Advancing Medical Technology Using FPGAs

Author(s):  
Zach Olson

Field Programmable Gate Arrays (FPGAs) have dramatically changed the design of medical devices in the past decade. FPGAs offer the flexibility of writing software on a standard microprocessor and the reliability and performance of dedicated hardware. In the design of medical devices that previously required the rigorous design of custom circuits or ASIC design, FPGAs are providing a good alternative at a much lower cost for low to mid-volume medical device design. In this session, we will explore how FPGAs relate to medical device technology including real-time processing of data, high performance image processing, precise control, and code reuse from prototype to deployed device. We will explore how this technology was applied to two devices that improve the success of high-risk surgeries. In the first, FPGA technology is used to monitor blood glucose levels in patients during open-heart surgery. The second example is a device that simulates electrical signals from the human nervous system to train neurophysiologists for events that may happen during surgery. We will explore the impact FPGAs have on design cycles, briefly explore the design process, and compare different programming methodologies including C, VHDL, and LabVIEW. Finally, we will discuss the impact of FPGAs with respect to the 510k process.

Author(s):  
Murat Aksun ◽  
Saliha Aksun ◽  
Mehmet Ali Çoşar ◽  
Elif Neziroğlu ◽  
Senem Girgin ◽  
...  

Objective: Thromboelastography (TEG) is a diagnostic modality that gives information about coagulation. Despite all blood-preserving precautions in open heart surgery there are blood losses and the use of blood and blood products becomes inevitable. TEG is mostly not available in every center and habits, trends and clinical experience in blood use create the possibility of causing unnecessary use of blood and blood products. In this study, it was aimed to determine the effect of the use of thromboelastography on the use of blood and blood products in cardiac surgery. Methods: Two hundred patients between 18-70 years old who underwent open heart surgery were included in the study. After the cardiopulmonary bypass (CPB), the cases were confirmed to have an Activated Clotting Time (ACT) value in the range of 120-150 sec after protamine administration. In 100 patients in the TEG group, the coagulation status was evaluated with TEG and it was decided how to apply blood and blood product use. Blood and blood product use was applied to 100 patients in the control group based on clinical experience and foresight. The total amount of blood and blood product used, fluid balance, need for inotropics, mechanical ventilator time, complications, duration of intensive care and discharge times were recorded. Results: Use of Fresh Frozen Plasma (FFP) at the after CPB in the TEG group was statistically significantly lower than that of the control group FFP (p<0.05). Postoperative FFP and postoperative platelet use in the study group were statistically significantly lower than in the postoperative FFP and postoperative platelet values of the control group (p <0.05). Conclusion: The use of thromboelastography is a very useful monitoring in terms of reducing FFP use after CPB and reducing FFP and platelet usage in the postoperative period. In this way, the unnecessary use of blood and blood products can be prevented.


2019 ◽  
Vol 10 (6) ◽  
pp. 778-788 ◽  
Author(s):  
Joel Bierer ◽  
Roger Stanzel ◽  
Mark Henderson ◽  
Suvro Sett ◽  
David Horne

Introduction: The use of cardiopulmonary bypass in pediatric cardiac surgery is associated with significant inflammation, fluid overload, and end-organ dysfunction yielding morbidity and mortality. For decades, various intraoperative ultrafiltration techniques such as conventional ultrafiltration, modified ultrafiltration (MUF), zero-balance ultrafiltration (ZBUF), and combination techniques (ZBUF-MUF) have been used to mitigate these toxicities and promote improved postoperative outcomes. However, there is currently no consensus on the ultrafiltration technique or strategy that yields the most benefit for infants and children undergoing open heart surgery. Methods: A librarian-conducted PubMed literature search from 1990 to 2018 yielded 90 clinical studies or publications on the various forms of ultrafiltration and the impact on physiologic markers and clinical outcomes. All publications were reviewed, summarized, and conclusions synthesized. The data sets were not combined for systematic or meta-analysis due to significant heterogeneity in study protocols and patient populations. Results: Modified ultrafiltration significantly promotes improved myocardial function, reduction in fluid overload, and reduced bleeding and transfusion complications. Furthermore, ZBUF has shown a consistent reduction in inflammatory cytokines and improved pulmonary function and compliance. There is conflicting evidence that MUF, ZBUF, and ZBUF-MUF culminate in reduced ventilation time and intensive care unit stay. Conclusion: Various modes of ultrafiltration have been shown to be associated with improved physiologic function or clinical outcomes in pediatric cardiac surgery. There are some inconsistent trial results that can be explained by heterogeneity in ultrafiltration, clinical staff preferences, and institution protocols. Ultrafiltration has some essential benefit as it is ubiquitously used at pediatric heart centers; however, the optimal protocol could be yet identified.


2016 ◽  
Vol 18 (2) ◽  
pp. 186-215 ◽  
Author(s):  
Noel Carroll ◽  
Ita Richardson

Purpose Connected Health is an emerging and rapidly developing field never before witnessed across the healthcare sector. It has the potential to transform healthcare service systems by increasing its safety, quality and overall efficiency. However, as healthcare technologies or medical devices continuously rely more on software development, one of the core challenges is examining how Connected Health is regulated – often impacting Connected Health innovation. The purpose of this paper is to present an understanding of how Connected Health is regulated. Many of these regulatory developments fall under “medical devices”, giving rise to Software-as-a-Medical Device (SaaMD). Design/methodology/approach Through an extensive literature review, this paper demystifies Connected Health regulation. It presents the outcome of expert discussions which explore the key regulatory developments in the context of Connected Health to provide a practical guide to understanding how regulation can potentially shape healthcare innovation. Findings Several key issues are identified, and the authors present a comprehensive overview of regulatory developments relating to Connected Health with a view to support the continued growth of IT-enabled healthcare service models. The authors also identify the key challenges in Connected Health and identify areas for future research. Originality/value A key outcome of this research is a clearer understanding of the opportunities and challenges that regulation and standards present to Connected Health. Furthermore, this research is of critical importance in a first attempt towards recognising the impact of regulation and standards compliance in Connected Health.


2019 ◽  
Vol 12 (1) ◽  
pp. 6-10
Author(s):  
Hakimeh Sheykhasadi ◽  
Abbas Abbaszadeh ◽  
Homira Bonakdar ◽  
Fatemeh Salmani ◽  
Asghar Tavan ◽  
...  

Background:One of the forms of ost-operative care after open heart surgery is controlling the pain resulting from chest tube insertion. Management of pain is considered vital and requires the awareness of health care providers. One of the main responsibilities of nurses is to prepare patients for invasive procedures such as the removal of the chest tube. This study was designed to analyze the impact of a loved one’s voice for distraction in patients undergoing open heart surgery.Methods:This study was a clinical trial. The research sample was randomly selected from patients undergoing open heart surgery. In this study, the number of samples for each group was considered to be 64 people, where the total number of samples was 128 people. The data collection tools included Visual Analog Scale (VAS) assessment tool and a researcher-made questionnaire. After selecting the eligible samples and obtaining the informed consent, each patient was randomly assigned to one of the two groups (intervention group and control group). The pain was measured before, immediately, and 10 minutes after removing the chest tube.Results:The findings of this study indicated that the two groups had no statistically significant differences in pain before chest tube removal. The mean pain during chest tube removal and 10 minutes later in both groups indicated a significant difference based on Mann-Whitney test (P<0.001).Conclusion:This study showed that a loved one’s voice is effective in reducing pain during chest tube removal after open heart surgery.


Author(s):  
Laura M. Wienecke ◽  
Sarah Cohen ◽  
Johann Bauersachs ◽  
Alexandre Mebazaa ◽  
Benjamin G. Chousterman

AbstractAlthough more than 90% of children born with congenital heart disease (CHD) survive into adulthood, patients face significantly higher and premature morbidity and mortality. Heart failure as well as non-cardiac comorbidities represent a striking and life-limiting problem with need for new treatment options. Systemic chronic inflammation and immune activation have been identified as crucial drivers of disease causes and progression in various cardiovascular disorders and are promising therapeutic targets. Accumulating evidence indicates an inflammatory state and immune alterations in children and adults with CHD. In this review, we highlight the implications of chronic inflammation, immunity, and immune senescence in CHD. In this context, we summarize the impact of infant open-heart surgery with subsequent thymectomy on the immune system later in life and discuss the potential role of comorbidities and underlying genetic alterations. How an altered immunity and chronic inflammation in CHD influence patient outcomes facing SARS-CoV-2 infection is unclear, but requires special attention, as CHD could represent a population particularly at risk during the COVID-19 pandemic. Concluding remarks address possible clinical implications of immune changes in CHD and consider future immunomodulatory therapies.


2016 ◽  
Vol 119 (suppl_1) ◽  
Author(s):  
Ahmed Bux ◽  
Hernan Vasquez ◽  
Heinrich Taegtmeyer ◽  
Romain Harmancey

Stress hyperglycemia and inflammation frequently develop in open heart surgery patients. Although both factors independently contribute to increased peri-operative morbidity and mortality, the impact of high glucose levels on cardiac inflammatory response remains unknown. We investigated the isolated working rat heart as a model to study cardiac early stress response to surgery. Hearts of male Sprague Dawley rats were cold-arrested and subjected to 60 minutes normothermic reperfusion in the working mode with Krebs-Henseleit buffer supplemented with ketone bodies and propionate plus glucose (25 mM) or mannitol (25 mM; osmotic control). Alterations of gene expression in the left ventricle were determined by microarray and real-time PCR analyses. Compared to non-perfused hearts, perfused hearts displayed a more than twofold increased expression for 71 genes (mannitol group) and 103 genes (glucose group) connected to inflammation, cell proliferation, and apoptosis. The transcriptional changes were highly similar to gene alterations previously reported in the right atrium ( P < 2.34E-16) and left ventricle ( P < 4.83E-46) of patients who underwent cardiac surgery with cardiopulmonary bypass. Pathway analysis with Reactome revealed an up-regulation of metabolic processes associated with the proliferation and activation of immune cells, including glycolysis, glutaminolysis, fatty acid synthesis, polyamine synthesis, and hexosamine synthesis. Although the transcriptional remodeling occurred independently from the presence of glucose, glucose significantly increased further the expression of several transcription factors and markers associated with M2 polarization of macrophages, including Myc (1.6-fold), Nr4a1 (1.3-fold), Nr4a2 (1.8-fold), Zc3h12a (1.3-fold), Fosl2 (1.4-fold), Cebpb (1.2-fold), and Arg1 (1.7-fold). Interestingly, glucose failed to enhance the expression of M2-related genes in the heart of rats rendered insulin resistant by high-sucrose feeding. Besides demonstrating that the isolated working rat heart accurately reproduces the stress response associated with open heart surgery, the results also suggest that glucose promotes the alternative activation of resident cardiac macrophages in the stressed heart.


2017 ◽  
Vol 313 (5) ◽  
pp. H1044-H1053 ◽  
Author(s):  
Rafael Jaimes ◽  
Adam Swiercz ◽  
Meredith Sherman ◽  
Narine Muselimyan ◽  
Paul J. Marvar ◽  
...  

Plastics have revolutionized medical device technology, transformed hematological care, and facilitated modern cardiology procedures. Despite these advances, studies have shown that phthalate chemicals migrate out of plastic products and that these chemicals are bioactive. Recent epidemiological and research studies have suggested that phthalate exposure adversely affects cardiovascular function. Our objective was to assess the safety and biocompatibility of phthalate chemicals and resolve the impact on cardiovascular and autonomic physiology. Adult mice were implanted with radiofrequency transmitters to monitor heart rate variability, blood pressure, and autonomic regulation in response to di-2-ethylhexyl-phthalate (DEHP) exposure. DEHP-treated animals displayed a decrease in heart rate variability (−17% SD of normal beat-to-beat intervals and −36% high-frequency power) and an exaggerated mean arterial pressure response to ganglionic blockade (31.5% via chlorisondamine). In response to a conditioned stressor, DEHP-treated animals displayed enhanced cardiovascular reactivity (−56% SD major axis Poincarè plot) and prolonged blood pressure recovery. Alterations in cardiac gene expression of endothelin-1, angiotensin-converting enzyme, and nitric oxide synthase may partly explain these cardiovascular alterations. This is the first study to show an association between phthalate chemicals that are used in medical devices with alterations in autonomic regulation, heart rate variability, and cardiovascular reactivity. Because changes in autonomic balance often precede clinical manifestations of hypertension, atherosclerosis, and conduction abnormalities, future studies are warranted to assess the downstream impact of plastic chemical exposure on end-organ function in sensitive patient populations. This study also highlights the importance of adopting safer biomaterials, chemicals, and/or surface coatings for use in medical devices.NEW & NOTEWORTHY Phthalates are widely used in the manufacturing of consumer and medical products. In the present study, di-2-ethylhexyl-phthalate exposure was associated with alterations in heart rate variability and cardiovascular reactivity. This highlights the importance of investigating the impact of phthalates on health and identifying suitable alternatives for medical device manufacturing.


2001 ◽  
Vol 25 (4) ◽  
pp. 300-305 ◽  
Author(s):  
Michael Klein ◽  
Chris Brown Mahoney ◽  
Chris Probst ◽  
Hagen D. Schulte ◽  
Emmeran Gams

2001 ◽  
Vol 25 (4) ◽  
pp. 300-305 ◽  
Author(s):  
Michael Klein ◽  
Chris Brown Mahoney ◽  
Chris Probst ◽  
Hagen D. Schulte ◽  
Emmeran Gams

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