To address this unmet surgical need, a team of researchers from Boston Children's Hospital and Brigham and Women's Hospital have developed a growth-accommodating implant designed for use in a cardiac surgical procedure called a valve annuloplasty, which repairs leaking mitral and tricuspid valves in the heart.
"Medical implants and devices are rarely designed with children in mind, and as a result, they almost never accommodate growth," said Pedro del Nido, MD, co-senior author on the study and chief of cardiac surgery at Boston Children's Hospital. "So, we've created an environment here where individuals with expertise and interest in medical devices can come together and collaborate towards developing materials for pediatric surgery."
del Nido partnered with Jeff Karp, a bioengineer and principal investigator at Brigham and Women's Hospital (BWH), who brought his laboratory's expertise in chemical engineering and biopolymer materials into the mix for this research.
After vetting many different concepts for a growth-accommodating implant, the team took its inspiration from the braided, expanding design of a Chinese finger trap, selecting their first proof-of-concept to be a tricuspid valve annuloplasty ring implant.
"The implant design consists of two components: a degrading, biopolymer core and a braided, tubular sleeve that elongates over time in response to the tensile forces exerted by the surrounding growing tissue," said Eric Feins, co-first author on the paper and a former research fellow in del Nido's lab. "As the inner biopolymer degrades, the tubular sleeve is becomes thinner and elongates in response to native tissue growth."
To create the degrading core, Karp's team recommended the use of an extra-stiff, biocompatible polymer that begins to erode on its surface following implantation. The polymer itself is made of components that already exist in the human body.
"By adjusting the polymer's composition, we can tune the core to degrade predictably over a pre-determined amount of time," said Karp.
"In combination with the braided sleeve exterior, this two-part implant concept could have many medical applications beyond the most obvious ones to enhance cardiac valve surgery in children," said del Nido.
The proprietary design of the braided sleeve developed by del Nido and Karp's team doesn't just share resemblance to a Chinese finger trap but also to an organic structure engineered by nature itself.
"We solved this problem of growth accommodation with a concept that already exists in nature: the octopus has a special ability to stretch its arms into confined cracks and spaces between rocks, in search of its prey," said Yuhan Lee, co-first author on the study and a materials researcher at BWH. "It can do this because of unique, braid-like crossfibers of connective tissue that enable the simultaneous elongation and shrinking diameter of its arms, allowing it to extend its reach two to three times beyond the original arm length."
Currently, children who undergo life-saving cardiac surgeries, such as mitral and tricuspid valve repairs, may require several additional surgeries over the course of their childhood to re-repair or replace leaking heart valves. The novel growth-accommodating implant is meant to enhance the durability of pediatric heart valve repairs while also accommodating a child's growth, decreasing the number of heart surgeries a child must endure.
Beyond cardiac repair, the research team says the tubular, expanding implant design used in their proof-of-concept—reported in Nature Biomedical Engineering—could also be adapted for a variety of other growth-accommodating implants throughout the body.
Based on the promising in vivo experimental data presented by del Nido and Karp's team, the biomedical device company CryoLife Inc., is already developing their concept into a growth-accommodating annuloplasty ring implant for pediatric heart valve repair.
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