Specialist Airway Stenting Solutions

Transcription

K a p i t e x h e a lt h c a r e - S p e c i a l i S t K n o w l e d g e , S u p p o rt a n d c a r e
S p e c i a l i S t a i rwaY
Stenting Solutions
Kapitex…Adding Quality of Life
to Airway Management
Specialist Airway Management
Solutions from the Specialists…
Kapitex Healthcare
This Stenting brochure highlights dedicated medical devices which are
used to manage difficult airways.
With the combination of Novatech GSS studded silicone stents, Silmet self expandable
Nitinol stents along with the Montgomery Safe-T-Tube, Kapitex offer the practitioner
a great deal of choice to help deliver individual solutions.
Our range of specialist airway products covered in this brochure include:
Gold Studded Stents (GSS™)
Dumon® Forceps
2
13
3
GSS Stent Applicator
9
Silmet® Nitinol stents
11
Endobronchial Watanabe
Spigots (EWS®)
14
Montgomery® Safe-T-Tube 17
GSS Gold Studded Stent™
Novatech® GSS
Gold Studded Stent™
Introducing the new gold standard in
Interventional Bronchoscopy
The NOVATECH® GSS™ – Gold Studded Stent is
made of transparent implant grade silicone with
studs filled with gold and barium sulfate, combining
good X-ray visibility with optimised endoscopic
tissue monitoring, i.e. X-ray visibility plus tissue
monitoring.
Novatech and the LOT number are imprinted on each GSS™.
This way, the stent can easily be traced back to its origin if
necessary.
The GSS™ comes sterile in blister packaging with Instructions
for Use, patient card, adhesive stickers for documentation,
and a 6 mil syringe of Optilube (a water based bio-compatible
lubricant) implantable for more than 29 days and perfectly
suited for stent placement.
INDICATIONS
Maintaining airway patency after desobstruction or
dilatation of a stenosis, in particular in the following cases:
• tracheobronchial tumours
• tracheal stenoses with scarring
• bronchial stenoses following surgical resection and
anastomosis
• bronchial stenoses following pulmonary
transplantation
• In general, in any case of reduction of airway diameter
due to intrinsic or extrinsic compression.
The GSS™ is available in the tried-and-tested
Novatech stent designs in a variety of sizes.
type
GSS™ TD
Tracheal Stent
wall
rows of
thickness (mm) studs
1.5
4
Ø≥ 18mm: 3)
GSS™ TF
Thin Tracheal Stent
1.0
GSS™ BD
Bronchial Stent
1.0
4
GSS™ Y
Total Carina Stent
1.0
3
GSS™ ST
Hourglass Stent
1.5
4
1.0
3
0.5
2
particularly for
post-intubation stenoses
FEATURES
• Removability
If necessary, GSS™ stents can easily be removed, even after
long-term implantation (positive results of removal even
after 11 years are available).
• Transparency and radio-opacity
Studs filled with gold and barium sulfate, combining good
X-ray visibility with optimised endoscopic tissue
monitoring.
• Large range for perfect adaption
The key condition for perfect tolerance of the stents is to use a
stent which is perfectly adapted to the patients’ needs. For this
reason and in order to be prepared for any situation, it is
essential to provide the clinician with a basic line of different
stent types, diameters and lengths.
• Anti-migration stud system
The patented stud design minimises the risk of migration of
the GSS™ by fixing it between the cartilaginous rings of the
tracheo-bronchial tree. The stent design inhibits cough
reflexes. The studs reduce direct contact between the stent
surface and the mucosa and distribute compressive forces
evenly among the small stud surfaces.
• Non-adherent smooth surface
GSS™ OKI
Right Upper Lobe
Departure Stent
for the right main stem
bronchus
Dumon®
BB
Ultra-thin Stent
Dumon®
CB
Carina Stent
The non-adherent stent surface is excellently tolerated by
the mucosa. It allows mucociliary clearance. In vitro tests
have shown that GSS™ silicone stents are highly efficient
compared to other stents available on the market.
• Bevelled ends
initially developed
for paediatric
1.0
used for stenoses in the
main bronchus close to
the carina
4
The ends of the stents are designed to reduce the risk of
mucus accumulation. They are specially bevelled to be
atraumatic and to improve mucociliary clearance.
• Long term implant grade silicone (over 29 days)
Other types and customised made stents available
3
OKI-Stent
Developed as a variation of a Y-Stent by Dr. Masahide Oki
(Nagoya Medical Center, department Dr. Saka), the OKIStent is designed for stenting the right main stem bronchus
around the right upper lobe departure and the bronchus
intermedius.
In most cases, the angle of the limb which is introduced into
the upper lobe bronchus conforms with the anatomic
situation and therefore facilitates stent placement.
The OKI-Stent is available as a standard stent with a specific
combination of diameters and lengths. Custom made OKIStents with different diameters and lengths are also
available.
The OKI-Stent complements the GSS™ range and features
the same benefits as all GSS™ stents.
Features
• Safe fit
• Easy placement with TONN/NOVATECH stent applicator
• Transparency and radio-opacity
• Bevelled ends
• Removability
• Unrestricted implant grade silicone
Before
After
dimensions (mm)
Ref
OS OKI 1309
outer
diameters
1
2
3
L1
L2
L3
wall
thickness
13
40
17
35
1.0
01OKIBAF
9
10
lengths
specify*
* Special custom lengths and diameters are available - contact Kapitex
for more information
Dumon® CB - Carina
Bronchus Stent
Dumon® CB stents have a collar ring which permits
placement in the bifurcation. CB stents allow treatment of
indications of the main bronchus close to the carina and
limit covering healthy mucosa. In certain cases, at the
doctor’s discretion, they may be used instead of Y-Stents.
Wall thickness: 1.0mm
Features
• Easy placement
• Bevelled ends
• Removability
• Unrestricted implant grade silicone
outer
diameters
(mm)
CB
9, 10, 11,12
Available upon request
4
lengths
(mm)
wall thickness
(mm)
20 to 60
in increments
of 10mm
1.0
BD - Bronchial Stents
Endotracheal GSS™ stents are available with two wall
thicknesses. The TD stents have a wall thickness of 1.5mm.
Additionally, endotracheal stents – with diameters of 12, 13,
14, 15, 16, 18 and 20mm – are available with a wall thickness
of only 1.0mm (TF stents).
GSS™ BD stents have been developed for bronchial
indications. The stent design corresponds to the smaller
bronchi diameters and ensure optimal ventilation of the
patient.
outer
diameters
(mm)
lengths
(mm)
wall thickness
(mm)
TD
11,12,13,14,
15,16,18,20
20 to 110
in increments
of 10mm
1.5
TF
12,13,14,
15,16,18,20
30 to 110
in increments
of 10mm
1.0
outer
diameters
(mm)
BD
10, 11,12
lengths
(mm)
wall thickness
(mm)
30 to 80
in increments
of 10mm
1.0
TD/TF - Endotracheal Stents
Please contact Kapitex for other diameters and lengths
GSS TF Features
• Enhanced respiratory flow
• Improved mucociliary clearance
The larger inner diameter of a TF stent significantly
enhances respiratory flow. When compared with a
standard TD a standard tracheal stent of 50mm in length
and 16mm in external diameter, the inner diameter
increases by approx. 6%, resulting in an increase of the
luminal volume of 16%.
The thinner walls of TF stents facilitate the internal
movements of the trachea (respiration, ease of the
peristaltic movements of the oesophagus). This dynamic
stent concept allows better mucociliary clearance
(depending on mucous viscosity).
TD stent in situ
BD stent in situ
5
GSS Tracheal (TD) Stent
Wall thickness 1.5mm -Sterile
Ref
Length
OD
(mm)
(mm
OS DTD 1240
40
12
OS DTD 1260
60
OS DTD 1280
80
OS DTD 1360
GSS Tracheal (TF) Stent
Wall thickness 1.0mm -Sterile
Ref
Length
OD
(mm)
(mm
OS DTF 1440
40
14
12
OS DTF 1460
60
14
12
OS DTF 1640
40
16
60
13
OS DTF 1660
60
16
OS DTD 1440
40
14
OS DTF 1680
80
16
OS DTD 1460
60
14
OS DTF 1840
40
18
OS DTD 1560
60
15
OS DTF 1860
60
18
OS DTD 1580
80
15
OS DTF 1880
80
18
OS DTD 1640
40
16
OS DTD 1660
60
16
OS DTD 1680
80
16
OS DTD 1695
100
16
OS DTD 1840
40
18
OS DTD 1860
60
18
OS DTD 1880
80
18
OS DTD 1895
100
18
OS DTD 2060
60
20
OS DTD 2070
70
20
OS DTD 2080
80
20
BD - Bronchial Stents
GSS™ BD stents have been developed for bronchial
indications. The stent design corresponds to the smaller
bronchi diameters and ensure optimal ventilation of the
patient.
outer
diameters
(mm)
BD
10, 11,12
lengths
(mm)
wall thickness
(mm)
30 to 80
in increments
of 10mm
1.0
GSS Tracheal (BD) Stent
Wall thickness 1.0mm - Sterile
Ref
Length
OD
(mm)
(mm
OS DBD 1020
20
10
OS DBD 1040
40
10
OS DBD 1060
60
10
OS DBD 1140
40
11
OS DBD 1160
60
11
OS DBD 1240
40
12
OS DBD 1260
60
12
For further details, please contact Kapitex Customer Services on 01937 580211
6
ST - Hourglass Stent
GSS™ Y-Stents have 3 rows of studs. The posterior side has
no studs in order to avoid trauma of the tracheo-oesophageal
wall. The branches are angled according to anatomy.
Customised lengths and diameters are available on request
(see separate customisation sheets ). The Y-Stents may be
modified by Novatech in order to allow airflow to the right
upper lobe.
GSS™ ST was created in collaboration with Prof. Vergnon
(Saint Etienne University Hospital, France). It is especially
adapted to:
A closed right branch stem for post pneumonectomy
patients with a fistula is available on a custom basis.
• complex benign stenoses
• post intubation stenoses
• post tracheostomy stenoses
• subglottic stenoses (only as customised made stent “BAF”).
Easy to place after laser resection or dilatation, this stent is
designed to avoid the risk of migration inherent to compression
reduction. No migration was observed in a study covering a
follow-up period of two years. With a mean duration of 19.6
months even a curative effect has been observed in 4 from
13 patients). The diameters of the distal and proximal ends
correspond to the size of the healthy trachea. The central part
is narrower, reducing the risk of traumatising the stenotic
part of the trachea while maintaining a sufficient lumen for
the airflow and thus reducing the risk of restenosis. In some
cases, this stent can prevent a tracheostomy.
Y-Stent - Bifurcation Stent
1) Pr Jean-Michel VERGNON, CHEST 2000 ; 118:422-426
dimensions (mm)
outer
diameters
1
2
3
Ref
lengths
L1
L2
L3
wall
thickness
OS DYS 1410
14
10
10
110
50
50
1.0
OS DYS 1512
15
12
12
110
50
50
1.0
OS DYS 1613
16
13
13
110
50
50
1.0
OS DYS 1814
18
14
14
110
50
50
1.0
* Special custom lengths and diameters are available
dimensions (mm)
outer
diameters
1
2
3
L1
L2
L3
wall
thickness
OS DST 1210
12
10
12
15
20
15
1.5
OS DST 1412
14
12
14
15
20
15
1.5
OS DST 1513
15
13
15
15
20
15
1.5
OS DST 1614
16
14
16
15
20
15
1.5
Ref
11,12,13,14,
outer diameter 20
1 to 110
15,16,18,20
in increments
of 10mm
12,13,14,
15,16,18,20
30 to 110
in increments
of 10mm
1.5
1.0
lengths
* Special custom lengths and diameters are available
Please contact us for other diameters
and lengths
L1
L1
outer diameter 1
outer diameter 2
L2
L2
L3
L3
outer diameter 3
7
Dumon® BB Paediatric Stent
Initially developed for paediatric indications, Dumon® BB
have a wall thickness of only 0.5mm.
The ratio between inner and outer diameter offers an
excellent resistance to compression. Stent placement is easy
with either a rigid scope or, for distal stenoses in adults, with
a flexible bronchoscope.
Excellent results have been obtained in indications of lobar
bronchi. The placement method is very simple under direct
view or X-ray control.
Placing a silicone stent with a flexible bronchoscope is a
kind of revolution as it is now possible to place a stent
distally and to remove it if necessary. For such indications it
is no longer necessary to place a self-expandable stent,
unless collateral ventilation is required (in such cases, a noncovered metallic stent must be used).
Paediatric Indications
For paediatric indications a rigid bronchoscopy must be
performed for safety reasons. There is no debate between
surgery and stenting as surgery must be the first choice to
solve a problem. In some case stenting can be a good
temporary alternative.
Like all Dumon® stents, the BB stent is made of implant
grade silicone. It is perfectly biocompatible and removal of
the stent is possible without any problem even after more
than 15 months.
In infants a lumen reduction due to cardiopathy or malacia
can be silicone stented endoscopically without suturing the
stent to the mucosa or performing a tracheostomy.
Dumon® BB are available in lengths of 10 to 50mm in order
to both cover the stenosis and anchor the stent perfectly.
The controlled wall thickness aids in avoiding obstruction.
In case of necessity, the stent can be removed with foreign
body forceps.
outer
diameters
(mm)
BB
5, 6, 7, 8, 9,
10, 11, 12
lengths
(mm)
wall thickness
(mm)
10 to 50
in increments
of 10mm
0.5
Before
After
Adult indications, placement by flexible
bronchoscope
Adult indications are rare and must be considered as an
exception.
Stenting must secure lobar ventilation. Patient quality of life
is a key issue to determine the necessity of stenting. It may
be indicated for a patient who has undergone right side
pneumonectomy to secure ventilation of the left lower lobe.
In some cases Dumon® BB can be placed instead of a selfexpandable stent which are presently the preferred stents
for such distal stenoses. The necessity of collateral
ventilation does not make the latter obsolete but Dumon®
BB can be used when self-expandable stents are useless or
even dangerous.
Standard BB stents have 2 rows of studs. BB stents
with 4 rows of studs are available as custom made stents
(only with diameter ≥ 8mm).
Left upper lobe indication
BB 10 L 20 grasped by forceps
Just released
After balloon dilatation
Wall thickness 0.5mm - Sterile
Ref
8
Length
OD
(mm)
(mm
OS DBB 0450
50
5
OS DBB 0550
50
6
OS DBB 0650
50
7
OS DBB 0750
50
8
TONN/NOVATECH® Stent Applicator
Tracheal & Bronchial
Stent Applicator
Developed by Dr. Tonn (Hanover, Germany), the TONN /
NOVATECH tracheal and bronchial Stent Applicator
facilitates the placement of NOVATECH’s tracheobronchial
stents Dumon® and GSS™ through a rigid bronchoscope.
Easy to handle, the TONN/NOVATECH Stent Applicator is
available in four sizes (BLUE, RED, GREEN AND WHITE)
allowing the insertion of silicone stents in a wide range of
sizes: Stents with an OD of up to 20mm and a length of up
to 160mm (Y-Stents) can be placed. Furthermore Y-Stent
insertion is facilitated. The position of the main branch can
be determined before insertion, minimising the risk of
misplacement and stent damage.
TONN/NOVATECH
Stent Applicator
for Dumon® and
GSS™
introducer
length
(cm)
introducer
ID
(mm)
Ref
BLUE
32
12.75
OS NOV 0002
RED
42
12.75
OS NOV 0003
GREEN
42
10.25
OS NOV 0001
WHITE
42
8.2
OS NOV 0004
Individual components available as spare parts. Please contact us for a quotation.
Which applicator to use for which stent (WHITE, GREEN, RED, BLUE)
TD
Length
7
8
9
10
11
12
P
P
P
P
P
P
P
P
BD
P
P
P
P
P
P
P
P
P
P
P
P
P
P
P
P
P
P
P
P
P
P
P
P
11
12
13
P
P
P
P
14
15
16
18
20
P P P
P P P
P P
P P
P P
P P
P
P
Y
Length
10
11
12
P
P
P
P
P
P
P
P
P
P
P
P
P
P
P
P
P
P P
P
P P P
P
P
P
P
P
P
P
P
P
P
P
P
P
P
P
P
P
P
P
P
P P P P
P P P P
P P P P
P
14
15
16
18
P
P
P
P
P
P
P
P
P
P
P
P
12
13
14
15
16
18
20
ST
Length
110 50 50
Diameter
Diameter
20 30 40 50 60 70 80
9
P
P
P
P
P
P
P
P
12
14
15
16
18
Length
30 40 50 60 70 80 90 100 110
Diameter
Diameter
6
P
P
P
P
P
P
P
P
Diameter
5
TF
Length
20 30 40 50 60 70 80 90 100 110
P P P P
P P P P
P P P P
P P P
P P P
P P P
P P P
P
P
P
P
P
P
P
P
P
P
P
P P
P P P
P P P
OKI
P
14
P
P
P
P
Diameter
10 20 30 40 50 60
Diameter
BB
13
P
NB : Stents which can be placed with the
BLUE system can also be placed with the
RED system. Stents not appearing in the
chart and/or for custom made stents,
please contact our Customer Services.
9
GSS Gold Studded Stent™ Accessories
Accessories
Survac Suction Catheters for Bronchoscopy
Novatech has developed atraumatically rounded suction catheters
which due to their materials are both bendable and resistant,
making them particularly suited for bronchoscopy.
The PTFE-catheters unite the bendability of polyethylene with the
resistance of polycarbonate. The diameter allows insertion
through the lateral port of a rigid bronchoscope. Their design
being perfectly adapted to the tracheobronchial tree, suctioning
beyond the lobar bronchi is easy.
The Polycarbonate (PC) catheters are bendable. For suctioning
beyond the lobar bronchi, the catheter end can be bent manually
before insertion.
Ref
Designation
Diameter
ID x OD (mm)
Length
(cm)
Items
per box
60
50
OS NOV 0125
PTFE 2 x 3 L 60
2x3
OS NOV 0126
PC 2 x 2.7 L 60
2 , 2.7
60
50
OS NOV 0127
PC 3 x 4 L 60
3x4
60
50
All with female, PVC connector
The PC catheters can be used for mechanical desobstruction.
The 3 x 4mm catheters are particularly suited for the axial
aspiration of larger tumour parts or suctioning of large quantities
in emergency cases.
Ergonomic Forceps
A range of ergonomic forceps for bronchoscopy is also available.
The forceps can be disassembled completely and thus be cleaned
safely and easily.
Complementing this product line, the Measuring Dilator provides
two functions in one instrument: In addition to opening not fully
deployed stents, it can be used to measure the diameter of the
bronchus or the trachea, helping doctors to choose the correct
stent diameter.
10
SILMET® Self-Expandable Nitinol Stent
SILMET®
Self-Expandable Nitinol Stent
SILMET® is a self-expandable stent made out of nitinol,
an alloy of nickel and titanium. SILMET® is entirely
handcrafted and comes sterile (ethylene oxide) inside
its placement system.
SILMET® complements the line of Dumon® and GSS™
silicone stents. The special mesh structure and the silicone
coating (medical grade silicone) of the nitinol reinforce the
resistance against compression. The standard length of the
meshes is 5mm.
For easier localisation by X-ray, SILMET® has radio-opaque
gold markers. As a standard, SILMET® are fully covered from
end to end by a polyester cover. Stents without cover or
with partial cover, as well as stents with individual
dimensions according to the patients’ needs, are available
only upon request. The polyester cover minimises the risk of
granulation tissue growth, which may happen if a noncovered or partially covered stent is used and also allows for
removability. Experience to date shows these stents being
easily removed 2 years post placement.
Compared to Dumon® and GSS™ stents, SILMET® stents
have thinner walls. SILMET® stents represent an unmatched
alternative among self-expandable metallic stents.
SILMET® MCS
SILMET® Conical
Fully covered, straight SILMET®
MCS is the standard stent
of the line. The polyester cover
minimises the risk of
granulation tissue growth and
avoids tumour ingrowth. Even
for benign stenoses, SILMET®
MCS, which is easy to remove
thanks to its cover, can be a
good alternative to Dumon® and GSS™ stents, for cases in
which a self-expandable metal stent is better suited.
A conical stent is defined by
three dimensions: its base, its
end and its length.
SILMET® Conical is adapted to
special situations which
cannot be resolved
immediately and in which the
physician expects an
improvement of the patients’
state on a medium or long term.
Indications: post-pneumonectomy fistula,
trachea/bronchial distortion caused by compression.
SILMET® MCS is available in all diameters from 6 to 24mm (in
increments of 1mm) and in lengths from 20 to 140mm (in
increments of 5mm).
SILMET® XF
Fully covered, extra-strong, straight SILMET® XF were
developed upon request of ENT surgeons mainly, who have
to deal with highly compressive post-intubation and
subglottic stenoses. Their resistance against compression is
at least equal to the resistance of Dumon® stents (study,
presented, but unpublished, by Dr Miyazawa Teruomi, Ste
Marianna University Hospital, Kawasaki, Japan) and superior
to the resistance of SILMET® MCS.
SILMET® MNC
Uncovered, straight SILMET® MNC have a mesh length of
5mm and are available in diameters from 6 to 24mm (in
increments of 1mm) and lengths from 10 to 140mm (in
increments of 5mm).
SILMET® CO standard
Fully covered, conical, 8 standard sizes, available
within 48 hours. These stents were developed to accelerate
the availability of custom made conical SILMET®.
SILMET® CO upon request
Fully covered, conical, available within 3 to 4 weeks. Two out
of three dimensions can be chosen by the doctor (see table).
SILMET® SM (customised)
Production time for SILMET® SM is generally 4
to 5 weeks, depending on the stent, including sterilisation.
SILMET® SM are custom made stents which can have
different shapes and features: diabolo, conical, Y, T, bevelled,
without cover, partial covers, etc. There can be a variation in
resistance to compression at different parts of the stent.
SILMET® SM gives the clinician a wide choice.
5
11
SILMET® Self-Expnadable Nitinol Stent
Features
•
Easy removal due to polyester which also avoids
tumour ingrowth
•
•
•
•
•
•
•
Self-expandable
•
•
Radio-opaque nitinol wire and markers at the ends
A
C
B
D
Atraumatic
Highly resistant to compression
Large choice of diameters and
Large diameters possible (28 more)
Custom made stents available
If one mesh breaks, covered SILMET stents
maintain their structure function
Can be placed by flexible bronchoscopy, under
direct vision or X-ray
By courtesy of Dr. Dutau, Ste Marguerite, Marseilles SILMET® CO in situ.
A: before stent placement. A hole created by suture release after
pneumonectomy (speleotomy). In the hole, compresses are visible.
B to D: After stent placement. The hole is sealed. The white spot
on the right side of B shows where the compresses are.
OD1
OD
L1,2
L1,2
Ref
OD2
OD1 : Outer diameter at the base
OD2 : Outer diameter at the tip
OD : Outer diameter
L1 : Total Length
L2 : Length of cover
Ref
L1 : Total Length
L2 : Length of cover
OD
(mm)
L1
(mm)
L2
(mm)
20
30
20
30
40
40
50
60
80
40
50
60
80
40
60
80
60
20
30
20
30
40
30
50
60
80
40
50
60
80
40
60
80
60
SILMET® MCS (covered)
OS MCS 1020
OS MCS 1030
OS MCS 1220
OS MCS 1230
OS MCS 1240
OS MCS 1440
OS MCS 1450
OS MCS 1460
OS MCS 1480
OS MCS 1640
OS MCS 1650
OS MCS 1660
OS MCS 1680
OS MCS 1840
OS MCS 1860
OS MCS 1880
OS MCS 2060
10
10
12
12
12
14
14
14
14
16
16
16
16
18
18
18
20
SILMET® XF (covered extra strong)
01XF144040
14
40
40
01XF145050
14
50
50
01XF164040
16
40
40
01XF165050
16
50
50
01XF166060
16
60
60
01XF185050
18
50
50
SILMET® XF (covered extra strong)
available upon request
01XFDDL1L2
12
DD
L1
L2
OD1
OD2
(mm)
(mm)
L1
(mm)
L2
(mm)
SILMET® CO standard (conical, covered)
01CO241660
01CO221650
01C0221460
01CO201450
01CO201260
01CO181440
01CO161050
01CO141040
24
22
22
20
20
18
16
14
16
16
14
14
12
14
10
10
60
50
60
50
60
40
50
40
60
50
60
50
60
40
50
40
SILMET CO upon request (conical, covered)
available within 3 to 4 weeks
01CO120830
12
08
30
30
01CO140850
14
08
50
50
01CO161240
16
12
40
40
01CO160860
16
08
60
60
01C0181250
18
12
50
50
01CO181060
18
10
60
60
01CO180880
18
08
80
80
01C0201640
20
16
40
40
01CO221840
22
18
40
40
01CO221280
22
12
80
80
01CO221090
22
10
90
90
01C02208110
22
08
110
110
01CO241850
24
18
50
50
01CO241470
24
14
70
70
01C0241290
24
12
90
90
01CO2410100
24
10
100
100
01CO2408120
24
08
120
120
SILMET® SM (customised)
available within 4 to 5 weeks
Dumon® Forceps for Bronchoscopy
Dumon® Forceps
For Bronchoscopy
NOVATECH presents the new and innovative product line of forceps
for bronchoscopy, developed in cooperation with Dr. Dumon. The
forceps can be disassembled completely and thus be cleaned safely
and easily.
The handles have been ergonomically redesigned in order to facilitate
handling. The ratchet is easy to manipulate with the little finger. The
forceps are color coded (i.e. yellow for open works forceps).
Complementing this line, the innovative stent measuring dilator
provides safe means of opening not fully deployed
Tracheobronxane™ Dumon® and GSS™ silicone stents. In addition it
can be used to measure the diameter of the bronchus or the trachea,
helping doctors to choose the correct stent diameter.
Description
Fenestrated forceps
Grasping forceps
(crocodile jaws)
Color
Yellow
Blue
Fenestrated forceps
Hook scissors
Grasping forceps
(crocodile jaws)
Red
Biopsy forceps
Red
Extra strong crocodile
forceps to remove
Dumon® and GSS™ stents
Green
Y stent placement
forceps
Green
Dimensions
RD*1
with
ratchet
HF*2
Extra-features
Ref
Head 3mm, L 60cm
x
Head 3mm, L 60cm
x
Head 3mm, L 60cm
x
Head 3mm, L 60cm
x
Head 3mm, L 60cm
x
Head 3mm, L 60cm
x
head 3mm, L 60cm
x
x
1 mobile jaw
02 BRO 01100C
Head 3mm, L 40cm
x
x
1 mobile jaw
02 BRO 01103C
Head 3mm, L 60cm
x
x
2 mobile jaws
02 BRO 01150C
x
x
x
2 mobile jaws
02 BRO 01010
2 mobile jaws
02 BRO 01012
1 mobile jaw
02 BRO 01050
1 mobile jaw
02 BRO 01052
2 mobile jaws
02 BRO 01060
2 mobile jaws
02 BRO 01062
Head 5mm
x
1 mobile prehensile jaw
02 BRO 02050
Head 5mm
x
x
1 mobile prehensile jaw
02 BRO 02052
Head 4.5mm, L 60cm
x
x
2 mobile jaws
0S NOV 0104
*1RD = rotatory and dismantlable
*2HF = high Frequency, coagulant forceps, with electrode.
ACCESSORIES
Y stent placement forceps
Scythe blade knife
3mm, L 60cm
OS NOV 0119
Suction cannula
OD 2.5mm
OS NOV 0120
Angular tip laser fibre
guide
OD 2.5mm, ID 2mm
OS NOV 0121
Dutau® forceps
Red
The Dutau® Forceps allows the physician to create a smooth fenestration in a
Tracheobronxane™ Dumon® or GSS™ silicone stent in order to adapt it to a specific
situation (e.g. ventilation of the upper lobe).
OS NOV 0122
Hook scissors
Dutau® forceps
13
EWS® Endobronchial Watanbe Spigots
EWS®
Endobronchial Watanabe
Spigots
EWS® – Silicone spigots for segmental
and subsegmental bronchi
Endobronchial Watanabe Spigots (EWS®) were developed
by NOVATECH in close cooperation with Dr. Y. Watanabe,
Okayama, Japan. They are made of implant-grade silicone
(implantable for more than 29 days), radio-opaque, sterile
and blister-packed (3 EWS per blister).
INDICATIONS
for re-expansion of the lung in case of
• inoperable pneumothorax
• bronchio-pleural fistula with a continuous loss of air and
AFTERCARE
• If the use of EWS® alone does not improve the patient’s
collapse of the lung despite thoracic suction drain, when
surgical intervention is not indicated.
• continuous bleeding from a subsegmental or segmental
bronchus1).
condition, pleurodesis (for example using Steritalc®) or
other therapy can follow after the collapsed lung has
re-expanded and the loss of air is stopped.
• The spigots can be removed after the patient’s condition
has improved and the thoracic drain is removed.
A study2) performed in Japan with 63 patients including
40 cases of intractable pneumothorax, 12 cases of pyothorax
with fistula and 7 cases of pulmonary fistula has shown that
using EWS® is safer and has more permanent results than
conventional methods.
Three Sizes available
S = Ø 5mm
M = Ø 6mm
L = Ø 7mm
After determination of the affected bronchi with a balloon
catheter (alternatively X-ray etc.), the EWS® are placed with a
flexible bronchoscope and forceps guided by the working
tube of the bronchoscope. The use of EWS® was successful
in 96.7% of the cases.
The loss of air was stopped or significantly reduced in
77.6% of the cases. No severe complications occurred.
1
Ref
EWS® Endobronchial Watanabe
Spigots, sterile
OS DWS 0001
12 EWS
4 blisters
3 x S, 6 x M, 3 x L
OS DWS 0002
6 EWS®
2 blisters
(3 x S), Ø 5mm
/ blister
OS DWS 0003
6 EWS®
2 blisters
(3 x M), Ø 6mm
/ blister
OS DWS 0004
6 EWS®
2 blisters
(3 x L), Ø 7mm
/ blister
) H. Dutau et al. Endobronchial Embolization with a Silicone Spigot as a
temporary treatment for Massive Hemoptysis.
Respiration DOI:101159/000092954, published online April 21, 2006
2
) Watanabe Y. et al. Bronchial Occlusion with Endobronchial
Watanabe Spigot, J bronchol., 10, 4, 2003
14
Request for customisation (BAF) GSS™/Dumon®
Patient name or number
Please mark the adequate
drawing and indicate:
Ø1___________mm
Ø2___________mm
Ø3___________mm
L1 ___________mm
L1 ___________mm
L1 ___________mm
Customer
Dimensioned drawing
Doctor’s Name
For a stent that does not correspond to any of the
above drawings, please provide a dimensioned
drawing:
_________________________________________
Address
_________________________________________
_________________________________________
Telephone
_________________________________________
Stamp & signature for approval
Distributor
Name
_________________________________________
Address
_________________________________________
Stamp & signature
Novatech
___________________________________
REF
___________________________
LOT
___________________________________ ____________________________
Official Representative
Novatech hereby certifies that the custom made
stent described above is manufactured in strict
compliance with the European Directive 93/42/CE
annex 1.
It is in the prescribing
doctor’s responsibility to
determine whether this
custom made stent is
suitable for the patient.
Date/ Visa
___________________________________ ____________________________
Kapitex Healthcare Ltd, 1 Sandbeck Way, Wetherby, West Yorkshire, LS22 7GH, UK
Tel: 01937 580211 • Fax: 01937 580796 • Email: [email protected]
www.kapitex.com
15
Request for customisation (BAF) Silmet® SM (custom made)
Unique patient identifier (patient name or number)
Distance
cover – distal end of stent
________mm
Cover
________mm
Distance
cover – proximal end of
stent
________mm
Please mark the adequate drawing
and indicate:
Total length of stent (L) ___________mm
Diameter (distal): ________________mm
Diameter (proximal)______________mm
Cover(s) requested:
yes
Distance
cover – distal end of stent
________mm
Cover 1
________mm
Distance between covers
________mm
Cover 2
________mm
Distance
cover – proximal end of
stent
________mm
Please provide exact dimensions of the
desired cover(s) and the distances between
covers and the ends of the stent.
straight, with two covers
conical, with two covers
straight, with two covers
conical, with two covers
no
complete cover
Customer
Dimensioned drawing
Doctor’s Name
For a stent that does not correspond to any of the above
drawings, please provide a dimensioned drawing:
_________________________________________
Address
_________________________________________
_________________________________________
Telephone
_________________________________________
Stamp & signature for approval
Distributor
Name
_________________________________________
Address
Novatech hereby certifies that the custom made stent described
above is manufactured in strict compliance with the European
Directive 93/42/CE annex 1.
_________________________________________
Stamp & signature
Novatech
___________________________________
REF
___________________________
LOT
___________________________________ ____________________________
Official Representative
Date/ Visa
___________________________________ ____________________________
Kapitex Healthcare Ltd, 1 Sandbeck Way, Wetherby, West Yorkshire, LS22 7GH, UK
Tel: 01937 580211 • Fax: 01937 580796 • Email: [email protected]
16
www.kapitex.com
It is in the prescribing
doctor’s responsibility to
determine whether this
custom made stent is
suitable for the patient.
Description
The Montgomery® Safe-T-Tube™ is designed to maintain an
adequate airway as well as to provide support in the stenotic
trachea that has been reconstituted or reconstructed. Our
exclusive design of ridges and grooves along the extraluminal
limb of the tube allows a ring washer to be attached,
significantly reducing the possibility of accidental posterior
displacement.
The Montgomery® Safe-T-Tube™ is available in five styles Paediatric, Standard, Thoracic, Extra-long and Tapered - in
both clear and radio-opaque models. Safe-T-Tubes™ are
easy to insert, suction and remove, and can be used with
anaesthesia. Speaking valves to facilitate vocalisation are
also available.
MONTGOMERY® Safe-T-Tube™ Series
Montgomery® Safe-T-Tube™ Series
In addition, we offer the 4500 Series Hebeler Safe-T-Tube™,
featuring an internal balloon system for adjustable airflow,
and the 8200 Series HMS System™, a complete
laryngotracheal repair system with inner cannula.
A video educational kit with a CD outlining the
Montgomery® Safe-T-Tube™ procedure is available. Please
call Customer Services for your copy.
Custom lengths
Special situations require shortened Safe-T-Tube™ limbs.
We offer a service to shorten any Safe-T-Tube™ to your exact
dimensions and finish the ends with a smooth taper. Please
call Customer Services for details.
For those who prefer to customise tubes in the field, we
offer the CK 1022 Tube Cutter to create an accurate and
straight cut on any diameter Safe-T-Tube™. (Caution: to
prevent potential damage to tracheal tissues, cut Safe-TTube™ limbs must be smoothed prior to tube insertion).
17
MONTGOMERY® Safe-T-Tube™ 3200
3200 Series Paediatric
Description
The 3200 Series Paediatric Safe-T-Tubes™ feature an angled
extraluminal limb to facilitate suctioning and airway
management.
Available in sizes 6mm, 7mm, 8mm and 9mm (outside
diameter) in either clear or radio-opaque implant grade
silicone. Each Safe-T-Tube™set includes the tube, two
plug/ring sets, and product information. Additional plug/ring
sets are available. Refer to chart below for corresponding
product codes.
Indications for use
•
•
•
•
•
•
•
Acute laryngotracheal injuries.
To support intrathoracic tracheal stenosis.
To support a reconstructed trachea.
Tracheal stenosis.
To support a reconstituted trachea.
Segmental resection and anastomosis.
To maintain a cervical trachea that cannot be repaired.
Supplied
Sterile
1 tube, 2 plug/ring sets
FEATURES
•
•
•
•
•
Angled extraluminal limb
Implant grade silicone
Non-adherent smooth surface
Safety ring and groove system
Available in clear or radio-opaque material
Montgomery 3200 Paediatric Safe-T-Tube
Radio-opaque
Ref
18
SIZE
Dimensions (mm)
Ref
A
B
C
D
E
F
Plug/Ring Set
OS STT 1001
6
6
94
45
42
45
6
OS STT 1105
OS STT 1002
7
7
95
46
42
45
6
OS STT 1105
OS STT 1003
8
8
96
45
42
45
8
OS STT 1106
OS STT 1004
9
9
97
46
42
45
8
OS STT 1106
4200 Series Standard
Description
The 4200 Series Standard Safe-T-Tube™ is the original design
featuring dimensions that will work for the majority of
surgical cases.
Available in sizes 10mm, 11mm, 12mm, 13mm, 14mm,
15mm and 16mm (outside diameter) in either clear or radioopaque implant grade silicone. Each Safe-T-Tube™set
includes the tube, two plug/ring sets and product
information. Also available are 15mm adaptors and
additional plug/ring sets. Refer to chart below for
corresponding product codes.
Indications for use
•
•
•
•
•
•
•
Tracheal stenosis.
FEATURES
Supplied
•
•
•
•
•
Sterile
Original design
Montgomery 4200 Standard Safe-T-Tube
Radio-opaque
Ref
SIZE
Dimensions (mm)
Ref
A
B
C
D
E
F
Plug/Ring Set
15mm
Adaptor
OS STT 1005
10
10
50
19
23
39
8
OS STT 1103
OS STT 1101
OS STT 1006
11
11
60
20
29
50
11
OS STT 1104
OS STT 1102
OS STT 1007
12
12
66
23
32
50
11
OS STT 1104
OS STT 1102
OS STT 1008
13
13
68
24
33
55
11
OS STT 1104
OS STT 1102
OS STT 1009
14
14
72
26
35
59
11
OS STT 1104
OS STT 1102
OS STT 1010
15
15
73
26
36
57
11
OS STT 1104
OS STT 1102
OS STT 1010A
16
16
75
27
37
66
11
OS STT 1104
OS STT 1102
19
4500 Series Hebeler
Description
The 4500 Series Hebeler Safe-T-Tube™ features an integral
internal balloon to adjust the airflow through the upper end
of the tube. The balloon can be inflated for intermittent
closure of the upper limb, creating a closed system between
the tracheostomy and lungs. Following anaesthesia or
ventilation, the balloon is deflated and the upper limb
becomes open for upper respiratory access.
Available in sizes 12mm, 15mm and 18mm (outside
diameter) in clear implant grade silicone. Each Safe-T-Tube™
set is supplied with the tube, two plug/ring sets and product
Indications for use
•
•
•
•
•
•
•
Tracheal stenosis.
FEATURES
•
•
•
•
•
Supplied
Sterile
Patented internal balloon design
Available in clear material
Hebeler Safe-T-Tube™
a) deflated internal balloon
b) inflated internal balloon
a)
b)
Montgomery 4500 Hebeler Safe-T-Tube
Clear
Ref
20
SIZE
Dimensions (mm)
Ref
A
B
C
D
E
F
Plug/Ring Set
15mm
Adaptor
OS STT 1201
12
12
76
25
40
60
11
321126
OS STT 1102
OS STT 1202
15
15
77
25
40
60
12
321156
OS STT 1102
OS STT 1203
18
18
79
25
40
60
14
321186
OS STT 1102
5200 Series Thoracic
Description
The 5200 Series Thoracic Safe-T-Tube™features an extra-long
lower limb for thoracic applications.
15 mm and 16mm (outside diameter) in either clear or radioopaque implant grade silicone. Each Safe-T-Tube™ set is
supplied with the tube, two plug/ring sets and product
Indications for use
•
•
•
•
•
•
•
Tracheal stenosis.
Supplied
Sterile
FEATURES
•
•
•
•
•
Extra-long distal limb
Montgomery 5200 Thoracic Safe-T-Tube
Radio-opaque
Ref
SIZE
Dimensions (mm)
Ref
A
B
C
D
E
F
Plug/Ring Set
15mm
Adaptor
OS STT 1011
10
10
112
30
74
38
8
OS STT 1103
OS STT 1101
OS STT 1012
11
11
115
30
74
50
11
OS STT 1104
OS STT 1102
OS STT 1013
12
12
112
29
72
50
11
OS STT 1104
OS STT 1102
OS STT 1014
13
13
116
31
74
58
11
OS STT 1104
OS STT 1102
OS STT 1015
14
14
119
33
75
58
11
OS STT 1104
OS STT 1102
OS STT 1016
15
15
119
33
75
58
11
OS STT 1104
OS STT 1102
OS STT 1016A
16
16
119
33
75
65
11
OS STT 1104
OS STT 1102
21
6200 Series Extra-Long
Description
The 6200 Series Extra-long Safe-T-Tube™ is designed to
provide the surgeon the total freedom to customise the
intraluminal limbs to any desired length.
15mm and 16mm (outside diameter) in either clear or radioopaque implant grade silicone. Each Safe-T-Tube™ set
includes the tube, two plug/ring sets and product
Indications for use
•
•
•
•
•
•
•
Tracheal stenosis.
Supplied
Sterile
FEATURES
•
•
•
•
•
Extra-long upper and lower limbs
Montgomery 6200 Extra-Long Safe-T-Tube
Clear
Ref
SIZE
Dimensions (mm)
Ref
A
B
C
D
E
F
Plug/Ring Set
15mm
Adaptor
OS STT 1017
10
10
156
74
74
38
8
OS STT 1103
OS STT 1101
OS STT 1018
11
11
159
74
74
50
11
OS STT 1104
OS STT 1102
OS STT 1019
12
12
161
75
74
50
11
OS STT 1104
OS STT 1102
OS STT 1020
13
13
161
75
74
58
11
OS STT 1104
OS STT 1102
OS STT 1021
14
14
161
75
75
58
11
OS STT 1104
OS STT 1102
OS STT 1022
15
15
161
75
75
58
11
OS STT 1104
OS STT 1102
OS STT 1023
16
16
163
76
75
65
11
OS STT 1104
OS STT 1102
Radio-opaque available - please contact Kapitex for more information
22
7200 Series Tapered
Description
The 7200 Series Tapered Safe-T-Tube™ is designed to assist
with the management of tracheal, subglottic and glottic
stenoses. The superior end conforms to the contour of the
glottis and subglottis, while the larger inferior portion
simultaneously acts as a stent for the trachea. The tapered
end is designed to project up beyond the true vocal cords to
the level of the laryngeal ventricle.
Available in sizes 8mm/10mm and 10mm/13mm (outside
diameters) in either clear or radio-opaque implant grade
silicone. Each Safe-T-Tube™ set includes the tube, two
plug/ring sets and product information. Also available are
15mm adaptors and additional plug/ring sets. Refer to chart
below for corresponding product codes.
Indications for use
•
•
•
•
•
•
•
To support subglottic stenosis.
Tracheal stenosis.
FEATURES
•
•
•
•
•
Supplied
Sterile
Tapered upper limbs
Montgomery 7200 Tapered Safe-T-Tube
Ref
SIZE
clear
radio-opaque
721008
71008R
721310
71310R
Dimensions (mm)
Ref
A
B
C
D
E
F
G
Plug/Ring Set
15mm
Adaptor
8/10
8
159
75
76
68
8
10
OS STT 1103
OS STT 1101
10/13
10
163
76
76
66
11
13
OS STT 1104
OS STT 1102
23
8200 Series HMS System™
Description
The 8200 Series HMS System™ is designed to provide
support during repair and/or reconstruction procedures of
the subglottis and trachea. The system combines the features
of the original Montgomery® Safe-T-Tube™ with the
advantages of an inner cannula system. Once the stent is in
place, the inner cannula can be removed for cleaning without
disturbing repaired areas. The inner cannula has a 15mm end
to connect to respiratory accessories. When repair is
complete, the HMS System™ can be removed
endoscopically.
Indications for use
•
•
•
•
•
•
Treatment of laryngotracheal stenosis.
Supplied
Sterile
1 HMS System™, 1 outer tube, 2 inner cannulas, 1 plug (for
upper internal limb), 1 exterior flange, 1 lubrication kit, 1
neck strap
FEATURES
•
•
•
•
Complete system with inner cannula
Medical grade material
Montgomery 8200 HMS System Safe-T-Tube
Ref
SIZE
Dimensions (mm)
A
B
C
D
E
F
OS STT 1024
7
7
100
50
37
45
7
OS STT 1025
9
9
100
50
37
45
9
OS STT 1026
11
11
110
50
45
60
11
OS STT 1107
HMS Safety Tube Lubricant Set
Kapitex - Adding Quality of Life to Airway Management
Kapitex Healthcare provide a wide range of products dedicated to Laryngectomy and Tracheostomy care. You can depend on our
experience, our product quality – and our quality of aftersales service. To order any of the products in this brochure or for details of
other Kapitex products contact Kapitex on 01937 580211, or by fax on 01937 580796 or write to us at the address below.
Tel: 01937 580211
Fax: 01937 580796
Email: [email protected]
Due to continuous product
developments it may be necessary to
alter without notice products within
our range. We endeavour to keep all
customers informed of product
improvements.
If dialling from outside the UK –
Tel: +44 (0)1937 580211 • Fax: +44 (0)1937 580796
© Kapitex Healthcare Ltd. 2012
Kapitex Healthcare Ltd.
Kapitex House, 1 Sandbeck Way, Wetherby,
West Yorkshire LS22 7GH, England.
PBOS 0055 Rev: 02_09/14

Specialist Airway Stenting Solutions

Transcription

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