CA2102664A1 - Spinal stabilization system and improved method - Google Patents
Spinal stabilization system and improved methodInfo
- Publication number
- CA2102664A1 CA2102664A1 CA002102664A CA2102664A CA2102664A1 CA 2102664 A1 CA2102664 A1 CA 2102664A1 CA 002102664 A CA002102664 A CA 002102664A CA 2102664 A CA2102664 A CA 2102664A CA 2102664 A1 CA2102664 A1 CA 2102664A1
- Authority
- CA
- Canada
- Prior art keywords
- affected
- vertebrae
- recited
- vertebra
- drill guide
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
- A61B17/7049—Connectors, not bearing on the vertebrae, for linking longitudinal elements together
- A61B17/7052—Connectors, not bearing on the vertebrae, for linking longitudinal elements together of variable angle or length
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
- A61B17/17—Guides or aligning means for drills, mills, pins or wires
- A61B17/1739—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body
- A61B17/1757—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body for the spine
Abstract
ABSTRACT
A spinal stabilization system for fixing affected vertebrae having anterior and posterior aspects. The system comprises a plurality of rods or plates disposed over the affected vertebrae, at least one rod or plate disposed anteriorly and at least one disposed posteriorly, and a plurality of bolts and nuts extending laterally through the affected vertebrae and attached to the rods.
A method for installing a spinal stabilization system to fix vertebrae, comprising the steps of: exposing the spine anteriorly and posteriorly to reveal a level of vertebrae, inserting a pair of beam means through the vertebrae; repeating the exposing and inserting steps for a next level or vertebrae; disposing column means over the anterior and posterior aspects of the two levels of vertebra; and connecting the ends of the beam means at each vertebrae level to the column means.
An alignment fixture for assisting in the installation of a spinal stabilization system, comprising, first and second arms, each arm having first and second ends, a drill guide means and an aiming pin. The drill guide means and aiming pin are fixedly connected to the first end of the first and second arms, respectively. The second ends of the first and second arms are connected in sliding engagement with one another. The first and second arms, the drill guide means and the aiming pin are all disposed in the same plane.
A spinal stabilization system for fixing affected vertebrae having anterior and posterior aspects. The system comprises a plurality of rods or plates disposed over the affected vertebrae, at least one rod or plate disposed anteriorly and at least one disposed posteriorly, and a plurality of bolts and nuts extending laterally through the affected vertebrae and attached to the rods.
A method for installing a spinal stabilization system to fix vertebrae, comprising the steps of: exposing the spine anteriorly and posteriorly to reveal a level of vertebrae, inserting a pair of beam means through the vertebrae; repeating the exposing and inserting steps for a next level or vertebrae; disposing column means over the anterior and posterior aspects of the two levels of vertebra; and connecting the ends of the beam means at each vertebrae level to the column means.
An alignment fixture for assisting in the installation of a spinal stabilization system, comprising, first and second arms, each arm having first and second ends, a drill guide means and an aiming pin. The drill guide means and aiming pin are fixedly connected to the first end of the first and second arms, respectively. The second ends of the first and second arms are connected in sliding engagement with one another. The first and second arms, the drill guide means and the aiming pin are all disposed in the same plane.
Description
/ ` . 2 1 ~ 2 ~
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SPl`i~L S .~3TL ~ J.~, SV 5~ '~' A~;i3 T'~ C~ ~Trl'S,~ J
FI.~LD OF T--~3 .~ YTTO~
This apolicati^n is a con~inllat on-in-pa-t of appl ca~ion Seri21 ~lo. 07/973,23-~, riled ~lov~ 9, 199~.
This invenSio-. -el2_eS to 2 system of sp,nal st2bili3a.ion a met~od for f~cing vertebra- and an aligr~n' fixture used ta install said sys'em.
X(-,P.OlJ~li) o~ T'IE INV~:~ITIO~
Spinal stabilization is a common methcd to treat pathological processes in tne spine and/or sacrum. Stabilization means eliminating movement ~etween adjacent vertebrae, and the_efors restoring structu-al intsgrity to the spine. Stabilization is achieved by f~sing affected verteb.ae to each other. The technical objective of stabilization ~s to achieve a solid bony fusion. This is usually done by creating a ~.racture situation" between adjacen'.
affected vertebrae, and fixating them mechanically with metal implants. Once fi~ation is accomplished, bone healing occur~, c-eating a fusion mas~, which re?;aces the s~anned verteb-ae wi.'a ons solid piece of bone. The tas~ of the implanted inst_umentation is to hold fractured or injured bone surfaces rigidly toge_he-until healin~ and fusion occur.
j - - 21~26~
Without bcn- fus cn the s abili~y of a mechanical ccn3t-uc~
is ina~eql2te T;le p-e_ ~ sur~-cal 5~a'e oE t~ a-. 15 a `~
circ~fe-ential lante=io- ard post-_ior) aop_oacn, to .ebuild ~lle ante-ior and the po3tQ-io- mechanical sesmsnts of the spinal colu:-.n sepa_ 2 _el~.
' ~ . '.:
The disadvanta~s3 o- the circ~mfa--ntial zoo cach æ-e sev~--al:
too much ~etal in t~o diff-_ent se.s of devices th- cons _~ct may fail to promo.e stres3 sharing and may c-sate st~ess shieldins; znd the construct ma~ be too st_ong fo_ osteogen c bone a~d th-ls cut th_ou~ it. -~' . `:,.' ,. .:
A major problem of the present day approach is what to do with - poor quality bone or with spines in which ade~uate attac~ment of the construct to the bone cannot be achieved. ~-S~ ~RY OF THE I~rENTI
The present invention in its broadest aspect provides a -single spinal stabilization system fo_ fixing affected vertebrae having anterior and posterio- aspec.s. The system co~p-ises a plu-ality of substantially risid, elor.sated column ~eans cisposed over the affected vertebraa. At least one of the column means is d~s?osed over the ante-io- aspec o~ the affected vertebrae. ~t least nnothsr of the col~ ean3 is di~pcsel over the posteric_ aspect o~ the af4ectsd ~er~eb- e. ~ plu~allty of substant1ally 2 ~ -~
' ' '-''"".' ' :''~
2~2~
rigi:l, elonsatod oea~ ~-ars which e~ctend thr_uq;. the_~ a r~ ~C t S
ve-teb-ae a-e attached to the column ~ear.,.
i Additionally, tne o-esent in~ien'ion ir. one of its b_oad?s as?~c-s providas a met!~od of ins':alling a spinal sta~ at o::
sys~e~ to ~ix af ected ~e-te~_ae. The s'eps co~?ri~e e:cposinq tha s?ine anteriorl~ and posts_io-ly at the level of ths affected ve-tebra, inse-ting or.e or a pair of beam means through t;^e affected vertebr2, repeating the exposing and inser.ins stapi fo-a ne:ct level of ~ertebra, disposing column means ~ver tne anterior and posterior asp~cts of the two lev21s of affected ve-te~ra~, and connecting the ends of the beam means at each affected vertebra . .
: level to said column means.
;....... ~ -. ;-.~... - . .
: '~? ~
'' ' ;'`'. :; ' ' - ' . . , Another feature of the pres2nt invention in its broad2s' aspect ls to provide an ali~nmen~ fi~cture which accurately place the elements of the spinal stab-lization system. The alignmer.t fixture comprises a first and second arm, each arm haqing first and ~econd ends, a drill guide means and an aiming pin. The arm pin and drill guide means are fi~edl~ connected to the first end of sa'd _i_st and second a~as, r~sp-cti~s'~ ha second er.ds o_ sa~d first and second arms a-e connected in sliding enqaqemen- with ona anothe-. ~he first and second arms, the drill guide means and the ai~inq pin are all disposed in ths same plane.
2 ~
.
Fu-the~ore, tn-~ present inv~r.tion in st-ll ano_'le- c_ L 3 broadost aspnc_s, p.-C-Jide3 a met~od of ins-a lins a s?t.al stabili~ation s~fstem to fi:~ the vert-brae o_ a pa~le~t usin~ t~.e ~ -;
alignins fixture which has a d_ ll guid- at one end and an aiminc;
pir. at tne othe- end. This mo'~.od c3r~:p-i_es the steps of:
.
a. surgically e~po~ing 1wo adjacer.t levels o~ afEe-t vertecrae ante-iorl~f and pos~e_lo-l~
~' b. cleaning out the con_sr.'s of the pedicle portions of the adjacent levals of affected ve-tebrae so as to pen~it sufficient movement of tha d_ill guide within the cleaned C'lt pedicle portions -- so that the aiming pin can be positioned at the desired exit points on the anterior aspect of the adjacent levels of affe~,ed vertebrae;
. , ..... . - -: ~ .
. . . ~ . - .
. - . :. . ~ .: :
c. inserting the driil guiae within the cleaned out psdicle portions of the adjacent levels of affected ve-tebrae;
', ' ~ . ~
d. positioning the aiming pin at the desired exit points on the an~erio~ aspect of the adjacent levels of affected vertebrae;
.
e. inserting a drilling means within the aligned drill guide dis~osed within the edicle por'ions of the adja_er.t le~els of affected vertebrae,. an~
::, 21~2t~6~
~ . drillinq holes t'n~ouSI tne aliqned drill su'c!_ in~o tho a.f-cted ~e~.ebr~e to the de~lre~ e~ points.
Th~ p~incipal c~ject oE the inven'ion is to c-eata a r_gi-struct~-e that wil' 2110'~ s~cces~fll bonv fusion b~ usin~ a ne conce~t ccDbin_ng anterior an~ 2oste~ior constructs into a S.' :'q7 ''`
unitar~ structu_e 2ch_evsd a' a single su_gicai sitting.
Another object of the inven';ion is to p-ovide a mc_~s rlsid construc. or cage in which bone and bone sraft can heal to a solid fusion.
-A furthe- object of the invention is to provide an improved solid construct, in which stress sharing is better distributed between anterior and posterior elements.
; . - . ' An additional object of the invention is to provide an improved method and an aliqnment fi~t~re for installing such construct or cage.
- .;
:
S ' ~
'"' ' . , ' ~ ~.
2102~g~
B~ F DE:iC?~IPTIO ~'T OF T~ D~ ^S ~ ~ -''` ''' :
FIG. 1 is a ~erspective view of an individuai ve-tebra showir.J .` ~.
the th.-eaded apertures which 2-2 fo~d by inse~~tic~. of a pai- 0 nu~ and bol. po_'icns of _h- ore:,en~ inven'icn;
: ,. ~. .
FIG. 2 is a pe~spectivs via~ of two vertebras and a in'e-verte~ral dlsc shcwing th~ threaded apertureâ w;~ich a-e fo-ms~ .
by insertion of two pairâ of nut and bolt portions of the pres3n~
inven.ion;
FIG. 3 is a pers~ective view of the implanted spinal . ~:~
stabilization system of the present invention;
FIG. 4A is a perspective view of a preferred embodiment of a single unassembled bolt and nut portions of the preser.t invention;
"'', FIG. 4B is a perspective view of a preferred embodiment of another slngle unassembled bolt and nut portions of the present invention for use with smaller vertebrae;
; ' ' ' ' ,.'. ,-FIG. 5 iS a perspective view 0.,c a single assembled bolt and nut portions attached at its ends to rods by tie wires; -~
. . .~, .
FIG. 6 is a pe~spective v~ew of an alignment fi~ture usecl Po~-installing the spinal stab'lization s~stem;
6 .~ ;
2 1 0 2 6 6 Lll ' FIG. 7 is a hori70ntaL o~ OJ._SeC;-iCra1 V~e,/ oE-tile p~tier.:: 2.`;~
spine L~nd a side vie:~ of th~ allgr.~.er.t fi~ u~ in it, inat;lLLa~
position adjacent the poste-io= and an~erio- as~ects of th:-~ spin-;
and FIG. 8 i5 a pe~soecti~/e vie~ of t~.e patier.~ ~lit~ 2 p^S~'-i`-_ incis~on an~ the align~er.' ~xt~re po3ition-d in t~e ins'allation position.
' ,: ' ' - ~ ' . . ... , ,- : ... :
.', .,,. . ' ~' .. ,~. , . ~ .
. . .
: ''' ' '`' ~ f 21~2~4 :. .. :.
C~C~<r?~Tv~l o~ ~;~ T~ ~
.' ~' '.-';
Th~ p-e~ d embsdi~ n' o~ the s~inal s'a~ilisa'ion or fixaticn system for t-ea.ir.~ pa'holcslcal p-oces3es o- rix-.
affoct~ verte,~-a~ hav n-, an-o-- o- an' pos'er-o- ,.s~ec generAlly desisnatod b-r the reference charac';e= 1 ,znd ts compl-te asse.~bl~ is shcwn in FIG. 3. Ar. e:~mpl~ of a patholcs-cal p~cca~
in the spins having a~fect-d ver'eb~2e is the co~on p-ola?s~
inver'ebral cisc; the ve-teb-ae adjacen' sai- disc are the a.~ected verteb-ae. The s~stem comprises con-;entional, colu~n m2ans 3 three in num~er, each of which is a rigid elonsated rod or plate, `~
one of which is disposed ove_ the anterior aspac' of at least two ~ -~
such affected vertebrae, and as shown in this figure two ve_tebrae, and two of which rods are disposed over the poster-or aspects of the two ver.ebrae. These rods 3 a.e attached to beam means S, four in number, each of which is a rigid elor.gated bea~ means which extends through indlvidual vertebrae. It should be noted however that t~o or three or more rods cou~d be used. Referring specifically to FIG. 4A, which illustrates in detail a single beæm means S which comprise~ a pedicle bolt section 7 and a nut section 9, each of whlch sec~'ons are adapt-d to join each othe- w:~en ~ev are inserted th~ough a vertebra when 'he sys~em 1 is installed.
Each of these bol~ and nut sec_ions 7 and 9, respectivel~, preferably have an ap~r ~re o~ car.nulation 11 axtendin~ along '::a longitudinal a;ces the-eof; such cannulation 11 i3 howeva_ op'ional.
Each o. the bolt and nut sec'~or.s 7 and 9, resDectivel~, have a 8 :-. .
. ~
2~2~
cu~t~ng end pe~ 13 a~.d 15, and 2 front po__ion 17 and 19, having a cylind~ic21 Der' ?hery 2! and 23, respa~ti~rely, which is exte_nally thr2ade~' with cutt~ns ed~s. The aperture 11 cf the n~' se_. on 9 has a c~lindrical pe~i~he-y which is inte-nall~ threaded fc~ eceiving and ensa~in~J the threads or tha f_cnt porti~ 17 of the bolt section 7. The hol' secticn 7 also c~mpris2s a m-ddlc po_tion 25 having a cylind-ical pe_i~`ne-y 27 which i9 e:c.grnally th-eaded with cuttins eci~es; e~ual diamete-s a_e used fo_ th-middle and fron. portions 25 and 19, respec.~val~. The middle portion 25 is connscted to a smooth sna.t po_~ion 28. Each of ths bolt and nut sections 7 and 9, respectivel~, have a rsar portion or encs 29 and 31, res~ectively, for attachins the ends of said nuts and bolts 7 and 9, respec~ively, to said rods 3, as is best shown in FIG. 3. These ends or attachments 29 and 31 are shown as : . ~
closed and open attachments, respectively, in FIG. 4A, whereas one of said beam means S is shown having closed attachments at both ends; after the attachments ars installed a staple or a plate (nct shown) can be disposed beneath the attachments.
Another preferred embodiment of the beam means 5 is shown in FIG. 4B and is utilized when the system is used for fixins smaller vertebrae. Its middle portion 33 comprises a smooth sh~ft por'ion, the diamete_ of which is sli~htly less than the diameter of the threaded portion 21 of the front po-ticn 17. Its at~achments ~9 and 31 are o4 the closed type.
. .
9 , ~' ' ', .
~ ` 2~2~g~ -:
The p-e'o-.od em~odi.~e-.t OL- the al-grl~en f ;:~u~Q u_ac assistir.g in the installa'io.. o the p-ov-ous'y coscr-_~d ~-~^.a_ sta~ ation syâ'e~ 1 is gene~llv dosigna.ed b~ 'he r~.eren ~
cha-acto~ 100 and its cc~lete asse~blv is shown in FIG. 6. The alignnen~ fixtu_o 100 COm?-iSQ3 L-shar~d first ar.d secon~ arm3 1(``
ar.d lOt, respectivel~, d_- l su.d-~ mear~ lOo and an aim ng pin 108, all of which a_e ~iscos~d in the sa~e plar-. Each of th~o first and second arms 102 and 104, respa_~-vely, hzv~ fi-s. and sec_nd er.c'_~
110, 112 and 114, 116 respectively. Additionall-y, each of th2 first and second arms 102 and 104, respec'ively, ha-te irst and sccon~ stra1ght po_tions lla, 120 ~nd 122, 124, -es~ctiv~l~. The - ~ .
first portions 118 and 120 o' the firs' 2r.d se~ond arms 102 and - -104, respectively, are disposed opposite one another as are thei--first ends 110 and 112. The second portion 122 is U-shaped in .. ..
cross-section and has a narrow slot 135 extending across it length in side walls 136. A slide 138 extends through the slots 135 and is fixedly attached to the second end 116 of the second por.ion 124. Accordingly, ths second portions 122 and 124 of the first and second arms 102 and 104, respectively, are connected in sliding engagement with one another as are their second ends 114 and 116.
The aiming pin 108 and the drill guide means 106 are a~ially aligned and fixedly disposed o~.hosonally cn the fi-st en~s 110 ar.d 112 of the first portions 118 and 120, respecti~tely, of ths first and secor.d armq 10~ and 104, re3pecti~1y. Th~ aimin~ pin 108 i~
gene-ally cylind-ical along its length e:~cepL tha~ _ts inwa_d er.d is conlcally shaoed. Thq d:ill guide means 106 comp~ise3 a hollo~r .~ . . .
- 21~2~6'~
.
tube which e:~tendci inwa_d fo_ moi,' c- it:; ler.g.h and A _e_`. ~..;
com~lQ'el~ thrcu~h thQ -rst en~ 112 Oc t'aa saccn~ a ~~
discuss~d belo.~, thi~ ai.~lrs p n lda and ~'.e ~.--11 guide m~'.n.n: 10 j on thQ firs and secon~l arms 102 ar.d 104, reS~Qc'i-:ely, cf ~h:-align~e?.t fi;ctur~ lOG, will ~a util i7e~ ard dispose~ at th anterior and pos.eriv~ aspects, res~sctively, of tha ve-teb~^ae durins the initial stageis of the in.~ailation o~~ the spir.a: -stabili7alior.syst~:r.;. Such posi ioning is acccmplished bi r.~.ovir.
the slids 130 appropriately therob~ movin~ the s'idins a-r.~s 10~ and lGI forward or bac~ards, untL~ the aimins pin 10~ and ~he drill guidd lOo are p-operly dispossd on the anterio- and 2osterio~
aspec's, rQspectively, of the vertebrae. ~-.
;~ The surgical technique used fo- implanting the preferred ' ;system of the present inven~ion without using the alignment fixture is generally described as follcws (for fixing two levels of affected vertebrae). A portion of the spine i9 surgically exposed anteriorly and posteriorly simultaneously to reveal two levels o' vertebrae, Then one or a pair o' beam means 5 are inserted through an lndividual vertebra; more specifically one or two pedicle bolt sections 7 each shawn as havlng a cannula'ion 11, ar~ insertsd from poste-ior to anterio~ throush the ve-teb=a so as to join i'3 opposite bolt section 7; that is the cannulation 11 of each nut section 9 engages tha ~h-eads on the rront po-tion 17 of each bolt section 7. The rou~ in the vart-brae (FT5.1) can be p_ep2:-ed ov~
a guide wire utiliz'ng a cannula, which requi-es us35e o' ` ` 21~2~64 :: ~
.: .
cannulatec bol. and r.u~ sec.ions. The abo~e de,cribod p-o~du-is 'h~ Apea'od ~o- tSe r.e:~t ~t-r' ~b~al le-~el and th~n th-~_ colu.,n means or rig}d elons2t~d _o~s 3 a_e d~s?osed o~e- tho an~e-io~ and pos~erior as?ects of th- two v~LteD-ae and connected to these rods 3. Mo-e specificallv .he rear po-~ions or ends 29 and 3l, res~ec'ivQl~, of the bcl~ and nut sec~ions 7 ar.d 9, respect~'~el~
are attached to the rods 3. Suc`~ an impl2n.tod s~inal stabili~atio~.
syste~ is shown in FIG. 3. Furth_r aspe^ts of .he present invention are as follows: the cannu'ated pedicle bolt 7 acco~modates a Rirschne- wi-e ("k-wiren) which is used as a pilc~
locator bolt 7 and is poste-io-l~r inse-ted ove- a prope~ly placed ;~
k-wi-e (not sho~) through its central aper~ure and through the pedicie portion of the verte~ra to form a posterior portion of a threaded aperture 35; the nut 9 is sLmilarly inse~t~d over the k~
wire anteriorly through its central aperture to form an anterior portion of the threaded aperture 35 - this aperture 35 is seen best ln FIG. 2.
As seen in FIG. 2 and FIG. 3 the two beam means S in an individual vertebra are disposed therein in di.feren. planes and forQ a triangle in cross section through said beam means 5. Also as seen best in FIG. l, the individual beam means S e~tends throllgh the superior and inferior portions of the same vertebra. Ths ~-wire guids inside th~ beams means S can be replacqd with two tie wires 37 which are th~n twist loc~ed on the rods 3, aq qeen in FIG.
5, afte_ the beam sections S ara in place in the ~-ertebra~ (no1 .
.:
21~2~64 sho~n in said figur~ h~se twis, lcc'c a-tacbm~nts se~Ja to lo~~
the bolt and nct sections 7 an~l 9, -esp~cti~:el~, to th^ rods 3 t-p~evont bac'~-o-'. -~ he i~proved su-gical tec'.-ni~ue use for i~planting the prefer_ed s~stem,o' ths present ir.Jent on is essentially the sa~
as ths a'oredescribsd o-ig nal technique ~:cco?t that the aligr~m-3n`~
fixturs lC0 is used .n th~ initial stases Oc the techniqc~2. ThiJ
improved techniqus ob~tiates the visual sighting requirement in tne ;~
o- ginal techni~cs which is usec to de-te~m-ne th- rout~ in t'..*
ve~te~-ae.
. ' ~
r , Referring now to FIGS. 7 and 8, ths initial stages or steps of the improved technique or process, which occur prior to the , installatio,n of the spinal stabilization system 1 are as follows: ~
a. surglcally exposing two adjacent levels of affected ~' ' verteb~ae; -~
. .~ .
b. cleaning out the contents of pedicle portions of the ' above affected vertebrae, preferably by curetting, so as to permit sufficient movement of ths d-ill guide means 106 (of ths alignment fixture 100) within the cleaned out pedicle portions so that the aiming pin 108 ~of the align~ent fixtu~e 100) can be (late-) positioned at the desi-~d exit points on ,he anterio- asoect oF th abo~e affected verts~rae (these ex;t points conform to the centn.- ' 13 , -' ' :
J ~ .
2 ~
of the e~i. o~er.ing of ape-'ure 35, a~ is seen best in F-~G. qj;
c. ma~ing an incision 130 (FIG. 7) in the lat~-a' aspec~ o~
a patient 132 of sufficien' si-e to pe-mit the a~ing pl-. 10~ and .-. `;
a po-ticn c~ its at.ached a_~ lOq enLry th=oush the incis-.on 13C~
. . .
d. insertir.s the aimin, pin 103 and a porLion oF it5 ~ . `,. ' attached ar~ 102 thrcugh the incision 13~ and positioning th2 aiming pin 108 (by moving first a-m 102 ir.ward using the slide) .-near the ante-ior aspect of one of the a'fected ~ rtebrae; .. ~.
. ~e. insertins the tip of the drill guide means 106 within one `..-.- of the cleaned out pedicle portions of one affected vertebra (first - ................................................................................. ::
level); - , -~
,........................................... f. positioning the aiming pin 108 at the desired exit point .-- . . on the anterior aspect of said one affected vertebrae as is seen . :::
best in F~G. 7;
, - g. inserting the drill bit of a drill 134 (only a portion of which is shown~ within the now aligned drill guide means 106 ~:
disposed within the pedicle porticn of the said one affected :~
vertebra;
h. drilling .an ape_tu~e into and through the said cne affested verteb-a; th-ough said d~ili guide means 106, which 2102~
.
e.~erges at t~e desire~ e~it Foint on th2 anterio_ aspe~'; of 5a' ' ;
ve~teb-a;
i. repeatinq steps e) through h; fo_ the othe- e~cit poir.
on the same affect2d -ie-teb-a;
j. inse-tins a pair of be m r.~e2n~ 5 through tha s~Qe sa'd ~`
affect-d va-teb-a (first level);
~ . re~2ating steps e) through j) for ths sscond lsvel of affecte~ verts~ra;
1. disposing three column means 3 over the anterior and posterior aspects o'f the two levels of affect-d ~er~ebrae; and ....
m. conneçtln~ the ends 29 and 31 of the beam means S at both levels o~ affected vertebrae to the column means 3.
The nut section 9 has a self-tapping bone screw on its exterior aspects as does the bolt section 7. The bolt section 7 of FIG. 4A preferably has a cuttLng edge portion,l3 around the cannulated opening 11 of 2 mm in lensth, an externally threaded front portion 17 of greater than between 10 mm to 30 mm in length, an externally thre~ded mlddle po-tion 25 of between lS mm to 40 n~.~
in length, ~nd a smo~th sha~t port'on 2a of be'ween 20 mm to ~lO n~m in length. The nut section 9 of FIG. 4~ preferably ha3 an . `
~ . ~ ,..-., 2 1 ~ 2 ~
ex--_nall~t th-eade~ r-o~' ,o~tl~n 19 of abou. between 10 ~m to 30 m~ in l~ h, an~ tne aee_tu-e 11 tlereOf has an inte=nal ~ac'l'ne thraad to mo~t the mach~ne th-ead or. ,he tip 13 and front po_~ior 17 o' t~e ~olt section 7. The pitch of t~.e matching mal~ ar.d female tr.-eads are the sa.~e. T~e p-eEer_od ~ate=ials fo~ the bolt a~d nu~ section3 ' and 9, res~ecti~relï, woul~ be Tl-6A~-~';, or ~
si~ilar mz'er'al because o~ its mech~nical stren~th p_ope-tie-~- ~nd co~ros on reqLstancs; other possible materlals could be a hi~J-h strsngth biodegrada`ola pol~me. su_h a3 a high molecular weight PL.
St,linl~ss steel could even be us-d.
Although the present invent-on has been described and illustrated with respect to a preferred embodiment; it is not to be so limited since modiEications and changes aar be made therein which are within the full intended scope of the invention.
.- --, . . - , - .
, .
.. .. . .
~'-` ' ' ' :
, :.
'
" , . .
SPl`i~L S .~3TL ~ J.~, SV 5~ '~' A~;i3 T'~ C~ ~Trl'S,~ J
FI.~LD OF T--~3 .~ YTTO~
This apolicati^n is a con~inllat on-in-pa-t of appl ca~ion Seri21 ~lo. 07/973,23-~, riled ~lov~ 9, 199~.
This invenSio-. -el2_eS to 2 system of sp,nal st2bili3a.ion a met~od for f~cing vertebra- and an aligr~n' fixture used ta install said sys'em.
X(-,P.OlJ~li) o~ T'IE INV~:~ITIO~
Spinal stabilization is a common methcd to treat pathological processes in tne spine and/or sacrum. Stabilization means eliminating movement ~etween adjacent vertebrae, and the_efors restoring structu-al intsgrity to the spine. Stabilization is achieved by f~sing affected verteb.ae to each other. The technical objective of stabilization ~s to achieve a solid bony fusion. This is usually done by creating a ~.racture situation" between adjacen'.
affected vertebrae, and fixating them mechanically with metal implants. Once fi~ation is accomplished, bone healing occur~, c-eating a fusion mas~, which re?;aces the s~anned verteb-ae wi.'a ons solid piece of bone. The tas~ of the implanted inst_umentation is to hold fractured or injured bone surfaces rigidly toge_he-until healin~ and fusion occur.
j - - 21~26~
Without bcn- fus cn the s abili~y of a mechanical ccn3t-uc~
is ina~eql2te T;le p-e_ ~ sur~-cal 5~a'e oE t~ a-. 15 a `~
circ~fe-ential lante=io- ard post-_ior) aop_oacn, to .ebuild ~lle ante-ior and the po3tQ-io- mechanical sesmsnts of the spinal colu:-.n sepa_ 2 _el~.
' ~ . '.:
The disadvanta~s3 o- the circ~mfa--ntial zoo cach æ-e sev~--al:
too much ~etal in t~o diff-_ent se.s of devices th- cons _~ct may fail to promo.e stres3 sharing and may c-sate st~ess shieldins; znd the construct ma~ be too st_ong fo_ osteogen c bone a~d th-ls cut th_ou~ it. -~' . `:,.' ,. .:
A major problem of the present day approach is what to do with - poor quality bone or with spines in which ade~uate attac~ment of the construct to the bone cannot be achieved. ~-S~ ~RY OF THE I~rENTI
The present invention in its broadest aspect provides a -single spinal stabilization system fo_ fixing affected vertebrae having anterior and posterio- aspec.s. The system co~p-ises a plu-ality of substantially risid, elor.sated column ~eans cisposed over the affected vertebraa. At least one of the column means is d~s?osed over the ante-io- aspec o~ the affected vertebrae. ~t least nnothsr of the col~ ean3 is di~pcsel over the posteric_ aspect o~ the af4ectsd ~er~eb- e. ~ plu~allty of substant1ally 2 ~ -~
' ' '-''"".' ' :''~
2~2~
rigi:l, elonsatod oea~ ~-ars which e~ctend thr_uq;. the_~ a r~ ~C t S
ve-teb-ae a-e attached to the column ~ear.,.
i Additionally, tne o-esent in~ien'ion ir. one of its b_oad?s as?~c-s providas a met!~od of ins':alling a spinal sta~ at o::
sys~e~ to ~ix af ected ~e-te~_ae. The s'eps co~?ri~e e:cposinq tha s?ine anteriorl~ and posts_io-ly at the level of ths affected ve-tebra, inse-ting or.e or a pair of beam means through t;^e affected vertebr2, repeating the exposing and inser.ins stapi fo-a ne:ct level of ~ertebra, disposing column means ~ver tne anterior and posterior asp~cts of the two lev21s of affected ve-te~ra~, and connecting the ends of the beam means at each affected vertebra . .
: level to said column means.
;....... ~ -. ;-.~... - . .
: '~? ~
'' ' ;'`'. :; ' ' - ' . . , Another feature of the pres2nt invention in its broad2s' aspect ls to provide an ali~nmen~ fi~cture which accurately place the elements of the spinal stab-lization system. The alignmer.t fixture comprises a first and second arm, each arm haqing first and ~econd ends, a drill guide means and an aiming pin. The arm pin and drill guide means are fi~edl~ connected to the first end of sa'd _i_st and second a~as, r~sp-cti~s'~ ha second er.ds o_ sa~d first and second arms a-e connected in sliding enqaqemen- with ona anothe-. ~he first and second arms, the drill guide means and the ai~inq pin are all disposed in ths same plane.
2 ~
.
Fu-the~ore, tn-~ present inv~r.tion in st-ll ano_'le- c_ L 3 broadost aspnc_s, p.-C-Jide3 a met~od of ins-a lins a s?t.al stabili~ation s~fstem to fi:~ the vert-brae o_ a pa~le~t usin~ t~.e ~ -;
alignins fixture which has a d_ ll guid- at one end and an aiminc;
pir. at tne othe- end. This mo'~.od c3r~:p-i_es the steps of:
.
a. surgically e~po~ing 1wo adjacer.t levels o~ afEe-t vertecrae ante-iorl~f and pos~e_lo-l~
~' b. cleaning out the con_sr.'s of the pedicle portions of the adjacent levals of affected ve-tebrae so as to pen~it sufficient movement of tha d_ill guide within the cleaned C'lt pedicle portions -- so that the aiming pin can be positioned at the desired exit points on the anterior aspect of the adjacent levels of affe~,ed vertebrae;
. , ..... . - -: ~ .
. . . ~ . - .
. - . :. . ~ .: :
c. inserting the driil guiae within the cleaned out psdicle portions of the adjacent levels of affected ve-tebrae;
', ' ~ . ~
d. positioning the aiming pin at the desired exit points on the an~erio~ aspect of the adjacent levels of affected vertebrae;
.
e. inserting a drilling means within the aligned drill guide dis~osed within the edicle por'ions of the adja_er.t le~els of affected vertebrae,. an~
::, 21~2t~6~
~ . drillinq holes t'n~ouSI tne aliqned drill su'c!_ in~o tho a.f-cted ~e~.ebr~e to the de~lre~ e~ points.
Th~ p~incipal c~ject oE the inven'ion is to c-eata a r_gi-struct~-e that wil' 2110'~ s~cces~fll bonv fusion b~ usin~ a ne conce~t ccDbin_ng anterior an~ 2oste~ior constructs into a S.' :'q7 ''`
unitar~ structu_e 2ch_evsd a' a single su_gicai sitting.
Another object of the inven';ion is to p-ovide a mc_~s rlsid construc. or cage in which bone and bone sraft can heal to a solid fusion.
-A furthe- object of the invention is to provide an improved solid construct, in which stress sharing is better distributed between anterior and posterior elements.
; . - . ' An additional object of the invention is to provide an improved method and an aliqnment fi~t~re for installing such construct or cage.
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:
S ' ~
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2102~g~
B~ F DE:iC?~IPTIO ~'T OF T~ D~ ^S ~ ~ -''` ''' :
FIG. 1 is a ~erspective view of an individuai ve-tebra showir.J .` ~.
the th.-eaded apertures which 2-2 fo~d by inse~~tic~. of a pai- 0 nu~ and bol. po_'icns of _h- ore:,en~ inven'icn;
: ,. ~. .
FIG. 2 is a pe~spectivs via~ of two vertebras and a in'e-verte~ral dlsc shcwing th~ threaded apertureâ w;~ich a-e fo-ms~ .
by insertion of two pairâ of nut and bolt portions of the pres3n~
inven.ion;
FIG. 3 is a pers~ective view of the implanted spinal . ~:~
stabilization system of the present invention;
FIG. 4A is a perspective view of a preferred embodiment of a single unassembled bolt and nut portions of the preser.t invention;
"'', FIG. 4B is a perspective view of a preferred embodiment of another slngle unassembled bolt and nut portions of the present invention for use with smaller vertebrae;
; ' ' ' ' ,.'. ,-FIG. 5 iS a perspective view 0.,c a single assembled bolt and nut portions attached at its ends to rods by tie wires; -~
. . .~, .
FIG. 6 is a pe~spective v~ew of an alignment fi~ture usecl Po~-installing the spinal stab'lization s~stem;
6 .~ ;
2 1 0 2 6 6 Lll ' FIG. 7 is a hori70ntaL o~ OJ._SeC;-iCra1 V~e,/ oE-tile p~tier.:: 2.`;~
spine L~nd a side vie:~ of th~ allgr.~.er.t fi~ u~ in it, inat;lLLa~
position adjacent the poste-io= and an~erio- as~ects of th:-~ spin-;
and FIG. 8 i5 a pe~soecti~/e vie~ of t~.e patier.~ ~lit~ 2 p^S~'-i`-_ incis~on an~ the align~er.' ~xt~re po3ition-d in t~e ins'allation position.
' ,: ' ' - ~ ' . . ... , ,- : ... :
.', .,,. . ' ~' .. ,~. , . ~ .
. . .
: ''' ' '`' ~ f 21~2~4 :. .. :.
C~C~<r?~Tv~l o~ ~;~ T~ ~
.' ~' '.-';
Th~ p-e~ d embsdi~ n' o~ the s~inal s'a~ilisa'ion or fixaticn system for t-ea.ir.~ pa'holcslcal p-oces3es o- rix-.
affoct~ verte,~-a~ hav n-, an-o-- o- an' pos'er-o- ,.s~ec generAlly desisnatod b-r the reference charac';e= 1 ,znd ts compl-te asse.~bl~ is shcwn in FIG. 3. Ar. e:~mpl~ of a patholcs-cal p~cca~
in the spins having a~fect-d ver'eb~2e is the co~on p-ola?s~
inver'ebral cisc; the ve-teb-ae adjacen' sai- disc are the a.~ected verteb-ae. The s~stem comprises con-;entional, colu~n m2ans 3 three in num~er, each of which is a rigid elonsated rod or plate, `~
one of which is disposed ove_ the anterior aspac' of at least two ~ -~
such affected vertebrae, and as shown in this figure two ve_tebrae, and two of which rods are disposed over the poster-or aspects of the two ver.ebrae. These rods 3 a.e attached to beam means S, four in number, each of which is a rigid elor.gated bea~ means which extends through indlvidual vertebrae. It should be noted however that t~o or three or more rods cou~d be used. Referring specifically to FIG. 4A, which illustrates in detail a single beæm means S which comprise~ a pedicle bolt section 7 and a nut section 9, each of whlch sec~'ons are adapt-d to join each othe- w:~en ~ev are inserted th~ough a vertebra when 'he sys~em 1 is installed.
Each of these bol~ and nut sec_ions 7 and 9, respectivel~, preferably have an ap~r ~re o~ car.nulation 11 axtendin~ along '::a longitudinal a;ces the-eof; such cannulation 11 i3 howeva_ op'ional.
Each o. the bolt and nut sec'~or.s 7 and 9, resDectivel~, have a 8 :-. .
. ~
2~2~
cu~t~ng end pe~ 13 a~.d 15, and 2 front po__ion 17 and 19, having a cylind~ic21 Der' ?hery 2! and 23, respa~ti~rely, which is exte_nally thr2ade~' with cutt~ns ed~s. The aperture 11 cf the n~' se_. on 9 has a c~lindrical pe~i~he-y which is inte-nall~ threaded fc~ eceiving and ensa~in~J the threads or tha f_cnt porti~ 17 of the bolt section 7. The hol' secticn 7 also c~mpris2s a m-ddlc po_tion 25 having a cylind-ical pe_i~`ne-y 27 which i9 e:c.grnally th-eaded with cuttins eci~es; e~ual diamete-s a_e used fo_ th-middle and fron. portions 25 and 19, respec.~val~. The middle portion 25 is connscted to a smooth sna.t po_~ion 28. Each of ths bolt and nut sections 7 and 9, respectivel~, have a rsar portion or encs 29 and 31, res~ectively, for attachins the ends of said nuts and bolts 7 and 9, respec~ively, to said rods 3, as is best shown in FIG. 3. These ends or attachments 29 and 31 are shown as : . ~
closed and open attachments, respectively, in FIG. 4A, whereas one of said beam means S is shown having closed attachments at both ends; after the attachments ars installed a staple or a plate (nct shown) can be disposed beneath the attachments.
Another preferred embodiment of the beam means 5 is shown in FIG. 4B and is utilized when the system is used for fixins smaller vertebrae. Its middle portion 33 comprises a smooth sh~ft por'ion, the diamete_ of which is sli~htly less than the diameter of the threaded portion 21 of the front po-ticn 17. Its at~achments ~9 and 31 are o4 the closed type.
. .
9 , ~' ' ', .
~ ` 2~2~g~ -:
The p-e'o-.od em~odi.~e-.t OL- the al-grl~en f ;:~u~Q u_ac assistir.g in the installa'io.. o the p-ov-ous'y coscr-_~d ~-~^.a_ sta~ ation syâ'e~ 1 is gene~llv dosigna.ed b~ 'he r~.eren ~
cha-acto~ 100 and its cc~lete asse~blv is shown in FIG. 6. The alignnen~ fixtu_o 100 COm?-iSQ3 L-shar~d first ar.d secon~ arm3 1(``
ar.d lOt, respectivel~, d_- l su.d-~ mear~ lOo and an aim ng pin 108, all of which a_e ~iscos~d in the sa~e plar-. Each of th~o first and second arms 102 and 104, respa_~-vely, hzv~ fi-s. and sec_nd er.c'_~
110, 112 and 114, 116 respectively. Additionall-y, each of th2 first and second arms 102 and 104, respec'ively, ha-te irst and sccon~ stra1ght po_tions lla, 120 ~nd 122, 124, -es~ctiv~l~. The - ~ .
first portions 118 and 120 o' the firs' 2r.d se~ond arms 102 and - -104, respectively, are disposed opposite one another as are thei--first ends 110 and 112. The second portion 122 is U-shaped in .. ..
cross-section and has a narrow slot 135 extending across it length in side walls 136. A slide 138 extends through the slots 135 and is fixedly attached to the second end 116 of the second por.ion 124. Accordingly, ths second portions 122 and 124 of the first and second arms 102 and 104, respectively, are connected in sliding engagement with one another as are their second ends 114 and 116.
The aiming pin 108 and the drill guide means 106 are a~ially aligned and fixedly disposed o~.hosonally cn the fi-st en~s 110 ar.d 112 of the first portions 118 and 120, respecti~tely, of ths first and secor.d armq 10~ and 104, re3pecti~1y. Th~ aimin~ pin 108 i~
gene-ally cylind-ical along its length e:~cepL tha~ _ts inwa_d er.d is conlcally shaoed. Thq d:ill guide means 106 comp~ise3 a hollo~r .~ . . .
- 21~2~6'~
.
tube which e:~tendci inwa_d fo_ moi,' c- it:; ler.g.h and A _e_`. ~..;
com~lQ'el~ thrcu~h thQ -rst en~ 112 Oc t'aa saccn~ a ~~
discuss~d belo.~, thi~ ai.~lrs p n lda and ~'.e ~.--11 guide m~'.n.n: 10 j on thQ firs and secon~l arms 102 ar.d 104, reS~Qc'i-:ely, cf ~h:-align~e?.t fi;ctur~ lOG, will ~a util i7e~ ard dispose~ at th anterior and pos.eriv~ aspects, res~sctively, of tha ve-teb~^ae durins the initial stageis of the in.~ailation o~~ the spir.a: -stabili7alior.syst~:r.;. Such posi ioning is acccmplished bi r.~.ovir.
the slids 130 appropriately therob~ movin~ the s'idins a-r.~s 10~ and lGI forward or bac~ards, untL~ the aimins pin 10~ and ~he drill guidd lOo are p-operly dispossd on the anterio- and 2osterio~
aspec's, rQspectively, of the vertebrae. ~-.
;~ The surgical technique used fo- implanting the preferred ' ;system of the present inven~ion without using the alignment fixture is generally described as follcws (for fixing two levels of affected vertebrae). A portion of the spine i9 surgically exposed anteriorly and posteriorly simultaneously to reveal two levels o' vertebrae, Then one or a pair o' beam means 5 are inserted through an lndividual vertebra; more specifically one or two pedicle bolt sections 7 each shawn as havlng a cannula'ion 11, ar~ insertsd from poste-ior to anterio~ throush the ve-teb=a so as to join i'3 opposite bolt section 7; that is the cannulation 11 of each nut section 9 engages tha ~h-eads on the rront po-tion 17 of each bolt section 7. The rou~ in the vart-brae (FT5.1) can be p_ep2:-ed ov~
a guide wire utiliz'ng a cannula, which requi-es us35e o' ` ` 21~2~64 :: ~
.: .
cannulatec bol. and r.u~ sec.ions. The abo~e de,cribod p-o~du-is 'h~ Apea'od ~o- tSe r.e:~t ~t-r' ~b~al le-~el and th~n th-~_ colu.,n means or rig}d elons2t~d _o~s 3 a_e d~s?osed o~e- tho an~e-io~ and pos~erior as?ects of th- two v~LteD-ae and connected to these rods 3. Mo-e specificallv .he rear po-~ions or ends 29 and 3l, res~ec'ivQl~, of the bcl~ and nut sec~ions 7 ar.d 9, respect~'~el~
are attached to the rods 3. Suc`~ an impl2n.tod s~inal stabili~atio~.
syste~ is shown in FIG. 3. Furth_r aspe^ts of .he present invention are as follows: the cannu'ated pedicle bolt 7 acco~modates a Rirschne- wi-e ("k-wiren) which is used as a pilc~
locator bolt 7 and is poste-io-l~r inse-ted ove- a prope~ly placed ;~
k-wi-e (not sho~) through its central aper~ure and through the pedicie portion of the verte~ra to form a posterior portion of a threaded aperture 35; the nut 9 is sLmilarly inse~t~d over the k~
wire anteriorly through its central aperture to form an anterior portion of the threaded aperture 35 - this aperture 35 is seen best ln FIG. 2.
As seen in FIG. 2 and FIG. 3 the two beam means S in an individual vertebra are disposed therein in di.feren. planes and forQ a triangle in cross section through said beam means 5. Also as seen best in FIG. l, the individual beam means S e~tends throllgh the superior and inferior portions of the same vertebra. Ths ~-wire guids inside th~ beams means S can be replacqd with two tie wires 37 which are th~n twist loc~ed on the rods 3, aq qeen in FIG.
5, afte_ the beam sections S ara in place in the ~-ertebra~ (no1 .
.:
21~2~64 sho~n in said figur~ h~se twis, lcc'c a-tacbm~nts se~Ja to lo~~
the bolt and nct sections 7 an~l 9, -esp~cti~:el~, to th^ rods 3 t-p~evont bac'~-o-'. -~ he i~proved su-gical tec'.-ni~ue use for i~planting the prefer_ed s~stem,o' ths present ir.Jent on is essentially the sa~
as ths a'oredescribsd o-ig nal technique ~:cco?t that the aligr~m-3n`~
fixturs lC0 is used .n th~ initial stases Oc the techniqc~2. ThiJ
improved techniqus ob~tiates the visual sighting requirement in tne ;~
o- ginal techni~cs which is usec to de-te~m-ne th- rout~ in t'..*
ve~te~-ae.
. ' ~
r , Referring now to FIGS. 7 and 8, ths initial stages or steps of the improved technique or process, which occur prior to the , installatio,n of the spinal stabilization system 1 are as follows: ~
a. surglcally exposing two adjacent levels of affected ~' ' verteb~ae; -~
. .~ .
b. cleaning out the contents of pedicle portions of the ' above affected vertebrae, preferably by curetting, so as to permit sufficient movement of ths d-ill guide means 106 (of ths alignment fixture 100) within the cleaned out pedicle portions so that the aiming pin 108 ~of the align~ent fixtu~e 100) can be (late-) positioned at the desi-~d exit points on ,he anterio- asoect oF th abo~e affected verts~rae (these ex;t points conform to the centn.- ' 13 , -' ' :
J ~ .
2 ~
of the e~i. o~er.ing of ape-'ure 35, a~ is seen best in F-~G. qj;
c. ma~ing an incision 130 (FIG. 7) in the lat~-a' aspec~ o~
a patient 132 of sufficien' si-e to pe-mit the a~ing pl-. 10~ and .-. `;
a po-ticn c~ its at.ached a_~ lOq enLry th=oush the incis-.on 13C~
. . .
d. insertir.s the aimin, pin 103 and a porLion oF it5 ~ . `,. ' attached ar~ 102 thrcugh the incision 13~ and positioning th2 aiming pin 108 (by moving first a-m 102 ir.ward using the slide) .-near the ante-ior aspect of one of the a'fected ~ rtebrae; .. ~.
. ~e. insertins the tip of the drill guide means 106 within one `..-.- of the cleaned out pedicle portions of one affected vertebra (first - ................................................................................. ::
level); - , -~
,........................................... f. positioning the aiming pin 108 at the desired exit point .-- . . on the anterior aspect of said one affected vertebrae as is seen . :::
best in F~G. 7;
, - g. inserting the drill bit of a drill 134 (only a portion of which is shown~ within the now aligned drill guide means 106 ~:
disposed within the pedicle porticn of the said one affected :~
vertebra;
h. drilling .an ape_tu~e into and through the said cne affested verteb-a; th-ough said d~ili guide means 106, which 2102~
.
e.~erges at t~e desire~ e~it Foint on th2 anterio_ aspe~'; of 5a' ' ;
ve~teb-a;
i. repeatinq steps e) through h; fo_ the othe- e~cit poir.
on the same affect2d -ie-teb-a;
j. inse-tins a pair of be m r.~e2n~ 5 through tha s~Qe sa'd ~`
affect-d va-teb-a (first level);
~ . re~2ating steps e) through j) for ths sscond lsvel of affecte~ verts~ra;
1. disposing three column means 3 over the anterior and posterior aspects o'f the two levels of affect-d ~er~ebrae; and ....
m. conneçtln~ the ends 29 and 31 of the beam means S at both levels o~ affected vertebrae to the column means 3.
The nut section 9 has a self-tapping bone screw on its exterior aspects as does the bolt section 7. The bolt section 7 of FIG. 4A preferably has a cuttLng edge portion,l3 around the cannulated opening 11 of 2 mm in lensth, an externally threaded front portion 17 of greater than between 10 mm to 30 mm in length, an externally thre~ded mlddle po-tion 25 of between lS mm to 40 n~.~
in length, ~nd a smo~th sha~t port'on 2a of be'ween 20 mm to ~lO n~m in length. The nut section 9 of FIG. 4~ preferably ha3 an . `
~ . ~ ,..-., 2 1 ~ 2 ~
ex--_nall~t th-eade~ r-o~' ,o~tl~n 19 of abou. between 10 ~m to 30 m~ in l~ h, an~ tne aee_tu-e 11 tlereOf has an inte=nal ~ac'l'ne thraad to mo~t the mach~ne th-ead or. ,he tip 13 and front po_~ior 17 o' t~e ~olt section 7. The pitch of t~.e matching mal~ ar.d female tr.-eads are the sa.~e. T~e p-eEer_od ~ate=ials fo~ the bolt a~d nu~ section3 ' and 9, res~ecti~relï, woul~ be Tl-6A~-~';, or ~
si~ilar mz'er'al because o~ its mech~nical stren~th p_ope-tie-~- ~nd co~ros on reqLstancs; other possible materlals could be a hi~J-h strsngth biodegrada`ola pol~me. su_h a3 a high molecular weight PL.
St,linl~ss steel could even be us-d.
Although the present invent-on has been described and illustrated with respect to a preferred embodiment; it is not to be so limited since modiEications and changes aar be made therein which are within the full intended scope of the invention.
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, :.
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Claims (35)
1. A spinal stabilization system for fixing affected vertebrae having anterior and posterior aspects; said system comprising:
a plurality of substantially rigid, elongated column means for being disposed over the affected vertebrae, at least one of said column means for being disposed over the anterior aspect of said affected vertebrae and at least another or said column means for being disposed over the posterior aspect of said affected vertebrae; and a plurality of substantially rigid, elongated beam means having a longitudinal axis for extending through said affected vertebrae and for attaching said column means to said beam means.
a plurality of substantially rigid, elongated column means for being disposed over the affected vertebrae, at least one of said column means for being disposed over the anterior aspect of said affected vertebrae and at least another or said column means for being disposed over the posterior aspect of said affected vertebrae; and a plurality of substantially rigid, elongated beam means having a longitudinal axis for extending through said affected vertebrae and for attaching said column means to said beam means.
2. The system as recited in claim 1, wherein each of said beam means has an aperture extending along its longitudinal axis.
3. The system as recited in claim 1, wherein said beams extending through the same individual said affected vertebrae are disposed therein in different planes.
4. The system as recited in claim 1, wherein said beam means extend from the posterior aspect to the anterior aspect of said affected vertebrae.
5. The system as recited in claim 1, wherein column means comprise rods or plates and wherein said plurality of column means comprise at least two column means.
6. The system as recited in claim 1, wherein said column means has a cross section and wherein the cross section of said columns means through said beam means form a triangular configuration.
7. The system as recited in claim 1 wherein said vertebrae have superior and inferior rim portions and wherein individual beams means extend through said superior and inferior rim portions of a common said affected vertebra.
8. The system as recited in claim 1, wherein each said beam means comprises separate bolt and nut sections having longitudinal axes which sections join each other when said sections are inserted into and through an individual said affected vertebra.
9. The system as recited in claim 8, wherein each of said bolt and nut sections has an aperture extending along the longitudinal axes thereof.
10. The system as recited in claim ?, wherein each of said bolt and nut sections comprises a cutting end portion and a front portion having an externally threaded cylindrical periphery with cutting edges, said aperture of said nut section having an internally threaded cylindrical periphery for engaging said cutting edges of said externally threaded cylindrical periphery of said front portion of said bolt section.
11. The system as recited in claim 10, wherein said bolt sections comprises a middle portion having an externally threaded periphery with cutting edges.
12. The system as recited in claim 10, wherein each of said bolt and nut sections comprises a rear portion for attaching said rear portions of said bolt and nut sections to said column means.
13. The system as recited in claim 10, further comprising wire means extending through said aperture of said beam means for attaching said column means to said beam means.
14. The system as recited in claim 11, wherein the diameter of the cylindrical peripheries of the middle portion of said bolt section and said front portion of said nut section are substantially equal.
15. The system as recited in claim 8 wherein said vertebras have pedicle portions and said bolt sections extend through the pedicle portions of said affected vertebrae.
16. The system as recited in claim 8 wherein said bolt sections and nut section extend from the posterior and anterior aspects, respectively, of said affected vertebrae, and towards each other.
17. A spinal stabilization system or fixing affected vertebrae having anterior and posterior aspects, said system comprising:
at least two rods or plates being disposed over the affected vertebrae, at least one of said rods or plates being disposed over the anterior aspect of said affected vertebrae and at least one said rod or plate being disposed over the posterior aspect of said affected vertebrae;
a plurality of elongated beam means having a longitudinally axis extending through said affected vertebrae and attached to said rods or plates, at least two of said beams extending through different planes of the same individual said affected vertebra; and each of said beam means comprising separate bolts and nut sections, said nut sections having longitudinal axes and an aperture, said aperture extending along its longitudinal axes, each said sections comprising a cutting end portion and a front portion having a cylindrical periphery externally threaded with cutting edges, the aperture of said nut section having a cylindrical periphery internally threaded for engaging said externally threaded cutting edges of said first portion of said bolt section.
at least two rods or plates being disposed over the affected vertebrae, at least one of said rods or plates being disposed over the anterior aspect of said affected vertebrae and at least one said rod or plate being disposed over the posterior aspect of said affected vertebrae;
a plurality of elongated beam means having a longitudinally axis extending through said affected vertebrae and attached to said rods or plates, at least two of said beams extending through different planes of the same individual said affected vertebra; and each of said beam means comprising separate bolts and nut sections, said nut sections having longitudinal axes and an aperture, said aperture extending along its longitudinal axes, each said sections comprising a cutting end portion and a front portion having a cylindrical periphery externally threaded with cutting edges, the aperture of said nut section having a cylindrical periphery internally threaded for engaging said externally threaded cutting edges of said first portion of said bolt section.
18. A method of installing a spinal stabilization system to fix affected vertebrae comprising the steps of:
exposing the spine anteriorly and posteriorly to reveal a level of affected vertebra;
inserting a pair of beam means through said affected vertebra;
repeating the exposing and inserting steps for a next level of affected vertebra;
disposing column means over the anterior and posterior aspects of the two levels of affected vertebrae; and connecting the ends of the beam means at each vertebra level to said column means.
exposing the spine anteriorly and posteriorly to reveal a level of affected vertebra;
inserting a pair of beam means through said affected vertebra;
repeating the exposing and inserting steps for a next level of affected vertebra;
disposing column means over the anterior and posterior aspects of the two levels of affected vertebrae; and connecting the ends of the beam means at each vertebra level to said column means.
19. A method as recited in Claim 18, wherein the step of exposing the spine reveals a level of vertebra including its pedicle portion.
20. A method as recited in Claim 19, wherein the step of inserting comprises inserting a pair of beams posteriorly through the pedicle portions of said vertebra and anteriorly through said vertebra.
21. A method as recited in Claim 20, wherein the beam means comprises pedicle bolt sections and nut sections.
22. A method as recited in Claim 21, wherein the beam means have cannulation.
23. A method as recited in Claim 22, wherein the column means comprise rigid elongated rod (s).
24. A method of installing a spinal stabilization system to fix affected vertebrae comprising the steps of:
exposing the spine anteriorly and posteriorly to reveal a level of affected vertebra including its pediccle portions;
inserting a pair of pedicle bolts sections posteriorly through the pedicle portion of said affected vertebra and a pair of nut sections having cannulations anteriorly through said sections;
repeating the exposing and inserting steps for a next level of affected vertebra;
disposing rigid elongated rods over the anterior and posterior aspects of the two levels of affected vertebrae; and connecting the ends of the bolt and nut sections at each affected vertebra to said rigid elongated rods.
exposing the spine anteriorly and posteriorly to reveal a level of affected vertebra including its pediccle portions;
inserting a pair of pedicle bolts sections posteriorly through the pedicle portion of said affected vertebra and a pair of nut sections having cannulations anteriorly through said sections;
repeating the exposing and inserting steps for a next level of affected vertebra;
disposing rigid elongated rods over the anterior and posterior aspects of the two levels of affected vertebrae; and connecting the ends of the bolt and nut sections at each affected vertebra to said rigid elongated rods.
25. A method of installing a spinal stabilization system to fix affected vertebrae of a patient using an aligning fixture having a drill guide at one end and an aiming pin at the other end, comprising the steps of:
a. surgically exposing at least one level of affected vertebra anteriorly and posteriorly;
b. cleaning out the contents of the pedicle portions of the level of affected vertebra so as to permit sufficient movement of the drill guide within the cleaned out pedicle portions so that said aiming pin can be positioned at the desired exit points on the anterior aspect of said level of affected vertebra;
c. inserting said drill guide within the cleaned out pedicle portions of the level of affected vertebra;
d. positioning said aiming pin at the desired exit points on the anterior aspect of said level of affected vertebra;
e. inserting a drilling means within the aligned drill guide disposed within said pedicle portions of the level of affected vertebra; and f. drilling holes through said aligned drill guide into said affected vertebra to said desired exit points.
a. surgically exposing at least one level of affected vertebra anteriorly and posteriorly;
b. cleaning out the contents of the pedicle portions of the level of affected vertebra so as to permit sufficient movement of the drill guide within the cleaned out pedicle portions so that said aiming pin can be positioned at the desired exit points on the anterior aspect of said level of affected vertebra;
c. inserting said drill guide within the cleaned out pedicle portions of the level of affected vertebra;
d. positioning said aiming pin at the desired exit points on the anterior aspect of said level of affected vertebra;
e. inserting a drilling means within the aligned drill guide disposed within said pedicle portions of the level of affected vertebra; and f. drilling holes through said aligned drill guide into said affected vertebra to said desired exit points.
26. The method as recited in claim 25, further comprising the steps of:
g) inserting a pair of beam means through said level of affected vertebra;
h) repeating steps a) through g) for the other level of affected vertebra;
i) disposing column means over the anterior and posterior aspect of the two levels of affected vertebrae; and j) connecting the ends of the beam means at each vertebra level to the column means.
g) inserting a pair of beam means through said level of affected vertebra;
h) repeating steps a) through g) for the other level of affected vertebra;
i) disposing column means over the anterior and posterior aspect of the two levels of affected vertebrae; and j) connecting the ends of the beam means at each vertebra level to the column means.
27. A method of installing a spinal stabilization system to fix affected vertebrae of a patient using an aligning fixture having a drill guide at one end and an aiming pin at the other end, comprising the steps of:
a. surgically exposing two adjacent level of affected vertebrae anteriorly and posteriorly;
b. cleaning out the contents of the pedicle portions of the adjacent levels of affected vertebrae so as to permit sufficient movement of the drill guide within the cleaned out pedicle portions so that said aiming pin can be positioned at the desired exit points on the anterior aspect of said adjacent levels of affected vertebrae;
c. inserting said drill guide within the cleaned out pedicle portions of the adjacent levels of affected vertebrae;
a. positioning said aiming pin at the desired exit points on the anterior aspect of said adjacent levels of affected vertebrae;
e. inserting a drilling means within the aligned drill guide disposed within said pedicle portions of the adjacent levels of affected vertebrae; and f. drilling holes through said aligned drill guide into said affected vertebrae to said desired exit points.
a. surgically exposing two adjacent level of affected vertebrae anteriorly and posteriorly;
b. cleaning out the contents of the pedicle portions of the adjacent levels of affected vertebrae so as to permit sufficient movement of the drill guide within the cleaned out pedicle portions so that said aiming pin can be positioned at the desired exit points on the anterior aspect of said adjacent levels of affected vertebrae;
c. inserting said drill guide within the cleaned out pedicle portions of the adjacent levels of affected vertebrae;
a. positioning said aiming pin at the desired exit points on the anterior aspect of said adjacent levels of affected vertebrae;
e. inserting a drilling means within the aligned drill guide disposed within said pedicle portions of the adjacent levels of affected vertebrae; and f. drilling holes through said aligned drill guide into said affected vertebrae to said desired exit points.
28. A method as recited in claim 27, further comprising after step c), 1) making an incision in the lateral aspect of a patient of sufficient size to permit the aiming pin and a portion of its attached arm entry therethrough; and 2) inserting said aiming pin and a portion of its attached arm through said incision and disposing the aiming pin adjacent said anterior aspect of said adjacent levels of affected vertebrae.
29. A method as recited in claim 27, wherein said cleaning is performed by curetting the pedicle portions of the adjacent levels of affected vertebrae.
30. A method of installing a spinal stabilization system to fix affected vertebrae of a patient using an aligning fixture having a drill guide at one end and an aiming pin at the other end, comprising the steps of:
a. surgically exposing two adjacent levels of affected vertebrae anteriorly and posteriorly;
b. cleaning out the contents of the pedicle portions of the adjacent levels of affected vertebrae so as to permit sufficient movement of the drill guide within the cleaned out pedicle portions so that said aiming pin can be positioned at the desired exit points on the anterior aspect of said adjacent levels of affected vertebrae;
c. inserting said drill guide within the cleaned out pedicle portions of the adjacent levels of affected vertebrae;
d. positioning said aiming pin at the desired exit points on the anterior aspect of said adjacent levels of affected vertebrae;
e. inserting a drilling means within the aligned drill guide disposed within said pedicle portions of the adjacent levels of affected vertebrae;
f. drilling holes through said aligned drill guide into said affected vertebrae to said desired exit points.
g. inserting a pair of beam means through each of said levels of affected vertebrae;
h. disposing column means over the anterior and posterior aspects of the two levels of affected vertebrae; and i. connecting the ends of the beam means at each affected vertebra level to said column means.
a. surgically exposing two adjacent levels of affected vertebrae anteriorly and posteriorly;
b. cleaning out the contents of the pedicle portions of the adjacent levels of affected vertebrae so as to permit sufficient movement of the drill guide within the cleaned out pedicle portions so that said aiming pin can be positioned at the desired exit points on the anterior aspect of said adjacent levels of affected vertebrae;
c. inserting said drill guide within the cleaned out pedicle portions of the adjacent levels of affected vertebrae;
d. positioning said aiming pin at the desired exit points on the anterior aspect of said adjacent levels of affected vertebrae;
e. inserting a drilling means within the aligned drill guide disposed within said pedicle portions of the adjacent levels of affected vertebrae;
f. drilling holes through said aligned drill guide into said affected vertebrae to said desired exit points.
g. inserting a pair of beam means through each of said levels of affected vertebrae;
h. disposing column means over the anterior and posterior aspects of the two levels of affected vertebrae; and i. connecting the ends of the beam means at each affected vertebra level to said column means.
31. An alignment fixture for assisting in the installation of a spinal stabilization system, comprising;
a first arm;
a second arm;
each arm having first and second ends, drill guide means; and an aiming pin;
said aiming pin and said drill guide means fixedly connected to the first end of said first and second arms, respectively, said second ends of said first and second arms being connected in sliding engagement with one another, and said first and second arms, said drill guide means and said aiming pin being disposed in the same plane.
a first arm;
a second arm;
each arm having first and second ends, drill guide means; and an aiming pin;
said aiming pin and said drill guide means fixedly connected to the first end of said first and second arms, respectively, said second ends of said first and second arms being connected in sliding engagement with one another, and said first and second arms, said drill guide means and said aiming pin being disposed in the same plane.
32. An alignment fixture as recited in claim 31, wherein said drill guide means and aiming pin being disposed orthogonally on said first and second arms, respectively.
33. An alignment fixture as recited in claim 32, wherein said drill guide means and aiming pin being axially aligned.
34. An alignment fixture as recited in claim 33, wherein each of said first and second arms having first and second portions, said first portions being disposed opposite one another, and said second portions being connected together in sliding engagement.
35. An alignment fixture as recited in claim 31, wherein said first and second arms being disposed at the anterior and posterior aspects, respectively, of said vertebrae during the initial stags of the installation of said system.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US97329492A | 1992-11-09 | 1992-11-09 | |
| US07/973,294 | 1992-11-09 | ||
| US08/145,603 | 1993-11-04 | ||
| US(08/145,603) | 1993-11-04 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2102664A1 true CA2102664A1 (en) | 1994-05-10 |
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ID=25520723
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002102664A Abandoned CA2102664A1 (en) | 1992-11-09 | 1993-11-08 | Spinal stabilization system and improved method |
Country Status (2)
| Country | Link |
|---|---|
| US (2) | US5562735A (en) |
| CA (1) | CA2102664A1 (en) |
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- 1993-11-04 US US08/145,603 patent/US5562735A/en not_active Expired - Fee Related
- 1993-11-08 CA CA002102664A patent/CA2102664A1/en not_active Abandoned
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1995
- 1995-09-15 US US08/528,801 patent/US5700292A/en not_active Expired - Lifetime
Also Published As
| Publication number | Publication date |
|---|---|
| US5562735A (en) | 1996-10-08 |
| US5700292A (en) | 1997-12-23 |
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| FZDE | Discontinued |