BME100 f2017:Group10 W0800 L1

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OUR TEAM

Name: Whitney Hirano
Name: Nicole Van Alstine
Name: Austin Copps
Name: Jacob Morris
Name: Osvaldo Pagan


LAB 1 WRITE-UP

Health Care Issue



We are trying to develop a solution for generalized anxiety and other neurological disorders. Many neurological disorders are caused from abnormal chemical imbalances within the brain due to over or under stimulation of certain neurotransmitters. For instance, the neurotransmitter serotonin is responsible for the effects of depression, melatonin controls the body's circadian rhythm and helps with sleep disorders, and dopamine levels are responsible for major diseases like Parkinson's and drug addiction. A neuron is able to release neurotransmitters once an action potential is generated along its axon. Once this neurotransmitter is released, it will create a reaction in another neuron or the target cell. The goal of this device is to be able to sense a drop in one of the major neurotransmitters, then administer an action potential through the basal ganglia that will release the desired neurotransmitter. This will be done through either an adhesive patch or small device.[1][2]

Customer Validation



1.Association for behavioral and Cognitive Therapies[1]

2. National Association of cognitive behavioral therapists[2]

3.Patients undergoing therapies for behavioral disorders

4. Barrow Neurological Institute[3]

5.Neurological Institute at UC San Diego Health[4]

6.Patient Undergoing Treatment for Anxiety and Depression

7. National institute of neurological disorders and stroke[5]

8. World Federation of Neurology[6]

9. Synergia Medical[7]

10. National Parkinson Foundation[8]

11. US Food and Drug Administration[9]

12. Mount Sinai Hospital Neurological Department[10]

13. Dr. Joel E. Parker, Psychiatrist[11]

14. Dr. Sami Victor , Psychiatrist[12]

15. Dr. Islam Abujabara, Neurologist[13]

16.Mayo Clinic[14]

17.Elite Clinical Studies, LLC[15]

18.Tucson Center For Neurosciences[16]

19. Foothills Neurology[17]

20.MIHS Behavioral Health[18]

Research Institutes and Hospital Organizations: The organizations that are included on this page are necessary to contact to be able to put us possibly in touch with patients to conduct a group survey on this type device. As well as give us insight on how to adapt this product and if it is feasible.

Patients: We hope to reach out to patients that our experiencing struggles adapting to treatment for various neurological and anxiety/depression disorders to receive their input on if they would like to partake in this type of treatment.

Doctors: The doctors we would like to reach out to are a group of well trained physicians that have either conducted clinical research or are currently heads of the department at well-established hospitals here in Phoenix that would be able to give us insight on our product.

Funding: On the list we have included companies that conduct clinical research and invest in products that they believe will impact patient care.

Competitors

- Electrocore Techniques - Medtronic - Two devices manufactured by Neuropace

Advantages
Some advantaged our product has over these current solutions is that ours is much less invasive. These products for the most part require surgery or scheduled treatments with a doctor, which is not only painful and a long process, but it also costs a lot of money and can literally be a pain. So our product would be much more user-friendly and more affordable that would not require a doctor or physician to use because it will be completely available to diagnosed persons for their personal use.

Disadvantages
The main disadvantage of our product is that it does not yet have the funding necessary for production and on top of that it has literally no recognition outside of the biomedical engineering lab professor. So in the beginning it will be hard to get the product started without the proper help and assistance from more connected individuals.

Why Ours is More Marketable
Like I said before, our product is much more affordable due to an only one time purchase so there would be no need for going back and paying for more treatments. It will also not require any surgery so it makes it much more appealing to the consumer eye as opposed to a surgical implant. Lastly, making the product more affordable makes it available to a much broader span of consumers because at this time there is only a few percentages of the population of not just in the United States, but in the world that can afford todays current medical solutions, so that would widen the consumer market vastly.

Unmet Needs
The unmet needs are very similar to the disadvantages of our product as we completely lack in funding and recognition. On top of that, we lack a drawup or sketch of our design so we can start determining what we need exactly to build it.

IP Position



Throughout the research that was conducted, these patents seemed to have similar qualities and characteristics of our idea. Although these patents all have similarities with our project, none of them encompass all of the aspects of our project.

Electrocore Techniques currently owns a patent (patent US6609030B1; created by Ali Rezai)(1) for a device that can regulate the electrical output of certain parts of the brain that are the cause of certain neurological disorders. This invention would also be able to regulate the amount of chemicals that specific parts of the brain creates. This patent is by far the closest in similarity to our idea although this invention would be far more invasive than our idea. This invention would require surgical placement into the brain whereas ours would be transdermal.

Medtronic has a patent for an invention that is supposed to help treat movement disorders (patent US 5832932; created by Dennis D Elsberry)(2). This is similar to our idea in that this invention uses the modification of certain chemicals in the brain to solve a neurological problem. Although the neurological problem here is movement throughout the body. Also our project uses a circuit that would tell the brain to make it’s own chemicals rather that just infuse chemicals into the brain. NeuroPace Inc has a patent for an invention that would prevent certain neurological disorders with a low frequency neurotransmitter that would create more electrical activity in certain parts of the brain ( patent US 6,591,138; created by David R Fischell)(3). This invention is similar to ours in that it tries to solve neurological disorders with an electrical current although where the idea differ is that this invention would try to stimulate the brain electrically whereas ours would stimulate the brain chemically through electricity.

NeuroPace Inc also has a patent to an invention that would prevent seizure and strokes by have electrodes be implanted into the brain to counteract the surplus in electrical activity in the brain. ( patent US 6647296; created by David R Fischell)(4). This invention is similar to ours our in it would use electrical currents to counteract neurological disorders but is different because of the fact that is surgically implanted and only uses electricity to solve the problem.

The Florida International Board of Tustees currently owns a patent (patent US 9272158, created by Khizroev; Sakhrat and Nair; Madhavan P. N.) for what they call a non-invasive method for brain stimulation. It consists of injecting people with an aqueous solution containing magneto-electric nanoparticles that will interact with an external magnetic field to cause stimulation of neural networks in the subject.(5) This method is really invasive since injecting a substance containing nanoparticles which have metals could be dangerous if the person develops an allergic reaction to one of the components or that the nanoparticles have a malfunction and could not be controlled since they are already in the person’s body.

Electrocore, LLC owns a patent (patent US 9174066, created by Simon; Bruce J., Errico; Joseph P., Raffle; John T.) for a non-invasive stimulation device for a treatment that comprises transmitting impulses of the energy to select nerve fibers that activate neural pathways to reduce the release of acetycholine from airway-related vagal preganglionic neurons within the brain of the patient. The device is made for treating bronchial constriction related to asthma, anaphylaxis, chronic obstructive pulmonary disease (COPD), exercise-induced bronchospasm and post-operative bronchospasm through broncodilation.(6) This device is similar to our invention in that it uses electrical impulses to stimulate a nerve, but the difference is that this one is for bronchodilation and ours is for mental disorders.

EBS Technologies GmbH currently owns a patent (patent US 8948875, created by Paulus; Walter and Warschewske; Udo) for a non-invasive electrical deep-brain stimulation device which can be placed on the head of a person to be treated and can be connected electrically to the signal generator so as to apply an alternating-current signal, wherein the electrode arrangement can be used to apply at least two alternating-current signals, of which the trajectories cross the region of the brain to be treated, such that their alternating currents are superposed, as a result of which the region of the brain to be treated is stimulated by electrical alternating currents in a targeted manner.(7) Even though this device is non-invasive it requires to be connected to a machine for generating the electrical impulses and is not portable. Also, treatments vary per person and it does not guarantee a person that she will not suffer symptoms during the rest of day. Our device is portable, efficient and convenient for everyday use without the need of removing it during the day and no need to worry if symptoms reappear during rest of day.

Fundability Worksheet Scores

Competitors:2


Customer Validation:2


IP Position:2

References

Health Care Issue

1. Cruciana, R. (n.d.). Neurotransmission - Neurologic Disorders. Retrieved August 30, 2017, from http://www.merckmanuals.com/professional/neurologic-disorders/neurotransmission/neurotransmission

2. Mandal, M. D. (2015, October 27). Dopamine Functions. Retrieved August 31, 2017, from https://www.news-medical.net/health/Dopamine-Functions.aspx

Customer Validation

[1]MUJIK.BIZ, Leonid Shiriaev -. “About ABCT.” Mission, History, and Contacts for ABCT, 2004, www.abct.org/About/?m=mAbout&fa=dAbout.

[2]“About the National Association of Cognitive-Behavioral Therapists.” National Association of Cognitive-Behavioral Therapists, 2017, www.nacbt.org/about/.

[3]“Research.” Barrow, 2017, www.barrowneuro.org/research/research-at-barrow/.

[4]“UC San Diego Health.” UC Health - UC San Diego, 2017, health.ucsd.edu/specialties/neuro/Pages/default.aspx.

[5]“NINDS Mission.” National Institute of Neurological Disorders and Stroke, U.S. Department of Health and Human Services, 2017, www.ninds.nih.gov/About-NINDS/Who-We-Are/Mission.

[6]About the WFN.” About Us, 2017, www.wfneurology.org/about-us.

[7]“About Us.” Synergia Medical, 2017, synergiam.com/about-us/.

[8]“Believe in Better.” National Parkinson Foundation, www.parkinson.org/expert-care-research.

[9]Center for Devices and Radiological Health. “Implants and Prosthetics.” U S Food and Drug Administration Home Page, Center for Devices and Radiological Health, 2017, www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/default.htm.

[10]“Department of Neurology.” Department of Neurology | Sinai, 2017, www.lifebridgehealth.org/Sinai/DepartmentofNeurology1.aspx.

[11]“Our Providers.” Biltmore Psychiatric Group, www.biltmorepsych.com/our-providers/.

[12]“Provider Profile.” Provider Profile | Integrated Medical Services, www.imsaz.com/provider/islam-abujubara-md.

[13]health.usnews.com/doctors/sami-victor-691609.

[14]“Neurology.” Mayo Clinic, Mayo Foundation for Medical Education and Research, www.mayoclinic.org/departments-centers/neurology/home/orc-20117057.

[15]“About Us.” Elite Clinical Studies, eliteclinicalstudies.com/about-us/.


[16]Solutions, Anchorwave Internet. “Clinical Research.” Center for Neurosciences, www.neurotucson.com/clinical-research/.

[17]“About Neurology Chandler | Foothills Neurology.” Neurologist Phoenix, foothillsneurology.com/neurology/.

[18]“Behavioral Health.” MIHS Behavioral Health, www.mihs.org/behavioral-health/


Competitors
(1)“US6609030B1 - Method of treating psychiatric diseases by neuromodulation within the dorsomedial thalamus.” Google Patents, Google, patents.google.com/patent/US6609030B1/en. Accessed 3 Sept. 2017

(2)“Easy To Use Patents Search & Patent Lawyer Directory.” US Patent # 5,832,932. Method of treating movement disorders by brain infusion - Patents.Com, www.patents.com/us-5832932.html. Accessed 3 Sept. 2017.

(2)“Easy To Use Patents Search & Patent Lawyer Directory.” US Patent # 6,591,138. Low frequency neurostimulator for the treatment of neurological disorders - Patents.Com, www.patents.com/us-6591138.html. Accessed 3 Sept. 2017.

(4)“Easy To Use Patents Search & Patent Lawyer Directory.” US Patent # 6,647,296. Implantable apparatus for treating neurological disorders - Patents.Com, www.patents.com/us-6647296.html. Accessed 3 Sept. 2017.

IP Position

(1)“US6609030B1 - Method of treating psychiatric diseases by neuromodulation within the dorsomedial thalamus.” Google Patents, Google, patents.google.com/patent/US6609030B1/en. Accessed 3 Sept. 2017

(2)“Easy To Use Patents Search & Patent Lawyer Directory.” US Patent # 5,832,932. Method of treating movement disorders by brain infusion - Patents.Com, www.patents.com/us-5832932.html. Accessed 3 Sept. 2017.

(2)“Easy To Use Patents Search & Patent Lawyer Directory.” US Patent # 6,591,138. Low frequency neurostimulator for the treatment of neurological disorders - Patents.Com, www.patents.com/us-6591138.html. Accessed 3 Sept. 2017.

(4)“Easy To Use Patents Search & Patent Lawyer Directory.” US Patent # 6,647,296. Implantable apparatus for treating neurological disorders - Patents.Com, www.patents.com/us-6647296.html. Accessed 3 Sept. 2017.

(5) “Easy To Use Patents Search & Patent Lawyer Directory.” US Patent # 9,669,232. Method for non-Invasive brain stimulation- Patents. Com,patents.com/ us-9669232.html. Accessed 4 Sept. 2017.

(6) “Easy To Use Patents Search & Patent Lawyer Directory.” US Patent # 9,415,219. Non-Invasive vagal nerve stimulation to treat disorders - Patents.Com, patents.com/us-9415219.html. Accessed 4 Sept. 2017.

(7) “Easy To Use Patents Search & Patent Lawyer Directory.” US Patent # 8,948,875. Device for non-Invasive, electrical deep-Brain stimulation - Patents.Com, patents.com/us-8948875.html. Accessed 4 Sept. 2017.