1. EXECUTIVE SUMMARY Success or failure in the medical industry begins with a diagnosis.

This fact is well known and revered by clinicians, therapists, and health care providers. However, despite this insight, inadequate diagnostic equipment persists. As a result, more than 40% of patients suffer through misdiagnosis, insurance companies are often speculative of treatment strategies, and therapists and clinicians have no way of communicating their concerns.1 Annually, over 18 million Americans will visit a physicians office for knee injuries.2 Patients are then given any one of several treatment strategies, depending on the diagnosis. The one unifying theme for over 50% of such patients is that treatment concludes with rehabilitation or physical therapy.2 During this time, joint flexion is one of the primary means of measuring patient progress. Physical therapists currently rely on a manual means of measuring degree of flexion known as a goniometer. By measuring the angle of intersection between two thin plastic arms, this gold standard is cheap method of measuring static values. However such a device is highly inaccurate for diagnostic purposes in situations outside of static range of motion. To improve upon this diagnostic process, we have designed a portable device capable of performing this measurement in a dynamic environment. The lightweight device will be worn by patients and will provide a visual output of angle of knee flexion. Currently, as competing products sell for anywhere from $2,000 - $3,000, the industry has grown to become a $2B market. However, our product is unique in the manner that it enables the patient, as well as the therapist, to actively monitor the degree of joint movement during treatment and daily activities without limiting range of motion or inducing fatigue. The system will improve upon current diagnostic strategies as well as allow for improved communication between patient and therapist. As a result of such benefits, the product will be a desirable tool for both therapists and health care providers to improve the quality of patient care.

2. PRODUCT SUMMARY The process of diagnosing and monitoring knee injuries has been left behind in the rapid advancement of medical technology. Manual goniometers are often an inaccurate means of diagnosing and monitoring progress towards recovery and only provide measurements while the joint is stationary. This intermittent, static measurement leaves much to be desired. Joint mobility is a transient motion and must be measured as such to provide an accurate means of monitoring flexion. Therefore, therapists are provided with mere glimpses of the joints true range of motion. Patients have no means of monitoring their own progress to prevent further injury. As a cumulative result, patients often re-injure the joint, are misdiagnosed, or are discharged inappropriately. Refining treatment strategies would benefit both health care providers and patients by reducing misdiagnoses, while improving recovery rates and overall quality of care.
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New England Journal of Medicine American Association of Orthopaedic Surgeons

As can be seen in the Gantt chart in Figure 1, a great deal of progress has been made towards significant market impact of the device. In four months time, the brace has been taken from initial concept to a prototype stage.

Figure 1: Group Progress Gantt Chart

Beginning in September 2004, the initial design was conceptualized through 3D-CAD rendering using SolidWorks (Figure 2). The device monitored rotation using a potentiometer and included compartments for circuitry as well as a battery pack, while maintaining minimum weight and area requirements of the desired final product.

Figure 2: Solidworks Model of Device

Following further analysis of the circuitry layout and ergonomics, a redesign was performed to produce prototype 2, the SmartBrace (Figure 3). Currently, the design mimics the function of a simple goniometer. Two arms are fixed at a central point coinciding with the axis of rotation. When worn, this axis will be aligned with the medial-lateral axis of the knee. As the knee undergoes flexion and extension, the device will follow a matching path.

4 in.

1 in. Figure 3: Solidworks model of Prototype 2: top of the device (left) showing dimensions and angled view to show contour (right).

The angle measurement will be performed using a rotary potentiometer centered at the axis of rotation. The potentiometer will send a scaled voltage proportional to the angle of rotation to the PIC. Using the PIC to perform an 8-bit analog to digital conversion, the signal will be processed and sent to an external LCD. The final output of the system will be a real-time representation of the inner knee angle in degrees with an accuracy of one degree. With a design focused on portability, most of the structural components had to be designed specifically for this application. Unique components of the device include the plastic housing and the power source. Components like the PIC microprocessor (PIC 16C745, Microchip) and the rotary potentiometer, can be purchased through a supplier. To function, the PIC requires a voltage of 5V 5%. This is accomplished through the use of a custom battery pack created from CR2302 lithium coin batteries. By following a 2x2 configuration, a battery pack rated at 6V at 1100 mAH is all that is necessary for the device to function continuously for over 24 hours. Weighing less than 40 grams combined, the electronic components follow the guidelines for portability. Another important aspect of the design is the alignment of the device with respect to the knee. This is accomplished through the use of a soft brace. These braces are typically used for secondary knee support, providing protection without imposing a hard limit to the joint. The current design utilizes a medium-stiffness commercially- available brace to act as a fixation point for the device itself. The advantages of using a soft brace rather than a structured or supportive knee brace are appropriate for the overall device design. Weight is kept to a minimum, joint movement is not significantly altered, and the separation between brace and device allows for the use of different size soft braces with one model of the goniometer, which therefore reduces overall cost.

Specific constraints were applied to the design of the device itself. The first and most important requirement was the devices range of motion must agree with the anthropometric range of motion of the knee. By allowing for 180 degrees of free rotation, from approximately 10 degrees hyperextension to 170 degress flexion, the device accomplishes this goal. The second requirement was accuracy. The specification required 1 degree of accuracy, which was exceeded by two orders of magnitude utilizing the current rotary potentiometer. The third requirement was an extended life cycle. A replaceable soft brace, an efficient ball bearing to serve as the connection between the two arms, and a rotary potentiometer rated to greater than one million revolutions all help to prolong its use. Currently, the only wear component that significantly impacts product use is the battery pack, which only provides 24 hours of continual usage. Overall, final product development status is divided into three components: structural, electronic, and alignment. The structural element of the design is approximately 85% complete. A prototype has been successfully produced and the only remaining variables are the final device appearance and material selection for the arms. The electronic element of the device is approximately 75% complete. Schematics for this are complete, and a prototype circuit has been assembled. The circuit only requires a more accurate potentiometer (only available in bulk quantities) and being miniaturized on a PIC board for the final product. The alignment element of the design is also near completion at 75%. While the brace has been fixed to a readily available soft knee brace for prototype purposes, production of a soft brace with pockets already in place will be necessary for consumer distribution. Functionality testing with the current prototype produced positive results. The desired potentiometer was not readily available in small quantities; therefore some variability in the LCD read out occurred during high rates of motion. Additionally, segments of the LCD were periodically dropped. However, the device successfully measured angles when static and at slow rates of joint rotation (Figure 4).

Figure 4: Analysis of accuracy of prototype angle measurement

Also due to the utilization of potentiometer not design for the specific processor being used, measurements were only possible from 5 90 degrees (Figure 5). However, linearity was observed in the 5 90 degree range (Figure 6). Therefore, such complications do not lie in the circuit analysis and will be corrected with implementation of a more suitable potentiometer.
Smart Brace Voltage
100
100

Linear Trend Line of Smart Brace Voltage

(Angle > 5o)

90
90

80
80

Angle (Degrees)

70 60 50 40 30 20 10 0 0 0.5 1 1.5 2 2.5 3 3.5 4 4.5 5

Angle (Degrees)

70 60 50 40 30 20 10 0 0 0.5 1 1.5 2 2.5 3 3.5 4 4.5 5

y = 27.907x - 27.379 R2 = 0.9709

Voltage (Volts)

Voltage (Volts)

Figure 5: Graphical representation of Smart Brace Voltage.

Figure 6: Graphical Representation of Linear Trendline of Smart Brace voltage (Angle > 5)

While development continues, the issue of regulation and intellectual property will also dealt with. As of December, 2004 there are no U.S. patents applied for or granted that apply directly to the device. Some existing patents apply directly to the mechanism of measurement we plan to employ, however they do so in a static or fixed manner (USP 5,263,492, 6,413,190, and 6,428,490)3. The closest patent is USP 5,754,121 Joint Monitor3, which applies the same concepts behind the current device design. It includes a portable option as well as the incorporation of a few of our future goals. However, application and implementation differ enough to allow both ideas to co-exist and retain a healthy market share.

3. MARKET ANALYSIS Over 18 million visits are made annually to doctors for the treatment of knee related injuries in the United States. Of these patients, approximately 54 percent require some form of physical therapy or rehabilitation.2 This gives a vast potential user basis of nearly 10 million patients. It is understood that a new device would not be sold for each patient as the device would be reusable and applicable to several patients during its lifetime. Given that the average healing time for a moderate knee injury is 6 8 weeks, and each device will monitor one patient during the course of his or her rehabilitation, each device could be utilized in the treatment of approximately 8 patients per year. 2 above2 Considering the nearly 10 million patients being treated with physical therapy each year in the US, the potential of selling over one million devices annually to physical therapy centers is reasonable.

United States Patent and Trademark Office http://www.uspto.gov/patft/

During preliminary interviews, physical therapists at the University of Pittsburgh Medical Center (UPMC) have expressed interest in the device as a means to replace conventional goniometers. The portability, dynamic measurement ability and direct feedback of the device are all highly desired features. Additionally, with conventional equipment, more than 40% of patients suffering from such injuries are misdiagnosed. Such misdiagnoses only serve to increase the health care providers expenditures as it may lead to malpractice lawsuits or inadequate periods of rehabilitation. Therefore, health care providers may not only support the product as a means to more accurately monitor rehabilitation progress and increase the quality of patient care, but also as a means of decreasing the cost associated with misdiagnoses. The proposed design would attempt to break in on a potential $2B market created by the competing devices. Such devices include the SG150 Twin-Axis goniometer from Biometrics4, LTD and the MLTS700 joint angle sensor from ADInstruments5 (Figure 7), both which employ fiberoptic angle measurent.

Figure 7: Competing products: Biometrics (left) and ADInstruments (right)

Through novel design technology and an emphasis upon portability, our product should capitalize on a large share of the proposed market by reducing the cost while offering the increased patient mobility only a stand alone system could provide.

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http://www.biometricsltd.com/gonio.htm http://www.adinstruments.com