Description

The BoNee Needle for Bladder Injection 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 particularly beneficial during transurethral endoscopic procedures, addressing bladder dysfunctions like overactive bladder (OAB), neurogenic detrusor overactivity (NDO), and female stress urinary incontinence in patients who have not responded to other treatments.

Key Features

• Single-Use and Sterile: Each needle is provided sterile and intended for single use only, ensuring safety and preventing cross-contamination.
• Flexible Design: Available in two lengths, 35 cm and 70 cm, to accommodate both rigid and flexible cystoscopes. The needle's 5 Fr flexible body prevents kinking while maintaining the rigidity needed for effective injection.
• 22G Gauge with 4 mm Tip: Designed for precision, minimizing the risk of bladder perforation with features like a pointer stop.
• Secure Attachments: Equipped with a Luer or Luer Lock connector for syringe attachment and a Tuohy Borst locking connector or adapter for secure needle control.
• Protective Cap: Includes a protective tip cap to prevent damage during insertion and handling.

Construction

The needle is constructed from high-quality materials, including thermoplastic polyamide tubing and a stainless steel needle, assembled with UV gluing techniques. It is free from natural rubber latex, reducing the risk of allergic reactions.

Handling and Operation

• Professional Use: Intended for use by trained healthcare professionals. The needle must be flushed before use and carefully handled to maintain integrity.
• Insertion and Withdrawal: Inserted through the cystoscope with the cap fitted, the cap is removed before patient introduction. After injection, the needle is withdrawn and inspected for integrity.

Packaging and Storage

• Sterilization: Sterilized using ethylene oxide and packaged as a single unit per box.
• Shelf Life: Offers a shelf life of 2 years, with storage recommended in a cool, dry place away from light.

Contraindications and Precautions

• Not Suitable For: Patients with coagulation disorders, known allergies to device materials, or contraindications to cystoscopy or the injected substance.
• Prescription Use Only: Restricted to sale by or on the order of a physician.

Potential Complications

Users should be aware of potential complications such as bleeding, bladder wall perforation, and urinary tract infection. Developed in collaboration with physicians, the BoNee Needle aims to provide precise medication delivery, with procedures typically well tolerated and potentially requiring repetition every 4 to 9 months.

Regulatory Information

Classified under the FDA's gastroenterology-urology panel as a Class II device, it complies with relevant regulatory standards, ensuring quality and reliability in medical settings.