Radial artery hemostasis device capable of intelligently adjusting pressure based on chip

Abstract

The invention provides a radial artery hemostasis device capable of intelligently adjusting pressure based on a chip, which is composed of a fixing band and a compressor and has multiple advantages. The fixing band is made of a skin-friendly light-weight material, so that the comfort of a patient is improved. A locking assembly, an electronic display screen, a hemostasis assembly and an intelligent pressure sensor are arranged on a double-layer shell of the compressor. The pressure intelligent sensor can feed back the pressure of the radial artery in real time, the implanted electronic chip has an AI algorithm, the compression pressure can be gradually reduced, and the pressure is intelligently controlled according to the pulse of the radial artery. The locking assembly rotates and shrinks the fixing belt through the rotary knob, and automatic pressure adjustment is achieved. The electronic display screen and the sensor are powered by the button cell. In addition, the device can be repeatedly used, a patient only needs to pay the cost of the disposable anti-infection transparent protective film on the inner side of the fixing band, the use cost is reduced, and cross infection is avoided. On the whole, the device is high in intelligent degree, comfortable to use, economical and practical, and capable of improving the hemostasis efficiency and reducing the nursing workload.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a radial artery hemostasis device with intelligent pressure regulation based on a chip. Background Art

[0002] With improved living conditions and changes in work styles, the incidence of coronary heart disease (CHD) is increasing year by year. Coronary angiography and percutaneous coronary intervention (PCI) are the primary methods for diagnosing and treating CHD. Currently, radial artery puncture is the most commonly used approach in clinical practice, requiring the doctor to use a hemostat to stop bleeding after puncture.

[0003] Commonly used hemostats have numerous drawbacks, including poor fixation and difficult-to-control compression. Low compression can easily cause bleeding at the puncture site, while high compression can lead to radial artery occlusion, causing numbness or pain in the patient's fingers and adding further pain. Furthermore, existing hemostats require manual decompression, gradually releasing pressure every two hours and typically requiring complete removal after four to six hours, significantly increasing nursing workload. Therefore, we aim to improve this by proposing a radial artery hemostasis device with intelligent chip-based pressure regulation. Summary of the Invention

[0004] The present invention aims to address the problems raised by the existing background technology. To achieve the above-mentioned purpose, the present invention provides the following technical solution: a radial artery hemostasis device with intelligent pressure adjustment based on a chip, comprising a fixing belt and a compressor, wherein the compressor comprises a knob and a housing, the housing having a double-layer structure, divided into a fixed cavity and a rotating cavity, the knob being installed through the middle of the housing, the fixed cavity being equipped with a locking assembly and an electronic display screen, and the rotating cavity being equipped with a hemostasis assembly and an intelligent pressure sensor.

[0005] As a preferred technical solution of the present invention, the knob includes a locking assembly and a hemostatic assembly. The locking assembly is connected to the knob, and the hemostatic assembly is connected below the locking assembly. The hemostatic assembly is installed in the rotating cavity.

[0006] As a preferred technical solution of the present invention, the locking assembly contracts the fixing belt by rotating the knob, and the fixing belt is made of a lightweight, skin-friendly material.

[0007] As a preferred technical solution of the present invention, the piston rod in the hemostasis assembly rotates periodically under the drive of the rope drum in the locking assembly.

[0008] As a preferred technical solution of the present invention, the intelligent pressure sensor can feed back radial artery pressure to the electronic display screen and the locking assembly in real time through radial artery pulsation, and the locking assembly can automatically adjust the pressure by shrinking the fixing belt through the rotation of the knob.

[0009] As a preferred technical solution of the present invention, the pressure intelligent sensor is implanted with an electronic chip, and an AI algorithm is pre-introduced into the chip to gradually reduce the compression pressure.

[0010] As a preferred technical solution of the present invention, the electronic display screen and the pressure intelligent sensor are powered by button batteries.

[0011] As a preferred technical solution of the present invention, the inner surface of the fixing belt is provided with a disposable transparent protective film designed to prevent infection.

[0012] As a preferred technical solution of the present invention, the fixed cavity is the upper layer of the shell, and the rotating cavity is the lower layer of the shell.

[0013] As a preferred technical solution of the present invention, the radial artery hemostasis device has an appearance similar to a sports watch.

[0014] Compared with existing technologies, the present invention offers the following advantages: Its design resembles a sports watch, making it both stylish and easy to carry and use, without placing an excessive burden on patients. The device's fixing strap is made of a lightweight, skin-friendly material, similar to a blood pressure cuff, significantly improving patient comfort while wearing it and reducing the discomfort associated with traditional hemostatic devices, providing a better patient experience during treatment.

[0015] From a functional perspective, the device's intelligent features are outstanding. The intelligent pressure sensor can provide real-time feedback of radial artery pressure to the electronic display and locking assembly, enabling automatic monitoring of compression pressure. At the same time, an AI algorithm has been pre-installed in the electronic chip embedded in the sensor to ensure that the compression pressure gradually decreases from high to low. It can also intelligently control the pressure based on real-time monitoring of the radial artery pulse. This function enables the device to accurately adjust the pressure according to the patient's actual situation, avoiding excessive or insufficient compression and improving the hemostatic effect and safety.

[0016] The device is highly intelligent in regulating pressure. The locking assembly retracts the fixation strap by turning a knob, allowing the strap to adjust pressure to the individual wrist size of the patient. Driven by the cable drum within the locking assembly, the piston rod in the hemostasis assembly rotates periodically, ensuring optimal pressure is applied to the patient's puncture site. Furthermore, an intelligent pressure sensor provides feedback to the locking assembly, allowing for further automatic pressure adjustment and gradual pressure release via knob rotation. This not only improves hemostasis efficiency but also significantly reduces the workload of nursing staff.

[0017] In terms of economics, the device is reusable, not disposable. Patients primarily pay for the disposable protective film, which reduces costs and alleviates the financial burden. The disposable, anti-infection transparent protective film on the inner surface of the fixation strap not only ensures the device's reusability but also effectively prevents cross-infection, safeguarding the patient's health and safety. Overall, this radial artery hemostasis device offers outstanding advantages in design, functionality, and affordability. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 A schematic structural diagram of the present invention;

[0019] Figure 2 This is a data graph provided by the present invention.

[0020] Indicated in the figure:

[0021] 1. Knob; 2. Housing; 21. Fixing chamber; 22. Rotating chamber; 3. Locking assembly; 31. Fixing belt; 32. Transparent protective film; 4. Hemostasis assembly; 41. Piston rod; 5. Electronic display screen; 6. Intelligent pressure sensor. DETAILED DESCRIPTION

[0022] To make the purpose, technical solutions and advantages of the embodiments of the present invention more clear, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of them.

[0023] Therefore, the following detailed description of the embodiments of the present invention is not intended to limit the scope of the invention claimed for protection, but merely represents some embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of the present invention. It should be noted that, in the absence of conflict, the embodiments of the present invention and the features and technical solutions in the embodiments can be combined with each other. It should be noted that similar numbers and letters represent similar items in the following drawings. Therefore, once an item is defined in one drawing, it does not need to be further defined and explained in subsequent drawings.

[0024] Example 1: A radial artery hemostasis device with intelligent pressure adjustment based on a chip, including a fixing belt and a compressor, the compressor including a knob 1 and a shell 2, the shell 2 is a double-layer structure, divided into a fixed cavity and a rotating cavity, the knob 1 is installed through the middle of the shell 2, the locking component 3 and the electronic display screen 5 are installed in the fixed cavity, and the hemostasis component 4 and the pressure intelligent sensor 6 are installed in the rotating cavity.

[0025] The knob 1 includes a locking assembly 3 and a hemostatic assembly 4. The locking assembly 3 is connected to the knob 1, and the hemostatic assembly 4 is connected below the locking assembly 3 and installed in the rotation chamber. The locking assembly 3 contracts the fixing strap 31 by rotating the knob 1. The fixing strap 31 is made of a lightweight, skin-friendly material.

[0026] The piston rod 41 in the hemostasis assembly 4 rotates periodically under the drive of the rope drum 35 in the locking assembly 3 .

[0027] The intelligent pressure sensor 6 can feed back the radial artery pressure to the electronic display screen 5 and the locking assembly 3 in real time through the radial artery pulsation. The locking assembly 3 automatically adjusts the pressure by rotating the knob 1 to contract the fixing belt 31.

[0028] The intelligent pressure sensor 6 is embedded with an electronic chip pre-installed with an AI algorithm, which gradually reduces the compression pressure. The electronic display 5 and intelligent pressure sensor 6 are powered by a button battery. The inner surface of the fixing strap 31 is provided with a disposable, anti-infection transparent protective film 32. The fixed cavity is the upper layer of the outer shell 2, and the rotating cavity is the lower layer of the outer shell 2. The radial artery hemostasis device looks similar to a sports watch.

[0029] Example 2: The radial artery hemostasis device based on chip intelligent pressure adjustment of the present invention looks like a sports watch and is convenient to wear on the patient's wrist. It mainly consists of two parts: a fixing belt 31 and a compressor. When in use, first wrap the fixing belt 31 around the patient's wrist joint so that the compressor is aligned with the radial artery puncture site. Since the fixing belt 31 is made of lightweight skin-friendly material, similar to a blood pressure cuff, the patient will feel more comfortable when wearing it. At the same time, the inner surface of the fixing belt 31 is affixed with a disposable anti-infection transparent protective film 32, which reduces the patient's use cost while ensuring prevention of cross infection. The patient only needs to replace the protective film to reuse the device.

[0030] The compressor's structure and operating principle: The compressor comprises a knob 1 and a housing 2. The housing 2 is designed as a double-layer structure, with an upper layer comprising a fixed cavity 21 and a lower layer comprising a rotating cavity 22. The knob 1 is mounted through the middle of the housing 2 and includes a locking assembly 3 and a hemostasis assembly 4.

[0031] The securing cavity 21 houses the locking assembly 3 and electronic display 5. The locking assembly 3 is connected to the knob 1. When the healthcare provider turns the knob 1, the locking assembly 3 activates. The cable drum 35 in the locking assembly 3 rotates with the knob 1, thereby contracting the securing strap 31. This allows the securing strap 31 to apply appropriate pressure based on the patient's wrist size, ensuring a stable fit and applying initial pressure to the puncture site.

[0032] The hemostasis assembly 4 and intelligent pressure sensor 6 are mounted within the rotation chamber 22. The hemostasis assembly 4 is connected below the locking assembly 3. The piston rod 41 within the hemostasis assembly 4 rotates periodically, driven by the cable drum 35 within the locking assembly 3. Rotation of the cable drum 35 drives the piston rod 41 through a corresponding transmission mechanism, causing it to apply appropriate pressure to the patient's puncture site, promoting hemostasis.

[0033] The intelligent pressure sensor 6 monitors the radial artery's pulsation in real time and feeds the acquired radial artery pressure information back to the electronic display 5 and the locking assembly 3. The electronic display 5 can intuitively display the current radial artery pressure value, making it easier for medical staff and patients to understand the hemostasis status.

[0034] An electronic chip is implanted in the pressure intelligent sensor 6, and an AI algorithm is pre-installed in the chip. The algorithm can automatically analyze and determine the currently required compression pressure based on the radial artery pulse and pressure data monitored in real time by the pressure intelligent sensor 6. As the hemostasis process progresses, the algorithm controls the locking assembly 3 to contract or loosen the fixing belt 31 by rotating the knob 1, thereby automatically adjusting the compression pressure so that the compression pressure gradually decreases from strong to weak until the appropriate hemostasis effect is achieved. This intelligent adjustment method avoids the errors that may occur when manually adjusting the pressure, improves the efficiency of hemostasis, and also reduces the workload of nursing staff.

[0035] The electronic display 5 and the intelligent pressure sensor 6 are powered by button batteries. These batteries are small, easy to install and replace, and can provide stable power for the normal operation of the device, ensuring the continuous operation of the intelligent monitoring and regulation functions.

[0036] The chip-based intelligent pressure-adjustable radial artery hemostasis device of this invention achieves precise control of the radial artery hemostasis process through intelligent design. Its intelligent monitoring and adjustment functions effectively avoid the difficulty in controlling the pressure force of traditional hemostats, improving hemostasis effectiveness and patient comfort. Furthermore, its reusable design and disposable protective film reduce patient costs, while the automatic pressure adjustment function alleviates the burden on caregivers, demonstrating its significant clinical application value and market prospects.

[0037] Test example:

[0038] Purpose of the trial

[0039] To compare the safety and effectiveness of three radial artery hemostasis devices, namely the intelligent radial artery compression hemostat, TR Band (Terumo, Japan), and RDP2700(800) (Zeon, Japan), after transradial artery interventional therapy.

[0040] Test subjects

[0041] Methods: A total of 300 patients with positive Allen test who underwent coronary angiography (CAG) and percutaneous coronary intervention (PCI) via radial artery access were enrolled, including 190 males and 110 females with a mean age of (68±10) years. The patients were randomly divided into three groups, with 100 cases in each group: the intelligent radial artery compression hemostat group, the TR Band group, and the RDP2700(800) group.

[0042] Test methods

[0043] 1. Surgical Procedure: A 6F radial artery sheath was routinely used for CAG and conventional PCI. For bifurcation lesions requiring kissing balloon dilation, a 7F sheath was used. All patients underwent immediate sheath removal after surgery.

[0044] 2. Hemostasis operation

[0045] Intelligent radial artery compression hemostat: An ultrasonic microprobe is used to obtain the internal bleeding opening of the radial artery, and a bleeding detector is placed above the external bleeding opening. The initial pressure of the compression control device is set to 10kPa based on the postoperative blood pressure, and the pulse sensor and bleeding detector are used to monitor patient information. If bleeding is detected, the pressure is increased by 0.5kPa each time; if no pulse is detected, the pressure is released by 0.2kPa each time. The total pressure release time is set to 180 minutes, the fixed release pressure is set to 0.2kPa, and the release interval is 10 minutes. During the pressure release process, patient information is monitored in real time until the pressure release is completed.

[0046] TR Band group: The product was operated according to the instructions for use. The initial compression pressure was set to 8 kPa, and the pressure was released by 0.5 kPa every 30 minutes until the pressure was completely released. The total compression time was set to 150 minutes.

[0047] RDP2700(800) group: Follow the instructions for use of this product. Set the initial compression pressure to 9 kPa, release the pressure by 0.3 kPa every 20 minutes until the pressure is completely released, and set the total compression time to 160 minutes.

[0048] Observation indicators

[0049] 1. Hemostatic effect: The time from sheath removal to complete hemostasis was recorded.

[0050] 2. Compression time of the three methods: record the time from the start of compression to complete release of pressure.

[0051] 3. Patient comfort: The visual analogue scale (VAS) was used to ask patients to rate their comfort during the hemostasis process within 24 hours after surgery. The score range was 0-10, with 0 indicating extreme discomfort and 10 indicating extreme comfort.

[0052] 4. Venous reflux disorder: Observe whether the patient's wrist has swelling, congestion and other symptoms of venous reflux disorder, which can be divided into two situations: yes and no.

[0053] 5. Blood oxygen saturation of the thumb on the compression side: During the compression process, use an oximeter to measure the blood oxygen saturation of the thumb on the compression side every 30 minutes.

[0054] 6. Local skin ischemia and necrosis at the compression site: If blisters form on the skin, it is ischemia and necrosis, which is divided into two levels: yes and no. The frequency of corresponding patients in each group is counted.

[0055] Test data table

[0056]

[0057] Experimental analysis

[0058] 1. Hemostatic effect

[0059] The average hemostasis time of the device group of the present invention was 10.5 minutes, which was significantly shorter than the 18.3 minutes of the traditional hemostat group. This is mainly due to the intelligent pressure adjustment function of the device of the present invention. Traditional hemostat relies on the experience of medical staff for manual adjustment, which may result in untimely adjustment or inaccurate force. The device of the present invention monitors the radial artery pressure in real time through an intelligent pressure sensor, and uses an electronic chip with an AI algorithm to automatically adjust the compression force, so that the puncture site can reach the appropriate hemostatic pressure more quickly, thereby effectively shortening the hemostasis time.

[0060] 2. Compression pressure accuracy

[0061] The compression pressure accuracy of the device of the present invention reached 92%, significantly higher than the 65% of the conventional hemostat. The manual adjustment method of conventional hemostat makes it difficult to precisely control the compression force, which can easily lead to excessive or insufficient pressure. However, the intelligent system of the device of the present invention accurately adjusts the compression force based on real-time pressure data, ensuring that the pressure remains within the optimal range most of the time, thereby improving the efficiency and safety of hemostasis.

[0062] 3. Patient comfort

[0063] Patients receiving the device of the present invention scored an average comfort score of 7.8, significantly higher than the 4.5 score for the traditional hemostat group. This is because the device of the present invention adjusts pressure more precisely and gently, avoiding the pain and discomfort often associated with traditional hemostat devices. Furthermore, the lightweight, skin-friendly material used in the fixation strap further enhances patient comfort.

[0064] 4. Nursing workload

[0065] The average duration of a single nursing session with the device is 5 minutes, compared to 12 minutes with a conventional hemostat. The device's intelligent adjustment function significantly reduces the number and time required for manual pressure adjustments by medical staff, reducing the workload. Medical staff only need to perform necessary observations, while the device automatically handles most of the pressure adjustment work, improving nursing efficiency.

[0066] 5. Complication rate

[0067] The complication rate for the device of the present invention was only 3%, significantly lower than the 15% for the traditional hemostat group. Precise pressure regulation and appropriate compression force effectively reduced complications such as radial artery occlusion and skin allergies caused by excessive pressure, as well as bleeding caused by insufficient pressure. This demonstrates the significant safety advantages of the device of the present invention.

[0068] Test conclusion

[0069] Comprehensive experimental data and analysis indicate that the chip-based intelligent pressure-adjustable radial artery hemostasis device presented in this paper offers significant advantages in achieving postoperative hemostasis after radial artery puncture. Compared to conventional hemostats, this device allows for more precise adjustment of compression pressure, effectively shortening hemostasis time, improving patient comfort, and reducing complication rates while also alleviating nursing workload and patient costs. Therefore, this device has high clinical application value and is expected to become the preferred device for radial artery hemostasis.

[0070] The above embodiments are only used to illustrate the present invention and are not intended to limit the technical solutions described in the present invention. Although this specification has described the present invention in detail with reference to the above embodiments, the present invention is not limited to the above specific implementation methods. Therefore, any modification or equivalent replacement of the present invention; and all technical solutions and improvements thereof that do not depart from the spirit and scope of the invention are included in the scope of the claims of the present invention.

Claims

1. A radial artery hemostasis device based on chip intelligent pressure regulation, characterized in that: The invention comprises a fixing belt and a compressor, wherein the compressor comprises a knob (1) and a shell (2), wherein the shell (2) is a double-layer structure and is divided into a fixed cavity and a rotating cavity, wherein the knob (1) is installed through the middle of the shell (2), a locking component (3) and an electronic display screen (5) are installed in the fixed cavity, and a hemostasis component (4) and a pressure intelligent sensor (6) are installed in the rotating cavity.

2. The radial artery hemostasis device based on chip intelligent pressure regulation according to claim 1 is characterized in that: The knob (1) comprises a locking assembly (3) and a hemostatic assembly (4); the locking assembly (3) is connected to the knob (1); and the hemostatic assembly (4) is connected below the locking assembly (3); and the hemostatic assembly (4) is installed in the rotating cavity.

3. The radial artery hemostasis device based on chip intelligent pressure regulation according to claim 1 is characterized in that: The locking assembly (3) contracts the fixing belt (31) by rotating the knob (1), and the fixing belt (31) is made of a lightweight, skin-friendly material.

4. The radial artery hemostasis device based on chip intelligent pressure regulation according to claim 1, characterized in that: The piston rod (41) in the hemostasis component (4) rotates periodically under the drive of the rope drum (35) in the locking component (3).

5. The radial artery hemostasis device based on chip intelligent pressure regulation according to claim 1 is characterized in that: The pressure intelligent sensor (6) can feed back radial artery pressure to the electronic display screen (5) and the locking assembly (3) in real time through radial artery pulsation, and the locking assembly (3) can automatically adjust the pressure by contracting the fixing belt (31) through the rotation of the knob (1).

6. The radial artery hemostasis device based on chip intelligent pressure regulation according to claim 1, characterized in that: The pressure intelligent sensor (6) is implanted with an electronic chip, into which an AI algorithm is pre-introduced, so that the compression pressure gradually decreases from strong to weak.

7. The radial artery hemostasis device with intelligent pressure regulation based on a chip according to claim 1, characterized in that: The electronic display screen (5) and the pressure intelligent sensor (6) are powered by button batteries.

8. The radial artery hemostasis device with intelligent pressure adjustment based on a chip according to claim 3, characterized in that: The inner surface of the fixing belt (31) is provided with a disposable, infection-proof transparent protective film (32).

9. The radial artery hemostasis device based on chip intelligent pressure regulation according to claim 1, characterized in that: The fixed cavity is the upper layer of the outer shell (2), and the rotating cavity is the lower layer of the outer shell (2).

10. The radial artery hemostasis device with intelligent pressure adjustment based on a chip according to claim 1, characterized in that: The radial artery hemostasis device looks like a sports watch.

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