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1 Isocentric Neck Rotator for MRI and CT Appel, B.L., Huser, A.J., Karas, A.L., Nadler, D.C., Pauls, S.J., Wentland, A.L. BME 200/300 Department of Biomedical Engineering University of Wisconsin-Madison December 10, 2003 Client Victor M. Haughton, M.D., Professor Department of Radiology Advisor Robert G. Radwin, Ph.D., Professor Department of Biomedical Engineering Abstract MRI and CT can be used to study the physiology of the neck and the hemodynamic significance of cerebral spinal fluid when the neck is rotated and flexed/hyperextended. A device was needed to move the neck into known degrees of rotation and flexion/hyperextension so that scans could be repeated at a future time. Rotation must be performed about the isocentric axis. On the device, a rod is centered about the spinal axis and can move freely to provide any rotational degree. Flexion and hyperextension must be performed about the temporomandibular joint. Side supports allow for flexion about this axis. The design has been tested with a finite element analysis about the rotation pin. Currently, the device is half-finished and constructed out of PVC. 2 Table of Contents Page Abstract 1 Table of Contents 2 Problem Statement 3 Client Research 3 Background-MRI 3 Background-CT 5 Background-Anatomy 5 Current Devices 7 Literature Search 9 Design Constraints 10 Design 1—The Helmet Design 11 Design 2 12 Design 3 14 Meeting with Professors 19 Finite Element Analysis 19 Concerns 20 Future Plans 21 References 22 PDS 23 3 Problem Statement Our client needs a device that will rotate and flex/hyperextend the neck in both CT and MRI scanners. Movements must be reproducible and isocentric about the spinal column. Client Research Our client, Dr. Haughton has three main objectives/hypotheses: (1) Rotation narrows the neural foramen, which might cause compression in some patients. He plans on collecting different measurements from scans of patients in a neutral and a rotated position. (2) Flexion increases the velocity of cerebrospinal fluid (CSF) flow in the foramen magnum during the cardiac cycle. He intends on measuring CSF flow through the foramen magnum in patients with Chiari I malformation (a neuromuscular deformation). (3) With an interest in the cervical vertebrate (C1 – C5), he intends to discover how they are affected when a patient rotates and flexes/hyperextends the neck. In Dr. Haughton’s study, the ability to repeat particular positions is crucial because it creates and provides another control in the study. Furthermore, if he wants to re-image a patient he can replicate a specific position to detect a physiological change from the previous scan. Background-Magnetic Resonance Imaging Magnetic Resonance Imaging (MRI) is an extremely helpful tool in the medical industry. An MR scanner can display small differences in tissue density and it is especially advantageous over other imaging techniques because of its extraordinary ability to show contrast in soft-tissues (Figure 1). The scans (with contrast agent) are painless and have no known side effects. Commercial scanners have been utilized since the early 1980’s and can be very effective in diagnosing several different types of medical problems. MR images can be used to detect many 4 different injuries including head trauma, aneurysms, strokes, and brain tumors. The contrast agent (gadolinium) used in MRI makes the imaging technique useful in evaluating joints and other soft-tissues. Figure 1: An MRI scan of the brain (www.gemedicalsystems.com). In MRI, radio-frequency pulses are transmitted to a patient’s body, whereby protons spin and generate signals. These signals are then transformed to an image that radiologists use to diagnose the various physiological conditions mentioned above. 1.5 Tesla MR imaging utilizes a large magnet to produce a magnetic field 15,000 times the strength of the earth’s field. A consequence of this fact is that ferromagnetic materials—cobalt, iron, and nickel—cannot be placed in or near the MRI scanner. If inside of the scan’s field of view, a non-ferromagnetic metal can cause a susceptibility artifact, a blurred and distorted appearance over a region of interest. However, non-ferromagnetic metals can be used if they are outside of the field of view. Scans typically range from one to ten minutes in duration, but could last as long as twenty minutes for fMRI. The patient must lie totally still during the entire scan and must be able to relax. This is extremely important since any movement by the patient could cause the image to be distorted. 5 Background Information on Computed Tomography Computed Tomography (CT) allows physicians to obtain high-quality cross-sectional images of structures within the body. CT images are put together from a large number of small cross-sectional x-ray measurements that are taken from the patient. Adding these cross-sectional views together allows for imaging in three dimensions. CT scans can take approximately one half hour to one and a half hours for a specific part of the body. The accuracy of this type of imaging is dependent on total immobilization of the patient. The scans can be used for various situations and on various parts of the body. CT scans may be used for analysis of head trauma, spine structure, tumor sites, osteoporoses, or specific anatomy. Scans can also be used to assist in the guidance or placement of instruments or treatments. Patients must have no metallic material on them while having a CT scan because it can interfere with the image clarity. There are low risks involved in CT scans. The worst possible adverse affect usually comes from iodic material injected into the patient to help with picture contrast. There is also minimal radiation exposure during these procedures. Background Information on Anatomy, Basic Biomechanics, and Range of Motion of the Head and Neck The skull and spine are two of the most important protective bone structures of the human body. The skull protects the brain, and the spine protects thirty-one pairs of nerve roots, which branch out of the neural foramen and run throughout the body. The neck consists of intricate vertebrae that have articulations, which are called amphiarthrodial joints. These joints allow movement in three different planes. The overall structure of the spine allows for a large variety of movements. Two of the most important joints are found in the neck where the spinal column joins with the head. The atlantooccipital joint is between the first cervical vertebra (the 6 atlas) and the occipital bone of the head. This joint allows for movements of the head in the sagittal plane (flexion and hyperextension) and the frontal plane (lateral bending) (Nordin, 1999). The first 10º-15º of flexion occurs at this joint, but further flexion occurs in all cervical vertebrae (Banna, 1985). The atlantoaxial joint is between the atlas and the odontoid process of the head and allows the head to rotate in the transverse plane (Nordin, 1999). The first 40º-50º of head rotation occur at this joint while further rotation takes place in the facet joints in the lower cervical spine (Banna, 1985). The movements of the neck are controlled and coordinated by a large, complex group of muscles that are beyond the scope of this background information. It is important to note that there is considerable variation between people in their neck’s range of motion (Hay, 1988). Figure 2. Head and neck model: (A) Neutral position (B) Full extension (C) Full rotation (Vasavada, 1998). The vertebrae of the cervical spine contain large openings in the bone called foramina. These allow passage of arteries, nerve roots, and the spinal cord. These spaces will shift and change when the neck is moved into different positions. The goal of this project was to create a device that could allow doctors to investigate the changes in these spaces by allowing the head to be supported in a variety of different positions during an MR or a CT scan. Our device should 7 confine the neck and head to a specific movement at a time. This includes isocentric rotation about the spinal axis and flexion/hyperextension about the coronal plane (Figure 2). Current Devices Used and the Need for a Device to Rotate the Head and Neck Accurately and Efficiently in MR and CT Imaging Currently there are two head cradles in use in MR and CT imaging machines (Figure 3). Both head cradles are designed solely for the purpose of supporting the head of the patient. Neither cradle restricts movement of the neck about any axis. Although our proposed device would allow for movement, it will lock in place for the scanning procedure and diminish patient movement. Figure 3: The current head cradle used in MRI. The patient lays on his/her back and simply rests the head on the cradle. This cradle does not allow for rotation of the neck in any direction. Currently there are no head cradle designs that provide for rotation and flexion/hyperextension. However, there are designs for other parts of the body that have a similar application relative to the site on the body in which they are used. One such design was created by a biomedical engineering group in the spring of 2001 at the University of Wisconsin – Madison. Their goal was to design a device that would create graded pelvic rotation about an 8 axis passing through the spine (Asti, 2001). Their solution was to place rollers on the MRI and CT stretchers. A backboard rests superjacent to these rollers and rocks back and forth to achieve pelvic rotation in the desired direction (Figure 4, 5). Although this device is not in direct competition with our potential design, it is important to note that there are other devices which have been developed with similar applications focused on different parts of the body. Figure 4. End view of the device designed to create graded pelvic rotations. The rollers underneath the bench are unidirectional and are responsible for rotation (Asti, 2001). Figure 5. Final drawing of the pelvic rotation device previously designed (Asti, 2001). A device to accurately and efficiently lock the head and neck into various positions, other than the comfortable straight resting position, could prove very useful in helping to explain physiological changes that occur during motion. Changing the position of the head and neck would allow for comparisons of spinal anatomy during those movements. Our client, Dr. Victor 9 Haughton, plans to use a head and neck rotation device in order to research physiological changes that occur both during flexion/hyperextension of the neck and during isocentric rotation about the spinal axis. Although the interest in building a head and neck rotation device is rooted in Dr. Haughton’s research, such a device, if built, could have a much broader range of use. According to our client, the full advantages of using such a device have not been realized partially because such a device does not currently exist. A head and neck rotation device for use in MR and CT imaging could eventually help radiologists to diagnose patients that have undergone serious trauma, or even those with unusual neck pains that otherwise go undiagnosed. Much more research on such a device is needed before the potential uses can be completely realized. Our client envisions this device as something that could be used daily in a large hospital setting. Literature Search A great amount of research was conducted in order to understand the operating environment of the device. Using Chiu’s work Clinical Computed Tomography for the Technologist (Chiu, 1995) and Hashemi’s work MRI: The Basics (Hashemi, 1997), our team began to understand the limitations that these radiographic techniques impose on engineering design. To understand the osteological and muscular significance in rotation and flexion/hyperextension, we consulted Gray’s anatomy (Gray, 1977). Through a series of visits to UW-Madison’s Waisman Center and UW Hospital, we were able to measure and sketch the components of the CT and MRI machines. Additionally, we consulted a CT technician, who explained the effects of metals and how patients are brought into the scanner. 10 We consulted the US Patent and Trademark Office to find devices that pertained to our design (U.S. Patent and Trademark Office, 2003). However, there were no devices that were able to perform either rotation or flexion/hyperextension. General Electric Medical Systems had two different designs for head and neck supports, but none of these designs had the ability to rotate. Design Constraints The design must allow rotation to the left and right approximately 45° as well as flexion and hyperextension approximately 25° about the mandible. The axis of rotation must be in line with the spinal axis of the patient. A technician must manually move the neck to the desired degree of movement. The device should be situated to this position, stable enough to prevent deflections and small shifts that could affect reproducible positions. Movement should be continuous and isolable at any position. The device will be used more often in the CT scanner because of its ability to image bone. However, the device should also fit in an MRI machine. The design must accommodate for the MRI flex coil, which fits underneath the head and neck. This flex coil should be as close to the head as possible, allowing for the clearest possible picture. The further away the coil is from the region being scanned, the more unclear the image turns out. Safety is an important factor to consider in this design. The safety of the technicians as well as the safety and comfort of the patients is essential. The device must be lightweight and portable so that technicians can easily attach and detach it from the stretcher. The structure will accommodate all types of patients, regardless of size or physical ailments. Additionally, the device should not enclose the head, because many patients suffer from claustrophobia. 11 The materials in this design are extremely important. Because of the large magnetic field of the MRI machine, the design cannot contain ferromagnetic materials. Because X-rays are used in CT, radiolucent materials are essential about the region of interest. Plastics, such as polyvinyl chloride (PVC), are ideal. Design One – The Helmet Design Rotation The Helmet Design uses a rotating locking hinge (Figure 6A) for rotation about the spinal axis. It rotates about the hinge in the back, which is approximated to be the spinal axis of the patient lying within the head cradle. This is the only portion of the design that supports the head cradle. Flexion/hyperextension The first design uses a telescoping joint (Figure 6B) for flexion/hyperextension about the coronal axis. Since the head cradle is elevated by the locking hinge, it has the capacity to angle up and down. B A Figure 6. The Helmet Design. This design uses two very different methods of rotation. A. A rotating locking joint. B. A telescoping joint. 12 Advantages The design makes use of the basic head cradle design currently used for CT scanners. The Helmet Design rests on the table making it easily compatible with both MR and CT scanners. This design has the advantage that both methods of achieving rotation are very different from each other. This makes rotations about the separate axes completely independent of each other. That is, rotation around one axis can be locked while the head cradle is free to move about the other. The use of the single pin attachment to the head cradle allows for the fixing of rotation about the spinal axis. The proposed locking mechanisms allow for the head to be locked at almost any angle. Disadvantages One disadvantage of the Helmet Design is that the two methods of rotation make the design complicated. Since the head cradle is slightly elevated, patients may need to be propped up to straighten the spine. This adjustment is necessary for the patient’s comfort and for achieving a baseline for cervical physiology. Additionally, there is no mechanism to fix the rotation about the coronal axis. The telescoping joint doesn’t necessarily rotate about the coronal axis, but raises and lowers the head. This would provide some physiological changes, but not the desired positions. This design was used as a building block from which the other design alternatives were constructed. Design Two Rotation Attached to the axle is a U-shaped bar (Figure 7) that is as wide as the slit-to-slit distance on the bed and projects outwards towards the patient’s mandible. This U-shaped bar houses the 13 head cradle. About the axle, the U, and therefore, the head cradle, rotates to the desired angle. A clamping mechanism incorporated into the tower can maintain this angle and the angle can be read by markings on the back of the tower. When switching to flexion/hyperextension, this clamping mechanism can be locked down to the original neutral, isocentric position. Figure 7. Design 2. The head cradle is held by a U-shaped bar that is attached by a pin to a tower in the back of the structure. Flexion/hyperextension Near the mandible and about the temporomandibular joint for flexion/hyperextension, pins from the U-shaped bar attach to the head cradle (these are the only two locations that the Ushaped bar is attached to the head cradle). About these pins, technologists can angle the head cradle and lock the location in a fashion similar to the rotation axle (therefore, these pins are locked during rotation). Again, markings indicate the angle that the head cradle is tipped. Miscellany There is a single tower near the top of the patient’s head and this piece is supported by the base that runs a distance along the slits of the stretcher (the base’s latching mechanism being compatible for both the CT and MRI stretchers). This tower has a series of pin holes where a 14 single axle can be adjusted to a patient’s head. Ideally, this adjustment would align the vertebral column and maintain a neutral position prior to any rotation or flexion/hyperextension. Advantages This design can provide for free rotation about a single isocentric axis. Additionally, this design can provide greater degrees of flexion and hyperextension when compared to the helmet design. Disadvantages However, there are quite a few flaws with this design. The adjusting rotation axel has a limited amount of positions it can adjust to. This feature is merely as good as the number of axel points, which in turn, is controlled by the diameter of the pin. There is a severe tradeoff between this diameter and the number of holes in the tower. While a smaller diameter allows for a greater number of holes and a greater number of positions for the U and head cradle, a smaller diameter is far less stable than a thicker one. Hence, another flaw in this design is the great amount of stress placed on the single pin near the top of the head. This location maintains the weight of the patient’s head and of the entire structure. Additionally, the point of flexion/hyperextension is constant. This isolation vastly underestimates the different sizes inherent in the population. Without tailoring to each patient’s unique point of flexion/hyperextension, the neck may experience variable changes in physiology unrelated to isocentric movements. Design Three The third design (Figure 8) was developed by combining ideas from each of the other two designs. Pin joints were used for rotary motion. Clamping mechanisms were used to isolate various positions. 15 Figure 8. The third design. The third design can flex/hyperextend about the temporomandibular joint and rotate about the isocentric axis of the spine. Rotation The third design consists of a pin-supported head cradle much like those of the two earlier designs. The pin located at the back of the head cradle serves to set the spinal axis about which the head can rotate. By manually rotating about this pin, continuous isocentric movement can be achieved. Any position can be stabilized by a clamp in the back, which depends on friction between the pin and U-shaped bar. A scale around the rear pin can indicate the degree of rotation. The pin has a notch that can line up with the scale. Therefore, when the head cradle is rotated, the pin’s notch will rotate and indicate the angle on the scale. The scale will be critical in isolating different angles of rotation. These positions can be repeated in future scans, increasing the accuracy of rescanned positions. In other words, by specifying the position on the scale where a scan was first performed, a technician can easily repeat this position in a future scan. Flexion/hyperextension 16 Like the helmet design, design three has a mechanism for rotation about the temporomandibular joint for flexion and hyperextension. The U-shaped bar is supported by the rear arm and two side supports (Figure 9). Pins from opposite sides of the U-shaped bar rest in slits of parallel side supports. Since these pins freely rotate, they allow continuous motion for flexion and hyperextension. By manually raising or lowering the entire U-shaped bar by sliding the pins in the slits of the side supports (Figure 9), the height of the head cradle can be adjusted for differently-sized patients. A scale on one of the side supports can measure the degree of flexion or hyperextension. With a notch in the U-shaped bar, the degree of movement can be annotated by following this notch on the scale. Figure 9. Side support of the third design. Adjusting the pins into different notches can move the U-shaped bar, and therefore, the head cradle, to different heights. Miscellany After consulting our client, the head cradle was reduced in size as compared to the helmet design. By reducing this size, a patient’s head can move more freely because the top of the head 17 cradle cannot hit the U-shaped bar as readily as the previous designs. Like the helmet design, the head cradle still incorporates padding for patients’ comfort. Another important aspect of the design is the base. This base must attach to both the MRI and CT stretchers, which are not the same size. The MRI stretcher measures 39.5 cm in width and the CT stretcher measures 42.0 cm in width. The most important aspect of the base is that it keeps all three of the side supports in the same plane. The bottom edge of the base is slightly curved to accommodate the different curvatures of the stretchers. A B Figure 10. A. The back pin of the third design pushed nearly all the way back. B. The back pin of the third design pushed nearly all the way forward. These adjustments can align a patient’s head so that the temporomandibular joint is centered for flexion and hyperextension. The ability to accommodate varying sizes of patients’ heads is very important, especially since the spinal axis can vary from person to person. Design three compensates for these variations by adjusting for head lengths and elevations. As previously mentioned, the side supports can be adjusted to different levels, allowing for different elevations of the head (Figure 9). These adjustments are necessary for patients with varying shoulder sizes. For example, a large person would have a spinal axis at a higher elevation from the stretcher than a small person. Furthermore, patients’ heads are of varying lengths. The pin at the back of the head cradle not 18 only serves to rotate the head cradle, but also to move the head cradle closer to or farther from the U-shaped bar in order to properly align the axis of rotation about the temporomandibular joint (Figure 10). Advantages As was described, design three provides for continuous rotation and flexion/hyperextension. Design three can accommodate many different patients by adjusting the position and height of the head cradle. The device is simple to use with clamps and screws readily accessible to a technician, given that the stretcher is extraneous of the scanner’s bore. These clamps and screws can be hand-tightened, allowing for quick and easy adjustments of various positions. Disadvantages To provide for free rotation, the head cradle is supported by a single pin. However, the materials are great enough to compensate for some of the stress on the back pin. Additionally, near the front of the head cradle where the neck would be, a flex coil (MRI only) and padding could support and counterbalance more of the stress. Disregarding these counterbalances, a finite element analysis was performed to ensure the viability of this design. The degrees of hyperextension are limited because the device cannot angle lower than the plane of the stretcher. It is possible to extend the structure off of the CT stretcher, but there is no room to do this in an MRI machine. Our Chosen Design Since design three was conceived by taking into account the flaws of the first two designs, we chose design three as the final design. It satisfied the client’s requirements and was 19 compatible with both MRI and CT scanners. Although the mechanism for attaching to the stretchers still needs to be determined, the design shows great potential for its intended use. Meetings with Professors The team members consulted Professor Frank J. Fronczak in refining joint designs. Professor Fronczak advised that the design was unstable because the structure was supported by only the side supports. He recommended that a back support could compensate for this instability. Professor Tim A. Osswald recommended performing a finite element analysis on the design to determine whether the material could support the load being applied. Professor Kim J. Manner identified the area (rear axle) under the greatest amount of stress and suggested that a finite element analysis be performed about this point. Finite Element Analysis The part of the design that will be under the most stress is the pin, from the clamp up to the back of the head cradle. To ensure that the pin would adequately support the head cradle without failure and with minimal deflection, a finite element analysis was performed on this specific part. The analysis was done with a solid mesh, 8998 elements, and 17114 nodes. The pin was restrained in all directions with no translation (immovable) where the clamp would be affixed (given at 2 inches from the head cradle). A distributed load of eight pounds was applied to the head cradle normal to the surface. A von Mises stress analysis was calculated and diagrammed (Figure 11). The majority of the stress was concentrated in the pin between the clamp and the head cradle. The minimum factor of safety was calculated to be nineteen. This is a more than suitable factor of safety for the given application of the device. 20 Figure 11. Finite element analysis of the rear pin of the head cradle. In a von Mises stress analysis, the pin can hold a minimum safety factor of nineteen. Concerns Since scans can last up to several hours long, a patient lying on the neck rotator may grow uncomfortable. Because our device is made of PVC and lends no comfort to the system, we rely on the multitude of padding already available to CT and MRI technicians. Additionally, padding can compensate for misalignment of the isocentric axis of rotation. The weakest point of the design is the area around the axle of rotation. In addition to supporting the majority of the structure’s weight and the average head weight of eight pounds, this pin should ideally withstand a minimum safety factor of two (roughly thirty pounds). Indeed, according to our finite element analysis, this point supports a minimum safety factor of nineteen. 21 Future Plans Given our temporal and monetary constraints, our device is considerably stable. For further development, we would continue to research different types of radiolucent materials to make certain that we have found the strongest, most pliable, and most economical material(s) for use in building the entire device. We would continue to run finite point analyses with different materials until we determined which one was the best. Since aluminum is a non-ferromagnetic material, we could look into incorporating aluminum pins and testing whether blurring and susceptibility artifacts will obscure the region of interest in the field of view. Aluminum pins would last considerably longer than plastic axles. Upon completion of the material testing, we would further develop quality clamps that would maintain the desired positions. This stability is very important for the design because it ensures the reproducibility of exact head and neck positions. The degree of reproducibility has extremely important implications when considering the need for accurate results in our client’s research. The ability to prevent the device from moving during use is also important in attaining accurate results for our client’s study. Further work should be done to develop a method to maintain the stability and position of the device on the stretcher during scanning procedures. One solution to this problem would be to fasten the device to the table. Finally we would test the product in the hospital environment. Ideally, the device could be tested on men and women in a range of ages to ensure the reproducibility, comfort, and stability of the device. These tests should be performed in both the MRI and CT scanners. 22 References Asti, B. “Insert for an MRI Gantry that Provides Graded Rotation of the Spine’s Lumbar Vertebrae.” University of Wisconsin-Madison Biomedical Engineering Design Courses – Spring 2001 Archives. 2001. Banna, Mohamed. 1985. Clinical Radiology of the Spine and the Spinal Cord. Aspen Systems Corporation, Rockville, Maryland. Chiu, L.C., Lipcamon, J.D., Yiu-Chui, V.S. 1995. Clinical Computed Tomography for the Technologist. 2nd Edition. Raven Press, New York. Gray, H. 1977. Anatomy. Random House, New York. Hashemi, R.H., Bradley, W.G. 1997. MRI: The Basics. Williams & Wilkins, Baltimore, MA. Hay, J.G., Reid, J.G. 1988. Anatomy, Mechanics, and Human Motion. 2nd Edition. Prentice Hall, Englewood Cliffs, NJ. Nordin, M., Ozkaya, N. 1999. Fundamentals of Biomechanics: Equilibrium, Motion, and Deformation. Springer-Verlag New York, Inc. U.S. Patent and Trademark Office. “Patent full-text and full-page image database.” 2003. Accessed September 28, 2003. URL: http://www.uspto.gov/patft/ Vasavada, A.N., Siping, L., Delp, S.L. “Influence of Muscle Morphometry and Moment Arms on the Moment-Generating Capacity of Human Neck Muscles.” Spine 23(4): 412-422, 1998. 23 PDS: v. 3.0 Date: December 5, 2003 Title: Neck Rotator Group Members: Betsy Appel Aaron Huser Anna Karas Dana Nadler Steve Pauls Andrew Wentland Problem Statement: Our client needs a device that will rotate and flex/hyperextend the neck in both CT and MRI scanners. Movements must be reproducible and isocentric about the spinal column. Client Requirements: A device with the ability to rotate the neck The ability to flex and hyperextend the neck Compatible with CT and MRI scanners Reproducible positions of rotation and flexion/hyperextension Able to secure the head in place Radiolucent/non-ferromagnetic materials Relatively light and portable Aesthetically pleasing Design Requirements 1. Physical and Operational Characteristics a. Performance requirements: This device needs to function in both a CT and MRI scanner. Specifically, the scanner models are a GE Lightspeed CT scanner and a GE Signa 1.5 T MRI scanner. The head support must allow isocentric spinal motion, including manual rotation of 24 the head and flexion/hyperextension of the neck. The device should attach to the stretcher of both machines. The size of the device cannot exceed the size of the opening in the CT or MRI bore and an MRI flex coil must fit underneath the head cradle. The support must hold the neck and spine stable and not inflict any more pain or anxiousness. It must be stable enough to be used daily by technicians. b. Safety: For the safety of technicians using the neck rotator, it must be lightweight and easily movable to prevent long-term injury. The device must lock at the rotated/hyperextended position to provide the necessary stability to the neck and spine of the patients. c. Accuracy and Reliability: The degree of motion must be known. This position can be in actual degrees or based on a relative numbering system (to repeat the position in the future). Therefore, technicians and doctors can replicate an image by knowing the exact position the scan was taken in. d. Life in Service: The device must endure a daily usage (four or more hours per day) for twenty years. e. Shelf Life: The device should last approximately twenty or more years in a clinical atmosphere. f. Operating Environment: The device will remain indoors under a medical/clinical atmosphere (STP). A minimal amount of heat will be sent into the neck rotator from the frequent cessations of the MRI’s RF pulses. X-rays will also be transmitted through it. Since patients will be lying on it, any bacteria or fluids generated by them will also get onto the device. g. Ergonomics: In the extreme case, the neck rotator should support kyphotic patients. Let us say that the average patient is 75 kg, or 165 lb. Also, let’s assume that 60% of the body weight is in the torso, which is unsupported lumbarly, and that the average moment arm for the center of mass of the torso is 0.28 m above the waist. This generates a moment arm of 25 124 Nm that must be rigidly supported by the hinge joints. All screws should circumvolve smoothly. h. Size: 1. CT: -The neck rotator must fit within the CT’s bore, measuring 67 cm in diameter. -To latch onto the stretcher, the neck rotator should attach to the 42 cm between the two slits (on the stretcher). -The current neck piece has a tongue that locks into the bottom of the stretcher. This tongue measures 17.7 cm in width and 13.5 cm in length. Our device should be similar to this, if appropriate and not considering the extra length needed for kyphotic patients. 2. MRI: -If the neck rotator attached to the stretcher, it must fit onto the 39.5 cm gap between the slits. -Our device should not measure more than 50 cm in length, as is the length of the current head cradle. i. Weight: Primarily, CT and MRI technicians will be lifting the neck rotator throughout the day. Therefore, the device should weigh thirty pounds or less, but ideally the mass of an MRI head coil (approximately 10-15 lbs). j. Materials: The device should not contain ferromagnetic materials. The device will contain PVC for its radiolucency and stability. k. Aesthetics, Appearance, and Finish: The device should be off-white or black to match the color of the CT and MRI scanners. It should also accommodate an attachment for padding, which will support the patient’s neck. 2. Production Characteristics a. Quantity: One main unit with the ability to move in rotation and flexion/hyperextension b. Target Product Cost: 26 PVC Type I Rectangular Bar: 1” Thick, 2” Width: $12.48 PVC Type I Square Bar: 1.5” Square, 5’ Length: $33.90 Clear PVC Type I Rod: ¾” Diameter, 5’ Length: $11.15 PVC Type I Sheet: 1” Thick, 12” x 12”: $23.23 8 nylon 3/8”x2” bolts: $0.60/bolt 8 nylon 3/8” nuts: $0.15/nut 8 nylon 3/8” washers: $0.07/washer 2 PVC 1”x12” long pipes: $2.99/pipe PVC primer and glue: $13.69 4 industrial strength 3”x3” square Velcro sheets: $4.99/pack Total Cost: $126.95 3. Miscellaneous a. Standards and Specifications: None yet, but possibly some health code issues, e.g. the device cannot absorb liquids or bacteria. b. Customer: The customer prefers to use the CT scanner with his patients. Since we are detecting physiological changes in the neck, radiologists must have the ability to see the bones and spinal column. Because the bones do not have hydrogen, they are missing in MRI images. Therefore, our project should conform to CT before MRI. c. Patient-related concerns: There are two main patient concerns. The first is that patients can become claustrophobic while being scanned. Therefore, the design should take into account that a patient may not want his/her face covered in any way. The second concern is comfort. The design should include a pad so a patient can rest his/her head comfortably. d. Competition: There is no competition for a mechanistic way of rotating the head in MRI and CT scanners. However, another design team created a device with a similar application, but it was used to rotate the lower back instead of the head and neck.