Novel Spine Stabilization System

1. Novel Spine Stabilization System Saluki Engineering Company

2. Outline • Executive Summary • Background(George Trifon) • What We Are Doing • Why It Is Needed • How It Is Different • Deliverables • Designation of Principal Responsibilities • Required Financing • Price List (Materials) • Resources • Tech Discussion • Project description (Kyle Halfacre) • Subsystems • Block Diagram • Subsystem Relationship • Literature Review Summary (Luciana Mottola) • Plan For Completion • Timeline • Action Item List • Resources • Price list • Equipment • Summary (Kyle Halfacre)

3. Executive Summary • Background • The majority of procedures today utilize the pedicle screw stabilization system. • The system screws into the pedicle. • It fuses vertebra together. • Screws tend to brake of come out of bone. • Pedicle can brake off.

4. Executive Summary • What We Are Doing • There a many problems associated with the current pedicle screw stabilization system (Some of which can be life threatening). • By eliminating the screws, we are drastically reducing the trauma to the bone. • We are supporting the spine without any sort of cutting, drilling or grinding on the bone. • We are developing a system that is durable and reliable.

5. Executive Summary • The only options with current systems are; • A complete inter-vertebral fusion which does not allow for any motion and generally utilizing the pedicle screw system. • A dynamic system which has a high risk of failure (currently being recalled). • Or other, more exotic systems that are still very risky extremely traumatic and extremely invasive (meaning, they are very painful requiring long recovery time). • Why It Is Needed

6. Executive Summary • Why It Is Needed • Most of these systems require large and or heavy hand tools and/or large and heavy power tools for cutting and/or bending strong materials during the installation procedure. (difficult installation usually means long procedure, very invasive and extremely traumatic)

7. Executive Summary • How It Is Different • Instead of drilling, our system will use • Pressure from pseudo-elastic, spring, or memory-shape alloy • High friction microstructure • Mechanical hold from shape to secure our device into place. • Instead of complete fusion between vertebrae (which immobilizes the spine), our system will utilize • Sintered alloy matrix • Infused with a bone morphogenetic protein (to induce bone growth into it) • Bone fusion to Hardware which will allow motion between vertebrae.

8. Executive Summary • Deliverables • We will deliver an effective and efficient device. • THE SPINESTB WILL RETAIN THE SPINE’S NORMAL FUNCTION!!! • By design the SPINESTB will be simple to assemble and simple to install. (Lowering the possibility for human error) • The SPINESTB will be minimally invasive thereby reducing recovery time. • The SPINESTB will cause little to no trauma to the bone tissue during installation and during function. • The SPINESTB will allow for intra-vertebral disk recovery and healing. • The SPINESTB will be modular, for easy modification and upgrade.

9. Executive Summary DR.MAHAJAN FACULTY TECHNICAL ADVISOR Mechanical engineering • Designation of Principal Responsibilities GEORGE TRIFON (ME, PM) • Horizontal Force Applicator • Vertical Force Applicator • Ergonomic Interaction and Optimization KYLE HALFACRE (ME) • Contact Pad • Contact Site • Material Selection LUCIANA MOTTOLA (ME) • Lateral Bracket • Rear Linkage • BMP (Bone Morphogenetic Protein)

10. Executive Summary • Required Financing • Price List (Materials) • 200g Tantalum ……………………………$100.00 • 0.5”x 3” Titanium.……………………………..$100.00 • Stainless Steel (Bar Stock)……………………$100.00 • Resources • Materials Processing Lab • Hot Press • Machine Shop • Lathe • Mill • Oxy-Acetelyne Torch • Tig Welder

11. Technical Discussion • Lateral Force Applicator • Spring-like material • Subsystem Relationship • Vertical Force Applicator • Spring-like material • Rear Linkage • Metal • Lateral Brackets • Metal • Contact Pad • Metal • Contact Site • Porous Metal Bone

12. Technical Discussion Axial View • Subsystem Relationship Lateral View

13. Technical Discussion • Introduction • 400,000 lower back operations performed every year in the United States. • Herniated or Ruptured Disk, Lumbar Spinal Stenosis, and Osteoarthritis. • Anatomy of the Vertebrae • Facet joints, spinal canal, nucleus and the annulus. • L1-L5, are the ones most frequently involved in back pain. • The highest activity is located on the segments L3-L4 and L4-L5. • The most strain is taken by the segments L4-L5 and L5-S1. • Literature Review Summary

14. Technical Discussion • One Level Fusion • The one level fusion surgery normally contains four pedicle screws and two rods along with connective hardware. • Approaches: Anterior Lumbar Interbody fusion,Posterior Lumbar fusion Interbody Fusion, Transforaminal Lumbar Interbody Fusion. • Literature Review Summary • Dynamic Stabilization systems • One of the most prevalent systems available today for spine stabilization is the Dynesys Neutralization system.

15. Technical Discussion • Literature Review Summary • Spinal fusion through the use of bone cement • Cements introduced in 1940. • The most common use is in securing artificial joints in place. One application is in hip replacement. • The cement is used to fill gaps between the hardware that is inserted into hollowed out hip bone and the bone itself.

16. Technical Discussion • Timeline

17. Technical Discussion • Action Item List

18. Technical Discussion Resources Needed RASI Chart

19. Summary • Project Overview • Elimination of bone anchors • Designation of Principal Responsibilities • Subsystem distribution • Plan to Finish on Time • Follow the projected timeline for milestones and due dates • Resources Needed • Most resources will be from the ME Computer lab, i.e. MS Office, ANSYS, and printer

20. Thank you,There be any questions?