Mechanical CPR Devices: Needs Specification Statement

Transcription

1 Bioengineering Scholars Summer Immersion Program Mechanical CPR Devices: Needs Specification Statement Morgan Dean Senior Mechanical Engineer July 10th,

2 Table of Contents The Need 3 The Problem 3 Disease State 4 Existing Solutions 5 Stakeholders 7 Market Analysis Criteria References 2

3 The Need There is a need to address cardiopulmonary resuscitation (CPR) in out-of-hospital cardiac arrest adult patients that improves both efficiency and survival rates. The Problem Mechanical cardiopulmonary resuscitation (CPR) devices exist, such as the LUCAS machine, that aim to automate, or make easier, chest compressions. The use of these machines in out-of-hospital cardiac arrests has doubled survival rates. However, these machines are also associated with frequent medical complications, such as skin lesions, a fractured sternum, and fractured ribs 1. Less common, but more serious, complications are internal bleeding and organ injuries. There is a question regarding the percentage of times these complications are necessary so successfully resuscitate the patient. Additionally, a situation requiring CPR is most likely a stressful one. Depending on who is administering the CPR, they could become distracted, fatigued, or emotional to the point of not performing effective CPR. Several people also fear causing further injury to the cardiac arrest victim. Complications In 2009, these were the percentages of occurrence for the three most frequent complications while using the LUCAS device: Skin lesions*: 42% Mechanical techniques yielded a higher percentage than manual. Sternal fracture*: 29% Mechanical and manual percentages were approximately the same. Rib fracture(s)*: 47% Mechanical and manual percentages were approximately the same. *Values based on the combined results of 12 studies found via a Medline search 1. Organ injury and bleeding varied from 3-10%. Generally speaking, these 3

4 values doubled with mechanical compressions, but also doubled survival percentages. Technique-based complications also exist and are most relevant to manual CPR: Less than one in six people can perform standardized compressions (depth of 2 ) on an adult for ten minutes 19. o Often because the rescuer does not weigh enough. Disease State Cardiac Arrest: What is it and How Does it Differ From a Heart Attack? Cardiac arrest is defined by the American Heart Association as an electrical malfunction of the heart that causes it to stop beating suddenly. On the contrary, they define a heart attack as a circulation problem, caused by the blockage of blood perfusion to the heart 8. In a cardiac arrest, the electrical malfunction of the heart causes an irregular heartbeat, a condition called arrhythmia. As a result, several organs do not receive the amount of blood they need to function properly, which is what causes the patient to lose consciousness. Frequency More than 350,000 out-ofhospital cardiac arrests occur every year 2. Although the elderly population makes up most of this count, children are also subjected to cardiac arrests (8-10 cases/10,000 people 6 ). Of the annual average, most of the arrests Figure 1: Survival Rates for Out-of-Hospital Cardiac Arrest Patients Reprint on the SCAF website. 4

5 are EMS treated, and there is only a survival rate of 10.6% 3. This percentage decreases when only considering survivors with good neurological functions. Who s at Risk? There are several factors that can put someone at risk for sudden cardiac arrest (SCA). Some have to do with race and gender (blacks and males are said to be at higher risk). Additionally, first-degree family members with a history of SCA or other cardiopulmonary conditions can also increase risk. The biggest risk factor is coronary heart disease, which can remain symptomless/painless 7. Several sources indicate that the average age of a cardiac arrest victim is between 60 and 70 years old. Existing Solutions LUCAS (Pneumatic) A study published on NCBI compared a group of 26 cardiac arrest patients, using the Lund University Cardiopulmonary Assist Generation 2 (LUCAS2), to 32 cardiac arrest control-group patients. The control group was given manual CPR. The results showed an increase in time, anterior lesions, and rib fractures for the LUCAS2 group 5. Despite this, the LUCAS2 death rate was either half of, or less than half of, the control group death rate. This seems to be the leading product in the market, as most other devices get pitted up against the LUCAS in studies. Figure 2: The LUCAS Chest Compression System Reprint on the NCBI website. 5

6 Thumper (Pneumatic) 12 published studies were selected to be analyzed, nine of which consisted of outof-hospital CA patients, three of which were in-hospital. Ten of these (seven and three, respectively) reported cases of ROSC and were, in turn, used to calculate risk ratios for mechanical vs. manual compressions. The out-of-hospital risk ratio was 0.87, suggesting mechanical compressions did more harm than help 12. AutoPulse (Battery) A study was done on 374 patients;; 115 were treated with AutoPulse, 122 with LUCAS, and 137 with manual compressions. 11.6% of the AutoPulse patients ended up with compression-induced internal damage. This was more than the percentage of LUCAS-patient damages and even more than those who received manual compressions 13. Figure 3: The Thumper CPR Device, a Michigan Instruments product. From Michigan Instruments Official Site Figure 4: AutoPulse CPR Device Reprint from ZOLL Corporation 6

7 CPR RsQ Assist Device (CPR RAD) (Manual) The CPR RAD, although still requiring some manual input, was designed to improve manual CPR techniques. As shown in a study, the device produced less fatigue and a more correct compression rate as opposed to those manually performing CPR 10. Figure 5: CPR RAD Device Reprint from the NCBI website Stakeholders Individual consumers: These people would want to invest in this product, for a reasonable price, if they knew their relative(s) or themselves to be of high-risk for cardiac arrest. EMS personnel: If enough statistical evidence is produced, EMS personnel would want to invest in these to perform out-of-hospital resuscitation, as they show lower survival rates than in-hospital. Hospital/healthcare providers: Government Insurance?? Market Analysis Leading Companies/Devices An automated CPR devices market forecast ( ) states that ZOLL Medical Corporation, Zhuhai Kindway Medical Science & Technology Co., Ltd, CPR Medical Devices, Inc., and Medtronic, Inc. are some of the competing companies within the market 11. 7

8 Figure 6: This figure shows the market price per unit for three of the existing devices. The device not mentioned, the Thumper, requires a quote for a price 14,15,16. Gross domestic value & Global market value Incidence Breakdown Figure 7: Breakdown of location of occurrence for adults (³ 18 years) experiencing an out-of-hospital cardiac arrest 17. Figure 8: Breakdown of adult outof-hospital cardiac arrests by race 18. 8

9 S.W.O.T. Analysis Strengths Engineering experience/background Good communication skills Disease state knowledge Weaknesses Limited medical knowledge Manufacturing Opportunities Large market Lives saved are compromised with significant complications Threats Several MCCDs exist Competing, established medtech companies LUCAS/LUCAS2 Criteria Functional requirements Measures the patient s heart rate Incorporates imaging to secure correct placement Uses an adjustable mechanism to adapt to patient height and weight Performance requirements American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care 9 Adheres to the American Heart Association pumps per minute recommendations compressions/minute without breaths Sets of 30 compressions followed by two breaths Reads and displays vitals in real-time Successful outcomes should be produced within (TIME) Interface requirements Powered by? 9

10 Remaining criteria Affordable for at-risk families Moving Forward Discussing potential solutions Discussing clinic project feasibility Gather a team and preliminary resources Designing and manufacturing the first prototype 10

11 References 1 2http:// Cardiac-Arrest_UCM_307905_Article.jsp#.Wz-RVthKgWo 3http:// 4https:// 5https://link.springer.com/article/ %2Fs x 6https:// http:// eart-attack-or-sudden-cardiac-arrest-how-are-they- Different_UCM_440804_Article.jsp#.Wz-rNthKgWo AutoPulse $6,

12 15 CPR RsQ $