Delivery of Aerosolized Medication through Continuous Positive Airway Pressure Device BME 402 BIOMEDICAL ENGINEERING DESIGN Team Leader: Patrick Kurkiewicz Team Leader: Annie Loevinger BSAC: Joe Decker BWIG: Ryan Kimmel Communicator: Steve Welch Client: Dr. Mihai Teodorescu Advisor: Professor John WebsterBMEBME 402402 (B(BIOMEDICAL IOMEDICAL EENGINEERING NGINEERING DDESIGNESIGN)) FINAL REPORTFINAL REPORT AADVISORDVISOR:: DDRR.. JJOHN OHN WWEBSTEREBSTER CPAPCPAP DDRUG RUG DDELIVERYELIVERY !! Page 2 of 31 !Table of Contents Abstract…………………………………………………………………………………..3 Problem Statement…………………………………………………………………….....3 Motivation……………………………………………………………………………......3 Background……………………………………………………………………………....4 Design Specifications…………………………………………………………………….8 Commercially Available Products……………………………………………………….8 Previous Design………………………………………………………………………….10 Current Design…………………………………………………………………………...11 Mechanical………………………………………………………………………12 Electrical…………………………………………………………………………15 Testing…………………………………………………………………………………...18 Rate Methods……………………………………………………………………19 Delivery Methods……………………………………………………………….20 Results…………………………………………………………………………..22 Rate……………………………………………………………………..22 Delivery…………………………………………………………………23 Efficiency………………………………………………………………24 Discussion………………………………………………………………………………25 Future Work……………………………………………………………………………26 References……………………………………………………………………………..27 Appendix A-Product Design Specifications…………………………………………..28 Appendix B-Budget……………………………………………………………………30 Appendix C-Circuit Diagram…………………………………………………………31BMEBME 402402 (B(BIOMEDICAL IOMEDICAL EENGINEERING NGINEERING DDESIGNESIGN)) FINAL REPORTFINAL REPORT AADVISORDVISOR:: DDRR.. JJOHN OHN WWEBSTEREBSTER CPAPCPAP DDRUG RUG DDELIVERYELIVERY !! Page 3 of 31 ! ABSTRACT A device has been constructed for the purpose of aerosolizing albuterol with an ultrasonic piezoelectric crystal and delivering it through corrugated tubing using a continuous positive airway pressure (CPAP) machine. It has been proven that the device delivers albuterol through standard CPAP tubing (6 ft (1.8 m) length, 0.75 in (1.9 cm) inner diameter) to a CPAP mask at an efficiency of 42.5% ± 11%. A program was also constructed to control the functioning of the ultrasonic crystal and shown to be effective at responding to a patient’s breathing cycle. PROBLEM STATEMENT The goal of this project is to develop a device and accompanying method for automated delivery of aerosolized medication, such as the bronchodilator, albuterol, within the main airflow circuit of a continuous positive airway pressure (CPAP) device, wherein the system is programmable for various dosages, start times, and durations of medication administration. MOTIVATION More than 12 million people in the United States are currently affected by sleep apnea (ASAA, 2008). Several forms of the disease exist. The most common form, obstructive sleep apnea, is characterized by the periodic cessation of breathing during sleep due to tracheal muscle relaxation, which causes narrowing and closing of the patient’s airway. The most widely used treatment is to employ a continuous positive airway pressure (CPAP) device during sleep to open the airways. The main goal of developing a CPAP drug delivery device is to automatically deliver aerosolized albuterol to a sleeping patient. It is hoped that the developed device will better alleviate the symptoms of sleep apnea than either the CPAP or bronchodilators alone. The drug delivery system developed in this paper uses ultrasonic nebulization to generate a medicatedBMEBME 402402 (B(BIOMEDICAL IOMEDICAL EENGINEERING NGINEERING DDESIGNESIGN)) FINAL REPORTFINAL REPORT AADVISORDVISOR:: DDRR.. JJOHN OHN WWEBSTEREBSTER CPAPCPAP DDRUG RUG DDELIVERYELIVERY !! Page 4 of 31 !aerosol which enters the CPAP airflow through an elongated reservoir designed to maximize drug uptake efficiency while still allowing the CPAP to function properly. The system is controlled via an adaptive computer interface which reads pressure data from the CPAP system and uses a predictive algorithm to optimally synchronize aerosol generation and patient breathing. Proof of concept testing was performed to verify drug delivery efficiency and justify moving to clinical trials. BACKGROUND CPAP devices provide therapy to a sleep apnea patient by delivering positive pressure to the patient’s airway to keep it open as the tracheal muscles relax. Most CPAP designs include a pressure source, circuitry to control the pressure source, and tubing connected to a mask worn by a patient. The CPAP pressure source, connective tubing, and mask create a selectively closed circuit for airflow between the patient’s airways and the CPAP device. The blower (or other pressure source) creates a positive pressure within the airway of the system. This positive pressure helps to open the patient’s airway, preventing airway collapse during inhalation. When the patient begins to exhale, CPAP devices, such as the CPAP used for this study (Respironics REMstarPro M Series Model #400M), sense an increase in pressure and shut off the positive pressure source. This allows the patient to exhale
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