Patent Application
20200268592
All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.
Embodiments of the invention relate generally to systems and methods to provide compression therapy to a body part, and more specifically, to systems and methods to provide active and/or adaptive compression therapy to a body part.
Compression therapy (CT), is the selective external compression of a portion of the body using wraps, stockings, inflatable cuffs and bandages. CT can be either passive compression using elastic or inelastic bandages or multiple layers of bandages (no external energy applied) or active, where an external energy source augments a compressive force applied to body part(s), as shown in
Examples of the some of the commercially available compression bandages currently available include those made by 3M, BSN Medical, Convatec, Derma Sciences, Hartman group, Kendall/Covidien, Lohmann and Rauscher, Medline Industries, and Smith and Nephew. The compressive force of compression bandages is achieved in the application or wrapping of the bandage by a caregiver. The consistency of the compression is dependent on the skill of the caregiver applying the bandage. There is no feedback on the amount of compressive force applied with bandages. The patient is wears the bandage until the stocking loses its compliance or become soiled. Bandages are typically applied to the arms or legs.
Compression stockings (CS) are elastic stockings that are typically placed over the lower leg like long length sock or leg hosiery. The stockings are marketed to provide a specific level of compression, often greater compression at the ankle with reducing levels of compression toward the knee to compensate for the higher hydrostatic pressure toward the ankle when standing.
CS can be designed to provide a range of pressures to the lower leg. For example, a CS that delivers light compression can provide less than 20 mmHg of pressure; moderate compression is between 20 to 40 mmHg, strong compression between 40 and 60 mmHg and very strong compression can be over 60 mmHg.
Manufacturers offer a variety of compression levels up to 60 mmHg. Some manufacturers of CS include Bauerfeind, BSN, Kendell/Covidien, and Sigvaris.
Active compression (AC), often referred to as pneumatic compression devices use air chamber containing sleeves that enclose the patient's leg or foot. The three main categories of AC are foot pumps, that compress the venous sinus of the foot, intermittent pneumatic compression (IPC) that inflate and deflate the entire sleeve at the same time and sequential compression pumps (SC) that sequentially inflate chambers in the sleeve to move the blood (or milk) the blood toward the foot to enhance arterial flow, or toward the waist to improve venous, lymphatic fluid or enhance removal of lactic acid post-exercise.
AC devices are made in both plug-in and battery-powered mobile units as shown in
There is strong evidence that all these forms of compression therapy are helpful in treating or preventing the conditions for which they are used. The significant deficiencies that all of these technologies suffer from is unknown/inconsistent pressure application, poor comfort due to bulky, non-breathable cuffs and difficulty in donning/doffing the stockings or wraps. These design deficiencies result in non-compliance with the technologies, estimated to be as high as 70%. The root cause for poor compliance with compression therapy is multi-factorial. Standard tight fit stockings are hard to don/doff for someone who already has limited mobility due to their disease. Some clinicians resort to recommending that patients apply KY jelly over the leg to help don/doff the stocking, as well as using an external donning/doffing aid, such as a Jobst Stocking Donner (Model number 110913). In addition, although these stocking can be provided in multiple sizes, too the stockings often have problems with poor fit, including areas that are too tight causing pain or too loose causing the stocking to droop. Inelastic compression wraps (e.g. Unna boot) where the lower leg is wrapped in a series of layers of cotton wraps with zinc oxide and other compounds, are not well tolerated by patients either as they are rigid, uncomfortable, can develop a foul smell due to accumulation of exudates from the ulcer and must be changed weekly. Inelastic compression wraps have an additional burden as compression wraps must be changed often, which typically requires the patient to travel to a venous clinic and utilizes expensive nursing resources.
With millions of affected patients affected in the US and billions of dollars spent attempting to treat patients with poorly understood treatment regimens with devices that patients are reticent to use due to discomfort, there is clearly a need for a better technology. Therefore, there is a need for an innovative, multi-mode compression therapy system that addresses these problems.
The present invention relates generally to systems and methods to provide compression therapy to a body part, and more specifically, to systems and methods to provide active and/or adaptive compression therapy to a body part.
In a first aspect, a system for providing compression therapy to a body part of a user is provided. The system comprises a wearable compression device, the wearable compression device comprising: a drive unit configured to be placed over or against a body part, the drive unit comprising; one or more motors; a controller configured to control operation of the one or more motors; a power source in electrical communication with the one or more motors and the controller, one or more compression members configured to be wrapped at least partially around a portion of the body part, wherein the one or more compression members are configured to be tensioned by the one or more motors; and a housing configured to enclose the one or more motors, the controller, and the power source.
The system can comprise a handheld computing device configured to communicate with the wearable compression device. The handheld computing device can be a smartphone. In some embodiments, the handheld computing device has a touch screen user interface.
The touchscreen user interface can comprise a display with a plurality of graphical icons along an edge of the display. In some embodiments, the graphical icons each link to a unique screen. The unique screens can include a prescription screen, wherein the prescription screen is configured to allow one or more treatment parameters to be set by the user. In some embodiments, the unique screens include a user treatment screen configured to allow the user to initiate, stop, and/or adjust treatment. The wearable compression device can comprise one or more sensors, wherein the unique screens further include a treatment data screen configured to graphically display data collected by the one or more sensors. The unique screens can include an alerts screen. The unique screen can include a user compliance screen.
The touchscreen user interface can have a photo section configured to allow for uploading of user photos. In some embodiments, the touchscreen user interface comprises a user feedback section configured to allow a user to provide feedback regarding treatment. The touchscreen user interface can comprise a notes section configured to allow for adding and viewing of notes. In some embodiments, the unique screen includes a treatment screen showing treatment status, treatment progress, and allows treatment control. The unique screens can include a history screen showing historical treatment and/or compliance information. In some embodiments, the unique screens include an account screen showing patient information and account settings.
The device can comprise a communications module. In some embodiments, the device is configured to send data regarding treatment, compliance, efficacy and/or sensor data to a remote database.
In some embodiments, the system comprises a clinician interface configured to display the data received from the device. The clinician interface can comprise an app or other software based program. The clinician interface can allow for viewing of sensor and compliance data from one or more wearable compression devices. In some embodiments, the clinician interface allows for entry or updating of prescription information. The clinician interface can allow for sending messages and alerts to the user.
In some embodiments, the system comprises a processor configured to receive and analyze treatment data from a plurality of users and recommend a specific treatment protocol for a specific user based on the specific user's information.
The device can comprise a force sensor configured to measure force in a body part. In some embodiments, a processor receiving data from the force sensor is configured to detect a deep vein thrombosis in a user based on data received from the force sensor. The system can be configured to produce an alert upon detection of the deep vein thrombosis.
In some embodiments, the device comprises a vibrating element. The device can comprise an accelerometer. In some embodiments, the wearable compression device comprises a cushioned cradle surrounding at least a portion of the housing. The one or more compression members can extend through or over the cradle. In some embodiments, a resilient and waterproof boot enclosure is positioned between each strap and the cradle. In some embodiments, a force sensor and/or vibrating element are positioned on a back surface of the housing. The cradle can comprise a recessed portion configured to receive a back surface of the housing.
In some embodiments, the straps are reversibly secured together using one or more magnetic clasps. Each clasp can comprise a male portion on a first strap and a female portion on a second strap. In some embodiments, the male portion comprises an overhang configured to be secured in an undercut of the female portion. In some embodiments, a cushioned backing component is positioned around the magnetic clasp on each strap, the cushioned backing component configured to be positioned between the user's skin and the magnetic clasp during use. The male portion can be configured to lock into the female portion when a circumferential tension is applied, and wherein the male portion is configured to be removed from the female portion by the application of inward radial force on the magnetic clasp.
In some embodiments, the device comprises a plurality of pulleys, one or more drive elements configured to be tensioned by the one or more motors, wherein the one or more drive elements are threaded around the plurality of pulleys. The one or more compression members can be attached to the pulleys and configured to be tensioned by the pulleys.
In some embodiments, the one or more compression members includes a safety breakaway feature that is configured to break apart when subjected to a predetermined amount of force. The safety breakaway feature can be a breakable clasp.
In another aspect, a device for providing compression therapy to a body part of a user is provided. The device comprises a drive unit configured to be placed over or against a body part, the drive unit comprising; one or more motors; a controller configured to control operation of the one or more motors; a power source in electrical communication with the one or more motors and the controller; and a plurality of pulleys; one or more drive elements configured to be tensioned by the one or more motors, wherein the one or more drive elements are threaded around the plurality of pulleys; one or more compression mechanisms configured to be wrapped at least partially around a portion of the body part, wherein the one or more compression mechanisms are attached to the pulleys and are configured to be sequentially tensioned by the pulleys; and one or more boot enclosures, each boot enclosure enclosing a portion of the one or more drive elements, wherein the one or more boot enclosures are configured to take up slack in the one or more drive elements.
In another aspect, a method for applying mechanical compression therapy to a body part of a user is provided. The method comprises placing a device on the body part of the user, the device comprising one or more motors, a controller configured to control operation of the one or more motors, a power source in electrical communication with the one or motors and the controller; wrapping straps of the device at least partially around the body part of the user; removably securing the straps together; and causing the controller to activate the device, thereby applying mechanical compression therapy to the body part.
In some embodiments, the applying mechanical compression therapy comprises powering the one or more motors, thereby applying tension to one or more compression members. Applying tension to one or more compression members can comprise tensioning one or more drive elements using the one or more motors, wherein the one or more drive elements are threaded around a plurality of pulleys and connected to the one or more compression members. In some embodiments, causing the controller to activate the device comprises using a user interface on the device or on an app or program in electrical communication with the device.
The method can comprise causing the controller to send data regarding treatment, compliance or sensor data received from sensors positioned on the device to a remote database. In some embodiments, the method comprises monitoring force in the body part using a force sensor on the device. The method can comprise a processor receiving data from the force sensor; processing the data using a processor; and executing algorithms on the processor configured to detect a deep vein thrombosis from the data.
In some embodiments, the method comprises sensing periodic limb movements using an accelerometer. The method can comprise the controller initiating treatment based on sensing periodic limb movements. In some embodiments, the method comprises causing the controller to activate a vibrating element on the device. The method can comprise the controller initiating compression and/or vibration based on sensing periodic limb movements. In some embodiments, the method comprises the controller stopping the device.
The method can comprise uploading user data using an app or program in electrical communication with the device. In some embodiments, the method comprises storing user data, treatment data, and/or compliance data in a remote database. The method can comprise generating recommended therapy protocols based on the stored data. In some embodiments, the data is received from a plurality of users and devices. The method can comprise zeroing the device to a baseline condition.
In yet another aspect, a method of monitoring a patient for deep vein thrombosis (DVT) is provided. The method comprises wrapping a compression device comprising a controller, a motor, and one or more compression members at least partially around a calf of a patient, the compression device comprising a force sensor positioned such that it is configured to measure tension in the patient's calf; causing the controller to activate the device to apply compression and measure the tension in the patient's calf; and using a processor to process data received from the force sensor, the processor configured to recognize data from the force sensor corresponding to development of a DVT in the patient.
In some embodiments, the method comprises the processor detecting a DVT. The method can comprise adjusting treatment applied by the compression device upon detection of the DVT. In some embodiments, the method comprises producing an alert upon detection of the DVT.
In another aspect, a method of monitoring a patient for onset of symptoms of restless leg syndrome is provided. The method comprises wrapping a device comprising a controller, a vibrating element, a motor, and one or more compression members in communication with the motor and configured to apply compression, at least partially around a portion of a leg of a patient, the device comprising an accelerometer; causing the controller to activate the accelerometer to monitor movement of the patient's leg; and using a processor to receive data from the accelerometer, the processor configured to recognize data corresponding to periodic limb movements of the patient.
In some embodiments, the method comprises the processor recognizing periodic limb movements of the patient. The method can comprise initiating compression therapy upon detection of periodic limb movements. In some embodiments, the method comprises initiating vibration therapy upon detection of periodic limb movements. The method can comprise modulating ongoing therapy upon detection of periodic limb movements.
The novel features of the invention are set forth with particularity in the claims that follow. 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 of which:
Described herein are systems, devices, and methods that make compression therapy comfortable, consistent, easy to use, and customized to increase compliance with a proven therapy. In addition, the use of an effective, low profile, mechanical drive system in combination with modern sensing, data management and remote interface enables the system to add functionality that will improve outcomes. The basis of the system is the mechanical tensioning and coordination of therapy among multiple compression bands around a part of the body. The system is further enabled by sensors, mechanical feedback, and user input that enable real-time monitoring, adjustments and adaptation to the individual patients' anatomy, physiology, tolerance, and therapeutic needs. Finally, the unique data streams from this device including mechanical, physiological, imaging, and patient feedback data can be leveraged on both an individual and population basis with analytics and artificial intelligence in order to optimize therapy for both individuals and populations.
Described herein are systems, devices, and methods that enable both standard compression and active therapy in a mobile, lightweight, breathable, simple interface that encourages compliance with remote monitoring capability. Additional features of strain gauge plethysmography, tilt sensing, compliance and remote monitoring are included to facilitate better outcomes through accumulation of a large database of treatment outcomes. Various embodiments include a “smart” stocking that can use real time data and proprietary algorithms in order to implement customized treatment that learns and adapts to the specific patient needs and disease state progression.
In some embodiments, as shown in
Alternative drive trains that may be pulley-less include using twisted pairs of drive cords that are attached on one end to the compression strap or mechanism, as described in U.S. Patent Publication No. 2008/0066574, for example. The other end of the twisted pair actuator can be attached to a motor that can twist the pair of drive cords to shorten the twisted pair and generate force and compression, and the motor can untwist the twisted pair to lengthen the twisted pair to reduce the force and compression. Yet another pulley-less drive train can include directly attaching the drive cord to the compression strap or mechanism and omitting the pulleys.
For example, the system can include the parts and features listed below in Table 1.
In summary, a motor turns a drive shaft with a drive pulley. The drive pulley spools a drive cord threaded through a pulley based drivetrain, which includes both compression plate pulleys that are fixed on a compression plate and movable compression strap pulleys that transmit force from the motor to a compression strap system. Tension is applied to the compression straps as the drive pulley spools the drive cord, and tension is released by reversing the motor and the rotation of the drive shaft and the attached drive pulley, thereby allowing the drive cord to unspool. In addition, the compressed leg or other body part naturally provides a reactive force that promotes unspooling and unloading. In some embodiments, a resilient element may be used to supplement the reactive force provided by the compressed body part, as described in further detail below.
The system will now be described in more detail. As shown in
The compression plate/active compression assembly can be indexed, aligned and positioned properly on and around the stocking by aligning the compression plate/active compression assembly with index markers or patterns on the compression stocking and/or attachment to a compression stocking attachment that is integrated on the stocking. As shown in
The active components of the system can index or zero itself to establish a reliable and consistent baseline configuration before initiating active compression therapy, as shown in
The compression straps of the system, as shown in
As shown in
The pad 602 and backing component 604 can be a molded EVA foam or plastic that fits over the front portion of the lower leg. Use of the pad and backing component may allow the compressive force to be more evenly transmitted to the body part than using discrete compression straps alone, which may improve patient comfort. The backing component can be sized and shaped to cover the portions of the leg that are adjacent or proximate the lace of the closure system in order to ensure that the lace does not transmit force directly against the patient's skin. If compression straps are used, the backing component 604 can include compression strap guides 620, such as loops, for attaching and aligning the backing component with the rest of the device, as shown in
Other embodiments can utilize an alternative closure system as shown in
The compression components that include the compression plate, motors, pulley system, controller, battery, and drive cord can also be disposed on a pad 602, which can be made of foam or other comfortable material as described above for the backing component 602. The compression component can be removably attached to the pad which allows the pad to be changed when needed, such as when the pad is soiled or the leg girth changes.
Other closure systems can use different tensioning mechanisms. For example,
In some embodiments, the foam components, which includes the backing component 604 and the pad 602 attached to the compression plate, can be made from two foam layers, a thin dense foam layer to provide structural integrity and a softer compressible foam layer that faces the skin to provide cushioning and improve comfort. The pad 602 for the compression plate can be made from one or more articulated sections to match the articulations in the compression plate and/or to define zones of compression. Use of multiple sections allows the pad to better conform to the shape of the patient's anatomy and also facilitates sequential compression from multiple zones of compression.
As shown in
In some embodiments, the compression device can be powered by a rechargeable battery that can be charged using a port in the housing and an electrical cable. In another embodiment as shown in
In some embodiments, the inductive charger can charge the rechargeable battery in the compression device in about 30 to 120 minutes (i.e., about 30, 60, 90, or 120 minutes), and from a full charge, the compression device can have at least about 4, 8, 12, or 24 hours of active run time.
In some embodiments as shown in
As shown in
In some embodiments, the mechanical pulley based drivetrain is separated and/or isolated from the electrical components with a cover or divider 2308 as shown in
As shown in
Although the descriptions herein generally discuss the use of compression straps, any of the closure systems described herein can be used instead.
In some embodiments, active feedback is provided via wearable sensor(s) (e.g., pressure, force and/or strain sensors) and a feedback system to index the pressure or tension applied by the compression straps and/or compression plate to a prescribed baseline condition or value. For example, the motor can be driven to rotate the drive pulley until a sensor in line with the drive cord reads a desired strain, or a sensor against the patient's skin or against the compression stocking measures a desired pressure, or a sensor measures that the motor draws a predetermined or a set current which can be correlated to a load on the motor, which can be correlated to strain.
Sensors can be integrated into the stocking, the backing component (e.g., the foam cuff), compression straps, the drive cord, the lace(s) for fastening mechanism, the tensioning reel of the fastening mechanism, the motor, and/or the force/pressure transmission components. Other sensors may be externally mounted onto the device, such as a pressure sensor disposed on a skin facing side of the compression plate, compression strap, or understocking, for example. These sensors may also provide feedback to the compression device and may communicate wirelessly or through a wired connection.
The system may be capable of providing user/patient feedback prior to active compression engagement to ensure that baseline conditions are achieved before beginning active compression therapy. For example, the system may be capable of verbally (e.g., in plain spoken language of recorded caregiver), auditory (beeps or other), or visually (on-board display, smartphone or remote control) providing a cue to engage the user/patient to reset device to baseline conditions. User feedback (e.g., auditory, visual, tactile) can be provided to the user when baseline compression level is achieved. In addition, user feedback (e.g., auditory, visual, tactile) can be provided to notify the user/patient that baseline compression level has not yet been reached.
In some embodiments, the drive pulley rotation is engaged for specific time interval, number of rotations, and/or power output (e.g. input drive function), per prescribed parameters, which may be predetermined or selected at the beginning or during treatment. In addition or alternatively, the input drive functions can be modulated by sensor measurements (e.g., stain gauge, accelerometer), in order to deliver a precise and consistent amount of compression to the user/patient. For example, an integrated strain gauge, pressure sensor, and/or force sensor can be provided to provide real time feedback of compression level in the mechanical compression system so that the system can provide a predetermined, set, or desired level of compression, such as light compression less than 20 mmHg of pressure, moderate compression between 20 to 40 mmHg, strong compression between 40 and 60 mmHg or very strong compression over 60 mmHg The pressure sensor, force sensor, or strain gauge can be positioned against the skin or against the stocking and under the base plate, compression straps, compression mechanism, pads, and/or backing to measure the interface pressure, which is the actual pressure applied to the body part, in contrast to an inflatable compression device that may only report the inflation pressure.
Integrated strain gauge plethysmography on the wearable treatment system can be used to adjust therapy system with real time feedback. The sensors can be placed on a skin facing surface, such as the back of the compression plate as shown in
The drive cord may be spooled and unspooled around a drive pulley that is fixed to the drive shaft of the motor. As the motor rotates the drive shaft and drive pulley, the spooling or unspooling of the drive cord generates or releases tension in the drive cord that is translated to individual or multiple compression straps through a pulley system that includes fixed pulleys attached to the compression plate and movable pulleys attached to the compression straps. The pulley system can provide a mechanical advantage greater or less than 1:1 depending on the pulley configuration used. For example, attaching two movable pulleys to a compression strap will generally increase the mechanical advantage to greater than 1:1, so long as the drive cord generating the force on the compression strap is oriented generally parallel to the direction of the generated force, while reducing the amount of travel of the moveable pulleys attached to the compression strap.
In addition, gearing can be used to obtain greater or less than a 1:1 gear ratio from the output of the drive motor, which also allows for the generation of mechanical advantage to increase the compressive force that can be achieved with a given motor.
In order the reduce tangle of the drive cord around the drive pulley, rotation and spooling of the drive cord around the drive pulley can be limited to about 360 degrees or less (i.e., about one rotation or less) of the drive pulley. The size and circumference of the drive pulley therefore can determine the amount of travel or spooling of the drive cord, which along with the pulley system configuration, determines the amount of compression applied by the compression straps. The size of the pulley can be chosen to have the smallest circumference that provides the desired amount of drive cord travel to generate the desired amount of compression. This would result in the smallest tangle free drive pulley, which allows the system to have a reduced, slimmer, more compact form factor. In some embodiments, the drive cord never crosses itself, meaning the drive cord is not wound around itself around a pulley (such as by limiting the spooling to less than 360 degrees) and the path the drive cord takes never crosses itself. This reduces tangling and wear from friction that would occur if the drive cord rubbed against itself.
The use of cams, different pulley sizes, different numbers of pulleys, allows for variation of mechanical advantage in specific zones, or remote adjustment of zone (e.g., use greater mechanical advantage, longer travel, drive cord with less elasticity to deliver more compression to lower leg zones). For example, the use of a cam allows the mechanical advantage to be varied during a compression cycle to better approximate native muscle contraction and/or to alter compression dynamics. One or more movable pulleys can be attached to each end of the compression strap in order to equalize and/or balance the forces applied to the compression strap. If a movable pulley is attached to only one end of the compression strap while the other end of the compression strap is, for example, fixed in place, then the generated force may tend to torque and twist the leg, which may be uncomfortable to the user, in addition to creating the desired compressive force. By balancing the forces with pulleys attached to both ends, the torqueing and twisting force is eliminated or reduced while still providing the compressive force. Similarly, a pulley based attachment system, as shown in
As shown in
The compression plate 316 shown in
A cover 740, as shown in
Active feedback from strain gauges can be used to evaluate efficacy of treatment and adjust treatment independent of user input for compression therapy system. The compression system may be capable of providing a compression cycle frequency of greater than 1 Hz, although in some embodiments, the system is also capable of providing a much lower cycle frequency, so as 1 compression and release about every 1 to 60 seconds, or about every 5, 10, 15, 20, 25, or 30 seconds, in order for blood to refill the veins between compressions. The ability to deliver compression cycles of less than 1 minute with a portable device has not been achieved using traditional pneumatic devices. The speed of compression allows the system and method to achieve native or healthy flow rates, volumes, and flow dynamics curves, and can be tailored to match the needs of each patient and disease state. The speed and timing of the compressions of the individual compression zones allows the system to generate specific venous, arterial, or lymphatic flow waveforms that cannot be achieved using an inflatable cuff. The compression system may be capable of generating compressive forces greater than about 60 mmHg and in some embodiments, in excess of 200 mmHg. In some embodiments, the compression system may be capable of generating compressive forces between about 0 and 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, or 200 mmHg The compression system may be capable of providing a circumferential stroke length of greater than about 0.5 in per compression zone, or greater than about 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, or 1.0 inch per compression zone. The circumferential stroke length is the reduction in circumference of the system, i.e. the compression straps and compression plate wrapped around the body part, and body part during a compression cycle. In some embodiments, the compression system is capable of delivering zone specific treatment, meaning each compression zone can independently deliver a prescribed amount of compression at a prescribed cycle frequency.
The compression zones can be generated using a variety of techniques. For example,
As shown in
For example, a unit placed on the lower leg may deliver a compression to the lower leg, and then a unit on the upper leg can deliver a compression to the upper leg after a set delay in order to drive blood through the venous vasculature. These modular features allow a set of smaller devices to be combined into a larger device that can still provide coordinated compression between each of the compression zones in the combined system. In addition, the units can have different sizes to fit the different body parts, such as the lower leg, the upper leg, the lower arm, the upper arm, the hand, the fingers, and the torso, for example. The units can come in multiple predetermined or customized sizes that fit various ranges of body part circumferences, such as extra small, small, medium, large, and extra-large. Although the units may be synchronized, the one or more units may be operated independently and be operated at its own compression level and frequency.
The compression systems and methods described herein include gathering position data (e.g., compression strap/pad position, patient position—standing or laying down or sitting, device position), pressure/compression data, temperature data and/or other relevant parameters and data from the sensors of the mobile/wearable compression therapy system. The data may be transmitted wirelessly or through a wired connection to a smart phone, smart watch, tablet, laptop computer, desktop computer, other computing device or other receiving device.
For example, integrated, wireless strain gauge plethysmography can be performed using a strain gauge to measure the change in the circumference and volume of the body part, which allows the determination of the volume of blood being pumped. Other techniques can also be used to determine the circumference and/or volume of the treated body part. For example, the drive cord position (i.e. how much of the drive cord is wound up) can be determined by using, for example, a Hall Effect sensor to monitor the rotation of the drive pulley and/or drive shaft. The current draw or load on the motor can also be correlated with drive cord position, and both the current draw and the drive cord position can be correlated with the compression pressure delivered to the body by the system. The compression strap or other closure mechanism position can be similarly determined (i.e. using a Hall Effect sensor or other sensor on the tightening mechanism or monitoring current of the motor if a motor is used to drive the tightening mechanism). Alternatively or additionally, the closure system, such as the compression straps, can have visual indicators or markings indicating the circumference of the body part.
Strain gauge plethysmography or other forms of plethysmography can also be used to determine blood flow hemodynamics, such as blood flow velocity and heart rate. See “Beat-by-beat forearm blood flow with Doppler ultrasound and strain-gauge plethysmography”, M. E. Tschakovsky, J. K. Shoemaker, R. L. Hughson, Journal of Applied Physiology, Sep 1995, 79 (3) 713-719. Other physiological measurements that can be determined include nitric oxide levels, which is a vasodilator and can be determined by using strain gauge plethysmography. See “New Methods to Evaluate Endothelial Function: Method for Assessing Endothelial Function in Humans Using a Strain-Gauge Plethysmography: Nitric Oxide-Dependent and -Independent Vasodilation”, Yukihito Higashi and Masao Yoshizumi, J Pharmacol Sci 93, 399-404 (2003).
Plethysmography can also be used to measure the venous volume and to calculate a venous filling index (VFI). Changes in leg volume can be measured using the compression device around the calf to deliver a pre-set compression pressure with the patient in a supine position. The limb being evaluated can then be elevated to drain the venous system. Once the venous system is emptied, the leg volume is determined by the system and recorded and the patient is asked to stand, after which the change in volume is determined and recorded again. The difference in the recorded leg volume is the functional venous volume. The time needed to fill 90 percent of the functional venous volume is the venous filling time. The venous filling index is functional venous volume divided by the venous filling time; a normal venous filling index is <2 mL/sec. The greater the venous filling index, the more severe the reflux. The residual volume fraction, which is the ratio of the residual volume to the function venous volume, is directly proportional to ambulatory venous pressure, which is used to diagnose venous hypertension. Each one of the parameters, the leg volume, the functional venous volume, the venous filling time, the venous filling index, and the changes of these parameters over time as the treatment progresses, can be used by the treatment algorithm to optimize compression treatment parameters. For example, if an adjustment of compression parameters results in an indication that the patient's condition is worsening, such as an increasing venous filling index, the treatment parameters can be reverted back to the previous treatment conditions and/or further modulated.
In addition, measurement of the circumference and volume of the treated body part may be correlated to healing progression for certain diseases, since as the body part heals, the swelling tends to be reduced, resulting in a decrease in circumference and volume for the treated body part. Data from the sensors can be transmitted and analyzed, using the processors on the compression system itself and/or using remote processing from a smart phone, smart watch, tablet, other computing device, server, or cloud computing network, and compression treatment can be adjusted based upon the data.
For example, an accelerometer or gyro can be used to determine body position, such as when the patient is lying down or standing up. Since there is often a significant difference in diameter and circumference of a swollen leg between the standing and lying down positions, the system can adjust the baseline compression pressure by tightening or loosening the drive cord or the closure mechanism when it detects a change in posture. The system may also include a delay before adjusting the baseline pressure to accommodate the lag or delay between a change in posture and a resulting change in the diameter/circumference of the body part, and to avoid changing the baseline pressure for a short duration change in posture.
The system can analyze personal health data that is collected and recorded from the patient, such as data in the patient's electronic health record and the data collected by the sensors during treatment, which includes compression treatment parameters such as compression/pressure magnitude, duration, and frequency along with patient compliance, and compare and correlate the compression treatment parameters and dosing with healing response and disease state outcomes or progression which can be monitored by the system as described herein. Treatment parameters and dosing can be modulated, and healing response and disease state outcomes can be monitored to determine whether the modulated parameters resulted in improved outcomes or healing response (e.g., reduced body part circumference, diameter, and/or volume).
In addition, the system can access population health data that is compiled from a variety of sources, such as medical studies, hospital data, and data recorded from a population of patients using the systems and devices described herein or other compression devices. The population health data can include data regarding the treatment given to the patient, the treatment outcome, healing progress, patient compliance, and demographic data such as the patient's age, race, sex, and other medical conditions. The system can analyze the population health data to find the treatments that resulted in the best outcomes in patients that have a similar background or demographic and can modulate the current treatment parameters based on those treatments.
The system can also access reference data, such as geolocation, income, and weather.
The data analysis can be performed by a variety of computing devices, such as on a smart phone, tablet, laptop computer, or desktop computer that is maintained by the patient. In some embodiments, the patient controlled computing devices can analyze patient health data and use such data to modulate treatment parameters. Analysis of data can also be done on remote computing devices, such as servers or cloud computing networks, which may be better suited to perform data analysis of population health data in addition to analysis of personal health data. In some embodiments, patient controlled devices may analyze both personal health data and population health data.
Important data streams that can be sensed, monitored and/or recorded by one or more sensors on the device or independent of the device and used to by the treatment algorithm to modulate treatment include compression pressure delivered to the patient, blood pressure, compression dose (i.e. compression level/magnitude, compression duration, frequency, dwell time, treatment duration), patient's position (standing versus lying down), leg girth, activity level, venous filling time, venous volume, venous reflux, venous index, ulcer status, heart rate, oxygen level (measured using pulse oximeter for example), temperature, auditory cues such as snoring, blood flow, and ischemia. For example, oxygen levels in the lower leg and/or foot can be correlated to the ability to pump blood.
In some embodiments, the compression device can include a plurality of positional sensors located throughout the device, such as against the shin on the foam padding, on the compression plate against the back of the calf, on the compression straps, on the compression sleeve, etc., so that a 3-D map of leg or body part can be constructed, which allows the leg or body part volume to be derived and allows the change/reduction in volume to be determined over time.
The mobile/wearable compression system and method can incorporate artificial intelligence, fuzzy logic, machine learning and/or other decision algorithms for determining and/or adjusting the treatment parameters based on feedback from the sensor data and analysis and comparison with personal health data and/or population health data. An onboard microprocessor system can be programmed to “learn” and adjust therapy based upon the integrated sensor data stream. The mobile/wearable compression therapy system is capable of monitoring compliance with the prescribed treatment algorithm by, for example, logging usage of the device and comparing it to the prescribed treatment regimen. An interactive compression therapy system can be provided that is capable of asking patient questions via graphical and text user interface and/or audio questions and prompts. The compression therapy system may adjust, adapt, and/or modulate treatment based upon user input or analyses of user input. For example, the patient may indicate that the treatment is not working well, and the system may then initiate a more aggressive treatment schedule by increasing the magnitude of the compression and/or the frequency of compression, and/or the duration of compression (i.e., increasing the compression dosing).The patient may input data, submit/upload pictures and/or input other information related to treatment. The data can be used to refine treatment based upon that data.
The compression therapy system, and/or a computing device, server, or cloud computing network associated with or part of the compression therapy system, may send patients reminders via text, phone, and/or email regarding their treatment or compliance with their treatment. The compression therapy system, and/or a computing device, server, or cloud computing network associated with or part of the compression therapy system, may be programmed to send caregivers, family or loved ones updates on therapy via text, phone and/or email. The compression therapy system may upload treatment data from the compression device on a prescribed schedule, such as at the end of a prescribed treatment, or at regular intervals during treatment, such as about every 1, 2, 3, 4, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 90, 120, 150, or 180 minutes, or at prescribed times of the day, such as once a day at 8 pm, for example. In some embodiments, the data may be uploaded continuously or in real-time during treatment. The system and method can use real time data and/or stored historical data acquired from a population of patients using compression therapy to adjust the treatment of some or all of those patients.
The system may have remote control capability for controlling the compression therapy system that allow a caregiver or other authorized person to be able to change the treatment algorithm and/or parameters remotely. For example, remote control may include operating the compression device using a smart phone, tablet, or other computing device. These remote control devices may be paired directly with the compression device, and/or may communicate wirelessly or through a wired connection with a device that has already been paired with the compression device, such as a smart phone that has been paired with the compression device. Authorized persons other than the patient, such as an authorized health care provider, may control or modulate administration of treatment and may review recorded data to verify treatment compliance. For example, a physician may modulate the treatment prescription based upon compliance, ulcer healing progression, and data from strain gauge plethysmography, which may be used to measure the circumference and volume of the treated body part which can be correlated to healing progression since as the body part heals, the swelling tends to be reduced, resulting in a decrease in circumference and volume.
The compression therapy system may “reward” patients for treatment compliance with positive reinforcement via verbal, text or email, for example. The system may also tabulate patient compliance and generate credits redeemable for gifts, prizes, or discounts or rebates that can be applied to medical fees and/or insurance fees such as copays and/or deductibles, for complying with a physician directed course of treatment. The system may provide the patient with automated reminders and instructions for using the system. The compliance data may be accessed by the patient and/or health care provider. Notifications can be provided to the patient and/or health care provider when the patient is out of compliance (i.e., missed a scheduled treatment).
The system can include a social network component. For example, the system can provide updates to social networking sites regarding the status of the treatment and the treatment compliance of the patient. A social hub can be created for patients that are using the treatment to discuss their treatment and to provide support. In addition, the social hub can create a competition or leaderboard that rewards patients that meet treatment compliance levels.
The compression therapy system may be capable of modulating between a “passive” mode at specific set point and “active” mode at specific compression function. In the “passive” mode the compression therapy system can act similarly to a passive compression stocking to deliver a static amount of compression to the body part, except that the pressure or tension delivered by the compression system can be specified and maintained, even in the body part changes size as the result of posture and time, such as caused in the leg by standing upright versus laying down for sleeping, which can be detected using an accelerometer or gyro, for example. Light compression can provide less than 20 mmHg of pressure; moderate compression is between 20 to 40 mmHg, strong compression between 40 and 60 mmHg and very strong compression can be over 60 mmHg The “active mode” has been described herein and provides active, cyclical compression of the body part according to prescribed treatment parameters, such as compression pressure magnitude, duration, and frequency, and overall treatment duration. Active compression can be provided while the patient is awake during specified times and/or upon initiation by the patient, while passive compression can be provided between active compression treatments, while the patient is asleep, and/or upon initiation by the patient.
Monitoring systems capable of notifying caregiver/manufacturer remotely of system malfunctions and/or need to replace components, and to automatically order and send those components to the patient/caregiver, can be integrated into the compression therapy system. The system may be capable of “learning” patient habits and adjusting treatment for convenience, comfort or efficacy of treatment based upon real-time and/or historic capture of diagnostic information.
For example, the system can identify wake and sleep patterns and activity patterns for the patient and can initiate treatments, such as active compression when the patient is awake, and passive treatment when the patient is asleep, or activate treatment when the patient is typically active and standing. The system can also identify what times compression treatments are most effective, as measured by reduction in leg girth or volume for example, as prioritize or direct compression treatment to those times.
The basic principle of operation of one embodiment is: two custom modified battery-powered brushless servo motors drive a single drive cord that is routed over a plurality of pulleys to sequentially pull and release one to six compression straps per motor. Two motors define lower calf and upper calf regions, activated sequentially to obtain natural, sequential compression from the lower to upper calf. The control unit, including electronic control systems and battery can be detached from the stocking, leaving the compression straps at a pre-defined compression level in a lightweight stocking mode.
The prototype electronic system is powered by a Raspberry Pi® zero that can support multi-client web access and local storage capability. The Raspberry Pi component can be replaced with a custom ASIC that incorporates all the needed components of the Raspberry Pi. Running the controller is a version 3.2Arduinio® platform, which can be replaced with custom ASIC and/or software. Voltage, current, Hall Effect, Wi-Fi and/or Bluetooth, force sensitive resistor (FSR) and tilt sensors allow efficient power control, positional sensing of bands, patient posture monitoring, and remote control and monitoring.
The proposed instructions for use for one embodiment are:
1) microfiber breathable soft stocking is pulled over leg, by for example, first releasing the front drawstring (running over pulley system to make release and tensioning easy), 2) pull compression device over stocking on lower leg, soft handles help user hold in place while positioning the device on alignment marking on the stocking, 3) tighten attachment system of compression device until movable pulleys are positioned against the physical stops and optionally until the compression device indicates appropriate pre-tension is achieved through an indicator, which can be auditory or visual 4) activate pre-tension routine on smart-phone to achieve appropriate set-point 5) active/passive compression routine activated, 6) release button and pre-tension released, 7) attachment system can be released and stocking removed. For cleaning, the motor drive module can be removed and stocking washed in washing machine.
Utilizing tension band positional, strain, current draw and pressure data, the device can incorporate strain gauge plethysmography capability, where the volume changes of the limb in response to applied pressure facilitate venous disease diagnosis. This would be very useful as it can be used to actively monitor progression of treatment and adjust if needed. Caregiver could remotely monitor real-time treatment progress and compliance. Ideally, this allows the clinicians to remotely make changes and schedule patients for visits based upon objective treatment data. This would reduce the burden on providers and facilitate better outcomes for this significant population of patients. This system also has significant market potential beyond venous ulcer treatment as it can be optimized for other conditions in which IPC is proven but compliance is low including DVT prophylaxis, lymphedema and peripheral arterial disease.
Current embodiments of the Radial system can achieve up to about 90 cm/s venous blood flow velocity in the veins in the legs. Pneumatic systems cannot achieve these venous blood flow velocities because of the long time it takes to fill the gas bladders, typically about 1 to 3 minutes, whereas the Radial system can deliver full compressions at a frequency of up to 1 Hz or more, such as up to 2, 3, 4, 5, 6, 7, 8, 9, and 10 Hz. Initial testing using the smart phone interface and remote Wi-Fi or Bluetooth control of the system has been successful with pre-tensioning, cycling and release modes achieved. Initial testing has demonstrated successful proof of concept that the Radial Medical SVS system is capable of delivering uniform and clinically meaningful pressures with fully functional remote control and monitoring.
The data also shows that a two zone compression device can result in two velocity peaks, depending on the timing between the two zones, with the greatest venous velocities achieved with the first zone of compression. The velocity profile can be controlled and modulated by adjusting the timings between the zones and the magnitude and speed of compression delivered by the pulley based drivetrain. For example, slowing the rotational velocity of the motors will result in a slower rate of compression and a lower venous velocity (lower peak) and a lower change in velocity (lower slope on graph). Similarly, reducing the amount of rotation of the motor during a compression cycle will reduce the amount of line or movable pulley travel, which reduces the amount of compression delivered which results in a lower venous velocity.
Since a single motor may be able to generate sufficient compression and venous velocity, some embodiments of the compression device utilize a single motor that drives compression in one or more zones of compression.
User Interfaces
In one aspect, one or more compression therapy parameters determined by a health care provider is transmitted to the memory of the compression device and auto fills one or more fields, parameters, characteristics or mode of a patient specific compression therapy protocol. In some aspects, a health provider determined compression protocol is loaded electronically by scanning a prescription or reading a physician provided code with a device associated with the compression device or the user.
Other functional screens include a details screen that displays treatment data to the patient. The data can be displayed graphically in bar or line graphs, for example, and/or can be displayed in a table. The overall patient results and the medical device attainments (i.e., usage data) can be shown.
In some embodiments, the user interfaces described herein allow the user to monitor therapy progress both while the compression device is on or off. In some embodiments, a passive compression sleeve with embedded sensors can be worn when the compression device is not worn so that the various parameters described herein, such as leg girth and leg compliance for example, can still be monitored even when the compression device is not being actively used.
In some embodiments, a physician or artificial intelligence or smart computing program can have access to one or more of the display screens as well as the underlying data. The physician may view the data over the cloud through a physician portal on any type of computing device, such as a smartphone, laptop computer, desktop computer, or tablet. After accessing the data and determining the progress of treatment, by examining leg girth and leg compliance data for example, the physician/AI can adjust the compression therapy parameters in real-time. The physician/AI changes can be sent to the user's smartphone wirelessly though a cellular network or internet network, which can then communicate and update the compression device parameters.
In some embodiments, certain data and/or certain user interface screens can be password protected. In some embodiments, there can be separate, password protected screens for the user, the physician, the caregiver, the therapist, the coach, etc. In some embodiments, the user and/or physician can give access to various password protected screens to other users.
Another functional screen can be the patient treatment screen which can display graphically and/or in text the location of compression device (i.e., lower left leg, lower right leg, upper left leg, upper right leg, etc.) during treatment, the steps for the patient to perform (i.e, fit the device to the body part, tighten the compression straps, etc.), start treatment, stop treatment, the treatment step being performed (i.e., compress, relax, the duration of the step, the time remaining of the step, etc.).
Graphical icons with optional text can be used to navigate between the various screens. Other screens include an alert screen to view alerts, error codes, and to set up alerts and reminders to perform treatment, an accessory screen to purchase accessories for the compression device, an identification screen to register the compression device with the application, a log screen, and a patient compliance screen.
In some embodiments, the user log screen allows the user to enter and upload any comments that the user deems relevant to the treatment. The log screen may also allow the user to rate various objective and subjective metrics regarding the treatment and/or compression device, such as usability, comfort, and efficacy.
In some embodiments, the compression device itself can include a user interface 2310 that can include a touch pad and/or button type user interface as shown in
In still other alternative configurations, one or more or a combination of the compression devices or methods of operation of one or more compression devices described herein may be scaled in size, modified, or adapted to be suitably configured to provide compression therapy to aid in sport preparation, sport training or recovery after activity specific, sports or athletic exertion. In these various embodiments, the compressive forces delivered by the one or more compression devices is aligned with muscle groups, joints or soft tissue to provide massage to affected areas alone or in combination with other affected regions as a result of the completed activity. In some configurations, one or more compression devices are adapted for use in blood flow restriction (BFR) training.
In one aspect, the one or more compression devices provided for this purpose are oriented and grouped according to the degree and manner of compression therapy suited to the desired outcome such as lactic acid removal, fluid removal, swelling, muscle fatigue and the like. As a result, the compression device or groups of devices are aligned to provide compression therapy or massage to affected areas. The compression devices may be placed on the affected area directly or incorporated on, in or within a suitable garment with a form factor appropriate to ease of donning and doffing while retaining the compression device in position for a particular therapy session. Exemplary garment form factors include, by way of example, a total body coverall, a jump suit, a pair of pants, a pair of shorts, a jacket, one or set of sleeves, gloves, boots, shoes, stockings, socks or a wrap. Exemplary compression devices are illustrated on, in or within a sleeve of jacket (see
The compression device or combination of compression devices for a particular limb are applied to the associated region of the body or regions of the body in any combination in relation to the therapy sought in relation to the completed activity, sport or athletic event. Thereafter, each of the compression devices is activated in a predetermined sequence which applies controllable, repeatable pressure to the muscles, vasculature and soft tissues including the lymphatic system in any desired sequence depending upon desired clinical results or patient specific needs such as pain, discomfort, localized swelling of a body part or limb. In one aspect, the one or more compression devices is activated in a serial compression mode. The serial compression mode of controllable compression therapy acts on the associated muscles and veins to mimic the action of walking As a result of serial compression mode operation, blood is moved through the veins towards the heart so as to prevent pooling of blood in the lower limbs. Additionally or optionally, the mode of operation of one or more compression devices may be to move fluids away from the heart or to provide compression at levels associated with massage—ranging from gentle to firm to deep tissue, based on degree of compression applied.
Still further, configurations of one or more controllable compression devices may be used to create gradient compression on the limbs to provide a massaging effect to imitate natural fluid flows toward or away from the core, or toward or away from an extremity as desired in a particular therapy. It is to be appreciated that the one or more controllable compression devices may be adapted and configured to vary the amount of compression, rate of the application of compression, hold time for compression, release time/rate of compression for each compression device operating alone or in conjunction with one or more other controllable compression devices as described herein. In one aspect, the one or more compression devices are applied to the patient and then sequentially operated to provide a gradient of pressure in the leg or any limb by adjusting the compression profile of each of the controllable compression devices. Moreover, the duty cycle of the compression cycle includes a compression period and a relaxation period. In one embodiment, the compression cycle is 10 seconds, 15 seconds, 20 seconds with a relaxation cycle of from 60 seconds or more between successive compression cycles. In some embodiments, the compression cycle is timed to operate in sequence with all or a portion of the patient's heartbeat.
Exemplary activity, sports and athletic recovery configurations include, for example, (a) compression devices worn on both legs and operated in sequence to provide compression therapy to a portion of the muscles, joints, soft tissue or lymphatic system in the legs; (b) compression devices worn on both legs configured with a support garment in the form of pants and operated in sequence to provide compression therapy to the muscles, joints, soft tissue or lymphatic system in the legs; (c) compression devices worn on one or both arms and the chest and operated in sequence to provide compression therapy to the muscles, joints, soft tissue or lymphatic system in the arms and the chest; (d) compression devices worn on worn on one or both arms and the chest and operated in sequence to provide compression therapy to the muscles, joints, soft tissue or lymphatic system in the arms and the chest configured with a support garment in the form of a jacket; (e) compression devices worn on one or both arms and operated in sequence to provide compression therapy to the muscles, joints, soft tissue or lymphatic system in the arms; (f) compression devices worn on worn on one or both arms and operated in sequence to provide compression therapy to the muscles, joints, soft tissue or lymphatic system in the arms and configured with a support garment in the form of jacket sleeves; (g) compression devices worn on one or both hands and operated in sequence to provide compression therapy to muscles, joints or soft tissue of the hands or fingers; and (h) compression devices worn on one or both hands and operated in sequence to provide compression therapy to muscles, joints or soft tissue of the hands or fingers and configured with a support garment in the form of gloves or mittens.
In sports recovery applications and heavy activity recovery applications and to treat fluid buildup symptoms, injuries and disorders such as swelling and lymphedema, multiple compression devices can be worn and used to sequentially pump body fluids, such as lymph, away from the body part. As described herein, the compression devices can be in communication (e.g. wirelessly) with each other to facilitate the sequential compression that moves from a distal portion of the body part (i.e., lower leg or lower arm) to a more proximal portion of the body part (i.e., upper leg or upper arm). Multiple devices can be worn sequentially along the length of the body part that is to be treated.
Sequential compression is also useful for treating soldiers out in the field to improve recovery rates and improve performance and to treat injuries. Whereas pneumatic compression devices generally utilize a large compressor that is bulky and heavy and is not portable, the pulley based compression devices described herein are compact, lightweight and portable. A soldier can easily carry one or more portable, active mechanical compression devices when out in the field to use during periods of downtime.
The portable, active mechanical compression devices described herein are also useful to many other users, such as travelers and athletes, for example.
The housing can comprise a low profile, extending minimally from a surface of a user's body. The edges and corners of the housing can be rounded to provide comfort to the user. The housing can comprise injection moldable thermoplastics or 3D printable materials (e.g., nylon, ABS, etc.). In some embodiments, the housing is about 5-10 inches long. In some embodiments, the housing is about 2-3 inches wide. A weight of the housing can be about 1 lb or less. In some embodiments, a weight of the device can be about 1 lb or less.
The housing 2602 can sit within a cushioned cradle 2610. The cradle 2610 is configured to conform to the body of the user (e.g., on or near the user's calf). The cradle is also used to connect a strap or cuff 2612 to the housing 2602. Tension members extend from the compression system in the housing 2602 through the cradle 2610 and connect to the strap 2612. The cradle 2610 can comprise any cushioning material, such as foam (e.g., EVA, polyurethane foam, etc.)
As shown in the back perspective view of
As shown in
In some embodiments, the force sensor on the system allows for the detection of deep vein thrombosis (DVT). A DVT can cause swelling in the leg, causing the baseline tension in the leg to be higher than that previously recorded. The system can be configured to detect this change in baseline tension, and alert both the user and a clinician that the user needs to go to the hospital.
The compression devices disclosed herein can be used to treat restless leg syndrome, which refers to when people experience uncomfortable sensations in their legs (and sometimes arms or other parts of the body) and an irresistible urge to move their legs to relieve the sensations. The condition causes an uncomfortable, “itchy,” “pins and needles,” or “creepy crawly” feeling in the legs. The sensations are usually worse at rest, especially when lying or sitting. The severity of RLS symptoms ranges from mild to intolerable. Symptoms can come and go and severity can also vary. The symptoms are generally worse in the evening and at night. For some people, symptoms may cause severe nightly sleep disruption that can significantly impair their quality of life.
Compression has been shown to be helpful in treating restless leg syndrome (RLS). Vibration has also been shown to address RLS symptoms. The devices described herein can be used to address the symptoms of restless leg syndrome by applying an appropriate level of compression. Once the system determines that symptoms are occurring, compression therapy can begin. The system can determine onset of symptoms manually, using user feedback, or automatically through use of an accelerometer. It has been found that 90% of RLS patients experience periodic limb movements with the onset of RLS symptoms. As such, an accelerometer can be used to detect such periodic limb movements and initiate treatment.
Treatment for restless leg syndrome has been found to be very patient specific. The system described herein allows for adjustability of treatment using the user interface (e.g., through an app on a smartphone). A user can adjust intensity, duration, and frequency of compression to find a compression therapy regimen that is suitable for addressing their symptoms. The system can allow for user feedback regarding efficacy of treatment. In this way, the system can compile data on what works best for a particular user. As the data is sent and stored in a remote database, the system can also collect data regarding efficacious and non efficacious treatment for larger populations. This data can be used to recommend therapies and treatments and adjust therapies and treatments for specific patients based on their specific information and demographic. Recommended therapies can include drug therapy, compression therapy, and vibration therapy. The therapies can also include electrical muscle stimulation, heat or cold therapy.
Experimental Data
Venous Flow Augmentation Compared to Commercially Available Devices
A study was done comparing the performance of a compression device of the type disclosed herein (e.g., device 300) to commercially available devices. ‘Cirvo 1’ corresponds to the device applying compression for 1 s. ‘Cirvo 3’ corresponds to the device applying compression for 3 s. ‘Cirvo 6’ corresponds to the device applying compression for 6 s.
Venous Flow Augmentation in Venous Leg Ulcer Patients
This study was designed to compare peak venous velocities in venous leg ulcer patients using the mechanical compression device of the type disclosed herein (e.g., device 300) and commercially available intermittent pneumatic compression devices. Ten patients meeting inclusion/exclusion criteria and with CEAP 3-6 venous insufficiency were enrolled into an IRB approved study of venous flow augmentation. One subject was excluded secondary to failed DVT screening. Nine patients underwent measurement of peak venous velocity at baseline and with the mechanical compression device at a low and high setting. Five patients underwent an additional measurement of peak venous velocities while wearing a commercially available pneumatic compression device (Actitouch®, Tactile Medical, Minneapolis Minn.). The mechanical compression device was programmed to deliver rapid intermittent compression at two pressure settings: Low (average pressure of 38 mm HG) and High (average pressure of 52 mm Hg). The commercially available pneumatic compression device has a single setting that was used in this study. The primary endpoint for the study was augmentation of venous blood flow as measured by peak venous velocity. Average and ranges of peak venous velocities are reported in Table 2.
As shown in Table 2 and
When a feature or element is herein referred to as being “on” another feature or element, it can be directly on the other feature or element or intervening features and/or elements may also be present. In contrast, when a feature or element is referred to as being “directly on” another feature or element, there are no intervening features or elements present. It will also be understood that, when a feature or element is referred to as being “connected”, “attached” or “coupled” to another feature or element, it can be directly connected, attached or coupled to the other feature or element or intervening features or elements may be present. In contrast, when a feature or element is referred to as being “directly connected”, “directly attached” or “directly coupled” to another feature or element, there are no intervening features or elements present. Although described or shown with respect to one embodiment, the features and elements so described or shown can apply to other embodiments. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed “adjacent” another feature may have portions that overlap or underlie the adjacent feature.
Terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. For example, as used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises” and/or “comprising,” when used in this specification, specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof. As used herein, the term “and/or” includes any and all combinations of one or more of the associated listed items and may be abbreviated as “/”.
Spatially relative terms, such as “under”, “below”, “lower”, “over”, “upper” and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures is inverted, elements described as “under” or “beneath” other elements or features would then be oriented “over” the other elements or features. Thus, the exemplary term “under” can encompass both an orientation of over and under. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, the terms “upwardly”, “downwardly”, “vertical”, “horizontal” and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.
Although the terms “first” and “second” may be used herein to describe various features/elements (including steps), these features/elements should not be limited by these terms, unless the context indicates otherwise. These terms may be used to distinguish one feature/element from another feature/element. Thus, a first feature/element discussed below could be termed a second feature/element, and similarly, a second feature/element discussed below could be termed a first feature/element without departing from the teachings of the present invention.
Throughout this specification and the claims which follow, unless the context requires otherwise, the word “comprise”, and variations such as “comprises” and “comprising” means various components can be co-jointly employed in the methods and articles (e.g., compositions and apparatuses including device and methods). For example, the term “comprising” will be understood to imply the inclusion of any stated elements or steps but not the exclusion of any other elements or steps.
As used herein in the specification and claims, including as used in the examples and unless otherwise expressly specified, all numbers may be read as if prefaced by the word “about” or “approximately,” even if the term does not expressly appear. The phrase “about” or “approximately” may be used when describing magnitude and/or position to indicate that the value and/or position described is within a reasonable expected range of values and/or positions. For example, a numeric value may have a value that is +/−0.1% of the stated value (or range of values), +/−1% of the stated value (or range of values), +/−2% of the stated value (or range of values), +/−5% of the stated value (or range of values), +/−10% of the stated value (or range of values), etc. Any numerical values given herein should also be understood to include about or approximately that value, unless the context indicates otherwise. For example, if the value “10” is disclosed, then “about 10” is also disclosed. Any numerical range recited herein is intended to include all sub-ranges subsumed therein. It is also understood that when a value is disclosed that “less than or equal to” the value, “greater than or equal to the value” and possible ranges between values are also disclosed, as appropriately understood by the skilled artisan. For example, if the value “X” is disclosed the “less than or equal to X” as well as “greater than or equal to X” (e.g., where X is a numerical value) is also disclosed. It is also understood that the throughout the application, data is provided in a number of different formats, and that this data, represents endpoints and starting points, and ranges for any combination of the data points. For example, if a particular data point “10” and a particular data point “15” are disclosed, it is understood that greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15 are considered disclosed as well as between 10 and 15. It is also understood that each unit between two particular units are also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.
Although various illustrative embodiments are described above, any of a number of changes may be made to various embodiments without departing from the scope of the invention as described by the claims. For example, the order in which various described method steps are performed may often be changed in alternative embodiments, and in other alternative embodiments one or more method steps may be skipped altogether. Optional features of various device and system embodiments may be included in some embodiments and not in others. Therefore, the foregoing description is provided primarily for exemplary purposes and should not be interpreted to limit the scope of the invention as it is set forth in the claims.
The examples and illustrations included herein show, by way of illustration and not of limitation, specific embodiments in which the subject matter may be practiced. As mentioned, other embodiments may be utilized and derived there from, such that structural and logical substitutions and changes may be made without departing from the scope of this disclosure. Such embodiments of the inventive subject matter may be referred to herein individually or collectively by the term “invention” merely for convenience and without intending to voluntarily limit the scope of this application to any single invention or inventive concept, if more than one is, in fact, disclosed. Thus, although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any and all adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description.
This application claims the benefit of U.S. Provisional Patent Application No. 62/577,643, filed on Oct. 26, 2017, the disclosure of which is incorporated by reference in its entirety. This application may be related to U.S. application Ser. No. 15/499,846, filed on Apr. 27, 2017, and U.S. application Ser. No. 15/499,850, filed on Apr. 27, 2017, each of which is herein incorporated by reference in its entirety.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2018/057778 | 10/26/2018 | WO | 00 |
| Number | Date | Country | |
|---|---|---|---|
| 62577643 | Oct 2017 | US |
