Duke University
Pratt School of Engineering
PULMOPIVOT
Cell Collection Method for Increased Diagnostic Yield in Thoracentesis Procedures
Anna Matthews, Brandon Tramontana, Nicolas Swischuk, Nina Chiu, Michael Wong
Advisory Board, Pratt School of Engineering: Eric Richardson, PhD; Paul Fearis, MSC; Joe Knight, PhD; Yaas Bigdeli
Advisory Board, Duke School of Medicine: Scott Schoffer, MD; Alejandro Pino, MD; John Carney, MD; Christopher Alley, MD
First Place Winner of Student Showcase Competition at Design of Medical Devices Conference 2021
This project was developed through the Duke University Master's Certificate in Medical Device Design in the Pratt School of Engineering. The team of graduate students involved in the project includes Anna Matthews, Brandon Tramontana, Michael Wong, Willi Swischuk, and Nina Chiu.
Clinical Need: Pleural Effusions & Thoracentesis
Thoracentesis Animation: Pleural effusion is being manually drained using a catheter, syringe and collection bag.
Pleural infection is generally diagnosed from cases of pleural effusion, a build-up of fluid in the space between the lung and chest. There are 1.5 million pleural infections in the US per year[4]. In thoracentesis, the pleural space is catheterized and manually aspirated by physicians. Fluid samples are collected for analysis. Although collection is routine, the cause of pleural effusions cannot be diagnosed in 26 percent of patients today[5]. In cases of malignancy, early detection is key to improved outcomes for the patient. Therefore, the diagnosis of pleural infections must be improved.
Unique Solution: Pulmopivot
This project presents a novel device to improve sampling and collection of infectious agents and malignancies in patients undergoing thoracentesis procedures. The design intends to increase the specificity and sensitivity of post-thoracentesis analysis by providing doctors with a cell collection method that improves current practices. There is untapped diagnostic potential in the preparation of pleural effusion fluid samples and direct sampling of the pleural lining. Our proposed solution is a filtration system to be added onto thoracentesis kits. Though pleural fluid aspiration results in up to 1-1.5L of volume, only 60cc of liquid is currently sampled and sent to pathology, cytology and microbiology. Through talks with pulmonologists and pathologists, we believe that potential false negatives could arise from the small number of bacteria in this 60cc sample. To address this, a filtration system integrated into the thoracentesis kit was designed to filter all aspirated fluid. The apparatus will be integrated as part of the thoracentesis kit and contains two primary filters: one to collect human tissue cells and another to collect bacterial cells. This acts as an intermediate step in the procedure to provide labs with more concentrated samples. This up-concentration of bacterial and human cells aims to increase the likelihood of confirming pathogenic presence or malignancy from this procedure. The team designed a tiered filter to be attached to thoracentesis kits through Luer-lock fittings already present in thoracentesis kits. A version of the prototype of the filter body can be seen here. Through the use of multiple filter layers, specimens of interest can be sequestered on a single layer, allowing for cytologists and microbiologists the ability to easily confirm the presence of specific bacteria or malignancies.
Mid-Project Update Video
The project is currently in testing design for proof of principle and gathering results. We have completed and designed several experiments including the following:
1. Efficacy of separation of a tiered filter system and power constraints.
2. Filtration Modeling and Clinically-Relevant Filtration Studies
3. Two Phase IRB Study at Duke University Medical Center
In conclusion, we have designed a novel device to be sold as an add-on to traditional thoracentesis kits that will improve the rapid diagnosis of pleural infections and malignancies. This approach draws from current research and benchtop testing. As the project progresses into the IRB testing stage, the design will be tested for efficacy to validate our concept as a useful medical device.
REFERENCES:
[1] Helen Davies, Robert Davies, Christopher Davies “Management of Pleural Infection in Adults: British Thoracic Society Pleural Disease Guideline 2010” Thorax 9 August 2010. http://dx.doi.org/10.1136/thx.2010.137000
[2] Andrew Rosenstengel “Pleural Infection -Current Diagnosis and Management” Journal of Thoracic Disease 1 April 2012. 10.3978/j.issn.2072-1439.2012.01.12
[3] Kan Zhai, Yong Lu, Huan-Zhong Shi “Tuberculous Pleural Effusion” Journal of Thoracic Disease 2016. http://dx.doi.org.proxy.lib.duke.edu/10.21037/jtd.2016.05.87
[4] Aaron Saguil, Kristen Wyrick, John Hallgren “Diagnostic Approach to Pleural Effusion” American Family Physician 15 July 2014. https://www.aafp.org/afp/2014/0715/p99.html#[
5] TR Collins, SA Sahn “Thoracocentesis. Clinical value, complications, technical problems, and patient experience.” Chest June 1987. 10.1378/chest.91.6.817
[6] Richard Light “Update on Tuberculosis Pleural Effusion” Respirology 29 March 2010. https://doi-org.proxy.lib.duke.edu/10.1111/j.1440-1843.2010.01723.x
[7] J. Brennan McNeil, Ciara M. Shaver, V. Eric Kerchberger, Derek W. Russell, Brandon S. Grove, Melissa A. Warren, Nancy E. Wickersham, Lorraine B. Ware, W. Hayes McDonald, and Julie A. Bastarache. Novel Method for Noninvasive Sampling of the Distal Airspace in Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med.2018 Apr 15;197(8):1027-1035. https://doi.org/10.1164/rccm.201707-1474OC[
8] Richard J Isaacs, Ken Debelak, Patrick R Norris, Judith M Jenkins, Jeffrey C Rooks, Todd R Young, Addison K May, and Erik M Boczko. Non-invasive detection of pulmonary pathogens in ventilator-circuit filters by PCR. Am J Transl Res 2012;4:72–82.
[9] Addison K. May, Jacob S. Brady, Joann Romano-Keeler, Wonder P. Drake, Patrick R. Norris, Judith M. Jenkins, Richard J. Isaacs, and Erik M. Boczko. A Pilot Study of the Noninvasive Assessment of the Lung Microbiota as a Potential Tool for the Early Diagnosis of Ventilator-Associated Pneumonia. Chest. 2015 Jun; 147(6): 1494–1502. https://doi.org/10.1378/chest.14-1687
[10] S Wilkosz, LA Edwards, S Bielsa, C Hyams, A Taylor, RJ Davies, GJ Laurent, RC Chambers, JS Brown, YC Lee “Characterization of a New Mouse Model of Empyema and the Mechanisms of Pleural Invasion by Streptococcus Pneumoniae.” American Journal of Respiratory Cell and Molecular BiologyFebruary 2012. 10.1165/rcmb.2011-0182OC
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