Disconnectable seal valve and disconnectable sheath assembly

Abstract

A detachable seal valve for a detachable sheath assembly, the detachable seal valve comprising a body comprising at least one cutout through which the body can be torn starting from when the detachable seal valve is subjected to a force or moment directed outwardly, characterized in that the detachable seal valve comprises at least one cutting thread extending through the at least one cutout, the cutting thread being capable of being tensioned and cutting the body when the detachable seal valve is subjected to the force or moment. Also provided is a detachable sheath assembly comprising the detachable seal valve.

Description

Technical Field

[0001] This invention relates to the field of medical devices, and more specifically to a separable sealing valve and a separable sheath assembly including the separable sealing valve. Background Technology

[0002] The Seldinger technique is the cornerstone of modern minimally invasive interventional surgery. It is a method of percutaneous puncture and placement of a catheter into a blood vessel or hollow organ (such as the bile duct or trachea) using a guidewire.

[0003] The Serdinger technique typically involves the following steps: puncture—the skin is punctured with a needle, which is then inserted into the target blood vessel (or cavity), allowing observation of blood (or liquid / gas) return; guidewire insertion—a soft guidewire is inserted into the blood vessel lumen through the needle's end hole and reaches the predetermined position; needle withdrawal—the guidewire is secured, and then the needle is withdrawn, leaving only the guidewire in place as a guide; introduction of a detachable guide sheath assembly—a thicker guide sheath assembly containing an internal dilator is placed over the guidewire and pushed along it into the blood vessel; guidewire withdrawal—the guidewire is withdrawn once the tip of the guide sheath assembly reaches the target position; device insertion—catheters or other devices are inserted through the guide sheath assembly for procedures such as infusion and pressure measurement; tearing off the guide sheath assembly—the tear wings of the guide sheath assembly are pinched and forcefully torn longitudinally to both sides, gradually withdrawing the device without affecting the position of the inserted device.

[0004] For example, during cardiac surgery, the Serdinger technique can be used to treat patients with heart failure, arrhythmias, or cardiac conduction abnormalities who require the use of rhythm management devices. Specifically, it allows access to cardiovascular devices such as leads and catheters to the venous system during cardiac surgery via a detachable guide sheath.

[0005] Separable guide sheath assemblies typically include a hemostatic valve as a seal, usually made of silicone. The main functions of the hemostatic valve include: tightly wrapping around the surface of the dilator and introduced instruments (such as catheters) to prevent blood leakage from the tail of the guide sheath assembly when the dilator or introduced instrument passes through; effectively preventing air from being drawn into the blood vessel under negative pressure (such as during central venous puncture), thus preventing air embolism; and automatically closing after the guidewire or catheter is removed, maintaining a sealed state due to the high elasticity and "self-healing" properties of silicone.

[0006] In addition, the hemostatic valve has a "tearable" feature, allowing it to be torn apart and removed along with the detachable guide sheath assembly. To ensure that the hemostatic valve can be easily torn open, its structure is typically specially designed. For example, a tear line is provided in the hemostatic valve so that at the end of the procedure, the hemostatic valve, along with the detachable guide sheath assembly, can be torn in half and removed.

[0007] Therefore, the hemostatic valve is a critical component in a separable guide sheath assembly; it should allow subsequent instruments to pass through, prevent leakage, and be easy to tear open. However, for conventional silicone valves, these three requirements conflict. Existing technology uses drilling holes and slits in the hemostatic valve to allow easy passage and tearing, but this leads to a high risk of leakage through the holes and slits, and vice versa. Summary of the Invention

[0008] Therefore, the present invention aims to provide a separable sealing valve that allows for easy tearing while maintaining easy passage of instruments through the seal and preventing leakage.

[0009] A separable sealing valve is provided for a separable sheath assembly, the separable sealing valve including a body having at least one notch, the body being capable of being torn from the notch when the separable sealing valve is subjected to an outward force or torque, characterized in that the separable sealing valve includes at least one cutting line extending through the at least one notch, the cutting line being capable of being tensioned and cutting the body when the separable sealing valve is subjected to the force or torque.

[0010] The separable sealing valve of this application does not rely on pre-cut slits to be torn open, thus reducing the length and number of slits compared to prior art sealing valves with larger lengths or more slits. When installed on the valve body, the length of the slits is insufficient to extend to the location of the lumen portion. Therefore, the sealing valve of this application better balances the performance requirements of the sealing valve, ensuring that the instrument can pass smoothly through the sealing valve while maintaining good sealing performance, and the sealing valve can be easily separated when the separable sheath assembly is split. Another problem with separable sealing valves in the prior art is that the pre-cut slits disappear after aging due to the silicone material creeping and growing together. The sealing valve of this application helps to improve this problem.

[0011] Preferably, the end of the cutting thread is fixed to the body at least at a first fixing point on the body, the first fixing point being spaced apart from the at least one cut. Preferably, the first fixing point and / or the cut is located at or near the edge of the body, so that the displacement of the first fixing point is maximized when the sealing valve is torn.

[0012] Preferably, the body includes two cuts spaced apart from each other, the first fixing point is located on a first surface of the body, the first end of the cutting line is fixed at the first fixing point and extends from the first fixing point on the first surface, through the first cut to a second surface of the body opposite to the first surface, then extends on the second surface, through the second cut back to the first surface, extends on the first surface, and the second end of the cutting line is fixed at the first fixing point. Preferably, the line connecting the first cut and the second cut passes through the center of the separable sealing valve.

[0013] Preferably, the body includes a second fixing point symmetrical about the center and the first fixing point, and the separable sealing valve includes two cutting lines arranged mirror images of each other. Preferably, the line connecting the first fixing point and the second fixing point is perpendicular to the line connecting the first cut and the second cut.

[0014] Preferably, the body includes a central cut, the second surface includes a central boss, and the cutting thread extends along one side of the central boss on the second surface, near the end of the corresponding cutting thread, around the central boss. Therefore, during the splitting of the sealing valve, the cutting thread always remains on the same side of the body and does not cross the crack formed by the cut, thus not hindering the splitting of the sealing valve, and there is no need to further cut the cutting thread after splitting.

[0015] Preferably, the first fixing point is located on a first surface of the separable sealing valve, the first end of the cutting wire is fixed at the first fixing point, and extends from the first fixing point on the first surface, through the cut to a second surface of the body opposite to the first surface, and then extends on the second surface, with the second end of the cutting wire fixed to the body. The cutting wire is wired on the body in a simple manner.

[0016] Preferably, the second end of the cutting thread is fixed at a second fixing point on the second surface. Preferably, the second fixing point is located at or near the edge of the body. More preferably, the first fixing point and the second fixing point are symmetrical about the center of the body.

[0017] Preferably, the body includes two cuts spaced apart from each other, and the separable sealing valve includes two cutting lines symmetrically arranged about the line connecting the first fixing point and the second fixing point. Preferably, the line connecting the first fixing point and the second fixing point is perpendicular to the line connecting the two cuts.

[0018] The two symmetrically arranged cutting lines facilitate installation. When installing the sealing valve on the valve body, it is only necessary to arrange the line connecting the cuts perpendicular to the line connecting the vanes. Regardless of which direction the user applies force perpendicular to the surface of the vanes, the cutting lines can be tensioned to cut the body of the sealing valve.

[0019] Preferably, the body is made of silicone, and the cutting lines are made of metal or polymer, such as stainless steel, nickel-titanium, titanium, PE, PA, or PP.

[0020] Preferably, the separable sheath assembly includes a flap, a valve housing, and a sheath tube. The flap is mounted on the valve housing on opposite sides of its diameter. A user can apply a force or torque through the flap to tear the valve housing, the body of the separable sealing valve, and the tube. The valve housing accommodates the separable sealing valve and includes a lumen portion communicating with the sheath tube. The body of the separable sealing valve includes a fixing device for securing it to the valve housing. When the separable sealing valve is mounted on the valve housing, the at least one cut is located entirely outside the area on the body corresponding to the lumen portion, thereby improving the sealing performance of the sealing valve relative to the lumen.

[0021] Preferably, the line connecting the at least one cut to the center of the body of the separable sealing valve is perpendicular to the line connecting the vanes.

[0022] A separable sheath assembly is also provided, comprising a cap, a flap, a valve body, and a sheath tube, characterized in that the separable sheath assembly further comprises a separable sealing valve according to the foregoing, wherein the flap is mounted on the valve body on opposite sides of the valve body in diameter, and a user can apply the force or torque through the flap to tear the valve body, the body of the separable sealing valve, and the sheath tube, the valve body for accommodating the separable sealing valve and including a lumen portion communicating with the sheath tube, and wherein the body of the separable sealing valve includes a fixing device for fixing to the valve body, and when the separable sealing valve is mounted on the valve body, the at least one cut is located entirely in an area outside the area on the body corresponding to the lumen portion, thereby improving the sealing performance of the sealing valve.

[0023] Preferably, the line connecting the at least one cut to the center of the body of the separable sealing valve is perpendicular to the line connecting the vanes.

[0024] The separable sealing valve according to the present invention can better balance the performance requirements of the sealing valve, ensuring that the instrument can pass smoothly through the sealing valve while maintaining good sealing performance, and the sealing valve can be easily separated when the separable sheath assembly is split. Attached Figure Description

[0025] The accompanying drawings illustrate preferred embodiments of the invention, wherein the same reference numerals denote the same or corresponding elements in all views.

[0026] Figure 1 An exploded view of the main components of the detachable guide sheath assembly is shown; Figure 2 Show Figure 1 A partial enlarged view of the detachable guide sheath assembly; Figure 3 A perspective view of a separable sealing valve according to a first embodiment of the present invention is shown; Figure 4 Show Figure 3 A schematic diagram of the forces acting on the sealing valve according to the invention when the guide sheath assembly is torn; Figure 5 Showing the torn Figure 4 A schematic diagram of a sealing valve; Figure 6 A perspective view of a sealing valve according to a second embodiment of the present invention is shown; Figure 7 Show Figure 6 Another perspective view of the sealing valve of the second embodiment shown; and Figure 8 Show Figure 6 , Figure 7 The diagram shows a torn sealing valve in the second embodiment. Detailed Implementation

[0027] Embodiments of this application will now be described in detail with reference to the accompanying drawings. However, it should be understood that aspects of this disclosure are merely examples and may be embodied in various forms. Well-known functions or structures have not been described in detail to avoid obscuring the disclosure with unnecessary detail. Therefore, the specific structural and functional details disclosed herein should not be construed as limiting, but rather serve as the basis for the claims and as a representative basis for teaching those skilled in the art to employ this disclosure differently with virtually any suitable detailed structure. Furthermore, directional terms such as front, back, up, down, top, bottom, and similar terms are used to aid understanding of the description and are not intended to limit the disclosure.

[0028] In this specification, the term "proximal" is generally used to refer to the portion of the device that is closer to the user during use in its usual manner, while the term "distal" is generally used to refer to the portion of the device that is further away from the user during use in its usual manner.

[0029] Figure 1 An exploded view of the detachable guide sheath assembly is shown. Figure 2 Show Figure 1 A partial enlarged view of the detachable guide sheath assembly.

[0030] See Figure 1 The separable sheath assembly 100 typically includes: a cap 101, a separable sealing valve 102, a flap 103, a valve housing 104, and a sheath 105, wherein the flap 103 is mounted on the valve housing 104 on opposite sides of its diameter, and a user can apply force or torque through the flap 103 to tear the valve housing 104, the sealing valve 102, and the sheath 105 apart, and the valve housing 104 is used to accommodate the sealing valve 102.

[0031] See Figure 2 The valve housing 104 includes a lumen portion 1041 communicating with the sheath 105, and the sealing valve 102 includes a first fixing device for fixing the sealing valve 102 to the valve housing 104. Figure 2 In the illustrated embodiment, the first fixing device includes a plurality of first holes 1021 for receiving a plurality of corresponding first protrusions 1042 on the valve housing 104, thereby mounting the sealing valve 102 in the valve housing 104. Therefore, when a user applies force or torque through the flap 103, the sealing valve 102 fixed in the valve housing 104 can also be torn apart. The sealing valve 102 is typically made of silicone.

[0032] See still Figure 2 The cap 101 comprises two separate parts, which are respectively fixed to the valve housing 104 by a second fixing device. For example, the periphery of the cap 101 includes a plurality of second holes 1011, and the outer periphery of the valve housing 104 includes a plurality of corresponding second protrusions 1043, thereby mounting the cap 101 onto the valve housing 104. The cap 101 also includes a cap center hole 1012.

[0033] The prior art sealing valve 102 includes a valve center recess 1023 (with a slit) and a plurality of edge slits 1022, the center recess 1023 being aligned with the cap center hole 1012. Therefore, as described in the background section, instruments such as wires or conduits can pass through the valve center recess 1023 and the cap center hole 1012 via the lumen portion 1041 into the sheath 105.

[0034] To ensure the tearability of the sealing valve 102, so that the sealing valve 102 can be torn when a user applies force or torque through the vane 103, the plurality of edge slits 1022 are typically long enough to extend into the region of the sealing valve 102 corresponding to the lumen portion 1041, thus reducing the sealing performance of the sealing valve 102 to the fluid in the lumen portion 1041.

[0035] This application provides a separable sealing valve including at least one cutting line capable of cutting the body of the sealing valve and extending through at least one slit in the sealing valve, such that when the separable sealing valve is subjected to a force or torque capable of splitting it, the cutting line can be tensioned and cut the body.

[0036] Figures 3-5 A separable sealing valve 1 according to a first embodiment of this application is shown, wherein Figure 3 A perspective view of a separable sealing valve 1 according to a first embodiment of the present invention is shown. Figure 4 Show Figure 3 A schematic diagram of the forces acting on the sealing valve 1 when the guide sheath assembly is torn. Figure 5 Showing the torn Figure 4 A schematic diagram of sealing valve 1.

[0037] See Figure 3 The separable sealing valve 1 according to the present invention includes: a body 10 in the shape of a flat cylindrical body; a first fixing point 11 located on a first surface of the body 10 and a second fixing point 12 located on a second surface opposite to the first surface; a first slit 13 and a second slit 14 located at the edge of the body 10, wherein the first slit 13 and the second slit 14 are located on the same diameter of the body 10; and a first cutting line 15 and a second cutting line 16.

[0038] The first fixing point 11 and the second fixing point 12 are located on the same diameter of the main body, and the line connecting the first fixing point 11 and the second fixing point 12 is perpendicular to the line connecting the first cut 13 and the second cut 14. The first fixing point 11 and the second fixing point 12 are located at or near the edge of the main body 10, so the displacement of the first fixing point 11 and the second fixing point 12 is relatively large when the main body 10 deforms.

[0039] See Figure 3 The first end of the first cutting line 15 is fixed at the first fixing point 11 and extends from the first fixing point 11 on the first surface, passes through the first cut 13 to reach the second surface of the body 10, and then extends on the second surface, and the second end of the first cutting line 15 is fixed at the second fixing point 12.

[0040] See Figure 3 The first end of the second cutting line 16 is fixed at the first fixing point 11, and extends from the first fixing point 11 onto the first surface, passes through the second cut 14 to reach the second surface of the body 10, and then extends on the second surface. The second end of the cutting line 15 is fixed at the second fixing point 12. Therefore, the line connecting the second cutting line 16 with respect to the first fixing point 11 and the second fixing point 12 is symmetrically arranged on the body 10 with respect to the first cutting line 15.

[0041] The ends of the first cutting wire 15 and the second cutting wire 16 can be fixed to the first fixing point 11 and the second fixing point 12 respectively by knotting, crimping, bonding, or other methods. The body 10 is typically made of silicone, and the first cutting wire 15 and the second cutting wire 16 are made of, for example, metal or polymer, such as stainless steel, nitinol, titanium, PE, PA, PP, or other materials with high tensile strength and low elongation under load. Before the body 10 deforms, there is only limited tension in the first cutting wire 15 and the second cutting wire 16, which allows the first cutting wire 15 and the second cutting wire 16 to remain on the body 10, but not enough to cut the body 10.

[0042] Furthermore, the separable sealing valve 1 according to this application also includes a connecting device, such as... Figure 2 The plurality of holes 17 shown are for receiving corresponding protrusions 1042 on the valve housing 104 of the separable sheath assembly 100, thereby securing the separable sealing valve 1 to the valve housing 104.

[0043] See Figure 4 It shows that when the user applies a force F or a torque M, such as Figure 1 , Figure 2 When the wing 103 is shown, since the separable sealing valve 1 is connected to the valve housing 104 through multiple holes 17, a force F or a torque M can act on both sides of the body 10 of the separable sealing valve 1, and as shown... Figure 4As shown, the first fixing point 11 and the second fixing point 12 are located in the middle of the corresponding side of the two sides, and the first cut 13 and the second cut 14 are located between the first fixing point 11 and the second fixing point 12.

[0044] In other words, reference Figure 2 , Figure 3 , Figure 4 The positions of the first fixing point 11 and the second fixing point 12 on the main body 20 respectively correspond to the positions where the wing 103 connects to the valve housing 104, that is, the positions where the wing 103 transmits the force F or torque M applied by the user to the valve housing 104, thereby maximizing the transmission of the force F or torque M to the fixing points of the first cutting line 15 and the second cutting line 16. See also... Figure 4 If the positions of the first fixing point 11 and the second fixing point 12 on the main body 10 are considered to be the 3 o'clock and 9 o'clock positions, then the first cut 13 and the second cut 14 are located at the 12 o'clock and 6 o'clock positions, respectively.

[0045] See Figure 4 , Figure 5 When force F or torque M is applied to the vane 103, the valve housing 104 will be torn. Therefore, the main body 10 deforms as the valve housing 104 cracks, increasing the distance between the first fixing point 11 and the second fixing point 12. Consequently, the tension in the first cutting line 15 and the second cutting line 16 increases, cutting the main body 10 from the roots of the first slit 13 and the second slit 14 until the main body 10 is cut into the shape shown below. Figure 5 As shown in the diagram, the two ends of the first cutting line 15 and the second cutting line 16 are fixed at the first fixing point 11 and the second fixing point 12, respectively, and the first cut 13 and the second cut 14 are connected to each other.

[0046] Among them, see Figure 1 The arrangement and orientation of the vanes 103 cause the direction of the force or torque F / M acting on the body 10 of the sealing valve 1 to be as follows: Figure 4 As shown, only the first cutting line 15 cuts the corresponding first slit 13. However, for ease of installation, a second cutting line 16 is symmetrically arranged on the sealing valve 1. That is, when the sealing valve 1 is installed on the valve housing 104, it is only necessary to arrange the line connecting the slits perpendicular to the line connecting the vanes. Regardless of which direction the user applies force perpendicular to the surface of the vanes, the cutting line can be tensioned to cut the body of the sealing valve 1. It is conceivable that in other embodiments of the separable sheath assembly, the vanes 103 have other arrangements and orientations, such that the direction of the force or torque F / M applied to the body 10 is different from that of the other. Figure 4 As shown, for example, with the paper facing downwards, in such a case, the first cutting line 15 and the second cutting line 16 cut the first slit 13 and the second slit 14 respectively when splitting.

[0047] The above embodiments are shown only in a preferred manner and can have various modifications. For example, two cutting lines may not be provided, such as only the first or second cutting line is retained, or more than two cutting lines may be provided, or the first and second cutting lines may not be symmetrically arranged, etc. Those skilled in the art can make appropriate modifications based on the teachings of the above embodiments and practical applications, and the modified schemes are also included within the scope of this application. It is also conceivable that the arrangement and fixing position of the cutting lines on the body can be modified in various ways according to actual needs. For example, the first and second fixing points may be set on the same surface of the body, or on the cylindrical surface of the body, or the first and second fixing points may not be symmetrically arranged, the first and second slits may not be symmetrically arranged, etc., as long as the cutting lines pass through the slits, and the cutting lines can be tensioned and cut the body at the root of the slits when the valve body cracks. The slits can be any form of cut, such as circular, triangular, irregular shapes, etc., and the cuts can be located at the edge of the body or inside the body, as long as the cutting lines can pass through them and thus cut the body when tensioned. The embodiment shown in the figure has slits cut perpendicular to the first and second surfaces of the body. It is also conceivable that the slits are not cut perpendicular to the first and second surfaces of the body, so that the projection of each slit on the first or second surface forms a surface instead of the line shape shown in the figure.

[0048] Figures 6-8 A separable sealing valve 2 according to a second embodiment of this application is shown, wherein... Figure 6 This shows a perspective view of the sealing valve 2 according to a second embodiment of the present invention, viewed from the first surface. Figure 7 Show Figure 6 A perspective view of the second surface of the sealing valve 2 of the second embodiment shown; and Figure 8 A schematic diagram showing the sealing valve 2 of the second embodiment being torn is shown.

[0049] See Figure 6 , Figure 7The first slit 13 and the second slit 14 are shown as those in the sealing valve 1 of the first embodiment. The difference is that the first cutting line 25 and the second cutting line 26 of the sealing valve 2 of the second embodiment are fixed and arranged on the body 20 differently from those in the sealing valve 1 of the first embodiment. The separable sealing valve 2 according to the second embodiment also includes connecting devices, such as a plurality of holes 17, for receiving corresponding protrusions 1042 on the valve housing 104 of the separable sheath assembly 100, for mounting the sealing valve 2 onto the valve housing 104.

[0050] See Figure 6 , Figure 7 According to a second embodiment of the present invention, a separable sealing valve 2 includes: a body 20 in the shape of a flattened cylinder; a first fixing point 21 and a second fixing point 22 located on a first surface 27 of the body 20; a first slit 13 and a second slit 14 located at the edge of the body 20, wherein the first slit 13 and the second slit 14 are located on the same diameter of the body 20; and a first cutting line 25 and a second cutting line 26. The body 20 includes a central recess, the central recess including a central slit 29 for the passage of instruments such as wires or catheters. The body 20 also includes a first protrusion 23 located on the first surface 27, and a second protrusion 24 located on a second surface 28 opposite to the first surface 27, the first protrusion 23 and the second protrusion 24 being located at the center of the body 20, surrounding the central slit 29.

[0051] The first fixing point 21 and the second fixing point 22 are located on the same diameter of the main body 20, and the line connecting the first fixing point 21 and the second fixing point 22 is perpendicular to the line connecting the first cut 13 and the second cut 14. The first fixing point 21 and the second fixing point 22 are located at or near the edge of the main body 20, so the displacement of the first fixing point 21 and the second fixing point 22 is relatively large when the main body 20 deforms.

[0052] The first end of the first cutting line 25 is fixed at the first fixing point 21, and extends from the first fixing point 21 onto the first surface 27, passes through the first slit 13 to reach the second surface 28, then extends around the second boss 24 on the second surface 28, passes through the second slit 14 back to the first surface 27, extends on the first surface 27, and the second end of the first cutting line 25 is fixed at the first fixing point 21. On the first surface 27, the first cutting line 25 extends around the first boss 23, or the first cutting line 25 and the first boss 23 do not interfere with each other.

[0053] The first end of the second cutting line 26 is fixed at the second fixing point 22, and extends from the second fixing point 22 onto the first surface 27, passes through the first slit 13 to reach the second surface 28, then extends around the second boss 24 on the second surface 28, passes through the second slit 14 back to the first surface 27, extends on the first surface 27, and the second end of the second cutting line 26 is fixed at the second fixing point 22. The second cutting line 26 extends around the first boss 23, or the second cutting line 26 and the first boss 23 do not interfere with each other.

[0054] like Figure 7 As shown, the first cutting line 25 and the second cutting line 26 extend around the second boss 24 on the second surface 28. Therefore, the first cutting line 25 and the second cutting line 26 do not obstruct the central slit 29, allowing instruments such as wires and catheters to pass through the central slit 29. Furthermore, the first cutting line 25 and the second cutting line 26 extend around the second central boss 24 on the second surface 28 along the side of the second central boss 24 near the end of the respective cutting line. In other words, see... Figure 6 , Figure 7 Assuming the first slit 13 and the second slit 14 are connected, dividing the main body 20 into left and right sides, the first cutting line 25 extends on the second surface 28 around the side of the second central boss 24 near the first fixing point 21, so that the first cutting line 25 is located on the same side of the main body on both the first surface 27 and the second surface 28. Figure 6 The second cutting line 26 extends on the second surface 28 around the side of the second central boss 24 near the second fixing point 22, such that the second cutting line 26 is located on the same side of the body on both the first surface 27 and the second surface 28. Figure 6 (The right side portion). Therefore, when the main body 20 is split into two parts, the first cutting line 25 and the second cutting line 26 are each located entirely on different split portions. See also Figure 8 After the main body 20 is split, the first cutting thread 25 is entirely located on the left half of the split main body 20, and the second cutting thread 26 is entirely located on the right half. Therefore, when the main body 20 is split, the first cutting thread 25 and the second cutting thread 26 will not become entangled, and no additional cutting is required.

[0055] The ends of the first cutting wire 25 and the second cutting wire 26 can be fixed to the first fixing point 21 and the second fixing point 22 respectively by knotting, crimping, bonding, or other methods. The body 20 is typically made of silicone, and the first cutting wire 25 and the second cutting wire 26 are made of metal or polymer, such as stainless steel, nitinol, titanium, PE, PA, PP, or other materials with high tensile strength and low elongation under load. Before the body 20 deforms, there is only limited tension in the first cutting wire 25 and the second cutting wire 26, which allows the first cutting wire 25 and the second cutting wire 26 to remain on the body 20, but not enough to cut the body 20.

[0056] The above embodiments are shown only in a preferred manner and can have various modifications. For example, two cutting lines may not be provided, such as only the first or second cutting line is retained, or more than two cutting lines may be provided, or the first and second cutting lines may not be symmetrically arranged, etc. Those skilled in the art can make appropriate modifications based on the teachings of the above embodiments and actual needs, and the modified schemes are also included within the scope of this application. Alternatively, the arrangement and fixing position of the cutting lines on the body can also be modified in various ways according to the application. For example, the first and second fixing points may be set on the cylindrical surface of the body or not set at the edge or attachment of the first and second surfaces, or the first and second fixing points may not be symmetrically arranged, the first and second slits may not be symmetrically arranged, etc., as long as the cutting lines pass through the slits, and the cutting lines can be tensioned and cut the body at the root of the slits when the valve body cracks. The slits can be any form of cut, such as circular, triangular, irregular shapes, etc., and the cuts can be located at the edge of the body or inside the body, as long as the cutting lines can pass through them and thus cut the body when tensioned. The embodiment shown in the figure has slits cut perpendicular to the first and second surfaces of the body. It is also conceivable that the slits are not cut perpendicular to the first and second surfaces of the body, so that the projection of each slit on the first or second surface forms a surface instead of the line shape shown in the figure.

[0057] The separable sealing valve according to the first and second embodiments of this application reduces the length and number of slits compared to prior art sealing valves with larger lengths or more slits. Therefore, when the separable sealing valve of this application is installed on the valve housing, the length of the slits is insufficient to extend to the location of the lumen portion. Thus, the sealing valve of this application better balances the performance requirements of the sealing valve, ensuring that instruments can pass smoothly through the sealing valve while maintaining good sealing performance, and allowing the sealing valve to be easily separated when the separable sheath assembly is split. Another problem with prior art separable sealing valves is that the pre-cut slits disappear after aging due to the silicone material creeping and growing together. The sealing valve of this application helps to improve this problem because it does not rely on the pre-cut slits being torn open.

[0058] This application also provides a separable sheath assembly, including a cap, a flap, a valve body, and a sheath tube, as well as separable sealing valves 1 and 2 according to this application. The flaps are mounted on opposite sides of the valve body's diameter. A user can apply a force or torque through the flaps, thereby tearing the valve body, the body of the separable sealing valve, and the tube. The valve body is used to accommodate the separable sealing valve and includes a lumen portion communicating with the sheath tube. Furthermore, the body of the separable sealing valve includes a fixing device for securing it to the valve body, and when the separable sealing valve is mounted on the valve body, the length of the at least one slit is insufficient to extend to the location of the lumen portion.

[0059] In the separable sheath assembly according to this application, the line connecting the at least one slit to the center of the body of the separable sealing valve is perpendicular to the line connecting the blades.

[0060] From the description provided based on the preferred embodiments, it will be apparent to those skilled in the art that modifications can be made without departing from the scope of the invention as defined by the following claims.

Claims

1. A separable sealing valve for a separable sheath assembly, the separable sealing valve comprising a body having at least one notch, wherein the body is capable of being torn from the notch when the separable sealing valve is subjected to an outward force or torque. Its features are, The separable sealing valve includes at least one cutting line extending through the at least one cut, which can be tensioned and cut the body when the separable sealing valve is subjected to the force or torque.

2. The separable sealing valve according to claim 1, characterized in that, The end of the cutting thread is fixed to the body at least at a first fixing point on the body, the first fixing point being spaced apart from the at least one cut. Preferably, the first fixing point and / or the cut is located at or near the edge of the body.

3. The separable sealing valve according to claim 2, characterized in that, The body includes two spaced-apart cuts. A first fixing point is located on a first surface of the body. A first end of the cutting thread is fixed at the first fixing point and extends from the first fixing point onto the first surface, passing through the first cut to a second surface of the body opposite the first surface. It then extends on the second surface, passes through a second cut back to the first surface, and extends on the first surface. A second end of the cutting thread is fixed at the first fixing point. Preferably, the line connecting the first cut and the second cut passes through the center of the separable sealing valve.

4. The separable sealing valve according to claim 3, characterized in that, The main body includes a second fixing point symmetrical about the center and the first fixing point, and the separable sealing valve includes two cutting lines arranged mirror images of each other. Preferably, the line connecting the first fixing point and the second fixing point is perpendicular to the line connecting the first cut and the second cut.

5. The separable sealing valve according to claim 3 or 4, characterized in that, The body includes a central cut, the second surface includes a central boss, and the cutting line extends on the second surface around the central boss along one side of the central boss near the end of the corresponding cutting line.

6. The separable sealing valve according to claim 2, characterized in that, The first fixing point is located on the first surface of the separable sealing valve, the first end of the cutting line is fixed at the first fixing point, and extends from the first fixing point on the first surface, through the cut to the second surface of the body opposite to the first surface, and then extends on the second surface, and the second end of the cutting line is fixed on the body.

7. The separable sealing valve according to claim 6, characterized in that, The second end of the cutting thread is fixed at a second fixing point on the second surface. Preferably, the second fixing point is located at or near the edge of the body. More preferably, the first fixing point and the second fixing point are symmetrical about the center of the body.

8. The separable sealing valve according to claim 6 or 7, characterized in that, The main body includes two cuts spaced apart from each other, and the separable sealing valve includes two cutting lines symmetrically arranged about the line connecting the first fixing point and the second fixing point. Preferably, the line connecting the first fixing point and the second fixing point is perpendicular to the line connecting the two cuts.

9. The separable sealing valve according to any one of claims 1-8, characterized in that, The body is made of silicone, and the cutting lines are made of metal or polymer, such as stainless steel, nickel-titanium, titanium, PE, PA, or PP.

10. The separable sealing valve according to any one of claims 1-9, characterized in that, The detachable sheath assembly includes flaps, a valve housing, and a sheath tube. The flaps are mounted on opposite sides of the valve housing, allowing a user to apply force or torque through the flaps, thereby tearing the valve housing, the body of the detachable sealing valve, and the tube. The valve housing accommodates the detachable sealing valve and includes a lumen portion communicating with the sheath tube. The body of the separable sealing valve includes a fixing device for fixing to the valve housing, and when the separable sealing valve is installed on the valve housing, the at least one cutout is located entirely outside the area on the body corresponding to the lumen portion.

11. The separable sealing valve according to claim 10, characterized in that, The line connecting the at least one cut to the center of the body of the separable sealing valve is perpendicular to the line connecting the vanes.

12. A detachable sheath assembly, comprising a cap, a fin, a valve housing, and a sheath tube, characterized in that, The separable sheath assembly further includes the separable sealing valve according to claims 1-9. The flaps are mounted on opposite sides of the valve housing, allowing the user to apply force or torque through them, thereby tearing the valve housing, the main body of the separable sealing valve, and the sheath. The valve housing accommodates the separable sealing valve and includes a lumen portion communicating with the sheath. The separable sealing valve body includes a fixing device for fixing to the valve housing, and when the separable sealing valve is installed on the valve housing, the at least one cut is located entirely outside the area on the body corresponding to the lumen portion.

13. The detachable sheath assembly according to claim 12, characterized in that, The line connecting the at least one cut to the center of the body of the separable sealing valve is perpendicular to the line connecting the vanes.

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