微创TLIF

Surgical Technique MAXIMUM ACCESS SURGICAL PLATFORM C O N T E N T S P r e f a c e 1 M A S ® T L I F S u r g i c a l Te c h n i q u e 2 M A S T L I F S u r g e r y C o n f i g u r a t i o n 2 P a t i e n t P o s i t i o n i n g a n d O . R . S e t u p 2 P e d i c l e Ta r g e t i n g 3 E x p o s u r e 5 F a c e t e c t o m y a n d D e c o m p r e s s i o n 14 D i s t r a c t i o n ( O p t i o n a l ) 15 D i s c P r e p a r a t i o n 16 I n t e r b o d y I m p l a n t S i z i n g 17 I m p l a n t I n s e r t i o n 18 S p h e R x ® P P S H e a d A t t a c h m e n t a n d R o d P l a c e m e n t 19 C o n t r a l a t e r a l F i x a t i o n U s i n g S p h e R x P P S w i t h D B R ® I I 2 2 C l o s u r e 2 2 M A S T L I F S y s t e m 2 3 C a t a l o g 2 8 MAXIMUM ACCESS SURGICAL PLATFORM 1 P R E FA C E Fellow Colleagues: Minimally disruptive spine surgery has been an elusive goal due to the challenges associated with steep learning curves, low efficiencies, and perceived limited effectiveness of minimally invasive procedures. Many of the technique principles used in conventional procedures are often compromised when working through small apertures, using small instruments and unconventional visualization technologies. MaXcess® was the first integrated access system to use a split-blade retractor to maximize the exposure, while minimizing soft tissue disruption. Surgeons were then able to perform conventional surgery using conventional instruments with direct visualization. The conventional nature of the surgery reduced the learning curve and enabled surgeons, who were previously frustrated by minimally invasive techniques, to be successful in accomplishing their surgical objectives. The MAS® TLIF technique further advances minimally disruptive surgery by using pedicles to define the exposure, and to provide stabilization of the access system as it is anchored to the spine. When exposure is achieved, surgeons are now able to easily identify the pedicles as a basis for anatomical orientation. The integrated product platforms: MaXcess® MAS TLIF Access system, SpheRx® PPS Pedicle Screw system, NVJJB™/M5® Nerve Monitoring system, Osteocel® Plus cellular bone matrix, and CoRoent® interbody implants combine to provide a seamless solution that delivers safe, reproducible MAS TLIF surgery. Cordially, Mark D. Peterson, M.D. Orthopaedic Spine Surgeon Southern Oregon Orthopedics Medford, OR USA William Taylor, M.D. Associate Professor Division of Neurologic Surgery University of California, San Diego San Diego, CA USA Antoine G. Tohmeh, M.D. Orthopaedic Spine Surgeon Northwest Orthopaedic Specialists Spokane, WA USA 2 M A S ® T L I F S U R G I C A L T E C H N I q U E MAS® TLIF SURGERY CONFIGURATION • MaXcess® MAS TLIF System • Articulating Arm • SpheRx® PPS 6.25 or 5.5 EXT System • SpheRx DBR® II • Decompression Instruments • Posterior General Instruments • TLIF Instruments (not necessary with CoRoent® LO) • CoRoent LO, LN, LW, LC (Options) • Osteocel® Plus, FormaGraft® (Options) • NVM5™ System • NVM5 Disposables (including I-PASTM) • MaXcess MAS TLIF Disposables Reference the SpheRx PPS, SpheRx DBR II, CoRoent, and NVM5 Surgical Techniques or Reference Manual(s) and/or Instructions for Use (IFU) for additional important labeling information. PATIENT POSITIONING ANd O.R. SETUP Position the patient on a radiolucent operating table in a prone position. A bedrail on the table is necessary in order to attach an Articulating Arm. Prepare and drape the patient in a conventional manner (Fig. 1). Under fluoroscopy, adjust the table so that the C-Arm provides an A/P image when the orbital angle is at 90.° Adjust the cranial/caudal angle of the C-Arm to obtain a true A/P image of the targeted vertebra, and a true lateral image when the orbital angle is at 0° (Figs. 2, 3). (Fig. 1) (Fig. 3)(Fig. 2) NVM5™ A/P VIEW LATERAL VIEW C-ARM FLUORO MONITORS MAXIMUM ACCESS SURGICAL PLATFORM 3 M A S ® T L I F S U R G I C A L T E C H N I q U E STEP 1: PEdICLE TARGETING Locate the affected level by using fluoroscopy in the A/P and lateral views. Obtain a true A/P image to identify and mark the starting location at each pedicle (Figs. 4, 5). It is recommended to obtain a distinct endplate view above the targeted pedicles. Contralateral pedicles may be targeted and marked in conjunction with the ipsilateral pedicles at this time (Fig. 6). Make an approximately 3cm skin incision between the pedicle entry point markings on the ipsilateral side (Fig. 7). (Fig. 4) (Fig. 5) (Fig. 6) (Fig. 7) 4 M A S ® T L I F S U R G I C A L T E C H N I q U E STEP 1: PEdICLE TARGETING (CONT.) Connect the NVJJBTM/M5® Stimulation Clip to the I-PASTM needle. Cannulate the pedicles with the I-PAS needle, using a standard percutaneous pedicle targeting technique. Use NVM5TM Dynamic Screw Test functionality throughout cannulation to provide stimulated EMG information in order to reduce the risk of pedicle wall violation (Fig. 8). Remove the purple handle from the I-PAS needle, place a K-Wire through the needle (Fig. 9), and remove the needle using the black handle. Repeat the cannulation technique described above for the other pedicles. Secure the contralateral K-Wires to the drape using towel clamps or similar instruments (Fig. 10). (Fig. 8) (Fig. 10)(Fig. 9) MAXIMUM ACCESS SURGICAL PLATFORM 5 M A S ® T L I F S U R G I C A L T E C H N I q U E STEP 2: ExPOSURE Release tissue from the facet joint between the ipsilateral K-Wires, using digital dissection, a Cobb, or Curette (Fig. 11). Ensure the space between K-Wires is free from fascia or tissue that would prevent Retractor Blades from being placed. Place 1st Dilator over one of the K-Wires down to the spine. Take a measurement using the scale on the Dilator to select the appropriate Retractor Blade length (Fig. 12). Select a blade length as indicated by the first marking that is above the skin, and note whether it is a right or left Blade, as viewed by the surgeon. Place the K-Wire Gauge over the K-Wire and use the measurements on the proximal end to determine the length of the K-Wire in the bone. This can be used to select the appropriate Screw Shank length (Fig. 13). (Fig. 11) (Fig. 13)(Fig. 12) 6 M A S ® T L I F S U R G I C A L T E C H N I q U E STEP 2: ExPOSURE (CONT.) The scrub assistant will then assemble the proper Blade, Hoop Shim, Screw Shank, and MAS® TLIF Shank Driver while the surgeon is tapping the pedicle (Fig. 14). Ensure that a cannulated Screw Shank is used, since it will be placed over the K-Wire. Place the 2nd Dilator over the 1st Dilator down to the spine (Fig. 15). Remove the 1st Dilator, select the appropriate Tap, and place over the K-Wire down to the spine. Attach the NVJJB™/M5® Stimulation Clip onto the Tap, and activate NVJJB/M5 to obtain dynamic monitoring readings while tapping (Fig. 16). (Fig. 14) (Fig. 16)(Fig. 15) MAXIMUM ACCESS SURGICAL PLATFORM NOTE: To ensure the Retractor will have adequate mobility throughout the procedure, it is best to stop advancing the Screw Shank/Blade assembly when resistance is encountered. The Screw Shank may be advanced to the desired depth following head attachment later in the procedure. 7 M A S ® T L I F S U R G I C A L T E C H N I q U E STEP 2: ExPOSURE (CONT.) Remove the 2nd Dilator. Place the Screw Shank/Blade assembly over the K-Wire, and drive the Screw Shank into the pedicle until either the distal end of the Shank Driver or the Blade bottoms out on bone (Figs. 17, 18). The K-Wire may be removed after the Screw Shank enters the posterior portion of the vertebral body. Release Shank Driver from the Screw Shank and withdraw from the Blade (Figs. 19, 20). (Fig. 17) (Fig. 19) (Fig. 20) (Fig. 18) 8 M A S ® T L I F S U R G I C A L T E C H N I q U E STEP 2: ExPOSURE (CONT.) Repeat Blade and Screw Shank measurement for the K-Wire in the other ipsilateral pedicle at the TLIF level. Tap and place the other Screw Shank/Blade assembly, as in the previous sequence (Fig. 21). Rotate the Blades so that the post on the proximal end of each Blade points medial. Insert posts into the Retractor Body and tighten set screws to secure Blades to the Retractor Body (Fig. 22). (Fig. 21) (Fig. 22) MAXIMUM ACCESS SURGICAL PLATFORM 9 M A S ® T L I F S U R G I C A L T E C H N I q U E STEP 2: ExPOSURE (CONT.) Attach the Articulating Arm Rail Clamp to the bedrail of the surgical table (Fig. 23). Place the Articulating Arm post through the Rail Clamp, adjust to the desired height, and lock into position by tightening the handle on the Rail Clamp (Fig. 24). Attach the opposite end of the Articulating Arm to the Retractor Body (Fig. 25). (Fig. 23) (Fig. 24) (Fig. 25) 10 M A S ® T L I F S U R G I C A L T E C H N I q U E STEP 2: ExPOSURE (CONT.) Position Retractor so that the Blades are parallel to the disc space, and so that the proper medial exposure trajectory is achieved (Figs. 26, 27). Lock the Articulating Arm by tightening the Articulating Arm handle. Place the Retractor T-Handle onto the hex, labeled C-C (cranial/caudal) on the Retractor Body, and turn clockwise to gain additional proximal exposure, if necessary (Fig. 28). (Fig. 26) (Fig. 28)(Fig. 27) MAXIMUM ACCESS SURGICAL PLATFORM 11 M A S ® T L I F S U R G I C A L T E C H N I q U E STEP 2: ExPOSURE (CONT.) Insert Light Cable tips approximately halfway down each of the right and left Blades, bend flush to the Retractor Body, and attach the other end of the Light Cable to a light source (Fig. 29). Palpate the facet joint with the index finger for anatomical reference. Use a small Cobb to elevate tissue from the facet capsule and lamina medial to the facet joint. Place the 1st Dilator through the exposure, down to the lamina, just medial to the facet joint. Select a center Blade based on the measurement at the center Blade post on the Retractor Body (Fig. 30). (Fig. 29) (Fig. 30) NOTE: The center rack on the Retractor Body may be adjusted laterally to engage the center Blade as it is positioned on top of the facet joint. 12 M A S ® T L I F S U R G I C A L T E C H N I q U E STEP 2: ExPOSURE (CONT.) Attach the appropriate center Blade onto the Medial Blade Handle so the Handle points in the same direction as the curve on the distal end of the center Blade (Fig. 31). Place the center Blade through the exposure down to the facet joint and attach it to the center arm on the Retractor Body (Fig. 32). Tighten the set screw that secures the center Blade to the Retractor Body with the Set Screwdriver and remove the Handle (Figs. 32, 33). (Fig. 32) (Fig. 33) (Fig. 31) MAXIMUM ACCESS SURGICAL PLATFORM 13 M A S ® T L I F S U R G I C A L T E C H N I q U E STEP 2: ExPOSURE (CONT.) The adjustable extension on the center Blade is intended to elevate tissue while following the topography of the facet, lamina, and base of the spinous process as it is retracted medial. Place the Shim Adjuster down the center Blade to apply light downward pressure on the adjustable Blade extension. Position the Retractor T-Handle onto the hex on the Retractor Body labeled M-L (medial/lateral), and then turn clockwise to retract medial (Figs. 34-36). (Fig. 36)(Fig. 35) (Fig. 34) 14 M A S ® T L I F S U R G I C A L T E C H N I q U E STEP 3: FACETECTOMY ANd dECOMPRESSION Locate the pedicle Screw Shank heads at the base of each of the cranial/caudal Blades. Identify the key anatomy, such as the facet joint, pars, and inferior edge of the lamina, based upon their location relative to the pedicles (Fig. 37). Perform the facetectomy by first using the Facet Rongeur to debulk the facet joint. A burr can be used to thin the remainder of the facet complex, and Kerrison Rongeurs can be used to complete the facetectomy and decompression (Fig. 38). If necessary, loosen the Articulating Arm and tilt the Retractor Body to obtain a more medial trajectory to perform a contralateral decompression. The Retractor pivots about the heads of the Screw Shanks and maintains proper position while undercutting the spinous process (Figs. 39, 40) (Fig. 39) (Fig. 40) (Fig. 38)(Fig. 37) Pars Inferior Edge of Lamina Facet Joint MAXIMUM ACCESS SURGICAL PLATFORM 15 M A S ® T L I F S U R G I C A L T E C H N I q U E STEP 4: dISTRACTION (OPTIONAL) If distraction is warranted, place the Retractor T-Handle onto the Blade distraction bolts and turn clockwise until the bottom of the bolts touch the Retractor Body (Fig. 41). This will then keep the Blades from tilting inward when using the C-C adjustment to open the Retractor. Place the Retractor T-Handle onto the hex, labeled C-C on the Retractor Body, and turn clockwise to distract off the Screw Shanks (Fig. 42). NOTE: Care must be taken to avoid damaging the pedicles, which could compromise pedicle screw purchase. An alternative approach is to wait until the disc space has been evacuated. First, use an interbody sizer or Trial to distract the disc space, and then follow the previous steps to hold distraction. (Fig. 42) (Fig. 41) 16 M A S ® T L I F S U R G I C A L T E C H N I q U E STEP 5: dISC PREPARATION Make an annulotomy and perform a conventional discectomy, using a combination of Pituitary Rongeurs, Disc Cutters, Endplate Scrapers, Curettes, and Rasps (Figs. 43-48). (Fig. 43) (Fig. 44) (Fig. 46) (Fig. 48) (Fig. 45) (Fig. 47) MAXIMUM ACCESS SURGICAL PLATFORM 17 M A S ® T L I F S U R G I C A L T E C H N I q U E STEP 6: INTERBOdY IMPLANT SIzING If the Retractor was used to distract the disc space, release distraction by turning the distraction bolts on the Blades counterclockwise until the bolts no longer touch the Retractor Body. This will reduce the possibility that distraction from the Screw Shanks will interfere with proper implant sizing. While NuVasive® offers a variety of interbody implant systems uniquely designed for different interbody grafting techniques and implant orientations, the CoRoent® LO implant placement summary is shown as an example in this technique. If the CoRoent LO system is selected, choose the appropriately sized starting Trial. Attach a T-Handle and insert the Trial into the disc space, using an oblique trajectory with the final disc height dimension oriented in the plane of the disc (Figs. 49, 50). When rotating the Trial to height, ensure that the “MEDIAL” and “LATERAL” markings are in the correct orientation upon completion (Fig. 51). Once the proper height and length have been determined using tactile feel and a lateral fluoroscopy image, obtain an A/P image to ensure the distal end of the Trial crosses the midline of the disc (Fig. 52). NOTE: The implant sizing technique will depend upon the particular interbody implant system used. Please refer to the associated technique guide or brochure for sizing and placement details. (Fig. 49) (Fig. 50) (Fig. 52)(Fig. 51) 18 M A S ® T L I F S U R G I C A L T E C H N I q U E STEP 7: IMPLANT INSERTION If the CoRoent® LO system is being used, place the appropriately sized implant onto the Inserter and tighten (Fig. 53). Pack the implant and interbody space with bone graft material. Osteocel® Plus may be placed in the interbody space using a bone funnel, however, CoRoent interbody devices are only approved for use when packed with allograft. Insert the implant into the interbody, using an oblique trajectory with the final implant height dimension oriented in the plane of the disc (Fig. 54). When rotating the implant to height, ensure that the “MEDIAL” and “LATERAL” markings on the Inserter are in the correct orientation upon completion (Fig. 55). Prior to releasing the implant from the Inserter, use lateral and A/P fluoro to ensure proper implant placement. After releasing, the implant position may be adjusted using an implant tamp (Fig. 56). Release distraction if distraction was used. This is performed by either slightly closing the Retractor, or turning the distraction bolts on the Blades counterclockwise. NOTE: Osteocel Plus is an advanced allograft cellular bone matrix, designed to mimic the biological profile of autograft. For more information, refer to the Osteocel Plus brochure. (Fig. 54)(Fig. 53) (Fig. 56)(Fig. 55) MAXIMUM ACCESS SURGICAL PLATFORM 19 M A S ® T L I F S U R G I C A L T E C H N I q U E STEP 8: SPhERx® PPS hEAd ATTAChMENT ANd ROd PLACEMENT Place the Hoop Shim Removal Tool down the shim track of the right or left Blade until it engages the Hoop Shim. Gently use the Hoop Shim Removal Tool to provide upward force, which will unlock the Hoop Shim from the Screw Shank and withdraw it from the Blade (Fig. 57). Repeat with the opposite Blade to disengage the other Hoop Shim. If necessary, the Blades can be expanded to gain additional space around Screw Shank heads to facilitate Tulip attachment. Attach a 6.25mm PPS Tulip to the 6.25mm Head Inserter by engaging the Tulip and threading the knob on the Inserter counterclockwise to secure (Fig. 58). Place the Tulip through the exposure onto one of the exposed Screw Shanks and press down firmly (Fig. 59). Pressing down using an orbital motion may help to engage the Tulip. The Verification Torque T-Handle must be used with the Head Inserter to verify the Tulip is properly attached to the Screw Shank. Refer to the SpheRx PPS Technique Guide for further details on its proper use (Fig. 60). Release the Tulip from the Head Inserter by unthreading the knob on the Inserter. Repeat the previously described process to attach the other SpheRx PPS Tulip. (Fig. 58) (Fig. 60) (Fig. 57) (Fig. 59) 20 M A S ® T L I F S U R G I C A L T E C H N I q U E STEP 8: SPhERx® PPS hEAd ATTAChMENT ANd ROd PLACEMENT (CONT.) If necessary, use the Screw Head Adjuster from the SpheRx PPS system to adjust the height of the screws to the desired final position. Also if necessary, use the Screw Head Adjuster from the SpheRx PPS system to position the Tulips in the proper orientation. Place the ball ends of the Caliper into the Tulips and take a measurement (Fig. 61). Select the corresponding DBR® II Rod from the DBR II implant tray and place into the Tulips (Fig. 62). With the Rod fully seated into the Tulips, insert the SpheRx PPS 6.25mm Lock Screws, using the Lock Screw Starter (Fig. 63). If necessary, align the “timing marks” on the Lock Screw and the Tulip prior to insertion to facilitate thread engagement. (Fig. 61) (Fig. 62) (Fig. 63) MAXIMUM ACCESS SURGICAL PLATFORM 21 M A S ® T L I F S U R G I C A L T E C H N I q U E STEP 8: SPhERx® PPS hEAd ATTAChMENT ANd ROd PLACEMENT (CONT.) Place the Counter-Torque over one of the Tulips. With the Torque T-Handle engaged to the Lock Screw Driver, place through the Counter-Torque to engage the Lock Screw, and tighten until the T-Handle breaks free (Fig. 64). Repeat with the other Tulip (Fig. 65). Alternatively, the Tulips may be placed with DBR® II Guides attached, using the Head Inserter and Verification Torque T-Handle. This is typically performed to enable multiple-level DBR II fixation (for example, to apply DBR II to additional levels of XLIF®). Refer to the SpheRx PPS and SpheRx DBR II Technique Guides for detailed instructions. (Fig. 65) (Fig. 64) 22 M A S ® T L I F S U R G I C A L T E C H N I q U E STEP 9: CONTRALATERAL FIxATION USING SPhERx® PPS WITh dBR® II (OPTIONAL) Use the technique described in the SpheRx PPS Technique Guide to assemble a SpheRx PPS Tulip to a cannulated PPS Screw Shank in the SpheRx PPS cannulated screw caddy, and use the Verification Torque T-Handle to verify proper attachment. Attach the assembled screw to a DBR