Download BackgroundWorksheet

Project 1 Background Worksheet
Team Members: Mario Rossi, Anne Tucker, Brian Ziola
Clinical Problem: Tendon/Ligament Scaffold Design
1. Strategic Focus
A. Team Name: Collagen Constructs
○ Mission: To focus on research which will have a strong impact in the field of
tendon/ligament tissue engineering by delivering new or better insight into current
field practices
○ Vision:Work on a novel tissue engineering project with Dr. Li which looks at a
new tendon/ligament scaffold
B. Strengths:
○ Currently in tissue engineering and tissue engineering lab
○ Chemistry background: Anne has taken organic chem, Mario has taken
biochemistry and organic chemistry
○ Brian has connections at Beaumont through his work. This provides access to
resources
○ Dr. Bou-akl is a good connection with her background in medicine and research
in the area
○ More interested in conducting some sort of novel research in the area of tissue
engineering than product design
○ We all live in the area, helpful with meetings
C. Weaknesses:
○ Lacking in electrical systems knowledge
○ Lacking in mechanical device design
○ Work or sports schedules could be a hindrance
○ Tend to procrastinate
○ Little experience with scaffold design outside of tissue engineering lab
○ Little experience with cells
D. Acceptance Criteria
○ Research involves creation of a novel scaffold design dealing with biocompatible
materials
○ Solution does not involve electrical or mechanical systems
○ The proposed research is able to be performed on campus or other collaborating
institutions with the required resources available
○ The proposed research must be able to provide deliverables by May 2017
○ The outcome of the research can deliver new, or better insight into current field
practices
○ Growth in communication among team members as well as the building of
relationships with other members in the field is a direct outcome of the proposed
research
2. Needs Exploration
A. ​Log of preparation and interactions.
○ (9/16/16): Meeting with Dr. Li
i.
Discussed different tissue engineering project ideas
ii.
Choose a time for weekly meetings
○ (9/27/16): Meeting with Dr. Li
i.
Discussed research articles
ii.
Decided to build scaffold using some kind of collagen
○ (10/6/16): Meeting with Dr. Bou-Akl
i.
Decided to build a unique anatomically accurate tendon scaffold
ii.
Discussed our areas of focus
○ (10/18/16): Meeting with Dr. Li
i.
Went over tentative protocol and timeline for experiment.
ii.
Setup time to meet with Tristan at Beaumont
○ See Appendix A for full meeting notes
B. Observed Needs
○ Biocompatible material and structure
■ Hold cells or recruit cells. If recruiting cells a scaffold design that will
release growth factor will be needed
○ Have good mechanical strength to hold up to the forces in vivo
○ Degradable material that is safe and does not release toxic byproducts as it
degrades
3. Disease State Fundamentals
A. Anatomy and pathophysiology:
Tendons and ligaments are important to the function of the body by distributing the stress
that bones and muscles endure during activity. Tendon’s are a connective tissue whose
primary function is to connect muscle and bone (Kirkendall). Ligaments are extremely
similar to tendons except that they connect bone to bone. Both tendons and ligaments are
capable of resisting high tensile forces (Kirkendall). The anatomy of tendons are very
similar to that of muscles. The primary unit of tendons are collagen fibers. These
primary fibers bunch together to form bundles called subfascicles. These subfascicles
then gather together to form secondary bundles called fascicles. Finally, these fascicles
then form tertiary bundle groups which compose the tendon (Tendon Anatomy).
Figure 1: Image of tendon anatomy form Encyclopaedia Britannica
Ligaments and tendons primary function are that of a connective tissue capable of
resisting large tensile forces. However, too much stress on the ligaments or tendons can
result in catastrophic tears or ruptures. When this happens, the tendons and ligaments can
no longer perform their primary function of connecting bone to bone or muscle to bone.
This can result in in symptoms such as reduced stability or inability to fully use a certain
muscle. Other symptoms could be muscle atrophy, or loss in muscle mass. Without
repairing these ligaments or tendons, the body will not be able to perform its full, normal
functions.
B. Clinical Presentation, Outcomes and Epidemiology
○ A tendon or ligament rupture occurs when the connective tissue fails and tears
completely
○ Tendon ruptures and ligament tears usually occur due to direct trauma or
excessive force on the tendon or ligament. This results in pain, swelling, and loss
of muscle or joint function
○ Tendon and ligament tears are most commonly associated with sports. It occurs
quite quickly but can be preluded by symptoms such as tendonitis
○ Some of the most common ligament injuries are ACL tears and lateral ankle
ligament tears There are around 95,000 ACL ruptures every year in the United
States and 23,000 occur a day in the United States, some of which result in torn
ligaments. Most common tendon injury is Achilles tendon ruptures. From the
years 2005 to 2011 there were 14,127 Achilles tendon tears in the US alone
4. Existing Solutions
A. Existing solutions:
○ Diagnosis- Physician feel for irregularity, imaging technique (MRI, X-ray, etc)
○ Treatment- Non-surgical: pharmaceuticals, icing to reduce inflammation, physical
therapy, Surgical: Suture tendon/ligament back together, graft other piece of
tissue to injured tissue, Tissue engineering: Seed cells onto scaffold for
implantation at injury site (research phase only), inject cells into injury site
through arthroscopy
○ Managing disease state- Pain relievers
B. Existing solutions presented in a useful format
Figure 2: Existing solutions presented in a flowchart
C. See Figure 3
5. Stakeholder Analysis
A. Influential Stakeholders: Patients, Athletes, Orthopaedic surgeons, Insurance providers
B. Insurance providers vs. orthopaedic surgeons: Surgeons are apt to choose the method of
repair which produces the best results independent of cost for repair. Insurance providers
are typically looking at the benefit-to-cost ratio, what type of dollar-figure will they be
incurring compared to the benefits of the new repair. Are there enough benefits seen by
the new repair that the costs associated with it can be overcome. Athletes, patients, and
surgeons: All have the common goal of using the repair that produces the best results.
C. Orthopaedic surgeons and insurance providers are the decision makers for the care
D. Continuum of care:
○ Onset of pain
○ Doctors visit
■ Review of medical history
■ Physical examination
■ Visual testing such as x-ray, MRI, and ultrasound
○ Diagnoses of tendon/ligament injury
○ Surgical treatment if injury is severe
■ Suture tendon/ligament together
■ Grafting of tendon/ligament
○ Rest and pain relievers if injury is less-severe
■ Reduce pain and inflammation of the tendon/ligament
■ Restore normal motion and strength
○ Physical therapy if pain is still present after rest and pain relievers
■ Reduce pain
■ Avoid further degeneration or tearing of the tendon/ligament
■ Encourage regeneration of the damaged tendon/ligament
6. Market Analysis
A. Current market landscape
Figure 3: Analysis of soft tissue market
B. Market segments:
○ Injury Prevention
■ Preventative devices
○ Revision
■ Non-surgical
1. DIY at-home care
2. Pharmaceutical interventions
3. Physical therapy
■ Surgical
1. Surgical methods/materials
2. Tissue engineering
○ Post-revision
■ Bracing
■ Pharmaceuticals
C. Orthopaedic soft tissue market size- $5B [1]
○ Includes: Biceps tenodesis, lateral epicondylitis, gluteal tendon, rotator cuff,
epicondylitis, achilles tendinosis, pelvic organ prolapse, gluteal tendon, cruciate
ligaments, hip arthroscopy
○ Growth: $9.39B by 2024 [1]
○ Competitive dynamics: Non-surgical repair is the preferred method. Preventative
devices are typically used by athletes or someone who suffered a tendon/ligament
injury in the past. They are less effective due to their low usage. Severe injuries
can only be repaired by surgical methods. Patient will usually be treated with
at-home methods and pharmaceuticals first. If this is not effective, they will add
in physical therapy. And, if this is not enough, they will be given a surgical
intervention. Hospitals, insurance providers, and doctors like to start with the
lower cost methods. Surgery is typically only chosen if necessary to repair the
damage due to its cost and invasiveness
○ Stakeholder needs being met:
■ Patients and athletes: Needs are met by the preventative, non-surgical, and
surgical methods when repair is completed
■ Orthopaedic surgeons: Needs are met through surgical methods of repair
■ Insurance providers: Needs are met by non-surgical methods of repair
○ Key considerations in choosing target market: Size of market, difficulty of repair,
current solutions, commonality of injury
References
1. By Procedure (Rotator Cuff Repair, Epicondylitis, Achilles Tendinosis Repair, Pelvic
Organ Prolapsed, Gluteal Tendon, Cruciate Ligaments Repair, Hip Arthroscopy, Biceps
Tenodesis), By Injury Location (Knee, Shoulder, Hip, Small Joints), And Trend Analysis
From 2013 To 2024. "Orthopedic Soft Tissue Repair Market Size, Share Report, 2024."
Orthopedic Soft Tissue Repair Market Size, Share Report, 2024. N.p., Oct. 2016. Web.
27 Oct. 2016.
2. Shearn, Jason T. et al. “Tendon Tissue Engineering: Progress, Challenges, and
Translation to the Clinic.” Journal of musculoskeletal & neuronal interactions 11.2
(2011): 163–173. Print.
3. "Research and Markets Adds Report: Orthopedic Soft Tissue Repair Market - Global
Industry Analysis, Size, Share, Growth, Trends and Forecast, 2013 - 2019."
PRNewswire. N.p., 25 Mar. 2014. Web. 27 Oct. 2016.
4. Kirkendall, DT and Garrett, WE. “Function and Biomechanics of Tenodons.”
Scandinavian Journal of Medicine and Science in Sports. 2(1997): 6-62. Web. 24 Oct.
2016.
5. “Tendon.” Encyclopaedia Britannica. Encyclopaedia Britannica, Inc. 2 Feb. 2016. Web.
25 Oct. 2016.
6. Renstrom, Per A.F.H. and Lynch, Scott A. “Ankle Ligament Injuries.” Brazilian Journal
of Sports Medicine. 4.3 (1998). Web. 27 Oct. 2016.
7. Erickson, Brandon J. et al. “Trends in the Management of Achilles Tendon Ruptures in
the United States Medicare Population, 2005-2011.” Orthopedic Journal of Sports
Medicine. 2.9 (2014). Web. 27 Oct. 2016.
Appendix A