2. 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. 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.  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.  Why It Is Needed 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).

6.  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.  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.  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.  Designation of Principal Responsibilities DR.MAHAJAN FACULTY TECHNICAL ADVISOR Mechanical engineering 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.  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.  Subsystem Relationship Contact Pad Metal Contact Site Porous Metal Rear Linkage Metal Lateral Brackets Metal Lateral Force Applicator Spring-like material Vertical Force Applicator Spring-like material Bone

12.  Subsystem Relationship Axial View Lateral View

13.  Literature Review Summary 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.

14.  Literature Review Summary 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. Dynamic Stabilization systems One of the most prevalent systems available today for spine stabilization is the Dynesys Neutralization system.

15.  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.  Timeline

17.  Action Item List Project: Spine Stabilization System Project Number: S09-98-SPINESTB Team Members: George Trifon,ME (PM) Luciana Mottola, ME Kyle Halfacre, ME #ActivityPersonAssignedDueStatus 1 Obtain current prices of materialsLM24-Aug7-Sep0% 2 Work Horizontal force applicatorGT24-Aug7-Sep0% 3 Work on vertical ApplicatorGT24-Aug7-Sep0% 4 Work on Rear LinkageLM24-Aug14-Sep0% 5 Work on Lateral BracketsLM24-Aug14-Sep0% 6 Work on contact PadKH24-Aug14-Sep0% 7 Produce Parts in solidworksKH24-Aug21-Sep0%

18. ItemDescription Quanti ty$ Each$ Subtot al 1Computer1 on hand$0.00 2MS Office1 on hand$0.00 3ANSYS or SolidWorks1 on hand$0.00 4Printer1 on hand$0.00 TASKGTLMKHDR.MAHAJAN Obtain current prices ( S )( R )( S )( A )Responsibility( R ) Work on Prototype ( R )( I ) ( A )Approval( A ) Produce parts in SolidWorks ( S ) ( R)( A )Support( S ) Information( I )

19. 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