TM Axium™ Neurostimulator System Physician Implant Manual Spinal Modulation, Inc. 1135 O’Brien Drive Menlo Park, CA 94025 USA Copyright © September 2011 by Spinal Modulation, Inc. All Rights Reserved. No portion of this manual may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, or any information storage and retrieval systems, without the express written permission of Spinal Modulation, Inc.
Spinal Modulation, Inc. Physician Implant Manual Contents Explanation of Symbols on Product or Package Labeling ................................................. 4 INTRODUCTION ............................................................................................................................ 5 System Overview ............................................................................................................ 6 Indications for Use ...........................................................
Spinal Modulation, Inc. Physician Implant Manual Percutaneous Extension Tunneling – Implant Lead Trial Only ........................................32 Removing Lead Extension – Implant Lead Trial Only ......................................................33 Creating the INS Pocket – Implant..................................................................................34 Lead or Extension Tunneling ..........................................................................................
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Spinal Modulation, Inc. Physician Implant Manual Limited waterproof. Applies to the TNS Applies to the Programmer in its carrying case Contents of Package are Non‐Sterile Keep Dry Storage temperature Store between 10% and 90% humidity Sterile Components Store between 0% and 93% humidity TNS and Programmers The device is a radio transmitter Magnet. Shows the location of the Programmer magnet. Authorized European Representative RF Operating Frequencies.
Spinal Modulation, Inc. Physician Implant Manual System Overview The Axium™ Neurostimulator System consists of an Implantable Neurostimulator (INS) device, Trial Neurostimulator (TNS) device, a Clinical Programmer, a Patient Programmer, one or more leads which may be used in combination with a lead extension and the accessories and tools used for implanting the system. The TNS or INS is connected to leads placed within the epidural space near the dorsal root ganglion (DRG).
Spinal Modulation, Inc. Physician Implant Manual Indications for Use The Axium™ Neurostimulator System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs.
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Spinal Modulation, Inc. Component Name Physician Implant Manual Package Content Instructions for Use 22 cm Small Curve MN12150 Delivery Sheath Kit MN22150 • 22 cm Small Curve Delivery Sheaths (2) Physician Implant Manual 22 cm Big Curve MN13650 Delivery Sheath Kit MN23650 • 22 cm Big Curve Delivery Sheaths (2) Physician Implant Manual 4.5” Needle Kit MN11700 MN21700 • 4.
Spinal Modulation, Inc. Physician Implant Manual The INS is packaged in a sealed inner tray within a sealed outer tray. Implant Leads / Trial Leads / Lead Extension The Lead Kits contain the Leads and the individual delivery devices that are required for their placement. CAUTION: The temporarily placed Trial Leads are intended for use for up to 30 days.
Spinal Modulation, Inc. • Physician Implant Manual Soft Tissue Anchor: The Soft Tissue Anchors are intended to anchor the Lead in the soft tissue or on the skin surface proximal to the distal contacts of the Lead. Implantation Tools • Tunneling Tool: The tunneling tool is used to provide a conduit for the Trial Lead, Implant Lead, or Lead Extension to the INS or away from the midline of the spine. It is packaged with 2 exchangeable tips: a blunt pencil tip and a sharp trocar tip.
Spinal Modulation, Inc. Physician Implant Manual Note: For detailed information and instructions related to the Clinical and Patient Programmer and the Trial Neurostimulator, refer to the respective user manuals. Sterilization Information Single‐use, sterile device ‐ The sterile components of the Axium™ Neurostimulator System are provided sterile in a double pouch or tray assembly and are intended for single use only. An expiration date (or “use‐before” date) is marked on the label of each package.
Spinal Modulation, Inc. Physician Implant Manual Safety Information General Warnings The following warnings apply to the use of the Axium™ Neurostimulator System: • External Defibrillators – Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. • Magnetic Resonance Imaging – The patient should be advised to not undergo any elective magnetic resonance imaging (MRI) with the system in place.
Spinal Modulation, Inc. Physician Implant Manual If the patient with an INS or TNS device is subsequently given any medical treatment in which an electrical current is passed through his/her body from an external source, either the device should first be deactivated, or care should be taken to monitor the functioning of the neurostimulator during the initial stages of treatment.
Spinal Modulation, Inc. Physician Implant Manual Warnings – For Use in Home or Work Environments • Equipment Operation – During stimulation, patients should be advised to not operate potentially dangerous equipment, such as power tools, automobiles, or other motor vehicles.
Spinal Modulation, Inc. • Physician Implant Manual Therapeutic Radiation – Therapeutic radiation may damage the electronic circuitry of an implanted neurostimulation system, although no testing has been performed and no definite information on radiation effects is available. Sources of therapeutic radiation include x‐rays, cobalt machines, and linear accelerators. If radiation therapy is required, the area over the implanted INS should be shielded with lead.
Spinal Modulation, Inc. Physician Implant Manual • TNS Device Care – The patient must be instructed to not spill fluids on, to wash or otherwise get their TNS device wet. The patient must not shower or bathe with it (sponge baths are acceptable as long as the TNS device does not get wet). The patient must be instructed not to drop or mishandle their TNS device. Physical damage to the unit may impair its function. The patient must be instructed to not open the TNS case.
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Spinal Modulation, Inc. Physician Implant Manual • When inserting the lead/sheath assembly through the needle into the epidural space, tighten the lead stabilizer to prevent lead migration out of the sheath. Failure to do so may cause harm to the patient such as damage to the dura. • Do not bend the sheath without the lead inside the sheath, as this will permanently kink it and make it difficult to deploy the lead. • Do not use surgical instruments to handle the lead.
Spinal Modulation, Inc. Physician Implant Manual B. Implanted Lead + Percutaneous Extension Trial – A trial is done with an Implant Lead sutured to the soft tissue just above the spinous process, using the soft tissue anchor to protect the lead. An extension is tunneled away from the needle insertion site where it exits the skin.
Spinal Modulation, Inc. Physician Implant Manual Choosing an Approach 2. Antegrade Approach Under fluoroscopic guidance, use a contralateral approach, with the bevel of the needle facing toward the target level, to insert the Delivery Needle into the epidural space at the appropriate angle until you encounter resistance from the ligamentum flavum. Start one or two levels below the target site. The needle angle should be no greater than 30 degrees to ensure smooth delivery of the delivery sheath and lead.
Spinal Modulation, Inc. Physician Implant Manual angle than in an antegrade approach and there is a greater chance of dural puncture that will lead to a cerebrospinal fluid leak. 4. Confirm entry into the epidural space using standard methods, such as a loss of resistance technique. 5. Once loss of resistance is achieved, the clinician may verify complete insertion into the epidural space using fluoroscopic guidance and/or inserting the guidewire through the needle.
Spinal Modulation, Inc. Physician Implant Manual Tightening the Lead Stabilizer WARNING: Insertion of a sheath without the lead may result in dural puncture. Securing the lead with the lead stabilizer will mitigate this risk. WARNING: Use of the delivery sheath is necessary for successful placement of the Lead. 9. Note that the steering wing on the sheath lines up with the bend in the sheath. 10. Before inserting the sheath into the needle, verify that the Lead is loaded.
Spinal Modulation, Inc. Physician Implant Manual to do so may result in damage to the sheath. Before reinserting sheath, verify there is no damage to the sheath. WARNING: If the sheath is not responding to rotation, do not rotate the steering wing out of plane from the curve of the sheath more than 90 degrees. The tip of the sheath may whip around and could cause harm to the patient. 12.
Spinal Modulation, Inc. Physician Implant Manual Lead Advanced Along Dorsal Aspect of DRG WARNING: Do not use excessive force to push the lead or sheath into the neural foramen as this may result in permanent or transient nerve damage. The patient should be awake and conversant during this part of the procedure so they can provide feedback to the physician. Intraoperative Testing 1. Connect the head to the cable.
Spinal Modulation, Inc. Physician Implant Manual NOTE: Refer to the Trial Neurostimulator User Manual and Clinical Programmer User Manual for specific instructions on the operation of these devices. WARNING: Maintain adequate slack in the cable. If there is not enough slack and the cable is pulled, the lead may be dislodged and will need to be replaced. This will extend the procedure. 4. Using the TNS, test the various electrode configurations used to obtain appropriate paresthesia or pain relief. 5.
Spinal Modulation, Inc. Physician Implant Manual WARNING: Failure to put a loop in the epidural space may result in lead migration and may lead to a procedure to revise the position. 5. Remove the sheath completely while holding forward pressure on the lead. WARNING: When removing the sheath, verify that the steering wing is no more than 90 degrees misaligned with the mark on the needle. Failure to do so may result in damage to the sheath.
Spinal Modulation, Inc. Physician Implant Manual place, will assist this process. Lead Anchoring – Percutaneous Lead Trial 1. After placing a Trial lead in its final position, it should be secured using a lead anchor on the skin. 2. Carefully slide the lead anchor over the proximal end of the Trial Lead and advance it to the puncture site. The short end of the suture anchor must be facing towards the incision. 3. Apply sutures around the anchor and cinch onto the Trial Lead as shown below.
Spinal Modulation, Inc. Physician Implant Manual parameters. NOTE: Refer to the Trial Neurostimulator User Manual and Clinical Programmer User Manual for specific instructions on the programming of these devices. Removing Trial Lead –Percutaneous Lead Trial WARNING: Always remove the Trial Leads before implanting the Implant Leads, as there is a risk of infection that may cause death if the leads are not removed.
Spinal Modulation, Inc. Physician Implant Manual longitudinal incision, centered on the needle to the depth of the supraspinous ligament. 2. Establish hemostasis and use retractors for good visualization. 3. Slowly remove the delivery sheath by first pulling back the sheath near the needle. Always hold forward pressure on the Lead while retracting the delivery sheath to prevent movement. 4. Retract the stylet into the needle so that it is retracted beyond the tip of the sheath. 5.
Spinal Modulation, Inc. Physician Implant Manual 7. Remove the needle following the same procedure. 8. It is recommended that the desired paresthesia be re‐tested after the removal of the delivery system components but before the complete removal of the stylet. With the external TNS amplitude set to 0 µA, reconnect the Connector Cable as described before. WARNING: Do not use excessive force if the lead needs to be removed. Excessive force may cause lead fracture. 9.
Spinal Modulation, Inc. Physician Implant Manual 3. Using the 2‐0 silk non‐absorbable suture, tie two ligatures around the center of the anchor to secure the anchor to the lead. If needed, make minor adjustments to the lead position. Tie one ligature around the leg and do not tie to the soft tissue. Verify that the short end of the anchor enters into the ligament.
Spinal Modulation, Inc. Physician Implant Manual 10. Slide the passing straw over the extension and out of the skin exit site, leaving the extension in place. 11. If not done previously, use blunt dissection to a form a subcutaneous pocket off the lead incision for the lead‐extension connection. 12. Wipe the lead and extension connector junction with sterile gauze. If necessary, moisten the gauze with sterile water or a nonionic antibiotic solution. 13. Dry all connections.
Spinal Modulation, Inc. Physician Implant Manual 6. Cut the extension near the lead‐extension connector. 7. Discard the lead‐extension connector. 8. Preserving sterility, pull the extension out through the skin exit site. 9. Discard the extension. 10. If multiple extensions are implanted, repeat the removal steps for the other extensions. Creating the INS Pocket – Implant Once the lead(s) has been anchored, a Neurostimulator pocket should be created and the lead tunneled for connection to the INS.
Spinal Modulation, Inc. Physician Implant Manual PRECAUTION: Do not apply electrocautery directly to the INS as this can damage the INS or cause interference while communicating with the INS. Lead or Extension Tunneling Tunnel the leads from the anchor site to the INS pocket. When tunneling to the abdomen, the clinician has two options: • Tunnel to a midpoint and then continue to INS site. • Use the 51 cm tunneling tool and curve the conduit around the side of the patient.
Spinal Modulation, Inc. Physician Implant Manual Connecting the INS The following steps outline the guidelines to connecting a Lead or Extension to the INS: PRECAUTION: Do not connect a lead with body fluid on its contacts because corrosion can occur and cause failure of the system. PRECAUTION: If there is a need to communicate with the INS prior to implantation, do not put the INS on a stainless steel table, as communication may be difficult. This may prolong the procedure. 1.
Spinal Modulation, Inc. Physician Implant Manual Implanting the INS The following steps outline the procedure for implanting the INS: PRECAUTION: Do not implant the INS face down. Always implant with the label facing up. Failure to do so will prevent communication with the programmer and/or magnet. PRECAUTION: If using more than INS, implant them at least 15 cm apart. Putting them too close together may interfere with the programmer’s ability to communicate with each one separately. 1.
Spinal Modulation, Inc. Physician Implant Manual 6. Slowly awaken the patient and test for stimulation perception and thereby verifying the system is operational. NOTE: The INS output may not be identical to the trial neurostimulator output. Always start stimulating from a setting lower than that used to stimulate with the trial neurostimulator. 7. Ensure that that the INS is away from the pocket incision suture line, close the pocket incision, and apply appropriate dressings. 8.
Spinal Modulation, Inc. Physician Implant Manual 6. Gently remove the lead from the INS header; then clean and dry all connections on the lead, ensuring they are free from fluid and tissue. PRECAUTION: If resistance is met while removing leads from the epidural space, do not use excessive force to extract. Always perform removal with the patient conscious and able to give feedback.
Spinal Modulation, Inc. Physician Implant Manual Appendix A: Trial Lead Kit / Implant Lead Kit How Supplied The components of the Spinal Modulation Trial Lead Kit and Implant Lead Kit are provided sterile in a double pouch assembly and are intended for single use only. Do not resterilize or reuse any devices from the Lead Kits, for any reason, because of risk of infection to the subject and malfunction of the devices.
Spinal Modulation, Inc. Physician Implant Manual Device Specification The Lead has four electrodes on the distal end and the proximal end fits into a four conductor connector on the Connector Cable or into the INS ports. The Complex Curved Stylet has been inserted into the proximal end of the lead and the lead has been pre‐loaded into a 22 cm Small Curve Delivery Sheath for user convenience. An illustration of the Trial Lead is given in Figure 1.
Spinal Modulation, Inc. Physician Implant Manual Appendix B: Trial Neurostimulator Device Description See the Trial Neurostimulator Manual for the full description of the device. The external Trial Neurostimulator (TNS) provides energy and controls electrical signals delivered to the Leads. The TNS device is intended to be connected to the Leads and worn by the subject for up to 30 days during the study period. The device is intended to be connected to the Spinal Modulation Connector Cable.
Spinal Modulation, Inc. Physician Implant Manual Handling Storage Conditions: ‐10°C ‐ 50°C Humidity Range: 10 – 93% Cleaning Instructions for Healthcare Professional: For disinfecting the TNS surfaces after gross filth and heavy soil loads have been removed, spray Cavicide or equivalent onto a paper towel, and then wipe the surface of the TNS with the wet paper towel. Allow the surface to remain damp for 2 minutes. Dry the surface using a dry paper towel. Do not immerse the TNS in liquid.
Spinal Modulation, Inc. Physician Implant Manual Appendix C: Implantable Neurostimulator How Supplied The Axium™ Implantable Neurostimulator is provided sterile in a double tray assembly and is intended for single use only. Do not resterilize or reuse, for any reason, because of risk of infection to the patient and malfunction of the devices. PRECAUTION: Do not resterilize the INS as it will create a risk of infection or malfunction of the device.
Spinal Modulation, Inc. Physician Implant Manual Therapy Accuracy.....................................10% over the range of 300 to 6000 µA Impedance Measurement Accuracy ........5% over the range of 400 to 2000 Ohms Height.......................................................6.52 cm (2.57 in) Width .......................................................4.77 cm (1.88 in) Thickness..................................................1.10 cm (0.43 in) Volume ....................................................
Spinal Modulation, Inc. Physician Implant Manual The Axium™ Neurostimulator System complies with the following International Standards: • IEC 60601‐1: 2005 • ISO 14708‐1: 2000 • IEC 60601‐1‐11: 2010 • ISO 14708‐3: 2008 • IEC 60601‐1‐2: 2007 Company and Authorized Representative Contact Information Spinal Modulation, Inc. Healthlink Europe B.V. 1135 O’Brien Drive Menlo Park, CA 94025 U.S.A.
