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0.035” OTW Self- Expanding Stent System. Flexibility and Precision in Peripheral Arteries. The Reality of Femoral Occlusions. R ange of diameter Range of length Usable Catheter lengt h Guide wire compatibility Introducer compatibility Construction & design Entry profile:
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0.035” OTW Self- Expanding Stent System Flexibility and Precision in Peripheral Arteries
Range of diameter Range of length Usable Catheter length Guide wire compatibility Introducer compatibility Construction & design Entry profile: On-stent Tantalum markers Ø 6, 7, 8, 9, 10, 12 mm 20, 30, 40, 60, 80, 120 mm 80 cm / 120 cm 0.035” 6F multisegmented design withreinforced link-elements 0.043” 1 @ each end In Summary
Basics on NiTiNOL • NiTiNOL was invented 1962 by the US-Naval Ordnance Laboratory, a department of the US-Navy. • Nickel Titanium Naval OrdnanceLaboratory • They were looking for a very hard, anti-magnetic and corrosion resistant material • They melted 45% Titanium and 55% Nickel, which developed the desired properties and even more. • NiTiNOL is a brand name, there are other NiTi-alloys with other names like • Sentinol, Sentalloy, ...
Properties of NiTiNOL • Superelasticity • In reality it is pseudo-elastic • if it is cooled down below 20°C, it becomes inelastic like pure Tin (Zn) so that it can be deformed in all facilities without breaking (Martensitic low temperature phase). If it is rewarmed above 20°C, it moves back in its previous shape. • Over 20°C it can be bended and twisted as desired and immediately it moves back to the old shape (Austenitichigh temperature phase). • Depending on the Alloy ingredients, the conversion temperature can vary from -15°C to +80°C.
Shape NiTiNOL • The material needs to be fixtured and constrained in the desired shape and heat-treated. Typically for superelastic material, a heat treatment in the 500°C range is adequate; the length of heat treatment varies with the equipment used for the heat treatment and the thermal mass of the shaping fixture. In a molten salt bath for example, the heat treatment time is generally between 2 and 5 minutes.
Highly flexible and conformable stent platform Laser cut, ultra-polished surfaces Multisegmented design well proven zigzag-Nitinol design oversized connecting links for improved fracture resistance Surface Quality Ultra high polished surface Increased corrosion resistance Stent Design
Stent Marker • Two Tantalum markers (one on each end of the stent) for enhanced visibility • High safety, because of Laser-welded markers • Unique inside oriented marker, for improved mechanical properties • Good radiopacity of the stent • Strut thickness: 0.18 mm • Strut width: 0.13 mm
Thin struts for high flexibility Expansion • Large strut width for sufficient radial strength Flexure Best Adaptability to the Vessel Dynamic Requirements Torsion • Oversized connecting links for improved fracture resistance Elongation • Adequate strut dimensions, number of links and design for dynamic adaptability Mechanical Stent Behaviour
Diameter dependent number of links • Number of link elements: • 3 link-elements • Ø 6, 7 and 8 mm • 5 link-elements • Ø 9, 10 and 12 mm • Optimized radial strength and response to different mechanical stress by the diameter specific design • Oversized connecting links for improved fracture resistance. 1 3 3 1 2 2
Shortening – a technical answer • Shortening is dependent from the nominal length & diameter of the stent! • When the stent is loaded in the delivery system, it is longer than the nominal length! • Since the proximal marker on the SDS is movable, the stent edges are clearly marked to enable a proper positioning in the lesion. • Even if the stent follows the sheath retraction for some mm, the distal markers stays always behind it. • We have measured a shortening of 3,9% in the worst case
The Wallstent Story This mechanical behaviour is HISTORY!
small large Metal-to Artery Ratio
Stent Ø 6.0 mm length 20, 30, 40, 60, 80, 100, 120 mm Stent Ø 7.0 mm length 20, 30, 40, 60, 80, 100, 120 mm Stent Ø 8.0 mm length 30, 40, 60, 80, 100, 120 mm Stent Ø 9.0 mm length 30, 40, 60, 80, 100 mm Stent Ø 10.0 mm length 30, 40, 60, 80, 100 mm Stent Ø 12.0 mm length 30, 40, 60, 80 mm Usable Shaft Length: 80 cm and 120 cm Model Mix Stent Ø := unconstrained stent diameter length := nominal length @ unconstrained diameter
SDS Construction • OTW • 0.035” guide wire compatible • Standard guidewire size, 0.018” is more exotic • 6F shaft • General accepted size for peripheral interventions • 80 and 120 cm usable shaft length • Suitable for antegrade or contralateral approaches • Delivery by holding the stainless steel tube in place and sliding back the Y-piece with Tuohy-Borst Valve • Straight forward technique • Tuohy-Borst Valve, better known as variable hemostatic valve
Radiopaque Markers on SDS • Proximal marker (1) • Proximal marker acts as the pusher to maintain the stent in place when the outer tube is retracted and the stent is deployed. • Distal marker is integrated in the outer tube (2) • Tip material is radiopaque (mixed with Barium Sulfate) (3) (1) (2) (3)
SDS Sheath Construction • Full length braided sheath design • This reinforcement combines pushability and flexibility to enable easy negotiation in tortuous anatomies without kinking • ideal balance for successful contra-lateral approaches • PTFE coating inside the sheath • Reduction of friction between sheath and stent for a gradual, controlled and safe deployment of the stent in the lesion
Tip Construction / Entry Profile • New Tip design entry profile of 0,043 “ (1.10 mm), • Tip composed of a corrugated tube and a radiopaque overmoulded tube • NEW: edges were rounded to avoid entrapment during retrievalNEW: security seal between white overmoulded tip and blue inner tube.
The Pull-Back-Handle • We have chosen the KISS approach! Keep It Simple & Safe • Delivery by sliding back the Y-piece with Tuohy-Borst Valve while holding the stainless steel tube in place • After flushing the inner lumen of the sheath through the side port… • With one hand keep the steel tube in position, with the other hand slide back the Y-piece • It is not a “Black-Box” Handle You see - what you get/do!
Stent Positioning • Controlled, precise positioning • minimal shortening to obtain an adequate lesion coverage • PTFE inner shaft coating for low-friction stent deployment • low compliant core-tube for direct transition from pull-back handle to sheath retraction
Product Features • Excellent Flexibility of the Stent Platform and the Delivery System • Inside shaft Teflon-liner for low friction deployment • Optimal balance of flexibility, radial force and strut fracture resistance • Diameter dependent design • Ø 6, 7, 8 mm - 3 links • Ø 9, 10, 12 mm - 5 links • Atraumatic, kink-resistant tip design • Braided outer catheter shaft with Pull-Back Handle