WO2017120387A1 - Bas de contention et leurs procédés - Google Patents

Bas de contention et leurs procédés Download PDF

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Publication number
WO2017120387A1
WO2017120387A1 PCT/US2017/012400 US2017012400W WO2017120387A1 WO 2017120387 A1 WO2017120387 A1 WO 2017120387A1 US 2017012400 W US2017012400 W US 2017012400W WO 2017120387 A1 WO2017120387 A1 WO 2017120387A1
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WO
WIPO (PCT)
Prior art keywords
compression
pressure
sensors
compression device
disclosed
Prior art date
Application number
PCT/US2017/012400
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English (en)
Inventor
John Menezes
Joshu GOLDMAN
Oliver MUSOVSKI
Original Assignee
Board Of Regents Of The Nevada System Of Higher Education On Behalf Of The University Of Nevada,
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Application filed by Board Of Regents Of The Nevada System Of Higher Education On Behalf Of The University Of Nevada, filed Critical Board Of Regents Of The Nevada System Of Higher Education On Behalf Of The University Of Nevada,
Publication of WO2017120387A1 publication Critical patent/WO2017120387A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/00051—Accessories for dressings
    • A61F13/00055—Saturation indicators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/06—Bandages or dressings; Absorbent pads specially adapted for feet or legs; Corn-pads; Corn-rings
    • A61F13/08—Elastic stockings; for contracting aneurisms
    • H—ELECTRICITY
    • H04—ELECTRIC COMMUNICATION TECHNIQUE
    • H04M—TELEPHONIC COMMUNICATION
    • H04M1/00—Substation equipment, e.g. for use by subscribers
    • H04M1/72—Mobile telephones; Cordless telephones, i.e. devices for establishing wireless links to base stations without route selection
    • H04M1/724—User interfaces specially adapted for cordless or mobile telephones
    • H04M1/72403—User interfaces specially adapted for cordless or mobile telephones with means for local support of applications that increase the functionality
    • H04M1/72409—User interfaces specially adapted for cordless or mobile telephones with means for local support of applications that increase the functionality by interfacing with external accessories
    • H04M1/72412—User interfaces specially adapted for cordless or mobile telephones with means for local support of applications that increase the functionality by interfacing with external accessories using two-way short-range wireless interfaces

Definitions

  • 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.
  • compression garments used to treat swelling after aesthetic procedures such as after abdominoplasty, liposuction or face and neck lift.
  • 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.
  • 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.
  • 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.
  • some sort of pressure is applied to compress the superficial veins, such as through compression therapy.
  • 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.
  • 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.
  • Atherosclerosis and arterial inflow disease compression therapy may be used.
  • 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.
  • 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.
  • 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.
  • 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%.
  • 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%).
  • 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.
  • 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.
  • 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.
  • 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.
  • the compression garment further includes a second set of fasteners 108 to secure the one or more sensors 102 within the compression garment 104.
  • 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.
  • 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.
  • a power source is a mobile power source, such as a battery which allows a user to be mobile and use the compression device.
  • the power source is a 9V battery.
  • the power source is a pair of 3.3 V coin cell batteries placed in series.
  • 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.
  • 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.
  • 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.
  • the one or more sensors provides the readings via wireless communications to a smartphone application.
  • 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.
  • FSR Force Sensing Resistors
  • 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.
  • the one or more piezoelectric sensors are
  • Flexiforce Pressure Sensors e.g. , Tekscan, Inc. Model A401.
  • 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 ⁇ , 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.
  • FIGS. 12A-12B are examples of sensors that can be configured into practical sensing methods by following the designs shown in FIGS. 12A-12B.
  • FIG. 12A is an oscillation counter
  • FIG. 12B is an alternating current bridge
  • 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.
  • 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.
  • an ATMEGA328p microcontroller is used.
  • the wireless communication platform is BLUETOOTH ® , RFID, Wi-Fi, wireless PAN, ZIGBEE ® or other like technologies.
  • 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.
  • a disclosed device measures pressure with +/- 2 mmHg range.
  • 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.
  • 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.
  • the device is integrated into a fabric cloth wrap with fasteners to fasten the wrap around the desired limb.
  • a disclosed device is used in combination with a compression stocking which is commercially available, such as from ACETM, PROFORE (Smith & Nephew), or Unna.
  • a disclosed device is used in combination with a thromboembolism deterrent hose, such as a T.E.D.TM stocking.
  • a disclosed device is used in combination with a deep vein thrombosis (DVT) stocking
  • 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®). ///.
  • 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.
  • the disclosed device is used to provide compression to a lower extremity.
  • a disclosed device is used to provide compression to an upper extremity.
  • 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.
  • the disclosed device is used to treat secondary lymphedema, such as that caused by removal of lymph nodes during cancer resection.
  • 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.
  • the sensors of the disclosed device are positioned as illustrated in FIG. 15.
  • a disclosed device can be used to treat venous stasis ulcers and lymphedema.
  • 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.
  • 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.
  • 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.
  • 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.
  • program modules may be located in both local and remote memory storage devices
  • the computing environment 200 includes at least one processing unit 210 coupled to memory 220.
  • 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.
  • 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 such as a bus, controller, or network interconnects the components of the computing environment 200.
  • operating system software 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.
  • 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.
  • communication mechanisms include wired or wireless techniques implemented with an electrical, optical, RF, infrared, acoustic, or other carrier.
  • 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.
  • 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.
  • the disclosed technology is not limited to any specific computer language or program.
  • the disclosed technology can be implemented by software written in C++, Java, Perl, JavaScript, Adobe Flash or any other suitable programming language.
  • the disclosed technology is not limited to any particular computer or type of hardware.
  • 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.
  • 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.
  • This example illustrates an exemplary compression device and system.
  • 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
  • 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.
  • the processed data was sent to an AndroidTM smartphone to be received by an application. This app displayed the pressure values applied to their leg in real time.
  • FIG. 4 A block diagram of the system is provided in FIG. 4.
  • a resistive divider formula was used to calculate the output voltage (Vout) that gets read by the analog inputs.
  • Vout the output voltage
  • 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.
  • 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.
  • 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.
  • the microcontroller was an ATMEGA328p with an chicken 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.
  • 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.
  • PCB Printed Circuit Board
  • 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.
  • 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.
  • 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 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.
  • 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.

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Abstract

La présente invention concerne un dispositif de compression et un système comprenant un ou plusieurs capteurs, tels que des capteurs piézoélectriques, permettant ainsi la surveillance dynamique de la pression appliquée. Un utilisateur et/ou un professionnel de la santé est apte à assurer une pression de vêtement correcte lors de l'application, et de surveiller de manière dynamique une pression, tel que par l'intermédiaire d'un système de communication sans fil. Les dispositifs et le système de la présente invention peuvent être utilisés lors d'une thérapie de compression, y compris pour traiter un sujet atteint ou présentant un risque de développer une stase veineuse ou un lymphœdème.
PCT/US2017/012400 2016-01-06 2017-01-05 Bas de contention et leurs procédés WO2017120387A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201662275616P 2016-01-06 2016-01-06
US62/275,616 2016-01-06

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Cited By (2)

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