BME100 s2017:Group8 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: Nicholas Chung Name: Salma Leyasi Name: Michelle Loui Name: Ezekiel Mendoza Name: Meghan Rasmussen Name: Nicholas Sora LAB 1 WRITE-UP Health Care Issue The anterior cruciate ligament (ACL) is a major ligament in the knee. The ACL, along with other ligaments, crosses in the middle of the knee and connects the femur to the tibia. Together, these ligaments are especially important in stabilizing knee joints. Our group will be focusing on surgery techniques for fixing ACL tears, specifically the creation and application of anchor to the bones to restore function and movement in the knee. [18] In the United States, more than 200,000 ACL injuries are reported, with approximately 100,000 surgeries conducted to fix the injuries. ACL injuries occur most commonly in people between the ages of 15-45 years old. This is because this age group is often more active and has a higher participation in sports than other age groups. [19] Currently, there are surgeries that use this method for patients with ACL injuries in the knee. However, the equipment being used, like the type of screw, have some complications. The screws themselves can cause strong discomfort, infections, and if the position of the screw is slightly off, then the patient will not regain function of the knee. Our group will be improving upon the current anchors and attempting to create better and more comfortable synthetic materials with osteoconductive properties for the screws and anchors. One idea is a silk-fiber matrix, as it is both suitable and durable for this kind of surgery. This specific protein matrix is able to help heal the injury and support the bone. A possible way to provide this silk would be through silkworms. [20] Customer Validation NFL Players - Around 70 professional players in the league suffer from a torn ACL each year. More specifically, Adrian Peterson had to “put in a lot of hours working hard, hard, non-stop to get back” in order to return [1]. The process is extremely tiring and requires an extended recovery time. With the new method of ACL repairs, NFL players are able to return to the field in a more efficient manner in a shorter amount in time, which is vital since these athletes constantly work throughout the entire year. NBA Players - Players take close to a year to recover from an ACL injury and that is crucial to an NBA player’s career [2]. Also, some players do not reach 100% mobility after the injury in the cases of Bernard King, Tim Hardaway, and Baron Davis. If they were offered a new way of ACL injury repair then the recovery time would me much less and the performance with the new product will be more effective. NHL Players - Through an experiment conducted in 2016, 47 players were identified as suffering an anterior cruciate ligament injury somewhere between 2006 and 2010. The experiment concluded that after suffering an ACL injury, the player’s career was 2.8 years. Compared to the 4.4 years held by the control group, suffering from an anterior cruciate ligament sufficiently affects the career of a professional hockey athlete in the National Hockey League [3]. Developing an alternate approach to ACL repairs could lower the year gap between injured players and non-injured players. MLB - After sustaining an anterior cruciate ligament injury, MLB players who return the season after their surgery play in less games than normal. The most common mechanism of injury for ACL injuries in the Major League Baseball organization was fielding and base running. While most players are able to come back after a reconstruction surgery, they play 21.2% fewer games in the season following the surgery. Players who underwent ACL reconstruction surgery in their rear batting leg also experienced a 12.3% decrease in batting average [4]. A reconstructive approach that promotes faster and better healing will result in players returning quicker and will reduce the decline in games played and batting average. Soccer- When looking at ACL injuries in soccer, female players are more likely to sustain them compared to their male counterparts. A study done in 1999 showed that females land from a jump differently than males. Some of these differences are that women land on straighter legs than men, which directly stresses the ACL, and the hamstrings are significantly weaker than the quads, which makes women more susceptible to injury [5]. Like other professional athletes, injuries impact their health and performance. Whether it’s atrophy of the affected muscles or loss of fine skills needed for their position, long healing times can greatly affect their careers. Our improved anchors for ACL reconstruction surgeries will result in faster healing and more natural movement after healing is completed. College Sports - Many college athletes of all different sports are susceptible to ACL injuries. These players have hopes for one day entering the professional level and will do anything to get back to where they were. For example, University of Washington running back Deontae Cooper has been through three ACL injuries in his college career [9]. This type of injury brings down the value of each player in the eyes of NFL scouts. Therefore, a device or product that would reduce the recovery process for ACL injuries would be of interest to college sports because they are the step before the professionals. Regular People - Athletes on the college or professional level are not the only ones to are at risk for suffering ACL injuries. People of all ages can receive the injury from doing everyday activities or hobbies. Evan, a thirty-one year old suffered an ACL injury when he was skiing [10]. He quoted in the article, “Once you’ve damaged your ACL… you end up with even bigger long-term problems,” and this just shows that even people who do not have a career in professional sports and gravely impacted by the injury. It can hinder everyday movements and cause extreme discomfort. Talking to the average citizen about this injury and what our product can do is extremely important because they are possible customers just as much as everyone else. Johns Hopkins Medicine - This medical facility has orthopedic surgery as a specialty area and has a team of doctors and professionals who work with this type of injury. Contacting the hospital directly would help validate our device because there are experts in the field that can give us feedback and improvements on the designing process. Arizona Orthopedic and Surgical Specialty Hospital - Hospitals and medical centers that specialize in orthopedic surgery are more beneficial than any other hospital who treats more than one department. They are full of medical professionals who could review our product and design and see how it can be applied with the current solutions now. Tarek O Souryal, MD - Dr. Souryal is a medical professional who mainly works with sports medicine and knee/ACL surgeries. He works with Texas Sports Medicine and is also the head physician for a major sports team, the Dallas Mavericks. He states approximately 250,000 ACL injuries occur every year and the treatment for it is not an easy process. “It takes at least six months” [6]. Our product would be of interest to him because of his background and his status as a sports physician. Scott D. Martin, MD - Dr. Martin is a professor at Brigham and Women’s Hospital in the orthopedic department [7]. He mainly deals with sports medicine injuries and focuses on joints within the body. He would be another source of validation because of his high status in this particular field and because of his experience with the ACL injury. Any product that would aid in this medical problem would be beneficial to professionals, such as Dr. Martin. Andrew John Cosgarea, MD - Dr. Cosgarea is a Professor of Orthopedic Surgery who has research interests in knee and shoulder rehabilitation [8]. He is also an expert in ACL/Meniscus reconstructions so his validation for the product would be essential. Rajwinder Singh Deu, MD - Dr. Deu is an assistant professor of orthopedic surgery. He has interests in joint pains and muscle strain injuries. Also, he prefers to work with athletes who suffer these types of injuries [8]. Sameer Dixit, MD - Dr. Dixit is another assistant professor and he has expertise in ankle, elbow, hip and knee injuries [8]. Although, his specialty may not be specific to ACL and knee, his knowledge of the other joints of the body is beneficial when validating the product. There may be insight that could aid in its production. R. Jay Lee, MD - Dr. Lee has expertise and interests in ACL tears with athletes [8]; therefore, his validation would be helpful because the main market for our product are athletes or anyone who is active and mobile. Knowing what works and what does not work would help. Miho Jean Tanaka, MD - She is the director of Women’s Sports Medicine Program and works with orthopedic surgeons [8]. She has interests in knee biomechanics and reconstruction. John Henry Wilckens, MD - Dr. Wilckens is a medical director for orthopedics at White Marsh and specializes in sports medicine [8]. With sports the main market for ACL injuries and surgeries, his expertise would validate our product. Physical Therapists - ATI Physical Therapy is a company that specializes in rehabilitation of the body due to certain injuries. Any physical therapy center would be a reliable source of validation because there is always a recovery process after the injury has occurred. Therefore, these professionals see the advantages and disadvantages of different types of solutions of ACL repairs. If we showed therapists what the advantages of our product, then they would be able to recommend it to their own customers. Army - Soldiers suffering from torn ACLs may have to take a medical leave or discharge. Hopefully, with our device, we can make the road to recovery cheaper, less painful and less time consuming enough so that injured soldiers can stay in the Army. Navy (Marine corps or equivalent)- The Marines also suffer from ACL injuries as much as the Army. The Navy and Airforce branches suffer less from ACL injuries than the Army and Marine Corps. Marketing should be to the whole military, but our main users would be the Army and Marine Corps. Competitors Mitek Sports Advantages: Enhances bone to graft contact, Offers distinct bundle separation in single tunnel to mimic the native anterior cruciate ligament, Eliminates problems with graft rotation and damage. Disadvantages: Not natural, Can cause bone to fracture even if surgery is done with minimal error. Neoligaments Advantages: No knotting due to sutures, Low profile design, No drilling necessary minimizes slippage under cyclic loading reduces suture/ graft loosening. Disadvantages: May need to remove/ second surgery is required, Discomfort is still a problem, Not as secure as a screw. SBM Advantages: Osteoconductive, Absorbable, Bioactive, No inflammatory reaction. Disadvantages: Still can cause fracture, May not completely degrade fracture bones. Teknimed Advantages: Absorbable, Stable for up to 10 months. Disadvantages: Does not promote healing, Takes up to 24 months for bone to be replaced, Healing may take longer than 10 months and cause complications. IP Position MedicineLodge, Inc.; Patent No: 5,702,397 ; Dec. 30, 1997 Ligament Bone Anchor and Method for its Use. A bone anchor used to mount a ligament graft. The tunnel section of the anchor allows a suture to pull a ligament graft through, and attach it to the adjacent bone cortex [11]. Wright Medical Technology, Inc.; Patent No.: US 7,250,550 B2 ; Jul. 31, 2007 Synthetic Bone Substitute Material A synthetic bone graft material used to replace cancellous bone in a bone graft composition [12]. Warsaw Orthopedic Inc; Patent No.: US 2003/0003160 A1; Jul. 31, 2007 Synthetic Biomaterial Compound of Calcium Phosphate Phases Particularly Adapted for Supporting Bone Cell Activity A biomaterial comprised of Calcium Phosphate. It's made of calcium, oxygen, and phosphate. The molecular structure and property that can be used in bone-related clinical condition [13]. Prochon Biotech Ltd; Avner Yayon; Patent No.:US 2006/0147547 A1; Jul. 6, 2006 Bone Enhancing Composite A composite that can be used as a powder, paste, or implant. The composite is a bone enhancing material made up of synthetic apatite and a supplementary bioactive agent from a polymer and an anti-resorption agent. [14] Teppo Järvinen; Patent No.:US 6,562,071 B2 ; May 13, 2003 Fixation Anchor An anchoring and fixation device for the fixation of a natural or artificial ligament into a drill-hole in the bone. The device is U-shaped with two arms, in which the transplant is passed through. A clamp is then placed between the device and locks the anchor into place [15]. Allergan Inc.; Patent No.: US 20110008406A1 ; Jan. 13, 2011 Silk Fibroin Hydrogels and Uses Thereof. A method of making pure fibroins and applying those fibroins to a variety of uses (including bone and tissue growth) Cayenne Medical Inc.; Patent No.: US 7651528B2 ; Jan 26 2010 Devices, systems and methods for material fixation. Devices, systems and methods for fixations of tendon to bone Mark Pelo, Pamela Pelo, Pamela Plouhar, Herbert Schwartz, Prasanna Malaviya, Terrence Whalen; Patent No.:2003/0032961 A1 ; Feb. 13, 2003 Devices From Naturally Occurring Biologically Derived Materials. An orthopedic device that is made of and extracellular matrix material that has been harden. The material can be machined to form a variety of devices. [16] Mark Siegel; Patent No.: US 20070055255 A1 ; March 8, 2007 Bioabsorbable Endosteal Fixation Device and Method of Use A device with a hallowed elongated body used for repairing connective tissues to the bone. The body is used with other techniques for repairing damaged tissue [17] Fundability Worksheet Scores Competitors Based on the openness of the artificial ACL ligament industry and the high demand for anterior cruciate ligament reconstruction surgeries, we gave ourselves a score of 3 in the Competitors section. While there are multiple companies offering their version of artificial ligaments to be used in reconstruction surgery, the demand among athletes and everyday people is great enough that there is massive room for growth and development for start-up companies. Customer Validation We gave ourselves a score of 3 in the Customer Validation category. ACL injuries affects thousands of professional athletes in every sport and greatly reduce the number of games they play in as well as their performance. National sports organizations and the players themselves would be willing to pay for our artificial ligament and anchors if it meant they could get back to playing sooner and maintain the skills and athleticism they had before the injury. IP Position Based on the patents we were able to find involving bone anchors for ligament reconstruction surgery, we gave ourselves a score of 3 in the IP Position category. Finding these patents helped our group solidify that we were heading in the right direction with our idea and inspired us to think about how to make our anchors and ligament more natural than these. Bibliography [1] Mihoces, Gary. "Adrian Peterson Leads Way in ACL Recovery in NFL." USA Today. Gannett Satellite Information Network, 07 Dec. 2012. Web. 25 Jan. 2017. [2]Bunn, Curtis. "5 Former NBA Players Who Were Never The Same After an ACL Injury." Atlanta Black Star. N.p., 22 Dec. 2014. Web. 25 Jan. 2017. [3] "Anterior Cruciate Ligament Injuries in Professional Hockey Players." The American Journal of Sports Medicine. U.S. National Library of Medicine, n.d. Web. 29 Jan. 2017. [4] Fabricant PD, Chin CS, Conte S, et al. Return to play after anterior cruciate ligament reconstruction in Major League Baseball athletes. Arthroscopy 2015 Feb 3. [5] "ACL Injury and the Female Soccer Player." US Youth Soccer. N.p., n.d. Web. 29 Jan. 2017. [6]"ESPN Feature on ACL Injuries, ACL Tear, ACL Surgery, ACL Injury, Dallas Texas Sports Medicine, Dallas Mavericks." ESPN Feature on ACL Injuries, ACL Tear, ACL Surgery, ACL Injury, Dallas Texas Sports Medicine, Dallas Mavericks. University Park, n.d. Web. 29 Jan. 2017. [7]"Scott D. Martin, MDSkip Navigation." BWH Department of Orthopedic Surgery, Advanced Center for Cartilage Shoulder and Sports Injuries (ACCSS) Scott D. Martin, MD. N.p., n.d. Web. 29 Jan. 2017. [8]Lannon, Jennifer. "ACL Tear Treatment." Johns Hopkins Department of Orthopaedic Surgery. N.p., n.d. Web. 29 Jan. 2017. [9]"Matt Murschel Football Repetitive Acl Injuries: Multiple ACL Injuries Slow but Don't Stop Athletes."Tribunedigital-orlandosentinel. N.p., 19 Aug. 2012. Web. 29 Jan. 2017. [10]"ACL Solutions - Real-life Stories." ACL Solutions - Real-life Stories. N.p., n.d. Web. 29 Jan. 2017. [11] Goble, Marlowe E , David P. Lumen, Alan Chervitz, C. Brad Story, and Ramaro Gundlalpalli. LIGAMENT BONE ANCHOR AND METHOD FOR ITS USE . MedicineLodge, Inc., assignee. Patent 5,702,397 . 30 Dec. 1997. Print. [12]Oberby, Robyn J., Olaf H. Schutz, Ann V. Burgess, Warren O. Haggard, and Michael Vincent. Synthetic Bone Substitute Material. Wright Medical Technology, Inc., assignee. Patent US 7,250,550 B2 . 31 July 2007. Print. [13]Pugh, Sydney M , Timothy J.N. Smith, Michael Sayer, and Dorthea Langstaff. Synthetic Bio material Compound of Calcium Phosphate Phases Particularly Adapted for Supporting Bonce Cell Activity. Warsaw Orthopedic Inc., assignee. Patent US 2003/0003160 A1. 2 Jan. 2013. Print. [14]Yayon, Avner . Bone Enhancing Composite. Prochon Biotech Ltd , assignee. Patent US 2006/0147547 A1. 6 July 2006. Print. [15]Javinen, Teppo. Fixation Anchor. Teppo Järvinen , assignee. Patent US6562071B2. 13 May 2003. Print. [16]Pelo, Mark J., Pamela L. Plouhar, Herbert E. Schwartz, Prasanna Malaviya, and Terrence D. Whalen. Devices From Naturally Occurring Biologically Derived Materials. Patent 2003/0032961 A1. 13 Feb. 2003. Print. [17]Siegel, Mark. Bioabsorbable Endosteal Fixation Device and Method of Use. Mark Siegel, assignee. Patent US20070055255A1. 8 Mar. 2007. Print. [18]"ACL Injury." Mayo Foundation for Medical Education and Research (MFMER). 2017. Accessed 25 Jan. 2017. [19]"Anterior Cruciate Ligament Injury (ACL)." UCSF Medical Center, Department of Orthopaedic Surgery. 2017. Accessed 25 Jan. 2017. [20]Altman, Gregory H. et al. "Silk matrix for tissue engineered anterior cruciate ligaments." Elsevier. 26 April 2002. Accessed 25 Jan. 2017.