Dr Liam Morris writes that GMedTech’s capacity for designing and developing in vitro testing systems has enabled it to develop three cardiovascular type simulators for assessing heart attacks, stroke and aortic aneurysms
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Author: Dr Liam Morris, co-founder and principal investigator of GMedTech; lecturer in Mechanical & Industrial Engineering Department, Galway Mayo Institute of Technology

The Galway Medical Technology Centre (GMedTech) develops advanced human anatomical simulators based on medical images. Established in 2006, within the Mechanical & Industrial Engineering Department of the Galway Mayo Institute of Technology, the biomedical engineering research centre GMedTech has obtained over €3.5 million worth of funding for applied biomedical research projects.

These projects have developed capabilities in generating realistic anatomical models based from medical images with the main objective of computationally and experimentally (in vitro) modelling different physiological type conditions to assess various disease types, the performance of medical devices and surgical procedures for academic, clinical and industrial proposes. A successful in vitro test system can keep animal testing and clinical trials to a minimum.

The GMedTech centre has engaged with over 200 companies and has presented and published 80 journal and conference papers. There are currently ten researchers (comprising of full-time researchers, academic staff and postgraduate students) and ten clinical partners within GMedTech.

The Centre has access to expert medical knowledge, medical imaging processing capabilities, engineering competence with advanced materials and manufacturing technologies, bench testing capacity for relevant physiological bio-fluids systems and state-of-the-art fluoroscopic and ultrasound imaging equipment.

The unique feature of the Centre is the capacity for designing and developing in vitro testing systems for replicating various haemodynamic conditions through different parts of the cardiovascular system that may or may not incorporate a disease type. Cardiovascular diseases are one of the leading causes of death in the western world and exceed those caused by cancer, infectious diseases and trauma. In Ireland, cardiovascular diseases account for approximately 36% of all deaths each year [1, 2].

Figure 1

GMedTech has developed three cardiovascular type simulators for assessing heart attacks, stroke and aortic aneurysms, as shown in Figure 1 (right). Figure 1 shows three patient-specific models (cardiac, cerebral and aortic) that were manufactured within our labs based on medical images.

EFFECTS OF CARDIOVASCULAR DISEASE

A heart attack is caused by a lack of blood supply to the heart muscle, which restricts the delivery of oxygen and nutrients to the heart. Over 50% of all cardiovascular deaths are attributed to heart attacks, making this the single largest killer globally. In Ireland, approximately 4,800 deaths occur from heart attacks [3]. Heart attacks are caused by the hardening and narrowing of the coronary arteries which supply the heart muscle with blood. A build-up of plaque material (primarily composed of cholesterol) on the inside of the arterial wall causes the narrowing of these arteries – this is known as coronary artery disease.

Stroke is the interruption of blood supply to the brain. This interruption in blood supply may be caused by blood clots, blocked or ruptured vessels. Stroke is the third leading cause of death in the western world. One in five people in Ireland will have a stroke at some time in their lives. Approximately 10,000 people will have a stroke in Ireland this year. Over 2,000 people will die and thousands more will be left disabled [4].

Abdominal aortic aneurysms are the abnormal dilation of the aorta. This is a life-threatening disease and is the 13th leading cause of death worldwide, with 80-90% of ruptured cases resulting in mortality [5].

The three simulators developed within the GMedTech labs for replicating these disease conditions are all based on patient-specific medical images (Figure 1). Various moulding and advanced manufacturing techniques were developed to replicate these vessels within physiological parameters with incorporated disease types such as plaque, aneurysms and blood clots.

These three test facilities are fully controlled and instrumented with the capacity of replicating complex physiological flow conditions through different parts of the cardiovascular system with and without its associated disease type. Each rig has its own or access to a fully instrumented, synchronised data acquisition and control system which monitors flowrates, pressures, wall displacements, temperatures and flow streamlines visualisation.

All of our testing rigs are integrated with National Instruments (NI) hardware and software (LabVIEW) that synchronises motion, data acquisition and vision system with triggering capabilities of various tasks. The NI system allows full integration with other external measurement instruments.

With the incorporation of the various disease types and physiological flow parameters, different medical devices such as stents, stent grafts and clot-retrieval devices and treatment options can be tested within these test systems. These bio-fluid testing facilities can assess the correct delivery and deployment of such devices and the monitoring of the longer-term impact that these medical devices or treatment procedures may have.

Such impacts include: arterial recoil, material mismatch, stroke, migration, endoleaks and the effects on the general blood-flow patterns. These pre-clinical in vitro simulators can prove device feasibility and accelerate the development of the next generation of medical devices and training platforms for clinicians with the potential to assist surgical planning.

INTERNATIONAL COLLABORATIONS 

In 2012, GMedTech provided experimental benchmarking data for the inaugural worldwide computational fluid dynamics (CFD) challenge with the findings presented at the 2012 American Society of Mechanical Engineers (ASME) Summer Bioengineering Conference held in Fajardo, Puerto Rico, with a subsequent journal article published in the February 2013 edition of the Journal of Biomechanical Engineering. This challenge was organised by the ASME bio-engineering fluids division, following a recent controversy in the neuroradiology literature, in which concerns were raised over the accuracy of CFD solutions for modelling cerebral blood-flow conditions through a giant cerebral aneurysm.

In collaboration with the CABER group (Dr Michael Walsh, University of Limerick), Biofluids Laboratory (Prof Frank Loth, University of Akron, USA) and the Biomedical Simulation Lab (Prof David Steinman, University of Toronto, Canada), a life-sized model of a giant cerebral aneurysm was replicated, with various steady and pulsatile flow conditions being simulated within the labs of GMedTech.

Our experimentally obtained data was used to validate CFD solutions obtained from 25 numerical research groups in which 12 were based in Europe, nine in North America, three in Asia and one in South America, resulting in a truly worldwide CFD challenge.

Last December, GMedTech was shortlisted as a finalist for the annual Med Tech CEO & Awards Forum 2013, hosted by Enterprise Ireland, IDA Ireland and the Irish Medical Devices Association. This was in recognition of the successful collaboration work that was conducted with Neuravi Ltd. Neuravi’s neurothrombectomy device for ischaemic stroke was tested within a challenging anatomy of the cerebral vasculature developed within the GMedTech centre.

The successful demonstration of Neuravi’s device within this challenging patient-specific anatomy helped Neuravi secure €5.2 million of venture-capital funding. This investment created 25 new jobs and resulted in a significant economic benefit to the Galway region.

GMedTech’s multidisciplinary team of researchers are working together to provide clinically inspired solutions to clinicians and the MedTech sector. A future vision of GMedTech is to provide a clinical training facility for clinicians to practice and assess various surgical procedures on any part of the human anatomy. This surgical testing has the potential to provide relevant clinical data to guide clinicians on the most appropriate surgical technique for a given disease situation.

References

  1. American Heart Association. (2009). ‘International Cardiovascular Disease Statistics.’ Downloaded from http://www.americanheart.org/downloadable/heart/1236204012112INTL.pdf.
  2. Lloyd-Jones, D., et al. (2009). ‘Heart Disease and Stroke Statistics–2009 Update: A Report From the American Heart Association Statistics Committee and Stroke Statistics Subcommittee’. Circulation 119: 480-486
  3. Central Statistics Office (2006). ‘Deaths from principal causes in the years 1998 to 2006. Dublin, Ireland.’
  4. Irish Heart Foundation Stroke Manifesto http://www.irishheart.ie/media/pub/strokeie/stroke_manifesto_IHF.pdf
  5. U.S. Preventive Services Task Force. (2005) ‘Screening for abdominal aortic aneurysm: recommendation statement’. Annals of Internal Medicine 142: 198 – 202.
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  Author: Dr Liam Morris, co-founder and principal investigator of GMedTech; lecturer in Mechanical & Industrial Engineering Department, Galway Mayo Institute of Technology The Galway Medical Technology Centre (GMedTech) develops advanced human anatomical simulators based on medical images. Established in 2006, within the Mechanical & Industrial Engineering Department of the Galway...