Safe Reorientation After a Single Entry Targeted Biopsy Needle Insertion (Case No. 2024-215)

Summary:

UCLA researcher Sara Babapour has developed a biopsy guidance platform featuring a flexible, artifact-generating sheath that enables safe, multi-directional navigation and improved trajectory measured visualization during image-guided tissue sampling. The technology is designed to reduce multiple needle insertions and improve time efficiency with accuracy in MRI, CT- and ultrasound-guided biopsies.

Background:

Image-guided biopsies, including MRI, CT- and ultrasound-guided procedures, often require multiple needle and constant radiation for a minimum of 20-30 minutes of insertions to achieve proper alignment and sufficient target tissue sampling. Even in targeted biopsy approaches, clinicians frequently adjust needle trajectory through repeated attempts, increasing the risk of complications such as vascular perforation, tissue damage, and patient procedure period discomfort. Additionally, multiple imaging cycles are often required to confirm breathing and positioning, which increases procedure time, radiation exposure (in CT-guided cases), and operational costs. These challenges are particularly pronounced when targeting small or difficult-to-access lesions and in settings with less experienced operators, such as teaching hospitals. Current coaxial guide systems provide limited support for safe in-body repositioning or trajectory correction once inserted, highlighting the need for a solution that enables accurate, single-entry access while minimizing tissue disruption and procedural complexity.

Innovation:

To address these unmet needs, Sara Babapour has developed a flexible, cylindrical silicon-based sheath/sleeve that covers and lines the biopsy needle and enables controlled navigation of the marked tip or entire needle measurement lines within tissue. The sheath is designed to allow safe rotational, re-orientation and directional adjustments after initial insertion by reducing friction and minimizing the risk of tissue perforation. A key feature of the system is the incorporation of radiopaque or echogenic materials (e.g., diamagnetic metals for MRI or calcium-based compounds) within or on the sheath, which generate a visible elongated linear or periodic rings/dashes artifact under MRI, CT or ultrasound imaging. This creates a real-time “roadmap” that helps clinicians visualize and maintain a precise trajectory toward the target tissue. The sheath also provides a protected internal channel for forward and backward needle movement, supporting accurate sampling once the optimal path is established. The design is compatible with existing biopsy needles and coaxial systems and can be adapted across different needle sizes, user demand and imaging procedures.

•    For subcostal liver, abdominal cavity advances for lymph nodes, transgluteal pelvic, lung (with pleura-safe features), renal (respiratory motion imaging problems), thyroid/breast (high-frequency US).
•    Curved-path navigation embodiments can be pre-formed curved distal segments, steerable distal tip, or segmented stiffness zones to permit controlled deflection after entry.
•    Multiple sheath lengths/coverage may be both distal-only sleeve vs longer sleeve extending proximally; partial circumferential coverage (e.g., “C-shaped” liner) to preserve tactile feedback based on necessity.
•    Specialty imaging needle compatibility: core biopsy guns, FNA, ablation probes, drain/intubation placement, biopsy + marker deployment through same channel.

Option to modify calcium powder shape within the cover based on user preferences:

•    ring/spiral band, dual parallel lines (to encode rotation), or a “T”/arrow marker at the distal end to show tip orientation.
•    Tunable visibility: selectable radiopacity/echogenicity levels (e.g., layered fillers) to avoid extra blooming in CT or excessive shadow in US.
•    Multi-modality markers: calcium density formulations can have controlled visibility in CT + US and optionally MRI (with MRI-safe susceptibility control).
•    Orientation encoding: asymmetric marker placement around circumference so rotation can be inferred from the adjusted image artifact pattern.
•    soft tapered nose, or compliant distal “skid” to reduce snagging/perforation during redirection except for needle shot gun protrusions.

Potential Applications:

•    CT- and ultrasound-guided core biopsies (e.g., abdominal, liver, kidney)
•    Fine needle aspiration (FNA) procedures
•    Interventional radiology and image-guided minimally invasive procedures
•    Biopsy procedures targeting small or difficult-to-access lesions
•    Training environments and teaching hospitals
•    Any application requiring precise needle navigation in soft tissue
•    Inserting the covered needle once, with an adjustable, distinct distal terminus calcium-filled radiopaque marker or graduated marker (measured fills and dashed lines) to have extra depth estimation based on demand
•    Imaging visualization of the artifact road map, a parallel straight line forward
•    Rotating/reorienting the tip-covered needle within tissue while maintaining a protected pathway
•    Advancing/retracting the biopsy needle along the roadmap to a new target without a new puncture

Advantages:

•    Reduces need for multiple needle insertions. reduction in number of repositioning attempts/imaging cycles (bench/phantom study).
•    Enables safer in-body needle repositioning and multi-directional navigation for multiple sampling
•    Radioapaque estimation of the tip and insertion depth with a calcium marker in a sheath/sleeve/liner fixed for reusable devices or a removable, disposable one-time purpose sampling
•    Provides real-time visual parallel-lined radiopaque “roadmap” for trajectory guidance in hollow spaces and body cavities
•    Minimizes risk of vascular perforation and tissue damage by the needle tip with a perforable or fissured tip cover/liner
•    Decreases procedure time, re-sampling due to inadequate tissue, imaging requirements, biopsy complications, and associated costs
•    Compatible with existing biopsy systems and workflows
•    Scalable, adjustable to user-specific demands, low-cost, and adaptable across needle types and sizes
•    Improves usability for less experienced operators and for training purposes
•    Better needle elongated tip and end (position) visualization, measured orientation feedback, and atraumatic rotation.
•    Device/system: needle sleeve/cover + artifact-generating feature(s) configured to create an elongated roadmap ahead of the needle tip, indicating position and/or orientation during imaging, and configured for rotation/reorientation in an organ.
•    Method independent: single insertion + imaging roadmap and depth estimation + rotating/reorienting within organ + advancing biopsy needle based on roadmap.
•    Kit independent (optional): cover + different needle compatibility for other purposes + instructions for imaging/body rotation interventions.

State of Development:

Functional prototype in development.

Reference:

UCLA Case No. 2024-215

Lead Inventor:

Sara Babapour, Department of Radiology

Patent Information:
For More Information:
Megha Patel
Business Development Officer
Megha.patel@tdg.ucla.edu
Inventors:
Sara Babapour