A light-reflecting balloon catheter for atraumatic tissue defect repair

Area of Science:

• Biomaterials Science
• Minimally Invasive Surgery
• Medical Device Engineering

Background:

• Tissue defects often require surgical closure, posing risks like tissue erosion from metallic implants.
• Current biodegradable adhesives lack specialized delivery tools, hindering clinical use.
• Sutures and staples are standard but can cause significant tissue trauma.

Purpose of the Study:

• To develop and evaluate a catheter-based system for minimally invasive delivery of light-activated tissue adhesives.
• To demonstrate the efficacy and safety of this novel device for tissue defect closure in various anatomical locations.
• To assess the potential of this technology as an alternative to traditional closure methods.

Main Methods:

• Development of a catheter system with an adhesive-loaded elastic patch and a double-balloon for tissue stabilization.
• Utilized fiber optics and a reflective coating for uniform ultraviolet light delivery to activate the adhesive.
• Ex vivo testing on porcine tissues (abdominal wall, stomach, heart) and in vivo studies in rats (heart, abdomen) and pigs (cardiac septal defect).

Main Results:

• Successful ex vivo closure of tissue defects in porcine models.
• In vivo demonstration of safe and effective tissue closure in rat models, with 100% survival.
• Significant reduction of a ventricular septal defect in a porcine model (<1.6 mm) using the perventricular approach.
• Comparable inflammatory response to sutures observed in attached tissues.

Conclusions:

• The developed catheter-based technology provides a minimally invasive and atraumatic method for tissue defect repair.
• This innovative therapeutic platform shows promise for a wide range of clinical applications, especially for hard-to-reach defects.
• The device offers a safe and effective alternative to conventional surgical closure methods, potentially improving patient outcomes.