Limb lymphedema air pressure detector

By designing a limb lymphedema barometric pressure detector, and utilizing a vacuum pump and various detection instruments, the accuracy and safety issues of limb lymphedema detection in existing technologies have been solved, achieving high-precision limb volume measurement and ease of operation.

CN120938409APending Publication Date: 2025-11-14高嵘
View PDF 0 Cites 0 Cited by

Patent Information

Application Number
CN202511168846.0
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-08-20
Publication Date
2025-11-14

AI Technical Summary

Technical Problem

Existing methods for detecting limb lymphedema are highly subjective, have poor accuracy, and involve expensive equipment or radiation risks. Traditional water replacement methods have large errors and are difficult to accurately detect the degree of edema.

Method used

A limb lymphedema barometric pressure detector was designed. It utilizes a vacuum pump to create a negative pressure environment and combines a gas volume flow meter, a barometer, and a temperature detector. Through an elastic sleeve and an inner and outer cylinder structure, it measures the limb volume in real time, reducing temperature and pressure interference. It is equipped with a display screen and operation buttons to control the detection process.

Benefits of technology

It improves the accuracy and safety of edema detection, reduces errors, ensures hygiene and safety and ease of operation during the detection process, and achieves high-precision limb volume measurement.

✦ Generated by Eureka AI based on patent content.

Smart Images

  • Figure CN120938409A_ABST
    Figure CN120938409A_ABST
Patent Text Reader

Abstract

The invention provides a limb lymphedema air pressure detector, and mainly relates to the technical field of limb lymphedema air pressure detection equipment. A limb lymphedema air pressure detector comprises a machine shell, supporting legs arranged at the bottom of the machine shell and a controller, a detection inner cylinder is arranged in the machine shell and communicated with a vacuum pump, an opening communicated with the detection inner cylinder is formed in the center of the top face of the machine shell, an elastic oversleeve is fixedly installed at the top of the opening, and the elastic oversleeve is fixedly connected with the controller. A gas inlet of the vacuum pump is fixedly connected with one end of a gas suction pipe, the other end of the gas suction pipe is communicated with the detection inner cylinder, and a gas volume flowmeter communicated with the gas suction pipe is arranged in the middle of the gas suction pipe. The device has the advantages that a negative pressure environment is formed through air exhaust of the vacuum pump, the air exhaust amount is measured in real time through the gas volume flow meter, the volume of limbs can be accurately measured, and compared with a traditional water replacement method, the water surface height reading error is avoided, and the edema degree detection accuracy is greatly improved.
Need to check novelty before this filing date? Find Prior Art

Description

Technical Field

[0001] This invention relates to the technical field of limb edema gas detection equipment, specifically a limb lymphedema gas pressure detector. Background Technology

[0002] Lymphedema is a disease caused by dysfunction of the lymphatic system, resulting in the abnormal accumulation of lymph fluid in the interstitial spaces. Limb lymphedema, as a common type, seriously affects patients' physical health and quality of life. Early and accurate diagnosis is crucial for developing treatment plans and slowing disease progression. Traditional methods for detecting limb lymphedema, such as physical examination, rely on the doctor's clinical experience, are highly subjective, and are difficult to quantify the degree of edema. Bioelectrical impedance analysis is easily affected by the patient's physical condition and the measurement environment, resulting in poor accuracy. Although imaging examinations such as MRI and CT can provide detailed anatomical information, the equipment is expensive, the examination process is cumbersome, and there are radiation risks, making them unsuitable for large-scale screening and frequent testing.

[0003] In existing technologies, the degree of edema is generally detected by water replacement method. A certain amount of water is placed in a steel barrel of a specific size, and then the limb is placed in the barrel for a certain length. The volume of the limb is calculated based on the change in water level. However, this method has a large error when reading the water level, which affects the detection results. Summary of the Invention

[0004] To address the shortcomings of existing technologies, this invention provides a limb lymphedema barometric pressure detector, achieved through the following technical solution: A limb lymphedema barometric pressure detector includes a housing, a support foot disposed at its bottom, and a controller. The housing contains a detection inner cylinder, which is connected to a vacuum pump. The center of the top surface of the housing has an opening communicating with the detection inner cylinder. An elastic sleeve is fixedly installed on the top of the opening. The air inlet of the vacuum pump is fixedly connected to one end of a suction pipe, and the other end of the suction pipe is connected to the detection inner cylinder. A gas volume flow meter communicating with the middle of the suction pipe is disposed. A pressure regulating component is disposed on the top surface of the housing. Furthermore, an outer detection cylinder is integrally fixedly installed on the outside of the inner detection cylinder. The outer wall of the inner detection cylinder has several through holes communicating with the outer detection cylinder. One end of the suction pipe penetrates the bottom of the outer detection cylinder and is fixedly connected to it.

[0005] Furthermore, a pressure detector and a temperature detector are fixedly installed on the bottom surface of the inner wall of the outer cylinder.

[0006] Furthermore, the gas volume flow meter has a temperature compensation function.

[0007] Furthermore, the pressure regulating assembly includes a pressure relief pipe and a sealing cap. One end of the pressure relief pipe is fixedly connected to the upper part of one side of the inner cylinder of the detection chamber, and the pressure relief pipe vertically penetrates one side of the top surface of the housing and is fixedly connected thereto. A removable sealing cap is provided at the external opening of the pressure relief pipe.

[0008] Furthermore, the elastic sleeve has a multi-layer composite structure, comprising, from the inside out, a skin-friendly and breathable inner layer, an elastic cushioning middle layer, and a wear-resistant and waterproof outer layer; the skin-friendly and breathable inner layer is made of soft cotton or silk to provide a comfortable limb contact experience; the elastic cushioning middle layer is made of highly elastic rubber or silicone to adapt to different limb shapes and provide cushioning; the wear-resistant and waterproof outer layer is made of nylon or polyurethane to improve the sleeve's durability and waterproof performance.

[0009] Furthermore, the housing is also equipped with a display screen and operation buttons. The display screen is electrically connected to the controller and is used to display the detection data of the barometer, temperature detector and gas volume flow meter in real time. The operation buttons include a power switch and a vacuum pump start / stop button to accommodate the detection of lymphedema in the limbs.

[0010] Furthermore, this also includes disposable limb sleeves with an opening at the top.

[0011] Furthermore, a loop fastener is fixedly installed on one side of the elastic sleeve, and a restraint strap is fixedly installed on the other side of the elastic sleeve. A hook fastener that matches the loop fastener is fixedly installed on the inner side of the restraint strap.

[0012] Compared with the prior art, the beneficial effects of the present invention are: 1. This detection device creates a negative pressure environment by using a vacuum pump. A gas volumetric flow meter measures the pumped air volume in real time. Combined with data from a barometer and a temperature detector, it accurately measures limb volume. Compared to the traditional water displacement method, this avoids errors in water level readings and significantly improves the accuracy of edema detection. Furthermore, the gas volumetric flow meter has a temperature compensation function, and the device analyzes data from the temperature detector, reducing the interference of temperature changes on gas volumetric flow measurement and further enhancing detection accuracy.

[0013] 2. The outer detection cylinder is fixedly installed as an integral part of the inner cylinder. A through-hole is provided on the outer wall of the inner cylinder to create a buffer space between the limb and the electrical components inside the outer cylinder, preventing direct contact between the patient and the electrical components and improving the safety of the device. Furthermore, the pressure regulating component ensures consistent internal pressure before and after the patient's limb is inserted into the inner cylinder.

[0014] 3. The machine casing is equipped with a display screen and operating buttons. Operators can easily control the start and stop of the detector and the working status of the vacuum pump using the buttons. The display screen shows the test data in real time, allowing operators to understand the test results promptly. Additionally, disposable limb covers are provided to effectively prevent cross-infection between different patients, ensuring hygiene and safety during the testing process. Attached Figure Description

[0015] Figure 1 This is a schematic diagram of the structure of the present invention; Figure 2 This is the front view of the present invention; Figure 3 It is along Figure 2 Schematic diagram of the cross-sectional structure along line AA; Figure 4 It is along Figure 3 Schematic diagram of the cross-sectional structure of the middle BB line; Figure 5 yes Figure 3 A magnified view of a portion of the image; Figure 6 This is a schematic diagram of the structure of the disposable limb sleeve of the present invention.

[0016] The following labels are shown in the attached diagram: 10, housing; 101, support foot; 102, elastic sleeve; 103, hook and loop fastener; 104, restraint strap; 105, hook and loop fastener; 20, inner detection cylinder; 201, through hole; 30, vacuum pump; 301, extraction pipe; 40, gas volume flow meter; 50, outer detection cylinder; 501, air pressure detector; 502, temperature detector; 60, pressure regulating component; 601, pressure relief pipe; 602, sealing cap; 70, disposable limb sleeve. Detailed Implementation

[0017] The present invention will be further described in conjunction with the accompanying drawings and specific embodiments. It should be understood that these embodiments are for illustrative purposes only and are not intended to limit the scope of the invention. Furthermore, it should be understood that after reading the teachings of this invention, those skilled in the art can make various alterations or modifications to the invention, and these equivalent forms also fall within the scope defined in this application.

[0018] Example 1: A limb lymphedema barometer like Figure 1-6 As shown, a limb lymphedema barometric pressure detector has the following specific structure: The device includes a housing 10, a support foot 101 at its bottom, and a controller. Inside the housing 10 is a detection inner cylinder 20 with a rectangular cross-section for easy insertion of the patient's leg. The detection inner cylinder 20 is connected to a vacuum pump 30. An opening communicating with the detection inner cylinder 20 is located at the center of the top surface of the housing 10. An elastic sleeve 102 is fixedly installed at the top of the opening, facilitating insertion and fixation of the patient's limb. The air inlet of the vacuum pump 30 is fixedly connected to one end of a suction pipe 301, the other end of which is connected to the detection inner cylinder 20. A gas volume flow meter 40 communicating with the middle of the suction pipe 301 is located therein. A pressure regulating component 60 is located on the top surface of the housing 10. The working principle described above is as follows: The patient's limb is inserted into the inner detection cylinder 20 through an opening at the center of the top surface of the housing 10 that communicates with the inner detection cylinder 20. The elastic sleeve 102 wraps around the limb, which can improve the sealing of the opening and prevent air leakage. The controller controls the vacuum pump 30 to start, and the vacuum pump 30 draws air from the inner detection cylinder 20 through the suction pipe 301 to create a negative pressure environment inside the inner detection cylinder 20. The gas volume flow meter 40 measures the volume flow rate of the gas in the suction pipe 301 in real time, and the pressure regulating component 60 can regulate the pressure inside the inner detection cylinder 20 to ensure that the internal pressure of the patient's limb is consistent before and after insertion into the inner detection cylinder 20, thereby improving the detection accuracy.

[0019] An outer detection cylinder 50 is integrally fixedly installed on the outside of the inner detection cylinder 20. The outer wall of the inner detection cylinder 20 has several through holes 201 communicating with the outer detection cylinder 50. One end of the suction pipe 301 penetrates the bottom of the outer detection cylinder 50 and is fixedly connected to it. The upper end of the suction pipe 301 is located between the inner detection cylinder 20 and the outer detection cylinder 50. During the vacuum pump 30's suction process, the gas inside the inner detection cylinder 20 enters the space between the inner detection cylinder 20 and the outer detection cylinder 50 through the through holes 201 on the outer wall of the inner detection cylinder 20, and is then extracted through the suction pipe 301. This structure provides a buffer space between the patient's limb and the outer detection cylinder 50, preventing the patient from contacting the electrical components inside the outer detection cylinder 50 and improving the safety of the device.

[0020] A pressure detector 501 and a temperature detector 502 are fixedly installed on the bottom surface of the inner wall of the outer detection cylinder 50. The pressure detector 501 and the temperature detector 502 detect the pressure and temperature data at the bottom surface of the inner wall of the outer detection cylinder 50 in real time. The pressure data can be used to determine whether the negative pressure state inside the inner detection cylinder 20 meets the detection requirements, while the temperature data can be used as an auxiliary parameter for temperature compensation and other processing when analyzing data such as gas volume flow rate, reducing the impact of temperature changes on gas volume flow rate measurement, thereby improving the accuracy of the detection data.

[0021] The gas volume flow meter 40 has a temperature compensation function. Since the gas volume flow rate is affected by temperature, the gas volume flow meter 40 with temperature compensation function will correct the measurement result based on the temperature data detected by the temperature detector 502 when measuring the gas volume flow rate, so as to eliminate the interference of temperature change on the gas volume flow rate measurement and further improve the detection accuracy of the device.

[0022] The pressure regulating assembly 60 includes a pressure relief pipe 601 and a sealing cap 602. One end of the pressure relief pipe 601 is fixedly connected to the upper part of one side of the inner detection cylinder 20, and the pressure relief pipe 601 vertically penetrates one side of the top surface of the housing 10 and is fixedly connected thereto. A removable sealing cap 602 is provided at the external opening of the pressure relief pipe 601. Before the patient's limb is inserted into the inner detection cylinder 20, the operator opens the sealing cap 602, allowing the inner detection cylinder 20 to communicate with the outside through the pressure relief pipe 601, thereby ensuring pressure balance between the inner detection cylinder 20 and the outside. After the patient's limb is inserted into the inner detection cylinder 20, the sealing cap 602 is closed, and the vacuum pump 30 starts to pump air. This ensures that the internal pressure of the inner detection cylinder 20 is the same before and after the patient's limb is inserted, avoiding the influence of sudden pressure changes on the detection results and improving the accuracy of gas detection.

[0023] The elastic sleeve 102 has a multi-layered composite structure, comprising, from the inside out, a skin-friendly and breathable inner layer, an elastic cushioning middle layer, and a wear-resistant and waterproof outer layer. The skin-friendly and breathable inner layer is made of soft cotton or silk to provide a comfortable limb contact experience. The elastic cushioning middle layer is made of highly elastic rubber or silicone to adapt to different limb shapes and provide cushioning. The wear-resistant and waterproof outer layer is made of nylon or polyurethane to improve the sleeve's durability and waterproof performance. When the patient's limb is inserted into the elastic sleeve 102, the skin-friendly and breathable inner layer directly contacts the limb, providing a comfortable feel; the elastic cushioning middle layer elastically deforms according to the limb shape, closely conforming to the limb and providing cushioning to reduce pressure on the limb; the wear-resistant and waterproof outer layer protects the internal structure from external environmental influences and prevents moisture from entering.

[0024] The housing 10 is also equipped with a display screen and operation buttons. The display screen is electrically connected to the controller and is used to display the detection data of the barometer 501, temperature detector 502, and gas volume flow meter 40 in real time. The operation buttons include a power switch and a vacuum pump 30 start / stop button to accommodate the detection of lymphedema in different limb areas. The display screen is electrically connected to the controller and receives the detection data transmitted by the barometer 501, temperature detector 502, and gas volume flow meter 40 in real time, and displays it on the screen. The operator controls the start and stop of the detectors using the operation buttons, such as the power switch, and controls the working status of the vacuum pump 30 using the vacuum pump 30 start / stop button to meet the detection needs of lymphedema in different limb areas.

[0025] Example 2: A limb lymphedema barometer It also includes a disposable limb sheath 70 with an open top. The disposable limb sheath 70 can effectively avoid cross-infection between different patients, ensure the hygiene and safety of the testing process, and comply with the usage specifications of medical equipment; specifically, a polyethylene film sheath can be used. The polyethylene film sheath is soft and easy to put on the limb, and the operation is simple and convenient, without causing additional pain and discomfort to the patient, and it is also convenient for the testing personnel to operate.

[0026] When measuring a limb, first, a disposable limb sleeve 70 is placed on the patient's arm or leg. Then, the patient's limb is slowly inserted into the inner detection cylinder 20 through the elastic sleeve 102. The sum of the volumes of the inner detection cylinder 20 and the outer detection cylinder 50 is the total volume of the air inside. When the patient's limb is inserted into the inner detection cylinder 20, some of the air inside the inner detection cylinder 20 is squeezed out. At this time, a vacuum pump 30 is used to evacuate the inner detection cylinder 20 and the outer detection cylinder 50, and the remaining air volume inside the inner detection cylinder 20 and the outer detection cylinder 50 is measured by a gas volume flow meter 40. The volume of the patient's limb is obtained by subtracting the remaining air volume from the volume of the inner detection cylinder 20 and the outer detection cylinder 50. By comparing the volume of the patient's limb before edema with the volume of the limb after edema, the degree of edema can be determined. Multiple measurements can be taken and the average value is taken when measuring the patient's limb volume.

[0027] One side of the elastic sleeve 102 is fixedly fitted with a loop fastener 103, and the other side is fixedly fitted with a restraint strap 104. The inner side of the restraint strap 104 is fixedly fitted with a hook-and-loop fastener 105 that mates with the loop fastener 103. When securing the patient's limb, medical personnel can hold the restraint strap 104 and wrap it around the elastic sleeve 102 and the limb, bringing the hook-and-loop fastener 105 on the inner side of the restraint strap 104 close to the loop fastener 103 on the other side of the elastic sleeve 102. Medical personnel can adjust the tightness of the restraint strap 104 according to the thickness of the patient's limb. When the appropriate tightness is achieved, the hook-and-loop fastener 105 and the loop fastener 103 are tightly fitted together, ensuring that the elastic sleeve 102 is securely and comfortably fixed to the patient's limb. The secured elastic sleeve 102 should neither restrict blood circulation to the limb due to excessive tightness nor cause air leakage during testing due to excessive looseness.

[0028] Example 3: A limb lymphedema barometer Based on Embodiment 1, the elastic sleeve 102 has a three-layer composite structure, comprising, from the inside out, a sealing and skin-friendly inner layer, an elastic cushioning middle layer, and a wear-resistant and waterproof outer layer. The elastic cushioning middle layer is made of silicone, and the wear-resistant and waterproof outer layer is made of polyvinyl chloride (PVC) coated nylon. This material has high strength, wear resistance, waterproofness, and tear resistance, effectively resisting external friction and liquid erosion, and extending the service life of the elastic sleeve 102. The sealing and skin-friendly inner layer is made of medical-grade thermoplastic polyurethane elastomer (TPU). This material has both good sealing performance, reducing gas leakage from the contact point between the limb and the sleeve during testing, and soft and skin-friendly properties, conforming to human skin without irritation. The overall thickness of the elastic sleeve 102 is controlled between 3 and 5 mm. The sleeve is designed to be millimeters thick to ensure both sufficient elastic deformation capacity and good structural strength. When the elastic sleeve 102 is applied to the patient's limb, the three-layer structure deforms in tandem within the normal operating air pressure range, allowing the elastic sleeve 102 to fit tightly against the limb surface of different thicknesses and shapes, forming an effective sealed space to prevent gas leakage during the test and ensure the accuracy and reliability of the test data.

[0029] The location of the controller described in this solution is set by the staff according to the actual situation during operation. The controller is used to control the electrical components used in this solution. The controller is an Intel processor, AMD processor, PLC controller, ARM processor, or microcontroller. It is used in conjunction with a motherboard, memory modules, storage media, and power supply. The power supply is AC power or a lithium battery. When a display screen is provided, a display card is also provided. For the operating principle of the controller, please refer to "Principles of Automatic Control", "Principles and Application Simulation Cases of Microcontrollers", and "Principles and Applications of Sensors" published by Tsinghua University Press. Other books in this field can also be consulted. Other automation control and electrical components not mentioned are knowledge well known to those skilled in the art and will not be described in detail here.

[0030] In explaining this invention, it should be noted that the terms indicating location are used only for ease of description and understanding, and are not intended to limit the installation location of specific technical features. Other possible installation methods are not excluded.

[0031] The serial numbers assigned to components in this document, such as "first," "second," etc., are merely used to distinguish the described objects and have no sequential or technical meaning. The terms "connection" and "linkage" used in this application, unless otherwise specified, include both direct and indirect connections (linkages). In the description of this invention, it should be understood that the terms "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," and "counterclockwise," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing the invention and for simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the invention.

[0032] In this invention, unless otherwise explicitly specified and limited, "above" or "below" the second feature can mean that the first and second features are in direct contact, or that they are in indirect contact through an intermediate medium. Furthermore, "above," "over," and "on top" of the second feature can mean that the first feature is directly above or diagonally above the second feature, or simply indicates that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature can mean that the first feature is directly below or diagonally below the second feature, or simply indicates that the first feature is at a lower horizontal level than the second feature.

[0033] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A limb lymphedema barometric pressure detector, comprising a housing (10), a support foot (101) disposed at its bottom, and a controller, characterized in that: The housing (10) is provided with a detection inner cylinder (20), which is connected to a vacuum pump (30). The center of the top surface of the housing (10) is provided with an opening that communicates with the detection inner cylinder (20). An elastic sleeve (102) is fixedly installed on the top of the opening. The air inlet of the vacuum pump (30) is fixedly connected to one end of the suction pipe (301). The other end of the suction pipe (301) is connected to the detection inner cylinder (20). A gas volume flow meter (40) is provided in the middle of the suction pipe (301) and communicates with it. A pressure regulating component (60) is provided on the top surface of the housing (10).

2. The limb lymphedema barometer according to claim 1, characterized in that: The outer cylinder (50) is integrally fixedly installed on the outside of the inner cylinder (20). The outer wall of the inner cylinder (20) has several through holes (201) that communicate with the outer cylinder (50). One end of the exhaust pipe (301) passes through the bottom of the outer cylinder (50) and is fixedly connected to it.

3. The limb lymphedema barometer according to claim 2, characterized in that: A pressure detector (501) and a temperature detector (502) are fixedly installed on the bottom surface of the inner wall of the outer cylinder (50).

4. The limb lymphedema barometer according to claim 3, characterized in that: The gas volume flow meter (40) has a temperature compensation function.

5. A limb lymphedema barometer according to claim 4, characterized in that: The pressure regulating assembly (60) includes a pressure relief pipe (601) and a sealing cap (602). One end of the pressure relief pipe (601) is fixedly connected to the upper part of one side of the inner cylinder (20), and the pressure relief pipe (601) vertically penetrates one side of the top surface of the housing (10) and is fixedly connected thereto. The external opening of the pressure relief pipe (601) is provided with a removable sealing cap (602).

6. The limb lymphedema barometer according to claim 1, characterized in that: The elastic sleeve (102) has a multi-layer composite structure, consisting of a skin-friendly and breathable inner layer, an elastic cushioning middle layer, and a wear-resistant and waterproof outer layer from the inside out. The skin-friendly and breathable inner layer is made of soft cotton or silk to provide a comfortable limb contact experience. The elastic cushioning middle layer is made of highly elastic rubber or silicone to adapt to different limb shapes and provide cushioning. The wear-resistant and waterproof outer layer is made of nylon or polyurethane to improve the durability and waterproof performance of the sleeve.

7. A limb lymphedema barometer according to claim 5, characterized in that: The housing (10) is also equipped with a display screen and operation buttons. The display screen is electrically connected to the controller and is used to display the detection data of the barometer (501), temperature detector (502) and gas volume flow meter (40) in real time. The operation buttons include a power switch and a vacuum pump (30) start / stop button to adapt to the detection of lymphedema in the limbs.

8. The limb lymphedema barometer according to claim 1, characterized in that: It also includes disposable limb sleeves (70) with an opening on the top surface.

9. A limb lymphedema barometer according to claim 1, characterized in that: One side of the elastic sleeve (102) is fixedly installed with a hook and loop fastener (103), and the other side of the elastic sleeve (102) is fixedly installed with a binding strap (104). The inside of the binding strap (104) is fixedly installed with a hook and loop fastener (105) that cooperates with the hook and loop fastener (103).

10. A limb lymphedema barometer according to claim 1, characterized in that: The elastic sleeve (102) has a three-layer composite structure, which includes a sealing and skin-friendly inner layer, an elastic cushioning middle layer and a wear-resistant and waterproof outer layer from the inside to the outside. The elastic cushioning middle layer is made of silicone, the wear-resistant and waterproof outer layer is made of polyvinyl chloride (PVC) coated nylon, and the sealing and skin-friendly inner layer is made of medical-grade thermoplastic polyurethane elastomer (TPU).