Active compression adjustable orifice twist hemostatic valve

Abstract

The utility model provides a kind of initiative extrusion type adjustable drift twist hemostatic valve, comprising: first fixed outer ring;Hemostatic valve body, one end is fixedly connected with first fixed outer ring;Second fixed outer ring, interval setting with first fixed outer ring, second fixed outer ring is fixedly connected with the other end of hemostatic valve body, and second fixed outer ring can rotate relative to first fixed outer ring and make the middle part of hemostatic valve body contract and close.The beneficial effects of the utility model include: reduce the number of valve pieces, simplify installation process, facilitate production.It is more compatible for the outer diameter of cooperating instrument, and the same specification hemostatic valve can be used for different size cooperating instruments, reducing production cost.When using, different size instruments can be optimized through, reducing valve body resistance.

Description

Technical Field

[0001] This manual relates to the field of interventional surgery technology, specifically to an active squeeze-type adjustable-bore torsion hemostatic valve. Background Technology

[0002] A catheter sheath is an auxiliary guiding device for peripheral and intracardiac minimally invasive interventional procedures. It is widely used in percutaneous coronary intervention, percutaneous interventional closure, and atrial septal puncture. The function of the catheter sheath is to establish a connection between the blood vessels and the outside world, providing a delivery channel for diagnostic and therapeutic instruments close to the surgical site. Due to the risks of excessive blood loss and air embolism during surgery, a hemostatic valve must be fitted to the proximal end of the catheter sheath. This reduces bleeding and prevents air from entering the blood vessel, effectively improving surgical safety and reducing the risk of complications. Common hemostatic valves for vascular sheaths include Luer open-ended and incisional types. In the case of incisional valves, the incision of the hemostatic valve needs to fit tightly against the outer wall of the instrument inserted into the sheath. However, in actual use, when the size of the inserted instrument does not match the incision well, the fit will decrease. Therefore, the sealing effect of incisional hemostatic valves needs to be improved. Utility Model Content

[0003] In view of this, the present invention provides an active compression type adjustable diameter torsion hemostatic valve to solve the problem of sealing effect of hemostatic valve.

[0004] The technical solution of this utility model is as follows: an active compression type adjustable diameter torsion hemostatic valve, comprising: a first fixed outer ring; a hemostatic valve body, one end of which is fixedly connected to the first fixed outer ring; a second fixed outer ring, which is spaced apart from the first fixed outer ring, and the other end of the second fixed outer ring is fixedly connected to the hemostatic valve body, and the second fixed outer ring can rotate relative to the first fixed outer ring and cause the middle part of the hemostatic valve body to contract and close.

[0005] Furthermore, the active compression adjustable diameter torsion hemostatic valve includes a hemostatic valve housing, and a first fixed outer ring is fixedly disposed on the hemostatic valve housing.

[0006] Furthermore, the active compression adjustable diameter torsion hemostatic valve includes a hemostatic valve cover, a second fixed outer ring fixed to the hemostatic valve cover, and the hemostatic valve cover can drive the second fixed outer ring to rotate.

[0007] Furthermore, the first fixed outer ring is provided with a first positioning part, and the second fixed outer ring is provided with a second positioning part, wherein the first positioning part can cooperate with the second positioning part for positioning.

[0008] Furthermore, the first positioning part includes a first fixed outer ring and a hemostatic valve body with a plurality of spaced first axial protrusions on the outer periphery of the connecting end face; the second positioning part includes a second fixed outer ring and a plurality of spaced second axial protrusions on the outer periphery of the connecting end face of the hemostatic valve body.

[0009] Furthermore, the first fixed outer ring is provided with a first positioning part, and the second fixed outer ring is provided with a second positioning part. The active compression type adjustable diameter torsion hemostatic valve includes a matching positioning part, and the first positioning part and the second positioning part are both matched and positioned through the matching positioning part.

[0010] Furthermore, the first positioning part includes a plurality of first grooves spaced apart along the outer periphery of the first fixed outer ring; the second positioning part includes a plurality of second grooves spaced apart along the outer periphery of the first fixed outer ring; the mating positioning part includes a positioning sleeve sleeved on the outer periphery of the hemostatic valve body, and positioning protrusions are provided at both ends of the positioning sleeve. The first grooves can engage with the positioning protrusions at one end of the positioning sleeve for positioning, and the second grooves can engage with the positioning protrusions at the other end of the positioning sleeve for positioning.

[0011] Furthermore, the hemostatic valve body includes a first conical segment and a second conical segment. The large-diameter end of the first conical segment is connected to the first fixed outer ring, the large-diameter end of the second conical segment is connected to the second fixed outer ring, and the small-diameter end of the first conical segment is connected to the small-diameter end of the second conical segment.

[0012] Furthermore, when the middle part of the hemostatic valve body contracts and closes, a device penetration cavity is formed at the first and second conical sections, and the inner diameter of the openings at both ends of the device penetration cavity is smaller than the outer diameter of the device to be passed through.

[0013] Furthermore, within the radial cross-section of the middle part of the hemostatic valve body, the hemostatic valve body includes multiple valves symmetrically distributed along the center, and the number of valves includes 3, 5 or 7.

[0014] Compared with the prior art, the beneficial effects that at least one technical solution adopted in the embodiments of this specification can achieve include at least:

[0015] 1. Reduce the number of valve plates, simplify the installation process, and facilitate production.

[0016] 2. It has higher compatibility with the outer diameter of the instruments being used, and the same specification of hemostatic valve can be used for instruments of different sizes, reducing production costs.

[0017] 3. When in use, the passage can be optimized for instruments of different sizes, reducing valve body resistance. Attached Figure Description

[0018] To more clearly illustrate the technical solutions of the embodiments of this application, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0019] Figure 1 This is an axial sectional view of an embodiment of the present invention;

[0020] Figure 2 This is a three-dimensional structural schematic diagram of an embodiment of the present utility model;

[0021] Figure 3 This is a schematic diagram of the hemostatic valve body structure according to an embodiment of the present invention;

[0022] Figure 4 This is a schematic diagram of the end opening structure of the through cavity of the instrument of this utility model;

[0023] Figure 5 This is a schematic cross-sectional view of the middle section of the through cavity of the instrument of this utility model;

[0024] Figure 6 This is a schematic diagram of the assembly structure of the positioning sleeve of this utility model.

[0025] In the figure, the following labels are used: 10, first fixing outer ring; 20, hemostatic valve body; 30, second fixing outer ring; 40, hemostatic valve outer shell; 50, hemostatic valve top cover; 60, positioning sleeve. Detailed Implementation

[0026] The embodiments of this application will now be described in detail with reference to the accompanying drawings.

[0027] The following specific examples illustrate the implementation of this application. Those skilled in the art can easily understand other advantages and effects of this application from the content disclosed in this specification. Obviously, the described embodiments are only a part of the embodiments of this application, and not all of them. This application can also be implemented or applied through other different specific embodiments, and the details in this specification can also be modified or changed based on different viewpoints and applications without departing from the spirit of this application. It should be noted that, in the absence of conflict, the following embodiments and features in the embodiments can be combined with each other. Based on the embodiments in this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0028] like Figures 1 to 6As shown, this application provides an active compression type adjustable diameter torsion hemostatic valve, including: a first fixed outer ring 10, a hemostatic valve body 20, and a second fixed outer ring 30. One end of the hemostatic valve body 20 is fixedly connected to the first fixed outer ring 10; the second fixed outer ring 30 is spaced apart from the first fixed outer ring 10, and the other end of the second fixed outer ring 30 is fixedly connected to the hemostatic valve body 20, and the second fixed outer ring 30 can rotate relative to the first fixed outer ring 10 and cause the middle part of the hemostatic valve body 20 to contract and close.

[0029] Compared to existing technologies, this invention can adapt to instruments of different outer diameters through the torsion adjustment of a single valve body, which greatly simplifies the installation process and reduces production and usage costs. At the same time, the adjustability of dynamic compression force optimizes the resistance to instrument passage, improving the flexibility and safety of surgical operations.

[0030] The active compression adjustable diameter torsion hemostatic valve includes a hemostatic valve housing 40, and a first fixed outer ring 10 is fixedly disposed on the hemostatic valve housing 40. The active compression adjustable diameter torsion hemostatic valve includes a hemostatic valve cover 50, and a second fixed outer ring 30 is fixed to the hemostatic valve cover 50, and the hemostatic valve cover 50 can drive the second fixed outer ring 30 to rotate.

[0031] The fixed connection between the hemostatic valve cap 50 and the second fixed outer ring 30 allows the operator to directly drive the second fixed outer ring 30 to rotate circumferentially by rotating the hemostatic valve cap 50, precisely controlling the radial contraction or expansion of the spiral grooved structure in the hemostatic valve body 20. This design simplifies the adjustment process, enabling dynamic adjustment of the duct diameter without complex tools, significantly improving the flexibility and efficiency of intraoperative operations.

[0032] By adjusting the rotation angle of the hemostatic valve cover 50, the radial compression force of the spiral groove on the instrument can be precisely controlled, optimizing the resistance when the instrument passes through. This avoids instrument deformation due to excessive pressure and prevents seal failure caused by insufficient pressure, thereby improving the safety and success rate of surgical procedures.

[0033] The first fixed outer ring 10 is provided with a first positioning part, and the second fixed outer ring 30 is provided with a second positioning part. The first positioning part can cooperate with the second positioning part for positioning.

[0034] The first and second positioning parts, through the cooperation of physical structures (such as bosses and grooves, gears and racks, or magnetic adsorption), provide a clear positioning reference for the circumferential rotation of the outer ring. During operation, the alignment of the two parts can achieve the preset deformation threshold of the spiral groove of the hemostatic valve body, ensuring the accuracy and repeatability of the hemostatic valve diameter adjustment and avoiding poor sealing or resistance fluctuations caused by rotation angle deviations.

[0035] The mechanical locking function of the positioning part prevents the second fixing outer ring 30 from rotating unexpectedly during the operation due to external forces (such as instrument collision or blood pressure), maintaining the stable compression state of the hemostatic valve body 20. Especially when no instruments pass through, the positioning part can fix the closed shape of the hemostatic valve, avoiding the risk of seal failure and significantly improving surgical safety.

[0036] In a specific embodiment, the first positioning part includes a first fixing outer ring 10 and a hemostatic valve body 20 with a plurality of spaced first axial protrusions on the outer periphery of the connection end face; the second positioning part includes a second fixing outer ring 30 and a second hemostatic valve body 20 with a plurality of spaced second axial protrusions on the outer periphery of the connection end face.

[0037] Multiple spaced first axial protrusions and second axial protrusions are respectively provided on the outer periphery of the connecting end faces of the first fixed outer ring 10 and the second fixed outer ring 30, forming a structure similar to "gear indexing". Through the meshing and misalignment between the protrusions, a clear physical positioning point is provided for circumferential rotation.

[0038] The uniform distribution of the protrusions allows for quantitative control of the rotation angle (e.g., a protrusion is set at 15° intervals). By rotating the cap 50 of the hemostatic valve, the operator aligns the protrusions of the second fixed outer ring 30 with the protrusions of the first fixed outer ring 10 step by step, quickly switching between different patency modes (e.g., corresponding to 3F, 6F, and 9F instrument outer diameters), ensuring standardized and repeatable adjustments.

[0039] The engagement between the protrusions forms a mechanical interlock after rotation into position, resisting accidental rotation caused by instrument collisions, blood pressure, or external vibrations during surgery. Especially when no instruments are passing through, the protrusion engagement can fix the compression state of the hemostatic valve body 20, maintain complete closure of the channel, and eliminate the risk of blood leakage or air intrusion.

[0040] The first fixed outer ring 10 is provided with a first positioning part, and the second fixed outer ring 30 is provided with a second positioning part. The active compression type adjustable diameter torsion hemostatic valve includes a matching positioning part. The first positioning part and the second positioning part are both matched and positioned through the matching positioning part.

[0041] By employing a mechanical interlocking mechanism and a graduated adjustment design in conjunction with the positioning section, the active compression adjustable-bore torsion hemostatic valve of this application achieves core advantages such as precise adjustment, stable anti-interference operation, high operational efficiency, and long service life. Its modular nature further reduces production costs and development cycles, providing clinicians with a more flexible and reliable surgical tool. This design not only solves the complexity of traditional hemostatic valves that rely on the coordination of multiple components, but also promotes technological iteration of minimally invasive interventional devices through a standardized positioning mechanism.

[0042] In another specific embodiment, the first positioning part includes a plurality of first grooves spaced apart along the outer periphery of the first fixed outer ring 10; the second positioning part includes a plurality of second grooves spaced apart along the outer periphery of the first fixed outer ring 10; the mating positioning part includes a positioning sleeve 60, which is sleeved on the outer periphery of the hemostatic valve body 20. Both ends of the positioning sleeve 60 are provided with positioning protrusions. The first grooves can engage with the positioning protrusions at one end of the positioning sleeve 60 for positioning, and the second grooves can engage with the positioning protrusions at the other end of the positioning sleeve 60 for positioning.

[0043] The engaging design of the positioning unit forms a rigid lock after rotation into position, effectively resisting accidental rotation caused by instrument collisions, blood pressure, or external vibrations during surgery. Especially when no instruments pass through, the locked state maintains the hemostatic valve body 20 in a completely closed state, ensuring reliable sealing.

[0044] The positioning parts produce a slight "click" sound and change in resistance during engagement, providing real-time feedback to the operator and allowing confirmation of adjustment completion without visual inspection. For example, each alignment of a set of positioning parts corresponds to one stage of diameter expansion, simplifying the intraoperative blind operation process.

[0045] With preset positioning points, operators only need to rotate the hemostatic valve cover 50 degrees to a specific position to adapt to different instrument outer diameters, eliminating the need for repeated angle calibration and significantly shortening intraoperative preparation time.

[0046] The hemostatic valve body 20 includes a first conical section and a second conical section. The large-diameter end of the first conical section is connected to the first fixed outer ring 10, the large-diameter end of the second conical section is connected to the second fixed outer ring 30, and the small-diameter end of the first conical section is connected to the small-diameter end of the second conical section.

[0047] The large-diameter end of the first conical segment is fixed to the first fixed outer ring 10, and the large-diameter end of the second conical segment is fixed to the second fixed outer ring 30. The small-diameter ends of the two segments are connected to each other to form a "double-conical continuous channel". When the second fixed outer ring 30 rotates circumferentially relative to the first fixed outer ring 10, the two conical segments generate synchronous helical twist due to the traction of the connecting ends, causing the small-diameter connecting area in the middle to contract or expand radially, thereby realizing dynamic adjustment of the channel diameter.

[0048] The tapered structure's gradually changing cross-section design allows torsional deformation to be transmitted uniformly along the axial direction, avoiding material fatigue or fracture caused by localized stress concentration and ensuring long-term reliability.

[0049] As the instrument passes through, the conical inner walls of the first and second conical sections form a continuous guide slope, guiding the instrument to pass through in the center and reducing skew frictional resistance. For example, the cone angle is designed to be 15°-30°, which ensures guiding efficiency while avoiding seal failure caused by excessive expansion.

[0050] When the middle part of the hemostatic valve body 20 contracts and closes, a device penetration cavity is formed at the first and second conical sections, and the inner diameter of the openings at both ends of the device penetration cavity is smaller than the outer diameter of the device to be passed through. When the device compresses the inner wall of the conical section, the elastic deformation of the conical structure causes it to tightly wrap around the outer surface of the device. Combined with the radial contraction force of the spiral groove, a double sealing mechanism is formed, effectively preventing blood leakage and air entry.

[0051] The difference between the inner diameter of the opening and the outer diameter of the instrument (e.g., 0.5 mm) is precisely matched by the elastic modulus of the material (e.g., silicone hardness 50 Shore A), so that the insertion resistance is controlled within the range of 10-15 N, which ensures both sealing and avoids instrument deformation or operational difficulties.

[0052] By employing an active contraction design of the inner diameter of the openings at both ends of the instrument's perforation lumen, the hemostatic valve body 20 of this application achieves the core advantages of dynamic sealing, centered guidance, wide-range compatibility, and fatigue-resistant operation. Its pre-tightening sealing mechanism significantly reduces the complexity of traditional multi-valve structures while ensuring surgical safety, providing a more efficient and reliable technical solution for minimally invasive interventional surgeries. This design is particularly suitable for complex procedures requiring frequent instrument changes (such as transcatheter aortic valve replacement) and has significant clinical application value.

[0053] Within the radial section of the middle part of the hemostatic valve body 20, the hemostatic valve body 20 includes a plurality of valves symmetrically distributed along the center, and the number of valves includes 3, 5 or 7.

[0054] The odd-numbered valve design achieves core advantages such as high-precision sealing, wide-range adaptability, and long-term durability through a combination of symmetry and independent deformation capability. Compared to traditional continuous annular valve discs, the multi-valve structure significantly reduces instrument passage resistance while improving pressure resistance through distributed stress design. This approach is particularly suitable for complex surgeries requiring frequent instrument changes or high-pressure environments (such as transjugular intrahepatic portosystemic shunt), providing a more efficient and reliable technical approach in the field of minimally invasive interventional procedures.

[0055] The odd-numbered design with 3, 5, or 7 valves avoids the misalignment that can occur with perfect symmetry (as even-numbered valves are prone to misalignment due to slight deviations), ensuring that all valve tips naturally converge at the center point during closure, forming a gapless sealing surface. For example, when 5 valves close, they converge in a pentagonal star shape, resulting in a more uniform coverage area.

[0056] Three valves: suitable for small to medium diameter instruments (such as 3-6F), with low deformation resistance, suitable for rapid insertion operations.

[0057] Five valves: Balanced design, suitable for a wide range of instruments (such as 5-10F), balancing sealing and operating force.

[0058] 7 valves: Designed specifically for extra-large outer diameter instruments (such as 8-12F), they disperse expansion stress through more contact points, avoiding localized tearing.

[0059] As the device passes through, the valves unfold gradually along the outer wall of the device, forming a spiral wrapping path (combined with the spiral grooves of the hemostatic valve body 20), reducing frictional resistance (e.g., 7 valves can reduce the peak resistance by 30%).

[0060] The above are merely specific embodiments of this application, but the scope of protection of this application is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the technical scope disclosed in this application should be included within the scope of protection of this application. Therefore, the scope of protection of this application should be determined by the scope of the claims.

Claims

1. A positive displacement adjustable-gauge torsion hemostasis valve, characterized in that, include: Hemostatic valve housing (40) The first fixed outer ring (10) is fixedly installed at the outer shell (40) of the hemostatic valve; The hemostatic valve body (20) is fixedly connected at one end to the first fixed outer ring (10); The second fixed outer ring (30) is spaced apart from the first fixed outer ring (10). The second fixed outer ring (30) is fixedly connected to the other end of the hemostatic valve body (20), and the second fixed outer ring (30) can rotate relative to the first fixed outer ring (10) and cause the middle part of the hemostatic valve body (20) to contract and close. The hemostatic valve body (20) includes a first conical segment and a second conical segment. The large-diameter end of the first conical segment is connected to the first fixed outer ring (10), the large-diameter end of the second conical segment is connected to the second fixed outer ring (30), and the small-diameter end of the first conical segment is connected to the small-diameter end of the second conical segment. The hemostatic valve cover (50) is fixed to the second fixing outer ring (30), and the hemostatic valve cover (50) can drive the second fixing outer ring (30) to rotate.

2. The active compression adjustable-gauge hemostatic valve of claim 1, wherein, The first fixed outer ring (10) is provided with a first positioning part, and the second fixed outer ring (30) is provided with a second positioning part. The first positioning part can cooperate with the second positioning part for positioning.

3. The active compression adjustable diameter torsion hemostatic valve according to claim 2, characterized in that, The first positioning part includes a first fixed outer ring (10) and a hemostatic valve body (20) with a plurality of spaced first axial protrusions on the outer periphery of the connection end face; The second positioning part includes a second fixed outer ring (30) and a hemostatic valve body (20) with a plurality of spaced second axial protrusions on the outer periphery of the connection end face.

4. The active compression adjustable diameter torsion hemostatic valve according to claim 1, characterized in that, The first fixed outer ring (10) is provided with a first positioning part, and the second fixed outer ring (30) is provided with a second positioning part. The active squeeze adjustable diameter torsion hemostatic valve includes a matching positioning part. The first positioning part and the second positioning part are both matched and positioned through the matching positioning part.

5. The active compression adjustable diameter torsion hemostatic valve according to claim 4, characterized in that, The first positioning part includes a plurality of first grooves spaced apart along the outer periphery of the first fixed outer ring (10); The second positioning part includes a plurality of second grooves spaced apart along the outer periphery of the first fixed outer ring (10); The positioning part includes a positioning sleeve (60) which is sleeved on the outer periphery of the hemostatic valve body (20). Positioning protrusions are provided at both ends of the positioning sleeve (60). The first groove can be engaged and positioned with the positioning protrusion at one end of the positioning sleeve (60), and the second groove can be engaged and positioned with the positioning protrusion at the other end of the positioning sleeve (60).

6. The active pinch adjustable-gauge twist-on hemostatic valve of claim 1, wherein, When the middle part of the hemostatic valve body (20) contracts and closes, a device penetration cavity is formed at the first conical segment and the second conical segment, and the inner diameter of the openings at both ends of the device penetration cavity is smaller than the outer diameter of the device to be passed through.

7. The active compression adjustable-gauge hemostatic valve of claim 1, wherein, Within the radial cross section of the middle part of the hemostatic valve body (20), the hemostatic valve body (20) includes a plurality of valve bodies distributed symmetrically along the center, and the number of valve bodies includes 3, 5 or 7.

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