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RIVANNA's Groundbreaking Initiative in Pediatric Care

RIVANNA®, a leading innovator in medical imaging technology, has received a significant boost with a $2.21 million grant from the National Cancer Institute (NCI) under the Small Business Innovation Research (SBIR) program. This funding aims to develop an advanced ultrasound guidance system specifically for pediatric lumbar punctures, utilizing RIVANNA’s state-of-the-art Accuro® 3S platform.

Lumbar punctures play a crucial role in managing acute lymphoblastic leukemia (ALL), the most prevalent cancer in children, accounting for roughly 25% of pediatric oncology cases. These procedures serve essential functions: confirming diagnoses and delivering vital intrathecal chemotherapy. As children undergo treatment, they may face up to 20 lumbar punctures over a two-year period, making advancements in this area imperative.

However, traditional lumbar puncture methods present numerous challenges. Recent studies indicate that traumatic lumbar punctures (TLPs), where cerebrospinal fluid becomes contaminated with blood, can occur in up to 38% of cases, leading to adverse patient outcomes. The procedure's difficulties increase substantially in younger patients or those with elevated body mass indices (BMI).

While fluoroscopy has been employed to enhance success rates, reliance on this technique exposes pediatric patients to cumulative radiation risks—an especially pressing concern given their need for frequent procedures. Although ultrasound guidance has been shown to minimize TLP rates and reduce radiation exposure, many practitioners still default to blind palpation or fluoroscopic assistance due to the complicated nature of traditional ultrasound systems.

To remedy these pressing issues, RIVANNA is set to roll out new pediatric-focused features on its Accuro 3S platform—an innovative, compact, and AI-powered bedside ultrasound system. The Accuro 3S features pioneering technologies that seamlessly integrate hardware and intelligent algorithms. It offers automatic detection of spinal anatomy and guidance for optimal needle insertion points. This in-built capability is particularly important for facilitating lumbar punctures in patients who might otherwise pose anatomical challenges.

Moreover, the system includes unique Dual-Array™ transducer technology, supporting precise needle trajectory management. The introduction of a disposable, sterile accessory to secure the ultrasound probe against the patient's back allows healthcare providers to maintain focus on needle control and tactile feedback during the procedure.

The design of the Accuro 3S accommodates a wide range of pediatric body types, ensuring its effectiveness from infants with sensitive anatomies to older adolescents with varying BMI. Significantly, the system is structured to lessen the learning curve associated with ultrasound guidance, allowing practitioners to achieve proficiency after only several supervised procedures. By limiting failed attempts and TLPs, the Accuro 3S is poised to enhance treatment outcomes and potentially increase survival rates for children afflicted with ALL, while also bolstering both patient and clinician satisfaction.

Paul Sheeran, PhD, Director of Research and Development at RIVANNA, emphasized the significance of this initiative, stating, "This project represents a monumental step toward ensuring safer, more effective spinal interventions for young oncology patients. Our Accuro 3S is meticulously designed to improve care delivery for pediatric ALL patients using our proprietary technologies, such as AI-BoneEnhance® imaging and SpineNav-AI™ anatomical recognition. These features not only simplify the procedure but also enhance precision and confidence for clinicians working with patients possessing complex anatomical needs."

The preclinical development phase will encompass AI features tailored explicitly to pediatric populations, together with collaborative usability studies to ensure that the platform adeptly meets clinical requirements. The collaboration involves esteemed clinical partners including experts from the University of Virginia Health, the University of Kentucky, and Oregon Health Science University, highlighting the commitment to advancing pediatric care.

With the backing of the National Cancer Institute under award number R44CA302033, RIVANNA aims to transform the landscape of pediatric lumbar punctures. The success of this project could significantly lower complication rates, elevate patient safety, and improve overall care experience in this vulnerable patient demographic.

For further insights into RIVANNA's initiatives, follow their journey of innovation in medical technologies that redefine care standards across pediatric oncology and beyond.