This application is a non-provisional conversion of the provisional patent application previously filed with USPTO: Application No. 60/583,544, USPTO Filing Date Jun. 29, 2004, Confirmation No. 4399, under the same title.
This invention relates to the field of physical medicine, rehabilitation and biomedical engineering describing the method and apparatus for automated monitoring and tracking of the trajectory of body movements in mobility-impaired patients, tracking the stability of mentally-unstable or intoxicated individuals, tracking the course of therapy, and as an aid for physical and mental training; and more specifically for prevention of pressure ulcers in mobility-impaired patients, and quantitative analysis of the degree of stability in able-bodied individuals.
The invention also has numerous other applications in non-medical fields such as sobriety testing, sports training, etc.
Around ten thousand cases are added each year to an estimated quarter to a half million individuals living with Spinal Cord Injury (SCI) or Spinal Dysfunction in the US, according to the National Spinal Cord Injury Association Resource Center[1,2]. The major causes of these are motor vehicle accidents, acts of violence, falls, and sports injuries. Damage caused by acute SCI—namely, contusion (bruising) or transection (tearing) of the spinal cord—can result in decreased (or complete disappearance of) movement, sensation, and body organ function below the level of the injury.
While SCI is a common cause of permanent disability, other causes include sudden afflictions such as stroke[3,4] (relatively common), as well as debilitating progressive diseases such as multiple sclerosis[5]. Regrettably (and recently high-profile), “man-made” causes also exist, including combat wounds suffered by military personnel[6].
Physically disabled wheelchair-bound individuals (such as paraplegic and quadriplegic people) as well as bed-bound patients such as stroke patients are prone to developing pressure-induced ulcers commonly known as decubitus ulcers—or in common parlance, bedsores[7,8,9]. Since stricken individuals in the population of interest lack the required sensory system in addition to motor abilities, they must rely on trained health care professionals or others to be moved and repositioned from time to time (every one to three hours) in order to prevent the occurrence of bedsores.
It is to be emphasized that bedsores are not to be dismissed trivially. They are akin to burns, and if not properly attended to, can progress to the point of causing severe infection and become life-threatening. If unchecked, the tissue destruction can lead to the necessity of amputation in advanced stages. Clearly, bedsores are a serious matter.
As bedsores are as old as medical care itself, naturally a variety of palliative and ameliorative treatments have been developed and are available on the market, in both conventional and alternative arenas[10,11]. However, nowhere has the homily “prevention is better than cure” been more true than in the case of bedsores[12]. Perhaps the most compelling argument for prevention is the fact that the occurrence of bedsores is viewed (with just cause) as being caused by negligence of the care provider, and prone to trigger hue and cry, and in extreme cases, lawsuits.
Examination of prior art reveals while there is no dearth of proposed means to prevent the occurrence of bedsores[13-21], not all have been implemented as commercially available products due to practical or cost considerations. Special mattresses and wheelchair cushions are on the market[22-24], and while these claim to providing relief; none of these is an effective substitute for a ministering attendant, and/or are very expensive. Pressure mapping systems that utilize multitude of pressure/force sensors pads are commercially available[25], but this technology is too expensive because of the number to independent sensors (and corresponding wiring) that would be needed to accurately map the pressure areas. Additionally, they do not have the intelligent algorithm for tracing the history of the patients' movements.
This approach is analogous to using a high resolution digital camera to locate the positioned an object instead of employing a few (3 or more) IR optical sensors and a triangulation algorithm.
In an NIH funded research grant[26], M. FRIEDMAN proposes to develop wireless wearable monitors to measure and record the average positions over the course of a day and range of motion of the thigh of nursing home residents who are at risk for developing pressure ulcers. The system records the events when the patient is moved voluntarily or by the attendant. Their main research focus is to use their motion sensor and wireless transmitter to determine if variations in the timeliness of scheduled repositioning (turning in bed and restraint release from chairs) correlates with variations in pressure ulcer prevention effectiveness.
In 2003, an American Paraplegia Society paper[2] suggested using the GPS (Global Positioning System) to determine if the individual has been motionless for a predetermined period of time. This approach is complex and has numerous disadvantages such as restrictions in the GPS signal reach within the buildings, spatial resolution of coordinates extracted from GPS signals, etc. To overcome some of these limitations, the authors proposed using DGPS (Differential GPS) with indoor transmitters, which adds to the complexity of the system. It is not self contained and relies on other sources.
We do not aim to replace the attendant, whom we regard as being vital to the care function for a mobility-impaired individual. We propose an inexpensive device and method for the prevention of bedsore injuries, which can regulate the intervention of the attendant, making it “interrupt-driven” and therefore freeing the attendant to perform other tasks without fear of overlooking the needed intervention. In addition to helping the conscientious attendant perform his/her duties more efficiently, this approach also identifies negligence, which is unfortunately casting an increasing aspersion on the health care industry today.
The principle of operation of the device is to characterize and monitor motion of the individual, and through the imposition of the movement thresholds, trigger events that correspond to the attainment of the necessary motion (required frequency and spatial extent) to prevent bedsores.
As another aspect and application, this invention enables the attendant to monitor stability in mentally-impaired and or intoxicated individuals by tracking the trajectory of their center of gravity during standing. This is helpful in the evaluating the degree of mental awareness and quantizing the course of treatment or therapy. The system may also be use to determine the degree of soberness in intoxicated individual. In this application, the apparatus may be used as alcohol consumption detection device that can more accurately determine the degree intoxication than the customary breathalyzer device currently used by law enforcement that simply measures the percentage of blood alcohol level. In this application, our invention may save thousands of deaths in traffic accidents alone.
The apparatus in this invention also has many applications in physical and occupational therapy and mental training (biofeedback), in sports and athletic training, sports paraphernalia design, etc.
According to the principles of the present invention, an apparatus and the associated method provided that performs real-time monitoring and tracking of the dynamics of the center of pressure (which is equivalent to the projection of the center of gravity) on a platform upon which the individual is supported. This method is self-contained and does not require external signal sources or triangulation techniques for position monitoring. In one physical embodiment, the purpose is to determine when repositioning is needed, with the objective of alerting a healthcare attendant, locally or remotely through wired or wireless means. The alert status is maintained until the patient is repositioned adequately. Because the system decides on the time interval between repositionings as well as the extent of repositioning, the need for a skilled nurse is reduced or eliminated, allowing the health care task to be adequately performed by a person with no special skills or training, such as a family member of the patient. Last but not least, the system lends itself readily to telemedicine applications such as remote monitoring over the telephone network or the Internet, if desired.
The principal objective of this embodiment of our invention is to provide a lack-of-movement alarm for bedsore prevention for wheelchair bound, bed ridden and other immobile patients. However the device can be used for collateral applications such as rehabilitation and physical therapy of recovering stroke patients, patients recovering from hip and knee surgery, etc. The same hardware infrastructure lends itself quite naturally, with the appropriate software, to manifest a balance training function that could be part and parcel of a physical therapy program. Lastly, it may be coupled with actuators to automatically reposition the patient when necessary, significantly reducing the physical burden on the attendant and making his job that much easier. As another embodiment this application the system allows monitoring the required repositioning of bed-ridden patients such as stoke patients.
In another embodiment, this invention enables the attendant to monitor stability in mentally-impaired and/or intoxicated individuals by tracking the trajectory of their center of gravity while standing. This is helpful in the evaluating the degree of mental awareness and quantizing the course of treatment or therapy. The system may also be used to determine the degree of sobriety of a potentially intoxicated individual. In this application, the apparatus may be used to as alcohol consumption detection device that can more accurately determine the degree intoxication the customary breathalyzer device currently used by law enforcement that simply measures the percentage of blood alcohol level. In this application, our invention may save thousands of deaths in traffic accidents alone.
In yet another embodiment, the system described by the present invention may be incorporated in the driver's seat or the back of the driver's seat of the deriver in motor vehicles and be trained to alert the driver if he/she dozes off during driving. In similar embodiment, the system may be used to quantitatively analyze the results of crash test in automobiles by analyzing the magnitude and the center of the forces exerted by the would-be driver.
Other embodiments are possible for other useful applications. Some typical applications are briefly listed below:
The apparatus in this invention also has many applications in physical and occupational therapy and mental training (biofeedback), in sports and athletic training, sports paraphernalia design, etc.
The system has significant other applications and markets outside of healthcare and law enforcement, such as in sports (e.g., golf swing training, baseball batting practice), gymnastics, yoga, dance/ballet, and a host of other areas.
A more complete understanding of the present invention may be obtained from consideration of the following detailed description of the invention in conjunction with the drawing, with like elements referenced with like references, in which:
(Cross sectional View).
A more complete understanding of the present invention can be obtained in view detailed description of the illustrative figures.
System Overview
Accordingly,
Basic Principle
The basic principle of the system is to rely on the motion of the center of gravity (COG) of a patient as an indicator of body movement. This principle has been exploited in earlier work by one of the inventors in the study of human gaits at the Ohio State University's Human gait Laboratory[28].
The success of the method is predicated on being able to distinguish legitimate motion from “false positive” indications. An immediately apparent issue is that lateral translation (with no change in the pressure points) can potentially masquerade as a valid repositioning. To avoid this problem, the motion-detection algorithms process higher-order moments in addition to the basic COG calculation so that simple lateral motions can be distinguished from proper repositioning or rolling of the patient.
The hardware infrastructure of the system consists of a few (three or more) sensors that can be an integral part of the bed or chair (i.e., embedded in the legs), or part of a removable unit useable with existing beds or chairs. Without losing the essence of the argument, we will present our discussion in the context of the removable unit, which we will call the COG (for “Center of Gravity”) plate.
COG Plate
A COG Plate consisting of three or more force sensors sandwiched between two rigid plates is schematically depicted in
Processor and Algorithm
The electrical output of each pressure sensor is fed to an electronic processing module, where it is amplified, conditioned, and digitized. The electronic module communicates the digitized information over a network (which could be wired or wireless) to a PC or processor, which uses the information to determine the COG (and higher-order moments relative to a fixed origin) of the load atop the plate assembly at fixed time intervals. The successive values of the calculated parameters are recorded in memory for analysis of the movement of the load, as well as for archiving the trajectories for later review, if necessary.
Finally, the processor runs an algorithm that operates on the motion data to realize the key function of our proposed system—the effective assessment of adequate position shift of the load, or lack thereof.
COG Calculation
In bed and wheelchair applications, the COG is the same as the Center Of Pressure (COP). In
Forces F1, F2 are measured by the two force sensors. Assuming that the plate is rigid, the location of COP in Y direction can be calculated from basic physics as follows:
Y=W*F2/(F1+F2) and total weight, FR=F1+F2.
This computation may be easily extended to two dimensions as shown in
In a manner similar to the previous one-dimension calculations, the X and Y coordinates of the COP can be found as follows:
FR=F1+F2+F3+F4
X*FR=L*(F3+F4)
Y*FR=W*(F2+F3)
Thus,
Output
If the forces are sampled at a fixed intervals of time T, then the trajectory (motion) of the center of pressure, COP, can be tracked displayed as a function of time X(t) and Y(t) as shown in
The graph shows a possible trajectory of COP as a function of time for a normal person: X(t), Y(t). The dashed (or red) circle (centered around instantaneous COP of a patient) shows a possible limit for normal motion. The solid (or green) circle (centered around instantaneous COP of a patient) shows a possible threshold for minimum motion. The minimum (solid or green shape) threshold would be used to detect absence of motion (to indicate a need for repositioning of a paralyzed patient, for example) while the maximum (dashed or red shape) threshold would be used to indicate excessive motion (such as a subject unable to maintain his balance during a sobriety test).
Higher-order moments, as well as the velocity and acceleration of the COP motion are also useful in analyzing the trajectory behavior. Slow, steady motion and rapid, jerky motion would be readily distinguishable using these higher-order moments.
Applications
The primary proposed application is in the field of healthcare, and will typically involve a person of limited mobility who is either bedridden or wheelchair-bound. The system has also other medical and none medical applications some of which are described herein.
As mentioned earlier, the sensors could (instead of being sandwiched between plates) be integrated into the legs of the bed or the frame of the wheelchair.
In the above, we presented a conceptual view of our method and devices to utilize COG monitoring and output to computer algorithms which determine whether it is necessary to issue an alert to reposition a mobility-impaired individual.
For DWI applications, law enforcement officers may use a COG plate apparatus to assess a driver's fitness to operate a motor vehicle in a manner which provides quantitative data which can be used in court.
As stated earlier, other embodiments of this system have many applications in physical and occupational therapy, gait training, mental training (biofeedback), sports and athletic training, (e.g., golf swing training, baseball batting practice), gymnastics, yoga, dance/ballet, sports paraphernalia design, and a host of other areas, etc.
It will be understood that the particular embodiments described above are only illustrative of the principles of the present invention, and that various modifications could be made by those skilled in the art without departing from the spirit and scope of the present invention. For example, the present invention may be advantageously used with other types of medical disability monitoring, therapy and training. For example for mentally-impaired children's gait training or stability training. Accordingly, the scope of the present invention is not limited only by the specifications listed above.
References cited: