Novel Spine Stabilization System

Saluki Engineering Company

Prepared by: George S. Trifon P.M., Kyle Halfacre,

Luciana Mottola

Spine Stabilization System Proposal # S09-98-SPINESTB |

OutlineExecutive 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)

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.

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.

Executive Summary 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).

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)

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 matrixInfused with a bone morphogenetic protein (to

induce bone growth into it) Bone fusion to Hardware which will allow motion

between vertebrae.

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.

Executive Summary 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)

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

Technical Discussion 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

Technical Discussion Subsystem RelationshipAxial View

Lateral View

Technical Discussion 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.

Technical Discussion 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.

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.

Technical Discussion Timeline

Technical Discussion Action Item List

Project: Spine Stabilization System Project Number: S09-98-SPINESTB

Team Members:

George Trifon,ME (PM)

Luciana Mottola, ME

Kyle Halfacre, ME

# Activity Person Assigned Due Status

1Obtain current prices of materials LM 24-Aug 7-Sep 0%

2Work Horizontal force applicator GT 24-Aug 7-Sep 0%

3 Work on vertical Applicator GT 24-Aug 7-Sep 0%

4 Work on Rear Linkage LM 24-Aug 14-Sep 0%

5Work on Lateral Brackets LM 24-Aug 14-Sep 0%

6 Work on contact Pad KH 24-Aug 14-Sep 0%

7Produce Parts in solidworks KH 24-Aug 21-Sep 0%

Technical Discussion

Resources Needed

Item DescriptionQuanti

ty $ Each $Subtot

al

1 Computer 1on

hand $0.00 $0.00

2 MS Office 1on

hand $0.00 $0.00

3 ANSYS or SolidWorks 1on

hand $0.00 $0.00

4 Printer 1on

hand $0.00 $0.00

TASK GT LM KH DR.MAHAJAN

Obtain current prices ( S ) ( R ) ( S ) ( A ) Responsibility ( R )

Work on Prototype ( R ) ( I ) ( I ) ( A ) Approval ( A )

Produce parts in SolidWorks ( S ) ( S ) ( R) ( A ) Support ( S )

Information ( I )

RASI Chart

SummaryProject Overview

Elimination of bone anchorsDesignation of Principal Responsibilities

Subsystem distributionPlan 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

Thank you,

There be any questions?