Optical and Acoustic Imaging for Interventional Device Guidance

Medical needles are central to a wide range of diagnostic and therapeutic interventions, including tissue biopsies and injections of anaesthesia. Accurately and efficiently reaching deep tissue targets can be very challenging. Many needle insertions are performed with ultrasound imaging systems that are exterior to the body, and with the sense of touch that is relayed via the needles to a physician's hands. These techniques are often insufficient for directly detecting the tissue targets, however, and consequently there is a risk of inaccurate needle placement. For instance, with biopsies of the prostate, the suspected cancerous lesions may not be visible with ultrasound imaging, and consequently the biopsies may be obtained from incorrect locations.

As a new Lecturer at the Department of Medical Physics and Bioengineering at UCL, one of my primary objectives is to transform medical needles so that they that can provide molecular information about tissue and thereby significantly improve the accuracy of needle-based procedures. Leveraging recent advances in optical telecommunications technologies, these needles will deliver brief light pulses to tissues at their tips. By virtue of the photoacoustic effect, absorption of light pulses will generate sound waves that can be detected and converted into images of molecular absorption in real-time. The research programme kick-started by an EPSRC First Grant will ultimately lead to the development of a broad range of medical devices that could directly detect tissue targets and critical structures to improve clinical outcomes and decrease the risks of complications.

As principal investigator, one of my most important roles is to maximize the likelihood that developments in my lab are translated into prototypes and products that can have a positive clinical impact. My experience with device development at Philips Research provided me with hands-on experience with overcoming challenges encountered in the translational process, and a wide range of connections within industry. Now, as an academic, I am well positioned to develop devices that address well defined needs and that are compatible with current clinical workflow.

The proposed research will result in the creation of entirely new types of interventional devices. Together with the optical console and conventional ultrasound imaging, they will significantly advance our ability to integrate of optical and acoustic imaging in clinical contexts. As such, they could lead to a wide range of engineering developments in which medical devices such as needles are fitted with sensors that can actively sense and respond to their environment. There is an urgent need to increase the accuracy and efficiency at which needles are placed during ultrasound-guided interventions. With the developments proposed in this research programme, clinically relevant structures that are currently poorly visible or invisible with conventional ultrasound could be clearly identified. The resulting clinical impact could include improved procedure outcomes and decreased risks of complications from vascular penetration events.

Starting with the engineering and scientific ideas outlined in this proposal, I will take the following steps to translate developments in my lab into prototypes and products.

1. First generation prototype development (with the EPSRC First Grant).

2. Pre-clinical imaging, including ex vivo tissue imaging on cadaveric specimens from animals and humans, and in vivo tissue imaging on swine (with the EPSRC first grant).

3. Second generation prototype development, with UCL Business (UCLB). UCLB is a subsidiary of UCL that offers assistance with the technology development process, including IP licensing and the creation of spinout companies and joint ventures. UCLB recently developed a facility for medical device production with ISO standards.

4. Human Pilot Study: with regulatory approval, measurements on a small number of patients (<20) who are already scheduled for interventional procedures, using second generation prototypes.

5. Third generation prototype development, with medical device industry partner.

6. Large-Scale Studies: pending successful results from the human pilot study, and with support from a commercial partner, measurements of clinical outcomes with a large number of patients (>100).

An EPSRC First grant scheme is critical to make steps 1-2, and to generate data that can support funding and industry partnerships for steps 3-6. If results from these steps are successful, follow-up funding will be sought from the EPSRC and the TSB. Funding for large-scale studies will be sought from the MRC in a joint proposal with physicians at UCL Hospital.