A Single Incision Delivery Tool for Epicardial Pacing and Defibrillation

PI: Charles Berul, MD
AFFILIATION Children’s National Health System
Award: $50,000

Abstract
Each year, nearly 7,200 infants in the United States are born with a complex congenital heart disease that will require surgical intervention within the first year of their life. For infants and young children suffering from arrhythmias, this treatment can be especially difficult, as the size of their vasculature, venous obstruction, and congenital anomalies can preclude a transvenous approach for implanting a cardiac therapy device. As a result, much of this population will undergo a sternotomy or thoracotomy to identify and expose the epicardial surface of the heart, so that pacemaker and defibrillation leads can be sewn directly to cardiac tissue. This open chest procedure is highly invasive, and children will spend multiple days in post-operative recovery which may include stays in the intensive care unit. There exists no technology to enable the non-surgical implant of cardiac therapy devices through a percutaneous minimally invasive approach.
Our multidisciplinary team at the Sheikh Zayed Institute for Pediatric Surgical Intervention has developed a surgical tool, and novel approach, to expose and deliver cardiac therapy to the epicardial surface of the heart, through a percutaneous procedure. Through internal funding, and external support from Medtronic, Inc., our team manufactured non-sterile prototypes that were used to successfully implant pacing and defibrillation leads within the pericardial space of phantom, cadaver, and in vivo models. For FDA approval, we will file a humanitarian device exemption while demonstrating the tool does not pose a significant risk to the patient, and that this risk is outweighed by probable patient benefit.

Innovative Use of 3D Printing in Gynecology: Customizable 3D Printed Pediatric Vaginal Stent and Vaginal Dilator

PI: Julie Hakim, MD
AFFILIATION Baylor College of Medicine
Award: $50,000

Abstract
Three-dimensional printing (3DP) enables fabrication of customized medical devices. 3DP has not been used within the field of gynecology. Vaginal dilators (VD) and vaginal stents (VS) are used post-surgically following neovagina (NV) creation. Neovaginal creation is necessary in girls born with Mayer Rokitansky Kuster Hauser syndrome (1/4500), Vaginal Agenesis (1/5000-7000), Complete Androgen Insensitivity (8/1000), cloacal anomalies, Congenital Adrenal Hyperplasia or other congenital anomalies1. Once the vaginal canal has been created surgically, most postoperative patients will need to wear the VS continuously for at least 7 days in order for the vaginal tissues to heal without apposing one another. Following stent use, most patients will need to transition to VD to maintain the VP if not sexually active. VD can be used for neovagina creation in patients with vaginal agenesis related to congenital conditions, who decline or who may not be candidates for surgery. In
addition, among patients who have undergone surgery, they are instrumental to use post operatively to
maintain the caliber of the neovaginal canal and prevent restenosis after a VS has been removed. Currently available VS and VD exist only in adult sizes that cannot be used safely or comfortably in the pediatric population. Restenosis rates post-vaginal surgery is as high as 73%6. Studies have suggested early discontinuation of VD use due in part to dilator design and discomfort related to the types of dilator material used4. Anecdotally, pediatric and adolescent patients express discomfort with dilator design, ergonomics of device insertion and removal, as well as with extrusion of VS from vagina5 .This unique interdisciplinary collaborative project combines the clinically proven expertise in Pediatric Adolescent Gynecology led by Dr. Jennifer Dietrich and Dr. Hakim (Baylor College Medicine) and the expertise in 3D printing for medical devices and device development led by Dr. William Cohn (Center for Technology Innovation). We hypothesize that currently available 3D scanning techniques can be used to customize 3DP VS and VD to improve patient comfort and clinical outcomes without having to rely on pre-surgical imaging. Our research will elucidate VD and VS materials for optimal device performance and demonstrate how 3D scanning, printing techniques can overcome anatomic variations and improve device function. This project is a novel method of translating new
technologies into innovative clinical applications, and will focus on development of a commercial prototype and testing of that prototype in live animal studies. We will have demonstrated that 3DP can be used successfully in the field of gynecology to create new VS and VD with improved functionality, fit, and clinical outcomes.

Pediatric Breathing Stimulator – Smart Apnea Stimulator (SAS)

PI: Richard diMonda, BEE, MSBME, MBA
AFFILIATION Sensory Innovation Solutions, Inc.
Award: $50,000

Abstract
Three-dimensional printing (3DP) enables fabrication of customized medical devices. 3DP has not been used within the field of gynecology. Vaginal dilators (VD) and vaginal stents (VS) are used post-surgically following neovagina (NV) creation. Neovaginal creation is necessary in girls born with Mayer Rokitansky Kuster Hauser syndrome (1/4500), Vaginal Agenesis (1/5000-7000), Complete Androgen Insensitivity (8/1000), cloacal anomalies, Congenital Adrenal Hyperplasia or other congenital anomalies1. Once the vaginal canal has been created surgically, most postoperative patients will need to wear the VS continuously for at least 7 days in order for the vaginal tissues to heal without apposing one another. Following stent use, most patients will need to transition to VD to maintain the VP if not sexually active. VD can be used for neovagina creation in patients with vaginal agenesis related to congenital conditions, who decline or who may not be candidates for surgery. In
addition, among patients who have undergone surgery, they are instrumental to use post operatively to
maintain the caliber of the neovaginal canal and prevent restenosis after a VS has been removed. Currently available VS and VD exist only in adult sizes that cannot be used safely or comfortably in the pediatric population. Restenosis rates post-vaginal surgery is as high as 73%6. Studies have suggested early discontinuation of VD use due in part to dilator design and discomfort related to the types of dilator material used4. Anecdotally, pediatric and adolescent patients express discomfort with dilator design, ergonomics of device insertion and removal, as well as with extrusion of VS from vagina5 .This unique interdisciplinary collaborative project combines the clinically proven expertise in Pediatric Adolescent Gynecology led by Dr. Jennifer Dietrich and Dr. Hakim (Baylor College Medicine) and the expertise in 3D printing for medical devices and device development led by Dr. William Cohn (Center for Technology Innovation). We hypothesize that currently available 3D scanning techniques can be used to customize 3DP VS and VD to improve patient comfort and clinical outcomes without having to rely on pre-surgical imaging. Our research will elucidate VD and VS materials for optimal device performance and demonstrate how 3D scanning, printing techniques can overcome anatomic variations and improve device function. This project is a novel method of translating new
technologies into innovative clinical applications, and will focus on development of a commercial prototype and testing of that prototype in live animal studies. We will have demonstrated that 3DP can be used successfully in the field of gynecology to create new VS and VD with improved functionality, fit, and clinical outcomes.

Dynamic Fitting Assistive Technology for Children Using JamFit Technology

PI: Jason Hill
BeTH | Benevolent Technologies for Health
Award: $50,000

Abstract
Human mobility is coming into a new era in which bionics are beginning to mimic human function and have become dynamic extensions of the body designed to deliver quality of life never before imagined. For children who have suffered an amputation bionic innovations enable necessary human development however the human-device connecting interface remains a largely undeveloped and these advanced technologies rely on materials and a process almost a half century year old. BeTH which stands for Benevolent Technologies for Health is a medical device company with a patent pending technology aimed at delivering unprecedented comfort and adjustability for amputees so that they can spend more time living life. BeTH uses JamFitTM shape-capturing technology uses vacuum pressure to adjust granular material in an enclosed membrane to conform to the body’s shape making it capable of evolving its shape as the body changes. BeTH’s first product is a dynamic socket liner that allows amputee to easily adjust the shape of their socket. The former lead prosthetist from Walter Reed Hospital called it ‘the first dynamic solution to a dynamic problem.

Non-Fusion, minimal invasive system for treatment of Adolescent idiopathic Scoliosis (AIS)

PI: Uri Arnin
ApiFix, Ltd.
Award: $25,000

Abstract
The ApiFix system (www.apifix.com) is intended to save the irreversible long spinal fusion for children suffering from AIS. The system is a ratchet based expandable rod that elongate, in a completely non invasive way, when the patient is doing physical therapy exercises post surgery, leading to a gradual curve correction over 3-6 months. The system is in limited clinical use for 3 years now but further clinical data is needed. ApiFix will use this grant to perform a controlled clinical study in Europe.

Rapid, automated detection of clinically significant TBI using the Head and Interocular Injury Test (HITT)

PI: Justin Shaka
ApiFix, Ltd.
Award: $25,000

Abstract
Concussive head injuries (often labeled mild traumatic brain injury or mTBI) can be difficult to diagnose, as the symptoms are protean and overlap with other neuropsychiatric disorders. Management of mTBI is complicated by the absence of safe, objective, and sensitive tools to assist providers in making the diagnosis. Patients with TBI exhibit abnormalities in fixation accuracy and stability, saccadic eye movements, and retinal structure that can be detected by eye movement recordings and retinal imaging. However, these technologies are expensive, complex, and unsuitable for point-of-care use and can be difficult for pediatric patients to complete. REBIScan has developed a noninvasive, handheld device that uses retinal birefringence scanning (RBS) to rapidly assess vision abnormalities in children. The instrument can be reliably used by a non-medical operator to provide clinically relevant information with high accuracy. Targeted modification of the current RBS device for assessment of TBI will allow a single-scan evaluation of the entire axis of potential injury from retina to cortex and key brain structures in-between. The ability to detect abnormalities, and thus rapidly and objectively identify pediatric patients with presumptive TBI, could improve quality outcomes, lower cost of care, and assist providers in reengaging kids to school and play.