BME100 f2017:Group16 W1030 L1

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OUR TEAM

Name: Alexia Kamau
Name: Alfred Abraham
Name: Hannah Correa
Name: Michelle Mungaray
[[Image:BME103student.jpg|100px|thumb|Name: Jaynee Monarrez]
Name: Your name

LAB 1 WRITE-UP

Health Care Issue

Strokes are caused by insufficient blood supply to the brain. Decreased blood supply to the brain causes the brain to lack the nutrients it needs to survive, allowing brain cells to die (Stroke). The main cause of this is a blocked artery from increased blood pressure within the body (Stroke).

The goal of our medical device is to detect oncoming strokes through the use of a pressure monitor device. The device will be placed near both of the carotid arteries and will measure any changes in the pressure of blood coming in and out of the neck that might suggest a potential blood clot which leads to a stroke. This device will be able to alert the device holder in time to contact emergency medical personnel as well as a family member in the event that the device holder is unable to contact others for help. For example, increased pressure in the blood flow coming into the neck will alert the device holder of a possible blood clot in the body. If this device is able to detect increased pressure in the body for a stroke patient specifically, the chances of essentially saving their life is greater.


Resources: "Stroke." Mayo Clinic. Mayo Foundation for Medical Education and Research, 15 Aug. 2017. Web.



Customer Validation

-Dignity Health Stroke Center

-Barrow Neurological Institute

-Johns Hopkins Stroke Center; Dr. Victor Urrutia

-Comprehensive stroke center through University Hospitals in UH, Cleveland where Dr. Cathy Sila MD is the director of this center, vascular neurology, vice chairman of the department of neurology and professor of neurology.


-Emory comprehensive stroke center

-Dr. Robert Ackerman MD, who specializes in neurology at the Massachusetts General Hospital

-National Stroke Association

-The University of Kansas Health System; Abraham Michael G MD whose clinical purpose is Acute Ischemic Stroke

-Dr. Gronseth, Gary MD whose clinical purpose is general neurology at the University of Kansas Health System


-Husmann, Kathrin R MD whose clinical focus is Neuro-intensive stroke

-Letchtenberg, Colleen G MD whose clinical focus is stroke


-Rehabilitation Institute of Chicago

-The institute for Rehabilitation and research Memorial Hermann, Houston, Texas

-Kessler Institute for rehabilitation, Chief director Bruce M. Gans, M.D

-American Stroke Association

-Stroke Shield Foundation, Dr. Jeffery Thomas

-North Carolina Stroke Association

-Mayo Clinic, Stroke department

-Providence Stroke Center, Providence Oregon

-Dr. Cigdem Akman (Neurology), New York-Presbyterian Hospital




Competitors

Advantages
1. Wearable bandage (uses heat sensors to detect changes in blood flow) --> The advantage with this device is that the installment of this device is non-invasive. Unlike the pressure monitors which require surgery to insert the devices into the arteries, the bandage is placed over the skin.

2. Finger Stick (draws blood and reads purine levels, which are produced during strokes) --> The advantage to implementing this device is that it provides quick readings using a very small amount of blood. The testing procedure is also minimally invasive, only requiring a finger-prick.

3.EKG-like band---> (placed on the forehead, uses an EKG-like test to detect brain abnormalities)--->The advantage with this device is mobility. Often times, in order to diagnose a stroke patients must visit doctors to rely on a hospital's not readily movable CAT scans. Studies show that this band has the potential to detect strokes more quickly than other solutions known today.

Disadvantages
1.Wearable bandage (uses heat sensors to detect changes in blood flow) --> The disadvantage with this device is that since it is placed on the surface of the skin, external factors can affect the heat sensors (i.e if the bandage gets wet or if you're by a fire, or if you're in the snow etc.), therefore affecting its accuracy and effectiveness in detecting a stroke.

2. Finger stick (draws blood and reads purine levels, which are produced during strokes) --> Generally, a person has suspicions of an oncoming stroke when they are already displaying multiple symptoms. With this being the case, by the time person feels the need to confirm an approaching stroke the symptoms may be too severe to allow the person to perform this test on themselves.

3.EKG-like band(placed on the forehead, uses an EKG-like test to detect brain abnormalities)-->Although portable, the design of this device makes it awkward and cumbersome(because of the wires) to wear on a day-to-day basis.


Resources: 1.)“Chip Hall of Fame.” IEEE Spectrum: Technology, Engineering, and Science News, www.spectrum.ieee.org/.

2.) Dale, Nick. “Producing a Rapid Diagnostic Blood Test for Stroke to Improve Treatment and Recovery.” Producing a Rapid Diagnostic Blood Test for Stroke to Improve Treatment and Recovery, National Institute for Health Research, www.nihr.ac.uk/news-and-events/features/behind-the-research/producing-a-rapid-diagnostic-blood-test-for-stroke-to-improve-treatment-and-recovery.htm.

3.) Mamula, Kris B. “New Stroke Detection Device Promises Faster Diagnosis.” Pittsburgh Post-Gazette , Pittsburgh Post-Gazette, 31 May 2016, www.post-gazette.com/business/healthcare-business/2016/06/01/New-stroke-detection-device-promises-faster-diagnosis/stories/201606010026.

Marketability of Device
Given the circumstances and result of suffering from a stroke, its detection is vital since it concerns the patient's current and long-term health. Therefore the device that is most marketable is one that will not be affected by any type of outside factors and is reliable in giving precise readings with minimal effort. Of the three competitor products listed above, the wearable temperature bandage seems the least likely to provide dependable results seeing that it is an external device that is susceptible to external heating and cooling factors. The fingerstick, which has the potential to provide precise readings requires the device holder to be alert and in a functional state, therefore in the event that the symptoms of one's stroke become too intense and they are left unable to operate this device, it will essentially do no good. The EKG-like band also offers possibly accurate results, however, it is impractical to walk around with a band and attached wires to one's head, making the process and technology in the device seem burdensome. Our device would have the ability to provide readings keeping all of the factors above in mind: accuracy, effortlessness, and practicality. The efficiency of our device in providing results would not be affected considering our device is inserted in the body, not only making it less of a hassle as opposed to carrying the device itself around but also avoiding the interference of outside componenets. Additionally, the device functions on its own, meaning that the person with the device does not need to activate it to run a detection test, but rather it is constantly measuring the changes in pressure on it own.



IP Position
Since the device is unique from what is already in the market, it is very unlikely that someone else already patented a device like ours. So our IP position is good. We should be able to get a patent without too much difficulty.

Current patents:

1.Early stroke detection device : {This device uses a fiber optics and a catheter and infrared light. The reflected infrared light is used to help detect an oncoming stroke.}

a).assignee(s)/inventor(s): George P. Teitelbaum

b.)publication #/type: WO2017123989 A1, application

c.)application#:PCT/US2017/013497

d.)filing date: 13 Jan 2017

2.Stroke Detection Device:: {This device includes several different components such as a: main body for the device,a detection rod, a stroke detection unit and an attracting unit.}

a.)assignee(s)/inventor(s): Komatsu Ltd. / , Daigoh Fujii, Shuuji Hori, Masato Kageyama

b .)publication #/type:US20170152965 A1 , application

c. )application#:US 15/322,214

d.) filing date: 30 Jun 2014


3.Portable stroke monitoring apparatus: {This device uses a processor and electrodes (placed on a patient's scalp) in order to receive at least two brain wave signal patterns from the patient. The device then compares the signals and reports a stroke and stores this data in an electronic memory for future.}

a).assignees/inventors: James Sherman Castle, Jonathan Axelrod

b.)publication #: US20110245707 A1

c.)application#: US 13/074,061 US20110245707A1-20111006-D00001.png

4. Non-invasive magnetic blood flow sensor: {This device uses a bipolar magnetic field to detect blood flow. An electrode that is connected to the skin relays signals that are synchronized with the magnetic field.}

a). assignees/inventors: John Sheldon Ogle

b.) publication #: US5935077 A

c.) application #: US 08/911,421

File:US5935077-1.png

Resource: https://www.google.com/patents/

Fundability Worksheet Scores

Competitors
2- There are a handful of products that also promise to detect and prevent an oncoming stroke, however, the detection techniques utilized contain flaws and possibly inaccurate readings. Our device makes a point to offer all of the components our competitors lack. The most important of these aspects are mobility considering that our product is inserted into the patient and does not need to be lugged around, uncomplicated testing procedures since the machine operates on its own, and dependability in its readings because it is less susceptible to outside factors.


Customer Validation
1- Over 800,000 people solely in the US suffer from a stroke each year with 25% of those cases being recurrent strokes. Patients who are at genetic risk for strokes may look into the product in order to prevent future strokes, and those who have already been affected may also look into the product to prevent a second one. Those who pay into health insurance are also more likely to look into such a device considering their likelihood of suffering from a stroke would be lessened and therefore changing not necessarily the need for life insurance, but rather the type and inherently the price.


IP Position
2- Patents for devices concerning similar issues regarding strokes and their detection have been filed, however, our device still holds its value and originality against other proposed products. The other patents include non-invasive blood flow monitors which once again may fail to warn a person appropriately and in a timely manner that a stroke may occur. The utility of our product and the fact that it is a two part device sets it apart from the rest.