A thin cryobiopsy device compatible with transnasal endoscopy for the gastrointestinal tract

Area of Science:

• Gastroenterology
• Medical Devices
• Biopsy Technology

Background:

• Traditional endoscopic biopsies use forceps, often requiring sedation and yielding suboptimal samples.
• Limitations include crush artifacts, poor tissue orientation, and depth control issues.
• Smaller endoscopes for unsedated procedures are limited by small working channels, restricting biopsy tool size.

Purpose of the Study:

• To develop and evaluate an image-guided, depth-controlled, ultrasmall-diameter (1.2 mm) cryobiopsy device (μCryoProbe).
• To assess the quality and dimensions of biopsies obtained by the μCryoProbe compared to traditional forceps.
• To explore the potential of μCryoProbe for unsedated endoscopic procedures.

Main Methods:

• Optimized coolant flow for enhanced tissue freezing and controlled freezing depth.
• Tested the μCryoProbe in ex vivo preclinical tissues, an in vivo porcine model, and sedated human participants.
• Compared cryobiopsies with forceps-derived biopsies from the esophagus, stomach, and duodenum.

Main Results:

• The μCryoProbe consistently produced high-quality mucosal cryobiopsies.
• Biopsies showed optimal tissue orientation and no crush artifacts.
• Successful gastrointestinal biopsy collection was demonstrated in human participants.

Conclusions:

• The μCryoProbe yields superior biopsy quality compared to forceps.
• This ultrasmall device facilitates the use of smaller endoscopes, potentially reducing sedation needs.
• Improved biopsy quality can enhance patient diagnosis and procedural feasibility.