An Innovation On The Existing Universal Large Distractor

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A Thesis presented to the Manufacturing Engineering and Management Engineering College of Engineering De La Salle University In Partial Fulfillment of the Degree of Bachelor of Science in Manufacturing Engineering and Management By Team Titans Bravo, Abigail Jao, Abigail Leocadio, Laraine Tan, Grace Ann 8/6/2009
Appendix A Definition of Terms.....................................................................5 Chapter 1......................................................................................................5 Chapter 2......................................................................................................6
An Innovation on the Existing Universal Large Distractor

Chapter 1 Introduction..................................................................................7 1.1 1.2 1.3 Introduction..........................................................................................7 Background of the Study......................................................................8 Statement of the problem..................................................................11
1.4 Significance of the Study......................................................................11 1.5 General Objective.................................................................................12 1.6 Specific Objective.................................................................................12 1.7 Scope and Limitations...........................................................................13 1.7.1 Scope..............................................................................................13 1.7.2 Limitations......................................................................................13 1.8 Conceptual Framework.........................................................................14 1.9 Methodology.........................................................................................16 1.9.1 Structure of the Phase....................................................................16 1.9.2 Timetable........................................................................................18 Chapter 2 Review of Related Literature......................................................19 Chapter 3 Design Control and Risk Management........................................19 3.1 Introduction..........................................................................................19 3.2 Design Control......................................................................................19
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Functional, Performance and Safety Requirements.................................20 Applicable Statutory and Regulatory Requirements................................22 Information derived from Similar Designs................................................22 Other requirements.................................................................................22 3.3 Risk Management.................................................................................23 3.4 Design Inputs........................................................................................25 Chapter 4 Theoretical Design and Considerations......................................26 4.1 Introduction..........................................................................................26 4.2 Design Number 1..................................................................................26 4.2.1 Sliding Carriage Assembly..............................................................27 4.2.2 Connecting Joint Assembly..............................................................27 4.2.3 Arm.................................................................................................27 4.3 Design Number 2..................................................................................29 4.4 Design Number 3..................................................................................31 4.5 Design Number 4..................................................................................33 4.6 Design Number 5..................................................................................35 4.7 Design Number 6 (Final Design)...........................................................37 4.8 Summary..............................................................................................39
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Chapter 5 Experimental Data / Design Verification.....................................43 5.1 Introduction..........................................................................................43 5.2 Material Selection.................................................................................44 5.2.1 Corrosion Resistant.........................................................................44 Autoclavable............................................................................................46 5.3 Concept Testing....................................................................................48 5.3.1 Experiment #1................................................................................48 5.3.2 Experiment #2................................................................................48 5.3.3 Degrees of Freedom.......................................................................48 5.3.4 Various Fracture Types...................................................................48 5.4 Cost Comparison...................................................................................50 Canvass......................................................................................................51 Components (For every X number of sets produced).................................52 5.5 Autoclave Testing.................................................................................54 5.6 Faster and Less Instrumentation..........................................................56 Chapter 6 Discussion of Experiment Results / Design Validation................57 6.1 Introduction..........................................................................................57 6.2 Analysis.................................................................................................57
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6.2.1 Faster and Less Instrumentation.....................................................57 6.2.2 Autoclave Testing...........................................................................57 Chapter 7 Conclusion and Recommendations.............................................58 7.1 Introduction..........................................................................................58 7.2 Conclusion............................................................................................58 7.3 Recommendation..................................................................................58 Chapter 8 Bibliography...............................................................................59 Appendix B Design Control Documentations...............................................59 Appendix C Risk Management Documentations..........................................59 Appendix D Matrix of Inter-relationship......................................................60 Appendix E Engineering Drawings..............................................................60 Appendix F Surgical Technique...................................................................60 Appendix G Bill of Materials........................................................................60 Raw Materials.............................................................................................60 Appendix H ROI Computation......................................................................62 Appendix I List of Tables.............................................................................62 Appendix J List of Figures............................................................................62 Appendix J List of Figures
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Appendix A Definition of Terms

A.1 Chapter 1
Word Anesthetic Aseptic Bone Intramedullary Bravo
Definition a drug that causes temporary loss of bodily sensations Free of disease-causing microbes; Used to protect against infection by disease-causing microbes rigid connective tissue that makes up the skeleton of vertebrates a medical term meaning the inside of a bone. Examples
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include intramedullary rods used to treat bone fractures in orthopedic surgery and intramedullary tumors occurring in some forms of cancer. containing or consisting of or resembling bone marrow A verb meaning to gouge out holes or enlarge holes already made, in orthopedic surgery, bones need to be reamed to allow for the implantation of a prosthesis. Intramedullary (IM) rods are used to align and stabilize fractures. IM rods are inserted into the bone marrow canal in the center of the long bones of the extremities (e.g. femur or tibia). is the branch of medicine associated with the musculoskeletal system the cutting of or into body tissues or organs (especially by a surgeon as part of an operation) Reduction is a medical procedure to restore a fracture or dislocation to the correct alignment. A device that amplifies the intensity of an image, but not the size. located at or near or behind a part or near the end of a structure of or near the head end or toward the front plane of a body Arbeitsgemeinschaft fur Osteosynthesfragen/Association for the Study of Internal Fixation. An association founded in Germany to study and promote the use of internal fracture fixation. The association has an education program for teaching surgical methods. There are national branches of the association in several countries. In the United States, it is the Association for the Study of Internal Fixation. The surgical procedure of cutting a bone. This is often performed to either lengthen, shorten, or straighten a bone the act of providing or using the instruments needed for some implementation
Medulla Reaming IM nail/rod
Orthopaedic Incision Reduction Image intensifier Posterior Anterior AO/ASIF
Osteotomy Instrumentation
A.2 Chapter 2
Word Vertebrates Rear Definition an animal having a backbone; having a backbone he back or hindmost part; that which is behind, or last on order; - opposed to front; Specifically, the part of an army or fleet which comes last, or is stationed behind the rest;
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Skull Knee Diaphyseal Diaphysis Vascular Epiperiosteal Devascularizes Lesion Collinear Pelvic Acetabular Polytrauma the bony skeleton of the head of vertebrates In humans, the joint in the middle part of the leg; The joint, or region of the joint, between the thigh and leg; relating to the diaphysis of a bone The diaphysis is the main or mid section (shaft) of a long bone. It is made up of cancellous bone (spongy bone) and usually contains bone marrow and adipose tissue (fat). Relating to the channels that carry body fluids, usually used in connection with the blood vessels. Also termed as the hypodermis layer. Loose connective tissue underneath the dermis which connects the dermis to muscle or bone. To make less vascular. A destructive change in body tissue, such as a wound, injury, or inflammation. Collinear points lie along a straight line. The three axis points cannot be collinear because graph coordinates are therefore impossible to compute. Having to do with the pelvis, the lower part of the abdomen, located between the hip bones. The cup-shaped cavity at the base of the hipbone into which the ball-shaped head of the femur fits. Polytrauma is defined as two or more injuries to physical regions or organ systems, one of which may be life threatening, resulting in physical, cognitive, psychological, or psychosocial impairments and functional disability. The plane of section which runs longitudinally through the body dividing it into left and right parts. Located closer to the mid line of, or point of attachment to the body; as in the "the elbow is proximal to the finger." Opposite of distal. Situated away from the center of the body, or from the point of origin; specifically applied to the extremity or distant part of a limb or organ. between two condyles rounded prominence at the end of a bone, most often for articulation with another bone. Relating to the area of bone that separates the metaphysis and the epiphysis, in which the cartilage grows. Pertaining to growth or to that part of a bone that is responsible for lengtheningthe physis.
Sagittal Proximal Distal Intercondylar Condyle Physeal
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Chapter 1 Introduction
1.1Introduction
This chapter includes sections that would give the reader an introductory knowledge of what the group will be doing. Supporting elements that are included in this chapter are: 1.2 Background of the Study, which gives an overview on what the groups study will be all about; 1.3 Statement of the Problem, that defines the problem that the group will have to solve in order to complete the project; 1.4 Significance of the Study, which states the purpose and relevance of the study; 1.5 General Objective, 1.6 Specific Objectives and 1.7 Scope and Limitations, serves as a guide in the process of the study in order to attain a specific, measurable, accurate, realistic and time bound project; 1.8 Conceptual Framework, that reveals the concepts and the idea of the group on how to go about the project; and finally, 1.9 Methodology shows the plans of the group on how to do the project and be able to finish it on time.
1.2Background of the Study

Intramedullary nailing is a procedure that has been practiced since 16th century in Mexico up until now. This procedure has continuously evolved and Bravo
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improved in the course of time, making it a medically sound and well accepted treatment for bone fractures. Additionally, its advancement in method, principle and design paralleled with that of anesthetic and aseptic techniques, making the discipline grow to be more concerned on forming a routine operative care for fractures. [1] Intramedullary nailing, in simplest term, is the process for fixing the parts of broken bone by means of a nail (long metal tube with screw holes along its length for screw fixation). For example, consider a femur that was fractured. Since the bone is broken, it is no longer in its proper anatomical position and needs to be aligned and fused together, thus a nailing operation is needed. First, the surgeon performs fracture reduction to correct alignment of the main fragments, as well as the length and rotation of the femur. [2] Once the fracture is reduced, they perform intramedullary reaming to allow ease of insertion of the nail. After reaming, a nail is inserted and locked by screws to ensure fixation. Today, the current and the only practice of orthopaedic surgeons here in the Philippines is to manually align the matured fractured bone (femur) using various kinds of bone clamps and bone extractors. It is a normal practice in our country to perform this procedure by open reduction (exposing the fracture site, making a long incision along the thigh). After they have
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exposed the fractured bone, they are now going to perform direct reduction by manually aligning the bone fragments together. This step usually lasts for 30 minutes to more than an hour depending on the age of the fractured bone. This maneuver may be less difficult for fresh fractures. But if you'll consider fractures that are already old (2 weeks and above), this maneuver may be very difficult and will require a very huge amount of effort to reduce. Additionally, the risk of experiencing complications arises as the duration of the surgery increases. Hence, the need for an instrument that will aid the surgeons in performing this part of the surgery with ease will be beneficial, not only for the surgeon, but for the patient as well. It is a known fact that surgery is expensive, not to mention the expenses for the implants. Being in a third world country and all, the popular mass can't afford to have their fractures fixed right away, which in turn causes fracture to undergo callous formation, which makes it more complicated to operate. In other countries such as United States of America, they perform indirect reduction with the use of femoral distractors. This method manipulates the fracture fragments by applying corrective force at a distance from the fracture with the use of distraction or other means without exposing the fracture site. This reduction necessitates the use of an image intensifier. [3] Arbeitsgemeinschaft fuer Osteosynthesefragen - Association for the Study of
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Internal Fixation (AO/ASIF) has developed an instrument for fraction reduction called the universal large distractor, however it is very expensive (similar second hand unit costs US $355.51 in ebay) and is still not available in Philippine market. AO's new universal large distractor is used in closed reduction. It works with pins or known as Schanz screw that are drilled into the bone which would hold the bone that will aid in distraction and alignment. So that it will not be in the way of the medullary reaming, the 5mm half proximal pin is positioned laterally into the lesser trochanter, with the half pin directed slightly upward (20 deg) from a posterior to anterior direction. [4] However good this device is, it is not applicable in Philippine setting, since most, if not all hospitals, do not have a reliable image intensifier in their operating room. Also, this method increases the risk of radiation exposure to the surgical team. In addressing the disadvantage of application of the universal large distractor, the group will be designing a similar instrument that will help orthopaedic surgeons in performing intramedullary operations on femoral fractures, specifically during open reduction. This instrument will act as a bone distractor for distracting the opposite sides of an osteotomy of the bone. It will also serve as a fracture reducer, having the capability to rotate and align the bone. It will lock the bone in place, giving a more stable ground for intramedullary reaming and nail insertion. Bravo
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1.3Statement of the problem

The need for a better method and innovative instrumentation that would give the surgeons convenience and ease in reducing fractures during open reduction in intramedullary (IM) nailing surgery.
1.4 Significance of the Study

The increasing number of motorcycle riders here in the Philippines has significantly increased the number of orthopaedic trauma cases, caused by vehicular accidents. Orthopaedic International Inc. (OII) is one of the many sources of intramedullary nails. And for the last 5 years, there were a total of 1,214 intramedullary nail fixation (femur), not including the many other cases that used a different brand of nails. An average of 248 nails a year (for OII), evident that femoral fracture cases are frequent. Femoral fractures fall under the trauma case category. In most hospitals, the patients are evaluated according to protocol devised to save them from life threatening conditions. After that, mild injuries are treated. A fracture in the femur is non-life threatening. So for those who can't afford the surgery right away they postpone it as long as they can. This leaves the bone to grow into its fracture, overlapping the bones and making it harder to operate. Bravo
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To address the problem, the group will design and fabricate a similar instrument as that of AOs universal distractor, which will have the following additional benefits: More options in holding the bone depending on the situation: provision of a clamp or pin, depending on the surgeons choice Less expensive or same price with the Large Distractors in the market (not including the clamp)Lesser instrumentation Lesser steps in surgical procedure when the clamp is used instead of the pin. Lesser Instrumentation if clamp is used
1.5 General Objective

To design and fabricate an innovative orthopaedic surgical instrument that improves the current method and instrumentation of reducing fracture in the Philippines.
1.6 Specific Objective

The device must be able to move the bone in 6 degrees of freedom The device must be able to distract - compress the bone fractures. The device must be able to move the bones fracture up and down. The device must be able to move the bones forward and backward. Bravo
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The device must be able to tilt the bone fractures side to side. The device must be able to tilt the bone fractures forward and backward. The device must be able to turn the bone fractures left and right (rotate). The device must have a provision for a clamp or pin to hold the bone. Using the clamp, the surgeon will not be required to drill pins to the bone, however, if the doctor choose to use the pin, it will just be the same with other universal distractors.
1.7 Scope and Limitations

1.7.1 Scope
The study must be able to produce a similar device as that of AOs universal distractor that would be applicable in Philippine setting. The study will be producing an actual prototype (stainless steel) of the device. The study will simulate the fracture reduction as proof of concept through Model Simulation/Cadaveric Surgery with an orthopedic surgeon.
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The device will be manually adjusted, but will include
mechanisms that would allow it to move in the surgeons desired position.
1.7.2 Limitations
Test to be conducted will be limited to the simple femoral fractures only. The study will not undergo an actual clinical trial. The device will be used for open reduction cases. The device will not be automated. Removal of bone fragments prior to fracture reduction will be necessary. The device may or may not be removed prior to reaming, depending on the surgeons convenience and chosen bone holder (clamp or pin) The device is intended for direct reduction to ensure effectivity.
1.8 Conceptual Framework

Suppose an old fracture has to be treated with an IM Femoral Nail. Since it is very hard to reduce old fractures, a tool that can distract the fracture bone while being able to manipulate the bone fracture and stabilize it may be very helpful for the surgeon. Thus a surgical instrument called a femoral distractor is designed to that job. First, the surgeon has the option of Bravo
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choosing which bone holder to use: pin or clamp. The pin may be used if youll be using the technique taught by AO in using their universal large distractor. However, if the surgeon would like to do it the Philippine setting way, wherein the manipulation is done right where the fracture is, then using the clamp instead will be good, so there will be no problem when its time for reaming. The surgeon will reduce the fracture by taking advantage of the 6 degrees of freedom offered by the instrument. Once the reduction is achieved, the femur can now be reamed and an IM nail can now be inserted to completely treat the fractured femur. (see Figure 1.1).
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Figure 1.1 Conceptual Framework
1.9 Methodology
1.9.1 Structure of the Phase
Included in the Phase 1 are information gathering, planning stage and review/study stage. During the information gathering, the group should have gathered relevant information that can help to the fulfillment of the study. It would also serve as an exposure for the group in the biomedical field to be able to understand the current and urgent needs of the country in that aspect. After having a finalized topic to be proposed, the group will move on to the planning stage. This stage will give some concrete details as to how the thesis will be made possible. It is the period where the group will generate a well-defined conceptual framework and clear objectives, scopes and limitations that could be presented to potential sponsors for the thesis project. Also, included in the Phase 1 is the study stage. It is a stage of mastery of the different subjects needed in order to finish the project. It will be an intensive learning that would help the group in developing the project. To follow is the Phase 2, which is composed of the design stage and data gathering. During the design stage, the group is supposed to give life to
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the concept generated. An application of different subjects, such as anatomy, physiology, mechanics, ergonomics, CAD and CAM, is required in the construction of the design. Data gathering, on the other hand, strengthens the study by ensuring the significance and usability of the design being constructed. It is also a stage for looking for parts needed in the design. Moving on to Phase 3 includes evaluation and experimentation. It is a stage of analysis and polishing for the design made in the previous phase. It is where the corrections are made and more research is done. Also, it contains the period wherein the revised design is to be fabricated and tested. Another set of analysis and re-evaluation will follow to complete this level and to be able to move on to the next phase. This phase includes the 8 hour reliability run. The Phase 4 or the Thesis Defense Phase is the final phase, where the final revised thesis documentation is made. This phase also includes the thesis oral defense and the submission of the final documentation.
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Thesis Stage Experimentati Evaluation Data Design Defense Review/Study Planning Stage InformationStructure of the Figure 1.2 Revise on Discussion Gathering CAD/CAM Stage documentation - Generating Gathering a wellPrepare presentation Fabrication Revisions Consultation Ergonomics Anatomy /Books defined conceptual Journals / Phase Result Improve Surveyanalysis Mechanics Physiology framework Internet design Re-evaluation Canvassing Mechanics - Sponsorship Hospital Ergonomics - Clearing observations ASTM Standards objectives, scopes Dialogue with and limitations doctors Exposure to surgeries
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1.9.2 Timetable
Table 1.1 Timetable
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Chapter 2 Review of Related Literature

2.1 Introduction
This chapter talks about the current methods of reducing fracture here in the Philippines. Section 2.2 discusses what the femur is and its parts. Section 2.3 discusses the different categories and types of fracture. Section 2.4 discusses fracture reduction and two types of techniques to achieve fracture reduction. Section 2.5 illustrates and discusses the current reduction techniques used in the Philippines which includes the use of reduction forceps, bone distractor and other reduction techniques. Section 2.6 illustrates and discusses the theoretical framework of this study and Section 2.7 contains a summary of this chapter.
2.2 The Femur

The femur or the thigh bone, is the bone of the leg that is closest to the body proximally. It enables vertebrates, such as land mammals, birds, many reptiles such as lizards, and amphibians such as frogs, jump and walk. The femur of vertebrates with four legs can only be found in the rear leg.
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Figure 2.1 Human Femur
In
humans, the femur is the longest, strongest and largest bone. The other strongest bone is the temporal bone of the skull. The average adult
Figure 2.2 Bovine Femur human
femur is 48 centimeters (19 in) in length
and 2.34 cm (0.92 in) in diameter and can support up to 30 times the weight of an adult. It forms part of the hip (at the acetabulum) and part of the knee. There are four eminences, or protuberances, in the human femur: the head, the greater trochanter, the lesser trochanter, and the lower extremity. The word femur is Latin for thigh. Theoretically, femur bone is more proper than saying femur alone. [3]
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Figure 2.3 Femoral Bone Anatomy
2.3 Femur Fracture

The femur is a thigh bone that extends from the hip join to the knee joint. It needs a great amount of force to cause a fracture on this strong bone. Car accidents and fall from a height are the frequent causes of femur fracture. A bone weakened due to osteoporosis, tumor, or infection can lead to a pathologic femur fracture. Femur fractures are generally separated into three broad categories. Proximal femur fractures or hip fractures, involve the upper-most portion of the thigh bone, just adjacent to the hip joint. A femoral shaft fracture is a severe injury that generally occurs in high-speed motor vehicle collisions and significant falls. Almost all femoral shaft fracture is treated by surgery and Bravo
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the most common procedure is to insert a metal rod down the center of the thigh bone called an intramedullary rod. The procedure reconnects both ends of the bone, and the rod is secured in place with screws both above and below the fracture. Other less commonly used treatments of a femur fracture include a plate and screws or an external fixator. A supracondylar femur fracture is an unusual injury to the femur just above the knee joint. This fracture often involves the cartilage surface of the knee joint. It is more common in patients with severe osteoporosis, who have previously undergone total knee replacement surgery and in times after high-energy injuries as described above. [6] There are three different types that can occur in a femoral shaft fracture. For a completely broken fracture, it can be subdivided into simple, wedge and complex.[7]
Simple Wedge Complex
Figure 2.4 Types of Fractures
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Simple fracture has only one fracture line, and the bone is broken into 2 pieces. The simple fracture can further be divided to Spiral, Oblique and Transverse. Simple, Fracture [8] Spiral
Simple, Fracture
Oblique
(>30 degrees)
Simple, Transverse Fracture degrees) (<30
Table 2.1 Types of Simple Fracture Bravo
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Comminuted and Wedge fractures has more than one fracture line, and there are more than 2 bone fragments at the fracture site. Wedge, Spiral
Wedge Fracture
Wedge, Wedge
Bending
Wedge, Fragmented Wedge
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Complex, Complex Spiral
Complex, Complex Segmental
Complex, Complex Irregular
Table 2.2 Types of Comminuted and Wedge Fracture
The area of fracture can either be closed or open. Closed fracture is a scenario in which the skin in the fracture area is not broken, and the break is not exposed to the outside while the Open fracture (Compound) the skin over the fracture is broken, exposing the broken bone. Bravo Jao Leocadio Tan Page 28
Figure 2.5 Open and Close Fracture Pathological fracture occurs when bone has been weakened or destroyed by disease so that it breaks easily. Stress fracture shows a hairline crack in a bone which is sometimes not even visible on an x-ray, which is caused by repeated injury or stress on the bone.
2.4 Open Reduction with Internal Fixation

The main goal of open reduction is to restore length, align two main bone fracture fragments, and rotate them back to their original position. The bones are aligned and held in place by implanted devices such as pins, nails, screws and plates, through an incision into the skin.[9] Achieving the same goal, there are two ways on how to do it, the direct and indirect way.
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2.4.1 Direct Reduction
Direct reduction means that hands or instruments directly manipulate fracture fragments. In simple diaphyseal fractures (eg, simple forearm shaft fractures), direct reduction is technically straightforward and the result is easy to control. Easy fracture cases may not add vascular damage to the bone or soft tissues if the surgery is done carefully (meticulous soft-tissue handling, and with limited, epiperiosteal exposure of the bone). [3] Direct reduction in complex diaphyseal fractures may expose, reduce and stabilize every single fragment. To avoid this, the surgeon devascularizes these fragments by stripping the periosteum and soft tissues. [3] Disastrous consequences for the healing process such as delayed union, nonunion, infection, or implant failure will be evident if the repeated use of reduction forceps and other reduction tools devitalize the fragments in the communited area. The biology of the bone, periosteum and soft tissues must be taken in consideration before reduction. [3]
2.4.2 Indirect Reduction

At a distance from the fracture, indirect reduction manipulate the fracture fragments by applying corrective force at a distance from the fracture with
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the use of distraction or other means without exposing the fracture site. This reduction necessitates the use of an image intensifier. [3] At the present, correct reduction by indirect techniques is more difficult to achieve than direct. It considers accurate assessment of the soft-tissue lesion, understanding of the fracture pattern, anatomy (muscle pull), and meticulous preoperative planning. The advantage of indirect reduction is that since the reduction tools act away from the fracture in focus, minimal surgical damage to the traumatized tissues can be achieved. Although the tools used will interfere the tissue, it will only affect the area not been damaged by initial trauma and will not affect the healing of the fracture. [3] Today, instruments and implants can be used for direct or indirect techniques. In the end, the success of preserving the tissues is not dependent on the instruments or implants itself, but on the surgeons skills in doing the technique. [3]
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2.5 Current Reduction Techniques Used in the Philippines

2.5.1 Reduction Forceps
Reduction Forceps is an instrument used to directly maneuver the fragments of the bones to achieve reduction. There are different types of reduction forceps: reduction forceps with points, toothed reduction forceps, self-centering bone holding forceps, bone spreader, collinear reduction forceps, pelvic reduction forceps with ballpoints, angled pelvic reduction forceps, pelvic reduction forceps (Faraboeuf Forceps) and pelvic reduction forceps (Jungbluth Forceps). [10] Reduction Forceps with Points (Weber Forceps)
Figure 2.6 Weber Forceps
The Weber Forceps is commonly used in bone reduction, because it is mild to the Periosteum. Periosteum is a membrane covering the outer surface of bones except at the joints [8]. This forceps can move in three linear planes and two rotational degrees of freedom. There are two techniques that can be used by this forceps: two-forceps technique (Figure 2.2) and single-forceps technique (Figure 2.3). [10] Bravo
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Figure 2.7 Two-Forceps Technique
Figure 2.8 Single-Forceps Technique
Figure 2.9 Direct Reduction using Two-Forceps Technique a. grasping of the two bones of a transverse fracture b. manual traction with correct rotation and axial alignment to achieve reduction
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Figure 2.10 Direct Reduction using Single-Forceps Technique in Oblique Fracture a. the two bones are held together by a single slightly tilted Weber forceps b. Maneuver the forceps until the bone is lengthened and the fracture decreased c. A second forceps is applied perpendicular to the fracture to stabilize the reduction
Reduction Forceps, toothed
Figure 2.11 Toothed Reduction Forceps The toothed reduction forceps is usually used in direct fracture reduction. Because of the toothed design, it often slips on the surface of the bone and damage the Periosteum. It is generally used to adjust fracture reduction and
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positioning of the plate during open reduction and plate fixation of a fracture of the femur or tibia. [10] Bone Holding Forceps, self-centering (Verbrugge Forceps)
Figure 2.12 Verbrugge Forceps The primary function of Verbrugge forceps is to hold a plate to the shaft of a long bone or the diaphyseal bone [11]. To ensure that there is minimal damage to blood supply, it must be used outside the fracture zone. A
considerable circumferential exposure of the bone can be seen, because of its pointed end that has to reach completely around the bone. For compression, the pointed end of the forceps may be hooked into an end hole of the plate while the broad end reaches around an independent screw head to pull the plate, thereby compressing the fragments (pull technique). [10]
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Bone Spreader
Figure 2.13 Bone Spreader
Bone spreader is used for distraction. It has one linear degree of freedom. Push-pull technique must be applied to achieve reduction. [10]
Figure 2.14 Push-Pull Technique a. the bone spreader is placed between two broken bones or between the end of a plate and a screw inserted 1cm from the end of the plate. The screw is used to push separately the fracture b. using a Verbrugge forceps, pull the plate towards the screw to achieve compression Collinear Reduction Forceps
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Figure 2.15 Collinear Reduction Forceps Collinear reduction forceps is a new design that has a sliding mechanism that only allows linear movement. It has a hook to go around the bone without damaging the soft tissues. Used only for compression. [10]
Pelvic Reduction Forceps with Ballpoints (King Tong, Queen Tong)
Figure 2.16 Pelvic Reduction Forceps with Ballpoints The pelvic reduction forceps are generally used for the reduction of pelvic and acetabular fracture. A mobile washer fixed in the ball points can be used to void the deep penetration of the points into the bone. The forceps can also
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be used in positioning medial and lateral fragments through small stab incision. [10] Angled Pelvic Reduction Forceps (Matta Forceps)
Figure 2.17 Matta Forceps The angled pelvic reduction forceps is design as such to reach parts of the body that are inaccessible to normal forceps. The ballpoints and mountable washers reduce point forces on weak bone. [10] Pelvic Reduction Forceps (Faraboeuf Forceps)
Figure 2.18 Faraboeuf Forceps The Faraboeuf forceps compresses two fractured bones by grasping two screw heads inserted on each side of the broken bones. It is helpful to close a side-to-side fracture gap. Used only for compression. Distraction of the bones is not possible. [10]
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Figure 2.19 Application of Faraboeuf Forceps
Pelvic Reduction Forceps (Jungbluth Forceps)
Figure 2.20 Jungbluth Forceps
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The Jungbluth forceps is screwed on both fragments of the broken bones with a cortex screw to tightly connect the bones to the forceps. This allows the bones to move in three planes (distraction and compression, and displacement in two planes) [10]
Lowman Bone Clamp Lowman Bone clamps are perpendicular bone clamps are used to reduce bone fractures. The clamps are inserted through the wound incision perpendicular with the axis of fracture. The fracture is reduced by tightening the jaws of the clamp with a screw mechanism. Bone clamps currently available are Lowman, Lowman-Gerster and the Lowman-Hoglund bone clamps. The screw mechanism often requires the use of both hands, the use of only one hand is preferable.
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Bone (d) (c) (b) (a) Clamps manufactured by Laraib (a) Lowman 170mm,6 3/4"-205mm,8" (b) Lowman-Gerster 210mm,8 1/4" (c) Lowman-Hoglund 175mm,7" (d) Gerster [10]
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2.5.2 Bone Distractor
A distractor is a unilateral mounted instrument that is used to maneuver mal-aligned main fracture fragments, before, during and after nail insertion. Distracting the fragments requires tension and angular or rotational correction, and can be considered difficult when working with curved bones. There is a tendency for the distractor to straighten a curve bone that may lead to additional deformity. [12] There are two distractor classifications depending on the size of the bone fractured, there are: Small Distractors and Large Distractors. Small distractors are used for small bone fractures that include forefoot, hand and wrist. The Larger unit is intended for use with larger bones such as femur, tibia, arms and mandible. For femoral fractures, the Universal Large
Distractor is commonly used for reduction.
Universal Large Distractor
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Figure 2.21 Universal Large Distractor
Figure 2.22 Parts of the Universal Large Distractor 14.0 mm Threaded Spindle (A), End Piece with double joint (B), cotter pin (C), knurled nuts (D), Holding Sleeve, 105 mm length (E), Spindle Nuts (F), Sliding Carriage (G), Holding Sleeve, 55 mm length (H). The universal large distractor is particularly suited to poly trauma patients. It is placed in the saggital plane to restore the length and alignment without the need of a fracture table. Without the table, it will allow the hip and knee to flex during nailing. The disadvantage is that intensifying the image control is difficult to obtain in the lateral view.[13]
Reduction Techniques
Distraction
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1.
Loosen the distal Spindle Nut. image intensification,
Under
apply distraction by moving the proximal Spindle Nut distally.

Figure 2.23 Bone Fracture Distraction
Rotation 2. Loosen both Spindle Nuts and the knurled nut on the End Piece with double by joint. Correct
rotation
simultaneously
rotating the Sliding (carriage and

Figure 2.24 Rotation of Bone Fracture
the 14.0 mm Threaded Spindle. Valgus Varus 3. Valgus Varus describes the alignment anatomical between segments two [14].
Loosen the knurled nut on the distal Holding Sleeve. Correction is achieved by manipulating the distal Schanz screw with the Bravo
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Figure 2.25 Valgus Varus Page 44

Universal Chuck with T-Handle. Definition
Figure 2.26 Aligning Valgus Varus with the aid of Distractor Anterior-Posterior Angulation 4. Loosen the knurled nut that the proximal Holding
secures
Sleeve in the End Piece with double joint, and correct the angulation using the Figure 2.27 Angulation
manipulation nail. Compression 5. Loosen the proximal Spindle Nut. Under image intensification, apply compression by moving the distal Spindle Nut proximally. After reduction, secure all Figure 2.28 Compression
distractor joints by tightening all
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connections. Pass the 3.0 mm Reaming Rod through across into the the the
manipulation fracture site
nail, and
intercondylar region at the level of the physeal scar. Remove the manipulation nail, and ream for nail insertion. [15]
2.6 Theoretical Framework

With the ideas gathered from the existing orthopedic instruments for reducing fracture, the group was able to conceptualize a new device that could replace the existing ones and be able to provide a better way of reducing the fracture. It is a combination of the bone extractor and bone distractor without sacrificing any purpose of those two instruments and even being able to provide a means to stabilizing the desired configuration of the bone.
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Bone Distractor and Fracture Reducer Ergonomics Materials Strength of Kinematics Movements of will let the the material's With principle joints in coordination with its This an understanding ofgroup Instrument members in a linkage applied in ability to resist different is critical forces, effectively design the instrument can analyze the the the group design and planning. With the use instrument in considering instruments of Kinematic principles, the group can capabilitypossible instabilities that can be surgeons to effectively perform its foresee well being and ease functions before and during the actual bone the procedure. The principle prevented in of use. will also aid in forecasting fatigue, reduction strength, strain not only in the instrument but also the forces produced by the instrument.
Figure 2.29 Theoretical Framework
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2.7 Summary
This chapter presented the researches that the group conducted. The team gained more knowledge about the topic and answered some of the questions in mind through the researches. The information gathered was relevant to the study. The review of the previous studies and existing patents helped the group to decide about the feasibility of the topic. It paved the way to the generation of more ideas on how to do the thesis. The researches were very useful for the thesis. The research regarding the current techniques used in the Philippines gave the group an idea on how to improve the instruments. Existing instruments gave the team several ideas on the physical design of the instruments and prevented the team in copying the designs.
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Chapter 3 Design Control and Risk Management

3.1 Introduction
This section details the procedure followed by the group in the design and development process. It covers the formulation of design and development inputs. Section 3.2 discusses various design requirements such as functional, performance and safety requirements according to the devices intended use. The section 3.3 details the risk analysis for the product designs consideration.
3.2 Design Control

In this section, the group thoroughly considered the various design requirements for the distractor. The group filled up the Checklist of Design and Development Inputs (see Appendix ____) to consider every requirements essential for the devices design and development.
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Functional, Performance and Safety Requirements
In this section, the group was able to define the three main purpose of the device to be developed, which is to: Distract the fractured bone Provide stability to the bone in preparation for IM Nailing Provide alignment Since the device to be developed is made of several components, a matrix of inter-relationship would be helpful in the design of the components in order to consider the mating parts and functionality of each components. This is especially helpful in assigning tolerances for the mating parts. Although this device can also be used in other long bone fractures, the group decided to limit the study for femoral fractures only. Old femoral fractures are much harder to reduce than any other long bone fractures. Thus, Dr, Cadag and the group decided to focus the study in reducing femoral fractures only. The group aims to produce a device prototype that can be used in actual surgery, with that the following additional requirements are to be fulfilled:
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Sturdy The prototype should be very sturdy, enough to provide stability and ease of use during actual operation. It should have good fittings, so as not to be disassembled on its own during use. It should be reliable and should show repeatable results.
Autoclavable The device should be autoclavable, since autoclaves are the most widely used sterilization method in hospitals. It would be a plus, if it can also be sterilized by other methods such as ETO, Gamma sterilization and so on.
Made from biocompatible materials Device that will come into contact with the patients blood, tissues and bone should be made from biocompatible materials. Other components of the device should at least be made from a corrosion resistant material. As for the user and patients requirements, the device ought to be user friendly and safe to use. There has to be no sharp edges that could damage the surgeons surgical gloves. The device should be easy to use, not to require special trainings prior to use.
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Applicable Statutory and Regulatory Requirements
For the purpose of this study, the group will not register the device for marketing.
Information derived from Similar Designs

Initially the group did not know of the existing large distractor that is able to perform the objectives of the groups study. After several research and interviews with surgeons, the group found out of the AOs distractor. However, the AOs distractor only uses pin to hold the bone. The group, as suggested by surgeons, wanted to incorporate a clamp in the distractor in order to minimize drilling through the bone and to make the operation faster. With that, the group innovated the design of AO in order to incorporate a clamp. Changes made in the design were as follows: Design to incorporate both pin and clamp Adaptor for pin Fixed joint, making it more stable Spanner for tightening nuts and screws
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Other requirements
The device has to be reproducible. Drawings with complete dimensions shall be furnished as part of the projects documentation. The devices cost should be comparable with other large distracters out in the market. Lifetime of the device is until it breaks or wears. The clamp and pin should have good interference with the assembly in order to provide stability.
3.3 Risk Management

In this section, the group thoroughly considered possible risks associated with the device by accomplishing the following forms found in appendix ____:
Product Requirements and Characterization

In this form, the group was able to define and assess the product requirements needed to be considered in the design. The device to be developed is an orthopedic (surgical) instrument used in reducing femoral fractures. It will be in contact with the patients bone and tissues for some time, until the fracture is aligned or be used to stabilize the fracture until the nail is inserted to the medullary canal. Majority of the devices construct will be made of Grade 304 Stainless Steel. If other material will be used, it should be corrosion resistant and autoclavable. The device should be autoclavable and easy to clean, since the product will be Bravo
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used repeatedly. However, since some components of the device will be repeatedly experiencing stress, especially during tightening, some
components will eventually wear and fail.
Checklist Conditions
of
Possible
Hazards
for
Normal
and
Fault
Possible hazards for medical devices such as the femoral distractor should be defined and considered in the design in order for it to be most beneficial to the users and to the environment. Various hazards discussed in the sheet includes energy hazards, biological hazards, environmental hazards, use of device hazards, and functional failure, maintenance and aging hazards.
FMECA Worksheet
See FMECA worksheet.
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3.4 Design Inputs

Design inputs derived from the design control and risk management are found in the table below.
No.
1 2 3 4 5 6 7 8 9 10
Requirements / Design Input

It should be able to distract the fractured bone. It should be able to align the fractured bone. It should be able to be held in place by a certain locking mechanism. It should incorporate a clamp in the design, so that the surgeon would not have to drill through the bone using a pin. Cost consideration - cheaper than current distractor in market Material should be made of stainless steel. Material should be able to withstand sterilization conditions. There should be no sharp edges It should have enough instrumentation to efficiently make it do its work. Corrosion resistant
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Chapter 4 Theoretical Design and Considerations

4.1 Introduction
This chapter discusses the theoretical design and considerations of the machine, which includes the mechanical core design components. Sections 4.2 to 4.6 will discuss the three possible designs for the prototype. From these, a final thesis design is generated and discussed in Section 4.7. Summary is provided in Section 4.8.
4.2 Design Number 1
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Figure 4.1. Design Number 1 The first design for the Femoral Distractor is composed of two (A) spindle nuts, a (B) threaded spindle with end piece, a (C) sliding carriage, four (D) large hex nuts, four (E) small hex nuts, two (F) sliding sleeves, two (I) tightening nuts, a (G) connecting rod and (H) connecting lock for one arm, two (J) clamp rods that serves as the devices arms and two (K) clamps that act as hands to hold the bone in place.
4.2.1 Sliding Carriage Assembly

The (A) spindle nut is threaded partway down the (B) threaded spindle. The (C) sliding carriage is then placed after the first (A) spindle nut. Then another (A) spindle nut is threaded to secure the sliding carriage in place.
4.2.2 Connecting Joint Assembly

The (G) connecting rod is placed at the distal end of the threaded spindle. The (H) connecting lock screwed the (B) threaded spindle and (G) connecting rod in place. The connecting joint assembly connects one arm to the whole system. It is also designed to allow the arm two degrees of motion.
4.2.3 Arm
The arm is composed mainly of the (J) clamp rod and the (K) clamp. The (F) sliding sleeves give the arm four degrees of motion. (D,E) Hex nuts are threaded to keep them in place. A (I) tightening nut on top of the clamp Bravo
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helps in adjusting its grip according to the size of the bone. One arm is connected to the (C) sliding carriage and the other is connected to the connecting joint assembly.
Figure 4.2. Design Number 1 Issues
Issues Proposed Solutions The clamp is having a hard time Place teeth at the posterior side gripping the bone of the clamp Curve the clamp to establish more grasp The tightening nut is having a A sleeve would make up for the difficulty secure the clamp in needed height of the nut place because its too short
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4.3 Design Number 2
Figure 4.3.Design Number 2 The second design is essentially composed of the components of the first design. However, in order to resolve the issues posed in the initial design, some changes were taken into account. To solve the first problem created by the first design, the clamp is curved more to establish further grasp to the bone. In addition, teeth are placed at the posterior of the clamp to enhance its grip.
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A revision is made at the tightening nut. To ensure that the clamps are in place once the correct bone grip is established, a sleeve is incorporated to the previous tightening clamp design.
Figure 4.4. Design Number 2 Issues Issues The tightening clamp is still A Proposed Solutions wing nut should lock
having issues securing the clamp everything in place in desired position
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4.4 Design Number 3
Figure 4.5. Design Number 3 In order to resolve the tightening problem of the tightening nut, it is replaced by a wing nut. A sleeve is still in place to give the proper anchorage to the wing nut in locking the clamp in place.
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Figure 4.6. Design Number 3 Issues Issues The design of the clamp doesnt meet the performance requirement needed for holding the fractured bones Proposed Solutions In exchange for the old clamp, the lowman clamp is proposed to be used since its reliability is already proven by orthopaedic surgeons Additional feature is needed at the sliding carriage to be able to hold the weight of the lowman clamp
The design of the sliding carriage needs to be replaced because reliability of the connection b/w body and arm is uncertain due to the proposed exchange of lowman clamps for existing clamps The threaded spindle needs to Add another component to be revised to accommodate connect the threaded spindle portability of the device when and connecting rod unassembled. Also, connection to connecting rod is longer than what is preferred to align both Bravo
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clamps.
4.5 Design Number 4
Figure 4.7. Design Number 4 After evaluating the third design, the proposed solutions were then incorporated to come up with Design Number 4. (K) Lowman clamps replaced the previous design of clamps in order to provide certainty with the clamp performance. (K) Lowman clamps has been used in the orthopaedic industry for quite some time and is already proven to hold fractured femoral bones in place while providing stability for when screwing plates or insertion
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of intermedullary nails. In order to accommodate the weight of the (K) lowman clamp, the diameter of the arm of the (C) sliding carriage was widen and a support feature was also introduced. To resolve the issue with the (B) threaded spindle, an (E) end piece was added to the device. The (E) end piece is designed to connect the connecting rod and the threaded spindle. A (D) cotter pin is used to connect and lock the end piece with the (B) threaded spindle. (I) Tightening screws were also incorporated to lock the lowman clamps to the (F) sliding sleeves that connects them to the arms of the device.
Figure 4.8. Design Number 4 Issues Bravo Jao Leocadio Tan Page 64
Issues The end piece was unstable
Proposed Solutions Weld back the end piece to the threaded spindle There is difficulty in locking the Revise the design with provision connecting lock and the for a tool to lock the components tightening screws in place in place
4.6 Design Number 5
Figure 4.9. Design Number 5
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To eliminate issues from Design Number 4, the threaded spindle and the end piece is welded back in to place to achieve the needed stability. This also worked out to the devices advantage of minimizing the number of components. The design of the heads of the (H) connecting lock and (D) tightening screws were also revised to provide ease in locking the components in place. A spanner will be provided to tighten or loosen the connecting lock and tightening screws.
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Figure 4.10. Design Number 5 Issues
Issues Lowman clamp is small and may not accommodate various femur sizes The hex nuts are difficult to loosen/tighten
Find clamp
Proposed Solutions a bigger sized Lowman
Revise hex nuts to look like the spindle nut to lessen the instrumentation by using the only the spanner for locking the whole device The design of the sliding sleeves Re-design the sliding sleeves may be a prone to mechanical without welding the two failure because it is only welded cylinders together
4.7 Design Number 6 (Final Design)

After much analysis on the last design (Design Number 5) that was tested in a mock reliability run, the proposed solutions were taken into consideration in creating a final design, Design Number 6.
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Figure 4.11. Final Design To improve the stability of the locking mechanisms of the distractor, the hex nuts were replaced by (I) sleeve tightening nuts that resembles the (A) spindle nut. With these new components incorporated, the use of a wrench was eliminated thus reducing the number of instruments needed in the operation. A spanner is provided and comes with the device is designed especially for the nuts and screws of this device. The sliding sleeves were revised to eliminate the use of welding to fuse to cylinders together. The new (F) sliding sleeves design is one solid component with two (2) cylindrical holes that serves the same functionality. Lastly, the previous lowman clamp Bravo
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was replaced with a larger lowman clamp that has a bigger grip that will accommodate various femoral sizes.
Image 1. Spanner
4.8 Summary
The design of the Universal Large Distractor was initially drafted by patterning it to the design of the AO Universal Femoral Distractor. The clamps were incorporated to replace the schanz screw that was standard in the use of that device. The clamps were integrated to address the concern of drilling into the fractured bone prior to intramedullary nailing. But provisions were made in the design so as to give the surgeon a choice between using the clamp or the schanz screw in holding the fractured bones.
Core design components include: Bravo
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Image 2. Threaded Spindle
Image 3. Sliding Carriage
Image 4. Connecting Rod
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Image 5. Clamps
Image 6. Schanz Screws (optional)
Issues were identified in the initial design and were resolved one by one thru design revisions and utilization of commercially proven medical instruments available in the market; these instruments include the Lowman clamp and the schanz screws. Overall, the Universal Large Distractor was designed to Bravo Jao Leocadio Tan Page 71

be simple mechanical device that will aid the surgeon in transforming a laborious operation into a simple procedure.
4.8 Material Selection

4.8.1 Corrosion Resistant
Stainless steel Depending on the intended use, there are several types of stainless steel recommended to be used for surgical instruments as per ASTM F899 Standard Specification for Stainless Steels for Surgical Instruments and ISO 7153/1 Instruments for Surgery Metallic Materials- Part 1:Stainless Steel. Stainless steel does not stain, corrode, or rust as easily as ordinary steel. For the purpose of this project, we considered various types of stainless steel locally available. The most common of which is Type 304. It also is one of the cheapest in the market. Type 304 is the most versatile and most widely used stainless steel, available in a wider range of products, forms and finishes than any other. It has excellent forming and welding characteristics. The balanced austenitic structure of type 304 enables it to be severely deep drawn without intermediate annealing, which has made this grade dominant in the manufacture of drawn stainless parts. Type 304 is readily brake or roll Bravo
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formed into a variety of components for applications in the industrial, architectural, and transportation fields. Grade 304 also has outstanding welding characteristics. Post-weld annealing is not required when welding thin sections. Type 304 for surgical instruments in the United States and in Europe is mostly used for non-cutting function. Examples are as follows: Retractors Cannula Clamps Forceps Holders Handles Needle vents Specula
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Key properties These properties are specified for flat rolled product (plate, sheet and coil) in ASTM A240/A240M. Similar but not necessarily identical properties are specified for other products such as pipe and bar in their respective specifications. As steel is heated above critical temperature (approx. 1335 F) it undergoes a phase change, recrystallizing as austenite. Continued heating to approx. 1450 - 1500F assures complete conversion to austenite. The high chrome and nickel content of austenitic stainless steel suppresses the transformation on cooling to a ferrite/cementite, keeping the material fully austenite, as well as rendering it essentially non-magnetic in the annealed condition. This gives austenitic stainless steels excellent cryogenic properties, good hightemperature strength and oxidation resistance. Excellent corrosion
resistance, non-magnetic properties and exceptionally high toughness at all temperatures make these steels suitable for a wide variety of applications.
4.8.2 Autoclavable
Materials to be used should be autoclavable. Stainless steel being the material used for the majority of the devices construct has no issue on this. However, since the pin adaptor will be made using a plastic material, the material used should be tested for its compatibility with this sterilization
method. Two plastic materials were tested for this function, namely, the UHMWPE and Pomalux. Both materials are implant grade materials and are already used as instrument and/or implant in orthopedics. Matrix of the materials compatibility with different sterilization methods are also already available in many references, sample of such is provided below: (table) However, for the purpose of this research, the group also had an actual testing for the two plastic materials, which are detailed in Chapter 5 and 6.
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Chapter 5 Experimental Data / Design Verification

5.1 Introduction
This chapter focuses on the experiments conducted in obtaining design verification data from the prototype fabricated after the design
conceptualization stage to achieve the teams objectives. Design verification processes ranges from as simple as literature review to actual testing. Design verification plan is detailed in the table below: N o. 1 2 3 4 Requirements / Design input It should be able to distract the fractured bone. It should be able to align the fractured bone. It should be able to be held in place by a certain locking mechanism. It should incorporate a clamp in the design, so that the surgeon would not have to drill through the bone using a pin. Cost consideration - cheaper than current distractor in market Material should be made of stainless steel. Material should be able to withstand sterilization conditions. There should be no sharp
Design Output prototype prototype prototype design / drawings
Verification Process concept testing concept testing concept testing Prototype
5 6 7
cost of prototype design / drawings material as per standard
compared to other distractor in market material used actual sterilization / literatures supporting our claim visual inspection
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edges It should have enough instrumentation to efficiently make it do its work. Corrosion resistant
totype design/drawing/pro totype prototype
actual testing
10
material used / literatures supporting our claim
5.2 Autoclave Testing

In this test, the group used the RBG Trading (formerly Orthopedic International Inc., Makati) autoclave machine and their standard parameters for sterilizing instruments. Parameter used is as follows: 1. Cycle Temperature: 270F 2. Cycle Time: 1 hour 3. Dry Time: 25 minutes The groups objective is to prove that the material (UHMWPE and Pomalux) is autoclavable. The group plans to subject the samples in ten (10) cycles using the parameters stated above until a degradation effect is observed. Once a degradation is observed, the group will discontinue the test. However if no degradation effect was observed until the 10th cycle, the group will conclude that the material is indeed compatible with autoclave.
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5.2.1 Ultra High Molecular Weight Polyethylene
Cycle No. Cycle 1
Date
Time 5mm
UHMWPE 6mm With visible degradation
Disposition
No observable defect
Discontinue Testing
5.2.2 Pomalux
Cycle No. Cycle 1 Cycle 2 Cycle 3 Cycle 4
Date
Time 5mm
Pomalux 6mm
Disposition
07/14/200 9 07/14/200 9 07/15/200 9 07/15/200 9
8:45pm
No observable defect
Continue Testing
9:45pm
6:00 am 8:00 am
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Cycle 5 Cycle 6 Cycle 7 Cycle 8 Cycle 9 Cycle 10
07/20/200 9 07/21/200 9 07/21/200 9 07/22/200 9 07/22/200 9 07/22/200 9
8:30 pm 5:00 pm 6:00 pm 5:00 am 2:00 pm 3:45 pm No observable defect Pass No observable defect Continue Testing
5.3 Concept Testing

5.3.1 Degrees of Freedom
DOF Compress (1) Inch Distract One (1) Bravo
Trial 1 One 21 turns 37
Trial 2 36 turns
Trial 3 27 turns
Trial 4 30 turns
Trial 5 30 turns
37 turns Tan Page 79
39 turns
40 turns
41 turns
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Inch Up and Down Forward Backward Side to Side Tilt Forward and backward Turn Left and and
turns P P P P P P P P P P
P P
P P
P P
P P
P P
Right (rotate)
5.3.2 Experiment #1 5.3.3 Experiment #2
5.4 Fracture Reduction

5.4.1 Test Plan
Single Rubber
Trial # 1 2 3 4 Initial Length (inch) 1.855 1.855 1.855 1.855
Elongate d Length (inch) 2.474 2.8865 2.5965 3.912
Elongati on (inch) 0.619 1.0315 0.7415 2.057
Max Force (lb) 2.607 2.654 2.963 3.202
Max Force (kg) 1.185 1.206363 636 1.346818 182 1.455454
Spring Constant (K) 1.914378 029 1.169523 642 1.816342 794 0.707561
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545 5 1.855 Average 3.3375 1.4825 1.1863 4.455 3.1762 2.025 1.443727 273
762 1.365935 919 1.394748 429
Double Rubber
Trial # 1 2 3 4 5 Initial Length (inch) 1.855 1.855 1.855 1.855 1.855 Average Elongate d Length (inch) 2.099 2.175 2.184 2.176 2.337 Elongati on (inch) 0.244 0.32 0.329 0.321 0.482 0.3392 Max Force (lb) 2.437 3.006 3.447 3.623 4.86 3.4746 Max Force (kg) 1.107727 273 1.366363 636 1.566818 182 1.646818 182 2.209090 909 1.57936 3636 Spring Constant (K) 4.539865 872 4.269886 364 4.762365 294 5.130274 71 4.583176 16 4.657113 68
Objective: Force (F) = 10 to 15kg Length of Overlap (x) = 1 to 1.5 inch F=kx Parallel:
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1 Rubber k 1.39 2.00 k 2.00
2 Rubber 4.66 4.00
3 Rubber K 6.00
4 Rubber K 8.00
5 Rubber K 10.00
keq=k1+k2+ k3+ k4 Let x = 1.5inch F = 8.00 (1.5) = 12kg
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In order to simulate the 10-15kg, the group will perform the experiment on different fractures (wood) with 1.5inch overlap and 4 rubber bands exerting force on the fracture in parallel, which theoretically will be equivalent to 12kg of force. Thirty (30) experiments will be conducted on three different types of simple fractures using two methods (pin and clamp). The summary of the experiment is as follows: Using Clamp Spiral Oblique Transverse 5 trials 5 trials 5 trials Table ___. Matrix of Experiment Plan Using Pin 5 trials 5 trials 5 trials
Figure ___. Spiral Fracture
Figure ___. Oblique Fracture
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Figure ___. Transverse Fracture
5.4.2 Using Clamp

LOWMAN CLAMP Surgeon Assistant Total Time # of times distracted # of attempts to align Was it able to distract? Was it able to align? Was it able to stabilize the fracture? Trial 1 1 1 5min 26sec 1 1 Y Y Y Trial 2 1 1 4min 40sec 1 1 Y Y Y Spiral Fracture Trial 3 Trial 4 1 1 1 1 5min 4min 10sec 34sec 1 1 Y Y Y 1 1 Y Y Y Trial 5 1 1 4min 30sec 1 1 Y Y Y
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Figure ___. Aligned Spiral Fracture Using Lowman Clamp
LOWMAN CLAMP Surgeon Assistant Total Time # of times distracted # of attempts to align Was it able to distract? Was it able to align? Was it able to stabilize the fracture?
Trial 1 1 1 4min 59sec 1 1 Y Y Y
Transverse Fracture Trial 2 Trial 3 Trial 4 1 1 1 1 1 1 4min 4min 4min 43sec 34sec 39sec 1 1 Y Y Y 1 1 Y Y Y 1 1 Y Y Y
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Figure ___. Aligned Transverse Fracture using Lowman Clamp

LOWMAN CLAMP Surgeon Assistant Total Time # of times distracted # of attempts to align Was it able to distract? Was it able to align? Was it able to stabilize the fracture? Trial 1 1 0 9min 57sec 6 6 Y Y Y Oblique Fracture Trial 2 Trial 3 Trial 4 1 1 1 1 1 1 9min 9min 8min58s 36sec 25sec ec 4 4 Y Y Y 4 4 Y Y Y 4 4 Y Y Y Trial 5 1 1 8min 33sec 3 3 Y Y Y
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Figure ___. Aligned Oblique Fracture using Lowaman Clamp
5.4.3 Using Pin

SCHANZ PIN Surgeon Assistant Total Time # of times distracted # of attempts to align Was it able to distract? Was it able to align? Was it able to stabilize the fracture? Trial 1 1 1 6min 20sec 1 1 Y Y Y Spiral Fracture Trial 2 Trial 3 Trial 4 1 1 1 0 1 1 4min 45 4min 4min sec 42sec 48sec 1 1 Y Y Y 1 1 Y Y Y 1 1 Y Y Y Trial 5 1 1 4min 46 sec 1 1 Y Y Y
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Figure ___. Aligned Spiral Fracture using Schanz Pin
SCHANZ PIN Surgeon Assistant Total Time # of times distracted # of attempts to align Was it able to distract? Was it able to align? Was it able to stabilize the fracture?
Transverse Fracture Trial 2 Trial 3 Trial 4 1 1 1 1 1 1 6min 5min 6min 3sec 51sec 27sec 2 2 Y Y Y 2 2 Y Y Y 2 3 Y Y Y
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SCHANZ PIN Surgeon Assistant Total Time # of times distracted # of attempts to align Was it able to distract? Was it able to align? Was it able to stabilize the fracture?
Oblique Fracture Trial 2 Trial 3 Trial 4 1 1 1 1 1 1 4min 5min 4min 59sec 8sec 47sec 1 1 Y Y Y 1 1 Y Y Y 1 1 Y Y Y
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5.5 Cost Optimization
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Company Kaushik Orthopedic Corporation, India

No.
Cost
Quality
1 Set ($140) + Made in India Freight Fee Fedex ($45) = $185
Canvass
Component Name
Material Cost
Labor Cost
Total
PN014 Synthes Rev.00 PN009 Rev.01
9,250php Washer
second hand unit costs US $355.51
nd
10 hand
N/A
10
Connecting Rod
208.55
450
658.55
17,775.50php
PN004 Thesis Rev.01 PN001 Rev.01 PN005 Rev.01 PN019 Rev.00 PN008 Rev.02 PN018
Threaded Spindle with End Piece Spindle Nut
2500.47
300
2800.47
23.69
450
473.69
Sliding Carriage
317.71
100
417.71
Sleeve Tightening Nut
44.14
450
494.14
Connecting Lock
12.5
450
462.5
Tightening Screw
20.84
450
470.84
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No.
Component Name
Material Cost
Labor Cost
Total
Rev.02 PN007 Rev.02 PN021 Rev.01 PN022 Rev.00 PN023 Rev.00 PN024 rev.00 PN025 rev.00 PN025 rev.00 6mm Pin Adaptor 114.53 250 364.53 6mm Schanz Pin 100 N/A 100 Spanner 104.20 250 354.2 5mm Pin Adaptor 114.53 250 364.53 5mm Schanz Pin 100 N/A 100 Lowman Clamp with Pole 4787.6 100 4887.6 Sliding Sleeve 104.67 605 709.67
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Chapter 6 Discussion of Experiment Results / Design Validation

6.1 Introduction 6.2 Analysis on Autoclave Testing
Ultra High Molecular Weight Polyethylene Pomalux
6.3 Analysis on Concept Testing

Experiment #1 Experiment #2 Degrees of Freedom
6.4 Analysis on Fracture Reduction

Fee: The basic OR fee in big private hospitals is 10k (usually for 2 hours) & addtnl 2 - 4k per hour Replaces: assistant, reduction clamp, blade handle, reduce OR time Bravo
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Significance: eases flow of surgery lower cost for patient OR time is lesser - More OR time inceases chances of morbidity - matagal nakabukas, blood loss Surgery procedure mallet old fracture resisting force is bone attached to muscle that formed over time
Old Fracture Using Clamp
Using Pin
Spiral
Transverse
Oblique
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6.5 Analysis on Cost Optimization
Chapter 7 Conclusion and Recommendations

7.1 Introduction
This chapter will summarize the study done by the group by stating its accomplishments in section 7.2. Section 7.3 will state suggestions on how the device can be improved further.
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7.2 Conclusion
The device had successfully delivered its objectives. Designing a mechanism for the distraction of the fractured bone has benefits to both the surgeon and patient. The instrument helped reduced the amount of force that the surgeon needed to exert in reducing the fracture and this in turn resulted to the reduction of cost and operating time that the patient has to pay for. The instrument is very practical and can be used by orthopedic surgeons for reducing femoral fractures. Contrary to the conventional way of reducing old femoral fractures, this device can easily and quickly reduce the old fracture.
7.3 Recommendation
Better machining capabilities such as forging A device that could help in distraction that is non-invasive or less invasive Better material such as SS LV316 or 17-4 SS Clearance for moving parts
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Chapter 8 Bibliography
[1] The history of intramedullary nailing. December 22, 2006. J. Michael Ryan Publishing Co. August 10, 2008 <http://www.highbeam.com/doc/1G1-166094 308.html>. [2] Application of the Large Distractor. 1995. AO Foundation. 2008 <http://www.aovideo.ch/published/player.aspx?id=20163eem0198>. AO Vid eo Catalog. [3] AO Surgical Reference, General Reduction Techniques; Available at http://www.ao-asif.ch/wps/portal/! Bravo
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ut/p/c1/04_SB8K8xLLM9MSSzPy8xBz9CP0os3hng7BARydDRwN39yBTAyMvLw OLUA93I4MQE6B8JJK8gUWAm4GRk6m_oUlwgJGBuwFJut3NDSyB8sYeoSGOfgY GJiYEdPt55Oem6hfkhkaUOyoqAgAvz9M7/dl2/d1/L2dJQSEvUUt3QS9ZQnB3LzZ fQzBWUUFCMUEwR0dSNTAySkowOFVIRzIwVDQ!/?contentUrl=%2fsrg %2fpopup%2ffurther_reading%2fPFxM2%2f311_1-22-Surg_redgen_red_tech.jsp&popupStyle=diagnosis&soloState=true&bone=Femur&seg ment=Shaft&BackMode=true [4] Technique of Using the AO Femoral Distractor for Femoral IM Nailing; F. Baumgaertel, C Dahlen, R. stiletto, and L. Gotzen.; J. Orthop. Trauma. Vol 8. No 4. p 315-321. [5] Femur; Available at http://en.wikipedia.org/wiki/Femur. [6] Femur Fracture; Available at http://orthopedics.about.com/od/brokenbones/a/femur.htm [7] Femur Shaft Fracture; Available at http://www.aofoundation.org/wps/portal/! ut/p/c1/04_SB8K8xLLM9MSSzPy8xBz9CP0os3hng7BARydDRwML1yBXAyMvYz 8zEwNPQwN3A6B8JJK8gUWAm4GRk6m_oUlwgBFIHr9uP4_83FT9SP0oc4Qqf28 TZ6AZnv6eLs6mxgbO5vqROanpicmVgW5EeX5joqKALLEg1M!/dl2/d1/L0lJSklna21BL0lKakFBRXlBQkVSQ0pBISEvWU ZOQTFOSTUwLTVGd0EhIS83X0MwVlFBQjFBME9LNEMwMkJJT0lEQzUzMEM3Lz FfX19fNg!!/? treatment=Operative&approach=&showPage=&bone=Femur&segment=Sh aft&qsfind=Find [8] Periosteum; Available at http://en.wikipedia.org/wiki/Periosteum [9] Open Reduction and Internal Fixation; Available at http://www.dns.amedd.army.mil/91d/docs/Ph1_Material/orif.ppt#256,1,OPEN %20REDUCTION%20AND [10] AO Surgical Reference, Reduction Forceps; Available at http://www.aoasif.ch/wps/portal/! ut/p/c1/04_SB8K8xLLM9MSSzPy8xBz9CP0os3hng7BARydDRwN39yBTAyMvLw OLUA93I4MQE6B8JJK8gUWAm4GRk6m_oUlwgJGBuwFJut3NDSyB8sYeoSGOfgY GJiYEdPt55Oem6hfkhkaUOyoqAgAvz9M7/dl2/d1/L2dJQSEvUUt3QS9ZQnB3LzZ fQzBWUUFCMUEwR0dSNTAySkowOFVIRzIwVDQ!/?contentUrl=%2fsrg %2fpopup%2ffurther_reading%2fPFxM2%2f311_233-Surg_redBravo
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other.jsp&popupStyle=diagnosis&soloState=true&bone=Femur&segment=S haft&BackMode=true#JumpLabelNr1 [11] Bone; Available at http://en.wikipedia.org/wiki/Bone [12] AO Surgical Reference, Reduction techniques - Traction or distraction; Available at http://www.ao-asif.ch/wps/portal/! ut/p/c1/04_SB8K8xLLM9MSSzPy8xBz9CP0os3hng7BARydDRwN39yBTAyMvLw OLUA93I4MQE6B8JJK8gUWAm4GRk6m_oUlwgJGBuwFJut3NDSyB8sYeoSGOfgY GJiYEdPt55Oem6hfkhkaUOyoqAgAvz9M7/dl2/d1/L2dJQSEvUUt3QS9ZQnB3LzZ fQzBWUUFCMUEwR0dSNTAySkowOFVIRzIwVDQ!/?contentUrl=%2fsrg %2fpopup%2ffurther_reading%2fPFxM2%2f311_231-Surg_redtrac_or_distrac.jsp&popupStyle=diagnosis&soloState=true&bone=Femur&se gment=Shaft&BackMode=true [13] Universal Large Distractor; Available at http://www.wheelessonline.com/ortho/universal_large_distractor [14] Varus and Valgus; Available at http://moon.ouhsc.edu/dthompso/NAMICS/valgus.htm [15] The Universal Large Distractor; Available at http://tristan.membrane.com/aona/tech/ortho/uns/uns12a.html
Images Images from google Laraib Bone Clamps; Available at http://www.laraib.com/bone_clamps.html
Appendix B Design Control Documentations

Checklist Bravo
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Summary of design inputs
Appendix C Risk Management Documentations

FMECA Prod Char Checklist of hazards
Appendix D Matrix of Interrelationship Appendix E Engineering Drawings Appendix F Surgical Technique Appendix G Bill of Materials
Raw Materials
No. PN014 Rev.00 Bravo
Componen Material t Name Washer Jao
Amo unt/i n.
Lengt Qty/ h /pc Set x1
Total Amount
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No. PN009 Rev.01
Componen Material t Name Connectin g Rod AISI 304 Round 1/2 AISI 304 Threaded Rod 5/16 AISI 304 Round 1/2 AISI 304 Threaded Rod 1/2 AISI 304 Round 11/4 AISI 304 Rod 5/16 AISI 304 Threaded Rod 5/16 AISI 304 Round 3/16 AISI 304 Round 11/4 TUBE AISI 304 Round 3/4 AISI 304 Round 1/2 AISI 304 Round 1/2 AISI 304 Rectangular x 1 ASTM F138 AISI 304 Round 3/8 ASTM F138
PN004 Rev.01
Threaded Spindle with End Piece
Amo unt/i n. 10.4 2 65.0 0 10.4 2 176. 00 23.6 9 15.7 1 65.0 0 7.86 23.6 9 22.0 7 10.4 2 10.4 2 32.7 1 n/a 12.5 0 n/a
Lengt Qty/ h /pc Set 1.3 3 3.5 x1 x1 x1
Total Amount 13.55 195.00 36.47
14 1/2 3 3.8 3
x1 x2 x1 x1 x1
2464.00 23.69 47.13 247.00 23.58
PN001 Rev.01 PN005 Rev.01
Spindle Nut Sliding Carriage
PN019 Rev.00 PN008 Rev.02 PN018 Rev.02 PN007 Rev.02 PN021 Rev.01
Sleeve Tightening Nut Connectin g Lock Tightening Screw Sliding Sleeve Lowman Clamp w/ Pole
0.5 1.2 1 1.6 n/a 7.5 n/a 0.8 10
x4 x1 x2 x2 x2 x2 x2 x2 x1
44.14 12.50 20.84 104.67 4600.00 187.50 100 114.53 104.20
PN022 Rev.00 PN023 Rev.00 PN024 rev.00 Bravo
5mm Schanz Pin 5mm Pin UHMWPE Round 71.5 Adaptor 8 Spanner AISI 304 Round 10.4 1/2 2 Jao
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No. PN025 rev.00 PN025 rev.00
Componen Material t Name
6mm ASTM F138 Schanz Pin 6mm Pin UHMWPE Round 71.5 Adaptor 8
Amo unt/i n. n/a
Lengt Qty/ h /pc Set n/a 0.8 x2 x2
Total Amount 100 114.53
Appendix H Raw Data of Experiments Appendix I List of Tables Appendix J List of Figures
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An Innovation On The Existing Universal Large Distractor

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An Innovation on the Existing Universal Large Distractor

An Innovation on the Existing Universal Large Distractor

An Innovation on the Existing Universal Large Distractor

An Innovation on the Existing Universal Large Distractor

An Innovation on the Existing Universal Large Distractor

Appendix A Definition of Terms

An Innovation on the Existing Universal Large Distractor

Medulla Reaming IM nail/rod

Orthopaedic Incision Reduction Image intensifier Posterior Anterior AO/ASIF

An Innovation on the Existing Universal Large Distractor

Sagittal Proximal Distal Intercondylar Condyle Physeal

An Innovation on the Existing Universal Large Distractor

1.2Background of the Study

An Innovation on the Existing Universal Large Distractor

An Innovation on the Existing Universal Large Distractor

An Innovation on the Existing Universal Large Distractor

An Innovation on the Existing Universal Large Distractor

1.3Statement of the problem

1.4 Significance of the Study

An Innovation on the Existing Universal Large Distractor

1.5 General Objective

1.6 Specific Objective

An Innovation on the Existing Universal Large Distractor

1.7 Scope and Limitations

An Innovation on the Existing Universal Large Distractor

mechanisms that would allow it to move in the surgeons desired position.

1.8 Conceptual Framework

An Innovation on the Existing Universal Large Distractor

An Innovation on the Existing Universal Large Distractor

An Innovation on the Existing Universal Large Distractor

An Innovation on the Existing Universal Large Distractor

An Innovation on the Existing Universal Large Distractor

Table 1.1 Timetable

An Innovation on the Existing Universal Large Distractor

Chapter 2 Review of Related Literature

2.2 The Femur

An Innovation on the Existing Universal Large Distractor

Figure 2.1 Human Femur

femur is 48 centimeters (19 in) in length

An Innovation on the Existing Universal Large Distractor

Figure 2.3 Femoral Bone Anatomy

2.3 Femur Fracture

An Innovation on the Existing Universal Large Distractor

Figure 2.4 Types of Fractures

An Innovation on the Existing Universal Large Distractor

Simple, Transverse Fracture degrees) (<30

Table 2.1 Types of Simple Fracture Bravo

An Innovation on the Existing Universal Large Distractor

Wedge, Fragmented Wedge

An Innovation on the Existing Universal Large Distractor

Complex, Complex Segmental

Complex, Complex Irregular

Table 2.2 Types of Comminuted and Wedge Fracture

An Innovation on the Existing Universal Large Distractor

2.4 Open Reduction with Internal Fixation

An Innovation on the Existing Universal Large Distractor

2.4.2 Indirect Reduction

An Innovation on the Existing Universal Large Distractor

An Innovation on the Existing Universal Large Distractor

2.5 Current Reduction Techniques Used in the Philippines

Figure 2.6 Weber Forceps

An Innovation on the Existing Universal Large Distractor

Figure 2.7 Two-Forceps Technique