Ultrasonic Needles based on Mn-doped Ternary Piezocrystals

Lead Research Organisation: University of Glasgow
Department Name: School of Engineering

Abstract

Ternary piezocrystals is the name given to a new group of single crystal piezoelectric materials that have a much higher mechanical Q and much higher energy densities than the binary compositions. Ternary piezocrystals have properties that are now sufficient for enabling their incorporation in high power ultrasonic devices. Their doped counterparts are a very recent development offering previously unavailable properties. Most importantly for high power ultrasonic transducers, they have increased the mechanical Q from around 100 to nearly 1000. However, completely new ultrasonic transducer configurations are needed to exploit fully this increased performance. Through characterisation and incorporation of doped ternary piezocrystal materials, and by capitalising on their significant potential for transducer enhancements, we will be able to create next generation high performance, high power ultrasonic devices for surgery. We will particularly investigate their integration in novel orthopaedic devices, aiming at the extremely challenging and potentially disruptive technology of ultrasonically-assisted needles. For minimally invasive, highly accurate, interventional surgery via direct penetration through bone, we will deliver devices offering the clinician entirely new and potentially transformational capabilities in a range of clinical applications including oncology, neurosurgery, orthopaedics, bone biopsy, regional anaesthesia and rheumatology. In meeting this challenge, we will develop new techniques for characterisation of the materials and create designs for novel transducers, based on the measured characteristics, for actuation of power ultrasonic surgical tools. We will research a new class of devices in the form of bone-penetrating ultrasonic needles that can be realised with doped ternary piezocrystals to permit the highly challenging surgical tasks of (i) direct delivery of therapeutic drugs to targets within or obscured by bone, (ii) gaining access within medullary canals and inside cranial sinuses/cavities for surgical procedures, and (iii) obtaining biopsies from the inside of the bone for diagnosis. Binary compositions of the new materials are already replacing conventional piezoceramics in biomedical imaging applications and adoption of these and the newer ternary compositions for other high value applications will increase as on-going efforts to scale up crystal growth techniques mature. This project will thus position the UK in the forefront of research, while simultaneously offering transformative research in ultrasonic devices for surgery.

Planned Impact

Societal impact will be generated through the diagnostic and therapeutic uses of the needles we will create. In diagnosis, the ability to penetrate bone will be particularly useful for biopsy and will also be explored for neural procedures, in which the capability to penetrate the skull with a needle will avoid the need for a separate tool and ease transcranial access. In therapy, the possibility to inject drugs directly at the site of treatment even when the path is obstructed by bone will offer new possibilities in the markets for targeted drug delivery treatments.
Our outreach activity, aimed at showcasing ultrasonics in interventional surgery at the Glasgow Science Festival, will create impact through public awareness of the opportunities afforded by this technology. This activity will also impact our early career research team in training for and management of this activity.

Our partnership with four companies will be our basis to address economic impact in the project.

Ethicon Endo-Surgery is a multinational supplier of surgical products, including a range of ultrasound actuated devices, and a key partner for us, representing the link between our work and commercial supply to clinicians. Our academic research on ultrasonic needles will therefore have a focus on practical outcomes that will lead to commercial products. This collaboration will also create impact beyond the highly innovative development of needles to penetrate bone, in improving other surgical devices such as ultrasonic scalpels.

TRS Technologies is an international leader in the development of piezocrystals, with major supply contracts with medical imaging companies in the binary crystal compositions it pioneered. It has subsequently developed ternary piezocrystal compositions specifically for high power applications, and is now exploring doped ternary compositions and new capabilities, such as continuous crystal growth rather than growth within a crucible, to assist their commercialization and bring down costs. The research in ultrasonic needles is a first demonstrator of doped ternary piezocrystals in high power ultrasonic devices and will be highly influential in creating new commercial opportunities for these materials.

PZFlex is a software package for virtual prototyping through finite element analysis. Supplied in the UK by Weidlinger Associates Ltd, it provides specialized capabilities for the simulation of piezoelectric devices, and is in use in many major medical ultrasound imaging companies. It remains at the forefront of piezoelectric device modelling through its use in many universities. By measuring piezocrystal material properties and incorporating them in complete PZFlex models, our work will provide data for a wide range of customers of PZFlex, enabling them to incorporate these new materials across a very wide range of transducer applications.

Our work with piezocrystals and high power, low frequency ultrasound devices has application in underwater SONAR. In this domain, transducer structures and issues such as physical size and power handling capability are very similar to those in surgical tools. We have partnered with Thales Underwater Systems Ltd to deal with this through a parallel programme in the development of piezocrystal-based transducers. TUSL is also planning to sponsor UK-based work in piezocrystal growth, offering another potential commercial route to these new materials for the first time from a company within the EU.
 
Description Ultrasonic bone biopsy needles have been designed that can successfully extract a biopsy from trabecular and cortical bone with less damage than a conventional bone biopsy needle.
Two different configurations have been successfully realised; one that uses a resonant needle and one that uses an ultrasonic-sonic transducer/needle arrangement.
A new characterisation technique has allowed the properties of ternary piezocrystal to be obtained and incorporated in the design of devices.
Ongoing research has allowed us to reduce heating and increase speed by tailoring the driving signal.
Exploitation Route We are working with a Skull Base Surgeon and Ethicon to develop the bone biopsy needle towards clinical uptake via EPSRC IAA funding.
Sectors Healthcare

 
Description Public demonstration at Dundee Science Centre in November 2015 and public exhibit at the Kelvingrove Museum in March 2016. We have further developed the bone biopsy needles through continuation of a sponsored PhD and have continued to improve performance. We have developed a miniaturised ultrasonic-sonic drill with the needle replacing the drill bit to provide an alternative new configuration of an ultrasonic needle. We have been awarded EPSRC IAA funding to work with the NHS Medical Devices Unit, a Skull Base Surgeon and Ethicon to develop and ultrasonic bone biopsy needle for penetration of the Petrous Apex.
First Year Of Impact 2015
Sector Education,Healthcare,Culture, Heritage, Museums and Collections
Impact Types Societal

 
Description An ultrasonic device for the surgical treatment of the Petrous Apex (and other challenging biopsy applications)
Amount £61,500 (GBP)
Organisation University of Glasgow 
Sector Academic/University
Country United Kingdom
Start 11/2018 
End 10/2019
 
Description EPSRC IAA and Stryker
Amount £60,000 (GBP)
Organisation Engineering and Physical Sciences Research Council (EPSRC) 
Sector Public
Country United Kingdom
Start 01/2017 
End 11/2017
 
Description Ethicon 
Organisation Ethicon
Country United States 
Sector Private 
PI Contribution Research input to penetrating bone with ultrasonic surgical devices, research on ultrasonic bone biopsy needles, integration of needles with Ethicon ultrasonic device platforms.
Collaborator Contribution Co-sponsorship of a PhD student, expertise, product information and equipment, advice on IP and pathways to clinical and commercial impact, support for EPSRC IAA award
Impact dx.doi.org/10.1016/j.phpro.2015.08.005; dx.doi.org/10.1109/TUFFC.2016.2633286
Start Year 2014
 
Description Stryker 
Organisation Stryker
Department Stryker Ireland
Country Ireland 
Sector Private 
PI Contribution We lead a strategic partnership with Stryker for their ultrasonics technical area. We collaborate on a range of ultrasonic interventional surgical devices, especially for bone cutting, and surgical navigation systems.
Collaborator Contribution Stryker have co-funded or fully funded 4 PhD students and an EPSRC IAA award. They are currently partners on our EPSRC Programme Grant (Surgery enabled by ultrasonics) and our EPSRC CDT FUSE (Future ultrasonic engineering). As well as direct funding, supervision and expertise, Stryker manufacture all the test samples and device components for our collaborative research. Stryker are co-funding a PhD studentship on the EPSRC Programme Grant - Surgery enabled by ultrasonics.
Impact Richards, D., Mathieson, A., Lucas, M. and Pretorius, N. (2015) An Ultrasonically Assisted Sagittal Saw for Large Bone Surgeries. In: IEEE International Ultrasonics Symposium (IUS), Taipei, Taiwan, 21-24 Oct 2015, pp. 1-4. ISBN 978147998182315 (doi:10.1109/ULTSYM.2015.0279)
Start Year 2014
 
Company Name Active Needle Technology 
Description Active Needle Technology is a pre-revenue medical device company exploiting technology developed at the University of Dundee. The company aims to commercialise its award-winning "needle actuating device" technology into a well-segmented $4+ Billion special purpose needle market, especially $1Billion biopsy market, to enable precise needle targeting in ultrasound-guided needle interventional procedures. 
Year Established 2016 
Impact ActiveNeedle makes standard needle visible in colour under Doppler ultrasound. Active Needle Technology reduces penetration force and thus tip deflection.
Website http://www.activeneedle.com/
 
Description Museum display 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact A display of an ultrasonic bone biopsy needle and explanation formed a display for 2 months at the Kelvingrove Museum and Art Gallery, Glasgow, which is one of Scotland's most popular visitor venues.
Year(s) Of Engagement Activity 2016