Sealing valve body and guiding sheath

Abstract

The invention relates to the technical field of medical instruments, and provides a sealing valve body and an introducer sheath wherein the sealing valve body comprises a sheath tube joint, a sealing end cover connected to the near end of the sheath tube joint, a sealing valve core for an instrument to pass through and an inner membrane member; the sheath tube joint is provided with a chamber capable of accommodating the sealing valve core; the sealing valve element is installed in the cavity, and the sealing end cover is located at the near end of the sealing valve element. The inner membrane piece comprises a positioning part and a redundant part which is located in the far-end direction of the sealing valve element and allows an instrument to penetrate through. According to the technical scheme, the sealing performance of the sealing valve body can be improved.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and more specifically, to a sealing valve body and a guide sheath using the sealing valve body. Background Technology

[0002] A guide sheath is a medical device used in interventional medical procedures, typically to guide medical devices, catheters, or medications into the body during surgery or treatment. To prevent blood loss, a sealing valve is usually installed on the guide sheath.

[0003] Existing hemostatic valves in sealed valve bodies mostly use silicone hemostatic valves and silicone sheets. The silicone hemostatic valve has a slotted hole or a cross-shaped slot. When the instrument passes through or is withdrawn from the hemostatic valve, the slot of the hemostatic valve will be stretched open. In many cases, the hemostatic valve is difficult to fit completely with the instrument that has passed through, and bleeding often occurs. Summary of the Invention

[0004] The technical problem to be solved by this application is to provide a sealing valve body that is conducive to improving sealing performance and a guide sheath using the sealing valve body.

[0005] To solve the above-mentioned technical problems, this application adopts the following technical solution: In a first aspect, this application provides a sealing valve body, comprising: a sheath connector, a sealing end cap connected to the proximal end of the sheath connector, a sealing valve core through which an instrument can pass, and an inner diaphragm; the sheath connector is provided with a chamber for accommodating the sealing valve core; the sealing valve core is installed in the chamber, and the sealing end cap is located at the proximal end of the sealing valve core; the inner diaphragm includes a positioning portion and a redundant portion located at the distal end of the sealing valve core and through which an instrument can pass.

[0006] In the process of implementing the above technical solution, the sealing valve body includes a sheath connector, a sealing end cap connected to the proximal end of the sheath connector, a sealing valve core that allows instruments to pass through, and an inner diaphragm. The sheath connector has a chamber that can accommodate the sealing valve core, and the sealing valve core is installed in the chamber. The sealing end cap is located at the proximal end of the sealing valve core, which not only seals the chamber but also axially limits the sealing valve core. The inner diaphragm includes a positioning part and a redundant part located at the distal end of the sealing valve core that allows instruments to pass through. Since the redundant part is located at the distal end of the sealing valve core and allows instruments to pass through, at the moment the instrument passes through or is withdrawn from the sealing valve core, the negative pressure at the distal end can stack or press the redundant part into the slit position of the sealing valve core, thereby reducing the leakage of the sealing valve core and improving the sealing effect of the sealing valve body.

[0007] In one embodiment, the inner diaphragm component includes a connecting portion located between the redundant portion and the positioning portion; the sealing valve core includes a base and a protruding portion extending distally from the base, the protruding portion being located within the connecting portion.

[0008] In the process of implementing the above technical solution, the inner diaphragm component includes a connecting part located between the redundant part and the positioning part, which connects the redundant part and the positioning part; the sealing valve core includes a base and a protruding part extending from the base to the distal end, which is located inside the connecting part, so that the connecting part can wrap around the outer surface of the protruding part. Thus, the redundant part is also located at the distal end of the sealing valve core, that is, the outer surface of the protruding part is the inner diaphragm component. In this way, when the instrument passes through or withdraws from the sealing valve core, the negative pressure at the distal end can press the redundant part or the redundant part and the connecting part into the cut position of the sealing valve core, thereby reducing the leakage of the sealing valve core and improving the sealing effect of the sealing valve body.

[0009] In one embodiment, the sealing valve core includes a positioning edge connected to the base, the positioning edge being positioned between the sealing end cap and the sheath joint; the positioning portion is positioned between the positioning edge and the sheath joint.

[0010] In the process of implementing the above technical solution, the sealing valve core includes a positioning edge connected to the base. The positioning edge is positioned between the sealing end cap and the sheath joint. The positioning edge can provide more contact area with the sealing end cap and the sheath joint, thereby improving the sealing performance of the sealing valve body. The positioning part is positioned between the positioning edge and the sheath joint, so that the positioning edge and the sheath joint squeeze and fix the positioning part to improve the structural stability of the inner membrane component and reduce the problem of displacement of the inner membrane component when the instrument passes through.

[0011] In one embodiment, the inner membrane component includes at least one first fixing part connected to the redundant part; the sealing valve body includes a sheath cap connected to the sheath connector, the sheath cap being located at the distal end of the sheath connector, and the first fixing part being positioned between the sheath connector and the sheath cap.

[0012] In the process of implementing the above technical solution, the inner membrane component includes at least one first fixing part, which is connected to the redundant part; the sealing valve body includes a sheath cap connected to the sheath connector, the sheath cap being located at the distal end of the sheath connector and used to fix the sheath between the sheath cap and the sheath connector. The first fixing part is positioned between the sheath connector and the sheath cap. On the one hand, this can improve the structural stability of the inner membrane component; on the other hand, since the redundant part is a flexible segment, it is connected to the redundant part through the first fixing part. When the first fixing part is fixed, it can also provide support for the periphery of the redundant part. This facilitates the passage of the instrument through the redundant part and avoids the instrument puncturing the redundant part.

[0013] In one embodiment, there are two first fixing parts, which are arranged symmetrically.

[0014] In the process of implementing the above technical solution, there are two first fixing parts, which are symmetrically arranged. In this way, the redundant parts can play a role in slightly expanding and supporting through two directions, making it easier for the instrument to pass through.

[0015] In one embodiment, the inner diaphragm component includes a second fixing portion connected to the distal end of the redundant portion; the sealing valve body includes a sheath cap connected to the sheath connector, the sheath cap being located at the distal end of the sheath connector, and the second fixing portion being positioned between the sheath connector and the sheath cap.

[0016] In the process of implementing the above technical solution, the inner membrane component includes a second fixing part, which is connected to the distal end of the redundant part; the sealing valve body includes a sheath cap connected to the sheath connector, the sheath cap being located at the distal end of the sheath connector and used to fix the sheath between the sheath cap and the sheath connector. The second fixing part is positioned between the sheath connector and the sheath cap. On the one hand, this can improve the structural stability of the inner membrane component; on the other hand, since the redundant part is a flexible segment, it is connected to the distal end of the redundant part through the second fixing part. When the second fixing part is fixed, it can also provide support for the periphery of the redundant part. This facilitates the passage of the instrument through the redundant part and avoids the instrument puncturing the redundant part.

[0017] In one embodiment, the second fixing part extends circumferentially along the redundant part to form an annular part, the annular part extending axially along the sheath joint and positioned between the sheath joint and the sheath cap.

[0018] In the process of implementing the above technical solution, the second fixing part extends circumferentially along the redundant part to form an annular part. The annular part extends axially along the sheath joint and is positioned between the sheath joint and the sheath cap. The formation of the annular part by the second fixing part can increase the circumferential area of ​​the second fixing part. The annular part is positioned between the sheath joint and the sheath cap, which increases the area of ​​the annular part between the sheath joint and the sheath cap and improves the stability of the inner diaphragm component inside the sealing valve body.

[0019] In one embodiment, the protrusion is provided with at least one slit through which an instrument can pass, and at least one reinforcing rib is provided on the periphery of the protrusion, the reinforcing rib being connected to the base and the protrusion.

[0020] In the process of implementing the above technical solution, the protruding part is provided with at least one slit for the instrument to pass through, and at least one reinforcing rib is provided on the periphery of the protruding part. The reinforcing rib is connected to the base and the protruding part. By setting the reinforcing rib, the reinforcing rib plays a supporting role on the periphery of the slit, thereby reducing the problem of the slit curling inward when the instrument is withdrawn from the slit due to the friction between the instrument and the sealing valve core. This also improves the sealing effect of the sealing valve core. At the same time, it also reduces the situation where the slit turns outward when the instrument is inserted.

[0021] In one embodiment, the thickness of the protrusion gradually increases from the distal end to the proximal end.

[0022] In the process of implementing the above technical solution, the thickness of the protrusion gradually increases from the distal end to the proximal end, thereby increasing the structural strength of the protrusion. This reduces the problem of the slit curling inward when the instrument is withdrawn from the slit due to the friction between the instrument and the sealing valve core, and also improves the sealing effect of the sealing valve core. At the same time, it also reduces the situation where the slit turns outward when the instrument is inserted.

[0023] In one embodiment, the sealing end cap includes an insertion portion, the radial dimension of which is smaller than the radial dimension of the proximal end of the sheath connector, and the insertion portion is threadedly connected to the sheath connector.

[0024] In the process of implementing the above technical solution, the sealing end cap includes an insertion part. The radial dimension of the insertion part is smaller than the radial dimension of the proximal end of the sheath joint. The insertion part is threadedly connected to the sheath joint, thereby realizing the sealing connection between the sealing end cap and the sheath joint and improving the sealing performance inside the sheath joint. At the same time, it also facilitates the assembly of the sheath joint and the sealing end cap.

[0025] Secondly, this application also provides a sealing valve body, comprising: the sealing valve body described in the first aspect.

[0026] In the implementation of the above technical solution, the guide sheath includes the sealing valve body provided in the first aspect and a sheath tube connected to the distal end of the sealing valve body. By setting the sheath tube, the device can be guided for intervention, and at the same time, it can also protect the blood vessel and reduce the risk of the device scratching the blood vessel wall. Attached Figure Description

[0027] 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. It should be understood that the following drawings only show some embodiments of this application and should not be regarded as a limitation of the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0028] Figure 1 This is a schematic diagram of the sealing valve body structure provided in the first embodiment of this application; Figure 2 for Figure 1 A schematic diagram of the cross-sectional structure along the AA direction; Figure 3 This is an exploded structural diagram of the sealing valve body provided in the first embodiment of this application; Figure 4 Exploded structural diagrams of the sealing valve body provided in the first embodiment of this application from different perspectives; Figure 5 This is a schematic diagram of the sealing valve body structure provided in the second embodiment of this application; Figure 6 for Figure 5 A schematic diagram of the cross-sectional structure along the BB direction in the middle; Figure 7 This is an exploded structural diagram of the sealing valve body provided in the second embodiment of this application; Figure 8 Exploded structural diagrams of the sealing valve body from different perspectives provided in the second embodiment of this application; Figure 9 This is an exploded structural diagram of the sealing valve body provided in the second embodiment of this application from another perspective.

[0029] Icons: 1-Sheath connector; 2-Sealing end cap; 21-Insert part; 3-Sealing valve core; 31-Base; 32-Protrusion; 33-Reinforcing rib; 34-Slit; 35-Positioning edge; 4-Inner diaphragm; 41-Redundant part; 42-Connecting part; 43-Positioning part; 44-First fixing part; 45-Second fixing part; 5-Sheath; 6-Sheath cap. Detailed Implementation

[0030] The technical solutions in the embodiments of this application will now be described with reference to the accompanying drawings.

[0031] It should be noted that similar reference numerals and letters in the following figures indicate similar items; therefore, once an item is defined in one figure, it does not need to be further defined and explained in subsequent figures. Furthermore, in the description of this application, the term "distal" refers to the end of the delivery system closer to the heart tissue, and "proximal" refers to the end of the delivery system closer to the operator. The terms "first," "second," etc., are used only for distinguishing descriptions and should not be construed as indicating or implying relative importance.

[0032] In the first aspect, the embodiments of this application provide a sealing valve body applied to a guide sheath. When the instrument passes through or is withdrawn from the sealing valve body, the inner diaphragm 4 inside the sealing valve body can promptly seal the slit 34 position of the sealing valve core 3, thereby solving the problem that the slit 34 position of the sealing valve core 3 cannot completely match the instrument passing through, resulting in bleeding or leakage.

[0033] like Figures 2 to 4 As shown in Figures 6 and 9, the sealing valve body includes a sheath connector 1, a sealing end cap 2 connected to the proximal end of the sheath connector 1, a sealing valve core 3 that allows instruments to pass through, and an inner diaphragm 4. The sheath connector 1 has a chamber that can accommodate the sealing valve core 3, and the sealing valve core 3 is installed in the chamber. The sealing end cap 2 is located at the proximal end of the sealing valve core 3, which not only seals the chamber but also axially limits the sealing valve core 3. The inner diaphragm 4 includes a positioning part 43 and a redundant part 41 located at the distal end of the sealing valve core 3 that allows instruments to pass through. Since the redundant part 41 is located at the distal end of the sealing valve core 3 and allows instruments to pass through, at the moment the instrument passes through or is withdrawn from the sealing valve core 3, the negative pressure at the distal end can stack or press the redundant part 41 into the slit 34 position of the sealing valve core 3, thereby reducing the leakage of the sealing valve core 3 and improving the sealing effect of the sealing valve body.

[0034] Optionally, in some cases, when the device is withdrawn, the redundant part 41 will also be driven into the cut 34 position of the sealing valve core 3, thereby improving the sealing performance of the sealing valve core 3.

[0035] Optionally, the distal negative pressure may include saline solution or human blood, etc., and the distal negative pressure exists in the sheath 5.

[0036] Optionally, the inner membrane component 4 can be an ePTFE membrane, which can improve the permeability, sealing and hydraulic resistance of the internal instruments during insertion, making it easier for the instruments to pass through; the inner membrane component 4 can also be made of PTFE membrane, PVDF membrane, PP membrane, PE membrane, nanofiber membrane and other materials.

[0037] Optionally, the inner diaphragm 4 can be sleeved on the distal end of the sealing valve core 3 and wrap the outer surface of the sealing valve core 3. The positioning part 43 can be used as part of the inner diaphragm 4 to fix the entire inner diaphragm 4 inside the sheath connector 1. The redundant part 41 is the part of the inner diaphragm 4 that is not wrapped on the surface of the sealing valve core 3 at the distal end of the sealing valve core 3. The redundant part 41 can swing freely without passing through the instrument.

[0038] Optionally, when the instrument is inserted into the redundant part 41, the redundant part 41 will form wrinkles on the outer surface of the instrument, making it easier for the redundant part 41 to be stacked or pressed into the cut 34 position of the sealing valve core 3.

[0039] Optionally, the device may be a catheter for delivering implants or repairing endovascular tissue, a guidewire, or a delivery sheath for valves and peripheral vascular interventional treatment products.

[0040] Optionally, the inner diaphragm 4 itself is flexible, and the structure of the inner diaphragm 4 in the attached figure is a schematic diagram after assembly and being stretched open by other parts in the sealing valve body.

[0041] Optionally, the sealing valve body in this embodiment can be applied in fields involving interventional surgery, such as heart valve replacement, repair, peripheral intervention, and gastrointestinal intervention, thereby improving the applicability of the product.

[0042] Optionally, the sheath connector 1 is also provided with an exhaust channel, which is connected to the chamber. The exhaust channel can remove the air that is originally present inside the sheath connector 1, the sheath 5 and other components, to prevent air bubbles from being introduced into the blood vessels and causing air embolism. At the same time, the entire system is pre-filled with liquid to ensure a stable flow field and clear vision during subsequent aspiration, perfusion or instrument delivery.

[0043] like Figure 2 , 4 As shown in Figures 6 and 8, in one embodiment, the inner diaphragm 4 includes a connecting portion 42 located between the redundant portion 41 and the positioning portion 43, which connects the redundant portion 41 and the positioning portion 43. The sealing valve core 3 includes a base 31 and a protruding portion 32 extending from the base 31 toward the distal end. The protruding portion 32 is located inside the connecting portion 42, so that the connecting portion 42 can wrap around the outer surface of the protruding portion 32. Consequently, the redundant portion 41 is also located at the distal end of the sealing valve core 3, that is, the outer surface of the protruding portion 32 is the inner diaphragm 4. Thus, when the instrument passes through or withdraws from the sealing valve core 3, the negative pressure at the distal end can press the redundant portion 41 or the redundant portion 41 and the connecting portion 42 into the cut 34 position of the sealing valve core 3, thereby reducing the leakage of the sealing valve core 3 and improving the sealing effect of the sealing valve body.

[0044] Optionally, when installing the inner diaphragm 4 and the sealing valve core 3, the inner diaphragm 4 is elastic, and an inner diaphragm 4 with a diameter smaller than that of the base 31 can be selected. The sealing valve core 3 is inserted into the inner diaphragm 4, and the inner diaphragm 4 is spread open so that the connecting part 42 is located on the outer surface of the protrusion 32, and the redundant part 41 is located at the far end of the protrusion 32.

[0045] Optionally, the base 31 can be cylindrical and the protruding part 32 can be conical.

[0046] Optionally, the distal end of the connecting part 42 is provided with an opening that allows instruments to pass through, and the shape of the opening can be adapted to the slit 34. The redundant part 41 is connected to the periphery of the opening position, that is, the redundant part 41 is a closed structure on all four sides, so that the circumferential direction of the inner membrane 4 is a closed structure to avoid leakage.

[0047] Optionally, the cross-section of the redundant part 41 perpendicular to the axial direction of the sheath 5 can be elongated. Of course, when the opening at the distal end of the connecting part 42 is circular, the cross-section of the redundant part 41 perpendicular to the axial direction of the sheath 5 can also be circular.

[0048] like Figure 3 and 8 As shown, in one embodiment, the sealing valve core 3 includes a positioning edge 35 connected to the base 31. The positioning edge 35 is positioned between the sealing end cap 2 and the sheath connector 1. The positioning edge 35 can provide more contact area with the sealing end cap 2 and the sheath connector 1, thereby improving the sealing performance of the sealing valve body. The positioning part 43 is positioned between the positioning edge 35 and the sheath connector 1, so that the positioning edge 35 and the sheath connector 1 squeeze and fix the positioning part 43, thereby improving the structural stability of the inner diaphragm 4 and reducing the problem of displacement of the inner diaphragm 4 when the instrument passes through.

[0049] Optionally, the positioning edge 35 extends outward in the radial direction of the base 31.

[0050] Optionally, the positioning part 43 may include a radial extension section and an axial extension section. The radial extension section is connected to the axial extension section and the connecting part 42 respectively. The radial extension section can be squeezed between the positioning edge 35 and the sheath joint 1. The axial extension section extends proximally and is threadedly connected to the proximity of the sealing end cap 2 and the sheath joint 1. That is, when the sealing end cap 2 and the sheath joint 1 are threadedly connected, the axial extension section of the positioning part 43 can be sleeved on the outer periphery of the threaded section of the sealing end cap 2, between the sheath joint 1 and the sealing end cap 2, thereby further improving the stability of the inner diaphragm 4. At this time, the positioning part 43 is also located between the positioning edge 35 and the sheath joint 1.

[0051] Optionally, the radial dimension of the positioning part 43 is larger than that of the connecting part 42, so that the positioning part 43 can be easily positioned between the positioning edge 35 and the sheath joint 1, thereby increasing the contact area and improving the stability of the inner diaphragm part 4.

[0052] like Figure 2 and 4As shown, in one embodiment, the inner membrane component 4 includes at least one first fixing part 44, which is connected to the redundant part 41; the sealing valve body includes a sheath cap 6 connected to the sheath connector 1. The sheath cap 6 is located at the distal end of the sheath connector 1 and is used to fix the sheath 5 between the sheath cap 6 and the sheath connector 1. The first fixing part 44 is positioned between the sheath connector 1 and the sheath cap 6. On the one hand, this can improve the structural stability of the inner membrane component 4; on the other hand, since the redundant part 41 is a flexible segment, it is connected to the redundant part 41 through the first fixing part 44. When the first fixing part 44 is fixed, it can also provide support for the periphery of the redundant part 41. In this way, it is convenient for the instrument to pass through the redundant part 41 and avoids the instrument puncturing the redundant part 41.

[0053] Optionally, the first fixing part 44 may be integrally formed with the redundant part 41, or it may be connected to the redundant part 41 by adhesive or heat fusion.

[0054] Optionally, the first fixing part 44 has a strip-shaped structure.

[0055] like Figure 2 and 4 As shown, in one embodiment, there are two first fixing parts 44, which are symmetrically arranged. In this way, the redundant part 41 can play a role in slightly expanding and supporting through two directions, making it easier for the instrument to pass through.

[0056] Optionally, the first fixing part 44 can also be provided in three or four, etc.

[0057] like Figure 6 , 8 As shown in Figure 9, in a parallel embodiment, the inner membrane component 4 includes a second fixing part 45, which is connected to the distal end of the redundant part 41; the sealing valve body includes a sheath cap 6 connected to the sheath connector 1, the sheath cap 6 being located at the distal end of the sheath connector 1, for fixing the sheath 5 between the sheath cap 6 and the sheath connector 1. The second fixing part 45 is positioned between the sheath connector 1 and the sheath cap 6. On the one hand, this can improve the structural stability of the inner membrane component 4; on the other hand, since the redundant part 41 is a flexible segment, it is connected to the distal end of the redundant part 41 through the second fixing part 45. When the second fixing part 45 is fixed, it can also provide support for the periphery of the redundant part 41. In this way, it is convenient for the instrument to pass through the redundant part 41 and avoids the instrument puncturing the redundant part 41.

[0058] Optionally, the second fixing part 45 may be integrally formed with the redundant part 41, or it may be connected to the redundant part 41 by adhesive or heat fusion.

[0059] like Figure 6 , 8As shown in Figure 9, in one embodiment, the second fixing part 45 extends circumferentially along the redundant part 41 to form an annular part. The annular part extends axially along the sheath joint 1 and is positioned between the sheath joint 1 and the sheath cap 6. By forming an annular part through the second fixing part 45, the circumferential area of ​​the second fixing part 45 can be increased. Furthermore, the annular part is positioned between the sheath joint 1 and the sheath cap 6, increasing the area of ​​the annular part between the sheath joint 1 and the sheath cap 6, thereby improving the stability of the inner diaphragm 4 inside the sealing valve body.

[0060] Optionally, the sheath connector 1 is threaded to the sheath cap 6, and the second fixing part 45 can be threaded between the sheath connector 1 and the sheath cap 6.

[0061] Optionally, the annular portion may include an inclined section and an extension section, with the distal end of the inclined section connected to the redundant portion 41 and the proximal end connected to the extension section. The inclined section and the extension section may wrap around the distal end of the sheath connector 1.

[0062] like Figure 8 As shown, in one embodiment, the protruding portion 32 is provided with at least one slit 34 for instruments to pass through, and at least one reinforcing rib 33 is provided on the periphery of the protruding portion 32. The reinforcing rib 33 is connected to the base 31 and the protruding portion 32. By providing the reinforcing rib 33, the reinforcing rib 33 provides support to the periphery of the slit 34, thereby reducing the problem of the slit 34 curling inward when the instrument is withdrawn from the slit 34 due to the friction between the instrument and the sealing valve core 3. This also improves the sealing effect of the sealing valve core 3. At the same time, it also reduces the situation where the slit 34 flips outward when the instrument is inserted.

[0063] Optionally, two slits 34 can be set, with the two slits 34 intersecting to form a cross slit 34.

[0064] Optionally, two reinforcing ribs 33 are provided, and the two reinforcing ribs 33 are respectively provided on opposite sides of the cut 34, so as to support the two sides of the cut 34 and further improve the structural stability of the cut 34.

[0065] Optionally, the reinforcing rib 33 is integrally formed with the base 31 and the protruding part 32.

[0066] Optionally, as a preferred implementation, it is preferable to provide only one slit 34, that is, the sealing valve core 3 is provided with a straight slit 34. This is because the overall opening and closing area of ​​the straight slit 34 is small, resulting in better static sealing. Under normal circumstances, the straight slit has only one linear opening of 3–6 mm. When no instruments pass through, the two sides of the slit 34 can be completely fitted together. In contrast, the cross slit 34 leaves four 90° fan-shaped micro-gap. When the blood pressure is higher, the micro-gap is more easily opened, and the probability of bleeding or bubble leakage is higher.

[0067] In addition, the single-line incision 34 has lower puncture force, allowing for smoother instrument passage. When an instrument passes through, the single-line incision 34 experiences less frictional resistance than the cross-shaped incision 34, reducing the jerking sensation during instrument insertion and the momentary displacement of the blood vessel wall. Furthermore, the single-line incision 34 heals faster; after instrument withdrawal, it rebounds and closes more quickly than the cross-shaped incision 34, further reducing the risk of leakage from the sealing valve core 3.

[0068] like Figure 2 and 6 As shown, in one embodiment, the thickness of the protrusion 32 gradually increases from the distal end to the proximal end, thereby increasing the structural strength of the protrusion 32. This reduces the problem of the slit 34 curling inward when the instrument is withdrawn from the slit 34 due to the friction between the instrument and the sealing valve core 3, and also improves the sealing effect of the sealing valve core 3. At the same time, it also reduces the situation where the slit 34 flips outward when the instrument is inserted. Furthermore, the thickness of the protrusion 32 refers to the wall thickness of the protrusion 32. The interior of the protrusion 32 is a conical chamber, and the wall thickness of the protrusion 32 gradually increases from the distal end to the proximal end. The slit 34 is opened at the distal end of the protrusion 32. Near the slit 34, the wall thickness of the protrusion 32 is relatively thinner than that at the proximal end. This allows the instrument to pass through more easily without affecting the toughness around the slit 34. At the same time, the wall thickness is thicker at the connection between the protrusion 32 and the base 31, that is, the wall thickness is thickest at the proximal end of the protrusion 32, which provides support for the root of the protrusion 32 and improves the structural strength of the sealing valve core 3. Moreover, the protrusion 32 has a conical design, and the diameter at the connection with the base 31 is larger, requiring a thicker wall to support the entire protrusion 32.

[0069] Optionally, the sealing valve core 3 includes a base 31 that is inserted into the distal opening of the sealing end cap 2 and a protrusion 32 disposed on the base 31. The protrusion 32 may include at least two elastic valve plates disposed opposite to each other to form a slit 34.

[0070] Optionally, the protrusion 32 and the base 31 can be integrally formed.

[0071] Optionally, the sealing valve core 3 can be made entirely of rubber or silicone.

[0072] like Figure 2 As shown, in one embodiment, the sealing end cap 2 includes an insertion part 21. The radial dimension of the insertion part 21 is smaller than the radial dimension of the proximal end of the sheath connector 1. The insertion part 21 is threadedly connected to the sheath connector 1, thereby realizing the sealing connection between the sealing end cap 2 and the sheath connector 1 and improving the sealing performance inside the sheath connector 1. At the same time, it also facilitates the assembly of the sheath connector 1 and the sealing end cap 2.

[0073] Optionally, the radial dimension of the base 31 does not exceed the radial dimension of the insertion portion 21, so that the proximal end of the base 32 can be inserted into the insertion portion 21 and abut against the sealing end cap 2.

[0074] like Figure 1 and 5 As shown, in a second aspect, embodiments of this application provide a guiding sheath, including the sealing valve body provided in the first aspect and a sheath tube 5 connected to the distal end of the sealing valve body. By providing the sheath tube 5, it is possible to guide the intervention of instruments, and at the same time, it can also protect blood vessels and reduce the risk of instruments scratching the blood vessel walls.

[0075] Optionally, the sheath 5 is an expandable sheath, typically composed of a three-layer structure: an inner layer of ultra-low friction polytetrafluoroethylene (PTFE), a middle layer of stainless steel or nickel-titanium braided / wound reinforcing mesh, and an outer layer of soft and biocompatible polyurethane or nylon elastomer. This composite structure provides the guiding sheath with sufficient radial support to resist vascular tortuosity, spasm, and external pressure, while retaining good flexural strength and flexibility.

[0076] The above description is merely an embodiment of this application and is not intended to limit the scope of protection of this application. Various modifications and variations can be made to this application by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the scope of protection of this application.

[0077] The above description is merely a specific embodiment of this application, but the scope of protection of this application is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the scope of the technology disclosed in this application should be included within the scope of protection of this application. Therefore, the scope of protection of this application should be determined by the scope of the claims.

[0078] It should be noted that, in this document, relational terms such as "first" and "second" are used only 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 one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes said element.

Claims

1. A sealing valve body, characterized in that, include: The sheath connector, the sealing end cap connected to the proximal end of the sheath connector, the sealing valve core through which the instrument can pass, and the inner diaphragm component; The sheath connector has a chamber for accommodating a sealing valve core; the sealing valve core is installed in the chamber, and the sealing end cap is located at the proximal end of the sealing valve core; the inner diaphragm includes a positioning part and a redundant part located at the distal end of the sealing valve core and allowing instruments to pass through.

2. The sealing valve body according to claim 1, characterized in that, The inner diaphragm component includes a connecting portion located between the redundant portion and the positioning portion; the sealing valve core includes a base and a protruding portion extending distally from the base, the protruding portion being located within the connecting portion.

3. The sealing valve body according to claim 2, characterized in that, The sealing valve core includes a positioning edge connected to the base, the positioning edge being positioned between the sealing end cap and the sheath joint; the positioning part is positioned between the positioning edge and the sheath joint.

4. The sealing valve body according to any one of claims 1 to 3, characterized in that, The inner membrane component includes at least one first fixing part, which is connected to the redundant part; The sealing valve body includes a sheath cap connected to the sheath connector, the sheath cap being located at the distal end of the sheath connector, and the first fixing part being positioned between the sheath connector and the sheath cap.

5. The sealing valve body according to claim 4, characterized in that, There are two first fixing parts, and the two first fixing parts are arranged symmetrically.

6. The sealing valve body according to any one of claims 1 to 3, characterized in that, The inner membrane component includes a second fixing part, which is connected to the distal end of the redundant part; The sealing valve body includes a sheath cap connected to the sheath connector, the sheath cap being located at the distal end of the sheath connector, and the second fixing part being positioned between the sheath connector and the sheath cap.

7. The sealing valve body according to claim 6, characterized in that, The second fixing part extends circumferentially along the redundant part to form an annular part, which extends axially along the sheath joint and is positioned between the sheath joint and the sheath cap.

8. The sealing valve body according to claim 2, characterized in that, The protruding portion is provided with at least one slit through which an instrument can pass, and at least one reinforcing rib is provided on the periphery of the protruding portion, the reinforcing rib being connected to the base and the protruding portion.

9. The sealing valve body according to claim 8, characterized in that, The thickness of the protrusion gradually increases from the distal end to the proximal end.

10. The sealing valve body according to any one of claims 1 to 3, characterized in that, The sealing end cap includes an insertion portion, the radial dimension of which is smaller than the radial dimension of the proximal end of the sheath connector, and the insertion portion is threadedly connected to the sheath connector.

11. A guiding sheath, characterized in that, Includes the sealing valve body as described in any one of claims 1 to 10.

Images