Patent Publication Number: US-2009234262-A1

Title: Health Monitoring and Management System

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     This application claims benefit of U.S. Provisional Patent App. No. 61/036,122, filed Mar. 13, 2008, which application is incorporated by reference herein in its entirety. 
    
    
     FIELD OF THE INVENTION 
     The present invention relates to a health monitoring and management system. Such a health monitoring and management system may be useful for automatic monitoring of changes in a patient&#39;s condition and providing real-time interventions in response to those changes. 
     BACKGROUND OF THE INVENTION 
     The velocity of blood flow is an important indicator of vascular efficiency. The velocity of arterial blood flow serves as an indicator of the efficiency of nutrient and oxygen delivery, and the velocity of venous blood flow serves as an indicator of the efficiency of waste removal. A decrease in the velocity of blood flow, particularly in venous blood flow, can increase the potential for formation of dangerous blood clots and lower leg swelling, which can lead to certain vascular pathologies. Compressive pressure applied on and/or near an area of lower leg swelling and/or decreased venous blood flow can improve blood flow and decrease the risk of resulting complications. 
     Such compressive pressure applied with a compression garment can be static compression or dynamic compression. In conventional compression garments, static compression can be provided by a single layer fabric or multiple layer fabrics that are designed to provide a single, constant level of compressive pressure on an anatomical structure, such as a leg. Such static compression garments can have disadvantages. For example, the amount of compressive pressure provided in static compression systems may vary over time due to yarn fatigue (which can cause stretched yarn) and swelling of the anatomical structure being compressed. 
     Some conventional dynamic compression devices can apply variable pressures at different locations on an anatomical structure. These dynamic compression devices often make use of pneumatically controlled compression bladders. Dynamic compression devices can also have disadvantages. For example, dynamic compression devices are often found to be uncomfortable due to quick changes in the amount of compressive pressure being delivered. In addition, pneumatic compression bladders require pumps, which can make the devices bulky, noisy, and require an external source of energy to operate. As a result, such dynamic compression devices may not be suitable for wearing by a patient. A further disadvantage of some conventional pump and sleeve compression devices is that they control compression levels based on patient status information that is old (or lags from real time) and/or without direct patent status data. 
     Thus, there is a need for a health monitoring and management system that can provide monitoring of health indicators and dynamic management of therapeutic interventions in response to the monitored health indicators in real time. There is a need for such a system that is easily wearable. There is a need for such a system that can operate wirelessly. 
     SUMMARY 
     Some embodiments of the present invention can include a health monitoring and management device, system, and/or method. In some embodiments, the health monitoring and management system can include a sensor adapted to detect changes in one or more health indicators and transmit data related to the health indicators. The system can further include an interventional element adapted to receive a health intervention command and provide a health intervention related to the health indicators. In some embodiments, the system can further include a microprocessor adapted to receive and analyze the health indicator data transmitted by the sensor, formulate the health intervention command related to the health indicator data according to pre-determined parameters, and transmit the health intervention command to the interventional element. 
     Certain embodiments of the health monitoring and management system can further include a plurality of sensors, each sensor adapted to detect changes in a different one of the health indicators. Such an embodiment can further include a plurality of interventional elements, each interventional element adapted to provide a different health intervention related to one of the different health indicators. In some embodiments, the health intervention command can be transmitted to the interventional element within a clinically relevant time period. In certain embodiments, the pre-determined parameters comprise a control algorithm configured to automatically control formulation of the health intervention command and transmission of the command to the interventional element. 
     In some embodiments of the health monitoring and management system, the sensor can be attachable to, or integrated with, a garment. In certain embodiments, the microprocessor can be attached to, or integrated with, a garment. In some embodiments, the system can further include a computer, and the health indicator data detected by the sensor can be transmitted from the microprocessor to the computer. The computer can be adapted to receive and analyze the health indicator data transmitted by the microprocessor, formulate the health intervention command related to the health indicator data according to pre-determined parameters, and transmit the health intervention command to the interventional element. In particular embodiments, at least the sensor, the microprocessor, and the interventional element can communicate with each other wirelessly. 
     In certain embodiments, the system can further include a capability to learn patterns in an individual&#39;s health indicators monitored over time, predict health interventions based on those patterns, and formulate intervention commands based on those predictions in response to subsequent changes in the individual&#39;s health indicators. In certain embodiments, the system can further include a computer database in which the health indicator data for a plurality of persons is stored and analyzed, whereby intervention commands based on collective data in the database are determined for health indicators subsequently monitored in individuals. 
     In some embodiments, the sensor can comprise an electrical, mechanical, ultrasonic, acoustic, optical, or tactile sensor, or combination thereof. In some embodiments, the sensor can be adapted to detect changes in a person&#39;s body movements. 
     In an illustrative embodiment, the system can include an adjustable compressive pressure garment, and the health intervention comprises adjustment of the compressive pressure in the garment. Such an embodiment including an adjustable compressive pressure garment can include a first sensor comprising a blood flow sensing system and second sensor comprising an edema sensing system. The interventional element can comprise an air pump connected to a pneumatic compression stocking, and the health intervention can comprise adjustment by the air pump to the amount of air in the compression stocking related to the level of edema and blood flow detected. 
     Some embodiments can comprise a health monitoring system that includes a sensor adapted to detect changes in one or more health indicators and transmit data related to the health indicators, and a microprocessor adapted to receive, store, and transmit the health indicator data transmitted by the sensor. 
     In some embodiments, a health monitoring and management method can include detecting changes in one or more health indicators, and transmitting data related to the health indicators to a microprocessor, where the health indicator data can be analyzed. A health intervention command can be formulated related to the health indicator data according to pre-determined parameters, and the health intervention command can be transmitted to an interventional element. In certain embodiments of a method of health monitoring and management, the health intervention command can be transmitted to the interventional element within a clinically relevant time period related to the health indicators. In particular embodiments of such a method, the health intervention command can be automatically formulated according to pre-determined parameters and the intervention command transmitted to the interventional element by utilizing a control algorithm. 
     Features of a health monitoring and management device, system, and/or method may be accomplished singularly, or in combination, in one or more of the embodiments of the present invention. As will be realized by those of skill in the art, many different embodiments of a health monitoring and management device, system, and/or method are possible. Additional uses, advantages, and features of aspects of the present invention are set forth in the illustrative embodiments discussed in the detailed description herein and will become more apparent to those skilled in the art upon examination of the following. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a view of a health monitoring and management system in an embodiment of the present invention. 
         FIG. 2  is a diagrammatic illustration of a health monitoring and management system in another embodiment of the present invention. 
         FIG. 3  is blood flow velocity sensing system in an embodiment of the present invention. 
         FIG. 4  is an edema sensing system in an embodiment of the present invention. 
     
    
    
     DETAILED DESCRIPTION 
     Some embodiments of the present invention can provide a health monitoring and management device, system, and/or method.  FIGS. 1-4  illustrate various aspects of embodiments of such a health monitoring and management device, system, and/or method. 
     Some embodiments of the health monitoring and management system  10  can include one or more sensors  20  capable of monitoring external and/or internal conditions of a patient so as to detect changes in those conditions. In certain embodiments, a “sensor”  20  can be defined as having capability of monitoring and transmitting health indicator information. A sensor  20  can be adapted to detect some change in one or more health indicators. Health indicators include, for example, skin temperature, muscle activity, body motion, parameters related to musculoskeletal tissues, nerve conduction, blood flow, cardiac conductivity, cardiac output, respiratory activity, arterial and/or venous oxygenation levels, blood values such as blood chemistries, and the girth of a portion of an anatomical part (as an indicator of the volume of that anatomical part), among others. 
     Some embodiments can include both (a) sensor(s)  20  capable of monitoring and transmitting health indicator information and (b) interventional element(s)  30  capable of receiving health management intervention commands and providing intervention(s) related to those commands. 
     Some embodiments of the health monitoring and management system  10  can include a plurality of sensors  20 . In this way, various combinations of health indicators can be monitored, and if desired, interventions related to the monitored indicators performed, in a single device and/or system. As a result of monitoring multiple health indicators simultaneously, the status of multiple body systems in a patient can be evaluated together. Accordingly, a more comprehensive view of a patient&#39;s overall clinical status can be ascertained, thereby allowing more accurately targeted interventions. The system  10  comprising a plurality of sensors  20  and interventional capabilities can thus have much greater functionality, efficiency, and efficacy than a conventional monitoring system in which a single health indicator is monitored. 
     The sensors  20  can be different types of sensors, including, for example, ultrasonic, acoustic, optical, and/or electrical sensors  20  to monitor different types of health indicator information. Any type of sensor  20  suitable for monitoring health indicators, or medical parameters, in a patient can be adapted for use in certain embodiments of the present invention. Such sensors  20  can utilize a sensing mechanism that monitors patient conditions in a non-invasive manner. For example, in certain embodiments, the sensor  20  can be configured to detect changes in a health indicator by contact with a patient&#39;s skin. In other embodiments, the sensor  20  can utilize one or more probes that can be placed in an internal body location for detecting changes in a health indicator. 
     The health monitoring and management system  10  can include various embodiments of a sensor  20 , each sensor  20  configured to monitor a particular health indicator, for example, pulse rate or blood flow or another health indicator. In some embodiments, the sensor  20  can be adapted to monitor multiple health indicators. For example, an ultrasound sensor  20  that can typically be used to monitor blood flow may be adapted to also monitor bone density. Ultrasound waves impinging on bone produce a different and distinct wave shape, or signature, than the wave shape signature produced from ultrasound waves impinging on blood vessels. Thus, a single ultrasound sensor  20  can be adapted to monitor both blood flow and bone density. 
     Some embodiments of the health monitoring and management system  10  can include sensors  20  having the capability of monitoring a person&#39;s health status indicators, such as physiological measures, and/or behaviors over various periods of time. For example, the system  10  can be configured to monitor a person&#39;s exercise levels and patterns, as well as physiological responses to those behaviors, over a relatively short period of time, such as during a workout period. For instance, such a system  10  may be utilized to monitor whether an athlete is training at an optimal level, at a sub-optimal level, or is overtraining. Alternatively, or in addition, the system  10  can be configured to monitor a person&#39;s activities and physiological responses to those activities over a relatively long period of time, such as over several weeks of therapy. In this way, such a system  10  can monitor, record, analyze, and use information related to a person&#39;s activities and changes in health status indicators over time, including patterns of both health deterioration and health improvement. 
     Some embodiments of the health monitoring and management system  10  can include sensors  20  having the capability of monitoring a particular health indicator within pre-set ranges. For example, for tachycardic patients, the sensor  20  may be set to monitor only pulse rates above 100 beats per minute, and for bradycardic patients, the sensor  20  may be set to monitor only pulse rates below 60 beats per minute. Alternatively, a pulse rate sensor  20  may be set to monitor pulse rates either below 60 beats per minute, above 100 beats per minute, or both below 60 beats per minute and above 100 beats per minute. A sensor  20  for one health indicator can monitor that indicator at different intervals or within different ranges than a sensor  20  for a different health indicator. As an example, a sensor  20  configured to monitor pulse rate may be pre-set to measure pulse on a continuous basis, whereas a sensor  20  configured to monitor skin temperature may be pre-set to measure skin temperature only once every hour. 
     The combination of sensors  20  utilized for individual patients can be customized. For example, a particular patient may need sensors  20  to monitor both cardiac conductivity and oxygenation levels. The suite of sensors  20  incorporated into the health monitoring and management system  10  for that patient can include cardiac conductivity and oxygenation sensors  20 , and may or may not include other sensors  20 . For another patient who may need to have respiratory activity and body motion monitored, the suite of sensors  20  incorporated into the health monitoring and management system  10  for that patient can include those sensors  20  for respiratory activity and body motion, and may or may not include other sensors  20 . 
     The design of a particular embodiment of the sensor  20  depends on the health indicator it is intended to monitor. Various embodiments of sensors  20  can utilize combinations of electrical, mechanical, acoustic, tactile, and/or other sensing mechanisms to monitor the intended health indicator. For example, one embodiment of the sensor  20  can include electrical components and may be configured to detect, for example, a change in flow of electrical current between two locations on a patient&#39;s body. Another embodiment of the sensor  20  can include mechanical components and may be configured to detect, for example, a change in movement of the patient. Another embodiment of the sensor  20  can include an ultrasound detection mechanism and may be configured to detect, for example, blood flow. Certain embodiments of an ultrasound sensor  20  can provide the advantage of monitoring vascular blood flow while a person is moving around, whereas conventional monitoring devices, such as an ultrasonic Doppler device require a person to remain still during monitoring. In some embodiments of the system  10 , two or more of various types of sensing mechanisms can be utilized. 
     The sensor  20  preferably comprises a sensing capability that is sufficiently sensitive to detect desired changes in the particular health indicator it is monitoring. As examples, a blood flow sensor  20  can have a sensitivity appropriate to detect clinically important increments of change in blood flow, such as in volume of flow in a pre-set time; an oxygenation sensor  20  can have a sensitivity appropriate to detect change in percentage of blood oxygen saturation; and a temperature sensor  20  can have a sensitivity to detect a change in each tenth of a degree of temperature. Other sensors  20  can have a sensitivity appropriate to detect clinically important increments of change in the health indicator being monitored. In certain embodiments, the sensitivity of the sensor  20  can be adjusted, depending on desired thresholds or ranges for measurements for the particular health indicator(s). Desired thresholds or ranges for measurements of a particular health indicator can vary depending on the clinical status of a particular patient and the data needed to determine optimal interventions. 
     In some embodiments, the sensor  20  may include a display mechanism (not shown) to display changes in the health indicator data being monitored. As an example, the sensor  20  may include a light emitting diode (LED) display that changes in illumination intensity, frequency of blinking, color, or some other indication correlating to a change in health indicator being monitored. To illustrate, a pulse rate sensor  20  having an LED indicator can begin to blink when the patient&#39;s pulse exceeds a pre-set threshold, such as 100 beats per minute. As the patient&#39;s pulse rate continues to increase above 100 beats per minute, the LED indicator can blink at an increasingly faster rate. Likewise, when the patient&#39;s pulse decreases, the LED indicator can blink at a progressively slower rate. Such a visual display can provide the patient and/or another observer such as a caretaker with immediate qualitative feedback regarding the patient&#39;s pulse rate. In certain embodiments, the sensor  20  can include other types of visual indicators of changes in health indicator(s) being monitored. For example, in certain embodiments of the health monitoring and management system  10 , the sensor(s)  20  can display the actual data being collected, such as pulse rate, skin temperature, or other health indicator. 
     In some embodiments, raw health indicator data collected by the sensor(s)  20  can be transmitted to a microcontroller, or microprocessor,  40  which can organize the data in one or more ways. For example, in one exemplary embodiment, one sensor  20  may collect data indicating the intensity of body motion at specific times. Another sensor  20  may collect data indicating pulse rate at specific times, and yet another sensor  20  can collect data indicating respiratory rate at specific times. From data collected by the sensor(s)  20 , the microprocessor  40  may relate changes in pulse rate and/or respiratory rate to the intensity of body motion over a period of time. The related data can be sorted in an organized manner, for example, into a cardiovascular response index. In another embodiment, one sensor  20  may collect data indicating blood flow, for example, in a patient&#39;s leg. Another sensor  20  may collect data indicating a change in volume, or edema, in the leg. The microprocessor  40  may relate the raw blood flow data and leg volume data in an organized manner to provide a peripheral blood flow index. 
     The microprocessor  40  can be attached to, or integrated with, the health monitoring and management system  10 , which may be attached to a patient, for example, by being in or on a garment being worn by the patient. The monitored health indicator data can be analyzed at the level of the on-patient microprocessor  40 . Health indicator data received by the microprocessor  40  from the sensor(s)  20  can be analyzed and used to manage a response to the monitored health indicator data by providing one or more clinical interventions. For example, as shown in  FIG. 1 , in an embodiment of the health monitoring and management system  10  comprising an adjustable compressive pressure stocking  41 , a signal  42  comprising health indicator data from the patient wearing the stocking  41  can be transmitted to the on-patient microprocessor  40 , where the data can be analyzed and a desired response, or health intervention, to the health indicator data, such increasing compressive pressure by a certain amount to enhance blood flow, can be formulated for that patient. A signal  43  comprising a health intervention command coded to effectuate the interventional response can then be transmitted from the microprocessor  40  to one or more interventional elements  30  within the system  10 . The microprocessor  40  can thereby cause the compressive pressure to adjust in portions or in all of the compression stocking  41  according to the response formulated for the patient&#39;s most recent data. In this manner, compressive pressure(s) in the compression adjustable device  41  can be controlled in such as way as to be most medically beneficial and comfortable to the patient. 
     In other embodiments, health indicator data monitored by the sensor(s)  20  can be transmitted from the microprocessor  40  by means of the health indicator signal  42  to an off-patient computer  44  for “offline” analysis. At the offline computer  44 , the data can be analyzed and a desired interventional response to the health indicator data can be formulated for that patient. As in the example above, the interventional response can be increasing compressive pressure by a certain amount to enhance blood flow. The signal  43  comprising a health intervention command coded to effectuate the interventional response can be transmitted from the offline computer  44  to the microprocessor  40  and then to one or more interventional elements  30  within the system  10 . Alternatively, the health intervention command signal  43  may be transmitted directly from the computer  44  to the interventional element(s)  30  within the system  10 . In this way, the offline computer  44  can cause the compressive pressure to adjust in portions or in all of the compression stocking  41  according to the formulated response. 
     In some embodiments, the health monitoring and management system  10  can detect various physiological changes in a patient and analyze those changes relative to predetermined parameters. A management response signal, or health intervention command signal,  43  can be transmitted from the computer  44  to the microprocessor  40  and then to the interventional element(s)  30 , or directly from the computer  44  to an interventional element  30 , from which therapeutic interventions can be effectuated. When measurements taken by the health monitoring and management system  10  are outside the predetermined parameters, the system  10  can provide interventions based on those measurements. For example, in an embodiment in which the system  10  is associated with the compressive pressure garment  41 , the system  10  can control adjustments of the levels of compressive pressure applied by the entire garment  41  or by particular portions of the garment  41  (such as in the toe  45 , foot  46 , heel  47 , ankle  48 , calf  50 , and/or thigh  51 ), depending on detection and analysis of certain health indicators outside predetermined parameters. For example, when the compression adjustable garment  41  is a compression stocking and the health monitoring and management system  10  detects that blood flow in the calf  50  area has decreased below a predetermined level and/or that the compressive pressure being applied in the ankle  48  area is less than that applied in the calf  50 , the system  10  can automatically increase the compressive pressure in the ankle  48  area in order to improve blood flow in the calf area  50 . 
     Physical and/or physiological data of a patient using an embodiment of the health monitoring and management system  10  can be collected and analyzed in real time with desired changes in therapeutic interventions made by the interventional element(s)  30 , or management component(s), of the system immediately or within a clinically relevant time period. A “clinically relevant time period” is defined as the time period for intervening related to a monitored health indicator that is outside predetermined parameters and beyond which period the patient is likely to experience deterioration in that indicator and/or other indicators if the intervention is not provided. The “clinically relevant time period” can vary depending on the health indicator and the extent to which the indicator is outside the predetermined parameters. For example, the “clinically relevant time period” for intervening for moderately decreased blood flow in a leg may be one hour, while the “clinically relevant time period” for intervening for a sustained heart rate of 200 may be less than one minute. 
     In some embodiments, the microprocessor  40  and/or the computer  44  can provide control of monitoring mechanisms to adjust to various movements of the patient and positions in which the sensor  20  may be placed by the patient. For example, if a wearer of a garment in the health monitoring and management system  10  changes position from sitting to standing, walking, and/or lying down, the microprocessor  40  and/or computer  44  can automatically adjust the sensitivity of the sensors  20  and/or which sensors  20  are monitored at a particular point in time. In this way, the system  10  can monitor health indicators on an uninterrupted basis and account for some patient-initiated variables, thereby providing health care providers more complete and accurate information about the person&#39;s physiological status and health patterns. 
     Some embodiments of the health monitoring and management system  10  can comprise a control system for automatically controlling interventions in response to health indicator measurements taken by the system  10 . As shown in  FIG. 2 , such a control system may comprise an algorithm  52  programmed in the sensor  20 , microprocessor  40 , local electronic device  53 , and/or computer  44 . As an example, the control algorithm  52  for adjustment of compressive pressure in the compressive pressure stocking  41  can include commands for adjusting the compressive pressure provided by the stocking  41  depending on the volume, or girth, of the leg underneath the stocking  41  measured by the sensor  20 . For example, if the girth of a leg changes as a result of a change in posture, the control system  52  can command activation of a pump  54  to increase/decrease pressure as needed to maintain the desired level of compression in the compressive pressure stocking  41 . 
     Another example of a control system algorithm  52  is that for controlling patency of an arteriovenous fistula or dialysis shunt (together defined as “dialysis access route”). Such a control system algorithm  52  can include commands for activating a pump for flushing the dialysis access route when blood flow in the dialysis access route drops below a pre-set level. The control algorithm  52  can include commands for various levels of intervention. For example, if the sensor  20  detects that blood flow in the dialysis access route drops below a first level, the control system  52  can command a pump to flush the dialysis access route with a first solution, for example, a bolus of saline. If the sensor  20  detects that blood flow in the dialysis access route drops below a second, lower level, the control system  52  can command a pump to flush the dialysis access route with a second solution, for example, an anticoagulant flush. Alternatively, if after administration of the first solution the blood flow in the dialysis access route does not increase, the control system  52  can command a pump to flush the dialysis access route with a second solution, for example, an anticoagulant flush. 
     Another example of a control algorithm  52  is that for control of insulin delivery. Such a control system algorithm  52  can include commands for adjusting the rate of insulin being delivered by a pump depending on the blood sugar level measured by the sensor  20 . For example, if a patient&#39;s blood sugar exceeds a pre-determined level as measured by the sensor  20 , the control system  52  can command the insulin pump to deliver a certain amount of insulin to the patient. The control system algorithm  52  can comprise multiple levels of control related to the monitored health indicator. For example, for a first blood sugar level measured by the sensor  20 , the control system  52  can command the insulin pump to deliver a first amount of insulin to the patient. If after an appropriate period of time following administration of the first dose of insulin, the blood sugar level monitored by the sensor  20  continues to exceed a pre-determined threshold related to expected blood sugar parameters following such a first dose, the control system  52  can command the insulin pump to deliver a second amount of insulin to the patient. Some embodiments of the health monitoring and management system  10  can comprise a control system  52  for controlling interventions in response to other health indicator measurements taken by the system  10 . 
     In some embodiments, the sensor  20  can be self-contained. That is, the sensor  20  can comprise all components necessary to perform its intended function, such as sensing, collecting, and transmitting health indicator data. In some embodiments, the sensor  20  can be miniaturized. An exemplary embodiment of a sensor  20  can include an ultrasound sensing mechanism, a transmitter, and a battery. Such an embodiment may have dimensions of about ¼ inch by ¼ inch. In certain embodiments, the ultrasound sensor, transmitter, battery, and other electronic connections and/or components can be contained within a polymeric material poured about all of these components. In this way, the components can be protected against exposure to environmental variables. In addition, the sensor  20  can be disposable, so that when the battery life is exceeded, the sensor  20  can be replaced by another sensor  20 . Such embodiments of self-contained and/or miniaturized sensors  20  can thus be easily worn by a patient. For example, the sensor  20  can be attached to, or integrated into, a garment. The garment may be one that is typically worn by a patient, such as an undergarment. 
     In certain embodiments of the health monitoring and management system  10 , one or more sensors  20  can be attached to, or integrated into, a garment adapted to provide health management, or therapeutic, interventions. Thus, in certain embodiments, the health monitoring and management system  10  can further comprise a wearable therapeutic device. For example, sensors  20  can be attached to, or integrated into, the compressive pressure stocking  41 , a wound dressing, a vest, an abdominal binder, a lymphedema sleeve, etc. For purposes of illustration, some embodiments of the health monitoring and management system  10  can include the compression adjustable garment  41  and have the capability of changing or adjusting the compressive pressure of selected portions of the garment  41  or of the entire garment  41  while the garment  41  is being worn. Changing the compressive pressure of the garment  41  can help manage vascular flow in an anatomical structure underneath the garment  41 . 
     In certain embodiments, self-contained and/or miniaturized sensors  20  can be modular, such that the sensors  20  can be placed at various desired locations on a patient, such as at different locations in or about a garment. The sensor(s)  20  for monitoring a particular health indicator may be attached to specific locations on a garment so as to provide measurements from critical points on a patient&#39;s body. Multiple ones of a certain sensor  20  can be placed at various locations on a garment so as to provide a profile of measurements for the particular health indicator being monitored. 
     In certain embodiments of the present invention, the health monitoring and management system  10  can comprise electronic components integrated into the fabric of a wearable system. For example, a wearable health monitoring and management system  10  can include components such as electronic circuits, resistors, capacitors, and coils made from conductive yarns or other materials. A material&#39;s response to changes in pressure, humidity, temperature, or other conditions can be measured by observing a textile electronic element&#39;s response to a finite impulse of voltage or current. The response of the electronic element can be analyzed to determine changes in impedance, capacitance, and/or inductance of the element. In a particular illustrative embodiment, the health monitoring and management system  10  can include sensor(s)  20  that can gather arterial and venous blood flow information using continuous wave ultrasonic and body impedance feedback. Bio-impedance analysis techniques may be utilized to analyze and manage particular health conditions, such as lower leg swelling. In certain embodiments, such a bio-impedance system adapted to monitor and manage lower leg swelling can be a stand-alone system that is wearable. The “smart” or “intelligent” fabric of such a health monitoring and management system  10  can utilize combinations of such electrical components to provide sensors  20  that can sense a variety of behavior and health indicators and microcontrollers  40  that can allow use of interactive digital devices with the garment. 
     In certain embodiments, the sensor  20  may be an electrically passive device, or an integrated device, with measurement and transmission capability. For example, a garment comprising the biomedical sensor(s)  20  can include electrical power distribution and data transmission capabilities. Such a garment can further include a coupling circuit for allowing contactless transmission of power and data between sensors  20  and a circuit external to the garment. 
     In some embodiments, the sensor  20  can operate in a wireless manner, as illustrated in  FIG. 1 , for example. That is, the sensor  20  can wirelessly transmit collected health indicator data to the microprocessor  40 . In embodiments in which the sensor  20  incorporates the interventional element  30 , the sensor  20  can wirelessly receive health intervention commands. In certain embodiments, the sensor  20  can comprise the microprocessor  40  within the sensor  20 . In this way, the sensor  20  can wirelessly transmit collected health indicator data directly to a database and/or to a computer  44 , or other appropriately configured electronic device, at a location remote from the patient, such as at a hospital or clinic. 
     In other embodiments, the microprocessor  40  can be included in an appropriately configured electronic device separate from the sensor  20  that is attached to a desktop or laptop computer  44 , or to a local electronic device  53  such as a personal digital assistant (PDA) or “smart phone” equipped with an appropriate software application.  FIG. 2  shows an example of a local electronic device  53 . In this embodiment, the microprocessor  40  and control algorithm  52  can be separate from the local electronic device  53 . In other embodiments, the local electronic device  53  can include the microprocessor  40  and control algorithm  52  incorporated into the device  53 . The electronic device  53  can be located at the patient&#39;s location, such as in the patient&#39;s home. The electronic device  53  can transmit the collected health indicator data to the computer  44 , a designated database, and/or to a healthcare practitioner. In some embodiments, the microprocessor  40  and/or electronic device  53  can have a capability to provide local data storage. The electronic device  53  may be able to transmit health indicator data and/or receive health intervention commands either in a wired or wireless manner. In certain embodiments, the local electronic device  53  can be a remote transmission device that can be worn by the patient, for example, on a belt. 
     Embodiments of the health monitoring and management system  10  can be utilized with patients in a healthcare setting, such as a clinic, hospital, or long-term care facility. In this way, a healthcare practitioner can directly observe a patient while also receiving health indicator data collected by the sensor(s)  20 . In addition, embodiments of the system  10  can be utilized with patients in settings remote from a healthcare practitioner. For example, the system  10  having one or more sensors  20  and/or interventional elements  30  can be worn by a patient while at home, at work, or in other locations, and the health indicator data detected by the sensor(s)  20  can be transmitted to a remote site, such as a hospital or clinic, where a healthcare practitioner can receive the transmitted data and provide therapeutic intervention commands to the system, if desired. Embodiments of such a system can provide real-time health indicator monitoring and management. 
     In certain embodiments, the health indicator data monitored for an individual patient can be utilized by a software program to “learn” patterns in that patient&#39;s health status over time. For example, if the venous blood flow in a patient&#39;s calf  50  area decreases by approximately the same amount each time the patient moves from a sitting to a standing position, the software program can “learn” that pattern of change and predict that the compression stocking  41  being worn by the patient should have a certain calculated amount of increase in compressive pressure below and/or in the calf  50  area for each subsequent time the patient stands. Such “data mining,” or “machine learning” can allow the health monitoring and management system  10  to provide quicker and more accurate and effective responses to changes in a particular patient. 
     In certain embodiments, the health monitoring and management system  10  can further include the collection of health indicator data from groups of patients into a database. The “offline” computer  44  can be programmed to analyze and learn patterns of health indicator data related to certain patient behaviors for clinically relevant samples of patients and/or entire populations of patients. To illustrate hypothetically, collections of data from a large sample of patients may reveal, for example, that in 80 percent of male patients over age 65 having Type II diabetes and who weigh over 220 lbs., for those who have a venous stasis pressure ulcer on the heel  47  or ankle  48 , venous blood flow in the heel  47  or ankle  48  drops on average by 20 percent when the patients move from a sitting to standing position. The program may also have learned, as a hypothetical illustration—from storing real-time data related to patient management interventions by the system—that increasing the compressive pressure by 30 percent on the foot  46  of those same patients when they move from a sitting to standing position causes the venous blood flow to return to the sitting rate within one minute. This type of patient information data collection, storage, and analysis can allow the health monitoring and management system  10  to provide more effective and reliable care for groups of patients. 
     The “offline” computer  44  may be a stand-alone computer  44  or may be connected to a computer network. The network connection may be accomplished by physically connecting a cable from the monitoring device to a terminal connected to the network. Alternatively, the health monitoring system network connection can be wireless. The network can be a private networked system, such as a network operated by a hospital or clinic. In certain embodiments, the network database can be an internet web site. The internet site can be a proprietary site in which confidentiality of patient information can be maintained. Uploading monitored patient data onto a network database can allow long-term tracking of an individual patient&#39;s health patterns, as well as cumulative researchable data for particular patient populations. 
     In certain embodiments of the system  10  comprising only the sensor(s)  20 , the system  10  can be utilized to gather health indicator data from a particular patient and store that data for later use. Such an embodiment of the system  10  can further include the microprocessor  40  adapted to receive, store, and transmit the health indicator data transmitted by the sensor. Because of these capabilities, such an embodiment of the monitoring system  10  in a garment can be known as a “smart sleeve.” For example, an embodiment of a sensor-only system  10  can be utilized to monitor a first set of health indicator data for a patient at a first time point, the data can be stored within the system  10  or externally in a data storage device such as a computer, and a second and subsequent sets of health indicator data can be monitored for the patient at a second and subsequent time points. The health indicator data for the patient gathered at the first time point can be a baseline of clinical information against which the second and subsequent sets of health indicator data can be compared. In this way, changes in the clinical status of the patient can be evaluated over various time periods. 
     As an example of how an embodiment of a sensor-only system  10  can be utilized, having health indicator data for a patient available at different time points can allow a clinician, such as a physician, evaluate changes in clinical status of the patient without any interventions over time or in response to one or more interventions. To illustrate, a patient&#39;s health indicator data can be monitored on four different dates. Selected health indicators monitored on the first monitoring date can provide a baseline of clinical data. After an appropriate interval related to the health indicators being monitored, the same health indicators can be monitored on a second monitoring date. During the interval between the first and second monitoring dates, there may be no intervention related to the monitored health indicators provided to the patient. Thus, a comparison of the health indicator data monitored on the first and second monitoring dates can provide an indication of the patient&#39;s change in clinical status without any purposeful therapeutic intervention. Following the second monitoring date, a first therapeutic intervention related to the health indicators being monitored can be provided to the patient. Then, on a third monitoring date at an interval following the first intervention sufficient to allow for a clinical response from the first intervention, the health indicators can be monitored again. Likewise, following the third monitoring date, a second therapeutic intervention related to the health indicators being monitored can be provided to the patient. Then, on a fourth monitoring date at an interval following the second intervention sufficient to allow for a clinical response from the second intervention, the health indicators can be monitored again. In this way, responses in the patient&#39;s health indicators can be evaluated with respect to no intervention and to both the first and second interventions. Accordingly, by monitoring responses to different interventions, the most effective interventional modality can be determined for a patient. 
       FIGS. 2-4  illustrate aspects of an exemplary embodiment of the health monitoring and management system  10 . As shown in  FIG. 2 , the adjustable pneumatic compression stocking  41  can have the pump  54 , such as a miniature diaphragm pump, connected to the compression stocking  41 . A blood flow sensing system  55 , an example of which is illustrated in  FIG. 3 , can be connected to the compression stocking  41 . The blood flow sensing system  55  comprising a microphone sensor  56  can detect blood flow velocity in the leg of a person wearing the compression stocking  41 . In addition, or alternatively, a lower leg volume, or edema, sensing system  57 , an example of which is illustrated in  FIG. 4 , can be connected to the compression stocking  41 . The edema sensing system  57  can sense and detect changes in edema, or swelling, in the leg of a person wearing the compression stocking  41 . In some embodiments, as shown in  FIG. 2 , the compression stocking  41 , blood flow sensing system  55 , and edema sensing system  57  can collectively comprise a compression stocking network  58 . 
     Health indicator data related to blood flow velocity and edema sensed by the blood flow sensing system  55  and edema sensing system  57 , respectively, can be input to a data processor. The data processor can be, for example, the microprocessor (microcontroller)  40 , or other integrated circuit possessing computing functionality. The input data can be processed through the control algorithm  52 , for example, the compressive pressure control algorithm  52 . In certain embodiments, when blood flow velocity and/or lower leg edema reach pre-set thresholds (or a single threshold for a combined profile of blood flow and edema values), the microcontroller  40  can control a system for changing the compressive pressure on the wearer&#39;s leg(s) provided by the compression stocking  41 . For example, in an embodiment in which the compression stocking  41  includes the pump mechanism  54  for changing compressive pressure, the microcontroller  40  can send a control signal to actuate the pump  54  to increase or decrease the air pressure within the compression stocking garment  41  and thereby increase or decrease the compressive pressure on the wearer&#39;s leg(s). 
     In some embodiments, the health monitoring and management system  10  can further include the local electronic device  53 , for example, a wireless communication device, as shown in  FIG. 2 . The wireless communication device  53  can be in communication with the microcontroller  40 . In this manner, the wireless communication device  53  can capture and store on a local level the blood flow velocity and edema data sensed by the blood flow sensing system  55  and edema sensing system  57 , respectively, and/or processed by the microprocessor  40 . In addition, the wireless communication device  53  can capture and store data related to control of compressive pressures in the compression stocking  41  actuated by the microprocessor  40  in response to the sensed blood flow and edema data values. In certain embodiments, the microprocessor  40  can communicate with the wireless communication device  53  in a wireless manner. In other embodiments, the microprocessor  40  can be physically connected to the wireless communication device  53 , such as with a cable. In some embodiments, as shown in  FIG. 2 , the microprocessor  40  and control algorithm  52  and the wireless communication device  53  can collectively comprise a local control and data storage system  60 . 
     In some embodiments, the wireless communication device  53  can be in communication with the centralized computer  44  and database, as shown in  FIG. 2 . The central computer  44  and database can be in a location remote from the patient. In the embodiment in  FIG. 2 , the central computer  44  and database can be in a location remote from the compression stocking network  58  and the local control and data storage system  60 . Thus, the computer  44  and database can comprise a remote data storage system  61 . The remote computer and database system  61  can be utilized to store data transmitted from the local control and data storage system  60 , for example, the monitored data and the management, or control and intervention, data captured by the wireless communication device  53 . In certain embodiments, the central computer  44  and database can be further utilized for various purposes related to collected data. For example, the central computer  44  and database can be utilized to store data from a plurality of persons wearing one of the compression stockings  41 . Such collective data can be processed to improve the control algorithm  52  for the health monitoring and management system  10 , for example, to enhance intervention responsiveness and treatment results for individuals wearing the compression stocking  41 . In addition, such collective data may be used for health research purposes, for example, related to lower leg edema and blood flow with respect to particular patient conditions and physical metrics. 
       FIG. 3  illustrates one example of the sensor  20 , in particular, the blood flow sensing system  55  useful in some embodiments of the health monitoring and management system  10 . Such a blood flow sensing system  55  can be adapted to monitor blood flow and can include the microphone  56  attached to the compression stocking  41 , as shown in  FIG. 2 . Blood flow in the leg of a wearer of the compression stocking  41  can produce sound variations, depending on the velocity and quality of blood flow. The microphone  56  can sense such sound variations and create an acoustic signal  62  that is representative of those sounds. Acoustic signals  62  from the microphone  56  can be transmitted to an amplifier  63 . An amplifier  63  is a device for converting a low energy signal into a higher energy signal, that is, for increasing the power or amplitude of an input signal. Accordingly, the amplifier  63  can convert low energy acoustic signals  62  input from the microphone into first, higher energy, or amplified signals  64 . In some embodiments of the system, a fixed amplification can be applied if the characteristics of the incoming signal  62  are well-known, or a variable amplification can be applied to account for individual differences. 
     The first amplified acoustic signals  64  can then be transmitted to filtering circuitry  65 . High pass filters can be used to pass frequencies above a specified “cutoff frequency” and attenuate, or reduce the amplitude of, signals with lower frequencies. Such high pass filters are useful for eliminating signal offsets (that is, dc-shift) which may result from constant background noise. Low pass filters can be used to pass frequencies below a specified “cutoff frequency” and attenuate signals with higher frequencies. Such low pass filters are useful for eliminating 50/60 Hz noise for other electronic sources. Bandpass filters can be created by combing high and low pass filters, and can be used in an embodiment of the acoustic blood flow monitoring system  55  to smooth the incoming acoustic signal  62  and extract useful signal components. 
     The filtered acoustic signals  66  representing blood flow velocity can then be transmitted to a half-wave rectifier  70 . A half-wave rectifier  70  is an electrical circuit that can be used to block either the positive or negative portion of an alternating current (AC) signal. In this embodiment, the negative portion of the signal  66  is eliminated so that the signal  71  can be sampled by the analog-to-digital (ADC) module on a microprocessor  40 . The microprocessor  40  can then process the acoustic data  71  through various computing functions. For example, the signals  71  received by the microprocessor  40  may be compared with normative blood flow velocities, compared with previous blood flow data for a particular person, stored in one or more databases including wirelessly transmitting data to a remote site, utilized to actuate a change in compressive pressure in the compression stocking  41 , and/or further analyzed. 
       FIG. 4  illustrates an edema sensing system  57  useful in an embodiment of the health monitoring and management system  10 . Such an edema sensing system  57  can include four electrodes at spaced-apart locations in the compression stocking  41 . In such a system  57 , an electrical current  76  can be transmitted across the outer pair of electrodes  74 ,  75  and recorded by the inner pair of electrodes  72 ,  73 . For example, the two recording electrodes  72 ,  73  can be positioned in the calf  50  area, the current-originating electrode  74  placed in the thigh  51  area, and the current-terminating electrode  75  placed in the foot  46  area of the person. The change to the signal  76  as it passes between the current-originating and current-terminating electrodes  74 ,  75 , respectively, is sensed by the recording electrodes  72 ,  73 . This change  78  represents a change in impedance, or resistance to the flow of the electrical current  76 . An increase in impedance can represent a decrease in edema in the person&#39;s leg (that is, the electrical resistance of a conductor varies inversely with volume). 
     With respect to the edema sensing system  57 , changes  78  in impedance can be measured through application of Ohm&#39;s Law (i.e., Voltage=Current*Resistance): if a constant current  76  is applied to the leg, then a change  78  in impedance/resistance can be seen as a change  78  in voltage. As is shown in  FIG. 4 , a Howland current pump  85  can be used to provide a constant current source  76  regardless of the load attached. Other current sources may be utilized to provide the electrical current  76  for monitoring edema in certain embodiments of the present invention. Furthermore, in certain embodiments of the system, the frequency of the current source  85  can be varied using signaling commands  86  sent from the microprocessor  40  to specialized circuitry  83 , for example, adjustable frequency sine wave circuitry. 
     In order to maintain safe levels of current  76  being applied to the body, the stimulating current  76  and recorded signals  78  can often be very small in amplitude. The recorded signal  78  can thus be amplified by an amplifier  63 , and the amplified signal  80  passed through a demodulator  81 . A demodulator  81  is an electronic circuit used to recover the information content from the carrier wave of the signal  78 . In this embodiment, the demodulator  81  can recover, for example, the amplitude of the recorded signal  78  (i.e., which varies inversely with leg volume). The demodulated signal  82  can then be transmitted to a microprocessor  40  in which the signal  82  data can be processed through various computing functions. For example, the signals  82  received by the microprocessor  40  may be compared to signals representative of normative leg volume, compared with previous leg volume data for a particular person, stored in one or more databases including wirelessly transmitting data to a remote site, utilized to actuate a change in compressive pressure in the compression stocking  41 , and/or further analyzed. 
     In another embodiment (not shown), the health monitoring and management system  10  may be adapted to detect nerve signals. The health monitoring and management system  10  may further include the capability of analyzing and creating a response to analysis of the detected nerve signals. In certain embodiments, the system  10  may translate detected nerve signals into operational signals. For example, the system may translate nerve signals into signal commands for operating a prosthetic limb. 
     Some embodiments of the health monitoring and management system  10  according to the present invention can provide advantages over conventional health monitoring and health intervention systems. For example, some embodiments of the present invention can provide both monitoring of a patient&#39;s health indicators and management of health indicator status by therapeutic interventions in a single device and/or system  10 . The responses to changes in health indicators can occur in real time. As a result, such a system  10  can provide quicker and more accurate management of certain health conditions. Another advantage is that some embodiments of the present invention can provide a plurality of sensors  20  for monitoring various combinations of health indicators in a single device and/or system  10 , thereby allowing a more comprehensive view of a patient&#39;s overall clinical status and more accurately targeting interventions. Another advantage is that some embodiments of the present invention can provide interventional elements  30  capable of intervening to managing the monitored health indicators within predetermined parameters. 
     Another advantage is that some embodiments of the present invention can provide health monitoring and management components in a device and/or system  10  that can be utilized remotely from a healthcare setting such as a hospital or clinic. Another advantage is that some embodiments of the present invention can provide a health monitoring and management system  10  that is wearable for extended periods and that is mobile and comfortable. Another advantage is that some embodiments of the present invention can provide a health monitoring and management system  10  that is capable of transmitting health indicator data and receiving health intervention data wirelessly. Another advantage is that some embodiments of the present invention can provide a health monitoring and management system  10  that is a stand-alone system. 
     The present invention can include embodiments of a method of making a health monitoring and management system  10 . The present invention can include embodiments of a method of using a health monitoring and management system  10 . Such methods of making and/or using the health monitoring and management system  10  can include aspects and features of various embodiments of the health monitoring and management system  10  as described herein. 
     For example, in some embodiments, a health monitoring and management method can include detecting changes in one or more health indicators, and transmitting data related to the health indicators to the microprocessor  40 , where the health indicator data can be analyzed. A health intervention command can be formulated related to the health indicator data according to pre-determined parameters, and the health intervention command can be transmitted to the interventional element  30 . In certain embodiments of a method of health monitoring and management, the health intervention command can be transmitted to the interventional element  30  within a clinically relevant time period related to the health indicators. In particular embodiments of such a method, the health intervention command can be automatically formulated according to pre-determined parameters and the intervention command transmitted to the interventional element  30  by utilizing a control algorithm  52 . 
     Embodiments of the health monitoring and management device, system, and/or method can be utilized in a variety of applications. For example, some embodiments of the device, system, and/or method can be utilized with humans, while others may be utilized for monitoring and therapeutic purposes in animals. As described herein, some embodiments of the system  10  can be utilized to monitor health indicator data and/or manage therapeutic interventions related to the monitored data. Some embodiments of the system  10  can be utilized in care of wounds, either alone or in conjunction with other therapies. For example, the system  10  can include sensor(s)  20  adapted to detect changes in blood flow in a wound and can provide an intervention, such as a change in compressive pressure about the wound, in response to the blood flow health indicator data monitored by the sensor(s)  20 . Some embodiments of the device, system, and/or method can be utilized to record changes in a patient&#39;s condition over time so as to document those changes for insurance purposes. In another application, health indicator data from a population of patients using an embodiment of the health monitoring and management device, system, and/or method can be stored in a common database. The collective data can then be used for research purposes, for example, to design parameters for therapeutic interventions across populations of patients. 
     Some embodiments of self-contained, miniaturized sensors  20  can be attached to, or integrated with, systems for monitoring and managing indicators other than those related to health. For example, a plurality of such sensors  20  may be molded in, or attached to, a motorized vehicle, such as an automobile, boat, train, submarine, or aircraft. Such sensors  20  may be configured to monitor various indicators related to the integrity and/or operation of such a vehicle. In one illustrative embodiment, such sensors  20  can be attached to, or integrated within, the skin of an aircraft to monitor the structural integrity, vibration patterns, or other engineering and/or performance indicators of the skin. 
     Features of a health monitoring and management device and/or system  10  and methods of making and/or using a health monitoring and management system  10  of the present invention may be accomplished singularly, or in combination, in one or more of the embodiments of the present invention. Although particular embodiments have been described, it should be recognized that these embodiments are merely illustrative of the principles of the present invention. For example, although the health monitoring and management system  10  of the present invention has been described herein in terms of embodiments including a compression adjustable stocking  41 , such descriptions are for illustrative purposes only. It is contemplated that embodiments of the health monitoring and management system  10  of the present invention can comprise capabilities for monitoring various types of physical and health data other than blood flow and capabilities for managing various types of therapeutic interventions other than controlling compressive pressure in the stocking  41 . Those of ordinary skill in the art will appreciate that a health monitoring and management system  10  and methods of making and/or using a health monitoring and management system  10  of the present invention may be constructed and implemented in other ways and embodiments. Accordingly, the description herein should not be read as limiting the present invention, as other embodiments also fall within the scope of the present invention.