Growing heart valve prosthesis that mitigates need for repeat surgery

This technology is a hybrid regenerative prosthetic heart valve that can grow with the patient over time, eliminating the need for multiple valve replacement surgeries in pediatric patients.

Unmet Need: Growing and biologically-responsive heart valve prosthesis

Manufactured heart valves for pediatric heart valve replacement are challenging due not only to the complexity of the valve’s structure and function, but also to the necessity for the valve to be durable and grow with the patient over time. Currently available bioprosthetic and mechanical valves suffer from poor durability and blood circulation and do not have the capacity to grow, requiring pediatric patients to get repeating valve surgeries every few years to manually replace each implant. A bioprosthetic valve capable of growing with the patient will avoid the need for reoperations, decrease mortality, and improve the quality of life for pediatric heart valve recipients.

The Technology: Biohybrid, tissue-engineered, growing valved tube

The technology is a hybrid regenerative prosthetic heart valved conduit that can grow with the patient over time, eliminating the need for multiple valve replacement surgeries in young patients as they age. The tubular component of the prosthesis is made of a bioresorbable polymer that degrades and is replaced with living, growing tissue over time. The valve component is composed of a non-biodegradable polymer and features an increased height of coaptation, which allows the valve to remain mechanically competent as the tube diameter and tissue component grows. The valve itself will remain polymeric and will not be replaced by a neo living tissue, whereas the tube (or vessel) will be. The implant is made with a mixture of 3D and dip-molding techniques for maximal durability, using biocompatible polymers available at low cost and currently used in clinical devices. The design is free of sutures, which negates the need for human dependencies during the fabrication process and ensures valve reproducibility and durability.

Applications:

• Heart valved conduit prosthesis
• Other implantable tubular device which requires growth (pediatric urology, GI surgery, or neurosurgery)
• Design for expandable catheter tubing
• Other implantable devices containing both biodegradable and biostable components

Advantages:

• Grows with patient
• Reduces need for reoperation, decreasing patient morbidity and mortality
• Decreases healthcare costs
• Polymeric valve with no risk of intimal proliferation and structural degeneration
• Uses a biostable polymer that maintains the competency of the valve component in vivo
• Tube is replaced with living tissue as it degrades in vivo
• Can incorporate peptide functionalization of the bioresorbable polymer to enhance tissue regeneration
• Can be manufactured with existing techniques - injection molding, extrusion, dip molding, dip coating, 3D printing, electrospinning, or another type of fabrication process
• High reproducibility and lower manufacturing costs
• Suture-free, removing human component during the fabrication process to improve reproducibility and durability of prosthetic
• Made of low-cost biocompatible polymers

Lead Inventor:

David Kalfa, M.D., Ph.D.

Patent Information:

Patent Pending(EP 4081274)

Related Publications:

Tech Ventures Reference:

• IR CU20164

• Licensing Contact: Kristin Neuman