% Medtronic
`
`Interbody Fusion
`
`DLIF Surgical Technique
`
`D RECT LATERAL
`
`
`
`I
`
`.1
`
`F T
`
`a MICHELSDN
`‘ TECHNOLOGY
`AT WOFIK
`
`N UVAOOOOO14
`NUVASIVE 2027
`Medtronic v. NuVasive
`|PR2013-00506
`|PR2013-00507
`|PR2013-00508
`
`1
`
`NUVASIVE 2027
`Medtronic v. NuVasive
`IPR2013-00506
`IPR2013-00507
`IPR2013-00508
`
`

`

`MAST onADRANTW DL
`Retractor System
`Illuminated surgical access with
`minimal soft tissue disruption
`Vertebral body stabilization pins
`to prevent [retractor migration
`
`CLYDFSDALP Spinal System
`Bullet nosed tip to aid in distraction
`Convex design to contact vertebral
`body end plates
`
`NlM-ECLIPSE‘a
`
`CD HORIZON? SEXTANT‘E’ || Percutaneous Rod Insertion
`
`N UVA0000015
`
`The Direct Lateral Interbody Fusion
`procedure provides spine surgeons with
`a complete minimally invasive solution
`for the treatment oldegenera ,ive lumbar
`conditions Ely utilizing a direr:t lateral
`approach to the spine, this procedure
`enables placement of a large i tterbody
`gratt into the dlSC space for anterior
`(,olurnn support while avoiding the
`obstacles associated with trad'tional
`
`
`
`anterior or pt'rsterior a pproat lies. The DLIF
`procedure intorporates a comprehensive
`t
`t
`t
`t
`set of Instr uments and rmplan ,s rrrr ludrng
`fljlly intengEd neurorrronitori 19'
`streamlined access irrstrumenration,
`anatomically designed implan is and
`perttrtarreous fixation systems.
`
`Spinal System*
`Advanced surgeon directed
`and neuro h
`iolo ist
`, dp ys
`g
`supporte
`neuromonitoring.
`Accurate and immediate
`warning of Potential harm
`to nerves with real time
`nerve proximity detection.
`
`System and CD HORIZON” LONGITUDE” Multi-Ievel
`Fixation System
`-
`‘
`Repmquc'b'e Pércumnews “’d and
`screw Implantation.
`Minimally invasive fixation for complex
`spine procedures.
`
`2
`
`

`

`% Medironic
`
`RECT LATERAL
`
`Interbody Fusion
`
`nsrrumem SH
`
`Jrewwmrive Planninc}
`
`HIWB' LIPSIE“ Spinal bysham Needle Elm Mode PIJK emenl
`
`Jaflent Posirimning
`
`Jucializarinr'm
`
`Dissec Hon m The P%( m
`
`leummm‘limling H‘nnugl’m The Psms’
`
`DildTiHl'l
`
`ieTmctmr le'en‘lel Ir
`
`Disc Prepamrk m
`
`Tr’ialing
`
`Transpsoas Approach
`DLIF Surgical Technique
`
`N UVA0000016
`
`
`
`n'wplam PIM'H‘HEI'H
`
`( Insure
`
`:Xplar'flafimw
`"Ixarinn
`
`erdum ()n’lming Immmal’lnn
`
`mpunan 1' valucl’ Ir'lfmrrr‘larh m
`
`3
`
`

`

`DLIF | SURGICALTECHNIQUE
`
`Instrument Set
`
`Retractor/Access Instruments
`
`
`
`
`
`Rotating Flex Arm Attachment
`(9568010)
`
`Stability Pin Driver
`(8970400)
`
`Rotate Kerrison Punch
`
`3mm (29—0068)
`
`5mm (2940069)
`
`Pituitary Rongeur
`Up (2940076)
`Straig ht (2940075)
`
`Retractor Blades
`
`9cm Left, Right (9567309, 9567319)
`10cm Left, Right (9567300, 9567310)
`11cm Left, Right (9567301, 956731 1)
`12cm Left, Right (9567302, 9567312)
`13cm Left, Right (9567303, 9567313)
`15cm Left, Right (9567305, 9567315)
`
`5”,
`
`x“;
`
`Stability Pins
`9cm (9569309)
`10cm (9569310)
`11cm 9569311)
`12cm 9569312)
`13cm 9569313)
`15cm 9569315)
`
`Guidewire-Trocar Tip
`Short (8670005)
`Long (8670002)
`
`5.3cm Dilator
`
`(9560420)
`
`10.6cm Dilator
`
`(9561421)
`
`
`
`16.0cm Dilator
`
`(9561422)
`
`20.8cm Grooved Dilator
`
`Direct Lateral Retractor
`
`(9561424)
`
`(9569000)
`
`N UVA0000017
`
`4
`
`

`

`Instrument Set continued
`
`
`Disposables
`
`DLIF | SURGICALTECHNIQUE
`
`3
`
`NIM® X—PAK Probe
`(9450069)
`
`NIM-SPINE® 23cm Ball-tip Probe
`(9450015)
`
`,f/f“ A
`
`x if;
`
`
`
`Bayoneted Discectomy Knife
`(9560659)
`
`MAST QUADRANT‘1m Illumination
`System (9560658)
`
`Flexible Arm
`
`
`
`Flexible Arm
`(9561524)
`
`Bed Rail Clamp
`(9561523)
`
`N UVA0000018
`
`5
`
`

`

`4
`
`DLIFI SURGICALTECHNIQUE
`
`Instrument Set Continued
`
`
`Disc Preparation Instruments
`
`w"
`
`Reverse Angle
`Serrated Cup Curette
`(2940055)
`
`Straight Ring Curette
`(2940056)
`
`10mm Cobb Elevator
`
`(2940057)
`
`g 1
`
`8mm Cobb Elevator
`
`(2940059)
`
`
`
`mm
`Combo Tool
`
`(2940050)
`
`vv.
`
`Angled Combo Tool
`(2940051)
`
`Reverse Angle
`Combo Tool
`
`(2940052)
`
`W S
`
`traight Serrated
`Cup Curette
`(2940053)
`
`“E
`
`Angled Serrated
`Cup Curette
`(2940054)
`
`
`
`/’/ A
`
`Shavers, 45mm length
`8mm (2941608) Green
`10mm (2941610) Blue
`12mm (2941612) Yellow
`14mm (2941614) Brown
`
`16mm (2941616) Purple
`
`Long Suction
`(2940200)
`
`Cannulated Reamer T—Handle
`
`(2900165)
`
`NUVA0000019
`
`6
`
`

`

`Instrument Set continued
`
`
`Disc Preparation Instruments («manned
`
`DLIF | SURGICALTECHNIQUE
`
`5
`
`Wide Nerve Root Retractor, Long
`(9561 554)
`
`6/8mm Distractor
`
`(29401 86)
`
`Bayoneted Penfield 4
`(9569650)
`
`
`Implant Instruments
`
`fix \
`
`
`
`Threaded lnserter
`
`(2982001)
`
`Removal Tool
`
`(2982002)
`
`7-5,-
`.géAf'gll t,
`
`Slap Hammer
`(9074002)
`
`8mm Trial/Distractor
`
`45mm (2986845)
`50mm (2986850)
`
`|
`U
`
`55mm (2986855)
`
`I”
`
`10mm Trial/Distractor
`
`45mm (2986045)
`50mm (2986050)
`55mm (2986055)
`
`|
`U
`I”
`
`12mm Trial/Distractor
`
`|
`45mm (2986245)
`50mm (2986250) U
`55mm (2986255)
`I“
`
`14mm Trial/Distractor
`
`45mm (2986445)
`50mm (2986450)
`55mm (2986455)
`
`|
`U
`I”
`
`16mm Trial/Distractor
`
`|
`45mm (2986645)
`U
`50mm (2986650)
`55mm (2986655) ”I
`
`NUVAOOOOOZO
`
`7
`
`

`

`NUVA0000021
`
`8
`
`

`

`Preoperative Planning
`
`Preoperative planning can be useful in determining:
`
`>> Location of the iliac crest and lower ribs in relation to disc space of
`interest (Figure 1)
`
`>> Position of the anterior vasculature and posterior nerve structures via axial l\/lR|
`
`>> Curvature ofthe spine (Figure 2)
`
`Although infrequent, a few patients may have a deep—seated L4— L5 disc space
`that could be difficult to reach via a direct lateral approach, even iftable breaking
`options are employed Obtaining standing anterior—posterior x—ray images with
`the patient bending laterally can help determine whether or not a level can be
`accessed above the iliac crest.
`
`Standard lateral surgical positioning is right lateral decubitus, or left side up,
`however the surgeon should consider ease ofaccess and surgeon preference in
`determining which side to approach. Correction can be achieved equally from
`either the convex or concave side ofthe curve. However, approaching from the
`concave side allows the skin incision to be minimized in some cases.
`
`
`
`Figure I
`
`Figure 2
`
`DLIF| SURGICALTECHNIQUE
`
`7
`
`N UVA0000022
`
`9
`
`

`

`8
`
`DLIF| SURGICAL TECHNIQUE
`
`NIM—ECLIPSE® Spinal System Needle Electrode Placement
`
`After the patient is asleep, needle recording electrodes are m
`placed in the innervated muscles in the legs to monitor
`the affected nerve roots during the procedure Please
`Let the anesthesiologistknow Ell/16 monitoring Will
`follow the instructions below, as well as the accompanying
`be used during the procedure to ensure {/70an
`electrode placement 9“er to correctly place the
`neuromuscu/ar blocking agents are administered
`electrodes in the appropriate muscles for the desired levels.
`during monitoring. During intubation a fastvacting
`i. Electrodes are placed prior to patient draping and the
`”EUTOWUSCU/Or ”CC/(”79 UQEIVTShOU/d be U564-
`establishment of the sterile field.
`
`2. Clean the areas with alcohol wipes.
`
`3. The green lead ground electrode should be placed
`between the stimulator and the monitoring electrodes
`in a location where the bone is close to the skin and the
`electrode will not contact muscle.
`
`4. The white stimulus retum electrode should be
`
`placed near the location of stimulation. Connect the
`Probe lead wire to the instrumentjack ofthe patient
`interface module.
`
`5. Tape all ofthe electrodes securely in place and plug
`the leads into the patient interface box and turn on the
`‘NllVl—ECLIPSE® Spinal System to begin monitoring.
`
`Sample L215 Setup
`
`Active: needle inserted four to five fingerbreadths (fb) below
`the pubic tubercle and deeply into the palpable muscle belly.
`
`Reference: needle inserted subcutaneously above the
`active needle.
`
`(’I'iaiiriel {T-
`
`ngl’it L2 7 L3 AL
`Right L2 — L4 VL
`
`Adduc‘ror Longus (AL)
`
`Active: insert needle tangentially but deep into muscle belly
`one handbreadth above the patella.
`
`Reference: insert needle subcutaneously at patellar tendon.
`
`i2
`
`liunn-Pl h
`
`NIM~ECLIPSE® Spinal System is manufactured by Axon Systems, inc. Distributed by Medtronic.
`
`NUVA0000023
`
`Vastus Latera/is (i/L)
`
`10
`
`10
`
`

`

`NIM-ECLIPSE® Spmal System Needle EIGCtrOde Placement eominued
`
`DLllF | SURGICAL TECHNIQUE
`
`9
`
`Active; insert needle into in uscle belly three fb above the midpoint
`of the bl—malleolar llne (lateral to the tibial crest).
`
`Reference: insert needle over the tibial crest (chin).
`
`EHL lr’litliii‘I-e'l 7
`
`Right L5
`
`Active: insert needle into: the muscle belly one handbreadth below
`the posterior crease of the knee;
`
`Reference: insert needle subcutaneously 2cm to 3cm away from the
`active electrode.
`
`1- Law 42 mm
`m mama am
`
`Extensor Hallucr's Longus {EHO
`
`Ground
`
`Stimulus Return ;‘
`
`Ground/Stimulus Return
`
`N‘UVA0000024
`
`11
`
`11
`
`

`

`10
`
`DLiF | SURGICAL TECHNIQUE
`
`Patient Positioning
`
`The patient is placed in the lateral decubitus position and should be
`positioned so that the top otthe iliac crest is in line with the break ofthe
`radiolucent surgical tablet An axillary roll is placed to protect the neurovascular
`structures in the axilla. Padding is placed between the arms to ensure they
`remain suspended in the neutral position. The top leg ofthe patient should be
`flexed in order to relax the psoas muscle and prevent spreading ofthe nerves
`across the psoas. Padding is also placed beneath and in between the legs from
`the knees distally (Figure 3).
`
`The patient is secured to the surgical table with tape at four locations (Figure 4):
`
`1.
`
`Just beneath the iliac crest
`
`2‘ Over the thoracic region, just beneath the shoulder
`
`3.
`
`From the back of the table, over the ankle, and pastthe knee to
`the front ofthe table
`
`4.
`
`From the shin to the back ofthe table
`
`Starting in a reverse trendelenb‘urg position, the head of the table is dropped
`and a slight flexion is applied to the surgical table. This technique allows for
`better access to the lumbar spine by increasing the distance between the iliac
`crest and lower rib as well as by opening up the disc to be entered.
`
`m—
`
`For certain tables, the bed must be set up in the reverse
`position to ensure that the C—arrn has adequate
`room to maneuver under the break of the table.
`
`
`
`
`
`
`Figure 4
`
`Figure 3
`
`12
`
`N UVA0000025
`
`12
`
`

`

`Patient Positioning continued
`
`First, a true AP image should be obtained to ensure the
`patient is positioned in a true lateral position On the AP
`X—ray, clear, distinct pedicles that are equidistant from the
`spinous process should be visible. (Figure 5). Then a lateral
`X—ray is obtained and clean, distinct end plates should be
`seen (Figure 6).
`
`“—
`
`lt is critical the C—arrn remain in the 0 and 90 degree
`positions at all times to ensure a safe lateral working
`channel across the disc space. For mu/ti level
`cases, rotate the surgical table independent of the
`C—arrn for each level to re—obtain true images.
`
`DLIF | SURGICALTECHNIQUE
`
`11
`
`FigureS
`
`
`
`
`Flgure 6
`
`13
`
`N UVA0000026
`
`13
`
`

`

`112
`
`DU”;
`
`
`
`
`SURGICAL TEE ~ [VI-QUE-
`
`Localization
`
`Fluoresce py is used t9 confirm the target segment and
`mark the location for the initial incision. For a single—level
`case the patient should be marked over the midgectien
`at the target disc and an approximately 3an horizontal,
`vertical or oblique incision can be made (Figure 7). For
`a two—level case, the patient should be marked over the
`mid-section of the intervening vertebral body (Figure 8).
`
`We ' Helpful Tip
`
`it may be possible to access multiple levels through
`
`one vertical skin incision, depending on the anatomy
`and curvature ofthe spine. A/ih ough a single
`incision may be Used to reach multiple levels, the
`surgeanzmust perfarm‘ separate dilatians thraugll
`the psoas for each operative disc space
`
`
`
`Figuire 7
`
`
`
`Figure 8
`
`14
`
`NUVAODOOOZ7
`
`14
`
`

`

`Dissection to the Psoas
`
`Step1 After making a single skin incision, the
`subcutaneous fat layers are dissected until the
`abdominal musculature is reached. A monopolar
`cautery may be used for hemostasis and a small
`self—retaining retractor can be used for initial
`dissection of the skin and subcutaneous layer.
`
`Step2 The external oblique fascia will be the first plane
`encountered and is the only layer thatwill need to
`be sharply incised. A Kelly Clamp is then used to
`bluntly spread through the fibers of the external
`oblique, internal oblique and transversalis muscles.
`All dissection is done in line with the muscle fibers
`
`as these muscles layers run in opposite directions.
`After bluntly penetrating the transversalis facia, the
`yellow retroperitoneal fat is exposed (Figure 9).
`
`Par/paring the auadratus muscle, followed by the tip ofthe
`transverse process and finally the psoas muscle will verily
`that the correct retroperitoneal plane is being entered
`and ensures that the peritoneum is not compromised
`
`DLIF
`
`SURGICALTECIINIQUE
`
`13
`
`Step 3 Once inside the retroperitoneal space, the index
`finger is used to follow the internal abdominal
`wall posteriorly down to the psoas muscle, which
`can be visualized. Use of the finger to sweep the
`peritoneal contents as well as the retroperitoneal
`fat anteriorlywill allow a clear path down to the
`psoas muscle (Figure 10).
`
`
`
`
`a.” mominis
`. muscle-
`
`Figure 9
`
`
`
`15
`
`N UVA0000028
`
`15
`
`

`

`14
`
`DLIF | SURGICALTECHNIQUE
`
`Neuromonitoring through the Psoas
`
`Step 1 After a safe retroperitoneal pathway to the psoas
`has been established, the Nll\/l® X—PAK Probe is
`guided down to the psoas while using the finger
`to protect the peritoneal membranes The NilVi®
`X—PAK Probe includes an electrified handle stylet
`assembly and an insulated cannula that enables
`controlled electrification at the tip of the device
`(Figure 11).
`
`Step 2 A Needle Driver is used to position the NWl® X—PAK
`Probe onto the top surface of the psoas. The entry
`point of the Nlivl® X—PAK Probe into the psoas
`should be targeted between the anterior halfto
`third of the disc space in order to avoid the nerves
`ofthe lumbar plexus and to remain posterior to
`vascular structures. Cadaver studies have shown
`that the motor nerves typically reside in the
`posterior one third ofthe psoas muscle (Figure 12)
`Lateral fluoroscopy is used to make adjustments
`until the NIME‘ XPAK Probe is in the proper position
`(Figure 13).
`
`'
`
`'
`
`23
`
`ii
`
`2X3
`35
`
`Si
`
`Figure l 2
`sxs
`Figure ii
`
`EH
`4:
`
`4i
`
`415
`55
`
`Si
`
`Figure 73
`
`N UVA0000029
`
`16
`
`16
`
`

`

`DLIF | SURGICAL TECHNIQUE
`
`15
`
`Neuromonitoring through the Psoas continued
`
`Step 3 After the proper position has been established,
`carefully pass the Nll\/l® XPPAK Probe through the
`psoas muscle. As the fibers of the muscle are
`being split, current is delivered to monitor for any
`neural structures. The recommended stimulating
`current setting is between 6—8 milliamps. lfan Elle
`response is generated at this level, the NIl\/l® X—PAK
`Probe should be repositioned slightly anterior until
`a nerve free pathway is located (Figure 14).
`
`Step 4 After the N|l\/l® X—PAK Probe has safely dissected
`through the psoas, the tip of the probe as well
`as a portion ofthe insulated cannula should be
`tapped into the disc space to secure its location
`(Figure 16).
`
`Step 5 AP fluoroscopy is used to confirm proper probe
`alignment into the disc space and the blue
`stimulating handle is then removed, leaving only
`the insulated cannula within the disc space. A
`
`,_
`
`-"Helpfum"
`When monitoring with the AIM—ECLIPSE“) Spinal System, the
`surgeon has the additional option ofsetting the machine
`to nerve proximity mode. in this mode, the system will
`send out a cycling current to continuously search for the
`stimulus threshold required to elicit an EMG response.
`The displayed current value will decrease as the l\//l\/l®
`X—PAK Probe is moved closer to a nerve. Ensuring threshold
`
`guidewire is then placed through the cannula into
`
`the desired disc space and its position confirmed
`Wlth AP fluoroscopy (Flgure 17)
`
`values above 8 mill/amps is recommended (Figure 75).
`
`
`Figure i6
`
`Figure l7
`
`Figure 75
`
`17
`
`NUVA0000030
`
`17
`
`

`

`16
`
`DLIF
`
`SURGICALTECHNIQUE
`
`Dilation and Retractor Placement
`
`With the Guidewire in place, sequential dilation -HelpfulTip
`
`"
`
`To minimize the amount ofresidual muscle, employ
`a backand forth twisting motion with each dilator
`and use AP fluoroscopy to confirm that each dilator
`W5 reached the d/5CSPGC3 The fir“ dilator may
`be extended slightly into the discspace to ensure
`complete 07/0le “”0119”? tlie/95005 mUSC/er
`
`Step 1
`
`Step 2
`
`is used to spread the fibers of the psoas up to a
`diameter of 22mm and free—running ElVlG is active
`
`to detect any mechanical affect to the nerve roots
`(Figure 18)
`Measure the depth from the skin to the disc space
`using the graduated markings on the dilators and
`select the appropriate retra ctor blades (Figure 19).
`Attach the blades to the Direct Lateral Retra ctor
`
`Dilator (Figure 20),The Retractor should be
`
`base and place the assem bly over the Grooved m
`advanced employing a baCk and forth twisting
`The grooves on the largestdilator should be aligned
`motion with only gentle downward pressure
`cepha/ad and caudal and must be aligned with the
`thiO‘UQh the faSCla and mUSCle- Thls technique
`corresponding retractorStabi/ity Pin channels on the blades.
`helps To ensure the facial and m uscle fibers are
`Failure to mate the grooves could cause the blades to splay.
`not pulled down into the surgical corridor
`
` Figure 79
`
`.qo‘giqq'fiquil-iumiv
`
`
`18
`
`NUVAOOOOO31
`
`18
`
`

`

`DLIF| SUEGICALTECHNIQUE
`
`17
`
`Dilation and Retractor Placement continued
`
`Step 3 The Retractor Assembly is then attached to
`the Flexible Arm using the Rotating Flex Arm
`Attachment to provisionally maintain retractor
`position (Figure 21 )i
`
`Step 4 Use the NlW Ball—ti p Probe to test both Stability
`Pin channels ofthe Retra'ctor Blades to ensure
`a nerve free pathway before placing a pin
`(Figure 22).
`
`
`
`Figure 2 i
`
`19
`
`NUVA0000032
`
`19
`
`

`

`18
`
`DLIF| SURGICALTECHNIQUE
`
`Dilation and Retractor Placement continued
`
`Step 5 Insert a Stability Pin through one of the retractor
`blades to help prevent retractor migration during
`the procedure (Figure 23) U56 the Stability
`Pl“ DFlVEF to thread the Pl“ l“ the ChaWEl 0f
`whichever blade is closest to the end plate
`(Figure 24).
`
`Step6 With the Stability Pin in place, the DilatorTubes
`are removed, leaving only the Retractor Assembly
`and Guidewire. The Guidewire may be left in
`place as a final reference point to verify position.
`t
`_
`Step 7 A final lateral fluoroscopy image IS taken to
`confirm proper retractor placement over the
`lateral spine (Figure 25).
`
`l
`.g
`
`Important
`
`Placemehtnear the end plate will avoid the middle ofthe
`vertebral body where the segmental vessels typically course
`
`
`
`Fig ure 23
`
`Figure 24
`
`
`
`Figure 25
`
`20
`
`NUVA0000033
`
`20
`
`

`

`DUF| SURGICALTECHNIQUE
`
`19
`
`Disc Preparation
`
`Step1 The MAST QUADRANT‘W‘ Illumination System is
`attached to the retractor blades by placing the
`metal tips of the light source into the holes on the
`top of the blades and then sliding the tips under
`the built—in retaining sleeves. (Figure 26).
`
`Step 2 Typically, a thin layer ofsof‘t tissue will remain at
`the base of the retracto’r blades. The NllVl" Ball—tip
`Probe is used to stimulate in all four quadrants
`at the Retractor Base in order to identify any
`nerve structures that may be present in the
`residual muscle.
`
`
`
`FigureZé
`
`21
`
`NUVAOOOOO34
`
`21
`
`

`

`2O
`
`DLIF | SURGICALTE‘CHNIQUE
`
`DiSC Preparation cominued
`
`Step 3 A Penfield 4 is then used to sweep the residual
`muscle off of the disc space until the annulus
`is visualized,
`
`Step 5 A thorough discectomy is then performed using
`pituitaries and other disc preparation instruments
`(Figure 29).
`
`Step 4 The annulus is then incised and an annulotomy‘
`at least 18mm in length is created using the
`Bayoneted Knife (Figures 27 and 28).
`
`
`
`Figure 79
`
`
`
`Figure 27
`
`
`
`Figure 25
`
`22
`
`NUVAOOOOO35
`
`22
`
`

`

`DLIF
`
`SURGICALTECHNIQUE
`
`21
`
`Disc Preparation continued
`
`Step6 A large Cobb is passed along both end plates to
`the contralateral annulus (Figure 30) A mallet
`is then used to gently release both the superior
`and inferior aspects of the contralateral annulus
`(Figure 31). This step is critical to ensure that
`appropriate distraction and coronal alignment can
`be achieved.
`
`Step 7 A Paddle Style Shaver is placed into the disc space
`and rotated several times to clean the end plates
`(Figures 32 and 33). A/P fluoro should be used
`to center the shaver in the disc before turning.
`The appropriate sized shavers should be carefully
`selected to ensure the end plates are
`not compromised.
`
`
`
`Figure 30
`
`Figure 32
`
`
`
`Figure 3 I
`
`Figure 33
`
`m—
`
`It is important that the working trajectory of the instruments
`stay perpendicular to the floor in order to avoid injury to
`vessels or nerve structures.
`
`23
`
`N UVAOOOOO36
`
`23
`
`

`

`22
`
`DLIF
`
`SURGICAL TECHNIQUE
`
`Disc Preparation continued
`
`Step 8 Serrated curettes, a Ring curette, Combo Tools
`are used to ensure proper end plate preparation.
`It is extremely important that the end plates be
`meticulously prepared for fusion by removing the
`cartilaginous disc without destroying the cortical
`
`end plates (Figure 34 and 35).
`
`Figure34
`
`Figure 35
`
`24
`
`NUVAOOOOO37
`
`24
`
`

`

`DLIF] SURGICALTECHNIQUE
`
`23
`
`Triah'ng
`
`Step 1 The disc space is sequentially distracted with Trials
`until adequate disc space height is obtained and
`adequate foraminal size is restored.
`
`
`
`Step 2 ’he Trial is passed through the Retractor and
`mpacted into the disc space. A properly sized
`‘rial should be centered with the spinous
`process and span the ring apophysis in order to
`reach fully across the vertebral body end plate
`(Figure 36 and 37).
`
`
`
`Figure 37
`
`Figure 36
`
`25
`
`N UVA0000038
`
`25
`
`

`

`24
`
`DLIF
`
`SURGICALTE‘CHNIQUE
`
`Implant Placement
`
`Step 1 Once trialing is complete, the corresponding
`CLYDESDALETM Spinal System implant is attached to
`the Inserter (Figure 38). if using a lordotic implant,
`take note ofthe anterior side of the implant,
`marked ”ANTERIOR”.
`
`Step 3 After the implant is positioned in the center of
`the disc space from a medial/lateral perspective,
`the inserter is unthreaded from the implant and
`removed (Figures 39,40, and 41).
`
`Step 2 Before inserting the CLYDESDALETM Spinal System
`device, place autograft in the implants central
`cavity. A mallet is then used to gently insert the
`implant While monitoring placement under AP
`fluoroscopy. Care should be taken to ensure
`the CLYDESDALETM Spinal System implant is
`
`Figure 39
`
`aligned properly.
` figure 38
`
`
`’
`
`“$-
`
`
`mmumm-“
`gumnumuE
`
` ’'uuuuuuuu
`
`‘
`IIIIHIINII‘H
`
`
`
`Figure 4/
`
`NUVAOOOOO39
`
`26
`
`26
`
`

`

`DLIF| SURGICALTECHNIQUE
`
`25
`
`Closure
`
`Step 1 After the autograft material has been inserted into
`the disc space, the Stability Pin may be unthreaded
`and removed.
`
`Step 3 The surgical site is irrigated appropriately and the
`fascia over the external oblique is then closed with
`interrupted vicryl suture.
`
`Step 2 The retractor is then detached from the Flex Arm
`and the Retractor Blades are carefully Withdrawn
`from the surgical site. As the Retractor is removed,
`the muscle and fat layers can be visualized closing
`back into place
`
`Step 4 Finally, the subcutaneous layers and skin are closed
`and the skin is sealed With skin adhesive.
`
`27
`
`N UVAOOOOO4O
`
`27
`
`

`

`26
`
`D‘LIF
`
`SURGICAL TECHNIQUE
`
`Explantation
`
`Should it be necessary to remove or reposition the
`CLYDESDALE1M Spinal System device,the Removal Tool may
`be used.
`
`To remove the implant, first fit the tips of the Removal Tool
`with the divots at the end of the implant (Figure 42). Next,
`
`depress the trigg‘erto lock onto the implant. Finally, attach
`
`the Slap
`ammer to the Removal Tool and gently impact
`
`the Slap ammer to facilitate implant removal (Figure 43).
`
`
`
`Figure 42
`
`
`
`Figure 43
`
`28
`
`N UVA0000041
`
`28
`
`

`

`DLIF| SURGICALTECHNTQUE
`
`27
`
`Fixation
`
`Supplemental instrumentation is then placed according
`to the appropriate surgical technique. The CLYDESDALETM
`Spinal System can be used with any Medtronic posterior or
`anterior fixation system.
`
`» CD HORIZON® SEXTANT® ll
`
`Percutaneous Rod System
`iVlulti—level Percutaneous Fixation
`
`» CD HORIZON® LONGlTUDE®
`
`29
`
`N UVAOOOOO42
`
`29
`
`

`

`28
`
`DLIF | SURGICAL TECHNIQUE
`
`Product Ordering Information
`
`INSTRUMENT CASEZ
`INSTRUMENT CASE 1
`SP502027 — CLYDESDALE‘” Trial and Inserter Removal Trays
`SP502028 — Retractor and Kerrison Pituitary Trays
`
`Part Number Description
`Set Quantity
`Part Number Description
`Set Quantity
`
`Trials
`2986845
`2986850
`2986855
`2986075
`2986050
`2986055
`2986215
`2986250
`2986255
`
`2986
`5
`2986150
`298655
`298664 5
`2986650
`2986655
`
`
`
`
`
`8 x 45 DLTrial
`8 x 50 DL Hal
`8 X 55 1111131
`o x 45 j :13
`0 X 50 3:13
`0 x 55 3:11;:
`2 X 45 351-3
`2 x 50 Dina
`2 X 55 1’13
`2X 45 3:113
`2 X 50 )7 r'a
`"x 55 3:16
`6 X 45 3:13
`6x 50 3:19
`6 x 55 Bfria
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Instruments
`9074002
`2982002
`2982001
`
`Slap Hammer
`DL Removal Tool
`DLThreaded Inserter
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Retractor, Blades, Pins, and Driver
`9569000
`Retmor 8399
`95680 0
`Rotating Flex Arm Auachmen
`95673 g
`9cm Retractor Bade Internal
`11, R‘gh
`9557309
`9cm Retractor B ade Internal
`'1, Left
`
`0cm Retractor Blade Internal P’n, ngh
`95673 0
`9567300
`‘Ocm Retractor 3|adc lntcma 319; 40,
`
`95673 1
`1cm Retractor Blade Internal 3n, R’gh
`9567301
`‘ lcm Retractor 3|ade lntema 319; 49
`
`95673 2
`2cm Retractor Blade Internal j'n, R'gh
`‘2cm Retractor 3lade Interna 3In, e
`9567302
`95673 3
`3cm Relrador Blade Internal 31r1,Righ
`9567303
`3cm Retractor Blade Intema ’10, 9
`95673 5
`5cm Retractor Blade Internal Jin, Rig
`9567305
`Scm Retractor Blade Interna ’19 49
`9569309
`9an Blade Pin
`95693 0
`Gem Blade Pin
`1
`2:: :23: :2
`1
`3““ Blade Pm
`5cm Blade Pin
`Stability Pin Driver
`
`
`
`:2: i
`95693 3
`95693 5
`8970400
`
`
`
`Dilators
`
`9560420
`
`9561421
`9561422
`9561424
`Guidewires
`8670002
`8670005
`
`5.3cm Dilator
`
`10.6cm Dilator
`16'0““ Dim”
`20.8cm Grooved Dilator
`
`Guidewire Sharp (long)
`fzgavgiggfizglfi)
`'
`’
`
`,
`.
`Kerrisons and Pituitaries
`2940068
`3mm Rotate Kemson PunCh
`2940069
`5mm Rotate Kerrison Punch
`
`2940075
`2940076
`
`P11111130, Rongeur, 4 X 10 511319111
`Pituitary Rongeur,4 X 10 Up
`
`
`
`2
`2
`
`:
`2
`2
`1
`
`1
`
`1
`l
`1
`
`2
`2
`
`1
`1
`
`1
`1
`
`1
`1
`1
`1
`1
`1
`1
`1
`1
`1
`1
`1
`1
`1
`1
`
`1
`1
`1
`
`
`
`2
`
`INSTRUMENT CASE4
`SP502029 — Instrument Trays 1 and 2
`
`Part Number Description
`Set Quantity
`
`
`
`Disc Preparation Instruments Tray 1
`294 0050
`Combo Tool
`2940051
`Angled Combo Tool
`294 0052
`Reverse Angle Com bo 1001
`2940053
`Straight Serrated Cup Curette
`294 0054
`Angled Serrated Cup Curette
`29! 0056
`Straight Ring Curette
`294 0055
`Reverse Angle Serrated Cup Curette
`2943057
`10mm Cobb Elevator
`2910059
`18mm Cobb Elevator
`
`Disc Preparation Instruments Tray 2
`2910186
`6/8mm Distractor
`9561554
`Wide Nerve Root Retractor, Long
`9569650
`Bayoneted Penfield 4 Push/Pull
`Long
`Long Suction
`Cannulated ReamerTeHandle
`
`2940200
`2900165
`
`2941608
`2941610
`2941612
`2941614
`2941616
`
`8mm Shaver, 45mm length
`10mm Shaver, 45mm length
`12mm Shaver, 45mm length
`14mm Shaver, 45m m length
`16mm Shaver, 45mm length
`
`1
`1
`1
`1
`1
`N UVA0000043
`
`30
`
`30
`
`

`

`DLIF l SURGICAL‘TECIMQUE
`
`29
`
`Product Ordering Information wnfinued
`
`DISPOSABLE CASES
`SP500589 — Disposables
`
`Part N umber Description
`Set Quantity
`
`CLYDESDALE‘“ SPINAL SYSTEM IMPLANTS
`.
`.
`
`Part Number
`Description
`
`6° CLYDESDALE" Spinal System SPSOztl 56
`29é88’45
`8mm X mm
`
`NIM-SPINEa Probes, Dilator, Light Eourcej and Knife
`945001
`N IM'SF‘I man p mm
`1
`
` MA , QUADRAW‘“ illuminafianfiys'tem
`
`9560659
`
`Bayanefied Di5ce€tcmy Knife
`
`1
`
`
`296.9450;
`
`
`INSTRUMENT CASE 3
`SP500586 — Flex Arm Tray
`Part Number Description Set Quantity
`
`
`
`iJH"‘J
`U”,
`
`2mm x45mm
`
`J
`
`2968245
`
`
`
`
`
`Bed Rail Clamp
`
`Flair Armand Attachment
`
`9561523
`
`2969050:
`
`296.9243
`
`296.
`
`,
`
`..
`
`fimmxfi‘srr‘m‘
`
`31
`
`NUVAODZGOOM
`
`31
`
`

`

`3O
`
`DLIF | SURGICAL TECHNIQUE
`
`Important Product Information
`
`
`
`
`
`
`
`lltiPORiAAT lhliltRi/tAilON EUR MEE‘ERONlE SOEAileR DANEK iNSiiitlileNiE
`Purpose:
`This irstrunent is intended for use in surgical procedures,
`Description:
`Unless otherwise stated, ins-iruments are made out ofa var ety of materials com monly used in orthopedic atd
`neurological pi‘ocecuies incliding stainless steel and acetyl copolyner materials which meet available national or
`international standards;
`
`'fi:ations Snme instruments are made out ofalumtnittm, and somewith handles made
`of resin onded composttes, and whilethese can be steam autoclaved, certain cleaning titids must not be employed.
`one ofthe instruments should be implanted
`Intended Use:
`his irs runent isa precisron device which may inzorparate a measuring functior anc has uses as described on the
`abet.
`.inless abeled or single usethis instrument may be refused.
`there is any to ub’or unce tainty concerning the pro pet use otthis instrument, please contact MEEJTROtilC SOEAMOR
`iANEt (usiomei Service for inst uctiuns. Any aya table surgical techniques Will be provided at no charge.
`Warnings:
`he ine hcds ouse ot instrtments are to be determined by the user‘s expenenceandtraining in surgical procedires
`3 not use this insnumentfor any acnon for which it was rot intended such as l'ian'imenng, prying, or lifting.
`his trstrunent should we, treated as any arecision instrument and stoulrl be carefully placed on tnys, cleaned after
`1
`:ach use, and s ored in a dryenvrronmeni.
`o ayoi
`inyury,the instrumentshould becarefullyexamined prior to useforfunctionality or damage A damaged
`instiiimerrshculd not be used Additional backfiip ii'istruments should be available in case ofan unexpected need
`MEDTRONlE SO ’AA/rOR DANEK does not and cannot warrantthe use ofttis instrument no any oftte component
`arts upor wh ch repairs have been made or attempted except as performed by l/lEDTintllE SDEAl/lOR DANEK or an
`autho‘ized MEDTROle SOEAMOR DANEK repair representative
`mplied warran iesofmerchantabilityand titres; for a particular th’pOE-E or use are specifically excluded. Seethe MED
`:atalog for further information aaoutwarrantres and limitations of liability.
`[i NOi li/iF‘LA
`iHEliiLTihUMENiS.
`Possible Adverse Effects:
`treakage, slippage, misuse, or mishandling of instrumen s, such as on s tarp edges, nay cause mum to the patient cr
`operative personnel.
`mproper main enance, handling, or aoorcieaning procedures can render the instrument unsu table for its intended
`urpose, or even dcnge’ousto the patient or surgical staff
`ropei patient selection and operative care are crit cal tothe sutcessoft ie devicean avoidanceofiniu’yduring
`surgery. Read and follow all other product infor matron supplied by the manufacturerofthe implants ortlte
`instruments
`Special precautionsare’ieeced cunngpedratricuse l'zreshould betaket when usin
`stncethese patientscan be inoresusceptibietu the stresses involved int reir use.
`Thereare particular risks involved in the use of instruments used for bending and cutting rods. ii'ie use. ofthesetypes of
`instrurnerrs can cause mum to the patient by Virtue of theextrentely high forces which are involved. Do not cut rods
`in sttu. in addition, any oieakage ofan instrument ofthe implant in this SitdaiiOii cou d be extremely hazardousihe
`physical chararteristics iequ red for manyinstiuments does not permitt rem to be manufactured from implantable
`naterials, and if any broken fragmen’s ofinstruments remain in the bocy ota patien , they could cause allergicor
`ti’ifecttous consequences.
`Over-bending, notching, striking and scratching ofthe implants with any instrument should be
`avoided to reduce the risk of breakage. Under no Circumstances 3 odd rods or plates be study or reverse bent,
`since this woiiid reducethe’atigue life ofthe rod and increasette risk 0 breakage W en the configuration ofthe
`
`bon
`annot be titted with an availabledeyiceanc contour ng ofthe deuce isabsolutely rev
`ry. contour ng should
`be performed only with propei tending equipment, and SfiUtJlL be performed gradua ly and With great care to avoid
`notching or scratch rig the device.
`Extreme care should betaken to ensuretttat this ir strunent remains in good working order Any surgical techniques
`applicablefcir use ofthis system should be carefully followed. During the procedure, successfu utilization ofthis
`tnstrumeni ii-extremelylmportatt Unless labeled for singe use, this instrumentmay be reused. This mstrtment
`should not be bent or damaged n any way. Misuse ofthis instrument, caustng corroston,“freezrng up”, scratching,
`loosening, bending and/or fracture ofan'y or all sectioi'softhe instrument may inhibit or prevent proper function.
`it is importantthatthe surgeon exercise extreme caution when working in close pioxrnityto yital organs, nei yes or
`vessels, and that theforces applied whilecorrecting the position ofthe instrumentation is not excessive suct that it
`n‘ight cause iryury to the patient.
`Exce
`lye force applied by instruments to implants can dislodge dey ces, particularly hooks.
` 3t“ ( that may considerably modifythe phystcal characteristics
`Nayerexpose instruments to temperatures in excess of
`oitlie instruments.
`
`
`
`instrumentsrn pediatric patients,
`
`
`
`:PP"
`p
`
`l
`
`This device should be used only by physicians tamiliarwith the device, its intended use, any additional
`instrumentation and any available surgical techniques.
`For the best results MEDTRONK SOFAMOR DANEK implants should only be implanted
`with MEDTRONIC SOFAMOR DANEK instruments.
`Other complications to t