Smart adjustable compression garment with blood pressure measurement system

Abstract

The present invention relates to a smart adjustable compression garment for treating lymphoedema, which comprises a plurality of bandages (1) positioned horizontally and parallel with respect to one another and arranged consecutively or in sections, wherein each bandage (1) of the plurality of bandages is joined by a perpendicular bandage (4) by means of a seam in the central part thereof, and wherein the ends of the bandages (1) comprise a joining material (3) that allows same to be joined and / or fastened, wherein the joining material (3) can be formed by two strips of different fabrics that allow same to engage upon contact; and a protective case (10), wherein the garment is connected to a mobile application that collects and stores compression adjustment data and other clinical data.

Description

[0001] SMART ADJUSTABLE COMPRESSION GARMENT WITH TENSION MEASURING SYSTEM

[0002] TECHNICAL FIELD

[0003]

[0001] The present invention relates to the technical field of lymphatic rehabilitation devices, especially in the field of adjustable compression garments that can be elastic or inelastic with integrated electronic systems for monitoring the pressure exerted on an affected area.

[0004] STATE OF THE ART

[0005]

[0002] Lymphedema is known to affect more than 250 million people worldwide, causing stiffness and pain in the affected area, along with a high risk of infection, low self-esteem, and limitations in the patient's daily activities. Although compression therapy in lymphatic drainage is not standardized, the Rosidal K short stretch bandage is known to be indicated for phlebological and lymphological conditions for the treatment of acute and chronic lymphedema, edema, and venous insufficiency. This bandage produces low resting pressure and high working pressure, and can be used both day and night.However, it has disadvantages such as the long application time and the need for a specialized physiotherapist for its placement. It also suffers from a lack of functionality, as it is very restricted, and discomfort on the limb due to the thick texture of the bandages. Furthermore, there is no way to know the exact pressure and rigidity being applied to each affected area, since if applied improperly it can slip and exert pressure that is either too intense or too weak, causing blisters and, in the worst cases, necrosis due to high pressure.

[0003] In the field of patents, document US2023 / 0346605 is known, which refers to an apparatus for treating venous insufficiency. This apparatus includes a plurality of actuator assemblies that can be received on a user's limb and include a flexible element that integrates a body portion and two opposing end portions.The device may comprise sensors to measure or control tension / compression and may be between layers of the material and actuator devices that include a motor or servomotor and transmission to adapt the torque.

[0006]

[0004] Also known is document CA2901932, which focuses on a compression therapy apparatus and a method for applying compression therewith, including a bandage and a tension indicator attached to the bandage. The tension indicator may include a film having layers of liquid crystal droplets deposited on a polymer matrix that indicates tension by changing color under tension between the first and second ends of the bandage.

[0007]

[0005] For its part, document WO2018 / 209100 describes smart functional fabrics as therapeutic and diagnostic garments that use flexible wireless electronic devices to measure key therapeutic parameters and provide data to clinicians, and methods that use such devices and the devices described are multiplexed to allow the detection of multiple parameters of therapeutic interest and combinations of measured data for novel clinical metrics.

[0008]

[0006] Document WO2017 / 189926 describes systems, devices, and methods for providing active and / or passive compression therapy to a body part, which may include a compression device worn over a compression stocking. The compression device may have a pulley-based drive train that is powered by a motor to tighten and loosen compression elements, such as compression straps, and sensors may be used on the compression device and / or compression stockings to provide feedback for modulating the parameters of the compression treatment.

[0009]

[0007] Document WO20211 / 150619 refers to a feedback-controlled compression device that can be worn on the body and helps maintain proper blood pressure, reduce inflammation, and prevent clotting in the extremities. The compression device comprises a compression section; a housing that provides structural support for the compression section; an inner sleeve positioned between the housing and the body part being treated; and a tensioning system located in the housing and coupled to the inside of the sleeve, the tensioning system applying a quantity of compression to the body part being treated.

[0010]

[0008] Finally, document WO2015 / 188158 is known, which discloses a therapeutic system with gauges that can be applied to a compression garment. The compression produced by various parts of a compression garment can be precisely controlled, where the compression garment can be continuous or discrete to induce stretching of the garment in one or more portions of the affected area.

[0011]

[0009] In this sense, it is clear that there is an unmet need to provide a compression garment or therapeutic device with adjustable elastic or inelastic characteristics that is simple and can contain a circuit for reading strain gauges located in a plurality of bandages or wraps at strategic points of the affected area that allows measuring, monitoring and generating a record of the pressure exerted on the area to be treated during the rehabilitation of lymphedema in the first phase.

[0012] SUMMARY

[0013]

[0010] The present invention relates to an adjustable and intelligent compression garment comprising a plurality of bandages and strain gauges that allow precise control of the pressure exerted on an affected area for the rehabilitation of lymphedema in the first phase.

[0014] DESCRIPTION OF THE FIGURES

[0015]

[0011] Figure 1 shows a therapeutic device or intelligent adjustable compression garment according to the present invention, wherein an arrangement of a plurality of strain gauges (2) located in a plurality of bandages (1) of the compression garment is shown, wherein the plurality of bandages (1) comprises at their ends a joining material (3) for fastening.

[0016]

[0012] Figure 2 shows how the plurality of bandages of the smart adjustable garment can be adjusted by said joining material (3) that adjust the ends of each bandage (1).

[0017]

[0013] Figure 3 shows the internal configuration of a housing (10) to which the cables of the strain gauges (2) are connected and which comprises a microprocessor (5), a Bluetooth module (6), a battery charging module (7), a Li-Po battery (8) located between the rear housing (10a) and front housing (10b), and an on / off button (9).

[0014] Figure 4 shows how the compression garment or intelligent adjustable therapeutic device according to the present invention is placed on the leg and calf of a user and how the cables of the plurality of strain gauges are connected to the housing (10).

[0018]

[0015] Figure 5 shows an illustrative configuration of how the smart, adjustable compression garment can be distributed along a limb, for example, along the leg, calf and foot in a discontinuous manner.

[0019]

[0016] Figure 6 shows a modular diagram of the electronic circuit of the compression garment or intelligent adjustable therapeutic device according to the present invention.

[0020] DETAILED DESCRIPTION OF THE INVENTION

[0021]

[0017] The present invention refers to an adjustable and intelligent compression garment that is a bandage of elastic or inelastic material comprising a plurality of bandages (1) positioned horizontally and parallel to each other, located consecutively or in sections, wherein the bandages (1) of the plurality of bandages are joined together by a perpendicular bandage (4) in their middle part as can be seen in figure 1.

[0022]

[0018] The bandages (1) of each plurality of bandages have at their ends a joining material (3) that allows them to be joined and / or fastened, where the joining material (3) may consist of two strips of different fabrics that allow them to hook together upon contact, for example, a sail. The joining between the ends of each bandage (1) may also be made with any other joining material (3) that can join and connect the ends of each bandage (1) of the plurality of bandages (1).

[0023]

[0019] As shown in Figures 1 and 2, each bandage (1) may comprise one or more strain gauges (2) located along the longitudinal axis of each bandage (1), and the wires of each strain gauge (2) may be located along the perpendicular bandage (4) to ultimately connect said wires to a microprocessor (5) located inside a housing (10). The wires of the strain gauges (2) are joined at the top of the compression garment to form a single terminal cable to facilitate connection to the device.

[0024]

[0020] Strain gauges (2) correspond to sensors whose resistance varies with the applied pressure and allow the measurement of pressure as a change in electrical resistance through the microprocessor (5).

[0025]

[0021] In one embodiment of the invention, the compression garment and its bandages (1) can be non-stretch (inelastic) to promote a greater reduction in limb volume.

[0026]

[0022] In another embodiment of the invention, the compression garment with the strain gauges (2) is connected to the strain gauge reading circuit inside the protective housing (10) by means of cables that run along the perpendicular bandage (4).

[0027]

[0023] The protective casing (10) consists of a rear casing (10a) and a front casing (10b) and houses the processing unit (100) (Fig. 6) responsible for managing the garment's operation and collecting the pressure data generated by the strain gauges (2). This device can be an 8- or 32-bit microprocessor (5), with a minimum of 6 ADC pins, for the correct acquisition of the signals. It also controls the wireless communication with the corresponding module and the mobile application.

[0028]

[0024] The protective housing (10) is made of thermoplastic material and has a belt hook for attaching it to a belt during therapy sessions. It has two holes (11 and 12) for joining the two parts of the protective housing using bolts. It also has side openings for passing cables to the strain gauges and another for attaching an on / off switch (9).

[0029]

[0025] According to Figure 6, the charge controller and voltage regulator (101) is responsible for regulating the charge of the rechargeable battery (102), which can be Lithium polymer or Lithium ion, and maintaining a stable voltage for the proper functioning of the garment.

[0030]

[0026] The signal conditioning and amplification module (103) is responsible for conditioning and amplifying the signals generated by the strain gauges (2) strategically located on the compression garment. These signals represent the pressure exerted on specific points of the limb.

[0031]

[0027] The wireless communication module (104) allows the transmission of pressure data from the control unit to an external device with a mobile application. This wireless communication can be carried out using technologies such as Bluetooth or Wi-Fi.

[0028] The device also has a mobile application that displays a map of the limb, allowing the patient to apply the garment independently. The mobile application provides the pressure data obtained from the strain gauges (2) to guide the patient and / or physician in adjusting the bandages and ensuring correct distal-to-proximal decreasing pressure according to clinical guidelines for compression therapy in lymphedema.

[0032]

[0029] The mobile application requires that, upon first login, the patient's personal data, medical history, and the parameters previously established by the therapist or physician be registered. This allows both the patient and the specialist to access this data, providing a more complete record and overview of the disease treatment. Additionally, a calendar will be displayed showing the completion of compression sessions, as well as graphs illustrating the patient's progress in reducing the volume and circumference of the affected limb, which the patient will need to measure manually.

[0033]

[0030] For greater adherence to treatment, the mobile application will store and display the hours of use of the garment and the pressure of the bandages (1) of each bandage used over time.

[0034]

[0031] The mobile application is based on an algorithm for collecting and storing clinical information, risk factors, physical examination (limb appearance), and complementary tests related to the etiology and stage of lymphedema, in order to predict potential complications. The mobile application will obtain this data through simple questions that the patient will answer by selecting options. The more data entered, the more the diagnostic and predictive uncertainty will be reduced. The data will be stored in the cloud and compared with data from other patients to ensure the validity, sensitivity, and reproducibility of the algorithm, taking into account the biological variability of each individual.It is important to note that this function is not intended to replace medical care, but rather to standardize the treatment protocol and validate the diagnosis of lymphedema, since the treatment for this condition has not progressed as well as other diseases due to a lack of standardized quantitative data.

[0035]

[0032] The compression garment or therapeutic device for the treatment of lymphedema according to the present invention offers several advantages since, being a compression garment with joining material (3) at the ends, for example, Velcro, it allows personalized therapy according to the needs of the patient since, being adjustable, it ensures an optimal distribution of pressure during lymphatic rehabilitation therapy.

[0036]

[0033] Another advantage is the integrated electronic monitoring since the compression garment or therapeutic device incorporates a circuit with strain gauges (2) that are strategically placed in the garment to allow monitoring and recording of the pressure exerted on the affected area in real time, providing valuable data for health professionals to track progress and adjust treatment.

[0037]

[0034] Also, the compression garment or therapeutic device provides convenience and autonomy since the mobile application facilitates a map of the limbs and a guide for the independent application of the compression garment allowing patients to adjust the bandages or wraps (1) by themselves, guided by the pressure data shown in the mobile application, which improves comfort and allows patients to take an active role in their treatment.

[0038]

[0035] Another advantage is the improved comfort and functionality since the compression garment or therapeutic device according to the present invention is made of a material that can be elastic or inelastic, lightweight, waterproof, hypoallergenic and pleasant to the touch.

[0039]

[0036] Another pressure-related advantage is its optimization, as the device uses strain gauge measurements and an algorithm to guide the patient to achieve the ideal pressure in each specific area. This optimization is based on established clinical guidelines for lymphedema compression therapy, ensuring appropriate pressure levels and improved treatment outcomes.

[0040]

[0037] An additional advantage is the collection and analysis of data through the mobile application, which stores patient data, including pressure readings, treatment adherence, limb volume reduction, and circumference measurements. This comprehensive data allows healthcare professionals to track progress, assess treatment effectiveness, and make informed decisions.

[0041]

[0038] Finally, an additional advantage is standardization and protocolization since the device and mobile application, through data collection, allows the standardization and protocolization of the diagnosis and treatment of lymphedema, contributing to the establishment of validated diagnostic criteria and treatment guidelines.

Claims

CLAIMS 1. An adjustable and intelligent compression garment for the treatment of lymphedema, characterized in that it comprises a plurality of bandages (1) positioned horizontally and parallel to each other, located consecutively or in sections, wherein each of the bandages (1) of the plurality of bandages is joined together by a perpendicular bandage (4) by means of stitching in its middle part, and wherein the bandages (1) have at their ends a joining material (3) that allows their joining and / or fastening, wherein the joining material (3) can be made up of two strips of different fabrics that allow them to hook together upon contact, and further comprising a protective casing (10) to which the garment is connected and a mobile application that collects and stores compression adjustment data and other clinical data.

2. The smart, adjustable compression garment for the treatment of lymphedema according to claim 1, characterized in that it further comprises one or more strain gauges (2) located along the longitudinal axis of each of the bandages (1) and the wires of each strain gauge (2) are located along the perpendicular bandage (4) and are joined at the top of the compression garment to form a single terminal wire that is attached to the protective casing (10).

3. The smart, adjustable compression garment for the treatment of lymphedema according to claim 1, characterized in that the protective shell (10) consists of a back shell (10a) and a front shell (10b) and within it is a microprocessor (5), a Bluetooth module (6), a battery charging module (7), a Li-Po battery (8) and a power on / off button.

4. The smart, adjustable compression garment for the treatment of lymphedema according to claim 1, characterized in that the protective shell (10) is made of a thermoplastic material and has a belt hook fastener.

5. The smart, adjustable compression garment for the treatment of lymphedema according to claim 1, characterized in that the garment material is an elastic or inelastic, waterproof, lightweight, hypoallergenic and pleasant-to-the-touch material.

6. The smart, adjustable compression garment for the treatment of lymphedema according to claim 1, characterized in that the mobile application is based on an algorithm that collects data and stores clinical information and pressure data obtained by the strain gauges (2).

7. The smart, adjustable compression garment for the treatment of lymphedema according to claim 1, characterized in that the mobile application guides the patient or doctor in adjusting the garment and allows detailed monitoring of the treatment.

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