Monitoring physiological parameters during activity and time feedback to enhance performance in subject
By using the device configured by the processor, using the sensing device to monitor and stimulate the device to provide feedback, the complexity and inconvenience of monitoring physiological parameters in the prior art is solved, and efficient monitoring and feedback during activities is achieved.
Patent Information
- Application Number
- CN202411644546.0
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2018-05-22
- Filing Date
- 2019-05-20
- Publication Date
- 2025-03-11
AI Technical Summary
The prior art is difficult to provide a reliable, simple and cable-free method to monitor and manage physiological parameters of subjects, especially in mobile and telemedicine environments.
An apparatus including a processor and memory is employed, which monitors the physiological parameters of the subject through at least one sensing device and provides feedback to the subject according to a determined timing using at least one stimulation device to adjust its performance during activity.
Real-time monitoring and management of subjects’ physiological parameters during the activity is achieved, improving subjects’ cardiopulmonary performance and biomechanical movement efficiency without cable connection.
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Figure CN119586986A_ABST
Abstract
Description
[0001] This application is a divisional application of a Chinese invention patent application filed on May 20, 2019, with application number 201980034112.X, and invention name “Monitoring physiological parameters during activity and providing timely feedback to enhance subject performance”. Technical Field
[0002] The present disclosure relates to the field of physiological monitoring, and more particularly, to devices and systems for monitoring physiological parameters of a subject. Background Art
[0003] Physiological monitoring is performed for a variety of purposes. However, the prior art is not without disadvantages.
[0004] There is a need for reliable, simple and cable-free measurement of physiological parameters of a subject.With the increase in the proliferation of mobile and telemedicine, simplified and unobtrusive means for monitoring physiological parameters of patients are becoming increasingly important. Summary of the invention
[0005] One illustrative, non-limiting object of the present disclosure is to provide systems, devices, methods, and kits for monitoring and managing physiological parameters of a subject. Another illustrative, non-limiting object is to provide a simplified system for monitoring a subject. Another illustrative, non-limiting object is to provide a comfortable, long-term wearable system for monitoring a subject. Another illustrative, non-limiting object is to provide a system for facilitating stimulation of a subject based on the subject's monitored physiological parameters.
[0006] According to the present disclosure, the above-mentioned illustrative non-limiting objects are fully or partially met by devices, systems and methods according to the attached claims. According to the present disclosure, features and aspects are set forth in the attached claims, in the following description and in the drawings.
[0007] In one embodiment, an apparatus includes a processor and a memory coupled to the processor, the processor being configured to: monitor a first set of one or more physiological parameters and a second set of one or more physiological parameters from at least one location on a subject using at least one sensing device; identify a first event associated with the first set of one or more physiological parameters and a second event associated with the second set of one or more physiological parameters; generate a first timestamp for the first event and a second timestamp for the second event; determine a timing for providing feedback to the subject relative to the first timestamp and the second timestamp to adjust one or more characteristics of the subject during an activity; and provide one or more feedback signals to the subject using at least one stimulation device according to the determined timing.
[0008] Modulating one or more characteristics of the subject during the activity may include at least one of: enhancing the subject's cardiorespiratory performance during the activity; and providing a biomechanical enhancement of movement of at least a portion of the subject during the activity.
[0009] The at least one sensing device and the at least one stimulation device may be the same device.
[0010] At least one sensing device may include a first sensing device attached to the subject at a first location and at least a second sensing device attached to the subject at a second location. A first set of physiological parameters may be monitored at the first location using the first sensing device, and a second set of physiological parameters may be monitored at the second location using the second sensing device. The first location and the second location may be co-located on the subject. The first location may be located on an appendage, arm, hand, leg, foot, thigh, knee, calf, ankle, bicep, elbow, forearm, wrist, abdomen, or pelvis of the subject. The second location may be located on the subject's torso, ribs, abdomen, neck, head, ear, under the arm, or on an appendage. At least one of the first location and the second location may be on at least one machine that interfaces with the subject.
[0011] The first set of one or more physiological parameters may include at least one of one or more kinematic signals and one or more electromyographic signals from a first location on the subject. The second set of one or more physiological parameters may include at least one of one or more cardiac signals and one or more respiratory signals from a second location on the subject. The first event may correspond to at least one of: one or more muscle activity levels; onset of one or more muscle contractions; relaxation of one or more muscles; peak contraction of one or more muscles; fatigue of one or more muscles; peak force generation of one or more muscles; peak electromyographic activity of one or more muscles; peak high-frequency electromyographic activity of one or more muscles; peak fast-twitch activity of one or more muscles; and peak slow-twitch activity of one or more muscles. The first event may also or alternatively correspond to one or more kinematic and kinetic movements, the one or more kinematic and kinetic movements including one or more of: peak horizontal acceleration; peak horizontal velocity; minimum vertical acceleration; minimum vertical velocity; apex of an arc; base of an arc; impact; directional impact; and a free-fall condition.
[0012] Monitoring can be performed while the subject performs repetitive tasks. The repetitive tasks can include one of running, walking, bicycling, weight lifting, jumping, squatting, sit-ups, crunches, head movement, rowing, swimming, swinging tools, and climbing stairs.
[0013] Determining the timing for providing feedback to the subject relative to the first timestamp and the second timestamp can be based at least in part on one or more environmental factors.
[0014] Determining the timing for providing feedback to the subject relative to the first timestamp and the second timestamp can be based at least in part on one or more task-related factors for the repetitive task being performed by the subject.
[0015] Determining the timing for providing feedback to the subject relative to the first timestamp and the second timestamp may be based at least in part on one or more fatigue factors of the subject.
[0016] Determining the timing for providing feedback to the subject relative to the first timestamp and the second timestamp may include: executing a training procedure including applying stimulation to the subject using at least one stimulation device and monitoring one or more physiological parameters of the subject to determine one or more changes in at least one cardiac performance metric; and determining the optimal timing for providing feedback to the subject relative to the first timestamp and the second timestamp using the determined one or more changes in at least one cardiac performance metric.
[0017] The subject may be performing a repetitive task comprising a plurality of cycles, and the processor may be configured to perform monitoring during two or more of the plurality of cycles to perform an optimization of the time average in response to first and second timestamps associated with a first event and a second event in each of the two or more cycles to provide feedback to the subject.
[0018] The subject may be performing a repetitive task comprising a plurality of cycles, and the processor may be configured to perform monitoring during a first cycle of the plurality of cycles and provide feedback to the subject in a second cycle of the plurality of cycles subsequent to the first cycle.
[0019] The subject may be performing a task including two or more activities during the monitoring, and determining the timing for providing feedback relative to the first timestamp and the second timestamp may include coordinating the timing of the feedback for one or more specified activities within the task.
[0020] The feedback may include at least one of electrical stimulation, vibration stimulation, auditory stimulation, and visual stimulation.
[0021] The processor can also be configured to: apply stimulation to two or more locations on the subject using at least one stimulation device; monitor the subject's response to the stimulation provided at each of the two or more locations using at least one sensing device; determine the subject's reflection time to the stimulation applied to each of the two or more locations using the monitored responses; and select at least one given location of the two or more locations based on the determined reflection time for providing one or more feedback signals to the subject.
[0022] The processor may be configured to adjust the intensity of one or more feedback signals provided to the subject to achieve a desired level of enhancement in cardiorespiratory performance.
[0023] The processor can be configured to calculate one or more reflexes of the subject by monitoring the subject response relative to the timing of providing one or more feedback signals to the subject to determine when the subject adjusts the movement associated with the task in response to the one or more feedback signals. The processor can also be configured to monitor one or more changes in the reflex response time of the subject and adjust the timing of providing one or more feedback signals to the subject based on the one or more changes in the reflex response time of the subject.
[0024] In another embodiment, a method includes monitoring, using at least one sensing device, a first set of one or more physiological parameters and a second set of one or more physiological parameters from at least one location on a subject, identifying a first event associated with the first set of one or more physiological parameters and a second event associated with the second set of one or more physiological parameters, generating a first timestamp for the first event and a second timestamp for the second event, determining a timing for providing feedback to the subject relative to the first timestamp and the second timestamp to adjust one or more characteristics of the subject during an activity, and providing one or more feedback signals to the subject according to the determined timing using at least one stimulation device.
[0025] Modulating one or more characteristics of the subject during the activity may include at least one of: enhancing the subject's cardiorespiratory performance during the activity; and providing a biomechanical enhancement of movement of at least a portion of the subject during the activity.
[0026] In another embodiment, a computer program product includes a non-transitory processor-readable storage medium having executable program code stored therein, which when executed causes at least one processing device to: monitor a first set of one or more physiological parameters and a second set of one or more physiological parameters from at least one location on a subject using at least one sensing device; identify a first event associated with the first set of one or more physiological parameters and a second event associated with the second set of one or more physiological parameters; generate a first timestamp for the first event and a second timestamp for the second event; determine a timing for providing feedback to the subject relative to the first timestamp and the second timestamp to adjust one or more characteristics of the subject during an activity; and provide one or more feedback signals to the subject using at least one stimulation device according to the determined timing.
[0027] Modulating one or more characteristics of the subject during the activity may include at least one of: enhancing the subject's cardiorespiratory performance during the activity; and providing a biomechanical enhancement of movement of at least a portion of the subject during the activity. BRIEF DESCRIPTION OF THE DRAWINGS
[0028] Several aspects of the present disclosure may be better understood with reference to the following drawings.In the drawings, like reference numerals represent corresponding parts throughout the several views.
[0029] Figure 1 Various aspects of a modular physiological monitoring system according to an embodiment of the present invention are illustrated.
[0030] Figure 2 An adhesive-applied stimulation device comprising a pair of patch modules according to an embodiment of the present invention is illustrated.
[0031] Figure 3 A pair of patch modules with vibration stimulation components according to an embodiment of the present invention is illustrated.
[0032] Figure 4 A pair of patch modules having thermal stimulation components according to an embodiment of the present invention is illustrated.
[0033] Figure 5 A pair of patch modules having tactile stimulation components according to an embodiment of the present invention is illustrated.
[0034] Figure 6a-6e The diagram shows an electrode layout according to an embodiment of the present invention.
[0035] Figure 7a-7b The placement of sensors on a subject and the use of the sensors to determine a response to a stimulus are illustrated in accordance with an embodiment of the present invention.
[0036] Figures 8a-8dA diagram illustrating placement of sensors on a subject during an activity and detailing synchronization of feedback to improve the subject's performance during the activity in accordance with an embodiment of the present invention.
[0037] Figure 9a-9c A modular physiological monitoring system according to an embodiment of the present invention is illustrated.
[0038] Fig.10 A process flow for enhancing a subject's performance during an activity according to an embodiment of the present invention is illustrated. DETAILED DESCRIPTION
[0039] In the following, specific embodiments of the present disclosure are described with reference to the accompanying drawings; however, the disclosed embodiments are merely examples of the present disclosure and may be implemented in various forms. Therefore, the specific structural and functional details disclosed herein should not be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching those skilled in the art to adopt the present disclosure differently with virtually any appropriate detailed structure. Throughout the description of the drawings, similar reference numerals may refer to similar or identical elements.
[0040] A modular physiological monitoring system for evaluating one or more physiological parameters of a subject (e.g., a human subject, a patient, an athlete, a trainer, an animal (such as a horse, a dog, a pig, a cow, etc.)) according to the present disclosure may include one or more patches, each patch being suitable for attachment to the subject's body (e.g., attachable to its skin, reversibly attached, adhesively attached, having a disposable interface and a reusable module, etc.). In various aspects, the physiological monitoring system may include one or more modules, and each module may include a power source (e.g., a battery, a rechargeable battery, an energy harvesting transducer, a microcircuit and an energy storage device, a thermal gradient harvesting transducer, a kinetic energy harvesting transducer, a radio frequency energy harvesting transducer, a fuel cell, a biofuel cell, etc.), a signal conditioning circuit system, a communication circuit system, one or more sensors configured to generate one or more signals (e.g., physiological and / or physical signals), stimulation, etc., etc.
[0041] One or more of the patches may include one or more interconnects configured and dimensioned to couple with one or more of the modules, the modules including complementary interconnects configured and dimensioned to couple with the corresponding patches. The patches may include a bioadhesive interface for attachment to a subject, and the modules may be held against the subject via the interconnects with the patches.
[0042] In various aspects, the patch can be configured for single use (e.g., disposable). The patch can include a thin, breathable, stretchable laminate. In various aspects, the laminate can include a substrate, a bioadhesive, one or more sensing or stimulating elements according to the present disclosure, and one or more interconnects for coupling the one or more sensing elements to a corresponding module.
[0043] In various aspects, in order to maintain the high comfort and long-term wearability of the patch on the subject, limit the interference to normal body function, limit the interference to joint movement, etc., the patch can be thin enough and fragile so that it can not keep a predetermined shape basically when it is free standing. This definition is described in further detail below. The patch can be provided with a temporary reinforcement film to keep its shape before the patch is placed on the body of the subject. Once adhered to the subject, the temporary reinforcement film can be removed from the patch. When the patch is adhered to the subject, the shape and function of the patch can be kept basically. After removing the patch from the patient, the independent patch now is fragile enough so that the patch can no longer basically keep a predetermined shape (for example, fragile enough so that the patch will not survive in a free standing state). In various aspects, the stretching applied to the patch when removing the patch from the subject can cause the patch to rebound once it is in a free standing state that makes the patch wrinkled into a ball and no longer work.
[0044] In various aspects, the patch can include a film (e.g., substrate) having a sufficiently high tear strength so that the patch does not tear when the patch is peeled from the subject's skin. In various aspects, the ratio between the tear strength of the patch and the peel adhesion strength of the patch to the skin (e.g., tear strength: peel adhesion strength) is greater than 8:1, greater than 4:1, greater than 2:1, etc. This configuration can be advantageous to ensure that the patch can be easily and reliably removed from the subject without tearing after use.
[0045] In various aspects, the patch can include a bioadhesive having a peel adhesion to mammalian skin of greater than 0.02 Newtons / millimeter (N / mm), greater than 0.1 N / mm, greater than 0.25 N / mm, greater than 0.50 N / mm, greater than 0.75 N / mm, greater than 2 N / mm, etc. Such peel adhesion can be approximately determined using the American Society for Testing and Materials (ASTM) standard test, ASTM D3330: Standard test method for peel adhesion of pressure-sensitive tape.
[0046] In various aspects, the patch can exhibit a tear strength greater than 0.5 N / mm, greater than 1 N / mm, greater than 2 N / mm, greater than 8 N / mm, etc. Such tear strength can be approximately determined using the ASTM standard test, ASTM D624: Standard test method for tear strength of conventional vulcanized rubber and thermoplastomers.
[0047] In various aspects, the patch can be provided with a characteristic thickness of less than 50 micrometers (μm), less than 25 μm, less than 12 μm, less than 8 μm, less than 4 μm, etc. Also, in various aspects, a balance between thickness, stiffness, and tear strength can be achieved to maintain a sufficiently high level of comfort for the subject, minimize skin pressure during use (e.g., minimize discomfort and external signals related to skin stretching when the body moves locally around the patch during use), minimize effects on skin health, minimize the risk of wrinkling during use, and minimize the risk of maceration of the subject's skin, while limiting the risk of tearing the patch when it is removed from the subject, etc.
[0048] In various aspects, the characteristics of the patch can be further modified to balance the hydration level of one or more hydrophilic or amphiphilic components of the patch when the patch is attached to a subject. Such adjustments can be useful for preventing overhydration or drying of ionically conductive components of the patch, managing heat transfer coefficients within one or more elements of the patch, managing retention of salts in a container according to the present disclosure and / or migration during exercise, preventing accumulation of exudate, sweat, etc. into a fluid measurement sensor incorporated into the patch or associated module, and the like. In various aspects, the patch or its rate determining component can be provided with a rate of between 200 grams per square meter (g / m2) per 24 hours. 2 / 24hrs) and 20000g / m 2 / 24hrs, 500g / m 2 / 24hrs to 12000g / m 2 / 24hrs, 2000g / m 2 / 24 hours to 8000g / m 2 / 24hrs and the same water vapor transmission rate.
[0049] Such a configuration may be advantageous in providing a comfortable wearable physiological monitor to a subject while reducing material waste and / or cost of goods, preventing contamination or spread of disease due to uncontrolled reuse, and the like.
[0050] In various aspects, one or more patches and / or modules may be configured for conductive interconnection, inductive coupling interconnection, capacitive coupling interconnection with each other. In the case of conductive interconnection, each patch and module interconnection may include complementary conductive connectors that are constructed and dimensioned to fit together when attached. In the case of inductive or capacitive coupling interconnection, the patch and module may include complementary coils or electrodes that are constructed and dimensioned to fit together when attached.
[0051] Each patch or patch-module pair can be configured as a sensing device to monitor one or more local physiological and / or physical parameters of the attached subject (e.g., local to the attachment site, etc.), the local environment, combinations thereof, etc., and relay such information in the form of signals to a host device (e.g., via a wireless connection, via a human body area network connection, etc.), one or more patches or modules on the subject, etc. Each patch and / or patch-module pair can also or alternatively be configured as a stimulation device to apply stimulation to the subject in response to signaling from the host device based on an analysis of the subject's physiological and / or physical parameters measured by the sensing device(s).
[0052] In various aspects, the host device can be configured to coordinate the exchange of information to / from each module and / or patch and generate one or more physiological signals, physical signals, environmental signals, kinetic signals, diagnostic signals, alarms, reports, recommendation signals, commands, combinations thereof, etc. for a subject, a user, a network, an electronic health record (EHR), a database (e.g., as part of a data management center, an EHR, a social network, etc.), a processor, a combination thereof, etc.
[0053] In various aspects, a system according to the present disclosure may include a plurality of substantially similar modules (e.g., generally interchangeable modules, but with unique identifiers) for coupling with a plurality of patches, each patch optionally being different from other patches in the system (e.g., may include alternative sensors, sensor types, sensor configurations, electrodes, electrode configurations, etc.). Each patch may include an interconnection suitable for attachment to an associated module. After the module is attached to the corresponding patch, the module may verify the type and operation of the patch that has been paired therewith. In various aspects, the module may then initiate monitoring operations to the subject via the attached patch, communicate with one or more patches on the subject, hub, etc. Data collection from each module may be coordinated by one or more modules and / or with a host device according to the present disclosure. The module may report a timestamp together with the data so as to synchronize data collection across multiple patches on the subject and between subjects-modules. Therefore, if a module is to be replaced, a hot-swap replacement (e.g., replacement during the monitoring process) may be easily performed by the subject, a caregiver, a practitioner, etc. during the monitoring process. Such a configuration may be advantageous for performing redundant, continuous monitoring of a subject and / or obtaining spatially relevant information from multiple locations on the subject during use.
[0054] In various aspects, the module and / or patch may include corresponding interconnections for coupling to each other during use. The interconnection may include one or more connectors configured so that the module and patch can only be coupled relative to each other in a single unique orientation. In various aspects, the modules may be color-coded by function. The temporary reinforcement element attached to the patch may include instructions, corresponding color coding, etc., to help the user or subject simplify the process of monitoring.
[0055] In addition to physiological monitoring, one or more patches and / or modules may also be used to provide stimulation to a subject, as will be described in further detail below.
[0056] In some embodiments, the modular physiological monitoring system includes one or more sensing devices that can be placed or attached to one or more locations on the subject. Alternatively or additionally, the one or more sensing devices can be placed outside the subject, such as one or more sensors that are not physically attached to the subject (e.g., cameras, acoustic sensors, etc.). The sensing devices are used to determine whether an event is occurring and to determine one or more characteristics of the event by monitoring and measuring physiological parameters of the subject. Whether an event has occurred can be determined by a device that is at least partially external and physically different from the one or more sensing devices (such as a host device that is in wired or wireless communication with the sensor), as described below with respect to Figure 1The modular physiological monitoring system includes one or more stimulation devices, which again can be any combination of devices attached to a subject or placed "remote" from the subject to apply stimulation to the subject in response to a detected event. Various types of stimulation can be applied, including but not limited to stimulation via thermal input, vibration input, mechanical input, compression with electrical input, etc.
[0057] The sensing devices of the modular physiological monitoring system (such as the following Figure 1 The patch-module pair described herein can be used to monitor one or more physiological functions or parameters of a subject, as will be described in further detail below. A sensing device of a modular physiological monitoring system, or a host device configured to receive data or measurements from a sensing device, can be used to monitor one or more events (e.g., by analyzing a signal measured by the sensing device, based on a metric derived from the signal, etc.). A stimulation device of a modular physiological monitoring system can be configured to deliver one or more stimuli (e.g., electrical, vibrational, acoustic, visual, etc.) to a subject. The stimulation device can receive a signal from one or more of the sensing device or the host device, and provide stimulation in response to the received signal.
[0058] Figure 1 Various aspects of a modular physiological monitoring system according to the present disclosure are shown. Figure 1 , subject 1 is shown with multiple patches and / or patch-module pairs according to the present disclosure (each patch and / or patch-module pair is attached thereto at a location described below), a host device 145 according to the present disclosure, a feedback / user device 147 according to the present disclosure that displays some data 148 based on signals obtained from subject 1, and one or more feedback devices 135, 140 according to the present disclosure that are configured to convey one or more aspects of the signals or information collected therefrom to subject 1. In some embodiments, the feedback devices 135, 140 may also or alternatively be used as stimulation devices. The host device 145, the user device 147, the patches and / or patch-module pairs, and / or the feedback devices 135, 140 may be configured for wireless communication 146, 149 during a monitoring session.
[0059] In various aspects, the patch-module pair can be adapted to be placed at almost any location on the body of subject 1. Figure 1As shown in , some locations may include attachment to the skull or forehead 131, the temple, the ear or behind the ear 50, the neck, the front, side or back of the neck 137, the shoulder 105, the chest area 100 with minimal muscle mass, integrated into a piece of decorative jewelry 55 (which can be a host, hub, feedback device, etc.), placed on the torso 11a-c, placed on the abdomen 80 to monitor movement or breathing, under the rib cage 90 to monitor breathing (generally on the right side of the body to greatly reduce EC G on the measurement), on a muscle such as the biceps 85, on the wrist 135 or in combination with a wearable computing device 60 (e.g., a smart watch, fitness band, etc.) on the wrist, on the hip 25, on the thigh 75, on the calf muscle 70, on the knee 35, especially for proprioception-based research and impact research, on the calf 30, mainly for impact research, on the ankle 65, over the Achilles tendon 20, on the front or top of the foot 15, on the heel 5, or around the sole of the foot or toes 10. Other locations for placement of such devices are envisioned. The selection of monitoring and / or stimulation sites is generally determined based on the intended application of the patch-module pair described herein.
[0060] Additional placement sites on the abdomen, perineum region 142a-c, genitals, urogenital triangle, anal triangle, sacral region, inner thigh 143, etc. may be advantageous in assessing the subject's autonomic function. Such placement areas may be advantageous for assessment of parasympathetic nervous system (PNS) activity, somatosensory function, assessment of sympathetic nervous system (SNS) function, etc.
[0061] A placement location on the wrist 144a, hand 144b, etc. may facilitate interaction with a subject, such as via performing a pressure test, performing a thermal pressure test, performing a tactile pressure test, monitoring outflow, incoming flow, outgoing flow, etc.
[0062] Placement sites on the nipple, areola, lip, labia, clitoris, penis, anal sphincter, levator ani muscle, on the rhabdominis cavernosa, deep transverse perineal muscle, labia minora, labia majora, one or more nerves near their surface, posterior scrotal nerve, perineal membrane, perineal nerve, superficial perineal nerve, dorsal nerve, inferior rectal nerve, etc. can be beneficial for evaluating autonomic nerve ablation procedures, autonomic nerve modulation procedures, evaluation of the subject's PNS, evaluation of the subject's sexual dysfunction, etc.
[0063] Placement sites on the face 141, over eye muscles, near the eyes, over facial muscles (e.g., nasal, temporal, zygomaticus minor / major, orbicularis oculi, occipitofrontal), near the nasal ducts, over facial bones (e.g., frontal process, zygomatic bone / surface, zygomaticofacial face, macular bone, nasal bone, frontal bone, maxillary bone, temporal bone, occipital bone, etc.) can be beneficial for assessing eye function, salivary function, sinus function, interaction with the lips, interaction with one or more nerves of the PNS (e.g., interaction with the vagus nerve in, on and / or near the subject's ear), and the like.
[0064] In various aspects, a system according to the present disclosure can be configured to monitor one or more physiological parameters of subject 1 before, during, and / or after one or more of stress testing, medication consumption, exercise, rehabilitation training, massage, driving, watching a movie, amusement park rides, sleeping, sexual intercourse, surgery, interventional or non-invasive procedures, neuroremodeling procedures, denervation procedures, sympathectomy, nerve ablation, peripheral nerve ablation, radiosurgery procedures, interventional procedures, cardiac repair, administration of analgesics, combinations thereof, and the like. In various aspects, a system according to the present disclosure can be configured to monitor one or more aspects of the autonomic nervous response to a procedure, confirm the completion of a procedure, select candidates for a procedure, follow up with a subject after receiving a procedure, assess the durability of a procedure, and the like (e.g., such as where the procedure is a renal denervation procedure, a carotid artery denervation procedure, a hepatic artery denervation procedure, LUTs therapy, bladder denervation procedure, urethral therapy, prostate ablation, prostate nerve denervation procedure, cancer therapy, pain block, nerve block, bronchial denervation surgery, carotid sinus neuromodulation procedure, implantation of a neuromodulation device, tuning of a neuromodulation device, and the like).
[0065] Additional details regarding modular physiological monitoring systems, kits, and methods are further described in PCT application serial No. PCT / US2014 / 041339, published as WO 2014 / 197822 and entitled “Modular Physiologic Monitoring Systems, Kits, and Methods,” PCT application serial No. PCT / US2015 / 043123, published as WO 2016 / 019250 and entitled “Modular Physiologic Monitoring Systems, Kits, and Methods,” and PCT application serial No. PCT / US2017 / 030186, published as WO 2017 / 190049 and entitled “Monitoring and Management of Physiologic Parameters of a Subject,” the disclosures of which are incorporated herein by reference in their entirety.
[0066] Various embodiments are described below with respect to monitoring cardiac output using a modular physiological monitoring system and using information related to cardiac output to coordinate cyclical compression and relaxation of the microvascular vascular network. Such techniques provide various advantages, such as achieving significant afterload reduction, which reduces the workload of the heart because comparable blood flow is achieved with the same or less cardiac work. These and other advantages will be described in further detail below.
[0067] In some embodiments, the modular physiological monitoring system may include physically different sensing and stimulation devices, such as sensing and stimulation devices that are physically attached to the subject at different locations. For example, the sensing and stimulation devices may include the above-mentioned Figure 1 In other embodiments, one or more devices may provide both monitoring and stimulation functions. For example, Figure 1 One or more patch-module pairs described herein may be configured to function as both a sensing device and a stimulation device. However, it should be appreciated that embodiments are not limited to only those used with Figure 1 The patch-module pair is used together as a sensing and stimulation device. Various other types of sensing and stimulation devices can be utilized, including but not limited to sensors that are "ex vivo" relative to the subject 1.
[0068] The sensing and / or stimulation devices of the modular physiological monitoring system can be configured for radio frequency (RF) or other wireless and / or wired connections between each other and / or with a host device. Such RF or other connections can be used to transmit or receive feedback parameters or other signaling between the sensing and stimulation devices. For example, feedback can be provided based on measurements of physiological parameters obtained using the sensing device to determine when an event related to cardiac output occurs. In some embodiments, various thresholds for stimulation applied by the stimulation device can be determined based on such feedback. The threshold can be related to the amplitude or frequency of the electrical stimulation or other stimulation. The threshold can also be related to whether the stimulation is initiated by the stimulation device based on the feedback.
[0069] During and / or after applying stimulation with the stimulation device, the sensing device can monitor the subject's physiological response. If the stimulation successfully achieves the desired response, the stimulation can be stopped. Otherwise, the type, timing, etc. of the stimulation can be adjusted.
[0070] In some embodiments, the user of the modular physiological monitoring system can set preferences for stimulation types, levels, and / or otherwise personalize sensations during a set period or at any point during use of the modular physiological monitoring system. The user of the modular physiological monitoring system can be a subject monitored and stimulated by the sensing device and the stimulation device, or a physician, nurse, physical therapist, medical assistant, caregiver, etc. of the subject being monitored and stimulated. The user can also choose to disconnect or shut down the modular physiological monitoring system at any time, such as via operation of a switch, pressure sensation, voice-operated instructions, etc.
[0071] The stimulation or feedback that can be provided via one or more stimulation devices in the modular physiological monitoring system can have a variety of forms, including physical stimulation (e.g., electricity, heat, vibration, pressure, stroke, combinations thereof, etc.), optical stimulation, acoustic stimulation, etc.
[0072] Physical stimulation may be provided in the form of negative feedback, such as in a brief electric shock or pulse as described above. Data or knowledge from the waveform applied in a conducted electric weapon (CEW) (such as in an electric shock device) may be used to avoid painful stimulation. Physical stimulation may also be provided in the form of positive feedback, such as by invoking pleasant sensations by combining non-painful electrical stimulation with pleasant sounds, music, lighting, smells, etc. Physical stimulation is not limited to electric shocks or pulses. In other embodiments, physical stimulation may be provided by adjusting temperature or other stimulation, such as in providing bursts of cold or hot air, bursts of mist, vibrations, tension, stretching, pressure, etc.
[0073] Feedback provided via the physical stimulation described herein and other stimulation can be synchronized with, initiated by, or otherwise coordinated or controlled by one or more monitoring devices (e.g., a host device, one or more sensing devices, etc.). The monitoring device can be physically (e.g., via one or more wires or other connectors), wirelessly (e.g., via radio or other wireless communication) connected to the stimulation device. Physical stimulation can be applied to various areas of the subject, including but not limited to the subject's wrists, soles of the feet, palms, nipples, forehead, ears, mastoid areas, skin, etc.
[0074] Optical stimulation may be provided via one or more stimulation devices. Optical stimulation may be positive or negative (e.g., by providing pleasant or unpleasant lighting or other visual effects). Similarly, acoustic stimulation may be provided via one or more stimulation devices with positive feedback or negative feedback (e.g., by providing pleasant or unpleasant sounds). Acoustic stimulation may take the form of spoken words, music, etc. In some embodiments, acoustic stimulation may be provided via a smart speaker or other electronic device (such as an Amazon The stimulation itself can be provided to induce a specific psychological or psychoacoustic effect in the subject, such as instructing the subject to stop an action, restart an action (e.g., breathing), adjust an action (such as the timing between stepping and breathing action, muscle contraction and leg position, etc.).
[0075] As described above, the modular physiological monitoring system can be operated in a therapeutic mode in that stimulation is provided when one or more cardiac parameters of the subject indicate an event (e.g., an actual, impending, or predicted malfunction or deterioration). However, in other embodiments, the modular physiological monitoring system can also operate or provide as a type of cardiac "pacemaker." In such embodiments, the modular physiological monitoring system has the potential to reduce the frequency of cardiac events or potentially avoid certain cardiac events altogether. The modular physiological monitoring system can provide functionality for timing and synchronizing the periodic compression and relaxation of the microvascular vascular network with cardiac output. Such techniques can be used to respond to a class of malfunction events as indicated above. Alternatively or additionally, such techniques can be provided substantially continuously to improve overall cardiac performance (e.g., blood flow) with the same or less cardiac work.
[0076] In some embodiments, the modular physiological monitoring system can be configured to provide multimodal stimulation to the subject. Multimodal methods use one or more forms of stimulation (e.g., thermal and electrical, mechanical and electrical, etc.) to mimic another stimulus to induce local nerves to respond to the simulated stimulus in the same manner. In addition, in some embodiments, multimodal stimulation or input can be used to enhance specific stimulation. For example, adding simulated electrical stimulation can enhance the effect of thermal stimulation.
[0077] The modular physiological monitoring system can use pulses across space and time (e.g., frequency, pulse trains, relative amplitudes, etc.) to mimic vibration, comfort or discomfort, mild or severe pain, wetness, heat / cold, train neuroplasticity, taste (e.g., using a stimulation device placed in the subject's mouth or on the tongue to mimic sour, sweet, salty, bitter, or umami), tension or stretch, sound or acoustics, sharp or dull pressure, light polarization (e.g., linear versus polar, "Haidinger brush"), color or brightness of light, and the like.
[0078] Stimulation amplification may also be provided by one or more modular physiological monitoring systems using multimodal inputs. Stimulation amplification represents a hybrid approach in which a first type of stimulation may be applied and a second, different type of stimulation is provided to enhance the effect of the first type of stimulation. As an example, a first stimulation may be provided via a heating element, where the heating element is augmented by other stimulation devices that use electrical mimicry to amplify and augment the heating stimulation through nearby electrodes or other pacing modes. Electrical stimulation may also be used to supplement or mimic various other types of stimulation, including, but not limited to, vibration, heat, cold, etc. Different, potentially unique stimulation patterns may be applied to a subject, where the central nervous system and the peripheral nervous system interpret such different or unique stimulation patterns as different stimulation modalities.
[0079] Another example of stimulus augmentation is to sense a "real" stimulus, measure it, and construct a proportional response through mimicry (such as using electrical pulses). A real stimulus can be measured through electro-thermal conversion, such as sensing heat or cold from a Peltier device. This real stimulus can then be amplified using virtual mimicry, which can provide energy savings and the possibility of modifying the virtual stimulus to change the perception of the real stimulus.
[0080] In some embodiments, the stimulation device in the modular physiological monitoring system includes an electrode array that is attached (e.g., via an adhesive or otherwise held in place) to a preferred body part. One or more of the stimulation devices may include multiple sensing and stimulation electrodes, including different types of sensing and / or stimulation electrodes. In some embodiments, the sensing electrodes on the stimulation device may be different from the sensing devices in the modular physiological monitoring system, because the sensing devices in the modular physiological monitoring system can be used to measure physiological parameters of the subject, while the sensing electrodes on the stimulation device in the modular physiological monitoring system can be used to monitor the application of stimulation to the subject.
[0081] The test stimulation can be initiated in the form of a pattern in the electrode array, starting with application via one or a few of the stimulation electrodes and increasing in number over time to cover the entire or a larger portion of the electrode array. The test stimulation can be used to determine the subject's response to the applied stimulation. Sensing electrodes on the stimulation device can be used to monitor the application of the stimulation. The electrode array can also be used to record the desired output (e.g., a physiological parameter related to cardiac output). In this manner, one or more of the electrodes in the array can be configured to measure a locally induced response associated with the stimulation itself. Such an approach can be advantageous for confirming the capture of a target nerve during use. By monitoring the neural response to the stimulation, stimulation parameters including amplitude, duration, number of pulses, etc. can be adjusted while ensuring that the target nerve is enlisted by the stimulation in use.
[0082] The test stimulus can be migrated or applied in a pattern to different electrodes at different locations in the electrode array. The response to the stimulus can be recorded or otherwise measured using one or more of the sensing electrodes of the sensing device in the modular physiological monitoring system and / or the stimulation device in the modular physiological monitoring system. The response to the test stimulus can be recorded or analyzed to determine the optimal sensing or application site of the stimulus to achieve the desired effect or response in the subject. Therefore, the test stimulus can be used to find the optimal sensing (e.g., skin knife driver) position. This allows for powerful positioning for optimal pacing or other stimulation application, which can be personalized for different subjects.
[0083] The stimulation device applied to the subject via an adhesive (e.g., an adhesive-applied stimulation device) can be in the form of a disposable or reusable unit, such as a patch and / or a patch-module or patch / hub pair, as described above with respect to Figure 1 In some embodiments, the adhesively applied stimulation device includes a disposable interface that is configured to be thin, stretchable, conformable to the subject's skin, and soft enough to be worn comfortably. The disposable interface can be made of a very thin, stretchable, and / or breathable material so that the subject generally does not feel the device on his or her body.
[0084] The adhesively applied stimulation device also includes a component for interfacing with the subject through an adhesive interface and / or a window in the adhesive interface. Such a component may include a plurality of electrodes, which are coupled to the reusable assembly of the adhesively applied stimulation device and are coupled to the subject's body through the adhesive interface. The component may also or alternatively include: a vibration actuator to provide vibration perpendicular to and / or across the skin surface to which the adhesively applied stimulation device is attached; a thermal device, such as a Peltier device, a heating element, a cooling element, an RF heating circuit, an ultrasonic source, etc.; a component for stroking the skin, such as a shape memory actuator, an electroactive polymer actuator, etc.; a component for applying pressure to the skin, such as a pneumatic actuator, a hydraulic actuator, etc.
[0085] The actuation component of the adhesively applied stimulation device may be applied over a small area of the subject's applied area such that the adhesive interface provides the biasing force required to resist actuation of the actuation component relative to the subject's skin.
[0086] The adhesively applied stimulation device can be configured as two components - a disposable body interface and a reusable component. The disposable body interface can be applied to conform to the desired anatomy of the subject and wrapped around the body so that the reusable component can interface with the disposable component in an area that is open and without a natural interface between the subject and another surface.
[0087] Adhesively applied stimulation devices can also be a single component, rather than two components or other multi-component arrangements. Such a device implemented as a single component can include an adhesive interface with a subject, the adhesive interface including two or more electrodes applied to the subject. Adhesively applied stimulation devices implemented as a single component have potential advantages, such as easier application to the subject's body, but may be at a disadvantage relative to two or more component arrangements in terms of breathability, compliance, challenging interfaces, etc.
[0088] Figure 2An example of an adhesively applied stimulation device implemented as a patch-module pair 200 is illustrated. As shown, a patch-module pair 200 including a module 205 coupled to a patch 210 is applied to a skin surface 202 of a subject 201. It should be appreciated that, depending on the function of the electrodes 215a, 215b, 220a, 220b included in the patch 210, the patch-module pair 200 can be used as a sensing device in addition to or in place of the stimulation device. The electrodes 215a, 215b face outward (e.g., away from the skin surface 202 of the subject 201). The electrodes 220a, 220b interface with the skin surface 202 of the subject 201. One or more of the electrodes 215a, 215b, 220a, 220b can be used as a sensor to sense physiological parameters associated with the subject 201 and / or the surrounding environment around the subject 201. One or more of the electrodes 215a , 215b , 220a , 220b may also or alternatively be configured to apply stimulation to the subject 201 .
[0089] The patch-module pair 200 communicates 250 wirelessly with one or more other devices in a modular physiological monitoring system, such as one or more other stimulation devices, one or more sensing devices, and / or a host device. Advantageously, the patch 210 can be stretchable to maintain monitoring and / or application of stimulation to the subject 201 in accordance with movement, change of shape, or stretching along the skin surface 202 of the subject 201. The patch-module pair 200 is an example of a multi-component adhesively applied device because the patch-module pair 200 includes a low-cost disposable patch 210 and a miniature reusable module 205. This configuration can be advantageous for providing a soft, comfortable sensing and / or stimulation device for a modular physiological monitoring system.
[0090] As discussed above, various types of input or stimulation can be applied to the subject by the stimulation device. In some embodiments, the stimulation is in the form of an electric shock. For example, the skin interface electrodes 220a, 220b of the patch 210 can be configured to apply electrical energy to the subject 201. Figure 3-5 Examples of adhesively applied stimulation devices are shown that apply other types of stimulation using other means.
[0091] Figure 3A patch-module pair 300 configured to apply vibration energy or stimulation 325 to a skin surface 302 of a subject 301 is illustrated. The patch-module pair 300 includes an adhesive layer 310 (e.g., potentially forming part of a patch) and a module 315. The adhesive layer 310 secures the patch-module pair 300 to the skin surface 302 of the subject 301. The module 315 includes a transducer 305 configured to generate vibration energy 325 for transmission 330 into the body of the subject 301. The transducer 305 can be controlled and / or powered by an electronics unit 320 included in the module 315. In the non-limiting example shown, the transducer 305 can be a piezoelectric material (e.g., a polymer, a ceramic, etc.).
[0092] Figure 4 A patch-module pair 400 is illustrated for applying thermal energy or stimulation 430 to a subject 401. The patch-module pair 400 includes an adhesive layer 410 (e.g., potentially forming part of a patch) and a module 415. The adhesive layer 410 secures the patch-module pair 400 to a skin surface 402 of the subject 401. The module 415 includes one or more heating bands 405 or RF heating circuits, and a thermocouple 406 coupled to an electronic unit 420 including a power supply, microcircuitry, etc., for example, via one or more electronic interconnects 407, 408.
[0093] Figure 5 A patch-module pair 500 for applying tactile input or stimulation 525 to a subject 501 is illustrated. The patch-module pair 500 includes an adhesive layer 510 (e.g., potentially forming part of a patch) and a module 515. The adhesive layer 510 secures the patch-module pair 500 to a skin surface 502 of the subject 501. The module 515 includes a transducer 505 configured to generate torsional energy 525 for transfer 530, 535, 540 into the body of the subject 501. The transducer 505 may be controlled and / or powered by an electronics unit 520 included in the module 515. In the non-limiting example shown, the transducer 505 may be an electric motor having an eccentricity on its output shaft. The delivery 530, 535, 540 of energy into the skin surface 502 of the subject 501 can cause a range of sensations (e.g., poking, rubbing, etc.) depending on the amplitude, frequency, duration, duty cycle, etc. of the transducer 505 and the physical configuration of the patch-module pair 500 and the selection of the adhesive layer 510 (if such a layer is used in the embodiment discussed).
[0094] It should be recognized that Figure 2-5 The components described for applying stimulation to a subject are not limited to use in stimulation devices utilizing only adhesively applied form factors. Similar components may be utilized in other form factors described herein.
[0095] Figure 6a -e illustrates a non-limiting example of a patch electrode layout.
[0096] Figure 6a Patch 601 coupled to module 603 is shown. Patch 601 includes multiple electrodes 605a, 605b for interfacing with a subject. Electrodes 605a, 605b are arranged in a very tight bipolar arrangement, which is suitable for obtaining bipolar electrical readings from the surface of the subject with a very small profile. In various aspects, one or more of electrodes 605a, 605b may include electrode features for enhancing the electrical coupling between module 603 and the subject's underlying tissue. In various aspects, the pressure applied to the top of the attached module 603 can be suitable for engaging this electrode feature with the subject's underlying tissue. This arrangement can be advantageous for providing an ultra-miniature heart rate monitor, a pediatric heart rate monitor, an EMG sensor for being placed near a sex organ, an electrophysiological monitor behind the ear, on the neck, etc., and / or providing a stimulation device as described herein.
[0097] Figure 6b Patch 607 coupled to module 609 is shown. Patch 607 includes a bipolar electrode arrangement 611a, 611b for interfacing with a subject. Such an arrangement can be advantageous for monitoring a subject's heart rate, signal channel ECG, respiratory rate, etc. as part of a monitoring session and / or providing a stimulation device as described herein. Multiple such patches 607 can be applied to a subject to extract higher levels or spatially distributed electric fields on the subject's body simultaneously.
[0098] Figure 6c A patch 613 coupled to a module 615 is shown. The patch 613 includes three electrodes 617a, 617b, 617c for interfacing with a subject. The electrodes 617a, 617b, 617c may be arranged to allow for multi-site capture of the subject's electrophysiological activity. This arrangement may be advantageous for generating field vectors near the patch 613 and / or applying stimulation to the subject.
[0099] Figure 6d Patch 619 is shown coupled to module 621 according to the present disclosure. Patch 619 includes a quadrupole electrode arrangement 623a, 623b, 623c, 623d for interfacing with a subject. The quadrupole electrodes 623a, 623b, 623c, 623d may be arranged to allow for multi-site capture of electrophysiological activity of the subject, and / or application of stimulation to the subject. Such an arrangement may be advantageous for generating field vectors near patch 619, for mapping electric field propagation across the surface of the subject, and the like.
[0100] Figure 6eA patch 625 is shown that is coupled to a module 627 according to the present disclosure. The patch 625 includes a plurality of electrodes 629a, 629b for interfacing with a subject. The electrodes 629a, 629b are shown in a bipolar arrangement connected to stretchable conductive elements 631a, 631b. In various aspects, this configuration can be advantageous for freely bending and stretching 633 with the subject's nearby tissue during a monitoring and / or stimulation session. The stretchable conductive elements 631a, 631b can be arranged to change impedance repeatedly during stretching. Alternatively or in combination, a thin stretchable bielectric element can be arranged between two or more layered conductive elements 631a, 631b, and the impedance (i.e., capacitance) of the resulting structure can be measured by stretching. According to the present disclosure, this configuration can be advantageous for evaluating movement or local tissue stretching (e.g., due to muscle movement, breathing, etc.) under the patch 625 in combination with one or more physiological signals (e.g., such as electrophysiological signals, stretch-related artifacts, etc.). Such a configuration may be suitable for physical therapy monitoring sessions (e.g., combining EMG with proprioception monitoring, combining ECG to assess breathing, gait assessment, gait correction systems, etc.).
[0101] The non-contact stimulation device can be, for example, an audio and / or visual system, a heating or cooling system, etc. Smart speakers and smart TVs or other displays are examples of audio and / or visual non-contact stimulation devices. For example, a smart speaker can be used to provide auditory stimulation to the subject in the form of alarms, suggestions, commands, music, other sounds, etc. Other examples of non-contact stimulation devices include components for controlling temperature, such as fans, air conditioners, heaters, etc.
[0102] One or more stimulation devices may also be incorporated into other systems, such as stimulation devices integrated into a bed, chair, operating table, exercise equipment, etc., with which the subject interfaces. For example, a bed may include one or more pneumatic actuators, vibration actuators, shakers, etc., to provide stimulation to the subject in response to commands, feedback signals, or control signals generated based on measurements of one or more physiological parameters of the subject using one or more sensing devices.
[0103] Although the present disclosure has discussed devices attached to the body for monitoring various aspects of a subject's condition and / or physiological information, as well as providing stimulation, therapeutic stimulation, and the like, alternative devices are contemplated. Non-contact devices can be used to obtain movement information, audible information, changes in skin blood flow (e.g., such as by monitoring subtle skin color changes associated with heart rate, such as), respiration (e.g., audible sounds and movement associated with respiration), and the like. Such non-contact devices can be used in place of or in addition to human systems for monitoring certain conditions, applying stimulation, and the like. Information captured by the non-contact device can be used by itself or in combination with information collected from sensing devices on the body to guide the application of stimulation to the subject via one or more stimulation devices on the body and / or via one or more non-contact stimulation devices.
[0104] In some embodiments, monitoring various aspects of a subject using a sensing device in a modular physiological monitoring system can utilize a sensing device fixed to or implemented on one or more contact surfaces (such as the surface of a piece of furniture on which the subject is located) (e.g., the surface of a bed, a recliner, a car seat, etc.). The surface can be equipped with one or more sensors to monitor the subject's movement, breathing, HR, etc. In order to achieve reliable recording, it is advantageous to position such a surface well relative to the subject. It is also advantageous to construct such a surface to take into account the subject's comfort to prevent the subject from feeling the sensing surface and to maintain the use of the sensing surface over time.
[0105] As discussed above, the stimulation device may take the form of an audio, visual, or audio-visual system or device in the subject's sleep space. Examples of such stimulation devices include smart speakers. Such stimulation devices provide a means for instructing the subject to change their sleep state. The input or stimulation may take the form of a message, suggestion, command, auditory alarm, music input, change in music input, visual alarm, one or more lights, a combination of light and sound, etc. Such non-contact stimulation devices include And other systems.
[0106] Skeletal muscle is the primary effector of movement and locomotion in mammals, including humans. Physical activity in mammals, such as humans, originates from skeletal muscle, which is connected to attached muscles or bones via ligaments. The interaction of the proteins of the molecules actin and myosin in three dimensions results in muscle striations and cell contraction, thereby facilitating virtually all movement in humans and other mammals. Muscle energetics obeys the physical laws of energy transduction, converting biochemical energy into contractile or physical energy. The biochemical energy is derived from glucose, which initiates the chain of conversion from chemical energy to mechanical energy.
[0107] Chemical energy from glucose can be derived from aerobic metabolism (e.g., via O2 oxidation of glucose) or from anaerobic metabolism (e.g., anaerobic glucose-based energy via lactic acid intermediates). Aerobic metabolism is more efficient and is the primary pathway for muscle-derived energy.
[0108] Glucose metabolism involves two pathways, anaerobic and aerobic processes. Aerobic metabolism occurs in the mitochondria and is the most efficient muscle means of energy conversion (e.g., from biochemical to mechanical). Aerobic metabolism requires oxygen, while anaerobic metabolism occurs in the cytoplasm. Anaerobic metabolism is significantly less efficient than aerobic metabolism.
[0109] Anaerobic metabolism involves the diffusion of blood-borne glucose into the cytoplasm, which is immobilized and activated by phosphorylation. Glucose molecules are converted to fructose, which is then phosphorylated to fructose diphosphate. These are energy-demanding steps (e.g., two adenosine triphosphates (ATP) per glucose molecule). Fructose is cleaved into two glyceraldehyde phosphates (GPs).
[0110] Biochemical energy is released in the form of two ATP and two NADH (nicotinamide adenine dinucleotide (NAD) + hydrogen (H)), which are oxidized to phosphoglycerate. In the final stage, two additional ATP are produced when phosphoglycerate is oxidized to pyruvate. These ATP are the biochemical currency of metabolism and energy.
[0111] Aerobic metabolism of pyruvate is the starting point in the oxidative phosphorylation process via the Krebs citric acid cycle. In this process, all carbon-carbon (CC) and carbon-hydrogen (CH) bonds of pyruvate are transferred to oxygen. This process is more efficient in energy production than anaerobic glycolysis.
[0112] Therefore, optimal energy efficiency and muscle output strictly depends on the delivery of O2 and glucose to the functional muscles via the blood. This is equivalent to a large amount of blood flowing into the muscles, which delivers both glucose and oxygen.
[0113] Quantitative blood supply to muscles is essential for high muscle mechanical energy output, especially during exercise or other demands on body movement. Blood supply is a function of blood volume delivery over time (cardiac output, l / min) and the resistance around the blood vessels within the muscle (mmHg / flow in mmHg / ml / min). Inappropriate matching of pressure flow to surrounding resistance can lead to muscle inefficiency or failure.
[0114] Cardiovascular fitness and all physical activity are directly derived from the energy cycle described above. During exercise, the ability of the heart and lungs to deliver enough oxygen and glucose to skeletal muscles is the primary function of the heart and conductive blood vessels. Each heartbeat ejects a certain amount of blood into the aorta, which then flows throughout the body. Cardiac blood output can be measured in liters of blood per minute. Stroke volume is an indicator of blood delivery (e.g., the amount of blood per heartbeat). Stroke volume multiplied by heart rate produces cardiac output. If this volume of blood (e.g., cardiac output) is insufficient to meet muscle and oxygen needs, the muscles will not function at optimal performance, and athletic performance will be impaired compared to their potential if greater blood delivery is available.
[0115] Hypovolemia is similarly a problem in heart failure. In such cases, massage volume and cardiac output are usually impaired, and the body's muscle tissues do not receive enough blood to allow normal daily activities.
[0116] An important physiological parameter is vascular resistance. If vascular resistance decreases in failure, then blood perfusion improves and the patient's clinical condition improves. The main functions of modern heart failure drugs are to increase cardiac energy to improve stroke volume and systemic pressure, and to decrease peripheral vascular resistance, thereby allowing more blood to flow through it.
[0117] Heart failure with low cardiac output can be improved by increased contractility via inotropes, which increase the strength of cardiac contractions. Cardiac output can also be increased by vasodilators, which are drugs that manipulate small resistance blood vessels to relax them and increase blood flow. Thus, dilated microvasculature and improved cardiac contractility / muscle strength are key factors in increasing the delivery of oxygen and glucose to active muscles.
[0118] Mechanical devices can be used to provide assistance to the subject to increase blood volume and blood flow, and use an external energy source to optimize pressure. Some mechanical devices (such as total artificial hearts and left ventricular assist devices (LVAD)) work by increasing introversion. Other mechanical devices include intra-aortic balloon pumps (IABP). IABP is an inflated-deflated circulation / pressurized balloon placed in the peripheral aorta, and its expansion and contraction are synchronized with the heartbeat. The balloon inflation and deflation of IABP is very rapid, and helium (due to its low density) and very fast inflation / deflation cycles are often used. Effective balloon pump use requires precise timing of inflation and deflation, and is synchronized using a surface electrocardiogram (ECG). When the aortic valve is closed, the balloon must expand during diastole and quickly deflate or contract before or during ventricular contraction when the aortic valve has been opened or is opening. This fine-tuning reduces the afterload of the heart and helps ejection due to fine-tuning of inflation-deflation timing.
[0119] The inflation-deflation cycle and sequence is effective for increasing blood flow and / or blood pressure by rapid inflation-deflation in the distal aorta, thereby achieving two positive results. First, inflation assists blood flow by expanding the balloon and pumping blood. Inflation occurs during diastole with the aortic valve closed. Deflation occurs at the aortic valve opening, resulting in a significant reduction in afterload resistance, thereby reducing the workload of the heart because the deflation creates a lower pressure area of propagation. The end result is increased cardiac output at comparable or reduced myocardial energy expenditure because better matching is made possible by the external energy source. This assist device allows for more muscle glucose and oxygen delivery, which is derived from the external energy source via improved matching and the addition of timed energy delivery.
[0120] In some embodiments, techniques are provided to reduce technical and physiological vascular afterload in precise synchronization with cardiac pressure-volume boluses to improve muscle energetics.
[0121] The body's microvasculature consists of highly compliant, highly compressible reservoirs of blood. The microvasculature includes arteries, arterioles, capillaries, venules, and veins. Such vascular structures are ubiquitous in the human body, especially in the large muscle tissues of the limbs and the spinal cord.
[0122] Many blood vessels within skeletal muscle are compressed during skeletal muscle contraction and open during muscle relaxation. In some embodiments, compression of skeletal muscle achieves antegrade pressor, which increases cardiac output because compression is used to increase muscle blood flow.
[0123] Compliant multi-vascular micro- and macrovascular reservoirs are located in front of, at, and distal to the muscle cells, thus increasing blood flow via alternating tissue compression-release. That is, in effect, this is a physiological "turbocharger" that increases and enhances the heart's delivery of oxygen and nutrients to the muscle tissue.
[0124] When precisely timed and properly synchronized with cardiac output (e.g., cardiac pressure-flow bolus), cyclical compression and relaxation of the microvascular network provides multiple advantages. Such advantages include significant afterload reduction, thereby reducing the workload of the heart because comparable blood flow is achieved with the same or less cardiac work. Such advantages also include active blood pumping along the natural vascular pressure gradient of arteries and veins. The hemodynamic and fluid dynamic effects are similar to those achieved with an external balloon pump, with afterload reduction as the vasculature expands after compression. Active contractile pumping of the cardiac output or blood bolus along the veno-venous blood gradient further assists the heart's antegrade pumping, thereby amplifying the turbo-charging effect by increasing pressure and flow using energy or power from skeletal muscle.
[0125] In some embodiments, the technique includes signaling a subject to voluntarily feedback to initiate contraction or relaxation of a skeletal muscle (e.g., in a leg, arm, spinal cord, etc.). This signaling is performed in real time (e.g., such as via one or more stimulation devices in a modular physiological monitoring system described herein). The signaling is timed using various physiological parameters such as ECG, heart rate, respiration, or other physiological signals (e.g., measured or monitored using one or more sensing devices in a modular physiological monitoring system described herein). Notification of feedback is provided to the subject to give appropriate timing of the activity (e.g., contraction or relaxation of a skeletal muscle).
[0126] Activities can vary based on specific use case scenarios or operating environments. For example, activities can involve contraction and / or relaxation of specific muscle groups during a specific user activity. For example, in running, activities can include timing the foot hitting the ground or lifting from the ground. In cycling, activities can involve pedal rotation and phase. When the pedal is at its apex, the muscle tissue is relaxed and the large blood vessels (e.g., the iliofemoral system) have dilated, and when the pedal is in its pedigree, (one or more) muscles have contracted, pushing blood into their capillaries. Other examples of user activities that can time the contraction and relaxation of muscles include, but are not limited to, skating, walking, other sports involving applications for heart failure, etc.
[0127] More generally, embodiments may be used in any of a variety of user activities where there is an optimal muscle contraction in a cycle that can be used to improve performance, improve cardiovascular output, etc. Feedback may be provided to the user to influence or adjust the timed onset of muscle contraction or relaxation, the intensity of the contraction, the lack of antagonistic muscle contraction, the duration of muscle contraction, the timing of muscle inactivation in the cycle, the minimization of muscle activity during the off period of the cycle, etc. Feedback may be provided to any of a variety of muscles or areas, such as primary muscles, antagonist muscles, accessory muscles (e.g., muscles that are active for a given activity but are not primary muscles), etc.
[0128] In some embodiments, the power and / or energy generated by the skeletal muscles is applied to the vascular system through accurate sensing of cardiac bolus. Various physiological parameters can be used for accurate sensing of cardiac bolus, including but not limited to ECG, pressure waves, hemoglobin saturation, skin muscle hemoglobin saturation, etc. Timing signals or other stimuli are provided to the subject to allow coordination of user activities to perform desired increases, adjust biomechanics, prevent or encourage the use of cheating muscles, etc. In some embodiments, the goal is to adjust the biomechanics of cyclical motion or gait (e.g., such as to maintain force concentration through the subject's knee to limit knee injuries). Preventing or encouraging the use of cheating muscles can be used at various stages of exercise or other user activity sessions (e.g., discouraging the use of cheating muscles early in the session, encouraging the use of cheating muscles later in the session, etc.).
[0129] The technology described herein allows skeletal muscles to assist and enhance the effect of heartbeat at the same time, to improve energy efficiency and muscle strengthening effect. The technology described herein can also or alternatively be used to enhance biometrics during user activities. In such cases, the system can be configured to monitor muscle activity and events (e.g., impact events, such as the impact of a foot to the ground) for the contraction timing of one or more muscles during the activity. For example, timing can be established between two events (e.g., impact events and muscle contraction) to minimize the impact on the foot when completing the step. The feedback mechanism can be configured to stimulate the subject at the time of reflex compensation, thereby adjusting muscle contraction to better mitigate the impact of the step during the user's activity.
[0130] In some embodiments, it may be desirable to synchronize events that do not have the same period. As an example, consider the breathing and pedal position of a subject during a cycling activity. In this example, the breathing and pedal position of the subject may have different periods or cycles. In these and other scenarios, events with different periods may be synchronized to achieve a desired result. Continuing with the above example, this desired result may be to synchronize the start of inspiration with the subject's left leg at a specific pedal position during the movement of the pedaling cycle. The timing of synchronization may be selected to maximize the blood flow to the subject's legs, minimize the diaphragm force (e.g., it may be tracked using a sensor located on the subject's abdomen), etc. In general, embodiments may attempt to provide feedback or stimulation to synchronize two or more events to maximize or increase the desired output while alleviating the workload of the subject.
[0131] In some embodiments, the system may be configured to monitor limb or torso movement during user activity and actively signal to the subject in real-time to limit or adjust such movement to increase efficiency during the user activity.
[0132] The reduced peripheral resistance improves myocardial energy, while the energy consumption of comparable myocardial work in antegrade / advancing blood flow is lower. When timed and implemented using the technology described herein, afterload reduction reduces aortic blood volume during diastole and instead directs blood to the muscle for more oxygen and glucose delivery. Synchronization with the ejection reduces cardiac afterload because blood ejects into low resistance. Its effect is to improve myocardial efficiency by not only utilizing mechanical shortening but also using skeletal muscle energy in microvascular compression. Hardening or shortening increases intramuscular pressure proportional to the strength of muscle contraction.
[0133] In some embodiments, the key secondary effect is to squeeze the intramuscular capillaries, which increases the capillary flow from arteries to capillaries and then to veins. Most of the intravascular volume is located in the microvasculature, and periodic skeletal muscle contraction causes compression and resistance proportional to intramuscular contraction. In the environment of subjects who use muscles randomly (i.e., without feedback related to muscle contraction as described herein), the negative impact on performance is possible. In this case, the heart blood push arrives at the large blood vessels and microvasculature when compressed, thereby generating pressure on the blood vessels and wasting myocardial energy. Therefore, skeletal muscle contraction is not synchronized with cardiac ejection, and causes myocardial contraction for closed peripheral arteries and microvasculature. This results in: (i) significant negative effects on muscle and heart efficiency; (ii) heart and blood vessels are exposed to excessive pressure without flow or low flow; (iii) poor and inefficient inflow into muscle; (iv) skeletal muscle receives less blood and is at a lower pressure, thereby limiting its function; etc.
[0134] In some embodiments, the modular physiological monitoring system includes one or more sensing and / or stimulating devices that utilize periodic skeletal muscle contractions to synchronize with the heartbeat. The sensing device is configured to sense the timing of myocardial ejection, and the stimulating device is configured to provide feedback to the subject in response to the synchronized muscle contraction. Advantageously, the system provides a substantial reduction in afterload and increased muscle blood flow through periodic, timed skeletal muscle contractions and relaxations that are synchronized with appropriate timing through feedback sensing of cardiac boluses and ejections.
[0135] The integrated modular physiological monitoring system disclosed herein can increase endurance and enhance cardiovascular efficiency by the proper timing of cardiac ejection and muscle synchronization during user activities. In the example user activity of cycling, muscle synchronization involves the subject wearing a sensing and / or stimulating device of the modular physiological monitoring system, which receives a real-time indicator of ejection and an electromyographic indicator of muscle contraction. The subject can use this feedback to consciously coordinate muscle contraction with ejection and optimize to a timing delay. The delay can be timed based on feedback such as EMG, capillary or skin O2 saturation.
[0136] In some embodiments, the monitoring system includes components for sensing cardiac ejection, for sensing muscle contraction, and for defining the timing of algorithms for feedback to the subject.
[0137] Several techniques can be used to sense the environmental timing of aortic blood bolus, including by using ECG measurements. Electrical detection of any one of the various electrocardiogram components can be used to sense the timing of aortic blood bolus, such as using sensed ECG components (including QRS complex wave, R wave, P wave, T wave, etc.). Other techniques for sensing the timing of aortic blood bolus include using a module or sensor configured for multi-channel sensing. In such cases, a module with multi-channel sensing can be configured to simultaneously measure multiple parameters of a subject to assess cardiac function, ejection timing, etc. In some embodiments, a module or sensor may include hardware configured to measure ECG and precise acceleration at a location on the subject's torso. ECG signals can be used to assess the timing of various electrical activities of the heart, while acceleration can be used to assess the mechanical activity of the heart, including ejection timing from the left ventricle. In this example, acceleration can provide a precise cardiogram. The accuracy and / or noise floor of an accelerometer used to measure acceleration may be better than 150 ug / sqHz, better than 100 ug / sqHz, or better than 50 ug / sqHz to support capture of a cardiogram.
[0138] The characteristics of a cardiocardiogram (BCG) are as follows. The waveform can be divided into three groups, generally labeled with letters: before ejection (FGH), ejection (IJK), and the diastolic part of the cardiac cycle (LMN). In this way, the waveform of the BCG represents the different stages of the entire cardiac cycle. The peak of the H wave is at the end of the systolic phase of the heart, and blood is quickly discharged from the heart into the aorta. The I wave reflects the rapid acceleration of blood to the ascending aorta, pulmonary trunk, and carotid arteries. The J wave describes the acceleration of blood in the descending aorta and abdominal aorta, and the deceleration of blood in the ascending aorta. The IJ amplitude reflects the contractility of the left ventricle, and the IJ interval reflects its contractility.
[0139] In a non-limiting example, BCG and ECG can be collected and compared simultaneously. Timing between waves in ECG and BCG can be established under various postures, static or post-activity states (e.g., such as just before and just after running on a treadmill). Then, during the period of intense activity, the ECG waveform can be used to establish the approximate timing of the BCG waveform when the acceleration caused by the activity is large enough to capture BCG during the activity, which is impractical. In addition, the algorithm related to ECG and BCG can adaptively and opportunistically monitor the overall acceleration amplitude and posture (e.g., from a precision accelerometer) of the subject, and determine the period of limited movement, wherein the relationship between ECG waveform and BCG waveform in the entire given exercise or activity can be assessed. This configuration can be advantageous for establishing the timing of cardiac events (electrical and mechanical) in the entire cardiac cycle of the subject. Then, these can be related to activity, and feedback is provided to the subject by one or more algorithms described herein, so that activity and physiological events are synchronized, to maximize performance, while minimizing the effort of the subject in that activity.
[0140] In another non-limiting example, the module may include a phonograph to capture a cardiac and / or respiratory electrocardiogram or phonogram that is live with the ECG. Thus, valve closure / opening events and / or respiratory events may be assessed in real time with the ECG waveform to correlate mechanical events in the heart with electrical event timing. In the same context as the BCG, this may allow the relative timing of these events to be determined under various conditions. Then, during periods of intense exercise, the ECG may be relied upon to determine a timing reference independent of the movement required by the subject during the activity.
[0141] A timing delay algorithm can be used to account for the delay that exists between electrical excitation and mechanical contraction. The delay timing with variable sensing is typically in the range of 0-300 milliseconds (ms) between electrical contraction period (e.g., QRS complex) and ejection (e.g., vascular blood flow). Incorporating delay times allows optimization of the subject's muscle contraction.
[0142] In some embodiments, capillary filling is used for sensing. Using the feedback provided by the monitoring system described herein, the subject can time and synchronize the EMG readings of peak muscle activity to coincide with the optimized time delay after myocardial contraction to coincide with left ventricular (LV) ejection. At this point, the subject is in a state of maximum relaxation (e.g., in cycling, this corresponds to the downward stroke of one leg; in running, this corresponds to the contact of the ground with one leg, etc.). This fills the open blood vessels of one leg. In the next cycle, the muscles of that leg contract (which can be monitored using EMG or other physiological parameters) and force blood from the vascular system to the cells and through the blood vessels. In the next cycle, the opposite effect occurs, and the peak contraction of the contralateral leg / muscle ejects blood into the relaxed vascular system. Therefore, each ejection is assisted by the natural smooth muscle relaxation, while the muscle contraction helps to transfer blood to the contralateral blood vessels. Therefore, the subject can periodically and alternately help blood flow into the vascular system and alternately keep blood away from the contracted leg, limb or muscle by timing the maximum relaxation using the feedback provided from the system described herein. Although described above with respect to cycling and running, similar techniques can be applied to a variety of other activities, including other activities that involve movement of the leg muscles (such as skating).
[0143] In some embodiments, the influx of saturated blood is detected by measuring hemoglobin (Hgb) saturation. As muscles contract and relax, local Hgb saturation rises periodically. Blood influx can also or alternatively be detected by analyzing changes in volume and size of muscles / limbs using plethysmography.
[0144] The system described herein can provide sensing of muscle contraction, such as contraction of bones or other muscles, by using one or more sensors. Such sensors provide the ability to integrate and optimize determinations in real time. EMG sensors can be used to measure the electrical depolarization that produces a single contraction. Volume sensors can be used to measure the volume of an extremity, limb, or other area of a subject. As blood flows into an extremity or limb, its associated volume will increase slightly.
[0145] Accelerometers can also be used to sense muscle contractions for various activities, such as running and other upright movements. In the case of running and other upright movements, resistance increases as either (or both) of the right and left limbs (e.g., feet, calves, knees, etc.) hit the ground. As described in detail herein, this rise or peak can be synchronized with the push injection of blood. Accelerometers can detect such activities by measuring the center of mass of the body or limbs. In some cases, the center of mass of the body can provide optimal timing for injecting fluids. However, embodiments are not limited to use with measuring the center of mass of the body. In running, skating and other activities, the foot hitting the ground generates reflected waves associated with the gravity field and the long arteries in this field.
[0146] In one non-limiting example, electromyography of local muscle groups may be monitored simultaneously with local accelerations with one or more sensors. EMG allows real-time monitoring of muscle activity, strength, fatigue, onset of muscle tremors, onset of muscle lactic acidosis, analysis of fast and slow muscle fibers in a muscle, etc., while accelerometers allow real-time assessment of movement, onset of muscle tremors, delays between electrical activation and corresponding movement, etc. Such features and relative timing between features may be used as targets for synchronization, for analysis of the biomechanics of movement, for assessment of muscle activity throughout an action, and for optimization of any feature or relative timing thereof throughout an activity.
[0147] In some embodiments, light can be a sensed parameter for timing. In such embodiments, lasers or other light sources (e.g., light emitting diodes (LEDs), multiple wavelengths, etc.), infrared (IR), or spectroscopy can detect when the limbs are filled with blood. Reflectivity and colorimetric assessments can also be used in some embodiments. Ultrasound can also be used. Ultrasound beams can be used as transducers to sense various characteristics of active muscles to voluntarily adjust stiffness, compliance, thickness, reflection, reflectivity, specular reflectivity, etc. These characteristics can be used for timing purposes described herein.
[0148] In some embodiments, technology is used to adjust the timing of feedback to the subject in order to program a delay, or to accelerate muscle activation (e.g., conscious subject activity) relative to blood bolus (e.g., cardiac ejection). Embodiments may also provide real-time interval adjustment. Hgb saturation or muscle contraction sensing optimal results may be used to define an optimal configuration for cardiac optimization feedback. The cardiac optimization feedback to the subject is designed to optimize blood flow to a maximum value. Cardiac optimization feedback to the subject may be provided to the subject in real time, wherein scanning of the subject's physiological parameters across varying timing intervals includes continuous scanning, periodic scanning, and the like. The system described herein may sense the optimal timing of feedback, which may change over time, and adjust the timing of delivering feedback to the subject to provide flow optimization.
[0149] As discussed above, in some embodiments, the physiological monitoring system is configured to provide feedback to the subject to initiate conscious or voluntary synchronization of skeletal muscle activity (e.g., contraction, relaxation) with blood bolus. Advantageously, this results in a significant reduction in cardiac afterload, including low resistance. Such synchronization eliminates contractions that occur during high peripheral resistance and has the advantage of maintaining vascular health by preventing fibrosis that occurs during repetitive exercise. Synchronization can also reduce intravascular pressure while maintaining the same or increased flow. Therefore, some embodiments provide methods for vascular impedance matching.
[0150] The physiological monitoring system described herein provides feedback to the subject to maintain and enhance cardiac efficiency by notifying the subject whether the exercise change will provide increased cardiopulmonary efficiency. In addition, feedback increases the degree of skeletal muscle efficiency interaction to improve performance with the same or less cardiac energy expenditure. Other physiological parameters that can be improved using the technology described herein include respiration, respiratory quotient (e.g., O2 / CO2), anaerobic threshold level, etc.
[0151] Other important interactions include skeletal muscle and systemic efficiency. The feedback provided using the technology described herein allows the subject to understand how close the subject is to his or her maximum energy expenditure at the current activity level and timing. Similarly, the technology described herein facilitates arbitrary adjustment of skeletal muscle contraction time based on the sensing of various physiological parameters of the subject according to heartbeat, ejection or bolus arrival at an organ or tissue, etc.
[0152] The systems described herein can provide feedback to the subject in various ways. In some embodiments, feedback is provided to the subject by audio or acoustic signaling (such as using audible sounds) that gives the user guidance about when muscle contraction is optimal. The audio or acoustic signaling can be notified by pitch, amplitude, harmonically related sounds, pleasant sounds relative to unpleasant sounds, binary (e.g., off-on), etc., and the audio or acoustic signaling can be modulated with frequency, amplitude, pulse width modulation, harmonics, etc. Feedback can also or alternatively be provided to the user visually, such as providing feedback to the user with one or more lights with varying amplitude, color, frequency modulation, etc.
[0153] In some embodiments, feedback can be provided as tactile feedback stimulation, whereby the subject feels a sensation indicating proper or optimal synchronization. Such tactile feedback can be virtual or real, such as with vibration, pain, temperature (e.g., hot / cold or its perception), etc. Tactile feedback can be delivered in varying amounts to provide different indications to the subject. For example, low to high amplitudes can have qualities such as sharp to dull stimulation, hot to cold stimulation, painful to pleasant stimulation, etc. Tactile feedback can provide a physical sensation to the user to time skeletal muscle activity via vibration, off-on stimulation, frequency, pulse width modulation, amplitude, harmonic content, etc.
[0154] In some embodiments, a process for providing feedback to a subject to initiate conscious or voluntary synchronization of skeletal muscle activity with blood bolus injection includes monitoring one or more kinematic and / or myograph signals from a first site on the subject and monitoring one or more cardiac and / or respiratory signals from a second site on the subject, such as using one or more sensing devices described herein. This monitoring can be performed, for example, when the subject performs a repetitive task (such as running, cycling, skating, etc. described herein). The monitored signals are analyzed to identify one or more events, such as a first event associated with a kinematic and / or electromyographic signal and a second event associated with one or more cardiac and / or respiratory signals. Such events can be detected during each instance of the repetitive task. For example, a first event can include identifying when the subject's foot hits the ground while running. Such an event is repeatedly detected while the subject is running. Similarly, a second event can include identifying respiratory or cardiac actions (e.g., heartbeat, blood bolus injection, etc.) when the user performs a repetitive task. Timestamps are generated for the first event and the second event. In some cases, timestamps are generated for each instance of the first event and the second event. The optimal timestamp for providing feedback signals to the subject to enhance the subject's cardiopulmonary performance is calculated using the generated timestamps for the first event and the second event. Then, based on the optimal timestamps, a feedback signal is provided to the subject using one or more stimulation devices as described herein.
[0155] Although various embodiments are described herein with respect to the target of enhancing the cardiopulmonary performance of the subject during the activity, the embodiments are not limited to enhancing the cardiopulmonary performance of the subject. In some embodiments, in addition to enhancing cardiopulmonary function or as an alternative to enhancing cardiopulmonary function, the timing of determining the feedback signal is targeted at the biomechanical enhancement of the movement of the subject during the activity. Biomechanical enhancement is related to a variety of user activities, including most sports activities or other sports activities. For example, in golf, there is an ideal swing mechanism for the subject, which has associated muscle activation timing, hand grip strength, etc., which leads to the realization of an ideal swing (for example, this can be measured via one or more kinematic sensors). Alternatively, for a specific activity, there may be some muscles or muscle groups that should not be activated to enhance biomechanical movement. In such cases, the feedback device strategically placed on the subject can be used to apply negative feedback or stimulation during the subject's movement, to train the subject not to activate specific muscles or muscle groups, to change the breathing pattern (for example, such as related to the timing of the golf swing, etc.). These and other biomechanical enhancements can be key parameters, which significantly improve the performance of the subject during an activity (for example, a golf swing, a match process, exercise, or other activity sessions, etc.). Thus, embodiments may seek to provide improvements in a subject's biomechanical performance in addition to or instead of improvements in cardiorespiratory performance.
[0156] In addition, although various embodiments are described with respect to measuring physiological parameters at two or more locations on a subject, the embodiments are not limited thereto. In some embodiments, a plurality of sensors or actuators may be co-located at a given location on a subject, wherein the first of the plurality of sensors measures a first set of features or physiological parameters, and the second of the plurality of sensors measures a second set of features or physiological parameters. For example, a first sensor may measure a first feature of an activity (e.g., when a limb reaches the apex of a lap on a bicycle), while a second sensor may measure a second feature of an activity (e.g., activation of a muscle group in the subject's thigh). In this example, the system may be configured to determine timing and provide a timed feedback signal after compensating for reflex delays to align the timestamp of the first feature with the timestamp of the second feature in order to coordinate events associated with the first and second features. In some embodiments, it is desirable to time kinematic demands for myospectral activation, intensity, duration, etc., to optimize the efficiency or performance of the subject's activity.
[0157] The first event may correspond to one or more of the following: a muscle activity level, an onset of a muscle contraction, a relaxation of a muscle, a peak contraction of a muscle, fatigue of a muscle, a peak force generated by a muscle, a peak electromyographic activity, a peak high frequency electromyographic activity of a muscle, a peak fast twitch activity of a muscle, a peak slow twitch activity of a muscle, etc. The monitored electromyographic signals may be associated with one or more muscles selected from one or more of the following muscle groups: muscles on the trunk, muscles on the back, muscles on the abdomen, limbs, arms, legs, feet, face, neck, muscles on the pelvis, smooth muscle activity (e.g., GI smooth muscle, cardiac muscle, diaphragm muscle, etc.). Some of the target muscles in the leg include the thigh muscles, anterior muscles, posterior muscles, tibialis, psoas major and minor, quadriceps femoris, rectus femoris, vastus lateralis, vastus medialis, vastus intermedius, hamstrings, biceps femoris, vastus adductor, brevis, hamstrings, semimembranosus, semitendinosus, adductor longus, adductor magnus, sartorius, piriformis, gluteus maximus, gluteus medius, gluteus minimus, calf muscles, gastrocnemius, soleus, peroneus longus, peroneus brevis, tibialis anterior, extensor longus, flexor digitorum longus, peroneus tertius, flexor digitorum brevis, abductor digitorum, Achilles tendon, flexor digitorum longus, etc. It should be appreciated that embodiments may be used for various other target muscles in the subject's torso, back, face, arms, hands, feet, etc. With appropriate positioning of the sensors, any muscle group in the body may be targeted (e.g., for therapy, exercise, etc.).
[0158] The first event may also or alternatively correspond to one or more kinematic or kinetic movements of a first portion of the subject. Such kinematic or kinetic movements of the first portion may include one or more of the following: peak horizontal acceleration, peak horizontal velocity, minimum vertical acceleration, minimum vertical velocity, apex of an arc, impact, directional impact, free fall condition, one or more joint movements, including but not limited to abduction (extension), adduction (retraction), depression, elevation, rotation (e.g., including upward (supination) and downward (inferior rotation)), internal rotation, back rotation, etc.
[0159] The monitored cardiac or respiratory signals may vary as described herein, such as depending on the sensors used and their placement on the subject. In some embodiments, one or more features of the respiratory signal may be adapted to time activity (e.g., cyclic activity performed at substantially superharmonic, equivalent, or subharmonic frequencies associated with breathing), and / or synchronize respiratory features with movement, muscle activation, etc. Some non-limiting examples of respiratory features include inspiration, exhalation, automatic pauses with little or no breathing, tidal volume (depth of inspiration), respiratory frequency, inspiratory rate, expiratory rate, respiratory effort, respiratory muscle activity (intercostal muscles, diaphragm muscle activity, etc.), etc.
[0160] In some embodiments, a first part (from which motion and / or electromyographic signals are monitored) and a second part (from which cardiac and / or respiratory signals are monitored) can be co-located on a subject. In other embodiments, the first part and the second part can be at different locations on the subject, or can be outside the subject, such as on a contact surface, etc. The first part can be located, for example, on an appendage, arm, leg, foot, thigh, knee, calf, ankle, bicep, elbow, forearm, wrist, abdomen, or pelvis of the subject. The second part can be located, for example, on the trunk, rib cage, abdomen, neck, head, ear, under the arm, or on an appendage of the subject. In some cases, the first part is located on a machine that interfaces with the subject.
[0161] Repetitive tasks may include running, walking, biking, weight lifting, jumping, squatting, sit-ups, crunches, head movements, rowing, swimming, swinging tools, climbing stairs, stretching, relaxing, punching, kicking, diving, twisting, tapping, typing, etc.
[0162] In some embodiments, calculating the optimal timestamp (e.g., for providing feedback or stimulation to a subject) can take into account various parameters or influencing factors. Such parameters or influencing factors include, but are not limited to, environmental factors, task-related factors, fatigue and subject-related factors, etc., which have an impact on the optimal timing of the relationship between events (e.g., relative to when the first and second events identified based on monitoring should signal feedback).
[0163] Some non-limiting examples of environmental factors include ambient temperature, light, pressure, local wind speed / direction, movement over a map area, environmental obstacles, etc. These and other environmental factors can affect a subject's reflexes, optimal biomechanics for movement, optimal movement rates for a given task, etc.
[0164] Some non-limiting examples of task-related factors include the biomechanics of a given task (or the movements within the task, including the rate of movement), the type of repetitive motion being performed, changes to the task (as dictated by the overall plan of the activity). In one non-limiting example, a task may include riding a bicycle on a bicycle, and task-related factors may include changes to the gears on the bicycle during use. Such changes may alter the rate at which muscle groups may need to work, shorten or lengthen the timing between a measurable trigger and the point at which optimal synchronization is to be achieved in a cycle, etc.
[0165] Some non-limiting examples of fatigue / subject-related factors include specific features of the subject's anatomy (e.g., size, limb length, strength limitations, etc.), factors related to the subject's reflexes, attention-related factors (e.g., timing-related changes witnessed by a system observer that are related to the actual reaction time between giving the subject a trigger and recording their response; fatigue-related factors (e.g., timing-related changes that occur when one or more muscle groups in the subject enter a state of fatigue, when changes in the biomechanics of the movement indicate a loss of precision associated with a state of fatigue), movements related to the subject's loss of attention (e.g., insufficient response to the trigger, movements unrelated to the activity being studied, etc.), and the like.
[0166] In some embodiments, a training protocol is used to establish an optimal delay between the detection of the first and second events (e.g., timestamps associated with such events) and the optimal timestamp at which feedback should be signaled to the subject. The optimal delay may depend on the task (e.g., the optimal delay may vary based on whether the user is running, cycling, rowing, etc.). In general, a training protocol may involve changing the stimulus or other feedback provided to the subject while monitoring various parameters of the subject to find an increase or decrease in one or more cardiac performance metrics. Monitoring of the subject may be performed from cycle to cycle while the subject is performing a repetitive task so as to optimize over time (e.g., time-averaged optimization). In some cases, optimization may be performed for cycle N, with the optimal stimulus timing starting at the next cycle N+1 (or another cycle N+M).
[0167] The repetitive tasks performed by the subject may change over time. Consider, for example, running or cycling, where the subject may be running uphill, downhill, against or with the wind, etc. The optimal timing or delay of providing feedback stimulation to the subject may take into account such changes in the repetitive tasks performed by the subject.
[0168] In some embodiments, the repetitive task may refer to a long-term task, such as a gymnastics or other sports routine, ski jumping, etc. In such cases, the optimal timestamp or other timing of the feedback provided to the subject may be coordinated within the long-term task.
[0169] Various types of feedback can be used. As described herein, the stimulation device can be used to provide various types of stimulation or other feedback to the subject, including but not limited to audio and / or visual feedback, heat / cold, vibration, electricity, machinery, visual stimulation from a head-up display, from a dashboard, a handlebar display, a watch, a phone, etc. In some non-limiting examples, feedback can be provided in the form of tactile vibrations provided by an actuator placed against the skin of the subject, in a module as described herein, or placed in a wearable device worn somewhere on the subject. In another non-limiting application, it can be provided with a mild electric shock (e.g., electrical nerve stimulation, which waveform can be provided as described herein to provide mild pain, vibration and / or simulate a soft touch, thermal stimulation, etc.), a tingling sensation, a strong impulse, etc.
[0170] In some embodiments, the stimulation device can be placed at multiple locations on the subject, and feedback or other stimulation can be provided to specific locations on the subject to optimize reflex time. For example, the device can be placed at locations such as Figure 1 The test stimulus may be attached or placed on the subject at a location such as one of the locations highlighted in FIG. 1 . In this case, the time delay associated with receiving and transmitting the input signal to the brain or relay center and back to the effector muscle will determine the time delay that can be considered in determining the ideal time to provide the stimulus in order to align the effector muscle response with a specific event in the activity. The test stimulus may be provided to the subject at multiple locations while the subject's response is monitored to determine the optimal location for providing feedback to the user to optimize reflex time.
[0171] The feedback intensity may be modulated, such as based on monitoring the subject's response, to ensure that sufficient power is provided to the subject to achieve a desired response and increase the subject's cardiorespiratory performance.
[0172] The subject's reflex can be calculated from the feedback site to adjust and determine the optimal delay between the timestamps of the first and second events and the optimal timestamp for providing feedback to the subject. For example, the timing between the time when the feedback signal is sent to the subject and the determination of when the subject adjusts its movement related to the task can be measured to calculate the subject's reflex time. Therefore, the subject's reflex can be considered when determining the optimal timestamp for providing feedback to the subject. The reflex reaction time can be continuously monitored to change the timing of the feedback to account for changes in the subject's body related to fatigue or other factors described herein.
[0173] Figure 7aA collection of sensors or modules 710 attached to a subject 701 at various locations AG is illustrated. Each sensor 710 may represent a sensing device, a stimulation device, or a combination of sensing and stimulation devices. Sensor 710A is attached to location A on one or more eyes of subject 701 and may be a visual sensing / stimulation device. Sensor 710B is attached to location B on the ear of subject 701 and may be an audible sensing / stimulation device. Sensor 710C is attached to location C on the chest of subject 701 and may be a tactile or tactile sensing / stimulation device. Sensor 710D is attached to location D on the chest of subject 701 and may be an electrical sensing / stimulation device. Sensor 710E is attached to location E on the hand of subject 701. Sensor 710F is attached to location F on the foot of subject 701. Sensor 710G is attached to location G on the face of subject 701. Figure 7b A graph 702 of stimulus versus reaction time is shown. Graph 702 shows a stimulus given at time t1, with the response to the stimulus measured at sensors 710 at locations AG at times t2-t8, respectively. As shown, subject 701 may have varying response times to the stimulus applied. The response time may vary based on many factors, such as the type of stimulus applied, the location of the stimulus applied, the focus of subject 701, etc.
[0174] Figure 8a Subject 801 is illustrated performing an activity, more particularly a cyclical motion activity. Two sensors 810-1 and 810-2 are attached to subject 801. Sensor 810-1 is attached to the thigh of the right leg of subject 801, while sensor 810-2 is attached to the chest of subject 801. Each of sensors 810-1 and 810-2 may represent a sensing device, a stimulation device, or a combination of a sensing device and a stimulation device. Figure 8a In the example of , sensor 810 - 1 is more specifically configured to measure or monitor electromyography of muscles on the thigh of the right leg of subject 801 , while sensor 810 - 2 is configured to measure or monitor heart rate or respiration of subject 801 .
[0175] Figure 8b Shown for Figure 8a801 during the cyclic motion of the subject 801 in FIG. Graph 802 shows a first curve (denoted as "cyclic motion") indicating the measurement of the sensor 810-1 attached to the thigh of the subject 801, and can represent the movement or EMG trigger factor measurement of the cyclic motion. Graph 802 also includes a second curve (denoted as "respiration"), which indicates the measurement of the sensor 810-2 attached to the chest of the subject 801, and can represent the HR, respiration or other physiological parameters associated with the respiration of the subject 801. Graph 802 shows the timing trigger factor (e.g., the vertex of the first curve) at time t1 and the stimulation applied at time t2. The time delay between the timing trigger factor and the application of stimulation or feedback to the subject 801 can be determined using the technology described herein. Graph 802 also shows the desired waveform synchronization of the second (respiration) curve with the first (cyclic motion) curve in dashed outline. The desired waveform synchronization is the waveform synchronization that realizes the cardiopulmonary performance of the subject 801 during the activity or other enhancements of the performance.
[0176] The desired waveform synchronization or alignment between the first and second curves is created by applying appropriately timed stimulation or feedback to the subject 801. In some embodiments, the desired waveform synchronization can be subharmonic or superharmonic. The feedback or stimulation applied to the subject 801 creates a phase change to align the waveforms of the first and second curves with the desired waveform synchronization. It should be appreciated that during the activity, the application of stimulation or feedback to the subject 801 can be adjusted over time. For example, an estimate based on the type of stimulation, the location of the stimulation, the timing and / or focus of the subject's reflection, etc. can be used to determine the first or initial stimulation or feedback. The feedback can be as described above with respect to Figure 7a and 7b As well as determining such factors for a particular subject as described elsewhere herein. Adjusting the stimulation phase timing to better align the results to achieve the desired response.
[0177] Figure 8cA graph 804 of output / effort as a function of time is shown for a first curve (shown in solid lines) and a second curve (shown in dashed outline). The first curve indicates a situation during the activity without synchronization or without using the techniques described herein for enhancing the performance of subject 801, while the second curve indicates a situation during the activity with synchronization or using the techniques described herein for enhancing the performance of subject 801. Output / effort is a measurement of specified output and effort parameters of subject 801 during the cycling activity. An example output parameter is speed, while example effort parameters include HR, respiratory effort, muscle strain, muscle activation intensity, and / or duration of each cycle, among others. Output and effort parameters may be measured using sensing devices described herein, such as sensors 810-1 and 810-2 on subject 810. In general, it is desirable to increase output while maintaining or reducing the effort of subject 801, or to maintain output while reducing the effort of subject 801. During synchronization (e.g., such as described above with respect to Figure 8b and described elsewhere herein), the second curve exhibits some fluctuations and may even have a worse output / effort than the first curve during a certain period of time. However, once a synchronous optimization is found, use of the techniques described herein allows for enhanced performance of subject 801 (e.g., increased output / effort of the second curve relative to the first curve).
[0178] Figure 8d A graph 806 of stimulation / response measured over time by subject 801 during activity is shown. More particularly, graph 806 shows a first curve of right leg movement of subject 801 and a second curve of integrated EMG in the right thigh of subject 801. As shown, stimulation timing signals are applied at times t1, t3, and t5. Graph 806 also shows ideal muscle contraction timing (e.g., in the right thigh of subject 801, for enhanced performance) at times t2, t4, and t6. Graph 806 illustrates how muscle activation (e.g., in the right thigh of subject 801) is correctly timed with position (e.g., of the right leg of subject 801) during periodic activity. In some embodiments, an algorithm is used to adjust when to give stimulation to subject 801 so that response timing is "ideal" for enhancing the performance of subject 801. In addition to or in lieu of optimizing muscle contraction timing, some embodiments may optimize muscle amplitude (e.g., the intensity of contraction), the duration of muscle contraction, the end of timing, etc. For a given activity, some embodiments may seek to optimize the intensity of contraction (e.g., maximal voluntary isometric contraction) when muscle contraction begins in a particular cycle (e.g., partial rotation of subject 801's leg while pedaling), optimize the basal tone in the muscle during a particular cycle when the muscle is inactivated or relaxed in a particular cycle, and the like.
[0179] Figure 9a-9c A modular physiological monitoring system 900 is shown. The modular physiological monitoring system 900 includes a sensing device 910 and a stimulation device 920 attached to a subject 901, which are in wireless communication 925 with a host device 930. The host device 930 includes a processor, memory, and a network interface.
[0180] A processor may include a microprocessor, a microcontroller, an application specific integrated circuit (ASIC), a field programmable gate array (FPGA), or other type of processing circuitry, as well as portions or combinations of such circuitry elements.
[0181] The memory may include random access memory (RAM), read-only memory (ROM) or other types of memory in any combination. The memory and other memories disclosed herein may be viewed as examples of what is more generally referred to as "processor-readable storage media" storing executable computer program code or other types of software programs. Articles comprising such processor-readable storage media are considered to be embodiments of the present invention. A given such article may include, for example, a storage device, such as a storage disk, a storage array, or an integrated circuit containing a memory. The processor may load computer program code from the memory and execute the code to provide the functionality of the host device 930.
[0182] The network interface provides circuitry that enables wireless communication between the host device 930 , the sensing device 910 , and the stimulation device 920 .
[0183] Figure 9a A modular physiological monitoring system 900 is provided which, for clarity, includes only a single instance of a sensing device 910 and a stimulation device 920. However, it should be appreciated that the modular physiological monitoring system 900 may include multiple sensing devices and / or multiple stimulation devices. Figure 9a A modular physiological monitoring system 900 is illustrated in which a sensing device 910 and a stimulation device 920 are attached to a subject 901, but embodiments are not limited to such arrangements. As described above, one or more sensing and / or stimulation devices may be part of a contact surface or a contactless device. In addition, the placement of the sensing device 910 and the stimulation device 920 on the subject 901 may vary as described above. Moreover, the host device 930 may be worn by the subject 901, such as being incorporated into a smart watch or other wearable computing device. In some embodiments, the functions provided by the host device 930 may also be provided by one or more of the sensing device 910 and the stimulation device 920.
[0184] Figure 9bA schematic diagram of various aspects of a sensing device 910 in a modular physiological monitoring system 900 is shown. The sensing device 910 includes one or more of a processor, a memory device, a controller, a power supply, power management and / or energy harvesting circuitry, one or more peripheral devices, a clock, an antenna, a radio transceiver, a signal conditioning circuit, (one or more) light sources, (one or more) optical detectors, sensor communication circuitry, (one or more) vital sign sensors, and (one or more) auxiliary sensors. The sensing device 910 is configured for wireless communication 925 with a stimulation device 920 and a host device 930.
[0185] Fig.9c A schematic diagram of various aspects of a stimulation device 920 in a modular physiological monitoring system 900 is shown. The stimulation device 920 includes one or more of a processor, a memory device, a controller, a power supply, power management and / or energy harvesting circuitry, one or more peripheral devices, a clock, an antenna, a radio transceiver, a signal conditioning circuit, a driver, a stimulator, (one or more) vital sign sensors, sensor communication circuitry, and (one or more) auxiliary sensors. The stimulation device 920 is configured for wireless communication 925 with a sensing device 910 and a host device 930.
[0186] Communication of data from a sensing device and / or stimulation device (e.g., a patch and / or a patch-module pair) can be performed via a local personal communication device (PCD). In some embodiments, such communication occurs in two parts: (1) local communication between the patch and / or patch-module pair and the PCD (e.g., via a hub or a module of the patch-module pair); and (2) remote communication from the PCD to a backend server. The PCD and backend server can together provide the functionality of a host device, as described elsewhere herein.
[0187] Fig.10 A process flow for enhancing a subject's performance during an activity is shown. The process flow begins at step 1002, which monitors first and second sets of physiological parameters from at least one location on a subject using at least one sensing device.
[0188] In some embodiments, at least one sensing device includes a first sensing device attached to the subject at a first position and at least a second sensing device attached to the subject at a second position, wherein a first set of physiological parameters is monitored at the first position using the first sensing device, and a second set of physiological parameters is monitored at the second position using the second sensing device. In some embodiments, the first and second positions can be co-located on the subject. In other embodiments, the first and second positions can be different. For example, the first position can be located on an appendage, arm, hand, leg, foot, thigh, knee, calf, ankle, biceps, elbow, forearm, wrist, abdomen or pelvis of the subject, and the second position can be located on the trunk, ribs, abdomen, neck, head, ear, under the arm or on an appendage of the subject. In some cases, the first and / or second positions are located on one or more machines interfaced with the subject.
[0189] The first set of physiological parameters monitored in step 1002 may include one or more kinematic signals and at least one of one or more electromyographic signals from a first location on the subject, and the second set of physiological parameters may include at least one of one or more cardiac signals and at least one of one or more respiratory signals from a second location on the subject.
[0190] In some embodiments, the monitoring in step 1002 is performed while the subject performs a repetitive task. The repetitive task may include one of running, walking, bicycling, weight lifting, jumping, squatting, sit-ups, crunches, head movements, rowing, swimming, swinging tools, and climbing stairs.
[0191] Processing flow continues to step 1004, identifying first and second events associated with the first and second sets of physiological parameters. The first event may correspond to at least one of: one or more muscle activity levels; onset of one or more muscle contractions; relaxation of one or more muscles; peak contraction of one or more muscles; fatigue of one or more muscles; peak force generated by one or more muscles; peak electromyographic activity of one or more muscles; peak high-frequency electromyographic activity of one or more muscles; peak fast-twitch activity of one or more muscles; and peak slow-twitch activity of one or more muscles. The first event may correspond to one or more kinematic and kinetic movements, the one or more kinematic and kinetic movements including one or more of: peak horizontal acceleration; peak horizontal velocity; minimum vertical acceleration; minimum vertical velocity; apex of an arc; base of an arc; impact; directional impact; and a free-fall condition. The second event may correspond to one or more events associated with respiratory or cardiac activity of the subject.
[0192] In step 1006, first and second timestamps are generated for the first and second events identified in step 1004. In step 1008, timing for providing feedback to the subject to adjust one or more characteristics of the subject during the activity relative to the first and second timestamps is determined. Adjusting the one or more characteristics of the subject during the activity may include enhancing the subject's cardiorespiratory performance during the activity, providing a biomechanical enhancement of movement of at least a portion of the subject during the activity, or both.
[0193] Step 1008 may be based at least in part on one or more environmental factors, one or more task-related factors of the repetitive task being performed by the subject, and one or more fatigue factors of the subject.
[0194] In some embodiments, step 1008 includes executing a training procedure comprising applying stimulation to the subject utilizing at least one stimulation device and monitoring one or more physiological parameters of the subject to determine one or more changes in at least one cardiac performance metric, and utilizing the determined one or more changes in at least one cardiac performance metric to determine optimal timing for providing feedback to the subject relative to a first timestamp and a second timestamp.
[0195] The process flow continues to step 1010, using at least one stimulation device to provide a feedback signal to the subject according to the determined timing. In some embodiments, the at least one stimulation device used in step 1010 is the same as the at least one sensing device used for monitoring in step 1002.
[0196] In some embodiments, the subject is performing a repetitive task comprising multiple cycles, and the monitoring in step 1002 is performed during two or more of the multiple cycles so as to perform optimization of the time average to provide feedback to the subject in step 1010 in response to first timestamps and second timestamps associated with first events and second events in each of the two or more cycles.
[0197] In some embodiments, the subject is performing a repetitive task comprising a plurality of cycles, and the monitoring in step 1002 is performed during a first cycle in the plurality of cycles, and the feedback is provided in step 1010 in a second cycle after the first cycle in the plurality of cycles.
[0198] In some embodiments, the subject performs a task comprising two or more activities during monitoring in step 1002, and determining in step 1008 the timing for providing feedback relative to the first timestamp and the second timestamp comprises coordinating the timing of feedback for one or more specified activities within the task.
[0199] The feedback provided in step 1010 may include at least one of electrical stimulation, vibration stimulation, auditory stimulation, and visual stimulation.
[0200] In some cases, Fig.10 The processing flow also includes applying stimulation to two or more locations on the subject using at least one stimulation device, monitoring the subject's response to the stimulation provided at each of the two or more locations using at least one sensing device, determining the subject's reflection time to the stimulation applied at each of the two or more locations using the monitored response, and selecting at least a given location among the two or more locations based on the determined reflection time to provide one or more feedback signals to the subject.
[0201] In some embodiments, the intensity of the feedback provided in step 1010 is adjusted to achieve a desired level of cardiorespiratory performance enhancement.
[0202] In some embodiments, Fig.10 The processing flow includes calculating one or more reflexes of the subject by monitoring the subject response relative to the timing of providing one or more feedback signals to the subject to determine when the subject adjusts a task-related movement in response to the one or more feedback signals. Changes in reflex reaction times can be monitored, and the timing of providing the one or more feedback signals to the subject can be adjusted based on the one or more changes in the subject's reflex reaction times.
[0203] It will be appreciated that additional advantages and modifications will readily occur to those skilled in the art. Therefore, the disclosure given herein and its broader aspects are not limited to the specific details and representative embodiments shown and described herein. Thus, many modifications, equivalents and improvements may be included without departing from the spirit or scope of the overall inventive concept as defined by the appended claims and their equivalents.
Claims
1. A system comprising: a first sensing device configured for attachment to a first location of a subject, the first device configured to measure a first set of one or more physiological parameters; a second sensing device configured for attachment to a second location on the subject, the second device configured to measure a second set of one or more physiological parameters; at least one stimulation device configured to apply stimulation to the subject; as well as At least one processing device, comprising a processor coupled to a memory, the at least one processing device configured to: determining synchronization of the first set of one or more physiological parameters and the second set of one or more physiological parameters during two or more cycles of repetitive movement performed by the subject; as well as The stimulation applied to the subject by the at least one stimulation device is controlled prior to at least one additional cycle of the repetitive motion performed by the subject to adjust synchronization of the determined first set of the one or more physiological parameters and the second set of the one or more physiological parameters.
2. The system of claim 1, wherein the repetitive task comprises one of running, walking, bicycling, weight lifting, jumping, squatting, sit-ups, crunches, head movements, rowing, swimming, swinging tools, and climbing stairs. 3 . The system of claim 1 , wherein at least one sensing device is the same as one of the first sensing device and the second sensing device.
4. The system according to claim 1, wherein: The first set of one or more physiological parameters is associated with muscle activity of the subject, and the second set of one or more physiological parameters is associated with at least one of heart rate and respiration of the subject.
5. The system according to claim 4, wherein: Adjusting the determined synchronization includes: enhancing the subject's cardiorespiratory performance during the repetitive task.
6. The system according to claim 4, wherein: Adjusting the determined synchronization includes providing a biomechanical enhancement of movement of at least a portion of the subject during the repetitive task.
7. The system according to claim 4, wherein: The first set of one or more physiological parameters includes electromyographic measurements.
8. The system according to claim 4, wherein: The first site includes a thigh of the subject, and the second site includes a chest of the subject.
9. The system of claim 1 , wherein determining the synchronization comprises: A first curve is generated that represents a first set of the one or more physiological parameters, and a second curve is generated that represents a second set of the one or more physiological parameters.
10. The system of claim 9, wherein determining the synchronization further comprises: An alignment of the first curve and the second curve is determined.
11. The system according to claim 1, wherein: Controlling the stimulation applied to the subject by the at least one stimulation device to adjust the synchronization of the determined first set of the one or more physiological parameters and the second set of the one or more physiological parameters before at least one additional cycle of the repetitive motion performed by the subject includes: adjusting the timing of providing the stimulation to the subject by the at least one sensing device in each of two or more additional cycles of the repetitive motion in response to changes in the determined synchronization of the first set of the one or more physiological parameters and the second set of the one or more physiological parameters.
12. The system of claim 1, wherein: Controlling the stimulation applied to the subject by the at least one stimulation device to adjust synchronization of the determined first set of one or more physiological parameters and the second set of one or more physiological parameters prior to at least one additional cycle of the repetitive motion performed by the subject is based at least in part on: determining fatigue of the subject.
13. The system of claim 1, wherein: Controlling the stimulation applied to the subject by the at least one stimulation device to adjust synchronization of the determined first set of one or more physiological parameters and the second set of one or more physiological parameters prior to at least one additional cycle of the repetitive motion performed by the subject is based at least in part on: determining a reflex time of the subject.
14. The system of claim 1, wherein: Controlling the stimulation applied to the subject by the at least one stimulation device to adjust the synchronization of the determined first set of one or more physiological parameters and the second set of one or more physiological parameters prior to at least one additional cycle of the repetitive motion performed by the subject is based at least in part on: determining a desired intensity of muscle contraction of the subject in the at least one additional cycle of the repetitive motion performed by the subject.
15. The system of claim 1, wherein: Controlling the stimulation applied to the subject by the at least one stimulation device to adjust the synchronization of the determined first set of the one or more physiological parameters and the second set of the one or more physiological parameters prior to at least one additional cycle of the repetitive motion performed by the subject is based at least in part on: determining an expected duration of muscle contraction of the subject in the at least one additional cycle of the repetitive motion performed by the subject.
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