Systems and methods for applying manipulative myofascial therapy

A handheld device with transverse motion and sensors addresses superficial and deep fascia manipulation, effectively alleviating chronic pain by decompressing fascial densifications and improving musculoskeletal health.

WO2025117824A9PCT designated stage expired Publication Date: 2025-08-14PHYSIOHAND INC
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Patent Information

Application Number
PCT/US2024/057862
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2023-11-29
Filing Date
2024-11-27
Publication Date
2025-08-14

AI Technical Summary

Technical Problem

Existing myofascial therapy devices are ineffective in addressing superficial and deep fascia manipulation, leading to chronic pain and musculoskeletal issues due to unaddressed fascial densifications.

Method used

A handheld device with a motor-driven knuckle providing transverse motion, equipped with sensors to measure force and processors to assess treatment outcomes, applies manipulative myofascial therapy to decompress and loosen fascial densifications.

Benefits of technology

The device effectively deactivates mechanoreceptors, reduces tissue edema, and improves lubrication of connective tissues, alleviating chronic pain and promoting musculoskeletal health by restoring fascial balance.

✦ Generated by Eureka AI based on patent content.

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Abstract

A device for applying manipulative myofascial therapy to a target tissue is provided. The device comprises: a housing coupled to a handle, a motor assembly, a knuckle driven by the motor assembly to have a transverse motion relative to a surface of a target tissue; a pad configured to secure the device to the surface of the target tissue while allowing knuckle movement; a sensor operably coupled to the knuckle to measure a force applied to the device; and one or more processors configured to measure a treatment outcome based on the force; an ultrasound sensor; or a fiberoptic sensor.
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Description

SYSTEMS AND METHODS FOR APPLYING MANIPULATIVE MYOFASCIAL THERAPYCROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application No.63 / 603.975, (Attorney Docket No. PSH-0003-PR1), filed November 29, 2023, the entire content of which is incorporated by reference herein.BACKGROUND

[0002] Fascia is a physiological system that constitutes a large network of cobweb-like 3D features that cover all the muscles, tendons, ligaments, joints, and viscera of the human body. Scientific study of fascia remained limited until recent years. Fascia used to be the first "organ" that medical students would cut through during their anatomical dissections and subsequently discard while examining the organs that the fascia permeates. Now. recent research has shown that fascia plays important neurologic / physiologic roles in the human body. Fascia is collagenous connective tissue that surrounds and interpenetrates skeletal muscle, joints, organs, nerves, and vascular beds. It forms a whole-body, continuous 3D viscoelastic matrix of structural support and contains contractile elements enabling a modulating role in force generation and mechanosensory fine-tuning. Fascia spontaneously regulates and contributes to musculoskeletal dynamics.Imbalance of this regulatory mechanism can impair myofascial tonus, or diminish neuromuscular coordination, which over time contributes to the pathomechanisms of several musculoskeletal pathologies and pain syndromes. The superficial fascia, which lies beneath the dermis and adipose tissue, is rich with proprioceptors and mechanoreceptors. These receptors maintain the homeostasis of the connective tissue. If there is a disturbance to the homeostasis caused by strain to the local tissue, these mechanoreceptors will communicate the insult to the nervous system. The nervous system, in turn, sends protective signals to affected tissue that induce local spasms, resulting in more tightness and pain. These local trigger / tender points, left untreated, cause chronic pain. There is a need for handheld myofascial therapy devices that target densifications in superficial and deep fascia in order to restore the densified hyaluronic acid to its original liquid state thereby relieving pain and promoting musculoskeletal health.SUMMARY

[0003] In one aspect, the present disclosure provides a device for applying manipulative myofascial therapy to a target tissue, the device comprising: a housing coupled to a handle, an actuation assembly located within the housing, a knuckle driven by the motor assembly to apply pressure in a transverse motion relative to a surface of a target tissue, a pad configured to secure the device to the surface of the target tissue while allowing the knuckle to move, a sensor operably coupled to the knuckle to measure a force applied to the device, and one or more processors configured to measure a treatment outcome based at least in part on the force and a current consumption of the motor assembly.

[0004] In another aspect, the present disclosure provides a method for treating fascial densification of a patient with manipulative myofascial therapy, the method comprising: contacting a knuckle of a handheld device to a treatment area on a patient, activating a sensor on the tip of the knuckle to determine locations of fascial densification, and applying manipulative myofascial therapy to the one or more locations with the handheld device.INCORPORATION BY REFERENCE

[0005] All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference. To the extent publications and patents or patent applications incorporated by reference contradict the disclosure contained in the specification, the specification is intended to supersede and / or take precedence over any such contradictory material.BRIEF DESCRIPTION OF THE DRAWINGS

[0006] The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings (also "Figure" and “FIG.” herein), of which:

[0007] FIGS. 1A-1E show a handheld device for administering manipulative fascial therapy, in accordance with certain embodiments.

[0008] FIG. 2 shows an exploded view of a handheld device for administering manipulative fascial therapy, in accordance with certain embodiments.

[0009] FIG. 3 shows a motor and actuation assembly of a handheld device for administering manipulative fascial therapy, in accordance with certain embodiments.

[0010] FIG. 4 shows a handle of a handheld device for administering manipulative fascial therapy, in accordance with certain embodiments.[Oil] FIG. 5 shows a housing of a handheld device for administering manipulative fascial therapy, in accordance with certain embodiments.

[0012] FIG. 6A shows a slider, rail, and gears of a handheld device for administering manipulative fascial therapy, in accordance with certain embodiments.

[0013] FIG. 6B shows a scotch yoke mechanism of a handheld device for administering manipulative fascial therapy, in accordance with certain embodiments.

[0014] FIG. 7 shows a rail of a handheld device for administering manipulative fascial therapy, in accordance with certain embodiments.

[0015] FIG. 8 shows a motor of a handheld device for administering manipulative fascial therapy, in accordance with certain embodiments.

[0016] FIG. 9 shows a pad of a handheld device for administering manipulative fascial therapy, in accordance with certain embodiments.

[0017] FIG. 10 shows a knuckle assembly of a handheld device for administering manipulative fascial therapy, in accordance with certain embodiments.

[0018] FIG. 11 shows a knuckle of a handheld device for administering manipulative fascial therapy, in accordance with certain embodiments.

[0019] FIGS. 12A-12C show a knuckle fixture, knuckle cartridge, and the knuckle groove of a handheld device for administering manipulative fascial therapy in accordance with certain embodiments.

[0020] FIGS. 13A-13B show a knuckle of a handheld device and various motions that the handheld device can exhibit for administering manipulative fascial therapy, in accordance with certain embodiments.

[0021] FIGS. 14A-14B show7different embodiments of a scotch yoke mechanism and actuation assembly of a handheld device for administering manipulative fascial therapy.

[0022] FIGS. 15A - 15E show knuckle housing of a handheld device for administering manipulative fascial therapy in accordance with certain embodiments.

[0023] FIGS. 16A - 16B show7a bottom view7and side views of a knuckle base PCB of a handheld device for administering manipulative fascial therapy in accordance with certain embodiments.

[0024] FIG. 16C shows cross-sectional view of a knuckle assembly and rail of a handheld device for administering manipulative fascial therapy, in accordance with certain embodiments.

[0025] FIG. 16D shows cross-sectional view of a knuckle assembly and heating element of a handheld device for administering manipulative fascial therapy, in accordance with certain embodiments.

[0026] FIG. 16E shows a cross-sectional view of a knuckle assembly of a handheld device configured for use with an ultrasound sensor.

[0027] FIG. 16F shows a cross-sectional view of a knuckle assembly of a handheld device configured for use with a fiber-optic sensor.

[0028] FIG. 17 shows a non-limiting example of a computing device; in this case, a device with one or more processors, memory, storage, and a network interface.

[0029] FIG. 18 shows a non-limiting example of a web / mobile application provision system; in this case, a system providing browser-based and / or native mobile user interfaces.

[0030] FIG. 19 shows a non-limiting example of a cloud-based web / mobile application provision system; in this case, a system comprising an elastically load balanced, auto-scaling web server and application server resources as well synchronously replicated databases.DEFINITIONS

[0031] Unless otherwise defined, all technical terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the present subject matter belongs.

[0032] As used in this specification and the appended claims, the singular forms “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise. Any reference to “or” herein is intended to encompass “and / or” unless otherwise stated.

[0033] Reference throughout this specification to “some embodiments,” “further embodiments,” or “a particular embodiment,” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in one or more embodiment. Thus, the appearances of the phrase “in some embodiments.” or “in further embodiments,” or “in a particular embodiment” in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.

[0034] Example embodiments are described herein in the context of a system and method for applying therapeutic fascial manipulation. The following description is illustrative only and is not intended to be in any way limiting. Other embodiments will readily suggest themselves to thoseof ordinary skill in the art having the benefit of this disclosure. Reference will be made in detail to implementations of the example embodiments as illustrated in the accompanying drawings. The same reference indicators will be used to the extent possible throughout the drawings and the following description to refer to the same or like items.

[0035] In the description of example embodiments that follows, references to "one embodiment", "an embodiment", "an example embodiment", "certain embodiments," “some instances," and "‘some cases’7etc., indicate that the embodiment described may include a particular feature, structure, or characteristic, but every embodiment may not necessarily include the particular feature, structure, or characteristic. Moreover, such phrases are not necessarily referring to the same embodiment. Further, when a particular feature, structure, or characteristic is described in connection with an embodiment, it is submitted that it is within the knowledge of one skilled in the art to effect such feature, structure, or characteristic in connection with other embodiments whether or not explicitly described. The term "exemplary" when used herein means "serving as an example, instance or illustration." Any embodiment described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other embodiments.

[0036] Herein, "or" is inclusive and not exclusive, unless expressly indicated otherwise or indicated otherwise by context. Therefore, herein, "A or B" means "A, B, or both," unless expressly indicated otherwise or indicated otherwise by context. Moreover, "and" is both joint and several, unless expressly indicated otherwise or indicated otherwise by context. Therefore, herein, "A and B" means "A and B, jointly or severally." unless expressly indicated otherwise or indicated otherwise by context.

[0037] The term “user” as used herein refers to but is not limited to a layperson or medical professional who is operating the device.

[0038] The term “patient” as used herein refers to the recipient of treatment with the device, including but not limited to humans and other mammals. In the instance of self-treatment, the patient and user may be the same.

[0039] The term “healthcare professional” as used herein refers to but is not limited to a physical therapist, doctor, nurse, chiropractor, massage therapist, veterinarian, or myofascial release therapist.

[0040] The term “fascial densifi cation” or “fascial tissue densification” as used herein refers to a thickening of the fascial tissue and a lack of glide of the fascial tissue.

[0041] The term “treatment area” as used herein refers to the skin surface, i.e., location on the exterior of a patient’s body that corresponds to the location of possible or identified fascial densifications.

[0042] The terms “myofascial release'’ and “fascial manipulation” as used herein refers to a treatment technique that focuses on breaking up fascial densifications and relieving pain in myofascial tissue.

[0043] The term “target tissue” as used herein refers to the tissue of the treatment area.

[0044] The term “indentation depth” as used herein refers to the depth beneath the skin’s surface where a fascial densifi cation exists.

[0045] The term “transverse motion” as used herein refers to a movement that is transverse to (or substantially orthogonal to) the normal line to a plane that defines the treatment area.

[0046] The term “maneuvered” or “maneuverable” as used herein means the user is able to move the device for purposes of locating and / or treating a fascial densifi cation.METHODS OF USE

[0047] While various embodiments of the invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by w ay of example only. Numerous variations, changes, and substitutions may occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed.

[0048] Aspects of the invention include devices and methods for applying manipulative myofascial therapy to a patient. To deactivate mechanoreceptors in fascia and alleviate pain and discomfort, passive steady and slow manual pressure / decompression manipulations of the connective tissue can be used to release spasms. Decompression or friction massage maneuvers applied to the connective tissue have been found to be effective. During manual treatment of fascia, there is a palpable, often visible reduction in localized tissue edema which helps alleviate the chemical component of chronic soft tissue dysfunction. Manual treatment can reduce the viscosity of hyaluronic acid, which allows for better lubrication of connective tissues. The combination of inflammation drainage and pain receptor "deactivation" gives this maneuver unparalleled effect and duration when compared to kneading, shiatsu, percussion, or vibration. In some embodiments, the handheld device described herein delivers fascial manipulation treatment through transverse motion and applied heat. Unlike conventional devices that perform percussive forces substantially perpendicular to a treatment area (e g., skin of a subject) which may not be effective for superficial or deep fascia manipulation, the device provided herein can provide motion that is substantially transverse to a contact surface thereby improving the superficial and / or deep fascia manipulation effect or treatment result.

[0049] Aspects of the device can manipulate superficial fascia by decompressing the myofascial tissue. Aspects of the device include a handheld device that may mechanically deactivate mechanoreceptors and signal the nervous system to reset and stop its protective messages to the tissue, thereby halting the chronic spasms that can be debilitating, and limiting of strength, range of motion, mobility, and functional activities.

[0050] Aspects of the device include a housing coupled to a handle, a motor assembly located within the housing, wherein the motor assembly comprises a low-profile brushless DC motor; a knuckle driven by the motor assembly to have a transverse motion relative to the surface of a target tissue; a pad configured to secure the device to the surface of the target tissue while allowing the knuckle to move; a sensor operably coupled to the knuckle to measure a force applied to the device; and one or more processors configured to measure a treatment outcome based at least in part on the force and a current consumption of the motor assembly.

[0051] Aspects of the device include a housing shaped and sized to be maneuvered by a user; an actuation assembly disposed within the housing; a knuckle comprising: a first portion disposed within the housing and operably coupled to the actuation assembly; and a second portion extending outw ard from an opening in said housing; and a sensor disposed at a tip of a knuckle, wherein the sensor is configured to obtain measurements associated with the densification of fascia of the patient.

[0052] Aspects of the device include a housing that comprises at least one handle.

[0053] Aspects of the device include a pad attached to the housing that can be used to secure the device in place on a treatment area while the device is in operation.

[0054] Aspects of the device include a housing that comprises a first handle on a first side of the housing, and a second handle on an opposite, second side of the housing.

[0055] Aspects of the device include an actuation assembly that comprises one or more motors, a gear coupled to the motor, a rail operably coupled to the gear wherein the motor is configured to rotate the gear, and wherein the gear is configured to move the rail linearly. Further aspects include a crank rod coupled to the gear such that the gear is configured to rotate the crank rod, and a slider coupled to the crank rod and the rail such that the crank rod is configured to move the slider linearly and the slider is configured to move the rail linearly.

[0056] Aspects of the device include an actuation assembly that is configured to move the knuckle at a linear speed of up to approximately 0.5 meters per second, such as 0.05 m / s, 0. 1 m / s, 0.15 m / s, 0.2 m / s, 0.25 m / s, 0.3 m / s, 0.35 m / s. 0.4 m / s, 0.45 m / s, or 0.5 m / s.

[0057] Aspects of the device include an actuation assembly configured to apply a torque of up to 180 gem. such as 10 gem, 20 gem. 30 gem, 40 gem. 50 gem, 60 gem. 70 gem, 80 gem. 90 gem, 100 gem, 1 10 gem, 120 gem, 130 gem, 140 gem, 150 gem, 160 gem, 170 gem, or 180 gem.

[0058] Aspects of the device include a knuckle that is removable from the housing.

[0059] Aspects of the device include a knuckle that comprises four parts, wherein the second portion of the knuckle has a length that ranges from 8 millimeters (mm) to 20 mm, such as 8 mm, 9 mm, 10 mm. 11 mm. 12 mm, 13 mm, 14 mm. 15 mm. 16 mm, 17 mm, 18 mm. 19 mm, or 20 mm.

[0060] Aspects of the device include an actuation assembly configured to apply a torque of up to 180 gem when the second portion of the knuckle is pressed into the treatment area at the indentation depth, such as 10 gem, 20 gem, 30 gem. 40 gem, 50 gem. 60 gem, 70 gem. 80 gem, 90 gem, 100 gem, 110 gem, 120 gem, 130 gem, 140 gem, 150 gem, 160 gem, 170 gem, or 180 gem.

[0061] Aspects of the device include a temperature unit, further comprising a resistive heater.

[0062] Aspects of the device include different sensors to aid in measuring fascia densification and the progress of therapy during the myofascial therapy / treatment, such as a pressure sensor, an ultrasound sensor, and / or a fiber optic sensor.

[0063] Aspects of the invention include methods of impinging the fascia by manipulations with a knuckle to loosen or resolve fascia densification.

[0064] Aspects of the invention include methods for locating fascial densifications by contacting a first knuckle of a handheld device to the treatment area and activating a sensor disposed at a tip of the first knuckle to obtain measurements associated with the densification of a fascia of the patient.

[0065] Aspects of the methods include determining one or more treatment areas of the patient that correspond to one or more fascial densifications.

[0066] In some embodiments, the methods include locating fascial densifications through a pressure sensor, where force is applied to a treatment area and fascial densification is determined by the amount of force applied and the resulting pressure that is measured.

[0067] Aspects of the invention include methods to locate fascial densifications through an ultrasound sensor, wherein an ultrasound sensor in the tip of the first knuckle is contacted to the treatment area and a measurement of fascial densification is calculated. In some embodiments, an ultrasound coupling material is disposed on the tip of the first knuckle such that contacting the first knuckle of the handheld device to the treatment area comprises contacting the ultrasound coupling material to the treatment area of the patient.

[0068] Aspects of the invention include methods to locate fascial densifications through a fiber optic sensor, wherein a fiber optic sensor in the tip of the first knuckle is contacted to the treatment area and a measurement of fascial densification is calculated based on the density of the tissue.

[0069] In some embodiments, aspects of the methods include locating fascial densifications with an ultrasound sensor and a pressure sensor.

[0070] In some embodiments, aspects of the methods include locating fascial densifications with a fiber optic sensor and a pressure sensor.

[0071] In some embodiments, aspects of the methods include locating fascial densifications with an ultrasound sensor and a fiber optic sensor.

[0072] In some embodiments, aspects of the methods include locating fascial densifications with an ultrasound sensor, a fiber optic sensor and a pressure sensor.

[0073] Aspects of the invention include methods for locating fascial densification using the methods described above, followed by replacing the first sensor-containing knuckle of the handheld device with a second knuckle configured for administering treatment; pressing the second knuckle into the skin surface of the patient at a first fascial densification of the one or more fascial densifications such that the second knuckle presses on the first fascial densification; and moving the second knuckle in a plane parallel to the skin surface to treat the first fascial densification.

[0074] Aspects of the methods include applying manipulative myofascial therapy by pressing the first knuckle into the skin surface of the patient at a first fascial densification of the one or more fascial densifications such that the first knuckle presses on the first fascial densification; and moving the first knuckle in a plane parallel to the skin surface to treat the first fascial densification.

[0075] Aspects of the methods include moving the first knuckle at a linear speed of up to approximately 1.3 meters per second, such as 0.1 m / s, 0.2 m / s, 0.3 m / s, 0.4 m / s, 0.5 m / s, 0.6 m / s, 0.7 m / s, 0.8 m / s, 0.9 m / s, 1.0 m / s, 1.1 m / s, 1.2 m / s, and 1.3 m / s.

[0076] Aspects of the method include configuring the device to apply a torque of up to 180 gem, such as 10 gem, 20 gem. 30 gem, 40 gem. 50 gem, 60 gem. 70 gem, 80 gem. 90 gem, 100 gem, 110 gem, 120 gem, 130 gem, 140 gem, 150 gem, 160 gem, 170 gem, or 180 gem.

[0077] Aspects of the method include pressing the knuckle into the treatment area to an indentation depth that ranges from 8 millimeters (mm) to 30 mm, such as 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm. 15 mm, 16 mm, 17 mm, 18 mm. 19 mm, 20 mm, 21 mm, 22 mm, 23 mm, 24 mm, 25 mm, 26 mm, 27 mm, 28 mm, 29 mm, or 30 mm.

[0078] Aspects of the method include applying a torque of up to 180 gem, such as 10 gem, 20 gem, 30 gem, 40 gem, 50 gem, 60 gem, 70 gem, 80 gem, 90 gem, 100 gem, 110 gem, 120 gem, 130 gem, 140 gem, 150 gem, 160 gem, 170 gem, or 180 gem, when the first knuckle is pressed into the treatment area of the patient at the indentation depth.

[0079] Devices in accordance with embodiments of the invention are configured to maintain torque to deliver therapy at a consistent indentation depth and speed while the knuckle is operating in a transverse motion. Devices in accordance with embodiments of the invention are configured to maintain torque to deliver therapy at a consistent indentation depth and speed while the knuckle is operating in a rotational motion. Devices in accordance with embodiments of the invention are configured to maintain torque to deliver therapy at a consistent indentation depth and speed while the knuckle is operating in a revolutionary motion. Devices in accordance with embodiments of the invention are configured to maintain torque to deliver therapy at a consistent indentation depth and speed while the knuckle is operating in a vertical motion.

[0080] Aspects of the methods include applying manipulative myofascial therapy further comprising heating or cooling the treatment area using a temperature unit disposed within the device.

[0081] Aspects of the methods include utilizing tissue density (e.g., tissue density before and after treatment) to determine a treatment outcome. For instance, a greater tissue density may indicate a thickening of the loose connective tissue layer whereas a reduced tissue density may correspond to an improved treatment result. In some embodiments, the difference of tissue density before and after a treatment session may be used to quantify a treatment outcome. In some instances, the fascia densifi cation and / or the progress of therapy (e.g., based on tissue density) may be determined based at least in part on a calibrated current consumption or current load of the device motors. In some cases, the current load may be from a motor current of a motor (e.g., a DC motor) that can be measured directly (e.g., in the motor wire). A current consumption may be based on a plurality of factors including a motor speed, a vertical force applied to the device, and a tissue density7of a target treatment point (e.g., the contact point under a knuckle of the device that the force is applied to). To use the current consumption to predict tissue density7, the current consumption may be calibrated based at least in part on a vertical force applied to the knuckle or the device and the motor speed. In some cases, the vertical force applied to the knuckle may be obtained by utilizing a pressure sensor located under the knuckle (e.g., at the knuckle tip) which directly measures the force applied to the knuckle. Based on the vertical force, the motor speed (e.g.. obtained from the device set up or use command), thecurrent consumption can be calibrated so the calibrated current consumption (e.g., force- calibrated current consumption) can be used to accurately indicate the tissue density.

[0082] Aspects of the methods herein include measuring treatment progress in real-time in a compact and cost-efficient manner, by receiving a current consumption measurement from a motor assembly of the device, wherein the motor assembly drives a motion of a knuckle of the device; receiving a force measurement indicative of a measurement of a force applied to the knuckle; and supplying the current consumption measurement and the force measurement as input to a machine learning algorithm trained model to output a predicted tissue density of the tissue.

[0083] Aspects of the invention include methods for measuring fascial tissue densification determined by a sensor before and after administration of myofascial therapy. In some embodiments, the methods involve recording an initial fascial tissue densification value, administering a myofascial therapy, and obtaining a second fascial tissue densification value, and comparing it to the first value to determine whether the therapy decreased fascial tissue densification value. In some embodiments, the measurements are obtained by an ultrasound sensor. In some embodiments, the measurements are obtained by a fiberoptic sensor. In some embodiments, the measurements are obtained by a pressure sensor. In some embodiments, aspects of the methods include measuring fascial densifications with an ultrasound sensor and a pressure sensor. In some embodiments, aspects of the methods include measuring fascial densifications with a fiber optic sensor and a pressure sensor. In some embodiments, aspects of the methods include measuring fascial densifications with an ultrasound sensor and a fiber optic sensor. In some embodiments, aspects of the methods include measuring fascial densifications with an ultrasound sensor, a fiber optic sensor and a pressure sensor.

[0084] Aspects of the methods include estimation of tissue density as obtained above (i.e.. from the current load time series and force exerted on target treatment region or from measurements taken by the ultrasound sensor or fiber optic sensor), along with knowledge of the point of the body being treated. In some instances, the current load (e.g., the amount of electrical current that is passed from a power supply to the device or component receiving the power) increases with increasing force applied to the target treatment region. In some instances, the current load increases with increasing vertical force applied to the target treatment region. In some instances, the current load time series comprises the variation in electrical current load over a specific period of time drawn by a particular electrical circuit, component, or device over time. In some instances, the current load time series may comprise a measurement of the amount of electrical current passed from a power supply of the device to the component receiving power. In someinstances, the current load time series may comprise a measurement of the average amount of electrical current passed from a power supply of the device to the component receiving power during a time interval. For example, the current load time series comprises the average amount of current received by the component receiving power per second. In further examples, the current load time series comprises the average amount of current received by the component receiving power per second during a span of the handheld device operation. In some instances, the component receiving power may comprise any electronic component of the handheld device. For example, the component receiving power may comprise one or more motors. The current load time series may at least in part increase with increasing speed of the one or more motors.

[0085] Aspects of the methods include generating the predicted tissue density of a treatment area before and after a treatment session and developing a treatment plan based on the change in tissue density.

[0086] Aspects of the methods involve using information about the patient or data collected during usage of the device to further improve the estimate of fascial densification and help track changes in tissue densifications that correlate with the effectiveness of the treatment. For example, the effectiveness of treatment calculation may comprise a physiological profile and / or tissue location. The effectiveness of treatment may be determined utilizing machine learning techniques. In some cases, a machine learning algorithm trained model may take as input current consumption (e.g., current measurement unit output), vertical force applied to the device (e.g., a force measurement unit output), and a treatment area (e.g., based on user input) and output a predicted tissue density of tissue before and after treatment. In some cases, a machine learning algorithm trained model may take as input a current measurement unit output, a force measurement unit output, and a treatment area, and output a change in tissue densification. Alternatively, a model may be trained to correlate the change in tissue densification to the effectiveness of treatment. In some instances, a first model may calculate a change in tissue densification and a second model may correlate the change in tissue densification to the effectiveness of treatment. The first model and second model may comprise separate models. Alternatively, a single model may comprise the first model and second model.

[0087] Aspects of the methods include implementing a machine learning regressor separately in a mobile / computer application. In some cases, the machine learning regressor processes the measured data and predicts tissue density before and after treatment to determine a treatment outcome. In some cases, the machine learning regressor processes the measured data and correlates the change in tissue densification to the effectiveness of treatment.

[0088] Aspects of the methods include sensing myofascial stiffness in a target tissue area and mobilizing fascia to release tension where the device is controllable with a software application (e.g., an iOS / Android App on a mobile device) to control grip actuator(s), log historical stiffness measurements, provide users with therapeutic exercises that augment myofascial release, provide an educational platform for resources on fascial health with respect to nutrition, proper posture, body mechanics, and flexibility exercises. In some instances, the software application is capable of logging history of myofascial stiffness, muscle tonicity, and other factors for individual users who have their own custom accounts, which can be one of many located on a particular device.

[0089] Aspects of the methods involve applying heat and / or other energy' with the device, such as light or vibration to a target treatment area. In some cases, a temperature unit comprises heating elements for applying heat of about 100°F to about 120°F (between about 37.8°C to about 48.9°C), such as 100°F, 105°F, 110°F, 115°F, or 120°F. In some cases, the temperature unit is configured to lower the temperature of the target treatment area. In some instances, after fascial manipulation or myofascial release, cold therapy can be applied to reduce inflammation and alleviate any post-treatment discomfort. For example, the temperature of the one or more heating elements for the cold therapy may comprise between about 32°F to about 45°F (between about 0°C to about 7.2°C), such as 32°F, 35°F, 40°F, or 45°F. The duration and frequency of cold therapy can vary' (e.g., depending on the severity' of densification, tissue location, etc.)

[0090] Aspects of the device comprise a motor operable to impart to the movable knuckle and one or more of a translational, rotational, or revolutionary motions that are generally in a plane parallel to the skin of a patient during operation.DETAILED DESCRIPTIONDevice

[0091] The general design for the device in FIG. 1 provides, in certain embodiments, a device 10 that is compact, handheld, delivers manipulative fascial treatment via a deep pressure, transverse motion with adjuvant heat, and enables measuring a treatment outcome through tissue density, current load, ultrasound, or fiberoptic sensor. FIG. 1A shows an embodiment of the device with a dome-shaped handle on the top of the device. FIGS. 1B-1E show an embodiment of the device with paddle shaped handles on either side.

[0092] In some embodiments, the handheld device 10 comprises a compact general dimension. In some cases, the handheld device 10 comprises a compact general dimension comprising a handheld device length, handheld device width, and handheld device height.

[0093] In some instances, the handheld device length without handles comprises between about 90mm to about 150mm, such as about 90 mm, 100 mm, 110 mm, 120 mm, 130 mm, 140 mm, or 150 mm.

[0094] In some instances, the handheld device length with handles comprises between about 150 mm to about 210 mm, such as about 150 mm, 160 mm, 170 mm, 180 mm, 190 mm, 200 mm, or 210 mm.

[0095] In some instances, the handheld device width comprises between about 20 mm to about 100 mm, such as 20 mm, 30 mm, 40 mm, 50 mm, 60 mm, 70 mm, 80 mm, 90 mm, or 100 mm.

[0096] In some instances, the handheld device height comprises between about 100 mm to about 150 mm, such as about 100 mm, 110 mm, 120 mm, 130 mm, 140 mm, or 150 mm.

[0097] For example, the general dimensions of the handheld device may comprise the handheld device length of between about 100 mm to about 150 mm, the handheld device width of between about 20 mm to about 100 mm, and the handheld device height of between about 100 mm to about 150 mm.

[0098] In some cases, the handheld device 10 comprises a total weight for ease of handheld device 10 application to a target treatment area. In some instances, the handheld device 10 comprises a total weight of between about 0.2 kg to about 1 kg, such as 0.2kg, 0.3kg, 0.4kg, 0.5kg, 0.6kg, 0.7kg, 0.8kg, 0.9kg, or 1.0kg.

[0099] FIG. 2 shows an exploded view of the components of the handheld device for administering manipulative fascial therapy. The handheld device 10 may comprise internal and external components and / or assemblies for administering manipulative fascial therapy. In some cases, the handheld device 10 for administering manipulative fascial therapy comprises a handle 11, one or more motor gear 21, one or more motor 13, crank rod 14, crank gear 15, control knob board 16. power USB-C board 17. main board 18. housing 20, silicone pad 30, linear rail 40, slider 50, knuckle assembly 60, and one or more removable knuckles 65. In some cases, the handheld device 10 comprises the handle 11, shell 20, and a removable knuckle 65. In some instances, the one or more components may be made of any suitable materials such as plastic. For example, the handle 11, shell 20, or knuckle 65 may be formed of 3D printed PLA-12. In some embodiments, for example, as depicted in FIG. 1. a handle can include one or more extensions that extend away from the body of the device.

[0100] In representative embodiments described herein, the more compact size and height of the handheld device 10 is achieved by using two low profile high speed brushless direct current (“DC”) motors 13 connected to the same gear 15. In some instances, each of the two low profile high speed brushless direct current (“DC”) motors 13 comprises a height of between about 10mm to about 30 mm. In further instances, each of the two low profile high speed brushless direct current ("DC") motors 13 comprises a diameter of between about 25 mm to about 50 mm.

[0101] In some instances, the two low profile high speed brushless direct current C’DC ) motors 13 connected to the same gear 15 supply the required torque rating (e.g., a final maximum or stall torque of between about 600 gem to 700 gem). In further instances, each of the two low profile high speed brushless direct current ( DC") motors 13 comprises a rated torque of between about 160 gem to about 200 gem. In even further instances, each of the two low profile high speed brushless direct current ('‘DC”) motors 13 comprises a maximum torque of between about 600 gem to about 700 gem before reduction, such as 600 gem, 610 gem, 620 gem, 630 gem, 640 gem, 650 gem, 660 gem, 670 gem, 680 gem, 690 gem, or 700 gem.

[0102] In representative embodiments described herein, a top motor 13 cover is used as a handling section 11 and can be held with accessibility in all directions (e.g., front / back, left / right, top / bottom, etc.). In addition to the handle 11 design, in certain embodiments, the compact size makes the handheld device 10 flexible to use on all parts of the body.Handle

[0103] FIG. 4 shows a section view of a dome-shaped handle 11 and dual motor drive assembly 13 of a handheld device 10 for administering manipulative fascial therapy. The devices provided herein may comprise a device handle 11. The device handle 11 provided herein improves over devices in the art by providing, in certain embodiments, a handle 11 with a height configured for application of fascia therapy, thereby contributing to the device 10 compactness. The device handle 11 provided herein improves over devices in the art by providing, in certain embodiments a material with advantageous grip for applying fascial therapy (e.g., polyurethane, etc.).

[0104] In some cases, the handle 11 is substantially semi-oval. In some cases, the handle 11 is dome shaped. In some cases, the handle 11 comprises an upper surface of the handheld device 10. In some cases, the handle 11 is hollowed from the inside. In some cases, the handle 11 comprises a hollowed area proportional to the area of each motor 13. In some instances, the handle 11 hollowed area is configured for the one or more motors 13. In some instances, the handle 11 hollowed area is configured for the placement of at least two electric motors 13. In some instances, the motors 13s are held in place within the handle 11 hollowed area by the motor base plate 19 that is mechanically fastened (e.g., screwed, bolted, strapped, etc.) to threaded inserts in the handle 11 body. In some cases, the handle include one or more extensions that extend away from the body of the device, as in FIGS IB- IE.

[0105] In some cases, the handle 11 comprises a handle grip area. In some instances, the handle grip area comprises an upper external surface of the handheld device 10. In some instances, the handle grip area length comprises between about 80 mm to about 200 mm. In some instances, the handle grip area width comprises between about 20 mm to about 100 mm. In some instances, the handle grip area length comprises between about 80 mm to about 200 mm and the handle grip area width comprises between about 20 mm to about 100 mm.

[0106] In some cases, the device 10 comprises plastic components including the handle 11. In some instances, the device 10 plastic components are 3D printed PLA-12. In some cases, the handle 11 comprises a handle cover. In some instances, the handle cover comprises a material with significant grip (e.g., friction) for applying myofascial therapy. For example, the handle cover may comprise a layer of polyurethane.

[0107] The handle 11 may be configured to receive a force from a user (e.g., a hand). In some cases, the handle 11 is configured to apply a vertical force to internal components of the device 10. In some instances, the handle 11 is configured to apply a vertical force to the knuckle 65 of the device 10. In some instances, the handle 11 is configured to apply a vertical force to a bodily surface (e.g.. a target treatment area). In some instances, the handle 11 is configured to hold the motors 13 in place while the device 10 is operating (e g., applying myofascial therapy). In alternative instances, the handle 11 is configured to hold the motors 13 in place while the device 10 is at rest.Actuation Assembly

[0108] FIG. 3 shows a handheld device 10 comprising a dual motor drive assembly 13 for administering manipulative fascial therapy. The handheld devices 10 provided herein may comprise an actuation assembly 300. In some cases, the actuation assembly 300 is configured to actuate the motion of a knuckle assembly 60. In some cases, the actuation assembly 300 is configured to actuate the motion of a knuckle 65. In some instances, the actuation assembly 300 comprises one or more motors 13, a motor base plate 19, a crank gear 15, and a crank rod 14.

[0109] The handheld device 10 may achieve a compact design by comprising an actuation assembly 300 with reduced sized actuation components. In some instances, the actuation assembly 300 comprises one or more motors 13. In some cases, the one or more motors 13 are mounted vertically. In some cases, the one or more motor 13 are mounted horizontally. In some cases, the actuation assembly may comprise a reduced overall dimension / size by using one or more low profile motors 13. In some instances, the one or more low profile motors 13 comprises a Brushless DC motor 13. In some instances, the one or more low profile motors 13 comprisesone or more Brushless DC motor 13. In some instances, the one or more low profile motors 13 comprises two or more brushless DC motors 13. In some instances, the one or more motors 13 comprises two Brushless DC motors 13, which thereby make the handheld device 10 compact. In some embodiments, the Brushless DC motor 13 comprises a lower height than a single geared DC motor 13.

[0110] In some cases, the one or more motors 13 comprises one or more low-profile motors. In some instances, the one or more low-profile motors comprises an overall size of 50% to 99% of the overall size of a single geared DC motor. In some cases, the one or more low-profile motors comprises one or more brushless DC motor 13. In some instances, the one or more brushless DC motor 13 comprises an overall motor size about 50% the overall motor size of a single geared DC motor. In some instances, the one or more brushless DC motor 13 comprises an overall motor size of between about 50% to about 99% of the overall motor size of a single geared DC motor. For example, the one or more brushless DC motor 13 comprises a motor head about 50% the size of a single geared DC motor head. In other examples, the one or more brushless DC motor 13 comprises a motor head about 50% to about 99% the size of a single geared DC motor head. In some instances, each of the two low profile high speed brushless direct current (“DC7’) motors 13 comprises a height of between about 10 mm to about 50 mm, such as 10mm, 15mm, 20mm, 25mm, 30mm, 35mm, 40mm, 45mm, or 50mm.[OHl] In some cases, the one or more motor 13 comprises a substantially cylindrical shape. In some cases, the one or more motors 13 are connected to a central crank gear 15. In some instances, the one or more motor 13 comprises two brushless DC motors 13 connected to the central crank gear 15. In some cases, the central crank gear 15 comprises a gearing ratio. In some instances, the gearing ratio is 1: 10. For example, the gearing ratio of 1 : 10 may reduce the height of the base of the one or more motors 13. In some examples, the gearing ratio of 1 : 10 enables the compact handheld device assembly. In some cases, the gearing ratio supplies the required torque. In some instances, the one or more motors 13 comprises a torque of betw een about 2 gem to 20 gem, such as 2 gem, 3 gem, 4 gem, 5 gem, 6 gem, 7 gem, 8 gem, 9 gem, 10 gem, 11 gem, 12 gem, 13 gem, 14 gem, 15 gem, 16 gem, 17 gem, 18 gem, 19 gem, or 20 gem.

[0112] In some cases, the one or more motors 13 comprises two motors, wherein each of the two motors comprise a torque of between about 150 gem to 200 gem, such as 150 gem, 160 gem, 170 gem, 180 gem, 190 gem, or 200 gem. In some cases, the handheld device 10 comprises a final maximum torque of betw een about 600 gem to 700 gem. In some instances, the actuation assembly 300 comprises one or more motors 13 comprising a final maximum torque of between600 gem to 700 gem, such as 600 gem, 610 gem, 620 gem, 630 gem, 640 gem, 650 gem, 660 gem, 670 gem. 680 gem. 690 gem, or 700 gem.

[0113] In some cases, the crank rod 14 is connected directly to the crank gear 15. In some instances, the crank gear 15 may comprise a custom designed herringbone gear. In some instances, the custom designed herringbone gear comprises a custom-made module 0.45 gear.

[0114] In some instances, the crank gear 15 may comprise a spur gear. In some instances, the crank gear 15 eliminates an axial load on the one or more motor 13 (e.g.. otherwise present form normal helical gears).

[0115] FIG. 8 shows a motor 13 with a motor gear 21 of a handheld device 10 for administering manipulative fascial therapy. For example, the motor gear 21 may comprise a 12 teeth (“12 I”') herringbone gear 21. In some cases, the actuation assembly 300 comprises one or more motors 13 further comprising two low profile high-speed brushless DC motors 13. In some instances, the one or more motors 13 rest on top of a first surface of the base plate 19. In some instances, the one or more motors 13 are fixed to the motor base plate 19 through a mechanical fastener connection. In some instances, the one or more motors 13 are fixed to the motor base plate 19 through a mechanical fastener connection, wherein the mechanical fastener connection is affixed from a second surface of the base plate 19 to the first surface of the base plate 19. In some instances, the one or more motors 13 are fixed to the motor base plate 19 through a mechanical fastener connection, wherein the mechanical fastener connection is affixed from the first surface of the base plate 19 to the second surface of the base plate 19. In some instances, the motor 13 rests on the base plate 19. In some instances, the one or more motors 13 are fixed to the motor base plate 19 through a screw connection. In some instances, the motor 13 rests on the base plate 19. In some instances, the one or more motors 13 are fixed to the motor base plate 19 through a bolt connection. In some instances, the one or more motors 13 are connected to the main crank gear 15 using a motor gear (e.g., a 12 teeth herringbone gear) 21. In some instances, the one or more motors 13 is affixed to the first surface of the base plate 19. In some instances, the motor gear 21 is affixed to the second surface of the base plate 19, wherein the second surface of the base plate 19 is opposite the first surface of the base plate 19.

[0116] In some cases, the one or more motors 13 comprise a max no load speed, the maximum speed of the motor when the device is not applying force. In some instances, the max no load speed of the motors 13 is between about 5000 rpm to about 7000 rpm such as 5000 rpm, 5100 rpm, 5200 rpm, 5300 rpm, 5400 rpm, 5500 rpm, 5600 rpm, 5700 rpm, 5800 rpm, 5900 rpm, 6000 rpm, 6100 rpm, 6200 rpm. 6300 rpm, 6400 rpm, 6500 rpm, 6600 rpm, 6700 rpm. 6800 rpm, 6900 rpm, or 7000 rpm.

[0117] In some embodiments, the motor 13 is configured to not stall or decrease speed under increased load. In further instances, each of the two low profile high speed brushless direct current (“DC”) motors 13 comprises a rated torque of between about 160 gem to about 200 gem. In even further instances, each of the two low profile high speed brushless direct current (“DC”) motors 13 comprises a stall torque of between about 600 gem to about 700 gem before reduction, such as 600 gem, 610 gem, 620 gem, 630 gem, 640 gem, 650 gem, 660 gem, 670 gem, 680 gem, 690 gem. or 700 gem.Rail

[0118] The linear rail 40 of a handheld device 10 is configured to allow the knuckle 65 to provide a force to the target tissue for manipulative fascial therapy as depicted in FIG. 10. The devices provided herein may comprise a handheld device 10 comprising the linear rail 40. In some cases, the slider 50 comprises the linear rail 40. In some cases, the linear rail 40 is comprised of a steel material. In some cases, the linear rail 40 is configured to enable the scotch yoke mechanism. In some instances, the linear rail 40 provides a smooth and confined linear motion of the linear rail block 41 as in FIG. 7. In some instances, the linear rail block 41 is positioned between the slider 50 and the knuckle assembly base 62. In some instances, the linear rail 40 is configured to allow the knuckle 65 to apply a translational force to a target tissue. In some instances, the linear rail 40 is configured to allow the knuckle 65 to apply a penetrative force to a target tissue. In some instances, the linear rail 40 is configured to allow the knuckle 65 to apply a vertical force to a target tissue. In some instances, the linear rail 40 is configured to allow the knuckle 65 to apply a horizontal force to a target tissue. In some instances, the linear rail 40 is configured to allow the knuckle 65 to apply a rotational force to a target tissue.

[0119] In some cases, the linear rail 40 comprises a substantially rectangular shape. In some instances, the linear rail 40 comprises a substantially rectangular shape with two parallel linear rail half-cylindrical recessed regions along a left and right upper surface of the linear rail 40. In some instances, the linear rail 40 comprises a plurality of linear rail cylindrical recessed regions along a center surface of the linear rail 40. For example, the linear rail 40 may comprise the plurality7of linear rail cylindrical recessed regions configured for the crank rod 14. In some examples, the plurality of linear rail cylindrical recessed regions comprises one or more linear rail cylindrical recessed regions. In other examples, the plurality of linear rail cylindrical recessed regions comprises between about one to about five linear rail cylindrical recessed regions.

[0120] In some instances, the linear rail block 41 may comprise a substantially rectangular shape. In some instances, the linear rail block 41 comprises a linear rail block 41 abutment comprisingabout the same size as the two parallel linear rail half-cylindrical recessed regions. In some instances, the linear rail block 41 comprises the linear rail block rectangular recessed region comprising about the same size as the linear rail 40.Slider

[0121] FIG. 6A shows a slider 50 of a handheld device 10 for administering manipulative fascial therapy. In some instances, the slider 50 connects the one or more motors 13 to the linear bearings. In some instances, the crank rod 14 slides in the slider 50 groove. In some cases, the slider 50 is configured to enable the scotch yoke mechanism, as in FIG. 6B. In some instances, sliding / inserting the crank rod 14 in the slider 50 groove transforms the motion from rotational to translational along the linear bearing 42. For example, the slider 50 groove may comprise a slider cylindrical recessed portion configured to fit the crank rod 14. In another embodiment, the slider cylindrical recessed portion may be configured to allow the crank rod 14 to move from left to right or right to left, or a combination thereof.Housing

[0122] FIG. 5 shows a housing 20 design of a handheld device 10 for administering manipulative fascial therapy. The devices provided herein may compnse a handheld device 10 comprising a housing 20. In some embodiments, the housing 20 comprises a housing exterior surface and a housing interior surface. In some cases, the housing 20 exterior surface comprises an external cover for the device 10. In some cases, the housing groove 22 is located on the exterior surface. In some cases, a housing groove 22 is located around a top part of the housing 20 under the handle 11. In some instances, the housing groove 22 is designed to be a finger rest to improve the grip and device 10 control when the device 10 is in operation. In some instances, the housing groove 22 is designed to be a finger rest and to improve the grip and device 10 control. In some instances, the housing 20 exterior surface comprises a substantially cylindrical shape. In some instances, the housing 20 exterior surface comprises a substantially ovular shape with a housing groove 22. For example, the housing groove 22 may comprise the dimensions of one or more fingers. In another example, the housing groove 22 comprises a finger rest / finger grip area. In some instances, the housing exterior comprises a plurality of housing clip receptacle regions.

[0123] In some instances, the housing 20 interior surface is configured for housing the device 10 internal components. In some instances, the housing 20 interior surface comprises a support for the linear rail 40. In some instances, the housing 20 comprises a USB-C power board 17. Forexample, the USB-C power board 17 may be located on the housing interior surface. In further examples, the USB-C power board 17 may be mounted to the inner side of the shell 20. In some instances, the housing 20 interior surface comprises protection / organization for the device internal components including, at least part of the motor base plate 19, crank rod 14, control knobs board 16, slider 50, and the knuckle assembly 60.Pad

[0124] In certain embodiments, the device can contain a pad configured to secure the position of the device. Due to the high force that the motor can exert, the device can move around while in use, which decreases the control of knuckle placement. FIG. 9 shows a pad 30 of a handheld device 10 with a snap fit base 31 for administering manipulative fascial therapy. In some instances, the pad 30 is configured to secure the position of the device 10 in space. In some instances, the pad 30 is configured to allow only the knuckle 65 to oscillate. For example, the pad 30 is configured to secure the position of the device 10 in space by preventing the device 10 from moving left to right. In further examples, the pad 30 is configured to secure the position of the device 10 in space by preventing the device 10 from moving up and down.

[0125] In some cases, the pad 30 is advantageous over current devices in that it covers the whole device 10 area (e.g., the device length and the device width). In some instances, the pad 30 comprises a pad length. For example, the pad length may be between about 80 mm to about 150 mm, such that the pad length is 80 mm, 85 mm, 90 mm, 95 mm, 100 mm, 105 mm, 110 mm, 115 mm, 120 mm, 125 mm, 130 mm, 135 mm, 140 mm. 145 mm, or 150 mm. In some instances, the pad 30 comprises a pad width. For example, the pad width may be between about 5 mm to about 60 mm, such that the pad width is 5 mm, 10 mm, 15 mm, 20 mm, 25 mm, 30 mm, 35 mm, 40 mm, 45 mm, 50 mm, 55 mm, or 60 mm. In some instances, the pad 30 comprises a pad height. For example, the pad height is between about 10 mm to about 100 mm, such that the pad height is 10mm. 15 mm, 20 mm, 25 mm, 30 mm. 35 mm, 40 mm, 45 mm, 50 mm, 55 mm, 60 mm, 65 mm, 70 mm, 75 mm, 80 mm, 85 mm, 90 mm, 95 mm, or 100 mm.

[0126] In some cases, the pad 30 comprises a surface that conforms to a curvy surface of the body. In some cases, the pad 30 conforms to the different geometries of the body. In some cases, the pad 30 material is polyurethane foam. In some instances, the pad material is silicone. For example, the silicone may comprise comprises a soft low shore hardness silicone (e.g.. Ecoflex™ 00-31 and 00-45 Near Clear). In some instances, the pad 30 material comprises any material that provides significant friction to hold the handheld device 10 in place and secure it firmly onto the patient's body as the motor 13 is oscillating with high speed and exerting a high force.

[0127] In some cases, the device 10 comprises an adhesive to secure the pad 30 to the motor base plate 19. In some cases, the device 10 comprises a silicone-based adhesive to secure the pad 30 to the motor base plate 19. In some instances, the silicone-based adhesive provides the maximum pad area. In some instances, the motor base plate 19 is the pushed into the housing 20 and secured with a snap fit mount. For example, the pad 30 may comprise pad clips 32 on a pad top, wherein the pad top is opposite the pad base 31.

[0128] In some cases, the pad 30 comprises a pad base 31. In some instances, the pad base 31 comprises an array of half spherical bumps. For example, the pad base 31 may comprise between about 20 to about 100 half spherical bumps such that there are 20, 30, 40, 50, 60, 70, 80, 90, or 100 half spherical bumps on the pad base. In some instances, the array of half spherical bumps assists the device 10 gripping to the skin. In some instances, the array of half spherical bumps reduces the horizontal load on the user hand caused by the knuckle 65 reciprocating motion.

[0129] In some cases, the pad 30 comprises a pad exterior surface. In some instances, the pad exterior surface comprises the array of half spherical bumps. In some instances, the pad exterior surface comprises an exterior pad rounded rectangular or ovular shape. In some instances, the pad exterior surface comprises a plurality of pad clips 32. For example, the plurality of pad clips may comprise about the same dimension and numerosity as the plurality of housing clip receptacle regions. In some instances, the pad exterior surface comprises a bottom pad exterior surface. For example, the bottom pad exterior surface may comprise a bottom pad exterior surface rounded rectangular or ovular recessed region. In further examples, the bottom pad exterior surface rounded rectangular recessed region comprises a storage location for the knuckle assembly 60.Knuckle and Knuckle Assembly

[0130] Aspects of the invention include a knuckle assembly, for example, as depicted in FIG. 10 of a handheld device 10 for administering manipulative fascial therapy. The devices, systems, methods, and platforms provided herein may comprise a knuckle assembly 60.

[0131] In some embodiments, the knuckle assembly 60 comprises several parts. In some instances, the knuckle assembly 60 comprises a connection to the slider 50, the knuckle base 62 and the knuckle 65 with a knuckle changing mechanism. In some instances, the knuckle assembly 60 comprises a Knuckle Base PCB 63. For example, the Knuckle Base PCB 63 may power the knuckle 65 and route the knuckle 65 detection and temperature signals to the main board 18. The knuckle base PCBs 63 may comprise spring load pogo pins that allow contact with the knuckle signal pad.

[0132] In some instances, the knuckle assembly 60 comprises a knuckle receiving portion and a knuckle 65 portion. For example, the knuckle receiving portion may comprise the slider 50, the linear rail 40, linear rail block 40, and the linear rail block adapter 41. In further examples, the knuckle receiving portion comprises a knuckle receiving portion recessed region. The knuckle receiving portion recessed region comprises about the same size as the knuckle base 62. In some further examples, the knuckle receiving portion recessed region may comprise knuckle base clip recessed regions for reception of knuckle base clips.

[0133] In some cases, the knuckle assembly 60 comprises a knuckle rail block adapter 67 as in FIG. 10. In some instances, the knuckle rail block adapter 67 may connect to the slider 50 and the linear rail block 41. In some instances, the knuckle rail block adapter 67 is configured to fit one or more of the Knuckle Base PCBs 63.

[0134] FIG. 11 shows a knuckle 65 of a handheld device 10 for administering manipulative fascial therapy. The devices, systems, methods, and platforms provided herein may comprise a knuckle 65. In some cases, the knuckle 65 may comprise a substantially cylindrical shape. In some cases, the knuckle 65 comprises at least three regions. In some instances, the knuckle 65 comprises a knuckle conical shape region, knuckle cylindrical shape region, and knuckle recessed cylindrical shape region. For example, the knuckle cylindrical shape region may connect the knuckle conical shape region to the knuckle recessed cylindrical shape region. The knuckle cylindrical shape region may share a knuckle cylindrical shape region first surface with the knuckle conical shape region. The knuckle cylindrical shape region may share a knuckle cylindrical shape region second surface with the knuckle recessed cylindrical shape region. For example, the knuckle cylindrical shape region first surface and the knuckle cylindrical shape region second surface may be located at opposite sides of a knuckle body 66.

[0135] In some cases, the knuckle 65 comprises the knuckle body 66, knuckle base PCB 63 and knuckle sleeve 64. In some instances, the knuckle 65 design of the knuckle sleeve 64, e.g., bottom half, is the same for all lengths. In some instances, the knuckle 65 design of the knuckle bodies 66 (e.g., middle section) varies depending on the length of the knuckle 65. In some instances, the knuckle sleeve 64 comprises silicone. In some instances, the knuckle fit is achieved through a tight fit and friction that is caused by the silicone pad 30 and the knuckle sleeve 64. For example, the dimensions of the knuckle sleeve 64 may allow it to be held in place with a force tapered fit. The knuckle sleeve 64 may be constantly pressed down on during therapy, which provides additional force to make sure that it remains in place.

[0136] FIG. 15C shows a knuckle housing of a handheld device for administering manipulative fascial therapy. In some embodiments, the knuckle 65 comprises the knuckle body 66 (as show inFIG. 15C). In some embodiments, the knuckle body 66 comprises the section between the knuckle sleeve 64 and the knuckle base.

[0137] In some embodiments, the knuckle 65 comprises a knuckle length. In some cases, the knuckle 65 comprises a knuckle length of between 40 mm to 55 mm, such as 40 mm, 45 mm, 50 mm, or 55 mm. In some cases, the knuckle 65 comprises the knuckle length of between about 16 mm to about 30 mm in height from the pad 30 surface, such that the knuckle extends, 14 mm, 16 mm, 18 mm. 20 mm. 22 mm, 24 mm, 26 mm. 28 mm, or 30 mm from the pad surface.

[0138] In some instances, the knuckle body 66 comprises a knuckle body length of between about 3 mm to about 13 mm, such that the knuckle is 3 mm, 5 mm, 7mm, 9 mm, 11 mm, or 13 mm.

[0139] FIG. 15A - 15B show a knuckle housing 69 and removeable knuckle 65 of a handheld device 10 for administering manipulative fascial therapy. In a further example, the knuckle 65 comprises knuckle locking teeth 160. In even further examples, the knuckle base 62 comprises corresponding knuckle locking teeth pockets 161 to receive the knuckle locking teeth 160. In even further embodiments, the knuckle locking teeth 160 and the corresponding knuckle locking teeth pockets 161 in the knuckle base 62 are offset apart by 150 degrees. For example, the knuckle locking teeth 160 and the corresponding knuckle locking teeth pockets 161 in the knuckle base 62 are offset apart by 150 degrees, thereby ensuring the knuckle 65 can only be interested in only one orientation. In further examples, knuckle locking teeth pockets 161 ensure the knuckle locking teeth 160 are secured when the knuckle locking teeth are inserted into the knuckle locking teeth pockets 161 and twisted.

[0140] FIG. 15D-15E show a knuckle press fit housing 164 and a removeable knuckle 65 of a handheld device 10 for administering manipulative fascial therapy. In one embodiment, the knuckle 65 comprises a knuckle notch 162 that slides in and locks with the knuckle slit 163 in a knuckle press fit housing 164.

[0141] In some instances, the knuckle base 62 houses at least a portion of the knuckle 65 (e.g., bottom section) with a knuckle press fit housing 164. In some instances, the knuckle base 62 may comprise structures or features to allow insertion of the knuckle 65 only in the correct orientation. For example, the bottom section of the knuckle 65 may have two or more press fit structures arranged asymmetrically such that the knuckle notch 162 can only be coupled to the knuckle slit 163 in the orientation defined by the press fit structures. The press fit structures may be formed and positioned at an angle of between about 120 to about 180 degrees. For example, the knuckle press fit position may ensure that the knuckle 65 is fitted snugly and firmly duringtreatment. In further examples, the knuckle press fit 164 position ensures that the knuckle 65 stays in the housing while it operates transversely to the treatment area.

[0142] In some embodiments, the knuckle 65 comprises silicone. In some embodiments, the knuckle 65 comprises RTV-2 silicone.

[0143] The knuckle 65 may be configured to perform fascial manipulation on the target tissue at a trigger point. The knuckle 65 can come in contact with the body part that needs to be treated. In some cases, the knuckle 65 comprises a range of lengths. In some instances, the knuckle 65 length depends on the body part that is being treated. In some instances, the knuckle 65 is configured to fit directly to the lower section of the knuckle assembly 60. For example, the knuckle 65 may be configured to fit directly into the lower section of the knuckle receiving portion. In further examples, the knuckle 65 may be releasably coupled to the knuckle receiving portion.

[0144] FIG. 12A-12B show a knuckle fixture 69 and knuckle cartridge 70 of a handheld device 10 for administering manipulative fascial therapy. The knuckle fixture 69 may be configured for insertion into the knuckle cartridge 70. In some cases, the knuckle cartridge 70 is housed in the center of the knuckle 65. In some cases, the knuckle 65 is configured to come in contact with the patient body. In some instances, the knuckle cartridge 70 comprises heating elements, sensing elements, or a combination thereof. In some cases, the knuckle 65 comprises a knuckle tip. In some instances, the knuckle tip comprises a silicone sleeve 64 that provides soft touch and a firm grip. For example, the silicone sleeve 64 may be configured to prevent the knuckle tip from rubbing onto the skin. In some cases, the knuckle 65 comprises an embedded knuckle base PCB 63. For example, the knuckle base PCB 63 may be located at a knuckle 65 surface opposite a most narrow point of the silicone sleeve 64. In some instances, the knuckle base PCB 63 comprises connection pads that mate with the pogo pins in the knuckle base 62 to provide connection to the main board 18.

[0145] FIG. 16A - 16B show a bottom view and side views of a knuckle base PCB 63 of a handheld device 10 for administering manipulative fascial therapy. FIG. 16C shows cross- sectional view of a knuckle assembly 60 of a handheld device 10 for administering manipulative fascial therapy.

[0146] In some embodiments, the knuckle base PCB 63 comprises a suspended center part 170. In some cases, the suspended center part 170 comprises an orthoplanar spring mechanism. In some cases, the suspended center part 170 further comprises spring loaded pogo pins to connect the signals from the main board 18 to the knuckle 65.

[0147] In some embodiments, the knuckle assembly 60 comprises a heating element 71 (as shown in FIG. 16D).

[0148] In some embodiments, the knuckle assembly 60 comprises a knuckle base PCB 63, pogo pins 172, knuckle 65, and a force sensitive resistor (FSR) 171 (e.g., as shown in FIG. 16C). In some embodiments, the knuckle base PCB 63 comprises the force sensitive resistor (FSR) 171. In some cases, the knuckle base PCB 63 comprises a suspended center part 170 (e.g., shown in FIG. 16B). In some cases, wherein the knuckle base PCB 63 comprises the suspended center part 170, the force 173 applied to the knuckle 65 is directed from the knuckle tip to the pogo pins 172. In some instances, the force 173 applied to the knuckle 65 is directed from the pogo pins 172 to the knuckle base PCB 63. In some instances, the knuckle base PCB 63 will deform and direct the force 173 to a force sensitive resistor 171 mounted underneath the knuckle base PCB 63.

[0149] As described further herein, in some embodiments, a knuckle comprises one or more sensors, such as a pressure sensor, a fiberoptic sensor, an ultrasound sensor, or any combination thereof. In some embodiments, a knuckle does not comprise a sensor.Handheld Device Operation

[0150] The handheld device may comprise a scotch yoke mechanism for administering manipulative fascial therapy as depicted in FIG. 14A-14B. FIG. 6B shows a scotch yoke mechanism of a handheld device 10 for administering manipulative fascial therapy. The handheld device 10 for administering manipulative fascial therapy may comprise an actuation assembly 300. In some cases, the actuation assembly 300 may comprise a component orientation that enables the device 10 to operate in accordance with the scotch yoke mechanism.

[0151] The handheld device 10 may be operated by a user (e.g., patient, healthcare professional, layperson, etc.) via self-administration or administration by another. The user operating the device 10 comprises a user holding the device 10 from the handle 11 (e.g., the dome section). In some cases, the user operating the device 10 comprises the user pressing the device 10 against the body (e.g., of the patient onto a certain region). In some instances, after the user presses the device 10 against the body (e.g., of the patient), the user secures the device 10. For example, the user pressing the device 10 against the body (e.g., of the patient) holds the knuckle 65 in place due to friction.

[0152] In some cases, when the knuckle 65 comes into contact with the patient, the knuckle base PCB 63 sends a signal to the main board 18 which activates the actuation assembly 300, (e.g., including one or more motor 13). In some embodiments, after securing the device, the motor 13 is configured to be turned on and therefore start the knuckle 65 movement.

[0153] In some instances, the activation of the one or more motor 13 may drive the one or more motors 13 to rotate clockwise. In alternative instances, the activation of the one or more motor 13 may drive the one or more motors 13 to rotate counterclockwise. In some instances, the motor 13 rotation may drive the motor gear 12 to rotate clockwise. In alternative instances, the motor 13 rotation may drive the motor gear 12 to rotate counterclockwise. In some instances, the motor gear 12 rotation may drive the crank gear 15 to rotate clockwise. In alternative instances, the motor gear 12 rotation may drive the crank gear 15 to rotate counterclockwise. In some instances, the crank gear 15 rotation may drive the crank rod 14 to rotate counterclockwise. In alternative instances, the crank gear 15 rotation may drive the crank rod 14 to rotate clockwise. In some instances, the crank rod 14 rotation may drive the slider 50 to move transversely from left to right along linear bearing as in FIG. 10. In alternative instances, the crank rod 14 rotation may drive the slider 50 to move transversely from right to left along the linear bearing. In some instances, the slider’s 50 transverse movement from right to left may drive the linear rail block 41 to move transversely. In alternative instances, the slider’s 50 transverse movement from left to right maydrive the linear rail block 41 to move transversely. In some instances, the linear rail block’s 41 transverse movement may drive the linear rail 40 to confine the linear rail block’s 41 transverse movement. In some instances, the linear rail block’s 41 transverse movement may drive the knuckle rail block adapter 67 to move transversely. In some instances, the knuckle rail block adapter’s 67 transverse movement may drive the knuckle 65 to move transversely. For example, the knuckle rail block adapter’s 67 motion may drive the knuckle 65 to oscillate transversely to a bodily surface, e.g., skin, target tissue, etc.

[0154] In some instances, the one or more motors 13 rotate relative to the pad 30. For example, the pad 30 may be stationary relative to a contact skin surface when the one or more motors 13 rotate. In some instances, the knuckle 65 moves / oscillates transversely relative to the pad 30. For example, the pad 30 may be stationary relative to a contact skin surface when the knuckle 65 moves / oscillates transversely. In some instances, when the motor 13 rotates the pad 30 beneficially secures the device 10 in a fixed position on a bodily surface. In some instances, when the knuckle 13 moves / oscillates the pad 30 secures the device 10 in a fixed position on a bodily surface. For example, the pad 30 may beneficially secure the position of the handheld device 10 in space allowing only the knuckle 65 to oscillate.

[0155] The therapy may include application of force through a combination of motions, including a transverse motion or a penetrative motion (oriented substantially perpendicular to the skin surface). In certain embodiments, the devices provided herein can apply force through only a transverse motion. Before therapy, the fascia and muscle / other tissue are in a stretched or tautcondition which is debilitating to the patient / user, causing pain and tension, poor posture, headaches, chronic shoulder, and neck issues, and other bodily pain. The therapeutic application can be applied to any part of the body, such as the forearm, shoulder, neck, back, thigh, calf and any other body part, and the device 10 can be appropriately sized (e.g., larger grip opening for larger body parts). Since the fascia is rich with proprioceptors and mechanoreceptors, a decompression maneuver imparted to the connective tissue and fascia can reduce unnecessary distress signaling from these tissues, reducing local spasms and tightness, and relieving shortterm and chronic pain and discomfort. The pad 30 can be adapted and sized for placement on any part of the body, to remain for a set period of time until the desired effect, in terms of tissue slackening, viscosity reduction, loosening of any knots, or any other desired effect, is achieved. In certain embodiments, the period of time can be between about 1 to about 4 minutes, such as 1 minute, 1 minute 30 seconds, 2 minutes, 2 minutes 30 seconds, 3 minutes, 3 minutes 30 seconds, or 4 minutes. The set period of time for treatment may also include breaks depending on the patient's treatment tolerance level.Knuckle Movement

[0156] FIG. 13A-13B shows the knuckle 65 of a handheld device 10 and various motions that the handheld device can exhibit for administering manipulative fascial therapy. The handheld device 10 comprises a knuckle assembly 60. The handheld device 10 may comprise a knuckle 65. In some cases, the knuckle 65 is removably coupled to the handheld device 10. In some cases, the knuckle 65 contacts a treatment area. In some embodiments, the knuckle 65 may comprise a removable or interchangeable knuckle 65. where a knuckle groove 74 as in FIG. 12C allows for a user to easily grip the knuckle for interchangeability.

[0157] The knuckle 65 motion can be any combination of suitable motions (e.g., elliptical), that are generally repetitive, with or without pauses. The motions may be adjustable, either by the user or by a program sequence of a controller in extent, speed, frequency of vibration, and duration of pauses. In some embodiments, a component of a motion may be axially along the linear rail 40, can be added to the other motions, and can also be adjustable in extent, frequency, and pauses.

[0158] In some cases, a translational motion 590x and 590y and rotational motion 610 are all in the same plane, substantially parallel to the skin of the patient, and an axial motion 630 is normal to that plane. In some instances, a rotational motion 610 can be a vibration twisting back and forth, through a limited arc, for example between about 5 to about 90 degrees, about the axis 650,such that the twisting motion can move 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60. 65, 70, 75, 80, 85, or 90 degrees.

[0159] In another embodiment, the rotational motion can be revolutionary motion, where the contact pad 30 and linear rail 40 circle in their entirety in orbits around central axis.

[0160] A combination of parallel, rotational, and axial motion may be used along with pauses of different duration.

[0161] The device 10, in some cases, may also be configured to apply additional motions as shown in FIG. 13B. The knuckle 65 may be controlled or actuated by the one or more motors 13 to move translationally relative to the treatment area. A motor 13 and suitable mechanical linkage can be used to effect the transverse motion of the knuckle 65. In some cases, the knuckle 65 is configured to oscillate transverse, rotational, or vertical, or a combination thereof about a body, e.g., skin, tissue, etc. The force provided by reciprocation in the transverse direction can assist with the therapeutic manipulation of the fascia, and with the reduction in viscosity of the hyaluronic acid therein and can loosen any fascial densification / knots to help restore the hyaluronic acid to its healthy fluid state.

[0162] In some instances, one or more knuckle press fit 164 components may be provided in the knuckle assembly 60 to mount the knuckle 65 for transverse motion along the patient surface. The transverse motion is indicated by arrow 590x and 590y. In some instances, the one or more knuckle 65 press fit components may be disposed on the knuckle assembly 60, to direct the knuckle force at an angle of between about 0 to about 360 degrees with respect to the patient's skin and body. For example, the one or more knuckle press fit components may be disposed on the knuckle assembly 60, to direct the knuckle 65 force at an angle of between about 120 to about 180 degrees with respect to the treatment area.

[0163] In some instances, the knuckle 65 comprises a reciprocating knuckle. In some instances, the knuckle 65 is configured to oscillate transverse to the skin. In some instances, the knuckle 65 is configured to oscillate translational to the treatment area. In some instances, the knuckle 65 is configured to apply a translational force to a target tissue. In some instances, the knuckle 65 is configured to apply a penetrative force to a target tissue. In some instances, the knuckle 65 is configured to apply a vertical force to a target tissue. In some instances, the knuckle 65 is configured to apply a horizontal force to a target tissue. In some instances, the knuckle 65 is configured to apply a rotational force to a target tissue.

[0164] In some instances, the knuckle 65 is configured to exert a force on the treatment area. For example, the force may be directly proportional to the depth of the knuckle 65. In furtherexamples, the knuckle 65 oscillation is transverse to the skin and the depth of the knuckle 65 is maintained during treatment of the treatment area.

[0165] In some instances, the knuckle 65 comprises a knuckle stroke, the distance traveled by the knuckle transversely across a treatment area. The knuckle stroke may be proportional to the penetrative force of the handheld device 10. The knuckle stroke may be configured to deliver a deep pressure. In other examples, the knuckle 65 stroke is between about 0 mm to about 30 mm, such as 5 mm, 10 mm. 15 mm. 20 mm, 25 mm, or 30 mm.

[0166] In some instances, the knuckle 65 comprises a knuckle linear speed (e.g., measure of how fast an object is moving in a straight-line path). For example, the knuckle linear speed may be between about 0 m / s to about 1.3 m / s, such as 0.1 m / s, 0.2 m / s, 0.3 m / s, 0.4 m / s, 0.5 m / s, 0.6 m / s, 0.7 m / s, 0.8 m / s, 0.9 m / s, 1.0 m / s, 1.1 m / s, 1.2 m / s, and 1.3 m / s. In some instances, the knuckle linear speed comprises a maximum knuckle linear speed. For example, the maximum knuckle linear speed may comprise about 1.3m / s.Treatment Effect Measurement

[0167] In some embodiments, the device 10 includes multiple sensing capabilities to measure fascia densification and the progress of myofascial therapy / treatment. The present disclosure may utilize tissue density (e.g., tissue density before and after treatment) to determine a treatment outcome. For instance, a greater tissue density may indicate a thickening of the loose connective tissue layer whereas a reduced tissue density may correspond to an improved treatment result. The difference of tissue density before and after a treatment session (e.g.. application of the handheld device 10 to a target tissue area) may be used to quantify a treatment outcome.

[0168] The effectiveness of treatment calculation may comprise information regarding the user (e.g., a physiological profile). In some cases, the densified fascia that may feel thicker, less pliable, and have areas of increased tension or adhesions when compared to healthy, relaxed fascia. The treatment effect may be determined utilizing machine learning techniques. In some cases, a machine learning algorithm trained model may take as input a current measurement unit output, a force measurement unit output, and a tissue location and output a tissue density of a tissue before and after treatment. In some cases, a machine learning algorithm trained model may take as input a current measurement unit output, a force measurement unit output, and a tissue location and output a change in tissue densification. Alternatively, a model may be trained to correlate the change in tissue densification to an effectiveness of treatment. Other factors in addition to the point of body being treated can be added, such as information about the patient or data collected before, during, or after usage of the device. These factors can be utilized to furtherimprove an estimate of the fascial tissue densification to help track changes in tissue densifications that are then correlated to effectiveness of the treatment. In some instances, a user of the handheld device may determine the treatment area. In some instances, the tissue location may be determined by a skilled therapist or healthcare professional wherein the skilled therapist or healthcare professional can use their hands to assess the feel and texture of fascial tissues (i.e., palpation). In some instances, the tissue location can be determined via assessment by a healthcare professional, wherein an experienced healthcare professional can perform a comprehensive evaluation to identify fascial densification based on a combination of factors, including the patient's medical history, physical examination, and palpation.Treatment Measurement Unit

[0169] The devices, systems, methods, and platforms provided herein may comprise a treatment measurement unit. In some embodiments, the treatment measurement unit is configured to measure a treatment outcome. In some embodiments, treatment measurement unit comprises a plurality of sensors. In some embodiments, the plurality of sensors comprises at least three sensors. In some embodiments, the treatment measurement unit comprises the knuckle 65.

[0170] The treatment measurement unit may comprise a model configured to measure a treatment outcome. The model may be configured to receive additional inputs from the devices, systems, methods, and platforms provided herein to determine a patient profile and / or predict a treatment effect. In some cases, the knuckle cartridge 70 comprises pressure sensors, temperature sensors, moisture sensors, sensors for measuring fascial stiffness and muscle tonicity such as tonometers, tissue compliance meters, EMG sensors, fiber optic sensors, ultrasound sensors, or a combination thereof. Heat transducers can also be provided, and / or devices to administer electrical pulses, vibrations, light / heat at prescribed wavelengths. Any of the knuckle or knuckle assemblies 60 may comprise support for such devices, using suitable electrical connections to the knuckle 65 or knuckle PCB 63.

[0171] In some embodiments, the knuckle contains a conditioning circuit and a micro-controller unit that enables the knuckle to communicate with the main controller unit using a communication standard such as SPI or I2C, allowing real-time, online transmission of measurements while the device is running.

[0172] In some embodiments, the knuckle can connect to an auxiliary port on the device for transmission of measurements after the device has been stopped.

[0173] In some embodiments, the knuckle cartridge 70 will contain an ultrasound sensor 72, as in FIG. 16E. An ultrasound coupling material can be disposed on the tip of a knuckle such thatcontacting the treatment area with the knuckle allows for ultrasound visualization of the target tissues.

[0174] In some embodiments, the knuckle cartridge will contain a fiberoptic sensor 73 as in FIG. 16F that allows for identification of tissue densification based on reflected light properties.

[0175] In some embodiments, different combinations of sensors may be used in the same knuckle.Temperature unit

[0176] The treatment measurement unit may comprise a temperature unit. The treatment measurement unit may be configured to heat / cool a target treatment area via the knuckle assembly 60 or knuckle 65. In some cases, the temperature unit may be located within the knuckle assembly 60. In some instances, the temperature unit may be located within the knuckle 65 as in FIG. 16C. In some cases, the temperature unit may be configured to apply heat / cooling to the target tissue. In some cases, the temperature unit comprises one or more heating elements 71 as in FIG. 16D. In some cases, the temperature unit comprises a heating element of a wi rewound power resistor with ceramic coating. In some instances, the temperature unit is configured to raise the temperature of a target tissue. In some instances, the temperature unit may apply heat via heating therapy before fascial manipulation or myofascial release (e.g., by the knuckle 65) to warm up the tissues, increase blood flow, and make the fascial tissue more pliable. For example, the temperature of the one or more heating elements for heating therapy comprises between about 100°F to about 120°F (between about 37.8°C to about 40.6°C), such as 100°F, 105°F, 110°F, 115°F, or 120°F. In some cases, the temperature unit is configured to lower the temperature of a target tissue. In some instances, after fascial manipulation or myofascial release (e.g., by the knuckle 65), cold therapy can be applied to reduce inflammation and alleviate any post-treatment discomfort. For example, the temperature of the one or more heating elements for cold therapy comprises between about 32°F to about 45°F (between about 0°C to about 7.2°C). In some instances, the duration and frequency of cold therapy can vary’ (e.g., depending on the severity of densification, tissue location, etc.)

[0177] In some cases, the temperature unit is located in the knuckle cartridge 70. In some cases, the temperature unit is located in the knuckle sleeve 64. In some cases, the one or more heating element comprises a power resistor. In some instances, the one or more heating element comprises the power resistor in a ceramic carrier. In some instances, the one or more heating element comprises a power resistor in a ceramic carrier w ith a power of about 5W to about 10W, such as 5W, 6W, 7W, 8W, 9W, or 10W. In some instances, the one or more heating element is embedded with a thermally conductive resin material inside a thermally conducing metalcartridge. In some cases, the knuckle base 62 comprises a housing that contains conductive surfaces for power and thermal control. In some instances, the thermally conducing metal cartridge is located in the knuckle sleeve 64. For example, the thermally conducing metal cartridge may be located in the knuckle tip. In some instances, the heating element 71 is located in the knuckle 65, as in FIG. 16D. In some instances, the heating element is located in the knuckle sleeve 64. In some instances, the heating element is located in the knuckle cartridge 70.

[0178] The temperature unit may be configured for measuring the applied temperature (e.g.. by the heating element). In some cases, the temperature unit may comprise a temperature sensor. In some instances, the temperature sensor may be located within the knuckle assembly 60. In some instances, the temperature sensor may be located within the knuckle 65. In some instances, the temperature sensor may comprise a thermistor for measuring the applied temperature to the target tissue. In some instances, the thermistor may be in communication with the heating element. For example, the heating element may raise / lower the heating element output based upon the thermistor reading. In further examples, the heating element will raise / lower the heating element output based upon the end of heating therapy. In further examples, the heating element will be raise / lower the heating element output based upon the start of cold therapy.Current Consumption Measurement

[0179] The fascia densification and / or the progress of therapy may be estimated based at least in part on a calibrated current consumption measurement. The devices, systems, methods, and platforms provided herein may provide a current measurement.

[0180] The current measurement unit may be configured to output the calibrated current consumption measurement to a computing system and / or a model configured to estimate fascia densification and / or progress of therapy. The one or more motors 13 may comprise the current measurement unit. In some cases, the one or more motors 13 comprising the current measurement unit enables the devices, systems, methods, and platforms provided herein to predict a tissue density before and after treatment and / or correlate an effectiveness of treatment without the use of complex and expensive modalities (e.g., high-resolution ultrasound, MRI, or elastography). In some cases, the one or more motors 13 comprising the current measurement unit beneficially allows for the compact design of the device by eliminating the need for complex and expensive modalities (e.g., high-resolution ultrasound, MRI, or elastography).

[0181] In some cases, the current measurement unit is configured to measure a current consumption, power, voltage, or combination thereof of the one or more motors 13. In some instances, the current measurement unit may comprise a multimeter (e.g., a “True RMS” multimeter). In some instances, the current measurement unit may comprise a current clamp ortransformer (e.g., around one of the motor leads). In some instances, the current measurement unit may comprise a motor-control system configured to use high side measurements, low side measurements or inline measurements. In some instances, the current measurement unit may comprise a voltmeter. For example, the voltmeter may comprise a voltmeter across the voltage supply, an ammeter across the motor current supply wire (e g., to measure the current to the motor) or a combination thereof.

[0182] In some cases, the current measurement unit comprises one or more current consumption sensing element. In some instances, the current consumption sensing element comprises one or more force sensor. For example, the current measurement unit may be configured to measure the current consumption of the device motors 13 at least in part based upon an output of the current consumption sensing element (e.g., force sensor).

[0183] The devices, systems, methods, and platforms provided herein may comprise a model in communication with the current measurement unit. In some cases, the model may comprise a current consumption model. In some instances, the current consumption model is configured to calculate cunent consumption at least in part based on measurements of a force applied to the knuckle tip of the handheld device 10. In some instances, the cunent consumption model is configured to calculate current consumption at least in part based on measurements of a cunent load applied to a component of the handheld device 10. For example, the current consumption model may be configured to calculate current consumption at least in part based on measurements of a current load applied to the one or more motor 13 of the handheld device 10 over a period of time (e g., of device operation).

[0184] In some cases, the fascia densification, and / or the progress of therapy (e.g., based on tissue density) may be determined by the current measurement unit based at least in part on a calibrated current consumption, a current load of the device motors, or a combination thereof. The current load may be obtained from a motor current of a DC motor that can be measured directly (e.g., in the motor wire). A current consumption may be based on a plurality of factors including a motor speed, a vertical force applied to the device and a tissue density7of a target treatment point (e.g.. the contact point under a knuckle of the device that the force is applied to). The current consumption may be calibrated based at least in part on a vertical force applied to the knuckle 65. In some cases, the vertical force applied to the knuckle 65 may be obtained by utilizing a force sensor located under the knuckle 65 which directly measures the pressure applied to the knuckle. Based on the vertical force, the motor speed (e.g., obtained from the device set up or use command), the current consumption can be calibrated so it can accurately indicate the tissue density. For example, the calibrated current consumption may be obtained bysubtracting the current consumed by the motors due to the vertical force applied to the device from the total current consumed by the motors (e.g., during device operation). In further examples, the calibrated cunent consumption correlates to a current consumption by the motors due to the tissue density.

[0185] The current consumption of the device motors 13 may increase with increasing motor speed. The current consumption of the device motors 13 may also increase with increasing vertical force applied to the device 10. Furthermore, the current consumption of the device motors 13 may increases with increasing tissue density under the knuckle 65. The current consumption of the device motors 13 may increase with increasing motor speed, vertical force applied to the device, tissue density under the knuckle, or a combination thereof. Furthermore, the current load may increase with increasing force applied to the target treatment region. In some instances, the current load time series may comprise a measurement of the amount of electrical current passed from a power supply of the device to the component receiving power at a given time point. In some instances, the current load time series comprises the variation in electrical current load over a specific period of time drawn by a particular electrical circuit, appliance, or system over time. In some instances, the current load time series comprises the average amount of current received by the component receiving power per second. In some instances, the current load time series comprises the average amount of current received by the component receiving power per second during a span of the handheld device operation. In some instances, the component receiving power may comprise one or more motors 13. For example, the current load time series may at least in part increase with increasing speed of the one or more motors 13.Force Measurement

[0186] The devices, systems, methods, and platforms provided herein may comprise a force measurement unit. The force measurement unit may be configured to measure the force applied to the device 10 and / or the one or more motors 13. The force measurement unit may be configured to output the force measurement to a computing system and / or a model configured to estimate fascia densification and / or progress of therapy. In some cases, the force measurement unit output may comprise the treatment measurement computing system or model configured to estimate fascia densification and / or progress of therapy input for determining the force-calibrated current consumption measurement.

[0187] In some cases, the force measurement unit comprises one or more pressure sensors which measure the force applied to the treatment area from the unit. In some instances, the pressure sensor is located at the knuckle tip. In some instances, the pressure sensor is located in theknuckle cartridge 70. In some instances, the pressure sensor directly measures the vertical force applied to the knuckle 65. In some instances, the pressure sensor directly measures the vertical force applied to the knuckle 65 from the handle 11. In some instances, the pressure sensor directly measures the vertical force applied to the knuckle 65 from the target surface.

[0188] In some cases, the force measurement unit comprises one or more pressure sensors. In some instances, a pressure sensor is mounted in the knuckle base 62. In some instances, a pressure sensor is mounted in the knuckle cartridge 70. In some instances, a pressure sensor is mounted in the knuckle 65. In some instances, a pressure sensor is mounted in the knuckle sleeve 64. In some instances, the one or more pressure sensor is mounted in the knuckle 65 beneath the sleeve 64.

[0189] The force measurement unit can be in communication with a treatment measurement computing system or model. In some cases, the treatment measurement computing system or model is configured to calibrate current load measurements collected before treatment for a target trigger point location. In some cases, the treatment measurement computing system or model is configured to calibrate current load measurements collected after treatment for a target trigger point location. In some cases, the treatment measurement computing system or model is configured to calibrate current load measurements collected before and after treatment for a target trigger point location. In some cases, the treatment measurement computing system or model is configured to generate one or more force-calibrated current load measurement. In some instances, the one or more force-calibrated current load measurement is used to model target fascia densification trend before and after treatment.

[0190] In some embodiments, the one or more force-calibrated current load measurement is used to model the target fascia densification before and after treatment via a force-calibrated current load measurement algorithm. In some cases, the force-calibrated current load measurement algorithm comprises the steps of 1) registering the applied knuckle force at the target treatment point, 2) measuring the current load demand at the target treatment point at that registered applied force for some time duration (e.g. 10 seconds), 3) at the end of the treatment session reapplying the earlier registered knuckle force at the target treatment point, 4) measuring the current load demand at the target treat point at the registered applied force for some duration of time (e g. 10 seconds), or a combination thereof. In some cases, the force-calibrated current load measurement algorithm further comprises, wherein both measurements are collected, the step of 5), using an offline trained machine learning (ML) regressor model to predict the tissue density' before and after treatment. In some instances, the offline trained ML regressor model is trained and correlated to ground truth measurements of tissue stiffness. For example, with highresolution ultrasound or digital palpation using a handheld device designed for non-invasive and objective measurement of muscle biomechanical properties (e.g., a myoton device).Electronics

[0191] The device 10 design comprises one or more custom-made PCB with an onboard microcontroller for controlling the device. In some instances, the onboard microcontroller comprises an ESP32-S3 series microcontroller for controlling the device. For example, the onboard microcontroller may comprise an ESP32-S3-MINI-1-N8 for controlling the device. In some instances, the one or more custom-made PCB with an onboard microcontroller for controlling the device is located in the knuckle 65. In some instances, the one or more custom- made PCB with an onboard microcontroller for controlling the device comprises a knuckle base PCB 63. In some instances, the one or more custom-made PCB with an onboard microcontroller is configured to directly connect to potentiometers to control the electric motor 13 speed, the temperature, and pressure sensors in the knuckle 65. In some instances, the onboard microcontroller comprises a Wi-Fi connectivity to connect to a mobile application for remotely controlling the temperature unit and knuckle velocity. In some instances, the onboard microcontroller comprises the Wi-Fi connectivity to record knuckle 65 temperature, velocity, surface pressure, and current load measurements.

[0192] In some instances, one or more custom-made PCB is configured to sit on the knuckle assembly base. In some instances, one or more custom-made PCB is configured to sit on the knuckle rail block adapter 67. In some instances, one or more custom-made PCB is configured to sit on the knuckle base 62. In some instances, the one or more custom-made PCB comprises two custom-made PCBs. For example, the knuckle 65 insertion may beneficially allow for the two custom-made PCBs to connect, and the temperature to be controlled, measured, or a combination thereof. In further examples, the knuckle 65 insertion beneficially allows for the two custom- made PCBs to connect, and the pressure can be controlled, measured, or a combination thereof. In further examples, one or more of the two custom-made PCBs is located in the knuckle base PCB 63, and one or more of the two custom-made PCBs is located in the knuckle rail block adapter 67. In some instances, the knuckle base PCB 63 comprises a connection pad with spring pogo pins that mate with the PCB located in the knuckle rail block adapter 67.

[0193] In some embodiments, the device 10 comprises a small power board. In some embodiments, the small power board comprises a USB-C or USB-A power board 17. In some embodiments, the USB-C power board 17 comprises a USB-C connector and a USB-C sink controller to provide the correct voltage from a USB-PD adapter.Firmware

[0194] The user may set up or configure the device 10. For example, the user turns on the device 10. The user turning on the device 10 may allow the user to create a Wi-Fi connection from their computer, phone, or internet connected device to the device 10. After the user establishes a Wi-Fi connection, the user may go onto a website which provides an interface for the device 10. On the website, the user may connect their device to a Wi-Fi network. After adding the Wi-Fi information to the device on the website, the user can set the name of the device. The user may set up multiple devices, for example, and each device may have its own name separate from other devices.

[0195] The mobile application / website may automatically locate devices that the user has named and connect those devices directly to the user's Wi-Fi network. For example, by using the device name for the connection of the device to the router, when the router is restarted, the device name information is stored, and the device remains connected to the user’s Wi-Fi network.

[0196] A user may establish a Wi-Fi connection for device communication to the mobile app as the communication takes place through an IP communication. For example, some of the device communication may take place as a JSON string. There may be at least three communications that take place with the mobile application. For example, one or more communication that takes place with the mobile application may be configured to make sure that the device is connected to the App by sending a “true” to the App. Furthermore, for example, one or more communication that takes place with the mobile application may be configured to send the current speed and temperature setting of the device. Lastly, for example, one or more communication that takes place with the mobile application may be configured to receive the new' setting commands of speed and temperature from the App.

[0197] The device 10 may act as a server with a port 5000 and the mobile device may act as the client. For example, the communications from the mobile application to the server may take place through the IP of the device 10.

[0198] The motor 13 may be controlled through a PID communication that takes in information about the current speed of the motor 13. For example, one or more communication that takes place with the mobile application may comprise several points that are equally spaced around the motor 13. The device 10 may comprise a ticker. The ticker may be configured to count how many times points are passed in a certain time frame. By using the ticker information, the one or more motors 13 may be configured to define the current speed of the one or more motors 13. Theticker information may be used as feedback on the speed of the motor 13. The motor 13 speed may be compared to the set speed of the motor 13.

[0199] The device 10 may use a PID controller equation and a PID constants to control the motor 13 speed. For example, using the PID controller equation and the PID constants may allow the motor 13 speed to be changed to match the set motor 13 speed on the PID controller. The motor 13 speed may be changed to match the set motor 13 speed on the PID controller when the device 10 is placed on the patient and the resistance of the motor 13 slows down the speed of the knuckle 65. To counter resistance, the motor 13 may be configured to take in more current and balance the speed to fit the set speed of the device 10.

[0200] The temperature may be regulated directly through a control knob board 16. For example, the temperature may be regulated directly through the control knob board 16 by setting the temperature to somewhere between 100°F-120°F, such as 100°F, 105°F, 110°F, 115°F, or 120°F.

[0201] The handheld device 10 may comprise a controller (not shown) programmable to execute multiple therapy regimens associated with one of multiple authorized users. Therapy regimens can be customized to users and stored on remote servers, then downloaded as needed, and can be based on payment or prescription from a professional therapist. A mobile application or other remote program running on a different device, such as a smart phone, desktop or laptop computer, or the like, can be configured to control the device 10 or augment its functionality' and features, for example providing bio measurement feedback about the fascia (stiffness / tone), disseminating knowledge about fascia health and pertinent exercises (akin to a virtual physiotherapist), and providing an interface for programming and accessing the device and some or all of its features. Thus, in certain embodiments the controller is in communication with the mobile application or other remote program and can exchange commands or information that relate to one or more of device operation, patient data, educational information, and the like.Machine Learning

[0202] The devices, systems, methods, and platforms provided herein may comprise a machine learning model. The machine learning model may' be a machine learning regressor. Using a machine learning model significantly simplifies current methods of measuring tissue densification which require the use of complex and expensive modalities such as high-resolution ultrasound. MR1. or elastography. The machine learning regressor may be implemented separately in a mobile or computer application.

[0203] The machine learning regressor may be configured to process the measured data and predict tissue density before and after treatment to determine the treatment outcome. Themachine learning model may be configured to receive several factors to calculate the effectiveness of treatment. In some cases, the machine learning regressor is configured to receive a machine learning regressor input. In some cases, the machine learning regressor is configured to process a plurality of inputs. In some cases, the machine learning regressor is configured to receive a plurality of machine learning regressor inputs. In some instances, the plurality7of machine learning regressor inputs comprise a plurality of data measurements. For example, the plurality of data measurements may comprise a treatment unit measurement, a force unit measurement, a current unit measurement, or a combination thereof. In further examples, the plurality of data measurements may comprise outputs from pressure sensors, current consumption measurement units, temperature units, moisture sensors, sensors for measuring fascial stiffness and muscle tonicity such as tonometers, tissue compliance meters, EMG sensors, or a combination thereof.

[0204] The model may be configured to receive data from one or more of the force measurement unit, current measurement unit, temperature unit, or combination thereof. In some instances, the model is configured to receive data from one or more of the pressure sensors, current measurement unit, temperature sensors, moisture sensors, sensors for measuring fascial stiffness and muscle tonicity such as tonometers, tissue compliance meters, EMG sensors, or a combination thereof. In some cases, the model is configured to process information from the force measurement unit, and the current measurement unit.

[0205] The machine learning regressor input may comprise information regarding the user (e.g.. a physiological profile). In some cases, the information regarding the user may comprise a tissue location or target tissue point. In some cases, the machine learning regressor input comprises a current measurement unit output and a force measurement unit output, and a treatment area. In some instances, the plurality of machine learning regressor inputs comprise a location of a tissue receiving treatment by the devices, systems, methods, and platforms provided herein. In some instances, the plurality of machine learning regressor inputs comprise a temperature unit output.

[0206] The plurality of machine learning regressor inputs may comprise a densification of a mammalian tissue calculated by another machine learning model and / or computing system. In some cases, the plurality of machine learning regressor inputs comprise a densification of a mammalian tissue pre-treatment calculated by another machine learning model and / or computing system. In further cases, the plurality of machine learning regressor inputs comprise a densification of a mammalian tissue post-treatment calculated by another machine learning model and / or computing system. In some instances, the machine learning regressor is configured to interpret the plurality of machine learning regressor inputs to predict a tissue density7of themammalian tissue post-treatment, pre-treatment, or a combination thereof, correlate a change in tissue densification to an effectiveness of treatment, or a combination thereof.

[0207] The machine learning regressor may be configured to receive a current consumption measurement. In some cases, the machine learning regressor may be configured to calibrate the current consumption measurement based at least in part on a vertical force applied to the knuckle 65. In some instances, the vertical force applied to the knuckle may be obtained by utilizing a force sensor located under the knuckle 65 which directly measures the pressure applied to the knuckle 65.

[0208] In some cases, the machine learning regressor may be configured to calibrate the current consumption measurement based on a current load time series. In some instances, the model receives the current load time series (e.g., of the one or more motors 13 during device operation), and pressure exerted on target treatment region. In some instances, the model is configured to compute the current load time series. For example, the current load time series may comprise a measurement of the amount of electrical current passed from a power supply of the device to the component receiving power. In further examples, the cunent load time series may comprise the average amount of current received by the component receiving power per second. In further examples, the current load time series comprises the average amount of current received by the component receiving power per second during a span of the handheld device operation. For example, the component receiving power may comprise the motor. In some instances, the current load time series may at least in part increase with increasing speed of the motor.

[0209] The machine learning regressor may be configured to accurately indicate the tissue density based on the vertical force, the motor speed (e.g., obtained from the device set up or use command), and the calibrated current consumption. In some instances, the machine learning regressor may compute the calibrated current consumption by using appropriate machine learning techniques or mathematical models. For example, the machine learning regressor may be configured to subtract the current consumed by the one or more motors due to the vertical force applied during device operation to the device from the total current consumed by the motors during device operation to generate a force-calibrated current consumption measurement. In some instances, the machine learning regressor is configured to correlate the force-calibrated current consumption to a current consumption by the motors due to the post-treatment and pretreatment tissue densities.

[0210] The machine learning regressor may be configured to determine a treatment outcome. For example, a machine learning trained model may take as input a current measurement unit output, a force measurement unit output, and a treatment area and output a predicted tissue density of atissue before and after treatment. In further embodiments, a machine learning algorithm trained model may take as input a current measurement unit output, a force measurement unit output, and a treatment area, and output a change in tissue densification. Alternatively, a model may be trained to correlate the change in tissue densification to an effectiveness of treatment. In some embodiments, a first model may calculate a change in tissue densification and a second model may correlate the change in tissue densification to an effectiveness of treatment. In some embodiments, the first model and second model are separate models. In some embodiments, a single model comprises the first model and second model.

[0211] In some embodiments, the machine learning regressor is configured to produce a machine learning regressor output. In some cases, the machine learning regressor output comprises a treatment outcome. In some cases, the machine learning regressor output comprises an estimate of the fascial tissue densification. In some cases, the machine learning regressor output comprises a change in tissue densification. In some cases, the change in tissue densification is correlated to an effectiveness of treatment. In some cases, the machine learning regressor output comprises a prediction of a tissue densification pretreatment. In some cases, the machine learning regressor output comprises a prediction of a tissue densification post-treatment. In some embodiments, the treatment comprises application of any of the devices, systems, methods, and platforms of this disclosure to any tissue.

[0212] In some embodiments, the devices provided herein may comprise a treatment measurement unit. The treatment measurement unit may comprise a model configured to measure a treatment outcome. The model may be configured to receive additional inputs from the devices, systems, methods, and platforms provided herein to determine a patient profile and / or predict a treatment effect. In some instances, the additional inputs from the devices, systems, methods, and platforms provided herein may comprise outputs from pressure sensors, temperature sensors, current measurement assemblies, moisture sensors, sensors for measuring fascial stiffness and muscle tonicity such as tonometers, tissue compliance meters, EMG sensors, or a combination thereof. For example, the knuckle 65 may comprises pressure sensors, temperature sensors, moisture sensors, current measurement units, sensors for measuring fascial stiffness and muscle tonicity such as tonometers, tissue compliance meters. EMG sensors, or a combination thereof. In some instances, the model receives the location of the bodily surface being treated. In some cases, the treatment measurement unit estimates the fascial tissue densification of a target tissue. In some cases, the treatment measurement unit determines a change in tissue densifications of the target tissue. In some cases, the treatment measurement unitdetermines a change in tissue densifications of the target tissue that are then correlated to effectiveness of the treatment.Computing system

[0213] Referring to FIG. 17, a block diagram is shown depicting an exemplary machine that includes a computer system 100 (e.g., a processing or computing system) within which a set of instructions can execute for causing a device to perform or execute any one or more of the aspects and / or methodologies for static code scheduling of the present disclosure. The components in FIG. 17 are examples only and do not limit the scope of use or functionality of any hardware, software, embedded logic component, or a combination of two or more such components implementing particular embodiments.

[0214] Computer system 100 may include one or more processors 101, a memory 103, and a storage 108 that communicate with each other, and with other components, via a bus 140. The bus 140 may also link a display 132. one or more input devices 133 (which may, for example, include a keypad, a keyboard, a mouse, a stylus, etc.), one or more output devices 134, one or more storage devices 135, and various tangible storage media 136. All of these elements may interface directly or via one or more interfaces or adaptors to the bus 140. For instance, the various tangible storage media 136 can interface with the bus 140 via storage medium interface 126. Computer system 100 may have any suitable physical form, including but not limited to one or more integrated circuits (ICs), printed circuit boards (PCBs), mobile handheld devices (such as mobile telephones or PDAs), laptop or notebook computers, distributed computer systems, computing grids, or servers.

[0215] Computer system 100 includes one or more processor(s) 101 (e.g., central processing units (CPUs), general purpose graphics processing units (GPGPUs), or quantum processing units (QPUs)) that carry out functions. Processor(s) 101 optionally contains a cache memory’ unit 102 for temporary' local storage of instructions, data, or computer addresses. Processor(s) 101 are configured to assist in execution of computer readable instructions. Computer system 100 may provide functionality for the components depicted in FIG. 19 as a result of the processor(s) 101 executing non-transitory, processor-executable instructions embodied in one or more tangible computer-readable storage media, such as memory' 103, storage 108, storage devices 135, and / or storage medium 136. The computer-readable media may store software that implements particular embodiments, and processor(s) 101 may execute the software. Memory 103 may read the software from one or more other computer-readable media (such as mass storage device(s) 135, 136) or from one or more other sources through a suitable interface, such as network interface 120. The software may cause processor(s) 101 to carry' out one or more processes orone or more steps of one or more processes described or illustrated herein. Carrying out such processes or steps may include defining data structures stored in memory 103 and modifying the data structures as directed by the software.

[0216] The memory 103 may include various components (e.g., machine readable media) including, but not limited to, a random-access memory component (e.g., RAM 104) (e.g., static RAM (SRAM), dynamic RAM (DRAM), ferroelectric random access memory (FRAM). phasechange random access memory (PRAM), etc.), a read-only memory component (e.g., ROM 105), and any combinations thereof. ROM 105 may act to communicate data and instructions unidirectionally to processor(s) 101, and RAM 104 may act to communicate data and instructions bidirectionally with processor(s) 101. ROM 105 and RAM 104 may include any suitable tangible computer-readable media described below. In one example, a basic input / output system 106 (BIOS), including basic routines that help to transfer information between elements within computer system 100, such as during start-up, may be stored in the memory 103.

[0217] Fixed storage 108 is connected bidirectionally to processor(s) 101, optionally through storage control unit 107. Fixed storage 108 provides additional data storage capacity and may also include any suitable tangible computer-readable media described herein. Storage 108 may be used to store operating system 109, executable(s) 110, data 111, applications 112 (application programs), and the like. Storage 108 can also include an optical disk drive, a solid-state memory' device (e.g., flash-based systems), or a combination of any of the above. Information in storage 108 may. in appropriate cases, be incorporated as virtual memory in memory 103.

[0218] In one example, storage device(s) 135 may be removably interfaced with computer system 100 (e.g., via an external port connector (not shown)) via a storage device interface 125. Particularly, storage device(s) 135 and an associated machine-readable medium may provide non-volatile and / or volatile storage of machine-readable instructions, data structures, program modules, and / or other data for the computer system 100. In one example, software may reside, completely7or partially, within a machine-readable medium on storage device(s) 135. In another example, software may reside, completely or partially, within processor(s) 101.

[0219] Bus 140 connects a wide variety of subsystems. Herein, reference to a bus may encompass one or more digital signal lines serving a common function, where appropriate. Bus 140 may be any of several ty pes of bus structures including, but not limited to, a memory bus, a memory7controller, a peripheral bus, a local bus, and any combinations thereof, using any of a variety of bus architectures. As an example and not by way of limitation, such architectures include an Industry Standard Architecture (ISA) bus, an Enhanced ISA (EISA) bus, a Micro Channel Architecture (MCA) bus, a Video Electronics Standards Association local bus (VLB), aPeripheral Component Interconnect (PCI) bus, a PCI-Express (PCI-X) bus, an Accelerated Graphics Port (AGP) bus, HyperTransport (HTX) bus, serial advanced technology attachment (SATA) bus, and any combinations thereof.

[0220] Computer system 100 may also include an input device 133. In one example, a user of computer system 100 may enter commands and / or other information into computer system 100 via input device(s) 133. Examples of an input device(s) 133 include, but are not limited to. an alpha-numeric input device (e.g., a keyboard), a pointing device (e.g., a mouse or touchpad), a touchpad, a touch screen, a multi-touch screen, a joystick, a stylus, a gamepad, an audio input device (e.g., a microphone, a voice response system, etc.), an optical scanner, a video or still image capture device (e.g., a camera), and any combinations thereof. In some embodiments, the input device is a Kinect, Leap Motion, or the like. Input device(s) 133 may be interfaced to bus 140 via any of a variety of input interfaces 123 (e.g., input interface 123) including, but not limited to, serial, parallel, game port, USB, FIREWIRE, THUNDERBOLT, or any combination of the above.

[0221] In certain embodiments, when computer system 100 is connected to network 130, computer system 100 may communicate with other devices, specifically mobile devices and enterprise systems, distributed computing systems, cloud storage systems, cloud computing systems, and the like, connected to network 130. Communications to and from computer system 100 may be sent through network interface 120. For example, network interface 120 may receive incoming communications (such as requests or responses from other devices) in the form of one or more packets (such as Internet Protocol (IP) packets) from network 130, and computer system 100 may store the incoming communications in memory 103 for processing. Computer system 100 may similarly store outgoing communications (such as requests or responses to other devices) in the form of one or more packets in memory 103 and communicated to network 130 from network interface 120. Processor(s) 101 may access these communication packets stored in memory 103 for processing.

[0222] Examples of the network interface 120 include, but are not limited to, a netw ork interface card, a modem, and any combination thereof. Examples of a network 130 or network segment 130 include, but are not limited to. a distributed computing system, a cloud computing system, a wide area network (WAN) (e.g., the Internet, an enterprise network), a local area network (LAN) (e.g., a network associated with an office, a building, a campus or other relatively small geographic space), a telephone network, a direct connection between tw o computing devices, a peer-to-peer network, and any combinations thereof. A network, such as network 130, mayemploy a wired and / or a wireless mode of communication. In general, any network topology maybe used.

[0223] Information and data can be displayed through a display 132. Examples of a display 132 include, but are not limited to, a liquid crystal display (LCD), a thin film transistor liquid cry stal display (TFT-LCD), an organic liquid crystal display (OLED) such as a passive-matrix OLED (PMOLED) or active-matrix OLED (AMOLED) display, a plasma display, and any combinations thereof. The display 132 can interface to the processor(s) 101, memory 103, and fixed storage 108, as well as other devices, such as input device(s) 133, via the bus 140. The display 132 is linked to the bus 140 via a video interface 122, and transport of data between the display 132 and the bus 140 can be controlled via the graphics control 121. In some embodiments, the display is a video projector. In some embodiments, the display is a headmounted display (HMD) such as a VR headset. In further embodiments, suitable VR headsets include, by way of non-limiting examples, HTC Vive, Oculus Rift, Samsung Gear VR, Microsoft HoloLens, Razer OSVR, FOVE VR, Zeiss VR One, Avegant Glyph, Freefly VR headset, and the like. In still further embodiments, the display is a combination of devices such as those disclosed herein.

[0224] In addition to a display 132, computer system 100 may include one or more other peripheral output devices 134 including, but not limited to, an audio speaker, a printer, a storage device, and any combinations thereof. Such peripheral output devices may be connected to the bus 140 via an output interface 124. Examples of an output interface 124 include, but are not limited to, a serial port, a parallel connection, a USB port, a FIREWIRE port, a THUNDERBOLT port, and any combinations thereof.

[0225] In addition, or as an alternative, computer system 100 may provide functionality as a result of logic hardwired or otherwise embodied in a circuit, which may operate in place of or together with software to execute one or more processes or one or more steps of one or more processes described or illustrated herein. Reference to software in this disclosure may encompass logic, and reference to logic may encompass software. Moreover, reference to a computer- readable medium may encompass a circuit (such as an IC) storing software for execution, a circuit embodying logic for execution, or both, where appropriate. The present disclosure encompasses any suitable combination of hardware, software, or both.

[0226] Those of skill in the art will appreciate that the various illustrative logical blocks, modules, circuits, and algorithm steps described in connection with the embodiments disclosed herein may be implemented as electronic hardware, computer software, or combinations of both. To clearly illustrate this interchangeability of hardware and software, various illustrativecomponents, blocks, modules, circuits, and steps have been described above generally in terms of their functionality.

[0227] The various illustrative logical blocks, modules, and circuits described in connection with the embodiments disclosed herein may be implemented or performed with a general-purpose processor, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field programmable gate array (FPGA) or other programmable logic device, discrete gate or transistor logic, discrete hardware components, or any combination thereof designed to perform the functions described herein. A general-purpose processor may be a microprocessor, but in the alternative, the processor may be any conventional processor, controller, microcontroller, or state machine. A processor may also be implemented as a combination of computing devices, e.g., a combination of a DSP and a microprocessor, a plurality of microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration.

[0228] The steps of a method or algorithm described in connection with the embodiments disclosed herein may be embodied directly in hardw are, in a software module executed by one or more processor(s), or in a combination of the two. A software module may reside in RAM memory, flash memory, ROM memory. EPROM memory, EEPROM memory, registers, hard disk, a removable disk, a CD-ROM, or any other form of storage medium known in the art. An exemplary storage medium is coupled to the processor such the processor can read information from, and write information to, the storage medium. In the alternative, the storage medium may be integral to the processor. The processor and the storage medium may reside in an ASIC. The ASIC may reside in a user terminal. In the alternative, the processor and the storage medium may reside as discrete components in a user terminal.

[0229] In accordance with the description herein, suitable computing devices include, by w ay of non-limiting examples, cloud computing platforms, distributed computing platforms, server clusters, server computers, desktop computers, laptop computers, notebook computers, subnotebook computers, netbook computers, netpad computers, set-top computers, media streaming devices, handheld computers, Internet appliances, mobile smartphones, tablet computers, personal digital assistants, video game consoles, and vehicles. Those of skill in the art will also recognize that select televisions, video players, and digital music players with optional computer network connectivity are suitable for use in the system described herein. Suitable tablet computers, in various embodiments, include those with booklet, slate, and convertible configurations, known to those of skill in the art.

[0230] In some embodiments, the computing device includes an operating system configured to perform executable instructions. The operating system is, for example, software, includingprograms and data, which manages the device’s hardware and provides services for execution of applications. Those of skill in the art will recognize that suitable server operating systems include, by way of non-limiting examples, FreeBSD, OpenBSD, NetBSD®, Linux, Apple® Mac OS X Server®, Oracle® Solaris®, Windows Server®, and Novell® NetWare®. Those of skill in the art will recognize that suitable personal computer operating systems include, by way of nonlimiting examples, Microsoft® Windows®, Apple® Mac OS X®. UNIX®, and UNIX-like operating systems such as GNU / Linux®. In some embodiments, the operating system is provided by cloud computing. Those of skill in the art will also recognize that suitable mobile smartphone operating systems include, by way of non-limiting examples, Nokia® Symbian® OS, Apple® iOS®, Research In Motion® BlackBerry OS®, Google® Android®, Microsoft® Windows Phone® OS, Microsoft® Windows Mobile® OS, Linux®, and Palm® WebOS®. Those of skill in the art will also recognize that suitable media streaming device operating systems include, by way of non-limiting examples, Apple TV®, Roku®, Boxee®, Google TV®, Google Chromecast®, Amazon Fire®, and Samsung® HomeSync®. Those of skill in the art will also recognize that suitable video game console operating systems include, by way of non-limiting examples, Sony® PS3®, Sony® PS4®, Microsoft* Xbox 360®, Microsoft Xbox One, Nintendo® Wii®, Nintendo® Wii U®, and Ouya®.Non-transitory computer readable storage medium

[0231] In some embodiments, the platforms, systems, media, and methods disclosed herein include one or more non-transitor ' computer readable storage media encoded with a program including instructions executable by the operating system of an optionally netw orked computing device. In further embodiments, a computer readable storage medium is a tangible component of a computing device. In still further embodiments, a computer readable storage medium is optionally removable from a computing device. In some embodiments, a computer readable storage medium includes, by w ay of non-limiting examples, CD-ROMs, DVDs, flash memory devices, solid state memory, magnetic disk drives, magnetic tape drives, optical disk drives, distributed computing systems including cloud computing systems and services, and the like. In some cases, the program and instructions are permanently, substantially permanently, semipermanently, or non-transitorily encoded on the media.Computer program

[0232] The platforms, systems, media, and methods disclosed herein include one or more computer program, or use of the same. A computer program includes a sequence of instructions, executable by one or more processor(s) of the computing device’s CPU, written to perform a specified task. Computer readable instructions may be implemented as program modules, such asfunctions, objects, Application Programming Interfaces (APIs), computing data structures, and the like, which perform particular tasks or implement particular abstract data ty pes. In light of the disclosure provided herein, those of skill in the art will recognize that a computer program may be written in various versions of various languages.

[0233] The functionality of the computer readable instructions may be combined or distributed as desired in various environments. A computer program may comprise one sequence of instructions. A computer program may' comprise a plurality of sequences of instructions. A computer program may be provided from one location. A computer program may be provided from a plurality' of locations. A computer program may include one or more software modules. A computer program includes, in part or in whole, in various examples, one or more web applications, one or more mobile applications, one or more standalone applications, one or more web browser plug-ins, extensions, add-ins, or add-ons, or combinations thereof.Web application

[0234] A computer program may include a web application. In light of the disclosure provided herein, those of skill in the art will recognize that a web application, in various embodiments, utilizes one or more software frameworks and one or more database systems. A web application may be created upon a software framework such as Microsoft® .NET or Ruby on Rails (RoR). In some embodiments, a web application utilizes one or more database systems including, by way of non-limiting examples, relational, non-relational, object oriented, associative, XML, and document-oriented database systems. In further examples, suitable relational database systems include, by way of non-limiting examples, Microsoft® SQL Server, my SQL™, and Oracle®. Those of skill in the art will also recognize that a web application, in various examples, is written in one or more versions of one or more languages. A web application may be written in one or more markup languages, presentation definition languages, client-side scripting languages, serv er-side coding languages, database query' languages, or combinations thereof. In some embodiments, a web application is written to some extent in a markup language such as Hypertext Markup Language (HTML), Extensible Hypertext Markup Language (XHTML), or extensible Markup Language (XML). In some embodiments, a web application is written to some extent in a presentation definition language such as Cascading Sty le Sheets (CSS). In some embodiments, a web application is written to some extent in a client-side scripting language such as Asynchronous JavaScript and XML (AJAX). Flash® ActionScnpt. JavaScript, or Silverlight®. In some examples, a w eb application is written to some extent in a server-side coding language such as Active Server Pages (ASP), ColdFusion®, Perl, Java™, JavaServer Pages (JSP), Hypertext Preprocessor (PHP), Python™, Ruby, Tel, Smalltalk, WebDNA®, or Groovy'. In someexamples, a web application is written to some extent in a database query language such as Structured Query Language (SQL). In some examples, a web application integrates enterprise server products such as IBM® Lotus Domino®. In some examples, a web application includes a media player element. In various further embodiments, a media player element utilizes one or more of many suitable multimedia technologies including, by way of non-limiting examples, Adobe® Flash®, HTML 5, Apple® QuickTime®, Microsoft® Silverlight®, Java™, and Unity®.

[0235] Referring to FIG. 18, in a particular example, an application provision system comprises one or more databases 200 accessed by a relational database management system (RDBMS) 210. Suitable RDBMSs include Firebird, MySQL, PostgreSQL, SQLite, Oracle Database, Microsoft SQL Server, IBM DB2, IBM Informix, SAP Sybase, Teradata, and the like. In this example, the application provision system further comprises one or more application severs 220 (such as Java servers, .NET servers, PHP servers, and the like) and one or more web servers 230 (such as Apache, IIS, GWS and the like). The web server(s) optionally expose one or more web services via app application programming interfaces (APIs) 240. Via a network, such as the Internet, the system provides browser-based and / or mobile native user interfaces.

[0236] Referring to FIG. 19, in a particular example, an application provision system alternatively has a distributed, cloud-based architecture (content delivery network, CDN) 300 and comprises elastically load balanced, auto-scaling web server resources 310 and application server resources 320 as well synchronously replicated databases 330.Mobile application

[0237] In some examples, a computer program includes a mobile application provided to a mobile computing device. In some examples, the mobile application is provided to a mobile computing device at the time it is manufactured. In other examples, the mobile application is provided to a mobile computing device via the computer network described herein.

[0238] In view of the disclosure provided herein, a mobile application is created by techniques known to those of skill in the art using hardware, languages, and development environments know n to the art. Those of skill in the art will recognize that mobile applications are written in several languages. Suitable programming languages include, by way of non-limiting examples, C, C++, C#, Objective-C, Java™, JavaScript, Pascal, Object Pascal, Python™, Ruby, VB.NET, WML, and XHTML / HTML with or without CSS. or combinations thereof.

[0239] Suitable mobile application development environments are available from several sources. Commercially available development environments include, by way of non-limiting examples, AirplaySDK, alcheMo, Appcelerator®, Celsius, Bedrock, Flash Lite, .NET Compact Framework, Rhomobile, and WorkLight Mobile Platform. Other development environments areavailable without cost including, by way of non-limiting examples, Lazarus, MobiFlex, MoSync, and Phonegap. Also, mobile device manufacturers distribute software developer kits including, by way of non-limiting examples, iPhone and iPad (iOS) SDK, Android™ SDK, BlackBerry® SDK, BREW SDK, Palm® OS SDK, Symbian SDK, webOS SDK, and Windows® Mobile SDK.

[0240] Those of skill in the art will recognize that several commercial forums are available for distribution of mobile applications including, by way of non-limiting examples, Apple® App Store, Google® Play. Chrome WebStore, BlackBerry® App World, App Store for Palm devices, App Catalog for webOS, Windows® Marketplace for Mobile, Ovi Store for Nokia® devices, Samsung® Apps, and Nintendo® DSi Shop.Standalone application

[0241] In some examples, a computer program includes a standalone application, which is a program that is run as an independent computer process, not an add-on to an existing process, i.e., not a plug-in. Those of skill in the art will recognize that standalone applications are often compiled. A compiler is a computer program(s) that transforms source code written in a programming language into bi nan object code such as assembly language or machine code. Suitable compiled programming languages include, by way of non-limiting examples, C. C++, Objective-C, COBOL, Delphi. Eiffel, Java™, Lisp, Python™, Visual Basic, and VB .NET, or combinations thereof. Compilation is often performed, at least in part, to create an executable program. In some embodiments, a computer program includes one or more executable complied applications.Web browser plug-in

[0242] In some examples, the computer program includes a web browser plug-in (e.g., extension, etc.). In computing, a plug-in is one or more software components that add specific functionality to a larger software application. Makers of software applications support plug-ins to enable third- party developers to create abilities which extend an application, to support easily adding new features, and to reduce the size of an application. When supported, plug-ins enable customizing the functionality of a softw are application. For example, plug-ins are commonly used in web browsers to play video, generate interactivity, scan for viruses, and display particular file types. Those of skill in the art will be familiar with several web browser plug-ins including, Adobe® Flash® Player, Microsoft® Silverlight®, and Apple® QuickTime®. In some embodiments, the toolbar comprises one or more w eb brow ser extensions, add-ins, or add-ons. In some embodiments, the toolbar comprises one or more explorer bars, tool bands, or desk bands.

[0243] In view of the disclosure provided herein, those of skill in the art will recognize that several plug-in fra ew orks are available that enable development of plug-ins in variousprogramming languages, including, by way of non-limiting examples, C++, Delphi, Java™, PHP, Python™, and VB .NET, or combinations thereof.

[0244] Web browsers are software applications, designed for use with network-connected computing devices, for retrieving, presenting, and traversing information online. Suitable web browsers include, by way of non-limiting examples, Microsoft® Internet Explorer®, Mozilla® Firefox®. Google® Chrome, Apple® Safari®. Opera Software® Opera®, and KDE Konqueror. In some embodiments, the web browser is a mobile web browser. Mobile web browsers (also called microbrowsers, mini -browsers, and wireless browsers) are designed for use on mobile computing devices including, by way of non-limiting examples, handheld computers, tablet computers, netbook computers, subnotebook computers, smartphones, music players, personal digital assistants (PDAs), and handheld video game systems. Suitable mobile web browsers include, by way of non-limiting examples, Google® Android® browser, Apple® Safari®, Palm® Blazer, Palm® WebOS® Browser, Mozilla® Firefox® for mobile, Microsoft® Internet Explorer® Mobile, Amazon® Kindle® Basic Web, Nokia® Browser, Opera Software® Opera® Mobile, and Sony® PSP™ browser.Software modules

[0245] The platforms, systems, media, and methods disclosed herein include software, server, and / or database modules, or use of the same. In view of the disclosure provided herein, software modules are created by techniques know n to those of skill in the art using machines, softw are, and languages known to the art. The software modules disclosed herein are implemented in a multitude of ways. In various embodiments, a software module comprises a file, a section of code, a programming object, a programming structure, a distributed computing resource, a cloud computing resource, or combinations thereof. In further various embodiments, a software module comprises a plurality of files, a plurality7of sections of code, a plurality of programming objects, a plurality7of programming structures, a plurality7of distributed computing resources, a plurality of cloud computing resources, or combinations thereof. In various examples, the one or more softw are modules comprise, by way of non-limiting examples, a web application, a mobile application, a standalone application, and a distributed or cloud computing application. In some examples, software modules are in one computer program or application. In other examples, software modules are in more than one computer program or application. In some examples, software modules are hosted on one machine. In other examples, software modules are hosted on more than one machine. In further examples, software modules are hosted on a distributed computing platform such as a cloud computing platform. In some examples, software modulesare hosted on one or more machines in one location. In other examples, softw are modules are hosted on one or more machines in more than one location.Databases

[0246] The platforms, systems, media, and methods disclosed herein include one or more databases, or use of the same. In view of the disclosure provided herein, those of skill in the art will recognize that many databases are suitable for storage and retrieval of handheld device 10 information. In various examples, suitable databases include, by way of non-limiting examples, relational databases, non-relational databases, object-oriented databases, object databases, entityrelationship model databases, associative databases. XML databases, document-oriented databases, and graph databases. Further non-limiting examples include SQL, PostgreSQL, MySQL, Oracle, DB2, Sybase, and MongoDB. In some examples, a database is Internet-based. In further examples, a database is web-based. In still further embodiments, a database is cloud computing based. In a particular embodiment, a database is a distributed database. In other examples, a database is based on one or more local computer storage devices.Machine Learning Definitions

[0247] In some cases, the fascial densification treatment platform may include a backend management system for training one or more predictive models. In some cases, the backend management system may perform continual training or improvement after deployment. In some cases, the predictive model provided by the platform may be dynamically adjusted and tuned to adapt to different individuals, different deployment environment, or different environment conditions over time. The predictive model provided by the platform may be improved continuously over time (e.g., during implementation, after deployment). Such continual training and improvement may be performed automatically with little user input or with user intervention by involving device operators as validators of the logged safety related events to accumulate the statistics of true positives, false positives, true negatives, and false negatives. Negative events are treatment related events that normally would not be logged because no treatment event was detected or predicted, or if the system confidence level were below the threshold to generate an event, and only generated for validation purposes at random time intervals or predetermined time intervals. The fascial densification treatment platform may also allow- remote users, or remote entities to monitor fascial densification treatment event occurrence. Backend management system can be applied in various scenarios such as in cloud or an on-premises environment.

[0248] Recognized herein is a need for methods and systems for fascial densification treatment with improved efficiency and accuracy. The present disclosure provides systems and methods for fascial densification treatment. In particular, the provided systems and methods utilize artificialintelligence (Al) solution that scans through multi-sensor inputs in real-time and proactively adjusts a handheld fascia manipulation device. In some embodiments of the disclosure, the provided multimodal fascial densification treatment system includes computer vision, real-time locating system (RTLS), light detection and ranging (LIDAR) system and other sensors to provide a comprehensive coverage for each target tissue. The multimodal safety system of the present disclosure merges computer vision, real-time locating, Al, sensor fusion and analytics in combination with multiple sensors to provide real time, actionable fascial densification treatment progress.

[0249] An aspect of the present disclosure provides an adaptive multimodal system. The adaptive multimodal system may employ a framework that is capable of dynamically adjusting the computing power available to the multimodal sensory systems. In particular, the adaptive multimodal framework may dynamically allocate computing power to the computer vision system for processing the image data based on an output of the real-time locating system and / or real-time conditions. Moreover, the adaptive multimodal framework may be capable of dynamically adjusting one or more imaging acquisition parameters of the computer vision system (e.g.. zoom factor, spatial resolution, etc.) and / or LIDAR system based on the location tracking result (i.e., temporal-spatial data per identity ) generated by the real-time locating system. This adaptive multimodal framework may fuse the multimodal sensory data dynamically based on real-time conditions which beneficially improves the accuracy and efficiency of providing understanding of the 3D target scene with reduced computation overhead and / or computational power.

[0250] In preferable embodiments of the present disclosure, the system comprises: a computer vision component for generating a computer vision output data: a real-time locating component for generating location data about a target tissue; a LIDAR component for generating 3D point cloud data of the target tissue environment; and one or more processors coupled to the computer vision component, the real-time locating component and the LIDAR component and configured to: (i) obtain an identity of the target tissue and the location data, and (ii) adjust, based at least in part on the identity and the location data, one or more parameters for acquiring the 3D point cloud data, the process for generating the computer vision output data, or one or more parameters for acquiring an image data by the computer vision component.

[0251] The real-time platform of the present disclosure may cooperate ultra-accurate and reliable wearables with computer vision, machine learning and Al to improve fascial densification treatment. The platform may be configured fascial densification treatment The platform may comprise a multimodal fascial densification treatment system utilizing machine learning and Altechnologies to optimize fusion of multimodal data. In some embodiments of the disclosure, the multimodal fascial densification treatment system may utilize three different sensory modalities: a computer vision component, a real-time locating component, and a LIDAR component.

[0252] Each of the three modalities may have their own advantages and disadvantages. It is desirable to provide an intelligent system to fuse these modalities in an optimized manner to improve the accuracy and efficiency of providing a 3D scene map with understanding of the target tissue location thereby causing an appropriate action such as increase / decrease current / motor speed, etc., to improve fascial densification treatment.

[0253] Computer vision (CV) techniques or computer vision systems have been used to process images to extract high-level understanding of the target tissue. CV techniques may have the capabilities of tissue detection, tissue tracking, tissue recognition or generating descriptions of a tissue (e.g., tissue detection, tissue classification). However, CV systems are known to have limited accuracy such as due to limited computational power. For example, deep convolutional neural networks are known to improve accuracy with an increased number of network layers. One source of inaccuracy in computer vision is the limited computational power, constrained by cost, size, weight, power, and heat dissipation. Another source of inaccuracy in computer vision is the limited resolution. An effective system resolution is a product of the intrinsic and extrinsic factors. Intrinsic factors may include, for example, optical blur of the camera’s lens, focal length, and the spatial sampling rate of the image sensor. Extrinsic factors include illumination of the scene and its dynamic range. Target image brightness under given illumination is typically achieved by setting the exposure time. Longer exposure causes motion blur as a result of object motion or camera physical motion thereby reducing effective system resolution. To avoid motion blur, target image brightness may be achieved by increasing or decreasing the imaging system’s gain. Increased gain amplifies signal noise which similarly reduces the effective system resolution. Light detection and ranging (LIDAR) technology can be used to obtain three- dimensional information of a target tissue.

[0254] The multimodal safety system or platform may combine the three different sensory modalities i.e., a computer vision component, a real-time locating component, and a LIDAR component via an intelligent fusion framework. In some cases, the multimodal safety system may be capable of detecting a target tissue and identifying them by utilizing mobile tag data provided by the real-time locating component and then tracking objects' orientation, relative positions, and boundaries in three dimensions in real-time by using LIDAR point cloud data and camera images. In some cases, a proximity between two or more tissues in proximity as determined bythe system from mobile tag data, camera images and LIDAR data may cause an alert delivered to a user if such proximity falls below set thresholds.

[0255] In one aspect, an adaptive multimodal system for fascial densification treatment is provided. The system comprises: a computer vision component for generating a computer vision output data; a real-time locating component for generating location data about a target tissue; a light detection and ranging (LIDAR) component for generating 3D point cloud data of the target tissue environment; and one or more processors coupled to the computer vision component, the real-time locating component and the LIDAR component and configured to: obtain an identity of the target tissue and the location data, and adjust, based at least in part on the identity and the location data, (i) a pixel distribution for acquiring the 3D point cloud data, and one or more of (ii) a process for generating the computer vision output data, and one or more parameters for acquiring an image data by the computer vision component.

[0256] Adjusting the process for generating the computer vision output data may comprise not performing computer vision techniques for recognizing the identity of the target tissue. In some instances, adjusting the process for generating the computer vision output data comprises performing action recognition or objection recognition for the target tissue to determine whether the object complies with a safety7protocol. In some instances, the one or more processors are configured to further adjust a computational resource allocated to the computer vision component.

[0257] In some instances, the computer vision output data comprises a description of the target tissue environment. In some instances, the one or more parameters for acquiring the image data include a spatial resolution for acquiring the image data, a zoom level, or region of interest to zoom-in. In some instances, the one or more processors are configured to further generate a control command to an imaging device of the computer vision component to adjust the one or more parameters.

[0258] In some instances, the real-time locating component comprises a mobile tag device carried by the object and one or more reference point devices deployed within the target tissue environment. In some instances, the mobile tag device provides at least the identity of the target tissue. In some embodiments, adjusting the pixel distribution for acquiring the 3D point cloud data comprises controlling a scanning pattern of the LIDAR component.

[0259] In a related yet separate aspect, a method for fascial densification of a target tissue is provided. The method comprises: generating a computer vision output data using a computer vision component; generating location data and an identity about an target tissue within the target tissue environment using a real-time locating component; generating 3D point cloud data of theindustrial environment using a light detection and ranging (LIDAR) component; and adjusting, based at least in part on the identity and the location data, (i) a pixel distribution for acquiring the 3D point cloud data, and one or more of (ii) a process for generating the computer vision output data, and one or more parameters for acquiring an image data by the computer vision component.

[0260] In some cases, adjusting the process for generating the computer vision output data comprises not performing computer vision techniques for recognizing the densification of a target tissue. Alternatively, adjusting the process for generating the computer vision output data comprises performing action recognition or objection recognition for the target tissue to determine whether the target tissue is densified. In some cases, the method further comprises adjusting a computational resource allocated to the computer vision component.

[0261] In some cases, the computer vision output data comprises a description of the target tissue. In some cases, the one or more parameters for acquiring the image data include a spatial resolution for acquiring the image data, a zoom level, or region of interest to zoom-in. In some cases, the method further comprises generating a control command to an imaging device of the computer vision component to adjust the one or more parameters.

[0262] In some cases, the real-time locating component comprises a mobile tag device carried by the object and one or more reference point devices deployed within the target tissue environment. In some cases, the mobile tag device provides at least the identity' of the object. In some embodiments, adjusting the pixel distribution for acquiring the 3D point cloud data comprises controlling a scanning pattern of the LIDAR component.

Claims

Claims1. A device for applying manipulative myofascial therapy to a patient, the device comprising: a housing shaped and sized to be maneuverable by a user; an actuation assembly disposed within the housing; a knuckle comprising: a first portion disposed within the housing and operably coupled to the actuation assembly; and a second portion extending outward from an opening in said housing; and a sensor disposed at a tip of the knuckle, wherein the sensor is configured to obtain measurements associated with a densification of a fascia of the patient.

2. The device of claim 1, wherein the knuckle is removeable from the housing.

3. The device of claim 1, wherein the sensor comprises an ultrasound sensor.

4. The device of claim 3, wherein an ultrasound coupling material is disposed on the tip of the knuckle over the ultrasound sensor.

5. The device of claim 1, wherein the sensor comprises a fiber optic sensor.

6. The device of claim 1, wherein the actuation assembly is configured to move the knuckle translationally within a plane parallel to a treatment area of the patient.

7. The device of claim 1, wherein the actuation assembly comprises: a motor; a gear coupled to the motor; and a rail operably coupled to the gear. wherein the motor is configured to rotate the gear, and wherein the gear is configured to move the rail linearly.

8. The device of claim 7, wherein the knuckle is coupled to the rail such that the actuation assembly is configured to move the knuckle linearly along an axis parallel to a treatment area of the patient.

9. The device of claim 7, wherein the actuation assembly further comprises: a crank pin coupled to the gear such that the gear is configured to rotate the crank pin; and a slider coupled to the crank pin and the rail such that the crank pin is configured to move the slider linearly and the slider is configured to move the rail linearly.

10. The device of claim 1, wherein the actuation assembly is configured to move the knuckle at a linear speed of up to approximately 1.3 meters per second (m / s).

11. The device of claim 1, wherein the actuation assembly is configured to apply a torque of up to 180 gem.

12. The device of claim 1, wherein the second portion of the knuckle has a length that ranges from 16 millimeters (mm) to 30 mm.

13. The device of claim 12, wherein the knuckle is configured to be pressed into a treatment area of the patient at an indentation depth that ranges from 16 mm to 30 mm.

14. The device of claim 13, wherein the actuation assembly is configured to apply a torque of up to 180 gem when the second portion of the knuckle is pressed into the skin surface of the patient at the indentation depth.

15. The device of claim 1, wherein the housing comprises at least one handle.

16. The device of claim 15, wherein the housing comprises a first handle on a first side of the housing and a second handle on an opposite, second side of the housing.

17. The device of claim 1, which is a handheld device.

18. The device of claim 1, comprising a pad coupled to the housing, wherein the pad comprises a grip surface facing away from the housing that is configured to contact a treatment area of the patient.

19. The device of claim 18, wherein the pad is configured to contact a treatment area and maintain device position while the device is in operation.

20. The device of claim 1, wherein the knuckle comprises a resistive heater.

21. A method of treating fascial densifications of a patient, the method comprising: contacting a first knuckle of a handheld device to a treatment area of the patient; activating a sensor disposed at a tip of the first knuckle to obtain measurements associated with a densification of a fascia of the patient; determining one or more locations on the skin surface of the patient that correspond to one or more fascial densifications of the fascia; and applying manipulative myofascial therapy to the one or more treatment areas using the handheld device.

22. The method of claim 21, wherein applying manipulative myofascial therapy comprises: replacing the first knuckle of the handheld device with a second knuckle; pressing the second knuckle into the skin surface of the patient at a first fascial densification of the one or more fascial densifications such that the second knuckle presses on the first fascial densification; and moving the second knuckle in a plane parallel to the skin surface to treat the first fascial densification.

23. The method of claim 20, wherein applying manipulative myofascial therapy comprises: pressing the first knuckle into the skin surface of the patient at a first fascial densification of the one or more fascial densifications such that the first knuckle presses on the first fascial densification; and moving the first knuckle in a plane parallel to the skin surface to treat the first fascial densification.

24. The method of claim 23, wherein the handheld device is configured to move the first knuckle at a linear speed of up to approximately 1.3 meters per second (m / s) within the plane.

25. The method of claim 23, wherein the handheld device is configured to apply a torque of up to 180 gem.

26. The method of claim 23, wherein pressing the first knuckle into the treatment area of the patient comprises pressing the first knuckle to an indentation depth that ranges from 16 millimeters (mm) to 30 mm.

27. The method of claim 26, wherein the handheld device is configured to apply a torque of up to 180 gem when the first knuckle is pressed into the treatment area of the patient at the indentation depth.

28. The method of claim 23, wherein applying manipulative my ofascial therapy further comprises heating the first fascial densification using a heater disposed within the first or the second knuckle.

29. The method of claim 21, wherein the sensor comprises an ultrasound sensor, a fiber optic sensor, a pressure sensor, or any combination thereof.

30. The method of claim 29, wherein the sensor comprises an ultrasound sensor, and wherein an ultrasound coupling material is disposed on the tip of the first knuckle over the ultrasound sensor such that contacting the first knuckle of the handheld device to the skin surface of the patient comprises contacting the ultrasound coupling material to the skin surface of the patient.