E-finger: a tactile diagnostic device with microscale resolution

Lead Research Organisation: Heriot-Watt University
Department Name: Sch of Engineering and Physical Science

Abstract

An approach is proposed to the in vivo assessment of soft tissue quality using multi-scale mechanical measurements. The approach is applied to prostate gland compliance (as measured by dynamic modulus, E) using a micro-engineered probe for the detailed assessment of prostate cancer (PCa) building on our earlier work applied to benign prostatic hyperplasia (BPH). We have previously shown for the first time that a relationship exists between the mechanical and histological characteristics of the prostate in vitro. We wish to apply our findings to the in vivo setting, with the development of a remote palpation instrument for in vivo measurement of prostatic compliance in malignant disease. Such a device is likely to lead to major advances in the diagnosis, assessment and surveillance of men with PCa and emphasis is therefore placed on minimum levels of invasiveness. It is also expected that the study will result in a novel medical instrument and associated design paradigm of generic value for other applications where a remote or minimally-invasive measure of tissue quality is desired. The work will emphasise the importance of probe size and will investigate the interface between meso- and micro-scale measurements (tissue-level) and micro- to nano-scale measurements (cell-level) and a simple method for producing a range of probe sizes and levels of resolution is outlined.The projected is expected to deliver:- the first in vivo mechanical measurement of dynamic modulus- the first micro-scale in vivo mechanical measurement- the first approach applied to prostate compliance which integrates trans-urethral, trans- rectal and laparoscopic measurements- the first study of mechanically-assessed prostate tissue quality which uses a large number of patients A major feature of the work is the co-operation of clinicians and medical and engineering academics focused onto a problem with potential huge implications for the ageing population. The impact plan aims top exploit the immediate application to urology through two key industrial partners and a strong engagement with the UK and European urological community. A separate group will be established to examine the transfer of the findings to other medical specialisms, including hepato-biliary surgery and gastro-enterology.

Planned Impact

The primary beneficiaries of the work are ultimately the patients who suffer from prostate cancer. Development of a successful device would represent a significant advance in PCa diagnosis, assessment and surveillance. This guide to therapeutic decision-making would assist the urologist in avoiding the situation where a man with a clinically insignificant cancer may undergo radical treatment unnecessarily, whilst others may not receive the treatment they require. A longer-term benefit of tissue quality assessment associated with assessing the positive surgical margin during radical prostatectomy is also likely. Here, this technology may lead to improved results from radical prostatectomy, both in terms of oncologic outcome and the effect upon the patient's quality of life. A more general benefit in tissue quality assessment in minimally invasive surgery generally, providing a degree of force feedback to the surgeon, is also possible and the significance of this will become clearer as the project progresses and we engage with specialisms outside the area of urology. Finally, the most exciting potential benefit is in further miniaturisation to improve the resolution of the assessment as this will provide motivation for further research. Manufacturers of cystoscopes and laparoscopic surgical devices will benefit through exploitation of any probes designed specifically to complement their range of products. It may be anticipated that the current indications for local anaesthetic cystoscopy will be increased if it can be shown that such an examination can provide detailed diagnostic information allowing better direction of therapeutic interventions. Similarly force feedback devices that can be delivered along laparoscopic ports providing quantitative tissue quality measures during surgery can help to improve decision-making during such interventions. Similarly, TRUS system manufacturers will benefit through the development of current applications of TRUS-based assessment of the prostate. The device would allow more detailed TRUS prostate assessment both with and without needle biopsy and other methods of assessing tissue quality, such as electrical impedance tomography [48] can also benefit from benchmarking against an absolutely-calibrated technique. Ultimately, the difference between the palpation device and any other elastography system is in the imaging of the strain, here done directly using a displacement measurement with high spatial resolution. The scientific benefits are in improved medical diagnostics, including the development of the notion of structure-property relationships for tissue quality assessment, and an increased understanding of the issues involved in the design and fabrication of microdevices for real-world applications and in dealing with the interfacing and packaging issues. The project team will use two main groups to engage users and beneficiaries; a high-level Advisory Committee and a Steering Group, to be co-ordinated by the Commercialisation Officer, who will keep records of the Steering Group and Advisory Committees and the Focus Group and Brainstorming Events, and also attend relevant conferences and visit companies in pursuit of the interests of the project. The project will create a large number of new cross functional collaborative links between industry / academia in the field of medical device design, micro-mechanics and sensing. Results of the project will be disseminated in the normal way, through conferences and publications in the engineering and medical literature. Our publication strategy will engage with the international communities in the three specialist areas; medical engineering, microengineering and urology, but in a co-ordinated and integrated way to the extent that some publications will involve both of the project partners. There is now a growing world-wide community in mechanical-based medical diagnostics and we expect to continue to cite and be cited by these groups.

Publications

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Palacio-Torralba J (2018) A novel method for rapid and quantitative mechanical assessment of soft tissue for diagnostic purposes: A computational study. in International journal for numerical methods in biomedical engineering

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Alogla A (2013) A scalable syringe-actuated microgripper for biological manipulation in Sensors and Actuators A: Physical

 
Description A method for screening for prostate cancer for patients with a positive blood test, prior to biopsy
Exploitation Route As well as commercialisation of a trans-rectal probe, there are opportunities to develop a miniaturised version for intra-operational tissue assessment.
Sectors Healthcare

 
Description We are in the process of commercialising an early emobodiment of the palpation probe for digital rectal examination (DRE), which we call iDRE (instrumented Digital Rectal Examination). The PIs on this grant (Reuben) and the related grant (EP/I020101, McNeill) have set up a company (Palpation Diagnostics Ltd.) on which they are co-Directors with the CRF (Daniel Good) and the PDRA (Steven Hammer) of the grant. The company was recently awarded 50keuro from the Horizon 2020 SME Instrument, for Stage 1 commercialisation. Simultaneously, the two PIs named above have been successful in obtaining £200k from prostate cancer charities (the Urology Fund and John Black Trust) to carry out a pre-clinical study on several hundred urology patients at various stages in the diagnosis and treatment of prostate cancer. This has been supplemented by an award of ca. £75k from the MRC Confidence in Concept scheme and ca. £50k from the RSE for an Enterprise Fellowship for Steven Hammer. The company has recently made a large proposal (ca. £3M) to Horizon 2020 under Stage II of its SME Instrument Although we were unsuccessful, we received an H2020 Seal of Excellence, described by the Directorate as follows: "Although there is no automatic guarantee of funding, you can use this seal to seek possible funding under an operational programme supported by the European Structural and Investment Funds (ESIF) in your country or region or under other funding schemes." Our plan at present is to pursue UK sources of funding for engineering developments of the probe and for a multi-centre clinical study to add robustness to the diagnostic algorithms, work already started under TUF/JB charity funding, thus taking us to TRL 7 from the clinical perspective. The study will focus on high volume centres where mpMRI is carried out pre-biopsy, which is then targeted depending on MRI findings. This is because we recognise that undertaking only TRUS-guided biopsies will miss some cancers, which will obviously affect the accuracy of the algorithm. Alongside the clinical aspect, we will incorporate a health economic analysis based on our findings, rather than the suppositions made thus far. As well as the clinical study (using ECTU), the MS2 head will be integrated into the WGH part of the study in preparation for full clinical evaluation to give us a hook for investors to go to TRL 8 and 9. Project partners will be University of Edinburgh (Lead), Heriot-Watt University, NHS Lothian, Palpation Diagnostics and, possibly, Wideblue.
First Year Of Impact 2005
Sector Healthcare
Impact Types Societal

Economic

 
Description EPSRC Impact acceleration account
Amount £84,871 (GBP)
Organisation Heriot-Watt University 
Sector Academic/University
Country United Kingdom
Start 01/2016 
End 05/2016
 
Description EPSRC Institutional Sponsorship Fund
Amount £10,000 (GBP)
Organisation Heriot-Watt University 
Sector Academic/University
Country United Kingdom
Start 11/2015 
End 03/2016
 
Description EPSRC Platform Grant
Amount £1,302,969 (GBP)
Funding ID EP/P027415/1 
Organisation Engineering and Physical Sciences Research Council (EPSRC) 
Sector Public
Country United Kingdom
Start 06/2017 
End 07/2022
 
Description Enterprise Fellowship for Steven Hammer (former RA on project)
Amount £50,000 (GBP)
Organisation Royal Society of Edinburgh (RSE) 
Sector Charity/Non Profit
Country United Kingdom
Start 03/2017 
End 03/2018
 
Description Horizon 2020 SME Instrument 2014
Amount € 71,429 (EUR)
Funding ID 718244 
Organisation European Commission 
Sector Public
Country European Union (EU)
Start 03/2016 
End 10/2016
 
Description James Watt Scholarship
Amount £60,000 (GBP)
Organisation Heriot-Watt University 
Sector Academic/University
Country United Kingdom
Start 03/2013 
End 02/2016
 
Description The Urology Foundation: John Black Charitable Foundation
Amount £249,998 (GBP)
Organisation Urology Foundation 
Sector Charity/Non Profit
Country United Kingdom
Start 01/2016 
End 01/2019
 
Description Dynoclaw 
Organisation Heriot-Watt University
Department School of Engineering & Physical Sciences
Country United Kingdom 
Sector Academic/University 
PI Contribution Pilot project on miniaturised palpation device for minimally invasive intervention
Collaborator Contribution Manufacturing of miniaturised devices (Heriot-Watt University). Clinical support for in vivo trial (University of Edinburgh)
Impact None as yet
Start Year 2019
 
Description Dynoclaw 
Organisation University of Edinburgh
Department Medical School Edinburgh
Country United Kingdom 
Sector Academic/University 
PI Contribution Pilot project on miniaturised palpation device for minimally invasive intervention
Collaborator Contribution Manufacturing of miniaturised devices (Heriot-Watt University). Clinical support for in vivo trial (University of Edinburgh)
Impact None as yet
Start Year 2019
 
Description Dynoclaw 
Organisation Western General Hospital
Country United Kingdom 
Sector Hospitals 
PI Contribution Pilot project on miniaturised palpation device for minimally invasive intervention
Collaborator Contribution Manufacturing of miniaturised devices (Heriot-Watt University). Clinical support for in vivo trial (University of Edinburgh)
Impact None as yet
Start Year 2019
 
Company Name Palpation Diagnostics Limited 
Description  
Year Established 2015 
Impact Main impact will be in the clinical exploitation of dynamic instrumented palpation as a diagnostic instrument for prostate cancer.
 
Description Launch of surgical robot at Western General Hospital 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Supporters
Results and Impact Launch of new surgical robot at Western General Hospital, organized by Prostate Scotland as the result of it Blue Horizon Appeal. Attended by senior NHS managers, politicians, practitioners and patients. Associated press article in the Times (Scotland) Technology Supplement authored by McNeill and Reuben (21 Nov 2016)
Year(s) Of Engagement Activity 2016
URL http://www.prostatescotland.org.uk/robot-appeal.html