Surgery – Diagnostic testing – Measuring anatomical characteristic or force applied to or...
Reexamination Certificate
2000-06-15
2002-08-20
Shaver, Kevin (Department: 3736)
Surgery
Diagnostic testing
Measuring anatomical characteristic or force applied to or...
C482S001000
Reexamination Certificate
active
06436058
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates in general to orthopedic rehabilitation devices, and in particular, to a system and method for implementing rehabilitation protocols for such devices.
2. Description of the Related Art
It is widely known that injuries to bones, muscle tissue, connective tissue, and the like, often heal faster, stronger, and more predictably with physical therapy. For a patient needing physical therapy, a clinician typically prescribes a rehabilitation protocol, or exercise regimen, specifically designed for that patient. The rehabilitation protocol often includes a wide number of differing exercises depending upon the type of injury and patient progression with rehabilitation. In addition, the rehabilitation protocol generally includes specific recommendations for each exercise. For example, each exercise may differ in its recommended number of repetitions, sets, motions, duration, resistance, frequency, and the like. In performing the rehabilitation protocol, the patient has to remember which exercises were prescribed by a clinician, how to perform those exercises, and of those exercises, which parameter recommendations were provided. Moreover, the patient has to record or remember his or her success and progression for each exercise such that the clinician can accurately analyze the patient's progress.
However, patients often provide inaccurate data regarding their performance of rehabilitation protocols. Such inaccuracies come from a wide number of possible sources. For example, a patient often does not follow a particular protocol because of pain, lack of motivation, misunderstanding, or simply forgetting some or all of the parameters and instructions associated with each exercise. For these and other reasons, the patient may keep inaccurate data for a given exercise. On the other hand, the patient may keep accurate or inaccurate data of an exercise performed improperly, or even keep no data at all. In each of the foregoing situations, a clinician may be placed in the position of modifying a rehabilitation protocol based on inaccurate patient data. By relying on inaccurate data, the clinician may exacerbate the patient's condition, and thereby potentially harm the patient's rehabilitation progress.
Therefore, a need exists to develop a system that allows clinicians to prescribe rehabilitation protocols, that motivates and instructs patients in how to follow the protocols, that tracks the patients' progress through the protocols, and that accurately reports the data back to the clinicians.
One system attempting to meet the foregoing need is disclosed in U.S. Pat. No. 5,823,975, issued to Stark et al. (the “Stark reference”). The Stark reference discloses a monitoring system for an orthopedic brace. The Stark system includes a monitoring device, clinician software, and a brace having a hinge with an incrementally adjustable lock. The brace includes an angle sensor for detecting an angle between components of the hinge. The brace also includes a load sensor for detecting a load on the brace. The angle sensor and the load sensor communicate with the monitoring device such that the monitoring device records data from the brace. The monitoring device also communicates with the clinician software such that the recorded data is uploaded to the clinician software and protocol parameters are downloaded to the monitoring device.
Using the Stark system, a clinician downloads preferably his or her recommended exercise parameters into the monitoring device. The patient views instructions relating to recommended exercises, performs the recommended exercises, and the monitoring device records data from the sensors relating to the performance. Later, the recorded data is uploaded to the clinician software for analysis by the clinician.
Thus, the Stark system provides the brace, the monitoring device, and the clinician software, which enable clinicians to prescribe and receive data regarding patient rehabilitation protocols. However, the Stark system suffers from a variety of drawbacks causing the components individually, and the Stark system as a whole, to be inefficient and cumbersome.
For example, the Stark system fails to incorporate visual indicia on the brace representing differing configurations of the brace. Rather, the Stark system relies entirely on the monitoring device to provide feedback to the patient as to the recommended lock angle for the brace. For example, when the patient is to lock the brace at a twenty-degree angle, the patient moves the brace until the monitoring device confirms the brace is configured to twenty-degrees. The patient then locks the brace at that configuration. Such reliance on the monitoring device is problematic for several reasons. On one hand, the angle sensor on the brace may be miscalibrated, thereby causing the patient following the monitoring device to exceed the prescribed range of motion. In addition, the patient must redirect the focus of their attention from the monitoring device to the brace in order to lock the brace at the correct angle. Such action again may cause the patient to set the brace at angles differing from those prescribed.
The Stark brace also fails to provide limit stops for limiting the available range of motion in the brace. Rather, the Stark brace either locks at a particular setting, or is free to move through the entire range of motion provided by the brace. Moreover, the Stark system fails to recommend resistance types or amounts, thereby forcing the clinician to prescribe portions of the rehabilitation protocol outside the system, or to simply leave such decisions to patient guesswork. Also, the Stark system fails to provide a protocol review mode, thereby limiting the clinician in their ability to quickly determine or review which of potentially many protocols is loaded on a given monitoring device.
Moreover, the Stark system includes a very limited and absolute rehabilitation protocol. For example, the Stark system includes only a few transducer-oriented exercises focusing on loads and positions. In addition, for each of those exercises, the Stark system employs absolute load and position parameters. Such absolute parameters are generally overly limiting and often counterproductive. For example, an absolute parameter generally pushes patients to reach the parameter from the very beginning. Therefore, in order to ensure safe operation, the clinician will be inclined to set very low initial exercise parameters, and then reset those parameters based on each patient's progression. Such resetting may require frequent patient visits and/or monitoring device uploads and data analysis. In addition, if the clinician wrongly estimates a patient's abilities or injury, the initial low parameters may induce the patient to become unmotivated based on early goal attainment or abysmal failure.
Also, the Stark system is inefficient in the manner it gathers and stores data, thereby requiring the monitoring device to include large and often expensive data storage capabilities. For example, the Stark system stores real-time data from the sensor at a given sample rate. Such sampled data consists of many data points. Storage of many data points dictates either large storage capacity needs on the Stark monitoring device or frequent data uploads to the clinician software. In addition, the Stark sampled data points also dictate sophisticated clinician software to map the data points to timing graphs and sophisticated clinician analysis to track patient progress. Based on the above, the Stark system stores inefficient data, some of which may not be intuitive or even analyzable to ordinary physical therapists. Such storage dictates expensive storage capacity or frequent uploads. In addition, such storage may limit the clinician's ability to delegate patient progress monitoring.
Based on the above, a need exists to provide a system for implementing rehabilitation protocols that is flexible, comprehensive, and efficient.
SUMMARY OF THE INVENTION
Ther
Bastyr Charles A.
Krahner Angela M.
Pflaster Daniel S.
Rowland Marjorie Ann
DJ Orthopedics, LLC
Knobbe, Martens Olson, and Bear, LLP.
Shaver Kevin
Wingood Pamela
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