CD HORIZON SEXTANT II ® ® Rod Insertion System As described by: Kevin Foley, M.D. Department of Neurosurgery University of Tennessee Memphis, Tennessee David Rouben, M.D. River City Orthopaedic Surgeons Louisville, Kentucky Najeeb Thomas, M.D.
CD HORIZON® SEXTANT ® II Rod Insertion System The CD HORIZON® SEXTANT® II Rod Insertion System provides surgeons with next-generation technology that will revolutionize the future of spine care. The global leader in today’s spine market, we combine our lifestyle friendly Minimal Access Spinal Technologies (MAST™), integrated image-guided products and neural monitoring tools to help surgeons shorten surgical and recovery time and return patients more quickly to normal, active lives.
2 Table of Contents Instruments CD HORIZON® SEXTANT ® II Rod Insertion System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Instruments and Implants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Preliminary Steps Preoperative Planning and Set Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Positioning of Skin Incisions . . . . . . . . . . . . . . .
CD HORIZON® SEXTANT ® II R O D I N S E RT I O N S Y S T E M INSTRUMENTS/ IMPLANTS
4 General Instruments CD HORIZON® SEXTANT ® II Rod Insertion System CD-HORIZON® SEXTANT® II Rod Inserter (7575300) Two-Level Outer Extender (7575301) Two-Level Middle Extender (7575302) One-Level Extender A (7575303) One-Level Extender B (7575304) Inner Sleeves (7575305)
General Instruments CD HORIZON® SEXTANT ® II Rod Insertion System 5.6mm Dilator (9560420) 9.3mm Dilator (9560421) Sextant Dilator (8675422) 4.5, 5.5, 6.5, 7.5mm taps 4.5 – 5.5mm, 5.5 – 6.
6 General Instruments CD HORIZON® SEXTANT ® II Rod Insertion System Stationary Rod Template (7575311) Rod Template Pointer (7575312) PAK Needle 1 Bevel, 1 Trocar Tip (8670009) 2 Bevel Tips (8670010) 2 Trocar Tips (8670015) X-PAK Needle 2 Bevel Tip (8670210) 2 Trocar Tips (8670215) Set Screw Retaining Compressors (7570095) Break Off Handle (7570090) Guidewires: Sharp 8670001 Blunt 8670002 Implants CD HORIZON® LEGACY™ Cannulated Screws Standard Configurations 5.5, 6.5, 7.5mm available in 4.5 and 8.
CD HORIZON® SEXTANT ® II R O D I N S E RT I O N S Y S T E M ONE-LEVEL SURGICAL STEPS
8 SURGICAL STEPS CD HORIZON® SEXTANT ® II Rod Insertion System Preliminary STEP 1 | Preoperative Planning And Set Up Preoperative planning can be useful in determining the proper starting point and screw trajectory. An axial view demonstrates the distance lateral to the pedicle initially taken through the skin (FIGURE 1). TLIF Trajectory 4.0 – 4.5cm Pedicle Screw 3.0 – 3.5cm PLIF Trajectory 3.0 – 4.0cm Discectomy 1.0 – 1.5cm TIP The starting point is rarely directly over the pedicle.
SURGICAL STEPS CD HORIZON® SEXTANT ® II Rod Insertion System 9 Positioning of Skin Incisions | STEP 2 The skin incision is slightly lateral to the pedicle on fluoroscopy. This will help to ensure the needle follows the normal lateral to medial trajectory of the pedicle. Figure 3A A 22-gauge spinal needle may be used to verify the appropriate location of the skin incisions. The needle is positioned on the skin directly over the pedicle on an AP image.
10 SURGICAL STEPS CD HORIZON® SEXTANT ® II Rod Insertion System Preliminary STEP 3 | Considering Pedicle Anatomy Consider the pedicle as roughly a cylindrical structure. As the pedicle is traversed, the trajectory should allow the needle or screw to remain lateral to the medial pedicle wall (FIGURE 5). TIP Figure 5 The ideal starting point is at the intersection of the facet and the transverse process (the lateral edge of the cylinder).
CD HORIZON® SEXTANT ® II Rod Insertion System SURGICAL STEPS 11 Considering Navigation Options | STEP 4 Figure 7A Figure 7B The primary benefit of using the FLUORONAV® MAST™ Spinal Procedural Solution is that a virtual extension of the instruments will demonstrate the safety of any proposed pedicle trajectory. The proper trajectory can be determined prior to navigating the pedicle.
12 SURGICAL STEPS CD HORIZON® SEXTANT ® II Rod Insertion System One-Level Procedure STEP 5 | Accessing the Pedicle PAK Needle Insertion A PAK (Pedicle Access Kit) Needle is used to gain access to the pedicle. After placing the PAK needle at the intersection of the facet and the transverse process, the needle is advanced (FIGURE 8). Figure 8 An AP image should show the needle tip at the lateral margin of the pedicle initially.
SURGICAL STEPS CD HORIZON® SEXTANT ® II Rod Insertion System 13 Guidewire Insertion | STEP 6 Figure 10 TIP “I recommend placing the Guidewire 60 – 70% of the VB for a ‘safe zone’ of bony anatomy during pedicle preparation and screw insertion. This tactic allows for space if the Guidewire advances inadvertently.” — Najeeb Thomas. M.D. Figure 11 One-Level Procedure The inner stylet of the needle is removed to allow the Guidewire to be inserted into the pedicle (FIGURES 10 and 11).
14 SURGICAL STEPS CD HORIZON® SEXTANT ® II Rod Insertion System One-Level Procedure STEP 7 | Dilating the Fascia The fascia and muscle must be dilated to allow for screw placement. Three Dilators are used to gently make a path of the appropriate dimension (FIGURE 12). The first two Dilators are removed, leaving the third Dilator to serve as a tissue protection sleeve during the Tapping step.
SURGICAL STEPS CD HORIZON® SEXTANT ® II Rod Insertion System 15 Pedicle Preparation | STEP 8 Figure 13 TIP Use the Self Drilling Tap option if particularly hard bone is encountered. If using the NIM-SPINE™ System during this procedure, the Large Insulated Dilator (8675424) must be used. Further evaluation of the tapped pedicle can be performed by using the NIM-SPINE™ System Stim-controlled Ball Tip Probe to stimulate the Tap.
16 SURGICAL STEPS CD HORIZON® SEXTANT ® II Rod Insertion System One-Level Procedure STEP 8 | Pedicle Preparation (cont.) Screw length can be estimated by referencing the depth marks on the Tap with the rim of the large Dilator (FIGURE 14). TIP If you tap beyond the tip of the Guidewire, bone within the end of the Tap may cause the Guidewire to pull out as you remove the Tap. To avoid this, advance the Guidewire through the Tap before you remove the Tap from the vertebral body.
CD HORIZON® SEXTANT ® II Rod Insertion System SURGICAL STEPS 17 Extender Sleeve and Screw Assembly | STEP 9 Figure 16 One-Level Procedure To insert two Screws, use the silver one level Extenders: Single Level Extender A (7575303) and Single Level Extender B (7575304) (FIGURE 16).
18 SURGICAL STEPS CD HORIZON® SEXTANT ® II Rod Insertion System STEP 10 | Extender Sleeve And Screw Assembly (continued) One-Level Procedure HEAD of Outer Sleeve Before a screw can be inserted into the pedicle, the Screw extenders must be assembled with the Multi-Axial Screws. To assemble the Screw Extender, insert the Inner Sleeve into the Extender. Squeeze the flexible tabs of the Inner Sleeve together and insert into the Outer Extender.
SURGICAL STEPS CD HORIZON® SEXTANT ® II Rod Insertion System 19 Extender Sleeve And Screw Assembly (continued) | STEP 11 Open to load Figure 18A Figure 18B Closed and secure Figure 18C Once the Screw is seated in the tabs, push the Screw and Inner Sleeve into the Extender. Push the head of the Outer Extender down and push the Inner Sleeve with the screw into the Extender to lock the assembly (FIGURES 18B – C). To verify the assembly is connected properly, pull on the Screw.
20 SURGICAL STEPS CD HORIZON® SEXTANT ® II Rod Insertion System One-Level Procedure STEP 12 | Screw Insertion Insert the Retaining Bonescrew Driver (7570023) into the Screw Extender Assembly. The tip of the driver passes into the head of the Multi-Axial Screw until the driver fully engages the Bone Screw (FIGURES 22 and 23). Thread the sleeve of the Retaining Driver into the head of the Screw before inserting over the Guidewire (FIGURE 23).
CD HORIZON® SEXTANT ® II Rod Insertion System SURGICAL STEPS 21 Second Screw Insertion | STEP 13 Figure 24 One-Level Procedure The process is repeated for additional Screws on the same side. After inserting the assemblies, the Screw Extenders should be at approximately the same height outside the patient. The assemblies should move freely following Screw insertion (FIGURE 24).
22 SURGICAL STEPS CD HORIZON® SEXTANT ® II Rod Insertion System One-Level Procedure STEP 14 | Connecting the Extenders Rotate the Extenders so that the flat sides are facing each other (FIGURE 25A). The male and female parts are then mated together and rotated so there is no gap between the Extenders (FIGURE 25B). Once the Extenders are connected and the flat surfaces are completely flush, the Rod Inserter can be attached.
CD HORIZON® SEXTANT ® II Rod Insertion System SURGICAL STEPS 23 Attaching Rod Inserter To Screw Extenders | STEP 15 Closed and secure Figure 26 Open the latch on the side of the Rod Inserter to connect to the Extenders. Return to the LOCKED position once Extenders fit securely in the arc. (FIGURES 27A and B). Please see the next page for important details regarding the assembly of the Rod Inserters to the Screw Extender Assembly.
24 SURGICAL STEPS CD HORIZON® SEXTANT ® II Rod Insertion System One-Level Procedure STEP 15 | Attaching Rod Inserter To Screw Extenders (continued) TIP The following steps should be taken to ensure that the Inserter is properly attached to the Extender Assemblies: 1. Push one side of the Inserter arm onto the Extender with thumb. 2. Hold and squeeze the other side of the Inserter to engage the other Extender. 3. Tip 1 Lock assembly with lever arm.
CD HORIZON® SEXTANT ® II Rod Insertion System SURGICAL STEPS 25 Passing The Trocar | STEP 15 Figure 29 Figure 30 One-Level Procedure The Rod Trocar is used to help make a path through the fascia and muscle down to the saddle of the first Screw (FIGURE 29). A small skin incision is required and then the Trocar is advanced through the muscle until it hits the first screw saddle as confirmed by lateral fluoroscopy (FIGURE 30).
26 SURGICAL STEPS CD HORIZON® SEXTANT ® II Rod Insertion System One-Level Procedure STEP 17 | Measuring the Rod To determine the appropriate Rod length, place the Rod Templates into the cephalad and caudal Screw Extenders. Place the Rod Template Pointer toward the Stationary Rod Template to determine the measurement (FIGURE 31).
SURGICAL STEPS CD HORIZON® SEXTANT ® II Rod Insertion System 27 Passing the Rod | STEP 18 Closed and Secure Figure 32 TIP 1. Ensure that the Rod is fully seated in the Rod Inserter by pushing the Rod firmly into the tip. 2. Ensure alignment of the Rod with the axis of the arc by sighting both the side and top-down view for confirmation. To confirm that the Rod is through all screw heads, use any of the Bonescrew Drivers for visual verification. Drop the Driver down the shaft of the Extenders.
28 SURGICAL STEPS CD HORIZON® SEXTANT ® II Rod Insertion System One-Level Procedure STEP 19 | Set Screw Insertion And Final Break-Off After verifying that the Rod is seated in all the Screws, the Set Screws can be inserted with the Set Screw Retaining Compressors (7570090). The Compressors act as: • Compressors or Distractors • Self-retaining Break-Off Driver Begin by loading the Set Screw on the tip of the Compressor. Push the button on the Compressor Handle (FIGURE 34).
SURGICAL STEPS CD HORIZON® SEXTANT ® II Rod Insertion System 29 Set Screw Insertion And Final Break-Off (cont.) | STEP 19 Compression or Distraction: Figure 36 Compression To Compress or Distract: Provisionally tighten one of the Set Screws. To compress, squeeze the two Compressors together and lock down the final Set Screw. (FIGURE 37) To distract, pull the two handles apart and lock down the Set Screw. (FIGURE 38). TIP The Break-Off Handle can also assist in provisionally tightening the Set Screw.
30 SURGICAL STEPS CD HORIZON® SEXTANT ® II Rod Insertion System One-Level Procedure STEP 19 | Set Screw Insertion And Final Break-Off (cont.) The Rod Inserter Assembly serves as the counter-torque device during final break-off. The Break-off handle should be used for the final break-off and to help provisionally tighten the Set Screw. The Compressor retains the sheared-off portion of the Set Screw (FIGURE 39).
SURGICAL STEPS CD HORIZON® SEXTANT ® II Rod Insertion System 31 Removing Assembly | STEP 20 Open and Unload Figure 40A Remove the Extenders from the Screws by depressing buttons on the Outer Extenders and lifting the head of the Extender — remove from the screw heads by pulling the Extender assemblies out individually (FIGURE 41). The final construct can be viewed with AP and lateral fluoroscopy. TIP Gentle side-to-side rocking may assist in removal of the Extenders.
32 SURGICAL STEPS CD HORIZON® SEXTANT ® II Rod Insertion System One-Level Procedure STEP 21 | Closure The entire process is repeated on the contralateral side. Closure is accomplished with a few interrupted stitches in the fascia, a subcuticular skin suture, and Steri Strips (FIGURE 42).
CD HORIZON® SEXTANT ® II R O D I N S E RT I O N S Y S T E M TWO-LEVEL SURGICAL STEPS
34 SURGICAL STEPS CD HORIZON® SEXTANT ® II Rod Insertion System Two-Level Procedure Accessing the Pedicle PAK Needle Insertion: A PAK (Pedicle Access Kit) Needle is used to gain access to the pedicle. After placing the PAK needle at the intersection of the facet and the transverse process, the needle maybe advanced partially through the pedicle (FIGURE 43). An AP image should show the needle tip at the lateral margin of the pedicle initially.
SURGICAL STEPS CD HORIZON® SEXTANT ® II Rod Insertion System 35 Accessing the Pedicle (continued) | STEP 5 Either oblique or AP fluoro should be used to insert PAK Needles in all three pedicles so that the skin insertion and pedicle insertion points are aligned in the axial plane. Drawing a line on the skin prior to insertion can facilitate this (FIGURE 45). Insert the Guidewire as with single level procedures by removing the PAK handle and inner stylet.
36 SURGICAL STEPS CD HORIZON® SEXTANT ® II Rod Insertion System Two-Level Procedure STEP 6 | Screw Extender Assembly To insert three screws, use the gold Two-Level Extenders: two Two-level Outer Extenders (7575301) and the Two-Level Middle Extender (7575302) (FIGURE 47, 48). NOTE For a multi-level procedure, the Screw Extenders labeled as “Outer Extenders” (7575301) should be used at the cephalad or caudal pedicles (FIGURE 48).
SURGICAL STEPS CD HORIZON® SEXTANT ® II Rod Insertion System 37 Screw Insertion | STEP 7 After tapping through the large Dilator, insert the Screw Extender Assemblies over the Guidewire into the pedicle, similar to the onelevel technique. Insert all 3 Screws and Extenders into the pedicles, using the Outer Extenders for the most caudal and cephalad levels, and the Middle Extender for the middle level (FIGURE 50). Proceed to Step 10 on page 40.
38 SURGICAL STEPS CD HORIZON® SEXTANT ® II Rod Insertion System Two-Level Procedure STEP 8 | Screw Insertion (continued) Alignment Guide Method: Insert Screws connected to the Outer Screw Extenders at the most caudal and cephalad levels (FIGURE 51A). Connect the Guide to the Outer Screw Extenders and attach the Extender Clamp (FIGURE 51B – C). Insert the X-PAK Needle through the Guide and target the middle pedicle using fluoroscopy, NIM, or a navigation system.
SURGICAL STEPS CD HORIZON® SEXTANT ® II Rod Insertion System 39 Connecting the Extenders | STEP 9 Disconnect and remove the Extender Clamp and Guide. Also remove the X-PAK to leave the Guidewire in place. Dilate and tap over the Guidewire. Assemble the Inner Screw Extender with the appropriate size Screw and insert over the Guidewire into place (FIGURE 53A – B). Figure 53A Figure 54A Figure 53B Figure 54B Rotate the Extenders so that the flat sides are facing each other (FIGURE 54A – B).
40 SURGICAL STEPS CD HORIZON® SEXTANT ® II Rod Insertion System Two-Level Procedure STEP 10 | Attaching Rod Inserter To Screw Extenders Before connecting the Rod Inserter to the Extenders, attach the Trocar tip into the tip of the Rod Inserter by lifting the latch on the top of the Rod Inserter. This will allow the Rod Inserter to receive the Trocar tip. Insert the Trocar tip into the Collet and return the latch to the original position to secure the tip (FIGURE 55A – B).
SURGICAL STEPS CD HORIZON® SEXTANT ® II Rod Insertion System 41 Attaching Rod Inserter To Screw Extenders (continued) | STEP 11 The following steps should be taken to ensure that the Inserter is properly attached to the Extender Assemblies: Tip 1 1. Push one side of the Inserter arm onto the Extender with index finger. 2. Hold and squeeze the other side of the Inserter to engage the other Extender. The inserter should now be flush with both sides of the mated Extender Assemblies.
SURGICAL STEPS 42 CD HORIZON® SEXTANT ® II Rod Insertion System Two-Level Procedure STEP 12 | Passing the Rod Once all three extenders have been inserted, proceed with attaching the Rod Inserter as indicated in the one-level procedural steps. Replace the Trocar tip with the appropriately sized Rod as determined by the Rod Template. Remove the Trocar by lifting the Rod attachment lever to open the Rod Collet. Insert the Rod and return the lever to the locked position.
CD HORIZON® SEXTANT ® II Rod Insertion System Important Information on the CD HORIZON® Spinal System PURPOSE: The CD HORIZON® Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine.
44 Important Information on the CD HORIZON® Spinal System !USA For US Audiences Only CAUTION: FEDERAL LAW (USA) RESTRICTS THESE DEVICES TO SALE BY OR ON THE ORDER OF A PHYSICIAN. Other preoperative, intraoperative, and postoperative warnings and precautions are as follows: Implant Selection: The selection of the proper size, shape and design of the implant for each patient is crucial to the success of the procedure.
The surgical technique shown is for illustrative purposes only. The technique(s) actually employed in each case will always depend upon the medical judgement of the surgeon exercised before and during surgery as to the best mode of treatment for each patient. MEDTRONIC SOFAMOR DANEK USA, INC. Spinal Division Worldwide Headquarters 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133 (800) 876-3133 Customer Service: (800) 933-2635 www.sofamordanek.com For more information go to www.myspinetools.
