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Piston Kurz NitiBOND Titane/Nitinol D 0,4mm L:4,75mm

1007108

NiTiBOND® 

Prosthesis for Otosclerosis

The KURZ middle ear prostheses are designed to restore the function of the middle ear in cases of pathological changes to the sound conduction system by replacing the auditory ossicles.

The NiTiBOND stapes prosthesis bridges the gap between the long process of the incus and the stapes footplate, with the piston inserting into the perilymphatic space.

Indications : 
Before opting for prosthesis implantation, it is essential to ensure that all elements of the patient's history are considered:

  • Otosclerosis (stapes fixation) / congenital stapes fixation
  • Traumatic injury to the ossicular chain
  • Malformation of the middle ear
  • Revision surgery due to insufficient hearing improvement, such as prosthesis dislocation.

Contraindications:

  • Allergy to nickel, titanium, or titanium-nickel alloys (Nitinol)
  • To reduce the risk of allergy, it is recommended to perform an allergy test before surgery. In patients with known allergies to nickel, titanium, or titanium-nickel alloys (Nitinol), implants made from these materials should be avoided.
  • Cases where conservative treatment methods (e.g., hearing aids) are sufficient
  • Acute middle ear infection, which could cause labyrinthitis or prosthesis dislocation
  • Ear canal infection increases the risk of spreading the infection to the middle or inner ear.
  • If the ear to be operated on is the patient's only functioning ear, there is a risk of bilateral total deafness. This possibility should be discussed on a case-by-case basis between the patient and the physician.
  • Acute and chronic infectious diseases
  • General healing disorders
  • Alcoholic, drug-addicted, or smoking patients.

Possible complications and side effects:
Adverse effects or injuries may occur during or after the operation. During surgery, delicate bone structures are affected or mobilized, which can cause operative trauma or infection. These injuries may be irreversible or may require revision surgery.

  • Postoperative dislocation or fracture of the implant
  • Tinnitus
  • Necrosis or erosion in contact areas (incus)
  • Tissue irritation / scar formation / granuloma
  • Recurrent middle ear inflammation
  • Vertigo
  • Inner ear damage leading to deafness
  • Tympanic membrane perforation
  • Perilymphatic fistula
  • Irritation or injury to the facial nerve, leading to facial paralysis
    Intolerance reactions, such as granuloma formation and rejection, or interaction with medications, are currently unknown. In such cases, the prosthesis must be removed using established surgical procedures.

Characteristics: 

  • Material: Nitinol
  • Pure Titanium - ASTM F67 Medical Grade
  • Diameter: Ø 0.4/0.6 mm
  • Loop width: 0.25 mm
  • MRI compatibility up to 7 Tesla
  • Thermal Blocking Zones protect the mucosa and the incus from excessive heating
  • The flat, wide NiTiBOND® loop minimizes the risk of damaging the mucosa by distributing pressure on the incus
  • Non-Contact Zones potentially prevent strangulation of the long process
  • Well-defined areas for heat application increase the safety of the surgical procedure
  • Shape memory properties allow implant placement without clamping
  • Guaranteed safety of using a titanium shaft in the inner ear
  • The 0.94 mm loop opening should fit any incus diameter.

Surgical experience with various prostheses for otosclerosis and a thorough understanding of the middle ear mechanisms have laid the conceptual foundation for this new loop design. It not only facilitates surgical fixation to the incus but also enhances patient safety and improves the efficiency of the implant-ossicle coupling.

The NiTiBOND® prosthesis for otosclerosis is the result of a multi-stage development process in close partnership with Zurich University Hospital, Switzerland, and the Institute for Engineering and Assisted Mechanics at the University of Stuttgart, Germany.

Reliable coupling to the lenticular process:
The flat loop distributes pressure on the incus. The application of heat to the "Non-Contact Zones" closes the loop due to the shape memory effect of Nitinol.

Thanks to their thermal blocking function, the Non-Contact Zones limit heat dispersion to the mucosa, minimizing the risk of strangulation of the incus and mucosa.

Titanium Shaft and Stem:
Except for the Nitinol loop, the prosthesis is entirely made of pure titanium (ASTM F67 Standard). Like other KURZ prostheses for otosclerosis, its surface is smooth, and all edges are rounded to minimize traumatic risks in the perilymphatic space.

The Thermo-Dummy or Thermal Template:
The Thermal Template, provided with the NiTiBOND® otosclerosis prosthesis in its plastic container, allows the user to determine the optimal laser setting outside the middle ear, thereby increasing the chances of surgical success.

►Piston NitiBOND Titane/Nitinol D:0,4mm L:4,75mm

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