Single-piece three-leaf squeeze sheath hemostatic valve

Abstract

This utility model provides a single-piece three-leaf squeeze sheath hemostatic valve, comprising: a first fixed outer ring; a multi-leaf valve disc, one end of which is fixedly connected to the first fixed outer ring; a second fixed outer ring, spaced apart from the first fixed outer ring, and fixedly connected to the other end of the multi-leaf valve disc; and a tightening ring, detachably clamped at the middle of the multi-leaf valve disc, which causes the multi-leaf valve disc to contract inward and close. The use of a single-piece multi-leaf valve disc replaces the traditional dual-piece combination structure of a cross valve disc and a round-hole valve disc, significantly reducing the number of valve discs and lowering installation complexity. The spaced fixing by the first and second fixed outer rings, combined with the detachable tightening ring, simplifies the assembly process, reduces process control requirements, and improves production efficiency.

Description

Technical Field

[0001] This utility model relates to the field of interventional surgery technology, specifically to a single-piece three-leaf squeeze sheath 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 a single-piece three-lobe compression sheath hemostatic valve to solve the problem of sealing effect of hemostatic valve.

[0004] This utility model provides the following technical solution: a single-piece three-leaf squeeze sheath hemostatic valve, comprising: a first fixed outer ring; a multi-leaf valve plate, one end of which is fixedly connected to the first fixed outer ring; a second fixed outer ring, spaced apart from the first fixed outer ring, the second fixed outer ring being fixedly connected to the other end of the multi-leaf valve plate; and a tightening pressure ring, a detachable clamp located in the middle of the multi-leaf valve plate, the tightening pressure ring enabling the multi-leaf valve plate to contract inward and close.

[0005] Furthermore, the outer periphery of the multi-leaf valve is provided with multiple circumferentially spaced and evenly distributed outer protrusions on the valve plate. The extension direction of the outer protrusions on the valve plate is the same as the axial direction of the multi-leaf valve plate, or the extension direction of the outer protrusions on the valve plate is spirally arranged along the axial direction.

[0006] Furthermore, the inner wall of the multi-leaf valve is provided with multiple inner protrusions, and the positions of the multiple inner protrusions correspond one-to-one with the positions of the multiple outer protrusions.

[0007] Furthermore, multi-leaf valves include three-leaf, five-leaf, and seven-leaf valves that are symmetrically distributed along the center.

[0008] Furthermore, when the multi-leaf valve is in the contracted and closed state, the contracted position of the multi-leaf valve forms the valve plate inner hole; when the multi-leaf valve is a three-leaf valve, the valve plate inner hole is a triangular hole; when the multi-leaf valve is a five-leaf valve, the valve plate inner hole is a five-sided hole; when the multi-leaf valve is a seven-leaf valve, the valve plate inner hole is a seven-sided hole.

[0009] Furthermore, one end of the tightening ring is provided with multiple evenly spaced positioning holes, and the other end of the tightening ring is provided with a positioning part that engages with any of the positioning holes.

[0010] Furthermore, the tightening ring also includes a positioning component that can lock the positioning part with any positioning hole.

[0011] Furthermore, the single-piece three-leaf squeeze sheath hemostatic valve includes a hemostatic valve housing, and a first fixed outer ring is fixedly disposed on the hemostatic valve housing.

[0012] Furthermore, the single-piece three-leaf squeeze sheath hemostatic valve includes a hemostatic valve cover and a second fixing outer ring fixed to the hemostatic valve cover.

[0013] Furthermore, the multi-leaf valve includes a first conical section and a second conical section. The large-diameter end of the first conical section is connected to a first fixed outer ring, the large-diameter end of the second conical section is connected to a second fixed outer ring, and the small-diameter end of the first conical section is connected to the small-diameter end of the second conical section.

[0014] Compared with the prior art, the beneficial effects that the above-mentioned at least one technical solution adopted by this utility model can achieve include at least the following:

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

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

[0017] 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.

[0018] Figure 1 This is a structural schematic diagram of an embodiment of the present utility model; Figure 2 This is a schematic diagram of the structure of the multi-leaf valve plate according to an embodiment of the present invention; Figure 3 This is a three-dimensional structural schematic diagram of an embodiment of the present utility model; Figure 4This is a schematic diagram of the outer and inner protrusions of the valve plate in an embodiment of this utility model; Figure 5 This is a schematic diagram of the valve plate inner hole structure according to an embodiment of the present utility model.

[0019] In the figure, the following labels are used: 10, first fixing outer ring; 20, multi-leaf valve plate; 21, outer protrusion of valve plate; 22, inner protrusion of valve plate; 23, inner hole of valve plate; 30, second fixing outer ring; 40, hemostatic valve housing; 50, hemostatic valve cover; 60, tightening pressure ring. Detailed Implementation

[0020] The embodiments of this application will now be described in detail with reference to the accompanying drawings.

[0021] It should be noted that, unless otherwise specified, the embodiments and features described in this application can be combined with each other. The present invention will now be described in detail with reference to the accompanying drawings and embodiments.

[0022] like Figures 1 to 5 As shown in the figure, an embodiment of the present invention provides a single-piece three-leaf squeeze sheath hemostatic valve, comprising: a first fixed outer ring 10, a multi-leaf valve plate 20, a second fixed outer ring 30, and a tightening pressure ring 60. One end of the multi-leaf valve plate 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 multi-leaf valve plate 20; the tightening pressure ring 60 is detachably clamped at the middle of the multi-leaf valve plate 20, and the tightening pressure ring 60 can cause the multi-leaf valve plate 20 to retract inward and close.

[0023] The use of a single-piece multi-leaf valve disc 20 replaces the traditional dual-piece combination structure of cross valve disc and round hole valve disc, significantly reducing the number of valve discs and lowering installation complexity. The assembly process is simplified by the interval fixing of the first fixed outer ring 10 and the second fixed outer ring 30, combined with a detachable tightening ring 60, reducing process control requirements and improving production efficiency.

[0024] The tightening ring 60 applies radial compression force to cause the multi-leaf valve 20 to contract inward and close the central hole, forming a reliable seal when no instrument passes through; when an instrument is inserted, the multi-leaf valve 20 extends outward along the conical slope, tightly wrapping the outer wall of the instrument, effectively preventing blood leakage and air entry, and improving surgical safety.

[0025] The detachable design of the tightening ring 60 allows for flexible adjustment of the compression force during the operation, ensuring a good seal while avoiding excessive compression that would increase resistance to instrument passage, thus balancing sealing performance and smooth operation.

[0026] The outer periphery of the multi-leaf valve 20 is provided with multiple circumferentially spaced outer protrusions 21. The extension direction of the outer protrusions 21 is the same as the axial direction of the multi-leaf valve 20, or the extension direction of the outer protrusions 21 is spirally arranged along the axial direction. The inner wall of the multi-leaf valve 20 is provided with multiple inner protrusions 22, and the positions of the multiple inner protrusions 22 correspond one-to-one with the positions of the multiple outer protrusions 21.

[0027] The outer circumferential protrusions 21 of the valve plate are evenly distributed and correspond one-to-one with the inner circumferential protrusions 22 of the valve plate on the inner wall, forming a symmetrical force-bearing structure. When the tightening pressure ring 60 applies radial compression force, the inner and outer protrusions work together to distribute the valve plate contraction force evenly, avoid local stress concentration, and improve the valve plate's fatigue resistance and sealing stability.

[0028] If the outer protrusion 21 adopts an axial spiral extension design, it can provide a spiral guide when the instrument is inserted, reduce the sliding friction resistance between the instrument and the valve plate contact surface, ensure smoother instrument passage, and reduce wear on the valve plate material.

[0029] The corresponding design of the inner and outer protrusions enhances the structural coordination of the valve plate during contraction or expansion. When the instrument passes through, the outer protrusion guides the valve plate to expand outward along a predetermined path, while the inner protrusion simultaneously conforms to the instrument surface, forming a dynamic wrapping seal. This effectively adapts to the deformation requirements caused by the movement or rotation of the instrument, preventing blood leakage.

[0030] The multi-leaf valve 20 includes three-leaf, five-leaf, and seven-leaf valves symmetrically distributed along the center. When the multi-leaf valve 20 is in the contracted and closed state, the contracted position of the multi-leaf valve 20 forms the valve inner hole 23; When the multi-leaf valve 20 is a three-leaf valve, the valve inner hole 23 is a triangular hole; When the multi-leaf valve 20 is a five-leaf valve, the inner hole 23 of the valve is a pentagonal hole; When the multi-leaf valve 20 is a seven-leaf valve, the inner hole 23 of the valve is a seven-sided hole.

[0031] The symmetrical distribution of three-, five-, and seven-leaf valve discs forms corresponding triangular, five-, and seven-sided orifices. By increasing the number of leaflets, the number of sides when the inner orifice is closed can be flexibly adjusted. Three-leaf valve discs (triangular orifices) are suitable for conventional instruments, while five- and seven-leaf valve discs provide denser wrapping contact points with more closing sides, adapting to smaller outer diameter or irregularly shaped instruments and significantly improving sealing versatility.

[0032] The multi-leaf symmetrical structure ensures a uniform distribution of closing force among the leaves during contraction and closure. The number of inner orifice sides increases with the number of leaves, forming a continuous linear closing surface and reducing local stress concentration. For example, the seven-leaf valve's seven-sided orifice closing surface is closer to a circular contour, achieving near-full circumference sealing when no instruments pass through, reducing the risk of blood leakage.

[0033] Different numbers of blades correspond to different deformation characteristics. The three-bladed valve (three-sided hole) has sharp edges when contracted, providing high guidance; the five-bladed and seven-bladed valves have smoother closing surfaces, and the blades expand more smoothly when instruments pass through, reducing frictional resistance on the instrument surface, while maintaining a tight seal, making them suitable for high-speed or frequent instrument exchange scenarios.

[0034] Three-leaf, five-leaf, and seven-leaf valves form a tiered product series, allowing users to select the appropriate number of leaflets based on the type of surgery (such as cardiovascular intervention, neurointervention, etc.) to balance sealing strength and operational flexibility. For example, seven-leaf valves are suitable for high-precision, low-invasive surgeries, while three-leaf valves are better suited for routine, rapid procedures.

[0035] The tightening ring 60 has multiple evenly spaced positioning holes at one end, and a positioning part that engages with any of the positioning holes at the other end. The tightening ring 60 also includes a positioning assembly that can lock the positioning part with any of the positioning holes.

[0036] By setting multiple evenly spaced positioning holes and cooperating with the selective engagement of the positioning part, the stepped radial compression force of the tightening ring 60 can be adjusted. The operator can select the appropriate setting according to the instrument size or sealing requirements, precisely controlling the degree of contraction of the multi-leaf valve 20 to ensure the best balance between sealing strength and instrument passage. At the same time, the modular design of the positioning holes and the positioning part simplifies the adjustment process, allowing for quick setting switching and locking without complicated tools. This is especially suitable for scenarios requiring frequent instrument changes or emergency intraoperative adjustments, significantly improving operational efficiency.

[0037] Positioning components (such as spring pins, snaps, or screws) can securely lock the positioning part to the selected positioning hole, preventing the pressure ring from accidentally loosening during the operation due to instrument movement or external force interference, ensuring the continuous stability of the sealing state, and reducing the risk of secondary adjustment.

[0038] It should be noted that the number and spacing of the positioning holes can be flexibly designed according to clinical needs (such as increasing the number of holes to refine the adjustment accuracy), adapting to the different requirements of sealing strength in different surgical scenarios, and providing basic infrastructure support for product function expansion.

[0039] The single-piece three-lobe squeeze sheath hemostatic valve includes a valve housing 40, with a first fixing outer ring 10 fixedly disposed on the valve housing 40. The single-piece three-lobe squeeze sheath hemostatic valve also includes a valve top cover 50, with a second fixing outer ring 30 fixed to the valve top cover 50. Both the valve housing 40 and the valve top cover 50 are fixed components, providing stable support for the first fixing outer ring 10 and the second fixing outer ring 30.

[0040] The multi-leaf valve 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.

[0041] 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 tightening ring 60 tightens inward, the small-diameter connection area between the two conical segments contracts radially, realizing dynamic adjustment of the duct diameter.

[0042] The above description is merely a specific embodiment of this utility model and should not be construed as limiting the scope of its implementation. Therefore, any substitution of equivalent components or equivalent changes and modifications made within the scope of protection of this utility model patent should still fall within the scope of this patent. Furthermore, the technical features, technical features and technical solutions, and technical solutions in this utility model can be freely combined and used.

Claims

1. A single-piece three-lobe squeeze sheath hemostatic valve, characterized in that, include: First fixed outer ring (10); A multi-leaf valve plate (20) is fixedly connected at one end to a first fixed outer ring (10); the multi-leaf valve plate (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; The second fixed outer ring (30) is spaced apart from the first fixed outer ring (10), and the second fixed outer ring (30) is fixedly connected to the other end of the multi-leaf valve plate (20); The tightening ring (60) has a detachable clamp located in the middle of the multi-leaf valve plate (20). The tightening ring (60) can cause the multi-leaf valve plate (20) to contract inward and close.

2. The single-piece three-lobe squeeze sheath hemostatic valve according to claim 1, characterized in that, The outer periphery of the multi-leaf valve (20) is provided with multiple circumferentially spaced and evenly distributed outer protrusions (21). The extension direction of the outer protrusions (21) is the same as the axial direction of the multi-leaf valve (20) or the extension direction of the outer protrusions (21) is spirally arranged along the axial direction.

3. The single-piece three-lobe squeeze sheath hemostatic valve according to claim 2, characterized in that, The inner wall of the multi-leaf valve (20) is provided with multiple inner convex marks (22), and the positions of the multiple inner convex marks (22) correspond one-to-one with the positions of the multiple outer convex marks (21).

4. The single-piece three-lobe squeeze sheath hemostatic valve according to claim 1, characterized in that, Multi-leaf valves (20) include three-leaf valves, five-leaf valves and seven-leaf valves that are symmetrically distributed along the center.

5. The single-piece three-lobe squeeze sheath hemostatic valve according to claim 4, characterized in that, When the multi-leaf valve (20) is in the contracted closed state, the contracted position of the multi-leaf valve (20) forms the valve inner hole (23). When the multi-leaf valve (20) is a three-leaf valve, the inner hole (23) of the valve is a triangular hole; When the multi-leaf valve (20) is a five-leaf valve, the inner hole (23) of the valve is a pentagonal hole; When the multi-leaf valve (20) is a seven-leaf valve, the inner hole (23) of the valve is a heptagonal hole.

6. The single-piece three-lobe squeeze sheath hemostatic valve according to claim 1, characterized in that, One end of the tightening ring (60) is provided with a plurality of evenly spaced positioning holes, and the other end of the tightening ring (60) is provided with a positioning part that positions and cooperates with any of the positioning holes.

7. The single-piece three-lobe squeeze sheath hemostatic valve according to claim 6, characterized in that, The tightening ring (60) also includes a positioning component that can lock the positioning portion to any of the positioning holes.

8. The single-piece three-lobe squeeze sheath hemostatic valve according to any one of claims 1 to 7, characterized in that, The single-piece three-leaf squeeze sheath hemostatic valve includes a hemostatic valve housing (40) and a first fixed outer ring (10) fixedly disposed on the hemostatic valve housing (40).

9. The single-piece three-lobe squeeze sheath hemostatic valve according to claim 8, characterized in that, The single-piece three-leaf squeeze sheath hemostatic valve includes a hemostatic valve cover (50) and a second fixing outer ring (30) fixed to the hemostatic valve cover (50).

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