Compression device for femoral artery and vein

Abstract

The femoral artery and femoral vein compression device can realize controllable pressure, convenient carrying and real-time monitoring. The femoral artery and femoral vein compression device has a pressure device main body, which is in the shape of a cuboid and has a surface in contact with the human body, and the surface is an outward convex arc-shaped contact surface. A fixing device is used to fix the pressure device main body, and the pressure device main body comprises a double-layer inflatable air bag with an inflation system for adjusting the pressure by inflation or deflation. A flexible pressure sensing film is integrated in or near the double-layer inflatable air bag to monitor the actual pressure in real time. A control unit receives the actual pressure data from the flexible pressure sensing film, controls the pressure of the double-layer inflatable air bag according to the preset pressure value or user adjustment instruction, and a monitoring module displays the actual pressure data and counts the compression time.

Description

Technical Field

[0001] This utility model relates to a compression device for the femoral artery and femoral vein, and particularly to a vascular compression device after femoral artery / vein intervention. Background Technology

[0002] Femoral artery and vein puncture is a commonly used vascular interventional diagnostic and therapeutic technique in clinical practice, widely applied in cardiovascular angiography, stent implantation, and hemodialysis. Post-puncture, local pressure hemostasis at the puncture site is crucial to prevent complications such as bleeding and hematoma. Timely, effective, and safe local pressure is essential for the patient's rapid recovery and prognosis.

[0003] Currently, commonly used compression methods and devices after femoral artery / vein puncture in clinical practice mainly include: manual compression, which is the most traditional method, where medical staff directly press the puncture site with their fingers or palms; sandbag compression, where a sandbag of a certain weight is placed above the puncture site for compression; tourniquet / hemostat, where a tourniquet or hemostat is used for circumferential compression or local clamping; and balloon / fluid-filled compression hemostat, which uses an inflatable / fluid-filled balloon to generate pressure for local compression.

[0004] The manual compression method described above is simple and direct, but it suffers from drawbacks such as difficulty in controlling the pressure, easy fatigue, long compression time (usually 15-30 minutes or longer), affecting the work efficiency of medical staff, poor patient comfort, and a high risk of complications due to improper compression. The sandbag compression method is simple and easy to perform, freeing up the hands of medical staff, but it suffers from problems such as non-adjustable pressure, easy displacement, unstable compression effect, and difficulty in observing the puncture site. The tourniquet / hemostat method provides good hemostasis, but it is prone to excessive compression, causing serious complications such as distal limb ischemia and nerve damage, and suffers from poor comfort, making it difficult for patients to tolerate. The aforementioned pneumatic / liquid-filled compression hemostats offer relatively controllable pressure, reducing the workload of medical staff. However, some products are bulky, making them inconvenient to carry and use in specific locations (such as the femoral artery / vein). Furthermore, the pressure adjustment is not precise enough, failing to achieve fine-grained control. Most products lack visual monitoring functions, making it impossible to intuitively understand the puncture site. The fixation method is not comfortable or secure enough, making it prone to displacement. Additionally, the breathability and antibacterial properties need improvement.

[0005] Other specialized hemostatic devices besides those mentioned above include femoral artery hemostatic devices such as FemoStop. Although they offer visualization and pressure adjustment, they are relatively large, complex to operate, expensive, and require a learning curve.

[0006] In view of the above, the main clinical needs for compression hemostasis after puncture are as follows:

[0007] 1) Effective hemostasis: Quickly and reliably compresses the puncture site to stop bleeding and prevent hematoma formation.

[0008] 2) Controllable pressure: The pressure should be sufficient to stop bleeding, but excessive pressure should be avoided to prevent complications such as vascular occlusion, tissue ischemia and necrosis. An ideal compression device should provide precise and adjustable pressure.

[0009] 3) Comfort and safety: The compression device should be reasonably designed with a comfortable contact surface with the human body to avoid causing discomfort or injury to the patient. It should also have good biocompatibility to prevent infection.

[0010] 4) Easy to operate: The device should be easy to use, allowing medical staff to operate it quickly and accurately, shortening the compression time and improving work efficiency.

[0011] 5) Real-time monitoring: It can monitor the puncture site and surrounding tissues in real time, and promptly detect abnormalities such as bleeding and hematoma, so that medical staff can take corresponding measures. Summary of the Invention

[0012] To address the aforementioned problems, this invention provides a compression device for the femoral artery and femoral vein that can effectively stop bleeding, has controllable pressure, is compact, portable, and allows for real-time monitoring, and can be used in confined spaces such as the femoral artery / vein.

[0013] This utility model relates to a compression device for the femoral artery and femoral vein, which is used to compress the femoral artery and / or femoral vein after vascular puncture, and includes:

[0014] The main body of the pressure device is in the shape of a cuboid and has a surface that comes into contact with the human body. The surface is a convex arc-shaped contact surface.

[0015] A fixing device is provided to secure the main body of the pressure device.

[0016] The main body of the pressure device includes:

[0017] A double-layered inflatable airbag, wherein the double-layered inflatable airbag is equipped with an inflation system, and the pressure is adjusted by inflating or deflating;

[0018] A flexible pressure sensing membrane is integrated inside or near a double-layered inflatable airbag to monitor the actual pressure in real time.

[0019] The control unit receives actual pressure data from the flexible pressure sensing membrane and controls the pressure of the double-layer inflatable airbag according to a preset pressure value or user adjustment command.

[0020] The monitoring module displays the actual pressure data and times the compression time.

[0021] According to the compression device for the femoral artery and femoral vein, preferably, the main body of the compression device has a medical silicone shell.

[0022] According to the compression device for the femoral artery and femoral vein, the rectangular body of the compression device preferably has dimensions of 60-100mm in length, 30-50mm in width, and 15-20mm in height, and is particularly preferably 60mm×40mm×18mm.

[0023] According to the compression device for the femoral artery and femoral vein, the main body of the compression device preferably has the shape of a column with an outwardly convex arc-shaped contact surface.

[0024] According to the compression device for the femoral artery and femoral vein, the convex arc-shaped contact surface preferably has an arc curvature radius set based on the relationship between the body mass index (BMI) and the femoral triangle plane, and the convex arc-shaped contact surface has a bending characteristic along a constant curvature radius.

[0025] R=R bone ×(1+α×h)h (1)

[0026] h = 0.5 × BMI - 7 (2)

[0027] Among them, R bone The average radius of curvature of the triangular plane forming the femoral triangle in Chinese adults is 85 mm, and α is the fat deformation coefficient, which is 0.015 mm. -1 BMI is the body mass index.

[0028] According to the compression device for the femoral artery and femoral vein, the monitoring module preferably includes: an LED indicator that indicates the current pressure status by different colors or flashing frequencies; and a miniature display screen that displays precise pressure values ​​and compression time.

[0029] According to the compression device for the femoral artery and femoral vein, the monitoring module preferably has a transparent window for viewing the contact status.

[0030] According to the compression device for the femoral artery and femoral vein, the fixation device is preferably a medical elastic bandage or a Velcro bandage.

[0031] According to the compression device for the femoral artery and femoral vein, the preferred fixing method of the fixing device is a four-sided fixing method.

[0032] Invention Effects

[0033] According to this invention, hemostasis can be effectively achieved, and precise, adjustable pressure can be provided. Real-time monitoring and control are also possible, enabling timely, effective, and safe local compression to facilitate rapid patient recovery. Attached Figure Description

[0034] Figure 1 This is a schematic cross-sectional view of the pressure device body of the femoral artery and femoral vein compression device of this utility model.

[0035] Figure 2 This is a diagram illustrating the basic structure of the human femoral triangle.

[0036] Figure 3 This is a schematic diagram of the internal structure of the pressure device body of the femoral artery and femoral vein compression device of this utility model.

[0037] Figure 4 This is a schematic perspective view of the internal structure of the pressure device body of the femoral artery and femoral vein compression device of this utility model.

[0038] Figure 5 This is a schematic plan view of the internal structure of the pressure device body of the femoral artery and femoral vein compression device of this utility model.

[0039] Figure 6 This is a diagram showing the usage and effect of the femoral artery and femoral vein compression device of this utility model.

[0040] Explanation of reference numerals in the attached figures

[0041] 1. Compression device for femoral artery and femoral vein; 2. Main body of pressure device; 3. Arc-shaped contact surface; 4. Double-layered inflatable bladder; 5. Flexible pressure sensing membrane; 6. Control unit; 7. Monitoring module. Detailed Implementation

[0042] The following detailed description of the femoral artery and femoral vein compression device of this invention provides a specific embodiment. However, this invention is not limited to the embodiments described below; any modifications and implementations are permitted without departing from the spirit and scope of this invention.

[0043] Figure 1 This is a schematic cross-sectional view of the pressure device body of the femoral artery and femoral vein compression device of this utility model. (See diagram below.) Figure 1 As shown, the femoral artery and femoral vein compression device (1) of this utility model comprises a pressure device body (2), which is approximately rectangular in shape, with dimensions of 60-100mm in length, 30-50mm in width, and 15-20mm in height. The preferred dimensions of the body are 60mm × 40mm × 18mm. Figure 1), having a surface that comes into contact with the human body (the side that contacts the skin), said surface being an outwardly convex arc-shaped contact surface (3) having a bending characteristic along a constant radius of curvature to better fit the femoral artery / vein region.

[0044] The main body (2) of the pressure device of this utility model can be a cylindrical shape with an outwardly convex arc-shaped contact surface. When the outwardly convex arc-shaped contact surface is in contact with and compresses the femoral artery / vein area, it conforms to the anatomical curvature characteristics of the skin surface of the femoral triangle of the thigh. Specifically, Figure 2 The diagram illustrates the basic structure of the femoral triangle in the human body. A typical effective compression area at the puncture point in the femoral triangle needs to cover 40 mm × 30 mm (length × width). An extra-long design, such as 60 mm, and more preferably 70 mm, can cover the vascular pathway, reducing the risk of distal bleeding at the puncture point. When the width is insufficient, for example below 30 mm, in obese patients (BMI > 30) with increased subcutaneous fat thickness, the excessively narrow compression surface can easily lead to pressure concentration in the midline area, potentially causing skin damage. The thickness of a normal compression device is controlled at 15-20 mm (after compression). An excessively thick structure, such as exceeding 20 mm (e.g., 25 mm), may affect the patient's limb movement (e.g., hip flexion). Therefore, in this invention, the dimensions are optimized to 60 mm × 40 mm × 18 mm (length × width × thickness). The width is increased to 40 mm to improve pressure distribution for obese patients; the thickness is reduced to 18 mm (expanding to 20-22 mm after inflation) to reduce movement interference.

[0045] In addition, the surface of the main body (2) of the pressure device, namely the convex arc-shaped contact surface (3), can be set with an arc curvature radius based on the human body mass index (BMI) in the following manner, based on ergonomic analysis and clinical adaptability optimization (different weights - distinguished by BMI).

[0046] Specifically, the skeletal curvature of the femoral triangle is primarily determined by the anatomical morphology of the superior pubic ramus and the anterior superior iliac spine. Based on skeletal anatomical data of the Chinese population (such as in *Color Atlas of Human Anatomy* (People's Medical Publishing House)), and referencing clinical experience in locating the femoral triangle during orthopedic surgery, the line connecting the pubic symphysis to the anterior superior iliac spine (roughly corresponding to the inguinal ligament) forms an arc, reflecting the morphological characteristics of the groin region to some extent. The radius of curvature ranges from 80-90 mm, with the median value of 85 mm taken as the average baseline.

[0047] The actual radius of curvature of the femoral triangle region bones (superior pubic ramus and anterior superior iliac spine) varies significantly among individuals, and relying solely on BMI for estimation may lead to errors. Obese patients (BMI > 30) require a radius of curvature greater than the skeletal curvature rather than approaching the baseline value due to fat accumulation. Therefore, a linear composite curvature model is constructed.

[0048] R=R bone×(1+α×h)h

[0049] Among them, R bone = Approximately 85mm (the average radius of curvature of the femoral triangle plane in Chinese adults, located in the upper 1 / 3 of the anterior thigh, a triangular depression with the base at the top and the apex at the bottom, the base being the inguinal ligament, the lateral side being the medial border of the sartorius muscle, and the medial side being the medial border of the adductor longus muscle; the femoral nerve, femoral artery, and femoral vein are present), α = 0.015mm -1 (Fat Deformation Coefficient) The fat deformation coefficient is a quantitative indicator that measures the degree of deformation of adipose tissue under external force. Specifically, it reflects the degree of deformation of adipose tissue under pressure. According to previous literature, through compression experiments on ex vivo adipose tissue, the deformation coefficient has been measured to be in the range of 0.01-0.02 mm. -1 Take the median value of 0.015mm. -1 As empirical parameters of this utility model.

[0050] h = 0.5 × BMI - 7 (Empirical formula for subcutaneous fat thickness in the Chinese population)

[0051] Based on obesity studies in the Chinese population (such as "The Relationship between Adult BMI and Body Fat Content and Fat Distribution" and "Correlation Study of Fat Thickness in Various Parts by Ultrasound Measurement and Obesity-Related Diseases"), by measuring the subcutaneous fat thickness in the femoral triangle region by ultrasound, it was found that for every 1 kg / m² increase in BMI, the fat thickness increased by an average of 0.4-0.6 mm. A simplified offline relationship model was established: h = 0.5 × BMI – 7.

[0052] Calculation results:

[0053]

[0054] Final recommended curvature range:

[0055] BMI 18-25: R=90-95mm

[0056] BMI 26-35: R=95-105mm

[0057]

[0058] Based on the cuboid structure of the main body (2) of the pressure device with a convex arc-shaped contact surface (3) that contacts the human body, the long axis (60-100mm) of the main body is consistent with the vascular course of the femoral artery and vein in the groin area and the inner thigh. The short axis (30-50mm) can accurately compress the femoral artery / vein puncture site, and avoid the occurrence of pressure sores in non-puncture sites caused by excessive and prolonged compression by traditional compression devices. The arc-shaped contact surface conforms to the ergonomic design of skin and soft tissue indentation when local pressure is applied, ensuring that the pressure applied by the compression device is more closely aligned with the femoral artery / vein puncture site.

[0059] The above structure can reduce the discomfort caused by traditional salt sandbag pressure methods (usually 15-20cm long), which occupy a large area of ​​skin and apply strong pressure. It can also reduce the risk of skin damage in other areas of pressure, such as the femoral artery / vein, which may occur with prolonged large-area pressure, especially in elderly patients or diabetic patients, who are prone to pressure sores.

[0060] In addition, the main body (2) of the pressure device preferably has a flexible silicone and a TPU shell (not shown). The medical silicone shell can softly conform to the skin and can be repeatedly disinfected with iodine or alcohol to prevent local pressure damage. In addition, considering antibacterial properties, it can have an antibacterial coating, and considering breathability, a mesh fabric can be used in non-pressure areas.

[0061] Figure 3 This is a schematic diagram of the internal structure of the pressure device body of the femoral artery and femoral vein compression device of this utility model. Figure 4 This is a schematic perspective view of the internal structure of the pressure device body of the femoral artery and femoral vein compression device of this utility model. Figure 5 This is a schematic plan view of the internal structure of the pressure device body of the femoral artery and femoral vein compression device of this utility model. (See diagram below.) Figures 3-5 As shown, the main body (2) of the pressure device includes: a double-layer inflatable airbag (4), a flexible pressure sensing membrane (5), a control unit (6), and a monitoring module (7).

[0062] The double-layered inflatable airbag (4) is equipped with an inflation system, which can be manually or electronically inflated. The pressure is adjusted by inflating or deflating to ensure proper pressurization. As the core pressurization component, the double-layered inflatable airbag (4) is made of medical-grade silicone or TPU material, which has good biocompatibility and elasticity. The pressure is adjusted by inflating or deflating, making it suitable for different patients and different puncture sites.

[0063] The double-layered inflatable airbag (4) preferably adopts a biomimetic layered airbag design, such as Figures 3-5As shown, the central main airbag is 5mm thick with a radius of curvature R=90mm, made of medical-grade silicone, and provides basic pressure after inflation (target pressure 20-30kPa). The two auxiliary airbags are 3mm thick with an adjustable curvature range R=90-105mm, and their inflation volume is dynamically adjusted by independent air pumps to adapt to the fat thickness of patients with different BMIs.

[0064] The double-layer inflatable airbag (4) preferably also has an intelligent feedback layer, which integrates a thin-film pressure sensor (such as FlexiForce A201) to monitor the pressure distribution on the contact surface in real time 214.

[0065] The double-layered inflatable airbag (4) preferably has a dynamic adjustment mechanism. For example, when BMI>25, the inflation volume of the auxiliary airbag increases, and the overall radius of curvature expands (e.g., when BMI=30, R=95.8mm), avoiding local pressure concentration. Pressure data is transmitted to the medical terminal via Bluetooth.

[0066] The double-layered inflatable airbag (4) preferably has an elliptical main airbag (60×40mm) and an elongated auxiliary airbag that is symmetrically distributed along the long axis of the main airbag.

[0067] The flexible pressure sensing membrane (5) is integrated inside or near the double-layer inflatable airbag (4) to monitor the actual pressure in real time. The flexible pressure sensing membrane (5) is made of graphene / carbon nanotubes, and the human body contact surface is placed at the puncture site to provide uniform pressure, monitor the actual pressure in real time, and feed the data back to the control unit.

[0068] The control unit (6) receives actual pressure data from the flexible pressure sensing membrane (5) and controls the pressure of the double-layer inflatable airbag (4) according to the preset pressure value or user adjustment command to achieve precise pressure regulation.

[0069] Through the structure of the above-mentioned double-layer inflatable airbag (4), flexible pressure sensing membrane (5), and control unit (6), the pressure can be precisely controlled, which can effectively stop bleeding and avoid complications caused by excessive pressure.

[0070] The monitoring module (7) displays the actual pressure data and times the compression time. The monitoring module (7) preferably has an LED indicator light, which indicates the current pressure status through different colors or flashing frequencies (e.g., green - normal range, yellow - low, red - high). It also preferably has a miniature display screen to display the accurate pressure value and compression time, which is convenient for medical staff to grasp. It also preferably has a transparent window, which can be used to view the puncture point in real time to ensure that there are no abnormalities.

[0071] The monitoring module (7) has a transparent window and LED indicator / miniature display screen, which makes it convenient for medical staff to observe the puncture site, pressure status or pressure application time in real time.

[0072] The pressure state or pressure application time, such as the safe range of pressure values ​​and the interval of time reminders, can be set according to medical standards.

[0073] The monitoring module (7) preferably also has an alarm function, which emits sound or vibration when the pressure is abnormal or the time is reached.

[0074] The LED indicator / micro-display is preferably designed for low power consumption to ensure battery life.

[0075] The main body (2) of the pressure device preferably has a matrix of vent holes on its side wings, for example, with a pore diameter of 0.8 mm and a porosity of 62%.

[0076] The compression device (1) for the femoral artery and femoral vein also includes a fixation device (8). Preferably, the fixation device (8) is a medical elastic bandage (elastic fixation) or Velcro bandage, for example, 50mm wide and with an adjustable length range of 200-450mm, similar to a blood pressure cuff, which can be adjusted to ensure appropriate pressure. Preferably, the fixation device (8) is fixed in a four-sided fixation manner to ensure the device is stable and avoid displacement.

[0077] Figure 6 This is a diagram showing the usage and effect of the femoral artery and femoral vein compression device of this utility model. In this diagram, the compression device of this utility model is fixed by a medical elastic bandage (elastic fixation) connection method. According to the femoral artery and femoral vein compression device of this utility model, it has the following main functions: (1) accurate compression of blood vessels at the puncture site; (2) adjustable pressure; (3) comfortable fixation, breathable and antibacterial properties; and (4) visual monitoring of pressure and time. Moreover, it adopts the design concept of "miniaturization, integration, and intelligence" to achieve multi-functional integration within a limited volume, thereby effectively stopping bleeding and providing precise and adjustable pressure. At the same time, it can perform real-time monitoring and control, and further enable timely, effective, and safe local compression to achieve rapid recovery of patients.

[0078] The above description of the embodiments is intended to help understand the present invention. For those skilled in the art, improvements and modifications can be made to the present invention without departing from the mechanism of the present invention, and all such modifications are included within the protection scope of the present invention.

Claims

1. A device for compressing the femoral artery and / or femoral vein, used to compress the femoral artery and / or femoral vein after vascular puncture, comprising: The main body of the pressure device is in the shape of a cuboid and has a surface that comes into contact with the human body. The surface is a convex arc-shaped contact surface. A fixing device is provided to secure the main body of the pressure device. The main body of the pressure device includes: A double-layered inflatable airbag, wherein the double-layered inflatable airbag is equipped with an inflation system, and the pressure is adjusted by inflating or deflating; A flexible pressure sensing membrane is integrated inside or near a double-layered inflatable airbag to monitor the actual pressure in real time. The control unit receives actual pressure data from the flexible pressure sensing membrane and controls the pressure of the double-layer inflatable airbag according to a preset pressure value or user adjustment command. The monitoring module displays the actual pressure data and times the compression time.

2. The compression device for the femoral artery and femoral vein according to claim 1, wherein, The main body of the pressure device has a medical-grade silicone shell.

3. The compression device for the femoral artery and femoral vein according to claim 1, wherein, The dimensions of the cuboid body of the pressure device are: length 60-100mm, width 30-50mm, and height 15-20mm.

4. The compression device for the femoral artery and femoral vein according to claim 3, wherein, The rectangular dimensions of the main body of the pressure device are 60mm × 40mm × 18mm.

5. The compression device for the femoral artery and femoral vein according to claim 1, wherein, The main body of the pressure device has the shape of a column with an outwardly convex arc-shaped contact surface.

6. The compression device for the femoral artery and femoral vein according to claim 1, wherein, The convex arc-shaped contact surface has a radius of curvature R based on the following formulas (1) and (2). R=R bone ×(1+α×h)h (1) h = 0.5 × BMI - 7 (2) Among them, R bone The average radius of curvature of the triangular plane forming the femoral triangle in Chinese adults is 85 mm, and α is the fat deformation coefficient, which is 0.015 mm. -1 BMI is the body mass index.

7. The compression device for the femoral artery and femoral vein according to claim 1, wherein, The monitoring module includes: LED indicator lights that indicate the current pressure status through different colors or flashing frequencies; and a miniature display screen that displays precise pressure values ​​and compression time.

8. The compression device for the femoral artery and femoral vein according to claim 7, wherein, The monitoring module also has a transparent window for viewing contact information.

9. The compression device for the femoral artery and femoral vein according to claim 1, wherein, The fixation device is a medical elastic bandage or a Velcro bandage.

10. The compression device for the femoral artery and femoral vein according to claim 9, wherein, The fixing device is fixed in a four-sided fixing manner.

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