REMOVALPROCEDURES - Obalon

R E M O V A L
  P

LIT-­‐8100-­‐

R O C E D U R E S
 

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Balloon
 Remov

The
 following
 informa;on
 
the
 personnel
 performing
 
administering
 any
 balloons
•  Proper
 prepara6on
 and
 

necessary
 to
 safely
 perfo
•  Failure
 to
 follow
 this
 info

prolonged/difficult
 proce


 

LIT-­‐8100-­‐

val
 Prepara6on
 


 should
 be
 reviewed
 with
 

 gastroscopies
 prior
 to
 
s
 

 the
 correct
 tools
 are
 
orm
 removal
 procedures
 
orma6on
 may
 result
 in
 
edures
 or
 pa6ent
 injury
 

-­‐0005-­‐01
 

Balloon
 Removal
 Pr

1.  Anesthe6ze
 pa6ent
 per
 hospital
 p
intuba6on
 has
 been
 the
 preferred

2.  Insert
 gastroscope
 and
 confirm
 sto
clinical
 condi6ons
 that
 warrant
 po

3.  View
 all
 balloons
 
4.  Insert
 the
 puncture/aspira6on
 nee

the
 scope
 and
 puncture
 the
 balloo
5.  Aspirate
 the
 balloon
 using
 suc6on
6.  Remove
 the
 needle
 and
 insert
 the

of
 the
 scope
 
7.  Grasp
 the
 aspirated
 balloon
 and
 sl

esophagus
 and
 mouth
 
8.  Repeat
 for
 any
 addi6onal
 balloons

  LIT-­‐8100-­‐

rocedure
 Summary
 

protocol.
 
 Conscious
 seda6on
 and
 no
 
d
 method
 to
 date
 
omach
 is
 empty
 and
 that
 there
 are
 no
 
ostponement
 of
 the
 procedure
 

edle
 through
 the
 working
 channel
 of
 
on
 
n
 or
 a
 60
 cc
 syringe
 
e
 graspers
 through
 the
 working
 channel
 

lowly
 extract
 the
 balloon
 through
 the
 

s
 

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Recommended
 A

Aspira;on
 Needle
 Requirements
 

•  Injector
 Needle
 in
 Teflon
 Sleeve
 
•  21
 –
 25
 Gauge
 Lumen
 
•  Needle
 length
 ≥
 6
 mm
 

Suggested
 tools
 based
 on
 clinical
 studie

•  Olympus
 NM-­‐200L-­‐0821
 
•  Olympus
 NM-­‐200L-­‐0623
 
•  Olympus
 NM-­‐200L-­‐0625
 
•  Cook
 G22525
 

Other
 tools
 have
 not
 been
 tested
 and
 a
recommended.
 
Tools
 for
 other
 manufacturers’
 gastric
 b
not
 recommended.
 

LIT-­‐8100-­‐

Aspira6on
 Needle
 

es
 

are
 not
 
balloons
 are
 

-­‐0005-­‐01
 

Important
 Notes

•  Needles
 <
 6
 mm
 may
 be
 
maintain
 in
 the
 balloon
 w

•  >
 25
 G
 
 have
 lumens
 that
result
 in
 longer
 and
 more

•  <
 21
 G
 have
 lumens
 that
resul6ng
 in
 larger
 than
 n
difficult
 aspira6on
 if
 >
 1
 p


 

LIT-­‐8100-­‐

s
 on
 Needle
 Size
 


 too
 short
 and
 difficult
 to
 
while
 aspira6ng
 
t
 are
 too
 small
 and
 may
 
e
 difficult
 aspira6on
 
t
 are
 unnecessarily
 large
 
necessary
 holes
 and
 
puncture
 occurs
 

-­‐0005-­‐01
 

Recommended
 G

Forceps
 Requirements
 
•  Opening
 width
 ≥
 15
 mm
 
•  Rat-­‐tooth
 Alligator
 or
 2
 jaw
 grasping
 

forceps
 (recommended)
 
•  2-­‐prong
 graspers
 may
 also
 be
 used
 
Suggested
 forceps
 based
 on
 clinical
 studies
 
•  Olympus
 FG-­‐49L-­‐1
 
•  1800Endoscope.com
 SF1239
 
•  ESS
 Forked
 Jaw
 Grasper
 
•  EndoFlex
 MAGNA
 04
 
Other
 tools
 have
 not
 been
 tested
 and
 are
 no
recommended
 
Tools
 for
 other
 manufacturers’
 gastric
 
balloons
 are
 not
 recommended.
 

Grasping
 Forceps
 


 

ESS
 Forked
 Jaw
  Olympus
 FG-­‐49L-­‐1
 

ot
  EndoFlex
 
MAGNA
 04
 
SF1239
 

LIT-­‐8100-­‐0005-­‐01
 

Important
 Notes
 on
 P

Puncturing
 the
 Balloon
 
•  For
 easier
 puncture,
 inflate

air
 

•  The
 balloon
 may
 be
 punctu
film.
 
 Some
 have
 reported
 t
more
 difficult
 

•  More
 than
 one
 puncture
 m
difficult
 aspira6on
 

Aspira;on
 may
 be
 performed
manually
 

•  Manual
 aspira6on
 with
 60c
least
 4-­‐5
 syringes
 

LIT-­‐8100-­‐

Puncture
 &
 Aspira6on
 

e
 the
 stomach
 with
 less
 
ured
 anywhere
 on
 the
 
that
 the
 seam
 may
 be
 
may
 result
 in
 more
 
d
 with
 vacuum
 or
 
cc
 syringe
 will
 require
 at
 

-­‐0005-­‐01
 

Normal
 Appeara

Fully
 inflated
 balloon
 at
  Temperature
normal
 stomach
  posi;ve
 pres
temperature
 and
  during
 endos
pressure
  change
 appea

LIT-­‐8100-­‐

ance
 of
 Balloons
 

e
 and
  Temperature
 change
 
ssure
  during
 endoscopy
 may
 
scopy
 may
  cause
 condensa;on
 
arance
 

-­‐0005-­‐01
 

Where
 to
 Grasp
 the

Balloon
 should
 always
 be
 grasped
 at
 the
 seam,
 
ideally
 at
 the
 6:00
 posi@on
 opposite
 the
 valve
 

Balloon
 Seam
  12:00
Good

9:00 Apex 3:00
Poor (Top
 or
 Bottom) Poor

Worst
 

6:00
Optimal

LIT-­‐8100-­‐

e
 Aspirated
 Balloon
 

Posi;on
  Descrip;on
  Preference
 

6:00
  Opposite
 valve
  Op6mal
 
12:00
  on
 seam
 
Good
 
3:00
  Near
 valve
 on
 
seam
  Poor
 
9:00
 
90°
 with
 respect
  Poor
 
Apex
  to
 valve,
 but
 on
 
 
(Top
 or
 
BoSom)
  seam
  Worst.
 
90°
 with
 respect
  Re-­‐grasp
 at
 
to
 valve,
 but
 on
 
beher
 
seam
  posi6on.
 

Top
 or
 bohom
 
farthest
 away
 

from
 seam
 

-­‐0005-­‐01
 

Grasp
 Loca6

Grasping
 at
 the
 seam
 at
 the
 6:00
 po
shape
 to
 facilitate
 the
 easiest
 remov

Op;mal
 6:00
 Loca;on
 

Lower
 Profile
 Shape
 

LIT-­‐8100-­‐

6on
 Mahers
 

osi@on
 creates
 the
 lowest
 profile
 
val
 

Worst
 Apex
 Loca;on
 

Higher
 Profile
 Shape
 

-­‐0005-­‐01
 

Passage
 throug

•  Balloon
 should
 be
 adjacent
 to
 dista
the
 EG
 junc6on
 

Preferred
 

LIT-­‐8100-­‐

gh
 EG
 Junc6on
 

al
 end
 of
 scope
 during
 pull-­‐through
 

Not
 Preferred
 

-­‐0005-­‐01
 

When
 to
 Rem

All
 balloons
 must
 be
 remove
months
 
•  Pa6ents
 should
 be
 reminde

balloon
 removals
 aier
 3
 m
•  Pa6ents
 should
 be
 instruct

guidelines
 prior
 to
 gastrosc
protocol
 
Failure
 to
 remove
 balloons
 a
likelihood
 of
 spontaneous
 de
events
 

LIT-­‐8100-­‐

move
 Balloons
 

ed
 by
 gastroscopy
 aXer
 3
 
ed
 of
 the
 importance
 of
 
months
 
ted
 to
 fast
 and
 follow
 other
 
copy
 according
 to
 hospital
 
aXer
 3
 months
 increases
 the
 
efla;on
 and
 other
 adverse
 

-­‐0005-­‐01