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Title:
COMPRESSION STOCKINGS AND METHODS OF THEREOF
Document Type and Number:
WIPO Patent Application WO/2017/120387
Kind Code:
A1
Abstract:
Disclosed herein are a compression device and system which includes one or more sensors, such as piezoelectric sensors, thereby allowing dynamic monitoring of the applied pressure. A user and/or healthcare provider is able to ensure correct garment pressure at application, and dynamically monitor pressure, such as via a wireless communication system. The disclosed devices and system can be used for compression therapy, including to treat a subject afflicted with or at risk to develop venous stasis or lymphedema.

Inventors:
MENEZES JOHN (US)
GOLDMAN JOSHU (US)
MUSOVSKI OLIVER (US)
Application Number:
PCT/US2017/012400
Publication Date:
July 13, 2017
Filing Date:
January 05, 2017
Export Citation:
Click for automatic bibliography generation   Help
Assignee:
BOARD OF REGENTS OF THE NEVADA SYSTEM OF HIGHER EDUCATION ON BEHALF OF THE UNIV OF NEVADA (US)
International Classes:
A61B5/021; A61B5/00; H04M1/72412
Domestic Patent References:
WO2014066077A12014-05-01
WO2015089383A12015-06-18
Foreign References:
US20150177080A12015-06-25
US20120065561A12012-03-15
US20090055148A12009-02-26
Attorney, Agent or Firm:
BRADLEY, Karri, Kuenzli et al. (US)
Download PDF:
Claims:
We claim:

1. A compression device, comprising:

one or more sensors for detecting pressure;

a power source that supplies power to the one or more sensors and allows pressure to be detected;

a microcontroller that translates detected pressure values; and

a wireless communication platform that transmits the translated detected pressure values to a user interface so that the translated detected pressure values may be displayed, thereby allowing pressure to be monitored.

2. The compression device of claim 1, further comprising a display for displaying the translated detected pressure values.

3. The compression device of claim 2, wherein the display comprises a mobile phone display or computing device display.

4. The compression device of claim 3, wherein the wireless communication platform transmits the translated detected pressure values to a smartphone application.

5. The compression device of any one of claims 2-4, wherein the one or more sensors are one or more piezoelectric sensors.

6. The compression device of any one of claims 2-4, wherein the one or more sensors are one or more force sensing resistors.

7. The compression device of any one of claims 1-6, wherein the device is integrated into a compression garment.

8. The compression devices of any one of claims 1-6, wherein the device is used with a compression garment.

9. A method of providing compression therapy, comprising utilizing a compression device of any one of claims 1-8 to provide compression therapy to a subject in need thereof.

10. The method of claim 9, wherein the method is used to treat a subject afflicted with or at risk to develop venous stasis or lymphedema.

11. The method of claim 9, wherein the method is used for wound prevention and/or healing.

12. The method of claim 9, wherein the method is used to prevent or reduce deep vein thrombosis or mild varicose veins.

13. The method of any one of claims 9-12, wherein the method comprises:

placing the device with one or more sensors against a desired limb;

applying pressure to the limb until desired pressure is obtained; and monitoring pressure by reviewing pressure values displayed on a user interface, thereby allowing the user to monitor pressure and alter pressure as desired.

14. The method of claim 13, wherein the limb is an arm or calf. 15. The method of claim 13 or 14, wherein the limb is an arm and the user is being treated for breast cancer.

Description:
COMPRESSION STOCKINGS AND METHODS OF USE THEREOF

CROSS REFERENCE TO RELATED APPLICATION

This application claims the benefit of U.S. Provisional Patent Application No. 62/275,616, filed on January 6, 2016, which is herein incorporated by reference in its entirety.

FIELD

This disclosure relates to devices and methods of compression therapy and in particular to compression devices with integrated force sensors and methods of use thereof, including treatment of venous stasis disease, lymphedema of the upper (e.g., arm swelling after axillary lymph node dissection in patients with breast cancer) and lower extremity, and management of postoperative extremity edema (e.g. , after lower extremity reconstruction with microsurgical free tissue transfer or open reduction and internal fixation of a fracture), and may include compression garments used to treat swelling after aesthetic procedures such as after abdominoplasty, liposuction or face and neck lift.

BACKGROUND

It is estimated that 1-2% of the population will have one or more episodes of leg ulcer during life, and moreover, venous ulceration accounts for 80% of these lower extremity insults. Ulcerations secondary to venous stasis can persist from weeks to years, and can be complicated by cellulitis or osteomyelitis. Healing rates for ulcers remain low at 50-70% at 12 weeks. Overall, these ulcers are estimated to cost $2 billion per year in the United States. Treatment of venous stasis and ulcers has been controversial, but compression is regarded as the standard of care. After an ulcer has healed, lifelong maintenance by compression therapy has been shown to reduce the risk of recurrence. The major types of compression are inelastic and elastic. Foul smell with time and inability to conform to changes in leg size limit the use of inelastic compression stockings, and it has been found that a component of elastic therapy is more effective. In both cases, compression stockings lose pressure over time, and pressure gradients are not uniform amongst groups of patients. Thus, a need exists for new designs for compression devices, which overcome the limitations of the current art.

SUMMARY

Currently, compressive wraps and stockings are applied for a variety of chronic ailments including, but not limited to, venous stasis and lymphedema. The best pressure range for compression treatment of the lower extremity at multiple levels has been determined but currently, there is no way to know if a garment is being wrapped too tightly or loosely to reach optimal pressure. For example, treatment of venous stasis it has been recommended that pressures of 30 mmHg should be exerted at the ankle with linearly decreasing pressures proximally down to 6 mmHg just below the knee. Difficulty in maintaining these pressures with the topography of the lower extremity and the dynamic nature of muscle flexion with gait makes consistency particularly challenging. Additionally, elastic compression loses elasticity over time, so pressure monitoring is desirable for appropriate adjustment.

Disclosed herein is a compression device and system which includes one or more sensors, such as piezoelectric sensors, thereby allowing dynamic monitoring of the applied pressure. A user and/or healthcare provider is able to ensure correct garment pressure at application, and dynamically monitor pressure, such as via a wireless communication system (e.g. , Bluetooth®). The monitored pressure helps optimally treat the condition/disease for which the compression device is being used, as well as prevent and aid in healing of ulcers and chronic wounds associated with the condition/disease. The foregoing and other features and advantages of the disclosure will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures. BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a digital image of an exemplary compression device integrated into a compression garment.

FIG. 2 is a diagram of a voltage divider.

FIG. 3 is a schematic illustrating the arrangement of various components of a disclosed compression system.

FIG. 4 is a block diagram of a disclosed system.

FIG. 5 is a graph illustrating sensor characteristic resistance versus applied weight.

FIG. 6 is a graph illustrating sensor characterization results.

FIG. 7 is a screen shot of a block diagram used to "code" the application for allowing pressure to be evaluated.

FIGS. 8 and 9 are screen shots of the application.

FIG. 10 is a schematic of an exemplary printed circuit board used with a disclosed compression system.

FIG. 11 is a digital image of an exemplary printed circuit board.

FIG. 12A is a schematic of an oscillation counter.

FIG. 12B is a schematic of an alternating current bridge.

FIG. 12C is a schematic of a charge time method and provides an equation that relates voltage to the measured capacitance, which can be implemented into an analogue to digital converter via a microcontroller

FIG. 13 is a schematic of an exemplary computing environment for performing aspects of the disclosed system.

FIG. 14 is a schematic illustrating positioning of sensors on a human calf in an exemplary embodiment. FIG. 15 is a schematic illustrating positioning of sensors on a human arm in an exemplary embodiment.

DETAILED DESCRIPTION OF SEVERAL EMBODIMENTS

The disclosure is set forth below in the context of multiple representative embodiments, which are not intended to be limiting in any way.

The drawings are intended to illustrate the general manner of construction and are not necessarily to scale. In the detailed description and in the drawings themselves, specific illustrative examples are shown and described herein in detail. It will be understood, however, that the drawings and the detailed description are not intended to limit the invention to the particular forms disclosed, but are merely illustrative and intended to teach one of ordinary skill how to make and/or use the invention claimed herein.

The described things and methods described herein should not be construed as being limiting in any way. Instead, this disclosure is directed toward all novel and non-obvious features and aspects of the various disclosed embodiments, alone and in various combinations and sub-combinations with one another. The disclosed things and methods are not limited to any specific aspect or feature or combinations thereof, nor do the disclosed things and methods require that any one or more specific advantages be present or problems be solved.

Although the operations of some of the disclosed methods are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth below. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed things and methods can be used in conjunction with other things and methods. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present disclosure, suitable methods and materials are described below. All publications, patent applications, patents, and other references mentioned herein are incorporated by reference in their entirety. In case of conflict, the present specification, including explanations of terms, will control.

I. Introduction

Venous stasis is a condition of slow blood flow through the veins which form blood clots. These blood clots then produce ulcers which cause swelling, discoloration, and patient discomfort. Typically, to treat these ulcers some sort of pressure is applied to compress the superficial veins, such as through compression therapy. For example, compression stockings help remedy the condition by compressing the superficial veins that are located right under the skin and in the fat layer underneath. The pressure exerted on the surface then pushes the blood into the deep venous system that runs inside the muscles of the legs and on to the heart, reducing the pooling that occurs in spider and varicose veins. Thus, the role of compression therapy is to assist the muscle pump system of the legs, a major mechanism promoting the return of venous blood to the heard during normal locomotory activity.

There is a clinically proven pressure pattern or gradient that is designed to reduce venous stasis in the entire leg. This gradient goes from ankle to upper thigh and helps ensure optimum blood flow (e.g., upper thigh, 8 mmHg; lower thigh, 10 mmHg; Popliteal, 8 mmHg; calf, 14 mmHg; and ankle 18 mmHg). In addition to creating a pressure gradient, there are different levels of pressure therapy. Lower levels are used to prevent swelling when standing for long periods, while higher levels are used to treat postoperative swelling or venous stasis edema. Current compression stockings are typically offered in Low Compression(8-15 mm Hg), Moderate Compression (15-20 mm Hg), Firm Compression(20-30 mm Hg), and High Compression(30-40 mm Hg). Moreover the therapeutic range can be exceeded. Capillary closing pressure, (the pressure at which small capillaries collapse) is 35 mm Hg. While delivering higher pressures than this, while not closing large arteries, an overly applied compression garment can have a negative effect on tissue oxygenation and subsequently impair healing. For patients with severe

atherosclerosis and arterial inflow disease compression therapy may be

contraindicated, acknowledging that there is currently no good way to measure and prevent delivery of too high a pressure.

Current compression therapy is associated with many limitations. Two different types of compression devices are currently available, pneumatic devices and elastic devices. Some of the limitations of pneumatic devices are that they are cumbersome, often do not fully deflate, expensive, and cannot be worn all day. Elastic devices lose elasticity and many patients are unaware of when their stocking must be replaced due to being overstretched, and overused and thus, resulting in insufficient pressure being applied. Also, as therapy succeeds in reducing edema, the volume of the extremity decreases and the applied pressure decreases and is no longer in the therapeutic range. Current compression sleeves/garments do not allow for efficient monitoring of pressure.

II. Terms

Unless otherwise explained, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. As used in this application and in the claims, the singular forms "a," "an," and "the" include the plural forms unless the context clearly dictates otherwise. Hence "comprising A or B" means including A, or B, or A and B. Additionally, the term "includes" means "comprises." Further, the term "coupled" encompasses mechanical as well as other practical ways of coupling or linking items together, and does not exclude the presence of intermediate elements between the coupled items. The description sometimes uses terms like "produce" and "provide" to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms will vary depending on the particular implementation and are readily discernible by one of ordinary skill in the art.

In the following description, certain terms may be used such as "up," "down,", "upper," "lower," "horizontal," "vertical," "left," "right," and the like. These terms are used, where applicable, to provide some clarity of description when dealing with relative relationships. But, these terms are not intended to imply absolute relationships, positions, and/or orientations. For example, with respect to an object, an "upper" surface can become a "lower" surface simply by turning the object over. Nevertheless, it is still the same object.

In order to facilitate review of the various embodiments of the disclosure, the following explanations of specific terms are provided:

Compression Stocking: A stocking which compresses superficial veins that are located right under the skin and in the fat layer underneath. The pressure exerted on the surface then pushes the blood into the deep venous system that runs inside the muscles of the legs and on to the heart, reducing the pooling that occurs in spider and varicose veins. Thus, the role of compression therapy is to assist the muscle pump system of the legs, a major mechanism promoting the return of venous blood to the heart during normal locomotor activity. A compression stocking can be used to treat venous stasis ulcers and lymphedema. Examples of different levels of compression therapy include delivery of less than 20 mmHg for preventing deep vein thrombosis. Pressure in the 20-30 mmHg range is prescribed for mild varicose veins, after sclerotherapy, pregnancy, long flights. Pressure in the 30-40 mmHg range is most suitable for venous ulcers and greater than 40 mmHg reserved for most severe cases. Compression therapy may not be advisable in subjects with severe arterial disease. Lymphedema: A collection of fluid that causes swelling (edema) in the arms and legs. The prevalence of primary lymphedema within North America has been estimated as 1.15 per 100,000 children. Secondary lymphedema occurs in 1.33 out of 1000 people within the population, increasing to 5.4 out of 1000 in patients over 65 years of age. Twenty nine percent of patients had experienced recurrent cellulitis. Symptoms of lymphedema can include chills, swollen lymph glands, fever, malaise, loss of appetite, aching muscles, headache and red streaks along the surface of the skin from the infected area to the nearest lymph gland. One of the most common causes of secondary lymphedema is removal of lymph nodes during cancer resection. For example, this can occur due to breast cancer, in which axillary lymphadenectomy (removal of the lymph nodes from the armpit) is performed and can result in lymphedema of the arm (Hayes et al, 26:21, 3536-3542, 2008). Chronic lymphedema of the arm in breast cancer patients can occur in as many as 40%. As described herein, a disclosed device can be used to reduce, inhibit, and/or prevent lymphedema in an arm of a breast cancer patient. (See FIG. 15).

Piezoelectric Sensor: A sensor that uses the piezoelectric effect to measure changes in pressure , acceleration, temperature, strain or force by converting them to an electrical charge. The piezoelectric effect is the ability of certain materials to generate an electric charge in response to applied mechanical stress.

Venous stasis: A condition often accompanied by swelling in the legs and ankles, and skin discoloration (including brown, red or bluish). Further, the skin is dry, scaly and itchy and a subject often complains of aching or "feeling tiredness in legs" that is relieved by elevating their legs. Also, this condition is associated with prominent superficial veins. Venous stasis is most commonly caused by the mechanical failure of valves in the lower extremity which allows pooling of blood in the superficial system. This causes swelling and injury to the superficial soft tissues (skin and fat ) and eventual ulceration. Compression of the superficial system, ideally in a vertical pressure gradient, will allow return of blood upward and through the deep system (as illustrated in FIG. 14). Venous stasis ulcers: Ulcers which occur when blood does not circulate back to the heart normally from the legs. Venous skin ulcers typically occur above the ankle on the inside surface of the leg. Venous ulcers affect up to 2.5 million patients per year in the United States (1-2%).

III. Devices and Systems

Disclosed herein are compression devices and systems which include a means to measure pressure and allow pressure to be monitored. A disclosed compression device 100 is illustrated in FIG. 1. In this embodiment, compression device 100 includes one or more sensors 102, such as piezoelectric sensors, which detect the amount of pressure being applied, such as pressure being applied by a surrounding compression garment/sleeve 104. In some examples, the compression garment is formed of fabric, such as cotton, knit, cotton-blend or other suitable fabric, and shaped to conform to that of a subject's appendage, such as a human calf. In some examples, one or more fasteners 106 are positioned on compression garment 104, such as on the outer facing side, so that the garment can be placed securely around the appendage. In one example, a series of strips of hook and loop fastener material is placed across the outer facing side. In some examples, the compression garment further includes a second set of fasteners 108 to secure the one or more sensors 102 within the compression garment 104. For example, the compression garment includes a second set of hook and loop fasteners to which the one or more sensors are attached to position the sensors in the desired locations when the compression garment is attached to the subject.

In embodiments, a compression device comprises a power source, such as one or more batteries, so that pressure can be detected by the one or more sensors 102. In some examples, a power source is a mobile power source, such as a battery which allows a user to be mobile and use the compression device. In one example, the power source is a 9V battery. In another example, the power source is a pair of 3.3 V coin cell batteries placed in series. In some examples, the detected pressure values are translated by a microcontroller 110 (see FIGs. 3 and 4) and transmitted, such as by wireless communications 1 12, to a device 1 14 for displaying the results to a user or caretaker so that pressure can be monitored and altered, if desired. In some examples, the one or more sensors provides the readings via wireless communications to a computing device, such as server computers, desktop computers, laptop computers, notebook computers, handheld devices, netbooks, tablet devices, mobile devices, smart phones, PDAs, and other types of computing devices. In some examples, the one or more sensors provides the readings via wireless communications to a smartphone application.

In some examples, the one or more sensors are piezoelectric sensors. It is contemplated that piezoelectric sensors made from different materials can be used with the present device. In some examples, the sensor itself is made of an elastic piezoelectric material. In some examples, the one or more sensors are simple Force Sensing Resistors (FSR) which provide resistive values based on force applied. For examples, commercially available force resistors can be employed, such as FSR 402, FSR 404, FSR 406, and/or FSR 408 from Interlink Electronics, Inc. FSRs have many advantages including, but not limited to, the following: (1) sensors are on average able to withstand 10 million accuations; (2) sensitivity range of 0.2N - 20N; (3) continuous force resolution; < 3 microsecond response time; not sensitive to electrostatic discharge; no generation of electromagnetic interference; resistive values deviate by large amounts only in extreme temperatures -25 °C and 85 °C; and are low cost. Example 1 below provides a detailed description of a compression device with FSR and methods of configuring FSRs so that pressure can be measured and monitored. In some examples, the one or more piezoelectric sensors are

Flexiforce Pressure Sensors (e.g. , Tekscan, Inc. Model A401).

It is contemplated that other sensors, such as capacitive sensors or other like means, can be utilized within the disclosed compression device and system.

Capacitive sensors are desirable because of their resistance to aging, simple components and low cost. The capacitance, C, for such sensors are usually affected by only three variables. The first is ε, which is the dielectric constant of the material. The second is A, which is the active area, and finally d, which is the distance between the two plates. These are all related under the equation:

However, once transferred into a parallel plane sensing capacitance the equation changes to involve the divergence of the capacitance multiplied by the initial capacitance with no pressure applied, this may be given by the equation:

"^ "1

<" = C„ + AC ; AC = C ^, f-™- + ~~~AJ + ^jA ) - ■ ■ >g . 1 C

It is believed that this configuration allows for enhanced sensitivity. These sensors can be configured into practical sensing methods by following the designs shown in FIGS. 12A-12B. Where FIG. 12A is an oscillation counter, FIG. 12B is an alternating current bridge, and FIG. 12C is the charge time method and also provides the equation that relates voltage to the measured capacitance, which can be implemented into an analogue to digital converter via a microcontroller.

In some examples, the microcontroller of the compression device reads the values being sent from each sensor and employs an algorithm, such as those provided herein (see Example 1), to change those values into a meaningful pressure value. In one particular example, an ATMEGA328p microcontroller is used.

In some examples, the wireless communication platform is BLUETOOTH ® , RFID, Wi-Fi, wireless PAN, ZIGBEE ® or other like technologies.

Most compression stockings are rated to provide a 10 mmHg range of pressure for a certain diameter leg (e.g. , 20-30 mmHg). In one embodiment, a disclosed device measures pressure with +/- 1 mmHg range, +/- 2 mmHg range, +/- 3 mmHg range, +/- 4 mmHg range, +/- 5 mmHg range, +/- 6 mmHg range, +/- 7 mmHg range, +/- 8 mmHg range, +/- 9 mmHg range or +/- 10 mmHg range. In some examples, a disclosed device measures pressure with +/- 2 mmHg range. In some examples, a disclosed device is designed so that as the limb, such as a leg, diameter decreases (a byproduct of the treatment itself in disease states including both venous stasis and lymphedema), pressure can be adjusted and maintained. It further contemplated that one or more sensors can be integrated into an array of materials. For example, a disclosed device can be engineered to be incorporated into compression garments or to be worn as an adjunct, such as with any compression device (warp or stocking) to provide dynamic monitoring of the applied pressure. In some examples, the device is integrated into a fabric cloth wrap with fasteners to fasten the wrap around the desired limb.

In some examples, a disclosed device is used in combination with a compression stocking which is commercially available, such as from ACE™, PROFORE (Smith & Nephew), or Unna. In some examples, a disclosed device is used in combination with a thromboembolism deterrent hose, such as a T.E.D.™ stocking. In some examples, a disclosed device is used in combination with a deep vein thrombosis (DVT) stocking

Thus, a disclosed compression device can increase the consistency of pressure applied, provide patients with a reusable product, and has the ability to facilitate compression therapy while decreasing the cost of said treatment. A user and/or healthcare provider is able to ensure correct garment pressure at application, and dynamically monitor pressure, such as via a wireless communication system (e.g. , BLUETOOTH®). ///. Methods of Use

Also provided are methods of using a disclosed compression device. In some examples, a disclosed device is used to treat a subject with any aliment requiring compression treatment, such as, but not limited to venous stasis or lymphedema. In one example, the disclosed device is used to provide compression to a lower extremity. In some examples, a disclosed device is used to provide compression to an upper extremity. In some examples, a disclosed device is used for wound prevention and/or healing. This may include its use as after procedures which cause swelling and benefit from postoperative compression therapy such as liposuction, abdominoplasty and face/neck lift. In some examples, the disclosed device is used to treat secondary lymphedema, such as that caused by removal of lymph nodes during cancer resection. In some examples, the disclosed device is used to provide compression to an upper extremity, such as to an arm of a subject following removal of axillary nodes to reduce, inhibit, and/or prevent lymphedema in an arm of a breast cancer patient. In one example, the sensors of the disclosed device are positioned as illustrated in FIG. 15.

In some examples, a disclosed device can be used to treat venous stasis ulcers and lymphedema. For example, compression therapy of less than 20 mmHg is prescribed for preventing deep vein thrombosis. Pressure in the 20-30 mmHg range is prescribed for mild varicose veins, after sclerotherapy, pregnancy, long flights. Pressure in the 30-40 mmHg range is most suitable for venous ulcers and greater than 40 mmHg reserved for most severe cases.

In some examples, a disclosed device is used for compression therapy by placing the device with sensors against the desired limb, such as the outer part of a leg, power on the device, providing power to the device, activating the wireless communication system of the device, applying pressure to the limb until the desired pressure is reached. If desired, monitoring the pressure by reviewing the values displayed to a user interface, such as a phone screen which employs an application specifically designed for controlling and monitoring the pressure of the disclosed compression device.

IV. Exemplary Computing Environment

The techniques and solutions described herein can be performed by software, hardware, or both, of a computing environment, such as one or more computing devices. For example, computing devices include server computers, desktop computers, laptop computers, notebook computers, handheld devices, netbooks, tablet devices, mobile devices, PDAs, and other types of computing devices.

FIG. 13 illustrates a generalized example of a suitable computing environment 200 in which the described technologies can be implemented. The computing environment 200 is not intended to suggest any limitation as to scope of use or functionality, as the technologies may be implemented in diverse general- purpose or special-purpose computing environments. For example, the disclosed technology may be implemented using a computing device comprising a processing unit, memory, and storage, storing computer-executable instructions implementing methods disclosed herein. The disclosed technology may also be implemented with other computer system configurations, including hand held devices, multiprocessor systems, microprocessor-based or programmable consumer electronics, network PCs, minicomputers, mainframe computers, a collection of client/server systems, and the like. The disclosed technology may also be practiced in distributed computing environments where tasks are performed by remote processing devices that are linked through a communications network. In a distributed computing environment, program modules may be located in both local and remote memory storage devices

With reference to FIG. 13, the computing environment 200 includes at least one processing unit 210 coupled to memory 220. In FIG. 13, this basic configuration 230 is included within a dashed line. The processing unit 210 executes computer- executable instructions and may be a real or a virtual processor. In a multiprocessing system, multiple processing units execute computer-executable instructions to increase processing power. The memory 220 may be volatile memory (e.g., registers, cache, RAM), non-volatile memory (e.g. , ROM, EEPROM, flash memory, etc.), or some combination of the two. The memory 220 can store software 280 implementing any of the technologies described herein.

A computing environment may have additional features. For example, the computing environment 200 includes storage 240, one or more input devices 250, one or more output devices 260, and one or more communication connections 270. An interconnection mechanism (not shown) such as a bus, controller, or network interconnects the components of the computing environment 200. Typically, operating system software (not shown) provides an operating environment for other software executing in the computing environment 200, and coordinates activities of the components of the computing environment 200.

The storage 240 may be removable or non-removable, and includes magnetic disks, magnetic tapes or cassettes, CD-ROMs, CD-RWs, DVDs, or any other computer-readable media which can be used to store information and which can be accessed within the computing environment 200. The storage 240 can store software 280 containing instructions for any of the technologies described herein.

The input device(s) 250 may be a touch input device such as a keyboard, mouse, pen, or trackball, a voice input device, a scanning device, or another device that provides input to the computing environment 200. For audio, the input device(s) 250 may be a sound card or similar device that accepts audio input in analog or digital form, or a CD-ROM reader that provides audio samples to the computing environment. The output device(s) 260 may be a display, printer, speaker, CD- writer, or another device that provides output from the computing environment 200.

The communication connection(s) 270 enable communication over a communication mechanism to another computing entity. The communication mechanism conveys information such as computer-executable instructions, audio/video or other information, or other data. By way of example, and not limitation, communication mechanisms include wired or wireless techniques implemented with an electrical, optical, RF, infrared, acoustic, or other carrier.

The techniques herein can be described in the general context of computer- executable instructions, such as those included in program modules, being executed in a computing environment on a target real or virtual processor. Generally, program modules include routines, programs, libraries, objects, classes, components, data structures, etc., that perform particular tasks or implement particular abstract data types. The functionality of the program modules may be combined or split between program modules as desired in various embodiments. Computer-executable instructions for program modules may be executed within a local or distributed computing environment. V. Methods in Computer-Readable Media

Any of the disclosed methods can be implemented as computer-executable instructions or a computer program product stored on one or more computer- readable storage media (e.g., non-transitory computer-readable media, such as one or more optical media discs such as DVD or CD, volatile memory components (such as DRAM or SRAM, or non-volatile memory components such as hard drives) and executed on a computer (e.g., any commercially available computer, including smart phones or other mobile devices that include computing hardware). Computer- readable media does not include propagated signals. Any of the computer- executable instructions for implementing the disclosed techniques as well as any data created and used during implementation of the disclosed embodiments can be stored on one or more computer-readable media (e.g. , non-transitory computer- readable media). The computer-executable instructions can be part of, for example, a dedicated software application or a software application that is accessed or downloaded via a web browser or other software application (such as a remote computing application). Such software can be executed, for example, on a single local computer (e.g. , any suitable commercially available computer) or in a network environment (e.g. , via the internet, a wide-area network, a local-area network, a client-server network (such as a cloud computing network), or other such network using one or more network computers.

For clarity, only certain selected aspects of the software-based

implementations are described. Other details that are well known in the art are omitted. For example, it should be understood that the disclosed technology is not limited to any specific computer language or program. For instance, the disclosed technology can be implemented by software written in C++, Java, Perl, JavaScript, Adobe Flash or any other suitable programming language. Likewise, the disclosed technology is not limited to any particular computer or type of hardware.

Furthermore, any of the software-based embodiments (comprising, for example, computer-executable instructions for causing a computer to perform any of the disclosed methods) can be uploaded, downloaded or remotely accessed through a suitable communication means. Such suitable communication means include, for example, the internet, the World Wide Web, an intranet, cable (including fiber optic cable), magnetic communications, electromagnetic communications (including RF, microwave, and infrared communications), electronic communications, or other such communication means.

The following examples are provided to illustrate certain particular features and/or embodiments. These examples should not be construed to limit the invention to the particular features or embodiments described.

EXAMPLES

Example 1

Compression Device and System

This example illustrates an exemplary compression device and system.

In this example, a disclosed compression device is integrated into a compression garment. A standard black cotton fabric was selected for the physical stocking design. The cloth was cut to conform to the shape of a human calf or arm. A series of VELCRO® strips were placed across the outer facing side of the fabric so that the stocking could be placed securely around the leg as well as fit varying sizes. Force resistors were placed on the inside of the compression sleeve with VELCRO® tabs placed beneath them. They are placed at ascending intervals along the extremity to allow for measurement as several points and to assist in the establishment of a pressure gradient. FSR 402 were used, all manufactured by

Interlink Electronics, Inc. A PCB BLUETOOTH® module and 9 volt battery were placed in a cloth pocket and zipped shut with a zipper to enclose it. The cloth pocket was then fastened to the back of the calf near the top of the compression stocking with VELCRO®. By doing so, the packaging for the PCB Bluetooth module was still on the stocking, but out of the way enough for the leg to be wrapped. A microcontroller was used to measure voltage. The resistance of the force sensing resistor(s) correlated to some voltage that could be measured. This was set up with a voltage divider (see diagram provided in FIG. 2). The output analog voltage increased with the decreasing resistance of the force sensing resistor. The decreasing resistance corresponded to an increase in pressure applied to the resistor. The voltage due to the pressure applied at the force sensing resistor was read by an analog pin. Six analog pins were in the present system (see FIG. 3). The total system worked by the FSR's sending analog values through the microcontroller. The microcontroller then coded these analog values into readable values of voltage, and force. Finally, via a BLUETOOTH® antennae attached to the controller the processed data was sent to an Android™ smartphone to be received by an application. This app displayed the pressure values applied to their leg in real time. A block diagram of the system is provided in FIG. 4.

FSR. A resistive divider formula was used to calculate the output voltage (Vout) that gets read by the analog inputs. A voltage divider works by simply applying a voltage source across two resistors in series. It works by taking one resistance, and multiplying it by the input voltage, then dividing it by the two resistances added together. This provided a fraction of the voltage was initially generated. By using the FSR, varying output voltages were obtained depending on the force exerted, thus providing more real time results. The equation used was:

RM is the resistance set by the user and that remains fixed. This fixed resistor is chosen for maximum force sensitivity range and to limit current. After the resistance value and voltage were determined, the values were converted to pressure. Pressure is force over the area, so data can be plotted from calibrated pressure tests using digital scales. Different forces are applied to a test force sensing resistor in order to yield a 100kQ resistance until saturation occurs. Then the force will be known due to the resistors being placed on a calibrated digital scale. Once resistance versus force were plotted, a "best fit" curve was extrapolated. The formula was then programmed into the microcontroller for calculating pressure values.

In order to derive a characteristic curve weight was applied by an index finger to a test sensor. The sensor was placed on a digital scale in order to determine how much weight was applied for the corresponding resistance that was measured. Data was then plotted on a spreadsheet and polynomial regression applied. The extrapolated curve was then programmed into the microcontroller. For the test, the Interlink Model 400 Sensor and AODE 100542 scale were used. FIG. 5 provides the results of the test and the characteristic plot.

An additional test of the FSR was conducted using a sphygmomanometer. A blood pressure cuff was continually pumped to 20mmHg and then these values were then compared to the pressure values displace on a smart phone through use of the application. FIG. 6 illustrates the generated data. Normally compression stockings are rated in lOmmHg range, for example, 20-30mmHg. The present data fell much closer to the line than that was generally within a plus/minus 2 mmHg range.

Information provided by Interlink Electronics, Inc. is as follows

Table 1: Specifications are derived from measurements taken at 1000 grams, and are given as (one standard deviation/mean), unless otherwise noted:

Long Term Drift <5% per logio(time) Tested to 35 days, 1kg load

Force Resolution Continuous Depends on measurement electronics

Stand-Off Resistance >10ΜΩ Unloaded, unbent

Switch Travel 0.05mm Typical; depends on design

Device Rise Time <3 microseconds Measured with drop of steel ball

Maximum Current 1 mA/cm 2 of applied force

EMI/ESD Generates no EMI; not

ESD sensitive

Table 2: Specifications are derived from measurements taken at 1000 grams

Table 3: Specifications are derived from measurements taken at 1000 grams

Microcontroller. The microcontroller was an ATMEGA328p with an Arduino bootloader. The current code utilized for the present Example was disclosed in US Provisional Application No. 62/275,616, filed on January 6, 2016, which is hereby incorporated by reference in its entirety. This code sends the data via

BLUETOOTH ® to a smartphone application where it can be displayed.

BLUETOOTH ® Application. A BLUETOOTH ® application was designed to detect the amount of pressure being applied to the FSR by using the MIT App Inventor product online. MIT App Inventor provides an interface to create Android™ applications. A label was set for each FSR output, and certain number ranges were searched for each label. If a number in that range was detected, the value was outputted to that label space. FIG. 7 is a screenshot of the app inventor block diagram that was used to "code" the application. Each labels number range was selected to be about 500 numbers large. This number was selected because the pressure being applied in the disclosed compression device and system would not exceed 500 mmHg, so there would be no overlap in values. The same number was added to the final value that is output in the code to the microcontroller so that the two match. FIG. 8 provides a screenshot of the layout. FIG. 9 provides a final screenshot of the application showing the pressures in mmHg.

Printed Circuit Board (PCB). A PCB was designed using Cadsoft Eagle PCB design software. As illustrated in FIG. 10, a 9V battery, coupling capacitors, a diode, a 5V voltage regulator, and a 9V barrel jack was used as a power source. A 3.3V voltage regulator was used to power BLUETOOTH®. Six repeated headers were all set up through voltage dividers to calculate force. An ATMEGA328P

microcontroller which was located at the center of the board. All components were compatible with through-hole soldering and a 2-sided PCB was formed. An image of a PCB with components soldered is provided in FIG. 11.

Example 2

Characterization of a Compression Device

This example provides a controlled trial with two study arms measuring care providers' ability to achieve recommended pressures with compression wraps. One arm will be composed of experienced wound care specialist, such as specialty nurses, that place multiple compression garments per week, while the other will be other caretakers without specific wound care experience that, on average, place less than one compression garment per day but greater than one per month (such as floor nurses).

A synthetic leg composed of plaster cast human lower extremity bones (from femoral head to toes) has been set in FBI grade ballistics gel; the gel most similar to human soft tissue. The construct has been wrapped in a hydrophobic material to emulate a layer of skin and to protect the gel from drying. The process has made the leg as realistic as possible and will remove any inconsistencies that would be seen between patient legs or even within the same patient's leg over time. The care providers will first wrap the leg and pressure monitor without being able to see the applied pressures. Each care provider will apply an ACE Bandage, Profore, and Unna. This procedure will be done three times per bandage to assess for variation in accuracy and precision. The same procedure will then be applied unblinding the care provider to the applied pressures to garner whether or not they are able to obtain optimal pressures more satisfactorily.

Statistical Analysis:

Each care provider will be measured for precision and accuracy in placing the garment. Chi-square analysis will then be utilized to compare the ability to achieve optimal pressure between wound care specialty care provider and non- specialists with a significant p value of < 0.05. The care providers will also be compared to themselves by chi-square analyzing the pressure achieved without viewing of the pressure monitoring and with active Bluetooth monitoring. Again, a significant p value will be set at < 0.05. A power calculation will be obtained to determine the number needed to study to have a well-powered study.

In view of the many possible embodiments to which the principles of the disclosed invention may be applied, it should be recognized that the illustrated embodiments are only preferred examples of the invention and should not be taken as limiting the scope of the invention. Rather, the scope of the invention is defined by the following claims. We therefore claim as our invention all that comes within the scope and spirit of these claims.