NeoGen Knee Nail System(Tibia Mode) Product Catalog & Surgical Technique

Transcription

1 NeoGen Knee Nail System(Tibia ode) Product Catalog & Add: No.-8, Tianshan Road, Xinbei District, Changzhou, Jiangsu, China 30 Tel: Fax: Add: F5, Shanghai International Pharmaceutical Trad & Exhibition Tower, No,399, Jinqiao Road, Pudong District, Shanghai, China 009 Tel: Fax:

2 Content PREFACE INTRODUCTION NAIS SURGICA TECHNIQUE PATIENT PREPARATION ENTRY PORTA FRACTURE REDUCTION CANA PREPARATION NAI SEECTION NAI INSERTION DRI GUIDE ASSEBY INTEROCKING DISTA SCREWS OPTIA DISTA A/P OCKING COSURE POST-OPERATIVE ANAGEENT WEIGHTBEARING NAI EXTRACTION TECHNIQUE INSTRUENT & IPANTS

3 NeoGen Knee Nail System(Tibia ode) PREFACE The NeoGeon Tibia Knee Nail System designed with a hybrid bow to allow the implant to be used to treat femoral shaft fractures in the retrograde mode or tibia shaft fractures. The short Knee Nail is used in the femur for supracondylar fractures or in the ankle for ankle arthrodesis. The NeoGon Tibia Nail System is indicated for shaft fractures between the proximal and distal third of the tibia. Indications include transverse, comminuted, spiral, oblique, and segmental fractures. The Tibia Nail may also be used for treatment of non unions or malunions as well as prophylactic nailings of impending pathological fractures. INTRODUCTION NAIS The locations of the distal screw holes have been moved closer to the non-driving end of the nail which allows the surgeon to nail more distal tibia fractures. The distal locking holes are now located at 5, 5, and 5mm from the distal tip of the nail. The oblique locking screws in the driving end of the nail offer a multiplanar locking configuration which has been clinically proven to increase the stability of the nail construct. A/P & / Screw Holes The non-driving end of the nail offers the choice of two anterior/posterior or two medial/lateral screw options. The design allows for more options in fracture management and better stability in some fracture patterns. The non-driving end of the implant offers a compression slot in the medial/lateral plane. This allows the fracture to be dynamized while maintaining rotational stability. - Round Shape Nails Design Allows the implant to be inserted over a Ball Tip Guide Rod and aids in removal. Diameter choices Standard sizes are 9mm, 0 mm, mm, mm and 3 mm diameters. Addresses virtually all indications without carrying a large inventory of implants.

4 3 NeoGen Knee Nail System(Tibia ode) 4 SCREWS ade of Titanium 6A4V -An alloy that offers strength and improved biocompatibility. Fluted Self-tap Tip Designed to make the screw easier to capture bone, and minimize the need for surgical step. Special Captured Feature-The head of the screw features internal threads that allows it to be captured by the Screwdriver for locking screw. Thread Design Enlarged threads at the head of the screw allows for solid bone purchase at the near cortex and minimize screw back out. The first mm of the screw has no threads to allow for guiding. Concise Product Selection 4.5 mm = Grey (8.0mm and 9.0mm diameter nails) 5.0 mm = Gold (Knee and FAN ) 6.4 mm = Blue (Proximal for recon mode or Gamma nails) SURGICA TECHNIQUE PATIENT PREPARATION Position the patient supine. Place a sterile bolster (leg roll) under the thigh and flex the knee for positioning. Check the axial alignment by stretching a bovie cord through the middle of the patella to the second toe. The cord should bisect the middle of the tibial plateau and talar dome in the A/P view when the leg is straight. Adjust the leg for rotation and length by comparison with the uninjured leg and by visualizing the fracture configuration. Insertion alignment can be slightly proximal to the fibular neck, but below the articular surface of the knee to avoid meniscular damage. A slightly lateralized entry portal is optimal (Fig.). Fig.

5 5 NeoGen Knee Nail System(Tibia ode) 6 ENTRY PORTA ake a 3 cm incision medial to the patellar tendon. Rotate the barrel of the Entry Tool with Honeycomb Insert (500) until the NK is seen, then place the Entry Tool (with Honeycomb Insert) through the incision to bone (Fig.). Adjust to align the Entry Tool with the axial line of the tibial shaft in the A/P and lateral image views. Attach the Tip-Threaded Guide Wire (50) to power. Insert the Guide Wire when the axial alignment is acceptable and centered along the tibia. The target zone should be just lateral to the medial tibia tubercle. The Entry Tool may be backed out as needed to confirm that the pilot hole is started correctly. Insert the wire approximately 3 cm in depth. Once proper placement of the Guide Wire has been established, the honeycomb insert should be removed (Fig.3). FRACTURE REDUCTION Snap the T-Handle with Quick Coupling (030070) onto the Reducer (550) (Fig.5). Insert the Reducer through the Entry Tool and advance into the distal medullary canal to reduce the fracture (Fig. 6). Attach the Gripper (570) to the Ball-Tipped Guide Rod (560) and introduce it into the medullary canal through the Reducer and Entry Portal Tool (Fig.7 and 7 Inset). The Guide Rod can be positioned by rotating the Reducer while placing the rod into the medullary canal. Remove the Gripper from the guide rod to allow for removal of the Reducer. When Guide Rod is in place, remove the Reducer. Note: The Reducer may be too large to use if the patient has a small diameter intramedullary canal. If this is the case, reduce the tibia manually. Fig.5 Fig.6 Fig. Fig.3 Attach suction to the Entry Tool to assist in blood evacuation and minimize aerosolisation of blood to operative team. Attach the.5mm Entry Reamer (530) to power and insert over the Tip Threaded Guide Wire (50) to ream the proximal portion of the tibia. The reamer should be inserted such that it is reaming the anterior cortex and not directed toward the posterior cortex. The Entry Portal Tool functions as a soft tissue protector. The reamer should be advanced to the medullary canal of the tibia, approximately 4-5 cm. Confirm the position of the reamer under lateral X-ray views as well. Remove the flexible.5 mm Entry Reamer and Tip Threaded Guide Wire (Fig.4). Fig.4 Fig.7 3

6 7 NeoGen Knee Nail System(Tibia ode) 8 CANA PREPARATION NAI INSERTION Canal preparation is dependent on surgical decision. If reaming is planned, use progressive reamers through the Entry Tool. Unreamed nails are selected based on preoperative planning, but should be of sufficient size to provide translational fill of the intramedullary canal in mid-diaphysis. If reaming is selected, proceed to sequentially ream the tibial shaft beginning with the 9 mm reamer head. Sequentially ream in half millimeter increments to 0.5 mm to.0 mm larger than the selected nails size (Fig.8). NAI SEECTION Determine nail diameter from image intensifier, or sounding the canal. Never insert a nail that has a larger diameter than the last reamer used. Confirm placement of the Ball Tip Guide Rod at the desired portion of the distal tibia metaphysis and then insert the Nail Depth Gauge (580) over the exposed end of the guide rod pushing the end down to the level where the top of the nail will stop. Confirm the position on the image intensifier (Fig. 9). eave the Guide Rod in place. Exchange of the ball-tipped Guide Rod is NOT necessary. Fig.8 DRI GUIDE ASSEBY Attach the Drill Guide (590) to the Proximal Aiming bar(eft,600;right,60). The Drill Guide is keyed so that the Proximal Aiming bar will only fit one way. Secure the Proximal Aiming bar to the Drill Guide by tightening the Proximal Guide Bolt (500) by hand. Final tightening can also be accomplished by placing the end of the Guide Bolt Wrench (50) into the hex holes in the Proximal Guide bolt. Insert Quick Bolt (530) in the Drill Guide to secure nail. The Quick Bolt will also be used to rotate Drill Guide 80 as needed for lateral oblique screw insertion. Alternatively, the Proximal Aiming bar may be assembled to the Drill Guide after the nail is inserted (Fig.0). Advance the nail over the Guide Rod and carefully pass the fracture. Countersink the nail approximately -5 mm into the tibia proximally (Fig.A and Fig.B). Confirm rotation as is appropriate. Remove the Guide Rod. Fig.0 Fig.A Note: ake provisions for countersinking the tibial nail to minimize impingement problems at the knee. Allow for reduction of the fracture, if dynamization is required. Read the nail length from the calibrations exposed at the other end of the Gauge. Fig.9 Fig.B

7 9 NeoGen Knee Nail System(Tibia ode) 0 INTEROCKING Proximal Screws: Transverse and edial Oblique 5 Placement Insert the Outer Drill Sleeve (560) through the proximal holes. ake a skin incision and insert the sleeve to bone. A. Pre-drilling Technique - The Inner Drill Sleeve (570) is introduced through the Outer Drill Sleeve. Attach the 4.0 Drill bit (590) to power. Insert the 4.0 Drill bit through both cortices (Fig.). The appreciate screw length could be taken by the mark on the Drill bit shaft corresponding with the top of the Outer Sleeve. B. Screw ength Gauge After predrilling through both cortices as outlined above, remove the Inner Drill Sleeve, leaving the Outer sleeve in place. Use the Screw ength Gauge (5340) through the Outer Drill Sleeve from the far cortex to measure for proper length screw (Fig.4). Final tightening of the screws should always be under manual control using the Screwdriver for locking screw (5350) (Fig.5). Note: Once screw is seated, turn the Nut in the canulate Screwdriver counterclockwise. The Screwdriver releases the screw and the Screwdriver for locking screw removed. Fig. Fig.4 Fig.5 Fig.6 Fig.3

8 NeoGen Knee Nail System(Tibia ode) Continue with the placement of the medial 5 oblique screw by following the predrilling technique (Fig.7). Proximal ateral Oblique Screw Placement - For insertion of the lateral oblique screw, the Quick Bolt (530) is loosened and back-turned two complete revolutions. This allows the Knee Guide to be lifted and rotated 80. After rotating the Knee Guide, retighten with the Quick Bolt, making sure the key is engaged. The guide is now in correct position for placement of the lateral oblique screw (Fig.7 and Fig.8). Unscrew the Proximal Guide Bolt and the Proximal Aiming device (Knee) (60)s removed. The Distal Aiming bar(knee) (630) is introduced into the Proximal Aiming bar, (Knee), moved downwards until the number corresponding to the nail length is at the level of the front of the Distal Aiming bar, and locked firmly into place with Distal Guide Bolt (540). Note that there is an arrow on the Proximal Aiming bar and Distal Aiming bar corresponding to each nail length. The distal locking screws are inserted in the frontal plane, normally from the medial side. On rare occasions, because of skin damage medially, or because of the configuration of a distal fracture, the surgeon may wish to insert the screws from the lateral side. The Targeter(Knee)(650) is mounted on the Distal Aiming bar(knee) (630) so that it lies on the correct side of the tibia, and the Outer Sleeve are inserted into the Targeter, but no incision is made as yet. The system is first stabilized in exact alignment, utilizing the Positioning Rod (5390). A Inner Drill Sleeve(570) and Small Drill Sleeve(580) is inserted into the middle hole in the Targeter(Knee). An incision is made in the skin directly beneath it. A 4.0 Drill Bit is now used to drill the anterior cortex only. The Drill Bit is removed. Fig.7 DISTA SCREWS Fig.8 The square ended Positioning Rod Drill (5380) is passed down the Small Drill Sleeve, and used to complete the hole down to the nail, and to remove intervening debris. It should be possible to feel and hear the tip of the reamer touching the nail. The Positioning Rod Drill and Drill Sleeve are now removed, and replaced by the Position Rod, which is inserted through the anterior cortex down to the nail, again gently tapping it on to the nail to confirm that there is no intervening debris. The Distal target technique is used. First, the rotation is confirmed with the tibia to be satisfactory. Next, the image intensifier is used to obtain perfect circles radiographically on the medial view or the anterior view. There are four screw hole options in the standard Knee Nail sizes. The Positioning Rod must now be fixed in an exact position according to the diameter of the nail, and this is achieved by clipping the appropriate E Block-I (Knee) (670) on to the Targeter, so that its forks engage the two recesses in the Position Rod. The three spacers are each calibrated for two nail diameters, with a figure from 8 to engraved on each side. A spacer should be positioned so that the correct nail diameter is visible on the upper surface, facing towards the surgeon.

9 3 NeoGen Knee Nail System(Tibia ode) 4 An incision is now made beneath each Drill Sleeve, and the cortex exposed in each incision by blunt dissection, taking care to avoid entrapment of, or damage to, the neurovascular structures. Similarly, if the approach is from the lateral side, the surgeon must ensure that the tendons and vessels are not damaged during the locking procedure, by careful soft tissue dissection down to the bone. The Drill Sleeves are then advanced until they are in contact with the cortex, and the Distal Guide Bolt (630) on the Distal Aiming bar tightened to hold them firmly in place. As with all nails distal locking procedures, the surgeon's drilling technique is vital to the success of the procedure. Excessive force should be avoided, so that the surgeon can "feel" the drill passing through the bone and the nail. The surgeon should check that the Outer Drill Sleeve is positioned so that it is touching the bone. The Screw Depth Gauge (5340) cover is then unscrewed and removed. The hooked end is inserted down the Screw Guide and through the bone. It is then drawn back so that the hook engages the outer surface of the far cortex. The correct length of screw can now be read at the top of the Otter Drill Sleeve. All NeoGen locking screw measuring devices, measure from bottom of head to the last complete thread of screw. This is the working length of the screw. Thus, the screw itself is longer than the measurement and adding length is not necessary. The appropriate length and diameter screw is attached to the Screwdriver for locking screws and place screws in bone. Note: Bone graft or bone graft substitutes should be used to fill in gaps around the bones to enhance bony union. Fig.9 OPTIA DISTA A/P OCKING After perfect circles are confirmed, the two Outer Drill Sleeves and Inner Drill Sleeves are inserted into the Distal Aiming bar to locate the sites for the incisions. Before making the incisions, the surgeon should carry out a final check for reduction of the fracture, remembering the possibility of distraction. An incision is made beneath each Screw Guide, and the tibial cortex exposed in each case by blunt dissection. If he approach is from the lateral side, the surgeon must ensure that the tendons and vessels are not damaged during the locking procedure, by careful soft tissue dissection down to the bone. The Outrigger (Knee) (650) is mounted on the Distal Aiming bar (Knee) so that it lies on the correct side of the tibia, and the Inner(Fig.0) Drill Sleeve are inserted into the Outrigger. Fig.0

10 5 NeoGen Knee Nail System(Tibia ode) 6 A stab incision is now made beneath the Inner Drill Sleeve, and the cortex exposed in each incision by blunt dissection, taking care to avoid damage to, the neurovascular structures. The Inner Drill Sleeves are then advanced until they are in contact with the cortex, and the Distal Guide Bolt tightened to hold the Targeter (knee) (650) firmly in place. Use of the standard predrill technique can be used to finish screw placement. The Targeter (knee) can be used for A/P placement of the second screw. (Figure and Inset) NEOGEN NAI EXTRACTION TECHNIQUE Nail removal may normally be carried out after 8-4 months provided that there is radiological evidence of union. Union may be expected to occur after 6 months with nailing procedures in the tibia. The situation may be different in open fractures, nonunions or corrective osteotomies. In such cases the nail should be left in situ for a minimum of 4 months. COSURE Final position of the fracture is confirmed. Following completion of nailing and interlocking screw placement, the Knee Guide and Drill Guide are disassembled by backing off the Quick Bolt. Irrigate incision with saline and close in a standard fashion POST-OPERATIVE ANAGEENT WEIGHTBEARING The patient is mobilized on crutches immediately, but the knee is rested in an immobilizer for - days. Dressings are changed daily, and, after the drain has been removed, the knee may be mobilized freely. With a stable fracture, a patient may weightbear as able, increasing to full weightbearing by 4 weeks. If the fracture is unstable, toe touch weightbearing is permitted immediately, with gradually increasing partial weightbearing over the next 6 weeks. Full weightbearing is only advised once there is some continuity of callus across the fracture site. Fractures with severe comminution, should be supported before weightbearing with an external brace, if an 8 mm or 9 mm nail has been used, until the fracture is healed. Place the patient in the supine position on a radiolucent table. After prepping and draping, remove any distal screws and all but one proximal screw from the nail, leaving the screw closest to the driving end of the nail. Under fluoroscopy, the proximal end of the nail is exposed through a small incision. It may be necessary to clear some new bone from the end of the nail. The nail end cap is removed with the Screwdriver for locking screws, and the Extractor(5370) is screwed on to the nail, and tightened firmly. This should be accomplished prior to the removal of the proximal locking screws to prevent the nail from deflecting posteriorly. The locking screw proximal is now removed. The nail is then removed, either by manual traction on the Extractor, or by reverse hammering using Hammer (540), after the Hammer screwing on to the proximal end of the Extractor.

11 7 NeoGen Knee Nail System(Tibia ode) 8 INSTRUENT & IPANTS INSTRUENT Product Code Product Description Quantity Product Code Product Description Quantity 500 Entry Tool 540 Hammer 50 Tip Threaded Guide Wire Skin Protector mm Channel Reamer.5mm Entry Reamer Outer Drill Sleeve Inner Drill Sleeve T-Handle with Quick Coupling Flexible Reamer, Φ Flexible Reamer,(Φ4.0) 540 Adaptor 580 Small Drill Sleeve 550 Reducer Drill Bit T-Handle with Quick Coupling Tapping 560 Ball Tip Guide Rod Tapping 570 Gripper Drill Bit 0500 Flexible Reamer Shaft Tap Flexible Reamer,(Φ8.5) 5340 Screw Depth Gauge Reamer Head,(Φ9.0) Reamer Head,(Φ9.5) ScrewDriver for locking screws Connecting Rod 500 Entry Tool 500 Entry Tool 500 Entry Tool Reamer Head,(Φ0.0) 5370 Extractor Reamer Head,(Φ0.5) 5380 Positioning Rod Drill 0500 Reamer Head,(Φ.0) 5390 Position Rod 0505 Reamer Head,(Φ.5) 5400 Replacement Rod 0500 Reamer Head,(Φ.0) 540 Handle with Quick Coupling 0505 Reamer Head,(Φ.5) 5430 Trocar Reamer Head,(Φ3.0) 5440 Thread Pin Sleeve Reamer Head,(Φ3.5) Reamer Head,(Φ4.0) Threaded Pin, Proximal Aiming bar,left(knee) 50 Tip Threaded Guide Wire 50 4mm Channel Reamer 530.5mm Entry Reamer 580 Nail Depth Gauge 60 Proximal Aiming device(knee) 590 Drill Guide 630 Distal Aiming bar(knee) 500 Proximal Guide Bolt 650 Targeter(Knee) 540 Distal Guide Bolt 670 E Block-I(Knee) 50 Guide Bolt 680 E Block-II(Knee) 50 Guide Bolt Wrench 60 Proximal Aiming bar,right(knee) 530 Quick Bolt 550 Reducer 560 Ball Tip Guide Rod 570 Gripper

12 9 NeoGen Knee Nail System(Tibia ode) Nail Depth Gauge 590 Drill Guide 500 Proximal Guide Bolt 5350 ScrewDriver for locking screws 5360 Connecting Rod 5370 Extractor 540 Hammer 550 Skin Protector 560 Outer Drill Sleeve 5380 Positioning Rod Drill 5390 Stabling Rod 5400 Replacement Rod 5430 Trocar 5440 Thread Pin Sleeve 560 Distal Aiming bar(femoral) 570 Inner Drill Sleeve 580 Small Drill Sleeve Drill Bit Tapping Tapping 5340 Screw Depth Gauge 670 E Block-I(Knee) 680 E Block-II(Knee) 60 Proximal Aiming Drill Bit bar,right(knee)

13 NeoGen Knee Nail System(Tibia ode) IPANTS NeoGen ocking Screw Φ5 NeoGen Knee Nails Proximal Radian: 0 Product code Products Description NeoGen ocking Screws, 5 5mm NeoGen ocking Screws, 5 30mm Remark C Product code Products Description NeoGen ocking Screws, 5 5mm NeoGen ocking Screws, 5 30mm Remark C Product Code Products Description Proximal ocking Screws NeoGen Knee Nails,8X60mm NeoGen Knee Nails,8X80mm NeoGen Knee Nails,8X300mm NeoGen Knee Nails,8X30mm NeoGen Knee Nails,8X340mm NeoGen Knee Nails,8X360mm Distal ocking Screws Type Non- Non- Non- Non- Non- Non- Remark NeoGen ocking Screws, 5 35mm NeoGen ocking Screws, 5 40mm NeoGen ocking Screws, 5 45mm NeoGen ocking Screws, 5 50mm NeoGen ocking Screws, 5 55mm NeoGen ocking Screws, 5 60mm NeoGen ocking Screws, 5 65mm NeoGen ocking Screws, 5 35mm NeoGen ocking Screws, 5 40mm NeoGen ocking Screws, 5 45mm NeoGen ocking Screws, 5 50mm NeoGen ocking Screws, 5 55mm NeoGen ocking Screws, 5 60mm NeoGen ocking Screws, 5 65mm NeoGen Knee Nails,8X380mm Non NeoGen Knee Nails,9X60mm NeoGen Knee Nails,9X80mm NeoGen Knee Nails,9X300mm NeoGen Knee Nails,9X30mm NeoGen Knee Nails,9X340mm NeoGen Knee Nails,9X360mm NeoGen Knee Nails,9X380mm NeoGen Knee Nails,0X60mm NeoGen Knee Nails,0X80mm NeoGen Knee Nails,0X300mm NeoGen Knee Nails,0X30mm NeoGen Knee Nails,0X340mm NeoGen ocking Screw Φ4.5 Product code Products Description Remark NeoGen ocking Screws, 4.5 5mm NeoGen ocking Screws, mm NeoGen ocking Screws, mm NeoGen ocking Screws, mm NeoGen ocking Screws, mm NeoGen ocking Screws, mm NeoGen ocking Screws, mm C Product code Products Description NeoGen ocking Screws, 4.5 5mm NeoGen ocking Screws, mm NeoGen ocking Screws, mm NeoGen ocking Screws, mm NeoGen ocking Screws, mm NeoGen ocking Screws, mm NeoGen ocking Screws, mm Remark C C C NeoGen Knee Nails,0X360mm NeoGen Knee Nails,0X380mm NeoGen Knee Nails,.5X60mm NeoGen Knee Nails,.5X80mm NeoGen Knee Nails,.5X300mm NeoGen Knee Nails,.5X30mm NeoGen Knee Nails,.5X340mm NeoGen Knee Nails,.5X360mm NeoGen Knee Nails,.5X380mm NeoGen Caps(Knee) Product code Products Description NeoGen Nails Cap, NeoGen Nails Cap,.5,+5 Remark Product code Products Description NeoGen Nails Cap,.5, NeoGen Nails Cap,.5,+5 Remark *C: Customer ade

14 3 NeoGen Knee Nail System(Tibia ode) NOTE