With Applicator

1
With Applicator

• Selfexpanding stent made of silicone with
  polyester mesh

2
Package contents
Esophageal stent
Applicator sleeve
Stent loader
Guide Tube with Dilator tip
Soft positioner
Stopper
Fixation Aid
Instruction for use and Patient-Labels
3
Indications

• Maintaining esophageal luminal patency in
  esophageal strictures caused by intrinsic and/or
  extrinsic malignant tumors
• Occlusion of malignant esophagotracheal/-bronchial
  fistulas

4
(No Transcript)
5
(No Transcript)
6
Contraindications 1

• Serious blood clotting disorders
• Not treat4ed primary tracheal stenoses which
  would deteriorate using esophageal intubation
• Non controllable secondary tracheal stenoses
  arising during esophageal intubation

7
Contraindications 2

• Extremely narrow and rigid stenoses which cannot
  be widened sufficiently through dilation
• stenoses which are located extremly high
  (proximal end of stent less than 2 cm distal from
  the esophagus-opening
• Patients, with whom endoscopic techniques cannot
  be performed and/or are contra-indicated

8
Available Sizes

9
Characteristics

• Silicone coating throughout
• prevents ingrowth of tumour tissue
• closes tracheo-oesophageal and broncho-oesophageal
  fistulae

10
Characteristics

• Mesh structure of the outer surface of the stent
• increases security against dislocation

11
Characteristics

• Smooth inner surface
• hinders bolus obstruction

12
Characteristics

• mesh geometry
• optimized radial force
• easier application of the stent
• adapts elastically to the anatomy of the
  oesophagus

13
Characteristics

• The stent narrows under tension
• allows simple change of stent

14
Characteristics

• Thin wall
• suitable for stent-in-stent insertion

15
Characteristics

• Funnel-shaped proximal end
• helps to prevent distal dislocation

16
Characteristics

• Broad range of widths and lengths
• can be coordinated for each indication and
  anatomical situation

17
Characteristics

• Radiopaque insertion set
• facilitates precise positioning and monitoring of
  use

18
Characteristics

• Silicone reinforcement protects the edges
• less stimulation for granulation

19
Characteristics

• markers for X-ray and endoscopic controll
• improved visibility during placement and
  post-operative follow-up

20
Selection of stent size - Diameter

• The selected stent diameter must be individually
  calculated and will depend upon the given
  anatomic conditions

21
Selection of stent size - Length

• The stent must always be 3 4 cm longer than the
  stenosis, so that it extends the stenosis at
  least 1 2 cm at both ends of, thus minimising
  the risk of tumor overgrowth. !
• Do not shorten the Polyflex stent!!

22
Loading the stent (1)

• Insert the stent about halfway into the basket of
  the applicator as far as the marker

23
Loading the stent (2)

• Pull the stent with the basket into the
  introducer sleeve, stretching the stenttogether
  with the basket in order to achieve a narrowing
  of the funnel-shaped stent end.

24
Loading the stent (3)

• Pull the stent in until only about 1 mm of it
  projects from the transparent introducer sleeve

25
Loading the stent (4)

• Use the stopper to secure the stent in the
  introducer sleeve so that it cannot be inserted
  any further

26
Loading the stent (5)

• Pull the loader off the stent by pulling it
  backwards with an even movement

27
Loading the stent (6)

• Push the stent with the aid of the
  soft-positioner into the introducer sleeve up the
  marker

28
Loading the stent (7)

• Pull the guide tube with dilatior-tip through the
  loaded stent
• The soft-positioner is pushed onto the guide-tube
  and into the applicator-sleeve

29
Application of the stent (1)

• The guide-wire is in place
• fed the guide-wire through the dilator-tip and
  the guide-tube
• place the application-system with the stent in
  the centre of the tumor

30
Application of stent (2)

• The transparent introducer sleeve is held at its
  upper end with the reinforced netting and is
  withdrawn over the positioner
• Do not push the soft-positioner forwards - it
  must be held in position!

31
Removal of the stent

• The Polyflex stent narrows under traction.
• Because of this, the stent can be removed with an
  atraumatic foreign body forceps by pulling it
  back slowly and carefully

32
Questions and Answers 1

• The POLYFLEX-STENT can be withdrawn proximally
  under careful traction

• ???
• The POLYFLEX-STENT is placed too distally...

33
Questions and Answers 2

• Pushing the POLYFLEX-STENT distally is not
  advisable because of the particular material
  characteristics of the netting material
  (squashing).
• Remove it and place it once more.

• ???
• The POLYFLEX-STENT is placed too proximally ...

34
Questions and Answers 3

• NO! Do not shorten the POLYFLEX-STENT.(risk of
  damage by projecting netting fibres).

• ???
• Can I shorten the POLYFLEX-STENT?

35
Questions and Answers 4

• NO! Protect POLYFLEX-STENT from direct laser
  bombardment.
• Magnetic resonance imaging and CT are possible

• ???
• Can I use laser while the POLYFLEX-STENT is in
  place?

36
High grade distal stenosis
37
Applicator-Sleeve with loaded Stent
38
Released Stent with Guide Tube
39
Dilator-Tip is pulled back through the Stent
40
Stent in place
41
Potential Complications

• The following complications have been reported in
  the literature for esophageal prostheses
• Procedural Complications
• Perforation
• Aspiration
• Bleeding
• Stent migration
• Pain

42
Potential Complications (ctd.)

• Post-Stent Placement Complications
• Perforation
• Bleeding
• Stent migration
• Pain
• Tumor Overgrowth around ends of stent
• Food bolus impaction
• Reflux
• Esophagitis ? Fever
• Edema ? Fistula
• Ulceration ? Septicemia

43
(No Transcript)
44
(No Transcript)
45
(No Transcript)
46
COMPETITION
COOK-ZSTENTS

• GIANTURCO-RÖSCH COVERED ESOPHAGEAL DESIGN
• Cook

47
COMPETITION

• Flamingo
• covered conical esophageal Wallstent
• Schneider/Boston

48
COMPETITION

• Ultraflex
• Nitinol
• covered and
• uncovered version
• Boston
• Scientific
• MICROVASIVE