A new type of vascular closure device

Abstract

The application relates to a novel vascular closure device, which comprises: (1) a delivery assembly comprising a core rod and an outer tube, used for loading or releasing a blocking member; (2) a handle connected to the proximal end of the delivery assembly, wherein the handle comprises an operating knob and a transmission mechanism, the operating knob has opposite initial and working positions along its own movement path, in the initial position, the core rod and the outer tube do not move relatively, and in the working position, the operating knob drives the core rod and the outer tube to move relatively through the transmission mechanism to release the blocking member. The vascular closure device of the application realizes structure simplification and function expansion through the adaptive improvement between the operating knob and the transmission mechanism.

Description

Technical Field

[0001] This application relates to the field of medical device technology, specifically to a novel vascular closure device. Background Technology

[0002] In modern minimally invasive interventional diagnostic and treatment techniques, percutaneous puncture has become an important means of clinical diagnosis and treatment, widely used in cardiovascular diseases, interventional oncology, emergency resuscitation, and many other fields. This type of procedure typically requires establishing a channel from the skin to the target organ using a puncture needle. Post-procedure, effective closure of the puncture site is essential to prevent complications such as bleeding, hematoma, and infection. Currently, suture devices are commonly used clinically to suture the puncture site. This technique uses a mechanical structure to pull and knot the tissue around the puncture path, achieving channel closure. It is convenient to operate and allows for rapid closure, meeting clinical needs to a certain extent.

[0003] However, existing stapler suturing techniques still have significant drawbacks in practical applications, with post-puncture bleeding and vascular lumen loss after suturing being among the most prominent problems. Specifically, the suturing effect of staplers is highly dependent on the operator's experience and tissue conditions: when patients have coagulation disorders, when the puncture path involves areas with dense vascular branches, and when tissue alignment deviations or uneven suturing force occur during the suturing process, it is very easy for the vascular wall or surrounding soft tissue at the suture site to fail to close completely, leading to immediate bleeding or delayed oozing, or over-suturing during the suturing process, causing vascular lumen stenosis after suturing and leading to serious complications. Summary of the Invention

[0004] To address the shortcomings of existing technologies, this application provides a vascular closure device that can effectively prevent bleeding at the puncture site and loss of the vascular lumen after closure, thereby improving the reliability of puncture site closure.

[0005] This application provides a novel vascular closure device having opposing distal and proximal ends, the vascular closure device comprising:

[0006] (1) A conveying assembly, the conveying assembly including a core rod and an outer tube, the outer tube having a receiving cavity for loading a sealing element, at least a portion of the core rod extending into the receiving cavity for cooperating with the outer tube to release the sealing element, a hollow protective element sleeved on the proximal end of the outer tube, the outer periphery of the protective element having a reduced diameter portion, an end cap fixed to the proximal end of the core rod, the outer periphery of the end cap having a reduced diameter portion;

[0007] (2) A handle, connected to the proximal end of the conveying assembly, the handle including an operating button, a transmission mechanism, and a housing, the transmission mechanism being located inside the housing, the housing being composed of a first housing and a second housing that can be interlocked, a first opening being located on one side of the housing, and a second opening being located at the distal end of the housing, the operating button having a relative initial position and a working position along its own movement path, one end of the operating button being a pressing part exposed to the first opening, and the other end of the operating button extending into the first opening and cooperating with the transmission mechanism, the operating button being pressed can drive the outer tube and the core rod to move relative to each other through the transmission mechanism to release the sealing element.

[0008] The housing has a fixing groove inside, which is fixedly connected to the inner wall of the housing.

[0009] The connecting sleeve is fitted onto the proximal end of the outer tube and located inside the housing, and can slide between the end cap and the protective member. The outer periphery of the connecting sleeve has a reduced diameter section.

[0010] One end of the main body of the operation button is connected to the pressing part, and a linkage tooth is provided on one side wall of the main body along the movement path of the operation button. The fixing groove is located between the far end of the main body and the housing.

[0011] The transmission mechanism includes a rack assembly and a transmission gear. The transmission gear meshes with the linkage gear. A rack is located at the proximal end of the rack assembly, and the rack meshes with the transmission gear. The distal end of the rack assembly has a bent portion with a groove. In the initial state, the transmission gear meshes with the rack but not with the linkage gear. In the working state, pressing the operation button engages the linkage gear with the transmission gear, thereby causing the rack assembly to slide axially along the housing.

[0012] The relative movement between the outer tube and the core rod can be one of the following two methods:

[0013] Method A: The reduced diameter portion of the end cap is fixedly fitted into the slot, thereby fixing the core rod and the rack assembly together. The fixing groove engages with the reduced diameter portion of the connecting sleeve, thereby fixing the outer tube to the handle.

[0014] Method B: The reduced diameter portion of the connecting sleeve is fixedly embedded in the slot, thereby fixing the outer tube and the rack assembly together. The fixing groove engages with the reduced diameter portion of the end cap, thereby fixing the core rod to the handle.

[0015] In some cases, the meshing teeth of the linkage tooth and at least one of the transmission gears are provided with a clearance zone. In the initial position, the linkage tooth disengages from the transmission gear through the clearance zone, and in the working position, it re-engages after passing through the clearance zone.

[0016] In some cases, the linkage tooth has a missing tooth portion, forming a first clearance area. The transmission gear includes a first gear tooth, a second gear tooth, and a third gear tooth arranged coaxially. The first gear tooth can mesh with the linkage tooth. The second gear tooth and the third gear tooth are located on both sides of the first gear tooth and can mesh with the rack. The first gear tooth has a missing tooth portion, forming a second clearance area. In the initial position, the first clearance area and the second clearance area are aligned in position, so that the linkage tooth and the first gear tooth are disengaged. In the working position, by pressing the operation button, the linkage tooth and the first gear tooth are re-engaged.

[0017] In some cases, the size of the first gear tooth is smaller than that of the second gear tooth and the third gear tooth, the size of the second gear tooth and the third gear tooth are the same, and the transmission ratio of the first gear tooth to the second gear tooth is 5:1 to 1:5.

[0018] In some cases, the inner wall of the second housing is provided with a first gear slot, the central shaft of the transmission gear extends from one end of the transmission gear, and a hollow first metal ring is fitted onto the extended central shaft portion. The first metal ring is embedded in the first gear slot and can rotate within the first gear slot.

[0019] In some cases, the inner wall of the first housing is also provided with a second gear slot, the second gear slot and the first gear slot are spatially aligned and located near the first opening, the central shaft also extends from the other end of the transmission gear, the hollow second metal ring is sleeved on the central shaft portion extending from the other end of the transmission gear, the second metal ring is fixedly embedded in the second gear slot, the second metal ring can rotate in the second gear slot, and the transmission gear is nested between the first gear slot and the second gear slot.

[0020] In some cases, the inner wall of the second housing is further provided with a first guide and a second guide parallel to the axial direction of the housing. The second guide and the first guide have a height difference in the height direction of the housing and partially overlap when projected in the height direction. The non-overlapping part of the first guide is used to contact and support the rack assembly. The proximal end of the second guide is connected to the proximal end of the first guide, and the distal end of the second guide is connected to the distal end of the first guide. The rack is provided on the upper surface of the rack assembly. The first guide contacts the lower surface of the rack assembly without the rack and supports at least 1 / 3 of the lower surface of the rack assembly. The height of the second guide is greater than that of the first guide. Therefore, the rack assembly can slide along the first guide channel formed between the second guide and the first guide under the support of the first guide in the axial direction of the housing.

[0021] A third guide and a fourth guide parallel to the axial direction of the housing are provided on the inner wall of the first housing. The third guide and the fourth guide have a height difference in the height direction of the housing and partially overlap when projected in the height direction. The non-overlapping portion of the third guide is used to contact and support the rack assembly. The proximal ends of the third guide and the fourth guide are connected together, and the distal ends of the third guide and the fourth guide are connected together. The third guide contacts the lower surface of the rack assembly without the rack and supports at least 1 / 3 of the lower surface of the rack assembly. The respective areas of the lower surface of the rack assembly that contact the first guide and the third guide do not overlap. The height of the fourth guide is greater than that of the third guide. Therefore, the rack assembly is attached to the fourth guide and, supported by the third guide, can slide along the second guide channel formed between the third guide and the fourth guide in the axial direction of the housing. The first guide channel and the second guide channel are aligned in the height direction of the housing.

[0022] In some cases, the inner wall of the second housing is further provided with a fifth guide and a sixth guide parallel to the axial direction of the housing. The fifth guide and the sixth guide have a height difference in the height direction of the housing and at least partially overlap when projected in the height direction. The proximal ends of the fifth guide and the sixth guide are connected together, and the distal ends of the fifth guide and the sixth guide are connected together. The height of the connection between the fifth guide and the sixth guide is lower than the height of the fifth guide and the sixth guide, which is 1 / 4 to 3 / 4 of the height of the fifth guide or the sixth guide. The rack and pinion assembly can slide along the third guide channel formed between the fifth guide and the sixth guide in the axial direction of the housing.

[0023] The inner wall of the first housing is further provided with a seventh guide and an eighth guide parallel to the axial direction of the housing. The seventh guide and the eighth guide have a height difference in the height direction of the housing and at least partially overlap when projected in the height direction. The proximal ends of the seventh guide and the eighth guide are connected together, and the distal ends of the seventh guide and the eighth guide are connected together. The height of the connection between the seventh guide and the eighth guide is lower than the height of the seventh guide and the eighth guide, which is 1 / 4 to 3 / 4 of the height of the seventh guide or the eighth guide. The rack and pinion assembly can slide along the fourth guide channel formed between the seventh guide and the eighth guide in the axial direction of the housing.

[0024] The first guide channel and the third guide channel are aligned front to back in the axial direction of the housing, and the second guide channel and the fourth guide channel are aligned front to back in the axial direction of the housing; the third guide channel and the fourth guide channel are aligned in the height direction of the housing.

[0025] In some cases, the fifth and sixth guide members, along with the second and first guide members, are distributed on both sides of the lower end of the main body. Similarly, the third and fourth guide members, along with the seventh and eighth guide members, are distributed on both sides of the lower end of the main body. In the initial position, the rack abuts against the proximal ends of the fifth and eighth guide members, preventing the rack assembly from moving towards the distal end of the housing, thus determining the starting point of the rack assembly's movement trajectory. In the working position, compared to the initial position, the rack assembly moves a distance towards the proximal end of the housing. The distal ends of the fifth and eighth guide members then contact the bent portion, preventing the rack assembly from moving further towards the proximal end of the housing, thus determining the ending point of the rack assembly's movement trajectory. This distance is equal to the length of the rack assembly's movement trajectory.

[0026] In some cases, a first fixing member is provided on the inner wall of the first housing, and a second fixing member is provided on the inner wall of the second housing. The first fixing member and the second fixing member are parallel to the height direction of the housing, spatially aligned, and respectively provided with a first half-groove and a second half-groove. The first fixing member and the second fixing member are located between the far end of the main body and the housing. When the first housing and the second housing are engaged together, the first half-groove and the second half-groove together constitute the fixing groove.

[0027] In some cases, the first opening is assembled by a first notch on one side of the first housing and a second notch on one side of the second housing. The inner wall of the second housing is also provided with a second support member parallel to the axial direction of the housing and a first support member perpendicularly connected to the second support member. One end of the first support member is connected to the bottom of the second notch. The width of the first support member gradually increases from the end of the first support member connected to the second notch to the other end of the first support member. The height of the first support member gradually decreases from the end of the first support member connected to the second notch to the other end of the first support member. One end of the second support member is connected to the second fixing member, and the other end of the second support member is connected to the middle part of the first support member. In the width direction of the housing, the width of the bottom of the second notch is smaller than that of the second support member, and the width of the second fixing member is smaller than that of the bottom of the second notch.

[0028] In some cases, a first structural fastener and a second structural fastener are provided on the inner wall of the second housing. The second structural fastener, the first structural fastener, and the fifth guide are parallel to the axial direction of the housing. The first structural fastener is located between the second structural fastener and the fifth guide in the height direction of the housing. The width of the first structural fastener is greater than that of the second structural fastener and the fifth guide. In this way, the first structural fastener, the second structural fastener, and the fifth guide together form a first groove structure in space.

[0029] A first structural connector and a second structural connector are provided on the inner wall of the first housing. The first structural connector, the second structural connector and the eighth guide are parallel to the axial direction of the housing. The first structural connector is located between the second structural connector and the first structural connector in the height direction of the housing. The width of the first structural connector is greater than that of the second structural connector and the first structural connector. In this way, the first structural connector, the first structural connector and the eighth guide together form a second groove structure in space.

[0030] When the first housing and the second housing are assembled together, the two opposite sides of the connecting sleeve are respectively attached to the first groove structure and the second groove structure, thereby allowing the connecting sleeve to move along the axial direction of the housing.

[0031] In some cases, the width of the fifth guide is smaller than that of the second structural fastener and the width of the eighth guide is smaller than that of the first structural connector in the width direction of the housing.

[0032] In some cases, a notch is provided at the distal end of both the fifth and eighth guide members to reduce the impact force exerted on the fifth and eighth guide members by the bent portion during movement. In some cases, the direction of movement of the operating button is perpendicular to the direction of movement of the outer tube. Furthermore, in some cases, the direction of movement of the operating button can also be parallel to the direction of movement of the outer tube.

[0033] The vascular closure device of this application belongs to the first generation of vascular closure devices developed by the inventor. Through adaptive improvements between the operating button and the transmission mechanism, the operating button can interfere with the relative movement between the outer tube and the core rod in the initial position, avoiding unintended exposure of the sealing component. At the same time, no additional limiting mechanism is required, thus balancing structural simplification and functional expansion. Attached Figure Description

[0034] Figure 1 This is a schematic diagram of the structure of a blood vessel closure device according to an embodiment of this application; Figure 2 for Figure 1 Schematic diagram of the internal structure of the central vascular closure device;

[0035] Figure 3 This is a schematic diagram illustrating the delivery of a vascular closure device along a suture according to an embodiment of this application;

[0036] Figure 4 This is an exploded view of the internal components of a vascular closure device according to an embodiment of this application; Figure 5 for Figure 4 A diagram showing the central control button in its initial position; Figure 6 This is a cross-sectional view of the vascular closure device when the operating button is in the initial position.

[0037] Figure 7 for Figure 4 A diagram showing the central control button in its working position; Figure 8 for Figure 7 The diagram shows the operation button being pressed further into the self-locking position. In the coordinate system, the x-axis is the length direction of the rack and pinion assembly, and the length direction of the housing (i.e., the axial direction) and the length direction of the outer tube (i.e., the axial direction) are parallel to the x-axis. The y-axis is the width direction of the rack and pinion assembly, and the width direction of the housing is parallel to the y-axis. The z-axis is the height direction of the rack and pinion assembly, and the height direction of the housing is parallel to the z-axis.

[0038] Figure 9 A cross-sectional view of the vascular closure device when the operating button is in the self-locking position; Figure 10 This is a schematic diagram of the guiding fit between the operating button and the housing;

[0039] Figure 11 This is another exploded view of the internal components of a vascular closure device according to an embodiment of this application;

[0040] Figure 12 This is a schematic diagram of the internal structure of the second shell of this application; Figure 13 This is a projection view of the internal structure of the second housing in this application; Figure 14 This is a projection view of the internal structure of the first housing in this application;

[0041] Figure 15 for Figure 2 A structural schematic diagram of a rack and pinion assembly (with a limiting groove located on the inner side of the rack and pinion assembly), including explanations of the x, y, and z axes of the coordinate system. Figure 8 same;

[0042] Figure 16 for Figure 2 A schematic diagram of a rack and pinion assembly (with a limiting groove located on the outside of the rack and pinion assembly), including explanations of the x, y, and z axes of the coordinate system. Figure 8 same. Detailed Implementation

[0043] To make the above-mentioned objectives, features, and advantages of this application more apparent and understandable, the specific embodiments of this application are described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of this application. However, this application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of this application. Therefore, this application is not limited to the specific embodiments disclosed below.

[0044] It should be noted that when a component is referred to as being "fixed to" or "set on" another component, it can be directly on the other component or there may be an intermediate component. When a component is considered to be "connected to" another component, it can be directly connected to the other component or there may be an intermediate component present. The terms "vertical," "horizontal," "upper," "lower," "left," "right," and similar expressions used in this application's specification are for illustrative purposes only and do not represent the only possible implementation.

[0045] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this application, "multiple" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0046] In this application, unless otherwise expressly specified and limited, "above" or "below" the second feature can mean that the first feature is in direct contact with the second feature, or that the first feature and the second feature are in indirect contact through an intermediate medium. Furthermore, "above," "on top of," and "over" the second feature can mean that the first feature is directly above or diagonally above the second feature, or simply indicates that the first feature is at a higher horizontal level (or in a usage state, or from a certain viewpoint in the drawing) than the second feature. "Below," "below," and "under" the second feature can mean that the first feature is directly below or diagonally below the second feature, or simply indicates that the first feature is at a lower horizontal level (or in a usage state, or from a certain viewpoint in the drawing) than the second feature.

[0047] Unless otherwise defined, all technical and scientific terms used in this application have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used in this application is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. The term "and / or" as used in this application includes any and all combinations of one or more of the associated listed items.

[0048] When used to indicate direction, the proximal end generally refers to the side closest to the operator (e.g., a doctor), and the distal end is the side relatively far away. Correspondingly, each component itself has a relative distal and proximal end. When used to refer to a structure, the term "end" indicates the endpoint of the structure, a point or region in that lateral direction, or a specific structure connected to that point or region. Furthermore, in this application, when describing the length, width, and height of any component of the vascular closure device (e.g., the housing, the rack assembly, or the outer tube), the vascular closure device is described with the operating button directly above it after complete assembly (e.g., the...). Figure 1 and Figure 8 (As shown) can be used as a reference standard, for example, one can utilize Figure 8 The three-dimensional coordinate system is used to represent the length, width, and height directions of any component in this application.

[0049] See Figures 1-16 In order to further improve the safety of the vascular closure device and prevent the occlusion element 3 from being released unintentionally, one embodiment of this application provides a novel vascular closure device, including a delivery assembly 1 and a handle 2, wherein the delivery assembly 1 can be used to load or release the occlusion element 3.

[0050] The handle 2 is connected to the proximal end of the conveying assembly 1. The handle 2 includes an operating button 4 and a transmission mechanism. The operating button 4 has a relative initial position and a working position along its own movement path. A part of the operating button 4 serves as a limiting part 41. In the initial position, the limiting part 41 restricts the movement of the transmission mechanism and the conveying assembly 1, thereby maintaining the loading state of the sealing member 3 to avoid unexpected release. In the working position, the operating button 4 releases the restriction on the transmission mechanism and the conveying assembly 1, allowing the conveying assembly 1 to release the sealing member 3 through the transmission mechanism.

[0051] In some cases, the delivery assembly 1 includes a core rod 11 and an outer tube 12. The outer tube 12 has a receiving cavity 13 for loading the sealing element 3. At least a portion of the core rod 11 extends into the receiving cavity 13, and this portion cooperates with the outer tube 12 to release the sealing element 3. The cooperation between the outer tube 12 and the core rod 11 ensures that they can move relative to each other. In the working position, the operating button 4 drives the outer tube 12 and the core rod 11 to move relative to each other through a transmission mechanism to release the sealing element 3.

[0052] The sealing element 3 can be made of existing materials, such as a liquid-absorbing and swelling hydrogel (e.g., collagen), and is loaded into the distal end of the receiving cavity 13 during use. The sealing element 3 can be pre-placed in the distal end of the receiving cavity 13 by means of insertion, or it can be formed by adding the material used to prepare the sealing element 3 during use, allowing it to expand on its own. When releasing the sealing element 3, the sealing element 3 may be displaced relative to the receiving cavity 13 (e.g., pushed out or pulled out from the distal end of the receiving cavity 13), or it may not be displaced (e.g., the outer tube 12 is retracted to the proximal end, or the sealing element 3 is exposed from the receiving cavity 13 by rotation).

[0053] The occlusion element 3 can be a single-layer structure or a double-layer structure. For example, the occlusion element 3 can be clamped by an external clip. Specifically, at the distal end of the occlusion element, a clip structure made of medical-grade stainless steel or absorbable polymer is pre-wrapped. This clip structure is in a folded shape during delivery and is attached to the receiving cavity 13 of the outer tube 12 together with the occlusion element. When the vascular closure device is pushed to the inside of the vascular puncture site, the operator releases the clip structure by retracting the outer tube 12. This clip structure, relying on its own shape memory or spring force, unfolds outward into a geometric structure such as an umbrella, "clamping" and completely covering the occlusion element from the inside of the blood vessel, pressing it tightly against the puncture site on the inner wall of the blood vessel. This clip structure and the occlusion element together constitute a stable mechanical and physiological occlusion barrier. Alternatively, medical adhesive can be used to bond the occlusion component 3 together. Specifically, a thin layer of "water-activated" medical adhesive coating is uniformly coated on the surface of the occlusion component facing the blood vessel wall. This medical adhesive coating contains hydrophilic polymers, such as PEG or its derivatives. In a dry state, the medical adhesive coating is not sticky, and the occlusion component can be delivered smoothly. When placed at the puncture site and in contact with blood or tissue fluid, the coating will quickly absorb water, dissolve, and undergo a cross-linking reaction. After the cross-linking reaction is initiated, on the one hand, the medical adhesive will tightly bond with the occlusion component itself; on the other hand, the medical adhesive will penetrate into the tissue microstructure of the blood vessel wall, forming a strong physical interlock and chemical bond, thereby achieving a strong "adhesion" of the occlusion component to the blood vessel wall and achieving a strong puncture site occlusion effect. In addition, the sealing component 3 can also be a water-expandable patch. Specifically, the sealing component is a freeze-dried sponge patch made of cross-linked gelatin or oxidized dextran and other biocompatible materials with shape memory function. When assembled into the receiving cavity 13 of the outer tube 12, it is radially compressed into a thin strip. When the sealing component is pushed out of the outer tube 13 and comes into contact with the blood flowing out of the puncture site, the dry sponge quickly absorbs water and expands back to the preset disc or plug shape within 30 seconds, physically blocking the puncture site. At the same time, the biocompatible material used to prepare the freeze-dried sponge patch dissolves under blood triggering, and the released long-chain molecules automatically penetrate and cross-link, forming a strong gel barrier in the puncture channel, achieving the dual effects of "physical expansion sealing" and "chemical in-situ gelation".

[0054] The relative movement of the outer tube 12 and the core rod 11 can be in the following ways: Method A, the outer tube 12 is fixed relative to the handle 2, while the core rod 11 moves to the distal end and pushes the sealing element 3 out of the receiving cavity 13 to achieve release; Method B, the core rod 11 is fixed relative to the handle 2, and the outer tube 12 moves to the proximal end. At this time, the sealing element 3 is gradually exposed to the outer tube 12 under the restraint of the core rod 11 to achieve release.

[0055] The handle 2 includes a housing 21, which is composed of a first housing 211 and a second housing 212 that can be interlocked. Figure 1 , Figure 2 (The first shell is removed for easier observation). A first notch is provided on one side of the first shell 211, and a second notch is provided on one side of the second shell 212. When the first shell 211 and the second shell 212 are fastened together, these two notches together form the first opening 213 of the shell 21. The first opening 213 can take any suitable geometric shape, such as a circle, ellipse, square, or rectangle. A second opening 235 is provided at the distal end of the shell 21. Correspondingly, the second opening 235 is assembled from a third notch at the distal end of the first shell 211 and a fourth notch at the distal end of the second shell 212. The second opening 235 can take any suitable geometric shape; for example, the second opening 235 can be circular, and the third and fourth notches can both be semi-circular. The outer tube 12 extends distally through the second opening 235. A hollow protective element 122 is fitted onto the proximal end of the outer tube 12. The protective member 122 has a reduced diameter portion 123 on its outer periphery, which engages with the second opening 235 to securely connect the protective member 122 to the housing 21. When the operating button 4 is pressed to the working position, the outer tube 12 slides along its axial direction relative to the protective member 122, thereby preventing the outer tube 12 from colliding with the housing 21. Preferably, this engagement does not prevent the protective member 122 from rotating around the outer periphery of the outer tube 12.

[0056] The transmission mechanism is located inside the housing 21. One end of the operating button 4 is a pressing part 38 exposed in the first opening 213, and the other end of the operating button 4 extends into the first opening 213 to cooperate with the transmission mechanism. The operating button 4 is slidably fitted into the housing 21. The movement direction of the operating button 4 can be perpendicular to the movement direction of the outer tube 12. For example, the operating button moves along the height direction of the housing 21, and the outer tube 12 moves along the axial direction of the outer tube 12. Preferably, the pressing part 38 is provided with multiple rows of small protrusions 39. These small protrusions are designed to increase the friction between the operator's fingers and the pressing part 38 and prevent the fingers from slipping when pressing the pressing part 38. Multiple ribs 20 can also be provided at the bottom of the first housing 211 and the second housing 212 respectively. These ribs 20 contact the operator's fingers and can further increase the friction between the operator's fingers and the housing 21.

[0057] One end of the main body 40 of the operating button 4 is connected to the pressing part 38, preferably in a one-piece design. The other end of the main body 40 is provided with a first pin 47, a second pin 45, and a third pin 46. Preferably, it also includes an elastic support 48, which is located axially between the second pin 45 and the third pin 46 of the housing 21. One sidewall of the main body 40 has linkage teeth 43 arranged along the movement path of the operating button 4. Preferably, the linkage teeth 43 have a missing tooth portion, forming a first clearance area 44. The other opposite sidewall of the main body 40 has a positioning step 42 that interacts with the inner wall of the housing 21. This interaction prevents the operating button 4 from detaching from the housing 21 after the vascular closure device is assembled. The first pin 47 is an extension arm extending from the positioning step 42 away from the main body 40, and its end is bent to form a limiting part 41. The ends of the second pin 45 and the third pin 46 are bent respectively, each forming a hook 49. The handle 2 is provided with a first elastic element 28 that acts on the operation button 4. The first elastic element 28 is sleeved on the elastic element support 48, so that the operation button 4 tends to the initial position.

[0058] The operating button 4 causes relative movement between the outer tube 12 and the core rod 11 via a transmission mechanism. In the following embodiments, taking method B as an example, the core rod 11 is fixed to the handle 2, and the outer tube 12 is slidably mounted on the handle 2. During use, the sealing member 3 is released by retracting the outer tube 12 towards the proximal end, which reduces release resistance. This is especially beneficial when the sealing member 3 is long, preventing excessive release resistance caused by deformation and expansion of the sealing member 3 under pressure in the receiving cavity 13. In some cases, the end cap 111 fixed to the proximal end of the core rod 11 has a reduced diameter portion 112 on its outer periphery. A first fixing member 247 is provided on the inner wall of the first housing 211, and a second fixing member 230 is provided on the inner wall of the second housing 212. The first fixing member 247 and the second fixing member 230 are parallel to the height direction of the housing 21 and are spatially aligned. They are respectively provided with a first half-groove 248 and a second half-groove 231. When the first housing 211 and the second housing 212 are engaged together, the first half-groove 248 and the second half-groove 231 together form a fixing groove. This fixing groove engages with the reduced diameter portion 112 of the end cap 111, thereby fixing the core rod 11 to the handle 2. The first fixing member 247 and the second fixing member 230 are located between the main body 40 of the operating button 4 and the far end of the housing 21. In some cases, the first fixing member 247 and the second fixing member 230 are 0~10mm away from the main body 40.

[0059] Touching the outer tube 12 during storage, transportation, or use may cause the sealing element 3 to be released unexpectedly. Therefore, the limiting part 41 of the operation button 4 can be used to restrict the relative movement of the outer tube 12 and the core rod 11 in the initial position. The outer tube 12 is only allowed to move when the operation button 4 is pressed to the working position. The movement sequence of the outer tube 12 and the operation button 4 can be locked in the operation logic to improve the safety of the instrument.

[0060] Combination Figure 3 After the suture 6 is threaded through the suture site 5 and a knot 61 is formed, the vascular closure device of this embodiment can be delivered along the suture 6 to the adjacent site to be sealed. The outer tube 12 of this embodiment can be a single-lumen structure or a multi-lumen tube, that is, it has at least two lumens, such as two parallel lumens, one of which serves as a guide lumen 14 for the suture 6 to be inserted from the distal end. The proximal end of the guide lumen 14 is open, allowing the suture 6 to exit the guide lumen 14. Alternatively, the side wall of the guide lumen 14 may have an extension opening 15 for the suture 6 to exit the guide lumen 14. The other lumen of the multi-lumen tube serves as a receiving cavity 13. The core rod 11 can extend distally through the receiving cavity 13. The occlusion element 3 is mounted on the distal end of the receiving cavity 13. The proximal end of the outer tube 12 is slidably mounted on the handle 2 (i.e., relative sliding can occur between the proximal end of the outer tube 12 and the handle 2) and is linked to the transmission mechanism. When the outer tube 12 retracts proximally, the occlusion element 3 is gradually exposed to the outer tube 12 due to the obstruction of the core rod 11, and finally the occlusion element 3 is released. When the outer tube 12 has a single-lumen structure, the outer tube 12 does not need to be provided with a guide cavity 14. The knot 61 can be sewn with suture 6 using an internal guide, and then the vascular closure device enters the puncture site along the suture 6. When the outer tube 12 is a multi-lumen tube, a guide lumen can be provided inside the outer tube 12, allowing the guide wire to pass through the guide lumen, and the vascular closure device reaches the puncture site under the guidance of the guide wire. Alternatively, a ring made of materials such as nickel-titanium can be used to guide the vascular closure device to the puncture site.

[0061] Regardless of how the vascular closure device enters the puncture site, it will position the occluder 3 at the puncture site and release it from the distal end of the outer tube 12, achieving the purpose of large-diameter hemostasis. After the occluder 3 is released, in order to prevent the released occluder 2 from seeping into the blood vessel through the puncture site and causing vascular complications, the position of the occluder 3 can be restricted by setting an inflatable balloon, a biodegradable baffle, and a deployable structure (such as a stent, venous filter, or mitral valve clip) at the distal end of the outer tube 12; the occluder 3 can also interact with the suture knot 61 to prevent the occluder 3 from entering the blood vessel; or a finite length of suture can be used to connect the occluder 3, and the tension of the suture can prevent the occluder 3 from entering the blood vessel; in addition, a limiting protection device can also be adopted, such as a protective pad placed under the occluder 3, which can prevent the occluder 3 from entering the blood vessel.

[0062] The initial position of the operating button 4 is not strictly required to be a unique position in space. It can correspond to a certain stroke of the operating button 4 (e.g., the first stroke). Within this stroke range, the limiting part 41 always blocks the movement of the outer tube 12. For example, the limiting part 41 can directly contact and block the outer tube 12 in the initial position, or it can interfere with the movement of any component in the transmission mechanism, so that the outer tube 12 cannot move relative to the core rod 11. Similarly, the working position can also be understood as corresponding to a certain stroke of the operating button 4 (e.g., the second stroke). Within this stroke range, the operating button 4 and the outer tube 12 are linked together, so that the outer tube 12 can move relative to the core rod 11.

[0063] The transmission mechanism can be implemented in various ways. One embodiment of this application provides an improved transmission mechanism, specifically including a rack and pinion assembly 22 and a transmission gear 23. The transmission mechanism can drive the rack and pinion assembly 22 to slide axially along the housing 21. The transmission mechanism can drive the rack and pinion assembly 22 in the following ways: mechanical drive, motor drive, hydraulic drive, or pneumatic drive. Among these, mechanical drive, in addition to gear-rack transmission, can also be selected from belt-pulley transmission, chain-sprocket transmission, worm-worm gear transmission, screw-nut transmission, friction wheel transmission, ratchet transmission, cam transmission, or linkage mechanism transmission, etc.

[0064] The rack assembly 22 has a rack 24 at its proximal end and a bent portion 25 at its distal end, with a slot 26 formed in the bent portion 25. A connecting sleeve 121 is fitted onto the proximal end of the outer tube 12. The connecting sleeve 121 is located inside the housing 21 and can slide between the end cap 111 and the protective member 122. In the initial position, the connecting sleeve 121 is in contact with the protective member 122 and cannot continue to move to the distal end. In the working position, the connecting sleeve 121 moves a distance toward the end cap 111 and may or may not touch the end cap 111. Preferably, it touches the end cap 111, at which point the obstruction of the end cap 111 further prevents the connecting sleeve 121 from moving to the proximal end. The outer periphery of the connecting sleeve 121 has a reduced diameter portion 124, which is fixedly embedded in the slot 26, thereby fixing the outer tube 12 and the rack and pinion assembly 22 together. When the operating button 4 is pressed to the working position, the transmission gear 23 meshes with the rack 24, driving the rack and pinion assembly 22 to move along the axial direction of the housing 21, thereby driving the outer tube 12 to slide relative to the core rod 11 along the axial direction of the outer tube 12. The bent portion 25 and the length direction of the rack and pinion assembly 22 form a certain angle, which is between 75° and 150°, preferably substantially perpendicular, that is, the height direction of the bent portion 25 and the rack and pinion assembly 22 are substantially parallel.

[0065] A limiting groove 27 is provided on the rack assembly 22. The limiting part 41 is inserted into the limiting groove 27 in the initial position to block the movement of the rack assembly 22. When in use, after pressing the operation button 4 to enter the working position, the limiting part 41 moves out of the limiting groove 27 to allow the rack assembly 22 to move.

[0066] To reduce interference between different components, a limiting groove 27 is provided on the outer or inner side of the rack assembly 22. Both the outer and inner sides of the rack assembly 22 are sides enclosed by the length and height directions of the rack assembly 22. When the operating button 4, transmission gear 23, rack assembly 22, and second housing 212 are combined (e.g.... Figure 2 When (as shown), the outer side of the rack assembly 22 ( Figure 15 and Figure 16 (A1 in the middle) is exposed from the second housing 212, inside the rack assembly 22 ( Figure 15 and Figure 16 (A2 in the diagram) Located inside the second housing 212, on the side opposite to the outer side of the rack assembly 22. When the limiting groove 27 is located on the outer side of the rack assembly 22, the end of the first pin 47 is bent inward to form a limiting part 41. The first pin 47 does not pass through the clearance groove 30 of the rack assembly 22, but passes through the outer periphery of the rack assembly 22 and is inserted into the limiting groove 27 in the initial position. When the limiting groove 27 is located on the inner side of the rack assembly 22, the end of the first pin 47 is bent outward to form a limiting part 41. The first pin 47 does not pass through the clearance groove 30 of the rack assembly 22, but passes through the inner periphery of the rack assembly 22 and is inserted into the limiting groove 27 in the initial position.

[0067] In some cases, when the limiting groove 27 is located inside the rack assembly 22, two limiting guides 220 parallel to the height direction of the housing 21 are also provided on the inner wall of the second housing 212. These two limiting guides 220 are located between the first guide channel and the third guide channel, which will be detailed later. In the initial position, the opening of the limiting groove 27 is close to or even in contact with the limiting guide channel formed between the two limiting guides 220, and the limiting portion 41 of the first pin 47 is inserted into the limiting groove 27 along this limiting guide channel to prevent the rack assembly 22 from moving. Furthermore, by reasonably setting the height of these two limiting guides 220, the limiting guides 220 can also be used to support the rack assembly 22, making the force more even when the rack assembly 22 slides along the axial direction of the housing 21, and less prone to bending. Furthermore, as... Figure 15As shown, an indicator groove 27' can also be provided on the inner side of the rack and pinion assembly 22. The indicator groove 27' is located between the distal end of the rack and pinion assembly 22 and the limiting groove 27. In the working position, the indicator groove 27' is close to or even in contact with the limiting guide channel. When the housing 21 is transparent or semi-transparent, it can be determined whether the rack and pinion assembly 22 has moved to the end point by observing whether the indicator groove 27' is close to or even in contact with the limiting guide channel. It can also be seen that the distance between the limiting groove 27 and the indicator groove 27' on the same side of the rack and pinion assembly 22 determines the movement distance of the rack and pinion assembly 22 when the operating button 4 switches from the initial position to the working position.

[0068] In addition, a second elastic element 29 acting on the connecting sleeve 121 may be provided inside the handle 2, which can adjust the transmission damping when the operating button 4 is pressed. The second elastic element 29 is sleeved on the outside of the core rod 11, the connecting sleeve 121 is open towards the proximal end, one end of the second elastic element 29 abuts against the end cap 111, and at least a part of the other end extends into the connecting sleeve 121.

[0069] Since the operating button 4 blocks the movement of the outer tube 12 in the initial position, the operating button 4 and the outer tube 12 are not linked in the initial position. They only become linked when the operating button 4 enters the working position, at which point the operating button 4 engages with the transmission gear 23. To address this, at least one of the meshing teeth of the operating button 4 and the transmission gear 23 can be provided with a clearance area. In the initial position, the operating button 4 disengages from the transmission gear 23 through the clearance area, and in the working position, it engages with the transmission gear 23 after passing through the clearance area.

[0070] Combination Figure 6 The linkage tooth 43 has a missing tooth portion forming a first clearance area 44, and the first gear tooth 23-1 of the transmission gear 23 has a missing tooth portion forming a second clearance area 23-4. In the initial position, the first clearance area 44 of the linkage tooth 43 and the second clearance area 23-4 of the first gear tooth 23-1 are aligned in position, preventing the linkage tooth 43 and the first gear tooth 23-1 from meshing. (Comparison) Figure 9 When the operating button 4 is pressed down a certain distance to enter the working position, the linkage tooth 43 and the first gear tooth 23-1 resume meshing. At this time, the limiting part 41 just moves out of the limiting groove 27, thereby allowing the rack and pinion assembly 22 to move. Through the meshing transmission of the first gear tooth 23-1 and the rack 24, the outer tube 12 can be driven to slide towards the proximal end.

[0071] In some cases, the transmission gear 23 includes one or two of the following: a first gear 23-1, a second gear 23-2, and a third gear 23-3, arranged coaxially. The first gear 23-1 meshes with the linkage gear 43, the second gear 23-2 meshes with the first pinion 24-1 of the rack 24, and the third gear 23-3 meshes with the second pinion 24-2 of the rack 24. Furthermore, when the second gear 23-2 and the third gear 23-3 are arranged coaxially on the outer periphery of the first gear 23-1, they are located on opposite sides of the first gear 23-1. This arrangement results in more even force distribution on the rack 24, helping to ensure axial linear motion of the rack assembly 22 in the working position. In the working position, the linkage gear 43 drives the coaxially arranged first gear 23-1, second gear 23-2, and / or third gear 23-3 to rotate, thereby driving the outer tube 12, which is fixedly connected to the rack assembly 22, to move axially, thus releasing the sealing element 3 loaded in the receiving cavity 13. Furthermore, when the operating button 4 is inserted into the housing 21 at the first opening 213 in the wrong direction, the positioning step 42 provides spatial resistance to at least one of the second gear 23-2 and third gear 23-3, preventing the operating button 4 from being inserted into the housing 21. This ensures that the operating button 4 is inserted into the housing 21 in the correct direction. Preferably, the first gear 23-1, the second gear 23-2, and the third gear 23-3 are integrally formed, with the first gear 23-1 being smaller than the second gear 23-2 and the third gear 23-3, and the second gear 23-2 and the third gear 23-3 being the same size. To further optimize operation and release efficiency, the transmission ratio between the first gear 23-1 and the second gear 23-2 is 5:1 to 1:5, for example 3:1 to 1:3, or 3:1 to 2:1. Taking 2:1 as an example, when the operating button 4 is pressed for a stroke X, the release length of the sealing component 3 is 2X.

[0072] In some cases, the inner wall of the second housing 212 is provided with a first gear slot 214, and the central shaft 51 of the transmission gear 23 extends from one end of the transmission gear 23. A hollow first metal ring 50 is fitted onto the extended central shaft 51. The first metal ring 50 may or may not rotate around the central shaft 51 of the transmission gear 23. The first metal ring 50 may be fitted into the first gear slot 214, and the first metal ring 50 may rotate within the first gear slot 214. A small amount of machine oil may be added to the first gear slot 214 or a small amount of machine oil may be applied to the first metal ring 50 to reduce the friction between the first metal ring 50 and the first gear slot 214 during rotation. When the first housing 211 and the second housing 212 are engaged together, the transmission gear 23 meshes with the rack 24. The presence of the rack 24 and the first gear slot 214 prevents the transmission gear 23 from moving in the height direction of the housing 21, but allows the transmission gear 23 to rotate.

[0073] In some cases, the inner wall of the first housing 211 is also provided with a second gear slot 238. The first gear slot 214 and the second gear slot 238 are spatially aligned, preferably have the same shape, and are located near the first opening 213 of the housing 21. The central shaft 51 of the transmission gear 23 extends from the other end of the transmission gear 23, and a hollow second metal ring 50' (not shown in the figure) is fitted onto the central shaft 51 extending from the other end of the transmission gear 23. The second metal ring 50' can be fixedly fitted into the second gear slot 238, and the second metal ring 50' can rotate in the second gear slot 238. A small amount of machine oil can be added to the second gear slot 238 or a small amount of machine oil can be applied to the second metal ring 50' to reduce the friction between the second metal ring 50' and the second gear slot 238 during rotation. When the transmission gear 23 is nested between the first gear slot 214 and the second gear slot 238, the first metal ring 50 and the second metal ring 50' fitted at different ends of the central shaft 51 of the transmission gear 23 can ensure that the transmission gear 23 does not easily slip off the rack 24 during rotation.

[0074] The inner wall of the second housing 212 is further provided with a first guide 215 and a second guide 216 parallel to the axial direction of the housing 21. The second guide 216 and the first guide 215 have a height difference in the height direction of the housing 21, and partially overlap when projected in the height direction. The non-overlapping portion of the first guide 215 is used to contact and support the rack and pinion assembly 22. The proximal end of the second guide 216 is connected to the proximal end of the first guide 215, and the distal end of the second guide 216 is connected to the distal end of the first guide 215. This connection can be direct or via a connector. Given that the upper surface of the rack and pinion assembly 22 has a rack 24, while the lower surface does not, and the first guide 215 contacts the lower surface of the rack and pinion assembly 22 without a rack, the height of the second guide 216 is greater than that of the first guide 215. Preferably, this height difference ensures that, upon contact, the first guide 215 supports at least 1 / 3 of the lower surface of the rack and pinion assembly 22. The rack and pinion assembly 22 can move along the first guide channel formed between the second guide 216 and the first guide 215. Specifically, the rack and pinion assembly 22 slides along the axial direction of the housing 21 while attached to the second guide 216 and supported by the first guide 215.

[0075] Correspondingly, a third guide 236 and a fourth guide 237, parallel to the axial direction of the housing 21, are also provided on the inner wall of the first housing 211. The third guide 236 and the fourth guide 237 have a height difference in the height direction of the housing 21, and partially overlap when projected in the height direction. The non-overlapping portion of the third guide 236 is used to contact and support the rack and pinion assembly 22. The proximal ends of the third guide 236 and the fourth guide 237 are connected together, and the distal ends of the third guide 236 and the fourth guide 237 are connected together. This connection can be direct or through a connector.

[0076] The third guide 236 contacts the lower surface of the rack assembly 22 without the rack. Therefore, the height of the fourth guide 237 is greater than that of the third guide 236. This height difference ensures that, upon contact, the third guide 236 supports at least one-third of the lower surface of the rack assembly 22. To reduce interference between different components, the areas of the lower surface of the rack assembly 22 that contact the first guide 215 and the third guide 236 do not overlap. The rack assembly 22 can move along the second guide channel formed between the third guide 236 and the fourth guide 237. Specifically, the rack assembly 22 slides along the axial direction of the housing 21 while adhering to the fourth guide 237 and supported by the third guide 236.

[0077] In some cases, the inner wall of the second housing 212 is further provided with a fifth guide 217 and a sixth guide 218 parallel to the axial direction of the housing 21. The fifth guide 217 and the sixth guide 218 have a height difference in the height direction of the housing 21, and their projections in the height direction at least partially overlap, preferably completely overlap. The proximal ends of the fifth guide 217 and the sixth guide 218 are connected together, and the distal ends of the fifth guide 217 and the sixth guide 218 are connected together. This connection can be direct or via a connector. In the height direction of the housing 21, the height of the connection between the fifth guide 217 and the sixth guide 218 is lower than the height of the fifth guide 217 and the sixth guide 218, being 1 / 4 to 3 / 4 of the height of either the fifth guide 217 or the sixth guide 218. The rack and pinion assembly 22 can perform linear axial movement of the housing 21 along the third guide channel formed between the fifth guide 217 and the sixth guide 218. Preferably, the proximal end of the fifth guide 217 is fixedly connected to one end of the second fixing member 230, which makes the fifth guide 217 and the second fixing member 230 more stable in spatial structure and less prone to breakage.

[0078] The inner wall of the first housing 211 is further provided with a seventh guide 241 and an eighth guide 242 parallel to the axial direction of the housing 21. The seventh guide 241 and the eighth guide 242 have a height difference in the height direction of the housing 21, and their projections in the height direction at least partially overlap, preferably completely overlap. The proximal ends of the seventh guide 241 and the eighth guide 242 are connected together, and the distal ends of the seventh guide 241 and the eighth guide 242 are connected together. This connection can be direct or through a connector. In the height direction of the housing 21, the height of the connection between the seventh guide 241 and the eighth guide 242 is lower than the height of the seventh guide 241 and the eighth guide 242, approximately 1 / 4 to 3 / 4 of the height of either the seventh guide 241 or the eighth guide 242. The rack and pinion assembly 22 can slide axially along the fourth guide channel formed between the seventh guide 241 and the eighth guide 242. Preferably, the proximal end of the eighth guide 242 is fixedly connected to one end of the first fixing member 247, which makes the eighth guide 242 and the first fixing member 247 more robust in spatial structure and less prone to breakage.

[0079] The first and third guide channels are aligned front to back in the axial direction of the housing 21, and the second and fourth guide channels are aligned front to back in the axial direction of the housing 21. The first guide channel, the second guide channel, the third guide channel, and the fourth guide channel are aligned in the height direction of the housing 21, which fully ensures that the outer and inner sides of the rack and pinion assembly 22 slide linearly along the axial direction of the housing 21 and are not prone to bending, thereby driving the outer tube 12 to move linearly relative to the core rod 11.

[0080] Since the rack 24 does not move between the fifth guide 217 and the sixth guide 218, nor between the seventh guide 241 and the eighth guide 242, there may or may not be a width difference between the fifth guide 217 and the sixth guide 218, or between the seventh guide 241 and the eighth guide 242. The fifth guide 217 and the sixth guide 218, along with the second guide 216 and the first guide 215, are distributed on both sides of the lower end of the main body 40 of the housing 21. The third guide 236 and the fourth guide 237, along with the seventh guide 241 and the eighth guide 242, are also distributed on both sides of the lower end of the main body 40 of the housing 21. This facilitates uniform support of the rack assembly 22, ensuring that the rack assembly 22 maintains as linear a movement as possible during the axial movement of the housing 21. In the initial position, the rack 24 abuts against the proximal ends of the fifth guide 217 and the eighth guide 242, and the connecting sleeve 121 abuts against the protective member 122, preventing the rack assembly 22 from moving further towards the distal end of the housing 21. This defines the starting point of the rack assembly 22's movement trajectory. In the working position, compared to the initial position, the rack assembly 22 has moved a certain distance towards the proximal end of the housing 21. The distal ends of the fifth guide 217 and the eighth guide 242 come into contact with the bent portion 25 of the rack assembly 22, preventing the rack assembly 22 from moving further towards the proximal end of the housing 21. This defines the ending point of the rack assembly 22's movement trajectory. This distance is precisely the movement trajectory of the rack assembly 22.

[0081] To better prevent the rack assembly 22 from moving further toward the distal end of the housing 21, a trajectory limiting member (not shown) can be provided on the inner wall of the first housing 211 and the second housing 212 between the distal ends of the fifth guide 217 and the sixth guide 218, the distal ends of the seventh guide 241 and the eighth guide 242 and the second opening 235 of the housing 21. These spatially aligned trajectory limiting members, together with the rack 24, can effectively prevent the rack assembly 22 from moving further toward the distal end of the housing 21 at the starting point of the movement trajectory, thereby preventing the safety risks caused by the outer tube 12 extending further into the blood vessel. In addition, each trajectory limiting member has a notch. When the first housing 211 and the second housing 212 are engaged together, the notches of each trajectory limiting member together form an opening through which the outer tube 12 can pass but prevents the bending portion 25 from passing through, thereby preventing the bending portion 25 from moving further toward the distal end of the housing 21. Alternatively, a single trajectory limiting element may be provided on the inner wall of either the first housing 211 or the second housing 212.

[0082] On the inner wall of the second housing 212, from the distal end to the proximal end of the housing 21, a first guide 219, a second guide 221, a third guide 222, and a fourth guide 223, parallel to the height direction of the housing 21, may be sequentially provided. The first guide 219 and the fourth guide 223 are located between the first guide channel and the third guide channel, and the second guide 221 and the third guide 222 are located between the first guide 219 and the fourth guide 223. In the initial position of the operating button 4, the first guide 219, the second guide 221, the third guide 222, and the fourth guide 223 are located below the clearance groove 30 of the rack and pinion assembly 22 in the height direction of the housing 21. When the operation button 4 is pressed to the working position or even to the self-locking position, the second pin 45, the third pin 46, and the elastic support 48 of the operation button 4 pass through the clearance groove 30 and move to the guide channel formed between the first guide 219 and the second guide 221, the guide channel formed between the fourth guide 223 and the third guide 222, and the guide channel formed between the second guide 221 and the third guide 222, respectively. This ensures that when the operation button 4 is pressed, the second pin 45, the third pin 46, and the elastic support 48 of the operation button 4 move in their respective guide channels without interfering with each other.

[0083] After pressing the operation button 4 to the working position, in order to prevent the operation button 4 from unexpectedly rebounding, the operation button 4 can be moved from the working position to the self-locking position. For this purpose, a locking structure that cooperates with each other is provided between the operation button 4 and the housing 21 to keep the operation button 4 in the self-locking position.

[0084] In some cases, the locking structure includes cooperating blocking parts and latches 49. The blocking parts are located on the inner wall of the housing 21. For example, the blocking parts are a pair of positioning posts 224 fixed to the inner wall of the second housing 212. These positioning posts 224 are formed by one end of the first guide member 219 and the fourth guide member 223 extending along the width direction of the housing 21, respectively. The pair of latches 49 are formed by bending the ends of the second pin 45 and the third pin 46, respectively. When the operating button 4 moves from the working position to the self-locking position, the latches 49 of the second pin 45 engage with the positioning posts 224 of the first guide member 219, and the latches 49 of the third pin 46 engage with the positioning posts 224 of the fourth guide member 223, thereby keeping the operating button 4 in the self-locking position. Figure 6 and Figure 9 It can be seen that the pair of hooks 49 are positioned and engaged with the blocking part after the position of the operating button 4 changes.

[0085] Furthermore, a first positioning groove 239 and a second positioning groove 240 may be provided on the inner wall of the first housing 211. During assembly, the first positioning groove 239 and the second positioning groove 240 are spatially aligned with the positioning post 224 of the first guide member 219 and the positioning post 224 of the fourth guide member 223, respectively, so that they are nested together. Multiple pairs of such first positioning grooves 239, second positioning grooves 240 and positioning posts can be provided on the inner wall of the housing, thereby ensuring that the first housing 211 and the second housing 212 are tightly fastened together.

[0086] The inner wall of the second housing 212 is further provided with a second support member 229 parallel to the axial direction of the housing 21 and a first support member 227 perpendicularly connected to the second support member 229. One end of the first support member 227 is connected to the bottom of the second notch of the second housing 212. The width of the first support member 227 gradually increases from the end where it is connected to the second notch of the second housing 212 to the other end, and the height of the first support member 227 gradually decreases from the end where it is connected to the second notch of the second housing 212 to the other end. One end of the second support member 229 is connected to the second fixing member 230, and the other end of the second support member 229 is connected to the middle part of the first support member 227. In the width direction of the housing 21, the width of the bottom of the second notch is smaller than that of the second support member 229, and the width of the second fixing member 230 is smaller than that of the bottom of the second notch. This design ensures that when assembling the handle 2, the operating button 4 enters the first opening 213 along the direction of decreasing height and increasing width. At the same time, the side of the operating button 4 with the linkage tooth 43 enters the guide channel formed between the second gear tooth 23-2 and the third gear tooth 23-3 in the transmission gear 23, so that the linkage tooth 43 can mesh with the first gear tooth 23-1 located in this guide channel.

[0087] Preferably, the first guide 215 and the second guide 216 can be connected to different positions on the inner wall of the second housing 212 using a first structural fastener 225 and a second structural fastener 226 provided on the inner wall of the second housing 212 and parallel to the height direction of the housing 21, respectively. Correspondingly, the third guide 236 and the fourth guide 237 can be connected to different positions on the inner wall of the first housing 211 using a first structural connector 249 and a second structural connector 250 provided on the inner wall of the first housing 211 and parallel to the height direction of the housing 21, respectively. The fifth guide 217 can also be connected to the inner wall of the second housing 212 using a first structural connector 232, a second structural connector 233, and a second fastener 230 provided on the inner wall of the second housing 212 and parallel to the height direction of the housing 21. The second structural connector 233 extends downward along the height direction of the housing 21 and connects to the sixth guide 218, thereby also connecting the sixth guide 218 to the inner wall of the second housing 212. Alternatively, a second structural fastener 234 and a first structural fastener 228, whose two ends are respectively connected to the first structural connector 232 and the second structural connector 233, can be provided on the inner wall of the second housing 212. The second structural fastener 234, the first structural fastener 228, and the fifth guide 217 are parallel to the axial direction of the housing 21. The first structural fastener 228 is located between the second structural fastener 234 and the fifth guide 217 in the height direction of the housing 21. The width of the first structural fastener 228 is greater than that of the second structural fastener 234 and the fifth guide 217, so that the first structural fastener 228, the second structural fastener 234, and the fifth guide 217 together form a first groove structure in space. The second structural connector 245, the first structural connector 244, and the eighth guide 242 are parallel to the axial direction of the housing 21. The first structural connector 244 is located between the second structural connector 245 and the first structural connector 242 in the height direction of the housing 21. The width of the first structural connector 244 is greater than that of the second structural connector 245 and the first structural connector 242. Thus, the first structural connector 245, the first structural connector 244, and the eighth guide 242 together form a second groove structure in space. When the first housing 211 and the second housing 212 are assembled together, the two opposite sides of the connecting sleeve 121 are respectively attached to the first groove structure and the second groove structure, thereby allowing the connecting sleeve 121 to move along the axial direction of the housing 21. In addition, in the width direction of the housing 21, the width of the fifth guide 217 is smaller than that of the second structural fastener 234, and the width of the eighth guide 242 is smaller than that of the first structural connector 245. This ensures that the connecting sleeve 121 moves as far along the axial direction of the housing 21 as possible during movement, without interfering with the axial movement of the rack and pinion assembly 22.

[0088] Alternatively, the seventh guide 241 and the eighth guide 242 can be connected to different positions on the inner wall of the first housing 211 using the third structural connector 243, the fourth structural connector 246, and the first fixing member 247, respectively. The third structural connector 243 and the fourth structural connector 246 are parallel to the height direction of the housing 21. At the same time, a first structural joint 244 and a second structural joint 245 can be provided on the inner wall of the first housing 211, with their two ends connected to the third structural connector 243 and the fourth structural connector 246, respectively. The first structural joint 244 and the second structural joint 245 are parallel to the axial direction (i.e., the length direction) of the housing 21. The ultimate purpose of these structural connectors is to make the corresponding guides more robust in spatial structure and less prone to breakage. Furthermore, the second structural connector 233 and the third structural connector 243 are parallel to the height direction of the housing 21 and spatially aligned, and are respectively connected to the fifth guide 217 and the eighth guide 242. This significantly increases the contact area between the second structural connector 233 and the third structural connector 243 and the bent portion 25 of the rack assembly 22, further preventing the rack assembly 22 from moving proximally, while effectively reducing the impact force of the bent portion 25 on the fifth guide 217 and the eighth guide 242 during movement. A notch can also be provided at the distal end of the fifth guide 217 and the distal end of the eighth guide 242. Each notch can be formed by cutting a portion of the distal end of the fifth guide 217 and the distal end of the eighth guide 242. This further reduces the contact area between the bent portion 25 and the distal ends of the fifth guide 217 and the eighth guide 242, or even completely avoids contact, thereby further reducing the impact force.

[0089] To ensure stable transmission, the rack and pinion assembly 22 has sufficient length. Considering structural optimization and space constraints, the rack and pinion assembly 22 has a clearance groove 30 extending along its own direction of movement. The hooks 49 of the second pin 45 and the third pin 46 pass through the clearance groove 30 and engage with a blocking part located on the inner wall of the housing 21. Specifically, the hook 49 of the second pin 45 engages with the positioning post 224 of the first guide member 219, and the hook 49 of the third pin 46 engages with the positioning post 224 of the fourth guide member 223. The clearance groove 30 divides at least a portion of the rack 24 into two smaller racks located on either side of the clearance groove 30: a first smaller rack 24-1 and a second smaller rack 24-2. When the second gear tooth 23-2 and the third gear tooth 23-3 are arranged on both sides of the first gear tooth 23-1 in the axial direction, the second gear tooth 23-2 and the third gear tooth 23-3 respectively mesh with the first small rack 24-1 and the second small rack 24-2 located on both sides of the clearance groove 30 in the rack 24.

[0090] This application can also operate in the manner described above, i.e., the outer tube 12 is fixed relative to the handle 2, while the core rod 11 moves distally and pushes the sealing member 3 out of the receiving cavity 13. In this case, the outer circumference of the connecting sleeve 121 of the outer tube 12 can be provided with a reduced diameter portion. The inner walls of the first housing 211 and the second housing 212 are respectively provided with a first fixing member 247 and a second fixing member 230 that are spatially aligned. The first fixing member 247 and the second fixing member 230 are parallel to the height direction of the housing 21 and are respectively provided with a first half-groove 248 and a second half-groove 231. When assembled together, the first half-groove 248 and the second half-groove 231 together form a fixing groove, which engages with the reduced diameter portion of the connecting sleeve 121, thereby fixing the outer tube 12 to the housing 21 of the handle 2. At the same time, the slot 26 in the bent portion 25 of the rack assembly 22 engages with the reduced diameter portion in the end cap 111 of the core rod 11, thereby fixing the rack assembly 22 and the core rod 11 together. Apart from these two differences, the operating button 4 and the housing 21 remain unchanged. When the operating button 4 is pressed to the working position, the operating button 4 drives the rack and pinion assembly 22 to slide axially along the housing 21 under the meshing linkage of the linkage gear 43 and the transmission gear 23, thereby driving the core rod 11 to move to the distal end and pushing the sealing element 3 loaded in the receiving cavity 13 of the outer tube 12 out of the receiving cavity 13, thereby releasing the sealing element 3.

[0091] The technical features of the above embodiments can be combined arbitrarily. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as the combination of these technical features does not contradict each other, it should be considered to be within the scope of this specification. When technical features of different embodiments are embodied in the same drawing, it can be regarded as the drawing also disclosing examples of combinations of the various embodiments involved.

[0092] The embodiments described above are merely illustrative of several implementation methods of this application, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent application. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these all fall within the scope of protection of this application. Therefore, the patent protection scope of this application should be determined by the appended claims.

Claims

1. A vascular closure device having opposing distal and proximal ends, characterized in that, The vascular closure device includes: (1) A conveying assembly, the conveying assembly including a core rod and an outer tube, the outer tube having a receiving cavity for loading a sealing element, at least a portion of the core rod extending into the receiving cavity for cooperating with the outer tube to release the sealing element, a hollow protective element sleeved on the proximal end of the outer tube, the outer periphery of the protective element having a reduced diameter portion, an end cap fixed to the proximal end of the core rod, the outer periphery of the end cap having a reduced diameter portion; (2) A handle, connected to the proximal end of the conveying assembly, the handle including an operating button, a transmission mechanism, and a housing, the transmission mechanism being located inside the housing, the housing being composed of a first housing and a second housing that can be interlocked, a first opening being located on one side of the housing, and a second opening being located at the distal end of the housing, the operating button having a relative initial position and a working position along its own movement path, one end of the operating button being a pressing part exposed to the first opening, and the other end of the operating button extending into the first opening and cooperating with the transmission mechanism, the operating button being pressed can drive the outer tube and the core rod to move relative to each other through the transmission mechanism to release the sealing element. The housing has a fixing groove inside, which is fixedly connected to the inner wall of the housing. The connecting sleeve is fitted onto the proximal end of the outer tube and located inside the housing, and can slide between the end cap and the protective member. The outer periphery of the connecting sleeve has a reduced diameter section. One end of the main body of the operation button is connected to the pressing part, and a linkage tooth is provided on one side wall of the main body along the movement path of the operation button. The fixing groove is located between the far end of the main body and the housing. The transmission mechanism includes a rack assembly and a transmission gear. The transmission gear meshes with the linkage gear. A rack is located at the proximal end of the rack assembly, and the rack meshes with the transmission gear. The distal end of the rack assembly has a bent portion with a groove. In the initial state, the transmission gear meshes with the rack but not with the linkage gear. In the working state, pressing the operation button engages the linkage gear with the transmission gear, thereby causing the rack assembly to slide axially along the housing. The relative movement between the outer tube and the core rod is one of the following two methods: Method A: The reduced diameter portion of the end cap is fixedly fitted into the slot, thereby fixing the core rod and the rack assembly together. The fixing groove engages with the reduced diameter portion of the connecting sleeve, thereby fixing the outer tube to the handle. Method B: The reduced diameter portion of the connecting sleeve is fixedly embedded in the slot, thereby fixing the outer tube and the rack assembly together. The fixing groove engages with the reduced diameter portion of the end cap, thereby fixing the core rod to the handle.

2. The vascular closure device according to claim 1, characterized in that, The linkage tooth and at least one of the transmission gears have a clearance zone. In the initial position, the linkage tooth disengages from the transmission gear through the clearance zone, and in the working position, it re-engages after passing through the clearance zone.

3. The vascular closure device according to claim 2, characterized in that, The linkage tooth has a missing tooth portion, forming a first clearance area. The transmission gear includes a first gear tooth, a second gear tooth, and a third gear tooth arranged coaxially. The first gear tooth can mesh with the linkage tooth. The second gear tooth and the third gear tooth are located on both sides of the first gear tooth and can mesh with the rack. The first gear tooth has a missing tooth portion, forming a second clearance area. In the initial position, the first clearance area and the second clearance area are aligned in position, so that the linkage tooth and the first gear tooth are disengaged. In the working position, by pressing the operation button, the linkage tooth and the first gear tooth are re-engaged.

4. The vascular closure device according to claim 3, characterized in that, The size of the first gear tooth is smaller than that of the second gear tooth and the third gear tooth. The size of the second gear tooth and the third gear tooth are the same. The transmission ratio between the first gear tooth and the second gear tooth is 5:1 to 1:

5.

5. The vascular closure device according to claim 1, characterized in that, The inner wall of the second housing is provided with a first gear slot. The central shaft of the transmission gear extends from one end of the transmission gear. A hollow first metal ring is sleeved on the extended central shaft portion. The first metal ring is embedded in the first gear slot and can rotate within the first gear slot.

6. The vascular closure device according to claim 5, characterized in that, The inner wall of the first housing is also provided with a second gear slot. The second gear slot and the first gear slot are aligned in space and located near the first opening. The central shaft also extends from the other end of the transmission gear. A hollow second metal ring is fitted onto the central shaft portion extending from the other end of the transmission gear. The second metal ring is fixedly embedded in the second gear slot and can rotate in the second gear slot. The transmission gear is nested between the first gear slot and the second gear slot.

7. The vascular closure device according to claim 1, characterized in that, The inner wall of the second housing is also provided with a first guide and a second guide parallel to the axial direction of the housing. The second guide and the first guide have a height difference in the height direction of the housing and partially overlap when projected in the height direction. The non-overlapping part of the first guide is used to contact and support the rack assembly. The proximal end of the second guide is connected to the proximal end of the first guide, and the distal end of the second guide is connected to the distal end of the first guide. The rack is provided on the upper surface of the rack assembly. The first guide contacts the lower surface of the rack assembly without the rack and supports at least 1 / 3 of the lower surface of the rack assembly. The height of the second guide is greater than that of the first guide. Therefore, the rack assembly can slide along the first guide channel formed between the second guide and the first guide under the support of the first guide in the axial direction of the housing. A third guide and a fourth guide parallel to the axial direction of the housing are provided on the inner wall of the first housing. The third guide and the fourth guide have a height difference in the height direction of the housing and partially overlap when projected in the height direction. The non-overlapping portion of the third guide is used to contact and support the rack assembly. The proximal ends of the third guide and the fourth guide are connected together, and the distal ends of the third guide and the fourth guide are connected together. The third guide contacts the lower surface of the rack assembly without the rack and supports at least 1 / 3 of the lower surface of the rack assembly. The respective areas of the lower surface of the rack assembly that contact the first guide and the third guide do not overlap. The height of the fourth guide is greater than that of the third guide. Therefore, the rack assembly is attached to the fourth guide and, supported by the third guide, can slide along the second guide channel formed between the third guide and the fourth guide in the axial direction of the housing. The first guide channel and the second guide channel are aligned in the height direction of the housing.

8. The vascular closure device according to claim 7, characterized in that, The inner wall of the second housing is further provided with a fifth guide and a sixth guide parallel to the axial direction of the housing. The fifth guide and the sixth guide have a height difference in the height direction of the housing and at least partially overlap when projected in the height direction. The proximal ends of the fifth guide and the sixth guide are connected together, and the distal ends of the fifth guide and the sixth guide are connected together. The height of the connection between the fifth guide and the sixth guide is lower than the height of the fifth guide and the sixth guide, which is 1 / 4 to 3 / 4 of the height of the fifth guide or the sixth guide. The rack and pinion assembly can slide along the third guide channel formed between the fifth guide and the sixth guide in the axial direction of the housing. The inner wall of the first housing is further provided with a seventh guide and an eighth guide parallel to the axial direction of the housing. The seventh guide and the eighth guide have a height difference in the height direction of the housing and at least partially overlap when projected in the height direction. The proximal ends of the seventh guide and the eighth guide are connected together, and the distal ends of the seventh guide and the eighth guide are connected together. The height of the connection between the seventh guide and the eighth guide is lower than the height of the seventh guide and the eighth guide, which is 1 / 4 to 3 / 4 of the height of the seventh guide or the eighth guide. The rack and pinion assembly can slide along the fourth guide channel formed between the seventh guide and the eighth guide in the axial direction of the housing. The first guide channel and the third guide channel are aligned front to back in the axial direction of the housing, and the second guide channel and the fourth guide channel are aligned front to back in the axial direction of the housing; the third guide channel and the fourth guide channel are aligned in the height direction of the housing.

9. The vascular closure device according to claim 8, characterized in that, The fifth and sixth guide members, along with the second and first guide members, are distributed on both sides of the lower end of the main body. The third and fourth guide members, along with the seventh and eighth guide members, are also distributed on both sides of the lower end of the main body. In the initial position, the rack abuts against the proximal ends of the fifth and eighth guide members, preventing the rack assembly from moving towards the distal end of the housing, thereby determining the starting point of the movement trajectory of the rack assembly. In the working position, compared to the initial position, the rack assembly moves a distance towards the proximal end of the housing. The distal ends of the fifth guide and the eighth guide come into contact with the bent portion, preventing the rack assembly from moving further towards the proximal end of the housing. This determines the endpoint of the rack assembly's movement trajectory, and this distance is equal to the length of the rack assembly's movement trajectory.

10. The vascular closure device according to claim 1, characterized in that, The first housing has a first fixing member on its inner wall and the second housing has a second fixing member on its inner wall. The first fixing member and the second fixing member are parallel to the height direction of the housing and are spatially aligned. They are respectively provided with a first half-groove and a second half-groove. The first fixing member and the second fixing member are located between the far end of the main body and the housing. When the first housing and the second housing are engaged together, the first half-groove and the second half-groove together form the fixing groove.

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