Prostheses for Stapes Surgery. Self-Crimping Hook in Superelastic NITINOL. Reconstructive Biomaterials Prostheses for Otosurgery

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1 Self-Crimping Hook in Superelastic NITINOL Bandage for Rhinoplasty Surgical Instruments PVA Anatomical Swabs Disposable Suction Tubes Prostheses for Stapes Surgery Reconstructive Biomaterials Prostheses for Otosurgery

2 What is NITINOL? NITINOL is a Nickel (Ni) and Titanium (Ti) alloy accidentally discovered by two American researchers at the Naval Ordinance Laboratory (NOL) who called it NiTiNOL, which is the acronym of Nickel (Ni) Titanium (Ti) and the laboratory where it was discovered. The microscopic structure of this alloy presents a distinctive molecular reticule which can work in two ways: the molecular reticule shapes in two different ways depending on the temperature THERMAL MEMORY NITINOL: coldworked Nitinol can be deformed but it returns to its original shape if is subjected to heat. The molecular reticule always maintains the same shape and it never deforms. SUPERELASTIC NITINOL: it can be bended and twisted but it always returns to its original shape. No case of allergy to Nitinol in otologic application has ever been signaled in scientific literature. An allergic test for Nitinol is not available and a test for Nickel is generic. It s recommended to gather the patient s anamnesis regarding allergy to metals. In case the surgeon decide not to implant the Nitinol prosthesis we suggest using the Self-crimping piston in elastic Titanium. These prostheses have less elasticity compared to the Nitinol prostheses but are self-crimping anyway. See Audio-Technologies catalogue on the web site: Fields of application Both the thermal memory NITINOL and the superelastic NITINOL find application in a number of medical fields, mainly in cardiovascular surgery and in endoscopic surgery. NITINOL application in otology Audio Technologies has developed an industrial process to create a prosthesis that is fitted to the long apophysis of the incus with a simple vertical movement requiring only 4 milligram load. Shape Memory Mechanism COOL HEAT Austenite DEFORM Twinned Martensite Deformed Martensite Superelasticity Mechanism DEFORM RELEASE Austenite Deformed Martensite

Self-Crimping Superelastic NITINOL / PTFE Piston Self-Crimping Superelastic NITINOL / PTFE Piston available in diameters of 0.4-0.5-0.6-0.8 mm and lengths from 4.00 to 9.

46 Features: NITINOL HOOK The classic Audio flat hook in combination with the super elastic NITINOL is the result of a unique Audio Technologies manufacturing process.

SEMPLIFICATION OF THE OPERATION The hook elasticity reduces the surgery steps and the difficulties that may occur during the closing phase.

3 Self-Crimping Superelastic NITINOL / PTFE Piston Self-Crimping Superelastic NITINOL / PTFE Piston available in diameters of mm and lengths from 4.00 to 9.99 mm. (PTFE: polytetraflorethylene) CODE SPL SPL SPL SPL Features: NITINOL HOOK The classic Audio flat hook in combination with the super elastic NITINOL is the result of a unique Audio Technologies manufacturing process. This characteristic is combined with the other good qualities of NITINOL: mechanical resistance, bioinertia, and lightweight. SEMPLIFICATION OF THE OPERATION The hook elasticity reduces the surgery steps and the difficulties that may occur during the closing phase. The hook closes softly, uniformly wrapping the pressure along the total periphery of the long incus process, so to minimize the risk of compressive necrosis. EASY ASSEMBLING The piston attaches to the incus with an easy downward movement. The micro forceps Audio ref. SPL makes it widely easy assembling the prosthesis to the incus.

4 Self-Crimping Superelastic NITINOL/PTFE Piston CODE SPL Designed by Dott. Franco Beoni Columella ø: 0.40 mm SPL SPL SPL SPL SPL SPL SPL SPL SPL SPL SPL SPL SPL SPL SPL SPL SPL SPL Self-Crimping Superelastic NITINOL Piston CODE SPL Columella ø: 0.50 mm SPL SPL SPL SPL SPL SPL SPL SPL SPL SPL SPL SPL SPL SPL SPL SPL SPL SPL Self-Crimping Superelastic NITINOL Piston CODE SPL Columella ø: 0.60 mm SPL SPL SPL SPL SPL SPL SPL SPL SPL SPL SPL SPL SPL SPL SPL SPL SPL SPL Self-Crimping Superelastic NITINOL Piston CODE SPL Columella ø: 0.80 mm SPL SPL SPL SPL SPL SPL SPL SPL SPL SPL SPL SPL SPL SPL SPL SPL SPL SPL

5 Trimmable Self-Crimping Superelastic NITINOL \ PTFE Piston Self-Crimping Superelastic NITINOL Piston, available in diameters mm and length 7.0 mm trimmable to 4.25 mm*. (PTFE: polytetraflorethylene) CODE SPL 03.43S SPL 03.44S SPL 03.45S SPL 03.46S * It is advisable to use Trimmable prosthesis measuring plate code SPL for the prosthesis trimming phase. Features: NITINOL HOOK The classic Audio flat hook in combination with the super elastic NITINOL is the result of a unique Audio Technologies manufacturing process. This characteristic is combined with the other good qualities of NITINOL: mechanical resistance, bioinertia, and lightweight. SEMPLIFICATION OF THE OPERATION The hook elasticity reduces the surgery steps and the difficulties that may occur during the closing phase. The hook closes softly, uniformly wrapping the pressure along the total periphery of the long incus process, so to minimize the risk of compressive necrosis. EASY ASSEMBLING The piston attaches to the incus with an easy downward movement. The micro forceps Audio ref. SPL makes it widely easy assembling the prosthesis to the incus.

6 Trimmable Self-Crimping Superelastic NITINOL \ PTFE Piston CODE SPL 03.43S PTFE Columella ø: 0.40 mm Designed by Dott. Franco Beoni 7.00 trimmable 6.00 trimmable SPL 03.43S to 4.25 to 3.25 Trimmable Self-Crimping Superelastic NITINOL \ PTFE Piston CODE SPL 03.44S PTFE Columella ø: 0.50 mm 7.00 trimmable 6.00 trimmable SPL 03.44S to 4.25 to 3.25 Trimmable Self-Crimping Superelastic NITINOL \ PTFE Piston CODE SPL 03.45S PTFE Columella ø: 0.60 mm trimmable 6.00 trimmable SPL 03.45S to 4.25 to 3.25 Trimmable Self-Crimping Superelastic NITINOL \ PTFE Piston CODE SPL 03.46S PTFE Columella ø: 0.80 mm lants trimmable 6.00 trimmable SPL 03.46S to 4.25 to 3.25

Forceps for Nitinol Prosthesis CODICE SPL 03.01 Claudia forceps Designed by Dott.

0 mm Width: 0.9 mm 1 2 Use: 1) Grasping of the prosthesis hook in the micro-forceps.

3 3) The prosthesis hook opens when it is pressed into the grooves of the micro-forceps.

7 Forceps for Nitinol Prosthesis CODICE SPL Claudia forceps Designed by Dott. Franco Beoni Material: Stainless Steel Weight: 12 Gr Lenght: 70 mm Jaws: Lenght: 4.0 mm Width: 0.9 mm 1 2 Use: 1) Grasping of the prosthesis hook in the micro-forceps. 2) The jaws of the micro-forceps feature grooves for the prosthesis hook. 3 3) The prosthesis hook opens when it is pressed into the grooves of the micro-forceps. 4) The open prosthesis hook is easily assembled onto the incus. 5) Opening of the micro-forceps releases the prosthesis hook. 4 5 Designed by Dr. F. Beoni

Ancillary equipment for Nitinol Prosthesis CODE SPL 03.

micro-forceps. 1 2) The jaws of the micro-forceps feature grooves for the prosthesis hook.

2 Forceps alignment bar 3 4 5 Use 1) The hook of the prosthesis is inserted on the stop pin of the instrument.

aligned with the alignment bar underneath.

prosthesis stem should be positioned forward or backward by reference to the alignment bar underneath 3) Place the

8 Ancillary equipment for Nitinol Prosthesis CODE SPL Material: Stainless Steel Prosthesis stem alignment bar Use: 1) Grasping Stop pinof the prosthesis hook in the micro-forceps. 1 2) The jaws of the micro-forceps feature grooves for the prosthesis hook. 3) The prosthesis hook opens when it is pressed into the grooves of the micro-forceps. 2 Forceps alignment bar Use 1) The hook of the prosthesis is inserted on the stop pin of the instrument. If it is required that the prosthesis is in axial direction with the forceps, the stem of the prosthesis should be aligned with the alignment bar underneath. 2) If it is required that the prosthesis stem is moved forward or backward by reference to the forceps axis, the prosthesis stem should be positioned forward or backward by reference to the alignment bar underneath 3) Place the forceps on the forceps alignment bar and move forward till the stop pin. 4) Close the forceps grasping tips and slip off the stop pin from the prosthesis hook. 5) The forceps with the inserted prosthesis pass from the hands of the instrument nurse to the hands of the surgeon, without the surgeon having to look away from the operating microscope.

9 Revisione 02 Novembre 2009 Audio Technologies S.r.l Gossolengo - Piacenza (ITALY) - Tel Fax info@audiotechnologies.it -

Reading assignment. Shape memory. Shape-memory alloy (SMA) Superelastic behavior. Topic 11

Reading assignment. Shape memory. Shape-memory alloy (SMA) Superelastic behavior. Topic 11 Reading assignment Shape memory Topic 11 Lecture notes on Shape Memory on the course webpage Askeland and Phule, The Science and Engineering of Materials, 4 th Ed., Sec. 11-11 (first page only) and Sec.