BME100 s2018:Group3 W0800 L1

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OUR TEAM

Name: Maria Soldevila
Name: Isaac Heath
Name: Camryn Garza
Name: Maximo Gutierrez

LAB 1 Needs Identification

Health Care Issue

The health care issue we are focusing on is Osteoarthritis, which is also called the “degenerative joint disease” and occurs when the cartilage or cushion between joints begin to wear away leading to swelling and or stiffness (1). Osteoarthritis can target any joint in the body, but it is most commonly found in the joints of the knees, hands, hips, and spine. Patients often suffer from joint tenderness, and a loss of flexibility -a lack of a full range of motion in joint. This is due to the deterioration of the slick cartilage, and a combination of an inflamed synovial membrane, and a reduced joint space. If the cartilage is completely destroyed, one may be left with bone rubbing on bone. Current medical treatments include acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs) , and or duloxetine - commonly used as an antidepressant (1). These are only meant to relieve the pain the patient would experience. The current surgical procedures that treat Osteoarthritis are comparatively invasive, and include among cortisone injections, realignment of the bones, and joint replacements (1).

Impact of Issue on Society
The current impact osteoarthritis places on society includes not only disability, pain, and a decreased ability to perform activities of daily living, but an increased potential for depression/anxiety (3). Indirect costs such as lost time from work, disability compensation and an overall decreased productivity increases the risk factor for depression. It affects a patient both physically, and mentally by decreasing the overall quality of life for the patient. Economical impacts include direct-costs such as hospital resource use, management of side-effects caused by pharmaceutical treatments, and research (3).

Solution

Our solution would be a neural implant that would send electrical stimulations to the vagus nerve, and block the production of inflammatory proteins such as tumor necrosis factor (TNF) and prostaglandins that result in pain, warmth, and swelling. The implant would respond to a biological marker of arthritis, cartilage oligomeric matrix protein (COMP) in the bloodstream, and would release stimulation accordingly. By regulating the release of these proteins in a routine-like manner, the immune system could be regulated, and the patient could experience a reduction in pain during therapy or recovery.




Customer Validation

1. On The Mend On The Move, 480-354-2911

     http://onthemendpt.net/arthritis-rehab/ 

2. Center for Athletic Performance,

     https://rebuildingchampions.com/arthritis-physical-therapy-exercises-symptoms.html 

3. Daniel Choi, Pain Management Doctor, 5425 E Bell Rd # 115, Scottsdale, AZ 85254, (480) 991-3005
4. Johns Hopkins Hospital, 1800 Orleans St, Baltimore, MD 21287
5. Cleveland Clinic, 800.223.2273
6. Mayo Clinic Scottsdale, 13400 E Shea Blvd, Scottsdale, AZ 85259, (480) 301-8000
7. Arthritis Care Specialists, 1300 N 12th St # 618, Phoenix, AZ 85006, (602) 258-1231
8. Dr. Saima Chohan, 4550 E Bell Rd, Phoenix, AZ 85032, (480) 443-8400
9. Jajoo Ramina, 9305 W Thomas Rd #505, Phoenix, AZ 85037, (623) 512-4800
10. Valley Arthritis Care, 20033 N 19th Ave, Phoenix, AZ 85027, (623) 815-2690
11. Arthritis Foundation,1355 Peachtree St NE Suite 600 Atlanta,GA 30309

     http://www.arthritis.org/ 

12. Arthritis Today Magazine

     http://www.arthritis.org/arthritis-today-magazine/ 

13. Arizona Pain Treatment Centers, 602) 833-4364

     http://arizonapaintreatmentcenters.com/arizona-pain?_vsrefdom=cpc-google&gclid=EAIaIQobChMIwMup9Lzf2AIVFGV-
     Ch0CzAcZEAAYASAAEgLXxPD_BwE 

14. Advanced Pain Management, (602) 899-PAIN

     http://advancedpainmanagement.com/

15. Brigham and Women’s Hospital, 75 Francis St, Boston, MA 02115
16. Arizona Arthritis Clinic, 480-372-8200

     https://www.azarthritisclinic.com/

17. Johns Hopkins Arthritis Center, 5501 Hopkins Bayview Circle
18. Hospital for Special Surgery, New York-Presbyterian University Hospital of Columbia and Cornell
19. Banner Desert Medical Center Campus, 2145 W Southern Ave, Mesa, AZ 85202, (602) 230-2273
20. American College of Rheumatology




Competitors

Compitition Table .jpg
[6] [7] [8]




IP Position

Patent 1: Prescription Pad for Treatment of Inflammatory Disorders

VagusNerve1.jpg

Prescription pad for treatment of inflammatory disorders, ZITNIK, Mar 3, 2011. 

The following is a patent for a cuff that goes around the vagus nerve that is surgically implanted in the patient. Once it has healed it sends information wirelessly to an electronic tablet that can keep track of the status of the implant as well as control the stimulation of the cuff. The prescription pad is then charge by a traditional charging module. The amount of stimulation will be entirely controlled by the doctor who will have access to input “prescriptions” into the pad. The doctor will get information from biomarkers in the patient and will use that information to determine the dose; therefore, the actual patient will not be able to accidentally over or under treat themselves.The controller would control the intensity of the stimulation the patient would receive. This device is designed to be mainly used for inflammatory disorders.

Assignee: Zitnik Ralph J, Faltys Michael A

Filed: Sep. 1, 2010

Application Number: 12/874,171

Publication Number: US 2011/0054569


Patent 2: Implantable Therapeutic Systems Including Neurostimulation Circuits, Devices, Systems and Methods
Contraption1.jpg

Implantable Therapeutic Systems Including Neurostimulation Circuits, Devices, Systems and Methods, Scott Armstrong et. al, Nov 26 2011. 

This patent consists of two neurostimulation devices that will be connected and an array of neurostimulators that are controlled by an external controller. It is connected by the external device with an electrode on each end of the device. The neurostimulators contain non-volatile memory and respond to communications using identification codes. A polymer connector is attached to the first implantable stimulator which would form a neurostimulator array. Functions are performed by integrated circuits which have an input current rating from about zero to about five milliamps. The external controller (the control system) receives communications from the internal device, and allows the internal device to proceed with its function; Therefore, the external control system is composed of software and hardware that allows the control function. There are several different models for the process of stimulation including coils. This device does not target any specific disease and is simply a design for a nerve stimulation device and therefore is a very broad therapy.

Assignees:The Board of Regents, The University of Texas System, Austin, TX (US); MicroTransponder, Inc., Austin, TX (US)

Filed: Apr. 27, 2011

Application Number: 13/095,542

Publication Number: US 2011/0288615



Patent 3:
Cartoon1.jpg

Treating inflammatory disorders by electrical vagus nerve stimulation, Jared Huston and Kevin Tracey, Aug 10, 2006.

This patent includes a device to stimulate the vagus nerve using voltage to treat the inflammatory cytokine cascade. A teflon-coated silver electrode .003 inch in diameter is wrapped around the nerve. Stimulation is performed using the STMISOC stimulation adapter (a Biopac system). This device is designed to be used on an array of conditions, but focuses on the anti-inflammatory potential of nerve stimulation. The vagus nerve is stimulated by a signal voltage from 0,01 Volt to 1 Volt. However, this device is not effective if the patient suffers from asthma or cystic fibrosis. The half-life of TNF suppression by electrical vagus nerve stimulation was between two and three days, which is long-lasting compared to the pharmaceutical alternatives.The device can be implanted onto any surface of a nerve that branches off the main vagus nerve, and can be used to target a variety of inflammatory diseases.

Assignee:North Shore-Long Island Jewish Research Institute

Filed: Jun. 22, 2005

Application Number: PCT/US2005/022409

Publication Number: WO2006073484 A2


Patent 4:
Electrode11.jpg
Peripheral nerve field stimulation and spinal cord stimulation, Rooney, et. al, Jun 9, 2005.

This is a patent for a device that delivers peripheral nerve field stimulation along with spinal cord stimulation to treat unidentified conditions. This is a device that is implanted into the nervous system at different locations depending on the site of the therapy. The electrodes are positioned in the specific area where a patient experiences pain. The controller or sensing module will sense the physiological parameter of the patient: respiratory rate, muscle activity, blood flow rate, etc. The sensing module will send signals to a processor which would then determine the patient's pain state, and prompt/control the delivery of peripheral nerve stimulation. The patient only has control of whether the stimulation is deactivated or reduced. The technique for controlling therapy delivery is based on the fact that a physiological parameter characteristic must be detected; Therefore, a patient can only turn off or reduce the intensity of the stimulation, and not the initial intensity of the voltage.

Assignee: Medtronic, Inc., Minneapolis, MN (US)

Filed: Jun. 9, 2006

Application Number: 11/450,144

Publication Number: US 8,644,941 B2





Fundability Worksheet Scores

FundabilityWorksheet.jpg


Customer Validation
The Vagus Nerve Stimulator would be a unique alternative to current solutions such as the compression/heat therapy, pharmaceutical drugs, or the invasive surgical procedures. More than 27 million people are affected by osteoarthritis and are often required to refrain from daily activities (4). Vagus nerve stimulation has been used in epilepsy and depression patients, and is generally known as a safe therapy (5). Preclinical studies have also shown that the cholinergic anti-inflammatory pathway by vagus nerve stimulation has had a beneficial effect on synovial inflammation and joint damage (5). If similar studies that use vagus nerve stimulation have had beneficial outcomes, it is likely that consumers would be more likely to invest in the product.

Competitors
The Vagus Nerve Stimulator would receive the score of a two in Competition because although a number of competitors exist, clinical improvements and research is still being done to finalize the product towards treating arthritis specifically.

IP Position
The IP Position was estimated to receive an score of 1, because there would be a freedom to operate, however, we have not issued a patent for the device yet. Existing and similar solutions were able to issue patents, therefore it would be comparably feasible to issue a patent.



References

1. "Osteoarthritis." Mayo Clinic,https://www.mayoclinic.org/diseases-conditions/osteoarthritis/diagnosis-treatment/drc-20351930.

2. Ben-Menachem, E., Revesz, D., Simon, B. J. and Silberstein, S."Surgically Impanted and Non-invasive Vagus Nerve Stimulation: A Review of Efficacy, Safety and Tolerability." European Academy of Neurology, vol. 22, no. 1, 2015, pp. 60–68. doi:10.1111/ene.12629.

3. Breedveld, F.C. "Osteoarthritis- the impact of a serious disease."Rheumatology, vol. 43, no. 1, 2004, pp- i4-i8. doi:10.1093/rheumatology/keh102.

4. "Osteoarthritis." U.S. Department of Health and Human Services,https://report.nih.gov/NIHfactsheets/ViewFactSheet.aspx?csid=55.

5. Koopman, F.A., Schuurman, P.R., Vervoordeldonk, M.J., Tak, P.P."Vagus Nerve Stimulation: A New Bioelectronics Approach to Treat Rheumatoid Arthritis?"Best Practice & Research Clinical Rheumatology, vol. 28, no. 1, 2014, pp. 25-35. doi:10.1093/rheumatology/keh102. doi: 10.1016/j.berh.2014.10.015

6. Manno, Rebecca L. “Osteoarthritis Treatment Information.” Arthritis Information, Johns Hopkins University, 11 Dec. 2011, www.hopkinsarthritis.org/arthritis-info/osteoarthritis/oa-treatments/#pharm.

7. “Osteoarthritis Treatment.” Www.arthritis.org, Arthritis Foundation , www.arthritis.org/about-arthritis/types/osteoarthritis/treatment.php.

8. Foltz-Gray, | By Dorothy. “Surgery: Why Wait? Why Not?” Www.arthritis.org, Arthritis Foundation , www.arthritis.org/living-with-arthritis/treatments/joint-surgery/candidates/waiting-surgery.php.