Hemostatic valve, sheath and catheter sheath assembly

Abstract

The present invention provides a hemostatic valve, sheath, and catheter sheath assembly. The hemostatic valve comprises a valve body and a valve core disposed within the valve body. The valve core comprises a valve core body and a cover connected to the distal end of the valve core body. An axial through-hole is defined within the valve core body, and the cover opens or automatically closes relative to the valve core body to expose or seal the axial through-hole. This hemostatic valve offers an ideal sealing effect, prevents blood leakage or gas intrusion, and is highly reliable. It is particularly suitable for use with larger-diameter dilators or other diagnostic and treatment instruments.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a hemostatic valve, a sheath tube, and a catheter sheath assembly. Background Art

[0002] As an auxiliary guide device for peripheral and intracardiac minimally invasive interventional procedures, catheter sheaths play a vital role in percutaneous coronary intervention, percutaneous interventional occlusion, and atrial septal puncture. They establish a connection between human blood vessels and the outside world, assisting the delivery system in delivering diagnostic and / or therapeutic devices to the target lesion. The hemostatic valve is an essential component of the catheter sheath, typically installed at the proximal end of the sheath. It prevents blood loss, reduces bleeding, and prevents air from entering the blood vessels and forming air emboli, thereby reducing complications for patients.

[0003] In the prior art, the structural forms of hemostatic valves mainly include:

[0004] 1. Luer-opening type: This involves rotating the axially open Luer to squeeze the cylindrical elastic member at the distal end, causing the diameter of the elastic member's central hole to change. When the dilator or other diagnostic instrument is removed from the hemostatic valve, the Luer is rotated to move the Luer distally until the elastic member is squeezed to the point where the diameter of the elastic member's central hole is reduced to zero, sealing the proximal end of the sheath. When the dilator or other diagnostic instrument is inserted into the sheath, the Luer is rotated in the opposite direction to move the Luer proximally, loosening the elastic member appropriately so that the elastic member's central hole surrounds the outer circumference of the dilator or other diagnostic instrument, creating a sealing effect. However, this type of hemostatic valve with a Luer opening structure has a relatively obvious defect: when a dilator or other diagnostic and treatment instrument with a larger diameter needs to be inserted into the hemostatic valve, the initial aperture of the center hole of the elastic part is correspondingly larger, and then the center hole of the elastic part may not be reduced to completely closed by Luer squeezing. Therefore, the sealing effect of this type of hemostatic valve is not ideal, and the reliability of preventing blood loss is limited. When used in conjunction with a dilator or other diagnostic and treatment instrument with a larger diameter, there is still a risk of blood leakage or gas entering the body.

[0005] 2. "X"-shaped or "cross"-shaped incision type, that is, two intersecting penetrating incisions are set on the hemostatic valve. In the natural state, each penetrating incision is closed to seal the proximal end of the sheath. When the dilator or other diagnostic instrument is inserted into the sheath through each penetrating incision, each penetrating incision opens and fits the outer surface of the dilator or other diagnostic instrument to act as a seal. However, this "X"-shaped or "cross"-shaped incision type hemostatic valve also has obvious defects: when a dilator or other diagnostic instrument with a larger diameter is inserted into the hemostatic valve, the starting and tail ends of each penetrating incision cannot completely fit the outer peripheral surface of the dilator or other diagnostic instrument; in addition, after repeatedly inserting and withdrawing a dilator or other diagnostic instrument with a larger diameter into the hemostatic valve, each penetrating incision may not return to a completely closed state in the natural state. Therefore, the sealing effect of this type of hemostatic valve is not ideal, and the reliability of preventing blood loss is limited. When a dilator or other diagnostic instrument with a larger diameter enters and exits the hemostatic valve, there is still a risk of blood leakage or gas entering the body. Summary of the Invention

[0006] The purpose of the present invention is to provide a hemostatic valve with ideal sealing effect, preventing blood leakage or gas from entering the body, and high reliability, which is particularly suitable for use with dilators or other diagnostic and treatment instruments with larger diameters.

[0007] The present invention also aims to provide a sheath tube and a catheter sheath assembly provided with the hemostatic valve, which has an ideal sealing effect, can eliminate the risk of bleeding or gas entering the body, and improve the safety and success rate of the operation.

[0008] In order to solve the above technical problems, the present invention first provides a hemostatic valve, including a valve body and a valve core arranged in the valve body, the valve core including a valve core body and a cover body connected to the far end of the valve core body, an axial through hole is opened in the valve core body, and the cover body opens or automatically closes relative to the valve core body to expose or close the axial through hole accordingly.

[0009] The present invention further provides a sheath tube, comprising a tube body with a certain axial length and the hemostatic valve, wherein the hemostatic valve is arranged at the proximal end or adjacent to the proximal end of the tube body.

[0010] The present invention also provides a catheter sheath assembly, comprising the sheath tube and a dilator, wherein the dilator is movably installed in the tube body of the sheath tube and the axial through hole of the valve core body of the hemostatic valve.

[0011] The hemostatic valve, sheath, and catheter sheath assembly provided by the present invention have a valve core of the hemostatic valve with a structure similar to a hatch, including a valve core body and a cover body connected to the distal end of the valve core body. The cover body can open or automatically close relative to the valve core body to expose or seal the axial through hole accordingly. When the dilator or other diagnostic and treatment instrument pushes the cover body toward the distal end to release the cover body from sealing the axial through hole, a seal is formed between the dilator or other diagnostic and treatment instrument and the axial through hole; when the dilator or other diagnostic and treatment instrument is withdrawn from the axial through hole, the cover body automatically resets itself under the action of blood pressure to seal the axial through hole, thereby preventing blood leakage or gas from entering the body. The sealing effect is ideal and the reliability is high. Moreover, compared with existing hemostatic valves, the hemostatic valve with a hatch-like structure in the present invention breaks through the diameter limit of the dilator or other diagnostic and treatment instrument and is particularly suitable for sealing with dilators or other diagnostic and treatment instruments with larger diameters. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the following briefly introduces the drawings required for use in the implementation. Obviously, the drawings described below are some implementations of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0013] Figure 1 It is a schematic diagram of the three-dimensional structure of the catheter sheath assembly provided by the first embodiment of the present invention.

[0014] Figure 2 yes Figure 1 Schematic diagram of the three-dimensional structure of the hemostasis valve.

[0015] Figure 3 yes Figure 2 Schematic diagram of three-dimensional decomposition.

[0016] Figure 4 yes Figure 3 Schematic diagram of the three-dimensional structure of the valve core from another perspective.

[0017] Figure 5 yes Figure 4 Cross-sectional view along line V-V.

[0018] Figure 6 yes Figure 4 Schematic diagram of the three-dimensional structure of the valve core in another state.

[0019] Figure 7 yes Figure 6 Cross-sectional view along line VII-VII.

[0020] Figure 8 yes Figure 3 A three-dimensional schematic diagram of another structural form of the valve core.

[0021] Figure 9 yes Figure 8 Rear view of the valve core in.

[0022] Figure 10 yes Figure 8 Cross-sectional view along line X-X.

[0023] Figure 11 yes Figure 3 A cross-sectional schematic diagram of another structural form of the valve core in FIG.

[0024] Figure 12 yes Figure 3 A cross-sectional schematic diagram of another structural form of the valve core in FIG.

[0025] Figure 13 yes Figure 3 A three-dimensional assembly diagram of the valve housing from another perspective.

[0026] Figure 14 yes Figure 13 Cross-sectional view along line XIV-XIV.

[0027] Figure 15 yes Figure 3 Schematic diagram of the three-dimensional assembly of the valve housing and valve cover.

[0028] Figure 16 yes Figure 15 Cross-sectional view along line XVI-XVI.

[0029] Figure 17 yes Figure 2 Cross-sectional view along line XVII-XVII.

[0030] Figure 18 yes Figure 1 Schematic diagram of the three-dimensional structure of the catheter sheath.

[0031] Figure 19 - Figure 20 It is a schematic diagram of the use process of the catheter sheath of the present invention.

[0032] Figure 21 yes Figure 19 Magnified view of section XXI.

[0033] Figure 22 yes Figure 20 Magnified view of section XXII.

[0034] Figure 23 It is a schematic diagram of the three-dimensional exploded structure of the hemostatic valve provided by the second embodiment of the present invention.

[0035] Figure 24 Is set with Figure 23Schematic diagram of the structure of the catheter sheath assembly with a hemostatic valve.

[0036] Figure 25 yes Figure 24 Magnified view of section XXV. DETAILED DESCRIPTION

[0037] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0038] In addition, the following descriptions of the embodiments refer to the accompanying drawings to illustrate specific embodiments in which the present invention may be implemented. Directional terms used in the present invention, such as "upper," "lower," "front," "back," "left," "right," "inner," "outer," and "side," are used solely with reference to the directions in the accompanying drawings. Therefore, the use of directional terms is intended to better and more clearly illustrate and understand the present invention, and is not intended to indicate or imply that the device or component referred to must have a specific orientation, be constructed, or operate in a specific orientation. Therefore, they should not be construed as limiting the present invention.

[0039] To more clearly describe the structure of the hemostatic valve, sheath, and catheter sheath assembly, the limiting terms "proximal" and "distal" described in the present invention are commonly used terms in the field of interventional medicine. Specifically, "distal" refers to the end away from the operator during the surgical procedure, and "proximal" refers to the end close to the operator during the surgical procedure. Unless otherwise defined, all technical and scientific terms used in the present invention have the same meaning as commonly understood by those skilled in the art to which the present invention belongs. The commonly used terms used in the specification of the present invention are only for the purpose of describing specific embodiments and are not to be construed as limitations of the present invention.

[0040] See also Figure 1 、 Figures 18 to 20The present invention provides a catheter sheath assembly 100 comprising a sheath tube 10 and a dilator 70. The sheath tube 10 includes a hemostatic valve 20 and a tubular body 50 having a predetermined axial length. The hemostatic valve 20 is disposed at or near the proximal end of the tubular body 50. Furthermore, the sheath tube 10 includes a handle 54 disposed at the proximal end of the tubular body 50. The hemostatic valve 20 is detachably connected to the proximal end of the handle 54. The dilator 70 is capable of being movably inserted into the hemostatic valve 20, the handle 54, and the tubular body 50, in sequence. The tubular body 50 may be an adjustable or non-adjustable bendable tubular body. The handle 54 is capable of manipulating the tubular body 50, such as bending the distal end of the tubular body 50. It is understood that in other embodiments, the hemostatic valve 20 is detachably connected to the distal end of the handle 54, and the dilator 70 is capable of being movably inserted into the handle 54, the hemostatic valve 20, and the tubular body 50, in sequence.

[0041] See also Figures 2 to 7 The hemostatic valve 20 includes a valve core 22 and a valve body 25. The valve core 22 is disposed within the valve body 25. The valve core 22 includes a valve core body 221 and a cover 225 connected to the distal end of the valve core body 221. The valve core body 221 defines an axial through hole 220 for inserting a dilator 70 or other diagnostic and treatment instruments. The cover 225 opens or automatically closes relative to the valve core body 221 to expose or block the axial through hole 220, respectively. The dilator 70 is movably mounted within the axial through hole 220 of the valve core body 221 of the hemostatic valve 20 and the tubular body 50. The dilator 70 pushes the cover 225 of the valve core body 221 toward the distal end to release the cover 225 from blocking the axial through hole 220. When the dilator 70 is withdrawn, the cover 225 automatically returns to its original position to block the axial through hole 220.

[0042] The hemostatic valve 20, sheath tube 10 and catheter sheath assembly 100 provided by the present invention, since the hemostatic valve 20 includes a valve core body 22 and a cover body 225, the valve core body 22 is provided with an axial through hole 220 for inserting the expander 70, and the cover body 225 can be opened or automatically closed relative to the valve core body 221 to expose or close the axial through hole 220 accordingly, which is similar to the structure of a hatch. When the expander 70 or other diagnostic and treatment instrument pushes the cover body 225 toward the distal end and releases the cover body 225 from the axial through hole 220, a seal is formed between the expander 70 or other diagnostic and treatment instrument and the axial through hole 220; when the expander 70 or other diagnostic and treatment instrument is withdrawn from the axial through hole 220, the cover body 225 automatically resets itself immediately under the action of blood pressure and closes the axial through hole 220 to form a seal, preventing blood leakage or gas from entering the body throughout the operation. The sealing effect is ideal and the sealing reliability is high, which helps to improve the safety and success rate of the operation; and this hemostatic valve 20, which is similar to a hatch structure, breaks through the limitation on the diameter of the expander or other diagnostic and treatment instruments compared to the existing hemostatic valve, and is particularly suitable for sealing with expanders or other diagnostic and treatment instruments with larger diameters.

[0043] Please also refer to Figures 4 to 7 The valve core 22 is made of an elastic and waterproof material. Specifically, the valve core 22 can be made of other elastic and waterproof materials such as silicone, elastic rubber, elastic plastic, etc. Preferably, the valve core 22 can be made of materials such as polystyrene elastomer, polyethylene elastomer, polyurethane elastomer, silicone rubber, or polyisoprene rubber elastomer. In this embodiment, the valve core 22 is made of silicone. The shape of the valve core 22 can be cylindrical, rectangular, waist-shaped, polygonal, or irregular, as long as the valve core 22 can be sealed and accommodated in the valve body 25. In this embodiment, the valve core 22 is cylindrical.

[0044] like Figure 4 and Figure 5As shown, the distal end of the valve core body 22 is provided with the cover 225. In this embodiment, the cover 225 is rotatably connected to the distal end surface of the valve core body 22 adjacent to the axial through hole 220. The cover 225 is similar to a hatch. When subjected to a distal thrust, the cover 225 rotates relative to the valve core body 221 and away from the axial through hole 220, thereby exposing the axial through hole 220 and opening it. Specifically, the distal end of the expander 70 passes through the axial through hole 220 and pushes the proximal end of the cover body 225 facing the axial through hole 220, so that the cover body 225 rotates and leaves the axial through hole 220 to release the cover body 225 from closing the axial through hole 220. At this time, the connection part between the cover body 225 and the valve core body 221 is elastically deformed; when the expander 70 retreats, the thrust pushing the cover body 225 toward the distal end disappears, and the cover body 225 will reset under the action of its own elastic recovery and close the axial through hole 220 again, so that the axial through hole 220 is in a closed state, and the blood will press the cover body 225 toward the proximal end, so that the cover body 225 closes more quickly and reliably. Only when the thrust toward the distal end of the cover body 225 is greater than the pressure of the blood on the cover body 225, will the cover body 225 be pushed open. Specifically, when the expander 70 withdraws from the axial through hole 220 and releases the resistance to the cover body 225 , the connection portion between the cover body 225 and the valve core body 221 elastically resets and drives the cover body 225 to reset, thereby closing the axial through hole 220 .

[0045] The axial through hole 220 extends along the axial direction of the tube body 50 and passes through the proximal and distal surfaces of the valve core body 221. Specifically, the axial through hole 220 is opened in the middle position of the valve core body 221 along the axial direction of the valve core body 221. The valve core body 221 is provided with a plurality of inner flanges 2212 axially spaced on the inner peripheral wall of the axial through hole 220. Each inner flange 2212 is arranged in a circle along the inner peripheral wall of the axial through hole 220, and an annular groove 2214 is formed between each two adjacent inner flanges 2212. Because the inner flanges 2212 are made of elastic waterproof material, when the outer peripheral wall of the expander 70 squeezes each inner flange 2212, the inner flange 2212 will elastically deform and be accommodated in the corresponding annular groove 2214. Therefore, the inner diameter of the axial through hole 220 determines the maximum diameter of the sheath core (i.e., a dilator or other diagnostic and therapeutic device) that can pass through it. The inner diameter of the inner flange 2212 determines the interference fit between the inner flange 2212 and the sheath core, as well as the minimum diameter of the sheath core that can pass through it. Theoretically, a larger interference fit results in a better sealing effect. However, an excessive interference fit can also result in greater resistance to the sheath core during pumping. The inner diameters of the axial through hole 220 and inner flange 2212 can be adaptively designed based on the actual diameter range of the sheath core to be inserted. This ensures that the hemostatic valve 20 provides an effective seal even for sheath cores with larger diameters. The hemostatic valve 20 of the present invention is suitable for use with large sheaths ranging from 24F to 15F. Preferably, the inner diameter of the inner flange 2212 is 5mm-10mm smaller than the inner diameter of the axial through hole 220. When a dilator 70 having a diameter greater than the inner diameter of the inner flange 2212 is inserted into the axial through hole 220, the interference fit between the inner flange 2212 and the dilator 70 provides a seal, preventing blood from leaking between the dilator 70 and the inner circumference of the axial through hole 220 when the cover 225 is opened. The number of inner flanges 2212 is not limited, but is preferably 1-3. In this embodiment, the number of inner flanges 2212 is 3.

[0046] like Figure 6 and Figure 7 As shown, a first stop structure is provided on one of the distal end of the valve core body 221 or the proximal end of the cover body 225, and a second stop structure adapted to the first stop structure is provided on the other. The first stop structure and the second stop structure are interlocked to form a stop, so that the cover body 225 can tightly and sealingly cover the axial through hole 220 of the valve core body 221.

[0047] In this embodiment, the distal end surface of the valve core body 221 is provided with a stepped hole 2217 coaxial with the axial through hole 220, serving as the first stop structure. The diameter of the stepped hole 2217 is larger than the diameter of the axial through hole 220 and smaller than the outer diameter of the cover 225. The proximal end of the cover 225 is provided with an annular flange 2251 that mates with the stepped hole 2217, serving as the second stop structure. The annular flange 2251 engages with the stepped hole 2217 to form a stop. When the cover 225 is placed over the valve core body 221, the annular flange 2251 engages with the stepped hole 2217. It will be appreciated that in other embodiments, the annular flange may be provided on the distal end surface of the valve core body 221, while the stepped hole is provided at the proximal end of the cover 225.

[0048] In this embodiment, the stepped hole 2217 extends along the edge of the axial through hole 220 and communicates with the axial through hole 220. Because the inner diameter of the stepped hole 2217 is larger than the inner diameter of the axial through hole 220, the valve core body 221 forms a stepped surface 2218 between the stepped hole 2217 and the axial through hole 220. Because the inner diameter of the stepped hole 2217 is smaller than the outer diameter of the cover body 225, the cover body 225 is prevented from being trapped in the stepped hole 2217. Preferably, the inner diameter of the stepped hole 2217 is approximately two-thirds of the diameter of the cover body 225. The outer diameter of the annular flange 2251 is equal to or slightly larger than the inner diameter of the stepped hole 2217. When the cover 225 is placed on the valve core body 221, the annular flange 2251 can be tightly inserted into the stepped hole 2217, and the annular flange 2251 abuts against the stepped surface 2218, thereby closing the axial through hole 220 and preventing the cover 225 from sinking into the axial through hole 220. When the cover 225 is placed on the valve core body 221, the cover 225 can effectively seal the distal end of the axial through hole 220. When the hemostatic valve 20 is used in the sheath tube 10 and the catheter sheath assembly 100, after the cover 225 closes the axial through hole 220, the blood pressure in the tube body 50 will further press the cover 225 toward the proximal end, further improving the sealing reliability and sealing effect of the hemostatic valve 20.

[0049] In other embodiments, the second stop structure may also be a plate body that can be accommodated in the step hole 2217, that is, the plate body may be a circular plate protruding from the proximal end of the cover body 225 toward the side of the axial through hole 220, the diameter of the circular plate is equal to or slightly larger than the inner diameter value of the step hole 2217, the circular plate can be sealedly accommodated in the step hole 2217, and the proximal end surface of the circular plate abuts against the step surface 2218.

[0050] Combine Figures 4 to 7 as well as Figure 16 and Figure 17 The outer circumference of the valve core 22 is in sealed contact with the valve body 25. Preferably, the outer circumference of the valve core 22 and the valve body 25 are positioned by the fit of a positioning ring and a positioning groove. Specifically, a positioning ring 2219 is provided on the outer circumference of the valve core body 221, and a positioning groove 2526 is defined within the valve body 25 to fit with the positioning ring 2219. When the valve core 22 is accommodated within the valve body 25, the positioning ring 2219 engages with the corresponding positioning groove 2526 to prevent the valve core body 221 from sliding axially. Furthermore, the positioning ring 2219 and the positioning groove 2526 form a radial interference fit, preventing blood from leaking between the valve core 22 and the valve body 25. The number of positioning rings 2219 is not limited, but is preferably one or two. In this embodiment, the number of the positioning snap ring 2219 is one, and the positioning snap ring 2219 is provided in a continuous circle along the circumferential direction of the outer circumference of the valve core body 221 .

[0051] like Figure 4 As shown, the cover body 225 is provided with a plurality of reinforcing ribs 2255, which are used to strengthen the strength of the cover body. Specifically, a plurality of reinforcing ribs 2255 are provided on the distal surface and / or the proximal surface of the cover body 225 to strengthen the strength of the cover body 225 to prevent the cover body 225 from warping and deforming toward the distal end under the pressure of a large blood pressure, thereby causing bleeding. Furthermore, the plurality of reinforcing ribs 2255 can be evenly distributed crosswise through the center of the circle of the cover body 225, or can be distributed in a crisscross pattern or other distribution forms. In this embodiment, the reinforcing ribs 2255 are provided on the distal surface of the cover body 225, and the reinforcing ribs 2255 are evenly distributed crosswise through the center of the circle of the cover body 225.

[0052] The cover 225 is connected to the valve core body 221 via an elastic connecting portion 226. In this embodiment, the connecting portion 226 is an elastic connecting piece connected between the cover 225 and the valve core body 221. The elastic connecting piece extends along the periphery of the axial through hole 220 and is basically an arc-shaped entity. The connecting portion 226 forces the cover 225 to automatically close the axial through hole 220 in a natural state. The natural state refers to a state in which the cover 225 is not subject to external forces. After the cover 225 is opened, the connecting portion 226 elastically resets, driving the cover 225 to automatically close. In addition, due to the pressure of blood on the cover 225, the cover 225 will close the axial through hole 220 more quickly and tightly. Figure 5As shown, when the cover 225 closes the axial through hole 220, the cross section of the connecting portion 226 is L-shaped or arc-shaped. In this embodiment, the valve core body 221, the cover 225 and the connecting portion 226 are made of an elastic waterproof material in one piece.

[0053] Please also refer to Figures 8 to 10 Another structural form of the valve core of the present invention is similar to that of the first embodiment, except that in this structural form, the connection portion 226a between the cover 225 and the valve core body 221 is a plurality of elastic connecting rods. These elastic connecting rods are capable of elastically returning to their original position and automatically driving the cover 225 to close the axial through hole 220 of the valve core body 221. The plurality of elastic connecting rods are spaced apart from one another, and preferably, are spaced apart from one another along the periphery of the axial through hole 220.

[0054] The connecting portion 226a can be connected between the cover body 225 and the valve core body 221 as an independent component; the connecting portion 226a can also be made of an elastic waterproof material and integrally formed with the valve core body 221 and the cover body 225.

[0055] See also Figure 11 Another structural form of the valve core in the present invention is similar to the structure of the first embodiment, except that: in the valve core in another structural form, the distal end surface of the valve core body 221 is convexly provided with an annular flange 2211, and the annular flange 2211 serves as a first stop structure; a positioning annular groove 2257 adapted to the annular flange 2211 is provided on the cover body 225 as a second stop structure, and when the cover body 225 closes the axial through hole 220, the annular flange 2211 is clamped in the positioning annular groove 2257.

[0056] In the further embodiment of the valve core, the annular flange 2211 is protruding from the distal end surface of the valve core body 221 and surrounds the edge of the axial through hole 220. The positioning annular groove 2257 is formed on the proximal end surface of the cover 225. When the cover 225 closes the axial through hole 220, the annular flange 2211 is engaged with the positioning annular groove 2257.

[0057] See also Figure 12Another structural form of the valve core in the present invention is similar to that of the first embodiment, except that: in this structural form of the valve core, the outer circumferential surface of the valve core body 221 is provided with at least one positioning groove 2213 along its circumference. A positioning ring corresponding to the positioning groove 2213 is provided within the valve body 25. When the valve core 22 is accommodated within the valve body 25, the positioning ring of the valve body 25 engages with the corresponding positioning groove 2213 to prevent the valve core body 221 from sliding axially. The positioning ring and the positioning groove 2213 form a radial interference fit, which can prevent blood from leaking between the valve core 22 and the valve body 25. The number of positioning grooves 2213 is not limited, but is preferably one or two. In this embodiment, the positioning grooves 2213 are provided in a continuous circle along the outer circumference of the valve core body 221.

[0058] Please also refer to Figures 13 to 16 The valve body 25 can be made of a polymer material or a metal material. Preferably, the valve body 25 in this embodiment is made of a transparent PC material. The valve body 25 includes a valve housing 252 and a valve cover 255 connected to the valve housing 252. Specifically, the valve cover 255 is detachably connected to the proximal end of the valve housing 252. The valve body 25 is provided with a cavity 256 that passes through the valve housing 252 and the valve cover 255 along the axial direction of the tube body 50. The valve housing 252 is basically a tubular body, and the outer shape of the valve housing 252 can be a cylindrical tubular body, a rectangular tubular body, a polygonal tubular body or a tubular body of other shapes. In this embodiment, the valve housing 252 is a cylindrical tubular body, and the cavity 256 axially passes through the distal end surface and the proximal end surface of the valve housing 252. A receiving space 2520 coaxial with the cavity 256 is defined in the valve housing 252 . The inner diameter of the receiving space 2520 is greater than the inner diameter of the cavity 256 . The receiving space 2520 is used to receive the valve body 22 .

[0059] Specifically, the receiving space 2520 includes a positioning section 2522 and a relief section 2524 axially connected to the positioning section 2522. The positioning section 2522 is used to position the valve core body 221, and the relief section 2524 is used to provide space for opening the cover body 225 of the valve core 22. Specifically, the positioning section 2522 and the relief section 2524 are coaxial, and the positioning section 2522 and the relief section 2524 are arranged in sequence from the proximal end to the distal end of the valve core body 221. That is, the positioning section 2522 is located at the proximal end of the valve housing 252 and extends through the proximal end surface of the valve housing 252. The relief section 2524 is located at the distal end of the positioning section 2522. The inner diameter of the positioning section 2522 is equal to or slightly smaller than the outer diameter of the valve core body 221, thereby sealingly contacting the outer circumference of the valve core body 221 with the inner circumference of the positioning section 2522 within the receiving space 2520. The inner diameter of the positioning section 2522 is greater than the inner diameter of the relief section 2524, forming a positioning surface 2535 between the positioning section 2522 and the relief section 2524 within the valve housing 252. When the valve core body 221 is received within the positioning section 2522, the distal end of the valve core body 221 can contact the positioning surface 2535. The inner diameter of the relief section 2524 is greater than the outer diameter of the cover 225 of the valve core 22, and the axial extension of the relief section 2524 is greater than the outer diameter of the cover 225. Therefore, when the cover 225 is opened, the cover 225 can be completely received within the relief section 2524.

[0060] The outer circumferential surface of the valve body 22 and the inner circumferential surface of the positioning section 2522 of the receiving space 2520 are positioned by engaging a positioning snap ring with a positioning slot. Specifically, in this embodiment, at least one annular positioning slot 2526 is provided on the inner wall surface of the positioning section 2522 of the receiving space 2520 of the valve core body 221. The at least one positioning slot 2526 is arranged along the circumference of the positioning section 2522. The inner diameter of the positioning slot 2526 is greater than the inner diameter of the positioning section 2522. The positioning slot 2526 is used to engage the positioning snap ring 2219 of the valve core body 221, thereby positioning the valve core 22 in the valve housing 252 and preventing it from moving axially. Furthermore, the inner diameter of the positioning groove 2526 is slightly smaller than the outer diameter of the positioning snap ring 2219 of the valve core body 221, and the axial extension length of the positioning groove 2526 is greater than the axial extension length of the positioning snap ring 2219 of the valve core body 221. When the valve body 22 is accommodated in the accommodation space 2520, the positioning snap ring 2219 of the valve core body 221 and the positioning groove 2526 form a radial interference fit, thereby preventing blood from leaking between the outer circumference of the valve body 22 and the inner circumference of the valve housing 252. In addition, there is an axial deformation space between the positioning snap ring 2219 and the positioning groove 2526. When the valve core body 221 is squeezed, the positioning snap ring 2219 can fill the deformation space, thereby sealing the valve core 22 and the valve body 25 in the radial direction.

[0061] It is understood that in other embodiments, at least one annular positioning snap ring is convexly provided on the inner wall surface of the positioning section 2522 of the receiving space 2520 of the valve housing 252, and at least one positioning snap ring is arranged along the circumference of the positioning section 2522. The inner diameter of the positioning snap ring is smaller than the inner diameter of the positioning section 2522, and the positioning snap ring is used to be clamped to the valve housing 252. Figure 12 The spool body 221 is shown as a locating retaining ring, thereby preventing the spool 22 from moving in the axial direction. Specifically, the inner diameter of the locating retaining ring is slightly smaller than the inner diameter of the locating retaining ring 2213, so that the locating retaining ring and the locating retaining ring 2213 form an interference fit in the radial direction, thereby preventing blood from leaking between the outer circumference of the valve body 22 and the inner circumference of the valve housing 252.

[0062] In one embodiment, the distal end of the valve housing 252 is provided with an internal thread 2527 on the inner wall surface of the cavity 256. The internal thread 2527 is used to thread the valve body 25 onto the handle 54. The outer circumference of the distal end of the valve housing 252 is provided with several anti-slip strips to facilitate gripping. The outer circumference of the proximal end of the valve housing 252 is provided with an external thread 2528, which is used to connect to the valve cover 255. The valve housing 252 is also provided with a through hole 2529 that radially extends into the cavity 256. Specifically, the through hole 2529 extends to the avoidance section 2524 of the receiving space 2520. The through hole 2529 is used to connect to a three-way valve located outside the valve body 25.

[0063] The outer shape of the valve cover 255 can be cylindrical, rectangular, polygonal, or other shapes. In a specific embodiment, the valve cover 255 is cylindrical. The valve cover 255 includes a circular proximal end plate 2552, an annular side plate 2553 extending from the peripheral edges of the proximal end plate 2552 toward the distal end, and an extrusion block 2555 protruding from the middle of the proximal end plate 2552 toward the distal end. There is a gap between the extrusion block 2555 and the side plate 2553. The inner circumference of the side plate 2553 is provided with an internal thread 2556. The internal thread 2556 cooperates with the external thread 2528 provided at the proximal end of the valve housing 252 to facilitate the connection of the valve cover 255 to the proximal end of the valve housing 252. The cavity 256 axially passes through the extrusion block 2555 and the proximal end plate 2552.

[0064] See also Figure 2 、 Figure 3 and Figure 17 When assembling the hemostatic valve 20, the distal end of the valve core 22, equipped with the cover 225, is inserted into the receiving space 2520 from the proximal end of the valve housing 252 until the valve core body 221 of the valve core 22 is received in the positioning section 2522 and the cover 225 is received in the avoidance section 2524. At this point, the positioning snap ring 2219 is engaged with the positioning groove 2526. The outer circumference of the valve core body 221 is tightly fitted with the inner circumference of the positioning section 2522. The positioning snap ring 2219 forms an interference fit with the positioning groove 2526. The cover 225 seals the axial through hole 220 of the valve core body 221, and the annular flange 2251 is engaged with the stepped hole 2217, thereby forming a sealed connection between the valve core 22 and the valve housing 252. The valve cover 255 is then screwed onto the proximal end of the valve housing 252.

[0065] Please also refer to Figures 18 to 22Taking atrial septal puncture as an example, the practical process of the catheter sheath assembly 100 is as follows: first, the distal end of the hemostatic valve 20 is connected to the proximal end of the handle 54 of the sheath tube 10. Specifically, the proximal end of the handle 54 is provided with a connecting tube 55 with external threads, and the internal threads 2527 of the distal end of the valve housing 252 of the hemostatic valve 20 are screwed onto the external threads of the connecting tube 55. Then, the blood vessel puncture is performed, and the distal end of the tube body 50 of the sheath tube 10 is delivered to the adjacent atrial septum. At this time, the cover body 225 of the hemostatic valve 20 closes the axial through hole 220. Under the action of blood pressure, the cover body 225 fits tightly on the valve core body 221 to prevent blood leakage and gas from entering the body; then, the dilator 70 is inserted into the sheath tube 10. Specifically, when the distal end of the dilator 70 pushes against the proximal end surface of the cover body 225 of the valve core 22, the cover body 225 is separated from the valve core 22. The core body 221 is fitted until the distal end of the expander 70 completely opens the cover body 225, and the cover body 255 is accommodated in the avoidance section 2524 of the accommodating space 2520, and the connection part 226 between the cover body 225 and the valve core body 221 is elastically deformed; the expander 70 can continue to be pushed to the distal end to reach the specified position. In this process, the inner flange 2212 in the axial through hole 220 is interference fit with the expander 70 to perform a seal to prevent blood leakage and gas from entering the body. Then, a puncture needle is inserted into the dilator 70 so that the puncture needle punctures the atrial septum of the heart. After the puncture is completed, the puncture needle is put into the dilator 70 and withdrawn together with the dilator 70. During the withdrawal of the dilator 70, when the distal end of the dilator 70 withdraws into the axial through hole 220 of the valve core body 221, the dilator 70 releases the push on the cover body 225. The elastic restoring force of the connecting portion 226 between the cover body 225 and the valve core body 221 and the blood pressure pressure cause the cover body 225 to instantly return to its initial position and fit with the valve core body 221, that is, the cover body 225 closes the axial through hole 220 of the valve core body 221 for sealing, and the annular flange 2251 is stuck in the step hole 2217. Therefore, during the backward withdrawal of the dilator 70, no blood will leak or gas will enter the body. The hemostatic valve 20 can play a reliable and good sealing role throughout the operation. The hemostatic valve 20 of the present invention ensures a good sealing effect for dilators 70 with larger outer diameters by adaptively designing the dimensions of the cover 225, axial through-hole 220, and inner flange 2212. This overcomes the diameter limitations of existing hemostatic valves for dilators or other diagnostic and therapeutic instruments, making it particularly suitable for sealing dilators 70 or other diagnostic and therapeutic instruments with larger diameters. Furthermore, the provision of an openable and closable cover 225 and the plurality of inner flanges 2212 disposed within the axial through-hole 220 of the valve core body 221 can minimize the resistance applied to the dilator 70 during its advancement.

[0066] After atrial septal puncture, if other diagnostic and treatment instruments need to be delivered, they can be delivered through the inner cavity of the tube body 50 and the axial through hole 220 of the hemostatic valve 20 .

[0067] The hemostatic valve 20 of the present invention can reliably seal throughout the entire process with excellent sealing effect, eliminating the risk of bleeding and gas entering the body, improving the safety and success rate of the operation, and only needs to push or withdraw the expander 70 or other diagnostic and treatment equipment, without the need for additional operation on the hemostatic valve 20, so it is simple to operate and easy to use.

[0068] In other embodiments, the hemostatic valve 20 and the sheath tube 10 may be connected by means of clamping, gluing, or welding, so as to ensure that the cavity 256 of the hemostatic valve 20 is connected to the sheath tube 10 .

[0069] Please also refer to Figures 23 to 25 The structure of the catheter sheath assembly provided in the second embodiment of the present invention is similar to that of the first embodiment, except that, in the second embodiment, the hemostatic valve 20 further includes an elastic gasket 27, which is clamped between the valve core body 22 and the valve cover 255. Axial movement of the valve cover 255 compresses and deforms the elastic gasket 27. Specifically, the elastic gasket 27 defines an axial through-hole 272 that communicates with the axial through-hole 220 of the valve core body 22. The inner diameter of the through-hole 272 is equal to or slightly smaller than the outer diameter of the dilator 70, thereby creating an interference fit between the inner circumference of the through-hole 272 of the elastic gasket 27 and the outer circumference of the dilator 70, thereby achieving a seal when the dilator 70 is inserted. By driving the valve cover 255 axially distally or proximally, the valve cover 225 compresses or releases the elastic gasket 27, causing the elastic gasket 27 to deform and thereby control the diameter of the through-hole 272 within the elastic gasket 27 to decrease or increase. Specifically, tightening or loosening the valve cover 255 causes the extrusion block 2555 of the valve cover 255 to compress or loosen the elastic gasket 27, which can deform the elastic gasket 27 to control the reduction or expansion of the inner diameter of the through hole 272 of the elastic gasket 27 to accommodate expanders 70 with different outer diameters.

[0070] The elastic gasket 27 can be cylindrical, polygonal, etc. Preferably, the elastic gasket 27 is cylindrical. The elastic gasket 27 is made of materials such as silicone, elastic rubber, elastic plastic, etc. In this embodiment, the elastic gasket 27 is made of silicone.

[0071] In this embodiment, since the hemostatic valve 20 is provided with a cover body 225, after the expander 70 is withdrawn, the cover body 225 automatically closes the axial through hole 220, and there is no need to tighten the valve cover 255 to reduce the inner diameter of the through hole 272 of the elastic gasket 27 to 0 for sealing.

[0072] In this embodiment, the inner flange 2212 provided on the inner peripheral wall of the axial through hole 220 of the valve core body 22 can be omitted.

[0073] The above is an implementation of the embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the embodiment of the present invention. These improvements and modifications are also considered to be within the scope of protection of the present invention.

Claims

1. A hemostatic valve, characterized in that: The valve body comprises a valve core disposed in the valve body, wherein the valve core comprises a valve core body and a cover body connected to the distal end of the valve core body, an axial through hole is formed in the valve core body, and the cover body opens or automatically closes relative to the valve core body to expose or seal the axial through hole accordingly; The valve core further includes an elastic connecting portion, and the cover body is connected to the distal end of the valve core body through the connecting portion adjacent to the axial through hole, and the connecting portion forces the cover body to automatically close the axial through hole in a natural state; A first stop structure is provided on one of the distal end of the valve core body and the proximal end of the cover body, and a second stop structure adapted to the first stop structure is provided on the other, and the first stop structure and the second stop structure are interlocked to form a stop; a step hole coaxial with the axial through hole is provided at the distal end of the valve core body as the first stop structure, the aperture of the step hole is larger than the aperture of the axial through hole and smaller than the outer diameter of the cover body, and an annular flange adapted to the step hole is provided at the proximal end of the cover body as the second stop structure; a step surface is formed between the valve core body and the axial through hole, the annular flange is stuck in the step hole, and the annular flange abuts against the step surface; the inner diameter of the step hole is smaller than the outer diameter of the cover body, which can prevent the cover body from sinking into the step hole; A plurality of reinforcing ribs are provided on the distal end and / or the proximal end of the cover body.

2. The hemostatic valve according to claim 1, characterized in that The connecting portion is an elastic connecting piece connected between the cover body and the valve core body, and the elastic connecting piece extends along the periphery of the axial through hole.

3. The hemostatic valve according to claim 1, characterized in that The connecting portion is a plurality of elastic connecting rods connected between the cover body and the valve core body, and the plurality of elastic connecting rods are arranged at intervals along the periphery of the axial through hole.

4. The hemostatic valve according to claim 1, characterized in that A plurality of inner flanges spaced apart in the axial direction are provided on the inner peripheral wall of the axial through hole, and each inner flange is arranged in a circle along the circumferential direction of the inner peripheral wall of the axial through hole.

5. The hemostatic valve according to claim 1, characterized in that The valve body is provided with a cavity running through its proximal end surface and distal end surface, and the cavity has a receiving space; the receiving space includes a positioning section and an avoidance section which are arranged in sequence from near to far and are coaxial, the positioning section is used to position the valve core body, and the avoidance section is used to provide space for opening the cover body.

6. The hemostatic valve according to claim 5, characterized in that: A positioning snap ring is provided on one of the outer peripheral surface of the valve core body or the positioning section of the accommodating space, and a positioning groove adapted to the positioning snap ring is provided on the other. The positioning snap ring is inserted into the positioning groove and has an interference fit in the radial direction.

7. The hemostatic valve according to claim 5, characterized in that The valve body includes a valve housing and a valve cover connected to the proximal end of the valve housing. The accommodating space is located at one end of the valve housing adjacent to the valve cover.

8. The hemostatic valve according to claim 7, characterized in that The hemostatic valve also includes an elastic gasket, which is clamped between the valve core and the valve cover. The elastic gasket is provided with a through hole connected to the axial through hole of the valve core body. The valve cover is driven to move axially toward the distal end or the proximal end so that the valve cover presses or loosens the elastic gasket, so that the elastic gasket is deformed to control the reduction or expansion of the aperture of the through hole in the elastic gasket.

9. A sheath tube, characterized in that: It comprises a tubular body with a certain axial length and the hemostatic valve according to any one of claims 1 to 8, wherein the hemostatic valve is arranged at the proximal end or adjacent to the proximal end of the tubular body.

10. The sheath tube according to claim 9, characterized in that It also includes a handle arranged at the proximal end of the tube body, and the hemostatic valve is arranged at the proximal end or the distal end of the handle.

11. The sheath tube according to claim 9, characterized in that The pipe body is an adjustable bend pipe body or a non-adjustable bend pipe body.

12. A catheter sheath assembly, characterized in that: It comprises the sheath tube as described in any one of claims 9 to 11, and further comprises an expander, which is movably installed in the axial through hole of the tube body and the valve core body of the hemostatic valve; the expander pushes the cover body of the valve core body toward the distal end to release the cover body from closing the axial through hole; when the expander is withdrawn, the cover body automatically resets to close the axial through hole.

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