Coronary angiography distal radial artery path hemostat

Abstract

This invention belongs to the field of hemostatic devices, specifically a hemostatic device for the distal radial artery pathway in coronary angiography. It includes a flexible positioning band with a balloon-type pressure mechanism mounted on it. The balloon-type pressure mechanism comprises an outer liner, an inner liner, and a main compression balloon. Both the outer and inner liners are fixedly connected to the positioning band. The top of the main compression balloon is fixedly connected to the outer liner and is connected to a precision air pump. The bottom of the main compression balloon is fixedly connected to the inner liner. In this invention, the top of the main compression balloon is positioned by the outer liner, and the bottom is positioned by the inner liner. During hemostasis, the main compression balloon inflates, tightening both the outer and inner liners, thus increasing rigidity and improving the positional stability of the main compression balloon. This prevents the main compression balloon from deviating from the puncture point due to the patient's hand movements, ensuring effective hemostasis.

Description

Technical Field

[0001] This invention belongs to the field of hemostatic devices, and in particular a hemostatic device for the distal radial artery pathway in coronary angiography. Background Technology

[0002] Currently, coronary angiography is typically performed via distal radial artery puncture. After angiography, pressure hemostasis is required at the distal radial artery puncture site. To avoid damage to the radial artery endothelium caused by prolonged high pressure and to prevent delayed bleeding at the puncture site due to sudden decompression, a step-down decompression protocol is commonly used. This means that after coronary angiography, decompression typically begins gradually about 1.5 hours later; after interventional treatment, decompression also begins gradually about 90-120 minutes later, eventually leading to the removal of the hemostat. This step-down approach ensures continuous hemostasis while gradually restoring local blood flow, reducing the risk of complications such as radial artery occlusion and hand swelling. Existing hemostatic devices include knob-adjustable hemostatic devices and balloon-type hemostatic devices. Knob-adjustable hemostatic devices adjust the pressure by rotating a knob. Balloon-type hemostatic devices can be referenced in utility model patent application number CN202420006537.8, which describes a hemostatic device for radial artery puncture sites after coronary angiography. The pressure at the puncture site is adjusted by regulating the inflation volume of the balloon. During hemostasis, it is usually necessary to monitor the oxygen saturation (SaO2) and perfusion index (PI) of the affected thumb in real time to avoid excessive pressure that could lead to radial artery occlusion and hand ischemia.

[0003] Distal radial artery puncture is usually performed at the nasal cavity, Hegu acupoint, etc., which are areas of depression in the hand. Existing hemostatic devices cannot well match the shape characteristics of the nasal cavity and Hegu acupoint, and have poor fit with the skin and bones of the hand. In addition, the balloon expands after inflation, has poor stability, and is easy to slide, causing the pressure point to deviate from the puncture point. Summary of the Invention

[0004] The technical problem to be solved by the present invention is to provide a hemostat for the distal radial artery pathway in coronary angiography, which better matches the shape of the puncture site area, improves the stability of the balloon, and reduces the risk of compression point deviation.

[0005] To solve the above problems, the technical solution adopted by the present invention is: a coronary angiography distal radial artery path hemostat, including a flexible positioning band, wherein an airbag pressure mechanism is provided on the positioning band;

[0006] The airbag-type pressure mechanism includes an outer pad, an inner pad, and a main pressure airbag. The outer pad and the inner pad are both fixedly connected to the positioning belt. The top of the main pressure airbag is fixedly connected to the outer pad, and the main pressure airbag is connected to a precision air pump. The bottom of the main pressure airbag is fixedly connected to the inner pad.

[0007] A first pressure sensor is located between the top of the main compression airbag and the outer liner; multiple micro-airbags are arranged on the inner liner, forming multiple micro-airbag rings around the main compression airbag, and a second pressure sensor is arranged between each micro-airbag and the inner liner; the first pressure sensor, the second pressure sensor, and the precision air pump are all connected to a processor.

[0008] Furthermore, in the initial stage of hemostasis, the processor receives detection signals from the first pressure sensor and each of the second pressure sensors. Simultaneously, the processor controls the precision air pump to inflate the main compression airbag. When the pressure value detected by the first pressure sensor reaches the set range, the processor controls the precision air pump to slowly inflate and deflate. During the inflation and deflation process, it is ensured that the pressure value detected by the first pressure sensor is always within the set range. When the pressure value detected by the first pressure sensor is the minimum value that meets the condition, inflation and deflation are stopped. The condition is that the pressure values ​​detected by each of the second pressure sensors decrease at a uniform speed from the center of the main compression airbag outwards.

[0009] Furthermore, after inflation and deflation are stopped, the processor records the pressure values ​​detected by each of the second pressure sensors. During hemostasis, the processor receives the real-time pressure values ​​detected by the second pressure sensors. When the real-time pressure value on one side of the bottom of the main compression airbag increases and the real-time pressure value on the other side of the bottom of the main compression airbag decreases, and the change in real-time pressure value exceeds the set threshold, a pressure point deviation warning is issued.

[0010] Furthermore, during the hemostasis process, if the pressure values ​​detected by the first pressure sensor and each of the second pressure sensors increase simultaneously, a swelling warning will be issued at the puncture site.

[0011] Furthermore, the second pressure sensor is fixedly connected to the inner liner, the micro-airbag is fixed to one side of the substrate, and the other side of the substrate is detachably connected to the inner liner.

[0012] Furthermore, the substrate is bonded to the inner liner.

[0013] Furthermore, the inner cavity of the micro-airbag is divided into two storage cavities by ultrasonic destruction of the diaphragm, and the two storage cavities respectively store a first agent and a second agent, and the first agent and the second agent absorb heat after reacting.

[0014] The beneficial effects of this invention are as follows: In this invention, the top of the main compression airbag is positioned by the outer liner, and the bottom is positioned by the inner liner. When hemostasis is achieved, gas is introduced into the main compression airbag, causing it to expand. During the expansion process, the bottom of the main compression airbag presses against the puncture point, and at the same time, it moves the inner liner towards the skin, making the inner liner adhere tightly to the skin. At this time, the shape of the inner liner matches the shape of the area where the puncture point is located (such as the nasal cavity or Hegu acupoint), and both the outer and inner liners are tightened, thus improving rigidity. This can improve the positional stability of the main compression airbag, prevent the main compression airbag from deviating from the puncture point due to the patient's hand movements, and ensure the hemostasis effect. Attached Figure Description

[0015] Figure 1 This is an overall schematic diagram of the invention;

[0016] Figure 2 This is a schematic diagram of the airbag-type pressure mechanism for hemostasis in this invention;

[0017] Figure 3 This is a schematic diagram of the substrate in which the first and second agents are disposed within the micro-airbag according to the present invention;

[0018] Figure 4 yes Figure 3 The diagram shows the substrate preparation process.

[0019] Reference numerals: 1—positioning band; 2—outer liner; 3—inner liner; 4—main pressure airbag; 5—micro airbag; 6—precision air pump; 7—second pressure sensor; 8—processor; 9—first pressure sensor; 10—substrate; 11—ultrasonic destruction diaphragm; 12—first agent; 13—second agent; 14—mold; 15—cavity. Detailed Implementation

[0020] The present invention will be further described below with reference to the accompanying drawings and embodiments.

[0021] The coronary angiography distal radial artery pathway hemostat of the present invention, such as... Figure 1 and Figure 2 As shown, it includes a flexible positioning band 1, on which an airbag-type pressure mechanism is provided. The positioning band 1 can adopt any existing technology that can stably fix it to the hand.

[0022] The pneumatic pressure mechanism is used to apply pressure to the puncture site to stop bleeding. Specifically, the pneumatic pressure mechanism includes an outer pad 2, an inner pad 3, and a main pressure pneumatic balloon 4. The outer pad 2 and the inner pad 3 are both fixedly connected to the positioning band 1. The top of the main pressure pneumatic balloon 4 is fixedly connected to the outer pad 2, and the main pressure pneumatic balloon 4 is connected to a precision air pump 6. The bottom of the main pressure pneumatic balloon 4 is fixedly connected to the inner pad 3.

[0023] Both the outer liner 2 and the inner liner 3 are made of harmless flexible materials, such as thermoplastic polyurethane or fiberglass. The main compression airbag 4 can be cylindrical and is connected to the outer liner 2 and the inner liner 3 by means of bonding or other methods. The precision air pump 6 is used to inflate or deflate the main compression airbag 4 to regulate the air pressure inside the main compression airbag 4.

[0024] When using this invention, the hemostat is fixed to the upper part by the positioning strap 1, and the bottom of the main compression airbag 4 is aligned with the puncture point. Then, the main compression airbag 4 is supplied with air by the precision air pump 6, which causes the main compression airbag 4 to expand. After the main compression airbag 4 expands, it applies pressure to the puncture point to achieve hemostasis.

[0025] The top of the main compression airbag 4 is positioned by the outer liner 2, and the bottom is positioned by the inner liner 3. After the main compression airbag 4 inflates, it... Figure 2 As shown, during the expansion of the main compression balloon 4, the outer liner 2 moves upward, while the inner liner 3 moves downward. This causes both the outer and inner liner 2 to be taut and tightened. At this time, the overall rigidity of the main compression balloon 4, the outer liner 2, and the inner liner 3 is improved. The top and bottom of the main compression balloon 4 are subjected to balanced force, resulting in high stability. This effectively prevents the patient's hand from deviating from the puncture point, thus ensuring hemostasis. In addition, when the inner liner 3 is tightened, it conforms to the skin around the puncture point, and the shape of the inner liner matches the shape of the area where the puncture point is located (such as the nasal cavity or Hegu acupoint).

[0026] Existing hemostatic devices are usually adjusted by medical staff based on experience, which can easily lead to over-compression. Each time the pressure is reduced, manual adjustment is required, which is labor-intensive for medical staff. In addition, the compression pressure cannot be accurately obtained, and it cannot be detected in time when the compression area of ​​the main compression balloon 4 deviates from the puncture point.

[0027] To solve the above problems, in this invention, a first pressure sensor 9 is provided between the top of the main compression airbag 4 and the outer liner 2; multiple micro-airbags 5 are provided on the inner liner 3, and the multiple micro-airbags 5 form multiple micro-airbag rings around the main compression airbag 4; a second pressure sensor 7 is provided between each micro-airbag 5 and the inner liner 3; the first pressure sensor 9, the second pressure sensor 7 and the precision air pump 6 are all connected to a processor 8, and the processor 8 can be a conventional microprocessor.

[0028] The first pressure sensor 9 can detect the pressure between the bottom of the main compression airbag 4 and the outer liner 2. Although the main compression airbag 4 is an elastic body, once its volume stabilizes, the pressure of the top of the main compression airbag 4 on the outer liner 2 should be equal to the pressure of the bottom on the inner liner 3. Therefore, the pressure value detected by the first pressure sensor 9 is basically the same as the pressure experienced at the puncture point, and the detection value of the first pressure sensor 9 can be used as the hemostatic pressure value. Based on the detection results of the first pressure sensor 9, the hemostatic pressure at various stages can be obtained, avoiding excessive or insufficient hemostatic pressure.

[0029] The micro-inflator 5 is smaller than the main compression inflator 4. Specifically, 3 to 5 micro-inflators 5 can be arranged around the main compression inflator 4. The function of the micro-inflator 5 is to form protrusions on the inner liner 3, which directly contact the skin and effectively transmit the pressure on the skin to the second pressure sensor 7. When the main compression inflator 4 compresses the puncture point, it squeezes the muscle at the puncture point, causing the muscle to deform and causing the surrounding muscles to deform as well. Pressure is generated between the surrounding muscles and the micro-inflators 5. Under normal conditions, the pressure on the micro-inflators 5 decreases uniformly from the main compression inflator 4 outwards. The second pressure sensor 7 can detect the pressure between each micro-inflator 5 and the skin and transmit the detection results to the processor 8.

[0030] Traditional hemostatic devices apply indiscriminate pressure to the puncture site and surrounding tissue, resulting in high overall pressure and impaired blood flow to the hand. This invention uses a main pressure balloon 4 to provide primary pressure to the puncture site, while micro-balloons 5 provide auxiliary pressure to the surrounding tissue, filling the space around the main pressure balloon 4, eliminating pressure dead zones, and resulting in a more rational pressure distribution at and around the puncture site. This ensures unobstructed blood flow to the hand. When the main pressure balloon 4 deviates from the puncture site, the micro-balloons 5 move to the puncture site, achieving dynamic pressure compensation and ensuring that the pressure area always covers the puncture site, guaranteeing stable hemostasis.

[0031] The hemostat of this invention can automatically detect and adjust the pressure of the main compression balloon 4 on the puncture point. First, it can automatically adjust the initial pressure (i.e., the pressure at the initial stage of hemostasis) to a suitable value. Specifically, at the initial stage of hemostasis, the main compression balloon 4 is aligned with the puncture point, the positioning strap 1 is fixed to the hand, and the processor 8 receives the detection signals from the first pressure sensor 9 and each of the second pressure sensors 7. At the same time, the processor 8 controls the precision air pump 6 to inflate the main compression balloon 4. When the pressure value detected by the first pressure sensor 9 reaches the set range, which is the initial hemostatic pressure range, it is generally 80–120 mmHg based on past hemostatic experience. Converted to SI units, the pressure is approximately 10666 Pa–15999 Pa. When the detection value of the first pressure sensor 9 is between 10666 Pa and 15999 Pa, the processor 8 controls the precision air pump 6 to slowly inflate and deflate. During the slow inflation and deflation process, the pressure value detected by the first pressure sensor 9 remains within the above-mentioned set range. When the pressure value detected by the first pressure sensor 9 is the minimum value that meets the condition, inflation and deflation stop. The condition is that the pressure values ​​detected by each of the second pressure sensors 7 decrease at a constant speed in all directions around the main compression airbag 4.

[0032] Radial artery occlusion (RAO) is one of the most serious complications, mainly caused by excessive and prolonged compression leading to damage to the vascular endothelium and complete blockage of blood flow, resulting in thrombus formation. This invention can prevent radial artery occlusion to the greatest extent by finding the minimum pressure value within a set range.

[0033] When the pressure value detected by the second pressure sensor 7 decreases uniformly from the center of the main compression airbag 4 outwards, it indicates that the pressure between the micro-airbags 5 around the main compression airbag 4 and the skin is balanced. This prevents the micro-airbags 5 on both sides of the main compression airbag 4 from becoming unbalanced in blood supply, avoids tissue shear deformation, further reduces the risk of radial artery occlusion, and increases patient comfort.

[0034] After adjusting the initial pressure in the above manner, the force distribution on the skin on both sides of the main compression airbag 4 should be nearly symmetrical. When the main compression airbag 4 deviates from the puncture point, the pressure becomes unbalanced. The pressure of the micro-airbag 5 on the side of the main compression airbag 4 that deviates from the direction of deviation increases, while the pressure of the micro-airbag 5 on the side away from the direction of deviation decreases. Moreover, the two change simultaneously. Therefore, it can be determined whether the main compression airbag 4 deviates based on the pressure values ​​detected by each of the second pressure sensors 7.

[0035] Specifically, after inflation and deflation stop, the processor 8 records the pressure values ​​detected by each of the second pressure sensors 7. During hemostasis, the processor 8 receives the real-time pressure values ​​detected by the second pressure sensors 7. When the real-time pressure value on one side of the bottom of the main compression airbag 4 increases, and the real-time pressure value on the other side of the bottom of the main compression airbag 4 decreases, and the change in real-time pressure value exceeds a set threshold, a pressure point deviation warning is issued. The processor 8 can issue a pressure point deviation warning through an alarm, such as an audible alarm or a visual alarm. If the real-time pressure values ​​detected by each of the second pressure sensors 7 fluctuate within a stable range, it indicates that the main compression airbag 4 has not deviated.

[0036] In addition, the swelling around the puncture site can be assessed. Specifically, during hemostasis, if the pressure values ​​detected by the first pressure sensor 9 and each of the second pressure sensors 7 increase simultaneously, a swelling warning is issued at the puncture site. When swelling occurs, the tissue volume increases, which inevitably leads to an increase in the pressure exerted on the skin by the main pressure balloon 4 and the micro-balloons 5. Therefore, when the detection values ​​of the first pressure sensor 9 and each of the second pressure sensors 7 increase synchronously, it can be considered that swelling has occurred.

[0037] Traditional hemostatic devices are relatively inexpensive and typically disposable. However, this invention uses components such as a second pressure sensor 7, a first pressure sensor 9, a processor 8, and associated circuitry, resulting in higher costs. If used as disposable consumables, this would increase treatment costs for patients. Therefore, in this invention, the second pressure sensor 7 is fixedly connected to the inner liner 3, and the micro-inflator 5 is fixed to one side of the base material 10. The other side of the base material 10 is detachably connected to the inner liner 3. Specifically, the base material 10 can be bonded to the inner liner 3, for example, using Velcro. After hemostasis is achieved for each patient, the base material 10 can be removed. After disinfecting the inner liner 3, outer liner 2, and positioning band 1, a new base material 10 can be installed on the inner liner 3 for reuse. The consumables are only the base material 10 and the micro-inflator 5, resulting in low operating costs.

[0038] When severe swelling occurs, cold compresses are usually applied to the swollen area. Traditional treatments require removing the hemostat, making further hemostasis impossible. In this invention, as... Figure 3 As shown, the inner cavity of the micro-airbag 5 is divided into two storage cavities by ultrasonic destruction of the diaphragm 11. The two storage cavities store the first agent 12 and the second agent 13 respectively. The first agent 12 and the second agent 13 absorb heat after reacting.

[0039] When swelling occurs, ultrasonic waves are emitted toward the airbag pressure mechanism. The ultrasonic waves destroy the diaphragm 11, causing it to rupture. This allows the first agent 12 and the second agent 13 to come into contact and react, absorbing heat and cooling the micro-airbag 5. This provides a cold compress to the tissue around the puncture point, relieving swelling.

[0040] The first reagent 12 and the second reagent 13 can be ammonium nitrate powder and deionized water. The ultrasonically destroyed diaphragm 11 has a certain toughness. When the micro-airbag 5 is squeezed, the ultrasonically destroyed diaphragm 11 is not easy to break. However, it will break under ultrasound. Specifically, an elastomer (such as polydimethylsiloxane PDMS or medical silicone) can be used as the main body. A large number of glass microspheres are uniformly dispersed in the main body. The local stress generated by the ultrasonic cavitation effect will preferentially concentrate at the interface between the rigid glass microspheres and the elastomer, causing interface debonding and microcracks. These microcracks expand and connect with each other, eventually leading to the brittle fracture of the entire membrane layer.

[0041] When the diaphragm 11 is destroyed by ultrasound, it is made of medical-grade polydimethylsiloxane (PDMS), model Dow Corning Sylgard 184, with a thickness of 150 micrometers. Untreated solid glass microspheres are then filled in, with a particle size range of 10-50 micrometers and a mass fraction of 60% ± 5%. When swelling occurs, a portable ultrasound device (model US-101L) is used for treatment. Sufficient medical ultrasound coupling agent is applied to the transmitting probe, which is then attached to the outer surface of the outer pad 2. The device is set to pulse wave mode, with an intensity of approximately 1.2 W / cm², and the outer pad 2 is irradiated continuously for 60 seconds.

[0042] The aforementioned micro-airbag 5 can be integrally formed with the substrate 10, and the specific manufacturing process is as follows:

[0043] like Figure 4 As shown, a mold 14 is used, and multiple hemispherical cavities 15 are set on the upper surface of the mold 14. The size, number and distribution pattern of the cavities 15 are adapted to the micro-airbags 5. The substrate 10 is laid flat on the upper surface of the mold 14, and the substrate 10 is made into the cavity 15 by vacuum forming or hot pressing, forming a semi-micro-airbag integrated with the substrate 10 in the cavity 15. Two membranes with semi-micro-airbags are made in the above way. Then, the first agent 12 is filled into the semi-micro-airbags of the first membrane, and the ultrasonically destroyed diaphragm 11 is used to cover all the semi-micro-airbags. The ultrasonically destroyed diaphragm 11 and the substrate 10 are connected together by adhesive or heat sealing. Then, the second agent 13 is filled into the semi-micro-airbags of the second membrane, and the first membrane is laid on the second membrane to ensure that the micro-airbags on the two membranes are aligned to form a complete micro-airbag 5. Then, the two membranes are connected together by heat sealing.

[0044] The above description is merely a preferred embodiment of the present invention and is not intended to limit the invention. Various modifications and variations can be made to the present invention by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. A hemostat for the distal radial artery pathway in coronary angiography, comprising a flexible positioning band (1), wherein a pneumatic pressure mechanism is provided on the positioning band (1); characterized in that: The airbag-type pressure mechanism includes an outer liner (2), an inner liner (3), and a main pressure airbag (4). The outer liner (2) and the inner liner (3) are both fixedly connected to the positioning belt (1). The top of the main pressure airbag (4) is fixedly connected to the outer liner (2), and the main pressure airbag (4) is connected to a precision air pump (6). The bottom of the main pressure airbag (4) is fixedly connected to the inner liner (3). A first pressure sensor (9) is located between the top of the main compression airbag (4) and the outer liner (2); multiple micro-airbags (5) are provided on the inner liner (3), and multiple micro-airbags (5) form multiple micro-airbag rings around the main compression airbag (4). A second pressure sensor (7) is provided between each micro-airbag (5) and the inner liner (3); the first pressure sensor (9), the second pressure sensor (7) and the precision air pump (6) are all connected to a processor (8); In the initial stage of hemostasis, the processor (8) receives the detection signals from the first pressure sensor (9) and each of the second pressure sensors (7). At the same time, the processor (8) controls the precision air pump (6) to inflate the main compression airbag (4). When the pressure value detected by the first pressure sensor (9) reaches the set range, the processor (8) controls the precision air pump (6) to slowly inflate and deflate. During the inflation and deflation process, the pressure value detected by the first pressure sensor (9) is always within the set range. When the pressure value detected by the first pressure sensor (9) is the minimum value that meets the condition, inflation and deflation are stopped. The condition is that the pressure value detected by each of the second pressure sensors (7) decreases at a uniform speed from the center of the main compression airbag (4) outwards.

2. The coronary angiography distal radial artery path hemostat of claim 1, wherein: After inflation and deflation are stopped, the processor (8) records the pressure values ​​detected by each of the second pressure sensors (7). During hemostasis, the processor (8) receives the real-time pressure values ​​detected by the second pressure sensors (7). When the real-time pressure value on one side of the bottom of the main compression airbag (4) increases and the real-time pressure value on the other side of the bottom of the main compression airbag (4) decreases, and the change in the real-time pressure value exceeds the set threshold, a pressure point deviation prompt is issued.

3. The coronary angiography distal radial artery pathway hemostat as described in claim 1, characterized in that: During the hemostasis process, if the pressure values ​​detected by the first pressure sensor (9) and each of the second pressure sensors (7) increase simultaneously, a swelling warning will be issued at the puncture site.

4. The coronary angiography distal radial artery pathway hemostat as described in claim 1, characterized in that: The second pressure sensor (7) is fixedly connected to the inner liner (3), the micro airbag (5) is fixed on one side of the substrate (10), and the other side of the substrate (10) is detachably connected to the inner liner (3).

5. The coronary angiography distal radial artery pathway hemostat as described in claim 4, characterized in that: The substrate (10) is bonded to the inner liner (3).

6. The coronary angiography distal radial artery pathway hemostat as described in claim 1, characterized in that: The inner cavity of the micro-airbag (5) is divided into two storage cavities by ultrasonic destruction of the diaphragm (11). The first agent (12) and the second agent (13) are stored in the two storage cavities respectively. The first agent (12) and the second agent (13) absorb heat after reacting.

Images