Radial artery hemostat kit and monitoring system

Abstract

The application discloses a radial artery hemostasis device kit, which comprises a plug-in part, an air bag, a bandage, a patch, a fixing part and a pressure sensor, wherein the air bag is arranged on the plug-in part, the plug-in part is provided with a plug-in convex part, the fixing part comprises a far radial fixing part and a near radial fixing part which are respectively provided with plug-in grooves, the plug-in convex part can be selectively inserted into any plug-in groove, so that the same plug-in part can be detachably adapted to two hemostasis positions of the far end or the near end radial artery; the patch is used for being attached to the skin of a puncture point and is provided with a mark structure for indicating the puncture point and an impedance electrode array; and the pressure sensor is arranged at a bag wall of the air bag for pressing the puncture point. The application also provides a radial artery hemostasis monitoring system, which combines a pressure signal, a bioimpedance signal and a systolic pressure value to identify a hemostasis state, dynamically adjusts the air bag pressure in a closed loop, realizes objective and quantitative hemostasis and early warning of rebleeding, and reduces the risk of related complications.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a radial artery hemostat kit and monitoring system. Background Technology

[0002] The radial artery approach has become the mainstream vascular access for interventional procedures such as coronary intervention, cerebrovascular intervention, peripheral vascular intervention, and visceral vascular intervention due to its advantages of minimal invasiveness, rapid postoperative recovery, and fewer complications. In clinical practice, there are two main types of radial artery puncture approaches: the classic radial artery approach (TRA), located proximal to the radial styloid process at the wrist; and the rapidly developing distal radial artery approach (dTRA), located in the region from the snuffbox to the distal radial styloid process in the hand anatomy. The distal radial artery approach has unique advantages in reducing the incidence of radial artery occlusion and improving postoperative patient comfort, and its clinical application is becoming increasingly widespread.

[0003] Regardless of the approach used, effective pressure hemostasis at the puncture site is necessary after interventional procedures. However, most interventional centers currently still use pressure bandages for hemostasis. Although specialized radial artery hemostatic devices are available on the market, they generally lack pressure monitoring capabilities. Hemostatic pressure relies primarily on the experience and judgment of medical staff, making it difficult to objectively quantify and dynamically adjust the pressure. The inability to monitor pressure in real time easily leads to excessive or insufficient pressure. Excessive pressure may cause complications such as vascular occlusion and tissue ischemia, while insufficient pressure may lead to hematoma or rebleeding. Furthermore, the lack of individualized hemostasis protocols results in poor consistency in procedures, making it difficult to avoid risks arising from differences in technique.

[0004] Secondly, existing hemostatic devices mainly rely on visual observation of bleeding at the puncture site, which is a reactive measure and makes it difficult to provide early warning of potential rebleeding or hematoma formation. The decompression process still depends on repeated manual inspection and operation, lacking continuity and automation.

[0005] Furthermore, there is a lack of a universal hemostasis protocol that accommodates both approaches. The classic radial artery approach is located at the wrist, while the distal radial artery approach is located in the hand. The puncture site locations and surrounding anatomical structures differ significantly between the two approaches, posing different requirements for the fit and pressure application of the hemostat. Existing hemostats are typically designed for only a single approach, failing to accommodate both proximal and distal puncture sites on a single device. This necessitates interventional centers stocking different instruments separately, increasing the variety of equipment and operational complexity, and reducing operational flexibility.

[0006] Therefore, there is an urgent need for a new type of radial artery hemostat kit and monitoring system that can achieve real-time quantitative monitoring of hemostatic pressure and early warning of bleeding, and can be flexibly adapted to both proximal and distal radial artery puncture approaches. Summary of the Invention

[0007] This invention provides a radial artery hemostat kit and monitoring system to overcome the shortcomings of the prior art.

[0008] In a first aspect, the present invention provides a radial artery hemostat kit, comprising: a connector, an airbag, a bandage, a patch, a fixation element, and a pressure sensor; The airbag is disposed on the connector, and the connector is provided with a gas channel communicating with the airbag. The gas channel is used to inflate or deflate the airbag. The fastener includes a distal radial fastener and a proximal radial fastener. The connector has a plug-in protrusion. The distal radial fastener has a first plug-in groove, and the proximal radial fastener has a second plug-in groove. The plug-in protrusion can be selectively inserted into either the first plug-in groove or the second plug-in groove, so that the connector is detachably and fixedly connected to the distal radial fastener or the proximal radial fastener. The fastener is provided with a strap structure for engaging with the strap to secure it to the wearer's back of hand or wrist; The patch is used to be attached to the skin at the radial artery puncture point and includes a marking structure for indicating the radial artery puncture point and an impedance electrode array. The impedance electrode array includes multiple impedance electrodes disposed around the marking structure for detecting changes in bioimpedance of the tissue around the radial artery puncture point and outputting a bioimpedance signal. The pressure sensor is located on the wall of the airbag used to compress the radial artery puncture point, and is used to detect the compression pressure between the airbag and the marker structure during the wearing state and output a pressure signal.

[0009] In this invention, the hemostat can be detachably fixed to either the distal or proximal radial artery via a connector, allowing the same hemostat to be adapted to both distal and proximal radial artery compression hemostasis positions. Since the marking structure on the patch indicates the radial artery puncture point, the contact pressure between the balloon wall and the marking structure when the balloon is inflated and compresses the marking structure reflects the compression pressure exerted by the balloon on the puncture point.

[0010] In some implementations, the gas channel can be connected to an external gas pressure regulating device to inflate or deflate the airbag. In one implementation, the connector may have one or two gas channels, preferably one, to reduce design and usage complexity. Specifically, the external gas pressure regulating device may include one or more of the following: a manual inflation pump, a manual deflation valve, a syringe, a needle valve, a pressure regulating valve, a pressure reducing valve, a check valve, a pressure relief valve, a safety valve, a solenoid valve, a miniature air pump, and a suction pump. These devices can be connected individually or in combination to the gas channel via an interface to achieve airbag inflation, deflation, and pressure regulation.

[0011] In some embodiments, the patch may be strip-shaped or arc-shaped, with self-adhesive layers at both ends. The impedance electrode array and the marking structure are located in the central region between the self-adhesive layers at both ends of the patch. The self-adhesive layers and the impedance electrode array do not overlap on the patch, thereby ensuring that the patch is stably attached to the skin around the radial artery puncture point through the self-adhesive layers at both ends, and that the impedance electrode array located in the central region can directly contact the skin to collect bioimpedance signals.

[0012] In other embodiments, in addition to being attached to the skin separately as a standalone component, the patch can also be detachably connected to the distal radial fixation member or the proximal radial fixation member, for example, by means of Velcro, snap fasteners, etc.

[0013] In some embodiments, the proximal radial fixation device may have a rectangular outline for securing to the wearer's wrist and aligning the airbag with the radial artery puncture point located proximal to the radial styloid process to compress the puncture point for hemostasis; both ends of the proximal radial fixation device are provided with strap structures. In this invention, the proximal radial fixation device covers the area of ​​the wearer's wrist from the radial styloid process to the vicinity of its proximal wrist crease, the area corresponding to the radial artery puncture point via the radial artery approach. In some embodiments, the distal radial fixation device may include a central portion and a first connecting arm, a second connecting arm, and a third connecting arm extending outward from the central portion, the first connecting arm, the second connecting arm, and the third connecting arm being distributed around the central portion, and each connecting arm having the strap structure at its end; the distal radial fixation device is used to fix to the back of the wearer's hand and to align the airbag with the distal radial artery puncture point located at the distal end of the radial styloid process to compress the puncture point to stop bleeding.

[0014] In this invention, the central portion of the distal radial fixation member corresponds to the area between the anatomical snuffbox and the distal end of the radial styloid process on the radial side of the wearer's back of the hand, and the area corresponds to the radial artery puncture point of the distal radial artery approach (dTRA); the first connecting arm, the second connecting arm and the third connecting arm extend from the central portion in different directions toward the wearer's hand to work together to stably attach and fix the distal radial fixation member to the radial side of the back of the hand.

[0015] In one implementation, the distal radius fixation device can be divided into left-hand and right-hand specifications.

[0016] In some implementations, the patch can be strip-shaped or arc-shaped. In other implementations, the patch can be further divided into distal radial patch and proximal radial patch. The proximal radial patch can still be strip-shaped to fit the wrist. The distal radial patch can be arc-shaped to match the area on the radial side of the dorsum of the hand from the anatomical snuffbox to the distal end of the radial styloid process. The distal radial patch can also be available in left-hand and right-hand sizes, with the arc contours of the two sizes being mirror images of each other to fit the corresponding skin areas of the left and right hands, respectively.

[0017] In one embodiment, the first and second insertion slots have matching shapes and sizes so that the same insertion member can be used with either the distal radial fixation member or the proximal radial fixation member.

[0018] The fit between the protrusion and the slot can be a slight interference fit or a flexible interference fit, so that the protrusion and slot can maintain a fixed connection through friction, while allowing the operator to perform insertion and removal by hand. To achieve this slight interference fit or flexible interference fit, the material of the connector is preferably a polymer material with a certain degree of elasticity (such as TPU, silicone, elastic PA, etc.).

[0019] In this invention, both ends of the strap are free ends, and the two cooperate with each other to fix the fastener to the back of the wearer's hand.

[0020] In a second aspect, the present invention also provides a radial artery hemostasis monitoring system, comprising: The radial artery hemostat kit described in the first aspect; The signal processing host is electrically connected to the pressure sensor and the impedance electrode, respectively, and is used to acquire the pressure signal and the bioimpedance signal, and to acquire the systolic blood pressure value output by the external monitoring device to identify the wearer's radial artery hemostasis status, and send the generated hemostasis status information and / or control instructions to at least one user terminal.

[0021] In some implementations, the signal processing host is configured to perform the following processes: determine a compression pressure value based on the pressure signal, and compare the compression pressure value with the systolic pressure value to obtain a pressure difference; determine the rate of change of impedance over time based on the bioimpedance signal; and identify the radial artery hemostasis status using preset judgment logic based on the pressure difference and the rate of change of impedance over time.

[0022] In some implementations, the preset determination logic includes: When the pressure difference is within a preset range (e.g., [SBP] When the blood pressure is within 10 mmHg and the blood pressure is within 30 mmHg, the distal radial artery is considered to be under appropriate compression. When the pressure difference is less than the lower limit of the preset range and the rate of change of impedance over time is less than the preset decrease threshold, the radial artery hemostasis state is determined to be a state of insufficient compression. When the pressure difference is greater than the upper limit of the preset range and the rate of change of impedance over time is greater than the preset rising threshold, the radial artery hemostasis state is determined to be an excessive compression state.

[0023] In some embodiments, the signal processing host is configured to output a feedback control signal to an external gas pressure regulating device based on the identified radial artery hemostasis status to adjust the real-time pressure of the airbag; wherein, when insufficient compression is determined, the feedback control signal controls the external gas pressure regulating device to increase the pressure of the airbag; when appropriate compression is determined, the feedback control signal controls the external gas pressure regulating device to maintain the pressure of the airbag; and when excessive compression is determined, the feedback control signal controls the external gas pressure regulating device to decrease the pressure of the airbag.

[0024] In some embodiments, the signal processing host is further configured to issue a warning message to at least one user terminal if, after outputting a feedback control signal, the identified radial artery hemostasis status remains in an over-compression or under-compression state and continues for more than a preset duration. In this invention, the monitoring system monitors the hemostasis status of the radial artery in real time and dynamically adjusts the real-time pressure of the cuff based on the monitoring results. When the hemostatic pressure is insufficient, the pressure is increased by inflation; when the hemostatic pressure is excessive, the pressure is decreased by deflation. Furthermore, if the system automatically reduces the cuff pressure but still indicates excessive or insufficient pressure for more than a preset duration, the system can send an alert to medical personnel to prompt manual intervention.

[0025] The radial artery hemostat kit and monitoring system provided by this invention can bring at least the following beneficial effects: This invention addresses the problem of a single structure being unable to accommodate the anatomical differences of different puncture sites by incorporating detachable distal and proximal radial fixation devices. The distal radial fixation device is specifically designed to fit the skin contour of the radial side of the dorsum of the hand, from the snuffbox area to the distal end of the radial styloid process. The proximal radial fixation device is adapted to the area of ​​the wearer's wrist, from the radial styloid process to the proximal wrist crease. This dual-fixation design allows the same connector to flexibly adapt to both distal and proximal puncture needs.

[0026] By integrating a pressure sensor within the balloon, this invention enables real-time, continuous, and quantitative acquisition of the contact pressure at the radial artery puncture point. Compared to traditional bandages or ordinary hemostatic devices that rely on the experience and feel of medical staff, this design provides objective data for hemostatic pressure. During the postoperative decompression observation period, medical staff can precisely adjust the external gas pressure regulator based on real-time pressure values, avoiding the risk of rebleeding due to blind decompression or prolonged excessive pressure caused by untimely decompression. This helps promote the standardization of hemostasis procedures and reduce the incidence of complications due to individual differences in experience.

[0027] Simply relying on pressure monitoring cannot determine the actual blood flow closure within blood vessels or the state of tissue microcirculation. Visual observation of bleeding or using humidity sensors to detect changes in skin surface humidity are only reactive warnings (i.e., bleeding has already occurred). However, when subcutaneous bleeding occurs, the local accumulation of blood (whose conductivity is significantly higher than normal subcutaneous tissue) along the electrode path causes detectable changes in bioimpedance. This change occurs the instant the blood accumulates subcutaneously, much earlier than when the blood reaches the skin surface and is observed by the naked eye. Therefore, an impedance electrode array can identify bleeding trends and trigger warnings before clinicians or patients can visually detect bleeding, gaining valuable time for timely adjustments to pressure-based hemostasis. Therefore, this invention integrates an impedance electrode array into a patch to utilize bioimpedance for early detection of potential rebleeding risks. Combining a dual-judgment logic of pressure and bioimpedance signals (e.g., pressure difference combined with impedance change rate), the system can accurately distinguish between "insufficient pressure" (low pressure and decreased impedance), "excessive pressure" (high pressure and abnormally increased impedance), and "appropriate pressure."

[0028] When the system determines that the hemostasis status is abnormal (such as the pressure difference deviating from the preset range), it can automatically trigger the inflation or deflation of the air bladder for fine-tuning. This dynamic and automatic pressure regulation mechanism solves the problem of discontinuous decompression process and reliance on repeated manual checks in traditional hemostats. Under the premise of ensuring effective hemostasis, it can automatically attempt to reduce the pressure intensity and minimize the time of high-intensity compression, thereby reducing the probability of long-term complications such as radial artery occlusion.

[0029] The elastic interference fit design of the plug protrusion and the plug groove makes the assembly and disassembly of the fastener and the plug convenient and quick, and the same plug can be used interchangeably, reducing the variety of items that hospitals need to stock and the complexity of operations. Attached Figure Description

[0030] To more clearly illustrate the technical solutions in this invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of this invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0031] In this invention, "bottom" or "below" generally refers to the side facing the object being applied, while "top" or "above" generally refers to the side facing the operator or the side away from the object being applied.

[0032] Figure 1 A schematic diagram of the overall structure of one embodiment of the radial artery hemostat kit provided by the present invention shows the situation when the kit is assembled into a distal radial hemostat, including a connector (1), a first connecting arm (101) and a second connecting arm (102), an airbag (5) and a distal radial first strap (4). Figure 1 The image also shows an airbag (5) and a gas channel (3), as well as a pressure sensor (7) arranged on the wall of the airbag.

[0033] Figure 2 for Figure 1 The bottom view of the distal radial hemostat shown shows the distal radial fixation member (100), the third connecting arm (103), the second distal radial strap (2), the air bladder (5), and the insertion slot (10).

[0034] Figure 3 for Figure 1 The schematic side view of the radial artery hemostat kit showing the connector (1) separated from the distal radial fixation member shows the connector protrusion (9), the air bladder (5), and the gas channel (3) of the connector (1).

[0035] Figure 4 This is a side view cross-sectional schematic diagram of the fixation member in the radial artery hemostat kit of the present invention, showing the cross-sectional structure of the insertion groove (10) on the top surface of the fixation member; the fixation member can be a distal radial fixation member or a proximal radial fixation member.

[0036] Figure 5 This is a side view of the insertion and engagement state of the connector (1) and the fixation member in the radial artery hemostat kit of the present invention. It shows the assembly state after the insertion protrusion (9) of the connector (1) is inserted into the insertion groove (10) of the fixation member, wherein the fixation member can be a distal radial fixation member or a proximal radial fixation member.

[0037] Figure 6 The bottom view of the near-radial fixation member (11) shows the insertion slot (10) and the airbag (5).

[0038] Figure 7A top view of the patch (14) used for distal radial artery puncture. (See image below.) Figure 7 As shown, the patch (14) is arc-shaped and has self-adhesive layers (12) at both ends for attaching to the skin. A marking structure (13), an impedance electrode array (8), and electrode lead outlets (15) are also shown.

[0039] Figure 8 A top view of the patch (14') used for near-radial artery puncture, as shown. Figure 8 As shown, the patch (14') is strip-shaped with self-adhesive layers (12') at both ends for skin adhesion. A marking structure (13'), an impedance electrode array (8'), and electrode lead outlets (15') are also shown.

[0040] Figure Labels 1. Connector; 101. First connecting arm; 102. Second connecting arm; 103. Third connecting arm; 2. Second strap for distal radius; 3. Inflation channel; 4. First strap for distal radius; 5. Airbag; 6. First strap for proximal radius; 7. Pressure sensor; 8 (8') Impedance electrode array; 9. Connecting protrusion; 10. Connecting groove; 100. Fixing member for distal radius; 11. Fixing member for proximal radius; 12 (12') Connecting part; 13 (13') Marking structure; 14 (14') Patch; 15 (15') Electrode lead outlet. Detailed Implementation

[0041] To make the objectives, technical solutions, and advantages of this invention clearer, the technical solutions of this invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, embodiments of this invention, and should not be construed as limiting the invention. All other embodiments obtained by those skilled in the art based on the embodiments of this invention without creative effort are within the scope of protection of this invention. In the description of this invention, it should be understood that the terminology used is for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0042] In this invention, "bottom" generally refers to the side facing the object of application, while "top" refers to the side facing the operator or the side away from the object of application.

[0043] Figures 1 to 8 This is a schematic diagram of a specific embodiment of the radial artery hemostat kit provided by the present invention.

[0044] See Figures 1 to 8 The present invention provides a radial artery hemostat kit, which may include: The device includes a connector 1, straps (including a first strap 4 for distal radius, a second strap 2 for distal radius, and a first strap 6 for proximal radius), an airbag 5, a patch 14 (14'), a fixation member 100 for distal radius (including a first connecting arm 101, a second connecting arm 102, and a third connecting arm 103), a fixation member 11 for proximal radius, a pressure sensor 7, and an impedance electrode array 8 (8').

[0045] An airbag 5 is disposed at the bottom of the connector 1 (preferably on the bottom surface of the connector protrusion 9). The connector 1 has a gas channel 3 communicating with the airbag 5 for inflating or deflating the airbag 5. The gas channel 3 can be connected to an external gas pressure regulating device, thereby enabling the airbag to be inflated or deflated. The external gas pressure regulating device may include one or more of the following: a manual inflation pump, a manual deflation valve, a syringe, a needle valve, a pressure regulating valve, a pressure reducing valve, a one-way valve, a pressure relief valve, a safety valve, a solenoid valve, a miniature air pump, and a suction pump. The above device is connected to the gas channel through an interface to realize the inflation, deflation, and pressure regulation of the airbag.

[0046] The airbag 5 can be made of a soft, inflatable medical elastic material with good airtightness, preferably a medical TPU film, a medical silicone film, a TPE elastomer film, or other materials with flexibility, fatigue resistance, and airtightness.

[0047] The bottom of the connector 1 is provided with a plug-in protrusion 9, the top surface of the distal radial fixing member is provided with a first plug-in groove, and the top surface of the proximal radial fixing member is provided with a second plug-in groove. The plug-in protrusion 9 can be selectively inserted into the first plug-in groove or the second plug-in groove so that the connector 1 is detachably fixedly connected to the distal radial fixing member or the proximal radial fixing member 11.

[0048] The distal radial fixation device 100 includes a central portion and a first connecting arm 101, a second connecting arm 102, and a third connecting arm 103 extending outward from the central portion. The first, second, and third connecting arms are distributed around the central portion, and each connecting arm has a strap structure at its end. The distal radial fixation device is used to fix the device to the back of the wearer's hand and align the airbag with the distal radial artery puncture point located at the distal end of the radial styloid process to compress the puncture point for hemostasis. The central portion of the distal radial fixation device corresponds to the area between the anatomical snuffbox on the radial side of the wearer's hand and the distal end of the radial styloid process, which corresponds to the radial artery puncture point of the distal radial artery approach (dTRA). The first connecting arm 101, the second connecting arm 102, and the third connecting arm 103 extend from the central portion in different directions toward the wearer's hand to work together to stably attach and fix the distal radial fixation device to the back of the hand.

[0049] The proximal radial fixation 11 has a rectangular outline that covers the area of ​​the wearer's wrist from the radial styloid process to the proximal wrist crease, the area corresponding to the radial artery puncture point via the radial artery approach. Figure 7 and Figure 8 Distal radial patch 14 and proximal radial patch 14' are shown respectively. Figure 8 As shown, the radial patch 14' is strip-shaped to suit application to the wrist. (As indicated...) Figure 7 As shown, the distal radial patch 14 is arc-shaped to match the area on the back of the hand from the anatomical snuffbox to the distal end of the radial styloid process. The patch 14 (14') includes a marker structure 13 (13') for indicating the radial artery puncture point and an impedance electrode array 8 (8'). The impedance electrode array 8 (8') includes multiple impedance electrodes disposed around the marker structure 13 (13') for detecting changes in bioimpedance of the tissue surrounding the radial artery puncture point and outputting a bioimpedance signal. The pressure sensor 7 is disposed inside the airbag 5 to compress the wall of the radial artery puncture point. When worn, the airbag 5 compresses the radial artery puncture point indicated by the marking structure 13 (13'). The pressure sensor 7 is used to detect the compression pressure between the airbag and the marking structure and output a pressure signal.

[0050] The first insertion slot and the second insertion slot have the same dimensions (not shown in the figure) so that the same insertion member can be used with either the distal radial fixing member or the proximal radial fixing member.

[0051] The fit between the protrusion and the slot can be a slight interference fit or a flexible interference fit, allowing the protrusion and slot to maintain a fixed connection through friction while still allowing the operator to manually insert and remove the connector. The preferred materials for the connector are TPU, silicone, and elastic PA.

[0052] In some implementations, the distal and proximal radial fixators can be made of transparent or translucent materials, allowing healthcare personnel to directly observe the alignment of the connector base with the marking structure and the color change of the skin around the puncture point during wear, thus enabling timely assessment of the compression effect. Suitable materials for the fixators include, but are not limited to: polycarbonate (PC), polymethyl methacrylate (PMMA, commonly known as acrylic), polyetheretherketone (PEEK), medical-grade polypropylene (PP), and medical-grade polyethylene (PE), with polycarbonate and polymethyl methacrylate being preferred. The fixators can be manufactured using injection molding to achieve precise molding of complex contours (including arcuate and rectangular contours) while ensuring consistency in mass production.

[0053] In clinical practice, the location of the puncture point can be determined based on the anatomical course of the distal radial artery and bony landmarks of the hand. It is generally placed in an area that facilitates vascular puncture and subsequent compression for hemostasis, so that the connector can provide stable and effective local compression of the punctured vascular point, while also ensuring wearing comfort and fixation stability. Therefore, in one embodiment, the patch 14 (14') is provided with a marking structure 13 (13') corresponding to the puncture point. The marking structure can be distinguished by different appearance or tactile features, such as dot marks, line marks, color marks, pattern marks, raised structures, recessed structures, printed marks, or luminescent marks, to facilitate rapid identification and positioning of the compression area corresponding to the puncture point.

[0054] To accommodate different hand sizes, the dimensions of the marking structure can be set according to the distribution range of puncture points corresponding to different hand shapes. Preferably, the length, width, diameter, thickness, or area of ​​the marking structure can adopt multiple specifications, or be adjusted within a preset range, so that the marking structure can accurately indicate the corresponding compression positioning area under different hand size conditions.

[0055] In one embodiment, to achieve fixation, a tightening component is provided at the free end of the strap for tightening and locking the strap after it is wrapped around the wearer's wrist. The tightening component can tighten and fix the strap through methods such as adhesion, fastening, insertion, sliding locking, or ratchet engagement to accommodate different wrist circumferences and provide stable fixation force. Specific forms of the tightening component may include Velcro structures, snap-on structures, buckle structures, sliding buckle structures, ratchet-type tightening structures, or other structural forms capable of adjusting and fixing the strap length.

[0056] The pressure sensor 7 is embedded in the wall of the airbag 5 and located at the point where the airbag 5 is used to compress the radial artery puncture point. When the airbag 5 compresses the radial artery puncture point, the pressure sensor 7 is used to detect the contact pressure at the interface between the airbag 5 and the skin in real time and outputs a pressure signal related to the compression state of the puncture point. Since the pressure sensor 7 is located at the point where the airbag compresses the puncture point, the contact pressure it detects can characterize the actual compression pressure of the airbag 5 on the radial artery puncture point, thereby accurately reflecting the compression status of the puncture point, avoiding hemostasis failure due to insufficient compression or skin injury due to excessive compression, and improving the safety and accuracy of the hemostasis process. The pressure sensor 7 is preferably a flexible thin-film or piezoresistive structure to adapt to the deformation of the airbag 5 during the force process and to ensure stable measurement performance during repeated compression cycles. The pressure signal output by the pressure sensor 7 can be transmitted to the signal processing host via wired or wireless means. In one embodiment, the pressure sensor 7 is connected to an electrical channel (not shown in the figure) within the connector 1 via a flexible lead. The outlet of the electrical channel can be located at the rear, side, or connecting arm of the connector 1, for leading the pressure signal out to the signal processing host via the flexible lead. In another embodiment, the pressure sensor 7 integrates a wireless transmission module, and the pressure signal is wirelessly transmitted to the signal processing host via the wireless transmission module, thereby eliminating the need for a lead connecting the pressure sensor 7 and the signal processing host, avoiding the lead passing through the airbag wall of the airbag 5 and affecting the airbag's sealing performance, and improving the convenience and comfort of wearing it. The impedance electrode array 8 (8') is used to apply a weak alternating current to the tissue and detect impedance changes between the electrodes to reflect changes in the tissue state around the puncture point, such as hematoma formation or tissue fluid exudation, thereby providing real-time monitoring of the hemostasis process. The impedance electrodes can be made of medical conductive materials, preferably silver / silver chloride, conductive carbon film, or conductive rubber. For each puncture point, at least two electrodes can be provided, preferably in the form of a two-electrode, four-electrode, or multi-electrode array, to improve the stability and spatial resolution of the impedance measurement. Specifically, the impedance electrode array can be arranged circumferentially or radially along the marked structure. The spacing between the impedance electrodes is set according to the anatomical location of the puncture point, enabling the electrodes to cover the tissue area around the puncture point and obtain stable impedance measurements. The shape of the impedance electrodes can be circular, elliptical, strip-shaped, or other conductive structures suitable for skin adhesion.

[0057] Based on the radial artery hemostat kit described above, the present invention provides a radial artery hemostasis monitoring system, which may include: the radial artery hemostat kit described above; a signal processing host, the signal processing host being electrically connected to the pressure sensor 7 and the impedance electrode 8 (8'), for acquiring the pressure signal and the bioimpedance signal, and acquiring the systolic blood pressure value output by an external monitoring device, so as to identify the wearer's radial artery hemostasis status, and sending the generated hemostasis status information and / or control instructions to at least one user terminal.

[0058] In one embodiment, the signal processing host is configured to perform the following processes: The compression pressure value is determined based on the pressure signal, and the compression pressure value is compared with the systolic pressure value to obtain the pressure difference ΔP; The rate of change of impedance over time, dZ / dt, is determined based on the bioimpedance signal. Here, dZ represents the change in impedance, dt represents the change in time, and dZ / dt represents the rate of change of bioimpedance Z relative to time t. This reflects the dynamic changes in the water content or density of the tissue around the puncture site. When dZ / dt decreases, it indicates that the impedance decreases over time, suggesting an increase in tissue water content, which may be caused by blood or tissue fluid exudation due to insufficient compression. When dZ / dt increases, it indicates that the impedance increases over time, suggesting that the tissue becomes tighter due to compression or that the extracellular fluid decreases. This is usually associated with ischemic edema caused by excessive compression. Based on the pressure difference and the rate of change of impedance over time, the radial artery hemostasis status is identified using preset judgment logic.

[0059] The preset determination logic includes: When the pressure difference is within the preset range ([SBP) When the radial artery hemostasis is within 10 mmHg and the SBP is within 30 mmHg, the compression status is considered appropriate. When the pressure difference is less than the lower limit of the preset range and the rate of change of impedance over time is less than the preset decrease threshold, the radial artery hemostasis status is determined to be insufficient compression. When the pressure difference is greater than the upper limit of the preset range and the rate of change of impedance over time is greater than the preset rising threshold, the radial artery hemostasis state is determined to be an excessive compression state.

[0060] Specifically, a low ΔP indicates insufficient compression, while a decrease in dZ / dt essentially reflects an increase in tissue water content due to insufficient compression, which may lead to bleeding. Conversely, a high ΔP indicates excessive compression, while an increase in dZ / dt reflects an increase in tissue swelling due to excessive compression, which may lead to tissue edema.

[0061] In one embodiment, the signal processing host is configured to output a feedback control signal to an external gas pressure regulating device based on the identified radial artery hemostasis status to adjust the real-time pressure of the airbag; wherein, when insufficient compression is determined, the feedback control signal controls the external gas pressure regulating device to increase the pressure of the airbag; when appropriate compression is determined, the feedback control signal controls the external gas pressure regulating device to maintain the pressure of the airbag; and when excessive compression is determined, the feedback control signal controls the external gas pressure regulating device to decrease the pressure of the airbag.

[0062] In this invention, the monitoring system monitors the radial artery hemostasis status in real time and dynamically adjusts the real-time pressure of the cuff based on the monitoring results. When the hemostatic pressure is insufficient, the pressure is increased by inflation; when the hemostatic pressure is excessive, the pressure is decreased by deflation. Furthermore, if the system automatically reduces the cuff pressure but still indicates excessive or insufficient pressure for more than a preset duration, the system can send a warning message to medical personnel to prompt manual intervention. The preset duration can be set by medical personnel based on the patient's actual condition or can use the system's default parameters.

[0063] In one embodiment, the radial artery hemostasis monitoring system may further include an alarm device connected to a signal processing host. This alarm device is used to alert medical personnel when a risk condition is detected, such as insufficient or excessive compression, or abnormal tissue impedance around the puncture site. The alarm signal may include at least one of the following: audible alarm (e.g., buzzer, voice prompt module, etc.), visual alarm (e.g., LED indicator, warning icon on display), vibration alarm (e.g., miniature vibration motor, suitable for wearable or mobile hemostasis devices), interface alarm (e.g., pop-up warning window, text prompt, graph, or risk level, etc.), or communication alarm (e.g., pushing alarms to a mobile app via Bluetooth, sending alarms to the nurse station via Wi-Fi, sending alarms to the hospital monitoring system, etc.). These alarms are used to remind medical personnel to promptly check the hemostasis status or take necessary actions, thereby improving the safety and reliability of the hemostasis process. In a preferred embodiment, a multimodal alarm combination can be used, such as sound + light, light + vibration, sound + light + interface, etc. In one embodiment, the alarm device outputs at least one of the following: audible alarm, visual alarm, vibration alarm, or interface prompt.

[0064] The following describes the method of using the radial artery hemostasis monitoring system of the present invention, in conjunction with the accompanying drawings and the above-described embodiments: First, select the appropriate fixation device according to the puncture approach—use a distal radial fixation device for the distal radial approach (dTRA) and a proximal radial fixation device for the classic radial approach (TRA). Insert the insertion protrusion of the connector into the insertion groove of the corresponding fixation device to complete the detachable and fixed connection between the connector and the fixation device.

[0065] Next, the patch is applied to the skin at the radial artery puncture site, aligning the markings on the patch with the puncture site, and the patch is then securely attached to the skin around the puncture site using the self-adhesive layers at both ends. Subsequently, the assembled hemostat is worn on the back of the wearer's hand or wrist, with the balloon aligned with the puncture site indicated by the markings, and the fixation device is tightened and secured using the straps that pass through the fixation device.

[0066] Then, the gas channel is connected to an external gas pressure regulator to inflate the cuff to compress the puncture site for hemostasis; at the same time, the signal processing host is connected to the pressure sensor and impedance electrode array respectively, and connected to an external monitoring device to obtain the wearer's systolic blood pressure value.

[0067] During hemostasis, the signal processing host acquires pressure signals, bioimpedance signals and systolic blood pressure values ​​in real time. Based on the pressure difference and the rate of change of impedance over time, it uses preset judgment logic to identify whether the compression is appropriate, insufficient, or excessive. Accordingly, it outputs feedback control signals to the external gas pressure regulating device to automatically increase, maintain, or decrease the airbag pressure, thereby achieving closed-loop dynamic pressure regulation.

[0068] Finally, during the decompression observation period, the signal processing host continuously monitors the hemostasis status and sends the hemostasis status information to the user terminal; if the hemostasis status is still excessive or insufficient after outputting the feedback control signal and continues for more than the preset time, an alarm message is sent to at least one user terminal to prompt medical staff to perform manual intervention.

[0069] This invention provides a radial artery hemostat kit and a radial artery hemostasis monitoring system. By designing anatomically adapted distal and proximal radial artery fixation devices for the distal and proximal radial arteries respectively, it ensures precise fit and stable pressure of the balloon in special anatomical locations such as the snuffbox to the styloid process area. Simultaneously, by integrating a pressure sensor within the balloon and setting an impedance electrode array on the patch, it achieves real-time dual monitoring of the compression force and the bioimpedance of the tissue around the puncture point. This allows the system to accurately identify insufficient, appropriate, or excessive compression based on objective pressure difference and impedance change rate data, thereby driving closed-loop dynamic balloon pressure fine-tuning. This not only provides objective and quantitative hemostasis indicators to guide standardized decompression operations but also uses impedance sensing to achieve early warning of potential hematoma or rebleeding. Ultimately, while improving hemostasis effectiveness, comfort, and operational consistency, it effectively reduces the risk of complications such as vascular occlusion, tissue ischemia, or hematoma caused by excessive or insufficient compression.

[0070] 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 radial artery hemostat kit, characterized in that, include: Connectors, airbags, straps, patches, fasteners, and pressure sensors; The airbag is disposed on the connector, and the connector is provided with a gas channel communicating with the airbag. The gas channel is used to inflate or deflate the airbag. The fastener includes a distal radial fastener and a proximal radial fastener. The connector has a plug-in protrusion. The distal radial fastener has a first plug-in groove, and the proximal radial fastener has a second plug-in groove. The plug-in protrusion can be selectively inserted into either the first plug-in groove or the second plug-in groove, so that the connector is detachably and fixedly connected to the distal radial fastener or the proximal radial fastener. The fastener is provided with a strap structure for engaging with the strap to secure it to the wearer's back of hand or wrist; The patch is used to be attached to the skin at the radial artery puncture point and includes a marking structure for indicating the radial artery puncture point and an impedance electrode array. The impedance electrode array includes multiple impedance electrodes disposed around the marking structure for detecting changes in bioimpedance of the tissue around the radial artery puncture point and outputting a bioimpedance signal. The pressure sensor is located on the wall of the airbag used to compress the radial artery puncture point, and is used to detect the compression pressure between the airbag and the marker structure during the wearing state and output a pressure signal.

2. The radial artery hemostat kit according to claim 1, characterized in that, The proximal radial fixation device has a rectangular outline and is used to fix it to the wearer's wrist and align the airbag with the radial artery puncture point located at the proximal end of the radial styloid process to compress the puncture point to stop bleeding; the proximal radial fixation device has a strap structure at both ends.

3. The radial artery hemostat kit according to claim 1 or 2, characterized in that, The distal radial fixation device includes a central portion and a first connecting arm, a second connecting arm, and a third connecting arm extending outward from the central portion. The first connecting arm, the second connecting arm, and the third connecting arm are distributed around the central portion, and each connecting arm has a strap structure at its end. The distal radial fixation device is used to fix the device to the back of the wearer's hand and align the airbag with the distal radial artery puncture point located at the distal end of the radial styloid process to compress the puncture point to stop bleeding.

4. The radial artery hemostat kit according to claim 1, characterized in that, The patch is strip-shaped or arc-shaped, with self-adhesive layers at both ends. The impedance electrode array and the marking structure are located in the central region between the self-adhesive layers at both ends of the patch.

5. The radial artery hemostat kit according to claim 1, characterized in that, The first and second insertion slots have matching shapes and sizes so that the same insertion member can be used with either the distal radial fixing member or the proximal radial fixing member.

6. A radial artery hemostasis monitoring system, characterized in that, include: Radial artery hemostat kit as described in any one of claims 1 to 5; The signal processing host is electrically connected to the pressure sensor and the impedance electrode, respectively, and is used to acquire the pressure signal and the bioimpedance signal, and to acquire the systolic blood pressure value output by the external monitoring device to identify the wearer's radial artery hemostasis status, and send the generated hemostasis status information and / or control instructions to at least one user terminal.

7. The radial artery hemostasis monitoring system according to claim 6, characterized in that, The signal processing host is configured to perform the following processes: The compression pressure value is determined based on the pressure signal, and the compression pressure value is compared with the systolic pressure value to obtain the pressure difference; The rate of change of impedance over time is determined based on the bioimpedance signal; The radial artery hemostasis status is identified using preset judgment logic based on the pressure difference and the rate of change of impedance over time.

8. The radial artery hemostasis monitoring system according to claim 7, characterized in that, The preset determination logic includes: When the pressure difference is within the preset range, the radial artery hemostasis state is determined to be a suitable compression state; When the pressure difference is less than the lower limit of the preset range and the rate of change of impedance over time is less than the preset decrease threshold, the radial artery hemostasis state is determined to be a state of insufficient compression. When the pressure difference is greater than the upper limit of the preset range and the rate of change of impedance over time is greater than the preset rising threshold, the radial artery hemostasis state is determined to be an excessive compression state.

9. The radial artery hemostasis monitoring system according to claim 8, characterized in that, The signal processing host is configured to output a feedback control signal to an external gas pressure regulating device based on the identified radial artery hemostasis status, so as to adjust the real-time pressure of the airbag; wherein, when it is determined that the compression is insufficient, the feedback control signal controls the external gas pressure regulating device to increase the pressure of the airbag; when it is determined that the compression is appropriate, the feedback control signal controls the external gas pressure regulating device to maintain the pressure of the airbag; when it is determined that the compression is excessive, the feedback control signal controls the external gas pressure regulating device to decrease the pressure of the airbag.

10. The radial artery hemostasis monitoring system according to claim 9, characterized in that, The signal processing host is also configured to issue a warning message to at least one user terminal if, after outputting a feedback control signal, the identified radial artery hemostasis status is still in an over-compression or under-compression state and continues for more than a preset time.

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