Surgical Technique. and Product Catalog FOR NON-USA USE ONLY

Transcription

1 Surgical Technique and Product Catalog FOR NON-USA USE ONLY

2 INTRODUCTION Percutaneous vertebroplasty and, more recently, kyphoplasty, are Vertebral Body Augmentation (VBA) procedures used for the treatment of painful vertebral compression fractures caused by osteoporosis, tumors or trauma. Unlike other vertebroplasty or kyphoplasty systems that inject cement directly into the vertebral body, with the CONFIDENCE PERIMETER SPINAL CEMENT SYSTEM, the cement is injected into a mesh bag. This mesh bag provides additional control over placement of the cement. As the cement expands the mesh bag, there may also be the possibility of re-gaining some of the lost vertebral body height1, if the fracture is still mobile. The porous construction of the mesh allows the cement to extrude through the barrier and interdigitate with the surrounding cancellous bone. Additionally, it allows the bag to be removed once cement introduction is complete. The CONFIDENCE PERIMETER SPINAL CEMENT SYSTEM is only used in conjunction with the CONFIDENCE SPINAL CEMENT SYSTEM s high viscosity cement and hydraulic delivery system. For a complete list of warnings, precautions and contra-indications, please refer to the CONFIDENCE PERIMETER SPINAL CEMENT SYSTEM Packaging Insert (IFU).

3 CONTENTS SURGICAL TECHNIQUE Preparation 4 Bone Access Needle Placement 5 Biopsy Needle Placement (if required) 6 Bone Drill - Space Creation 7 Insertion of the Mesh Assembly 7 Cement Preparation 8 Cement Delivery 10 Retracting the Mesh Bag Assembly 13 Working Time and Temperature 13 CONFIDENCE PERIMETER SPINAL CEMENT SYSTEM Mesh Cutter Surgical Technique 14 PRODUCT CATALOG CONFIDENCE PERIMETER SPINAL CEMENT SYSTEM 18 CONFIDENCE SPINAL CEMENT SYSTEM 19 CONFIDENCE Needleless Kit 20 INDICATIONS FOR USE The CONFIDENCE PERIMETER SPINAL CEMENT SYSTEM is indicated for use in combination with the CONFIDENCE SPINAL CEMENT SYSTEM. The CONFIDENCE SPINAL CEMENT SYSTEM is intended for percutaneous delivery of CONFIDENCE High Viscosity Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (haemangioma), and malignant lesions (metastatic cancer, myeloma). The CONFIDENCE PERIMETER cement injection cannula has a specifically designed luer lock fitting. It is designed for use only with CONFIDENCE SPINAL CEMENT SYSTEM and the CONFIDENCE High Viscosity Spinal Cement. The device is not compatible with alternate materials. A single CONFIDENCE SPINAL CEMENT SYSTEM is restricted to be used with only one CONFIDENCE PERIMETER SPINAL CEMENT SYSTEM. When using a bilateral approach or doing multiple levels with the CONFIDENCE PERIMETER SPINAL CEMENT SYSTEM, a new CONFIDENCE SPINAL CEMENT SYSTEM should be opened and used for each level/approach.

4 Vertebral Body Augmentation SURGICAL TECHNIQUE PATIENT POSITIONING AND PREPARATION The patient should be in a prone position on a radiolucent table, permitting AP and lateral imaging using uni or bi-planar x-ray and/or CT. Either local or general anaesthesia may be used. Prepare the operative site according to standard surgical techniques and hospital procedures. INSTRUMENT PREPARATION The bone access needle is packaged with a beveled tip stylet. If a diamond tip is preferred, remove the beveled stylet and replace with the diamond stylet. Ensure that the diamond stylet is adequately locked to the handle of the access needle. The mesh needle assembly should not be disassembled. Disassembly will lead to disengagement of the stylet from the mesh bag which may result in piercing of the mesh bag when reinserted. 4

5 Surgical Technique BONE ACCESS NEEDLE PLACEMENT Under fluoroscopy, insert the bone access needle (working cannula and stylet) down to the appropriate entry location to the vertebral body. The trajectory by which the needle is inserted varies depending on the vertebra to be treated. Most commonly a transpedicular or extrapedicular approach is performed. A uni-pedicular or bi-pedicular approach may be used at the operator s discretion. Using alternating A/P and lateral fluoroscopy, the needle can be guided into the vertebral body. The tip of the needle should commonly begin superior and lateral to the border of the pedicle on an A/P image. The needle is advanced, under lateral fluoroscopy, into the vertebral body. During needle advancement, great care should be taken to avoid breaching the medial border of the pedicle. This is accomplished by checking that when the tip of the needle on lateral fluoroscopy is flush with the posterior border of the vertebral body, that it is not medial to the medial border of the pedicle on the A/P image. Care should be taken to position the distal tip of the working cannula to allow space for the CONFIDENCE PERIMETER Mesh Bag (23mm beyond the distal tip). 5

6 Vertebral Body Augmentation The needle holder, in combination with the long-armed mallet, may be used to position and advance the needle under fluoroscopy, while keeping the physician s hands outside the x-ray field. In case of beveled tip needles, the arrows on the handle of the needle point to the direction of the bevel. After passing the vertebral posterior wall using the CONFIDENCE PERIMETER bone access needle, hold the working cannula firmly in place and remove the stylet. BIOPSY NEEDLE PLACEMENT (IF REQUIRED) Under fluoroscopy and/or CT guidance, insert the CONFIDENCE biopsy needle through the bone access needle for biopsy collection. According to the user s preference in biopsy technique, the stylet may be removed either before insertion of the biopsy needle, or after the vertebral posterior wall has been passed. 6

7 Surgical Technique BONE DRILL - SPACE CREATION If the predicted location of the mesh bag (indicated by the location of the drill tip) is unsatisfactory, re-position the working cannula and drill prior to insertion of the mesh assembly. Under fluoroscopy and/or CT guidance, fully insert the bone drill through the working cannula, using a clockwise, rotating motion. This will create a working space for the mesh bag. When the bone drill is fully inserted through the working cannula, the distal tip of the drill represents the location of the distal tip of the mesh bag. Attention should be paid not to breach the anterior wall of the vertebral body while advancing the bone drill. Once completed, remove the drill. INSERTION OF THE MESH ASSEMBLY To prevent advancement of the working cannula, firmly hold the cannula in place while inserting the mesh assembly. Insert the mesh assembly into the working cannula using a uni-directional motion. Withdrawal and re-insertion may cause the stylet s tip to disengage from the tip of the mesh bag and potentially pierce the bag. Under fluoroscopy and/or CT guidance, insert the mesh assembly through the working cannula until it is firmly attached to the handle of the working cannula. While firmly holding the working cannula s handle, remove the mesh assembly stylet using a counter-clockwise rotation. The CONFIDENCE PERIMETER cement injection cannula has a specifically designed luer lock fitting. It is designed for use only with CONFIDENCE SPINAL CEMENT SYSTEM and the CONFIDENCE High Viscosity Spinal Cement. The device is not compatible with alternate materials. Mesh bag tip Once removed, do not reinsert stylet as it may result in piercing of the mesh bag. 7

8 Vertebral Body Augmentation CEMENT PREPARATION Pour the entire contents of the cement powder into the mixing bowl. Pour the entire contents of the liquid monomer vial over the cement powder in the mixing bowl. Prior to cement mixing, ensure that the mesh assembly is in its final position. Important: CONFIDENCE PERIMETER working time = cement mixing, transfer, injection and mesh bag retraction. Powder should always be poured into the mixing bowl first. Care should be taken not to open the liquid monomer vial over the mixing bowl due to risk of glass splinters. Important: Timings provided begin at start of mixing. WORKING TIME AND TEMPERATURE Theatre Temperature ( C) End of Working Time (Cement mixing, transfer, injection and mesh bag retraction) 18 7 minutes 14 minutes 22 6 minutes 12 minutes Start of Setting Time (Working cannula removal) 25 5 minutes 10 minutes Prior to introducing the mixer handle into the mixing bowl, verify that the wiper blade is attached to the inside of the mixer handle. If it is not, attach the wiper blade to the mixer handle by snapping it into place. Keep in mind that the teeth should point upwards. Important: Closely monitor the working time of the procedure (see chart above). While holding the mixing bowl vertically on the table, push down on the outer ring of the mixer handle and screw this ring onto the mixing bowl in a clockwise direction. wiper blade 8

9 Surgical Technique Mix the cement by turning the handle 3 turns in one direction, then 3 turns in the opposite direction. Repeat for a total of seconds. Unscrew the ring on the mixer handle in a counter-clockwise direction and remove the handle from the mixing bowl. The cement and wiper blade will remain in the mixing bowl. Push and screw the cement reservoir adaptor onto the mixing bowl with a clockwise rotation until firmly seated in the bottom of the bowl. This process will force the cement into the cement reservoir. Ensure that the cement is fully distributed to the distal tip of the reservoir. Unscrew the cement reservoir from the cement reservoir adaptor with a counter-clockwise rotation. 9

10 Vertebral Body Augmentation CEMENT DELIVERY Ensure the piston inside the cap is properly attached to the cap before threading onto the reservoir. The reservoir cap must be fully seated against the flange on the cement reservoir. Screw the cement reservoir cap securely onto the cement reservoir. Care should be taken to align the cap carefully with the threaded reservoir to ensure proper thread engagement. It is important that the cap is fully tightened before pressurizing or delivering cement. A small amount of cement may extrude from the tip and should be removed before assembly to the needle. Connect the hydraulic pump s flexible tube to the cement reservoir cap by pushing and snapping the quick-connect assembly onto the cement reservoir cap. cap flange If the quick connect will not attach to the reservoir cap, rotate the handle of the pump counter-clockwise to relieve some pressure. This will allow the connector to attach to the cap. 10

11 Surgical Technique Care must be taken to avoid overtightening the cement reservoir to the mesh assembly (white luer). Screw the reservoir tip onto the luer fitting of the mesh assembly cement injection cannula (white in color). Keep hold of the working cannula to prevent advancing it further into the vertebral body. Prepare the system for delivery by turning the pump handle a few turns, until a small amount of cement extrudes into the mesh bag. This should be done under fluoroscopic guidance. While monitoring the mesh bag under fluoroscopy, slowly rotate the pump handle clockwise half a turn per second until cement begins to fill the mesh bag. The hydraulic pump has a safety release valve that restricts the build-up of excess pressure in the reservoir. The scale on the cement reservoir is intended to approximate the amount of cement introduced. Fluoroscopy should be used to confirm the correct amount of cement introduced into the vertebral body. Note that the volume of cement in the injection cannula is approximately 0.3ml. Each half turn (180 degrees) of the handle will inject approximately 0.15 ml/cc of cement. As the cement is introduced, the CONFIDENCE PERIMETER mesh bag will expand within the vertebral body. It takes approximately 2 ml/cc of cement to fully expand the bag. 11

12 Vertebral Body Augmentation Cement can continue to be introduced and will extrude through the pores of the mesh bag and interdigitate with the surrounding bone structure. Upon completion, or at any point during the procedure, cement flow can be stopped by rapidly rotating the handle counter-clockwise until pump handle spins freely. When cement introduction is complete, rotate the pump handle counter-clockwise until pump handle spins freely to depressurize the cement reservoir. While firmly holding the injection cannula cap (white in color) in one hand, disconnect the cement reservoir from the mesh assembly. Firmly hold the working cannula s handle (blue in color) and remove the injection cannula (white in color) from the mesh assembly, using a counter-clockwise rotation. 12

13 Surgical Technique Guide RETRACTING THE MESH BAG ASSEMBLY Ensure removal of the mesh bag from the vertebral body prior to the end of the cement working time. (see chart below). Flip up the winding handle on the mesh assembly (grey in color). Rotate the winding handle 3-4 full 360 turns until the mesh bag is completely retracted into the working cannula. Confirm that this step is complete using fluoroscopy. Prior to the start of the cement setting time (see chart below), remove the working cannula/ mesh assembly from the vertebral body by rotating and pulling the cannula. This will allow easier removal of the cannula. The needle introduction site can be closed with a single suture, a steri-strip, or in any other manner preferred by the operator. The CONFIDENCE PERIMETER SPINAL CEMENT SYSTEM must be stored at temperatures between 5 C (41 F) to 25 C (77 F). WORKING TIME AND TEMPERATURE Theatre Temperature ( C) End of Working Time (Cement mixing, transfer, injection and mesh bag retraction) Start of Setting Time (Working cannula removal) 18 7 minutes 14 minutes 22 6 minutes 12 minutes 25 5 minutes 10 minutes Please note that mesh bag is intended to be retrieved and working times in Time/Temperature Table should be followed carefully to retrieve the mesh bag during the required retraction time period. If the physician encounters a situation where they are unable to retrieve the mesh bag for any reason, or if it is in the best interest of the patient to keep the mesh bag in place, the following steps should be taken: 1. Pull out the winding handle from the mesh assembly. 2. Remove the working cannula. 3. Open skin incision to accept PERIMETER Mesh Cutter, if necessary. 4. Clamp onto the tail of the mesh bag and run the cutting tool (e.g. surgical scissors) down the length of the mesh bag. 5. Cut the mesh bag as close to the pedicle as possible and close the incision. 13

14 Vertebral Body Augmentation PERIMETER MESH CUTTER SURGICAL TECHNIQUE Please note that mesh bag is intended to be retrieved and working times in Time/Temperature Table should be followed carefully to retrieve the mesh bag during the required retraction time period. If the physician encounters a situation where they are unable to retrieve the mesh bag for any reason, or if it is in the best interest of the patient to keep the mesh bag in place, the following steps should be taken: 1. Pull out the winding handle from the mesh assembly. 2. Remove the working cannula from the patient. 14

15 Surgical Technique Guide 3. Open skin incision as needed to accept the PERIMETER Mesh Cutter. 4. Insert end of mesh bag into the slot of PERIMETER Mesh Cutter tip. 15

16 Vertebral Body Augmentation 5. Hold on to end of mesh bag while advancing PERIMETER Mesh Cutter along mesh bag until the Mesh Cutter contacts vertebral body. Use flouro to verify that PERIMETER Mesh Cutter is at the pedicle. 6. Cut the mesh bag as close to the pedicle as possible. 16

17 Surgical Technique Guide If desired, distal tip of working cannula stylet can be used to pack any protruding mesh into pedicle. 7. Remove PERIMETER Mesh Cutter and end of mesh bag from patient. 8. Close the incision. 17

18 Vertebral Body Augmentation PRODUCT CATALOG CONFIDENCE PERIMETER KIT / CATALOG NO Components included in kit: Bone Access Needle/Working Cannula, Beveled Tip, 11G, 100mm Additional Stylet, Diamond tip, 11G, 100mm Bone Drill Mesh Assembly Component Descriptions Bone Access Needle/Working Cannula Consists of a working cannula and a beveled tip stylet for percutaneous bone access. The needle also acts as a cannula through which the bone drill and PERIMETER Mesh Assembly are introduced into the vertebra. Stylet - Diamond Tip The beveled tip stylet in the introducer needle can be removed and replaced with the diamond tip stylet, if preferred. Bone Drill Inserted through the working cannula to create a working space for the introduction of the CONFIDENCE PERIMETER Mesh Assembly within the vertebral body. CONFIDENCE PERIMETER Mesh Assembly Consists of the mesh bag, an injection needle assembly and a blunt tip stylet. The mesh bag is made from a porous fabric and is equipped with a winding handle at its proximal end. It protrudes 23mm beyond the working cannula. Cement is introduced into the mesh bag through a small diameter injection cannula. PERIMETER MESH CUTTER / CATALOG NO MESH CUTTER CASE / CATALOG NO Advance mesh cutter along the mesh bag until the mesh cutter contacts vertebral body. Then cut the mesh bag as close to the pedicle as possible. 18

19 Product Catalog CONFIDENCE PLUS KIT / CATALOG NO Components included in kit: CONFIDENCE High Viscosity Spinal Cement (11ml) Hydraulic Pump Cement Reservoir & Mixer Mallet & Needle Holder 2 Introducer Needles, Diamond Tip, 13G, 100mm Biopsy Needle, 15G, 230mm CONFIDENCE High Viscosity Spinal Cement (11ml) Component Descriptions CONFIDENCE High Viscosity Spinal Cement Consists of a ampoule of liquid monomer and a packet of powder polymer. Mixing the 2 components for seconds results in a high viscosity, radiopaque cement. This high viscosity texture allows for an 8 10 minutes at 68F (20C), and enables a controlled introduction of cement. Hydraulic Pump The hydraulic pump enables a smooth and effortless introduction of highly viscous cement into the vertebra. It is provided pre-filled with sterile water. Its flexible extension tube enables the physician to keep his/her hands outside of the direct fluoroscopy exposure field. Cement Mixer Consisting of a mixing bowl and mixer handle, this unique, closed mixer enables easy mixing of the cement. Cement Reservoir & Cement Reservoir Adaptor The cement reservoir is an 11 ml/cc transparent barrel with volumetric reference markings. The cement reservoir adaptor enables the transfer of the cement into the cement reservoir following mixing. Long Handled Radiolucent Mallet A long handled, 150-gram disposable mallet to aid in needle introduction. The long radiolucent handle allows the physician to tap the needle during fluoroscopy, while keeping his/her hands outside of the direct fluoroscopy field. Needle Holder Radiolucent needle holder, allowing for manipulation of needle placement while keeping the hands of the physician outside the direct fluoroscopy field. Introducer Needle, Diamond Tip, 13G, 100mm Consists of a needle and a stylet for bone access. The needle also acts as a cannula through which the cement is introduced into the vertebra. Biopsy Needle, 15G, 230mm The biopsy needle consists of a needle and stylet intended for use through an 11 gauge or 13 gauge introducer needle. 19

20 Vertebral Body Augmentation CONFIDENCE NEEDLELESS KIT / CATALOG NO Components included in kit: CONFIDENCE High Viscosity Spinal Cement (11ml) Hydraulic Pump Cement Reservoir & Mixer Mallet & Needle Holder Component Descriptions CONFIDENCE High Viscosity Spinal Cement Consists of a ampoule of liquid monomer and a packet of powder polymer. Mixing the 2 components for seconds results in a high viscosity, radiopaque cement. This high viscosity texture allows for an 8 10 minutes at 68F (20C), and enables a controlled introduction of cement. Hydraulic Pump The hydraulic pump enables a smooth and effortless introduction of highly viscous cement into the vertebra. It is provided pre-filled with sterile water. Its flexible extension tube enables the physician to keep his/her hands outside of the direct fluoroscopy exposure field. Cement Mixer Consisting of a mixing bowl and mixer handle, this unique, closed mixer enables easy mixing of the cement. Cement Reservoir & Cement Reservoir Adaptor The cement reservoir is an 11 ml/cc transparent barrel with volumetric reference markings. The cement reservoir adaptor enables the transfer of the cement into the cement reservoir following mixing. Long Handled Radiolucent Mallet A long handled, 150-gram disposable mallet to aid in needle introduction. The long radiolucent handle allows the physician to tap the needle during fluoroscopy, while keeping his/her hands outside of the direct fluoroscopy field. Needle Holder Radiolucent needle holder, allowing for manipulation of needle placement while keeping the hands of the physician outside the direct fluoroscopy field. 20

21 Product Catalog CONFIDENCE NEEDLELESS KIT / CATALOG NO Components included in kit: CONFIDENCE High Viscosity Spinal Cement (7cc) Hydraulic Pump Cement Reservoir & Mixer Component Descriptions CONFIDENCE High Viscosity Spinal Cement Consists of a ampoule of liquid monomer and a packet of powder polymer. Mixing the 2 components for seconds results in a high viscosity, radiopaque cement. This high viscosity texture allows for an 8 10 minutes at 68F (20C), and enables a controlled introduction of cement. Hydraulic Pump The hydraulic pump enables a smooth and effortless introduction of highly viscous cement into the vertebra. It is provided pre-filled with sterile water. Its flexible extension tube enables the physician to keep his/her hands outside of the direct fluoroscopy exposure field. Cement Mixer Consisting of a mixing bowl and mixer handle, this unique, closed mixer enables easy mixing of the cement. Cement Reservoir & Cement Reservoir Adaptor The cement reservoir is an 11 ml/cc transparent barrel with volumetric reference markings. The cement reservoir adaptor enables the transfer of the cement into the cement reservoir following mixing. 21

22 Vertebral Body Augmentation NOTES 22

23 Surgical Technique Guide 23

24 Reference: 1. An Ex Vivo Biomechanical Evaluation of the CONFIDENCE PERIMETER SPINAL CEMENT SYSTEM used in the Treatment of Compression Fractures. White Paper, DePuy Spine TM, (Re-order code ) INDICATIONS The CONFIDENCE PERIMETER SPINAL CEMENT SYSTEM is indicated for use in combination with the CONFIDENCE SPINAL CEMENT SYSTEM. The CONFIDENCE SPINAL CEMENT SYSTEM is intended for percutaneous delivery of CONFIDENCE High Viscosity Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancer, myeloma). CONTRAINDICATIONS The use of CONFIDENCE PERIMETER SPINAL CEMENT SYSTEM is contraindicated in patients presenting with any of the following conditions: Use of CONFIDENCE High Viscosity Spinal Cement for prophylaxis (such as in metastatic or osteoporotic patients with no evidence of acute vertebral fracture). Coagulation disorders, or severe cardiopulmonary disease. Haemorrhagic diasthesis. Non-pathological, acute, traumatic fractures of the vertebra. Patient clearly improving on medical therapy. Spinal stenosis (>20% by retropulsed fragments). Compromise of the vertebral body or walls of the pedicles. Compromise or instability of vertebral fractures due to posterior involvement. Anatomical damage of the vertebra that prevents safe access of the needle to the vertebral body. Vertebral body collapse to less than 1/3 (33%) original height. Vertebral plana (collapse >90%). Active or incompletely treated infection. Coagulopathy or inability to reverse anti-coagulant therapy (both during and approximately 24 hours post-procedure). Severe pulmonary insufficiency. Allergic reaction to any of the components of the CONFIDENCE High Viscosity Spinal Cement. Limited Warranty and Disclaimer: DePuy Spine products are sold with a limited warranty to the original purchaser against defects in workmanship and materials. Any other express or implied warranties, including warranties of merchantability or fitness, are hereby disclaimed. DePuy Spine EMEA is a trading division of DePuy International Ltd. DePuy International Ltd. DePuy France SAS DePuy Orthopädie GmbH Registered office: St. Anthony s Road, Leeds LS11 8DT, England Registered in England No Not all products are currently available in all markets. DePuy International Ltd. St. Anthony s Road Leeds LS11 8DT England Tel: +44 (0) Fax: +44 (0) FOR NON-USA USE ONLY DePuy Spine, Inc All rights reserved. ADDB/UM 09/10 30%