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Revision Surgery CI512 to CI24RECA.pdf - For professionals

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CAM-MKTP-290<br />

Nucleus® CI24RE Cochlear<br />

Implant <strong>Surgery</strong> Tips<br />

<strong>Revision</strong> surgery<br />

from Nucleus® <strong>CI512</strong> Con<strong>to</strong>ur Advance<br />

<strong>to</strong> Nucleus® CI24RE Con<strong>to</strong>ur Advance


Nucleus® <strong>CI512</strong> <strong>to</strong> Nucleus CI24RE revision<br />

This presentation reviews key surgical steps<br />

This document is supplemental information – refer <strong>to</strong><br />

Nucleus ® CI24RE Con<strong>to</strong>ur Advance Surgeons Guide for<br />

complete information regarding implantation of the CI24RE<br />

Cochlear Implant<br />

Note: Every implant includes a copy of the Surgeons Guide<br />

as part of the document pack<br />

Ensure the following is available in OR prior <strong>to</strong> starting:<br />

• Primary and backup CI24RE device<br />

• Explant kit


Purpose of this supplemental information<br />

Primary goal of procedure is <strong>to</strong> describe surgical steps <strong>to</strong><br />

replace a Nucleus 5 Cochlear Implant (<strong>CI512</strong>) <strong>to</strong> a Nucleus<br />

CI24RE Cochlear Implant<br />

Note: If there are any questions regarding the steps provided<br />

in this document contact Steve Hazard – Surgical Support<br />

Manager <strong>to</strong> discuss further<br />

Mobile # 1-661-803-4745


Caution<br />

Monopolar Electrocautery cannot be used when a patient has<br />

a cochlear implant or any portion of an electrode lead/ground<br />

lead present – whether the implant is functioning or not<br />

Bipolar Electrocautery is acceptable as long as it remains a<br />

minimum of 1 cm away from any electrode lead or ground<br />

lead and does not <strong>to</strong>uch the receiver package


Primary physical differences: CI24RE and <strong>CI512</strong><br />

3.3mm<br />

3.6mm<br />

Nucleus CI24RE<br />

16 mm x 2.3 mm<br />

Nucleus <strong>CI512</strong><br />

3.9 mm<br />

4.6 mm<br />

1. CI24RE has a vertical lead and<br />

ground electrode exiting the<br />

receiver stimula<strong>to</strong>r package.<br />

• Recess this in electrode<br />

channel<br />

2. CI24RE has a pedestal<br />

• Recess the pedestal in bone<br />

2.3mm<br />

Note: With these differences the<br />

CI24RE should be placed slightly<br />

further away from the pinna <strong>to</strong><br />

avoid pressure between the<br />

electrode lead exit and the external<br />

sound processor.


Important point – No overlap<br />

As with all CI surgery<br />

It is important <strong>to</strong> mark<br />

out device location and<br />

ensure there is no<br />

overlap between the<br />

BTE processor and the<br />

internal device


Exposing receiver package<br />

Widen fibrous tissue pocket adjacent <strong>to</strong> coil <strong>to</strong> assist in<br />

“releasing” receiver package<br />

Exiting Lead


Removing receiver package<br />

Cut the electrode lead at a distal location leaving<br />

approximately 1 cm outside the facial recess – then remove<br />

the receiver package, most of the electrode lead and also<br />

remove the ground lead/pin


Clear fibrous tissue & line up recess instrument<br />

1. Clear fibrous tissue from the recessed seat and electrode<br />

channel. Note: The channel may require widening due <strong>to</strong> bone<br />

growth<br />

2. Use Bone Recess Template (Z60479) or Recess Check Gauge<br />

(Z60480) and place circular portion approximately 5mm behind<br />

the lead exit location<br />

5mm<br />

Figure 1. Bone Recess Template<br />

Caution: Always consider the<br />

possibility of exposed dura in<br />

the recessed seat or electrode<br />

lead/ground lead channel –<br />

proceed with care.


Mark location of recess for pedestal<br />

3. Mark location then drill recess including the electrode<br />

lead/ground lead exit in<strong>to</strong> the channel flush with the recess<br />

(Figure 3). Note: The electrode lead/ground lead channel<br />

may require widening due <strong>to</strong> bone growth<br />

Figure 2. Site for recess drawn Figure 3. Site for recess drilled including<br />

lowering of the electrode lead/ground<br />

lead exit <strong>to</strong> be flush with the recess


Create tie-down holes<br />

5. Drill (or reuse) tie-down holes adjacent <strong>to</strong> the new recess seat<br />

per Nucleus CI24RE Surgeons Guide. Use a non-absorbable<br />

synthetic suture <strong>to</strong> secure the receiver package <strong>to</strong> bone


Verify final recess dimensions<br />

4. Use the Recess Check Gauge (Z60480) <strong>to</strong> verify final<br />

dimensions including the electrode lead/ground lead exit<br />

being flush with the bot<strong>to</strong>m of the new recess seat for the<br />

CI24RE receiver package<br />

Figure 4. Verify dimensions using<br />

Recess Check Gauge<br />

NOTE: Failure <strong>to</strong> have the lead<br />

exit flush with the bot<strong>to</strong>m of<br />

the recess will force the exiting<br />

electrode lead/ground lead <strong>to</strong><br />

be deflected upward <strong>to</strong>ward<br />

the soft tissue.


Bony overhangs<br />

6. Verify there are bony overhangs in the mas<strong>to</strong>id cavity <strong>to</strong> retain<br />

excess electrode lead once coiled in<strong>to</strong> position (Figure 5)<br />

Figure 5. Verify bony overhangs are sufficient<br />

in mas<strong>to</strong>id cavity<br />

Bony Overhangs


Place device<br />

7. Place CI24RE receiver package in position and tie-down<br />

(Figure 6 and 7). Ensure knots are <strong>to</strong> the side of the receiver<br />

package.<br />

Figure 6. Freedom Receiver Package<br />

sutured in place<br />

Figure 7. Picture demonstrates a tiedown<br />

technique on an initial cochlear<br />

implant procedure, where a tight<br />

pocket could not be maintained


Electrode Array Removal and<br />

Replacement Considerations<br />

Con<strong>to</strong>ur Advance Electrode


Array considerations<br />

8. Considerations prior <strong>to</strong> removal and replacement of CA array:<br />

• Goal is <strong>to</strong> end up with same depth of insertion<br />

• Be observant of any dura exposure or facial nerve exposure<br />

• Leave old array in position until ready <strong>to</strong> insert new array<br />

• Allow array <strong>to</strong> serve as a stent until ready <strong>to</strong> replace<br />

• Use old cochleos<strong>to</strong>my site (if previously successful)<br />

• Clear away all fibrous tissue from around array at the<br />

cochleos<strong>to</strong>my site – including exposing Silastic Ribs<br />

• No delay between removal and replacement of electrode array –<br />

the “no blink” rule applies – primary concern is the potential for<br />

the fibrous tissue/tunnel <strong>to</strong> collapse once the old array is removed<br />

• Do not perform AOS insertion technique in any revision


Fibrous tissue considerations<br />

Note the fibrous tissue<br />

as electrode array<br />

enters the facial<br />

recess<br />

Caution: If in the<br />

previous surgery any<br />

facial nerve was<br />

exposed then fibrosis<br />

could be attached <strong>to</strong> it<br />

It is recommended <strong>to</strong><br />

assume that facial<br />

nerve is exposed


Silastic “ribs” or rings should be visible<br />

All fibrous tissue is<br />

dissected away at<br />

cochleos<strong>to</strong>my site<br />

Some surgeons<br />

use a laser<br />

Verify that Silastic<br />

“ribs” or rings are<br />

visible<br />

Silastic “rib”<br />

or ring


Preparation for new array insertion<br />

Prepare <strong>to</strong> go in<br />

with new array –<br />

loaded on AOS<br />

Insertion <strong>For</strong>ceps<br />

ready <strong>to</strong> insert<br />

New Array<br />

Old Array


Important reminder<br />

Do not take eyes off of the cochleos<strong>to</strong>my site during the<br />

transition from old array <strong>to</strong> new array. “No Blink” rule<br />

applies<br />

Transition within seconds<br />

If there is <strong>to</strong> be any delay place the tip of the array in<strong>to</strong><br />

the cochleos<strong>to</strong>my site 5 – 6 mm (<strong>to</strong> retain fibrous tunnel<br />

opening intact)


New array insertion / old array removal sequence 1<br />

View 1 of 7: Old array beginning <strong>to</strong> come out<br />

Verify that Silastic “ribs” exit cochleos<strong>to</strong>my site<br />

Silastic “ribs” coming out<br />

1 See the following seven slides (beginning with the current slide)


New array insertion / old array removal sequence<br />

View 2 of 7: Continue removing old array<br />

Silastic “Ribs” continuing<br />

<strong>to</strong> come out


New array insertion / old array removal sequence<br />

View 3 of 7: Old array out – note cochleos<strong>to</strong>my site – enter<br />

immediately with new array in<strong>to</strong> lumen<br />

New Array Old Array (out<br />

of cochlea)


New array insertion / old array removal sequence<br />

View 4 of 7: New array entering cochleos<strong>to</strong>my<br />

Do not perform AOS (Advance Off Stylet)


New array insertion / old array removal sequence<br />

View 5 of 7: Continue insertion – stylet left in place<br />

Do not perform AOS – Advance off-stylet)


New array insertion / old array removal sequence<br />

View 6 of 7: Almost fully inserted


New array insertion / old array removal sequence<br />

View 7 of 7: Fully inserted array – stabilize array and remove<br />

stylet completely


What If Array “Hangs Up”<br />

If insertion is less than 2/3rds complete<br />

• Back array out approximately 2mm<br />

• Rotate 90 degrees <strong>to</strong>ward floor of cochlea<br />

• Attempt <strong>to</strong> advance (if does not advance, rotate 180 degrees<br />

<strong>to</strong>ward osseous spiral lamina – then attempt <strong>to</strong> advance)<br />

If insertion is greater than 2/3 complete (3 – 4 electrodes<br />

outside cochleos<strong>to</strong>my)<br />

• Rotate array in<strong>to</strong> correct orientation then<br />

• Back up array approximately 2 mm – carefully and firmly hold<br />

array and pull stylet 1-2 mm. This allows the distal tip <strong>to</strong><br />

angle <strong>to</strong>ward modiolus (attempting <strong>to</strong> allow array <strong>to</strong> advance<br />

in new direction – and past any lateral wall fibrosis)<br />

• Advance array further if possible


Closure Preparation<br />

Place ground lead ball under temporalis/periosteum<br />

“Seal” cochleos<strong>to</strong>my site<br />

Coil excess lead in mas<strong>to</strong>id cavity and close


Closure


Plain Film Transorbital X-Ray<br />

Not required – at surgeon’s discretion

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