Encore TM ##

Encore#Tongue#Suspension#System:#Procedure#Guide##
Guide&for&anesthesia&and&implanta2on&according&to&Sam&Mickelson,&MD,&Atlanta,&GA&&(USA)&&

Ancillary)Equipment)
The#Encore#System#Bone#Screw#requires#a#1.5#mm#preIdrilled#pilot#hole#in#the#inferior#aspect#of#the#
mandible.##A#hand#drill#or#power#drill#with#a#1.5#mm#twist#drill#bit#(preferably#with#a#6I8#mm#stop)#is#
necessary#to#create#the#pilot#hole.#)

Anesthesia)and)Pre-op)Medica2on#
The#Encore#procedure#is#typically#performed#under#general#anesthesia,#but#may#be#performed#with#
local#anesthesia#and#seda>on.#
General&anesthesia:##Nasal#or#oral#intuba>on#or#a#laryngeal#mask#airway#(LMA)#can#be#used.##Using#
an#LMA#may#allow#for#easier#reduc>on#of#seda>on#during#the#final#tensioning#step#to#insure#overI
tensioning#is#not#done.#
Local&anesthesia:##This#technique#offers#safety#benefits#and#allows#for#the#airway#to#be#observed#
without#interference#from#an#endotracheal#tube;#however,#pa>ents#may#not#tolerate#the#oral#
access#required#for#suture#passing.#
Pa>ents#should#receive#an>bio>c#prophylaxis#and#steroids#prior#to#the#skin#incision.##
####
Prep,)Incision)and)dissec2on)
The#scrub#nurse#should#have#extra#gloves#available#so#the#surgeon#may#palpate#the#tongue#with#
one#hand#and#then#change#to#sterile#gloves#to#work#with#the#neck#incision.#
Pa>ents#should#be#posi>oned#supine,#with#neck#extended,#using#a#shoulder#roll#and#their#head#on#a#
donut.#The#sniffing#posi>on#will#aid#in#exposure#of#the#posterior#aspect#of#the#mandible.##Mark#the#
midline#of#the#tongue#with#a#skin#marker#either#before#or#aWer#induc>on#of#anesthesia.#Inject#
lidocaine#with#epinephrine#into#the#planned#incision#site#and#down#to#the#perios>um#of#the#
mandible.##If#performing#the#procedure#under#local#anesthesia,#use#a#long#needle#to#anesthe>ze#the#
base#of#the#tongue#and#the#submental#region#down#to#the#upper#aspect#of#the#hyoid#bone#and#
spray#the#oral#cavity#with#a#topical#anesthe>c.#Consider#placement#of#a#silk#suture#on#the#midI
tongue#dorsum#to#protrude#the#tongue,#as#necessary,#and#maintain#a#midline#posi>on.##
Use#your#preferred#prep#solu>on#on#the#
neck#from#the#lower#lip#to#the#sternum.#
Drape#with#sterile#towels#inferiorly,#
laterally#and#superiorly#above#the#upper#
lip.#Place#a#folded#towel#over#the#chin#to#
allow#access#to#the#oral#cavity.#Perform#
a#2I3#cm#horizontal#incision#in#the#
submental#crease#and#incise#down#to#
and#through#the#perios>um#on#the#
posteroIinferior#aspect#of#the#mandible.###
Clear#the#periosteum#from#the#por>on#
of#the#mandible#where#the#bone#screws#
will#be#inserted#(See#figure#1).#Obtain#
hemostasis#with#electrocautery.##
Fig.#1:##Incision#Site#

©#Copyright&2015,&Siesta&Medical,&Inc. & &LS0019.D & & & &Page&1/4&

Bone)Screw)Inser2on)
Using#the#drill,#create#one#or#two#(if#two#suspension#loops#are#to#be#placed)#pilot#holes#5I6#mm#
deep#using#suc>on#and#irriga>on.#If#using#one#suture#loop,#the#hole#will#be#in#the#midline#and#if#
using#two,#they#should#be#3I5#mm#off#midline.##Posi>oning#the#holes#at#the#posterior#aspect#will#
minimize#the#poten>al#for#the#pa>ent#to#feel#the#bone#screws#aWer#the#procedure.##Using#the#
inserter#with#preIloaded#bone#screw,#insert#the#bone#screws#into#the#pilot#holes#un>l#the#head#of#
the#bone#screw#comes#in#contact#with#the#bone.##The#dark#lines#on#the#inserter#should#be#in#an#AIP#
orienta>on#to#insure#that#the#bone#screw#has#its#throughIhole#aligned#properly.##AWer#inser>on,#
simply#pull#back#on#the#inserter#to#release#the#bone#screw.##The#white#suture#can#be#removed#by#
loosening#the#lock#screw#1I2#turns#(See#figure#2).#

Fig.#2:##Loca>on#of#bone#screw#inser>on# Fig.#3:#Suture#Passer#inser>on#for#ver>cal#loop#

Suspension)Line)Implanta2on:))Loca2on)and)Orienta2on)
The#suture#passer#is#used#to#place#a#“working#suture”#loop#deep#within#the#tongue#at#the#desired#
suspension#loca>on.##Ver>cal#or#horizontal#loops#can#be#made.##The#two#most#common#
configura>ons#are#stacked#midline#horizontal#loops#(one#loop#inferior#just#above#the#hyoid#bone#
and#one#superior#at#the#region#of#the#circumvallate#papilla)#or#stacked#midIline#ver>cal#loops.##To#
form#the#first#loop,#insert#the#suture#passer#in#the#desired#orienta>on#(ver>cal#or#horizontal)#
through#the#incision#and,#while#palpa>ng#the#base#of#tongue#with#the#free#hand,#direct#the#>ps#of#
the#suture#passer#to#the#desired#loop#posi>on.##The#>ps#of#the#suture#passer#are#blunt,#so#there#is#a#
natural#tendency#for#it#to#stop#against#the#tough#mucosa#at#the#base#of#the#tongue.##The#suture#
passer#should#dissect#easily#through#the#genioglossus.##If#resistance#is#felt,#a#small#incision#into#the#
genioglossus#muscle#can#be#made.##Once#the#suture#passer#is#in#its#most#posterior#posi>on,#create#
the#loop#by#pressing#on#the#needle#plunger#completely,#in#one#smooth#mo>on,#un>l#a#“click”#is#
heard#and#the#suture#capture#knob#on#the#suture#passer#has#moved#to#its#distal#posi>on#(See#figure#
3).##The#click#indicates#that#the#needle#has#been#fully#advanced#and#the#suture#capturing#
mechanism#has#been#triggered.##Gently#remove#the#suture#passer#being#careful#to#not#pull#the#
working#suture#completely#out#of#the#tongue#(See#figure#4).##To#release#the#working#suture#from#the#
suture#passer,#pull#back#on#the#suture#capture#knob#un>l#it#locks#in#its#proximal#posi>on.##To#
exchange#the#working#suture#for#the#suspension#line,#place#approximately#5#cm#of#the#suspension#
line#through#the#looped#end#of#the#working#suture#and#pull#the#working#suture#to#track#the#
suspension#line#through#the#tongue#(See#figure#5).##NOTE:)To)minimize)the)risk)of)contamina2ng)
the)wound/device)with)oral)bacteria,)be)sure)to)re-glove)the)hand)used)for)palpa2ng)the)tongue)
before)re-accessing)the)surgical)site)or)handling)the)Encore.)))

©#Copyright&2015,&Siesta&Medical,&Inc. & &LS0019.D & & & &Page2/4&

Fig.#4:#Suture#Passer#removal#with#working# Fig.#5:##Using#working#suture#to#advance#
suture# the#Suspension#Line#

Place#a#hemostat#on#the#ends#of#the#suspension#line.##To#create#the#second#suspension#loop,#reI
load#the#suture#passer#and#repeat#(See#figure#6).###At#this#point#in#the#procedure,#it#may#be#
desirable#to#evaluate#the#loop#orienta>on#and#loca>on#by#advancing#the#tongue#with#the#
suspension#loops#while#observing#the#airway#with#a#scope#or#palpa>ng#with#your#finger#to#
determine#the#effect#on#the#airway.#
####
Note:))If#the#suture#pass#fails#to#make#a#working#suture#loop,#ensure#that#there#is#no#torque#or#
twis>ng#forces#on#the#suture#passer#while#acemp>ng#to#make#the#suture#pass.##Twis>ng#or#
torqueing#can#cause#the#shaWs#of#the#suture#passer#to#become#misaligned.##

Fig.#6:##Reloading#the#
working#suture# Fig.#7:##Threading#tool#inser>on#

Suspension)Line)Threading)
To#thread#the#suspension#line#through#the#bone#screw,#first#insure#that#the#lock#screw#has#
been#unIscrewed#un>l#2I3#threads#are#exposed#to#allow#enough#room#for#the#suspension#
line#within#the#bone#screw.##Then,#insert#the#threading#tool#through#the#bone#screw#in#an#
anterior#to#posterior#direc>on#(See#figure#7).##Hemostats#may#be#helpful#to#spread#the#wires#
of#the#threading#tool#once#it#has#been#threaded#through#the#bone#screw.##Thread#1I2#cm#of#
both#ends#of#the#suspension#line#through#the#threading#tool#and#pull#in#an#anterior#direc>on#
to#pull#the#tails#of#the#suspension#line#through#the#bone#screw.####

©#Copyright&2015,&Siesta&Medical,&Inc. & &LS0019.D & & & &Page&3/4&

Suspension)Line)Tension)Adjustment)and)Locking)
The#amount#of#advancement#or#tension#applied#to#the#suspension#line#during#the#implanta>on#
procedure#will#depend#on#the#pa>ents#par>cular#needs#and#the#number#of#suspension#loops#
placed.##In#general,#the#greater#the#tension#applied#to#the#suspension#line,#the#greater#the#
discomfort,#and#altered#speech#and#swallowing#the#pa>ent#will#experience.##The#amount#of#ini>al#
advancement#reported#has#ranged#from#2#mm#to#20#mm.##Advancement#in#the#range#of#2#mm#to#7#
mm#is#generally#very#well#tolerated.##To#advance#and#lock#the#suspension#line,#pull#the#desired#
amount#and#while#maintaining#the#advancement,#>ghten#the#lock#screw#with#the#lock#tool#un>l#it#is#
“finger#>ght”.#When#placing#two#suspension#sutures,#be#sure#to#record#the#posi>on#of#each#suture#
line#and#which#screw#they#are#acached#to.##

Wound)Closure)and)Recovery)
Due)to)the)palpa2on)of)the)tongue)during)this)procedure,)it)is)possible)to)contaminate)
the)surgical)site)with)oral)bacteria.))Therefore,)the)wound)should)be)copiously)irrigated)
with)bacitracin)(or)other)an2bacterial)agent))and)saline)and)hemostasis)verified.#Leave#.5#
cm#of#excess#suspension#line#anterior#to#the#screws.##In#the#event#the#pa>ent#requires#tension#to#be#
reduced,#ensure#there#is#sufficient#suture#line#to#do#so.##Place#the#extra#suspension#line#medially#
between#the#screws.#Use#standard#closure#techniques#to#close#the#wound#in#layers.#A#sterile#
pressure#dressing#is#applied#on#comple>on#of#the#surgery.##
Recovery#from#the#implanta>on#procedure#depends#on#how#the#pa>ent#tolerates#the#degree#of#
advancement#applied#to#the#suspension#lines.##In#the#recovery#room,#it#is#important#to#ensure#that#
the#pa>ent#is#able#to#drink,#has#adequate#pain#control#and#does#not#have#any#significant#edema#or#
signs#of#hematoma#prior#to#discharge.#
Notes)
If#necessary,#postopera>ve#pain#may#be#treated#with#oxycodone,#hydrocodone,#acetaminophen,#
ibuprophen,#ketolorac#or#tramadol#as#needed#un>l#the#pain#subsides.#####
#
An>bio>c#prophylaxis#is#recommended#for#24I48#hours,#using#an#appropriate#broad#spectrum#
an>bio>c.#
#
To#reduce#poten>al#edema,#pa>ents#may#be#treated#with#a#short#course#of#steroids,#and#instructed#
to#sleep#with#head#of#bed#elevated.##If#using#CPAP#or#an#oral#appliance#preIopera>vely,#consider#
con>nued#use#un>l#procedure#efficacy#can#be#documented.###
#
Clinical#experience#indicates#that#some#pa>ents#may#need#suspension#line#tension#adjustment#if#
symptoms#do#not#improve#or#if#there#is#chronic#discomfort.##Tension#>tra>on#has#been#performed#
up#to#4#months#aWer#the#ini>al#implanta>on#procedure#under#local#anesthesia#and#is#generally#very#
well#tolerated.#

Disclaimer:#This#procedure#guide#does#not#replace#the#instruc>ons#for#use#for#the#Encore#System#and#any#
drugs#listed.#The##Instruc>onsIforIUse#provided#in#the#product#packaging#are#mandatory#and#have#to#be#
followed#stringently.##It#is#the#responsibility#of#the#user#to#perform#the#Encore#Procedure#according#to#the#
Instruc>onsIforIUse.#

©#Copyright&2015,&Siesta&Medical,&Inc. & &LS0019.D & & & &Page&4/4&&