Systems and methods for measuring edema at home and measurement patterns for use therewith - Patents.com

Abstract

A system and method for measuring edema at home, and a measurement pattern for use therewith, are provided. The system includes a computing system having an imaging device, a processor, a memory, and a wireless transmitter. The computing system is configured to capture edema data of a patient and transmit the data to a remote physician. The pattern may be incorporated into a flexible sheet substrate that can be placed over a portion of the patient's skin. Pressing the flexible sheet substrate into the patient creates a depression and distorts the pattern. The imaging device captures an image of the depression and the distorted pattern. The computing system processes the image and determines the depth of the depression based on the distortion of the pattern.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001]

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 151,952, filed February 22, 2021, which is incorporated by reference in its entirety into this specification. [Technical field]

[0002]

[0002] The present invention relates to the measurement of oedema and to the remote monitoring of oedema. [Background technology]

[0003]

[0003] Peripheral edema is a phenomenon in which there is abnormal infiltration and excessive accumulation of serous fluid in the connective tissue and / or serous cavities in one or more of the body's extremities, such as the feet, hands, ankles, calves, wrists, and arms. Peripheral edema can be benign and may resolve spontaneously in certain circumstances. However, it can also be a sign of various diseases, such as congestive heart failure (CHF), liver disease, kidney disease, lymphedema, hypoalbuminemia, and chronic venous insufficiency. For example, in CHF, the presence of edema in the extremities (e.g., lower legs) can be a useful diagnostic marker for the presence of disease. Furthermore, the progression of the edematous condition can be monitored over time and correlated with the progression of the disease.

[0004]

[0004] The most widely used clinical method for the assessment of edema is a finger maneuver, also known as the "pitting" technique. This assessment is accomplished by pressing the patient's skin near the bone surface and qualitatively assessing the degree of indentation. An indentation is a depression in the swollen tissue that remains after pressure is removed from the edematous area. Due to changes in tissue composition caused by edema, there may be a putty-like consistency to the tissue, and the tissue may remain in the depressed position for a few seconds before returning to its original shape. The individual performing the examination (a physician or other health care provider) evaluates one or more of the following: the depth of the indentation, how much force is required to reach the nearby bone, how long it takes for the tissue to return to its original state, and skin quality. The level of edema is typically described using a 1-3 ranking system that corresponds to mild, moderate, and severe edema.

[0005]

[0005] Additional methods of measuring edema are needed that are reliable, economical, rapid, easy to use, provide repeatable measurements (daily and / or by individual physicians), and have the potential for use at home as well as in physician's offices, hospitals, clinics, and veterinary settings. Summary of the Invention

[0006]

[0006] It is a feature of the present invention to provide a reliable at-home diagnosis for patients with edema.

[0007] Another feature of the present invention is to provide patient edema data to remote physicians, care partners, clinicians, and other caregivers.

[0008]

[0008] A further feature of the present invention is to provide a pattern, imaging device, and computing system that enables a remote physician or other remote caregiver to collect edema data about a patient and facilitates home diagnosis of the patient.

[0009]

[0009] To achieve these and other advantages, and in accordance with the objects of the invention as embodied and broadly described herein, the present invention includes a system for measuring and monitoring edema. The system may include a flexible sheet substrate having a pattern. The flexible sheet may be configured to be placed on a surface of a patient's skin. The system may further include an imaging device and a computing system. The imaging device is configured to capture image data including an image of the pattern while the flexible sheet substrate is on the surface of the patient's skin. The computing system includes a processor and a memory. The memory stores computer readable instructions that, when executed by the processor, configure the computing system to process image data captured by the imaging device. The image data includes at least an image of the pattern at a location on the surface of the patient's skin and a depression in the patient at the location. Processing the image data includes measuring a distortion of the pattern caused by the depression to determine a depth of the depression in the patient. The system may include a remote computing system. The computing system may further include a wireless transmitter configured to wirelessly transmit the processed image data and / or the unprocessed image data to the remote computing system. The remote computing system may be at a clinic.

[0010]

[0010] According to one or more embodiments, an edema measurement sheet is provided. The edema measurement sheet may include an upper flexible layer of an extensible material, the upper flexible layer having an upper surface and a lower surface, and including a pattern visible when viewing the upper surface. An adhesive layer may be adhered to the lower surface of the upper flexible layer and may be configured to be removably adhered to the patient's skin. The pattern includes a series of parallel lines, for example at least four parallel lines, and a grid with a plurality of markers surrounding the series of parallel lines. When the edema measurement sheet is adhered to a location on the patient's skin and the location on the skin is indented to form a depression in the patient, the edema measurement sheet is configured to stretch into and contour along the depression so that the pattern is distorted.

[0011]

[0011] The present invention also relates to a method for measuring and monitoring edema. The measuring method may include the steps of placing a pattern against a surface of a patient's skin at a location, indenting a portion of the patient's skin at the location of the pattern to create a depression in the patient, and measuring a distortion of the pattern caused by the depression in the patient to determine the depth of the depression in the patient. The pattern may be part of a sheet of stretchable material. Placing the pattern against the surface of the skin may comprise adhering a lower surface of the sheet to the surface of the skin at the location such that the pattern is visible by viewing the upper surface of the sheet. The method may further include capturing image data with an imaging device. The image data may include an image of the pattern against the surface of the patient's skin and the depression at the location. Measuring the distortion of the pattern may include processing the image data. The method may further include wirelessly transmitting the image data, a grade or value based on the image data, or both from the imaging device to a remote computing system, for example via a wireless network. The remote computing system may be in a clinic, a doctor's office, or the like.

[0012]

[0012] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are intended to provide further explanation of the invention as claimed.

[0013]

[0013] The present invention can be more fully understood with reference to the accompanying drawings, which are intended to illustrate, but not to limit, the present teachings in accordance with embodiments of the invention. [Brief description of the drawings]

[0014] [Figure 1A]

[0014] FIG. 1 is a schematic diagram of a flexible sheet substrate for attachment to a patient, an imaging device, a computing system, and a remote computing system according to an embodiment of the present invention. [Figure 1B]

[0015] FIG. 1B is a block diagram of components of the computing system illustrated in FIG. 1A. [Diagram 2]

[0016] 1 is a cross-sectional view of a flexible sheet substrate according to an embodiment of the present invention. [Diagram 3]

[0017] 1 is a side view of a computing system including a partial cross-sectional view of a flexible sheet substrate for application to a patient and an imaging device positioned to image the flexible sheet according to an embodiment of the present invention. [Figure 4]

[0018] FIG. 2 is a side view of a container and multiple flexible sheet substrates disposed within the container according to an embodiment of the present invention. [Diagram 5]

[0019] 2 is a schematic diagram illustrating each of several steps of a method according to an embodiment of the present invention; [Figure 6]

[0020] 1 shows a cross-sectional view of a patient's ankle with a dimple formed therein and a side view of an integrated pattern-casting and imaging device casting and imaging a pattern onto the ankle. [Figure 7]

[0021] FIG. 1 is a partially schematic perspective view illustrating triboelectric charging during peeling of non-adhesive patterned sheets from a stack, each non-adhesive patterned sheet having a front and back surface of first and second respective materials having different triboelectric properties. [Figure 8]

[0022] FIG. 2 is a perspective view of a dispenser for non-adhesive pattern sheets having a charge-imparting member located near an orifice through which individual non-adhesive pattern sheets can be drawn and charged, according to an embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0015]

[0023] According to various embodiments, the present invention provides a system for measuring and monitoring edema. The system may include a flexible sheet substrate, an imaging device, and a computing system. The flexible sheet substrate may include a pattern and may be configured to be placed on a surface of the patient's skin. The imaging device may be configured to capture image data including an image of the pattern while the flexible sheet substrate is on the surface of the patient's skin. The computing system may include a processor and a memory. The memory may store a set of computer-readable instructions that, when executed by the processor, may configure the computing system to process the image data captured by the imaging device. The image data may include at least an image of the pattern at a location on the surface of the patient's skin. The image data may also include a depression formed in the patient at the location. The depression may be formed by pressing a finger or probe against the patient's skin at the location to form a depression, indentation, dimple, or other temporary abnormality in the skin. Processing the image data may include measuring a distortion of the pattern caused by the depression to determine a depth of the depression formed in the patient.

[0016]

[0024] The flexible sheet substrate may comprise an extensible material. The flexible sheet may have an upper surface and a lower surface, and the pattern may be visible from the upper surface. The lower surface may be configured to be adhered to the patient's skin at the location. The flexible sheet substrate may, for example, comprise an upper flexible layer comprising the upper surface of the flexible sheet. The upper flexible layer may comprise a bottom surface. The flexible sheet substrate may comprise an adhesive layer having a first surface adhered to the bottom surface of the upper flexible layer and a second surface opposite the first surface, for example an adhesive surface opposite the first surface. A removable liner may be provided that is adhered to the adhesive surface of the adhesive layer and configured to protect the adhesive surface. The removable liner may be provided adhered to the adhesive surface to protect the adhesive surface. The removable liner may be peeled from the adhesive surface, for example immediately prior to use, to expose the adhesive surface.

[0017]

[0025] The pattern on the flexible sheet substrate may comprise a series of parallel lines. The flexible sheet substrate may further comprise a plurality of markers, for example, in addition to the pattern, at the corners of the pattern and surrounding the pattern. The image data may further comprise an image of the plurality of markers. Upon execution of the computer-readable instructions by the processor, the computing system may be configured to determine the angle of the imaging device relative to a location on the surface of the skin, for example, by using the plurality of markers, relative positioning, angles, triangulation, and the like. The flexible sheet substrate may be of any shape. The flexible sheet substrate may comprise a plurality of corners, and each of the plurality of markers may be disposed at a respective corner of the flexible sheet substrate.

[0018]

[0026] The system may further include a remote computing system. The computing system may further include a wireless transmitter configured to wirelessly transmit the image data to the remote computing system. The remote computing system may be located, for example, at a clinic, dialysis clinic, doctor's office, hospital, or caregiver location.

[0019]

[0027] The system may further include a smart device. The smart device may include an imaging device and a computing system. The smart device may be, for example, a smartphone, a tablet, a smart watch, or smart glasses. The smart device may be, for example, a smartphone that may include a touch screen interface. The computer readable instructions may be in the form of application software loaded onto the memory, for example, an app loaded onto the smartphone.

[0020]

[0028] According to various embodiments, an edema measurement sheet is provided. The edema measurement sheet may, for example, comprise an upper flexible layer and an adhesive layer and may include a pattern as described herein. The upper flexible layer may comprise, consist essentially of, or consist of an extensible material. The upper flexible layer may have an upper surface and a lower surface and may include a pattern. The pattern may be visible when looking at the upper surface. In other words, the pattern can be imaged by the imaging device if the imaging device is focused on the upper surface. The adhesive layer may be adhered to the lower surface of the upper flexible layer. The adhesive layer may be configured to, for example, be firmly adhered to the skin but removably adhere to the patient's skin so as not to cause lacerations, other damage, or rashes when removed from the skin. The pattern may comprise a series of parallel lines, for example at least three, at least four, or more parallel lines. The pattern may, for example, comprise a grid comprising a plurality of markers surrounding the series of parallel lines. The edema measuring sheet may be configured such that when the edema measuring sheet is adhered to a location on the patient's skin and the location on the skin is indented to form a depression in the patient, the edema measuring sheet may stretch into and contour to the depression such that the pattern is distorted. The amount or type of distortion may be analyzed to determine the degree of edema affecting the patient and to determine an appropriate course of action to treat the edema. The edema measuring sheet may further comprise a removable protective liner adhered to the adhesive layer.

[0021]

[0029] The top flexible layer of the edema measuring sheet may comprise a plurality of markers. The top flexible layer of the edema measuring sheet may comprise a plurality of corners. The plurality of markers may include at least one respective marker disposed at each corner of the plurality of corners. The pattern may be printed on the top surface of the top flexible layer. The pattern may be etched on the top surface of the top flexible layer. The pattern may be embedded in the top flexible layer.

[0022]

[0030] According to various embodiments, a container is provided for housing a plurality of edema measuring sheets. The container may include an opening and a lid covering the opening. A plurality of edema measuring sheets as described herein may be disposed within the container. Each of the plurality of edema measuring sheets may include a removable liner that protects an adhesive surface of the respective edema measuring sheet.

[0023]

[0031] According to the present invention, there is also provided a method for measuring edema. The method may involve placing a pattern against a surface of a patient's skin at a location and indenting a portion of the patient's skin at the location of the pattern. The indenting may be a force sufficient to cause a depression to form in the patient. The method may involve measuring a distortion of the pattern caused by the depression in the patient. The measurement may determine a depth of the depression in the patient. Based on the measured, determined, or calculated depth, an appropriate treatment for the patient may be known and prescribed.

[0024]

[0032] The method may involve using a pattern comprising a series of parallel lines. The pattern may be part of a sheet of stretchable material. The sheet may be configured to distort and contour to the depression in the patient. The method may involve placing the pattern against the surface of the skin by adhering a lower surface of the sheet of stretchable material to the surface of the skin at the location. For example, the placing may result in the pattern being visible by viewing the upper surface of the sheet. The sheet of stretchable material may further comprise a number of markers surrounding the pattern. The sheet of stretchable material may comprise a number of corners, at least some of the number of markers may be disposed at each corner of the number of corners. The method may involve capturing image data with an imaging device including an image of the pattern against the surface of the patient's skin. The method may involve capturing image data with an imaging device including an image of the depression at the location. Measuring the distortion of the pattern may comprise processing the image data. The processing of the image data may be performed by a computing system. The computing system and the imaging device may be part of a smart device, e.g., part of the same smart device. The smart device may be selected from a smartphone, a tablet, a smart watch, and smart glasses, etc. The smart device may be a smartphone with a touch screen interface.

[0025]

[0033] The method may further comprise transmitting the image data from the imaging device to a remote computing system, for example, via a wired or wireless network. The remote computing system may be at a clinic, and the method may comprise wirelessly transmitting the image data from the imaging device to a remote computing system at the clinic. In various embodiments, the image data may be wirelessly transmitted to the remote computing system as a live stream video. By using the systems, smart devices, and methods described herein, patients can provide physicians with important information that the physician can use to evaluate the patient's edema without the need for a clinic visit. The systems and methods can evaluate the image data and provide a grade or score, for example, 1, 2, or 3, corresponding to whether the edema is mild, moderate, or severe. The systems and methods allow results, recommendations, and questions to be discussed during a remote medical consultation between the physician and the patient, and can be used over time to monitor the edema.

[0026]

[0034] Other methods of placing the pattern on the patient's skin may additionally or alternatively be used. For example, placing the pattern against the surface of the patient's skin may comprise projecting a light pattern against the surface of the patient's skin. Placing the pattern against the surface of the patient's skin may comprise transferring a temporary tattoo of the pattern to the surface of the patient's skin. Placing the pattern against the surface of the patient's skin may comprise forming a permanent tattoo of the pattern on the surface of the patient's skin.

[0027]

[0035] According to various embodiments, instead of an adhesive pad, a non-adhesive pattern sheet may be provided that can adhere to the patient's ankle or other body part by electrostatic or similar charge. A method is provided that may comprise (i) treating the non-adhesive pattern sheet to provide the non-adhesive pattern sheet with a non-neutral surface charge, and (ii) placing the non-adhesive pattern sheet over the patient's body part, such as the ankle, such that the non-adhesive pattern sheet adheres to the patient's body part, such as the ankle, due to the non-neutral surface charge.

[0028]

[0036] According to various embodiments, at least 20%, at least 30%, at least 40%, at least 50%, at least 60%, at least 70%, at least 80%, at least 90%, and / or at least 95% of the surface area of ​​one side of the non-adhesive pattern sheet is intimately attached to and in contact with the body part. Such surface area percentages are herein considered to constitute a substantial portion of the Cove non-adhesive pattern sheet. In some embodiments, about 25%, or about 50%, or about 75% of the surface area of ​​one side of the non-adhesive pattern sheet can be attached to the surface of the body part for a period of time (e.g., more than 20 seconds).

[0029]

[0037] Handling the non-adhesive patterned sheet may include tribocharging (also known as "triboelectric charging," "contact charging," or "electrification by contact"). Handling may include passing the non-adhesive patterned sheet through an electric field.

[0030]

[0038] A charge difference can be established by triboelectric charging, dielectric polarization, passing an electric field, etc. The charge difference can be at least 5V, at least 7V, at least 10V, at least 15V, at least 20V, at least 25V, at least 30V, at least 50V, at least 75V, at least 100V, or more.

[0031]

[0039] A plurality of non-adhesive pattern sheets may be provided. The plurality may comprise layered (multi-layered) sheet-like materials having a first outer layer on one side and a second outer layer on the opposite side. The first and second layers may be constructed of first and second materials, the first and second materials having different triboelectric properties. Thus, when the surfaces of the first and second materials are in intimate contact with each other and then separated, each acquires a non-neutral surface charge. The plurality of non-adhesive pattern sheets may be releasably connected to each other end-to-end and rolled to define a roll configuration. A plurality of such sheet-like materials may be arranged in a stack, with each sheet-like material of the stack being disposed in intimate contact with its nearest neighbors (or one neighbor in the case of the first and last sheets). The first layer of each sheet-like material of the stack may be disposed facing a first direction, and the second layer of each sheet-like material of the stack may be disposed facing a second direction, the second direction being opposite the first direction. One of the layers may, for example, consist of a paper material, e.g., tissue, and the other of the layers may optionally be provided with adhesive properties, e.g., a slight degree of tackiness or adhesion. At least one of the layers may comprise an electret.

[0032]

[0040] A further aspect of the invention provides a dispensing device for dispensing non-adhesive pattern sheets. The dispensing device may comprise a compartment adapted to hold a plurality of non-adhesive pattern sheets, an orifice defined by the walls of the compartment and allowing one of the non-adhesive pattern sheets to be drawn for removal from the compartment, and a charge-imparting member positioned such that the non-adhesive pattern sheet drawn through the orifice must pass in close proximity to the charge-imparting member, e.g., must rub against the charge-imparting member. In use, the non-adhesive pattern sheet removed from the dispenser through the orifice acquires a non-neutral surface charge. The charge-imparting member and the non-adhesive pattern sheet may have different triboelectric properties. For example, the non-adhesive pattern sheet may be made of a paper material and the charge-imparting member may comprise a vinyl or Styrofoam® surface. The charge-imparting member may be an electrostatic generator.

[0033]

[0041] According to various embodiments, the present invention utilizes a phenomenon known as "triboelectric charging" or "tribocharging" for short. This phenomenon is also called "contact charging" or "charging by contact." There are several mechanisms that may contribute to the resulting charge generated by the triboelectric process. The four main factors that most significantly affect the triboelectric charging process are surface contact effect, work function, charge backflow, and gas breakdown. These factors, as well as other materials, systems, and methods that can be used in accordance with the present invention, are described in U.S. Patent No. 6,484,328 B1 to Frazier, which is incorporated herein by reference in its entirety.

[0034]

[0042] According to various embodiments of the present invention, the non-adhesive pattern sheet is triboelectrically charged before it is finally placed on the patient's body part. The charge established on the non-adhesive pattern sheet provides "adhesive" properties that help keep the non-adhesive pattern sheet in place once placed on the body part. The affinity of the non-adhesive pattern sheet with the body part can be sufficient to keep the non-adhesive pattern sheet in intimate adhesion and contact with the body part for at least 10 seconds, at least 15 seconds, at least 20 seconds, at least 30 seconds, at least 45 seconds, and / or at least 1 minute.

[0035]

[0043] The non-adhesive pattern sheet may be incorporated into a square or rectangular sheet. Perforations or score lines may allow the non-adhesive pattern sheet cover to be easily torn from a roll of such a sheet. The non-adhesive pattern sheet is planar in two dimensions to the naked eye, but is not necessarily flat. The non-adhesive pattern sheet has some thickness in the third dimension, but the third dimension is very small compared to the first two dimensions. The non-adhesive pattern sheet may exhibit good drapeability. Drapability is the tendency of the non-adhesive pattern sheet to conform perpendicular to its plane to a body part, such as the ankle of a patient, on which the non-adhesive pattern sheet is placed. The higher the drapeability of the non-adhesive pattern sheet, the more precisely it will conform to the body part. A more precise conformance to the body part may provide a greater holding force on the body part. The non-adhesive pattern sheet may comprise a paper material, a soft tissue type paper, a woven material, a cloth material, or the like. For various reasons, in certain embodiments of the present invention, fibrous non-adhesive pattern sheets may generally be preferred, for example, paper-based materials such as wood pulp, cellulosic materials, or tissue-type papers. For example, such materials are most compatible with existing sewage treatment facilities. Paper-based products are typically better in terms of biodegradability. Coatings, such as water-receptive waxes, may be applied to form one or more layers on the paper sheet.

[0036]

[0044] Triboelectric charging can occur during unwinding of the non-adhesive pattern sheet from the roll. The non-adhesive pattern sheet can be provided as a roll having the nature of a paper towel or toilet paper roll, whereby the user partially unwinds the roll to obtain the next available non-adhesive pattern sheet, which is then torn off from the roll. The tearing can be assisted by perforations or score lines. The non-adhesive pattern sheet can be a laminated article with upper and lower sides of different materials having separate rankings in the triboelectric series. For example, one side of each non-adhesive pattern sheet can be a paper-based tissue-type material and the other side can be a rubber-based film layer, whereby triboelectric charging occurs during unwinding in a manner similar to a tape dispenser. A dispenser having the nature of an elongated rod can be utilized to receive the roll in a manner that allows the roll to be unwound around it.

[0037]

[0045] So-called "cling films" can be used as non-adhesive patterned sheet materials. Non-limiting examples of films include polyvinyl chloride films (either plasticized or flexible), polyurethane films, high density polyethylene films, polypropylene films, tackified linear low density polyethylene films, acrylonitrile / butadiene / isoprene films, acrylonitrile / butadiene copolymers, styrene / butadiene copolymers (either random or block), styrene / isoprene copolymers (either random or block), styrene / ethylene-butylene block copolymers, and combinations thereof, as well as other films known in the art to make cling films. The inclusion of a high content of plasticizer in the plastic can impart "cling" properties to the plastic film. Polyvinyl chloride films with this property are commercially available from several sources. An example of a film with cling properties is Sure-State Series 9000 available from Tekra, Inc. (New Berlin, Wisconsin). Permacharge, Inc. (Rio Rancho, New Mexico) offers an electrostatic polypropylene material called ClingZ. ClingZ derives its adhesive properties from a permanent electrostatic charge. The film can be repositioned like other cling films, but ClingZ does not contain plasticizers. The present invention also contemplates the use of such materials in the construction of the non-adhesive pattern sheets herein. The non-adhesive pattern sheets may comprise electrostatically charged non-woven fabrics.

[0038]

[0046] 1A and 1B, FIG. 1A illustrates a system 100 for measuring and monitoring edema according to an exemplary embodiment of the present invention. FIG. 1B illustrates a block diagram of a computing system 120 according to an exemplary embodiment of the present invention. The system 100 may include a flexible sheet substrate 132 having a pattern 104. The system 100 includes an imaging device 116 and a computing system 120. The computing system 120 may include an imaging device 116, a processor 122, a memory 126, computer readable instructions stored in the memory 126, and a wireless transmitter 130. A patient 108, a physician, a technician, a caregiver, a care partner, or another user may place the flexible sheet substrate 132 on a surface of the patient's skin 112, such as the patient's foot, hand, ankle, calf, wrist, or arm. The user then presses the patient's skin 112 where the pattern 104 overlaps to create a depression 128. The indentations 128 may be formed by pressing a finger or probe against the skin 112 of the patient 108 at the location. If any indentations 128 remain on the patient after pressure is released, the user uses the imaging device 116 to capture an image of the indentations and the pattern, or more broadly, image data. The imaging device 116 may be a cell phone camera and the computing system 120 may be a cell phone. The image data may be captured by the imaging device 116 within 1 second, 2 seconds, 3 seconds, 4 seconds, 5 seconds, 6 seconds, 8 seconds, 10 seconds, 15 seconds, or more, after the pressure is released. The image data includes an image 124 of the pattern 104 on the surface of the skin 112 of the patient 108 and the indentations 128 on the patient 108 at the location of the pattern 104. The computing system 120 then processes the image data to determine the depth of the depression 128 in the patient 108 by measuring the distortion of the pattern 104 caused by the depression 128 .

[0039]

[0047] The computing system 120 may be a smart device, laptop, desktop, server, etc. Examples of smart devices may include smartphones, tablets, smart watches, and smart glasses. As illustrated in FIG. 1A, the computing system 120 may include a smartphone having a touch screen interface 144. The smartphone may include the computing system 120 including the imaging device 116. In such an embodiment, the computer readable instructions are in the form of application software (app) loaded into the smartphone's memory. After the depression 128 is created, the user may capture an image 124 of the depression using the smartphone's imaging device 116 and touch screen interface 144.

[0040]

[0048] Although the pattern 104 is illustrated as part of the flexible sheet substrate 132, the pattern 104 may be provided through different media. For example, the pattern 104 may be drawn on the patient using a marker, the pattern 104 may be projected onto the skin 112 by a light projector, or the pattern 104 may be part of a permanent or temporary tattoo, etc. The pattern 104 may include a series of parallel lines, each arranged horizontally and positioned above and below each other. The pattern 104 may include a series of parallel lines, each arranged vertically and positioned side by side. The pattern 104 may include a series of parallel lines arranged diagonally. The pattern 104 may include a grid pattern including multiple vertical and horizontal lines that cross each other. The pattern 104 may include a series of dots, a series of wavy lines, a series of zigzags, or any pattern that is preloaded on the memory 126 and can be recognized by the computing system 120. In the case of a series of parallel lines, the pattern may comprise, for example, at least three, at least four, at least five, at least six, or more parallel lines.

[0041]

[0049] The flexible sheet substrate 132 may further include a plurality of markers 136 surrounding the pattern 104, such as a quick response (QR) code. The plurality of markers 136 may include a marker at each corner of the flexible sheet substrate, at three of the four corners of the flexible sheet substrate, at an arc that partially surrounds the pattern, or at a circle that surrounds the pattern, etc. Each marker of the plurality of markers 136 may independently be any shape, such as a circle, a square, a rectangle, a triangle, a trapezoid, a star, or another shape. As illustrated in FIG. 1A, the markers 136 may include a circle disposed at each of the corners of the flexible sheet substrate 132. The plurality of markers 136 allows the computing system 120 to perform geometric calculations to determine where and at what angle the imaging device 116 is located relative to the pattern 104.

[0042]

[0050] When the computing system 120 and the imaging device 116 are part of a smart device, the app may guide the user to capture an image. For example, the smart device may include a display. The app may guide and prompt the user to capture an image that may be readable by the computing system 120 by displaying brackets, rectangles, squares, lines, dots, or other imaging guides on the display that overlay the live feed from the imaging device 116. The app prompts the user to capture an image when the pattern 104 is within the imaging guide during the live feed of the imaging device 116. This ensures that the computing system 120 can process the captured image to determine the depth of the depression 128. The app may also provide a timer for the computing system 120 to measure a period of time. For example, the timer may be activated by the user pressing an activator on the touch screen interface 144 when pressure is released from the skin 112. The timer may automatically stop when the image is captured by the user. The amount of time between when pressure is released and when the image is captured may be recorded. The amount of time may be superimposed on the image or otherwise merged with the image data. The length of time between when pressure is released and when the image is captured may be used to adjust, calibrate, or correct the image data or the processor may separately calculate a score for the depression based in part on the length of time. If the length of time between when pressure is released and when the image is captured is too long, an error message or signal may be sent and / or generated.

[0043]

[0051] As described above, the computing system 120 processes the image data by measuring the distortion of the pattern 104 caused by the depression 128 and uses the distortion to determine the depth of the depression 128 in the patient 108. The computing system 120 can first perform a geometric calculation to determine the angle of the imaging device 116 relative to the skin 112 of the patient 108 at the location of the pattern 104, which can be done by using a number of markers 136. The distance between the markers 136 can be preloaded on the memory 126 of the computing system 120. The computing system 120 can determine the angle by calculating the difference between the distance of the markers 136 in the image compared to the actual distance between the markers 136 on the flexible sheet substrate 132 and then calculating the relative angle. Once the angle is determined, the computing system 120 can use the angle and the distortion of the pattern 104 to determine the depth of the depression 128 in the patient 108. The pattern 104 can be preloaded on the memory of the computing system 120. Computing system 120 may compare the pattern 104 on the image with a pre-loaded version of pattern 104 to determine the degree of distortion of pattern 104 and thereby the depth of depression 128. The depth of depression 128 may be displayed on the display of computing system 120, the display of remote computing system 140, both, or not at all.

[0044]

[0052] Once the depth of the dent 128 is determined, the computing system 120 may assign a severity level of the dent 128 and display the severity level to the user, a remote physician, a caregiver, or a care partner, etc. For example, the level may be based on a scale, such as a three-point scale or a four-point scale. An exemplary four-point scale may include level 1, with slight indentation, level 2, with some indentation, level 3, with deep indentation, and level 4, with severely deep indentation. The computing system 120 may thereby determine the severity of the dent 128 and display the severity to the user, a remote physician, a caregiver, or a care partner, etc. Other types of grading scales may be used and presented on the display.

[0045]

[0053] Computing system 120 may further include a wireless transmitter 130 that wirelessly transmits data over wireless network 148. For example, computing system 120 may transmit data over the Internet to a remote computing system 140 or a remote server. The image data may be processed on computing system 120, at the remote computing system 140, or both. The processed and unprocessed image data, as well as the severity level, may be stored on a memory of computing system 120, on a memory of the remote computing system 140, on a remote server, such as a cloud-based server, or a combination thereof.

[0046]

[0054] Determining the depth of the dentition 128 may be performed on the computing system 120 hardwired to the imaging device 116, on the remote computing system 140, or both. For example, a user may capture image data and the depth may be calculated on an app on a smart device. Once the depth of the dentition 128 is calculated, the depth data including the depth of the dentition 128, the severity level, or both, may be transmitted to the remote computing system 140 via a wireless network 148. In certain embodiments, a user may capture image data, which is then transmitted to the remote computing system 140 via a wireless network 148 for the remote computing system 140 to determine the depth of the dentition 128, the severity level, or both.

[0047]

[0055] In addition, the image data, depth data, or both may be combined with other diagnostic data to be transmitted to the remote computing system 140. Other diagnostic devices capturing the patient's diagnostic data may communicate with the computing system 120 via BLUETOOTH, WIFI, or other wired or wireless connections to combine the diagnostic data with the image data, depth data, severity level, or combinations thereof. For example, the patient's heart rate, blood pressure, video screening, audio screening, or other diagnostic data may be captured by one or more diagnostic devices and transmitted wired or wirelessly to the computing system 120 or a central computing hub. The diagnostic data may be combined with the image data, depth data, severity level, or combinations thereof as a data package, and the data package may be transmitted to the remote computing system 140 for review by a remote physician, etc.

[0048]

[0056] The remote computing system 140 may be at a clinic, dialysis clinic, doctor's office, medical office, hospital, caregiver location, or veterinary practice, etc. The system 100 of the present invention allows a remote patient to transmit diagnostic data, image data, depth data, severity level, or combinations thereof to the remote physician's remote computing system 140 so that the remote physician can remotely diagnose the patient. Thus, the present invention can be used to prevent exposure of a patient to environments conducive to disease or other viral and bacterial infections, such as COVID-19. Once the remote physician receives the diagnostic data, image data, depth data, severity level, or combinations thereof and the depth of the cupping 128 is determined, the remote physician can determine the degree of the patient's edema and prescribe an appropriate treatment. Additionally, each of the diagnostic data, image data, depth data, severity level, or combinations thereof may be stored on the memory of either the computing system 120, the remote computing system 140, or a remote server. Multiple cupping depths captured over time may be saved and compared. The images over time can be processed to provide a time lapse or the like to determine if the patient's health is improving or deteriorating.

[0049]

[0057] 2 illustrates a cross-sectional view of an edema measurement sheet including a flexible sheet substrate 232. The flexible sheet substrate 232 may include an upper flexible layer 206 and a pattern layer or pattern 204. The upper flexible layer 206 may be placed against the patient's skin such that the pattern 204 covers a portion of the skin. The upper flexible layer 206 may be attached to the skin by adhesive, by electrostatic forces, by frictional charging, by being held by a user, etc.

[0050]

[0058] The flexible sheet substrates 232 may each independently have a width and length of 1 inch to 10 inches, 2 inches to 8 inches, 4 inches to 6 inches, or 5 inches. The flexible sheet substrates 232 may have a thickness of 6 μm to 6 mm, 10 μm to 2 mm, 20 μm to 1 mm, or 50 μm to 0.5 mm. The flexible sheet substrates 232 may be any shape, such as, for example, a square, a rectangle, a circle, an oval, or a trapezoid, and may have a flat profile made of a flexible and stretchable material. For example, the flexible sheet substrate 232 may have a rectangular shape with four corners. The flexible sheet substrate 232 may be stretchable 10% to up to 50%, 15% to up to 45%, 20% to up to 40%, 25% to up to 35%, or 30% beyond its rest length, rest width, or both. The upper flexible layer 206 may be made from a stretchable material, such as, but not limited to, a flexible fabric, a flexible polymer, or a combination thereof. Flexible polymers may include thin sheets of polyethylene, polypropylene, ethylene vinyl acetate (EVA), polyurethane, and the like.

[0051]

[0059] The top flexible layer 206 may have a top surface 218 and a bottom surface 220. The top flexible layer 206 further includes a pattern 204 that is visible when looking at the top surface 218. As illustrated in Figure 2, the pattern 204 is printed or attached to the top surface 218 of the top flexible layer 206. Alternatively, the pattern 204 may be etched into the top surface of the top flexible layer 206, embedded within the top flexible layer 206, screen printed on the top flexible layer 206, laser printed on the top flexible layer 206, etc.

[0052]

[0060] Top flexible layer 206 may include any color that contrasts with the color of pattern 204 so that pattern 204 is easily visible. For example, top flexible layer 206 may be white and pattern 204 may be black, or vice versa. In certain embodiments, top flexible layer 206 may be opaque and pattern 204 may include a dark color that is easily visible when placed on a patient's skin.

[0053]

[0061] The flexible sheet substrate 232 may further include an adhesive layer 210. The adhesive layer 210 may include a first surface adhered to the bottom surface 220 of the top flexible layer 206. The adhesive layer 210 may also have an adhesive surface opposite the first surface. The adhesive forming the adhesive layer 210 may be flexible enough to conform to the skin, may be non-irritating to the skin, may be free of chemicals that cause chemical irritation, may be free of properties that cause physical irritation, and may be moisture permeable. For example, the adhesive may be selected from a synthetic rubber adhesive, a styrene-isobutylene-styrene copolymer adhesive, a polyurethane adhesive, a polysiloxane adhesive, a natural rubber adhesive, a polyether adhesive, an acrylic adhesive, a wax adhesive, or a combination thereof. The adhesive may contain various additives as necessary, for example, plasticizers typified by polyhydric alcohols such as glycerol, polyethylene glycol, and polypropylene glycol, water-based or water-absorbent resins such as polyacrylic acid, crosslinked polyacrylic acid, and polyvinylpyrrolidone, rosin, terpene, petroleum-based tackifiers, softeners, fillers, pigments, and thickeners. The adhesive layer 210 is removably adhered to the patient's skin, for example, so as to adhere firmly to the skin but not cause lacerations, other damage, or rashes when removed from the skin. For example, the adhesive strength may be 10 g / inch to 200 g / inch, 30 g / inch to 150 g / inch, 40 g / inch to 100 g / inch, 50 g / inch to 70 g / inch, or 60 g / inch.

[0054]

[0062] A removable protective liner 214 can be adhered to the lower adhesive surface of the adhesive layer 210 and can cover the adhesive layer 210. The removable liner 214 can protect the adhesive layer 210 from debris and moisture and can preserve the adhesive properties of the adhesive layer 210. The removable liner 214 can be peeled away from the lower adhesive surface, thereby exposing the adhesive surface so that the edema measurement sheet can be adhered to the patient's skin when ready for use.

[0055]

[0063] Figure 3 is a cross-sectional view of a flexible sheet substrate 332 in which a removable liner has been peeled away from an adhesive layer 310 and the adhesive layer 310 has been adhered to a patient's skin 312. As illustrated in Figure 3, a depression 328 has been formed in the patient 308, distorting the pattern 304. The imaging device 316 of the computing system 320 is configured to capture image data of the depression 328, and the computing system 320 is configured to determine a depth of the depression 328 based on the distortion of the pattern 304.

[0056]

[0064] FIG. 4 illustrates a container 450 housing a plurality of edema measuring sheets 432. The container 450 may include an opening 458 and a lid 454 that may cover the opening or may be hinged to allow access to the edema measuring sheets 432. The lid 454 may be connected to the container 450 by a hinge, friction fit, clasp, lock, string, magnet, or the like. A plurality of edema measuring sheets 432 as described herein may be disposed in the container 450. Each of the plurality of edema measuring sheets 432 may include a removable liner that protects the adhesive surface of the respective edema measuring sheet 432. Alternatively, the edema measuring sheets 432 may be stored in the container 450 in the form of a roll. The lid 454 may be opened to expose the edema measuring sheets 432, thereby allowing at least one edema measuring sheet 432 to be removed and used. The edema measuring sheets 432 may be disposable or reusable and may be placed back into the container 450. After removing the edema measuring sheet 432, the lid 454 can be closed and the container 450 can be stored. The edema measuring sheet 432 can be packaged and shipped in the container 450. Additionally, the container 450 can be used to store the edema measuring sheet 432 at a patient's home, a doctor's office, clinic, hospital, or veterinary practice, etc.

[0057]

[0065] FIG. 5 illustrates a method for measuring edema, involving several steps 500. Step 500 may involve placing a pattern 504 against a surface of a patient's skin 512 at a location and indenting a portion of the patient's skin at the location of the pattern 504. The indentation may be a force sufficient to cause the patient to form a depression 528. Step 500 may involve measuring a distortion of the pattern 504 caused by the depression 528 in the patient. The measurement may determine a depth of the depression 528 in the patient. Based on the measured, determined, or calculated depth, an appropriate treatment for the patient may be known and prescribed. Edema may be monitored over time.

[0058]

[0066] The pattern 504 includes a series of parallel lines or another pattern 504 as described herein. The pattern 504 may be part of a sheet of stretchable material 532, may be a light projection, may be drawn on the skin 512 by a marker, may be part of a temporary or permanent tattoo, or the like. The sheet 532 may be configured to distort along and contour into a depression 528 created in the patient. Step 500 may involve placing the pattern 504 against a surface of the skin by adhering a lower surface of the sheet of stretchable material 532 to the surface of the skin 512 at the location. Alternatively, the sheet 532 may be stuck to the skin 512 by electrostatic forces or may be held against the skin 512 by a user. The placement may result in the pattern 504 being visible by looking at the top surface of the sheet 532. The sheet of stretchable material 532 may further include a plurality of markers 536 surrounding the pattern 504. The sheet of extensible material 532 may include a plurality of corners, and at least some of the plurality of markers 536 may be disposed at each corner of the plurality of corners. The method 500 may involve capturing image data including an image 524 of the pattern 504 against a surface of the patient's skin 512 with an imaging device. The step 500 may involve capturing image data including an image 524 of the depression 528 at the location with an imaging device. The step of measuring the distortion of the pattern 504 may include processing the image data. The processing of the image data may be performed by a computing system 520. The computing system 520 and the imaging device may be part of a smart device, for example, part of the same smart device. The smart device may be selected from a smartphone, a tablet, a smart watch, and smart glasses, etc. The smart device may be a smartphone having a touch screen interface 544.

[0059]

[0067] Step 500 may further include transmitting image data from the imaging device to a remote computing system 540, for example, via a wired or wireless network 548. The remote computing system 540 may be at a clinic, and step 500 may include wirelessly transmitting image data from the imaging device to the remote computing system 540 at the clinic. In various embodiments, the image data may be wirelessly transmitted to the remote computing system 540 as a live stream video. Method 500 may further include storing the image data, depth data, severity level score, or a combination thereof in a memory of either computing system 520, remote computing system 540, or remote server. Multiple cupping depths may be compared. Images 524 may be further processed by computing system 520 and / or remote computing system 540. A time-lapse sequence, series, video, or the like may be generated to determine whether the patient's health is improving or worsening over time. The method comprising step 500 allows the patient to provide important information to a physician that the physician can use to evaluate the patient's edema without the need for a clinic visit. The method allows for results, recommendations, and questions to be discussed during a remote medical consultation between a physician and a patient.

[0060]

[0068] FIG. 6 is a side view of an exemplary embodiment in which a pattern is projected in the form of light onto the skin 612 of a patient 608 without the need for a flexible sheet. The light pattern may be projected onto the skin by a pattern projector 650, which may project any type of visible light, such as laser light. The imaging device 616 and the computing device 620, including the pattern projector 650, may all be part of the same smart device or may be part of separate devices from each other. In certain embodiments, the pattern projector 650 may be separate from the smart device and may be removably attached to the smart device. For example, the pattern projector 650 may be part of an adapter that is removably attached to the smart device by clips, adhesive, magnets, strings, mating slots, or the like. The pattern projector 650 may include an attachment and may be configured to be mounted over the flashlight function of a cell phone device.

[0061]

[0069] As shown in Figure 6, pressing against the skin 612 creates a depression 628 in the patient 608. A pattern projector 650 projects light 654 in the form of a pattern onto the depression 628. The light pattern is distorted due to the depression 628. An imaging device 616 captures an image of the distorted light pattern and the depression 628. A computing system 620 compares a pre-loaded pattern with the captured distorted light pattern and calculates the depth of the depression 628.

[0062]

[0070] FIG. 7 is a partial schematic diagram of an embodiment of the present invention in which multiple non-adhesive pattern sheets are arranged in a stack, generally designated 730. Each non-adhesive pattern sheet in the stack is disposed in intimate contact with its nearest neighbors (or one neighbor in the case of the first and last sheets). A biasing mechanism may be provided to keep the non-adhesive pattern sheets in pressed engagement. Each non-adhesive pattern sheet is composed of at least two layers. The two layers are composed of materials that differ from each other in terms of their triboelectric properties. A first outermost layer of each non-adhesive pattern sheet in the stack is disposed facing a forward direction, and an opposite outermost layer of each non-adhesive pattern sheet is disposed facing a reverse direction. Triboelectric charging is generated by peeling the non-adhesive pattern sheet 720 from the stack 730. Note the plus (+) and minus (-) symbols in FIG. 7 to indicate positive and negative surface charges upon peeling. Conveniently, the non-adhesive pattern sheets of the present invention may be provided for use with a dispenser, such as a dispenser configured to hold, for example, 50 or 100 non-adhesive pattern sheets.

[0063]

[0071] FIG. 8 illustrates a dispenser 828 for non-adhesive pattern sheets having a charge-imparting member 832 mounted near an orifice 834 through which an individual non-adhesive pattern sheet, such as sheet 820, can be drawn. The charge-imparting member 832 may comprise a vinyl or styrofoam member mounted in the orifice of the dispenser 828 through which a new non-adhesive pattern sheet is drawn. For example, the vinyl member may include a surface portion arranged to be forced into contact with the non-adhesive pattern sheet drawn through the orifice, thereby providing a means for contact charging. The vinyl member may be bonded to the body of the dispenser 828 by a suitable insulating adhesive that does not adversely affect its electrostatic properties. An electrostatic generator may be mounted on the dispenser to impart a persistent electrostatic charge to the cover when the cover is removed from the dispenser.

[0064]

[0072] The entire contents of all references cited in this disclosure are incorporated herein by reference in their entirety.Furthermore, when an amount, concentration, or other value or parameter is given as a range, a preferred range, or a list of a preferred upper value and a preferred lower value, this should be understood as specifically disclosing all ranges formed from any pair of any upper range or preferred value and any lower range or preferred value, regardless of whether such ranges are disclosed separately.When a range of numerical values ​​is described herein, unless otherwise stated, the range is intended to include its end points, and all integers and fractions within the range.It is not intended that the scope of the present invention be limited to the specific values ​​described when defining the range.

[0065]

[0073] All patents, patent applications, and publications mentioned herein are incorporated by reference in their entirety unless otherwise indicated.

[0066]

[0074] Other embodiments of the invention will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the invention being indicated by the following claims and equivalents thereof.

Claims

1. 1. A system for measuring edema, comprising: a flexible sheet substrate including a pattern configured to be placed on a surface of a patient's skin; an imaging device configured to capture image data including an image of the pattern while the flexible sheet substrate is on the surface of the skin of the patient; A computing system including a processor and a memory; wherein the memory stores computer readable instructions that, when executed by the processor, configure the computing system to process image data captured by the imaging device, the image data comprising at least an image of the pattern at a location on the surface of the skin of the patient and a depression in the patient at the location, and processing the image data comprises measuring a distortion of the pattern caused by the depression to determine a depth of the depression in the patient.

2. 10. The system of claim 1, wherein the flexible sheet substrate comprises an extensible material and has an upper surface and a lower surface, the pattern being visible from the upper surface and the lower surface being configured to be adhered to the skin of the patient at the locations.

3. The flexible sheet substrate includes: an upper flexible layer having said top and bottom surfaces; an adhesive layer having a first surface adhered to the bottom surface of the upper flexible layer and an adhesive surface opposite the first surface; a removable liner adhered to the adhesive surface and configured to protect the adhesive surface; The system of claim 2 , comprising:

4. 2. The system of claim 1, wherein the flexible sheet substrate further comprises a plurality of markers surrounding the pattern, the image data further comprises an image of the plurality of markers, and upon execution of the computer readable instructions by the processor, the computing system is configured to use the plurality of markers to determine an angle of the imaging device relative to the location on the surface of the skin.

5. The system of claim 4 , wherein the flexible sheet substrate comprises a plurality of corners, and each of the plurality of markers is disposed at a respective corner of the flexible sheet substrate.

6. An edema measurement sheet, an upper flexible layer of extensible material, said upper flexible layer having an upper surface and a lower surface and including a pattern visible when viewed at said upper surface; an adhesive layer adhered to the lower surface of the upper flexible layer and configured to be removably adhered to the patient's skin; Equipped with the pattern comprises a series of at least four parallel lines and a grid comprising a plurality of markers surrounding the series of parallel lines; An edema measuring sheet, wherein when the edema measuring sheet is adhered to a location on the skin of the patient and the location on the skin is indented to form a depression in the patient, the edema measuring sheet is configured to extend into the depression and contour along the depression so that the pattern is distorted.

7. The edema measuring sheet according to claim 6 , wherein the upper flexible layer comprises a plurality of corners, and the plurality of markers includes at least one respective marker disposed at each corner of the plurality of corners.

8. A container having an opening and a lid covering said opening, wherein a plurality of the edema measuring sheets according to claim 6 are disposed in said container.

9. 1. A method for measuring edema, comprising: placing a pattern against a surface of the patient's skin at a location; indenting a portion of the skin of the patient at the location of the pattern to create a depression in the patient; measuring a distortion of the pattern caused by the indentation in the patient to determine a depth of the indentation in the patient; A method comprising:

10. 10. The method of claim 9, wherein the pattern is part of a sheet of extensible material, the sheet distorting to contour to the depression in the patient.

11. 11. The method of claim 10, wherein the step of placing the pattern against the surface of the skin comprises adhering an underside of the sheet to the surface of the skin at the location such that the pattern is visible by looking at an upper side of the sheet.

12. 10. The method of claim 9, further comprising capturing image data including an image of the pattern and the depression at the location relative to the surface of the skin of the patient with an imaging device, and wherein measuring the distortion of the pattern comprises processing the image data.

13. The method of claim 12 , further comprising wirelessly transmitting the image data from the imaging device to a remote computing system over a wireless network.

14. 10. The method of claim 9, wherein placing the pattern against the surface of the skin of the patient comprises projecting a light pattern against the surface of the skin of the patient.

15. 10. The method of claim 9, wherein placing the pattern against the surface of the skin of the patient comprises transferring a temporary tattoo of the pattern to the surface of the skin of the patient.

Images