`
`Unlted States Patent [19]
`Kambin
`
`USOO5395317A
`
`[11] Patent Number:
`[45] Date of Patent:
`
`5,395,317
`Mar. 7, 1995
`
`[S4] UN'ILATERAL BIPORTAL PERCUTANEOUS
`SURGICAL PRQCEDURE
`
`[75] Inventor: Parviz Kambin, Devon, Pa-
`[73] Assignee: Smith & Nephew Dyonics, Inc.,
`Andover, Mass.
`[21] Appl. No.: 784,693
`
`[22] Filed:
`
`Oct. 30, 1991
`
`[51] Int. C16 .................... .. A61M 31/00; A61M 5/00;
`A61B 10/00
`[52] US. c1. ...................................... .. 604/51; 604/22;
`604/116; 604/170; 128/753; 128/754;
`123/DIG_ 26; 606/61; 606/130
`[58] Field Of Search ............... .. 604/51, 116, 117, 170,
`604/174, 22; 128/DIG. 26, 749-755, 898;
`606/130, 61
`
`[56]
`
`References Cited
`
`U-s- PATENT DOCUMENTS
`2,919,692 1/1960 Ackermann ....................... .. 128/754
`3,017,887 1/ 1962 Heyer ........ ..
`604/174 X
`3,941,127 3/ 1976 Ffo?ing
`604/116 X
`4,539,476 9/1985 Sharpe .......................... .. 128/754X
`4,545,374 10/1985 Jacobson .
`4,573,448 3/1986 Kambin .
`4,638,799 1/1987 Moore ........................... .. 604/116 X
`4,678,459 7/1987 Onik et a1, .
`
`4,750,487 6/1988 Zanetti .............................. .. 606/130
`4,968,298 11/1990 Michelson .
`5,004,457 4/1991 Wyatt et a1. .................. .. 606/130 X
`5,047,036 9/1991 Koutrouvelis .................... .. 606/130
`FOREIGN PATENT DOCUMENTS
`.
`.
`2234906 2/1991 Umted Klngdom .
`
`OTHER PUBLICATIONS
`_
`,
`Schre1ber et a1, C1111, Orth. Rel. Res, 283, Jan. 1989, pp.
`3541
`
`Primary Examiner—Randa11L- Green
`Assistant Examiner—Mary Beth Jones
`Attorney, Agent, or Firm———Prave1, Hewitt, Kimball &
`Krieger
`
`ABSTRACT
`[57]
`A method of percutaneously emplacing at least two
`cannulae 1n a pat1ent, such as for percutaneous decom
`pression of a herniated disc, using a guide secured to
`0119 9911111119 to index a Second cannula as it is percutane
`ously advanced into the body. The guide may take the
`form of jigs adapted to be secured to one cannula with
`bores arranged to slidingly receive a guidewire or a
`cannula
`'
`
`8 Claims, 3 Drawing Sheets
`
` 1
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`NUVASIVE 1048
`NuVasive, Inc. v. Warsaw Orthopedic, Inc.
`IPR2013-00206
`IPR2013-00208
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`US. Patent
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`Mar. 7, 1995
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`Sheet 1 0f 3
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`5,395,317
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`F/G/
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`40¢
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`FIG 4-
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`US. Patent
`US. Patent
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`Mar. 7, 1995
`Mar. 7, 1995
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`Sheet 2 0f 3
`Sheet 2 of 3
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`5,395,317
`5,395,317
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`5/“ FIG 7
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`US. Patent
`US. Patent
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`Mar. 7, 1995
`Mar. 7, 1995
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`Sheet 3 of 3
`Sheet 3 of 3
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`5,395,317
`5,395,317
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`UNILATERAL BIPORTAL PERCUTANEOUS
`SURGICAL PROCEDURE
`
`25
`
`This invention relates to surgery and speci?cally to a
`novel method for accessing herniated intervertebral
`discs in a human patient.
`Low back pain syndrome with sciatica secondary to
`herniated intervertebral discs represents a major health
`problem in the United States. An intervertebral disc is a
`structure which occupies the space between the verte
`brae and acts, among other things, as a shock absorbing
`cushion. A normal disc consists of two parts: a central
`part known as the “nucleus” and a surrounding part
`known as the “annulus” or “annulus ?brosis”. The an
`nulus degenerates with age, as does the nucleus. Degen
`eration of the disc is characterized by collagenation, in
`which some of the ?uid content of the nucleus is lost
`and fragments of collagenized ?brous tissue are formed
`which ?oat in the tissue fluid. At this stage of degenera
`tion, external forces can readily increase the hydrostatic
`pressure on the nucleus, causing the ?bers of the annu
`lus to rupture. Nucleus fragments protrude. This, in
`turn, may cause pressure on the adjacent nerve root
`with resultant pain. Degeneration of the disc may also
`be caused by other factors, for example, by accidental
`injury.
`Several methods of treatment already exist. One
`method, usually referred to as “laminectomy” involves
`the surgical excision of the symptomatic portion of the
`herniated disc. This method of treatment has been used
`for many years, however, typical hospitalization time is
`nine days. Microsurgery has also been used in the treat
`ment of herniated discs, in a procedure known as “mi
`crolumbar discectomy.” This microsurgical procedure,
`although less invasive, nevertheless carries with it many
`of the complications associated with the older proce
`dure, including injury to the nerve root and dural sac,
`perineural scar formation, reherniation at the site of the
`surgery, and instability due to excess bone removal.
`Another method of treatment is known as chemonu
`cleolysis, which is carried out by injection of the en
`zyme chymopapain into the disc structure. This proce
`dure has many complications including severe pain and
`45
`spasm, which may last up to several weeks following
`injection. Sensitivity reactions and anaphylactic shock
`occur in limited but signi?cant numbers of patients.
`A further method of treatment, automated percutane
`ous lumbar discectomy, utilizes a specially designed
`needle which is inserted into a ruptured disc space. The
`nucleus of the disc is removed by suction instead of
`open surgery.
`Another method of treatment is discussed in US. Pat.
`No. 4,573,448 and involves the percutaneous evacuation
`of fragments of the herniated disc through an access
`cannula positioned against the annulus of the herniated
`disc. A measure of safety and accuracy is added to this
`operative procedure by the arthroscopic visualization
`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 existing
`procedures, nevertheless, this procedure does not en
`able the surgeon to directly view the resection of poste
`rior nuclear fragments. That is, the internal diameter of
`65
`the access cannula as described in US. Pat. No.
`4,573,448 limits the design of an operating discoscope
`and limits the type and size of instruments that would
`
`55
`
`60
`
`2
`allow for the visualization and simultaneous suction,
`irrigation and resection of the nuclear material.
`The introduction of a second portal to the annulus
`from the opposite side of a ?rst portal has been reported
`by Schreiber and his co-workers in Clinical Orthopae
`dics and Related Research, Number 238, page 36, Janu
`ary 1989. However, this bilateral, biportal procedure
`increases the operating room time, exposure to radiation
`by physician, patient and operating room personnel and
`also increases post~operative morbidity by involving
`both sides of the back and may cause excessive removal
`of nuclear material which increases the possibility for
`stenosis of the forarnen and nerve root compression.
`Thus, there is a need in the art for a percutaneous
`procedure to create an accessory unilateral portal in the
`annulus adjacent to an already positioned access can
`nula with a minimal additional exposure of the patient,
`physician and operating room staff to radiation and
`without unduly prolonging time spent in the operating
`room. A unilateral, biportal approach will allow for
`continuous visualization, identi?cation and extraction
`of nuclear fragments from the disc under discoscopic
`control. Large central herniations and partially ex
`truded fragments may be visualized and evacuated.
`Such a unilateral approach to place more than one per
`cutaneous portal in, for example, the L5-S1 vertebral
`joint, is also highly desirable because this procedure
`requires deflection of the patient’s spine to enable access
`on the one side, causing a corresponding restriction of
`access on the opposite side. Moreover, by using a unilat
`eral biportal approach, instruments do not need to tra
`verse across the disc nucleus from a second portal re
`mote from the symptomatic side. Therefore, the amount
`of non-symptomatic nuclear material removed by the
`unilateral approach is decreased as compared to the
`bilateral, biportal approach. This is important in pre
`venting collapse of disc space, which results in nerve
`compression and stenosis of the spinal canal. Also, an
`other signi?cant bene?t of the unilateral approach is
`that the musculature and soft tissue and disc are trauma
`tized on only one side of the back.
`The present invention provides a percutaneous surgi
`cal disc procedure, comprising the steps of percutane
`ously entering the back of the patient in a posterolateral
`direction with an access cannula, advancing said access
`cannula through a ?rst percutaneously created fenestra
`tion of the annulus of the disc, percutaneously entering
`the back of the patient in a posterolateral direction with
`an accessory cannula, and advancing said accessory
`cannula through a second percutaneously created fenes
`tration of the annulus adjacent to and on the same side
`of the disc as the first fenestration.
`The present invention also provides a method for the
`percutaneous decompression of a herniated interverte
`bral disc in a human patient, which comprises percuta
`neously entering the back of the patient in a posterolat
`eral direction with an access cannula, advancing the
`access cannula into the disc through a first percutane
`ously created fenestration of the annulus of the disc,
`percutaneously entering the back of the patient in a
`posterolateral direction with an accessory cannula, ad
`vancing the accessory cannula into the disc through a
`second percutaneously created fenestration of the annu
`lus adjacent to and on the same side of the disc as the
`?rst fenestration, removing nuclear material through
`one of the cannulae and observing the removal with an
`endoscope through the other cannula.
`
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`3
`In a broader sense, the present invention provides a
`method of percutaneously emplacing at least two can
`nulae in a patient, comprising percutaneously entering
`the back of the patient in a posterolateral direction with
`a ?rst cannula and advancing the ?rst cannula into the
`body of the patient to a position where the distal end of
`the ?rst cannula is at a ?rst predetermined location
`inside the body and the proximal end thereof projects
`beyond the outer surface of the back, securing a guide
`means to the proximal end of the ?rst cannula and using
`the guide means to guide a second cannula as it percuta
`neously enters the back of the patient in a posterolateral
`direction and is advanced to a second predetermined
`location relative to said ?rst predetermined location.
`The method of the present invention requires only a
`small incision to place the cannulae, since this biportal
`approach utilizes unilateral placement The unilateral
`biportal approach allows for continuous discoscopic
`control and visualization and provides adequate chan
`nels for ?uid management, which signi?cantly enhances
`the visual identi?cation of the posterior annulus. The
`method in accordance with the invention may be car
`ried out under local anesthesia, thus avoiding the risk of
`general anesthetics.
`The present invention is illustrated in terms of its
`preferred embodiments in the accompanying drawings,
`in which:
`FIG. 1 is a plan view of a guide wire useful in the
`present invention;
`FIG. 2 is a plan view, partly in section, of a cannu
`lated obturator useful in the present invention;
`FIG. 3 is a plan view, partly in section, of an access
`cannula useful in the present invention;
`FIG. 4 is a plan view of a trephine useful in the pres
`ent invention;
`FIG. 5 is an elevational view of a ?rst jig useful in the
`present invention;
`FIG. 6 is a view in section, taken along lines 6—6 in
`FIG. 5;
`FIG. 7 is an elevational view in section of a sealing
`adaptor useful in the present invention;
`FIG. 8 is an elevational view of a second jig useful in
`the present invention;
`FIG. 9is a view in section, taken along the lines 9-—9
`in FIG. 8;
`FIG. 10 is a schematic view of a ?rst access cannula
`inserted into the herniated disc;
`FIG. 11 is a view similar to FIG. 10 showing the use
`of the second jig to index a second access cannula rela
`tive to the ?rst access cannula; and
`FIG. 12 is a schematic view showing two access
`cannulae placed in the body of the patient.
`In the description that follows, instruments are gener
`ally made out of suitable austenitic stainless steel, unless
`otherwise speci?ed. While the surgical procedure de
`scribed herein refers to decompression of intervertebral
`lumbar discs, it is to be understood that the procedure is
`not limited to lumbar discectomy and may be used in
`any procedure for percutaneously emplacing at least
`two cannulae in a patient, such as an intervertebral disc
`procedure or operation.
`According to the method of the present invention,
`the patient is positioned on a radiolucent table in the
`appropriate prone or lateral position and a guidewire 10
`(FIG. 1), suitably of about 0.050 in. diameter, is ad
`vanced through the skin of the back posterolaterally
`under ?uoroscopic observation until the guidewire 10
`contacts the exterior symptomatic side of the annulus
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`5,395,317
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`?brosis of the herniated disc. Thereafter, the cannulated
`obturator 20 (FIG. 2), having a lumen with a diameter
`slightly larger than that of the guidewire 10, is passed
`over the guidewire 10 until the cannulated obturator 20
`contacts the external surface of the annulus ?brosis of
`the herniated disc. The removal of the guidewire 10 at
`this point is optional. An access cannula 300 (FIG. 3),
`suitably of about 0.25 in. outer diameter and having
`external gradations 31 of 10 mm, is then passed over the
`cannulated obturator 20 and advanced to the external
`surface of the annulus ?brosis. At this point, the guide
`wire 10 is removed if not previously removed. The
`inner diameter of the access cannula 30a is sized to
`closely ?t over the cannulated obturator 20. The cannu
`lated obturator 20 is then removed, and a 3 mm or 5 mm
`trephine 40 (FIG. 4) is introduced through the access
`cannula 30a. The trephine 40 has a plurality of saw teeth
`40a or other cutting members. The trephine 40 is ad
`vanced into the annulus of the disc, with rotation, creat
`ing an annular fenestration (that is, a bore) through the
`annulus ?brosis into the nucleus. The trephine 40 is then
`removed.
`The cannulated obturator 20 is reintroduced into the
`access cannula 30a and passed into the fenestration of
`the annulus. Fluoroscopic guidance may be utilized.
`The access cannula 30a is then advanced into the fenes
`tration of the annulus, with rotary movement. After the
`access cannula 30a is in the proper position, the cannu
`lated obturator 20 is removed. The proximal end of
`cannula 30a projects beyond the surface of the patient’s
`back (not shown) while the distal end is in the position
`shown in FIG. 10. The procedure described for place
`ment of cannula 30a into the annulus of the disc follows
`the procedure described in US. Pat. No. 4,573,448. As
`is known, suitable local anesthetic is used as appropri
`ate.
`Referring to FIG. 10, the procedure described above
`locates the distal end of the access cannula 30a adjacent
`the herniation 100 of the disc 101, which protrudes
`toward the posterior ligament 102 thus placing pressure
`on the nerves 103, which causes the pain characteristic
`of a herniated lumbar disc. First jig 50 (FIGS. 5, 6 and
`10) is slid downwardly over the proximal end of the
`access cannula 30a by passing the access cannula 300
`through the central bore 51 in the ?rst jig 50. Jig 50 is
`secured in place near the proximal end of cannula 3011
`by tightening the screw 53 thereby clamping the legs
`52a and 52b to the access cannula 30a.
`First jig 50 preferably has a plurality of smaller bores
`55 each having a diameter substantially the same as the
`diameter of the guidewire 10. The axes of the bores 55
`are spaced from and are preferably parallel to the axis of
`the large bore 51. Alternatively, jig 50 may have only
`one smaller bore 55. Moreover, the bores 55 may be
`oblique to the axis of the large bore 51.
`Under ?uoroscopic observation, the guidewire 10 is
`slid through a selected one of the small bores 55 so that
`the guidewire 10 will ideally be centered on the annulus
`?brosis. If necessary, a second guidewire 10 is passed
`through another of bores 55 and advanced toward the
`annulus ?brosis of the disc, while under ?uoroscopic
`observation. Proper positioning of the guidewire on the
`annulus is determined by palpation and, if necessary, by
`?uoroscopy. The surgeon can then evaluate the place
`ment of the guidewires and select the guidewire best
`positioned to provide the second fenestration of the
`annulus of the disc.
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`Having selected the desired guidewire 10, the other
`guidewire, if any, is removed, and the guidewire 10 is
`then introduced through the ?bers of the annulus ?bro
`sis for a distance of about three to about four millime
`ters. Jig 50 is removed, leaving the guidewire 10 and
`access cannula 30a in place.
`Second jig 70 (FIGS. 8, 9 and 11) is secured to access
`cannula 30a near the proximal end by passing access
`cannula 30a through bore 70a, passing the guidewire 10
`through bore 70b, and clamping legs 70c together by
`means of screw 70d. Cannulated obturator 20 is then
`advanced over the guidewire 10 by rotary movement
`through the bore 70b of the second jig 70 until the can
`nulated obturator 20 contacts the annulus ?brosis, as
`shown in FIG. 11. The guidewire 10 and jig 70 are
`removed leaving the cannulated obturator 20 in place.
`An accessory cannula 30b is passed over the cannulated
`obturator 20 and advanced toward the annulus ?brosis.
`Accessory cannula 30b is sized to slide in the annulus
`between bore 70b and the outer surface of cannulated
`obturator 20. The cannulated obturator 20 is then re
`moved, leaving the accessory cannula 30b in place.
`Although it is presently preferred to use second jig
`70, it is not necessary to do so. Moreover, while the
`bores 70a and 70b are presently preferred to be parallel,
`in some cases it may be desired to have one bore oblique
`to the other. Also, while it is presently preferred that
`cannulae 30a, 30b have the same inner and outer diame
`ters, one may have a smaller inner and/or outer diame
`ter than the other.
`The annulus ?brosis is inspected endoscopically
`through the accessory cannula 30b, and if satisfactory, a
`trephine 40 is passed through the accessory cannula 30b
`and a second fenestration is cut through the annulus
`?brosis into the nucleus. The trephine 40 is then re
`moved. The accessory cannula 30b is advanced into the
`annulus. Introduction of both cannulae into the annulus
`of the disc under fluoroscopic observation is carried out
`in a manner known per se, such as described in U.S. Pat.
`No. 4,573,448.
`Fragments of the herniated disc can be removed
`through the desired cannula 30a or 30b by inserting a
`trephine 40 in the desired cannula and moving it back
`and forth within the nucleus of the herniated disc as
`suction is applied. Alternatively, the trephine can be
`45
`removed and suction may be applied through the can
`nula itself. In another method, forceps, trimmer blades,
`suction punch forceps, laser lights, etc. are used to re
`move such fragments via one of the cannula.
`Preferably, however, before removal of nuclear ma
`terial, a sealing adaptor 60 (FIG. 7), which is suitably
`comprised of silicon rubber, is attached to the proximal
`extremity of the access cannula 30a and accessory can
`nula 30b, as shown in FIG. 12 with access cannula 30a
`and accessory cannula 30b received in bores 61a and
`61b of sealing adaptor 60. Insertion of access cannula
`30a and accessory cannula 30b into the sealing adaptor
`will stop when the cannulae contact shoulders 63 and
`64, respectively of bores 61a and 61b. Nuclear evacua
`tion through one of the cannulae 30a or 30b and simulta
`neous arthroscopic observation via the other of cannu
`lae 30a or 30b is possible by sealingly passing an arthro
`scope (not shown) into one of bores 62a and 62b and
`thence into one of cannulae 30a or cannula 30b, while a
`tool (not shown) is inserted into the other bore and
`65
`thence into the other cannula. Nuclear material may
`then be evacuated by a conventional powered surgical
`instrument (not shown) through the access cannula 30a
`
`6
`or accessory cannula 30b while under arthroscopic
`observation through the other cannula. A saline solu
`tion may be passed via the arthroscope through one
`cannula and excess ?uid may be evacuated through the
`other cannula. Direct visualization of the resection of
`the desired disc material is thus made possible.
`I claim:
`1. A percutaneous surgical disc procedure, compris
`ing the steps of:
`a) percutaneously entering the back of the patient in
`a posterolateral direction with an access cannula;
`b) advancing said access cannula through a ?rst per
`cutaneously created fenestration of the annulus of
`the disc;
`0) securing a guide means to said access cannula and
`orienting an accessory cannula relative to the guide
`means to guide said accessory cannula;
`d) percutaneously entering the back of the patient in
`a posterolateral direction with said accessory can
`nula;
`e) advancing said accessory cannula through a sec
`ond percutaneously created fenestration of the
`annulus adjacent to and on the same side of the disc
`as the ?rst fenestration so that the access cannula
`and the accessory cannula are oriented relative to
`each other on the same side of the disc.
`2. The procedure according to claim 1, wherein a
`surgical tool is operated through one of said cannulae.
`3. The procedure according to claim 2, wherein the
`operation of said surgical tool is observed through the
`other of said cannulae.
`4. A method for the decompression of a herniated
`intervertebral disc in a human patient, comprising the
`steps of:
`a) percutaneously entering the back of the patient in
`a posterolateral direction with an access cannula;
`b) advancing said access cannula into the disc
`through a ?rst percutaneously created fenestration
`of the annulus of the disc;
`0) securing a guide means to said access cannula and
`orienting an accessory cannula relative to the guide
`means to guide said accessory cannula;
`d) percutaneously entering the back of the patient in
`a posterolateral direction with said accessory can
`nula;
`e) advancing said accessory cannula into the disc
`through a second percutaneously created fenestra
`tion of the annulus adjacent to and on the same side
`of the disc as the ?rst fenestration so that the access
`cannula and the accessory cannula are oriented
`relative to each other on the same side of the disc;
`t) removing nuclear material from one of the cannu
`lae and observing the removal with an endoscope
`through the other cannula.
`5. A method for the decompression of a herniated
`intervertebral disc in a human patient, comprising the
`steps of:
`a) percutaneously entering the back of the patient in
`a posterolateral direction with an access cannula;
`b) advancing said access cannula into the disc
`through a ?rst percutaneously created fenestration
`of the annulus of the disc, said access cannula hav
`ing a distal end within said disc andaproximal end
`projecting beyond the surface of the patient’s back;
`0) securing a ?rst jig means to said access cannula’s
`proximal end, said ?rst jig means having at least
`one small bore therethrough;
`
`SO
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`f) percutaneously entering the back of the patient in a
`d) sliding a guidewire through said bore and embed
`ding said guidewire into the annulus ?brosis of said
`posterolateral direction with an accessory cannula;
`g) advancing said accessory cannula, with the use of
`disc;
`said embedded guidewire, into the nucleus of the
`e) removing said jig means from said access cannula;
`f) percutaneously entering the back of the patient in a
`disc through a second percutaneously created fen
`posterolateral direction with an accessory cannula;
`estration of the annulus adjacent to and on the same
`g) advancing said accessory cannula, with the use of
`side of the disc as said access cannula;
`said embedded guidewire, into the nucleus of the
`h) removing nuclear material from one of the cannu
`lae; and
`disc through a second percutaneously created fen
`i) observing the removal with an endoscope through
`estration of the annulus adjacent to and on the same
`the other cannula.
`side of the disc as the ?rst fenestration;
`7. The method according to claim 6, wherein after
`h) removing nuclear material from one of the cannu
`lae; and
`said ?rst jig means is removed from said access cannula,
`i) observing the removal with an endoscope through
`a cannulated obturator is percutaneously advanced to
`said disc by sliding said cannulated obturator over said
`the other cannula.
`guidewire, said accessory cannula is percutaneously
`6. A method for the decompression of a herniated
`advanced to said disc by sliding said accessory cannula
`intervertebral disc in a human patient, comprising the
`steps of:
`over said cannulated obturator, and after removal of
`a) percutaneously entering the back of the patient in
`said embedded guidewire and said cannulated obtura
`tor, a fenestration is created in said annulus ?brosis via
`a posterolateral direction with an access cannula;
`b) advancing said access cannula into the disc
`said accessory cannula and said accessory cannula is
`percutaneously advanced through said fenestration into
`through a ?rst percutaneously created fenestration
`of the annulus of the disc, said access cannula hav
`the nucleus of said disc on the same side of said disc as
`ing a distal end within said disc and a proximal end
`said access cannula.
`projecting beyond the surface of the patient’s back;
`8. The method according to claim 7, wherein after
`said ?rst jig means is removed from said access cannula,
`0) securing a ?rst jig means to said access cannula’s
`proximal end, said ?rst jig means having a plurality
`a second jig means having a bore therethrough is se
`of small bores therethrough arranged with their
`cured to said access cannula proximal end with said
`guidewire passing through said bore of said second jig
`axes parallel to one another and, when said ?rst jig
`means at least substantially parallel to the axis of said
`means is attached to said access cannula, spaced
`accessory cannula, and thereafter said cannulated obtu
`from and parallel to the axis of said access cannula;
`d) sliding a guidewire through a selected one of said
`rator and said accessory cannula are each advanced
`bores and embedding said guidewire into the annu
`through said bore of said second jig means to said disc
`and said nucleus, respectively.
`lus ?brosis of said disc;
`e) removing said jig means from said access cannula;
`* * * * *
`
`15
`
`20
`
`25
`
`45
`
`55
`
`60
`
` 8
`
`
`
`