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Zepeda-Echavarria A, Ratering Arntz NCM, Westra AH, van Schelven LJ, Euwe FE, Noordmans HJ, Vessies M, van de Leur RR, Hassink RJ, Wildbergh TX, van der Zee R, Doevendans PA, van Es R, Jaspers JEN. On the design and development of a handheld electrocardiogram device in a clinical setting. Front Digit Health 2024; 6:1403457. [PMID: 39184339 PMCID: PMC11341539 DOI: 10.3389/fdgth.2024.1403457] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/19/2024] [Accepted: 07/17/2024] [Indexed: 08/27/2024] Open
Abstract
Cardiovascular diseases (CVDs) are a global burden that requires attention. For the detection and diagnosis of CVDs, the 12-lead ECG is a key tool. With technological advancements, ECG devices are becoming smaller and available for home use. Most of these devices contain a limited number of leads and are aimed to detect atrial fibrillation (AF). To investigate whether a four-electrode arrangement could provide enough information to diagnose other CVDs, further research is necessary. At the University Medical Center Utrecht in a multidisciplinary team, we developed the miniECG, a four-electrode ECG handheld system for scientific research in clinical environments (TRL6). This paper describes the process followed during the development of the miniECG. From assembling a multidisciplinary team, which includes engineers, cardiologists, and clinical physicians to the contribution of team members in the design input, design, and testing for safety and functionality of the device. Finally, we detail how the development process was composed by iterative design steps based on user input and intended use evolution. The miniECG is a device compliant for scientific research with patients within Dutch Medical Centers. We believe that hospital-based development led to a streamlined process, which could be applied for the design and development of other technologies used for scientific research in clinical environments.
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Affiliation(s)
- Alejandra Zepeda-Echavarria
- Department of Medical Technology and Clinical Physics, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands
| | - Niek C. M. Ratering Arntz
- Department of Medical Technology and Clinical Physics, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands
| | - Albert H. Westra
- Department of Medical Technology and Clinical Physics, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands
| | - Leonard J. van Schelven
- Department of Medical Technology and Clinical Physics, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands
| | - Froukje E. Euwe
- Department of Medical Technology and Clinical Physics, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands
| | - Herke Jan Noordmans
- Department of Medical Technology and Clinical Physics, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands
| | - Melle Vessies
- Department of Cardiology, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands
| | - Rutger R. van de Leur
- Department of Cardiology, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands
| | - Rutger J. Hassink
- Department of Cardiology, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands
| | | | | | - Pieter A. Doevendans
- Department of Cardiology, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands
- Netherlands Heart Institute, Utrecht, Netherlands
- Department of Cardiology, Central Military Hospital, Utrecht, Netherlands
| | - René van Es
- Department of Cardiology, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands
| | - Joris E. N. Jaspers
- Department of Medical Technology and Clinical Physics, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands
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Sun T, Chen J, Zhang J, Zhao Z, Zhao Y, Sun J, Chang H. Application of micro/nanorobot in medicine. Front Bioeng Biotechnol 2024; 12:1347312. [PMID: 38333078 PMCID: PMC10850249 DOI: 10.3389/fbioe.2024.1347312] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/08/2023] [Accepted: 01/02/2024] [Indexed: 02/10/2024] Open
Abstract
The development of micro/nanorobots and their application in medical treatment holds the promise of revolutionizing disease diagnosis and treatment. In comparison to conventional diagnostic and treatment methods, micro/nanorobots exhibit immense potential due to their small size and the ability to penetrate deep tissues. However, the transition of this technology from the laboratory to clinical applications presents significant challenges. This paper provides a comprehensive review of the research progress in micro/nanorobotics, encompassing biosensors, diagnostics, targeted drug delivery, and minimally invasive surgery. It also addresses the key issues and challenges facing this technology. The fusion of micro/nanorobots with medical treatments is poised to have a profound impact on the future of medicine.
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Affiliation(s)
- Tianhao Sun
- Department of Thoracic Surgery, The First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, China
| | - Jingyu Chen
- Department of Oncology, The Fourth Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, China
| | - Jiayang Zhang
- Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Breast Oncology, Peking University Cancer Hospital and Institute, Beijing, China
| | - Zhihong Zhao
- Department of Thoracic Surgery, The First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, China
| | - Yiming Zhao
- Department of Thoracic Surgery, The First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, China
| | - Jingxue Sun
- Department of Endocrinology and Metabolism, The Second Affiliated Hospital of Harbin Medical University, Harbin, China
| | - Hao Chang
- Department of Thoracic Surgery, The First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, China
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Winters C, Subramanian V, Valdastri P. Robotic, self-propelled, self-steerable, and disposable colonoscopes: Reality or pipe dream? A state of the art review. World J Gastroenterol 2022; 28:5093-5110. [PMID: 36188716 PMCID: PMC9516669 DOI: 10.3748/wjg.v28.i35.5093] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/06/2022] [Revised: 06/21/2022] [Accepted: 09/01/2022] [Indexed: 02/06/2023] Open
Abstract
Robotic colonoscopes could potentially provide a comfortable, less painful and safer alternative to standard colonoscopy. Recent exciting developments in this field are pushing the boundaries to what is possible in the future. This article provides a comprehensive review of the current work in robotic colonoscopes including self-propelled, steerable and disposable endoscopes that could be alternatives to standard colonoscopy. We discuss the advantages and disadvantages of these systems currently in development and highlight the technical readiness of each system to help the reader understand where and when such systems may be available for routine clinical use and get an idea of where and in which situation they can best be deployed.
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Affiliation(s)
- Conchubhair Winters
- Leeds Institute of Medical Research, University of Leeds, St. James’s University Hospital, Leeds LS9 7TF, United Kingdom
| | - Venkataraman Subramanian
- Leeds Institute of Medical Research, University of Leeds, St. James’s University Hospital, Leeds LS9 7TF, United Kingdom
| | - Pietro Valdastri
- School of Electronic and Electrical Engineering, University of Leeds, Leeds LS2 9JT, United Kingdom
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Seva RR, Tan ALS, Tejero LMS, Salvacion MLDS. Multi-dimensional readiness assessment of medical devices. THEORETICAL ISSUES IN ERGONOMICS SCIENCE 2022. [DOI: 10.1080/1463922x.2022.2064934] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/18/2022]
Affiliation(s)
- Rosemary Ruiz Seva
- Industrial and Systems Engineering, De La Salle University, Manila, Philippines
| | - Angela Li Sin Tan
- Defence Medical and Environmental Research Institute - DSO National Laboratories, Singapore, Singapore
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Rier SC, Vreemann S, Nijhof WH, van Driel VJHM, van der Bilt IAC. Interventional cardiac magnetic resonance imaging: current applications, technology readiness level, and future perspectives. Ther Adv Cardiovasc Dis 2022; 16:17539447221119624. [PMID: 36039865 PMCID: PMC9434707 DOI: 10.1177/17539447221119624] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/16/2022] Open
Abstract
BACKGROUND Cardiac magnetic resonance (CMR) provides excellent temporal and spatial resolution, tissue characterization, and flow measurements. This enables major advantages when guiding cardiac invasive procedures compared with X-ray fluoroscopy or ultrasound guidance. However, clinical implementation is limited due to limited availability of technological advancements in magnetic resonance imaging (MRI) compatible equipment. A systematic review of the available literature on past and present applications of interventional MR and its technology readiness level (TRL) was performed, also suggesting future applications. METHODS A structured literature search was performed using PubMed. Search terms were focused on interventional CMR, cardiac catheterization, and other cardiac invasive procedures. All search results were screened for relevance by language, title, and abstract. TRL was adjusted for use in this article, level 1 being in a hypothetical stage and level 9 being widespread clinical translation. The papers were categorized by the type of procedure and the TRL was estimated. RESULTS Of 466 papers, 117 papers met the inclusion criteria. TRL was most frequently estimated at level 5 meaning only applicable to in vivo animal studies. Diagnostic right heart catheterization and cavotricuspid isthmus ablation had the highest TRL of 8, meaning proven feasibility and efficacy in a series of humans. CONCLUSION This article shows that interventional CMR has a potential widespread application although clinical translation is at a modest level with TRL usually at 5. Future development should be directed toward availability of MR-compatible equipment and further improvement of the CMR techniques. This could lead to increased TRL of interventional CMR providing better treatment.
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Affiliation(s)
- Sophie C Rier
- Cardiology Division, Department of Cardiology, Haga Teaching Hospital, Els Borst-Eilersplein 275, Postbus 40551, The Hague 2504 LN, The Netherlands
| | - Suzan Vreemann
- Department of Cardiology, Haga Teaching Hospital, The Hague, The Netherlands Siemens Healthineers Nederland B.V., Den Haag, The Netherlands
| | - Wouter H Nijhof
- Siemens Healthineers Nederland B.V., Den Haag, The Netherlands
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Onaizah O, Koszowska Z, Winters C, Subramanian V, Jayne D, Arezzo A, Obstein KL, Valdastri P. Guidelines for Robotic Flexible Endoscopy at the Time of COVID-19. Front Robot AI 2021; 8:612852. [PMID: 33718439 PMCID: PMC7947201 DOI: 10.3389/frobt.2021.612852] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/30/2020] [Accepted: 01/20/2021] [Indexed: 12/22/2022] Open
Abstract
Flexible endoscopy involves the insertion of a long narrow flexible tube into the body for diagnostic and therapeutic procedures. In the gastrointestinal (GI) tract, flexible endoscopy plays a major role in cancer screening, surveillance, and treatment programs. As a result of gas insufflation during the procedure, both upper and lower GI endoscopy procedures have been classified as aerosol generating by the guidelines issued by the respective societies during the COVID-19 pandemic-although no quantifiable data on aerosol generation currently exists. Due to the risk of COVID-19 transmission to healthcare workers, most societies halted non-emergency and diagnostic procedures during the lockdown. The long-term implications of stoppage in cancer diagnoses and treatment is predicted to lead to a large increase in preventable deaths. Robotics may play a major role in this field by allowing healthcare operators to control the flexible endoscope from a safe distance and pave a path for protecting healthcare workers through minimizing the risk of virus transmission without reducing diagnostic and therapeutic capacities. This review focuses on the needs and challenges associated with the design of robotic flexible endoscopes for use during a pandemic. The authors propose that a few minor changes to existing platforms or considerations for platforms in development could lead to significant benefits for use during infection control scenarios.
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Affiliation(s)
- Onaizah Onaizah
- School of Electronic and Electrical Engineering, University of Leeds, Leeds, United Kingdom
| | - Zaneta Koszowska
- School of Electronic and Electrical Engineering, University of Leeds, Leeds, United Kingdom
| | - Conchubhair Winters
- Leeds Institute of Medical Research, University of Leeds, Leeds, United Kingdom
| | | | - David Jayne
- Leeds Institute of Medical Research, University of Leeds, Leeds, United Kingdom
| | - Alberto Arezzo
- Department of Surgical Sciences, University of Torino, Torino, Italy
| | - Keith L. Obstein
- Department of Gastroenterology, Hepatology, Nutrition, Vanderbilt University Medical Center, Nashville, TN, United States
- Department of Mechanical Engineering, Vanderbilt University, Nashville, TN, United States
| | - Pietro Valdastri
- School of Electronic and Electrical Engineering, University of Leeds, Leeds, United Kingdom
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Hydro-jet propelled colonoscopy: proof of concept in a phantom colon. Surg Endosc 2020; 35:989-995. [PMID: 33090315 PMCID: PMC7819862 DOI: 10.1007/s00464-020-08089-z] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/03/2020] [Accepted: 10/03/2020] [Indexed: 10/28/2022]
Abstract
BACKGROUND Colonoscopy is a widely used and effective procedure, but it often causes patient discomfort and its execution requires considerable skill and training. We demonstrate an alternative approach to colonoscope propulsion with the potential to minimise patient discomfort by reducing the forces exerted on the colonic wall and mesentery, and to reduce the level of skill required for execution. METHODS A prototype colonoscopic device is described, consisting of a tethered capsule that is propelled and manoeuvred through a water-filled colon (hydro-colonoscopy) by an array of water jets. As an initial proof of concept, experiments were performed to assess the ability of the device to navigate through a simplified PVA cryogel human colon phantom arranged in various anatomical configurations. RESULTS The prototype was capable of successfully navigating through three out of four colon configurations: a simple layout, alpha loop and reverse alpha loop. It was unable to negotiate the fourth configuration involving an "N loop", but this was attributed to problems with the colon phantom. In the successful test replicates, mean complete insertion (i.e. caecal intubation) time was 4.7 min. Measured pressures, temperatures and forces exerted on the colon appeared to be within a physiologically acceptable range. The results demonstrate the viability of propelling a colonoscope through a colon phantom using hydro-jets. CONCLUSIONS Results indicate that this approach has the potential to enable rapid and safe caecal intubation. This suggests that further development towards clinical translation is worthwhile.
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Abstract
PURPOSE OF REVIEW Advanced endoscopy procedures are technically challenging and require extensive training. Recent technological advances made in computer science and robotics have the potential to enhance the performance of complex intraluminal and transluminal interventions and potentially optimize precision and safety. This review covers the different technologies used for robot-assisted interventions in the gastrointestinal tract, organized according to their clinical availability, and focusing on flexible endoscopy-based systems. RECENT FINDINGS In the curvilinear gastrointestinal anatomy, robotic technology can enhance flexible endoscopes to augment effectiveness, safety, and therapeutic capabilities, particularly for complex intraluminal and transluminal interventions. Increased visual angles, increased degrees of freedom of instrumentation, optimized navigation, and locomotion, which may lead to a reduced physician learning curve and workload, are promising achievements with the promise to ultimately replace conventional endoscopy techniques for screening and therapeutic endoscopy. SUMMARY The majority of these devices are not commercially available yet. The best clinical applications are also currently being researched. Nonetheless, robotic assistance may encourage surgeons to use flexible endoscopes to administer surgical therapies and increase interest among gastroenterologists in advanced therapies. Robotics may be a means to overcome the technical obstacles of incisionless natural orifice procedures and favor an increased adoption of complex endoscopic procedures such as third-space therapies.
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Affiliation(s)
- Calvin S H Ng
- Department of Surgery, The Chinese University of Hong Kong, Hong Kong SAR, China
| | - Jian Xing He
- Department of Thoracic Surgery, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou Institute of Respiratory Disease and China State Key Laboratory of Respiratory Disease, Guangzhou, China
| | - Gaetano Rocco
- Department of Thoracic Surgery, Istituto Nazionale Tumori, Fondazione Pascale, IRCCS, Naples, Italy
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Abstract
BACKGROUND Conventional colonoscopy requires a high degree of operator skill and is often painful for the patient. We present a preliminary feasibility study of an alternative approach where a self-propelled colonoscope is hydraulically driven through the colon. METHODS A hydraulic colonoscope which could be controlled manually or automatically was developed and assessed in a test bed modelled on the anatomy of the human colon. A conventional colonoscope was used by an experienced colonoscopist in the same test bed for comparison. Pressures and forces on the colon were measured during the test. RESULTS The hydraulic colonoscope was able to successfully advance through the test bed in a comparable time to the conventional colonoscope. The hydraulic colonoscope reduces measured loads on artificial mesenteries, but increases intraluminal pressure compared to the colonoscope. Both manual and automatically controlled modes were able to successfully advance the hydraulic colonoscope through the colon. However, the automatic controller mode required lower pressures than manual control, but took longer to reach the caecum. CONCLUSIONS The hydraulic colonoscope appears to be a viable device for further development as forces and pressures observed during use are comparable to those used in current clinical practice.
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