Q&A: LEAP Valve - Introducing a New Class of Stent Design

Q&A: LEAP Valve – Introducing a New Class of Stent Design

Med-Tech Innovation News invited Daniel F. King of Draper to provide exclusive executive commentary on the debut of the LEAP Valve. King is a senior member of the technical staff at Draper where he leads the development of the Pediatric Low-Force Expandable/Adaptable Valve (LEAP) – the first heart valve that can grow with a patient.

What is a LEAP valve made of?

Draper’s LEAP pediatric heart valve is the focus of preclinical studies at two US research institutions – Boston Children’s Hospital and Seattle Children’s Hospital. The LEAP valve used in the studies consisted of a nitinol stent and a tissue valve. The strut design allows for double the size, regardless of the starting diameter. We select small diameter tissue valves to meet the needs of the smallest patients for our first studies. However, the stent design can be minimized and a suitable fabric valve selected for larger sizes.

How do you expand?

The expandable and adaptive stent, when used as part of an artificial heart valve device, is designed to passively expand as the patient grows. The LEAP valve is improved hemodynamically for the baby and may be small enough for use in infants born with heart defects. The expandable design gives the LEAP valve enough stored energy for continuous expansion from an initial diameter to a fully extended diameter over time.

Stents can be classified into two broad categories: self-expanding stents and stretchable balloon stents. Draper offers a third class of stent design: a growth adaptive stent that conforms to a biological structure, such as a heart valve annulus, and expands as tissue structure grows or changes shape. This is achieved by designing the folds within the stent that are optimized to exert sufficient force to expand within the patient without damaging the patient’s tissue.

Where is the LEAP valve currently available?

The LEAP valve is currently undergoing preclinical studies at two US research institutions – Boston Children’s Hospital and Seattle Children’s Hospital. Because the device is patented, medical device manufacturers can license the design through an agreement with Draper.

Give us an insight into MANTIS technology and the impact it could have on device manufacturing?

One of the main challenges facing the biofabrication of prosthetics is the need to combine two different materials (soft tissue and metal) into a single functioning device. MANTIS (Mechanical Adhesive for TISsue) is an alternative attachment solution intended to solve this problem. MANTIS is developed to adhere to wet compliant surfaces while also having sufficient adhesive strength and flexibility to withstand dynamic environments inside the core and device expansion. For use with the LEAP valve, MANTIS will be made from biocompatible but non-biodegradable materials. For other indications where degradation is beneficial, the same MANTIS fabrication techniques can be applied to biodegradable materials.

MANTIS can save the labor-intensive labor of manual suture because it achieves valve stent integration through mechanical tissue adhesion method which can be more automatic. MANTIS will adhere quickly, be compliant yet robust enough to withstand dynamic conditions within the body and can be deployed in wet environments such as internal organs and wounds.

What kind of devices can be used?

MANTIS can be used as a medical adhesive coating to secure catheters, nasogastric tubes, endotracheal tubes, and chest tubes during en-route care. Besides medical intervention, MANTIS can enable new possibilities in deploying wearables and human technology interfaces.

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