Description

The BoNee® Needle for Bladder Injection, crafted by Coloplast, is a specialized medical device designed for precise delivery of low viscosity injectable medications, such as Botulinum toxin, into the urinary bladder wall. This device is intended for use during transurethral endoscopic procedures and is particularly beneficial in treating female stress urinary incontinence. Its versatile application extends to both human and veterinary medical settings for bladder and urethral injections.

Key Features

• Single-Use and Sterile: Ensures safety and hygiene for each procedure.
• Available in Two Sizes:
• 35 cm length (NBI035) for rigid cystoscopes.
• 70 cm length (NBI070) for flexible or rigid cystoscopes.
• Needle Specifications:
• Gauge: 22G
• French Size: 5 Fr (1.7 mm diameter)
• Needle Tip Length: 4 mm

Design and Construction

The needle's flexible body is engineered from thermoplastic polyamide (PA) tubing and stainless steel, allowing it to access any part of the bladder without kinking while maintaining the necessary rigidity for effective injection. It features a Luer Lock connector for secure syringe attachment and includes a blue Neoplex protective cap to safeguard the cystoscope channel during insertion.

Safety Features

• Pointer Stop: Minimizes the risk of bladder perforation.
• Locking Tuohy Borst Connector: Enables secure locking to the cystoscope’s working channel for controlled puncture and rotation.
• Compatibility: Suitable for cystoscopes with a working channel inner diameter of 5 French (1.7 mm) or larger.

Usage Instructions

Prior to use, the device must be flushed and inserted into the cystoscope with the cap fitted. The cap is removed before patient introduction. Post-procedure, the needle should be inspected for integrity. It is strictly a single-use device, prohibiting reuse.

Contraindications and Precautions

The device is contraindicated for patients with coagulation disorders, known allergies to its materials, or any contraindication to cystoscopy or the injected substance. It is intended for use only by trained professionals, with specific precautions to ensure compatibility with cystoscope dimensions and to maintain needle integrity.

Potential Complications

Possible complications include bleeding, bladder wall perforation, pain, and urinary tract infection. Proper handling and adherence to instructions are essential to mitigate these risks.

Regulatory Information

Classified as an endoscope accessory under the Gastroenterology/Urology panel, the device holds FDA 510(k) clearance (K090217). It is sterilized using ethylene oxide and offers a shelf life of two years, ensuring long-term availability for medical professionals.