Otologics Fully Implantable Hearing Systems

Surgical Guide Carina with MET V

For Conductive & Mixed Loss Applications
0123
2007

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This Instruction document outlines the basic steps required to implant the Carina Fully Implantable Hearing Device with the MET V transducer for treatment of conductive and mixed hearing losses. It is not intended to contain all information relating to the Otologics implant and its components. Refer to Otologics Surgical Training Manual D104096 for additional information.

Step 1 Planning Capsule Placement and Making the Incision

Prior to surgery an implant model or capsule template is used to identify the optimal implant placement and location of the incision. See dotted line in Figure 1. The implant capsule and coil are placed in a relatively flat region of the head. The capsule is placed in a bone bed so that it does not protrude more than ~2mm above the surface of the skull. Bending of coil more than 10 relative to capsule may cause damage, and often results in longer charging times for the patient. The optimal position of the implant capsule typically lies between lines of 30 and 90 degree angle relative to the horizontal with the silicone charging coil superior to the titanium capsule body, as shown in figure. The microphone must be firmly anchored to bone, and away from muscle. Proper position is directly posterior to ear canal. Deviations from this position may result in feedback and other performance issues for the patient.

CAUTION: Do not allow any of the implant components to touch each other.

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Step 2 Assembling the Prosthesis Guide

The Bending Guide with Prosthesis Template provides important guidance in drilling the mastoidectomy. Assemble the Bending Guide with Prosthesis Bending Template as shown below. Set the compression assemble to the middle of its range, to ensure that the real transducer will have some forward and backward adjustability available.

Bending Guide assembled with Prosthesis Template and Locking Collet Locking Collet Holds template in position Locking Tool Transducer Bone Mounting Bracket Prosthesis Template Formable wire with ball tip

Set compression assembly of Bending Guide to the middle of its range as shown

Bendable and Extendable tip

Tighten Locking Collet to Secure Prosthesis Template

This represents the length of a MET V with the longest possible prosthesis.

It is recommended that 5mm of the prosthesis template extend beyond the mock transducer, which approximates the length of the MET V transducer with full length prosthesis. If the anatomy or placement of the bracket requires less than 5mm, this implies that the prosthesis will need to be cut to match the prosthesis template.

5mm

Important: Do not extend the prosthesis template more than 5mm or less than 1mm beyond the Bending Guide, as this simulates a transducer length that cannot be achieved.

Example of Prosthesis bent and crimped to match.

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Step 3 Drill the Mastoidectomy and Facial Recess

Overview: The surgical approach for placement of the MET V transducer is typically through the facial recess. From this approach, the prosthetic transducer tip can be connected to the desired middle ear anatomy; stapes superstructure; stapes footplate; oval window; round window; or other ossicular structure.

Left Ear

Procedure: Drill a mastoidectomy to expose the facial recess. A full mastoidectomy is not usually needed. Use the Prosthesis Guide to determine the appropriate size and location of the mastoidectomy.

The mastoidectomy only needs to be large enough to accommodate the transducer and bracket. Open the facial recess to gain access to the middle ear. (NOTE: If a larger mastoidectomy has been drilled in a previous procedure, a special bone bracket may be necessary to span the larger opening.)

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Step 4 Positioning and Fastening the Mounting Bracket

Preliminary Placement Place the mounting bracket so that the Prosthesis Template can reach the desired middle ear anatomy. Bend the wire of the Prosthesis Template as needed to achieve an effective approach to the desired contact point.
Loosen the Locking Tool and move the Bending Guide as shown in the diagram to alter the angle of the Prosthesis Template. This will also allow forward and backward adjustment of the Bending Guide.

Left Ear

If necessary, loosen the Locking Collet for additional forward or backward adjustment of the Prosthesis Template.

Perform additional drilling as necessary to allow proper placement of the bone bracket and Bending Guide.
Important: Do not extend the Prosthesis Template more than 5mm or less than 1mm beyond the mock transducer, as this simulates a transducer length that cannot be achieved.

The mounting bracket legs should be bent to allow flush placement against the cortex. Fastening: Once the bracket legs have been bent to conform to the cortex, and the Prosthesis Template is able to contact the desired anatomy, drill a hole in each of the bracket legs. Screw down all four legs with at least one screw each. Final Adjustments to Prosthesis Template: After fastening the bracket to the skull, final adjustment to the Prosthesis Template may be made by loosening the Locking Collet and/or carefully bending the prosthesis tip with an instrument. After all adjustments are complete: Tighten the Locking Collet to maintain the position of the prosthesis template Loosen the Locking Tool. Carefully remove the entire Bending Guide assembly from the mounting bracket. Always maintain a hold on the Bending guide as it is loosened so that it does not slip and contact the ossicles.

Left Ear

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Step 5 Transducer Health Verification

Transducer Health
After removing the MET V transducer from the sterile package, connect the sterile TLA IS-1 clip cable and start the TLA software. IMPORTANT: The tip of the transducer is delicate, handle carefully and avoid contact with tip.

Run Initialization to ensure that the transducer is healthy Typically, initialization results in a Green reading.

Connect cable to transducer lead.

Initialize TLA
TLA Initialization is a measurement of transducer impedance. Most of the values are typically be in the range 150-400, with a peak value of 600-1300 identified by the green indicator.

NOTE: If TLA gives a yellow Initialization with MET V, look for 2 other things to know the transducer is healthy: 1. The Initialization values displayed on the right side of the software are in the 150-1300 range. 2. A normal Inductance value of 16.5 to 13 mH is measured after clicking Run

In determining transducer health, the Inductance values is just as important as Initialization. Once the Run button has been pressed, TLA should indicate an Inductance value of 13-16.5mH.

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Transducer Monitoring

Run TLA and monitor the Inductance and Impedance values to monitor transducer health and ensure that transducer is being handled within safe limits. IMPORTANT: During handling, crimping, and placement, the TLA Inductance value should remain above 10mH most of the time and should not drop below 7mH. An inductance value below 7mH indicates that the transducer is being handled outside its operational limits. If Inductance reading drops below 7mH, reduce the contact/loading of the transducer tip and ensure that Inductance returns to >12mH.

Inductance

Carefully place the transducer into the crimper as shown bellow. Push the transducer forward until it stops, so that the middle of the transducer tip is between the crimping pins. MAKE SURE THE TRANSDUCER LEAD IS NOT UNDERNEATH THE HANDLE, TO AVOID DAMAING THE LEAD WHEN CRIMPING.

SLIDE TRANSDUCER FULLY FORWARD

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Step 6 Prosthesis Shaping, Cutting, and Crimping

Once the Prosthesis Guide has been bent to achieve contact with the desired anatomy, remove the Prosthesis Guide from the bone bracket and place the entire assembly complete into the base of the crimper tool as shown. Ensure that the transducer portion of the laser guide is all the way forward as the arrow indicates.

Slide forward as shown.

NOTE: The edge of the crimper represents the end of the MET V transducer

Replicate bends on overhanging portion only

Cutting line provides correct final length.

Place prosthesis in hole on end of crimper tool. Continue to hold with tweezers do not let go at any time. Use one pair to hold the base of the prosthesis at the edge of the crimper block, and the other to manipulate and cut to length.

Important: Crimper block does not hold prosthesis securely. A firm grip must be maintained on the portion that is to be used.

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NOTE: Cut in a rocking motion with a rounded blade. DO NOT use a slicing motion. The discarded portion of the prosthesis wire will remain inside the fixture in this slot.

Transfer cut prosthesis to the tip of the transducer in the same orientation as the bending template guide.

Place the MET V Attachment prosthesis in the tip of the MET V Transducer. Rotate and align MET V Transducer attachment so that it matches the Prosthesis Guide as shown in diagram. Slide the MET V Transducer Attachment wire all the way into the transducer tip as far as it will go (2mm). The TLA readings will respond during this process, however they must return to the range of a healthy transducer once the crimp is complete, as detailed in the following steps. It is critical to the reliability of the crimp joint, that the MET V Transducer Attachment wire is inserted fully. While the MET V Transducer Attachment wire is inserted the full 2mm, the crimp is made by pushing down firmly on the handle once and only once, until it hits the stop.

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Insert MET V Attachment fully. Monitor TLA Inductance.

While gently holding MET V attachment, firmly press the crimper handle, all the way down, until it hits the stop. DO THIS ONLY ONCE

You may now release the crimper handle and the MET V Attachment. Verify attachment with a gentle tug. Verify TLA readings indicate a healthy transducer, i.e. >12mH Inductance; >500 Ohms Impedance. The MET V Transducer may now be removed from the crimper. Press the ejector button as shown below to raise the transducer. Gently grab the case of the transducer (DO NOT grab the tip of the transducer OR the prosthesis tip!) and lift it up and out.

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Step 7

Mounting the MET V Transducer

Place the locking ring firmly onto the Locking Tool. Slide the Locking Tool onto the Insertion Instrument Joystick. Grasp the MET V transducer with the thumbscrew and joystick assembly. Again, the TLA software should be monitoring the transducer during these steps. Guide the transducer into the mounting bracket, taking care to preserve the shape of the prosthesis as much as possible. Place the transducer such that the prosthesis attachment is near the target anatomical site. Tighten the locking ring to secure the transducer.

Left Ear

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Step 8

Final Placement of Prosthesis Tip

The transducer and prosthesis can be advanced by using the micro-adjust. Additional shaping of the prosthesis may be necessary, however the end of the MET V transducer is delicate and care must be taken when performing manipulations of the prosthesis attachment. If possible, stabilize the transducer tip with one instrument while manipulating the prosthesis with another. Monitor TLA software to guide final placement of transducer, as described below. The TLA software inductance value is used to ensure that manipulations of the prosthesis do not over-stress the transducer.

Left Ear Left Ear

Placement of MET V transducer on stapes capitulum Placement of MET V transducer on round window

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Understanding TLA: The TLA software should be used to monitor the transducer throughout final placement. Keep in mind that TLA measures pressure on the tip of the transducer. With the MET V prosthesis tip, there may not be as much pressure on the transducer as with standard incus placement; therefore, TLA loading guidelines are different for MET V.

Proper Visualization of Prosthesis is Critical!

Transducer Health: Use TLA Inductance as a monitor of transducer health. The Inductance may change very little, or it may drop 2 mH or more, depending on how much pressure is exerted back through the prosthesis to the transducer. Final loading is typically within 2mH of the initial Inductance value measured with transducer in free air. Final inductance MUST be >12mH. Transducer Contact: Use TLA Impedance as an indicator of transducer contact. The TLA Impedance value will often drop by several hundred Ohms when the transducer tip makes contact. However, it is not necessary to achieve <400 Ohms loading for MET V.

CAUTION: TLA Inductance values of less than 7mH indicate that the transducer is being handled outside its operation range. Reduce or eliminate contact with the transducer and ensure that Inductance returns to >12mH.

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Step 9

Securing the Electronics, SAFI Testing, and Closing the Incision

IMPORTANT: Place the microphone posterior to the pinna, away from any musculature. Muscle movement can cause unwanted noise for the microphone. Although the implant capsule and coil have been designed for long term implantation, care must be taken when inserting the coil into a tissue pocket. Excessive manipulation or bending of the coil can damage it. In addition, the coil should be placed such that it is not bent more than 10 relative to the implant capsule. Place the implant electronics capsule in the bone bed and secure with two bone screws. Place the microphone in the bone bed pocket and secure with two screws. Remember that no implant component may touch any other, as this will reduce performance and my cause feedback. The transducer and microphone leads should be free of tension and sharp bends. Verify that the skin flap is no thicker than 6mm. Thin down as necessary to ensure that the charger and programming coil will properly communicate with the implant once skin is covering the implant. Take care to avoid Is monopolar only forbidden with electronics damage to the electronics or lead during suturing. CAUTION: Once the electronics have been implanted, only bi-polar cauterization is permissible. The use of mono-polar cauterizing equipment may damage the electronics.

Right Ear

or also with the transducer???

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Test the system with the SAFI software for final functionality confirmation before suturing. With MET V, it is acceptable to have a resonance peak on the SAFI Impedance test, as shown. This peak may even extend above the upper red line.

Typically, if there is a peak in the SAFI Impedance data, this peak will correspond to the frequency which was selected by the TLA software (green or yellow bar) during Initialization, and the value will be similar to the final TLA Impedance value measured. SAFI Impedance and TLA impedance are similar measurements, and the SAFI Impedance chart will usually have similar values to the TLA Initialization bands.

Similar Frequency
SAFI Peak frequency similar to TLA Initialization frequency

Similar Value
SAFI Peak value similar to TLA final loading value

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