Surgical Technique. Navi Catheter. Innovative Pain Management Solution

Size: px

Start display at page:

Download "Surgical Technique. Navi Catheter. Innovative Pain Management Solution"

Daisy Blair
5 years ago
Views:

1 TM Innovative Pain Management Solution

Characteristics of Expedio TM Non-surgical procedure with the Navi catheter Procedure is very safe and simple with less pain, no general anesthesia,

reduces a risk of the dural perforation Bi-directional steering option with maximum m deflection of 180 degrees enables to access to the pain region

robust fixation Preparation and Exposure Position the patient in a prone position for optimal exposure on the operating table, with cushion being

NSAID and coumarin should be prohibited five days prior to the procedure, while aspirin and platelet coagulation inhibitor should be prohibited six

2 Characteristics of Expedio TM Non-surgical procedure with the Navi catheter Procedure is very safe and simple with less pain, no general anesthesia, and less scarring and bleeding - only 20~30 minute procedure time, resulting in quick recovery Product Feature Atraumatic tip with spring mechanism reduces a risk of the dural perforation Bi-directional steering option with maximum m deflection of 180 degrees enables to access to the pain region with ease Ergonomic steering handle design reduces the hand fatigue during procedure Push button down locking mechanism provides easy control but robust fixation Preparation and Exposure Position the patient in a prone position for optimal exposure on the operating table, with cushion being placed under the abdomen to minimize lumbar lordosis. Identify the appropriate spinous processes by using manual palpitation and imaging techniques. NSAID and coumarin should be prohibited five days prior to the procedure, while aspirin and platelet coagulation inhibitor should be prohibited six days prior to the procedure (the administration dose in patients with diabetes, hypertension, and cardiac disorder should be determined upon the judgment of a clinician). 3

Sacral Hiatus Centesis Placing Catheter Instrument PMC-14G-080 Guide Needle Instrument UC1020 Steerable Catheter UC3020 Guide Wire Adjust the C-arm fluoroscope for the shape of sacral hiatus to be

Conduct local anesthesia in the insertion site of the Guide Needle in order to numb the skin and all the tissue down to the surface of the sacral hiatus.

The Guide Needle is advanced until the ventral plate of sacrum is contacted. The needle is redirected so that the angle of insertion relative to the skin surface is decreased.

During redirection of the needle and after loss of resistance is again encountered, the needle is advanced approximately 1 to 2 cm into the caudal canal.

1 The protrusion positions of the Guide Wire are controlled Fig. 4 by the hemostasis valve of the Steerable Catheter and Stopper, respectively.

Once the distal end of the lesion is located, adjust the curve of the distal end of the catheter as desired (Fig. 6). Fig.

3 Sacral Hiatus Centesis Placing Catheter Instrument PMC-14G-080 Guide Needle Instrument UC1020 Steerable Catheter UC3020 Guide Wire Adjust the C-arm fluoroscope for the shape of sacral hiatus to be seen well, thus allowing for easy insertion of the Guide Needle. Check the location of the sacral hiatus through the C-arm fluoroscope (Fig. 1). Conduct local anesthesia in the insertion site of the Guide Needle in order to numb the skin and all the tissue down to the surface of the sacral hiatus. The Guide Needle is inserted at 45 degrees to the sacrum. While advancing the needle, a decrease in resistance to needle insertion should be appreciated as the needle enters the caudal canal. The Guide Needle is advanced until the ventral plate of sacrum is contacted. The needle is redirected so that the angle of insertion relative to the skin surface is decreased. In male patients, this angle is almost parallel to the coronal plane; in female patients, a slightly steeper angle (15 degrees) is necessary (Fig. 2). During redirection of the needle and after loss of resistance is again encountered, the needle is advanced approximately 1 to 2 cm into the caudal canal. Insert the assembled EXPEDIO through the mounted polymer sheath (Fig. 4). In this procedure, tip of Guide Wire are slightly protruded past the tip of the Steerable Catheter. Fig. 1 The protrusion positions of the Guide Wire are controlled Fig. 4 by the hemostasis valve of the Steerable Catheter and Stopper, respectively. Move the Steerable Catheter to vicinity of the lesion by using the steering lever to control the direction of the distal end of the catheter, as necessary (Fig. 5). Once the distal end of the lesion is located, adjust the curve of the distal end of the catheter as desired (Fig. 6). Fig. 5 Remove the protective cover, being careful not to damage the blade of the Guide Needle. Inject a contrast agent and physiological saline mixture through the mounted Guide Needle to check the positioning of the tip of the Guide Needle. Fig. 2 To maintain Steerable Catheter tip in the desired position, push down the holding button on the manipulator. (Fig. 7). Note In the lock down position, the Steerable Catheter tip can be adjusted by turning the steering lever to either left or right, which generates click sounds. Fig. 6 Once adhesion and foraminal stenosis are checked through the C-arm fluoroscope, remove the needle only while the polymer sheath remains mounted (Fig. 3). Fig. 3 Fig

The extent of balloon inflation volume is adjusted by degree of pain If patient complains of acute pain when balloon is inflated, discontinue procedure due to safety reasons.

4 The extent of balloon inflation volume is adjusted by degree of pain If patient complains of acute pain when balloon is inflated, discontinue procedure due to safety reasons. Take caution not to change the location of the during procedure. Ordering Information UC1020 Steerable Catheter Outer Diameter : Ø 2.0 mm Inject the medications for lysis of adhesion and/or reducing inflammation through the medication injection hole in the Steerable Catheter if needed (Fig. 12). Length : 300 mm UC3020 Guide Wire Fig. 12 Outer Diameter : Ø 0.89mm Catheter Removal Remove the Guide Wire, Steering Catheter and polymer sheath in order. Length : 510 mm Disinfect skin and follow the standard procedure of sterile dressing after procedure. PMC-14G-080 Guide Needle Length : 93 mm * Needle Size : 14 G 6 7

5 Headquarter 20, Sandan-ro, 76beon-gil(Rd), Uijeongbu-si, Gyeonggi-do, Korea Tel. +82 (31) Fax. +82 (31) ST-UC01, Rev. 00 U&i Corporation USA Office La Palma Ave., Unit. G Yorba Linda, CA Tel. + 1 (714) Fax. +1 (714)

Galt Medical Corp. A leader in vascular and interventional medical devices. part of the GaltNeedleTech TM Family

Galt Medical Corp. A leader in vascular and interventional medical devices. part of the GaltNeedleTech TM Family MICRO-INTRODUCERS Micro-Introducer Kits Galt s Micro-Introducer Kits with smooth transition,