mild Devices Kit - Instructions for Use

Transcription

1 INDICATION FOR USE The Vertos mild Devices are specialized surgical instruments intended to be used to perform lumbar decompressive procedures for the treatment of various spinal conditions. CONTENTS AND DEVICE DESCRIPTION The Vertos mild Devices are used for image-guided Minimally Invasive Lumbar Decompression, referred to as the mild procedure. The Vertos mild Devices are a sterile, single-use system of surgical tools consisting of one each of the following components (reference Figures 1 through 4): 1. mild Tissue Sculpter Device 2. mild Trocar and Handle 3. mild Portal 4. Surgical Clamp 5. Accessory Guide 6. mild Bone Sculpter Rongeur 7. Back Plate The mild Trocar and Handle, used with the mild Portal cannula, comprise the mild Tissue Access Device. The Device is used for initial access into the soft tissue of the posterior lumbar spine. The stainless-steel Trocar and plastic Handle couple with the stainless-steel Portal for the tissue access procedure. The Portal has markers every 1.0 cm for aiding the user in advancement depth into tissue. Following access, the Trocar and Handle are removed, leaving the Portal in place to receive the mild Tissue Sculpter Device and/or the mild bone sculpter rongeur. The mild Tissue Sculpter Device is designed for use through the Portal for access and to maintain an incision border while cutting and removing ligamentous and fatty tissues. The stainless-steel Device is manually engaged via a plastic pistol grip handle with a finger trigger. The cutting function is activated by depression of the trigger on the handle. The distal tip is comprised of a combined retracting, grasping and cutting component. The tip of the outer shaft initiates the cutting action by shearing the tissue at the incision border while closing down the cutting tip during manual engagement. Following Device removal from the patient, extension of the trigger opens up the cutting component and enables advancement of an integrated push rod to allow removal of excised tissue from the distal tip of the Device. The Surgical Clamp is an optional ancillary instrument provided for user convenience. This device may allow the user to handle and maintain the Portal position while keeping the user s hands away from the fluoroscopic imaging field. The Accessory Guide is a manually operated instrument used adjunctive to the mild Devices. It is an optional tool that can be used to adjust the extension or reach of the mild Tissue Sculpter upon its exit from the mild Portal tip in the lumbar spine. The individual mild Devices are utilized for bone and tissue access, retraction and resection within the lumbar spine via a minimally invasive posterior approach. The procedure is conducted through an introducer cannula, the mild Portal. Fluoroscopic imaging in the Anterior-Posterior (AP) and contralateral oblique planes is utilized to assess anatomical landmarks and guide the instruments to the lamina, through the interlaminar space and into the ligamentum flavum or bone in the posterior spine for tissue and bone removal. The mild Tissue Sculpter tip is designed to fit within the target region, beside and under the lamina for tissue resection. The mild devices can be engaged within tissue under or aside bony structures and manipulated using image guidance.

2 The Bone Sculpter Rongeur is a manually operated instrument used with the mild Devices for cutting bone adjunctive to the mild tissue resection procedure in the lumbar spine. Figure 3 depicts the Bone Sculpter Rongeur which consists of a handle and lever, connected to a 8.5 gauge, 8.5 inch (21.59 cm) long cutting tube and rod. The device can be inserted into the body through the mild Portal. During manual operation, as the lever is depressed toward the handle, the cutting tube is advanced over the cutting rod and to the tip. With the 120 backward angled tip positioned against bone, this manual motion enables the bone to be captured within the tip aperture, then cut and retained for removal from the body through the mild Portal. The Back Plate (or clamp) is used to secure the portal against the surface of the skin. Figure 4 depicts the back plate being secured to the portal. Figure 1 - Vertos mild Devices Package Contents Button to facilitate instrument cleaning 8.5 Gauge, 8.5 (21.59 cm) Working Length Specialized sculpting tip Ergonomically Designed Handle

3 Figure 2 - Vertos mild Devices Package Contents Trocar with Handle Comfortable Trocar grip Positive Trocar to Portal lock quarter-turn release Accessory Guide with depth indicators Graduated Portal markings Accessory Guide with Trocar 6.5 (16.51 cm) working length Clamp drilled to secure Portal Figure 3 - Vertos mild Devices Package Contents Bone Sculpter Rongeur

4 Durable Bone Sculpting Tip Balanced Ergonomically Designed Grip Forward Cut Figure 4 - Vertos mild Devices Package Contents Back Plate Device Orientation in relation to the patient Portal entry slot Ball Socket Top View Back Plate Being Positioned to Secure Portal Back Plate Positioned with Portal Locked-In CAUTION Federal (USA) law restricts this device to sale by or on order of a physician. The mild Devices are sterilized with gamma radiation. Do not use if the package is opened or damaged. Only the metal components of the set are non-pyrogenic. Do not use in a sterile or aseptic area without proper precautions PRECAUTIONS It is important to read the Instructions for Use prior to device operation. Use the mild Devices prior to the Use By date noted on the package.

5 Inspect the mild Devices and packaging to verify that no damage has occurred as a result of shipping and handling. In the event of damage to the sterile packaging, retain the package with the contents and notify the manufacturer. The mild Devices and Accessories should only be used by physicians who are trained in the techniques of its use and who have experience and training in image guided diagnostic and therapeutic spinal procedures. The mild Devices and Accessories should only be manipulated while under fluoroscopic observation with radiographic equipment which provides high quality images. Inadvertent movement of the device components outside the field of vision or without adequate assurance of device placement via fluoroscopy may result in patient injury. Avoid allowing the device components to come into contact with the dura, cauda equina / nerve roots or major blood vessels to avoid potential injury. The tip of the mild Tissue Sculpter has a sharpened inner edge but with a blunt profile to reduce the risk non-target tissue puncture. This blunt profile is designed to allow resection of firmer tissue captured within the tip, including ligament and fat, while displacing compressible tissue, such as the epidural tissue and the thecal sac. It is necessary to use Anterior-Posterior (AP) and contralateral-oblique fluoroscopic imaging to maintain tip position within the interlaminar space and toward the ventral laminar surface to additionally minimize inadvertent tissue contact. The mild devices are intended to be used under fluoroscopic guidance during a cephalad ipsilateral tissue resection procedure in the lumbar spine. The mild Devices are instruments that enable bilateral approaches to the interlaminar space, therefore, the mild Tissue Sculpter should not to be used in a contralateral approach to cross the medial plane of the posterior spine. It is recommended that epidurography using standard diagnostic techniques, equipment and nonionic contrast agents be performed to identify the dural and epidural anatomy prior to commencing the procedure. The mild procedure should be performed under local anesthesia. Use only manual power when using the mild Devices and Accessories. Never use electric power (or any other alternative power sources) in conjunction with the mild Devices and Accessories. The mild Devices and Accessories are intended for single use only. Do not re-sterilize and/or reuse. The mild Tool Kit and Accessories are intended for single use only. Do not re-sterilize and/or reuse. PREPARATION OF THE mild DEVICES 1. mild Trocar and Handle with the mild Portal Device The two components of the mild Tissue Access Device are assembled by inserting the Trocar through the central lumen of the Portal (Figure 2). Twist the Trocar Handle until the plastic connecting collar on the Trocar tightens into place with the Portal hub. 2. mild Tissue Sculpter The mild Tissue Sculpter is packaged ready for use. Inspect prior to use. Extend the trigger mechanism on the handle to open the tissue retraction, grasping and cutting element at the distal tip (Figure 5). Depress the proximal button to advance the push rod. Observe movement of the push rod within the distal tip of the Device. Depress the trigger to close the cutting element. Observe advancement of the outer shaft toward the distal tip of the Device, closing the cutting element.

6 Figure 5 represents the open and partially closed mild Tissue Sculpter tip relative to the Portal tip. The mild Tissue Sculpter is intended to be used as demonstrated, with the mild Portal functioning as the access cannula to the targeted anatomy for tissue resection. Figure 5: Vertos mild Tissue Sculpter Device Tip with mild Portal Open Tissue Sculpter tip extending from the mild Portal tip. Partially closed Tissue Sculpter tip extending from the mild Portal tip. 3. Accessory Guide Use of the Guide is optional (Figure 2). Rotate the Guide clockwise for setting the depth within the allowable 2.5 centimeter travel. Insert the mild Tissue Sculpter into the Guide and Portal and observe the distance of tip extension from the Portal over the adjustable length of the Guide. Instrument length exiting the tip can be adjusted utilizing the corresponding markings on the guide. After Portal placement into the patient, the Guide may be adjusted, attached to or removed from the Portal hub when desired. USE OF THE mild DEVICES Overview of Lumbar Spinal Anatomy and Approach for mild Procedure The mild devices are designed to access the interlaminar space from the posterior lumbar spine to enable the user to preferentially resect thickened ligamentum flavum. Figure 6 represents the relevant spinal anatomy for which the mild devices are intended. Figure 7 identifies a graphical representation of the lumbar spine from a lateral oblique perspective, revealing the interlaminar space for demonstration of the mild device trajectory. The lateral oblique graphics in Figure 7 demonstrate the landmarks to guide the mild procedure. These illustrate the position of the mild devices relative to bony and soft tissue landmarks for selection of the ligamentum flavum. Access begins at the inferior lumbar segment and is lateral to the spinous process margin. The mild Tissue Access Device is advanced through the back muscle and tissue to the inferior vertebral segment lamina, toward the border of the interlaminar space. The mild Portal accepts the mild Tissue Sculpter, which is advanced into the interlaminar space, toward the inferior border of the adjacent lamina for ligamentous tissue resection. Figure 6: Graphical Representation of Thickened Ligamentous Tissue in Lumbar Spine

7 Canal Stenosis by Thickened Ligamentum Flavum Lateral view illustration reveals a thickened ligamentum flavum (simulated) relative to the spinal canal. Thickened Ligamentum Flavum Space Lateral view MRI reveals a simulated (enhanced) thickened ligamentum flavum relative to the spinal canal. Description of the Recommended Fluoroscopic Imaging for mild Device Placement An image-guided posterior lumbar spinal access, lateral to the spinous process and with the cephalad approach is required for use of the mild Devices. By switching between an Anterior- Posterior (AP) view and a contra -lateral oblique view, or by using bi-plane fluoroscopy to view both the Anterior-Posterior (AP) and contralateral oblique images at the same time, the mild Tissue Sculpter can be advanced to ligamentum flavum in the target area with certainty. Figure 7: Lateral Oblique Graphic of Lumbar Spine with Demonstration of mild Device Placement Relative to Interlaminar Space and Bone/Tissue Landmarks Lamina Interlaminar Space Spinous process Ligamentum Flavum Lateral oblique graphic demonstrates the interlaminar space and bony landmarks to guide mild procedure. Illustration demonstrates the position of mild devices relative to bony and soft tissue landmarks for selection of the ligamentum flavum.

8 Initially, the Anterior-Posterior (AP) projection for identifying the target region and guiding mild Device placement for tissue resection is recommended for the mild procedure. This projection positions the fluoroscopic imaging head substantially parallel to the surface of the laminae to enable an unobstructed imaging trajectory into the interlaminar space and ligamentum flavum. Additionally, the contralateral-oblique imaging plane is required to assess the posterior-anterior depth, viewed from the lamina to the epidural space. This aids to determine the relative position of the mild Tissue Sculpter within the ligamentum flavum. Figures 8 and 9 demonstrate fluoroscopic images of the human lumbar spine. The primary anatomical landmarks that are relevant to the mild procedure are identified. In these projections, image guidance for the mild procedure is not obscured by the bony elements, allowing the target region underlying the lamina and the epidural space to be viewed relative to the mild Tissue Sculpter placement. As demonstrated in Figure 9, the injection of non-ionic contrast media to perform epidurography prior to mild Device insertion is recommended. The contralateral oblique orientation reveals a partial lateral view of the interlaminar space occupied by ligamentum flavum on the anterior side of the lamina and its position relative to the underlying contrast media-marked epidural space. Procedure: Summary Description of mild Devices in the mild Procedure A posterior lumbar spinal access, with an entry path lateral to the spinous process is required for use of the mild Devices. This is depicted in Figure 7. Following epidurography, image-guided cephalad placement of the mild Portal to the laminar surface of the inferior vertebral segment is initially completed. The mild Tissue Sculpter is then introduced through the Portal and advanced into the interlaminar space toward the superior vertebral segment. The open tip of the mild Tissue Sculpter is directed to the ventral surface of the superior lamina, remaining superior to the epidural space. This procedure selectively places the device within the ligamentum flavum to retract, grasp and excise tissue. The mild Devices enable the user to excise portions of the ligamentum flavum by procedure. In particular, with the image guided approach described and illustrated in these instructions, the interlaminar space and ligamentum flavum can be accessed, and tissue portions removed on the same lateral side (ipsilateral) as the median plane entry point of the mild Devices. Figure 8: Anterior-Posterior (AP) Projection of the Lumbar Spine

9 Note: Lumbar AP projection reveals the interlaminar space and bony landmarks to guide mild procedure. Lamina Interlaminar Space Spinous Process Figure 9: Contralateral-Oblique Projection of the Lumbar Spine with Epidurography & mild Tissue Sculpter Placement Lamina Interlaminar Space Epidural Space filled with contrast Note: The Contralateral oblique projection reveals the posterior to anterior plane with contrast mediamarked epidural space and the position of mild Tissue Sculpter tip relative to bony and soft tissue landmarks. Procedure: Part A. - Positioning of the mild Tissue Access Device 1. An access channel through tissue and to the target region is made using the mild Trocar and Handle, assembled with the mild Portal (Figure 2). The two components of the mild Tissue Access Device are assembled by inserting the Trocar through the central lumen of the Portal. Twist the Trocar Handle until the plastic connecting collar on the Trocar tightens into place with the Portal hub.

10 2. Position the patient in a prone manner for spinal access in accordance with standard medical practice. Perform diagnostic fluoroscopic assessments of the lumbar-sacral spine in the Anterior-Posterior (AP) and contralateral oblique projections as described previously. Assess the images to identify the path of entry. 3. Refer to Figure 10. Perform epidurography using standard diagnostic techniques and nonionic contrast agents to identify the border of the dural and epidural space relative to the ligamentum flavum and interlaminar space. 4. Make a small skin incision over the selected inferior lumbar region for ipsilateral access, approximately 1 to 1.5 vertebral segments caudad of the target region. Position the Trocar tip of the mild Access Device within the incision. 5. Using manual control and imaging guidance, advance the Access Device cephalad at an acute angle to the spine with gentle but firm pressure. Direct toward the dorsal surface of the spinal lamina of the adjacent vertebral segment, inferior to the interlaminar space and lateral to the spinous process. 6. Remove the Trocar with handle from the Portal by depressing the connecting collar and twisting the handle. Position the Portal tip atop the laminar surface and toward the superior margin of the laminar surface. 7. Once the inner trocar is removed leaving a hollow access portal into the interlaminar space, the portal may be secured against the skin surface by the mild back plate (or the surgical clamp). The Portal is now in position to accept the mild Tissue Sculpter Device. 8. At this time, the Accessory Guide may be attached over the Portal hub limiting the forward motion of the working instruments. Figure 10: Insertion and Positioning of the mild Tissue Access Device Cannula Placement Positioning with Clamp Positioning with Back Plate Procedure: Part B. - Use of the mild Bone Sculpter Rongeur 1. The Bone Sculpter is packaged ready for use. Inspect prior to use. Depress the lever mechanism on the handle and observe advancement of the cutting tube toward the tip. Release the lever and observe opening of the tip aperture as the cutting tube returns 2. Position the mild Portal in accordance with Part A of this IFU.

11 3. Using manual control and the appropriate imaging guidance, advance the Bone Sculpter through the mild Portal to the selected laminar bone surface, traversing the interlaminar space if desired, in accordance with the mild procedures. 4. Place the tip of the Bone Sculpter against the target bone and depress the lever to enable the cutting action at the tip. Maintain the lever in this position until removed from the Portal (refer to Figure 10). 5. Remove any bone and/or tissue from the device tip and repeat the procedure. Figure 11: Pre-Bone Sculpting Bone Sculpting Post Bone Sculpting Procedure: Part C. - Use of the mild Tissue Sculpter 7. The mild Tissue Sculpter is packaged ready for use. Reference preparation instructions. Reextend the trigger to open the tip in preparation for insertion into the mild Portal. Note: The mild Tissue Sculpter tip is designed to retract tissue and contours to the shape of the anatomy to specifically fit within the ligamentum flavum for capture and removal of tissue under image guidance. The approach allows the tools to avoid the neural elements and can optimize instrument orientation toward the ventral surface of the lamina to allow retraction and excision of ligamentous tissue. 8. Refer to Figure 12. Using the appropriate imaging guidance techniques as described previously, insert the open-tip mild Tissue Sculpter Device through the mild Portal, with or without the Guide in place, and advance to the Portal tip for exit near the margin of the interlaminar space. If used, adjust the Guide as needed. Note: The Tissue Sculpter is inserted in an open-tip position to allow for a preferential snug fit during advancement through the Portal. This configuration will set up the Tissue Sculpter function for advancement through the tissue upon exiting the Portal. 9. Prior to exiting the Portal tip, slightly depress the trigger to partially close the Tissue Sculpter tip. Slowly advance the Tissue Sculpter tip out of the Portal. The Tissue Sculpter is in position to advance and excise portions of ligamentum flavum on the same lateral side of median plane (ipsilateral), using the spinous process as an anatomical landmark. 10. If the Guide is attached, manually adjust by turning in a clockwise or counterclockwise direction to allow extension of the mild Tissue Sculpter from the Portal tip and into the tissue and interlaminar space as needed.

12 11. The mild Portal may be positioned at various angles relative to the lamina and interlaminar space to enable the Tissue Sculpter to select tissue for resection. The surgical clamp may be attached to the Portal to aid in maintaining a stable position while allowing the user s hands to remain away from the imaging field. Figure 12: Introduction and Positioning of the mild Tissue Sculpter with Fluoroscopic Images in AP and Lateral Projections Pre-Tissue Sculpting Tissue Sculpting Post-Tissue Sculpting 12. Fully extend the trigger to completely open the Tissue Sculpter tip. Advance the Tissue Sculpter tip into the interlaminar space and direct the tip toward the ventral aspect of the adjacent superior lamina to capture ligamentous and fatty tissue. 13. A single tissue cut can be completed by pulling the handle trigger. This enables the outer cutting tube to close over the Device tip for tissue resection. Maintain the trigger in this position for removal from the patient. 14. Completely withdraw the mild Tissue Sculpter through the Portal, extend the trigger to open the cutting element, and advance the push rod to remove the tissue specimen. 15. Steps 8 through 14 are repeated as necessary to complete the ipsilateral mild procedure. This requires progressive tissue cuts to the inferior edge and under the ventral surface of the lamina, using fluoroscopic imaging guidance to maintain the surgical field dorsal to the margin of the epidural space (reference Figure 12). The depth and lateral placement of the Tissue Sculpter is controlled by the Portal position. Note: Tissue excision is generally performed across the interlaminar space and laterally along the width of the ligamentum flavum, from the posterior toward the anterior border of the epidural space. The actual depth of the distal end of the mild Tissue Sculpter along the posterior-anterior plane is adjusted with fluoroscopic guidance from the contralateral oblique view and appropriate positioning of the mild Portal between 30 and 70 relative to the posterior back surface. 16. For tissue excision at another vertebral level, or, on the contralateral side of the medial plane, the Part A. Positioning of the Tissue Access Device procedure is repeated using the second mild Portal provided with the mild Devices. 17. Upon completion, follow standard medical practice for post-operative cleaning and closure of the surgical site.

13 HOW SUPPLIED The Vertos mild Devices are supplied sterile and non-pyrogenic (patient contact surfaces) in a thermoformed tray. In the event of damage to the sterile packaging, retain the contents and notify the manufacturer. STORAGE The instruments should be stored in their original shipping materials. Proper care should be taken to ensure that the instruments will not be damaged. Catalog Number Lot Number Use By Do Not Reuse Manufacturer: Vertos Medical, Inc 11 Columbia Suite B, Aliso Viejo, CA USA Tel :+1(408) Fax :+1(408) info@vertosmed.com Non-Pyrogenic *Reuse of devices can result in poor performance of the device and increase risk of infection Sterilized Using Radiation Caution: Consult Accompanying Documents