Development_of_a_Fully_Integrative_Navigation_System_for_Needle_Placement_during_Image_Guided_Cancer_Diagnosis_and_Treatment_SOW_(003).docx

Development of a Fully Integrative Navigation System for Needle Placement during Image Guided Cancer Diagnosis and Treatment

A. Scope of Work

A1. Objective:

The goal of this contract is to develop and validate a cost effective, easy-to-use and fully integrated navigation system for needle placement during image guided cancer diagnosis and treatment. Applications include but are not limited to biopsy, various thermal ablations (e.g. radiofrequency, cryo-, microwave, and laser ablation), and brachytherapy.

Accurate diagnostic and/or therapeutic intervention depends on accurate needle insertion, which may be extremely difficult in certain settings. In standard CT-guided needle placement procedures, translation from a pre-planned needle angle to the actual intra-procedural needle insertion is estimated only with the physician’s visuospatial abilities and experience.

The goal of this contract is to improve needle placement in clinical practice. Image-guided needle insertion is a promising method for fulfilling the project goal, but the system must be cost-effective, accurate, and ergonomic to be clinically feasible. The proposed system’s hardware includes a compact guidance platform that tracks needle-based interventional instruments, and provides navigation information to the clinician during the procedure. The system will be designed to assist with cancer treatment planning and procedure execution.

The technology will be a compact tracker design that can clip onto needles and provide Micro Electro Mechanical (MEM) inertial-based tracking. The hardware will also have fewer sterility requirements and it will be easier to calibrate compared to existing electromagnetic and optical tracking systems. The calibration step of the device only takes a few seconds, making it practically negligible. The wireless clip design allows the navigation device to be easily attached to and removed from any standard needles, which gives the physician the highly desired freedom to benefit from the navigation while minimizing its impact on the clinical workflow. Our device allows for visual guidance during procedures by providing real-time angulation tracking of needles, catheters, or interventional tools. Visual guidance will improve targeting accuracy, and reduce procedure time and side effects.

Outcome: The product of this contract is a fully integrated needle-guidance system prototype that is ready for human clinical trials. The system will be prototyped and evaluated in a live animal/human study to quantify the targeting accuracy and workflow for CT, Cone Beam CT, and Ultrasound-guided procedures

A2. Engineering Specifications:

1. Wireless needle tracker

The Government seeks prototypes of wireless needle trackers to address the challenges in needle placement procedures by accurately tracking the needle angular and positional information. The needle tracker design should be compact, wireless, and can be clipped onto any needle instrument (Fig. 1a-d). The system will provide 6 degrees-of-freedom (DOF) sensing at up to 40 Hz. The tracker should be configured to wirelessly stream data via Bluetooth. The system should be ready for calibration and validation.

Sensor Fusion The Government requires a method to combine the use of a gyroscopic sensing and the gravity vector to enhance needle tracking accuracy.

A3. Specific Instrument Descriptions and Deliverables: The contract deliverables include the wireless tracker electronics, mechanical protection cases, calibration docking stations, tracker chargers, and software source code for streaming out the positional information from the tracker.

· 3 prototype Micro Electro Mechanical (MEM) trackers for abdominal biopsy needles

· 3 prototype MEM trackers for abdominal ablation catheters

· 3 prototype MEM trackers for abdominal ultrasound probes

· 3 prototype universal MEM tracking beacons for multiple-propose tracking

· 3 prototype MEM trackers for Prototype MRI-guided prostate transperineal focal laser ablation

· 3 needle holders integrated with MEM trackers and an MRI visible needle-guide for navigation and registration

· 3 prototype 100mmX100mm MRI visible grid fiducial markers for prostate transperineal procedures

· 3 prototype electromagnetic tracker needle clips for multiple-propose needle procedures

· The tracker cases together with the tracker calibration docking station will be fabricated using 3D printing technology and are made deposable.

D. Period of Performance: 2-year contract with the start date of award and end date of 24 months following