Hemostatic valve assembly and device for delivering a delivery system

Abstract

The application discloses a hemostasis valve assembly and a device for delivering a delivery system, and applies to the technical field of medical devices, and has the technical scheme as follows: a head end hemostasis part comprises a hollow circular table provided with a first cavity, and a first hemostasis channel is arranged on the head side of the hollow circular table; a blocking filter membrane is installed on the tail side of the hollow circular table and blocks the first cavity, and a second hemostasis channel is arranged on the blocking filter membrane; a middle end hemostasis part comprises a ring-shaped cylinder provided with a second cavity, and the head end of the ring-shaped cylinder is in abutment with the blocking filter membrane; a tail end hemostasis part is sleeved on the tail part of the ring-shaped cylinder and is used for blocking the second cavity, a third hemostasis channel is arranged on the tail end hemostasis part, the first hemostasis channel, the second hemostasis channel and the third hemostasis channel are arranged along the same axis, and when a penetrating object is withdrawn in a reverse order, the blocking filter membrane moves to the tail side direction to make the pressure of the second cavity greater than the pressure of the first cavity. The application can reduce the occurrence of blood leakage and achieve a good blood sealing effect.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to hemostatic valve assemblies and devices for delivery systems. Background Technology

[0002] During interventional procedures, it is often necessary to place medical devices inside the body. For example, heart valve replacement or repair surgery requires delivering a delivery system from the neck, thigh, or other locations to the vicinity of the heart. Because the delivery system contains implanted devices, the tip of the delivery catheter is often too large to be inserted directly through the incision. In such cases, the surgeon typically uses a delivery device to assist in inserting the catheter into the patient's body.

[0003] Chinese Patent Publication No. CN114887215A discloses a delivery device, including a housing, a kit, and a hemostatic valve connected to the housing. The hemostatic valve includes a first hemostatic element, a second hemostatic element, and a third hemostatic element, which are sleeved together. The first, second, and third hemostatic elements each include: a first channel with a fan-shaped boss and a slit, a second channel with a straight through slit, and a third channel with a cross through slit. The hemostatic valve designed in this way will not leak blood when passing through an expander, a delivery catheter, or a guide wire.

[0004] In the aforementioned patent, due to the inconsistent axial diameter of the expander and the large diameter in some positions, the hemostatic valve of the delivery device is difficult to keep in constant contact with the surface of the expander during the withdrawal of the expander, which can easily lead to leakage or seepage, resulting in unnecessary blood loss. In addition, during the process of the delivery catheter passing through or being withdrawn from the delivery device, there is also the problem of leakage caused by the hemostatic valve not being in contact with the surface of the delivery catheter. Summary of the Invention

[0005] The purpose of this invention is to provide a hemostatic valve assembly and a device for a delivery system, which has the advantages of reducing blood leakage, achieving a better blood sealing effect, and meeting the needs of doctors in the delivery system during surgery.

[0006] The above-mentioned technical objective of the present invention is achieved through the following technical solution: a head-end hemostatic component, comprising a hollow frustum with a first chamber, wherein a first hemostatic channel is provided on the head side of the hollow frustum;

[0007] A barrier filter membrane is installed on the rear side of the hollow truncated cone and seals the first chamber. A second hemostatic channel is provided on the barrier filter membrane.

[0008] The mid-range hemostatic device includes an annular cylinder with a second chamber, the head end of which abuts against the barrier filter membrane;

[0009] A tail end hemostatic member sleeved on the tail end of the ring-shaped cylinder and used for plugging the second chamber, the tail end hemostatic member being provided with a third hemostatic channel;

[0010] The first, second and third hemostatic channels are arranged along the same axis, the penetrator contacts blood from the third, second and first hemostatic channels, when the penetrator is withdrawn in reverse order, the barrier filter moves to the tail side to make the pressure of the second chamber greater than that of the first chamber, a pressure difference is generated between the second and first chambers to prevent blood from overflowing from the second and third hemostatic channels.

[0011] In an embodiment, the volume of the second chamber is smaller than that of the first chamber.

[0012] In an embodiment, the middle end hemostatic member comprises a middle end limiting ring, the middle end limiting ring is connected with a middle end fixed table, the barrier filter is plugged on the tail side or tail end of the middle end fixed table, the middle thickness of the barrier filter is greater than the edge thickness, and the blood pressure adjusting holes are arranged in the area close to the edge of the barrier filter.

[0013] In an embodiment, the middle end limiting ring and the middle end fixed table form a “Z” shaped structure in cross section.

[0014] In an embodiment, the head end hemostatic member comprises a head end limiting ring, the head end limiting ring is connected with a head end fixed table, the head end fixed table is a hollow structure, at least two fan-shaped valve pieces are arranged in the head end fixed table, each fan-shaped valve piece is inclinedly extended from the inner wall of the head end fixed table to the head end of the head end fixed table and jointly forms a linear slit, and the linear slit constitutes the first hemostatic channel.

[0015] In an embodiment, each fan-shaped valve piece is provided with a reinforcing rib on one side close to the head end of the head end fixed table, and the reinforcing rib applies a pressing force to the fan-shaped valve piece to make the linear slit tightly close.

[0016] In an embodiment, the number of fan-shaped valve pieces is two, and the two fan-shaped valve pieces are oppositely inclinedly arranged.

[0017] The number of reinforcing ribs on each fan-shaped valve piece is two and arranged in parallel, and the reinforcing ribs on the two fan-shaped valve pieces are arranged in alignment.

[0018] In an embodiment, the tail end hemostatic member comprises a rear end limiting ring, the rear end limiting ring is connected with a rear end fixed table, the rear end fixed table is a hollow structure, the rear end fixed table is provided with a spherical valve piece for plugging the hollow structure of the rear end fixed table, and the third hemostatic channel is a linear slit arranged on the spherical valve piece.

[0019] In one embodiment, the reinforcing members are arranged equidistantly along the circumference outside the herringbone-shaped cut.

[0020] A device for delivering a delivery system, comprising a catheter sheath assembly and a dilator assembly, the catheter sheath assembly comprising an outer sheath, a fixation member, and a hemostatic valve assembly as claimed in any one of claims 1-9 disposed within the fixation member.

[0021] In summary:

[0022] 1、The hemostatic valve assembly in this application sets a barrier filter between the head end hemostatic member and the middle end hemostatic member to isolate two hollow cavities, the first cavity and the second cavity. When the penetrating object is withdrawn in reverse order, the head end hemostatic member is subjected to the pressure of the blood, causing the pressure in the first cavity to increase. When the penetrating object is withdrawn from the first hemostatic channel and the barrier filter is moved towards the tail side, the second cavity is subjected to the increased pressure of the first cavity and the volume is compressed at the same time, and its pressure is greater than that of the first cavity. Because the pressure of the second cavity acts on the second hemostatic channel, the second hemostatic channel can better prevent blood from overflowing when the penetrating object leaves the second hemostatic channel, thereby reducing the occurrence of blood leakage and achieving better blood sealing effect.

[0023] 2、The middle end hemostatic member has a blood pressure regulating hole, which can adjust the pressure difference between the first cavity and the second cavity, reduce the leakage of blood, and achieve better blood sealing effect.

[0024] 3、The head end hemostatic member is provided with a reinforcing rib on the side close to the head end, which can ensure that when the blood impacts the fan-shaped valve piece from the front of the head end, the sealing of the linear cut will be more firm, preventing the blood from flowing into the middle end hemostatic member. When the blood leaks out of the head end hemostatic member and flows into the middle end hemostatic member, the middle end hemostatic member prevents the blood from flowing outwards for the second time. When the blood flows into the tail end hemostatic member through the head end and middle end hemostatic members, the leakage of blood is already very small, thereby achieving better blood sealing effect. BRIEF DESCRIPTION OF DRAWINGS

[0025] Figure 1 is a structural schematic diagram of a hemostatic valve assembly according to an embodiment of the application;

[0026] Figure 2 is a force analysis diagram of a hemostatic valve assembly according to an embodiment of the application;

[0027] Figure 3 is a structural schematic diagram of a head end hemostatic member according to an embodiment of the application;

[0028] Figure 4 is a structural schematic diagram of a middle end hemostatic member according to an embodiment of the application;

[0029] Figure 5 is a structural schematic diagram of a tail end hemostatic piece according to an embodiment of the present application;

[0030] Figure 6 is a structural sectional view of a delivery delivery system device according to an embodiment of the present application;

[0031] Figure 7 is Figure 6 is a perspective view of a delivery delivery system device according to an embodiment of the present application;

[0032] Figure 8 is a structural schematic diagram of a dilator assembly according to an embodiment of the present application.

[0033] Reference signs: 1, outer sheath tube; 2, head end hemostatic piece; 21, head end limiting ring; 22, head end fixing table; 23, fan-shaped valve piece; 24, first hemostatic channel; 25, reinforcing rib; 3, middle end hemostatic piece; 31, middle end limiting ring; 32, middle end fixing table; 33, second hemostatic channel; 34, blood pressure adjusting hole; 4, tail end hemostatic piece; 41, rear end limiting ring; 42, rear end fixing table; 43, reinforcing piece; 44, third hemostatic channel; 5, blocking filter membrane; 6, dilator tube; 7, pu tube; 8, three-way valve; 9, head end of tube seat; 10, tube seat shell; 11, tail end of tube seat; 12, tail end connecting seat; 13, first chamber; 14, second chamber. DETAILED DESCRIPTION

[0034] In order to make the above objectives, features and advantages of the present application more obvious and easy to understand, the specific embodiments of the present application are described in detail below. In the following description, a large number of specific details are set forth in order to facilitate a full understanding of the present application. However, the present application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without departing from the spirit of the present application, so the present application is not limited by the specific embodiments disclosed below.

[0035] It should be noted that the structures, proportions, sizes, etc. shown in the drawings of the specification are only used to cooperate with the content described in the specification for the understanding and reading of those skilled in the art, and do not have technical substantial significance to limit the conditions that can be implemented by the present application, so any modification of the structure, change of the proportion relationship or adjustment of the size, without affecting the effects that can be produced by the present application and the purposes that can be achieved, should fall within the scope of the technical content disclosed by the present application.

[0036] The terminology used in the embodiments of this application is for the purpose of describing particular embodiments only and is not intended to be limiting of this application. The singular forms “a,” “the,” and “the” used in the embodiments of this application and the appended claims are also intended to include the plural forms unless the context clearly indicates otherwise.

[0037] It should be noted that the directional terms such as "upper," "lower," "left," and "right" described in the embodiments of this application are used to describe the angles shown in the accompanying drawings and should not be construed as limiting the embodiments of this application. The terms "bottom," "top," "lower part," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as limiting the present invention.

[0038] As used herein, the singular forms “a,” “an,” and “the” include plural objects unless otherwise expressly stated. The terms “first,” “second,” and “third” are used for descriptive purposes only and should not be construed as indicating or implying relative importance. The term “or” is generally used to include the meaning of “and / or” unless otherwise expressly stated.

[0039] As used in this article, the terms "head end" and "head side" refer to the end or side away from the operator; "tail end" and "tail side" refer to the end or side closer to the operator.

[0040] The present invention will be further described in detail below with reference to the accompanying drawings.

[0041] Example: Refer to as follows Figures 1-2 As shown, the hemostatic valve assembly includes a head hemostatic component 2, comprising a hollow frustum with a first chamber 13. A first hemostatic channel 24 is provided on the head side of the hollow frustum. A baffle filter membrane 5 is installed on the tail side of the hollow frustum and seals the first chamber 13. A second hemostatic channel 33 is provided on the baffle filter membrane 5. The middle hemostatic component 3 includes an annular cylinder with a second chamber 14. The head end of the annular cylinder abuts against the baffle filter membrane 5. A tail hemostatic component 4 is sleeved on the tail end of the annular cylinder and used to seal the second chamber 14. The tail hemostatic component 4 is provided with… A third hemostatic channel 44 is provided. The first hemostatic channel 24, the second hemostatic channel 33 and the third hemostatic channel 44 are arranged along the same axis. The inserted object comes into contact with blood through the third hemostatic channel 44, the second hemostatic channel 33 and the first hemostatic channel 24. When the inserted object is withdrawn in reverse order, the septum filter membrane 5 moves towards the tail side so that the pressure in the second chamber 14 is greater than the pressure in the first chamber 13. The pressure difference between the second chamber 14 and the first chamber 13 prevents blood from overflowing from the second hemostatic channel 33 and the third hemostatic channel 44.

[0042] In the above implementation process, a baffle filter membrane 5 is provided between the hemostatic valve assembly and the hemostatic member 2 at the tip and the hemostatic member 3 at the middle, isolating two hollow cavities, namely the first chamber 13 and the second chamber 14, between them. Before and during the insertion of the implant, the first chamber 13 and the second chamber 14 are filled with saline to prevent air from entering the blood. At this time, the pressure inside the first chamber 13 and the second chamber 14 is the same as atmospheric pressure. However, when the implant is withdrawn in reverse order, the first hemostatic channel 24, the second hemostatic channel 33, and the third hemostatic channel 44 are filled with the implant. The pressure of the blood on the hemostatic member 2 at the tip causes the pressure F1 in the first chamber 13 to increase. See [link to relevant documentation]. Figure 2 When the inserted object is withdrawn from the first hemostatic channel 24 and moves the septum filter membrane 5 towards the tail, the pressure F2 in the second chamber 14 is greater than the pressure F1 in the first chamber 13 due to the increased pressure from the first chamber 13 and the simultaneous compression of its volume. Since the pressure F2 in the second chamber 14 reacts to the second hemostatic channel 33, the second hemostatic channel 33 can effectively prevent blood leakage when the inserted object leaves it. Therefore, by creating a pressure difference between the second chamber 14 and the first chamber 13, it is possible to better prevent blood from leaking out of the second hemostatic channel 33 and the third hemostatic channel 44.

[0043] In one implementation scheme, see Figure 3 The hemostatic component 2 includes a head-end limiting ring 21, on which a head-end fixing platform 22 is connected. The head-end fixing platform 22 has a hollow structure and at least two sector-shaped valve plates 23 are disposed inside the head-end fixing platform 22. Each sector-shaped valve plate 23 extends obliquely from the inner wall of the head-end fixing platform 22 to the head end of the head-end fixing platform 22 and together forms a straight slit. The straight slit constitutes a first hemostatic channel 24. Each sector-shaped valve plate 23 has a reinforcing rib 2 on the side near the head end of the head-end fixing platform 22. 5. The reinforcing rib 25 applies a clamping force to the sector-shaped valve plate 23 to ensure the straight cut is tightly closed. There are two sector-shaped valve plates 23, arranged at relative angles. Each sector-shaped valve plate 23 has two reinforcing ribs 25 arranged in parallel. The reinforcing ribs 25 on the two sector-shaped valve plates 23 are aligned. The head hemostatic component 2 has a reinforcing rib 25 on the side near the head end, ensuring a stronger seal of the straight cut when blood impacts the sector-shaped valve plate 23 from the front, preventing blood from flowing into the middle hemostatic component 3. When blood leaks from the head hemostatic component 2 and flows to the middle hemostatic component 3, the middle hemostatic component 3 prevents further outflow. When blood flows from the head and middle hemostatic components 3 into the tail hemostatic component 4, the leakage is minimal, achieving a better blood sealing effect.

[0044] In one embodiment, the volume of the second chamber 14 is smaller than that of the first chamber 13. Under this structure, the pressure in the second chamber 14 increases more quickly and can quickly exceed the pressure in the first chamber 13, thereby improving the effect of preventing blood leakage.

[0045] In one implementation scheme, see Figure 4 The mid-end hemostatic component 3 includes a mid-end limiting ring 31, a mid-end fixing platform 32 connected to the mid-end limiting ring 31, a barrier filter membrane 5 is sealed at the tail side or tail end of the mid-end fixing platform 32, and the barrier filter membrane 5 has a second hemostatic channel 33, and the thickness of the middle of the barrier filter membrane 5 is greater than the thickness of the edge.

[0046] In one embodiment, a blood pressure regulating hole 34 is provided in the region near the edge of the barrier filter membrane 5. The function of the blood pressure regulating hole 34 is to regulate the blood pressure difference between the first chamber 13 and the second chamber 14, so that the blood pressure is balanced between the two chambers. The blood pressure regulating hole 34 should be positioned as close to the edge as possible during implementation. If it is positioned close to the center of the barrier filter membrane 5, there is a risk that the barrier filter membrane may deform and block the blood pressure regulating hole 34 when the insert is withdrawn.

[0047] In one embodiment, the middle limiting ring 31 and the middle fixing platform 32 form a "Z" shaped structure in cross-section. The Z-shaped structure can better ensure that the expansion tube 6 undergoes less overall deformation when passing through the barrier filter membrane 5, thereby achieving a better sealing effect.

[0048] In one implementation scheme, see Figure 5 The tail hemostatic component 4 includes a rear limiting ring 41, a rear fixing platform 42 connected to the rear limiting ring 41, the rear fixing platform 42 is a hollow structure, a spherical valve plate is provided in the middle of the rear fixing platform 42 to block the hollow structure of the rear fixing platform 42, the third hemostatic channel 44 is a cross-shaped slit opened on the spherical valve plate, and reinforcing members 43 are provided at equal intervals along the periphery on the outer side of the cross-shaped slit on the rear fixing platform 42.

[0049] According to another aspect of this application, an apparatus for a delivery system is also provided. The apparatus for the delivery system includes a catheter sheath assembly and a dilator assembly. See also Figures 6-8 The catheter sheath assembly includes an outer sheath 1, a fixing element, and a hemostatic valve assembly disposed within the fixing element. The structure of the hemostatic valve assembly is described in any of the hemostatic valve assembly configurations above, and will not be repeated here.

[0050] In one embodiment, the expander assembly includes an expander tube 6 and a tail connector 12 integrally formed with the expander tube 6. The diameter of the expander tube 6 is smaller than the diameter of the outer sheath tube 1. The head hemostatic element 2, the middle hemostatic element 3 and the tail hemostatic element 4 are made of rubber. The rubber hemostatic elements are sealed by compression, and the diameter of the catheter that can pass through can reach 36 mm when the outer diameter is fixed.

[0051] In the embodiments of this application, the inserted material includes, but is not limited to, a dilator tube. The following describes in detail the working steps of the delivery device using the aforementioned hemostatic valve assembly, taking a dilator tube as an example:

[0052] When the delivery system is delivered into the human body through the outer sheath 1, the dilator 6 is first inserted into the outer sheath 1 through the hemostatic valve assembly, so that the dilator 6 and the outer sheath 1 can be assembled together easily and quickly.

[0053] Next, the assembled device is delivered into the blood vessel through the surgical incision. When the dilator tube 6 is removed from the catheter sheath assembly, blood flows out through the outer sheath tube 1 and reaches the hemostatic element 2 at the tip. The blood impacts the 6 recesses divided by the reinforcing ribs 25 and the inclined surface of the fan-shaped valve plate. At this time, the sealing effect of the first hemostatic channel 24 is enhanced. Moreover, the four reinforcing ribs 25 can ensure that the first hemostatic channel 24 forms a good sealing effect under the pressure of the reinforcing ribs 25 when there is no blood impact.

[0054] When the dilator tube 6 is withdrawn from the head hemostatic element 2 into the first chamber 13, the pressure in the first chamber 13 is greater than the human blood pressure, and the first chamber 13 acts to prevent blood from flowing out. When the dilator tube 6 continues to be withdrawn towards the middle hemostatic element 3, because the wall thickness of the top middle part of the septum filter membrane 5 is relatively thin, the septum filter membrane 5 can pass through the catheter in the second hemostatic channel 33 without tearing, ensuring a sealing effect. At the same time, the volume of the second chamber 14 is compressed by the pressure of the first chamber 13, and the second hemostatic channel 33 can effectively prevent blood from overflowing when the dilator tube 6 leaves. When the blood flows into the tail hemostatic element 4, the amount of blood leakage is already very small. Through the blood pressure regulation function of the middle hemostatic element 3, the blood pressure is kept low and the amount of blood leakage is very small, achieving a blood sealing effect.

[0055] After the dilator tube 6 is completely withdrawn from the hemostatic valve assembly, the fluid in the second chamber 14 flows into the first chamber 13 through the blood pressure regulating port 34 until equilibrium is reached.

[0056] As can be seen from the above process, when the doctor retracts the dilation tube, the delivery system can be conveniently and quickly delivered into the patient's body through the outer sheath tube 1, and the occurrence of blood leakage can be reduced.

[0057] In one embodiment, a three-way valve 8 is connected to the outside of the tube housing 10 via a PU tube 7. The function of the three-way valve 8 is to inject saline solution through the three-way valve 8 using a syringe to purge air from the instrument and to inject contrast agent for enhanced CT.

[0058] This specific embodiment is merely an explanation of the present invention and is not intended to limit the invention. After reading this specification, those skilled in the art can make modifications to this embodiment without contributing any inventive step, but such modifications are protected by patent law as long as they are within the scope of the claims of the present invention.

Claims

1. A hemostatic valve assembly, characterized in that, include: The head-end hemostatic component (2) includes a hollow frustum with a first chamber (13) and a first hemostatic channel (24) on the head side of the hollow frustum. A barrier filter membrane (5) is installed on the rear side of the hollow truncated cone and seals the first chamber (13). A second hemostatic channel (33) is provided on the barrier filter membrane (5). The mid-end hemostatic component (3) includes an annular cylinder with a second chamber (14), the head end of which abuts against the barrier filter membrane (5); wherein the volume of the second chamber (14) is smaller than the volume of the first chamber (13); A tail-end hemostatic component (4) is fitted onto the tail of the annular cylinder and used to seal the second chamber (14). A third hemostatic channel (44) is provided on the tail-end hemostatic component (4). The first hemostatic channel (24), the second hemostatic channel (33), and the third hemostatic channel (44) are arranged along the same axis. The insert comes into contact with blood through the third hemostatic channel (44), the second hemostatic channel (33), and the first hemostatic channel (24). When the insert is withdrawn in reverse order, the barrier filter membrane (5) moves towards the tail side so that the pressure in the second chamber (14) is greater than the pressure in the first chamber (13). A pressure difference is generated between the second chamber (14) and the first chamber (13) to prevent blood from overflowing from the second hemostatic channel (33) and the third hemostatic channel (44).

2. The hemostatic valve assembly according to claim 1, characterized in that: The mid-end hemostatic component (3) includes a mid-end limiting ring (31), a mid-end fixing platform (32) is connected to the mid-end limiting ring (31), the barrier filter membrane (5) is sealed at the tail side or tail end of the mid-end fixing platform (32), the thickness of the middle of the barrier filter membrane (5) is greater than the thickness of the edge, and a blood pressure regulating hole (34) is opened in the area of ​​the barrier filter membrane (5) near the edge.

3. A hemostatic valve assembly according to claim 2, characterized in that: The mid-end limiting ring (31) and the mid-end fixing platform (32) form a "Z" shaped structure in cross-section.

4. The hemostatic valve assembly according to any one of claims 1 to 3, characterized in that: The hemostatic device (2) includes a head-end limiting ring (21), and a head-end fixing platform (22) is connected to the head-end limiting ring (21). The head-end fixing platform (22) has a hollow structure, and at least two fan-shaped valve plates (23) are provided inside the head-end fixing platform (22). Each fan-shaped valve plate (23) extends obliquely from the inner wall of the head-end fixing platform (22) to the head end of the head-end fixing platform (22) and together forms a straight slit. The straight slit constitutes the first hemostatic channel (24).

5. The hemostatic valve assembly according to claim 4, characterized in that: Each of the fan-shaped valve pieces (23) has a reinforcing rib (25) on one side near the head end of the head end fixing platform (22), and the reinforcing rib (25) applies a clamping force to the fan-shaped valve piece (23) to make the straight cut close together.

6. A hemostatic valve assembly according to claim 5, characterized in that: The number of fan-shaped valve plates (23) is two, and the two fan-shaped valve plates (23) are arranged at an angle to each other; Each sector valve plate (23) has two reinforcing ribs (25) arranged in parallel; the reinforcing ribs (25) on the two sector valve plates (23) are aligned.

7. A hemostatic valve assembly according to claim 4, characterized in that: The tail-end hemostatic component (4) includes a rear-end limiting ring (41), and a rear-end fixing platform (42) is connected to the rear-end limiting ring (41). The rear-end fixing platform (42) is a hollow structure, and a spherical valve plate is provided in the middle of the rear-end fixing platform (42) to block the hollow structure of the rear-end fixing platform (42). The third hemostatic channel (44) is a cross-shaped slit opened on the spherical valve plate.

8. A hemostatic valve assembly according to claim 7, characterized in that: The rear fixing platform (42) is provided with reinforcing members (43) at equal intervals along the periphery on the outer side of the cross-shaped cut.

9. An apparatus for a delivery and conveying system, characterized in that: It includes a catheter sheath assembly and a dilator assembly, the catheter sheath assembly including an outer sheath (1), a fixation element and a hemostatic valve assembly as described in any one of claims 1-8 disposed within the fixation element.

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