BME100 s2017:Group4 W8AM L1

BME 100 Spring 2017	Home People Lab Write-Up 1 | Lab Write-Up 2 | Lab Write-Up 3 Lab Write-Up 4 | Lab Write-Up 5 | Lab Write-Up 6 Course Logistics For Instructors Photos Wiki Editing Help
OUR TEAM Name: Kaitlin Masterson Name: Bat-El Shabtai Name: Sydney Horton Name: Mustafa Alsadiq Name: Timothy Styrlund LAB 1 WRITE-UP Health Care Issue Epilepsy is a neurological disorder that involves having recurrent seizures, loss of consciousness, sensory disturbance associated with abnormal electrical activity in the brain. Our device is intended to help prevent people with epilepsy from having seizures. The device involves improving the current vagus nerve stimulation (VNS) solution to make it more accommodatable for those with epilepsy. The current VNS sends regular, mild pulses of electrical energy to the brain through the vagus nerve (Epilespy Foundation). Our device will monitor signs of an oncoming seizure by measuring brainwaves. When the device senses the oncoming of a seizure, it will send a signal directly to the vagus nerve stimulator through bluetooth technology to activate the VNS. It will also send out a notification to the primary contact(s) of the individual to notify them of the potential seizure. Customer Validation Michael Privitera, MD, Director of the UC Epilepsy Center (Neurology) David Ficker, MD, Associate Director and Medical Director of the EEG Lab and Epilepsy Monitoring Unit (Neurology) Jennifer Cavitt, MD (Neurology) George Mandybur, MD, Director of the Division of Functional and Stereotactic Neurosurgy at UC (Neurological surgery) Ellen Air, MD, PhD Todd Abruzzo, MD (Interventional Radiology) Robert Lukin, MD (Radiology) National Association of Epilepsy Centers (NAEC) American Epilepsy Society (AES) Epilepsy Foundation of Arizona John Hopkins Hospital, #2 in Adult Neurology & Neurosurgery Hospitals David Treiman, MD (Neurologist Epilepsy) Michael Stein, MD (Neurologist Epilepsy) The Epilepsy Foundation of Greater Chicago Epilepsy Foundation of Oklahoma. Saudi Epilepsy Society (SES). Andrew Shetter, MD(Neurosurgeon) Kris Smith, MD (Neurosurgeon) George Prigatano, PhD, ABPP-Cn (Neuropsychologist) Gayle Kiyota EEGT (Coordinator, Epilepsy Program) Competitors Competitors Advantages Disadvantages Why our Device is More Marketable Vagus Nerve Stimulator This device is not a medication which means there are no medicinal side effects that accompany the device. The procedure to get the implant is on an outpatient basis and the risks are minimal compared to epileptic brain surgery, which is another option for epileptic patients. The device can be turned on manually (Uwmedicine). There is no evidence that proves that this implant is more effective than medications and studies show that the amount of seizures of an epileptic is reduced when using this device but the VNS does not completely get rid of the seizures. The device turns on automatically for 30 seconds every 5 minutes (Uwmedicine). The design of the current VNS is an issue because the device is connected to two things through long wires: a pacemaker that is installed in the chest and a brainwave sensor that is implanted in the person’s head. This problem is a technological issue. This device does not send a signal to family members so primary contacts would not be alerted if the person is having a seizure. Our updated device will be the same as the original VNS, but instead, we are planning to extend the function of the implant so it connects through bluetooth to a sensor that the epileptic person has in the back of their head and the sensor can monitor the seizure activity and automatically send a signal to a pacemaker in the person’s chest which can turn on the VNS when the person is seizing. The former product design has wires that connect the 3 implants but our modified solution will use bluetooth between the brainwave sensor and the pacemaker so the person does not need to have wires running through their chest, neck and head. Also, the device will be improved so it alerts primary contacts during a seizure by sending a bluetooth alert signal to their phones. Embrace Watch (Empatica) This watch detects when a person is about to seize by monitoring Blood Volume Pulse, their daily activity, sympathetic nervous system arousal, peripheral skin temperature, and sleep patterns (Empatica). The device is a detector, but has no preventative mechanism. Once it detects a seizure, it sends a signal to primary contacts and then they are the ones that need to help the epileptic person. Additionally, the charging slot is located on the back of the device so they wearer has to remove the watch for a period of time, sometimes as long as 2 hours, while they are charging it which means that the watch is not monitoring their bodily functions during the charging hours. This is a technological issue. The watch costs a lot of money, this specific brand being $1,690, which is a financial problem (Empatica). Our device will incorporate the pacemaker and brainwave sensor into our design so the watch will not be a part of our product and therefore will not be counted towards the overall cost. This will lower the potential cost of the device and the product will be internally implanted into the patient. This way, the person does not have to remember to wear or charge the watch and the product will be automatic. Our device will be a more effective way of preventing and monitoring the seizure. Medications (anticonvulsants) Anticonvulsants are drugs taken daily by epileptic patients that act on the brain to reduce the frequency and severity of seizures. The drug is taken daily for life and is only available upon prescription, since the drug is highly toxic and potent to the body if taken in excess, consumption of the drug calls for close monitoring of the patient by blood tests. The drugs has been known to depress cerebral, cerebellar and brainstem function, and potentially slow the peripheral nerve conduction, as well as prolonged intake causing hypocalcaemia and osteoporosis, folate depletion, various haematological and immunological abnormalities, and overgrowth of subcutaneous and gingival tissues. Our device is internally installed inside the epileptic patient. A one time implantation, compared to the anticonvulsants that are required to be taken everyday by the user throughout their life. Our device also takes action as the patient begins to seize, unlike the drugs that are taken regularly only to reduce the severity and frequency of a seizure taking place. Since this is not a medication, our device will also not involve the patient with any harmful medicinal side effects, compared to those of the anticonvulsant. IP Position Patent Number/Assignee Title Summary Image File Date 9,254,383/Electrocore, LLC Devices and Methods for Monitoring Non-invasive Vagus Nerve Stimulation A brace around the neck with electrodes embedded in the brace that interact with electrodes under the skin to stimulate the vagus nerve. It is meant to be a non-invasive way to stimulate the vagus nerve and allow the patient to stimulate the vagus nerve manually to treat their condition. 04-28-2013 5,713,923/Scott R. Ward Technique of Treating Epilepsy by Brain Stimulation and Drug Infusion A brain sensor that monitors brain activity and detects the symptoms of a seizure in a patient. It is used in conjunction with a pump and catheter that uses the information received from the sensor to adjust dosages of medicine. 05-13-1996 6,341,236/Ivan Osorio Vagal Nerve Stimulation Techniques for Treatment of Epileptic Seizures An implantable signal generator attached to the vagus nerve in order to stimulate the nerve with a sensor attached to monitor characteristics of the heart. This is meant to minimize the effect of the vagus nerve stimulation on the heart. 04-30-1999 Fundability Worksheet Scores Competitors Score: 2 This is because there are several competitors on the market, but the technology is not as effective as it could be so improvements are being made in order to increase efficiency. The product is mature and is currently being used in epileptic patients. Potential buyers will be interested in buying our improved product because the design is more practical and advanced than previous products. Customer Validation Score: 1 This is because their is not enough customer feedback on the product yet to make a conclusion on whether customers would purchase the product or not. IP Position Score: 2 This is because there are several patents that are similar to how our device will work, which means that our device will most likely have a much better chance of getting a patent. However, none of the current patents that are related to our device are expired, so there is a possibility of having a weak patent.

References

Medicine, UW. "Vagus Nerve Stimulation." Vagus Nerve Stimulation | UW Medicine. N.p., n.d. Web. 31 Jan. 2017. <http://www.uwmedicine.org/health-library/Pages/vagus-nerve-stimulation.aspx>.

"Real-time Physiological Signals - E4 EDA/GSR Sensor." Empatica. N.p., n.d. Web. 31 Jan. 2017. <https://www.empatica.com/e4-wristband>.

"Seven Epilepsy Center Specialists on 2013 'Best Doctors' Lists." UC Epilepsy Center. N.p., n.d. Web. 31 Jan. 2017. <http://ucepilepsycenter.com/press-releases/seven-epilepsy-center-specialists-on-2013-best-doctors-lists/>.

"Vagus Nerve Stimulation (VNS)." Epilepsy Foundation. N.p., n.d. Web. 31 Jan. 2017. <http://www.epilepsy.com/learn/treating-seizures-and-epilepsy/devices/vagus-nerve-stimulation-vns>.