Google Patentsopen access

Noninvasive medical monitoring device, system and method — Padraic R. Obma (US20160242646A1)

ABSTRACT

Abstract

A variety of device constructs are contemplated in the wearable sensing devices of the present invention, each of which facilitate the monitoring of physical and physiological parameters in humans. Wearable sensing devices are incorporated into a wearable and comprise a small portable power supply; monitoring electronics mounted to or used in the wearable; a processing unit or component; and a memory unit or component to continuously or intermittently record parameter data—such data then being stored in an onboard portable memory unit and/or wirelessly transmitted to another electronic device or devices. The wearable sensing device incorporates a wireless data transmission unit or component to link to a personal computing device. The memory unit can be synchronized with the processing unit to save and then later download monitoring data for detection of any physical or physiological condition that is benign or a condition that requires mediation of some sort.

Description

This application claims the benefit and priority of U.S. Provisional Patent Application No. 62/221,229 filed Sep. 21, 2015, and U.S. Provisional Patent Application No. 62/189,431 filed Jul. 7, 2015.

FIELD OF THE INVENTION

This invention relates very generally to electronic data management of the type that is used to sense, measure, acquire and monitor body metrics in the medical and healthcare industries, which also includes data management in the area of athletic training and conditioning, as well as personal self-monitoring of body metrics by laypersons. As used herein, the term “body metrics” includes any physical or physiological parameter related to the human body that can be measured in an objective fashion (the terms “body metrics,” “physical or physiological parameters” and “parameters” are used interchangeably throughout this written disclosure).

The present invention also relates very generally to clothing, portions of clothing, such as sleeves and leggings, body wraps, including braces and supports, and body-attachable patches that are identified in this application as “wearables,” such wearables incorporating “wearable sensing devices,” such wearable sensing devices incorporating electronic “sensors” or “sensing elements” (the terms “sensors” and “sensing elements” are used interchangeably throughout this written disclosure) that are constructed and used to acquire data relating to body metrics. The electronic sensing elements, and the methods for using them, measure a wide variety of body metrics, such sensing elements and methods being multifunctional where feasible and further being noninvasive, i.e., not subcutaneous, in application. In this last regard, it is to be understood that the human body is sheathed and protected by an outer layer of skin, which is the integumentary system comprised of an epidermis, dermis and hypodermis. In the context of the present invention, certain physical and physiological parameters can be derived from monitoring the user's skin, including skin disposed in the vicinity of the user's joints, or by monitoring muscles that are disposed at the hypodermis or deeper, i.e., subcutaneously. In the present invention, the sensing elements are intended to be completely “non-invasive” which shall mean that the sensing is accomplished without penetrating the user's skin.

The terms “sensor” and “sensing elements” shall further mean any general or special purpose mechanism or electromechanical sensor of the type that can measure any number of body metrics. Such sensing elements include, but are not limited to, sensors for determining spatial relationships, positions and changes in position in ten or nine axes, accelerometers, magnetometers, gyroscopes, barometers, range of motion (“ROM”) sensing elements, and global positioning system (“GPS”) sensing elements, among others. There are, however, sensing devices that sense other numbers of axes, such as three axis and six axis sensors, in addition to the nine axes and ten axes sensors mentioned above, and such sensors can be combined as desired or required. For example, a ten axis sensor may be used with a six axis sensor, or a nine axis sensor may be used with a three axis sensor, and so forth.

More particularly, the present invention relates to the incorporation of one or more medical monitoring functionalities into wearable patches, wraps, clothing and clothing portions such that a wide variety of body metrics can be noninvasively monitored and then mediated as may be desired or required. As used herein, the term “monitor” shall mean the detection and assessment of a medical or physical condition or one or several body metrics, as assessed instantaneously, in real time or over an extended period of time as may be desired or required. The term “mediate” shall mean the detection and reactionary response to a medical or physical condition that has been, or is capable of, being monitored. The monitoring and mediating functionalities and methodologies presented herein may be used for assessing “digital health.”

At the core of the present invention, is the concept of utilizing “dueling sensors.” As used herein, the term “dueling sensors” is intended to define at least two sensors whereby the sensors can monitor, detect and compare a body metric via one sensor with the same metric “delta” (or an incremental change in that body metric from one sensor in relation to the other) being detected by at least one other sensor. In this way, the pair of dueling sensors can determine, in a relative way, how a sensed parameter differs between the sensors. On detection of a delta in that parameter, the parameters are inputted into a computer processing device and an algorithm is used to provide an “end-state,” which may or may not be a desired outcome but which will provide the user or healthcare provider with important information and feedback in the form of body metric data.

As applied to a wearable such as a knee support or brace, for example, a pair of dueling sensors, or even just one of them, could detect certain “activity tracking” parameters such as distance traveled, calories burned, number of flights of stairs climbed, and the like. However, the same pair of dueling sensors, when comparing the position of a first sensor in relation to a second sensor (such as where the first sensor is positioned below a knee joint and the second sensor is positioned above the same knee joint), could also detect knee joint parameters such as range of knee motion (“bend”), knee alignment (“twist” or “flex”), time spent with the knee flexed more than 90°, and similar comparative parameters. Indeed, the present invention is particularly drawn to the use of dueling sensors wherein the sensors are placed to one side of a human joint and to the other side of the human joint, the joint being disposed between the dueling sensors.

Further, and regardless of the measured parameter, a centralized microprocessor can be used to apply the necessary algorithms to those parameters and provide feedback to the user and/or to a healthcare provider as desired or required. That is, the present invention is generally related to the application and use of multiple computer processing algorithms, which algorithms comprise finite sets of rules or detailed computer instructions and each varying in complexity and each being designed to perform specific computing tasks via the centralized microprocessor. However, a processor can also be built into each of the wearable sensing devices with one such processor serving as a “hub” for processing the objective metric data relative to specific physiologic parameters detected by a plurality of other like-configured sensors that are used in concert with the wearable sensing devices. The methodology of the device and system of the present invention essentially provides a structural view of performance and relays data in three dimensions (“3-D”) through specially designed algorithms to provide active coaching and exercise tips. This is accomplished via a mobile application, or “app.”

BACKGROUND OF THE INVENTION

Electronic devices, systems and methods are well known in the sports, athletic performance and medical arts for monitoring objective physical and physiological parameters in humans. Such devices, systems and methods typically comprise a sensing device, a processing component that is electronically connected (via hard wiring or via wireless transmission) to the sensing device and a visual display device, such as a monitor or other screen display. Other devices, systems and methods of this type can also comprise more than one sensing devices, at least one processing component that is electronically connected to all of such sensing devices, communication links for sending electronic signals (again, via hard wiring or via wireless transmission) from the multiple sensing devices via the processing component to the viewable monitor of a visual display device or to a local or remote medical information network. Transmitting data from such a sensing device is typically accomplished via a communications link, such as a transmitter that enables wireless biotelemetry and ambulatory wireless biotelemetry. Some devices of either type are provided bedside, in a setting where the patient is non-ambulatory, whereas others can be provided where the patient is fully ambulatory or where the patient is not a patient at all, but is an athlete in training, for example.

One of the most familiar monitoring devices of this type is the common inflatable arm or wrist cuff that can be used to detect and measure a patient's blood pressure and pulse. Another well-known monitoring device is the infrared finger clip that is used at the distal end of a digit to detect and measure the saturated percentage of oxygen in the blood of a patient using infrared technology. Yet another well-known monitoring device is the electromyograph (“EMG”) which is used to sense and measure the electrical activity of human muscles. EMG technology can be conducted subcutaneously, which is invasive, or via surface EMG, which is non-invasive and where skin surface electrodes assess muscle activity from the skin surface immediately above or atop the subcutaneous muscle. Again, such sensing and monitoring devices may be portable, but often are not. Other sensing devices of the type that are intended to be portable include thoracic transducer belts for monitoring respiratory rates and Holter monitors that record the electrical activity of the heart over a period of time using electrodes that are placed on a patient's body, typically over bones to minimize artifacts from muscular activity. The electrodes are sensors that are used to detect electrical changes on the patient's skin that arise from the heart muscle depolarizing during each heartbeat, which is also known as electrocardiogram (“ECG”) detection and measurement.

It is known in the art to provide wearable technology for the purpose of capturing motion positions, which is typically associated with sports and physical training activities to maximize performance, reinforce suitable muscle memory, prevent injuries and provide some limited data analytics. However, in the overwhelming majority of the currently-available types of wearable technology, basic single-purpose sensors are configured to sense a single physical parameter (e.g., sensor location or position) or slightly more complex multi-purpose sensors are configured to sense multiple parameters (e.g., sensor location of several points along a human limb, such as at a wrist, an elbow and a shoulder, or coupled with means for detecting sensor acceleration or deceleration). In the experience of this inventor, however, such wearable technology of current manufacture tends to be cumbersome and somewhat limited in scope of use. That said, the miniaturization of electronics to unprecedented levels and the ongoing development and implementation of microelectromechanical systems (“MEMS”) in a broad spectrum of applications, sensors and processors can, and should, be incorporated into a wide variety of human wearables and wearable sensing devices as well. The combined use of such electronics with wearables is not only possible, but is also desirable in that athletic and patient monitoring can be done non-invasively and with minimal interference to an athlete's episodic training performance or, in the case of medical application, with a patient's normal day-to-day activities.

In the view of this inventor, what is needed in the medical arts, as well as in the athletic training and performance arts, are wearables and wearable sensing devices that can be used to monitor any number of physical and physiological human parameters in a new and unique way. For example, one such wearable and wearable sensing device could be used to monitor leg swelling or sense a change in the circumference of a patient's leg, either of which could be an indicator of one of several deleterious post-operative complications. Circumference measurement could also be used to determine if a muscle, or muscle group, is in recovery (demonstrated by an increased circumference) or is in atrophy (indicated by a decreased circumference). Another such wearable could detect skin temperature—an increase in temperature similarly being an indicator of a localized or systemic infection. Irrespective of whether such wearables and wearable sensing devices serve as diagnostic tools and monitors of physical and physiological parameters in medical patients or as feedback devices for athletes, the electronics, or at least a portion of them, need to be incorporated directly into the wearable sensing devices which are, in turn, incorporated directly into the wearable. Some sensors can be disposed to the outside of the wearable whereas other sensors require that they be disposed to the inside of the wearable, adjacent the skin of the patient or athlete in order to achieve the functional parameter detection that is desired or required.

In the view of this inventor, there is also a need in the medical and athletic arts to provide wearables that can be variably interfaced with spatial or positional sensing means to detect metric deltas to very small but precise degrees. As alluded to above, current technology places a positional sensing device on joints or limbs for purposes of tracking movement or relational movement, shifting and positioning of that joint or limb. Such sensing devices provide feedback for a whole host of purposes such as perfecting a desired tennis overhand tennis serve, correcting body mechanics to achieve a better golf swing or analyzing body posture to enhance accuracy on a pistol shooting range.

In accordance with the present invention, however, such a wearable could be improved by providing a wearable sensing device with a sensing element or sensor to monitor the relative position of a patient's joint by assessing specific deltas above or below—or, more accurately, the relative position of points to either side of a patient's joint. By definition, a “joint” is the site of the junction of two or more bones of the body—its primary function being to provide motion and flexibility to the frame of the body. Further, most joints allow considerable motion, the most common type being “synovial joints” which have a complex internal structure which is composed of the ends of bones, ligaments, cartilage, the articular capsule, the synovial membrane and sometimes serous sacs, or bursa. For example, the knee joint is a compound joint, which is a type of synovial joint, between the femur, the patella and the tibia. The elbow joint is the synovial joint between the humerus, the ulna and the radius.

In the view of this inventor, there is a need to more accurately assess very specific changes in joint position and to assess such changes more precisely. This would preferably be done via a ten axis motion sensor that is capable of detecting rotation rates or angular velocities of the sensor, or a multiplicity of sensors (when attached to the patient), about the x, y and z axes of a Cartesian coordinate system (via a gyroscopic component or other positional relationship component) as well as axial acceleration (via an accelerometer component) and ambient magnetism (via a magnetometer component which is used to establish initial sensor calibration), all measured within the same coordinate system. However, it is also to be understood that motion sensors that sense other numbers of axes, such as three axis, six axis and nine axis sensors can be used in the present invention and that such sensors can be used in combination with other sensors, also selected from the group of three axis, six axis, nine axis and ten axis sensors. That is, a ten axis sensor may be used with a six axis sensor, or a nine axis sensor may be used with a three axis sensor, and so on, all to the same end.

Irrespective of the number of axes used in each sensor, all measuring is done via the sampling of objective measurement data detected from sensors within the wearable sensing devices in accordance with a pre-programmed scheme as determined by applied algorithms residing within a microprocessor. Further, optimal use of such a wearable sensing device would be its ability to detect one or more physical or physiological parameters and then wirelessly transmitting those metrics, in real time and via biotelemetry, to a remote server and memory unit that would then electronically store the transmitted data

This application claims the benefit and priority of U.S. Provisional Patent Application No. 62/221,229 filed Sep. 21, 2015, and U.S. Provisional Patent Application No. 62/189,431 filed Jul. 7, 2015.

FIELD OF THE INVENTION

This invention relates very generally to electronic data management of the type that is used to sense, measure, acquire and monitor body metrics in the medical and healthcare industries, which also includes data management in the area of athletic training and conditioning, as well as personal self-monitoring of body metrics by laypersons. As used herein, the term “body metrics” includes any physical or physiological parameter related to the human body that can be measured in an objective fashion (the terms “body metrics,” “physical or physiological parameters” and “parameters” are used interchangeably throughout this written disclosure).

The present invention also relates very generally to clothing, portions of clothing, such as sleeves and leggings, body wraps, including braces and supports, and body-attachable patches that are identified in this application as “wearables,” such wearables incorporating “wearable sensing devices,” such wearable sensing devices incorporating electronic “sensors” or “sensing elements” (the terms “sensors” and “sensing elements” are used interchangeably throughout this written disclosure) that are constructed and used to acquire data relating to body metrics. The electronic sensing elements, and the methods for using them, measure a wide variety of body metrics, such sensing elements and methods being multifunctional where feasible and further being noninvasive, i.e., not subcutaneous, in application. In this last regard, it is to be understood that the human body is sheathed and protected by an outer layer of skin, which is the integumentary system comprised of an epidermis, dermis and hypodermis. In the context of the present invention, certain physical and physiological parameters can be derived from monitoring the user's skin, including skin disposed in the vicinity of the user's joints, or by monitoring muscles that are disposed at the hypodermis or deeper, i.e., subcutaneously. In the present invention, the sensing elements are intended to be completely “non-invasive” which shall mean that the sensing is accomplished without penetrating the user's skin.

The terms “sensor” and “sensing elements” shall further mean any general or special purpose mechanism or electromechanical sensor of the type that can measure any number of body metrics. Such sensing elements include, but are not limited to, sensors for determining spatial relationships, positions and changes in position in ten or nine axes, accelerometers, magnetometers, gyroscopes, barometers, range of motion (“ROM”) sensing elements, and global positioning system (“GPS”) sensing elements, among others. There are, however, sensing devices that sense other numbers of axes, such as three axis and six axis sensors, in addition to the nine axes and ten axes sensors mentioned above, and such sensors can be combined as desired or required. For example, a ten axis sensor may be used with a six axis sensor, or a nine axis sensor may be used with a three axis sensor, and so forth.

More particularly, the present invention relates to the incorporation of one or more medical monitoring functionalities into wearable patches, wraps, clothing and clothing portions such that a wide variety of body metrics can be noninvasively monitored and then mediated as may be desired or required. As used herein, the term “monitor” shall mean the detection and assessment of a medical or physical condition or one or several body metrics, as assessed instantaneously, in real time or over an extended period of time as may be desired or required. The term “mediate” shall mean the detection and reactionary response to a medical or physical condition that has been, or is capable of, being monitored. The monitoring and mediating functionalities and methodologies presented herein may be used for assessing “digital health.”

At the core of the present invention, is the concept of utilizing “dueling sensors.” As used herein, the term “dueling sensors” is intended to define at least two sensors whereby the sensors can monitor, detect and compare a body metric via one sensor with the same metric “delta” (or an incremental change in that body metric from one sensor in relation to the other) being detected by at least one other sensor. In this way, the pair of dueling sensors can determine, in a relative way, how a sensed parameter differs between the sensors. On detection of a delta in that parameter, the parameters are inputted into a computer processing device and an algorithm is used to provide an “end-state,” which may or may not be a desired outcome but which will provide the user or healthcare provider with important information and feedback in the form of body metric data.

As applied to a wearable such as a knee support or brace, for example, a pair of dueling sensors, or even just one of them, could detect certain “activity tracking” parameters such as distance traveled, calories burned, number of flights of stairs climbed, and the like. However, the same pair of dueling sensors, when comparing the position of a first sensor in relation to a second sensor (such as where the first sensor is positioned below a knee joint and the second sensor is positioned above the same knee joint), could also detect knee joint parameters such as range of knee motion (“bend”), knee alignment (“twist” or “flex”), time spent with the knee flexed more than 90°, and similar comparative parameters. Indeed, the present invention is particularly drawn to the use of dueling sensors wherein the sensors are placed to one side of a human joint and to the other side of the human joint, the joint being disposed between the dueling sensors.

Further, and regardless of the measured parameter, a centralized microprocessor can be used to apply the necessary algorithms to those parameters and provide feedback to the user and/or to a healthcare provider as desired or required. That is, the present invention is generally related to the application and use of multiple computer processing algorithms, which algorithms comprise finite sets of rules or detailed computer instructions and each varying in complexity and each being designed to perform specific computing tasks via the centralized microprocessor. However, a processor can also be built into each of the wearable sensing devices with one such processor serving as a “hub” for processing the objective metric data relative to specific physiologic parameters detected by a plurality of other like-configured sensors that are used in concert with the wearable sensing devices. The methodology of the device and system of the present invention essentially provides a structural view of performance and relays data in three dimensions (“3-D”) through specially designed algorithms to provide active coaching and exercise tips. This is accomplished via a mobile application, or “app.”

BACKGROUND OF THE INVENTION

Electronic devices, systems and methods are well known in the sports, athletic performance and medical arts for monitoring objective physical and physiological parameters in humans. Such devices, systems and methods typically comprise a sensing device, a processing component that is electronically connected (via hard wiring or via wireless transmission) to the sensing device and a visual display device, such as a monitor or other screen display. Other devices, systems and methods of this type can also comprise more than one sensing devices, at least one processing component that is electronically connected to all of such sensing devices, communication links for sending electronic signals (again, via hard wiring or via wireless transmission) from the multiple sensing devices via the processing component to the viewable monitor of a visual display device or to a local or remote medical information network. Transmitting data from such a sensing device is typically accomplished via a communications link, such as a transmitter that enables wireless biotelemetry and ambulatory wireless biotelemetry. Some devices of either type are provided bedside, in a setting where the patient is non-ambulatory, whereas others can be provided where the patient is fully ambulatory or where the patient is not a patient at all, but is an athlete in training, for example.

One of the most familiar monitoring devices of this type is the common inflatable arm or wrist cuff that can be used to detect and measure a patient's blood pressure and pulse. Another well-known monitoring device is the infrared finger clip that is used at the distal end of a digit to detect and measure the saturated percentage of oxygen in the blood of a patient using infrared technology. Yet another well-known monitoring device is the electromyograph (“EMG”) which is used to sense and measure the electrical activity of human muscles. EMG technology can be conducted subcutaneously, which is invasive, or via surface EMG, which is non-invasive and where skin surface electrodes assess muscle activity from the skin surface immediately above or atop the subcutaneous muscle. Again, such sensing and monitoring devices may be portable, but often are not. Other sensing devices of the type that are intended to be portable include thoracic transducer belts for monitoring respiratory rates and Holter monitors that record the electrical activity of the heart over a period of time using electrodes that are placed on a patient's body, typically over bones to minimize artifacts from muscular activity. The electrodes are sensors that are used to detect electrical changes on the patient's skin that arise from the heart muscle depolarizing during each heartbeat, which is also known as electrocardiogram (“ECG”) detection and measurement.

It is known in the art to provide wearable technology for the purpose of capturing motion positions, which is typically associated with sports and physical training activities to maximize performance, reinforce suitable muscle memory, prevent injuries and provide some limited data analytics. However, in the overwhelming majority of the currently-available types of wearable technology, basic single-purpose sensors are configured to sense a single physical parameter (e.g., sensor location or position) or slightly more complex multi-purpose sensors are configured to sense multiple parameters (e.g., sensor location of several points along a human limb, such as at a wrist, an elbow and a shoulder, or coupled with means for detecting sensor acceleration or deceleration). In the experience of this inventor, however, such wearable technology of current manufacture tends to be cumbersome and somewhat limited in scope of use. That said, the miniaturization of electronics to unprecedented levels and the ongoing development and implementation of microelectromechanical systems (“MEMS”) in a broad spectrum of applications, sensors and processors can, and should, be incorporated into a wide variety of human wearables and wearable sensing devices as well. The combined use of such electronics with wearables is not only possible, but is also desirable in that athletic and patient monitoring can be done non-invasively and with minimal interference to an athlete's episodic training performance or, in the case of medical application, with a patient's normal day-to-day activities.

In the view of this inventor, what is needed in the medical arts, as well as in the athletic training and performance arts, are wearables and wearable sensing devices that can be used to monitor any number of physical and physiological human parameters in a new and unique way. For example, one such wearable and wearable sensing device could be used to monitor leg swelling or sense a change in the circumference of a patient's leg, either of which could be an indicator of one of several deleterious post-operative complications. Circumference measurement could also be used to determine if a muscle, or muscle group, is in recovery (demonstrated by an increased circumference) or is in atrophy (indicated by a decreased circumference). Another such wearable could detect skin temperature—an increase in temperature similarly being an indicator of a localized or systemic infection. Irrespective of whether such wearables and wearable sensing devices serve as diagnostic tools and monitors of physical and physiological parameters in medical patients or as feedback devices for athletes, the electronics, or at least a portion of them, need to be incorporated directly into the wearable sensing devices which are, in turn, incorporated directly into the wearable. Some sensors can be disposed to the outside of the wearable whereas other sensors require that they be disposed to the inside of the wearable, adjacent the skin of the patient or athlete in order to achieve the functional parameter detection that is desired or required.

In the view of this inventor, there is also a need in the medical and athletic arts to provide wearables that can be variably interfaced with spatial or positional sensing means to detect metric deltas to very small but precise degrees. As alluded to above, current technology places a positional sensing device on joints or limbs for purposes of tracking movement or relational movement, shifting and positioning of that joint or limb. Such sensing devices provide feedback for a whole host of purposes such as perfecting a desired tennis overhand tennis serve, correcting body mechanics to achieve a better golf swing or analyzing body posture to enhance accuracy on a pistol shooting range.

In accordance with the present invention, however, such a wearable could be improved by providing a wearable sensing device with a sensing element or sensor to monitor the relative position of a patient's joint by assessing specific deltas above or below—or, more accurately, the relative position of points to either side of a patient's joint. By definition, a “joint” is the site of the junction of two or more bones of the body—its primary function being to provide motion and flexibility to the frame of the body. Further, most joints allow considerable motion, the most common type being “synovial joints” which have a complex internal structure which is composed of the ends of bones, ligaments, cartilage, the articular capsule, the synovial membrane and sometimes serous sacs, or bursa. For example, the knee joint is a compound joint, which is a type of synovial joint, between the femur, the patella and the tibia. The elbow joint is the synovial joint between the humerus, the ulna and the radius.

In the view of this inventor, there is a need to more accurately assess very specific changes in joint position and to assess such changes more precisely. This would preferably be done via a ten axis motion sensor that is capable of detecting rotation rates or angular velocities of the sensor, or a multiplicity of sensors (when attached to the patient), about the x, y and z axes of a Cartesian coordinate system (via a gyroscopic component or other positional relationship component) as well as axial acceleration (via an accelerometer component) and ambient magnetism (via a magnetometer component which is used to establish initial sensor calibration), all measured within the same coordinate system. However, it is also to be understood that motion sensors that sense other numbers of axes, such as three axis, six axis and nine axis sensors can be used in the present invention and that such sensors can be used in combination with other sensors, also selected from the group of three axis, six axis, nine axis and ten axis sensors. That is, a ten axis sensor may be used with a six axis sensor, or a nine axis sensor may be used with a three axis sensor, and so on, all to the same end.

Irrespective of the number of axes used in each sensor, all measuring is done via the sampling of objective measurement data detected from sensors within the wearable sensing devices in accordance with a pre-programmed scheme as determined by applied algorithms residing within a microprocessor. Further, optimal use of such a wearable sensing device would be its ability to detect one or more physical or physiological parameters and then wirelessly transmitting those metrics, in real time and via biotelemetry, to a remote server and memory unit that would then electronically store the transmitted data in a database. However, both types of wearables are the subject of the present invention—wearable and wearable sensing devices having sensors that receive and store data via a transitory memory and wearables and wearable sensing devices having sensors that receive and transmit data to a non-transitory memory.

As alluded to above, the scale of the electronics that are contemplated for use in the wearable sensing devices and methodology of the present invention must be relatively small and unobtrusive—almost to the point of being undetectable, such as by using a MEMS platform and integrated circuit configurations. If possible, the electronics (including the sensors, processors, memory, input/output (or “I/O”) components and power supply, together with hard-wired electrical connections between components) would be built directly into the wearable sensing device. As alluded to previously, some sensing elements used within the wearable could be adhered to the outside surface of the wearable whereas others could be adhered to the inside surface, and adjacent the user's skin. Alternatively, wearable sensing devices would most desirably be placed into positions by virtue of a “band-aid”-type application or patch, where the wearable sensing device is adhered directly to the users skin via medical adhesive.

Lastly, it would be desirable that the sensors used in the wearable sensing device be capable of carrying an on-board electronic power supply, such as a coin-type disposable battery or a rechargeable battery. This would allow for repeated use of the sensor upon depletion of the electric charge carried by the battery. It is also desirable, in some applications, to devise such a sensing device where the battery possesses sufficient life for useful application without the need to charge the battery. In short, the sensing device would be a replaceable consumable.

SUMMARY OF THE INVENTION

In view of the foregoing, a wide variety of body metric sensing or wearable sensing device constructs are contemplated, devised and presented, all of which facilitate the monitoring of physical and physiological parameters in human subjects, be they medical patients, professional athletes, casual athletes or laypersons. Such wearable sensing devices are incorporated into systems and used in methods drawn to the use of such devices and systems.

The simplest construct in accordance with the present invention would be to use one wearable sensing device secured above a joint and another wearable sensing device secured below the same joint. Each wearable sensing device would necessarily require the incorporation of, or integral combination within a housing, the following: (a) one or more sensing elements; (b) a local memory; (c) a local microprocessor; (d) an on-board power supply; and (e) a local low energy wireless transceiver that would provide a wireless personal area network for use of the wearable sensing device with a smartphone. The low energy functionality is intended to provide considerably reduced power consumption and cost while also providing a sufficient wireless communication range. The smartphone would provide a user interface and an interactive screen display for the user, together with additional processing capabilities and memory. Irrespective of the mode used to secure each sensing unit, each positioned as mentioned above, the wearable sensing devices would “calibrate” from an initial position of one sensing device relative to the initial position of the other sensing device. In this last regard, at least one of the wearable sensing devices would serve as a compass for the sensing devices via a magnetometer. Following calibration, each wearable sensing device would be wirelessly queued via the smartphone to commence the gathering of body metrics. The data compiled by acquisition of the body metrics is stored within a local memory and/or be transmitted, via continuous real-time feed or via a “data dump” at a later time, to the smartphone via the low energy wireless transceivers. In this construct, each wearable sensing device could incorporate means for recharging the on-board power supply via inductive charging or other energy transfer means for re-use of the wearable sensing device.

Another construct would be to incorporate the above-referenced wearable sensing devices into a sleeve for a joint. In this construct, the sleeve would incorporate two pockets—each for housing a wearable sensing device. In this construct, it would be desirable for the housings of the wearable sensing devices to be configured to easily slide into the pockets and to be snuggly retained in them so as to prevent any movement of the wearable sensing device within the pocket. That is, any “slop” or lateral movement of the wearable sensing device within the pocket could result in the acquisition of false metrics or measurements relative to the joint.

Another construct would utilize one of the wearable sensing devices as identified above and a second wearable sensing device wherein the second wearable sensing device would be configured without a low energy wireless transceiver within it. Instead, the wearable sensing devices in this construct would be “hard wired” to one another. The metrics would be monitored using the dueling sensor concept, but only one wearable sensing device would transmit data via a low energy wireless transceiver. This alternative construct would reduce cost of the second wearable sensing device by eliminating the local low energy wireless transceiver within it. This alternative configuration would, however, function as described above in every other respect.

Another construct would be to provide two wearable sensing devices of the type that are not configured to have a local low energy wireless transceiver within them. Instead, both of the wearable sensing devices in this construct would be “hard wired” to another centralized processing unit. The centralized processing unit would be provided with the necessary functionality of the local low energy wireless transceiver, as described above. In all other respects, the configuration would also function as described above. Other sensing devices or elements could likewise be hard wired to the centralized processing unit to provide for the measurement of other body metrics.

Yet another construct would be to provide a sleeve for a leg or knee joint whereby at least one sensing element used within the wearable sensing device is incorporated into the sleeve such that swelling and concomitant circumference changes in the limb are monitored and detected. Such a wearable sensing device would necessarily require the incorporation of (a) a small on-board portable power supply; (b) limb circumference monitoring electronics in the form of longitudinally-extendable wires woven into the fabric of the wearable, or other design expediencies that would allow for measurement of such limb circumference, including a length of non-extendable material, the ends of which would be secured within a sensor having a stretch sensor, for example; (c) a processing unit or computing component; and (d) a memory unit or component to continuously or intermittently record limb circumference data—such data then being stored in an onboard portable memory unit and/or wirelessly transmitted to another electronic device or devices. In the case of the latter, the wearable would necessarily also incorporate (e) a wireless data transmission or biotelemetry unit, i.e., a transmitter or a transceiver, to enable telehealth or telemedical functionalities.

This construct could also incorporate pre-programmed instructions that are performed by the processing unit in implementing algorithmic steps to process the body metric measurements and provide the patient or the healthcare provider with real-time or time-delayed information concerning the patient's well-being in view of the measurements made. The algorithmic steps in accordance with the present invention utilize applied “quaternion” matrix mathematics, which are used to determine a rotation angle and the vectored direction of a rotation. Quaternions are used typically for calculations involving three-dimensional rotation, and describing spatial rotations in particular, while being more compact and quicker to compute than representations by other vector matrices. Lastly, the memory unit of this construct could also be synchronized with the processing unit to save and then later download monitoring data for short term detection or long term assessment of any physical or physiological condition that is benign or that requires mediation of some sort.

In another construct, a leg or knee wearable in accordance with the present invention could incorporate sensors to monitor parameters of temperature, pressure and joint angles in the knee. In yet another construct, a foot or ankle wearable could incorporate the same sensors for assessing the foot health of a diabetic patient. The monitored parameters could be used to inform the patient and his or her healthcare providers of any changes that would require mediation of a potentially problematic medical condition.

In yet another construct, a combination of sensors could be used to monitor multiple joints within an upper or lower limb or extremity. For example, a sensor could by placed above the shoulder (i.e., humeral) joint, at the middle of the upper arm, at the middle of the forearm and on the hand (i.e., four sensors in all) to measure three joints—the shoulder joint, the elbow joint and the wrist—in much the same relative fashion as described above.

In still another construct, cervical spine motion could be monitored via a sensor placed on the upper-most portion of the neck and another at the upper-most portion of the thoracic spine. Likewise, lower back, or lumbar spine, range of movement could be monitored using multiple sensors placed in strategic locations as well.

The construct of the present invention could also be incorporated into “orthopedic wearables” such as knee braces or sleeves, elbow braces or sleeves, ankle braces or sleeves, compression stockings, arm slings and the like. Sensors of the type described and claimed herein can be used in conjunction with orthopedic wearables such that data can be obtained for the purpose of decreasing complications and improving surgical or other treatment outcomes. Constructs of this nature can include sensors that are incorporated directly into the orthopedic wearable or, alternatively, sensors that are simply applied to the skin or included within a sleeve or other holder which can then be used with a conventional orthopedic brace that would then overlay the sensors.

As alluded to at the outset, the present invention also significantly relates to the novel concept of utilizing “dueling sensors.” The concept of “dueling sensors” is intended to define at least two sensors whereby the sensors can monitor, detect and compare a parameter of one sensor with the same parameter detected by another sensor. In this way, the pair of dueling sensors can determine how a sensed parameter differs between the sensors relative to their placement on a human body. As applied to a knee support or brace, a pair of dueling sensors could, for example, detect activity tracking parameters such as distance traveled, calories burned, number of flights of stairs climbed and other similar location-tracking parameters. However, the same pair of dueling sensors could also detect range of knee motion, knee alignment, time spent with the knee flexed more than 90° and virtually any other like-monitored joint parameters, as previously described.

The functionality of the present invention provides a novel solution that is itself inextricably tied to, and is necessarily rooted in, computer technology. The sensors of the wearable sensing devices secure specific data manipulations, data transformations and data transmissions that are performed by a local and integral microprocessor or by a remote microprocessor, thereby implementing the algorithmic steps as are pre-programmed within either. In alternative constructs and embodiments, other configurations for monitoring physical and physiological parameters, and for providing correlating data and feedback concerning those parameters, in real-time or time-delayed assessment format, are disclosed in the detailed description that follows, all of which are included within the scope of the present invention and the present invention not being limited to the specific embodiments disclosed.

The foregoing and other features of the present invention will be apparent from the detailed description that follows.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a front elevation view of a portion of a patient's leg (specifically, the patient's lower thigh, knee and upper calf) encircled by one embodiment of a wearable of the type that is constructed in accordance with the present invention.

FIG. 2 is a left side elevation view of the leg and knee wearable shown in FIG. 1 .

FIG. 3 is a front elevation view of a portion of a patient's leg (again, the patient's lower thigh, knee and upper calf) encircled by an alternative embodiment of a wearable of the type that is constructed in accordance with the present invention.

FIG. 4 is a left side elevation view of the leg and knee wearable shown in FIG. 3 .

FIG. 5 is a front elevation view of a portion of a patient's leg (again, the patient's lower thigh, knee and upper calf) encircled by yet another alternative embodiment of a wearable of the type that is constructed in accordance with the present invention.

FIG. 6 is a left side elevation view of the leg and knee wearable shown in FIG. 5 .

FIG. 6A is an enlarged left side elevation view of the wearable taken along line 6 A- 6 A of FIG. 6 and showing the wearable sensing device inserted into a pocket that is formed within the wearable.

FIG. 7 is a front elevation view of a portion of a patient's leg wherein the patient's lower thigh and upper calf (immediately above and below the knee, respectively) each has attached to it still another alternative embodiment of a strip-like wearable of the type that is constructed in accordance with the present invention.

FIG. 8 is a left side elevation view of the wearables shown in FIG. 7 .

FIG. 9 is an isometric view of a pair of wearable sensing devices, each having one or more sensing elements or sensors (i.e., “dueling sensors” as between each of the sensing devices) embedded within each of the wearable sensing devices in accordance with the present invention wherein the devices are shown in relation to the x, y and z axes of a Cartesian coordinate system.

FIG. 10 is a front elevation view of a pair of sensors shown in FIG. 9 wherein one of the sensing devices is rotated about the z axis in relation to the other sensing device, as would be the case where the sensing devices are placed to either side of a joint, which demonstrates a “bend” relationship relative to the joint.

FIGS. 11A, 11B and 11C are left side elevation views of the pair of sensors shown in FIG. 10 wherein one of the sensing devices is rotated about the y axis in relation to the other sensing device, as would be the case where the sensing devices are placed in vertical positions to either side of a joint and the joint is showing rotation or “twist.”

FIGS. 12A, 12B and 12C are top plan views of the sensing devices shown in FIGS. 11A, 11B and 11C , respectively.

FIGS. 13A, 13B and 13C are left side elevation views of the pair of sensors shown in FIG. 10 wherein one sensing device is rotated about the x axis in relation to the other sensing device, as would be the case where the sensing devices are placed in vertical positions to either side of a joint and the joint having exaggerated valgus and varus joint alignments, or “flex.”

FIGS. 14A, 14B and 14C are views that correlate to those shown in FIGS. 13A, 13B and 13C when viewed from the z-axis.

FIG. 15 is a schematic representation of a first microelectromechanical system (“MEMS”) configured in accordance with the present invention.

FIG. 16 is a schematic representation of a second MEMS configuration in accordance with the present invention.

FIG. 17 is a schematic representation of the electronics that would be used in one system embodiment of the present invention, that embodiment being shown in FIG. 1 and the components being hard wired to a processing component having wireless connectivity to a personal computing device.

FIG. 18 is a schematic representation of the electronics that would be used in an alternative system embodiment of the present invention, that embodiment being shown in FIG. 2 .

FIG. 19 is a schematic representation of the electronics that would be used in yet another alternative system embodiment of the present invention, that embodiment being shown in FIG. 3 .

FIG. 20 is a flow chart illustrating the steps taken to process data captured via a sensor or a plurality of sensors.

FIGS. 21 through 34 illustrate representative screen displays shown on a user's personal computing device in accordance with the present invention.

DETAILED DESCRIPTION

The noninvasive medical monitoring device, system and method that is configured in accordance with the present invention necessarily comprises a pair of wearable sensing devices, each sensing device comprising at least one sensor or sensing element. There can be, and preferably are, more than one sensor used in any of the preferred embodiments stated herein, with two ten axis sensors being desired, although other sensor combinations could be used. That is, sensing devices that sense other numbers of axes, such as three axis, six axis and nine axis sensors, can be used in the present invention and such sensors can be combined as desired or required. For example, a ten axis sensor may be used with a six axis sensor, or a nine axis sensor may be used with a three axis sensor, and so on.

In their most basic constructs, the sensors comprise devices for detecting a wide variety of objectively different physical parameters, such as the amount of light as detected by a light sensor; heat and cold as detected by temperature sensors; movement as detected by motion sensors, applied force as detected by pressure sensors; the presence or absence of certain harmful agents as detected by chemical sensors; electric field sensors; magnetic field sensors; displacement sensors; and acceleration sensors. Sensors of this nature are used for detecting absolute parameter values and, in more sophisticated models, used for detecting parameter deltas, or changes. Most importantly, however, is the fact that the “resolution” of a sensor is the smallest change that the sensor can detect in the relevant “quantity” that it is measuring, i.e. temperature measured in tenths of degrees Fahrenheit or Celsius; motion and displacement measured in inches, fractions of inches, millimeters, micrometers and smaller displacement distances; pressure in terms of force per unit area; and so on. In short, while such sensors typically measure “absolutes,” coupled with suitable software, algorithmic steps and memory, changes in parameters can be detected and monitored as well. These changes, or deltas, are an essential element of the present invention.

It should also be noted that each type of sensor mentioned above may have alternative terms that they are known by in the relevant arts—such as, for a pressure sensor, a pressure transducer or a piezometer and, for a force sensor, a load cell and so on—the point being that many types of sensors are available for sensing many objectively different physical parameters—any one or more of them being capable of incorporation into the monitoring device and methodology of the present invention.

In the medical arts, the types of sensors used have naturally and necessarily expanded into internal metabolic indicators, such as oxygen saturation levels and the like. In a specific medical application, such a sensor may be used to monitor and detect swelling and/or circumference changes in a limb as compared to a “baseline,” which would be a specific value or number of values (as in value ranges having an upper limit and a lower limit) that can serve as a comparison or control for that particular physical parameter.

Significantly, the wearable sensing devices and method in accordance with the present invention utilize a gyrometer for measuring limb joint rotation and an accelerometer to measure speed and directional changes in limbs or limb parts. More specifically, certain applied algorithmic steps are used to accomplish these measurements. The algorithmic steps in accordance with the present invention utilize applied “quaternion” matrix mathematics, which are used to determine a rotation angle and the vectored direction of a rotation. Quaternions are used in particular for calculations involving three-dimensional rotation, and describing spatial rotations in particular, and are more compact and quicker to compute than are representations by other vector matrices. As applied to the present invention, the accelerometer provides the amplitude of force in terms of “G-forces” (with “G” from the word “gravitational”), G-force being a measurement of the type of acceleration that causes weight. Viewed another way, physical parameters that are analyzed according to this aspect of the present disclosure include a “mass” in “motion”—the “mass” being a limb or limb part—as G-force can also be described as a “weight per unit mass”. The term “motion” can encompass rotation, reciprocation, oscillation, gyration, combinations thereof, or any other continuous, alternating, periodic, repetitive and/or intermittent change to the location or arrangement of the limb or limb part.

In the quaternion math matrix concept mentioned above, a magnetometer is also necessarily incorporated to measure directional orientation of the patient, the patient's limb or a limb part—the magnetometer providing a fixed point for the sensor in 3-dimensional space. This is an important addition as the magnetometer provides a fixed point in space that can be used to determine the spatial relationship between any two sensors. In the wearable sensing devices of the present invention, the magnetometer in a first wearable sensing device provides a point for initial calibration, or the point of start for positional changes to be detected, which essentially serves as a compass in the dueling sensor concept disclosed and claimed herein. In short, the magnetometer gives the gyrometer and accelerometer combination fixed points to calibrate from. Without the magnetometer, the only parameter that can be established is the distance between any two of the sensors, which is dynamically variable in almost all instances—one example being where one sensor is located above a joint and one is located below the joint. Upon continuous flexing of the joint, the distance between the two sensors is likewise continuously changing as is the relative rotation of the one sensor based on its orientation in relation to the other. This concept will be apparent later in this detailed description.

As an adjunct or alternative sensing element relative to the magnetometer could be a global positioning system (or “GPS”). GPS is a desirable functionality due to the fact that the magnetometer may not precisely detect and respond to an ambient magnetic field. That is, the magnetometer, more so than other MEMS-type sensing elements, is subject to undesirable magnetic fields of the type that can be generated by any number of electrical or electromechanical devices. Such fields can potentially interfere with conventional magnetometers, thereby making GPS functionality a desirable alternative in wearables that are made in accordance with the present invention. Multiple sensors could be used, and the GPS technology can be built into each sensor. Further, it would be possible for the sensors to “synch” with a personal computing device, which computing device could provide the sensor or sensing element with baseline GPS coordinates that would originate from the personal computing device. Movement of the sensor would be relative to the change in the GPS reading of the personal computing device, assuming that the personal computing device is in close proximity to the sensing element or the wearable sensing device.

Another sensor that can be used in the wearable sensing device and method of the present invention is a precision barometer, for measuring atmospheric pressure changes which can correlate to changes in elevation—even relatively small changes in elevation on the order of several inches.

The device and method in accordance with the present invention could also specifically comprise a sensor to monitor and detect skin temperature as compared to a baseline. While thermometers are well known in the medical arts, the temperature sensor of the present invention is miniaturized and adapted to be surface-mounted to the interior of a wearable, immediately on top of the skin.

Another device and method in accordance with the present invention would be a sensor to monitor and detect skin color or changes in skin color as compared to a baseline. The skin color sensor would comprise a light-emission component such as a light emitting diode (“LED”) coupled with light receiving component for the detection of the skin surface color based on skin reflectivity.

Yet another device and method in accordance with the present invention would comprise flexion, extension and positional sensors for measuring joint parameters such as joint range of motion (in degrees and minutes) as previously discussed. A limb strength sensor for measuring strength of a limb under flexion or extension could also be used in a wearable in accordance with the present invention.

Another wearable sensing device and method in accordance with the present invention could utilize electromyography (“EMG”), which is another type of electro-diagnostic technology. EMG is a technique for measuring the electrical potential generated by muscle cells and detecting the activation level or electrical potential of such cells. The activation level or electrical potential signals of such muscle cells can be used to detect medical conditions, including the biomechanics of patient movement. Detection of these levels or signals comprises the use of a muscle measurement device such as an electromyography which can produce a record over time, known as a electromyogram. This EMG technology can likewise be built into a wearable in accordance with the present invention.

Others sensing element constructs in accordance with the present invention could include a pulse rate monitor (sensing heart rate); a blood oxygenation monitor (pulse and oxygen saturation levels as compared to a baseline); a blood pressure monitor; a hemoglobin and/or hematocrit monitor; and other types of metabolic sensors.

Each sensor of the type mentioned above is incorporated into the wearable sensing device and the wearable sensing device is incorporated into the wearable. Again, the term “wearable” is intended to mean clothing, clothing portions, such as arm sleeves and leg sleeves, joint sleeves, joint wraps, torso coverings, other wraps, any type of removable patches, including both reusable and disposable patches that are attachable using medical grade adhesives, arm slings, knee braces, protective walking boots and other recuperative medical supports and braces.

Because each sensor alluded to above functions differently, placement of the sensor within the wearable sensing device or the wearable must be such that the sensor can actually “sense” the parameter or parameters that it is intended to sense. For example, the stretch of a sleeve which has conductive fibers woven into it requires only that the circumference of the sleeve be monitored in a relative fashion—that the sleeve be stretched at one or more points along the sleeve. A sensor used to measure the reflectivity of a patient's skin cannot be woven into such a sleeve in such fashion. Instead, the sensor must be at or near the surface of the wearable such that the sensor is able to sense the patient's skin color, as compared to a baseline. Such a sensor could also be incorporated into a sleeve or a patch that is worn over only a portion of the patient's skin. The point here is that the sensor(s) must be incorporated into the wearable(s) such that sensor functionality is not compromised such that the sensor is incapable of functioning as intended—and this is true for each type of wearable as it relates to each type of sensor.

It is also clear that any sensor that is incorporated into the wearable sensing device or the wearable must be capable of electronically communicating the parameters that the sensor is detecting and monitoring—as it is detecting them in real time. This is accomplished by some sort of “connectivity” between the sensor, which is preferably a MEMS-type unit that imparts an electrical signal the magnitude of which may be directly proportional to the “change” in the parameter being monitored, as analog or digital signals, and a processor. This “connectivity” allows the sensor to report physical and physiological parameter measurements to the processor, which processor is also preferably secured within the wearable sensing device or separately within the wearable. Further processing of the physical and physiological parameter measurements detected by the sensor may, however, be further processed by another centralized processor, as will be apparent later in this detailed description.

Each wearable sensing device preferably uses low energy digital technology and BlueTooth®, iBeacon™ or other short-wavelength ultra-high frequency (or “UHF”) radio wave technology in the industrial, scientific and medical (or “ISM”) band ranging from 2.4 to 2.485 GHz (BLUETOOTH is a registered certification mark of Bluetooth Sig, Inc. and IBEACON is a trademark of Apple Inc.); radio frequency (“RF” and “RFID”) technology; and/or other electronic data messaging modalities to send the monitored data to a receiver, a personal computing device, a smartphone, a terminal (as defined below) or to an electronic medical record (“EMR”) for the user patient. This functionality is consistent with the concepts of “telemedicine” and “telehealth.” The term “telemedicine” can be defined as the use of medical information exchanged from one site to another via electronic communications to improve a patient's clinical health status. Telemedicine includes a growing variety of applications and services using two-way video, email, smart phones, wireless tools and other forms of telecommunications technology. The term “telehealth” is sometimes used to refer to a broader definition of remote healthcare that does not always involve clinical services. Telemedicine is closely allied with the term health information technology (“HIT”). However, HIT more commonly refers to electronic medical records (“EMR”) and related information systems while telemedicine refers to the actual delivery of remote clinical services using technology, which can also be referred to as digital health. Both methods, however, must be compliant with the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”).

Concerning the mediation aspect of the present invention, it complements the monitoring of certain physical and physiological parameters as described above. For example, one such monitoring and mediating concept in accordance with the present invention would comprise the following steps. First, a sleeve or brace is placed around the patient's limb (the “surgical limb,” which could include a single limb or multiple limbs could be involved, such as an upper extremity and a lower extremity, or some combination thereof) immediately following surgery. The sleeve or brace is a “wearable” comprised of at least one wearable sensing device and sensing element, as previously described. Next, specific baseline measurements of the surgical limb are taken immediately following surgery. Alternatively, the same measurements from the non-surgical limb could also be used as a baseline. In either approach, the baseline measurements are sent, via electronic signal, to a processor or stored in the memory of an individual wearable sensing device. Throughout the patient's post-surgical course, limb circumference measurements are taken and processed. If the limb circumference of the surgical limb reaches a certain point of swelling, which point exceeds an acceptable level of post-operative swelling, mediation will be initiated. Such mediation would be to reduce swelling or reduce the risk of blood clots by using intermittent pneumatic compression or sequential compression of the type described and claimed in this inventor's co-pending Patent Cooperation Treaty Application PCT/US2015/36920 titled Intermittent and Sequential Compression Device and Method, the content of which is incorporated herein by reference. This would also trigger messages to medical providers alerting them that the patient may be at risk of a blood clot in the surgically invaded limb. All recorded and stored electronic data relative to this monitoring and mediation ca

CLAIMS

Claims ( 30 )

The details of the invention having been disclosed in accordance with the foregoing, I claim:

1 . A wearable for the noninvasive medical monitoring of physical and physiological parameters in a human limb of a user, the limb comprising at least one joint and skin that overlays the limb and joint, the wearable comprising:

a pair of wearable sensing devices; means for positioning each wearable directly or indirectly atop the user's skin, the position of each wearable sensing device being fixed; a ten axis sensing element integrated into each wearable sensing device; means for calibrating the integrated ten axis sensing elements in the pair of wearable sensing devices; means for detecting body metrics via the sensing elements in each wearable sensing device; means for measuring body metrics via the sensing elements in each wearable sensing device; a memory for storing the detected and measured body metrics; and a microprocessor for applying algorithmic steps in accordance with applied quaternion matrix mathematics analysis to assess physical and physiological delta information relative to the user.

2 . The wearable according to claim 1 , wherein one wearable sensing device is disposed to one side of a body joint and one wearable sensing device is disposed to the other side of the body joint.

3 . The wearable according to claim 1 , wherein the wearable sensing devices are electronically connected together via an input/output communications wire and wherein at least one of the wearable sensing devices comprises a local low energy wireless transceiver to provide a wireless personal area network for the wearable sensing devices.

4 . The wearable according to claim 1 wherein each of the wearable sensing devices comprises its own local low energy wireless transceiver to provide a wireless personal area network for each of the wearable sensing devices.

5 . The wearable according to claim 1 further comprising:

a stand-alone processing unit, the processing unit comprising a local low energy wireless transceiver to provide a wireless personal area network for the unit and the sensing devices connected to it; and

an input/output communications wire disposed between each of the wearable sensing devices and the stand-alone processing unit.

6 . The wearable according to claim 5 further comprising:

a stretch sensor;

a circumferential band having a fixed length and two ends, the band encircling one part of the user's limb; and

an input/output communications wire disposed between the stretch sensor and the stand-alone processing unit;

wherein the two ends of the circumferential band are used in conjunction with the stretch sensor to detect an increase or a decrease in the circumference of the user's limb.

7 . The wearable according to claim 5 further comprising at least one from a group consisting of:

an EMG sensing element and an input/output communications wire disposed between the EMG sensing element and the stand-alone processing unit;

a skin temperature sensing element and an input/output communications wire disposed between the skin temperature sensing element and the stand-alone processing unit; and

at least one skin color sensing element and an input/output communications wire disposed between the skin color sensing element and the stand-alone processing unit.

8 . The wearable according to claim 5 further comprising at least one from a group consisting of:

clothing;

a sleeve;

a legging;

a wrap;

a brace;

a support; and

body-attachable patches;

wherein the wearable is comprised of natural fibers, synthetic fibers, plastic materials, metals or a combination thereof.

9 . The wearable according to claim 1 further comprising pockets, one pocket for each wearable sensing device and each pocket retaining a wearable sensing device within it and wherein the wearable sensing devices are configured of MEMs circuitry encased within a housing, the housing comprising a tapered nose portion, which nose portion provides the leading edge for the wearable sensing device when inserted into the pocket.

10 . The wearable according to claim 1 wherein each wearable sensing device alternatively comprises an integrated ten axis, a nine axis, a six axis or a three axis sensing element and wherein each wearable sensing device comprising a ten axis, a nine axis, a six axis or a three axis sensing element can be combined with another wearable sensing device comprising a ten axis, a nine axis, a six axis or a three axis sensing element.

11 . A system for the noninvasive medical monitoring of physical and physiological parameters in a human limb of a user, the limb comprising at least one joint and skin that overlays the limb and joint, the system comprising:

a wearable; a pair of wearable sensing devices incorporated into the wearable; means for positioning each wearable directly or indirectly atop the user's skin, the position of each wearable sensing device being fixed; a ten axis sensing element integrated into each wearable sensing device; means for calibrating the integrated ten axis sensing elements in the pair of wearable sensing devices; means for detecting body metrics via the sensing elements in each wearable sensing device; means for measuring body metrics via the sensing elements in each wearable sensing device; a memory for storing the detected and measured body metrics; a microprocessor for applying algorithmic steps in accordance with applied quaternion matrix mathematics analysis to assess physical and physiological delta information relative to the user; and a portable computing device.

12 . The system according to claim 11 , wherein the wearable sensing devices are electronically connected together via an input/output communications wire and wherein at least one of the wearable sensing devices comprises a local low energy wireless transceiver to provide a wireless personal area network for the wearable sensing devices such that the network includes the portable computing device.

13 . The system according to claim 11 wherein each of the wearable sensing devices comprises its own local low energy wireless transceiver to provide a wireless personal area network for each of the wearable sensing devices such that the network includes the portable computing device.

14 . The system according to claim 11 further comprising:

a stand-alone processing unit, the processing unit comprising a local low energy wireless transceiver to provide a wireless personal area network for the unit, the sensing devices connected to it and the portable computing device that is wirelessly connected to the processing unit; and

an input/output communications wire disposed between each of the wearable sensing devices and the stand-alone processing unit.

15 . The system according to claim 14 further comprising:

a stretch sensor;

a circumferential band having a fixed length and two ends, the band encircling one part of the user's limb; and

an input/output communications wire disposed between the stretch sensor and the stand-alone processing unit;

wherein the two ends of the circumferential band are used in conjunction with the stretch sensor to detect an increase or a decrease in the circumference of the user's limb.

16 . The system according to claim 14 further comprising at least one from a group consisting of:

an EMG sensing element and an input/output communications wire disposed between the EMG sensing element and the stand-alone processing unit;

a skin temperature sensing element and an input/output communications wire disposed between the skin temperature sensing element and the stand-alone processing unit; and

a skin color sensing element and an input/output communications wire disposed between the skin color sensing element and the stand-alone processing unit.

17 . The system according to claim 14 further comprising at least one from a group consisting of:

clothing;

a sleeve;

a legging;

a wrap;

a brace;

a support; and

body-attachable patches;

wherein the wearable is comprised of natural fibers, synthetic fibers, plastic materials, metals or a combination thereof.

18 . The system according to claim 14 further comprising a pair of pockets defined in the wearable, each pocket retaining a wearable sensing device in it and wherein the wearable sensing devices are configured of MEMs circuitry encased within a housing, the housing comprising a tapered nose portion, which nose portion provides the leading edge for the wearable sensing device when inserted into the pocket.

19 . The system according to claim 15 wherein each wearable sensing device alternatively comprises an integrated ten axis, a nine axis, a six axis or a three axis sensing element and wherein each wearable sensing device comprising a ten axis, a nine axis, a six axis or a three axis sensing element can be combined with another wearable sensing device comprising a ten axis, a nine axis, a six axis or a three axis sensing element.

20 . A method for noninvasively monitoring of physical and physiological parameters in a human limb of a user, the limb comprising at least one joint and skin that overlays the limb and joint, the method comprising the steps of:

providing a wearable; incorporating a pair of wearable sensing devices into the wearable; positioning each wearable directly or indirectly atop the user's skin, the position of each wearable sensing device being fixed; integrating a ten axis sensing element into each wearable sensing device; calibrating the integrated ten axis sensing elements in the pair of wearable sensing devices; detecting body metrics via the sensing elements in each wearable sensing device; measuring body metrics via the sensing elements in each wearable sensing device; providing a memory; storing the detected and measured body metrics in the memory; providing a microprocessor; using the microprocessor to apply algorithmic steps in accordance with applied quaternion matrix mathematics analysis to assess physical and physiological delta information relative to the user; and providing a portable computing device.

21 . The method of claim 20 further comprising the steps of electrically connecting the wearable sensing devices and providing a local low energy wireless transceiver within one of the wearable sensing devices to provide a wireless personal area network for the wearable sensing devices such that the network includes the portable computing device.

22 . The method of claim 20 further comprising the steps of providing each wearable sensing device with its own local low energy wireless transceiver to provide a wireless personal area network for each of the wearable sensing devices such that the network includes the portable computing device.

23 . The method of claim 20 further comprising the steps of:

providing a stand-alone processing unit, the processing unit comprising a local low energy wireless transceiver to provide a wireless personal area network for the unit, the sensing devices connected to it and the portable computing device that is wirelessly connected to the processing unit; and

providing an input/output communications wire between each of the wearable sensing devices and the stand-alone processing unit.

24 . The method of claim 23 further comprising the steps of:

providing a stretch sensor;

providing a circumferential band having a fixed length and two ends, the band encircling one part of the user's limb;

providing an input/output communications wire between the stretch sensor and the stand-alone processing unit; and

using the two ends of the circumferential band in conjunction with the stretch sensor to detect an increase or a decrease in the circumference of the user's limb.

25 . The method of claim 23 further comprising at least one of the steps from a group consisting of:

providing an EMG sensing element and providing an input/output communications wire between the EMG sensing element and the stand-alone processing unit;

providing a skin temperature sensing element and providing an input/output communications wire between the skin temperature sensing element and the stand-alone processing unit; and

providing at least one skin color sensing element; and

providing an input/output communications wire between the skin color sensing element and the stand-alone processing unit.

26 . The method of claim 20 further comprising the step of configuring a wearable from at least one from a group consisting of:

clothing;

a sleeve;

a legging;

a wrap;

a brace;

a support; and

body-attachable patches.

27 . The method of claim 26 wherein the wearable is comprised of natural fibers, synthetic fibers, plastic materials, metals or a combination thereof.

28 . The method of claim 27 further comprising a pair of pockets defined in the wearable, each pocket retaining a wearable sensing device in it.

29 . The method of claim 28 wherein the wearable sensing devices are configured of MEMs circuitry encased within a housing, the housing comprising a tapered nose portion, which nose portion provides the leading edge for the wearable sensing device when inserted into a pocket.

30 . The method of claim 20 wherein the sensing element integration step alternatively comprises the step of integrating a ten axis, a nine axis, a six axis or a three axis sensing element into the sensing devices and the step of combining a sensing device comprising a ten axis, a nine axis, a six axis or a three axis sensing element with another wearable sensing device comprising a ten axis, a nine axis, a six axis or a three axis sensing element.

US15/079,394

2015-07-07

2016-03-24

Noninvasive medical monitoring device, system and method

Abandoned

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