 412 ~.~,~ndicular to and communicatin~ with the continuous channcl 417 of eion~sted tu~e 402. A valv~ 432 i~ conn~ct~d to the .
W O 97/40878 PCT~US97/07435 s~cond openin~ 430 of ¢ollar portion 412, with valve 432 extendin~
euhYardly from th~ transverse opposin~ side wall 420 at ~ first end 422 of collar portion 412. Valv~ 432 can b~ o~r~J and clo~d by ~e user to allow wntrollsd outRow of ~ fluid ~nd is of a bpe known 5 by thos~ skilled in ~e 8rt- In ~-~f,.-~d anbodiment, valv~ 432 i~ a manually op~rabb typ~ v~lv~ with a stop cock mechanism 431 for openin~ and closln~ ~e valve 432.
Ov~l cannula assembly 200 can also indude a sealin~ means 10 or cap 4~0 for sealin~ the first openin~ 42B d the oval cannula appara~ 400 ~or us~ wKh an irn~tion sy4t~m ~not sho Yn)~ Th~
~ealing cap 480 pr~wnb t~ outflow of fluids throu~h ffl~ fir~t openin~ 428 when ~n in Igation device i8 inserted th~ou~h the cap 4OO. Cap 4~0 i~ ~ener~lly cylindricd in shape and jB forrned ~f a 15 plhbl~ m~terial such as silicon rubber which allows an irri~affon device to ~e inserbd ~u~h a small openin~ in cap 460 but ~r~ uS ttle oufflow of tluid ttlmu~h the cap 4~0. Sealin~ cap 4~0 has a top portion 4~2 and ~ botk~m portion 4~4, with top po~ion 4B2 having a c~ntrally lo~t~ opsnin~ 4~B for the ins~rtion of th~
20 ;~ ltiGn device. Bottom porbon 4B4 of c~p 4~0 includ~s ~ lip 4~8 that i~ sked and shaped to en~a~e the annular ~.oo~a 42~ of the cylindrical n.~."~er 42B in order to securely fasten cap 4~0 to the cylindrical ".~.ub~,~ 462 of the oval cannula apparatu~ 400. Cap 480 contains interior wall6 470 that form an interior openin~ 472 in cap 25 4~0. The interio~ openin~ 472 includes 8 barrier w~ll 474 plac~d ~G.~u,l~ally to ~nd ~pacecl apart from the top portion 4B~ of csp 4~0.
Barrier wall 474 is co~-r~ d to and is part of th~ inbrior w~lb 470 of cap 460 and creabs an upper ~ be~ 476 w~hin ~ in~ or openin~ 472 of cap 460. Th~ barri~r wall 474 1,.~-. ts the outfbw 30 of fluid throu~h the fir8t openln~ 428 wl~n ttl~ irri~ation d~ce ~s placed through openin~ 466 in the top portion 4~2 of ths cap 4~0.
W O 97/40878 PCT~US97/07435 In a pr~ferred ~rnbo~ nl, bamer wall 474 can contain ~ small l-o,~orltal cut for ca~e in ins~rtin~ the i..is~on device through the c~p 4~0. When a clo#d i,-~tion ~yst~m i~ desir~d, the ir~-~tiul, device i8 in~rt~d throu~h openin~ 4~6 and bsrrier wall 474 of cap 5 460 and i6 plao~d into ~e continuou~ channel 417 of elon~a~d tube 402. A su~tion devioe, known to one skilled in the art, is connc ted to valve 432 for suctionins fluid out of the sccond openin~ 428 and throu~h valve 432. Thus, when c~p 4~0 is attached to the cylindrical "-e.,ll~_r 426, the oYal cannula apparatus 400 allows for a 10 closed i-,~hi~r, system wherein ffle fluid is int~ d into the first openin~ 4~8 ~nd circulate~ ~rou~ll tho conffnuous d~ann~l 417, out the distal end 410 of ebngat~d tub~ 402 and into ~e o~rdtin~ s~e and up and out the ~econd openin~ 430 and the valve 432 by means of the suction de~i~ce connected to valve 432. When the 15 irri~ation sy~tem i~ not required, the sealin~ cap 4B0 is ._h.~.v~.d from the cylindricsl .,.~ Lcr 42~ and the sur~ical instrumerts and vi~An~ de~ are in~erted throu~h th~ hr~t opening 42B and down the elongated tube 402 h order to p~ffDrn~ the sur~ical di~c ~ruc The ~uide 300, th~ elo"y..t-_d ".~ I,er 350 and the oval cannula apparatus 400 are p~ferably formed from a biocon~tible m~brial 8uch a~ stainless 8teel or ~ustinitic stainless steel.
Wnen ~e oval cannula 110 or the oval cannula assembly 200 25 is used in a percubnoous sur~ical disc procedure, uniportal access to the intervertebral disc space i~ established by ~dYancin~ a ~uidewire 10 throu~h the skin of a ~atic~,t'~ back posterolaterally underflou~scopic ob~enration unffl th~ ~uid~wir~ 10 contac~
ea~_. ior ~ ddo of the annulus fibrosis of th~ hemiatsd 30 disc. The cannulated obtur~tor 20 is pass~d o~er thc ~uideHllre 10 until th~ distal end of ~e cannulated obtu~tor 20 wllh_b the W O 97/40878 PCT~US97/07435 l su~ace of the annulu~ fibrosis of the hemiated disc (Fi~.
19). Therea~br, ~ c~nntJlatBd obturator 20 (Fb. 2), havin~ a lumen with a diameler 51i~ ~ lar9er than that ~ the ouidewire 10, 18 pa~sed over the ~uidowirs 10 until the cannulated obtur~tor 20 S ~, ~b the extemd ~;urf8ce ~f the annulu~ fibrosis of the hemi~t~d d~c. The remov~l of the guid~wire 10 at this point is opffonal. An acoes~ cannul~ ~Oa (Fb. 3), ~uibbiy of sbout 0.2~ in. (O~OS~n) oubr dbmet~r snd having ~ dd~ons 31 of 10 mm, i~ then ps~cd ove~ the csnnulated obturator 20 and ~ nced to th~
10 extem81 surfaoe of the annulus fibro6is. At this point, the ~uid~wire 10 is remov~d if not prev oudy remov~d. The inner diameter of thQ
acoes~ cannula 30a 18 sked to closely M over the cannulatsd obturator 20. The cannulsted ob~rator 20 is then remoYed, and a 3 mm or 5 mm trephine 0,0 (Fi~. 4) is introduc~d throu~h the access 15 c~nnula 30a. The trephine 40 has a pluralit~ of ~aw te~th 40a or other cuttin~ IllC..~ . The ~ephine 40 is advanced into the annulu~ af t~e disc, with rotation, creatin~ an annular f~nes~ation (that i8, a bore) through the annulu~ fib~osis into the nucleus. The trephine 40 is then removed.
Thc cannulated obturator 20 is .~ uduced into ths acce~
cannuls 30a and passed into the f~no~t,lation of the annulus.
Fluoroscopic ~uidsnc~ may b~ utilized. The acoeas cannula 30a is then removed. Guide 300 is placsd o~r the cannulated o~turator 25 20 with the o~Jal bor~ 308 of guide 300 sllowing for th~ insertion of the elongahd .,~ernber 350 through guide 300 and pbcin~ the ~longsted ~ bu 350 in n~n~ rehtionship with the cannulshd obtur~tor 20 (Fi~. 20). The nesbd cannulste obtu~tor 20 and elongated memb-r 350 fill the openln~ of ~e oYal bore 308 of guide 30 300 and create ~n a~sembly that has a generally oval cr~ection.
The bpered end 3~2 of the ehngat~d ",~.,lber 350 ~llow~ X to be easily in~d into th~ back of the patient and lo be easily wed~d into th~ dlse, alon~ the side of the obturator 20.
The ~uide 300 is removed from thc ns~t~d cannul~bd 5 obturator 20 and elon~abd ll~~ ar 350 and thQ ov~ nnul~ 110 or oval csnnula ~pparatus 400 is slid down~rdly ov~r ths nesbd cannulated obturator 20 and the elon~abd l~r.lb0r 350 tFig. 21) with the distal end 410 of the oval cannula appar~tus 400 or ~ oval canula 110 bein~ inserbd into the annulus of the disc. Th~
10 c~nnulaS~ obturator 20 and elon~ated n~a..~ber 350 are r~ G~_d from the oval c~nnula 110 or oYal cannula ~ ,z.~ 400 and the dbG and the sur~ical procedure is prefonned by introducing both the sur~ical instruments and/or the viewin~ apparatus into th~ oval Gannula 110 or oval cannula apparatus 400 (Fi~. 22). If a clo~d 15 ;.~ dt;~ll system is desired, the se~ling cap 460 can be plaoed over the ~rlindrical m~ ber 426 wi~ the i~ig~tion device bein~ plaoed throu~h the cap 4~0. A suc~on devic~ Is appli~d to valYe 432 which ~ill provide for a continuous flow of fluid fr~m the fir~t openin~ 42~, throu~h the c1~ ~J tube 402 and out the second openin~ 430 20 and valvc 432.
It should be U~ .s~DG~I that thue can be impro~ements and .,-Gdifications made to the embodiment~ of th~ invenUon described in detail above without dep~rtin~ from the spirit or scope o~ the 2~ invention. a~ set hrth in the ~,..~anyin~ claims.
.
Claims (31)
1. An apparatus for use in a percutaneous surgical disc procedure wherein the disc has an annulus, comprising:
a) an oval cannula having an elongated tube with an inner bore, an outer surface, and a transverse cross section that is defined by an X axis and a Y axis, wherein the X axis dimension is greater that the Y axis dimension so that the bore has a generally ovoid shape, the elongated tube having proximal and distal ends;
b) the inner bore being sized and shaped to allow an obturator and an elongated member to fit inside the inner bore when the obturator end elongated member are adjacent to one another and form an assembly with an oval cross-section;
c) the oval shaped bore of the oval cannula enabling a user to insert more than one instrument at a time into the bore when the obturator and elongated member have been removed from the oval shaped bore.
a) an oval cannula having an elongated tube with an inner bore, an outer surface, and a transverse cross section that is defined by an X axis and a Y axis, wherein the X axis dimension is greater that the Y axis dimension so that the bore has a generally ovoid shape, the elongated tube having proximal and distal ends;
b) the inner bore being sized and shaped to allow an obturator and an elongated member to fit inside the inner bore when the obturator end elongated member are adjacent to one another and form an assembly with an oval cross-section;
c) the oval shaped bore of the oval cannula enabling a user to insert more than one instrument at a time into the bore when the obturator and elongated member have been removed from the oval shaped bore.
2. The apparatus of claim 1, further comprising a collar portion with a longitudinal axis, a transverse axis, and upper and lower surfaces, longitudinal opposing side walls positioned between the upper and lower surfaces along the longitudinal axis, and transverse opposing side walls positioned between the upper and lower surfaces along the transverse axis, the collar portion having first and second end with the elongated tube extending through the collar portion from the lower surface to the upper surface proximal to the first end of the collar portion.
3. The apparatus of claim 2, further comprising an elevated cylinder extending from the upper surface of the collar portion in alignment with the elongated tube forming a first opening and a continuous channel from the opening of the elevated cylinder through the distal end of the elongated tube.
4. The apparatus of claim 2, further comprising a valve extending outwardly from the transverse opposing side wall at the first end of the collar portion, the valve forming a second opening communicating with the continuous channel of the elongated tube.
5. An apparatus for use in a percutaneous surgical disc procedure wherein the disc has an annulus, comprising:
a) an oval cannula having an elongated tube with an inner bore, an outer surface, and a transverse cross section that is defined by an X axis and a Y axis, wherein the X axis dimension is greater that the Y axis dimension so that the bore has a generally ovoid shape, the elongated tube having proximal and distal ends;
b) a collar portion with a longitudinal axis, a transverse axis, and upper and lower surfaces, longitudinal opposing side walls positioned between the upper and lower surfaces along the longitudinal axis, and transverse opposing side walls positioned between the upper and lower surfaces along the transverse axis, the collar portion having first and second ends;
d) the elongated tube extending through the collar portion from the lower surface to the upper surface proximal to the first end of the collar portion;
e) an elevated cylinder extending from the upper surface of the collar portion in alignment with the elongated tube forming a first opening and a continuous channel from the opening of the elevated cylinder through the distal end of the elongated tube;
and f) a valve extending outwardly from the transverse opposing side wall at the first end of the collar portion, the valve forming a second opening communicating with the continuous channel of the elongated tube.
a) an oval cannula having an elongated tube with an inner bore, an outer surface, and a transverse cross section that is defined by an X axis and a Y axis, wherein the X axis dimension is greater that the Y axis dimension so that the bore has a generally ovoid shape, the elongated tube having proximal and distal ends;
b) a collar portion with a longitudinal axis, a transverse axis, and upper and lower surfaces, longitudinal opposing side walls positioned between the upper and lower surfaces along the longitudinal axis, and transverse opposing side walls positioned between the upper and lower surfaces along the transverse axis, the collar portion having first and second ends;
d) the elongated tube extending through the collar portion from the lower surface to the upper surface proximal to the first end of the collar portion;
e) an elevated cylinder extending from the upper surface of the collar portion in alignment with the elongated tube forming a first opening and a continuous channel from the opening of the elevated cylinder through the distal end of the elongated tube;
and f) a valve extending outwardly from the transverse opposing side wall at the first end of the collar portion, the valve forming a second opening communicating with the continuous channel of the elongated tube.
6. The apparatus of claim 5, wherein the elevated cylinder has an outer surface that includes at least one annular groove.
7. The apparatus of claim 8, wherein the outer surface of the elevated cylinder includes a plurality of grooves.
8. The apparatus of claim 5, wherein the valve can be opened and closed by the user to allow controlled outflow of a fluid.
9. The apparatus of claim 8, wherein the valve is manually operable.
10. The apparatus of claim 5, wherein the oval cannula apparatus includes a sealing means for sealing the first opening in order to prevent the outflow of fluid through the first opening, the sealing means being formed to allow a fluid inflow device to be inserted through the sealing means while preventing the outflow of fluid through the sealing means.
11. The apparatus of claim 5, wherein the elongated tube and the first and second openings of the oval cannula allow for the introduction of a fluid through the first opening and the continuous flow of fluid through the elongated tube and out the second opening, providing an irrigation system for the percutaneous surgical disc procedure.
12. The apparatus of claim 5, wherein the elongated tube generally has a Y axis dimension of between about 3 to 11 millimeters and an X axis dimension of between about 5 to 22 millimeters and a length of between about 50 to 250 millimeters.
13. An apparatus for percutaneously performing surgical procedures on the spinal region of a patient, comprising:
a) a obturator for advancing through a percutaneously created fenestration of the annulus of the disc of a patient;
b) an elongated member;
c) the combination of the elongated member and the obturator having a generally oval shape upon assembly when the obturator is placed adjacent to elongated member;
d) a guide for guiding the obturator and elongated member together in an adjacent position;
e) an oval cannula having a generally oval shaped bore that can removably receive the obturator and elongated member assembly, the oval shaped bore enabling a user to insert more than one instrument at a time into the bore when the obturator and the elongated member have been removed from the oval shaped bore.
a) a obturator for advancing through a percutaneously created fenestration of the annulus of the disc of a patient;
b) an elongated member;
c) the combination of the elongated member and the obturator having a generally oval shape upon assembly when the obturator is placed adjacent to elongated member;
d) a guide for guiding the obturator and elongated member together in an adjacent position;
e) an oval cannula having a generally oval shaped bore that can removably receive the obturator and elongated member assembly, the oval shaped bore enabling a user to insert more than one instrument at a time into the bore when the obturator and the elongated member have been removed from the oval shaped bore.
14. The apparatus of claim 13, further comprising means for withdrawing fluid from the oval shaped bore.
15. The apparatus of claim 14, further comprising valve means for controlling the flow of fluid from the oval shaped bore.
16. The apparatus of claim 13, wherein the oval cannula further comprises an enlarged fitting at a proximal end of the oval cannula.
17. The apparatus of claim 18, wherein the enlarged fitting is sized and shaped to engage a sealing member, the sealing member being formed to allow a fluid inflow device to be inserted through the sealing member while preventing the outflow of fluid through the sealing member.
18. The apparatus of claim 13, wherein the guide allows for guiding and holding the obturator and elongated member together independently of the oval cannula.
19. The apparatus of claim 18, wherein the guide means comprises a body with an outer surface and a bore that closely conforms to the assembled obturator and elongated member.
20. An apparatus for percutaneously performing surgical procedures on the spinal region of a patient, comprising:
a) means, including an obturator having a lumen and an outer surface, for forming and advancing into a fenestration formed in a patient's back and spinal disc;
b) an elongated member having a longitudinal groove that is sized and shaped to receive a portion of the outer surface of the obturator, the groove being so shaped in transverse cross-section that a longitudinally extending portion of the obturator can occupy and nest in the groove;
c) the combination of the elongated member and the obturator having a generally oval shape upon assembly when the obturator closely fits into the groove; and d) an oval cannula that has a generally oval shaped bore that can removably receive the combination of the elongated member and the obturator, the oval shaped bore enabling a user to insert surgical instruments into the bore during disc surgery.
a) means, including an obturator having a lumen and an outer surface, for forming and advancing into a fenestration formed in a patient's back and spinal disc;
b) an elongated member having a longitudinal groove that is sized and shaped to receive a portion of the outer surface of the obturator, the groove being so shaped in transverse cross-section that a longitudinally extending portion of the obturator can occupy and nest in the groove;
c) the combination of the elongated member and the obturator having a generally oval shape upon assembly when the obturator closely fits into the groove; and d) an oval cannula that has a generally oval shaped bore that can removably receive the combination of the elongated member and the obturator, the oval shaped bore enabling a user to insert surgical instruments into the bore during disc surgery.
21. A percutaneous surgical disc procedure, comprising the steps of:
a) percutaneously entering the back of a patient in a posterolateral position with an obturator having a lumen;
b) advancing the obturator through a percutaneously created fenestration of the annulus of the disc;
c) placing a guide containing a generally oval shaped bore over the obturator;
d) inserting an elongated member through the bore of the guide and into the back of the patient into the percutaneously created fenestration of the annulus of the disc, the elongated member having a cross-sectional shape such that when placed adjacent to the obturator, forms an assembly having an oval cross-section;
e) removing the guide from the obturator and elongated member assembly;
f) sliding an oval cannula having a bore with an oval transverse cross-section and proximal and distal ends, downwardly over the obturator and elongated member assembly;
g) inserting the distal end of the oval cannula into the disc;
h) removing the obturator and elongated member assembly from the bore of the oval cannula and the disc; and i) introducing multiple surgical instruments into the oval cannula to perform the surgical procedure.
a) percutaneously entering the back of a patient in a posterolateral position with an obturator having a lumen;
b) advancing the obturator through a percutaneously created fenestration of the annulus of the disc;
c) placing a guide containing a generally oval shaped bore over the obturator;
d) inserting an elongated member through the bore of the guide and into the back of the patient into the percutaneously created fenestration of the annulus of the disc, the elongated member having a cross-sectional shape such that when placed adjacent to the obturator, forms an assembly having an oval cross-section;
e) removing the guide from the obturator and elongated member assembly;
f) sliding an oval cannula having a bore with an oval transverse cross-section and proximal and distal ends, downwardly over the obturator and elongated member assembly;
g) inserting the distal end of the oval cannula into the disc;
h) removing the obturator and elongated member assembly from the bore of the oval cannula and the disc; and i) introducing multiple surgical instruments into the oval cannula to perform the surgical procedure.
22. The percutaneous surgical disc procedure of claim 21, wherein the multiple surgical instruments include a viewing means for viewing the surgical procedure.
23. The percutaneous surgical disc procedure of claim 21, wherein the oval cannula includes an elongated tube and means for introducing a continuous fluid flow through the elongated tube for providing an irrigation system for the percutaneous surgical disc procedure.
24. The percutaneous surgical disc procedure of claim 23, wherein the means for introducing a continuous fluid flow includes first and second openings that allow for the introduction of a fluid through the first opening and the continuous flow of fluid through the elongated tube and out the second opening.
25. The percutaneous surgical disc procedure of claim 24, wherein the first opening is formed to accept a sealing means that enables fluid inflow while preventing the outflow of the fluid.
26. The percutaneous surgical disc procedure of claim 24, wherein the second opening includes a value that can be opened and closed by the user for controlling outflow of the fluid.
27. The percutaneous surgical disc procedure of claim 21, wherein the guide is in the form of a solid cylinder having opposing sides and a centrally located through bore, the bore being generally ovoid in shape for allowing the obturator and elongated member assembly to nest in relation to each other when the obturator and elongated member are inserted through the guide.
28. The percutaneous surgical disc procedure of claim 27, wherein the opposing sides of the solid cylinder including indentations that enable a surgeon's fingers to firmly grip the guide.
29. The percutaneous surgical disc procedure of claim 27, wherein the solid cylinder has an outer surface that includes serrations over a portion of the outer surface.
30. The percutaneous surgical disc procedure of claim 21, wherein the elongated member has a generally crescent-shaped cross-section and proximal and distal end portions and a longitudinal groove that is sized and shaped to cradle the obturator.
31. The percutaneous surgical disc procedure of claim 30, wherein the distal end of the elongated member is tapered to allow insertion of the elongated member into the back of the patient and into the percutaneously created fenestration of the annulus of the disc.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US08/643,056 US5762629A (en) | 1991-10-30 | 1996-05-02 | Oval cannula assembly and method of use |
| US08/643,056 | 1996-05-02 | ||
| PCT/US1997/007435 WO1997040878A1 (en) | 1996-05-02 | 1997-05-02 | Oval cannula assembly |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2253801A1 true CA2253801A1 (en) | 1997-11-06 |
Family
ID=24579184
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002253801A Abandoned CA2253801A1 (en) | 1996-05-02 | 1997-05-02 | Oval cannula assembly |
Country Status (6)
| Country | Link |
|---|---|
| US (1) | US5762629A (en) |
| EP (1) | EP0904123A4 (en) |
| JP (1) | JP2000509305A (en) |
| AU (1) | AU723126B2 (en) |
| CA (1) | CA2253801A1 (en) |
| WO (1) | WO1997040878A1 (en) |
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- 1997-05-02 WO PCT/US1997/007435 patent/WO1997040878A1/en not_active Application Discontinuation
- 1997-05-02 AU AU28243/97A patent/AU723126B2/en not_active Ceased
- 1997-05-02 JP JP9539260A patent/JP2000509305A/en not_active Ceased
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| AU723126B2 (en) | 2000-08-17 |
| EP0904123A4 (en) | 2000-03-29 |
| US5762629A (en) | 1998-06-09 |
| EP0904123A1 (en) | 1999-03-31 |
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| JP2000509305A (en) | 2000-07-25 |
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| Date | Code | Title | Description |
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| EEER | Examination request | ||
| FZDE | Discontinued |