Integra 110-4B: Camino OLM Intracranial Pressure Monitoring Kit SURGICAL TECHNIQUE
Surgical Technique Th OLM ICP Kit was developed in cooperation with Richard C. Ostrup, M.D., Thomas G. Luerssen, M.D. & Lawrence F. Marshall, M.D. (San Diego, California). As the manufacturer of this device, Integra does not practice medicine and does not recommend this or any other surgical technique for use on a specific patient. The surgeon who performs any implant procedure is responsible for determining and using the appropriate techniques for implanting the device in each patient. Indications The use of the OLM Intracranial Pressure Monitoring Kit by a qualified neurosurgeon is indicated when direct measurement of intracranial pressure in the parenchyma or the subarachnoid space is clinically important. Contraindications This device is not intended for any use other than that indicated. Risk and Complications Maintenance of sterility during placement and subsequent handling of the Camino Bolt is essential. Sterile technique should be used at all times when inserting, correcting, or adjusting the Camino Bolt and the Camino Transducer-Tipped Pressure Monitoring Catheter. If monitoring is continued for more than 5 days, placement of a new system under sterile conditions is recommended. Placement of the Camino Bolt must be carried out by a qualified neurosurgeon to avoid penetration of the cerebral cortical surface during the drilling process, which requires standard surgical procedure and skill. Hemorrhage from the dura or cortical surface at the bolt insertion site may occur. Patients should be tested for normal blood clotting function prior to bolt placement. Determination of possible extracerebral, subarachnoid, or intracerebral hemmorrhage at the bolt insertion site will be the sole responsibility of the operating neurosurgeon. Appropriate steps and procedures to control such hemorrhage should be taken when indicated by the neurosurgeon in charge.
Kit Components 6 a 1 2 3 4 5 7 11 10 9 8 1. Bolt with compression cap (a) 2. Spacer (to adjust seating depth of the bolt, more dedicated for pediatric use and can be removed if desired) 3. Drill bit 2.71 mm with safety stop 4. Zero adjustment tool 5. Stylet 6. Hex wrench 7. Transducer connector 8. Red depth indicator 9. Strain relief sheath 10. 1 cm markings up to 10 cm 11. Pressure tranducer 2
Surgical Technique This document does not replace the Instructions for Use accompanying the OLM Intracranial Pressure Monitoring Kit. The Instructions for Use must be read carefully before using this product. Step 1 Placement and Incision Area of Insertion: The primary sites of insertion are the right and left prefrontal areas and off the midline. 1-2 1-1 After the insertion site is chosen, shave the area and prepare in a sterile fashion. A Betadine solution can be used. Hairline Coronal suture Incision 1-2 Midline The area of the incision, which usually lies 2-3 cm anterior to the coronal suture in the mid-pupillary line, is infiltrated subcutaneously with 1% Shaved Area Xylocaine. An approximate half-centimeter linear incision is made and carried to the bone. Step 2 Prepare for Drilling and Drilling the Hole 2-3 2-1 2-2 2-3 2-4 Insert a self-retaining retractor to provide bone exposure and hemostasis of the skin edges. Estimate the thickness of the skull and adjust the safety stop on the drill bit with the hex wrench. Secure the drill bit to a twist drill and drill the hole. Remove the drill and irrigate the hole with sterile saline solution. Tip Open the dura in a cruciate fashion with an 18G spinal needle. The stylet can be inserted to ensure adequate opening of the dura. 3
Step 3 Screw in the Bolt 3-1 3-2 Following opening of the dura, the Camino Bolt is screwed manually into the skull. The seating depth of the Camino Bolt will be at the surgeon s discretion, pending the thickness of the skull: 2-3 mm for the neonatal age group. 3-5 mm for the pediatric age group. 5 mm to 1 cm for adults. (If desired, the spacer can be used as a guide, otherwise the spacer can be removed and discarded.) 3-1 Step 4 Clear Path with Stylet and Irrigate 4-1 4-2 The stylet provided in the kit is inserted through the Camino Bolt and the dura to clear the passage for the Camino Transducer-Tipped Catheter. The Camino Bolt is irrigated with non-bacteriostatic sterile saline solution. 4-1 4-2 4
Step 5 Transducer and Preamp Connection 5-1 Connect the black pre-amp transducer cable (catalog REF PAC-1) to the Camino monitor by inserting the two cable connectors in the appropriate receptacle (a). 5-1 5-2 Connect the preamp receptacle of the PAC-1 cable with the transducer connector of the 110-4B catheter (b). a PAC1 110-4B ICP Tip The 110-4B only measures pressure, so the temperature input connector on the patient end of the PAC-1 will not be connected. ICT b Step 6 Zero the Transducer 6-1 If the monitor ICP display does not read zero, use the adjustment tool from the catheter kit to zero the catheter until the monitor display reads 0 mmhg. 6-1 5
Step 7 Insert the Camino Catheter 7-1 Insert the Camino catheter into the Camino Bolt, using the centimeter markings on the catheter to gauge insertion depth (see Figure 7-1). 7-1 For example: If the surgeon places his fingers at the 5 cm mark (double dot), then inserts the catheter until his fingers touch the top of the bolt, the tip of the catheter will be 0.5 cm beyond the end of the bolt, approximately in the subarachnoid space. 1 cm 7-2 Pull the catheter back slightly. 7-3 6
Integra Camino OLM Intracranial Pressure Monitoring Kit Specifications Drill Bit Diameter (always use the drill bit provided into the kit) 2.71 mm Transducer Size 4 FR (1.35 mm 0) Transducer Type Fiber optic Zero drift (system) First 24 hours (maximum) 0 ± 2 mmhg 5 days (typical) Less than ± 1 mmhg per day Reference Pressure Magnetic Resonance (MR) Compatibility CT Scan Atmosphere The Camino 110-4B and accessories are not recommended for use in MR environment Yes For more information or to place an order, please contact: Integra n 311 Enterprise Drive, Plainsboro, NJ 08536 800-997-4868 USA n 609-936-5400 outside USA n 888-980-7742 fax integralife.com Camino, Integra, and the Integra logo are registered trademarks of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries. 2012 Integra LifeSciences Corporation. All rights reserved. Printed in the USA. 500. 00001810