Surgery – Diagnostic testing
Reexamination Certificate
1999-06-25
2001-09-11
Winakur, Eric F. (Department: 3736)
Surgery
Diagnostic testing
C128S897000, C340S573100
Reexamination Certificate
active
06287253
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention relates generally to sensing and monitoring one or more conditions related to the health of the human body, such as the development, prevention and treatment of pressure ulcers. The present invention more particularly relates to a medical sensor and a system and method of monitoring one or more pressure sensitive areas of a human body. Although aspects of the present invention have application with regard to other human body conditions, the invention will be specifically described in the context of pressure that contributes to the development of external skin ulcers (e.g., decubitus ulcers). In this context, the invention also relates to a computer-implemented pressure ulcer management method.
Pressure ulcers can develop in a person who is bedridden or confined to a wheelchair, for example. Intrinsic and extrinsic factors may be involved in the development of such pressure sores. Intrinsic factors include impaired mobility, incontinence, skin condition, nutrition, and mental status.
Exposure to pressure is one extrinsic factor. When a bony, protuberant body portion, for example, is pressed against a support such as a bed or a chair under the person's weight or part of that weight, pressure is applied to that portion; if this position is maintained, such as due to the person's immobility, this pressure can be at least one contributing factor in causing a break in the person's skin, reduced blood flow to that tissue and the loss of surface tissue and the disintegration and necrosis of epithelial tissue (i.e., an ulcer).
The scope and cost of such pressure ulcers in the United States are significant. No dollar amount is placed on the cost of human suffering from this debilitating condition.
Implementation of guidelines set forth by the Agency for Health Care Policy and Research (AHCPR) has resulted in measurable improvements in carefully monitored institutions. These studies demonstrated that with diligent nursing care, many pressure ulcers are preventable. However, with staff/patient ratios typically found in nursing homes, it may be impractical to expect all aspects of the AHCPR guidelines to be followed for all but high-risk patients. Factors found to influence pressure ulcer development in one study included: inadequate numbers of nursing staff, the use of agency personnel instead of regular staff, supply shortages, and the effects of micromanagement. The extent of this problem may grow as medical advances prolong the life expectancy of seriously ill patients and as the population over the age of
65
expands. In view of the foregoing, and as an increased number of patients are given home care, there is the need for effective and simple techniques and equipment for pressure ulcer prevention.
Various equipment has been proposed or used in trying to prevent or treat pressure sores. This equipment includes overlays, replacement mattresses, and specialty beds that attempt to reduce the amount of pressure to which tissues are exposed. These may vary in effectiveness, practicality of use, and maintenance requirements. Although pertinent to the prevention and treatment of pressure sores, this particular equipment is distinct from the sensing and monitoring equipment and methods to which the present invention is directed.
Pressure sensing and monitoring systems have been proposed in, for example, U.S. Pat. No. 4,554,930 to Kress and U.S. Pat. No. 5,253,656 to Rincoe et al. Another device, a Tekscan body pressure measurement system, monitors pressure; however, the sensor construction may lend itself to limited life because creases that may be formed in it due to a peak pressure may damage the small resistive ink sensors. Furthermore, this is a relatively complex and expensive system. Less expensive pressure analyzers have been available from Talley and Cleveland Medical Devices; however, these use air bladder sensors that have a relatively high profile not recommended for continuous pressure monitoring between a patient and an adjacent support.
Accordingly, there is still the need for novel and improved equipment and methods for sensing and monitoring one or more conditions related to the health of the human body and especially related to the development, prevention and treatment of pressure ulcers. There is the particular need for a novel and improved medical sensor and system and method of monitoring one or more pressure sensitive areas of a human body. There is also the need for a computer-implemented pressure ulcer management method. These preferably should facilitate the acquisition of pressure and time information that can be used in the prevention or treatment of pressure ulcers.
SUMMARY OF THE INVENTION
The present invention meets the aforementioned needs by providing novel and improved equipment and methods for sensing and monitoring one or more conditions related to the health of the human body and especially related to the development, prevention and treatment of pressure ulcers. The present invention particularly provides a novel and improved medical sensor and system and method of monitoring one or more pressure sensitive areas of a human body. The present invention also provides a computer-implemented pressure ulcer management method. These facilitate the acquisition of pressure and time information that can be used in the prevention or treatment of pressure ulcers.
The preferred embodiment of the present invention provides real-time monitoring of pressure status over time, whereby at-risk patients requiring immediate intervention can be quickly identified. The preferred embodiment also offers the advantage of relatively inexpensive disposable sensors that safely monitor exposure time to pressure. Although disposable, the sensors are repeatedly operable during their time of use. Such sensors provide for wireless communication so that there are no wires extending from the patients to whom the sensors are attached. The sensors are thin and flexible whereby they do not add significant profile to dressings with which they are preferably used, and they do not require additional manipulation by a care provider.
Monitoring the wireless communications from the sensors permits tracking when a patient is in a position in which pressure is applied to a pressure sensitive area. Tracking can occur from different directions since a patient might move in a variety of orientations relative to the monitoring equipment. Local warnings can be given in response to defined conditions, and data can be transferred to a central location managing a network of monitored sites. Monitoring at any one site can use a plurality of sensors, and the monitoring can be on an intelligent polling basis in which no polling occurs for sensors that are not present in a particular application.
The network can be used to provide warnings to a centralized location when defined conditions are sensed and reported, to manage overall monitored information for all patients in the network, and to monitor and record patient handling schedules, for example. This can include maintaining information about specific patient ulcer history/current status, prevention or treatment protocols used, and costs related to prevention or treatment. This can also include information about how long a patient remained in a particular condition, compliance by personnel with patient schedules, and data derived from the monitored conditions.
A medical sensor of the present invention responds to a predetermined condition, and the sensor provides wireless communication of the sensing of the condition. In one embodiment, the medical sensor comprises a substrate applicable to a human body and an electric circuit connected to the substrate. The electric circuit includes: a switch operable in a circuit operative state in response to the predetermined condition; and resonant circuit elements connected to the switch as a resonant circuit to provide a signal at a resonant frequency in response to electromagnetic induction when the switch is in the circuit operative state. Such a medical senso
Ortega Giovani M.
Sabolich John A.
Schwabe, IV George B.
Marmor II Charles
McAfee & Taft
Sabolich Research & Development
Winakur Eric F.
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