Resorbable Implant Technology

Transcription

1 Delta System Resorbable Implant Technology

2 A Legacy of Serving the Surgical Community For over half a century, Stryker has been developing products based on the expressed needs of leading practitioners. You will often find a Stryker product specialist speaking with a surgeon, learning and listening. By paying careful attention to the surgeon s needs, Stryker has been able to refine and augment its products to better serve the surgical community. The all-inclusive color-coded systems of plates and screws make identification easy. Biomaterials and resorbable products for bone repair and reconstruction offer surgeons a range of options as they help renew and rebuild lives. Stryker CMF takes pride in its close relationships with leading surgeons worldwide and has earned a reputation for excellence in the products that serve this collaborative surgeon community. Stryker constantly refines its products and continues focused research in biomaterials, fixation systems and surgical devices.

3 Our products are derived from a close working collaboration with surgeons, physicians and healthcare experts from the entire spectrum of the healthcare field.

4 Polymers and Resorbable Systems Resorbable systems are composed of different blends and ratios of lactide and/or glycolide copolymers, which produce distinguished features and characteristics. These lactide and glycolide polymers are connected through ester bonds to form long chains of polymers (polyesters). 1 Once these resorbable plates/screws are implanted into patients, their bodies breakdown and remove the polymers through two processes: hydrolysis and metabolism. Hydrolysis reaction breaks the ester bonds and degrades the polymers into lactic and/or glycolic acids. 1 These acidic products from the hydrolysis reaction are then removed and metabolized into glucose, carbon dioxide, or water. 1 The strength retention, resorption rate, and biocompatibility of resorbable implants are dependent on multiple factors: the crystalline/amorphous polymer structure, molecular weight, manufacturing process, implant size, patient anatomy/metabolism, and polymer composition. 1 Strength retention, resorption rate, and biocompatibility, to an extent, reflect the effectiveness of a resorbable system. Strength Retention plays an integral role in proper bone healing. For pediatric craniosynostosis cases in particular where there are large bony gaps due to expanded cranial vaults and frontal advancements, it is important for resorbable plates/screws to maintain their strength and structural integrity for a sufficient period of time for new bone formation to occur. 1 Resorption Rate, which affects strength retention, is also important. High resorption rates could potentially lead to premature loss of mechanical integrity and to adverse tissue-implant and inflammatory reactions caused by accumulation of polymeric acidic degradation products, 2 local sub-physiological low ph gradients, 3, 5 and adverse immune/foreign body reactions. 4 Inflammatory responses can also occur if the degradation rate is faster than the body s ability to handle the degradation products. 5 Evidence from clinical experience suggests that resorbable implants that degrade at a gradual rate is more preferred. 5 Biocompatibility is, for the most part, determined by resorption rate and polymer composition. In terms of polymer composition, clinical evidence demonstrates polylactide and polyglycolide polymer blends, in comparison with purely lactide copolymers (PLLA/PDLA), tend to produce better biocompatibility and long-term results. 4 However, high ratios of polyglycolide can potentially produce the opposite effect by causing rapid resorption and eliciting inflammatory reactions. 4

5 Delta Polymer Delta has a copolymer composition of poly L-lactide (PLLA), poly D-lactide (PDLA), and polyglycolide (PGA) in a ratio of 85:5:10. It has an attractive combination 6 of strength, contourability, and balanced resorption. Strength Retention: At 2 and 6 months, Delta maintains 78% and 50% of its initial strength respectively, 7 which can help facilitate structural fixation and reinforcement during osteosynthesis. Resorption Rate: The product has a gradual resorption time, depending on the patient anatomy and metabolism, of approximately months. 8 Biocompatibility: Compared to other resorbable systems containing polyglycolide, Delta has a relatively low ratio of PGA. 2 In a clinical study, Delta, compared to two other resorbable systems in terms of complications incited a relatively mild tissue reaction. 9 Indications for Use The Delta Resorbable Fixation System is intended for use in the fixation of bones of the craniofacial and midfacial skeleton affected by trauma or for reconstruction. The system can be used in both adult and pediatric patients but is not intended for use in the mandible and/or full load bearing procedures. Contraindications The Resorbable Implant System is not intended for use in the mandible or other load bearing regions. It is also not intended for regions with: Active infection Patient conditions including blood supply limitations, insufficient quality or quantity of bone or latent infection Mandible or temporal mandibular joint Full load bearing procedures

6 mm Delta Plates 1.7 mm Resorbable Plates 1.7 mm plates and mesh are designed for cranial and frontal non-load bearing applications. The 1.7 mm plates, mesh, and instruments are color coded purple Straight Plate, 14 Holes, 1.0 mm Thick Curved Plate, 8 Holes, 1.0 mm Thick Curved Plate, 10 Holes, 0.5 mm Thick L Plate, 7 Holes, 110 Right, 1.0 mm Thick L Plate, 7 Holes, 110 Left, 1.0 mm Thick Y Plate, 6 Holes, 1.0 mm Thick Double Y Plate, 6 Holes, 1.0 mm Thick Double Y Plate, 8 Holes, 1.0 mm Thick Box Plate, 2 x 2 Holes, 1.0 mm Thick Ladder Plate, 2 x 5 Holes, 1.0 mm Thick Strut Plate, 150 x 15 x 0.75 mm, 8 Holes

7 mm Delta Plates 1.7 mm Resorbable Plates Continued Strut Plate, 1 x 21 Holes, 0.5 mm Thick Strut Plate, 1 x 21 Holes, 0.75 mm Thick Strut Plate, 2 x 21 Holes, 0.5 mm Thick Strut Plate, 2 x 21 Holes, 0.75 mm Thick Strut Plate, 3 x 21 Holes, 0.5 mm Thick Strut Plate, 3 x 21 Holes, 0.75 mm Thick Curved Strut Plate, 144 x 12 x 0.75mm Staggered Hole 2 Row Plate, 0.5 mm Thick Staggered Hole 3 Row Plate, 0.5 mm Thick 1.7 mm Delta Partial Countersink Plates Partial Countersink Plate, 1 x 21, 0.50 mm Thick Partial Countersink Plate, 1 x 21, 0.75 mm Thick Partial Countersink Plate, 2 x 21, 0.50 mm Thick Partial Countersink Plate, 2 x 21, 0.75 mm Thick Partial Countersink Plate, 3 x 21, 0.50 mm Thick Partial Countersink Plate, 3 x 21, 0.75 mm Thick

8 mm Delta Plates 1.7 mm Resorbable Plates Continued X Plate, 49 Holes, 0.75 mm Thick

9 mm Delta Plates 1.7 mm Resorbable Plates 1.7 mm plates and mesh are designed for cranial and frontal non-load bearing applications. The 1.7 mm plates, mesh, and instruments are color coded purple Triangle Plate, 25 x 25 x 0.5 mm Triangle Plate, 30 x 30 x 0.5 mm Triangle Plate, 36 x 36 x 0.5 mm Mesh, 55 x 55 x 0.5 mm Mesh, 55 x 55 x 0.75 mm Panel, 55 x 55 x 1.0 mm Panel, 122 x 122 x 0.75 mm Staggered Hole Mesh, 116 x 116 x 0.5 mm Flexible Mesh, 55 x 55 x 0.5 mm Flexible Mesh, 122 x 122 x 0.5 mm

10 mm Delta Plates 1.7 mm Resorbable Plates Continued Mesh, 122 x 122 x 0.5 mm Mesh, 122 x 122 x 0.75 mm

11 mm Delta Plates 1.7 mm Resorbable Plates Continued Partial Countersink Mesh, 122 x 122 x 0.5mm Thick Partial Countersink Mesh, 122 x 122 x 0.75mm Thick

12 mm Delta Plates Delta Neuro Plates 1.7 mm plates and mesh are designed for cranial and frontal non-load bearing applications. The 1.7 mm plates, mesh, and instruments are color coded purple Burr Hole Cover 24 mm, 0.75 mm Thick Burr Hole Cover 14 mm, 0.5 mm Thick Burr Hole Cover 10 mm, 0.5 mm Thick Hole Straight Plate, 0.5 mm Thick Hole Straight Plate, 0.5 mm Thick Double Y-Plate 8 Hole, 0.5 mm Thick Double Y-Plate 6 Hole, 0.5 mm Thick

13 mm Delta Plates Delta Neuro Plates Continued Plates in-use Hole Straight Plate, 0.5mm Thick Burr Hole Cover 10mm, 0.5mm Thick Double Y-Plate 6 Hole, 0.5mm Thick

14 mm Delta Plates 2.2 mm Resorbable Plates 2.2 mm plates and mesh are designed for mid-face non-load bearing applications. Note: 2.2 mm implants are not indicated for load bearing applications in the maxilla and mandible. The 2.2 mm plates, mesh, and instruments are color coded black Straight Plate, 4 Holes, 1.4 mm Thick Straight Plate, 8 Holes, 1.4 mm Thick Curved Plate, 8 Holes, 1.4 mm Thick L Plate, 9 Holes, 110 Right, 1.4 mm Thick Straight Plate, 21 Holes, 1.4 mm Thick Straight Plate, 14 Holes, 1.4 mm Thick L Plate, 9 Holes, 110 Left, 1.4 mm Thick Y Plate, 9 Holes, 1.4 mm Thick Double Y Plate, 10 Holes, 1.4 mm Thick Ladder Plate 2 x 5 Holes, 1.4 mm Thick Strut Plate, 150 x 15 x 1.4 mm, 8 Holes

15 mm Delta Plates 2.2 Resorbable Plates Continued Panel, 116 x 11 x 1.4 mm Panel, 116 x 17 x 1.4 mm Mesh, 55 x 55 x 1.0 mm Mesh, 55 x 55 x 1.4 mm Strut Plate, 1 x 21 Holes, 1.4 mm Thick Strut Plate, 2 x 21 Holes, 1.4 mm Thick Panel, 55 x 55 x 1.4 mm Strut Plate, 3 x 21 Holes, 1.4 mm Thick 2.2 mm Delta Partial Countersink Plates Partial Countersink Plate, 1 x 21, 1.4mm Thick Partial Countersink Plate, 2 x 21, 1.4 mm Thick Partial Countersink Plate, 3 x 21, 1.4 mm Thick

16 mm Delta Plates 2.2 Resorbable Plates Continued X Plate, 49 Holes, 1.0 mm Thick

17 Screwdriver Blades The Delta screwdriver blades have flanges at the sides for grasping the Delta screws. Positive engagement feedback. Designed for increased retention. Has greater blade/screw head contact and shorter shaft to minimize screw insertion instability. Self-Drilling Taps Self-drilling taps allow for drilling and tapping in a single step. Comes in various fixed lengths. SD taps have dental and hex coupling options. VariSpeed Self-drilling taps allow for drilling and tapping in a single step.

18 Torque-Limiting Drivers Torque limiting driver's on/off switch allows for the option to increase or reduce torque for screw insertion or removal. Delta Screws Screw thread is designed to provide excellent purchase and functional stability during insertion. Excellent fit between screw head and driver blade allows for easy pickup, insertion and removal. Screw head sits flush within the plate, to ensure a true low profile plate and screw combination.

19 Delta Modules Minimized sterile field presence. Easy access to Delta instruments mm Instruments Module mm Instruments Module Instrument Tray Delta Sterilization Waterbath System Container The Delta sterilization container conveniently stores Heats the modules, water to instrument an optimal 150 trays, F and to minimize the waterbath, which plate contouring are the system time. components required for the sterile field. Stores conveniently in the Delta sterilization container. Non-sterile console equipped with indicator light to notify user when water is ready. Lids lock in place to provide a safe environment when not in use. Lightweight and fully autoclavable. Delta Sterilization Container Conveniently stores the modules, instrument trays and the water bath. Contains all components required for the sterile field Delta Sterilization Container VariSpeed Sterilization Tray

20 Delta Water Bath Stores conveniently in the sterilization container. No sterile drape required. Lightweight and fully autoclavable. Heats water to 155 F Water Bath Console Bath Sterilization Cord CMF Inventory Management Cart Designed specifically for CMF and Delta System inventory. Provides greater storage capacity. Flexible inventory management for increased efficiency. Adjustable in-drawer rows and columns allow for custom organization of space for Delta sterile implant packs or other items CMF Inventory Management Cart

21 DeltaSystem Ordering Information Product # Description 1.7 mm Plates Straight Plate, 14 Holes, 1.0 mm Thick L Plate, 7 Holes, 110 Right, 1.0 mm Thick L Plate, 7 Holes, 110 Left, 1.0 mm Thick Y Plate, 6 Holes, 1.0 mm Thick Double Y Plate, 6 Holes, 1.0 mm Thick Double Y Plate, 8 Holes, 1.0 mm Thick Curved Plate, 8 Holes, 1.0 mm Thick Curved Plate, 10 Holes, 0.5 mm Thick Box Plate, 2 x 2 Holes, 1.0 mm Thick Ladder Plate, 2 x 5 Holes, 1.0 mm Thick Mesh, 55 x 55 x 0.5 mm Mesh, 55 x 55 x 0.75 mm Mesh, 122 x 122 x 0.5 mm Mesh, 122 x 122 x 0.75 mm Flexible Mesh, 55 x 55 x 0.5 mm Flexible Mesh, 122 x 122 x 0.5 mm Staggered Hole Mesh, 116x116x0.5 mm Staggered Hole 2 Row Plate, 0.5 mm Thick Staggered Hole 3 Row Plate, 0.5 mm Thick Panel, 55 x 55 x 1.0 mm Panel, 122 x 122 x 0.75 mm X Plate, 49 Holes, 0.75 mm Thick Curved Strut Plate, 144 x 12 mm 0.75mm Strut Plate, 150 x 15 x 0.75 mm, 8 Holes Strut Plate, 1 x 21 Holes, 0.5 mm Thick Strut Plate, 2 x 21 Holes, 0.5 mm Thick Strut Plate, 3 x 21 Holes, 0.5 mm Thick Strut Plate, 1 x 21 Holes, 0.75 mm Thick Strut Plate, 2 x 21 Holes, 0.75 mm Thick Strut Plate, 3 x 21 Holes, 0.75 mm Thick Triangle Plate, 25 x 25 mm, 0.5 mm Thick Triangle Plate, 30 x 30 mm, 0.5 mm Thick Triangle Plate, 36 x 36 mm, 0.5 mm Thick 1.7 mm Neuro Plates Burr Hole Cover 10 mm, 0.5 mm Thick Burr Hole Cover 14 mm, 0.5 mm Thick Hole Straight Plate, 0.5 mm Thick Hole Straight Plate, 0.5 mm Thick Double Y-Plate 8 Hole, 0.5 mm Thick Double Y-Plate 6 Hole, 0.5 mm Thick Burr Hole Cover 24 mm, 0.75 mm Thick 1.7 mm Screws x 3 mm, Pkg x 4 mm, Pkg x 5 mm, Pkg x 6 mm, Pkg x 3 mm, Pkg x 4 mm, Pkg x 5 mm, Pkg x 6 mm, Pkg x 4 mm, Pkg x 5 mm, Pkg mm Plates Straight Plate, 4 Holes, 1.4 mm Thick Straight Plate, 8 Holes, 1.4 mm Thick Straight Plate, 14 Holes, 1.4 mm Thick Straight Plate, 21 Holes, 1.4 mm Thick L Plate, 9 Holes, 110 Right, 1.4 mm Thick L Plate, 9 Holes, 110 Left, 1.4 mm Thick Y Plate, 9 Holes, 1.4 mm Thick Double Y Plate, 10 Holes, 1.4 mm Thick Curved Plate, 8 Holes, 1.4 mm Thick Ladder Plate 2 x 5 Holes, 1.4 mm Thick Mesh, 55 x 55 x 1.0 mm Mesh, 55 x 55 x 1.4 mm Panel, 55 x 55 x 1.4 mm Panel, 116 x 11 x 1.4 mm Panel, 116 x 17 x 1.4 mm X Plate, 49 Holes, 1.0 mm Thick Strut Plate, 150 x 15 x 1.4 mm, 8 Holes Strut Plate, 1 x 21 Holes, 1.4 mm Thick Strut Plate, 2 x 21 Holes, 1.4 mm Thick Strut Plate, 3 x 21 Holes, 1.4 mm Thick 2.2 mm Partial Countersink Plates Partial Countersink Plate, 2 x 21, 1.4 mm Thick Partial Countersink Plate, 3 x 21, 1.4 mm Thick Partial Countersink Plate, 3 x 21, 1.4 mm Thick Partial Countersink Plate, 1 x 21, 1.4mm Thick 1.7 mm Partial Countersink Plates Partial Countersink Plate, 2 x 21, 0.50 mm Thick Partial Countersink Plate, 2 x 21, 0.75 mm Thick Partial Countersink Plate, 3 x 21, 0.50 mm Thick Partial Countersink Plate, 3 x 21, 0.75 mm Thick Partial Countersink Plate, 1 x 21, 0.50 mm Thick Partial Countersink Plate, 1 x 21, 0.75 mm Thick 1.7 mm Partial Countersink Mesh Partial Countersink Mesh, 122 x 122mm, 0.5mm Thick Partial Countersink Mesh, 122 x 122mm, 0.75mm Thick Twist Drills mm, 3 & 4 mm Screws, Stryker End mm, 5 & 6 mm Screws, Stryker End mm, 3 & 4 mm Screws, Stryker End mm, 5 & 6 mm Screws, Stryker End mm, 12 mm Length, Stryker End mm, 4 mm Screws, Stryker End mm, 6 mm Screws, Stryker End mm, 12 mm Length, Stryker End

22 2.2 mm Screws x 4 mm, Pkg x 6 mm, Pkg x 4 mm, Pkg x 6 mm, Pkg x 8 mm, Pkg x 10 mm, Pkg x 4 mm, Pkg x 6 mm, Pkg x 8 mm, Pkg x 4 mm, Pkg x 6 mm, Pkg mm Emergency Screws x 6 mm, Pkg x 8 mm, Pkg x 10 mm, Pkg x 4 mm, Pkg x 6 mm, Pkg x 8 mm, Pkg x 10 mm, Pkg. 2 Instruments mm Screwdriver Blade mm Screwdriver Blade, 80 mm mm Screwdriver Blade, 125 mm mm Screwdriver Handle Self-Drilling Tap 1.7 mm, 3 & 4 mm, Dent Self-Drilling Tap 1.7 mm, 5 & 6 mm, Dent Self-Drilling Tap 1.7 mm, 3 & 4 mm, Hex Self-Drilling Tap 1.7 mm, 5 & 6 mm, Hex Self-Drilling Tap 1.7 mm, 3 & 4 mm, Hex, 95 mm Self-Drilling Tap 1.7 mm, 5 & 6 mm, Hex, 95 mm Self-Drilling Tap 1.7 mm, 3 & 4 mm, Hex, 130 mm Self-Drilling Tap 1.7 mm, 5 & 6 mm, Hex, 130 mm mm Bone Tap mm Screwdriver Blade mm Screwdriver Blade, 80 mm mm Screwdriver Blade, 125 mm mm Screwdriver Handle Self-Drilling Tap 2.2 mm, 4 mm, Dent Self-Drilling Tap 2.2 mm, 6 mm, Dent Self-Drilling Tap 2.2 mm, 8 & 10 mm, Dent Self-Drilling Tap 2.2 mm, 4 mm, Hex Self-Drilling Tap 2.2 mm, 6 mm, Hex Self-Drilling Tap 2.2 mm, 8 & 10 mm, Hex Self-Drilling Tap 2.2 mm, 3 & 4 mm, Hex, 95 mm Self-Drilling Tap 2.2 mm, 5 & 6 mm, Hex, 95 mm Self-Drilling Tap 2.2 mm, 8 & 10 mm, Hex, 95 mm Self-Drilling Tap 2.2 mm, 3 & 4 mm, Hex, 130 mm Self-Drilling Tap 2.2 mm, 5 & 6 mm, Hex, 130 mm Self-Drilling Tap 2.2 mm, 8 & 10 mm, Hex, 130 mm mm Bone Tap /2.6 mm Screwdriver Blade mm Screwdriver Handle mm Bone Tap Plate Forceps Plate/Mesh Cutter Tap Handle VariSpeed Battery Powered Screwdriver VariSpeed Battery Pack Countersinks mm, 3 & 4 mm Screws, Stryker End mm, 5 & 6 mm Screws, Stryker End mm Countersink, Stryker End Containers & Instrument Modules Delta System Sterilization Container mm Instruments Module mm Instruments Module Instrument Tray CMF Inventory Management Cart VariSpeed Sterilization Tray Bath System Water Bath Console Bath Sterilization Cord

23 Reconstructive Hips Knees Trauma & Extremities Joint Preservation Orthobiologics Medical & Surgical Power Tools & Surgical Accessories Image Guided Navigation Endoscopy & Arthroscopy Integrated Communications Beds, Stretchers & EMS Sustainability Solutions Neurotechnology & Spine Craniomaxillofacial Interventional Spine A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a particular product when treating a particular patient. Stryker does not dispense medical advice and recommends that surgeons be trained in the use of any particular product before using it in surgery. The information presented is intended to demonstrate the breadth of Stryker product offerings. A surgeon must always refer to the package insert, product label and/or instructions for use before using any Stryker product. Products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. Please contact your Stryker representative if you have questions about the availability of Stryker products in your area. Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the following trademarks or service marks: Delta, QuikDrive, Stryker. All other trademarks are trademarks of their respective owners or holders. References: 1. Habal, M.B.: Innovations in Plastic and Aesthetic Surgery, Chapter 21: The Utility of Biomaterials in Reconstructive Facial Plastic Surgery, Pietrzak, W.S. and Habal, M.B.: First Bioabsorbable Fixation System in Craniofacial Surgery on the 15th Anniversary of its US Utility, Ignatius, A.A. and Claes, L.E.: In vitro biocompatibility of Bioresorbable Polymers: poly (L. DL-lactide) and poly (L-lactide-co-glycolide), Ashammakhi, N., Gonzalez, A.M., Tormala, P., and Jackson, I.T.: New Resorbable Bone Fixation. Biomaterials in Craniomaxillofacial Surgery: Present and Future, Losken, H.W., Aalst, J.A., Mooney, M.P., Godfrey, V.L., Burt, T., Teotia, S., Dean, S.B., Moss, J.R., and Rahbar, R.: Biodegradation of Inion Fast-Absorbing Biodegradable Plates and Screws, Laughlin, R.M., Block, M.S., Wilk, R., Malloy, R.B., Kent, J.N.: Resorbable Plates for the Fixation of Mandibular Fractures: A Prospective Study, Posnick, J.C., and Ricalde, P.: Degradation Rate of Delta (Resorbable) Internal Fixation: Report of 2 Cases, Sasaki, C.T., Marotta, Ross, D.A., Johnson, M., and Lowlicht, R.A.: Efficacy of Resorbable Plates for Reduction and Stabilization of Laryngeal Fractures, Wittwer, G., Adeyemo, W.L., Yerit, K., Voracek, M., Turhani, D., Watzinger, F., and Enislidis, G.: Complications after Zygoma Fracture Fixation: Is there a difference between Biodegradable Materials and How do they compare with Titanium Osteosynthesis?, Neurosurgical, Spine & ENT Neurovascular Spinal Implants Literature Number: Rev. A UnDe/P.S. Copyright 2015 Stryker Printed in USA Stryker Craniomaxillofacial Portage, MI USA t: toll free: f: