Self-Expanding Tympanostomy Tube System
This invention is a novel, self-expanding tympanostomy tube system designed to pierce the tympanic membrane directly without the need for a separate surgical incision. By enabling a simple, single-step insertion process, this technology allows ear tube procedures to move from the operating room into a standard clinic or doctor's office.
Description
The system features a flexible tube with distal and proximal flanges that is compressed into a low-profile first state for insertion. In one primary embodiment, the tube is housed within a pointed, degradable tip section made of soluble materials like sugar-based polymers or polyvinyl alcohol. This tip facilitates the initial piercing of the tympanic membrane under manual force. Once positioned, the tip section dissolves upon contact with moisture, releasing the compressed tube. The tube then expands to a second state, where the distal and proximal flanges deploy to anchor the device securely across the tympanic membrane. This creates a patent lumen that equalizes pressure and provides fluid drainage between the middle and external ear. The design may incorporate axially extending grooves to facilitate tight compression and rapid expansion, ensuring the device remains in the correct anatomical position.Applications
- In-office tympanostomy procedures for pediatric and adult patients suffering from chronic or recurrent middle ear infections.- Ventilation of the middle ear cavity to prevent fluid accumulation and facilitate pressure equalization without the need for surgical incisions.
- Reduction of hospital resource utilization by enabling procedures outside of operating rooms, minimizing the requirement for general anesthesia.
- Facilitation of middle ear ventilation in outpatient clinical settings such as general pediatric or otolaryngology clinics.
- Potential adaptation for other clinical scenarios requiring minimally invasive membrane penetration and device deployment.
Advantages
- Minimally Invasive Deployment: The compressed tube design eliminates the need for a separate incision, reducing tissue trauma and patient discomfort.- Degradable Tip Mechanism: The use of moisture-sensitive degradable materials enables automatic expansion post-insertion, simplifying procedural steps and enhancing patient safety.
- Shape Memory Technology: Controlled compression and expansion mechanisms ensure reliable placement and retention within the tympanic membrane.
- Biocompatibility: Utilization of medical-grade silicone and dissolvable polymers minimizes immunogenic responses and promotes patient tolerance.
- Enhanced Procedural Efficiency: Real-time visualization with adapted otoscopic tools improves precision and reduces procedural time.