4/16/2009
SALUKI
ENGINEERING
COMPANY
SPINE STABILIZATION SYSTEM
PROPOSAL
Prepared by: George S. Trifon,
Kyle A. Halfacre,
Luciana Mottola
Spine Stabilization System Proposal # S09-98-SPINESTB |
Saluki Engineering Company
Spine Stabilization System
Proposal # S09-98-SPINESTB
Spine Stabilization System Design Group 98
Saluki Engineering Company (SEC)
Southern Illinois University Carbondale
Mail code 6603
Carbondale, Illinois 62901
Dr. Ajay Mahajan
Southern Illinois University Carbondale
Mail code 6603
Carbondale, Illinois 62901
To Whom It May Concern:
The following proposal is in response to your request for an innovative spine stabilization
system, without the use of pedicle screws. We appreciate the opportunity to present our design
proposal, and we appreciate the time you are taking in the consideration of our proposal.
As most medical professionals are well aware, there is an abundance of spine stabilization
systems currently on the market. Orthopedic surgeons have a wide variety to choose from to
correct just about any back problem that exists. These devices come in all varieties of shapes
and sizes, with all kinds of functions and applications, but they all have one thing in common:
they are all permanent and cause a considerable amount of trauma to the surrounding tissue.
Also, the vertebrae that are being supported or fused are generally drilled and tapped, cut and or
trimmed. Even more, the disk is never given a chance to recover and possibly regain some of its
function ability. Essentially the disk is either removed or eventually encased in bone.
We are confident that our new system will not only eliminate the need for any screws, but it will
eliminate the need for any cutting, drilling or tapping of bone altogether. The new system will
also reduce the trauma sustained by the surrounding tissue. This is done by: (1) reducing the
number of ligaments that need to be cut (to access the required area), and (2) reducing the time it
takes to perform the procedure. This will be accomplished by reducing the number of
instruments necessary to insert the device (thus shortening and simplifying the procedure),
thereby reducing exposure time and the risk of human error and infection. In addition, other
benefits include the retention of some or all mobility (a.k.a. dynamic stabilization), modifiability,
reparability and upgradeability. Essentially the system will allow surgeons to add to the existing
hardware if more levels need stabilization, increase level of support if necessary, and repair or
replace individual components of the hardware (that are not fused to bone). All this will be done
while leaving the disk in place and allowing it to heal (if possible) to act as a redundant system.
After reviewing existing patents we have determined that our design will not infringe upon any
patents, in that it is entirely original and unique. Such a system is possible because of the recent
advances in material science technology and bone growth stimulation techniques. Our system
incorporates pseudo elastic alloys to support and keep the device in place while the utilization of
bone morphogenetic material induces bone growth into the device to make it stable and
permanent, yet minimally invasive.
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Saluki Engineering Company
Spine Stabilization System
Proposal # S09-98-SPINESTB
Sincerely,
George S. Trifon
George S. Trifon
SPINESTB Project Manager
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Saluki Engineering Company
Spine Stabilization System
Proposal # S09-98-SPINESTB
EXECUTIVE SUMMARY
The novel spine stabilization system (SPINESTB) consists of an estimated six specific
subsystems (may include more at a future time). The function principle is; a bilateral
compression of the inferior and superior rims of the vertebral body, with simultaneous vertical
expansion forces of respective regions, essentially encompassing approximately 60% to 80% of
the Annulus Fibrosus (the outer membrane of the vertebral disk). This action displaces the
forces on the disk to the contact regions of the SPINESTB system which transfers them to a
series of “Vertical Force Applicators” (pseudo elastic alloys set to simulate a response similar
to that of a healthy disk). The shape of the contact regions allow for stabilization of the
vertebrae while allowing natural flexion and tension of the spine. The contact regions are
designed to then fuse to the vertebral body and become a permanent part of the vertebrae. After
that any component is able to be replaced or upgraded as necessary through a quick minimally
invasive procedure. Each SPINESTB unit is placed between two vertebrae and can act alone or
in conjunction with other SPINESTB units, with semi rigid vertical stabilizers to create a fully
dynamic spine stabilization system of multiple levels.
The six subsystems are labeled as such; “contact site,” “contact pad,” “lateral brackets,”
“rear linkage,” “vertical force applicators” (VFAs) and, “horizontal force applicators” (HFAs).
Each subsystem contains one or more individual components that are defined by their location in
relation to the placement of the SPINESTB system.
A compilation of the research performed thus far, that was required for gaining an
understanding of the biological systems involved and affected by the SPINESTB device, is listed
in the following Literature Review section of the proposal along with a collection of relevant
existing devices with descriptions and a list of patents with descriptions to compare how the
SPINESTB device is fundamentally different from all existing devices.
Detailed information on the time spent progression of events on the research and
development of the SPINESTB system is also included in the following proposal. Most of the
materials have already been located, so the estimated cost of the project at this time is time itself.
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Saluki Engineering Company
Spine Stabilization System
Proposal # S09-98-SPINESTB
RESTRICTION NON-DISCLOSURE OF INFORMATION
The information provided in or for this proposal is the confidential, proprietary property of the
Saluki Engineering Company of Carbondale, Illinois, USA. Such information may be used
solely by the party to whom this proposal has been submitted by Saluki Engineering Company
and solely for the purpose of evaluating this proposal. The submittal of this proposal confers no
right in, or license to use, or right to disclose to others for any purpose, the subject matter, or
such information and data, nor confers the right to reproduce, or offer such information for sale.
All drawings, specifications, and other writings supplied with this proposal are to be returned to
Saluki Engineering Company promptly upon request. The use of this information, other than for
the purpose of evaluating this proposal, is subject to the terms of an agreement under which
services are to be performed pursuant to this proposal.
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Saluki Engineering Company
Spine Stabilization System
Proposal # S09-98-SPINESTB
TABLE OF CONTENTS
Contents
INTRODUCTION (GT) ................................................................................................................. 7
LITERATURE REVIEW ............................................................................................................. 12
LITERATURE REVIEW SURVEY (KH) ................................................................................... 51
PROJECT DESCRIPTION (GT) .................................................................................................. 53
DESIGN BASIS (GT)................................................................................................................... 54
SUBSYSTEM DESCRIPTIONS .................................................................................................. 55
Contact Pad/Contact Site (KH) ......................................................................................... 55
Axial Linkage (KH) .......................................................................................................... 55
Lateral Bracket (LM) ........................................................................................................ 55
Vertical/Horizontal Force Actuator (GT) ......................................................................... 55
PROJECT ORGANIZATION CHART (LM) .............................................................................. 57
RESPONSIBILITY APPROVAL SUPPORT INFORMATION CHART (LM)......................... 58
ACTION ITEM LIST (KH) .......................................................................................................... 59
TIMELINE (LM) .......................................................................................................................... 60
LIST OF RESOURCES NEEDED (KH) ..................................................................................... 61
RESUMES .................................................................................................................................... 62
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Saluki Engineering Company
Spine Stabilization System
Proposal # S09-98-SPINESTB
INTRODUCTION
Upon consideration of undertaking the Novel Spine Stabilization System project, a clear
distinction needs to be made. The distinction, that although the spine is an integral part of a
complex biological system (which is dynamic as well as reactive) the project is being approached
from a mechanical engineering perspective. With that being said; a lot of time and effort has
been devoted to learning and understanding the spinal anatomy, functions, properties, and
behavior.
The spinal column is the only thing keeping human beings upright and vertical. The spine
provides a rigid structure to erect and provide stability to the upper torso. The spine has a wide
range of motion for all the different movements that humans are capable of making. When the
spine is injured or its routine functions are impaired, the results can be extremely painful and
disabling. Back pain affects both male and female alike. The majority of back pain comes from
the lower back. Most people experience lower back pain between ages of twenty five to sixty
and twelve to twenty six percent of children experience lower back pain. Chronic back pain is
defined as pain lasting longer than three months to a year. (IN1)
According to the American Association of Neurological Surgeons; it is estimated that
seventy five to eighty five percent of all Americans will experience back pain at one point in
their lives. Also even though ninety percent of all cases involving back pain recover without
surgery, fifty percent of them will have reoccurring back pain within a year. (IN2) According to
Dr. Donald D. Dietze Jr. a Neurological/Orthopedic Surgeon; there are approximately 400,000
lower back operations performed every year in the United States. (IN3)The three most common
causes of lower back pain, and they are Herniated or Ruptured Disk, Lumbar Spinal Stenosis,
and Osteoarthritis. (IN2) Shown below in Figure 1 is a herniated disk, illustrating how the
annulus becomes ruptured and the nucleus drains into the interference zone.
Figure 1: A single vertebrae from the lumbar region, with a herniated disk defect. (IN4)
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Saluki Engineering Company
Spine Stabilization System
Proposal # S09-98-SPINESTB
A Ruptured Disk or Herniated Disk is when the gel-like tissue inside the disk between the
vertebrae leaks out or bulges out from under the vertebrae and pushes on the spinal column.
These pads are disc like in shape and are shock-absorbers for the spine. They are inserted
between each of the thirty three vertebrae in the spine. Each disc has a tough outer ring, named
the annulus, with a soft inner core named the nucleus. The nucleus is made up of jelly-like tissue.
As a person ages the disks begin to dry out. As that happens, the outer ring becomes brittle and
can develop cracks, making it susceptible to leakage and injury. When a weak area develops a
breach can occur in this outer ring and allow the inner gel to bulge or leak out. This is known as
a rupture or herniation. The gel-like tissue then presses on or entraps the spinal nerves, causing
pain. Surgeons sometimes perform a discectomy to remove part of the ruptured disc. Of course
at this point there is a weak spot in the annulus. Eventually the disk may collapse entirely which
would call for more drastic measures one of which entails the fusion of the vertebrae on either
side of the damaged disk. (IN4)
Figure 2: A single vertebrae from the lumbar region, with Spinal Stenosis. (IN4)
Stenosis by definition means: narrowing. The narrowing refers to the canals through which the
nerves pass. In spinal Stenosis, the narrowing occurs in the spinal canal, (the bony passage
through which the spinal cord runs). Also it can refer to the openings on either side of each
vertebra through which nerves exit the spine. Those nerves connect to muscles and organs in the
body. The narrowing can be caused by the inflammation of arthritis or by bony overgrowths
which are called spurs. Spurs can occur from long-term arthritis. When these openings are
narrowed, pressure is exerted on the nerves, which as a result can cause pain or numbness in the
back and/or other areas of the body containing the nerves that have been compressed. (IN4)
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Saluki Engineering Company
Spine Stabilization System
Proposal # S09-98-SPINESTB
Figure 3: A single vertebrae from the lumbar region, depicting the areas that can be affected by
Degenerating Spinal Joints. (IN4)
The back side or posterior of a vertebra has wing-like projections on each side called facets. The
purpose of these facets is to carry some of the weight that the spine must endure. Also they must
limit the amount the spine can flex to provide stability and protect the spinal column. The facets
of each vertebra interlock with the ones above and below. The contact points are known as facet
joints. Like any joint in the body, these facet joints are prone to wear and tear which is affected
proportionately with age. As a result of wear their cushioning cartilage can wear thin and become
inflamed (or they become arthritic). This is another cause of back pain which can be alleviated
with spinal fusion. (IN4)
Other disorders and diseases such as scoliosis and damage from external trauma (such as car
accidents) can be treated with the strategic fusion of specific vertebrae. Since these cases are
more diverse and specific to the patient and the situation, an analysis by the doctor needs to be
made on a case by case basis. The difference is that, when a disk fails completely or
degeneration of spinal joints reaches a critical level, it is almost definite that spinal fusion will be
the outcome.
Surgery is always a last resort when it comes to lower back pain (which is not caused by
severe external trauma). There are a number of non-surgical options available that are quite
successful, but in some cases surgery is the only option. To qualify for surgery a number of
criteria must be met along with the recommendation of a qualified osteopath and/or
Neurosurgeon. Some of the criteria include; Back and leg pain limits normal activity or impairs
quality of life, development of progressive neurological deficits; such as leg weakness and/or
numbness, loss of normal, bowel and bladder functions, and difficulty standing or walking. If
surgery is indeed the desired route, neurosurgeons have a variety of options available to help
relieve pressure on the nerve roots. Generally if the severity level is so high (which are the cases
that typically require surgery) that involves several nerve roots and discs that are causing the
pain or if there is degeneration and instability in the spinal column, the neurosurgeon may opt to
fuse the vertebrae together. Fusions are generally done with bone grafts (or other bone
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Saluki Engineering Company
Spine Stabilization System
Proposal # S09-98-SPINESTB
relocation or growth stimulation techniques) and stabilize the vertebrae with instrumentation.
The instrumentation includes metal plates, screws, rods and cages. When a successful fusion is
achieved it will prevent the disc from bulging or herniating again (if the disk is even left inside).
Following a fusion procedure, a patient should gain restored mobility in the back. The patient
should regain the ability to bend over and maybe experience even more mobility after surgery
than before. (IN5)
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Saluki Engineering Company
Spine Stabilization System
Proposal # S09-98-SPINESTB
Saluki Engineering Company
Spine Stabilization System
Literature Review
Authors:
George S Trifon
Kyle Halfacre
Luciana Mottola
Spring2009
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Saluki Engineering Company
Spine Stabilization System
Proposal # S09-98-SPINESTB
Preface
The following document has a unique reference format. It must be noted that the alpha numeric
tag following paragraphs and statements are labels referring to specific references in the
reference section. The references have been labeled with a prefix in accordance to the section to
which it belongs, and a reference number. The label in the body will direct the reader to the
appropriate reference. This has been done to reduce clutter and improve organization. The
reference to each figure is located in the text immediately adjacent to the figure.
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Saluki Engineering Company
Spine Stabilization System
Proposal # S09-98-SPINESTB
TABLE OF CONTENTS
Spine Stabilization System Design Group 98 ............................................................................. 2
Saluki Engineering Company (SEC) .......................................................................................... 2
Southern Illinois University Carbondale .................................................................................... 2
Mail code 6603 ........................................................................................................................... 2
Carbondale, Illinois 62901 .......................................................................................................... 2
Dr. Ajay Mahajan........................................................................................................................ 2
Southern Illinois University Carbondale .................................................................................... 2
Mail code 6603 ........................................................................................................................... 2
Carbondale, Illinois 62901 .......................................................................................................... 2
To Whom It May Concern: ......................................................................................................... 2
EXECUTIVE SUMMARY ............................................................................................................ 4
RESTRICTION NON-DISCLOSURE OF INFORMATION ........................................................ 5
TABLE OF CONTENTS ................................................................................................................ 6
INTRODUCTION .......................................................................................................................... 7
George S Trifon ........................................................................................................................... 11
Kyle Halfacre ............................................................................................................................... 11
Luciana Mottola .......................................................................................................................... 11
Preface........................................................................................................................................... 12
The following document has a unique reference format. It must be noted that the alpha numeric
tag following paragraphs and statements are labels referring to specific references in the
reference section. The references have been labeled with a prefix in accordance to the section to
which it belongs, and a reference number. The label in the body will direct the reader to the
appropriate reference. This has been done to reduce clutter and improve organization. The
reference to each figure is located in the text immediately adjacent to the figure.TABLE OF
CONTENTS................................................................................................................................. 12
TABLE OF CONTENTS ........................................................................................................... 13
List of Figures ............................................................................................................................... 15
INTRODUCTION ........................................................................................................................ 17
ANATOMY .................................................................................................................................. 18
ONE LEVEL FUSION ................................................................................................................. 23
DYNAMIC SATBILIZATION SYSTEMS ................................................................................. 28
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Saluki Engineering Company
Spine Stabilization System
Proposal # S09-98-SPINESTB
Dynesys System ........................................................................................................................... 28
Medical Procedure ...................................................................................................................... 29
Biomechanics of the System ....................................................................................................... 30
Complications .............................................................................................................................. 31
SPINAL FUSION AND THE USE OF BONE CEMENT ........................................................... 33
Conclusion and Transition ............................................................................................................ 34
REFERENCES ............................................................................................................................. 35
APPENDIX B ............................................................................................................................... 37
(Reference of notable patents for design purposes, The complete documents of the following
patents is located int the patents section of this groups’s Web Page.) .......................................... 37
DYNAMIC STABILIZATION SYSTEMS ................................................................................. 37
SINGLE-DOUBLE LEVEL FUSION .......................................................................................... 44
LITERATURE REVIEW SURVEY ............................................................................................ 51
PROJECT DESCRIPTION ........................................................................................................... 53
DESIGN BASIS............................................................................................................................ 54
SUBSYSTEM DESCRIPTIONS .................................................................................................. 55
PROJECT ORGANIZATION CHART ........................................................................................ 57
RESPONSIBILITY APPROVAL SUPPORT IINFORMATION CHART ................................. 58
ACTION ITEM LIST ................................................................................................................... 59
TIMELINE .................................................................................................................................... 60
LIST OF RESOURCES NEEDED ............................................................................................... 61
RESUMES .................................................................................................................................... 62
Education .................................................................................................................................. 63
Work Experience ...................................................................................................................... 63
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Saluki Engineering Company
Spine Stabilization System
Proposal # S09-98-SPINESTB
List of Figures
Figure 1: A single vertebrae from the lumbar region, with a herniated disk defect. (IN4) ........... 7
Figure 2: A single vertebrae from the lumbar region, with Spinal Stenosis. (IN4) ....................... 8
Figure 3: A single vertebrae from the lumbar region, depicting the areas that can be affected by
Degenerating Spinal Joints. (IN4).................................................................................................. 9
Figure 4: A depiction of the spinal column with its natural shape. (AN6) ................................. 18
Figure 5: A depiction of the Lumbar region with some key features labeled. (AN3) ................. 19
Figure 6: A depiction of the individual vertebra from the lumbar region (top). (AN3) .............. 20
Figure 7: A depiction of the individual vertebra from the lumbar region (lateral view). (AN1) . 20
Figure 8: Depictions of a posterior spinal segment located in the lubar region, identifying the
location of key features. (AN5) .................................................................................................... 21
Figure 9: Depictions of a posterior spinal segment located in the lumbar region, identifying the
location of key features. (AN5) .................................................................................................... 21
Figure 10: Depicts the location of various ligaments in relation to the vertebral body. (AN6) .. 22
Figure 11: Depicts the location of the spinal cord and nerve roots in reference to the vertebral
body. (AN6) ................................................................................................................................. 22
Figure 12: The basic orientation of the single level fusion hardware. (SL1) (SL10) ................ 23
Figure 13: The Infuse Bone Graft, known as rhBMP-2. (SL7) .................................................. 24
Figure 14: The LT-CAGE. (SL7, SL9) ....................................................................................... 24
Figure 15: The Bryan Cervical Disc. (SL6) ................................................................................ 25
Figure 16: The basic procedure of inserting the stabilization hardware. (SL10) ........................ 25
Figure 17: The CHARITÉ™ Artificial Disc. (SL2) ................................................................... 26
Figure 18: The CHARITÉ™ Artificial Disc. (SL4) ................................................................... 26
Figure 19: An example of Prosthetic disk replacement. (SL2) ................................................... 27
Figure 21: The Dynesys Stabilization System’s parts. (DS2)...................................................... 28
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Saluki Engineering Company
Spine Stabilization System
Proposal # S09-98-SPINESTB
Figure 22: A posterior view of the Dynesys Dynamic System. (DS1) ........................................ 29
Figure 23: The test results of the screw/cord/spacer constructs. (DS2) ....................................... 30
Figure 24: Normal, stretching, and compression of the dynamic system. (DS2) ........................ 31
Figure 25: The screw subsystem of the Aladyn Pedicle Screw Dynamic Stabilization System.
(DS4) ............................................................................................................................................. 32
Figure 26: The DIAM Spinal Stabilization System. (DS3) ......................................................... 32
Figure 27: The X’Stop device, or soft stabilization system, and its components. (DS5) ............ 32
Figure 28: The bonding mechanism of bone cement, developing a mechanical bond with the
bone. (BC2) ................................................................................................................................... 33
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Saluki Engineering Company
Spine Stabilization System
Proposal # S09-98-SPINESTB
INTRODUCTION
In attempting to develop a novel spine stabilization system, a deep and clear
understanding of the spine, needs to be attained. Along with an understanding of the spine, it is
essential to know what disorders are most commonly being corrected by spine stabilization
systems. Since there is a need for an improved system a complete analysis of existing devices
needs to be made in order to determine what they all have in common and to find out exactly
what is lacking.
The following document is a compilation of all the knowledge that was necessary in
understanding fundamental principles of how the spine works what usually goes wrong with the
spine, and what devices there are for correcting such disorders.
The first section, describes the spine anatomy, and since the spine carries the spinal
column, careful attention needs to be given to it as to not damage it. In fact, because it carries
the spinal column, is the main reason so much attention is given to correcting these disorders.
Most often the case is that such disorders compresses nerves that pass through and cause
excruciating pain and/or debilitating conditions. The goal of the stabilization systems is to relieve
the pressure off the nerves and keep the spine from doing it again.
The following sections describe the systems that are commonly utilized to correct
disorders, primarily in the lumbar region. They include a single level fusion, double level fusion,
dynamic stabilization, stabilization with the use of bone cements and other corrective devices
such as artificial disk replacements.
It should be observed how most procedures involve excessive cutting and/or drilling into
the vertebrae to secure the hardware.
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Saluki Engineering Company
Spine Stabilization System
Proposal # S09-98-SPINESTB
ANATOMY
The spinal column is designed to serve many functions. Every element of the spinal
column and vertebrae serves to protect the spinal cord. The spinal cord provides communication
to the brain to allow for mobility and sensation in the body. This occurs through the complex
interaction of bones, ligaments, muscles, the geographic features and structures of the back and
the nerves that permeate everything. Every Human is born with thirty three separate vertebrae.
Due to the natural fusion of the vertebrae in certain parts during normal development of the
spine, most adults will only have twenty four individual vertebrae. As can be observed in figure
4, the lumbar spine consists of five vertebrae labeled L1 through L5. Below the lumbar spine,
there are nine vertebrae at the base of the spine that grow together during the normal
development of the human into adulthood. Five vertebrae form the triangular bone called the
sacrum and the lowest four vertebrae form the tailbone named the coccyx. There are two dimples
in most everyone's back where the sacrum joins the hipbones and is named the sacroiliac joint.
(Those dimples are historically known as the "dimples of Venus.” (AN1) Since the problematic
region is in the Lumbar zone, and the majority of fusions are performed on the vertebrae located
in that region, the focus will be on the L1 through L5 vertebrae. The lumbar spine consists of
five vertebrae located in the lower part of the spine between the ribs and the pelvis.
Figure 4: A depiction of the spinal column with its natural shape. (AN6)
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Spine Stabilization System
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Since intervertebral discs are one of the major contributing factors to back pain resulting
in fusion, it is important to note their function and anatomy. They are found between each
vertebra, they are flat-round structures about a quarter to three quarters of an inch in thickness.
They all contain a tough outer ring of tissue called the annulus fibrosis. Within the annulus
fibrosis is contained a soft, white, gel-like center called the nucleus pulposus. Flat, circular plates
of cartilage connect to the vertebrae above and below each disc. The intervertebral discs separate
the vertebrae, and act as shock absorbers and as a sort of lubrication to prevent bone on bone
contact. They compress when weight is put on them, spring back when the weight is removed
and flex to allow the spine to bend and twist. The intervertebral discs contribute up about onethird of the length of the spine. They make up the largest organ in the body without its own blood
supply. (AN3) The discs receive their blood supply through movement and absorb nutrients in
the process. While at rest (without compressive forces) the discs expand, allowing them to
absorb nutrient rich fluid. Through repetitive movement, poor posture, or injury this process is
inhibited. The discs then become thinner and as a result more prone to injury. (AN3)
Of the thirty one pairs of spinal nerves and roots that protrude out from either side of the
spine, there are five lumbar nerve pairs and five sacral nerve pairs that begin from the bottom
and continue to the thoracic region. (AN2) The true spinal cord ends approximately at L1, where
it separates into many different nerve roots which travel to the lower body and legs. This
collection of nerves and roots is called the "cauda equina," which literally means horse's tail. It
describes the continuation of the nerves and roots at the end of the spinal cord. (AN3) The
lumbar vertebrae, L1-L5, are the ones most frequently involved in back pain. These vertebrae
carry most of the body’s weight and are subject to large forces and stresses. Most importantly,
the highest activity is located on the segments L3-L4 and L4-L5, which consequently have the
most injuries. The most strain is taken by the segments L4-L5 and L5-S1, which causes high
possibilities of disk herniation.
Figure 5: A depiction of the Lumbar region with some key features labeled. (AN3)
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Saluki Engineering Company
Spine Stabilization System
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The vertebra is a complex structure in and of itself. The vertebral body is comprised of a
thin shell of dense cortical bone and is shaped like an hourglass. The walls are thinner in the
center and continue on to thicker ends. The outer cortical bone extends above and below the
superior (above) and inferior (below) ends of the vertebrae to form rims. The superior and
inferior endplates are contained within these rims of bone. (AN3)
Figure 6: A depiction of the individual vertebra from the lumbar region (top). (AN3)
Figure 7: A depiction of the individual vertebra from the lumbar region (lateral view). (AN1)
The pedicles are an integral feature in most commonly practiced fusion procedures,
therefore special attention must be devoted to them. The pedicles are two short and rounded
processes that extend posteriorly (toward the back) from the lateral margin of the dorsal (rear)
surface of the vertebral body (figure 6). They are made of thick cortical bone which makes them
ideal for anchoring hardware.
The laminae are two flattened plates of bone extending medially (toward the middle)
from the pedicles to form the rear wall of the vertebral foramen (or the opening in the vertebrae
through which the spinal cord passes). The Pars Interarticularis is a special region of the lamina
between the superior and inferior articular processes. A fracture or some sort of congenital
anomaly of the pars may result in a spondylolisthesis (AN3) (the anterior displacement of the
vertebra also known as a slip) which mostly occurs in the lumbar region (AN4).
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Saluki Engineering Company
Spine Stabilization System
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Figure 8: Depictions of a posterior spinal segment located in the lubar region, identifying the location of key features.
(AN5)
Figure 9: Depictions of a posterior spinal segment located in the lumbar region, identifying the location of key features.
(AN5)
One of the other major contributors to lower back pain is the Facet Joint. These Facet
Joints are the locations between the bones in the spine are responsible for the ability to bend
backward, forward, twist and turn. The facet joints are a particular joint between each vertebral
body that assists with twisting motions and rotation of the spine by stabilizing through the
limitation of travel. The facet joints are part of the posterior features of each vertebra. Each
vertebra has facet joints that connect it with the vertebra above and the vertebra below it in the
spinal column. The surfaces of each facet joints are covered with smooth cartilage (like any other
joint in the human body) that help these parts of the vertebral bodies glide smoothly on each
other preventing bone on bone contact. (AN3)
The ligamentum flavum is the strongest of the spinal ligaments and connects the laminae
of the vertebrae. It is usually thinner in the middle section The term "flavum" is used to describe
its yellow appearance. The ligamentum flavum’s primary functions are to protect the neural
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Spine Stabilization System
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elements of the spinal cord and stabilize the spine so that excessive motion between the vertebral
bodies does not occur. Together with the laminae, it forms the rear wall of the spinal canal.
Figure 10: Depicts the location of various ligaments in relation to the vertebral body. (AN6)
Figure 11: Depicts the location of the spinal cord and nerve roots in reference to the vertebral body. (AN6)
The spinal canal is the anatomic casing for the spinal cord that is comprised of the
vertebrae and ligaments of the spinal column. They are aligned in such a way as to create a canal
that provides protection and support for the spinal cord. There are several different membranes
that enclose and nourish the spinal cord. The outermost layer is called the "dura mater." It is a
Latin term that means "hard mother." The dura encloses the brain and spinal cord and prevents
cerebrospinal fluid from leaking out from the central nervous system. The space between the
dura and the spinal canal is called the "epidural space". This space is filled with tissue, blood
vessels and large veins. The epidural space is important in the treatment of low-back pain,
because it provides a location to inject medications such as anesthetics and steroids.(AN3)
The spinal cord is a vital pathway that conducts electrical signals from the brain to the
body through individual nerve fibers. The spinal cord is a very delicate structure that requires
special attention during spinal fusion surgery. Any kind of trauma to the spinal cord can mean
permanent paralysis or even death. (AN3)
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ONE LEVEL FUSION
In spinal fusion surgeries pedicle screws are often the anchoring method for the hardware
that will stabilize the vertebrae until the bones can fuse together. They are designed to secure the
hardware that completely eliminates the motion and even micro motion of a vertebral segment,
to facilitate fusion between the vertebrae involved meanwhile eliminating or reducing the pain
caused by the joint. The process of one level fusion by the use of the pedicle screws is done by
inserting a metal screw into the pedicle bone of adjacent vertebrae and connecting them with
metal rods. Then inducing bone fusion with either the use of a bone graft or another device
which stimulates bone growth between the two segments. The one level fusion surgery normally
contains four pedicle screws and two rods along with connective hardware. The fusion consisting
of the use of pedicle screws in conjunction with a bone graft is considered the gold standard of
fusion techniques, which means that it is the most common. (SL1) Shown below in Figure 12 is
the load distribution on the spine after the implant, this is depicted by the smaller arrow, the one
on the left, or anterior side. The larger arrow, shown on the posterior side, depicts the larger load
that is supported by the hardware. Underneath the little arrow and between the vertebrae is
where the bone graft was inserted.
Figure 12: The basic orientation of the single level fusion hardware. (SL1) (SL10)
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Saluki Engineering Company
Spine Stabilization System
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There are different approaches to the interbody spinal fusion surgery. They include;
Anterior Lumbar Interbody Fusion, Posterior Lumbar Interbody Fusion and a Transforaminal
Lumbar Interbody Fusion. In an Anterior Lumbar Interbody Fusion, or ALIF, the disk is
removed and the endplates are cleaned. The Bone graft is placed between the vertebral bodies
into an interbody position through a small incision in the abdomen. Additionally, when the graft
is placed through the back, the approach is called Posterior Lumbar Interbody Fusion (PLIF) or
Transforaminal Lumbar Interbody Fusion (TLIF), depending on the angle of approach.
The following is a method used in disc replacement in conjunction with single level
fusion. Instead of using a bone graft it uses an artificially derived protein, a collagen sponge and
a threaded metal cage to support the vertebrae while allowing the bone to fuse. Infuse Bone
Graft, mostly known as rhBMP-2 (rhBMP-2 is “recombinant human bone morphogenetic protein
made by isolating the BMP-2 protein from bone tissue, and splicing the BMP-2 gene into a cell
line in the lab via recombinant DNA technology. The genetically engineered cells produce the
human BMP-2 protein.”)
Figure 13: The Infuse Bone Graft, known as rhBMP-2. (SL7)
The LT-CAGE shown in Figure 14 is an innovative fixation device developed by Medtronic that
is designed to help realign and fuse vertebrae of the lumbar spine to treat degenerative disc
disease.
Figure 14: The LT-CAGE. (SL7, SL9)
Figure 15 is the Bryan Cervical Disc. It is designed to alleviate pain and preserve motion and
flexibility while replacing a diseased disc that is removed from a patient’s cervical spine.
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Saluki Engineering Company
Spine Stabilization System
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Figure 15: The Bryan Cervical Disc. (SL6)
Shown below is the basic procedure of inserting the stabilization hardware. From the left,
beginning with the insertion of the pedicle screws in the appropriate locations and moving along
to bending, cutting, and securing the connecting rods to the other pedicle screws.
Figure 16: The basic procedure of inserting the stabilization hardware. (SL10)
Another technique used to repair one level problem is an artificial disk. This is not a
fusion technique, but nevertheless relevant to the overall task of investigation all single level
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options. There are a variety of artificial disks available, and there is also a considerable amount
of controversy. Figure 17 and Figure 18 show the CHARITE Artificial Disc. This and Figure 19
are two disc replacement techniques, although Figure 18 is a prosthetic disc replacement, which
only replaces the nucleus of the disc.
Figure 17: The CHARITÉ™ Artificial Disc. (SL2)
Figure 18: The CHARITÉ™ Artificial Disc. (SL4)
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Saluki Engineering Company
Spine Stabilization System
Proposal # S09-98-SPINESTB
Figure 19: An example of Prosthetic disk replacement. (SL2)
The system shown in Figure 19 is The PRESTIGE Cervical Disc. It is a metal-on-metal design
made of stainless steel. This is a dynamic system that is for upper vertebrae only,
Figure 20: The PRESTIGE® Cervical Disc. (SL3)
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Saluki Engineering Company
Spine Stabilization System
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DYNAMIC SATBILIZATION SYSTEMS
Dynesys System
One of the most prevalent systems available today for spine stabilization is the Dynesys
Neutralization system. The dynamic neutralization system for spine stabilization utilizes the
pedicle screw system, shown in Figure D1 as a lateral view and in Figure D2 as a posterior view,
for flexible stabilization of the spine. The system consists of titanium alloy screws (D1-A)
connected by an elastic synthetic compound that controls motion in any plane. Polycarbonate
urethane spacers (D1-B) and polyethylene terephthalate cords (D1-C) along with the screws
comprise the system. The pedicle screws are made of Ti-Al-Nb forge alloy (Protasul 100),
where the textured surface is sandblasted allowing for bone growth. Due to the conical core
diameter, the screw has the advantages of a biggest screw diameter in a highest bending moment,
a better bone compression (for Wolff’s Law to take effect) and anchorage in the pedicle canal,
and the low notch-factor, or low stress-concentration rate, through threads in highest bending
moment. Wolff’s Law essentially states that a bone will adapt to the loads it’s placed under.
The disadvantage of the conical screw is that the back and forth screwing is prohibited. The
polycarbonate urethane spacers adapt to the screw head, thereby preventing micro-motions and
wear debris formation in the contact area. The spacer between the screw heads limits degree of
lordosis that can be created, and the two screw heads are approximated to the extent the
interposed spacer allows. The polyethylene terephthalate cord connects the pedicle screw heads
via the hollow core of the spacer and holds the spacer in place. The stabilization cord limits
bending movements, while the spacers hold the segments in a position of anatomical function
and suppress extension and rotational movements (DS1). The system’s components are shown
in Figure 21 along with the lateral view of the spinal column, a posterior view is shown in Figure
22 with the system placed onto the vertebrae.
Figure 20: The Dynesys Stabilization System’s parts. (DS2)
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Saluki Engineering Company
Spine Stabilization System
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Figure 21: A posterior view of the Dynesys Dynamic System. (DS1)
Medical Procedure
The way the system works is the Dynesys instrumentation re-stabilizes unstable segments
without involving the intervertebral disks and the facet joints; the segments remain mobile within
a controlled range, permitting limited motion of the arthrodesed lumbar vertebrae. The spine
would then return to an anatomical function that is closer to the healthy status. The patient
would be under general anesthesia, where a posterior midline approach would be performed at
the area of the affected lumbar levels. After the pedicle screw insertion, the spacers are cut to the
proper size. The stabilizing cords are pre-tensioned separately for each segment before their
fixation in the pedicle screw. Hyper-mobility of the segments is corrected and the screws for
fixation of the stabilizing cord in the eyes of the pedicle screws are tightened. The stabilizing
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Spine Stabilization System
Proposal # S09-98-SPINESTB
cord is cut and the surgical wound closed. No bone grafts were used and the patients are given
prophylactic antibiotics 1 hour before and 3 days post-operatively (DS1).
Biomechanics of the System
Once the Dynesys System has been implanted, the mechanical properties of the system change
due to the thermal conductivity of the materials. As the spacer warms from room to body
temperature, the cord tension decreases between 25% and 33%. Near-term, the cord tension
decreases 25% from its post-operative level, and in long-term, the cord tension remains constant
at a 50% reduction from intra-operative levels. Listed below are the results of extensive testing
on the Dynesys System:





The pedicle screws, PET cord and screw-cord assemblies passed 5 million cyclic loading
cycles between 100N and 800N.
The PET cord static tensile strength is approximately 3000N; creep elongation at 20
hours is 1.27% of the initial cord length, with no rupture.
Tested to assess creep deformation in conditions that model the in situ environment, the
spacers demonstrated that at 600N -- double the 300N preload -- creep deformation
decelerated and was constant at 20 hours.
The screw-cord-spacer assemblies passed 10 million cycles of shear displacement or
axial rotational motion without cord failure and only inconsequential cord abrasion.
In axial compression, after 10 million cycles, the device maintained 525N tension
(including the 300N preload) and 200N compression.
Figure 22: The test results of the screw/cord/spacer constructs. (DS2)
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This testing confirmed that, together, the components exhibit robust static and cyclic
interconnection strengths. (DS2)
Once the devices are attached bilaterally to the affected segments, the dynamic push-pull
relationship between spacer and cord stabilizes the joints, keeping the vertebrae in a more natural
position:
Figure 23: Normal, stretching, and compression of the dynamic system. (DS2)
At ‘Normal’, the Dynesys System supports an intervertebral joint between L4 and L5. During
‘Flexion’ the pedicle screws hold the polyethylene cord secure, supporting the affected joint as
the spine bends forward. While in ‘Extension’ the external spacer-a polyurethane tube- provides
support for the affected joint as the spine bends backwards. (DS2)
Complications
Although very effective, the Dynesys Stabilization System still has complications. Reports of
screws loosening and deep spine infection have been documented. Nerve root compression from
the system could result in discomfort in the lower limbs as well (DS1). Not all patients are
candidates for this procedure, those who smoke have been shown to have an increased incidence
of non-union; obese, malnourished, and/or alcohol abuse patients are all poor candidates also.
Those with poor muscle tone and bone quality, and/or nerve paralysis all exhibit poor signs for
the Dynesys System.
Another dynamic stabilization system is the Aladyn Pedicle Screw System. This system utilizes
simplicity in its design. Shown in Figure 25, the pedicle screws are linked together through a
rigid member.
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Figure 24: The screw subsystem of the Aladyn Pedicle Screw Dynamic Stabilization System. (DS4)
Other Spine Dynamic systems such as artificial disk replacement have been listed in the
one lever fusion section. Below is the DIAM system, it is designed to relieve pressure caused by
a degenerative disk. This is done by maintaining the normal distance between the vertebrae.
The system is typically inserted after a discectomy.
Figure 25: The DIAM Spinal Stabilization System. (DS3)
Shown in Figure 27 is the X’Stop device, it is a kind of soft stabilization system.
Figure 26: The X’Stop device, or soft stabilization system, and its components. (DS5)
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Saluki Engineering Company
Spine Stabilization System
Proposal # S09-98-SPINESTB
SPINAL FUSION AND THE USE OF BONE CEMENT
There is not a large variety of bone cements available. Mainly because the ones that are
available do the job. The main application of bone cement is for anchoring hardware in place or
assisting in anchoring the hardware in place. A common type of bone cement is called
Polymethylmethacrylate. Cements were first introduced in 1940 and after clinical trials for
tissue compatibility; they were deemed acceptable and introduced into common practice by
1950. 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. It has to be very strong (to support the body’s weight many
times over) yet provide a level of elasticity to reduce risk of cracking and separation. The bone
cement is essentially Plexiglas and comes it two parts that are mixed on site and applied to
required areas. Usually there is an antibiotic mixed into the compound to reduce the risk of
common infections associated with such procedures such as staff or strep infections (BC1).
The bone cement is mixed with an accelerator to reduce set time. After the ingredients
are mixed the viscosity changes over time from a runny liquid into a dough like state that can be
safely applied and then finally hardens into solid material. The set time can be tailored with the
use of the accelerators to help the physician safely apply the bone cement into the bone bed or to
anchor metal or plastic prosthetic device to bone or used alone in the spine to treat osteoporotic
compression fractures.
Figure 27: The bonding mechanism of bone cement, developing a mechanical bond with the bone. (BC2)
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Saluki Engineering Company
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Conclusion and Transition
The attempt was made to uncover every type of current spine stabilization device, every
vertebrae fusing technique and other more elaborate methods for alleviating lower back pain
through the use of implanted hardware. There are three main goals that have been set forth after
reviewing the literature on the available hardware and technology. The first is that the new
system will be a dynamic stabilization system that will be easier and faster to install, it will be
modular (in that other segments can be added in later surgeries should the patient develop a need
for more vertebrae to be stabilized), and can be a dynamic stabilizer at every vertebrae it is
installed in. For example, an ideal system would involve a combination of artificial discs, the use
of cage-like devices containing the collagen sponge impregnated with bone growth protein. The
artificial disks would keep the segment dynamic while fusing bone to it, and if need be to add
other artificial disks in the same manner thereby replacing damaged disks with a dynamic system
at every level and essentially repairing the problem without eliminating any of the spine’s natural
mobility. This of course, would be done through a minimally invasive surgery while not
damaging any of the surrounding tissue or cutting any ligaments while taking only a matter of
minutes and thereby drastically reducing recovery time.
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REFERENCES
(IN1)
http://www.back.com/anatomy.html
(IN2)
http://www.neurosurgerytoday.org/what/patient_e/low.asp
(IN3)
http://www.back.com/articles-evolution.html
(IN4)
http://www.npr.org/programs/morning/features/2006/feb/backpain/graphic/graphic.html
(IN5)
http://www.neurosurgerytoday.org/what/patient_e/low.asp
(AN1) http://www.back.com/anatomy.html
(AN2) http://www.neurosurgerytoday.org/what/patient_e/low.asp
(AN3) http://www.back.com/anatomy-lumbar.html
(AN4) http://en.wikipedia.org/wiki/Spondylolisthesis
(AN5) http://images.google.com/imgres?imgurl=http://bhpain.com/yahoo_site_admin/assets/
images/facetJoints.138204352_std.jpg&imgrefurl=http://www.bhpain.com/facet_joint_syn
drome&usg=__SDGjcJdzVgn9tAA2x6TfsOMDuJo=&h=297&w=279&sz=68&hl=en&st
art=4&um=1&tbnid=DE33zqYC5a25LM:&tbnh=116&tbnw=109&prev=/images%3Fq%
3Dfacet%2Bjoint%26hl%3Den%26client%3Dfirefox-a%26rls%3Dorg.mozilla:enUS:official%26sa%3DX%26um%3D1
(AN6) http://www.spineuniverse.com/displayarticle.php/article895.html
(SL1)
http://www.back.com/back-articles-peek-rod-system.html
(SL2)
http://www.spineuniverse.com/displayarticle.php/article1671.html
(SL3)
http://www.spineuniverse.com/displayarticle.php/article1078.html
(SL4)
http://images.google.com/imgres?imgurl=http://www.spineuniverse.com/
displaygraphic.php/2255/artificialdiscBB.jpg&imgrefurl=http://www.spineuniverse.com/d
isplayarticle.php/article1679.html&usg=__zHYCUsUdog1QUUSUNfDfciA0GkU=&h=2
00&w=250&sz=13&hl=en&start=10&um=1&tbnid=lpb2Jx9JBYR7fM:&tbnh=89&tbnw
=111&prev=/images%3Fq%3DPRODISC%25C2%25AEL%2BTotal%2BDisc%2BReplacement%26hl%3Den%26client%3Dfirefoxa%26rls%3Dorg.mozilla:en-US:official%26sa%3DN%26um%3D1
(SL5) Spine Health 17 Mar.2009. www.spine-health.com.
(SL6) SpineUniverse.17Mar.2009 http://www.spineuniverse.com/displayarticle.php/article1671.html
(SL7) Medtronic 17 Mar.2009 http://www.medtronic.com/
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(SL8) Syncmedical.17Mar.2009 http://www.syncmedical.com/assets/Uploads/_
resampled/Resize,dImage184178-ETHOS-spine-pedicle-screw.jpg
(SL9) US Department of Health and Human Services.17Mar.2009
http://www.fda.gov/cdrh/annual/fy2002/ode/fig-4.gif
(SL10) http://www.or-live.com/medtronicspinal/1856/aboutProcedure.cfm
(DS1)
Sapkas GS, Themistocleous GS, Mavrogenis AF, Benetos IS, Metaxas N, and Papagelopoulos
PJ. "Stabilization of the lumbar spine using the dynamic neutralization system." 30
(2008): 859-65. MEDLINE. Morris Library, Carbondale. 17 Mar. 2009
<http://search.ebscohost.com/login.aspx?direct=true&db=cmedm&AN=17990413&site=
ehost-live&scope=site>.
(DS2)
"Dynesys."Zimmer.com.29Jan.2009
<http://www.zimmer.com/z/ctl/op/global/action/1/id/9165/template/IN>.
(DS3)
http://images.google.com/imgres?imgurl=http://www.neurocirugia.com/
intervenciones/diam/diam_archivos/image001.jpg&imgrefurl=http://www.neurocirugia.co
m/intervenciones/diam/diam.htm&usg=__yChc05vvGlzwF3ERG0JRoN4gy6o=&h=180&
w=226&sz=16&hl=en&start=3&um=1&tbnid=dVfu_YV32zPE7M:&tbnh=86&tbnw=108
&prev=/images%3Fq%3DDIAM%25E2%2584%25A2%2BSpinal%2BStabilization%2BS
ystem%26hl%3Den%26client%3Dfirefox-a%26rls%3Dorg.mozilla:enUS:official%26sa%3DN%26um%3D1
(DS4)
http://www.neurocirugia.com/instrumental/index.php?m=02&y=08&entry=entry
185940
080215-
(DS5) http://spinalneurosurgery.com/dynamic_stabilization.htm
(BC1) http://en.wikipedia.org/wiki/Bone_cement
(BC2) http://www.totaljoints.info/BoneCement_microscopy.jpg
1)
http://books.google.com/books?id=nxiCfmXPkzYC&pg=PA462&lpg=PA462&dq=pure+titanium+in+biomechanics&source=bl&ots=jO
7GG0S94o&sig=ydyrA7R12e0eCDN694LhLXDUkkQ&hl=en&ei=-7jSeXJA8HznQfFh5WwDg&sa=X&oi=book_result&ct=result&resnum=6#PPA462,M1
2)
http://www.ncbi.nlm.nih.gov/pubmed/11241337
3)
http://www.restoremedical.com/docs/PET_White_Paper.pdf
4)
http://www.devicelink.com/mtprecision/archive/08/04/007.html
5)
(DS2)
"Dynesys." Zimmer.com. 29 Jan. 2009 <http://www.zimmer.com/z/ctl/op/global/action/1/id/9165/template/IN>.
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APPENDIX B
(Reference of notable patents for design purposes, The complete documents of the following patents is
located int the patents section of this groups’s Web Page.)
DYNAMIC STABILIZATION SYSTEMS
Publication Number US 2005/0143737 A1 is a system grounded in the use of bone anchors, such
as bone bolts or screws. The dynamics system uses a flexible element connecting the anchors.
The flexible elements are able to be adjusted to change the flexibility of the element, which are
flexible bearing elements of a rod end bearing. Figures 1 and 2 from the publication indicate
how the system is fixed on the spinal column and how the screws are linked together.
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Saluki Engineering Company
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US Patent Number 7,083,621 B2 is a system that revolves around pedicle screws. The bone
anchors are connected through the use of linking rods which include at least one angularly
adjustable joint. The linking rods may be fixed by actuating the locking member. The bone
anchors and the linkage rod may be locked into place to form a spinal fusion or fixation
prosthesis. Figure 4A from the patent shows how the bone screws are linked together and figure
42 shows the screws inserted into the vertebrae and being linked together.
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Saluki Engineering Company
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The system of Publication Number US 2007/0088359 A1 utilizes pedicle screws for the fixation
of the spine. The device provides dynamics support for spinal vertebra, to better control load
transfers and avoid deterioration of the bone of adjacent spinal vertebra. The bone anchors are
connected through the use of a spring, which are interchangeable. The system is able to be
further added to after surgery. Figure 2C from the publication is a lateral view of the system
once it has been established. Figure 2A is a posterior view of the system, showing how the
levels are linked together.
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Patent Number US 6,783,527 B2 also uses the design of the pedicle screw. The screws have an
eye to lock links between the vertebrae. The system is comprised of an elongate member sized
to span a distance between at least two vertebral bodies and bone anchors. The members are
formed of a flexible material and can be tensioned to provide corrective forces to the spine and
the anchors can be compressed towards one another. This system can be used for multi-level
vertebral fusion or stabilization and is shown in Figure 1 from the patent, also shown is how the
members are linked together at the eye of the screws in Figure 9 of the patent.
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Saluki Engineering Company
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The design of US Publication Number 2008/0097441 A1 focuses on the use of pedicle screws.
The screws are attached such like lattice work. The two screws on each vertebral body are
attached with a rod, then the two vertebral bodies are attached between the ‘horizontally’ fixed
rods. The two intervertebral rods are used as springs. The interconnection between the two
components enables the spinal motion segment to move in a manner that mimics the natural
motion of the spinal motion segment while substantially offloading the facet joints of the spine.
Shown below are figure from the publication, in Figure 4B the system is shown from the
posterior view established in the vertebrae. Figure 5A shows the system independent of the
vertebral bodies, it shows how the bone screws attach to each other through the use of the rods.
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Saluki Engineering Company
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Patent Number 5,520,690 also uses the pedicle screw design. The system consists of a polyaxial
locking screw plate assembly which immobilizes the movement of the connected vertebral
bodies. The plate is fixed by the bone screws. This design is a continuation of a previous
design, where portions of the system are changed. This system renders a portion of the vertebral
column to become static, losing mobility. In Figures 6 and 3, shown below, from the patent,
show how the screw is attached to the plate.
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US Patent Number 6,036,693 utilizes bone screws in its design. This system is only for retaining
first and second cervical vertebrae. A plate is connected by the bone screws from each vertebra,
resulting in a rigid design. Within the patent, different methods of bone screw placement are
shown. The figures shown below are from the patent, Figure 3 shows how the screws are
inserted in the vertebral body, Figure 10 shows the plate which the screws fasten through, joining
the vertebrae and Figure 23 is a posterior view of the system after it has been attached to the
vertebrae.
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Saluki Engineering Company
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Proposal # S09-98-SPINESTB
SINGLE-DOUBLE LEVEL FUSION
SPINAL FUSION DEVICE WITH POROUS MATERIAL
(US patent # 5,645,598)
The cylindrical shape implant is designed to be placed into at least one bore formed
between opposing vertebras. It consists on threads between the first and second ends
of the body, which thread into bone tissue. Additionally, on opposite sides of the body
two indentations are located, creating contact with the bond part of the plates, and
consequently inducing vertebras to fuse.
In order to induce bone growth, a
biocompatible potentially osteoinductive ore oesteoconductive porous material could be
included in the device, through a slot between opposite sides of the indentations.
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Proposal # S09-98-SPINESTB
PERCUTANEOUS VERTEBRAL FUSION SYSTEM
(US patent # 6,821,277 B2)
The system consists on bone screws and an inflatable connection rod which comprises
a proximal end, creating a self-sealing valve. Torque is applied to the bone screw with a
screwdriver, and the inflatable connection is inserted between portals of bone screws.
After inflating the inflatable balloon, a rigid structure is created between the connection
rod and the bone screws.
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Saluki Engineering Company
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Proposal # S09-98-SPINESTB
ANTERIOR SPINAL IMPLANT
(US patent # 4,636,217)
The Anterior spinal implant is recommended for patients with injured vertebrae or spinal
disease. Before positioning the implant the damage vertebrae has to be removed. It is
essential that the spinal implant is height compatible to the anterior vertebral portion to
be replaced. The implant is inserted with screws into the adjacent lower and upper
vertebrae providing rigidity, limited only by the bone structure, and preventing
deformities. An advantage of the anterior spinal device is that it serves as a spacer,
maintaining alignment in the spinal column.
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Saluki Engineering Company
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Proposal # S09-98-SPINESTB
INTERVERTEBRAL IMPLANT
(US patent # 6,986,789 B2)
The intervertebral implant consists on an upper and lower support body with a dorsal
edge and a saddle joint, which is used as a replacement for an intervertebral disk. The
implant is designed with the same height of the disk, and According to Schultz et al “The
saddle joint includes two pivot axes and two saddle joint surfaces in contact with one
another rotated by 90 degrees in relation to one another”. On this way, the intervertebral
implant provides support via a joint, which are pivotable in relation to each other.
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Saluki Engineering Company
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Proposal # S09-98-SPINESTB
EXPANDABLE SPINAL IMPLANT
(US patent #5,059,193)
The expandable spinal implant is characterized by several deformable ribs between the
first and second state. The first state consists on ribs on a cylindrical implant, and the
second state on expanded spherical implant. The process is achieved by performing a
novel surgical method, by making an entrance bore into the degenerated disk area of
the spine, and an enlarged chamber between opposing vertebrae to be fused. The
implant is inserted between opposing vertebrae, and expanded to the second state.
TRANSVERSE CONNECTION FOR SPINAL COLUMN CORRECTIVE DEVICES
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Saluki Engineering Company
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Proposal # S09-98-SPINESTB
(US patent #5,522,816)
A device that interconnects two longitudinal members, which are connectable to the
vertebrae, by embracing two connector members to the longitudinal members. A plate is
placed between the longitudinal members, interconnecting the first and second
connector members. The longitudinal member is clamped using threadably screws to
the hook located on the first connector. A nut connects the set crew to the connector
member, so that this one could secure the elongate plate preventing it from pivoting.
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Saluki Engineering Company
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Proposal # S09-98-SPINESTB
THREADED SPINAL IMPLANT
(US patent # 5,015,247)
The threaded spinal implant is designed to improve method of performing a fusion,
discectomy and an internal stabilization of the spine. This invention’s main goal is to
improve the method of performing a discectomy, fusion and stabilization of the spine
simultaneously as a single procedure. The implant is placed between two adjacent
vertebrae inducing bone ingrowth through the implant and into the wall of the vertebrae.
Consequently, inducing fusion from one vertebra in join to the other, and providing
structural support to the two vertebrae.
Page | 50
Saluki Engineering Company
Spine Stabilization System
Proposal # S09-98-SPINESTB
LITERATURE REVIEW SURVEY
Although there are many materials available for all types of mechanical systems, only select
materials are biologically compatible with the human body.
The material must be
biocompatible, resist corrosion/degradation, and possess adequate mechanical properties.
Therefore choosing the correct material is crucial. The most commonly used metals are stainless
steel (316L and 22-13-5), cast Co-Cr-Mo, alloyed titanium, and pure unalloyed titanium. Of
these, the most predominantly used is the (pure and alloyed) titanium; even though they have
lower Young’s modulus the advantage is that they produce less distortion of CT or MR images(1).
Titanium (alloyed and pure) is a widely used material in reconstructive orthopaedics; it possesses
biocompatibility as well as mechanical strength. Another metal that is still being researched for
biomedical applications is tantalum. Thus far tantalum has shown superior biocompatibility, and
coupled with the material’s ability to provide osseous ingrowth (2) while providing structural
support makes this material a candidate for a number of clinical applications. Titanium and
tantalum are ideal materials to use where osseous growth is wanted or needed postoperatively,
coupled with their mechanical properties they also provide structure and support.
Strictly using metals for a biomechanical system may render it static, in the systems where
dynamic stabilization is desired, flexible materials are needed. In the Dynesys system,
polyethylene terephthalate cords are being utilized. Polyethylene terephthalate (PET) shows
notable biological characteristics, such as biostability, promotion of tissue ingrowth, and a well
characterized fibrotic response (3). PET demonstrates good tensile strength, therefore qualifying
it to be utilized in a suspension scenario in biomechanical systems. Another material currently
being used is polycarbonate urethane (PCU). The material, PCU, has good wear properties and
good compatibility with natural tissues (4). PCU is also a weight-bearing material; all these
properties make PCU a great candidate for biomechanical applications. The PET and PCU
materials have both been under extensive testing and have concluded in exceptional
biomechanical properties and cycle life (5).
Many components are currently available for stabilization systems. The last two
materials discussed, PET and PCU, are used in the Dynesys Dynamic System as linkages
between the stabilized vertebrae. Figure 1 is a depiction of the system shown from the posterior
view. The spacer is made of the polyurethane PCU and the cord is made of PET. Pedicle screws
provide anchorage for the system.
Page | 51
Saluki Engineering Company
Spine Stabilization System
Proposal # S09-98-SPINESTB
Figure 1: The Dynesys Dynamic Stabilization System.
The material that was reviewed was essentially the systems available and those that have not
been approved for medical use. A clear understanding of the systems that have patented was
needed in creating an innovative biomedical device and to not infringe on any other system’s
design. Improving a current system was possible but developing an almost totally modular
system that has nearly all replaceable parts was something the market has not seen yet, and can
benefit both surgeons and patients alike.
Page | 52
Saluki Engineering Company
Spine Stabilization System
Proposal # S09-98-SPINESTB
PROJECT DESCRIPTION
As stated previously, due to the nature and magnitude of such an undertaking and upon
the advice of the Faculty Technical Advisor only a limited description the SPINESTB device
will and can be presented at this time. The complete plans with technical drawings, mechanical
properties, and measurements will be submitted in a supplemental report after a thorough
examination of a human cadaver spine. Also an observation of surgical procedures on human
cadavers will be observed in addition to examination of spine to develop a better procedure for
application of hardware.
The SPINESTB consists of roughly sixteen components with an estimated six specific
subsystems. The components have yet to be clearly defined. The function principle is; a
bilateral compression of the inferior and superior rims of the vertebral body, with simultaneous
vertical expansion forces of respective regions, essentially encompassing approximately 60% to
80% of the Annulus Fibrosus (the outer membrane of the vertebral disk). This action displaces
the forces on the disk to the contact regions of the SPINESTB system which transfers them to a
series of “Vertical Force Applicators” (pseudo elastic alloys set to simulate a response similar
to that of a healthy disk). The shape of the contact regions allow for stabilization of the
vertebrae while allowing natural flexion and tension of the spine. The contact regions are
designed to then fuse to the vertebral body and become a permanent part of the vertebrae. After
that any component is able to be replaced or upgraded as necessary through a quick minimally
invasive procedure. Each SPINESTB unit is placed between two vertebrae and can act alone or
in conjunction with other SPINESTB units, with semi rigid vertical stabilizers to create a fully
dynamic spine stabilization system of multiple levels. The six subsystems are labeled as such;
“contact site,” “contact pad,” “lateral brackets,” “rear linkage,” “vertical force applicators”
(VFAs) and, “horizontal force applicators” (HFAs). These subsystems come together to form a
clamp type devise that is preloaded with tension to maintain appropriate disk height and simulate
disk resistance to movement.
The following is a very rough depiction of the arrangement of subsystems. There are
three groups because they have been grouped into groups of two and assigned to each member of
the group. The depiction is only half of the complete system (top view). There is an identical
system beneath it. The first group on the left represents the contact site and the contact pads.
The group in the center represents the lateral brackets and the rear linkage. The group on the
right represents the vertical and horizontal force applicators.
Page | 53
Saluki Engineering Company
Spine Stabilization System
Proposal # S09-98-SPINESTB
DESIGN BASIS



All the rough sketches are located in the design notebooks, which are numbered and
dated.
Design ideas are all original productions of the Project Manager, with modifications and
improvements from design group.
Nothing was taken from existing patents or advertized devices, as they were only used as
examples of what not to do.
Page | 54
Saluki Engineering Company
Spine Stabilization System
Proposal # S09-98-SPINESTB
SUBSYSTEM DESCRIPTIONS
Contact Pad/Contact Site
Many of the stabilization systems available have a bone anchor such as a screw that is
drilled into place, providing stability for the system. If the screw is broken or sheared off, the
system cannot be reversed and the bone cannot withstand another screw. The system being
developed will be one that has a clamp as an anchoring device. The clamp, or contact pad, will
partially wrap around the vertebral body from the posterior. Pressure from the contact pad will
be exerted onto the vertebra in the lateral directions, such as a mechanical vice exerts a force on
an object. A force, acting in the axial direction to the vertebral column, will be on the vertebral
body as well, pushing the vertebra away from the injured disk. This will be done by another
contact pad being placed on the vertebra just below the injured disk, acting the same except an
equal and opposite force will be acting downward instead of upward. This balance of forces will
relieve the injured disk from pressure, therefore reducing pain. Attached to the contact pad is a
different material, this is referred to as the contact site. The contact site is located on the inner
wall of the contact pad and will promote osseous ingrowth. The contact site will play a vital
role in bone growth, to aid the system in stabilization the contact site will be made of a porous
material, that way the bone will grow into and through the biomaterial matrix, resulting in a very
strong, reinforced system.
The contact site and contact pad will be either mechanically or chemically bonded
together for maximum strength. The contact site will aid the contact pad in forcing the vertebrae
in the axial direction; therefore the two materials will need to have a strong bond. Once bonded
together, these two materials cannot be separated. The bone will grow through the contact site,
resulting in a partially rigid area. Thus that portion of the system must remain and cannot be
replaced. This is done intentionally to provide a very stable base for the system to perform.
Axial Linkage
The brackets on the two vertebrae will be connected through the use of a linkage cord.
Two cords will be used, one on each side of the spinous process, this will reduce the amount of
force on each member. The connecting cords will be made of a material that possesses excellent
tensile, creep, and wear qualities. The cords will only be used for the tension that is created
when the spinal column is stretched, such as when a person leans or bends forward. The elastic
cords will elongate to a predetermined length, allowing the system and the spinal column as a
whole to remain dynamic. The cords stop stretching at a predetermined length in order to keep
the vertebral bodies off the inured disk, when the vertebral column is bent forward, the posterior
of the vertebra is raised from the disk and the anterior side of the disk is compressed.
The cords will be housed within a tube. This tube will be used in keeping the clamped
vertebral bodies at a constant distance at a static state. The length of the tube will be determined
pre-operatively to keep the vertebral bodies off the inured disk. Keeping the load off the injured
disk is the main purpose of the tube, so it will need to have excellent compressive qualities.
Page | 55
Saluki Engineering Company
Spine Stabilization System
Proposal # S09-98-SPINESTB
Although a purely rigid material would suffice for the tube’s material, a more elastic material
that absorbs force will be used.
The cords and tubes will be used as a combination. One will act when tensile forces are
present while the other acts during compression. The cord will not be affected during the
compression process; the cord will be pre-stressed, not only for this reason but to also help with
providing system stabilization. The tube will fit closely to the cord housed within, leaving only a
small amount of room between the two elements.
Lateral Brackets
The lateral bracket applies a vertical force on the contact pad. It has to be able to attach
and detach from the contact pad, and to pivot on a vertical plane (parallel to the spine). The
lateral bracket interacts with the contact pad and allows a connection with the vertical force
applicator.
The main function of the rear linkage is to provide stability for the lateral force applicator
and for the vertebra by compressing to the spine. Additionally, the rear linkage allows a
connection with the polyethylene terephthalate cord.
Vertical/Horizontal Force Applicator
The force applicators are a pseudo-elastic type of alloy that behaves mole like a memory
shape material than a spring. They appear to behave in the same way on the surface, but on the
molecular level they are much different. When a spring is stretched the molecular bonds either
stretch a little or microscopic cracks called creep develop along grain boundaries and propagate
through the material to allow a little movement, or both instances happen simultaneously to
allow the material to give to applied forces. In the case of pseudo elastic alloys the crystalline
structures change back and forth from Austenite to Martensite while the material experiences
elastic deformation. In addition to these properties, some of these types of alloys can be
triggered to return to a predetermined shape by applying relatively small amount of thermal
energy.
The goal is to incorporate such alloys into the system, so that after the material is inserted
into the correct location, it will conform to the natural shape of the bone and provide constant
pressure with the activation from ambient body heat.
Page | 56
Saluki Engineering Company
Spine Stabilization System
Proposal # S09-98-SPINESTB
PROJECT ORGANIZATION CHART
DR.MAHAJAN
FACULTY TECHNICAL ADVISOR
Mechanical engineering
GEORGE TRIFON
(ME, PM)







Delegating responsibilities
Designing and maintaining website
Updating the FTA
Responsible for Horizontal and
Vertical Force Applicators
KYLE HALFACRE
LUCIANA MOTTOLA
(ME)
(ME)
Responsible for Contact Pad and
Contact Site
Material Selection
Analyze System with Computer
Modeling


Responsible for Lateral
Bracket and Rear Linkage
Team minutes, timeline,
RASI, and project
organization chart.
Page | 57
Saluki Engineering Company
Spine Stabilization System
Proposal # S09-98-SPINESTB
RESPONSIBILITY APPROVAL SUPPORT
INFORMATION CHART
Team 98
Responsibility -Approval-Support-Information
(RASI)
Chart
TASK
GT
LM
KH
DR.MAHAJAN
Obtain current
(S)
(R) (S)
(A)
prices
Responsibility
(R)
Work on
Prototype
(R)
(I)
(I
)
(A)
Approval
(A)
Produce parts
in SolidWorks
(S)
(S)
( R)
(A)
Support
(S)
Assembling
device
(I)
(R)
(S)
(A)
Information
(I)
Device Testing
(R)
(S)
(I)
(A)
Perfect device
(I)
(I)
(R
)
(A)
Document
Design
(S)
(R)
(I)
(A)
Page | 58
Saluki Engineering Company
Spine Stabilization System
Proposal # S09-98-SPINESTB
ACTION ITEM LIST
Project: Spine Stabilization System
Proj Number: S09-98-SPINESTB
Action Item List
14-Apr-09
Team Members
George Trifton, ME (PM)
Luciana Muttola, ME
Kyle Halfacre, ME
#
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
Activity
Distribute Tasks
Research Lower Spine
Research Techniques
Research Current Problems
Construct Rough Design
Determine Kind of System
(dynamic, static, chemical)
Acquire Spine Model
Find Current Patents
Meet at Library
Meet at Library
Reserve room in Library
Organization of Lit Review
Revise Lit Review
Submit Lit Review to FTA
Meet at Library
Meet at Library
Research Bone Material
Properties
Research Material
Properties for System
Research patents for multilevel fusion
Research patents for single
level fusion
Research bone growth
chemical
Email Questions regarding
bone to Doctor
Acquire Quote of Materials
needed
Proposal Work
Person
GT
GT
LM
KH
All
Assigned
27-Jan
27-Jan
27-Jan
27-Jan
19-Feb
Due
New Due
26-Feb
26-Feb
26-Feb
3-Mar
10-Apr
Status
Done
Done
Done
Done
Done
8-Apr
Done
Comments
Assign individual tasks
Research the lumbar region of the spinal column
Find the products available for spine stabilization and manufacturers
Find the problems associated with current spine stabilization
On Paper
All
17-Mar
26-Mar
KH
KH
all
all
GT
GT
All
All
All
23-Feb
17-Mar
16-Mar
16-Mar
17-Mar
16-Mar
19-Mar
27-Feb
17-Mar
16-Mar
17-Mar
17-Mar
17-Mar
3-Apr
26-Mar
26-Mar
30-Mar
1-Apr
GT
1-Apr
7-Apr
9-Apr
Done Find bone properties of the lumbar region.
KH
1-Apr
7-Apr
9-Apr
Done Find the properties of possible materials for the system.
KH
1-Apr
LM
1-Apr
LM
1-Apr
7-Apr
GT
26-Mar
29-Mar
KH
8-Apr
12-Apr
all
9-Apr
15-Apr
Done
Done
Done
Done
Done
Done
Done
Done
Done
Done
7-Apr
Borrow spine model from local Chiropractor
Find Current patent(s) for Lit Review
Meet for Lit Review
Meet for Lit Review
Compile team members' works to construct Lit Review
Revise/Add to Lit Review
Changed to meet at ENGR computer lab.
Done
7-Apr
Done
10-Apr
Find information about bone growth chemical, one
that stimulates bone growth.
Get questions from group members and email to
Done
Doctor, about bone properties.
Done
0% Cancelled til next semester
Done Work on assigned parts of the Proposal
Page | 59
Saluki Engineering Company
Spine Stabilization System
Proposal # S09-98-SPINESTB
TIMELINE
Timeline GROUP 98
Activity
Verify specs
17-Aug
24-Aug
31-Aug
as bid
as
worked
as
revised
7-Sep
14-Sep
21-Sep
28-Sep
5-Oct
12-Oct
19-Oct
26-Oct
2-Nov
9-Nov
16-Nov
23-Nov
Design
subsystems
Design
Reviews
Produce parts
Build
subsystems
Progress
Report
Perfect
subsystems
Assemble
device
1st System
Test
Perfect device
Document
design
LEGEND
Activity
Page | 60
Saluki Engineering Company
Spine Stabilization System
Proposal # S09-98-SPINESTB
LIST OF RESOURCES NEEDED
Item
Description
Quantity
1
Computer
1
2
MS Office
1
3
ANSYS or SolidWorks
1
4
Printer
1
5
Metal
* means from machine shop
*
$ Each
on
hand
on
hand
on
hand
on
hand
on
hand
$
Subtotal
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
$0.00
Action Item List
Project: Spine Stabilization System
Proj Number: S09-98-SPINESTB
Action Item List
Team Members
George Trifton, ME (PM)
Luciana Mottola, ME
Kyle Halfacre, ME
#
Activity
Person
1 Obtain Current Prices of Material LM
2 Begin work on Prototype
GT
3 Produce parts in SolidWorks
KH
Assigned
24-Aug
24-Aug
24-Aug
Due
7-Sep
28-Sep
Status
0%
0%
0%
Page | 61
Saluki Engineering Company
Spine Stabilization System
Proposal # S09-98-SPINESTB
RESUMES
George Trifon
4532 Springer Ridge Road
Carbondale, IL 62902
(708)214-4757
gtrifon@gmail.com
Objective
To lead motivated engineers in the research, development and design of breakthrough medical technology
Page | 62
Saluki Engineering Company
Education
Spine Stabilization System
Proposal # S09-98-SPINESTB
Southern Illinois University
Carbondale, IL
Bachelor of Science, Mechanical Engineering
Minor: Mathematics
Dean’s List
Embry Riddle University
Beaufort, SC
Bachelor of Science, Professional Aeronautics
Fall 2010




Work
Experience
2002-2006
Minor: Business Management and Aviation Safety
Dean’s List
Machinist
Carbondale, IL
Southern Illinois University, College of Engineering
Fall 2009 – Present
Gaining manufacturing experience by creating intricate devices from engineered drawings
Perfecting welding skills through the use of TIG and Oxy-Acetylene welding methods
 Maintaining machining equipment
Undergraduate Research Assistant Carbondale, IL
Summer 2007 – Fall 2008
Southern Illinois University, College of Engineering


Gained experience in ceramics processing by manufacturing inter-metallic diamond-bonded materials
through sintering
 Acquired operational knowledge of hot press furnaces while controlling density, perocity and strength of
processed materials
Lead Technician
Beaufort, SC
2 004-2006
Able Company

Installed and maintained Heating Ventilation and Air Conditioning units
Developed strong, dependable reputation by responding to service calls
 Installed, troubleshot and repaired residential wiring and plumbing
Deputy Sheriff
Beaufort, SC
Beaufort County Sheriff’s Office


2004-2006
Developed interpersonal skills under stressful conditions by dealing with various personalities and
temperaments
 Patrolled assigned areas, while responding to emergency and non-emergency calls
Sergeant
Beaufort, SC
1999-2004
United States Marine Corps



Acquired management skills by overseeing maintenance personnel and being in charge of Aviation Support
Equipment
Developed skills in leadership, delegation, self-discipline, time management and communication
Page | 63
Saluki Engineering Company
Other
Spine Stabilization System
Proposal # S09-98-SPINESTB
Volunteer Work
Habitat for Humanity
Feeding the Homeless
 Community Service Activities
Accreditations and Licenses


HVAC Universal License
Hazmat Handling Certification
Professional Memberships and Organizations




American Society of Mechanical Engineers
Engineers Without Borders
Page | 64
Saluki Engineering Company
Spine Stabilization System
Proposal # S09-98-SPINESTB
Kyle Halfacre
kylehalf@yahoo.com
Permanent Address:
4041 State Route 154
Pinckneyville, IL 62274
(618) 357-5485
School Address:
506 South Dixon
Carbondale, IL 62901
(Cell) (618) 357-1038
Objective:
To obtain an entry level Mechanical Engineering position upon
graduation in January 2009
Career Focus:
Mechanical Design in Biological Systems or Mechanical Systems
Education
Bachelor of Science, Mechanical Engineering
Southern Illinois University, Carbondale
 Major: Mechanical Engineering
 Minor: Math
Fall 2009
Relevant course work:





Skills



Experience
Design of a Novel Spine
Stabilization System
Computer-Aided
Engineering
Thermodynamics
Material Science
Mechanics of Materials







Fluid Mechanics
Heat Transfer
Machine Design
Dynamic Modeling and Controls
Mechanical Analysis
Nanotechnology
Engineering Acoustics
Microsoft Word, PowerPoint, and Excel
AutoCAD
ANSYS


SolidWorks
C++(limited)
Southern Illinois University Transcripts Office; Carbondale, IL
Student Worker, (August 2008 – March 2009)

Handled transcript requests, payments, and incoming mail.

Provided assistance to customers via phone or in the office on how to order
or resolve problems.
Mathematics Tutor
Tutor, (2003-Present)
 Tutored Junior High and High School Students in Mathematics.
Perry County Market Place; Pinckneyville, IL
Deli Worker, (December 2002- August 2008)
 Ordered products to sell, handled inventory, assisted managing workers, and
provided excellent service to customers.
Guitar Instructor, Pinckneyville, IL
Teacher, (May 2004-August 2008)
 Gave guitar lessons and helped develop confidence and character in Junior
High level kids.
The Hunt Club; Percy, IL
Worker, (May 2001 - August 2001)
 Provided excellent lawn maintenance and served during catering events.
Page | 65
Saluki Engineering Company
Spine Stabilization System
Proposal # S09-98-SPINESTB
Luciana Mottola
luciana86_32@hotmail.com
714 E College lot A
Carbondale, IL 62901
Summary of Qualifications:


Worked with CAS for a period of 2 years.
Bilingual: Spanish and English.
Education:

Southern Illinois University, Carbondale, IL
Bachelor of Science in Mechanical Engineering Fall 2009

Institutos Educacionales Asociados, Caracas , Venezuela.
Relevant Course Work:



Introduction to AutoCAD
CESL
Introduction to engineering
Activities:

ASME member
Awards:


Best weblog award, December, 2004.
Scholastic Honors, 2006.
Skills:



Traditional Drafting Skills, basic AutoCAD.
Microsoft office 2007
Matlab
Page | 66