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Active MRI Needle

Description:

  1. Active MRI Needle

Fast-Track proposals will be accepted.

Number of anticipated awards: 2 Phase I, 2 Phase II

Budget (total costs, per contract): Phase I: up to $300,000 for up to 12 months; Phase II: up to $2,500,000 for up to 2 years

PROPOSALS THAT EXCEED THE BUDGET OR PROJECT DURATION LISTED ABOVE MAY NOT BE FUNDED.

Summary

Needle access to deep organs is common to numerous catheter, radiological, and surgical procedures, both diagnostic and therapeutic, including access to blood vessels, pericardial and cardiac chambers, viscera, etc.  MRI operation affords exquisite imaging and delineation of soft tissue beyond what is afforded by X-ray fluoroscopy, CT, and ultrasound guidance.  “Passive” needles visualized solely by their materials properties, afford inadequate tracking and visualization into and around precise or precious structures.  “Active” MRI catheter devices contain electronic elements to accomplish MRI visibility.  This solicitation aims to support the development of an active MRI needle tools for commercial clinical availability.

Project Goals

The goals of this project are to develop and obtain market clearance for an active MRI needle to be used in patients.

Phase I Activities and Expected Deliverables

The deliverable is a market-cleared system including active MRI needle and all necessary accessories for MRI-guided active needle access in patients. “Active” refers to visualization by virtue of serving as one or more resonant antennae connected or coupled to the MRI hardware system. 

The deliverable must have the following characteristics

  1. Available in a range of sizes as small as 21G and as large as 18G
  2. Available in a range of lengths as short as 5cm and as long as 20cm
  3. Accommodates guidewires from 0.014” to 0.035” outer diameter for the 21G to 18G embodiments, respectively
  4. Luer-type hub connection for syringes
  5. Conical hub inside Luer to simplify guidewire insertion
  6. Electrical isolation type “CF” for patient safety
  7. Free from clinically-important heating during continuous MRI at base magnetic fields up to 1.5T.  
  8. Visualized using continuous (“active profiled”) or interrupted (“active marker”) antenna or resonator designs
  9. Provides confident certain visualization of the needle tip under the full range of operating conditions.
  10. Ergonomic signal transmission system that does not impede mechanical operation of needle (such as a heavy connector cable to the scanner).
  11. Accessory capabilities, such as connectors, transmission lines, and/or coil configuration files, as required for operation with MRI systems, at least including the MRI system manufacturer allowing testing by NHLBI DIR (Siemens). This requires evidence of a collaboration agreement with a system manufacturer.
  12. Proposals that include novel strategies to mitigate heating of the needle or of transmission lines (connectors to MRI scanner hardware) are encouraged
  13. Proposals for novel visualization strategies are welcomed

A Phase I award would develop and test an actively visualized needle system in vivo.   The contractor should provide a detailed report of pre-IDE interactions with the Food and Drug Administration to identify requirements for premarket notification [510(K)] under Phase II, including the summary of mutual understanding.

The contracting DIR lab is willing to provide feedback about design at all stages of development.  The contracting DIR lab will test the final deliverable device for success in vivo in swine.   This requires specific hardware compatibility with the NIH Siemens Aera 1.5T MRI system.

Phase II Activities and Expected Deliverables

A phase II award would allow testing and regulatory development for the device (described under phase I) suitable for marketing in the United States, whether under premarket notification [510(k)] marketing clearance.  510(k) clearance would constitute the deliverable. 

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