Hemostatic valve and catheter sheath

Abstract

This application relates to the field of medical devices and discloses a hemostatic valve and a catheter sheath. The hemostatic valve includes a valve seat, a valve cap, and a sealing assembly. The valve seat includes a first valve body and a second valve body connected in a first direction. The first valve body has a first hole, and the second valve body includes a mounting hole communicating with the first hole. The valve cap has a second hole, and the valve cap and the valve seat are movably connected in the first direction. The sealing assembly is sandwiched between the first valve body and the valve cap. The sealing assembly includes a first sealing element and a second sealing element arranged in the first direction. The second sealing element is located in the mounting hole. The first sealing element has a notch, and the second sealing element has a third hole. The second hole, the notch, the third hole, and the first hole are sequentially connected. The hemostatic valve is configured such that when the valve cap moves the sealing assembly toward the first valve body, the second sealing element is compressed and deformed, and the diameter of the third hole is reduced at at least a portion of its position.

Description

Technical Field

[0001] This application belongs to the field of medical devices, and in particular relates to a hemostatic valve and a catheter sheath. Background Technology

[0002] With the development of science and technology, interventional and implantation surgeries have been increasingly used. In interventional and implantation surgeries, it is usually necessary to establish a pathway between the patient's blood vessels and the outside world through a catheter sheath for delivering surgical instruments. However, while surgical instruments are being delivered through this pathway, blood in the blood vessels may also flow out through the catheter sheath, thus affecting patient safety. Utility Model Content

[0003] This application provides a hemostatic valve and a catheter sheath, which can improve the reliability of the hemostatic valve.

[0004] On one hand, this application provides a hemostatic valve, which includes a valve seat, a valve cap, and a sealing assembly. The valve seat includes a first valve body and a second valve body connected in a first direction. The first valve body has a first hole, and the second valve body includes a mounting hole communicating with the first hole. The valve cap has a second hole, and the valve cap and the valve seat are movably connected in the first direction. The sealing assembly is sandwiched between the first valve body and the valve cap, and includes a first sealing element and a second sealing element arranged in the first direction. The second sealing element is located in the mounting hole. The first sealing element has a notch, and the second sealing element has a third hole. The second hole, the notch, the third hole, and the first hole are sequentially connected. The hemostatic valve is configured such that when the valve cap moves the sealing assembly towards the first valve body, the second sealing element is compressed and deformed, reducing the diameter of the third hole at at least a portion of its position.

[0005] In some embodiments, the second valve body includes a first portion and a second portion, the first portion being located on the side of the second portion closer to the first valve body, and the mounting hole including a first sub-hole formed by the first portion and a second sub-hole formed by the second portion. The minimum diameter of the first sub-hole is smaller than the minimum diameter of the second sub-hole.

[0006] In some embodiments, the diameter of the first sub-hole gradually decreases in the direction approaching the first hole.

[0007] In some embodiments, the second seal includes a first sub-part and a second sub-part, the second sub-part being located on the side of the first sub-part facing away from the first valve body. In the direction approaching the first valve body, the radial outer circumferential dimension of the first sub-part gradually decreases, while the radial outer circumferential dimension of the second sub-part remains constant.

[0008] In some embodiments, the elastic modulus of the valve seat is greater than that of the elastic modulus of the second seal; and / or, the second seal comprises an elastic material.

[0009] In some embodiments, the first seal is in contact with the second seal.

[0010] In some embodiments, the sealing assembly further includes a retainer disposed between the first seal and the second seal, the retainer having a fourth hole communicating between the cut and the third hole, and the retainer being connected to the valve cap.

[0011] In some embodiments, the fastener includes a body portion that protrudes from a limiting portion on the side of the body portion away from the second seal, and a fourth hole is located inside the body portion; The limiting part is located on the periphery of the first seal and is connected to the valve cap.

[0012] In some embodiments, the second valve body includes a second portion and a third portion, the second portion being located on the side of the third portion closer to the first valve body. The mounting hole includes a second sub-hole formed by the second portion and a third sub-hole formed by the third portion. A second seal is located between the third sub-hole and the first hole, and a valve cap is movably connected to the third portion. The diameter of the end of the third sub-hole facing the second sub-hole is larger than the diameter of the end of the second sub-hole facing the third sub-hole, forming a stepped surface on the sidewall of the mounting hole.

[0013] The fastener includes a first fixing part and a second fixing part. The first fixing part is located on the side of the second fixing part facing the first valve body, and the two together form a fourth hole. The radial dimension of the second fixing part in the second sub-hole is greater than the radial dimension of the first fixing part.

[0014] In some embodiments, the valve cap includes a first cap, a second cap, and a connecting portion. The first cap is located on the periphery of the second valve body, the second cap is at least partially located within a mounting hole, and the connecting portion is located on the side of the second valve body opposite to the first valve body and connects the first cap and the second cap. The first cap is connected to a valve seat, and the second cap is disposed in contact with a sealing assembly in a first direction.

[0015] In some embodiments, the first seal includes a central portion and an edge portion located around the central portion, with a cutout located on the central portion. In a first direction, the projection of the central portion coincides with the projection of the first hole, and the projection of the second cap portion lies within the projection of the edge portion.

[0016] Secondly, embodiments of this application provide a catheter sheath, which includes a catheter and a hemostatic valve as described in any of the foregoing embodiments.

[0017] In the hemostatic valve and catheter sheath embodiments of this application, both the first and second sealing elements can perform sealing functions. When an instrument component is present within the hemostatic valve, the structure near the incision of the first sealing element fits tightly against the instrument component to achieve a sealing function. When no instrument component is present within the hemostatic valve, in addition to the sealing function of the first sealing element, the valve cap can be controlled to move relative to the valve seat, causing the second sealing element to deform under pressure, achieving a double sealing effect. This satisfies the need for sealing and blood clogging in various situations and improves the reliability of the hemostatic valve. Attached Figure Description

[0018] 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.

[0019] Figure 1 This is a schematic diagram of the structure of the hemostatic valve in some embodiments of this application; Figure 2 This is a cross-sectional structural schematic diagram of a hemostatic valve according to some embodiments of this application; Figure 3 This is a schematic diagram of the sealing assembly in a hemostatic valve according to some embodiments of this application; Figure 4 This is a cross-sectional structural schematic diagram of a hemostatic valve according to some embodiments of this application; Figure 5 This is a schematic cross-sectional view of the catheter sheath in some embodiments of this application; Figure 6 This is a cross-sectional structural schematic diagram of a hemostatic valve according to some embodiments of this application; Figure 7 This is a schematic diagram of the exploded structure of a hemostatic valve according to some embodiments of this application; Figure 8 This is a cross-sectional structural schematic diagram of a hemostatic valve according to some embodiments of this application; Figure 9 This is a cross-sectional structural diagram of the fixing member in the hemostatic valve of some embodiments of this application; Figure 10 This is a cross-sectional structural diagram of the valve seat in a hemostatic valve according to some embodiments of this application; Figure 11 This is a cross-sectional structural diagram of the first sealing element in a hemostatic valve according to some embodiments of this application.

[0020] Figure label: 100. Hemostatic valve; 200. Catheter sheath; 10. Valve seat; 11. First valve body; 111. First hole; 12. Second valve body; 121. Mounting hole; 121a. First sub-hole; 121b. Second sub-hole; 121c. Third sub-hole; 122. First part; 123. Second part; 124. Third part; 20. Valve cap; 21. Second hole; 22. First cap; 23. Second cap; 24. Connecting part; 30. Sealing assembly; 31. First seal; 311. Cutout; 312. Center portion; 313. Edge portion; 32. Second seal; 321. Third hole; 322. First sub-part; 323. Second sub-part; 33. Fixing member; 331. Body portion; 3311. First fixing part; 3312. Second fixing part; 332. Limiting part; 333. Fourth hole; 40. Catheter; X, first direction; Y, radial direction. Detailed Implementation

[0021] The embodiments of the technical solution of this application will now be described in detail with reference to the accompanying drawings. These embodiments are only used to more clearly illustrate the technical solution of this application and are therefore merely examples, and should not be used to limit the scope of protection of this application.

[0022] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application pertains; the terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the application; the terms “comprising” and “having”, and any variations thereof, in the specification, claims, and foregoing description of the drawings are intended to cover non-exclusive inclusion.

[0023] In the description of the embodiments of this application, technical terms such as "first" and "second" are used only to distinguish different objects and should not be construed as indicating or implying relative importance or implicitly specifying the number, specific order, or primary and secondary relationship of the indicated technical features. In the description of the embodiments of this application, "multiple" means two or more, unless otherwise explicitly defined.

[0024] In this document, the term "embodiment" means that a particular feature, structure, or characteristic described in connection with an embodiment may be included in at least one embodiment of this application. The appearance of this phrase in various places throughout the specification does not necessarily refer to the same embodiment, nor is it a separate or alternative embodiment mutually exclusive with other embodiments. It will be explicitly and implicitly understood by those skilled in the art that the embodiments described herein can be combined with other embodiments.

[0025] In the description of the embodiments in this application, the term "and / or" is merely a description of the relationship between related objects, indicating that three relationships can exist. For example, A and / or B can represent: A existing alone, A and B existing simultaneously, and B existing alone. Additionally, the character " / " in this document generally indicates that the preceding and following related objects have an "or" relationship.

[0026] In the description of the embodiments of this application, the term "multiple" refers to two or more (including two), similarly, "multiple sets" refers to two or more (including two sets), and "multiple pieces" refers to two or more (including two pieces).

[0027] In the description of the embodiments of this application, the technical terms "center," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counterclockwise," "axial," "radial," and "circumferential" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing the embodiments of this application and simplifying the description, and are not intended to indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the embodiments of this application.

[0028] In the description of the embodiments of this application, unless otherwise expressly specified and limited, technical terms such as "installation," "connection," "joining," and "fixing" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. For those skilled in the art, the specific meaning of the above terms in the embodiments of this application can be understood according to the specific circumstances.

[0029] A hemostatic valve can be installed at the end of the catheter sheath furthest from the catheter, providing a certain degree of sealing and blood stasis. However, during interventional or implantation procedures, different components may need to be passed through the catheter sheath at different times to be positioned at specific locations within the patient's body. In this context, the hemostatic valve needs to provide a seal for small-diameter instruments while also allowing for the inward movement of larger-diameter instruments. Conventional hemostatic valves often fail to meet the sealing requirements in multiple situations, making them prone to problems such as blood loss due to improper operation.

[0030] Regarding the above issues, firstly, please refer to [link / reference needed]. Figures 1 to 3This application provides a hemostatic valve 100, which includes a valve seat 10, a valve cap 20, and a sealing assembly 30. The valve seat 10 includes a first valve body 11 and a second valve body 12 connected in a first direction X. The first valve body 11 has a first hole 111, and the second valve body 12 has a mounting hole 121 communicating with the first hole 111. The valve cap 20 has a second hole 21, and the valve cap 20 is movably connected to the valve seat 10 in the first direction X. The sealing assembly 30 is sandwiched between the first valve body 11 and the valve cap 20. The sealing assembly 30 includes a first sealing element 31 and a second sealing element 32 arranged in the first direction X. The second sealing element 32 is located in the mounting hole 121. The first sealing element 31 has a notch 311, and the second sealing element 32 has a third hole 321. The second hole 21, the notch 311, the third hole 321, and the first hole 111 are sequentially connected. The hemostatic valve 100 is configured such that when the valve cap 20 moves together with the sealing assembly 30 toward the direction of the first valve body 11, the second seal 32 is squeezed and deformed, and the diameter of the third hole 321 is reduced at at least part of the position.

[0031] A hemostatic valve 100 is applied to the catheter sheath 200 and installed at the proximal end of the catheter sheath 200. The catheter sheath 200 can be used in interventional procedures or implantation procedures. For ease of understanding, this application will subsequently use the application of the catheter sheath 200 in interventional procedures as an example.

[0032] Optionally, such as Figure 5 As shown, the catheter sheath 200 includes a catheter 40 and a hemostatic valve 100. Guide wires, coils, or other interventional instruments enter the catheter 40 through the hemostatic valve 100. The proximal end of the catheter sheath 200 refers to the end of the catheter sheath 200 facing the operator or physician.

[0033] The hemostatic valve 100 includes a valve seat 10, a valve cap 20, and a sealing component 30. The sealing component 30 is the core component of the hemostatic valve 100 that performs the function of sealing and blocking blood flow. The sealing component 30 is sandwiched between the valve seat 10 and the valve cap 20. The valve cap 20 and the valve seat 10 are connected and cooperate to press and fix the sealing component 30, so as to improve the positional reliability of the sealing component 30 relative to the valve cap 20 and the valve seat 10 when the interventional device passes through the hemostatic valve 100.

[0034] The valve seat 10 includes a first valve body 11 and a second valve body 12 connected in a first direction X. The first valve body 11 encloses a first hole 111 for the passage of an interventional instrument, and the second valve body 12 forms a mounting hole 121 for receiving at least a portion of the structure of the sealing assembly 30. The first hole 111 communicates with the mounting hole 121 in the first direction X.

[0035] In some embodiments of this application, the axial direction of the first hole 111 and the axial direction of the mounting hole 121 are both parallel to the first direction X. This helps to achieve the alignment and installation between the sealing assembly 30 and the first valve body 11, improving the reliability of their relative positions.

[0036] Optionally, the valve seat 10 may be provided with a branch pipe, which connects to other devices for injection during surgery. The branch pipe has a branch hole communicating with the first hole 111, the axis of which intersects the first direction X; further, the axis of the branch hole is perpendicular to the first direction X.

[0037] The valve cap 20 and the valve seat 10 are movably connected along the first direction X, meaning that the valve cap 20 and the valve seat 10 are connected and can move relative to each other along the first direction X. The specific connection method between the valve cap 20 and the valve seat 10 is not limited in this embodiment. Optionally, one of the valve cap 20 and the valve seat 10 includes a guide rail structure extending along the first direction X, and the other includes a slider structure that slides with the guide rail structure. Alternatively, one of the valve cap 20 and the valve seat 10 includes a slot structure spaced apart along the first direction X, and the other includes a protrusion structure that inserts into the slot structure.

[0038] Regarding the connection position between the valve cap 20 and the valve seat 10, this embodiment of the application does not impose any limitations. Optionally, the valve cap 20 and the valve seat 10 can be connected inside the valve seat 10. For example, the valve cap 20 can at least partially extend into the mounting hole 121, and the valve cap 20 and the valve seat 10 can be movably connected along the first direction X by means of mutual cooperation between the guide rail structure and the slider structure with the side wall of the mounting hole 121. Alternatively, the valve cap 20 and the valve seat 10 can also be connected outside the valve seat 10. For example, the valve cap 20 can be at least partially located on the outer periphery of the valve seat 10, and the valve cap 20 and the valve seat 10 can be movably connected along the first direction X by means of mutual cooperation between the guide rail structure and the slider structure with the outer surface of the valve seat 10.

[0039] The sealing assembly 30 is sandwiched between the valve cap 20 and the valve seat 10, and at least partially located within the mounting hole 121. Optionally, the sealing assembly 30 has a valve cap 20 and a valve seat 10 on both sides in the first direction X, thereby sandwiching the sealing assembly 30 between the valve cap 20 and the valve seat 10 in the first direction X. Alternatively, a portion of the structure at the peripheral edge of the sealing assembly 30 protrudes in the first direction X to form a clamping portion, with a valve cap 20 and a valve seat 10 on both sides in the radial direction Y of the first hole 111, thereby sandwiching the sealing assembly 30 between the valve cap 20 and the valve seat 10 in the radial direction Y.

[0040] The sealing assembly 30 includes a first seal 31 and a second seal 32. The first seal 31 is located on the side of the second seal 32 away from the first hole 111, and the second seal 32 is located within the mounting hole 121. The first seal 31 may be at least partially located within the mounting hole 121, or it may be completely located on the side of the first valve body 11 opposite to the second valve body 12. The first seal 31 and the second seal 32 may be in direct contact, or they may be spaced apart in the first direction X. Furthermore, when the first seal 31 and the second seal 32 are in contact, they may be connected to each other, or they may be independent and separable in the first direction X.

[0041] The first sealing element 31 has an incision 311, which can be actuated under a certain external force to meet the passage requirements of interventional devices. Furthermore, the structure located near the incision 311 in the first sealing element 31 can tightly adhere to the interventional device, thereby preventing blood from passing through the first sealing element 31 when the interventional device enters the patient, thus achieving a sealing function. The incision 311 can have various shapes and types, such as a straight incision, a round hole incision, a cross-shaped incision, a cross-shaped incision, or a curved incision.

[0042] The valve cap 20 is provided with a second hole 21, and the second sealing member 32 is provided with a third hole 321. The axial direction of the second hole 21 and the axial direction of the third hole 321 are both parallel to the first direction X. The interventional device that enters the hemostasis valve 100 can pass through the second hole 21, the incision 311, the third hole 321 and the first hole 111 in sequence, and then exit the hemostasis valve 100. Under this design, the second hole 21, the incision 311, the third hole 321 and the first hole 111 can also play a certain guiding role for the interventional device, helping the interventional device to gradually pass through the hemostasis valve 100 along the first direction X.

[0043] Optionally, at the end of the first hole 111 furthest from the third hole 321, the wall of the first hole 111 is fitted around the outer periphery of the catheter 40, and the interventional instrument exiting the first hole 111 enters the patient through the catheter 40. Optionally, the diameters of the first hole 111, the second hole 21, and the third hole 321 are consistent at different positions in the first direction X, and the first hole 111, the second hole 21, and the third hole 321 have the same diameter.

[0044] Furthermore, since the valve cap 20 can move relative to the valve seat 10 along the first direction X, as the valve cap 20 moves closer to the first valve body 11, it will come into contact with the sealing assembly 30 and drive the sealing assembly 30 to move along the first direction X. During this process, the second seal 32 will come into contact with and be squeezed against the second valve body 12. Under the action of the squeezing stress, at least a part of the structure in the second seal 32 will deform, thereby causing the aperture of the third hole 321 at least a part of the position in the first direction X to become smaller. Based on this, when the aperture of the third hole 321 is reduced to a certain range, it is difficult for blood to pass through the third hole 321 through the second seal 32, so the second seal 32 can also perform the sealing function.

[0045] The present application does not limit the method of compression deformation of the second seal 32, as long as the deformation of the second seal 32 occurs due to contact and compression with the second valve body 12 during the process of approaching the first hole 111. For example, using... Figure 2 Taking the structure shown as an example, the second valve body 12 includes a protruding structure that protrudes from the inner wall of the mounting hole 121. When the valve cap 20 moves the sealing assembly 30 downward, the second sealing member 32 will abut against the protruding structure and deform, thereby causing the diameter of the third hole 321 in the second sealing member 32 to decrease at the position corresponding to the protruding structure.

[0046] Next, this application embodiment will describe one usage method of the hemostatic valve 100 in conjunction with a specific application scenario. During interventional surgery, the catheter sheath 200 with a connector is inserted into the patient's body to establish a passage. Generally, a dilator is provided inside the connector and the catheter sheath 200. After the catheter sheath 200 is in place, the dilator is withdrawn. Because the outer diameter of the dilator is close to the outer diameter of the catheter 40, when the dilator is withdrawn, the first sealing member 31 will have a relatively open opening at the incision 311 due to inertia and other factors. At this time, the first sealing member 31 alone cannot meet the blood-blocking needs. However, in this application embodiment, the operator or physician can control the valve cap 20 to move the sealing component 30 towards the first hole 111 when the dilator is withdrawn, so that the second sealing member 32 is squeezed and deformed, thereby enabling the second sealing member 32 to have a sealing function and achieve a double seal for the blood.

[0047] When interventional instruments are needed, they can first be passed through the incision 311 of the first seal 31. Then, the operator or physician controls the valve cap 20 away from the first hole 111, reducing the compression between the second seal 32 and the second valve body 12. The shape and size of the second seal 32 gradually return to normal, allowing the interventional instrument to pass through the third hole 321 to meet the surgical requirements. Afterward, by controlling the positional relationship between the valve cap 20 and the valve seat 10, the wall of the third hole 321 can be in close contact with the peripheral surface of the interventional instrument, thereby improving the stability of the interventional instrument.

[0048] In summary, in the embodiments of this application, both the first sealing element 31 and the second sealing element 32 can perform sealing functions. When there are medical instruments inside the hemostatic valve 100, the structure near the cut 311 of the first sealing element 31 fits tightly with the medical instruments to achieve a sealing function. When there are no medical instruments inside the hemostatic valve 100, in addition to the sealing function of the first sealing element 31, the valve cap 20 can be controlled to move relative to the valve seat 10, thereby causing the second sealing element 32 to be squeezed and deformed, achieving a double sealing effect. This satisfies the need for sealing and blocking blood flow in various situations and improves the reliability of the hemostatic valve 100.

[0049] In some embodiments, please refer to Figures 4 to 6 The second valve body 12 includes a first portion 122 and a second portion 123. The first portion 122 is located on the side of the second portion 123 closer to the first valve body 11. The mounting hole 121 includes a first sub-hole 121a formed by the first portion 122 and a second sub-hole 121b formed by the second portion 123. The minimum diameter of the first sub-hole 121a is smaller than the minimum diameter of the second sub-hole 121b.

[0050] The first part 122 and the second part 123 are arranged in the first direction X. The first sub-hole 121a formed by the first part 122 and the second sub-hole 121b formed by the second part 123 have different apertures. The first sub-hole 121a and the second sub-hole 121b can have various forms. For example, the first sub-hole 121a can have the same aperture at different positions in the first direction X, or it can have different apertures. Similarly, the second sub-hole 121b can have the same aperture at different positions in the first direction X, or it can have different apertures.

[0051] It should be noted that the outer diameter of the first part 122 can be equal to the outer diameter of the second part 123, or the outer diameter of the first part 122 can be less than or greater than the outer diameter of the second part 123. This application embodiment does not impose any restrictions on this.

[0052] In this embodiment, the mounting hole 121 is not kept constant. The minimum diameter of the first sub-hole 121a is smaller than the minimum diameter of the second sub-hole 121b. As the valve cap 20 moves closer to the first valve body 11, the second sealing element 32 will be squeezed by the side wall of the first sub-hole 121a due to the change in diameter, thus deforming. This causes the diameter of the third hole 321 to become smaller in at least a part of the area, so that the second sealing element 32 has a sealing function and improves the reliability of the hemostatic valve 100.

[0053] In some embodiments, such as Figures 4 to 6 As shown, the diameter of the first sub-hole 121a gradually decreases in the direction close to the first hole 111.

[0054] The diameter of the first sub-hole 121a gradually decreases, becoming smaller the closer it is to the first hole 111. Furthermore, the sidewall of the first sub-hole 121a is an inclined surface that intersects the first direction X but is not perpendicular to it.

[0055] The morphology of the second sub-hole 121b is not limited in this embodiment. Optionally, the diameter of the second sub-hole 121b remains constant at different positions in the first direction X, that is, the sidewall of the second sub-hole 121b is parallel to the first direction X. Further optionally, the diameter of the end of the first sub-hole 121a near the second sub-hole 121b is the same as the diameter of the second sub-hole 121b, and the diameter of the end of the first sub-hole 121a near the first hole 111 is the same as the diameter of the first hole 111, thereby achieving a smooth transition between the second sub-hole 121b, the first sub-hole 121a, and the first hole 111.

[0056] In this embodiment, the diameter of the first sub-hole 121a is not constant, but gradually decreases in the direction approaching the first hole 111. Therefore, as the second seal 32 moves towards the first hole 111, the sidewall of the first sub-hole 121a gradually increases its pressure on the second seal 32, resulting in a gradual increase in the deformation of the second seal 32. This design causes the force fed back from the sealing assembly 30 to the valve cap 20 to gradually increase, while the non-sealing assembly 30 instantaneously provides greater resistance to the valve cap 20. This reduces the operational difficulty for the operator or physician and improves the practicality of the hemostatic valve 100.

[0057] In some embodiments, such as Figure 4 As shown, the second seal 32 includes a first sub-part 322 and a second sub-part 323, with the second sub-part 323 located on the side of the first sub-part 322 facing away from the first valve body 11. In the direction close to the first valve body 11, the outer peripheral dimension of the first sub-part 322 in the radial Y direction of the first sub-hole 121a gradually decreases, while the outer peripheral dimension of the second sub-part 323 remains constant in the radial Y direction.

[0058] The first sub-part 322 and the second sub-part 323 are integrally connected in the first direction X. During the assembly of the hemostatic valve 100, the first sub-part 322 can be disposed in the first sub-hole 121a, and the second sub-part 323 can be disposed in the second sub-hole 121b. Optionally, the outer peripheral dimension of the second sub-part 323 in the radial direction Y is equal to the maximum dimension of the first sub-part 322 in the radial direction Y. Further optionally, the outer peripheral surface of the first sub-part 322 matches the shape and size of the sidewall of the first sub-hole 121a, and the outer peripheral surface of the second sub-part 323 matches the shape and size of the sidewall of the second sub-hole 121b.

[0059] It should be noted that, considering that the axial directions of the first hole 111, the first sub-hole 121a, the second sub-hole 121b and the third hole 321 are all parallel to the first direction X, the radial directions Y corresponding to the above hole structures are all perpendicular to the first direction X. Based on this, for ease of understanding, the radial directions corresponding to the above multiple holes will be uniformly referred to as "radial Y" in the following description.

[0060] In this embodiment, the radial Y-dimensional dimensions of both the first sub-part 322 and the first sub-hole 121a gradually decrease in the direction approaching the first hole 111. Thus, as the second seal 32 moves towards the first hole 111, the compressive stress on the first sub-part 322 gradually increases due to both the change in the diameter of the first sub-hole 121a and the change in the radial Y-dimensional dimension of the first sub-part 322. This helps to increase the deformation degree of the first sub-part 322 and enhance its sealing performance. Furthermore, the outer peripheral surface of the first sub-part 322 can be designed to match the shape and dimensions of the sidewall of the first sub-hole 121a. Therefore, the sidewall of the first sub-hole 121a can also provide a limiting and bearing function for the first sub-part 322, improving the positional reliability of the second seal 32 relative to the valve seat 10.

[0061] In some embodiments, the elastic modulus of the valve seat 10 is greater than that of the elastic modulus of the second seal 32.

[0062] The elastic modulus is a measure of an object's resistance to elastic deformation; the higher the elastic modulus, the less easily the material deforms. Based on this, this embodiment controls the material composition of the valve seat 10 and the second seal 32 so that the elastic modulus of the valve seat 10 is greater than that of the second seal 32. Thus, as the valve cap 20 moves the second seal 32 closer to the first hole 111, the second seal 32 deforms due to compression, while the valve seat 10 only undergoes minor deformation or no deformation at all, thereby improving the reliability of the hemostatic valve 100.

[0063] In some embodiments, the second seal 32 comprises an elastic material.

[0064] Elastic materials can undergo elastic deformation when subjected to pressure or tension and quickly return to their original shape. The elastic material in the second seal 32 can take many forms. For example, the second seal 32 can be a silicone sheet with a certain degree of elasticity. Of course, the second seal 32 can also be made of other materials, such as latex or other polymer materials.

[0065] The material composition of the first seal 31 is not limited in this embodiment. Optionally, the first seal 31 and the second seal 32 may be made of the same material. Alternatively, the first seal 31 and the second seal 32 may be made of different materials, and the elastic modulus of the first seal 31 is greater than that of the second seal 32. In this way, when the sealing assembly 30 is squeezed by the valve seat 10, the second seal 32 can have a larger amount of deformation, while the first seal 31 can maintain its original shape and size.

[0066] In this embodiment, by including an elastic material in the second seal 32, the second seal 32 can deform due to compression as the valve cap 20 moves it closer to the first hole 111, thus meeting the sealing performance requirements. Conversely, as the valve cap 20 moves away from the first hole 111, the second seal 32 can quickly rebound, allowing the third hole 321 to return to its original shape, thereby accommodating the passage of interventional instruments through the second seal 32.

[0067] In some embodiments, such as Figure 3 and Figure 4 As shown, the first seal 31 and the second seal 32 are in contact with each other.

[0068] The first seal 31 and the second seal 32 can have various connection methods, such as bonding, welding and mechanical connection. Optionally, the first seal 31 and the second seal 32 are made of the same material and are an integral structure.

[0069] In this embodiment, the first seal 31 and the second seal 32 are in direct contact and together form a complete component. This component can integrate two sealing functions. This design can reduce the distance between the first seal 31 and the second seal 32, reduce the number of components in the hemostatic valve, improve sealing performance, reduce the number of components in the hemostatic valve 100, and reduce the size of the hemostatic valve 100 in the first direction X.

[0070] It should be noted that the relationship between the first seal 31 and the second seal 32 and the valve cap 20 is not limited in the embodiments of this application. Optionally, the component formed by the connection of the first seal 31 and the second seal 32 and the valve cap 20 can be two independent structures, that is, the valve cap 20 can be in contact with the surface of the first seal 31 away from the second seal 32, or it can be separated in the first direction X. Alternatively, the first seal 31 can also be connected to the valve cap 20, so that regardless of whether the valve cap 20 is close to or far from the first hole 111, the first seal 31 and the second seal 32 can move along the first direction X.

[0071] In some embodiments, please refer to Figure 7 and Figure 8 The sealing assembly 30 also includes a fixing member 33 disposed between the first sealing member 31 and the second sealing member 32. The fixing member 33 has a fourth hole 333, which communicates between the cutout 311 and the third hole 321. The fixing member 33 is connected to the valve cap 20.

[0072] The first sealing element 31, the fixing element 33, and the second sealing element 32 are arranged sequentially in the first direction X. The fixing element 33 causes the first sealing element 31 and the second sealing element 32 to no longer be in direct contact, but are spaced apart in the first direction X. The fixing element 33 is connected to the valve cap 20, and the connection between the two is not limited to, bonding, welding, and mechanical connection.

[0073] The fixation member 33 includes a fourth hole 333. An interventional device that enters the hemostasis valve 100 can pass through the second hole 21, the incision 311, the fourth hole 333, the third hole 321 and the first hole 111 in sequence, and then exit the hemostasis valve 100. Optionally, the diameter of the fourth hole 333 is consistent at different positions in the first direction X, and the fourth hole 333 has the same diameter as the third hole 321.

[0074] Next, this application embodiment will describe the usage process of the hemostatic valve 100. Since the fixing member 33 is connected to the valve cap 20, the first sealing member 31 is clamped and fixed between the first sealing member 31 and the valve cap 20. In the initial state, the fixing member 33 and the second sealing member 32 can be spaced apart in the first direction X. When the operator or physician controls the valve cap 20 to move towards the first hole 111, the valve cap 20 will drive the first sealing member 31 and the fixing member 33 to move towards the second sealing member 32 together. Then, the fixing member 33 contacts the second sealing member 32 and drives the second sealing member 32 to move synchronously. The second sealing member 32 is deformed due to compression during the movement, thereby achieving sealing performance. As the operator or physician controls the valve cap 20 to move away from the first hole 111, the valve cap 20 will move the fixing member 33 and the first seal 31 together. Then the fixing member 33 will separate from the second seal 32, the second seal 32 will rebound and the third hole 321 will gradually recover. At this time, the interventional device can pass through the second seal 32 through the third hole 321.

[0075] In this embodiment, a fixing member 33 is added between the first sealing member 31 and the second sealing member 32. By connecting the fixing member 33 to the valve cap 20, the first sealing member 31 is clamped and fixed between the fixing member 33 and the valve cap 20, thereby improving the relative positional reliability between the first sealing member 31 and the valve cap 20. Furthermore, during the movement of the second sealing member 32 toward the first hole 111, the reaction force generated by the deformation of the second sealing member 32 will act on the fixing member 33, rather than directly on the first sealing member 31, thereby reducing the degree of deformation of the first sealing member 31 and improving the reliability of the first sealing member 31.

[0076] Furthermore, since the first seal 31 is not located inside the second hole 21 to achieve relative fixation with the valve cap 20, but is outside the second hole 21 and is clamped by the fixing member 33 with the valve cap 20 to achieve relative fixation among the three, the presence of the first seal 31 will not affect the aperture size of the second hole 21. The projection of the first seal 31 in the first direction X can cover and exceed the projection of the second hole 21 in the first direction X. This design does not require increasing the aperture size of the second hole 21 at least part of the position in the first direction X, and therefore does not require additional increase in the outer diameter size of the valve cap 20, thereby reducing the overall volume size of the hemostatic valve 100.

[0077] In some alternative embodiments, the elastic modulus of the fastener 33 is greater than that of the second seal 32. This way, when the second seal 32 applies a reaction force to the fastener 33 due to deformation, the fastener 33 will undergo a smaller deformation or will not deform at all, thereby further reducing the adverse effect of the reaction force of the second seal 32 on the first seal 31.

[0078] In some embodiments, please refer to Figures 8 to 9 The fixing member 33 includes a body portion 331 and a limiting portion 332 protruding from the body portion 331 on the side opposite to the second sealing member 32. The fourth hole 333 is located inside the body portion 331, and the limiting portion 332 is located on the periphery of the first sealing member 31 and connected to the valve cap 20.

[0079] The main body 331 is the core part of the fixing member 33. The fourth hole 333 is provided through the main body 331 along the first direction X. The limiting part 332 is connected to the side of the main body 331 opposite to the second sealing member 32. The limiting part 332 is located on the periphery of the first sealing member 31 to limit the position of the first sealing member 31 in the radial Y direction. The dimension of the limiting part 332 in the first direction X can be equal to the dimension of the first sealing member 31 in the first direction X, or the dimension of the limiting part 332 in the first direction X can be greater than or equal to the dimension of the first sealing member 31 in the first direction X.

[0080] It should be noted that the limiting part 332 can have various forms. For example, the limiting part 332 can be in the form of a ring and surround the first sealing member 31, or multiple limiting parts 332 can be provided, with multiple limiting parts 332 arranged at intervals around the periphery of the first sealing member 31.

[0081] In this embodiment, the valve cap 20 and the first seal 31 are fixed in relative position in the first direction X by clamping the first seal 31 between the body 331 and the valve cap 20. Furthermore, the valve cap 20 and the first seal 31 are fixed in relative position in the radial direction Y by providing a limiting member on the periphery of the first seal 31 and connecting the limiting member to the valve cap 20. This design further improves the reliability of the relative position between the valve cap 20 and the first seal 31, reducing the risk of positional displacement of the first seal 31 relative to the valve cap 20 during the movement of the valve cap 20 relative to the valve seat 10.

[0082] In some embodiments, please refer to Figures 7 to 11 The second valve body 12 includes a second portion 123 and a third portion 124. The second portion 123 is located on the side of the third portion 124 closer to the first valve body 11. The mounting hole 121 includes a second sub-hole 121b formed by the second portion 123 and a third sub-hole 121c formed by the third portion 124. The second seal 32 is located between the third sub-hole 121c and the first hole 111. The valve cap 20 is movably connected to the third portion 124. The diameter of the end of the third sub-hole 121c facing the second sub-hole 121b is larger than the diameter of the end of the second sub-hole 121b facing the third sub-hole 121c, so as to form a stepped surface on the sidewall of the mounting hole 121.

[0083] The fastener 33 includes a first fastening part 3311 and a second fastening part 3312. The first fastening part 3311 is located on the side of the second fastening part 3312 facing the first valve body 11, and the two together form a fourth hole 333. The dimension of the second fastening part 3312 in the radial Y direction of the second sub-hole 121b is greater than the dimension of the first fastening part 3311 in the radial Y direction.

[0084] The second part 123 and the third part 124 are arranged in the first direction X. The third part 124 encloses and forms a third sub-hole 121c. The second sub-hole 121b and the third sub-hole 121c are connected in the first direction X. Since the second seal 32 is independently separated from the valve seat 10, the fixing member 33 and the first seal 31, the second seal 32 is located in the mounting hole 121 and is supported by the valve seat 10. Furthermore, the second seal 32 is located between the third sub-hole 121c and the first hole 111. Optionally, the second seal 32 is partially located in the first sub-hole 121a and partially located in the second sub-hole 121b.

[0085] The fastener 33 includes a first fastening part 3311 and a second fastening part 3312. The first fastening part 3311 and the second fastening part 3312 together form the body part 331 of the fastener 33. The first fastening part 3311 and the second fastening part 3312 may be made of the same material and have an integral structure, or the first fastening part 3311 and the second fastening part 3312 may be made of different materials and connected and fixed by means of bonding and welding.

[0086] In related technologies, sealing components are typically located near the port of the valve seat. However, in this embodiment, the second sealing member 32 is adjusted to be inside the valve seat 10. The valve seat 10 has a first valve body 11 and a third part 124 on both sides of the second sealing member 32 in the first direction X. Based on this, the valve cap 20 can be movably connected to the third part 124, thereby making the position of the valve cap 20 relative to the valve seat 10 adjustable in the first direction X, thus meeting the working requirements of the hemostatic valve 100.

[0087] Furthermore, in this embodiment, the diameter of the end of the third sub-hole 121c facing the second sub-hole 121b is set to be larger than the diameter of the end of the second sub-hole 121b facing the third sub-hole 121c, to form a stepped surface. The fixing member 33 is configured to include a first fixing part 3311 and a second fixing part 3312 with different radial Y dimensions. In this design, the first fixing part 3311 can enter the second sub-hole 121b, thereby driving the second sealing member 32 to move closer to the first hole 111, allowing the second sealing member 32 to deform due to compression and achieve a sealing function. The stepped surface serves to block the second fixing part 3312, preventing it from entering the second sub-hole 121b, thus limiting the degree of compression deformation of the second sealing member 32 and improving the reliability of the hemostatic valve 100.

[0088] In some embodiments, such as Figure 8 As shown, the valve cap 20 includes a first cap portion 22, a second cap portion 23, and a connecting portion 24. The first cap portion 22 is located on the periphery of the second valve body 12, the second cap portion 23 is at least partially located within the mounting hole 121, and the connecting portion 24 is located on the side of the second valve body 12 opposite to the first valve body 11 and connects the first cap portion 22 and the second cap portion 23. The first cap portion 22 is connected to the valve seat 10, and the second cap portion 23 is in contact with the sealing assembly 30 in the first direction X.

[0089] Both the first cap 22 and the connecting portion 24 are located outside the valve seat 10, while the second cap 23 can extend into the mounting hole 121 of the valve seat 10. The second valve body 12 is sandwiched between the first cap 22 and the second cap 23 in the radial Y direction, thereby helping to improve the relative positional reliability of the valve seat 10 and the valve cap 20 in the radial Y direction. Depending on the actual needs, the dimension of the first cap 22 in the first direction X can be greater than, less than, or equal to the dimension of the second cap 23 in the first direction X. The figure shows the case where the dimension of the first cap 22 in the first direction X is greater than the dimension of the second cap 23 in the first direction X.

[0090] The connecting part 24 is located on one side of the first valve body 11 along the first direction X. In addition to connecting the first cap 22 and the second cap 23 into one body, the connecting part 24 can also play a limiting role. When the valve cap 20 moves a certain distance closer to the first valve body 11, the connecting part 24 will abut against the second valve body 12 in the first direction X, thereby preventing the valve cap 20 from moving further and improving the operational reliability of the hemostatic valve 100.

[0091] In this embodiment, the valve cap 20 includes a first cap 22, a second cap 23, and a connecting portion 24. The first cap 22 is movably connected to the valve seat 10, satisfying the need for the valve cap 20 to move relative to the valve seat 10 along the first direction X. The second cap 23 can contact the sealing assembly 30. Thus, as the valve cap 20 approaches the first valve body 11, the second cap 23 can push the second sealing member 32 to move, causing the second sealing member 32 to deform due to compression, thereby improving the sealing and blood-blocking performance of the hemostatic valve 100.

[0092] It should be noted that, for the embodiment of the sealing assembly 30 including the fixing member 33, the fixing member 33 can be contacted with the second cap 23 in the first direction X. Furthermore, the outer peripheral contour shape of the fixing member 33 can be adapted to the outer peripheral contour shape of the second cap 23, thereby improving the structural compatibility between the two. This design also ensures that the first sealing member 31 is located inside the structure formed by the fixing member 33 and the second cap 23, thereby improving the positional reliability of the first sealing member 31.

[0093] In some embodiments, please refer to Figure 8 and Figure 11 The first seal 31 includes a central portion 312 and an edge portion 313 located around the central portion 312, with a cutout 311 located on the central portion 312. In the first direction X, the projection of the central portion 312 coincides with the projection of the first hole 111, and the projection of the second cap 23 is at least partially located within the projection of the edge portion 313.

[0094] The projection of the center portion 312 mentioned here refers to the orthographic projection of the center portion 312 in any projection plane perpendicular to the first direction X. Similarly, the projection of the first hole 111 refers to the orthographic projection of the first hole 111 in the projection plane, the projection of the second cap portion 23 refers to the orthographic projection of the second cap portion 23 in the projection plane, and the projection of the edge portion 313 refers to the orthographic projection of the edge portion 313 in the projection plane.

[0095] The central part 312 is a partial structure located in the central region of the first seal 31 and having a cut 311. The edge part 313 is a partial structure located in the edge region of the first seal 31. The projection of the central part 312 coincides with the projection of the first hole 111, indicating that the central part 312 and the first hole 111 are matched and correspond. Thus, the interventional instrument passing through the cut 311 can continue to move along the first direction X and enter the first hole 111.

[0096] In this embodiment, by aligning the projection of the central portion 312 with the incision 311 with the projection of the first hole 111, the interventional instrument can pass through the first seal 31 and enter the first hole 111 along the first direction X, reducing the difficulty of operation. Simultaneously, at least a portion of the projection of the second cap 23 is positioned within the projection of the edge portion 313. Thus, during the contact between the second cap 23 and the first seal 31, which causes the first seal 31 to move, the valve cap 20 applies force to the edge portion 313, thereby reducing the impact of external forces on the central portion 312, lowering the risk of deformation of the central portion 312, and improving the sealing reliability of the first seal 31.

[0097] It should be noted that the projection of the second cap portion 23 may be completely located within the projection of the edge portion 313, or the projection of the second cap portion 23 may be partially located within the projection of the edge portion 313 and partially located outside the projection of the edge portion 313.

[0098] In some embodiments, the outer surface of the second valve body 12 is provided with an external thread, and the surface of the first cap 22 facing the second cap 23 is provided with an internal thread, and the external thread and the internal thread are connected in a mating manner.

[0099] In this embodiment, the valve seat 10 and valve cap 20 are connected by a threaded connection on the outer surface of the second valve body 12. This connection method is simple in structure, and compared with other movable connection methods, the relative positional relationship between the valve cap 20 and the valve seat 10 in the first direction X can be adjusted more flexibly, thereby achieving stepless adjustment. Furthermore, this connection method allows for a detachable fit between the valve seat 10 and the valve cap 20, reducing the need to replace the entire hemostatic valve 100 due to the failure of other components, thus improving the utilization efficiency of each component of the hemostatic valve 100 and reducing resource waste. In addition, this connection method reduces the impact on the internal structural layout of the valve seat 10, helps to achieve a tight fit between the sealing assembly 30 and the valve seat 10, and reduces design complexity.

[0100] Of course, in other embodiments, the second cap 23 can also be threadedly engaged with the inner wall of the second valve body 12 to achieve a movable connection between the valve cap 20 and the valve seat 10 in the first direction X.

[0101] Secondly, such as Figure 5 As shown, this application provides a catheter sheath 200, which includes a catheter 40 and a hemostatic valve 100 as described in any of the foregoing embodiments.

[0102] In this embodiment, by placing the hemostatic valve 100 on the catheter 40 and positioning the end of the catheter 40 furthest from the hemostatic valve 100 towards the patient, interventional instruments can enter and exit the catheter 40 through the second hole 21, incision 311, third hole 321, and first hole 111 in the hemostatic valve 100, thus meeting surgical requirements. Simultaneously, the first sealing member 31 and the second sealing member 32 provide a double sealing effect, thereby reducing the risk of blood leaving the patient's body through the catheter 40 and the hemostatic valve 100, improving safety, and reducing the difficulty of operation for physicians.

[0103] 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 hemostatic valve, characterized in that, include: A valve seat includes a first valve body and a second valve body connected in a first direction, the first valve body having a first hole, and the second valve body having a mounting hole communicating with the first hole; The valve cap has a second hole, and the valve cap is movably connected to the valve seat along the first direction; A sealing assembly is sandwiched between the valve seat and the valve cap. The sealing assembly includes a first sealing element and a second sealing element arranged in the first direction. The second sealing element is located in the mounting hole. The first sealing element has a cutout, and the second sealing element has a third hole. The second hole, the cutout, the third hole, and the first hole are sequentially connected. The hemostatic valve is configured such that when the valve cap moves the sealing assembly toward the first valve body, the second seal is compressed and deformed, and the diameter of the third hole is reduced at at least a portion of its position.

2. The hemostatic valve according to claim 1, characterized in that, The second valve body includes a first part and a second part, the first part being located on the side of the second part close to the first valve body, and the mounting hole including a first sub-hole formed by the first part and a second sub-hole formed by the second part; The minimum diameter of the first sub-hole is smaller than the minimum diameter of the second sub-hole.

3. The hemostatic valve according to claim 2, characterized in that, The diameter of the first sub-hole gradually decreases in the direction close to the first hole.

4. The hemostatic valve according to claim 3, characterized in that, The second seal includes a first sub-part and a second sub-part, wherein the second sub-part is located on the side of the first sub-part opposite to the first valve body; In the direction close to the first valve body, the outer peripheral dimension of the first sub-part in the radial direction of the first sub-hole gradually decreases, while the outer peripheral dimension of the second sub-part in the radial direction remains constant.

5. The hemostatic valve according to claim 1, characterized in that, The elastic modulus of the valve seat is greater than that of the elastic modulus of the second seal; and / or, the second seal comprises an elastic material.

6. The hemostatic valve according to claim 1, characterized in that, The first seal is in contact with the second seal.

7. The hemostatic valve according to claim 1, characterized in that, The sealing assembly further includes a fixing member disposed between the first sealing member and the second sealing member. The fixing member has a fourth hole that communicates between the cut and the third hole. The fixing member is connected to the valve cap.

8. The hemostatic valve according to claim 7, characterized in that, The fastener includes a body portion and a limiting portion protruding from the body portion on the side opposite to the second seal, and the fourth hole is located inside the body portion; The limiting part is located on the periphery of the first seal and is connected to the valve cap.

9. The hemostatic valve according to claim 7, characterized in that, The second valve body includes a second part and a third part. The second part is located on the side of the third part close to the first valve body. The mounting hole includes a second sub-hole formed by the second part and a third sub-hole formed by the third part. The second seal is located between the third sub-hole and the first hole. The valve cap is movably connected to the third part. The diameter of the end of the third sub-hole facing the second sub-hole is larger than the diameter of the end of the second sub-hole facing the third sub-hole, so as to form a stepped surface on the sidewall of the mounting hole; The fastener includes a first fixing part and a second fixing part. The first fixing part is located on the side of the second fixing part facing the first valve body, and the two together form the fourth hole. The radial dimension of the second fixing part in the second sub-hole is greater than the radial dimension of the first fixing part.

10. The hemostatic valve according to claim 1, characterized in that, The valve cap includes a first cap, a second cap, and a connecting portion. The first cap is located on the periphery of the second valve body, the second cap is at least partially located within the mounting hole, and the connecting portion is located on the side of the second valve body opposite to the first valve body and connects the first cap and the second cap. The first cap is connected to the valve seat, and the second cap is in contact with the sealing assembly in the first direction.

11. The hemostatic valve according to claim 10, characterized in that, The first seal includes a central portion and an edge portion located around the central portion, and the cut is located on the central portion; In the first direction, the projection of the center portion coincides with the projection of the first hole, and the projection of the second cap portion is located within the projection of the edge portion.

12. A catheter sheath, characterized in that, Includes catheters and hemostatic valves as described in any one of claims 1-11.

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