Neonatal Lumbar Puncture Device

NU 2021-170

INVENTORS
Shankar Rajeswaran, MD*

SHORT DESCRIPTION
A medical device designed to increase the success rate of neonatal lumbar punctures performed by frontline medical providers.

BACKGROUND
Lumbar punctures (LPs) are a key diagnostic tool for standard fever workup in neonates. Approximately 180,000 neonatal LP’s are performed yearly in the United States. This procedure involves accessing the spinal canal between L3 and L5 to retrieve cerebrospinal fluid for laboratory analysis. In neonates, the success rate for LPs is 50-60%. Multiple LP attempts lead to increased trauma and discomfort for patients and families. If frontline providers are unsuccessful after multiple attempts, patients are generally transferred to interventional radiology (IR) for image-guided LPs. However, in community hospitals where IR is not available, patients may be treated without an LP or transferred to a tertiary center. This challenge puts vulnerable neonates at risk for delayed and/or suboptimal care.

ABSTRACT 
The Neonate Lumbar Puncture Device is a simple tool that assists frontline medical providers in performing neonatal LPs. This sterile, disposable tool is designed to improve success rates for neonatal LPs, particularly for providers who do not frequently perform lumbar punctures and do not have imaging resources available. The device markedly reduces user variability/error in LPs by eliminating multipe degrees of freedom for needle placement and insertion. The device was specifically designed based on comprehensive analyses of neonatal anatomy. To date, it has undergone initial end-user testing in benchtop models for the evaluation of usability and accuracy.

APPLICATIONS 

• Neonatal lumbar punctures in community hospitals, emergency rooms, NICU’s, and other inpatient wards.

ADVANTAGES

• Improved success rate of neonatal lumbar punctures performed by frontline medical providers
• Reduced transfers to tertiary care centers and/or pediatric interventional radiology (IR) departments
• Unlike ultrasound/IR, this device is a simple tool requiring minimal training and minimal disruption to current workflows
• IR equipment/personnel available for other high-impact procedures
• Reduced time to diagnosis/treatment
• Less trauma - physical and emotional - to child and family due to decreased number of punctures and duration of procedure

IP STATUS
US patent and PCT applications have been filed.