Contents. Introduction... Page 1. Implant Design... Page 2. Instruments... Page 4. Surgical Technique... Page 6. Product Information...

Transcription

1 Surgical Technique

2 Contents Introduction... Page 1 Implant Design... Page 2 Instruments... Page 4 Surgical Technique... Page 6 Product Information... Page 18 Post Operative Care... Page 20 Indications... Page 20 Sterilization Recommendations... Page 21 Contraindications... Page 21 Further Information... Page 22

3 Introduction The Ionic Spine Spacer is a titanium device designed to be inserted within the intervertebral space of the thoracolumbar region of the spine. The implant is designed to be used with dedicated instruments that prepare the adjacent endplates while protecting the surrounding soft tissues during insertion. The Ionic System is intended to provide stability within the axis of the spine, thereby creating an environment for a successful spinal fusion and pain relief for the patient. The Ionic Spine Spacer Device must be used in conjunction with the Biomet Omega21 System or the Spinelink System for supplemental internal fixation. 1

4 Implant Design The Ionic Spine Spacer is a single component device with a solid column that provides structural integrity as well as slotted platforms to allow for bone growth around the center column. The superior and inferior platforms are flared outward to allow greater surface contact. The platforms are also designed with fins, which grip into the endplates of the vertebral body to reduce implant migration. The unique design of this device allows for a broad bony surface area for fusion to occur and an enhanced radiographic assessment of the fusion mass in the post-operative period. The Ionic Spine Spacer device is available in height sizes from 9mm to 56mm in 2mm increments and lordotic angles of 0 and 8. Design Rational Intervertebral distraction allows tensioning of the outer annulus thereby creating a Tension-Band effect The shape of the Ionic device is contoured to match the shape of the vertebral body endplates. This design allows for placement of stress on the denser portion of the adjacent bony endplates to address subsidence The toothed thread design gains stability by engaging the bony endplates, thus enhancing the resistance to shear and rotational forces Intervertebral distraction creates enlargement of intervertebral foramen and neural decompression Sagittal plane alignment is maintained by restoring lumbar lordosis Available in a Range of Sizes Open Design Allows for Easy Bone Graft Placement Device is Designed to Match the Shape of the Vertebral Body End Plates 2

5 Material The Ionic Spine Spacer device is made from titanium alloy (Ti-6A1-4V ELI), conforming to ASTM Standard F136. Instruments designed to aid in the implantation of the device are made from stainless steel, conforming to ASTM Standard F899. Operative Ease And Safety Distraction instrumentation allows for tensioning of the outer annulus while providing soft tissue protection during implant insertion Positioning in the intervertebral space may be achieved from an anterior or lateral approach Intervertebral spacers (trials) allow accurate implant sizing and placement Device is Made from Titanium Alloy 3

6 Instruments Various instruments are available as part of the Ionic Spine Spacer System for use by the surgeon to facilitate implantation of the device. Implant Inserter Distraction Tips Bone Rasp Distractor Adjustable Trial Distraction Starter Inner Impactor 4

7 Implant Remover Trials Slap Hammer Mallet Outer Impactor Large Implant Inserter Trial Inserter 5

8 Surgical Technique Surgical Approach And Preparation The Ionic instrumentation is designed to facilitate implantation of the Ionic device through a transperitoneal (anterior) or a retroperitoneal (lateral) surgical approach. Once the appropriate exposure has been achieved, either though a transperitoneal or retroperitoneal approach, a corpectomy and discectomy of the adjacent discs is performed. A corpectomy can consist of the partial removal of a vertebral body or the total removal of one or more vertebral bodies. Distraction Starter The Distraction Starter (Catalog # 60166) instrument can be used to initiate the corpectomy. The flat edge (tip) of the distraction starter instrument is inserted into the central region of the selected vertebral space. It is important to note that when inserting the tip, the flat edge and the T handle must be oriented in a parallel fashion to the superior and inferior vertebral bodies. The T handle of the distraction starter instrument is then carefully rotated clockwise 90, creating an opening. Once confirmation has been made that the rotated starter tip is securely lodged between the vertebral bodies, the surgeon can perform the discectomy. Distraction Starter in Vertebral Space Rotate the Distraction Starter to Open the Vertebral Space 6

9 After the corpectomy has been performed the two-sided Bone Rasp (catalog # can be used to remove the disc and help prepare the adjacent endplates. The tip of the two-sided Bone Rasp has a 10 angle to accommodate the surgeon s approach when removing the disc and preparing the endplates. Distraction After the discectomy and corpectomy have been completed, the surgeon can select one of three modular distractor tip configurations based upon the approach. If the surgeon uses an anterior transperitoneal approach, the anterior tips are recommended. Two-Sided Bone Rasp Anterior Tips Rasp in Disc Space Image Needs To Be Silo Three Modular Tip Styles Rasp is Utilized to Prepare the End Plate 7

10 Surgical Technique (Continued) If the surgeon elects to do a retroperitoneal (direct lateral) approach, Lateral Tips are recommended. The Ionic system also offers Single Distractor Tips that can be used for initial distraction in a collapsed disc or an extremely tight disc space. Once the appropriate tips are selected, they must be attached to the Distractor (catalog # 60189). Push the button on the distal end of the Distractor with one hand and with the other hand slide the slotted end of the tip into the channel of the Distractor. Lateral Tips When placing the tip onto the Distractor, make sure the Tip A and Tip B markings are facing outside. When the tips are correctly attached to the Distractor, the tips form a box through which the implant passes. It is important to confirm that the tips are securely locked (snapped) into the channels of the Distractor. Single Tips Attaching Tips to Distractor 8

11 The tips are then carefully positioned within the vertebral space. Distraction is performed by squeezing the handles together. Implant Selection with Adjustable Trial Next, the surgeon measures the height of the vertebral space in order to determine the appropriate implant size. The tips are then locked in the open (distracted) position by tightening the lock knob on the Distractor Handle. Adjustable Trial Lateral Tips Rasp is Utilized to Prepare the End Plate 9

12 Surgical Technique (Continued) To measure vertebral spaces larger than 23mm, the Adjustable Trial is used. The Adjustable Trial (catalog #60324) is placed into the central region of the vertebral space. As the handles are squeezed together, the rounded paddle tips expand open and come into direct contact with the prepared endplates. Determination of the appropriate implant height is achieved through tactile feedback of the paddle tips coming into direct contact with the prepared endplates. Adjustable Trial Measuring Space When the desired level of surrounding soft tissue tension has been achieved, the knurled lock nut is tightened down onto the handle, locking the instrument into the exact open position. The threaded bar that the knurled lock nut is located on has numbers etched on it. The number within the small window located on one of the handles provides the required implant size. It is important to note that the Adjustable Trial Instrument is designed to measure the vertebral space and not be used as a vertebral distractor. Locking the Adjustable Trial Measurement Window on Handle 10

13 Implant Selection With Solid Trials Anterior Attachment Solid Trials are available in heights ranging from 9mm to 23mm in two millimeter increments, as well as 0 (nonlordotic) and 8 (lordotic) angles. To use the Solid Trial, the two piece Trial Inserter is assembled by threading the Trial Inner Inserter (catalog # 60171) into the Trial Outer Inserter (catalog # 60172). After the appropriate trial is selected, it is attached to the assembled trial inserter by threading the distal tip of the Trial Inserter into the anterior side of the trial. Please note that all of the Solid Trials and the Trial Inserter can be used for either an anterior or a lateral approach. NOTE: Make sure the Trial is fully inserted into the Trial Inserter. Image Needs To Be Silo Measurement Window on Handle Solid Trial Threaded onto Assembled Trial Inserter (Anterior Attachment) Inner and Outer Trial Inserters Inner and Outer Trials Inserters are Assembled Together 11

14 Surgical Technique (Continued) Lateral Attachment After the appropriate trial is selected, it is attached to the assembled Trial Inserter by threading the distal tip of the Trial Inserter into the lateral side of the trial. Please note that all of the Solid Trials and the Trial Inserter can be used for either an anterior or a lateral approach. If the surgeon is satisfied that the trial position and height is the appropriate size, the trial is removed. If necessary, the Slap Hammer (catalog # 60174) can be threaded onto the handle of the Trial Inserter to facilitate removal of the trial. The trial is then inserted through the Distractor with Lateral Tips and impacted into the vertebral space. Solid Trial Threaded onto Assembled Trial Inserter (Lateral Attachment) Slap Hammer Attached to Trial Inserter for Trial removal Trial Inserted Through the Distractor (Example of a Lateral Approach) 12

15 Implant Insertion The Implant Inserter can be used to deliver the implant for an anterior, a direct lateral, or an anterolateral approach. Once the appropriate height and lordotic angle of the implant is determined, the corresponding implant is attached to the Implant Inserter. Anterior Approach Anterior Attachment on Implant Inserter To accommodate an anterior approach, the distal tip of the Implant Inserter matches the anterior aspect of the implant s upper and lower slotted platforms. As the implant inserter handles are squeezed, the distal (grooved) tips expand and capture the implant. The same instrument designed for insertion also allows for the removal of the implant if changes in alignment or sizing are necessary. Lateral Approach To accommodate a lateral approach, the distal tip of the Implant Inserter is grooved to fit into the lateral aspect (either side) of the implant s upper and lower slotted platforms. As the Implant Inserter handles are squeezed, the distal (grooved) tips expand and capture the Ionic implant. Implant Affixed onto Implant Inserter By spreading the lateral margins of the disc space with the Distractor, the appropriate sized implant can be placed within the center of the disc space under direct visualization. Lateral Attachment on Implant Inserter 13

16 Surgical Technique (Continued) Insertion Once the implant is positioned on the Inserter in the desired orientation, the knurled knob (located on the same side of the strike plate) is turned clockwise, locking the handles and holding the implant securely in place. It is important to verify that the threaded lock nut is securely tightened after the implant has been attached to the implant inserter. The Ionic implant is passed through the inside channel of the Distractor Tips and tapped securely into the vertebral space with the mallet. Care is taken to insert the implant beyond the lateral margins of the vertebral body, so that it is centered in the AP and ML planes. Implant Insertion The unique implant design allows for some pre-packing of the implant prior to insertion, but also allows for additional graft to be placed within the disc space and device after implantation. Maximal disc space distraction with annular tensioning allows restoration of lordosis and indirect neural decompression. Bone Graft Placement Locking Implant Inserter Implant Impacted into Vertebral Space 14

17 At this point, the surgeon may choose to do a radiographic assessment to confirm proper placement of the Ionic implant in all planes. The surgeon can disengage the implant inserter from the Ionic implant and remove it from the surgical site. The distractors can be left in place or removed. The Distractor handles can also be disconnected from the body of the Distractor to facilitate the use of radiographic equipment in the AP plane view when leaving the Distractor in place. Distractor Handles detached Distractor left in Vertebral Space without handles 15

18 Surgical Technique (Continued) Optional: Implant Impaction If the surgeon determines that the implant needs additional impaction, a series of implant impactors are available. Depending on which size implant has been placed, either the Inner Impactor or the Outer Impactors may be used. The Outer Impactors are available in 9mm (catalog # 60177) and 11mm (catalog # 60179). These are designed to impact the 9mm and 11mm implant. This instrument is designed to be placed between the upper and lower flanges of the implant. The Inner Impactor (catalog # 60196) may be utilized with all other implant sizes. The distal tip of the Inner Impactor is placed around the center column of the implant. Once the Outer Impactor or Inner Impactor is positioned on the implant, the Strike Plate may be impacted with the mallet until the implant is in the desired position. Inner Impactor 9mm and 11mm Outer Impactor Inner Impactor on Implant Center Column Outer Impactor Tip on Implant Outer Edges 16

19 Implant Removal In the event the surgeon elects to remove the implant, the Implant Remover (catalog # 60188) instrument can be used. The Implant Remover should be utilized in conjunction with the Modular Distractor. Once distraction is applied, the Implant Remover tip is sit around the center column of the implant. The Slap Hammer threads into the Remover Handle. The Slap Hammer slides up and down to facilitate implant removal. Implant Remover Hooks Around Implant Implant Remover Slap Hammer Threaded onto Implant Remover Slap Hammer is Utilized to Remove Implant Slap Hammer Attached to Implant Remover 17

20 Product Information Ionic Spine Spacer System Catalog # Instruments Mallet Anterior Distractor Tip A Anterior Distractor Tip B Rasp Distraction Starter Lateral Distractor Tip A Lateral Distractor Tip B Distractor Handle A Distractor Handle B Trial Outer Inserter Trial Inner Inserter Large Implant Inserter Slap Hammer mm Outer Impactor mm Outer Impactor Implant Remover Distractor (For Modular Tips) Implant Inserter Inner Impactor Single Distractor Tip A Single Distractor Tip B Anterior Large Tip A Anterior Large Tip B Lateral Large Tip A Lateral Large Tip B Single Large Tip A Single Large Tip B Catalog # Instruments mm Anterior Trial 8 Lordosis mm Anterior Trial 8 Lordosis mm Anterior Trial 8 Lordosis mm Anterior Trial 8 Lordosis mm Anterior Trial 8 Lordosis mm Anterior Trial 8 Lordosis mm Anterior Trial 8 Lordosis mm Anterior Trial 8 Lordosis mm Anterior Trial mm Anterior Trial mm Anterior Trial mm Anterior Trial mm Anterior Trial mm Anterior Trial mm Anterior Trial mm Anterior Trial Adjustable Trial 18

21 Ionic Spine Spacer System Catalog # Implants mm Anterior Spacer mm Anterior Spacer mm Anterior Spacer mm Anterior Spacer mm Anterior Spacer mm Anterior Spacer mm Anterior Spacer mm Anterior Spacer mm Anterior Spacer mm Anterior Spacer mm Anterior Spacer mm Anterior Spacer mm Anterior Spacer mm Anterior Spacer mm Anterior Spacer mm Anterior Spacer mm Anterior Spacer mm Anterior Spacer mm Anterior Spacer mm Anterior Spacer 8 Lordosis mm Anterior Spacer 8 Lordosis mm Anterior Spacer 8 Lordosis mm Anterior Spacer 8 Lordosis mm Anterior Spacer 8 Lordosis mm Anterior Spacer 8 Lordosis mm Anterior Spacer 8 Lordosis mm Anterior Spacer 8 Lordosis 19

22 Post Operative Care Indications Routine monitoring of the vital signs, hemodynamic, and neurologic status of the patient Pain medication NG tubes and/or Foley catheters are discontinued within hours Diet is restricted to small amounts of liquids until return of bowel function The patient is encouraged to ambulate as soon as possible. The individual surgeon determines activity level Braces are to be used according to the individual surgeon's discretion The Ionic Spine Spacer System is intended for use in the thoracolumbar spine (i.e., T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Ionic Spine Spacer System is also indicated for treating fractures of the thoracic and lumbar spine. The Ionic Spine Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged time. The system must be used in conjunction with the Biomet Omega21 System or the SpineLink System. 20

23 Sterilization Recommendations Contraindications The Ionic Spine Spacer implant is provided nonsterile and must be sterilized prior to use. All packaging materials must be removed prior to sterilization. The following steam sterilization parameters are recommended. Ionic Spine Spacer devices should not be implanted in patients with an active infection at the operative site. Precautions Cycle: Temperature: Time: Note: High Vacuum 270 F/132 C Three minutes Allow for cooling Ionic Spine Spacer device is to be implanted using an open anterior or anterior-lateral approach The surgeon should only implant the Ionic Spine Spacer device after adequate training and familiarity with the information provided in the Surgical Technique Manual Individuals not using the recommended method temperature and time are advised to validate any alternative methods or cycles using an approved method or standard. See the Adverse Events section of the package insert for a compete list of potential risks. 21

24 Further Information CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician. For further information, please contact the Customer Service Department at: Biomet Spine, as the manufacturer of this device, does not recommend this or any other surgical technique for use on a patient. The surgeon who performs any implant procedure is responsible for determining and utilizing the appropriate techniques for implanting the device in each individual patient. Biomet Spine and their surgical consultants are not responsible for the selection of the appropriate technique to be utilized for an individual patient. Biomet Spine 100 Interpace Parkway Parsippany, NJ (973) (800)

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28 100 Interpace Parkway Parsippany, NJ For full prescribing information, contact Biomet Spine, a subsidiary of Biomet, Inc. Unless otherwise indicated, denotes a trademark, and denotes a registered trademark, of one of the following companies: Biomet, Inc.; Electro-Biology, Inc.; EBI, L.P.; Biolectron, Inc.; EBI Medical Inc.; Interpore Cross International, Inc.; Cross Medical Products; or Interpore Orthopaedics, Inc. Copyright 2007 Biomet, Inc. All rights reserved. P/N L 04/07