Device for intraluminal incision guided by endoluminal ultrasonography

Area of Science:

• Urology
• Medical Devices
• Surgical Innovation

Background:

• Intraluminal incisions are crucial for treating upper and lower urinary tract strictures.
• Accurate guidance is essential due to stricture depth and proximity of vital structures like blood vessels.
• Endoluminal ultrasonography offers precise periureteral anatomy visualization.

Purpose of the Study:

• To evaluate a novel 9F catheter integrating an endoluminal ultrasound transducer and a cutting device (electrocautery or laser fiber).
• To assess the device's capability in guiding intraluminal incisions for urinary tract strictures.
• To determine the accuracy and safety of incisions made using this combined technology.

Main Methods:

• Development of a 9F catheter with combined endoluminal ultrasound and cutting capabilities.
• In vivo evaluation in anesthetized pigs (four kidneys) and ex vivo assessment in four kidneys.
• Performance assessment of imaging periureteral structures and directing incision location and adequacy.

Main Results:

• Excellent endoluminal ultrasound imaging of periureteral structures was achieved.
• The integrated electrocautery wire was clearly visualized.
• The device facilitated well-defined, limited, full-thickness incisions.
• Incisions were accurately directed toward or away from periureteral vessels.

Conclusions:

• The novel integrated device shows significant potential for endoluminal ultrasound-guided intraluminal incisions.
• This technology can improve precision and safety in treating urinary tract strictures.
• Further clinical evaluation is warranted to establish its therapeutic value.