An adjustable hemostatic valve device

Abstract

This invention relates to an adjustable hemostatic valve device, comprising a catheter sheath housing, a catheter sheath cap, a seal, and an opening adjustment mechanism. The catheter sheath housing and the catheter sheath cap are connected and axially movable relative to each other. The seal and the opening adjustment mechanism are connected and disposed within the catheter sheath housing. The opening adjustment mechanism includes a first positioning plate and a mounting cylinder. The seal is fixedly connected to the first positioning plate and then installed within the mounting cylinder. The seal includes an axially extending spiral flow channel. The distal end of the seal is fixed to the mounting cylinder, and the proximal end is fixedly connected to the first positioning plate. Multiple first positioning pins are distributed on the outer periphery of the first positioning plate, and multiple spiral sliding guide grooves are formed at the proximal end of the mounting cylinder. The axial movement of the catheter sheath cap allows the first positioning pins of the first positioning plate to slide along the sliding guide grooves of the mounting cylinder, compressing and rotating or releasing and rotating the seal to adjust the opening size of the spiral flow channel of the seal.

Description

Technical Field

[0001] This invention relates to the field of medical devices, and in particular to an adjustable hemostatic valve device. Background Technology

[0002] Interventional therapy is a minimally invasive procedure that uses medical imaging equipment to guide the introduction of specialized guidewires, catheter sheaths, and other precision instruments into the human body for diagnosis and local treatment of internal diseases. It can treat diseases that were previously untreatable or had poor treatment outcomes, and it also has the advantages of minimal trauma, rapid recovery, and good results, making it one of the future directions of medical development.

[0003] During interventional procedures, one or more catheter sheaths are typically inserted into a blood vessel or tissue lumen using vascular puncture techniques, extending to the vicinity of the targeted tissue or structure. This establishes a channel from outside the body to the internal surgical tissue lumen, used to deliver minimally invasive surgical instruments and medications, or to enable real-time medical imaging monitoring within the body. To prevent air from entering the blood vessel through the catheter sheath, reduce blood loss during the procedure, and ensure vascular sterility, the catheter sheath used in interventional procedures must be fitted with a hemostatic valve with a certain degree of sealing. Firstly, effective sealing is required when instruments are inserted into or withdrawn from the sheath. Secondly, the frictional resistance generated by the hemostatic valve during instrument movement should be as minimal as possible; otherwise, it will affect the surgeon's control of the instruments during the procedure.

[0004] Traditional hemostatic valves are typically made of elastic materials such as silicone or silicone rubber. The valve body has a pre-cut slot (straight, cross, or circular) in the center, and its sealing is achieved by compressing the silicone elastomer. The size of the opening determines the size of the instruments that can pass through. When surgery requires the passage of large instruments and catheters, on the one hand, excessive deformation of the silicone can lead to failure, and on the other hand, the friction with the instruments increases dramatically, affecting the surgeon's control and increasing the difficulty and risk of the surgery. Furthermore, after the instruments are withdrawn, the silicone elastomer is difficult to return to its original position, and the channel loses its seal.

[0005] The preceding description is intended to provide general background information and does not necessarily constitute prior art. Summary of the Invention

[0006] The purpose of this invention is to provide an adjustable hemostatic valve device, which can adjust the size of the opening of the sealing element in the adjustable hemostatic valve device to accommodate the passage of surgical instruments of different sizes, and maintain good sealing performance and pushing performance when they pass through.

[0007] This invention provides an adjustable hemostatic valve device, including a catheter sheath and a seal. The catheter sheath is hollow inside, and the seal is located inside the catheter sheath. The seal is an elastic element and includes a spiral flow channel extending axially. The proximal and distal ends of the catheter sheath can move relative to each other axially. When the proximal end of the catheter sheath moves axially, it can compress and rotate or release and rotate the seal. The opening size of the spiral flow channel of the seal can be adjusted to accommodate surgical instruments of different sizes passing through the spiral flow channel.

[0008] Furthermore, the catheter sheath includes a distal catheter sheath shell and a proximal catheter sheath cap, which are axially movable relative to each other. The distal end of the catheter sheath cap extends inward to form a limiting ring, and the catheter sheath shell is provided with a limiting protrusion near the proximal end. The limiting ring of the catheter sheath cap and the limiting protrusion of the catheter sheath shell cooperate with each other to limit the relative displacement stroke between the catheter sheath cap and the catheter sheath shell.

[0009] Furthermore, it also includes an opening adjustment mechanism, which includes a first positioning plate and an installation cylinder. The first positioning plate is fixedly connected to the proximal end of the seal. After the seal is fixedly connected to the first positioning plate, it is installed inside the installation cylinder. Multiple first positioning pins are distributed on the outer periphery of the first positioning plate. Multiple spiral sliding guide grooves that cooperate with the positioning pins are formed at the proximal end of the installation cylinder. When the sheath cap of the conduit sheath moves axially, the first positioning pins of the first positioning plate slide along the sliding guide grooves of the installation cylinder to adjust the opening size of the spiral flow channel of the seal.

[0010] Furthermore, the opening adjustment mechanism also includes a second positioning plate, which is fixedly connected to the distal end of the seal. Multiple second positioning pins are distributed around the outer periphery of the second positioning plate, and multiple positioning holes are formed at the distal end of the mounting cylinder. The second positioning pins of the second positioning plate cooperate with the positioning holes of the mounting cylinder to fix the distal end of the seal to the mounting cylinder.

[0011] Furthermore, the first positioning plate and the second positioning plate are both provided with a first step on the surface near the seal, and the corresponding positions at both ends of the seal are provided with a second step. The first step and the second step are staggered in the circumferential direction, and the first positioning plate and the second positioning plate are bonded to the seal through the first step and the second step.

[0012] Furthermore, it also includes a one-way valve, which is axially positioned at both ends or in the middle of the seal.

[0013] Furthermore, a push ring is formed on the inner side of the catheter sheath cap, and the distal end of the push ring contacts the proximal end of the first positioning plate. When the catheter sheath cap moves axially, the push ring is linked with the first positioning plate.

[0014] Furthermore, it also includes a retaining ring, which is fixedly connected to the proximal end of the mounting cylinder. The outer periphery of the retaining ring is threadedly connected to the proximal inner wall of the catheter sheath housing, thereby fixing the mounting cylinder inside the catheter sheath housing.

[0015] Furthermore, the catheter sheath cap is threaded to the proximal end of the catheter sheath shell, and its axial movement along the catheter sheath shell can be controlled by rotating the catheter sheath cap.

[0016] Furthermore, it also includes a spring and a driving component. The spring is sleeved on the catheter sheath housing and located between the limiting ring of the catheter sheath cap and the limiting protrusion of the catheter sheath housing. The catheter sheath housing and the catheter sheath cap are in clearance fit. The driving component is rotatably fixed on the catheter sheath housing. The end of the driving component has a cam structure. The cam structure contacts the distal end of the catheter sheath cap and is used to control the displacement of the catheter sheath cap. Under the combined action of the spring and the cam structure, the catheter sheath cap can move axially along the catheter sheath housing.

[0017] Furthermore, the driving component includes a pressing part and a cam structure extending from both sides of the pressing part. The cam structure is provided with a mounting shaft, through which the driving component is rotatably fixed to the catheter sheath housing.

[0018] The adjustable hemostatic valve device of the present invention has the following beneficial effects:

[0019] (1) An adjustable hemostatic valve device, comprising a sealing element made of silicone or silicone rubber, which includes a spiral flow channel located in the middle of the sealing element along the axial direction and a straight flow channel located at both ends of the spiral flow channel, thereby achieving the function of adjusting the size of the opening of the sealing element by compressing and rotating the spiral flow channel at the center of the sealing element;

[0020] (2) The sealing element is equipped with a one-way valve with three or more leaflets to further enhance its sealing performance, so that it can be used when the pressure difference between the far and near ends is large.

[0021] (3) The opening adjustment mechanism is composed of a first positioning plate, a second positioning plate and an installation cylinder. The first positioning plate and the second positioning plate are provided with a first positioning pin and a second positioning pin. The installation cylinder is provided with a spiral guide groove. The compression and rotation of the sealing element are achieved by axially pushing and pulling the first positioning plate, thereby adjusting the opening size of the sealing element in the adjustable hemostatic valve device.

[0022] (4) A movable catheter sheath cap with a threaded structure, which can precisely control the axial movement of the catheter sheath cap by rotating the thread, thereby pushing the first positioning plate and realizing precise control of the opening size of the seal in the adjustable hemostatic valve device.

[0023] (5) The cam structure of the spring and the drive unit enables the catheter sheath cap to move axially along the catheter sheath housing. The size of the opening of the seal in the adjustable hemostatic valve device is controlled by the drive unit to allow the instrument to pass through. After the drive unit is released, the spring automatically resets and pushes the catheter sheath cap to move axially to maintain the seal. The drive unit and the spring cooperate with each other to achieve adaptive adjustment for instruments of different diameters. Attached Figure Description

[0024] Figure 1 This is an exploded schematic diagram of the adjustable hemostatic valve device in Example 1;

[0025] Figure 2 This is a cross-sectional view of the adjustable hemostatic valve device in Example 1;

[0026] Figure 3 This is a schematic diagram of the seal when it is not compressed and is rotating.

[0027] Figure 4 This is a cross-sectional view of the seal when it is not compressed and rotated.

[0028] Figure 5 This is a schematic diagram of the seal when it is compressed and rotated.

[0029] Figure 6 A cross-sectional view of the seal when it is compressed and rotated.

[0030] Figure 7 This is a schematic diagram of the assembly structure of the seal with the first and second positioning discs.

[0031] Figure 8 This is a schematic diagram of the mounting cylinder;

[0032] Figure 9 This is a schematic diagram of the assembly of the seal and the check valve;

[0033] Figure 10 This is an exploded schematic diagram of the adjustable hemostatic valve device in Example 2;

[0034] Figure 11 This is a schematic diagram of the adjustable hemostatic valve device in Example 2;

[0035] Figure 12 This is a cross-sectional view of the adjustable hemostatic valve device in Example 2;

[0036] Figure 13 This is a schematic diagram of the drive component in Example 2.

[0037] In the diagram, 1. Catheter sheath housing; 2. Catheter sheath cap; 3. Seal; 4. First positioning plate; 5. Mounting cylinder; 6. Second positioning plate; 7. Fixing ring; 8. One-way valve; 9. Sealing ring; 10. Spring; 11. Driving component; 12. Opening adjustment mechanism; 100. Adjustable hemostatic valve device; 101. Limiting protrusion; 102. Circular hole; 103. First cavity; 201. Pushing ring; 202. Limiting ring; 203. First thread; 204. Opening; 301. Spiral flow channel; 302. Straight flow channel; 303. Second step; 401. First positioning pin; 402. First step; 501. Sliding guide groove; 502. Positioning hole; 503. Second cavity; 601, Second locating pin; 701, Second thread; 1101, Cam structure; 1102, Pressing part; 1103, Connecting rod; 1104, Mounting shaft. Detailed Implementation

[0038] The specific embodiments of the present invention will be described in further detail below with reference to the accompanying drawings and examples. The following examples are for illustrative purposes only and are not intended to limit the scope of the invention.

[0039] First Embodiment

[0040] Please see Figures 1-2 An adjustable hemostatic valve device 100 includes a catheter sheath, a sealing element 3, and an opening adjustment mechanism 12. The catheter sheath is hollow inside and includes a catheter sheath shell 1 located at the distal end and a catheter sheath cap 2 located at the proximal end. Both the catheter sheath shell 1 and the catheter sheath cap 2 are provided with channels that allow surgical instruments to enter. The catheter sheath shell 1 has a first cavity 103 inside. The sealing element 3 and the opening adjustment mechanism 12 are connected and fixed in the first cavity 103 of the catheter sheath shell 1. The inner wall of the catheter sheath cap 2 and the outer wall of the proximal end of the catheter sheath shell 1 are both provided with a first thread 203. The catheter sheath cap 2 is threaded to the proximal end of the catheter sheath shell 1 through the first thread 203. Rotating the catheter sheath cap 2 can control its movement along the axial direction of the catheter sheath shell 1.

[0041] Please see Figures 2-6 The sealing element 3 is an elastic element, which is integrally molded from silicone or silicone rubber. It includes a spiral flow channel 301 located in the middle of the sealing element 3 along the axial direction and a straight flow channel 302 located at both ends of the spiral flow channel 301. The cross section of the spiral flow channel 301 can be a triangular or polygonal spiral.

[0042] Please see Figure 2 , Figure 7 and Figure 8The opening adjustment mechanism 12 includes a first positioning plate 4, a second positioning plate 6, and a mounting cylinder 5. The mounting cylinder 5 has a second cavity 503 inside. The sealing member 3 is installed in the second cavity 503 of the mounting cylinder 5 after being bonded or fused together with the first positioning plate 4 and the second positioning plate 6. For example, Figure 2 and Figure 7 As shown, the proximal end of the seal 3 is fixedly connected to the first positioning disk 4, and the distal end of the seal 3 is fixedly connected to the second positioning disk 6. Both the first positioning disk 4 and the second positioning disk 6 have a first step 402 (or pattern) on their surfaces near the seal 3, and corresponding positions at both ends of the seal 3 have a second step 303 (or pattern). The first step 402 and the second step 303 are staggered circumferentially. The first positioning disk 4 and the second positioning disk 6 are bonded to the seal 3 through the first step 402 and the second step 303, increasing the connection strength between the first positioning disk 4 and the second positioning disk 6 and the seal 3. For more details, please refer to the following: Figure 2 , Figure 7 and Figure 8 The first positioning disk 4 has multiple first positioning pins 401 evenly distributed around its outer periphery. The near end of the mounting cylinder 5 has multiple spiral sliding guide grooves 501 for mounting the first positioning disk 4. The first positioning disk 4 can slide along the sliding guide grooves 501. The displacement and rotation of the first positioning disk 4 are controlled by the cooperation of the first positioning pins 401 and the sliding guide grooves 501. The second positioning disk 6 has multiple second positioning pins 601 evenly distributed around its outer periphery. The far end of the mounting cylinder 5 has multiple positioning holes 502. The second positioning pins 601 of the second positioning disk 6 and the positioning holes 502 of the mounting cylinder 5 cooperate to fix the far end of the sealing member 3 to the mounting cylinder 5. In this embodiment, three of each of the first positioning pins 401, second positioning pins 601, positioning holes 502, and sliding guide grooves 501 are provided.

[0043] Please continue reading. Figure 2 , Figure 7 and Figure 8 A push ring 201 is formed on the inner side of the catheter sheath cap 2. The distal end of the push ring 201 contacts the proximal end of the first positioning disc 4. By rotating the catheter sheath cap 2, its axial movement along the catheter sheath housing 1 is controlled. When the catheter sheath cap 2 moves axially, the push ring 201 is linked with the first positioning disc 4, causing the first positioning pin 401 of the first positioning disc 4 to slide along the sliding guide groove 501 of the mounting cylinder 5, compressing the seal 3 and causing the proximal end of the seal 3 to rotate with the first positioning disc 4, realizing a combined compression and rotation motion of the seal 3, thereby adjusting the opening size of the spiral flow channel 301 at the center of the seal 3 to accommodate surgical instruments of different sizes passing through the spiral flow channel 301. More specifically, as Figure 2 , Figures 5-8As shown, when the catheter sheath cap 2 is rotated clockwise, the catheter sheath cap 2 moves forward along the axial direction of the catheter sheath housing 1. The pushing ring 201 on the catheter sheath cap 2 pushes the first positioning plate 4, and the first positioning pin 401 on the first positioning plate 4 slides spirally to the distal end along the sliding guide groove 501 on the mounting cylinder 5, rotating and squeezing the sealing element 3, thereby reducing the opening size of the sealing element 3 in the adjustable hemostatic valve device 100; Figures 2-4 , Figure 7 and Figure 8 As shown, when the catheter sheath cap 2 is rotated counterclockwise, the catheter sheath cap 2 retracts axially along the catheter sheath housing 1, and the push ring 201 on the catheter sheath cap 2 disengages from the first positioning plate 4. The elastic force of the seal 3 itself pushes the first positioning plate 4 to move proximally. The first positioning pin 401 on the first positioning plate 4 spirals proximally along the sliding guide groove 501 on the mounting cylinder 5 until it contacts the push ring 201 on the catheter sheath cap 2. Rotating and releasing the seal 3 increases the opening size of the seal 3 in the adjustable hemostatic valve device 100. Additionally, please refer to... Figure 1 and Figure 9 The adjustable hemostatic valve device 100 also includes a one-way valve 8, which is axially disposed at both ends or the middle of the sealing element 3. The one-way valve 8 has a three- or multi-leaf structure, which can further enhance the sealing performance of the sealing element 3 when the pressure difference between the two ends of the sealing element 3 is large, such as when the proximal end is under negative pressure. In this embodiment, the one-way valve 8 is disposed at the distal end of the sealing element 3. The leaflets of the one-way valve 8 are in a closed state by default. When a catheter needs to be inserted from the proximal end, the leaflets of the one-way valve 8 open to ensure the passage of the catheter. When the catheter is withdrawn, the shape of the leaflets of the one-way valve 8 returns to the closed state to maintain a better seal.

[0044] Please see Figure 2 A limiting ring 202 is formed inwardly on the inner wall of the distal end of the catheter sheath cap 2. A limiting protrusion 101 is provided around the proximal end of the catheter sheath housing 1. The limiting ring 202 of the catheter sheath cap 2 and the limiting protrusion 101 of the catheter sheath housing 1 cooperate with each other to limit the relative displacement travel between the catheter sheath cap 2 and the catheter sheath housing 1. Please refer to [link / reference]. Figure 1 The distal end of the catheter sheath cap 2 is provided with multiple axially extending openings 204 to increase the elasticity of the catheter sheath cap 2 and facilitate its installation.

[0045] Please see Figure 1 and Figure 2 The adjustable hemostatic valve device 100 also includes a fixing ring 7, which is fixedly connected to the proximal end of the mounting cylinder 5. The outer periphery of the fixing ring 7 and the inner wall of the proximal end of the catheter sheath housing 1 are both provided with a second thread 701. The fixing ring 7 is threadedly connected to the inner wall of the catheter sheath housing 1 through the second thread 701, thereby fixing the mounting cylinder 5 of the opening adjustment mechanism 12 in the first cavity 103 of the catheter sheath housing 1.

[0046] Please see Figure 1 and Figure 2 The adjustable hemostatic valve device 100 also includes a sealing ring 9, which is located at the junction of the first cavity 103 of the catheter sheath housing 1 and the second cavity 503 of the mounting cylinder 5, ensuring the sealing performance of the first cavity 103 of the catheter sheath housing 1 and the second cavity 503 of the mounting cylinder 5 after they are joined together.

[0047] Second Embodiment

[0048] This embodiment is basically the same as the first embodiment, the main difference being the driving method for the axial movement of the catheter sheath cap 2 along the catheter sheath housing 1. In the first embodiment, the catheter sheath housing 1 and the catheter sheath cap 2 are connected by a first thread 203. Please refer to... Figures 10-13 In this embodiment, the catheter sheath housing 1 and the catheter sheath cap 2 are moved axially along the catheter sheath housing 1 through the cooperation of the spring 10 and the cam structure 1101. In this embodiment, the adjustable hemostatic valve device 100 also includes a spring 10 and a drive member 11. The spring 10 is sleeved on the catheter sheath housing 1 and, after installation, is located between the limiting ring 202 of the catheter sheath cap 2 and the limiting protrusion 101 of the catheter sheath housing 1, with a clearance fit between the catheter sheath housing 1 and the catheter sheath cap 2. Please refer to [link / reference]. Figure 10 , Figure 11 and Figure 13 The driving component 11 includes a pressing part 1102, a connecting rod 1103, and two cam structures 1101 located at the ends of the driving component 11. The two ends of the connecting rod 1103 are connected to the pressing part 1102 and the cam structures 1101, respectively. A mounting shaft 1104 is formed on the inner side of the cam structure 1101. Two circular holes 102 are provided on the surface of the catheter sheath housing 1. The mounting shaft 1104 of the driving component 11 is installed in the circular holes 102, allowing the driving component 11 to be rotatably fixed to the catheter sheath housing 1. The cam structure 1101 contacts the distal end of the catheter sheath cap 2, used to control the displacement of the catheter sheath cap 2. The catheter sheath cap 2 can move axially along the catheter sheath housing 1 under the combined action of the spring 10 and the cam structure 1101. More specifically, as... Figure 3 , Figure 4 , Figure 7 , Figure 8 , Figure 12 and Figure 13As shown, when the drive member 11 is pressed, the cam structure 1101 on the drive member 11 rotates, pushing the catheter sheath cap 2 backward along the axial direction of the catheter sheath housing 1 and compressing the spring 10. The push ring 201 on the catheter sheath cap 2 disengages from the first positioning plate 4. The elastic force of the seal 3 itself pushes the first positioning plate 4 proximally. The first positioning pin 401 on the first positioning plate 4 slides spirally along the sliding guide groove 501 on the mounting cylinder 5 until it contacts the push ring 201 on the catheter sheath cap 2. The seal 3 is then rotated and released, realizing the function of reducing the opening of the seal 3 in the adjustable hemostatic valve device 100. Figures 5-8 , Figure 12 and Figure 13 As shown, when the drive member 11 is released, the cam structure 1101 on the drive member 11 rotates in the opposite direction under the action of the spring force of the spring 10, the drive member 11 is reset, and the spring force of the spring 10 pushes the catheter sheath cap 2 forward along the axial direction of the catheter sheath housing 1. The push ring 201 on the catheter sheath cap 2 pushes the first positioning plate 4, and the first positioning pin 401 on the first positioning plate 4 slides spirally to the distal end along the sliding guide groove 501 on the mounting cylinder 5, rotating and squeezing the silicone seal 3, thereby realizing the function of reducing the opening size of the seal 3 in the adjustable hemostatic valve device 100.

[0049] It is understood that there are various ways to drive the first positioning disc 4 (i.e., the driving method for the catheter sheath cap 2 to move axially along the catheter sheath housing 1), such as spring, threaded drive, gear and rack drive, linkage drive, cam drive, or micro linear motor drive. It is not limited to the two methods in the above embodiments.

[0050] In summary, the adjustable hemostatic valve device 100 of this application includes a sealing element 3 made of silicone or silicone rubber. The sealing element 3 includes a spiral flow channel 301 located in the middle along the axial direction and straight flow channels 302 located at both ends of the spiral flow channel 301. The function of adjusting the opening size of the sealing element 3 is achieved by compressing and rotating the spiral flow channel 301 at the center of the sealing element 3. The outer circumference of the first positioning disk 4 is provided with a plurality of first positioning pins 401. The proximal end of the mounting cylinder 5 is formed with a plurality of spiral sliding guide grooves 501 for mounting the first positioning disk 4. The first positioning disk 4 can slide spirally along the sliding guide grooves 501. The mutual cooperation of the first positioning pins 401 and the sliding guide grooves 501 achieves the compression and rotational compound movement of the sealing element 3 by axially pushing and pulling the first positioning disk 4, thereby adjusting the opening size of the adjustable hemostatic valve device 100. The second positioning disc 6 has multiple second positioning pins 601 around its outer circumference; the distal end of the mounting cylinder 5 has multiple positioning holes 502. The second positioning pins 601 of the second positioning disc 6 and the positioning holes 502 of the mounting cylinder 5 cooperate to fix the distal end of the sealing element 3 to the mounting cylinder 5. In addition, three- or multi-leaf one-way valves 8 are provided at both ends or the center of the sealing element 3 to further enhance the sealing performance of the sealing element 3, enabling it to be used when the pressure difference between the distal and proximal ends is large.

[0051] In this document, unless otherwise expressly specified and limited, the terms "installation," "connection," and "linkage" should be interpreted broadly. For example, they can refer to fixed connections, detachable connections, or integral connections; they can refer to mechanical connections or electrical connections; they can refer to direct connections or indirect connections through an intermediate medium; and they can refer to the internal connection between two components. Those skilled in the art will understand the specific meaning of these terms based on the specific circumstances.

[0052] In this paper, the sequential adjectives “first,” “second,” “third,” etc., used to describe elements are merely to distinguish elements with similar attributes and do not imply that the elements described in this way must follow a given order, or be subject to time, space, hierarchy, or other restrictions.

[0053] In this document, the terms "far", "near", "up", "down", "front", "back", "left", "right", "top", "bottom", "inner", "outer", "vertical", and "horizontal" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the purpose of clarifying the technical solution and for the convenience of description, and therefore should not be construed as limiting the present invention.

[0054] In this document, the terms “comprising,” “including,” or any other variations thereof are intended to cover non-exclusive inclusion, which includes not only the elements listed but also other elements not expressly listed.

[0055] The above description is merely a specific embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the technical scope disclosed in the present invention should be included within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be determined by the scope of the claims.

Claims

1. An adjustable hemostatic valve device (100), characterized in that: The device includes a catheter sheath, a seal (3), and an opening adjustment mechanism (12). The catheter sheath is hollow inside. The seal (3) and the opening adjustment mechanism (12) are connected and fixed inside the catheter sheath. The opening adjustment mechanism (12) includes a first positioning plate (4) and an installation cylinder (5). A spiral sliding guide groove (501) is provided. The first positioning plate (4) is fixedly connected to the proximal end of the sealing element (3). After the sealing element (3) is fixedly connected to the first positioning plate (4), it is installed in the mounting cylinder (5). The sealing element (3) is an elastic element, including a spiral flow channel (301) extending along the axial direction. The proximal and distal ends of the catheter sheath can move relative to each other in the axial direction. When the proximal end of the catheter sheath moves axially, it can push and pull the first positioning plate (4) along the sliding guide groove (501) to slide, compress and rotate or release and rotate the sealing element (3), and adjust the opening size of the spiral flow channel (301) of the sealing element (3) to accommodate surgical instruments of different specifications passing through the spiral flow channel (301).

2. The adjustable hemostatic valve device (100) according to claim 1, characterized in that: The catheter sheath includes a distal catheter sheath shell (1) and a proximal catheter sheath cap (2), which are axially movable relative to each other. The distal end of the catheter sheath cap (2) extends inward to form a limiting ring (202), and the catheter sheath shell (1) is provided with a limiting protrusion (101) near the proximal end. The limiting ring (202) of the catheter sheath cap (2) and the limiting protrusion (101) of the catheter sheath shell (1) cooperate with each other to limit the relative displacement stroke between the catheter sheath cap (2) and the catheter sheath shell (1).

3. The adjustable hemostatic valve device (100) according to claim 2, characterized in that: The outer periphery of the first positioning disk (4) is provided with a plurality of first positioning pins (401), and the proximal end of the mounting cylinder (5) is provided with a plurality of spiral sliding guide grooves (501) that cooperate with the positioning pins (401); when the sheath cap (2) of the catheter sheath moves axially, the first positioning pins (401) of the first positioning disk (4) slide along the sliding guide grooves (501) of the mounting cylinder (5) to adjust the opening size of the spiral flow channel (301) of the sealing element (3).

4. The adjustable hemostatic valve device (100) according to claim 3, characterized in that: The opening adjustment mechanism (12) further includes a second positioning disk (6), which is fixedly connected to the far end of the sealing member (3). The second positioning disk (6) has a plurality of second positioning pins (601) distributed on its outer periphery. The far end of the mounting cylinder (5) has a plurality of positioning holes (502). The second positioning pins (601) of the second positioning disk (6) and the positioning holes (502) of the mounting cylinder (5) cooperate to fix the far end of the sealing member (3) to the mounting cylinder (5).

5. The adjustable hemostatic valve device (100) according to claim 4, characterized in that: The first positioning disc (4) and the second positioning disc (6) are provided with a first step (402) on the surface near the seal (3), and a second step (303) is provided at the corresponding position at both ends of the seal (3). The first step (402) and the second step (303) are staggered in the circumferential direction. The first positioning disc (4) and the second positioning disc (6) are bonded to the seal (3) through the first step (402) and the second step (303).

6. The adjustable hemostatic valve device (100) according to claim 2, characterized in that: It also includes a one-way valve (8), which is axially disposed at both ends or in the middle of the seal (3).

7. The adjustable hemostatic valve device (100) according to claim 3, characterized in that: A push ring (201) is formed on the inner side of the catheter sheath cap (2). The distal end of the push ring (201) contacts the proximal end of the first positioning disk (4). When the catheter sheath cap (2) moves axially, the push ring (201) is linked with the first positioning disk (4).

8. The adjustable hemostatic valve device (100) according to claim 3, characterized in that: It also includes a fixing ring (7), which is fixedly connected to the proximal end of the mounting cylinder (5). The outer periphery of the fixing ring (7) is threadedly connected to the proximal inner wall of the catheter sheath housing (1) to fix the mounting cylinder (5) inside the catheter sheath housing (1).

9. The adjustable hemostatic valve device (100) according to claim 2, characterized in that: The catheter sheath cap (2) is threaded to the proximal end of the catheter sheath housing (1), and its axial movement along the catheter sheath housing (1) can be controlled by rotating the catheter sheath cap (2).

10. The adjustable hemostatic valve device (100) according to any one of claims 2-8, characterized in that: It also includes a spring (10) and a drive member (11). The spring (10) is sleeved on the catheter sheath housing (1) and located between the limiting ring (202) of the catheter sheath cap (2) and the limiting protrusion (101) of the catheter sheath housing (1). The catheter sheath housing (1) and the catheter sheath cap (2) are in clearance fit. The drive member (11) is rotatably fixed on the catheter sheath housing (1). The end of the drive member (11) has a cam structure (1101). The cam structure (1101) contacts the distal end of the catheter sheath cap (2) and is used to control the displacement of the catheter sheath cap (2). The catheter sheath cap (2) can move axially along the catheter sheath housing (1) under the combined action of the spring (10) and the cam structure (1101).

11. The adjustable hemostatic valve device (100) according to claim 10, characterized in that: The drive member (11) includes a pressing part (1102) and a cam structure (1101) extending from both sides of the pressing part (1102). The cam structure (1101) is provided with a mounting shaft (1104), and the drive member (11) is rotatably fixed on the catheter sheath housing (1) by the mounting shaft (1104).

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