Guiding assembly, sheath hub and hemostasis valve

Abstract

The application provides a guide assembly, a sheath seat and a hemostasis valve. The guide assembly comprises a sealing structure. The sealing structure is formed with a guide channel. A guided member can pass through the sealing structure through the guide channel and is guided by the guide assembly to a corresponding position in a human body. The sealing structure comprises a weakened structure. The weakened structure is arranged on opposite sides of the guide channel. After the guide assembly is used, an operator can tear the sealing structure from the weakened structure and withdraw the guide assembly from the human body. The difficulty of tearing the guide assembly is reduced. On this basis, a reinforcing structure is arranged in the sealing structure. During use of the guide assembly, the reinforcing structure can cooperate with the weakened structure to improve the structural strength of the weakened structure and further improve the sealing capacity of the weakened structure.

Description

Technical Field

[0001] This application belongs to the field of medical device technology, and in particular relates to a guide assembly, a sheath seat, and a hemostatic valve. Background Technology

[0002] The guiding device is an important auxiliary guiding device for minimally invasive interventional procedures in peripheral and intracardiac fields. It can be used to establish a connection channel between the human blood vessel and the outside world in interventional procedures such as thrombectomy, percutaneous coronary intervention, and percutaneous interventional closure, thereby assisting the delivery tube in delivering diagnostic and therapeutic instruments to the lesion site.

[0003] In some applications, the guidance component includes a tearable sheath base, a sheath tube, and a hemostatic valve. The sheath tube is connected to the sheath base, and its internal interventional channel communicates with the channel of the sheath base. The hemostatic valve is stacked on the sheath base, covering and sealing the channel of the sheath base. During the intervention, part of the sheath tube enters the blood vessel, while the hemostatic valve and the remaining part of the sheath tube remain outside the body and in the appropriate position. At this time, the interventional medical device can be inserted into the body sequentially through the hemostatic valve of the vascular sheath and the sheath tube. After the guidance component is used, the sheath base can be torn open, allowing the sheath tube and hemostatic valve connected to the sheath base to be torn open together under the action of the sheath base. During the tearing process, the sheath tube is gradually withdrawn from the body.

[0004] However, the aforementioned tearable guide components are prone to bleeding during use, which affects their safety. Summary of the Invention

[0005] This application provides a guide assembly, sheath seat, and hemostatic valve that improve safety while ensuring that the valve can be torn open.

[0006] On one hand, embodiments of this application provide a guiding component, including a sealing structure, the sealing structure forming a guiding channel, the sealing structure including a weakening structure and a reinforcing structure, the weakening structure being disposed on opposite sides of the guiding channel; the reinforcing structure being used to cooperate with the weakening structure to improve the sealing capability of the weakening structure.

[0007] In some embodiments, the sealing structure includes a sheath seat and a flow-blocking valve. The sheath seat has a through first sub-channel. The flow-blocking valve includes a first sealing sheet that overlaps with the sheath seat and covers one end of the first sub-channel. The first sealing sheet has a second sub-channel along a first direction. The first sub-channel and the second sub-channel communicate to form a guide channel. The second sub-channel is a hole structure for interference fit with the guided member. The reinforcing structure includes a first reinforcing member that is circumferentially arranged around the second sub-channel.

[0008] In some embodiments, the second sub-channel satisfies any one of the following:

[0009] (1) The second sub-channel has a circular hole structure, and the diameter of the second sub-channel is constant along the first direction;

[0010] (2) The second sub-channel is a tapered hole structure, and along the first direction, the aperture of the second sub-channel gradually decreases in the direction away from the sheath seat;

[0011] (3) The second sub-channel is an irregular hole structure, and the cross-sectional shape of the second sub-channel is adapted to the cross-sectional shape of the guided component.

[0012] In some embodiments, the sheath includes a first weakening portion located on opposite sides of the first sub-channel, and the first sealing sheet includes a second weakening portion located on opposite sides of the second sub-channel. The first weakening portion and the second weakening portion constitute a weakening structure, wherein the first weakening portion and the second weakening portion are aligned along a first direction.

[0013] In some embodiments, the first sealing sheet includes a first surface and a second surface disposed opposite to each other along a first direction. The first surface is formed with a first cut corresponding to the second weakening portion. The first cut is spaced apart from the second sub-channel along a second direction and spaced apart from the second surface along the first direction. The second direction is the radial direction of the second sub-channel.

[0014] In some embodiments, the first sealing sheet satisfies at least one of the following:

[0015] (4) The second surface of the first sealing sheet is positioned close to the sheath seat;

[0016] (5) In the second direction, the side of the first cut away from the second sub-channel extends toward the edge of the first sealing sheet;

[0017] (6) The side of the first incision away from the second sub-channel has a first depth in a first direction, and the side of the first incision close to the second sub-channel has a second depth in a first direction, and the first depth is greater than the second depth;

[0018] (7) The distance L from the side of the first incision near the second sub-channel to the edge of the second sub-channel satisfies: 0.2 mm ≤ L ≤ 3 mm.

[0019] In some embodiments, the flow control valve further includes a second sealing plate, which is stacked on top of the first sealing plate along a first direction. The second sealing plate includes a third surface and a fourth surface disposed opposite to each other along the first direction. The third surface forms a second cut, and the fourth surface forms a third cut.

[0020] Part of the second cut and part of the third cut are in contact with each other along the first direction to penetrate the second sealing sheet, and the second cut is aligned with the weakening structure along the first direction.

[0021] In some embodiments, the second sealing strip is located between the sheath body and the first sealing strip, and the third surface is close to the first sealing strip.

[0022] In some embodiments, the first sealing sheet and the second sealing sheet satisfy at least one of the following:

[0023] (8) The tensile strength of the first sealing strip is less than that of the second sealing strip;

[0024] (9) The elongation at break of the first sealing strip is less than that of the second sealing strip.

[0025] (10) The elongation at break of the first sealing strip is greater than or equal to 300% and less than or equal to 500%;

[0026] (11) The elongation at break of the second sealing strip is greater than or equal to 500% and less than or equal to 800%;

[0027] (12) The hardness of the first sealing sheet is 30-60 ShA, the tear strength is 10-15 KN / m, the tensile strength is 3-5 MPa, and the 200% tensile modulus is 0.5-1 MPa;

[0028] (13) The second sealing sheet has a tensile strength of 15-25 KN / m, a tensile strength of 3-5 MPa, and a tensile modulus of 0.8-1.5 MPa at 200%.

[0029] In some embodiments, in a plane perpendicular to the first direction, the contact portion of the second cut and the third cut at least partially overlaps with the projection of the second sub-channel along the first direction; and / or,

[0030] The length of the second incision is greater than the length of the third incision; and / or,

[0031] The second cut extends toward the edge of the second sealing strip on at least one side in the second direction, which is the radial direction of the second sub-channel.

[0032] In some embodiments, the weakening structure includes a first weakening portion disposed on the sheath seat and located on opposite sides of the first sub-channel. The reinforcing structure includes a second reinforcing member disposed on one side of the first weakening portion along a second direction. The second reinforcing member is integrally formed with the first weakening portion and can be separated from at least a portion of the first weakening portion after the guide assembly is used up. The second direction is the radial direction of the second sub-channel.

[0033] In some embodiments, the sealing structure includes a sheath seat and a flow-blocking valve. The sheath seat has a through first sub-channel. The flow-blocking valve includes a first sealing sheet that overlaps with the sheath seat and covers one end of the first sub-channel. The first sealing sheet has a second sub-channel, and the first sub-channel and the second sub-channel communicate to form a guide channel. The weakening structure includes a first weakening portion disposed on the sheath seat and located on opposite sides of the first sub-channel. The reinforcing structure includes a second reinforcing member disposed along a second direction on one side of the first weakening portion. The second reinforcing member is integral with the first weakening portion and can be separated from at least a portion of the first weakening portion after the guide assembly is used up. The second direction is perpendicular to the thickness direction of the first sealing sheet.

[0034] In some embodiments, the second reinforcing member is located on the side of the first weakening portion facing away from the first sub-channel along the second direction; and / or, the first weakening portion includes a first part and a second part, the first part being located on the side of the second part facing away from the first sub-channel along the second direction, and the second reinforcing member being connected to the first part for driving at least a portion of the first part to separate relative to the second part after the guide assembly has been used; and / or, the second reinforcing member includes an operating part and a connecting part connected together, the connecting part being at least partially combined with the first weakening portion, and the operating part being able to drive the connecting part to separate from the first weakening portion under load.

[0035] In some embodiments, the second reinforcing member and the first weakening part are integrally connected by injection molding; or, the second reinforcing member includes a buckle, the first weakening part is provided with a slot, the buckle is engaged in the slot, and is integrally connected with at least a portion of the inner wall of the slot.

[0036] In some embodiments, the sheath seat is provided with a tear, which is provided corresponding to the first weakening part and located on the side of the first weakening part facing away from the first sub-channel along the second direction. The second reinforcing member is located inside the tear and is at least partially attached to the inner wall of the tear.

[0037] Secondly, embodiments of this application provide a sheath seat, the sheath seat having a through first sub-channel along a first direction, the sheath seat including a first weakening part and a second reinforcing member, the first weakening part being located on opposite sides of the first sub-channel; the second reinforcing member being disposed on one side of the first weakening part along a second direction, the second reinforcing member being connected to the first weakening part as an integral structure, for separating from at least part of the first weakening part after the guide assembly is used up, the first direction intersecting the second direction.

[0038] Thirdly, embodiments of this application provide a flow-blocking valve, which includes a first sealing sheet. The first sealing sheet has a through second sub-channel, which is a hole structure for interference fit with a component being passed through. The first sealing sheet includes a second weakening portion and a first reinforcing member. The first reinforcing member is arranged circumferentially around the second sub-channel and is located between the second weakening portion and the second sub-channel.

[0039] This application provides a guiding component, a sheath seat, and a hemostatic valve. The guiding component includes a sealing structure with a guiding channel. The guided component can pass through the guiding channel and seal the corresponding position within the human body under the guidance of the guiding component. The sealing structure includes a weakening structure located on opposite sides of the guiding channel. After use, the operator can tear open the sealing structure from the weakening structure to remove the guiding component from the body, reducing the difficulty of tearing open the guiding component. Furthermore, by incorporating a reinforcing structure within the sealing structure, the reinforcing structure can cooperate with the weakening structure during use to improve the structural strength of the weakening structure, thereby enhancing its sealing capability. Attached Figure Description

[0040] To more clearly illustrate the technical solutions of the embodiments of this application, the accompanying drawings used in the embodiments of this application will be briefly introduced below. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0041] Figure 1 This is a top view of the sheath in the guidance assembly provided in some embodiments of this application;

[0042] Figure 2 This is a top view of the sealing structure in the guide assembly provided in some embodiments of this application;

[0043] Figure 3 This is a schematic diagram of the structure of the first sealing sheet in the guide assembly provided in some embodiments of this application;

[0044] Figure 4 This is a schematic diagram of the structure of the first sealing sheet in a guide assembly provided in other embodiments of this application;

[0045] Figure 5 In some embodiments of this application, the first sealing sheet is along Figure 3 A schematic diagram of the AA cross-section;

[0046] Figure 6 In other embodiments of this application, the first sealing sheet is along Figure 3 Another schematic diagram of the AA cross section;

[0047] Figure 7 This is a top view of the sheath of a guide assembly provided in other embodiments of this application;

[0048] Figure 8 This is a perspective view of the sheath of a guide assembly provided in other embodiments of this application;

[0049] Figure 9 yes Figure 7 Enlarged view of point D in the image;

[0050] Figure 10 This is a schematic diagram of the structure of the first and second sealing sheets of the guide assembly provided in some embodiments of this application;

[0051] Figure 11 This is a schematic diagram of the structure of the second sealing sheet of the guide assembly provided in some embodiments of this application;

[0052] Figure 12 In some embodiments of this application, the second sealing sheet is along Figure 11 Cross-sectional view of BB;

[0053] Figure 13 In some embodiments of this application, the second sealing sheet is along Figure 11 Cross-sectional view of CC;

[0054] Figure 14 This is another perspective view of the sheath in the guide assembly provided in some embodiments of this application;

[0055] Figure 15 This is a partial enlarged view of the sheath of the guide assembly provided in some embodiments of this application;

[0056] Figure 16 yes Figure 15 The corresponding exploded view.

[0057] Tag name:

[0058] Sealing structure 1; sheath seat 100; first weakening part 110; first part 111; second part 112; slot 113; second reinforcing member 120; operating part 121; connecting part 122; buckle 123; tear opening 130;

[0059] Flow control valve 200; first sealing plate 210; second weakening part 211; first reinforcing member 212; first surface 213; second surface 214; first cut 215; second sealing plate 220; third surface 221; fourth surface 222; second cut 223; third cut 224; operating handle 300; first sub-channel K1; second sub-channel K2; first direction X; second direction Y; third direction Z. Detailed Implementation

[0060] The features and exemplary embodiments of various aspects of this application will now be described in detail. To make the objectives, technical solutions, and advantages of this application clearer, the application will be further described in detail below with reference to the accompanying drawings and specific embodiments. It should be understood that the specific embodiments described herein are only configured to explain this application and are not configured to limit this application. For those skilled in the art, this application can be implemented without some of these specific details. The following description of the embodiments is merely to provide a better understanding of this application by illustrating examples of this application.

[0061] It should be noted that, in this document, relational terms such as "first" and "second" are used merely to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitations, an element defined by the phrase "comprising..." does not exclude the presence of additional identical elements in the process, method, article, or apparatus that includes said element.

[0062] In some applications, after the guide component is inserted into the human body, the guided device (such as a blood pumping catheter, a floating catheter, a thrombus aspiration catheter, etc.) can pass through the guide component's flow-blocking valve, sheath seat, and sheath tube, and be delivered to the corresponding location within the human body. The guide component in this application is used to establish a connection channel between the external environment and human blood vessels or artificial blood vessels. After the guide component is used, the sheath seat can be torn open; the flow-blocking valve and sheath tube will be torn open together under the action of the sheath seat, and the sheath tube can be gradually withdrawn from the human body during the tearing process. The following description uses an example of an application scenario where the guide component is used to establish a connection channel between human blood vessels and the external environment.

[0063] Currently, during use, the aforementioned tearable guide components are prone to bleeding, affecting their sealing and safety. For example, to facilitate tearing open the sheath seat, a weakening section can be provided. However, this weakening section affects the stress resistance of the sheath seat. During use, the weakening section is prone to cracking due to stress, leading to blood seeping out from the crack. Another example is that current flow control valves typically use a cross-shaped cut for the guided component to pass through. Therefore, during use, a leakage gap can easily form between the guided component and the cross-shaped cut of the flow control valve, allowing blood to seep out from this gap.

[0064] Therefore, to solve at least some of the above-mentioned problems, embodiments of this application provide a guiding component, including a sealing structure forming a guiding channel, wherein the guiding channel serves as a connection channel between the blood vessel and the outside world. In the sealing structure, by designing weakening structures on both sides of the guiding channel, the sealing structure can be torn (or pried open) under corresponding loads; and by the combined effect of the strengthening structure and the weakening structures on both sides of the guiding channel, the sealing capability at the weakening structures before the sealing structure is torn open is improved.

[0065] Figure 1 This is a top view of the sheath in the guidance assembly provided in some embodiments of this application; Figure 2 This is a top view of the sealing structure in the guide assembly provided in some embodiments of this application; Figure 3 This is a schematic diagram of the structure of the first sealing sheet in the guide assembly provided in some embodiments of this application; Figure 4 This is a schematic diagram of the structure of the first sealing sheet in a guide assembly provided in other embodiments of this application; Figure 5 In some embodiments of this application, the first sealing sheet is along Figure 3 A schematic diagram of the AA cross-section; Figure 6 In other embodiments of this application, the first sealing sheet is along Figure 3 Another schematic diagram of the AA cross section; Figure 7 This is a top view of the sheath of a guide assembly provided in other embodiments of this application; Figure 8 This is a perspective view of the sheath of a guide assembly provided in other embodiments of this application; Figure 9 yes Figure 7 Enlarged view of point D in the image.

[0066] Please see Figures 1-9 The guiding assembly includes a sealing structure 1, which forms a guiding channel. The sealing structure 1 includes a weakening structure and a reinforcing structure. The weakening structure is located on opposite sides of the guiding channel. The reinforcing structure is used to cooperate with the weakening structure to improve the sealing ability of the weakening structure.

[0067] The sealing structure 1 is a component used to seal the internal environment of the human body during the process of guiding the guided component into the human body through the guiding assembly. The sealing structure 1 forms a guiding channel through which the guided component can enter the human body.

[0068] In sealing structure 1, the structural strength of the weakening structure is lower than that of other parts of sealing structure 1. After the guide assembly is used, the operator can tear open sealing structure 1 from the weakening structure. The weakening structure being located on opposite sides of the guide channel can mean that the weakening structure is aligned with the central axis of the guide channel, located on opposite sides of the central axis. Alternatively, the weakening structure can also deviate to a certain extent from the central axis of the guide channel, as long as the tear surface of sealing structure 1 extends into the guide channel when it is torn from the weakening structure, allowing the guide channel to be separated. The weakening structure may be affected by factors such as material, size, and structure, resulting in its structural strength being lower than that of other parts of sealing structure 1. For example, the material of the weakening structure may be different from that of other parts of sealing structure 1, and the material of the weakening structure may have lower strength, resulting in lower structural strength of the weakening structure. Alternatively, the thickness of the weakening structure may be less than the thickness of other parts of sealing structure 1, resulting in lower structural strength of the weakening structure compared to those other parts. For example, a perforated structure such as a tear, cut, or groove can be formed on the outer periphery of the sealing structure 1. The perforated structure is spaced apart from the guide channel so that a weakening structure can be formed between the perforated structure and the guide channel.

[0069] It should be noted that, in some embodiments of this application, the sealing structure 1 can be as follows: Figure 2 The diagram shows a sheath seat 100 and a flow-restricting valve 200 superimposed on the sheath seat 100. The weakening structure can be as follows: Figure 1 The diagram shows a first weakening portion 110 located on the sheath seat 100, which can also be as follows: Figure 5 and Figure 6 The diagram shows a second weakening portion 211 located on the flow control valve 200. Alternatively, the weakening structure may also include a first weakening portion 110 located on the sheath seat 100 and a second weakening portion 211 located on the flow control valve 200.

[0070] The reinforcing structure is a component that works in conjunction with the weakening structure to enhance the sealing capability of the weakening structure during the process of guiding the guided component into the human body via the guiding assembly. When the sealing structure 1 includes a sheath seat 100 and a flow-blocking valve 200, the reinforcing structure can, as... Figures 7 to 9 The diagram shows a second reinforcing member 120 located on the sheath seat 100, which can also be as follows: Figures 2 to 6 The reinforcement structure may include a first reinforcing member 212 located on the flow control valve 200, or it may also include a second reinforcing member 120 located on the sheath seat 100 and a first reinforcing member 212 located on the flow control valve 200.

[0071] Optionally, the guiding component may also include a sheath (not shown) with an intervention channel. The sheath is connected to the sealing structure 1 and is located on the side of the sealing structure 1 closer to the human body. The intervention channel communicates with the guiding channel of the sealing structure 1. During the intervention of the guiding component into the human body, the sheath can be inserted into the human body. The sealing structure 1 is located outside the human body. The guided component can pass through the sealing structure 1 via the guiding channel and enter the intervention channel of the sheath, and enter the corresponding position inside the human body under the guidance of the sheath.

[0072] This application provides a guiding component, which includes a sealing structure 1 with a guiding channel. A guided component can pass through the guiding channel and into a corresponding position within the human body under the guidance of the guiding component. The sealing structure 1 includes a weakening structure located on opposite sides of the guiding channel. After use, the operator can tear open the sealing structure 1 from the weakening structure to remove the guiding component from the body, reducing the difficulty of tearing open the guiding component. Furthermore, by incorporating a reinforcing structure within the sealing structure 1, the reinforcing structure can cooperate with the weakening structure during use to improve the structural strength of the weakening structure, thereby enhancing its sealing capability.

[0073] It should be noted that the guiding component provided in this application is applicable to various interventional treatment scenarios involving diagnostic and therapeutic devices, especially those involving large-size and long-depth diagnostic and therapeutic devices, and is also suitable for long-term interventional scenarios involving diagnostic and therapeutic devices. The specific structure of the guiding component provided in this application will be described in detail below with reference to the accompanying drawings.

[0074] Please continue reading. Figures 1 to 6 In some embodiments, the sealing structure 1 includes a sheath seat 100 and a flow-blocking valve 200. The sheath seat 100 is provided with a through first sub-channel K1. The flow-blocking valve 200 includes a first sealing sheet 210 that overlaps with the sheath seat 100 and covers one end of the first sub-channel K1. The first sealing sheet 210 is provided with a second sub-channel K2 along a first direction X. The first sub-channel K1 and the second sub-channel K2 are connected to form a guide channel. The second sub-channel K2 is a hole structure for interference fit with the guided component. The reinforcing structure includes a first reinforcing member 212, which is arranged circumferentially around the second sub-channel K2.

[0075] For ease of description and understanding, the directions involved in this application are defined before describing the specific solutions. Specifically, the first direction in the embodiments of this application can be the axial direction of the second sub-channel K2 or the thickness direction of the sealing sheet in the flow-blocking valve 200, denoted as X; the second direction can be a direction parallel to the tear surface of the guide assembly or a direction that can characterize the weakened distribution area, denoted as Y. For example, the second direction can be one of the radial directions of the second sub-channel K2 or any direction perpendicular to the thickness direction of the sealing sheet; the third direction can be a direction intersecting the tear surface, denoted as Z, for example, another radial direction in the second sub-channel K3 perpendicular to the second direction.

[0076] It is understood that the tear surface of the guide component refers to the ideal plane in which the tear section is approximately located after the guide component is torn. In reality, the tear section may be uneven or have burrs due to product composition, internal structure, etc. Such a tear section can also be considered to be approximately located within the ideal plane, and is also within the scope of protection of this application.

[0077] In some implementations, the second direction Y and the third direction Z can be two mutually perpendicular radial directions of the guiding channel. That is, the first direction X, the second direction Y, and the third direction Z are mutually perpendicular to each other. For ease of description and understanding, the technical solution provided in this application will be described below with the example of the first direction X, the second direction Y, and the third direction Z being mutually perpendicular to each other.

[0078] In some embodiments, the first sub-channel K1 may be formed by the sheath seat 100 along the first direction X, and the first sub-channel K1 and the second sub-channel K2 may be aligned and connected to each other along the first direction X. After the guided member passes through the first sealing sheet 210 via the second sub-channel K2, it can directly enter the first sub-channel K1 without bending.

[0079] In some other embodiments, the first sub-channel K1 may also be formed by the sheath 100 along other directions intersecting the first direction X, and this application does not limit this.

[0080] In some embodiments, the flow control valve 200 includes a first sealing plate 210, which is a component for sealing a first sub-channel K1 on the sheath seat 100. The first sealing plate 210 is stacked on the sheath seat 100 and covers one end of the first sub-channel K1. The first sealing plate 210 may be made of an elastic material, such as an elastic silicone sheet.

[0081] A second sub-channel K2 can be formed on the first sealing plate 210. The second sub-channel K2 communicates with the first sub-channel K1 to form the aforementioned guiding channel. After passing through the first sealing plate 210 via the second sub-channel K2, the guided component can enter the first sub-channel K1 and then enter the sheath via the first sub-channel K1. The second sub-channel K2 is a hole structure for interference fit with the guided component. The diameter of the second sub-channel K2 is smaller than the outer diameter of the guided component to ensure interference fit.

[0082] Optionally, when the second sub-channel K2 is interference-fitted with the guided member, the aperture of the second sub-channel K2 is smaller than the outer diameter of the guided member, and the difference between the outer diameter of the guided member and the aperture of the second sub-channel K2 can be greater than or equal to 1 mm and less than or equal to 1.5 mm. This can reduce the risk of the first sealing sheet 210 cracking due to being squeezed by the guided member while ensuring that the inner wall of the second sub-channel K2 is in close contact with the outer wall of the guided member.

[0083] In some implementations, the second sub-channel K2 can be formed by the first sealing sheet 210 along its own thickness direction, in which case the axial direction of the second sub-channel K2 can be parallel to the thickness direction of the first sealing sheet 210. Alternatively, the axial direction of the second sub-channel K2 can intersect the thickness direction of the first sealing sheet 210 and form an angle of less than 90°.

[0084] The first reinforcing member 212 is a component used to improve the structural strength of the first sealing sheet 210. The first reinforcing member 212 is arranged around the second sub-channel K2 in a circumferential manner, and the second sub-channel K2 is equivalent to being formed by the first reinforcing member 212.

[0085] In some embodiments, when the weakening structure is such as Figure 5 and Figure 6 When the second weakening part 211 is included on the flow control valve 200, the second weakening part 211 can be connected to the first reinforcing member 212 and is located on the side of the first reinforcing member 212 facing away from the second sub-channel K2.

[0086] It should be noted that the shape of the first reinforcing member 212 can be various. For example, the first reinforcing member 212 can be... Figure 3 The annular structure shown has a circular outer contour, or, for example, the shape of the first reinforcing member 212 could also be... Figure 4 As shown, its outer contour is elliptical.

[0087] Understandably, in related technologies, the first sealing sheet 210 is usually provided with a cross-shaped cut for the guide to pass through. However, when the guide passes through the cross-shaped cut, the outer wall of the guide is prone to forming a leakage triangle with the cross-shaped cut, which affects the sealing ability of the first sealing sheet 210.

[0088] In view of this, in this embodiment, a second sub-channel K2 is formed on the first sealing sheet 210, and the second sub-channel K2 is configured as a hole structure for interference fit with the guided member. When the guided member passes through the second sub-channel K2, the inner wall of the second sub-channel K2 can fit more tightly with the outer wall of the guided member, thereby achieving a sealed connection between the guiding assembly and the guided member. This reduces the risk of a leakage gap forming between the guided member and the first sealing sheet 210, thereby reducing the risk of blood seeping out from the gap between the guided member and the first sealing sheet 210, and improving the sealing performance and safety of the guiding assembly.

[0089] Furthermore, in related technologies, the cross-shaped cut usually penetrates the first sealing sheet 210 in a direction perpendicular to the thickness direction of the first sealing sheet 210. During the use of the guide assembly, if the first sealing sheet 210 is subjected to external stress, it is easy to tear at the cross-shaped cut, affecting the sealing performance of the first sealing sheet 210.

[0090] Therefore, in this embodiment, while the first sealing sheet 210 is provided with the second sub-channel K2, the first sealing sheet 210 is also provided with a first reinforcing member 212. The first reinforcing member 212 surrounds the second sub-channel K2 in the circumferential direction. Compared with the cross-cut transverse penetration of the first sealing sheet 210 in the related art, the combination of the first reinforcing member 212 and the second sub-channel K2 can improve the structural strength of the first sealing sheet 210, further reduce the risk of bleeding during the use of the guide assembly, and further improve the safety of the guide assembly.

[0091] Optionally, the first sealing sheet 210 can be sealed to the sheath seat 100 along the circumference of the first sub-channel K1 to improve the sealing effect of the first sub-channel K1.

[0092] It should be noted that there are multiple ways to connect the first sealing plate 210 to the sheath seat 100. For example, the sealing structure 1 may further include a sheath cap connected to the sheath seat 100, and the first sealing plate 210 can be pressed between the sheath cap and the sheath seat 100. Further, a plurality of protrusions may be formed on the side surface of the sheath seat 100 facing the first sealing plate 210 (i.e., the side surface of the sheath seat 100 away from the human body). These protrusions are spaced apart circumferentially along the second sub-channel K2. Correspondingly, a plurality of through holes may be opened on the first sealing plate 210 along the first direction X, also spaced apart circumferentially along the second sub-channel K2. By inserting each protrusion into the corresponding through hole, the first sealing plate 210 can be positioned. Alternatively, the first sealing plate 210 can be connected to the sheath seat 100 using sealant.

[0093] Furthermore, in some embodiments of this application, a positioning step can be formed on the side of the sheath seat 100 facing the first sealing piece 210. The positioning step surrounds the first sealing piece 210. On the one hand, the positioning step can position the first sealing piece 210, which facilitates the assembly of the first sealing piece 210. On the other hand, setting the first sealing piece 210 on the positioning step can also increase the contact area between the first sealing piece 210 and the sheath seat 100, extend the sealing path between the first sealing piece 210 and the sheath seat 100, achieve the flow blocking effect on the circumferential surface of the flow blocking valve, and improve the sealing performance of the sealing structure 1.

[0094] Please continue reading. Figure 5 and Figure 6 In some embodiments, the second sub-channel K2 satisfies any one of the following:

[0095] (1) The second sub-channel K2 is a circular hole structure, and the diameter of the second sub-channel K2 is constant along the first direction X;

[0096] (2) The second sub-channel K2 has a tapered hole structure, and along the first direction X, the aperture of the second sub-channel K2 gradually decreases in the direction away from the sheath seat 100;

[0097] (3) The second sub-channel K2 is an irregular hole structure, and the cross-sectional shape of the second sub-channel K2 is adapted to the cross-sectional shape of the guided component.

[0098] In some of these embodiments, please refer to Figure 6 The second sub-channel K2 has a circular hole structure. The diameter of the second sub-channel K2 is constant along the first direction X. The second sub-channel K2 can be approximately cylindrical. Compared with setting the second sub-channel K2 as a square hole or other shaped through hole, when the guided part passes through the second sub-channel K2, all positions of the inner wall of the second sub-channel K2 can maintain tight contact with the outer wall of the guided part, and it is not easy to form a leakage gap. On the one hand, it improves the sealing performance between the second sub-channel K2 and the guided part, and on the other hand, it can reduce the stress concentration between the guided part and the second sub-channel K2, and improve the service life of the sheath seat 100 and the guided part.

[0099] In some of these embodiments, please refer to Figure 5The second sub-channel K2 has a tapered hole structure, and along the first direction X, the diameter of the second sub-channel K2 gradually decreases towards the direction away from the sheath seat 100. At this time, the diameter of the second sub-channel K2 on the side closer to the sheath seat 100 is larger than the diameter on the side farther away from the sheath seat 100. The second sub-channel K2 is approximately frustum-shaped. When the guided component passes through the second sub-channel K2, and the side of the second sub-channel K2 closer to the sheath seat 100 is in an interference fit with the guided component, the tightness of the contact between the inner wall of the second sub-channel K2 and the outer wall of the guided component along the first direction X... The sealing performance of the first sealing piece 210 gradually increases along the first direction X towards the side away from the sheath seat 100, thus gradually improving the sealing performance of the first sealing piece 210 along the first direction X towards the side away from the sheath seat 100. Therefore, when the guiding component is inserted into the human body, the difficulty of blood seeping out from between the inner wall of the second sub-channel K2 and the outer wall of the guided component gradually increases along the first direction X towards the side away from the sheath seat 100, thereby reducing the risk of blood seeping out from between the inner wall of the second sub-channel K2 and the outer wall of the guided component, and further improving the sealing performance, blood-blocking performance and safety of the guiding component.

[0100] In some embodiments, the second sub-channel K2 is an irregular hole structure. The cross-sectional shape of the second sub-channel K2 is adapted to the cross-sectional shape of the guided member, which can increase the contact area between the inner wall of the second sub-channel K2 and the outer wall of the guided member, extend the sealing path between the two opposite ends of the second sub-channel K2, and thus improve the sealing ability of the first sealing sheet 210.

[0101] Please continue reading. Figures 1 to 6 In some embodiments, the sheath 100 includes a first weakening portion 110 located on opposite sides of the first sub-channel K1, and the first sealing sheet 210 includes a second weakening portion 211 located on opposite sides of the second sub-channel K2. The first weakening portion 110 and the second weakening portion 211 constitute a weakening structure, wherein the first weakening portion 110 and the second weakening portion 211 are aligned along the first direction X.

[0102] In some embodiments, there may be two first weakening portions 110, with each first weakening portion 110 disposed on opposite sides of the first sub-channel K1. The first weakening portions 110 are connected to other parts of the sheath 100 to together enclose and form the first sub-channel K1. The structural strength of the first weakening portion 110 is lower than that of other parts of the sheath 100, allowing the operator to tear open the sheath 100 at the first weakening portion 110 after the guide assembly has been used. It should be noted that the structural strength of the first weakening portion 110 may be lower than that of other parts of the sheath 100 due to factors such as material, size, and structure. For example, the material of the first weakening portion 110 may be different from that of other parts of the sheath 100, resulting in lower structural strength. Alternatively, the size of the first weakening portion 110 may be smaller than that of other parts of the sheath 100, causing its structural strength to be lower than that of other parts of the sheath 100. For example, a perforated structure such as a tear, cut, or groove can be formed on the outer periphery of the sheath seat. This perforated structure is spaced apart from the first sub-channel K1 so that a first weakening portion 110 can be formed between the aforementioned perforated structure and the first sub-channel K1.

[0103] In some embodiments of this application, the first sealing sheet 210 includes two second weakening portions 211, which are respectively disposed on opposite sides of the second sub-channel K2. The structural strength of the second weakening portions 211 is lower than that of other parts of the first sealing sheet 210, and they are used to allow the operator to tear open the first sealing sheet 210 at the second weakening portions 211 after the guide assembly has been used. It is understood that there are various ways to form the second weakening portions 211. For example, the second weakening portions 211 can be formed by providing cuts, grooves or other hollow structures on the first sealing sheet 210.

[0104] In some embodiments, the second weakening part 211 is located along the second direction Y on the side of the first reinforcing member 212 away from the second sub-channel K2. That is, part of the first reinforcing member 212 is located between the corresponding second weakening part 211 and the second sub-channel K2. By combining the second weakening part 211, the first reinforcing member 212 and the second sub-channel K2, the structural strength of the first sealing sheet 210 can be improved, and the first sealing sheet 210 can be easily torn open.

[0105] In some embodiments of this application, the second weakening portion 211 is aligned with the first weakening portion 110 along the first direction X. It should be noted that the alignment of the second weakening portion 211 with the first weakening portion 110 along the first direction X can be achieved by the projections of the first weakening portion 110 and the second weakening portion 211 along the first direction X at least partially overlapping in a plane perpendicular to the first direction X, or by the first weakening portion 110 being spaced apart from the second weakening portion 211 in the second direction Y.

[0106] In these embodiments, by aligning the second weakening portion 211 with the first weakening portion 110 along the first direction X, after the guide assembly is used, the operator can tear open the sheath 100 from the first weakening portion 110. Simultaneously with the sheath 100 being torn open, the first sealing sheet 210 is torn open from the second weakening portion 211 under the influence of the sheath 100. It should be noted that both the sheath 100 and the first sealing sheet 210, after being torn open along the first direction X, have two parts. Each of these two parts has a tear surface on its opposite side. This tear surface can be a surface with many irregular burrs, and it can extend approximately along the second direction Y.

[0107] Please continue reading. Figure 5 and Figure 6 In some embodiments of this application, the first sealing sheet 210 includes a first surface 213 and a second surface 214 disposed opposite to each other along the first direction X. The first surface 213 is formed with a first cut 215 corresponding to the second weakening portion 211. The first cut 215 and the second sub-channel K2 are spaced apart along the second direction Y. The first cut 215 and the second surface 214 are spaced apart along the first direction X.

[0108] In some embodiments of this application, the dimension of the first cut 215 along the first direction X is 45% to 70% of the distance between the edge of the first sealing piece 210 and the center of the second sub-channel K2 at the corresponding position.

[0109] like Figure 5 and Figure 6 As shown, within the longitudinal section where the first cut 215 is located, the second weakening portion 211 can be the solid region between the first cut 215 and the second surface 214.

[0110] When the first sealing sheet 210 is disposed on the sheath seat 100, either its first surface 213 or its second surface 214 can be disposed close to the sheath seat 100 along the first direction X and fit against the side surface of the sheath seat 100 facing the first sealing sheet 210 (i.e. the side surface of the sheath seat 100 away from the human body), which can cover the first sub-channel K1 of the sheath seat 100, while the other is disposed away from the sheath seat 100 along the first direction X and exposed relative to the sheath seat 100.

[0111] In some implementations, the first surface 213 has a first cut 215, which can be formed by cutting the first surface 213 approximately along the first direction X and the second direction Y. The first cut 215 and the second surface 214 are spaced apart along the first direction X, and the first cut 215 does not penetrate the first sealing sheet 210 along the first direction X. Furthermore, the first cut 215 and the second sub-channel K2 of the first sealing sheet 210 are spaced apart along the second direction Y. Therefore, when the guide component is inserted into the human body, blood in the human body will not flow into the first cut 215 through the second sub-channel K2, which reduces the risk of blood seeping out from the first cut 215.

[0112] It should be noted that the first reinforcing member 212 is arranged circumferentially around the second sub-channel K2, and it may include the solid structure between the first cut 215 and the second sub-channel K2. That is, part of the first reinforcing member 212 may be located between the first cut 215 and the second sub-channel K2 along the second direction Y.

[0113] It is understandable that, since the first surface 213 of the first sealing sheet 210 forms the first cut 215, and the first cut 215 is spaced apart from the second surface 214 along the first direction X, the solid structure between the first cut 215 and the second surface 214 on the flow control valve 200 can be the second weakening part 211. The structural strength of the second weakening part 211 is lower than that of other parts of the first sealing sheet 210, and it is easier to tear open.

[0114] In these embodiments, by forming a first cut 215 in the first sealing sheet 210, the first sealing sheet 210 has a second weakened portion 211 with lower structural strength compared to other parts. Compared to forming the second weakened portion 211 by optimizing the material of the first sealing sheet 210, the manufacturing difficulty of the first sealing sheet 210 can be reduced. Compared to forming the second weakened portion 211 by forming tearing openings, transverse through-cuts, or other structures on the first sealing sheet 210, the impact of the formation of the second weakened portion 211 on the overall structural strength of the first sealing sheet 210 can be reduced, resulting in better sealing performance of the first sealing sheet 210. Furthermore, when it is necessary to tear open the guide assembly, the second weakened portion 211 of the first sealing sheet 210 can be torn open along the cutting path of the first cut 215 under the action of the sheath seat 100, thereby reducing the difficulty of tearing open the second weakened portion 211.

[0115] Optionally, there can be two first cuts 215. The two first cuts 215 are respectively disposed on opposite sides of the second sub-channel K2. The two first cuts 215 and the two second weakening parts 211 are aligned along the first direction X. One second weakening part 211 is located between one first cut 215 and the second surface 214 along the first direction X, and the other second weakening part 211 is located between the other first cut 215 and the second surface 214 along the first direction X. This can further reduce the difficulty of tearing open the first sealing sheet 210.

[0116] Optionally, the ratio between the length of the first cut 215 along the second direction Y and the dimension of the first sealing piece 210 along the second direction Y can be greater than or equal to 0.225 and less than or equal to 0.35, so as to reasonably set the length of the first cut 215 along the second direction Y.

[0117] In some embodiments, the first sealing sheet satisfies at least one of the following:

[0118] (4) The second surface 214 of the first sealing sheet 210 is disposed near the sheath seat 100;

[0119] (5) Please refer to Figures 3 to 6 In the second direction Y, the first cut 215 extends from the side away from the second sub-channel K2 toward the edge of the first sealing piece 210;

[0120] (6) Please refer to Figure 5 The side of the first cut 215 away from the second sub-channel K2 has a first depth H1 in the first direction X, and the side of the first cut 215 close to the second sub-channel K2 has a second depth H2 in the first direction X. The first depth H1 is greater than the second depth H2.

[0121] (7) The distance L1 from the side of the first cut 215 near the second sub-channel K2 to the edge of the second sub-channel K2 satisfies: 0.2 mm ≤ L1 ≤ 3 mm.

[0122] In some embodiments, the second surface 214 of the first sealing strip 210 is positioned close to the sheath seat 100.

[0123] In this structure, the first sealing sheet is stacked on the proximal end face of the sheath seat 100. The first surface 213 is disposed away from the sheath seat 100 along the first direction X and exposed relative to the sheath seat 100. The second surface 214 is disposed close to the sheath seat 100 along the first direction X and fits against the sheath seat 100. At this time, the first cut 215 located on the first surface 213 faces away from the sheath seat 100 along the first direction X. On the one hand, this can reduce the risk of bleeding caused by the first cut 215 located on the first surface 213 communicating with the first sub-channel K1 of the sheath seat 100, thereby improving the sealing performance of the sealing structure 1. On the other hand, it can prevent the blood pressure in the first sub-channel K1 from being directly applied to the first cut 215, thereby reducing the risk of failure of the first sealing sheet 210.

[0124] In some other embodiments of this application, the first sealing sheet 210 is stacked on the proximal end face of the sheath seat 100, and the first cut 215 is disposed toward the sheath seat 100, that is, the first surface 213 is disposed close to the sheath seat 100 along the first direction X and fits against the sheath seat 100, and the second surface 214 is disposed away from the sheath seat 100 along the first direction X and is exposed relative to the sheath seat 100.

[0125] In some embodiments, the side of the first cut 215 away from the second sub-channel K2 extends toward the edge of the first sealing sheet 210, which can extend the length of the first cut 215 in the second direction Y. On the one hand, it can reduce the forming difficulty of the first cut 215, and on the other hand, it can reduce the tearing difficulty of the first sealing sheet 210 while ensuring the structural performance, sealing performance, flow blocking performance and safety performance of the first sealing sheet 210.

[0126] Please see Figure 5 In some embodiments, the first depth H1 is the depth dimension of the first cut 215 along the second direction Y away from the second sub-channel K2 in the first direction X, and the second depth H2 is the depth dimension of the first cut 215 along the second direction Y close to the second sub-channel K2 in the first direction X, and the first depth H1 is greater than the second depth H2.

[0127] It is understood that the cut shapes shown in the embodiments and accompanying drawings of this application are only some examples, and other cut shapes that can meet the overall performance requirements are also within the protection scope of this application, and this application does not make specific limitations on them.

[0128] The side of the first cut 215 away from the second sub-channel K2 refers to the side of the first cut 215 away from the second sub-channel K2 along the second direction Y, that is, the side of the first cut 215 close to the edge of the first sealing piece 210. The side of the first cut 215 close to the second sub-channel K2 refers to the side of the first cut 215 close to the second sub-channel K2 along the second direction Y, that is, the side of the first cut 215 close to the center of the first sealing piece 210.

[0129] Understandably, the first sealing plate 210 is connected to the sheath seat 100, and the connection portion of the two is arranged circumferentially around the first sub-channel K1, so that the first sealing plate 210 can cover the first sub-channel K1 and seal it. When force is applied to the sheath seat 100 to tear it open, the force on the sheath seat 100 can be transmitted to the first sealing plate 210 through the aforementioned connection portion, and the force on the first sealing plate 210 is transmitted from the connection portion towards the direction closer to the second sub-channel K2. This force is continuously reduced during transmission. Therefore, in this embodiment, the first depth H1 of the first cut 215 on the side away from the second sub-channel K2 is greater than the second depth H2 of the first cut 215 on the side close to the second sub-channel K2. This allows for the corresponding adjustment of the thickness of the solid portion (i.e., the second weakening portion 211) between the first cut 215 and the second surface 214 along the first direction X. This results in a thinner thickness on the side of the aforementioned solid portion close to the edge of the first sealing sheet 210, and a thicker thickness on the side close to the center of the first sealing sheet 210. On the one hand, this reduces the difficulty of tearing the first sealing sheet 210, and on the other hand, it improves the structural strength of the first sealing sheet 210, reducing the risk of the first sealing sheet 210 being damaged by stress during use.

[0130] Optionally, the difference between the first depth H1 of the first cut 215 and the thickness of the first sealing sheet 210 along the first direction X can be about 0.5 mm. That is, the thickness of the second weakening part 211 on the side away from the second sub-channel K2 along the second direction Y (i.e. the side close to the edge of the first sealing sheet 210) in the first direction X can be about 0.5 mm, so as to reduce the difficulty of tearing the first sealing sheet 210.

[0131] Please see Figure 6 In some embodiments, in the second direction Y, the distance L1 from the side of the first cut 215 near the second sub-channel K2 to the edge of the second sub-channel K2 satisfies: 0.2 mm ≤ L1 ≤ 3 mm.

[0132] In these embodiments, in the second direction Y, the distance from the side of the first cut 215 near the second sub-channel K2 to the edge of the second sub-channel K2 is greater than or equal to 0.2 mm and less than or equal to 3 mm, which enables the portion of the second reinforcement 120 located between the first cut 215 and the second sub-channel K2 to have sufficient structural strength to resist stress during the use of the guide assembly, thereby reducing the risk of the first sealing sheet 210 cracking during the use of the guide assembly.

[0133] It should be noted that the distance from the side of the first cut 215 near the second sub-channel K2 along the second direction Y to the edge of the second sub-channel K2 can be the minimum distance between the first cut 215 and the second sub-channel K2, or it can be the average distance from the side of the first cut 215 near the second sub-channel K2 to the edge of the second sub-channel K2.

[0134] It should be noted that the above implementation methods only disclose a portion of the guiding components provided in this application. The disclosed technical solutions can be disassembled and recombined, and the resulting technical solutions are also within the protection scope of this application, which will not be elaborated here. The first sealing sheet 210 and the second sealing sheet 220 provided in the embodiments of this application can simultaneously include combinations of the above multiple embodiments.

[0135] Figure 10 This is a schematic diagram of the structure of the first and second sealing sheets of the guide assembly provided in some embodiments of this application. Figure 11 This is a schematic diagram of the structure of the second sealing sheet of the guide assembly provided in some embodiments of this application. Figure 12 In some embodiments of this application, the second sealing sheet is along Figure 11 Cross-sectional view of BB in the middle. Figure 13 In some embodiments of this application, the second sealing sheet is along Figure 11 Cross-sectional view of CC.

[0136] Please see Figures 10-13 In some embodiments, the flow control valve 200 further includes a second sealing sheet 220, which is stacked on top of the first sealing sheet 210. The second sealing sheet 220 includes a third surface 221 and a fourth surface 222 disposed opposite to each other along a first direction X. The third surface 221 forms a second cut 223, and the fourth surface 222 forms a third cut 224. A portion of the second cut 223 and a portion of the third cut 224 are in contact with each other along the first direction to penetrate the second sealing sheet 220 for a guided member to pass through. The second cut 223 is aligned with the weakening structure along the first direction X.

[0137] In its natural state, the second sealing sheet 220 is used to seal the first sub-channel K1 of the sheath seat 100, and the second sealing sheet 220 and the first sealing sheet 210 are stacked together along the first direction X.

[0138] In this application, after the guiding component is inserted into the human body and before the guided component is inserted into the human body through the guiding component, the second sealing plate 220 can seal the first sub-channel K1 of the sheath seat 100, reducing the risk of blood leakage through the guiding channel in this state. When the guided component is inserted into the human body through the guiding component, the guided component passes through the second sealing plate 220 through the contact area between the second incision 223 and the third incision 224, and the inner wall of the second sub-channel K2 forms a tight contact with the outer wall of the guided component, reducing the risk of blood seepage from the human body.

[0139] In some embodiments of this application, the edge of the second cut 223 facing the fourth surface 222 is arc-shaped or stepped.

[0140] In some embodiments, at the corresponding position, along the direction from the edge of the second sealing sheet 220 toward the center, the depth of the second cut 223 gradually decreases in the first direction X, while the thickness of the solid portion between the second cut 223 and the fourth surface 222 gradually increases in the first direction X. This is to reasonably set the shape of the edge of the second cut 223 toward the fourth surface 222, thereby reducing the difficulty of tearing the second sealing sheet 220 and giving the second sealing sheet 220 a certain structural strength to resist external stress.

[0141] In some embodiments of this application, the edge of the third cut 224 facing the third surface 221 is short arc-shaped.

[0142] In some implementations, the chord length of the third cut 224 is 40% to 60% of the distance between the two opposite edges of the second sealing piece 220 at the corresponding position.

[0143] In some embodiments, at the corresponding location, along the direction from the edge of the second sealing sheet 220 toward the center, the depth of the third cut 224 gradually increases in the first direction X, while the thickness of the solid portion between the third cut 224 and the third surface 221 gradually decreases in the first direction X. This ensures that the third cut 224 can contact the second cut 223 in the first direction X to penetrate the second sealing sheet 220, while reducing the size of the third cut 224 to a certain extent, thereby improving the structural strength of the second sealing sheet 220.

[0144] In some embodiments, the second sealing piece 220 may be located between the first sealing piece 210 and the sheath 100. Before the guided member is inserted into the human body through the guiding assembly, the second sealing piece 220 can seal the first sub-channel K1 of the sheath 100, reducing the risk of blood in the first sub-channel K1 entering the second sub-channel K2 of the first sealing piece 210. During the process of the guided member being inserted into the human body through the guiding assembly, the guided member first enters the second sub-channel K2 of the first sealing piece 210, and then passes through the second sealing piece 220 through the contact area between the second incision 223 and the third incision 224. During this process, when the guided member enters the second sub-channel K2, the inner wall of the second sub-channel K2 can form a tight contact with the outer wall of the guided member, thereby reducing the risk of blood seepage from the human body.

[0145] In some embodiments, the first sealing piece 210 may be located between the second sealing piece 220 and the sheath seat 100. It is understood that, because the second sealing piece 220 has a second cut 223 and a third cut 224, its structural strength is lower than that of the first sealing piece 210. Therefore, by placing the first sealing piece 210 between the second sealing piece 220 and the sheath seat 100, the first sealing piece 210 can buffer the stress from blood inside the body between the second sealing piece 220 and the sheath seat 100, reducing the risk of the second sealing piece 220 cracking due to this stress.

[0146] It should be noted that in the second sealing sheet 220, either the third surface 221 or the fourth surface 222 is disposed close to the sheath seat 100 along the first direction X, while the other is disposed away from the sheath seat 100 along the first direction X. When the guide assembly is inserted into the human body, the surface close to the sheath seat 100 is the side surface of the second sealing sheet 220 that is close to the human body, and the surface away from the sheath seat 100 is the side surface of the second sealing sheet 220 that is away from the human body.

[0147] like Figure 11 As shown, in some embodiments of this application, the third surface 221 is formed with a second cut 223. The second cut 223 can be formed by cutting the third surface 221 approximately along the first direction X and the second direction Y, that is, the second cut 223 is distributed or approximately distributed along the third surface 221. Figure 12 The second cut 223 and the fourth surface 222 are spaced apart along the first direction X, but do not penetrate the second sealing sheet 220 along the first direction X.

[0148] In some embodiments, the fourth surface 222 forms a third cut 224, which can be formed by cutting the fourth surface 222 approximately along the first direction X and the third direction Z, that is, the third cut 224 is distributed or approximately distributed in... Figure 13The third cut 224 is located within the XOZ plane. It may be spaced apart from the third surface 221 along the first direction X, but does not penetrate the second sealing sheet 220 along the first direction X.

[0149] In some embodiments, a portion of the second incision 223 and a portion of the third incision 224 are in contact with each other along the first direction X, such that the second incision 223 and the third incision 224 can overlap and penetrate the second sealing sheet 220. When the guiding component is inserted into the human body, the guided component used to deliver the diagnostic and therapeutic instrument can pass through the contact area between the second incision 223 and the third incision 224 to pass through the second sealing sheet 220.

[0150] In some embodiments, the second cut 223 is aligned with the weakening structure along the first direction X. When the operator tears open the sheath from the weakening structure, the second sealing sheet 220 can be torn open from the second cut 223 under the action of the sheath, thereby reducing the difficulty of tearing open the second sealing sheet 220.

[0151] It should be noted that the alignment of the second cut 223 with the weakening structure along the first direction X can mean that the projections of the second cut 223 and the weakening structure along the first direction X overlap in a plane perpendicular to the first direction X, or it can mean that the second cut 223 and the weakening structure are spaced apart in the second direction Y.

[0152] Please continue reading. Figure 12 and Figure 13 Optionally, the distance H3 between the second cut 223 and the fourth surface 222 along the first direction X, and the distance H4 between the third cut 224 and the third surface 221 along the first direction X, can be greater than or equal to 0.5 mm and less than or equal to 0.6 mm, so as to reasonably set the thickness of the solid portion between the second cut 223 and the fourth surface 222 and the solid portion between the third cut 224 and the third surface 221 along the first direction X, thereby improving the performance of the second sealing sheet 220.

[0153] In some embodiments, the second sealing piece 220 is located between the sheath seat 100 and the first sealing piece 210, and the third surface 221 is close to the first sealing piece 210. The second sealing piece 220 is stacked between the sheath seat 100 and the first sealing piece 210. The third surface 221 of the second sealing piece 220 is close to the first sealing piece 210 and overlaps with the side surface of the first sealing piece 210 along the first direction X that is close to the sheath seat 100. The fourth surface 222 is close to the sheath seat 100 and overlaps with the side surface of the sheath seat 100 along the first direction X. Correspondingly, the third cut 224 of the second sealing piece 220 faces the first sub-channel K1 of the sheath seat 100, while the second cut 223 faces away from the first sub-channel K1. After the guide assembly is inserted into the human body, the second sealing piece 220 is closer to the human body than the first sealing piece 210, and the fourth surface 222 of the second sealing piece 220 is closer to the human body than the third surface 221.

[0154] In this embodiment, before the guided member is inserted into the human body through the guiding assembly, the second sealing plate 220 can seal the first sub-channel K1 of the sheath seat 100, reducing the risk of blood in the first sub-channel K1 entering the second sub-channel K2 of the first sealing plate 210. During the process of the guided member being inserted into the human body through the guiding assembly, the inner wall of the second sub-channel K2 of the first sealing plate 210 can form a tight contact with the outer wall of the guided member, thereby reducing the risk of blood seepage from the human body.

[0155] In some embodiments, the first sealing sheet 210 forms a second sub-channel K2 and includes a first surface 213 and a second surface 214 disposed opposite to each other along the first direction X. The first surface 213 forms a first cut 215. The second sealing sheet 220 includes a third surface 221 and a fourth surface 222 disposed opposite to each other along the first direction X. The third surface 221 can be attached to the second surface 214 of the first sealing sheet 210, and the fourth surface 222 can be attached to the sheath seat 100 and cover the first sub-channel K1 of the sheath seat 100. The third surface 221 forms a second cut 223, and the fourth surface 222 forms a third cut 224. The second cut 223 and the third cut 224 can contact each other along the first direction X, and the contact portion of the two can be aligned with the second sub-channel K2 along the first direction X.

[0156] Before the guided component is inserted into the human body through the guiding assembly, the second sealing plate 220 can seal the first sub-channel K1 of the sheath seat 100, reducing the risk of blood in the first sub-channel K1 entering the second sub-channel K2 of the first sealing plate 210. After the guiding assembly is inserted into the human body, the inner wall of the second sub-channel K2 of the first sealing plate 210 can form a tight contact with the outer wall of the guided component, thereby reducing the risk of blood seepage from the human body.

[0157] In some embodiments, the first sealing sheet 210 and the second sealing sheet 220 provided in this application can satisfy at least one of the following:

[0158] (8) The tensile strength of the first sealing sheet 210 is less than that of the second sealing sheet 220.

[0159] (9) The elongation at break of the first sealing sheet 210 is less than that of the second sealing sheet 220.

[0160] Understandably, due to factors such as the number and size of cuts, when the materials of the first sealing sheet 210 and the second sealing sheet 220 are the same, the second sealing sheet 220 is easier to tear than the first sealing sheet 210.

[0161] Therefore, in these embodiments, by reasonably setting the first sealing sheet 210 and the second sealing sheet 220 and the tensile strength and / or elongation at break, and by using a material that is easier to tear than the material of the second sealing sheet 220 to prepare the first sealing sheet 210, the difficulty of tearing the first sealing sheet 210 can be reduced.

[0162] (10) The elongation at break of the first sealing piece 210 is greater than or equal to 300% and less than or equal to 500%. For example, the elongation at break of the first sealing piece 210 is any one of 300%, 350%, 400%, 450%, and 500%.

[0163] (11) The elongation at break of the second sealing piece 220 is greater than or equal to 500% and less than or equal to 800%. For example, the elongation at break of the second sealing piece 220 is any one of 500%, 550%, 600%, 650%, 700%, 750%, and 800%.

[0164] In these embodiments, by reasonably setting the elongation at break of the first sealing sheet 210 and / or the second sealing sheet 220, the first sealing sheet 210 can be torn open more easily than the second sealing sheet 220.

[0165] It should be noted that other properties of the materials of the first sealing sheet 210 and the second sealing sheet 220 can also be optimized to reduce the difficulty of tearing the first sealing sheet 210 and the second sealing sheet 220.

[0166] For example, the first sealing sheet 210 and the second sealing sheet 220 satisfy at least one of the following: the tensile strength of both the first sealing sheet 210 and the second sealing sheet 220 can be greater than or less than 3 MPa and less than or equal to 5 MPa; the hardness of the first sealing sheet 210 can be greater than or equal to 30 SHA and less than or equal to 60 SHA, and the hardness of the second sealing sheet 220 can be greater than or equal to 25 SHA and less than or equal to 45 SHA; the tear strength of the first sealing sheet 210 can be greater than or equal to 10 KN / m and less than or equal to 15 KN / m, and the tear strength of the second sealing sheet 220 can be greater than or equal to 15 KN / m and less than or equal to 20 KN / m; the 200% tensile modulus of the first sealing sheet 210 can be greater than or equal to 0.5 MPa and less than or equal to 1 MPa, and the 200% tensile modulus of the second sealing sheet 220 can be greater than or equal to 0.8 MPa and less than or equal to 1.5 MPa.

[0167] It should be noted that the materials of the first sealing sheet 210 and the second sealing sheet 220 satisfy any one of the above conditions and are within the protection scope of this application. This embodiment does not limit the specific model of the first sealing sheet 210 and the second sealing sheet 220.

[0168] In some embodiments, in a plane perpendicular to the first direction X, the contact portion of the second cut 223 and the third cut 224 at least partially overlaps with the projection of the second sub-channel K2 along the first direction X. Therefore, the guided member can extend approximately in a straight line when passing through the first sealing plate 210 and the second sealing plate 220 without having to bend at a large angle, which can reduce the difficulty of intervention of the guided member and reduce the risk of damage to the guided member during intervention.

[0169] Please continue reading. Figure 12 and Figure 13 In some embodiments, the length L2 of the second cut 223 is greater than the length L3 of the third cut 224, making it easier for the guided member to be inserted into the second sealing sheet 220 from the first sealing sheet 210 through the second cut 223, reducing the difficulty of the guided member passing through the second sealing sheet 220. Furthermore, the larger length of the second cut 223 makes it easier to tear open the second sealing sheet 220, thereby reducing the difficulty of tearing the second sealing sheet 220 from the second cut 223.

[0170] Furthermore, since the third incision 224 has a smaller length dimension than the second incision 223, the fourth surface 222 forming the third incision 224 is disposed on the side of the second sealing sheet 220 near the distal end of the guide assembly. After the guide assembly is inserted into the human body, the blood in the human body is less likely to seep out through the third incision 224, which reduces the risk of blood in the human body seeping out through the incision on the second sealing sheet 220 during the use of the guide assembly.

[0171] It should be noted that the length L2 of the second cut 223 refers to the size of the orthographic projection of the second cut 223 in a plane perpendicular to the first direction X, and the length L3 of the third cut 224 refers to the size of the orthographic projection of the third cut 224 in a plane perpendicular to the first direction X.

[0172] In some embodiments, the second cut 223 extends to the edge of the second sealing sheet 220 on at least one side in the second direction Y. The second cut 223 can penetrate the second sealing sheet 220 along the second direction Y. On the one hand, it can reduce the forming difficulty of the second cut 223, and on the other hand, it can extend the length of the second cut 223. Under the premise of ensuring the structural performance, sealing performance, flow blocking performance and safety performance of the second sealing sheet 220, the difficulty of tearing the second sealing sheet 220 is reduced.

[0173] It should be noted that the above implementation methods only disclose one form of the guiding component provided in this application. The disclosed technical solutions can be disassembled and recombined, and the resulting technical solutions are also within the protection scope of this application, which will not be elaborated here. The flow-blocking valve 200 of the guiding component provided in the embodiments of this application can simultaneously include a combination of the above multiple embodiments.

[0174] In some embodiments, the third cut 224 is spaced apart from the circumferential edge of the second sealing sheet 220 on both sides and does not penetrate the second sealing sheet 220 in a third direction, thereby improving the structural strength of the second sealing sheet 220 to a certain extent. Furthermore, when the third cut 224 is located close to the sheath seat in the first direction, it can also reduce the risk of blood in the human body seeping out from the side of the third cut 224 during the use of the guide assembly.

[0175] Please continue reading. Figure 2 , Figure 3 as well as Figures 7 to 9 In some embodiments, the sealing structure 1 includes a sheath seat 100 and a flow-blocking valve 200. The sheath seat 100 has a through first sub-channel K1. The flow-blocking valve 200 includes a first sealing sheet 210 that overlaps with the sheath seat 100 and covers one end of the first sub-channel K1. The first sealing sheet 210 has a second sub-channel K2. The first sub-channel K1 and the second sub-channel K2 communicate to form a guide channel. The weakening structure includes a first weakening part 110, which is disposed on the sheath seat 100 and located on opposite sides of the first sub-channel K1. The strengthening structure includes a second reinforcing member 120 disposed along the second direction Y on one side of the first weakening part 110. The second reinforcing member 120 is integrated with the first weakening part 110 and can be separated from at least part of the first weakening part 110 after the guide assembly is used up.

[0176] In some embodiments, the second reinforcing member 120 is used to improve the structural strength of the first weakening portion 110. The second reinforcing member 120 may be located on one side of the first weakening portion 110 along the second direction Y, for example, the second reinforcing member 120 may be located on the outer side of the first weakening portion 110 away from the first sub-channel K1 along the second direction Y. The second reinforcing member 120 can be connected to the first weakening portion 110 as an integral structure.

[0177] Therefore, the provision of the second reinforcing member 120 is equivalent to increasing the dimension of the first weakening portion 110 along the second direction Y, thereby improving the structural strength of the first weakening portion 110 and enhancing its stress resistance. This reduces the risk of the first weakening portion 110 cracking and bleeding due to stress during the use of the guide assembly, thus improving the safety of the guide assembly. Furthermore, after the guide assembly is used, the operator can apply force to the second reinforcing member 120 to remove it, separating it from at least part of the first weakening portion 110. This makes the first weakening portion 110 easier to tear open, reducing the difficulty of tearing the guide assembly.

[0178] In some implementations, an operator can apply force to the second reinforcement 120 along the second direction Y, causing the second reinforcement 120 to separate from at least a portion of the first weakening part 110.

[0179] It should be noted that when the second reinforcing member 120 is located on one side of the first weakening portion 110 along the second direction Y, the second reinforcing member 120 can be located on the outer side of the first weakening portion 110 away from the first sub-channel K1 along the second direction Y. Alternatively, the second reinforcing member 120 can also be located on the inner side of the first weakening portion 110 towards the first sub-channel K1 along the second direction Y, in which case the second reinforcing member 120 can be located between the first weakening portion 110 and the flow-blocking valve 200 along the second direction Y.

[0180] In some embodiments, the reinforcing structure may include both the first reinforcing member 212 and the second reinforcing member 120. Based on the increased structural strength of the first sealing sheet 210 through the first reinforcing member 212, the second reinforcing member 120 further enhances the structural strength of the first weakened portion 110, reducing the risk of cracking and bleeding of the first weakened portion 110 due to stress during the use of the guide assembly. After the guide assembly is used, the operator can apply force to the second reinforcing member 120 to remove it, separating it from at least part of the first weakened portion 110, making the first weakened portion 110 easier to tear open and reducing the difficulty of tearing the guide assembly.

[0181] Please continue reading. Figure 7 and Figure 8In some embodiments, the second reinforcing member 120 is located on the side of the first weakening portion 110 away from the first sub-channel K1 along the second direction Y. Compared with the second reinforcing member 120 being located on the side of the first weakening portion 110 close to the first sub-channel K1 along the second direction Y, the operator can pry the second reinforcing member 120 away from the first sub-channel K1 along the second direction Y after the guide assembly is used, so that the second reinforcing member 120 is separated from at least part of the first weakening portion 110, thereby making it more convenient and faster to remove the second reinforcing member 120.

[0182] Please see Figure 9 In some embodiments, the first weakening part 110 includes a first part 111 and a second part 112. The first part 111 is located on the side of the second part 112 facing away from the first sub-channel K1 along the second direction Y. The second reinforcing member 120 is connected to the first part 111 and is used to drive at least part of the first part 111 to separate relative to the second part 112 after the guide assembly is used up.

[0183] In some embodiments of this application, the first part 111 and the second part 112 may be two interconnected parts of the first weakening part 110, and the second part 112 may be located between the first part 111 and the first sub-channel K1 along the second direction Y. The first part 111 and the second part 112 may be an integrally formed structure.

[0184] In this application, the second reinforcing member 120 can cause at least part of the first part 111 to separate from the second part 112 after the guide component is used up. That is, when the second reinforcing member 120 is removed, the second reinforcing member 120 can destroy the structure of the first weakening part 110, so that part of the first weakening part 110 is removed along with the second reinforcing member 120, which means that the first weakening part 110 is further thinned, and thus the first weakening part 110 is easier to tear apart.

[0185] It should be noted that since the second reinforcing member 120 can cause at least a portion of the first part 111 to separate from the second part 112 after the guide assembly is used up, the thickness of the first weakening part 110 along the second direction Y can be increased to a certain extent before the sheath seat 100 is prepared, thereby improving the stress resistance of the first weakening part 110 during the use of the guide assembly. After the guide assembly is used up, the second reinforcing member 120 is removed, causing at least a portion of the first part 111 to be removed simultaneously, thereby further thinning the first weakening part 110 and reducing the difficulty of tearing the first weakening part 110.

[0186] Please continue reading. Figures 1-3In some optional embodiments, the sealing structure 1 may further include two operating handles 300, which are respectively disposed on opposite sides of the sheath seat 100 along the third direction Z, for the operator to apply force to the sheath seat 100, so that the sheath seat 100 can move along... Figure 8 The arrow shown indicates that the tear is oriented Z-axis from the first weakened portion 110 along a third direction.

[0187] In some embodiments, the second reinforcing member 120 and the first weakening part 110 are connected as an integral structure by injection molding, which can reduce the difficulty of manufacturing the sheath seat.

[0188] It should be noted that the material of the second reinforcing member 120 can be the same as that of the first weakening part 110, and the two can be integrally injection molded. Alternatively, the material of the second reinforcing member 120 can be different from that of the first weakening part 110, and the second reinforcing member 120 and the first weakening part 110 can be injection molded as inserts.

[0189] Optionally, the hardness of the second reinforcing member 120 can be greater than that of the first weakening part 110, thereby reducing the risk of the second reinforcing member 120 breaking during removal.

[0190] In some embodiments, the structural strength of the second reinforcing member 120 may be greater than the connection strength between the second reinforcing member 120 and the first weakening part 110, so as to reduce the risk of breakage when the second reinforcing member 120 causes the first weakening part 110 to separate.

[0191] It should be noted that the second reinforcing member 120 can have higher structural strength by optimizing the material of the second reinforcing member 120, or the structure of the second reinforcing member 120 can be optimized to have higher structural strength. This embodiment does not limit this.

[0192] Optionally, the second reinforcement 120 may be provided to protrude relative to the sheath 100 along the first direction X to facilitate operation by the operator.

[0193] Figure 14 This is another perspective view of the sheath seat in the guide assembly provided in some embodiments of this application.

[0194] Please see Figure 14 In some embodiments, the second reinforcing member includes an operating part 121 and a connecting part 122 connected together. The connecting part 122 is disposed on the side of the operating part 121 near the first weakening part 110 and is combined with at least a portion of the first weakening part 110. The operating part 121 can drive the connecting part 122 to separate from the first weakening part 110 under the action of a load.

[0195] The connecting part 122 is a component in the second reinforcing member 120 that is directly connected to the first weakening part 110, and the operating part 121 is a component in the second reinforcing member 120 that is operated by an operator.

[0196] In some implementations, the connecting portion 122 of the second reinforcing member 120 can be connected to a portion of the first weakening portion 110 along the first direction X. Based on improving the structural strength of the first weakening portion 110 through the second reinforcing member 120, the second reinforcing member 120 can have a hollow space on its side along the first direction X for setting other structures, such as other components of the sheath seat 100, to improve the overall structural strength of the sheath seat 100 and enhance its stress resistance.

[0197] Alternatively, in some other alternative implementations, the connecting portion 122 can be connected to the entire area of ​​the first weakening portion 110 along the first direction X to increase the connection area between the second reinforcing member 120 and the first weakening portion 110. When the second reinforcing member 120 is removed, the second reinforcing member 120 can cause more of the first portion 111 in the first weakening portion 110 to separate relative to the second portion 112, so as to further thin the first weakening portion 110 and reduce the difficulty of tearing the first weakening portion 110.

[0198] Figure 15 This is a partially enlarged view of the sheath of a guide assembly provided in some embodiments of this application. Figure 16 yes Figure 15 The corresponding exploded view.

[0199] Please see Figure 15 and Figure 16 In some embodiments, the second reinforcing member 120 includes a buckle 123, and the first weakening part 110 is provided with a groove 113. The buckle 123 is engaged in the groove 113 and is integrally connected to at least a portion of the inner wall of the groove 113. On the one hand, this can increase the connection area between the second reinforcing member 120 and the first weakening part 110, making the connection between the second reinforcing member 120 and the first weakening part 110 more secure and improving the stress resistance of the first weakening part 110 during the use of the guide assembly. On the other hand, it can enable the second reinforcing member 120 to pull more of the first weakening part 110 apart after the guide assembly is used, making the remaining first weakening part 110 on the sheath seat 100 easier to tear open, further reducing the difficulty of tearing open the first weakening part 110.

[0200] Optionally, the shapes of the buckle 123 and the slot 113 can be adapted to each other. The slot 113 may include a bottom wall and side walls disposed on opposite sides of the bottom wall. The opening of the slot 113 is disposed at a distance from the bottom wall, and the opening area of ​​the slot 113 is smaller than the area of ​​the bottom wall. In this case, the side wall of the slot 113 is equivalent to tilting towards the side closer to the center of the bottom wall in a direction away from the bottom wall. When the buckle 123 is engaged in the slot 113, the bottom wall and at least part of the side wall of the slot 113 can be connected with the buckle 123 to form an integral structure.

[0201] Please see Figures 14 to 16 In some embodiments, the sheath seat 100 is provided with a tear 130, which is correspondingly provided with the first weakening part 110 and located on the side of the first weakening part 110 facing away from the first sub-channel K1 along the second direction Y. The second reinforcing member 120 is located inside the tear 130 and is at least partially attached to the inner wall of the tear 130.

[0202] The tear 130 can be formed by a recess in the outer wall of the sheath 100 along the second direction Y. The portion of the sheath 100 corresponding to the tear 130 is thinner than other portions, resulting in lower structural strength. This thinner portion is the first weakening part 110, which is located between the tear 130 and the first sub-channel K1 along the second direction Y. The second reinforcing member 120 is located within the tear 130, and its shape can be adapted to the tear 130.

[0203] In these embodiments, by placing the second reinforcing member 120 within the tear opening 130, the space utilization of the guide assembly can be improved. Furthermore, by placing the second reinforcing member 120 at least partially attached to the inner wall of the tear opening 130, the structural strength of the second reinforcing member 120 can be improved, thereby enhancing the reinforcing effect of the second reinforcing member 120 on the structural strength of the first weakening part 110.

[0204] In some embodiments, the tear 130 may include a bottom wall and side walls disposed on opposite sides of the bottom wall. The bottom wall and the opening of the tear 130 are disposed opposite each other along the second direction Y. The bottom wall is the outer side wall of the first weakening part 110 facing away from the first sub-channel K1 along the second direction Y. When the second reinforcing member 120 is disposed in the tear 130, the second reinforcing member 120 can at least be combined with the bottom wall to improve the structural strength of the first weakening part 110. Of course, when the second reinforcing member 120 is disposed in the tear 130, the second reinforcing member 120 can also be further combined with part of the side wall of the tear 130. This embodiment does not limit this.

[0205] Please continue reading. Figure 15 and Figure 16In some embodiments, a portion of the second reinforcement 120 is embedded in the inner wall of the tear 130 along the circumference of the first sub-channel K1 to improve the structural stability of the junction between the second reinforcement 120 and the sheath seat 100.

[0206] Secondly, this application also provides a sheath seat 100. Any of the above-mentioned sheath seats 100 are within the protection scope of this application, and will not be described in detail here.

[0207] In some embodiments of this application, the sheath 100 is provided with a through first sub-channel K1 along the first direction X. The sheath 100 includes a first weakening part 110 and a second reinforcing member 120. The first weakening part 110 is located on opposite sides of the first sub-channel K1. The second reinforcing member 120 is disposed on one side of the first weakening part 110 along the second direction Y. The second reinforcing member 120 is connected to the first weakening part 110 as an integral structure, and is used to separate from at least part of the first weakening part 110 after the guide assembly is used up. The first direction X intersects with the second direction Y.

[0208] It should be noted that the sheath seat 100 provided in this embodiment has the technical effects of the technical solution corresponding to the sheath seat 100 in the guiding assembly of any of the foregoing embodiments. The explanations of the same or corresponding structures and terms as described in the above embodiments will not be repeated here.

[0209] Thirdly, embodiments of this application also provide a flow-blocking valve 200, which includes a first sealing plate 210. The first sealing plate 210 has a through second sub-channel K2. The second sub-channel K2 is a hole structure for interference fit with the part being passed through. The first sealing plate 210 includes a second weakening part 211 and a first reinforcing member 212. The first reinforcing member 212 is arranged circumferentially around the second sub-channel K2 and is located between the second weakening part 211 and the second sub-channel K2.

[0210] In some embodiments, the passable component of this embodiment can be the guide component that passes through the guide channel of the guide assembly in any of the foregoing embodiments.

[0211] It should be noted that the flow-blocking valve 200 provided in this embodiment has the technical effects of the flow-blocking valve 200 in the guide assembly of any of the foregoing embodiments. The explanations of the same or corresponding structures and terms as described in the above embodiments will not be repeated here.

[0212] The above description is merely a specific implementation of this application. Those skilled in the art will clearly understand that, for the sake of convenience and brevity, the specific working processes of the systems, modules, and units described above can be referred to the corresponding processes in the foregoing method embodiments, and will not be repeated here. It should be understood that the protection scope of this application is not limited thereto. Any person skilled in the art can easily conceive of various equivalent modifications or substitutions within the technical scope disclosed in this application, and these modifications or substitutions should all be covered within the protection scope of this application.

Claims

1. A guiding component, characterized in that, Includes a sealing structure having a guide channel, the sealing structure comprising: A weakening structure is provided on both sides opposite to the guide channel; A reinforcing structure is provided to cooperate with the weakening structure to improve the sealing capability of the weakening structure.

2. The guiding component according to claim 1, characterized in that, The sealing structure includes: Sheath base, wherein the sheath base is provided with a through first sub-channel; A flow-blocking valve, the flow-blocking valve including a first sealing sheet stacked on the sheath seat and covering one end of the first sub-channel, the first sealing sheet having a second sub-channel along a first direction, the first sub-channel and the second sub-channel communicating to form the guide channel; The second sub-channel is a hole structure for interference fit with the guided component, and the reinforcing structure includes a first reinforcing member, which is arranged circumferentially around the second sub-channel.

3. The guiding component according to claim 2, characterized in that, The second sub-channel satisfies any one of the following: (1) The second sub-channel has a circular hole structure, and the hole diameter of the second sub-channel is constant along the first direction; (2) The second sub-channel is a tapered hole structure, and along the first direction, the aperture of the second sub-channel gradually decreases in the direction away from the sheath seat; (3) The second sub-channel is an irregular hole structure, and the cross-sectional shape of the second sub-channel is adapted to the cross-sectional shape of the guided component.

4. The guiding component according to claim 2, characterized in that, The sheath seat includes first weakening portions located on opposite sides of the first sub-channel, and the first sealing sheet includes second weakening portions located on opposite sides of the second sub-channel. The first weakening portions and the second weakening portions constitute the weakening structure. The first weakening portion and the second weakening portion are aligned along the first direction.

5. The guiding component according to claim 4, characterized in that, The first sealing sheet includes a first surface and a second surface disposed opposite to each other along the first direction. The first surface has a first cut that corresponds to the second weakening portion. The first cut is spaced apart from the second sub-channel along the second direction and spaced apart from the second surface along the first direction. The second direction is the radial direction of the second sub-channel.

6. The guiding component according to claim 5, characterized in that, The first sealing sheet satisfies at least one of the following: (4) The second surface of the first sealing sheet is disposed close to the sheath seat; (5) In the second direction, the side of the first cut away from the second sub-channel extends toward the edge of the first sealing sheet; (6) The side of the first cut away from the second sub-channel has a first depth in the first direction, and the side of the first cut close to the second sub-channel has a second depth in the first direction, wherein the first depth is greater than the second depth; (7) The distance L from the side of the first incision near the second sub-channel to the edge of the second sub-channel satisfies: 0.2 mm ≤ L ≤ 3 mm.

7. The guiding component according to claim 2, characterized in that, The flow control valve further includes a second sealing plate, which is overlapped with the first sealing plate along the first direction. The second sealing plate includes a third surface and a fourth surface disposed opposite to each other along the first direction. The third surface forms a second cut, and the fourth surface forms a third cut. A portion of the second cut and a portion of the third cut are in contact with each other along the first direction to penetrate the second sealing sheet, and the second cut is aligned with the weakening structure along the first direction.

8. The guiding component according to claim 7, characterized in that, The second sealing piece is located between the sheath and the first sealing piece, and the third surface is close to the first sealing piece.

9. The guiding component according to claim 7, characterized in that, The first sealing sheet and the second sealing sheet satisfy at least one of the following: (8) The tensile strength of the first sealing sheet is less than the tensile strength of the second sealing sheet; (9) The elongation at break of the first sealing sheet is less than that of the second sealing sheet; (10) The elongation at break of the first sealing sheet is greater than or equal to 300% and less than or equal to 500%; (11) The elongation at break of the second sealing sheet is greater than or equal to 500% and less than or equal to 800%; (12) The hardness of the first sealing sheet is 30-60 ShA, the tear strength is 10-15 KN / m, the tensile strength is 3-5 MPa, and the 200% tensile modulus is 0.5-1 MPa; (13) The second sealing sheet has a 25-45 ShA, a tear strength of 15-25 KN / m, a tensile strength of 3-5 MPa, and a 200% tensile modulus of 0.8-1.5 MPa.

10. The guiding component according to claim 7, characterized in that, In a plane perpendicular to the first direction, the contact points between the second cut and the third cut at least partially overlap with the projection of the second sub-channel along the first direction; and / or, The length of the second incision is greater than the length of the third incision; and / or, The second cut extends toward the edge of the second sealing sheet on at least one side in a second direction, the second direction being the radial direction of the second sub-channel.

11. The guiding component according to any one of claims 2-10, characterized in that, The weakening structure includes a first weakening part disposed on the sheath seat and located on opposite sides of the first sub-channel. The strengthening structure includes a second reinforcing member disposed on one side of the first weakening part along a second direction. The second reinforcing member is integrated with the first weakening part and can be separated from at least a portion of the first weakening part after the guide assembly is used. The second direction is the radial direction of the second sub-channel.

12. The guiding component according to claim 1, characterized in that, The sealing structure includes: Sheath base, wherein the sheath base is provided with a through first sub-channel; A flow control valve, the flow control valve including a first sealing sheet stacked on the sheath seat and covering one end of the first sub-channel, the first sealing sheet having a second sub-channel, the first sub-channel and the second sub-channel communicating to form the guide channel; The weakening structure includes a first weakening part disposed on the sheath seat and located on opposite sides of the first sub-channel. The strengthening structure includes a second reinforcing member disposed on one side of the first weakening part along a second direction. The second reinforcing member is integrated with the first weakening part and can be separated from at least part of the first weakening part after the guide assembly is used. The second direction is perpendicular to the thickness direction of the first sealing sheet.

13. The guiding assembly according to claim 11 or 12, characterized in that, The second reinforcing member is located on the side of the first weakening portion facing away from the first sub-channel along the second direction; and / or, The first weakening part includes a first part and a second part. The first part is located on the side of the second part facing away from the first sub-channel along the second direction. The second reinforcing member is connected to the first part and is used to drive at least part of the first part to separate relative to the second part after the guide assembly is used up. And / or, The second reinforcing member includes an operating part and a connecting part connected together. The connecting part is at least partially combined with the first weakening part. The operating part is capable of driving the connecting part to separate from the first weakening part under the action of a load.

14. The guiding assembly according to claim 11 or 12, characterized in that, The second reinforcing member and the first weakening part are connected as a single structure by injection molding; or, The second reinforcing member includes a buckle, and the first weakening part is provided with a slot. The buckle is engaged in the slot and is connected to at least a portion of the inner wall of the slot as an integral structure.

15. The guiding assembly according to claim 11 or 12, characterized in that, The sheath seat is provided with a tear, which is provided corresponding to the first weakening part and located on the side of the first weakening part facing away from the first sub-channel along the second direction. The second reinforcing member is located inside the tear and is at least partially attached to the inner wall of the tear.

16. A sheath base, characterized in that, The sheath seat has a through first sub-channel along a first direction, and the sheath seat includes: The first weakening part is located on both sides opposite to the first sub-channel; The second reinforcing member is disposed on one side of the first weakening part along the second direction. The second reinforcing member is connected to the first weakening part as an integral structure and is used to separate from at least part of the first weakening part after the guiding assembly is used up. The first direction intersects the second direction.

17. A flow-restricting valve, characterized in that, The flow control valve includes a first sealing plate with a through second sub-channel. The second sub-channel is a hole structure for interference fit with the part being passed through. The first sealing plate includes a second weakening part and a first reinforcing member. The first reinforcing member is arranged circumferentially around the second sub-channel and is located between the second weakening part and the second sub-channel.

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