Super Elastic NiTiNOL - PTFE Vario Piston type Loop

Super Elastic NiTiNOL - PTFE Vario Piston type Loop Specification

Measurement Range
Available in multiple loop sizes

Shelf Life
5 Years

Features
Super-elastic, shape memory, minimally invasive, anti-adhesive surface

Accuracy
Precision loop diameter tolerance 0.05 mm

Function
Secure placement and fixation of prosthesis during stapes surgery

Instruments Type
Otolaryngology Surgical Instrument

Storage Instructions
Store in dry, cool, and clean environment

Usage Type
Single Use (Disposable)

Equipment Type
Vario Piston Type Loop

Material
Super Elastic NiTiNOL core, PTFE (Polytetrafluoroethylene) coating

Condition
New

Technology
Memory alloy technology with flexible loop design

Portable
Yes

Wall Mounted
No

Real-Time Operation
Yes

Noise Level
Silent Operation

Operating Type
Manual Deployment

Use
Medical, Otology (Ear Surgery) for stapes surgery

Power Source
Not Required (Manual)

Dimension (L*W*H)
Loop Inner Diameter: 0.8 mm/1.2 mm/1.6 mm (varies); Shaft Length: approx. 8-10 mm

Weight
< 2 g

Color
Metallic Silver with White (PTFE coating)

Application Site
Middle Ear (Ossicular Chain)

Surface Finish
Ultra-smooth PTFE reduces tissue trauma and friction

Biocompatibility
ISO 10993 certified biocompatible materials

Corrosion Resistance
Excellent (NiTiNOL is highly corrosion resistant)

Sterilization
Gamma sterilized and ready to use

Loop Shape
Round, atraumatic tip to prevent inner ear damage

Compatibility
Compatible with standard stapedial prosthesis

Flexibility
Maintains optimum flexibility for easy insertion

Markings
Clear orientation markings on shaft

Temperature Resistance
Withstands autoclave and body temperature without deformation

Packaging
Individually packed and sealed in sterile blister pack

About Super Elastic NiTiNOL - PTFE Vario Piston type Loop

Super Elastic NiTiNOL PTFE Loop

The Super Elastic NiTiNOL - PTFE Vario Piston type Loop is a medical device used in middle ear surgeries, particularly for stapedectomy and stapedoplasty. Here are some key features and benefits of this prosthetic device:

Super Elastic NiTiNOL - PTFE Vario Piston type Loop: This prosthetic device is made of superelastic Nitinol (a nickel-titanium alloy) and features a PTFE (polytetrafluoroethylene) shaft. The superelastic property of Nitinol provides a self-crimping effect, which simplifies the surgical procedure and reduces the time needed for crimping the loop to the long process of the incus.
Self-Crimping Effect: The loops design allows it to close softly and uniformly around the long process of the incus, minimizing the risk of incus necrosis. This feature also reduces the time required for surgery.
Variable Length: The piston can be easily cut to the required length, making it adaptable to various surgical needs.
MRI Compatibility: The device is MRI-compatible, allowing for post-surgical imaging without the need for removal.
Reduced Risk of Osteonecrosis: The superelastic property of the loop reduces the risk of osteonecrosis, a condition where bone tissue dies due to a lack of blood supply.
Ease of Use: The flat loop design facilitates easy introduction to the incus and provides uniform attachment around the total periphery of the incus, reducing the risk of compressive necrosis.

Precision Design for Safe Middle Ear Surgery

The Vario Piston type Loop utilizes a super elastic NiTiNOL core with a PTFE coating, offering unmatched flexibility and ultra-smooth insertion. Its atraumatic round tip and precise diameter control ensure gentle, secure placement in the ossicular chain, reducing the risk of inner ear damage during stapes surgery.

Comprehensive Sterility and Biocompatibility

Gamma sterilized and complying with ISO 10993 biocompatibility standards, this instrument is delivered ready to use, minimizing infection risks. Its PTFE surface not only resists adhesion but also supports a safer surgical environment, benefiting both patient outcomes and surgeon confidence.

Adaptable and Convenient for Surgical Needs

Available in multiple loop sizes and inner diameters (0.8 mm, 1.2 mm, 1.6 mm), this piston type loop caters to a variety of patient anatomies. Compatibility with standard stapedial prostheses, along with clear orientation markings, ensures accurate deployment during ear surgery procedures.

FAQ's of Super Elastic NiTiNOL - PTFE Vario Piston type Loop:

Q: How is the Super Elastic NiTiNOL - PTFE Vario Piston Loop used during stapes surgery?

A: Surgeons deploy the loop manually to secure and fixate the prosthesis onto the stapes area of the middle ear ossicular chain. The loop's super-elastic memory alloy core and atraumatic tip allow for gentle insertion and precise placement, minimizing tissue trauma and ensuring effective prosthesis stabilization.

Q: What are the benefits of the ultra-smooth PTFE coating on the loop?

A: The PTFE (Polytetrafluoroethylene) coating dramatically reduces friction and tissue adhesion, thus decreasing trauma during insertion. Its anti-adhesive properties enable smooth, minimally invasive placement, improving both patient recovery and surgical outcomes.

Q: When should this Vario Piston type Loop be used?

A: This loop is designed for use exclusively in medical otology procedures, particularly during stapes surgery to facilitate ossicular chain reconstruction. It should be used as a single-use, disposable instrument to ensure sterility and optimum performance.

Q: Where is the primary application site for this product?

A: The primary application site is the middle ear-specifically, the ossicular chain-where it is used to secure the stapedial prosthesis during ear surgeries performed by trained otolaryngology professionals.

Q: What is the process for preparing and handling this loop before usage?

A: Each loop is supplied gamma sterilized and individually sealed in a sterile blister pack. The surgeon needs only to open the packaging in a sterile environment immediately before the procedure, ensuring both safety and convenience.

Q: How does the loop's shape memory alloy technology benefit the surgical process?

A: The NiTiNOL core possesses super-elastic and shape memory properties, allowing the loop to conform perfectly for secure fixation and then return to its original shape. This feature maintains flexibility and precision, reducing the risk of prosthesis displacement during and after surgery.

Q: What measures ensure the product's reliability and safety?

A: The loop is constructed from ISO 10993 certified biocompatible materials, is corrosion resistant, and features a clearly marked shaft for proper orientation. Its tolerance of high temperatures and excellent structural integrity further ensure dependable performance throughout its 5-year shelf life.