The Implant. (Klappen außen sind nur 192 mm breit!)

Transcription

1 SEMIAL product information The Implant SEMIAL implants are designed to restore interbody vertebral disc height and maintain solid bony fusion when used in conjunction with bone graft material and supportive posterior instrumentation. The comprehensive selection of implant sizes and two angulation options provide the surgeon with maximum operative flexibility. The implants are made of PEEK-OPTIMA LT, a biocompatible thermoplastic polymer, which provides numerous benefits including an elasticity modulus similar to cortical bone and excellent postoperative imaging of the fused vertebral segment(s). F M F F M (Klappen außen sind nur 192 mm breit!) Shape Semicircular configuration with multiple fenestrations F for optimal bone in-growth Conforms to a varying range of intervertebral disc space anatomies Attachment sites for securing the Introducer at 0 and 45 angles Adapts to different surgical approaches, vertebral levels and pathology Titanium markers M for radiographic implant identification and positioning Sizes F = Fenestrations A = Introducer Attachment Sites M = Titanium Markers Height H: 8 mm through 18 mm (2 mm increments) Width W: 38 mm x 43 mm H = 8 mm H = 18 mm 5 A W = 38 mm W = 43 mm D = 25 mm A Depth D: 25 mm Angulation 10 5 and 10 Material In-vivo biocompatibility and elasticity modulus similar to cortical bone Radiolucent and artifact-free

2 This document was written by SIGNUS technical staff and is intended only to introduce the product. Information contained within this brochure should not be construed as surgical advice or medical opinion expressed or implied by SIGNUS. Signus Medizintechnik GmbH Carl-Zeiss-Strasse Alzenau /Germany phone: +49 (0) / fax: +49 (0) / info@signus-med.de web: MOBIS Monoportal Approach with Bilateral Support T.L.I.F Cage TETRIS Bilateral Lumbar Implant Fusion Cage P.L.I.F Cage KAINOS Exceptional Osteoconductivity Fully Resorbable Graft Matrix KIMBA Self-Guiding Spacer E.L.I.F Cage TLP Translaminar Pin Fixation with ECF PEEK -OPTIMA Implant E.L.I.F. Cage from ECF PEEK ConTact High Stability Minimally Invasive A.L.I.F. Frame Plate 02/Mai 2006 v01

3 SEMIAL Anterior Lumbar Interbody Fusion System Anatomically Adaptive Solid Support SEMIAL ALIF Spacer in PEEK-OPTIMA LT ALIF PRODuCT InFORMATIOn

4 SEMIAL Anterior Lumbar Fusion Implant The Concept The key concept behind the development of our products is simplicity and efficiency, in both design and function. SEMIAL implants may be implanted via a standard open or mini-open technique using either a transperitoneal or retroperitoneal anterior approach. Two attachment sites on the implant enable the introducer to be inserted into the implant at either a 0 or 45 angle as dictated by the surgical approach, vertebral level(s) to be fused, and degree of scar tissue present. The comprehensive offering of implants and instrumentation, combined with an atraumatic mini-open technique, provides multi-directional stability with minimal trauma. Patented Low Profile Inferior and Superior Teeth Configuration Provides a solid purchase between the implant and vertebral endplate Fenestrated and Semicircular Design Accommodates a large volume of bone graft material and facilitates implant insertion Embedded Titanium Markers Optimizes radiographic identification and positioning of the implant (Klappen außen sind nur 192 mm breit!) 0 and 45 Angle Implant Introducer Attachment Sites Adapts to different surgical approaches, vertebral levels and pathology Indications Mechanical instability Spondylolisthesis (Grades I and II) Degenerative Disc Disease Spinal Stenosis Disc Herniation

5 SEMIAL product information Implant and Instrument Set Semial implants and instrumentation are designed to provide the spine surgeon with the highest quality, easy to use and cost effective system for achieving anterior lumbar intervertebral body fusion. 1 Implant Set (Klappen außen sind nur 192 mm breit!) Instruments Attachment sites (on templates and implants) for securing the Introducer at 0 or 45 angles Art. No. Description Illust. No. Art. No. Description Illust. No. S002AY SEMIAL Sterilization Container SK-0101 Rake Curette 15, angled 9 SK-0102 Ring Curette 45, angled 8 SK-0103 Rectangular Rasp 7 SK-0201 Positioner 6 SK-0301 Revision Instrument 4 SK-0401 Slide Hammer 12 SK-3843 Graft-loading platform 2 S027AH Introducer 5 T029AH Graft Impactor 3 T030AH Universal-Soft-grip with Quick-release 11 T001AQ Mallet with Plastic Head S001AY Sizer Tray SK07AH Sizer for SK SK08AH Sizer for SK SK10AH Sizer for SK SK11AH Sizer for SK SK16AH Sizer for SK SK17AH Sizer for SK SK22AH Sizer for SK SK23AH Sizer for SK SK24AH Sizer for SK SK25AH Sizer for SK SK26AH Sizer for SK SK27AH Sizer for SK SK28AH Sizer for SK SK29AH Sizer for SK SK30AH Sizer for SK SK31AH Sizer for SK SK32AH Sizer for SK SK33AH Sizer for SK SK34AH Sizer for SK SK35AH Sizer for SK SK36AH Sizer for SK SK37AH Sizer for SK

6 SEMIAL Anterior Lumbar Interbody Fusion A Guide to the Surgical Technique Surgical Approach The procedure is performed under general anesthesia, with the patient placed in a supine position on the operating table. The lumbar spine is exposed via a retroperitoneal or transperitoneal approach based on the vertebral level(s) to be treated, individual patient anatomy and pathology, and surgeon preference. Following exposure of the anterior aspect of the spine, a k-wire or needle may be inserted in the midline of the disc, and A/P fluoroscopic images can be used to verify the appropriate vertebral level and midline reference point. Preparation of Intervertebral Disc Space An anterior discectomy is performed using the appropriate technique dictated by the approach (retroperitoneal or transperitoneal). An intact band of the annulus fibrosis should be preserved laterally to function as a tension band for stabilizing the vertebral segment. The cartilaginous endplates of the superior and inferior vertebrae are removed using the Rectangular Rasp or Ring Curette to create bleeding bone. Care must be taken only to remove the cartilaginous material and gently debride the cortical bone. Loose debris in the disc space may be removed using a small rongeur. The goal is to create a flat superior and inferior surface without compromising the integrity of the vertebral body to prevent the risk of implant subsidence. Instruments: Rectangular Rasp 7 Ring Curette 45, angled 8 Rake Curette 15, angled 9 2 mm Implant Selection An initial estimate of the implant width and height is determined from preoperative radiologic images of the adjacent disc spaces. The appropriate Sizer is mounted on the introducer and assessed in situ. As with the implants, the Sizers may be mounted on the Introducer at either 0 or 45. Based on the fit of the initial Sizer, wider/ narrower or taller/shorter Sizers may be similarly assessed until the appropriate size implant is determined. The height of the Sizer reflects the height of the implant minus the teeth. When positioned In the A-P direction and recessed approximately 2mm from the anterior lip of the vertebra (not including osteophytes) the correct implant should fit snug into the intervertebral disc space. Instruments: Implant Holder 5 Trials 10 Notes The Mallet may be used to seat the correct size implant into its final position by lightly tapping it on the distal end of the introducer. The procedure is greatly simplified with the use of fluoroscope. The correct size implant should NOT extend beyond the anterior margin of the adjacent vertebrae. The height of the Sizer reflects the plain Implant height without teeth.

7 SEMIAL product information Implant Insertion Once the interbody space has been adequately exposed and properly prepared, the appropriate SEMIAL implant size is determined by the corresponding Sizer. Prior to insertion into the disc space, the implants should be packed with bone graft material using the Graft Loading Platform and Graft Impactor. The Implant is mounted on the Introducer at either 0 or 45. Note: The fenestrations should be firmly packed with bone graft material to facilitate insertion and seating of the implant. Insertion of the Implant is performed using a similar technique for inserting the Sizers, the exception is the Implant is inserted approximately 2 mm deeper than the anterior cortical line. The Mallet is used to securely seat the Implant into its final position by lightly tapping the distal end of the Introducer. The Positioner may also be used for final positioning and for packing bone graft around the implant. Fluoroscopic imaging is used to confirm accurate positioning of the implant. Instruments: Graft-loading Platform 2 Graft Impactor 3 Introducer 5 Positioner 6 Use of the Revision Instrument 4 : If the Implant is improperly positioned in the disc space, it can be removed by reattaching the Introducer to the Implant and extracting it with the assistance of the Slide Hammer 12. If for any reason the Implant Holder may not be reattached to the implant the Revision Instrument 4 may be introduced into the attachment sites on the implant and used to remove the implant. To assist in the Implant removal, the Slide Hammer 12 may be mounted on the distal end of the Revision Instrument for additional leverage. Implants removed with the Revision Instrument SHOULD NOT be reused and should be discarded.

8 Lateral radiograph showing correct positioning of the implant. The titanium markers assist in the identification of the implant s location. Ordering Information Implants 1 Art. No. Dimensions Art. No. Dimensions SK , 8 x 38 mm SK , 10 x 38 mm SK , 8 x 43 mm SK , 10 x 43 mm SK , 10 x 38 mm SK , 12 x 38 mm SK , 10 x 43 mm SK , 12 x 43 mm SK , 12 x 38 mm SK , 14 x 38 mm SK , 12 x 43 mm SK , 14 x 43 mm SK , 14 x 38 mm SK , 16 x 38 mm SK , 14 x 43 mm SK , 16 x 43 mm SK , 16 x 38 mm SK , 18 x 38 mm SK , 16 x 43 mm SK , 18 x 43 mm SK , 18 x 38 mm SK , 18 x 43 mm (Klappen außen sind nur 192 mm breit!) Care and Handling SEMIAL instrumentation should be cleaned and sterilized according to standard hospital protocol. Steam sterilization in a standard hospital autoclave is recommended. Any instruments with detachable parts should be disassembled prior to cleaning and sterilization. SEMIAL Implants should only be used with SIGNUS instruments. Sharp edged instruments such as clamps or serrated forceps may damage the surface integrity of the implants. Should the threaded attachment site for the Introducer become damaged the Implant should be discarded. SEMIAL Implants are pre-packaged sterile and intended for single use only. Contaminated Implants should not be re-sterilized. In an emergency an Implant that has not been in physical contact with the patient may be re-sterilized in an autoclave. Temperatures involved should not exceed 134 C /275 F. Gas (Eto), Flash or chemical sterilization is not recommended.