Technique Guide. SynPOR HD Ocular Spheres. For augmentation or reconstruction.

Transcription

1 Technique Guide SynPOR HD Ocular Spheres. For augmentation or reconstruction.

2 Table of Contents Introduction SynPOR HD Ocular Spheres 2 Indications and Contraindications 3 Surgical Technique Sizing and Contouring 4 Implantation 5 Stabilization 7 Product Information Instruments 8 Set List 9 Synthes

3 SynPOR HD Ocular Spheres. For augmentation or reconstruction. SynPOR HD Ocular Sphere implants are suited for restoring the volume of an eviscerated or enucleated eye globe. The implant s network of open and interconnecting pores allow for fibrovascular ingrowth. Features Nonabsorbable, biocompatible material Anatomical design in multiple sizes to meet clinical needs Porous structure supports fibrovascular ingrowth Available diameters: 16 mm 22 mm Material SynPOR HD Ocular Sphere implants are manufactured from an inert, nonabsorbable high-density polyethylene (HDPE), which has a long history of use as a surgical implant. 2 Synthes SynPOR HD Ocular Spheres Technique Guide

4 Evaluation and Planning Successful implantations are technique sensitive and require careful preoperative planning. Proper sizing of the socket is essential to avoid complications and to achieve an optimum fit of the implant. Handling SynPOR HD Ocular Sphere implants are provided sterile for single-patient use. Do not resterilize. Do not remove the SynPOR HD Ocular Sphere implant from the protective package until the time of implantation. Handle the implant with clean, powder-free gloves to prevent contamination. SynPOR HD porous polyethylene three-dimensional implants can easily be trimmed and contoured with a scalpel to suit the individual needs of the patient. Caution: Do not place implants on surgical drapes, surgical clothing or any other material that may contaminate the implants with lint or other particulate matter. Implants may be placed in sterile saline to prevent contamination. Indications and Contraindications Indications SynPOR HD porous polyethylene three-dimensional implants are intended for the augmentation or reconstruction of the craniomaxillofacial skeleton. Specific indications: Ocular reconstruction Socket preservation Contraindications Synthes SynPOR HD porous polyethylene three-dimensional implants are not intended for use in: The presence of active or latent infections Inadequate coverage of healthy, vascularized tissue Full load-bearing applications or to lend structural support to bone Systemic disorders and/or limitations in blood supply that may cause slow healing and increase the possibility of infection and/or rejection of the implants. Note: For complete contraindications, warnings, and precautions, please refer to package insert. Synthes 3

5 Surgical Technique 1 Sizing and contouring Instruments Ocular Sphere Sizers, mm 22 mm A set of sizers identical in size and shape to the actual implants is available, in diameters of 16 mm 22 mm. Sizers aid in selection of the proper size implant. The implant should take up adequate volume to match the patient s anatomy. Do not implant sizers. SynPOR HD Ocular Sphere implants are available in a range of sizes to minimize the need for alteration. Note: If implant is burred, reestablish the open pore structure by shaving the outer surface with a scalpel. 4 Synthes SynPor HD Ocular Spheres Technique Guide

6 2 Implantation Instrument Ocular Sphere Inserter The Ocular Sphere Inserter holds the SynPOR HD Ocular Sphere and facilitates placement of the implant in the orbit. To load an implant into the Ocular Sphere Inserter: 1. Depress the plunger so that the center disc reaches the tips of the prongs. 2. Hold the SynPOR HD Ocular Sphere implant against the disc while slowly retracting the plunger until the implant is secured within all prongs. Apply light pressure to the implant to secure it in the inserter. Synthes 5

7 Surgical Technique 2 Implantation continued To insert the implant into the orbit: 1. Place the loaded Ocular Sphere Inserter in the orbit. Make sure the tissue edges are safely retracted to fully expose the muscle cone. 2. Position the loaded inserter with the tips as far posterior in the muscle cone as possible. 3. When the inserter is properly positioned, fully depress the plunger to release the implant. 4. Remove the Ocular Sphere Inserter. 6 Synthes SynPor HD Ocular Spheres Technique Guide

8 3 Stabilization After the SynPOR HD Ocular Sphere implant is seated in the socket, standard technique for implant stabilization may be used. Synthes 7

9 Instruments Ocular Sphere Inserter Ocular Sphere Sizers, mm 22 mm 8 Synthes SynPor HD Ocular Spheres Technique Guide

10 SynPOR HD Ocular Sphere Instrument Set ( ) Set SynPOR HD Ocular Sphere Instrument Set Module Components SynPOR HD Ocular Sphere Instrument Module Module (includes lid) Replacement Lid Label Sheet Instruments Ocular Sphere Inserter Ocular Sphere Sizers Diameter (mm) Also available Implants, available separately SynPOR HD Ocular Spheres, sterile Diameter (mm) S S S S S S 22 Diameter Note: For additional information, please refer to package insert. For detailed cleaning and sterilization instructions, please refer to In Canada, the cleaning and sterilization instructions will be provided with the Loaner shipments. Synthes 9

11 Synthes CMF 1302 Wrights Lane East West Chester, PA Telephone: (610) To order: (800) Fax: (610) Synthes (Canada) Ltd Meadowpine Boulevard Mississauga, Ontario L5N 6P9 Telephone: (905) To order: (800) Fax: (905) Synthes, Inc. or its affiliates. All rights reserved. SynPOR and Synthes are trademarks of Synthes, Inc. or its affiliates. Printed in U.S.A. 10/12 J9715-C