Ultrasound in a Needle: Minimally-invasive High Resolution Imaging for Neurosurgery

Lead Research Organisation: University of Dundee
Department Name: Imaging and Technology

Abstract

The research challenge we will tackle is to realise real-time visualisation of tissue in the brain with a needle capable of minimally-invasive, real-time, high resolution ultrasound imaging. This will, for the first time, enable the neurosurgeon to obtain immediate information about lesions and the location of critical structures in the brain intraoperatively, and thus to provide treatment with less morbidity and better patient outcomes.

Our specific engineering challenge is to create a needle carrying an integrated, miniature ultrasound array for high-resolution (~100 um) neurological imaging and to demonstrate feasibility for future translation into clinical practice. Previous EPSRC-funded collaboration by the Universities of Birmingham and Dundee has shown that piezocomposite material with microscale features can be realised with net-shape micromoulding techniques. Single element transducers based on these materials have been evaluated already and exploratory studies with Heriot-Watt University have demonstrated the capability to bond dense interconnects onto the new materials at low temperature and pressure to connect kerfless imaging arrays to external imaging electronics.

The research we now propose will extend and integrate this technical work with neurosurgery to determine basic capabilities using brain tissue in soft-embalmed cadavers and to explore potential surgical benefits and applications. As well as the three university partners, the work will benefit from support from four companies, covering all aspects of the technology as well as its translation into clinical practice.

Planned Impact

This project on ultrasound in a needle has its foundation in the unmet need for a truly intraoperative means of imaging for neurosurgical operations, and the deleterious effects this has on outcomes for patients. Thus we will focus our activity in impact on the technical capabilities of ultrasound in a needle, its integration into procedures already used by neurosurgeons, and the need for commercial delivery of devices and systems so that neurosurgeons can access the technology.

Our pathways to economic impact will rely heavily on our four company partners, Applied Functional Materials Ltd (ultrasound devices), Merlin Circuit Technology Ltd (interconnects and packaging), Diagnostic Sonar Ltd. (ultrasound systems) and Scottish Health Innovations Ltd (SHIL, commercialisation of clinical technology). The first three represent key stakeholders in the technical delivery of USIN while SHIL bring understanding of the process of translation, from the research bench to the operating room. We will meet representatives of all these companies regularly and will utilise their input in the impact plan that we will update and act upon continuously.
In recognition that the present proposal is structured as a feasibility study and that the pathway from research to commercial supply and use in healthcare is a long one, a key component in our impact plan is to obtain further funding; this will be done in partnership with our existing company partners, and with others, for example in the regulatory and testing sectors, as these are required. Through the project leadership in IMSaT, we already have routes to ISO-accredited working practices and contacts with companies such as Onorach (on the design of clinical studies) and Precision Acoustics (on safety testing of ultrasound devices).

Our pathways to societal impact ultimately rely on the need for a commercial supply of devices. Societal impact will then follow from the improved patient outcomes that are generated. Approximately 20% of hospital admissions in the UK are for neurological conditions, ranging from minor conditions to those with very significant mortality, such as stroke. All those requiring surgical intervention will be considered as having the potential to benefit from USIN. The new weapon our research will create in the neurosurgeons armamentarium will have a particularly large impact on haemorrhage, making it easier to avoid in the first place during intracranial intervention, and quicker to deal with if it has already occurred. It will also allow more accurate diagnosis and evaluation of conditions such as brain cancer and better placement of devices such as cannullae for aspiration and electrodes for deep brain stimulation.
As well as their immediate effects, neurological disorders have significant potential for short and long term morbidity following from the original condition and its treatment. USIN may thus beneficially affect a whole chain of people in society, from the neurosurgeons and theatre teams who operate on the patients, to the people who care for them either intensively or in dealing with long term problems, through to the patients themselves and their families, friends and colleagues.
 
Description Needle insertion into the body is generally done with no or only external guidance i.e. with the clinician relying entirely on her skill and knowledge of anatomy to reach the target or using external imaging, either prepared beforehand such as with MRI or in real time with ultrasound. This is acceptable for shallow insertion or into simple anatomy but causes difficulties if the insertion is deep and a specific small lesion is to be targeted or the anatomy is complex, such as in the brain.

In this project, we explored the feasibility to build miniature ultrasound devices for incorporation within the needle itself. This involved a great deal of discussion with clinicians and collaborative work between three universities, Dundee, Heriot-Watt and Birmingham. Dundee was responsible for device design and testing; Heriot-Watt for microengineering, including interconnecting the ultrasound devices and the miniature cable to create electrical connections at the end of the needle; and Birmingham for creation of the ultrasound devices themselves.

Extensive testing was done on phantoms, i.e. artificial ultrasound targets built to demonstrate the capabilities of a system, and on ex vivo tissue from both humans, using tissue donated and preserved for research, and animals, in this case waste taken from the abattoir and at an animal testing site. This showed both unexpected successes and some additional interesting problems.
Exploitation Route Whilst we generated a great deal of clinical interest, this was somewhat opportunistic. However, the neurosurgical Clinical Research Fellow working on the project considered the potential for future applications to be very bright indeed, with ultrasound-enabled needle guidance of use in every medical specialism in which deep insertion of needles or insertion into complicated anatomy is required. Additional interest was generated in breast cancer radiology, prostate cancer diagnosis and anaesthesia and a spin-off research project was funded by the NHS to explore applications in epidural needle guidance. It is intended that further development work will be undertaken in these areas as they are worked up into full projects.
Sectors Digital/Communication/Information Technologies (including Software),Electronics,Healthcare

 
Description A very large healthcare multinational invited relevant members of my team to work on a service contract to assist with manufacturing of a product, intended to sell in very large numbers, for ultrasound-guided needle insertion. This work was completed successfully. Additionally, discussions have taken place with clinicians, who are now aware of the potential for ultrasound as a sensing modality integrated in a needle.
First Year Of Impact 2017
Sector Electronics,Healthcare,Manufacturing, including Industrial Biotechology
Impact Types Economic

 
Description Surgery enabled by ultrasonics
Amount £6,114,693 (GBP)
Funding ID EP/R045291/1 
Organisation Engineering and Physical Sciences Research Council (EPSRC) 
Sector Public
Country United Kingdom
Start 11/2018 
End 10/2023
 
Description USINN - Edinburgh and Lothians Health Foundation
Amount £33,458 (GBP)
Funding ID 337-396 
Organisation Edinburgh & Lothians Health Foundation 
Sector Charity/Non Profit
Country United Kingdom
Start 12/2014 
End 05/2015
 
Description Ultrasonic differentiation of healthy and diseased neural tissue
Amount £46,000 (GBP)
Funding ID 1953632 
Organisation Stryker 
Sector Private
Country United States
Start 10/2017 
End 09/2019
 
Description Academic partnership with University of Edinburgh 
Organisation University of Edinburgh
Department School of Informatics Edinburgh
Country United Kingdom 
Sector Academic/University 
PI Contribution The University of Edinburghhosting a PhD student, Mr Rui Song, who worked on electronics for integration with piezoelectric devices ultimately to form large scale arrays for dexterous acoustic particle manipulation. I and my research team provided knowhow in electronics and piezoelectric devices and some physical devices for use in this work.
Collaborator Contribution The specialism of Prof. Underwood and his team at SMC is in integration of electronics with other devices. Hence, Prof. Underwood and Dr Song engaged particularly with electronics design, including development of an application specific integrated circuit and related electronics that allowed prototype acoustic tweezers to be demonstrated.
Impact This collaboration involved physics, electrical engineering and mechanical engineering.
Start Year 2015
 
Description Integrated ultrasound needle to facilitate placement of regional anaesthesia in obese pregnant women. 
Organisation Royal Infirmary of Edinburgh
Country United Kingdom 
Sector Hospitals 
PI Contribution Research on bonded technology
Collaborator Contribution Research on use of bonded technology to facilitate placement of regional anaesthesia
Impact Still active, not applicable to date
Start Year 2015
 
Description Invited Talk - Rotterdam - Utilisation of high resolution ultrasound for sensing in the body 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Postgraduate students
Results and Impact ~20 students and researchers from Erasmus Rotterdam attended a 1 hour talk by Prof. Cochran and Dr. Lay about the use of high resolution ultrasound for sensing in the body. This featured significant coverage of the work done in the USINN and SONOPILL projects.
Year(s) Of Engagement Activity 2016
 
Description Invited Talk - TU Delft - Utilisation of high resolution ultrasound for sensing in the body 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Postgraduate students
Results and Impact ~30 students from Delft University of Technology attended a 1 hour talk by Prof. Cochran and Dr. Lay about the use of high resolution ultrasound for sensing in the body. This featured significant coverage of the work done in the USINN and SONOPILL projects.
Year(s) Of Engagement Activity 2016