Vascular closure assembly and vascular closure apparatus

Abstract

The present application relates to a vascular closure assembly. A sheath tube inner cavity channel of an outer sheath tube (1100) comprises, along the axial direction, a main body channel section and a distal end channel section; an inner catheter (1200) is movably disposed in the sheath tube inner cavity channel of the outer sheath tube (1100); the inner catheter (1200) and the outer sheath tube (1100) are used for moving relative to one another along the axial direction, so that the catheter distal end of the inner catheter (1200) pushes a hemostatic material (A) stored within the distal end channel section out from the sheath tube distal end of the outer sheath tube (1100).

Description

Vascular sealing assembly and vascular sealing device

[0001] Related applications

[0002] This application claims priority to Chinese patent application No. 202311014359X, filed on August 11, 2023, entitled “Vascular Closure Assembly and Vascular Closure Device,” the entire text of which is incorporated herein by reference. Technical Field

[0003] The present application relates to the technical field of medical devices, and in particular to a vascular closure component and a vascular closure device. Background Art

[0004] Complications arising from the femoral artery puncture site during diagnostic and percutaneous coronary intervention are receiving increasing attention. Common complications include inguinal hematoma, arteriovenous fistula, and pseudoaneurysm. Since the introduction of percutaneous puncture, continuous pressure on the puncture site and bed rest after surgery have been considered the standard method for arterial hemostasis. This involves removing the vascular sheath from the artery and applying manual pressure combined with fixation with wide tape or elastic bandages to stop bleeding at the femoral artery puncture site.

[0005] Clinically, manual compression is commonly used to stop bleeding at arterial or venous puncture sites. This traditional method of manual compression of blood vessels can easily cause discomfort to patients, such as pain, insomnia, and difficulty urinating. Moreover, this physical compression time is usually more than 30 minutes or even longer, which can easily cause long-term pain to patients and increase the workload of medical staff. Moreover, the hemostatic effect is affected by the experience and skills of the person implementing the compression and the degree of cooperation of the patient, which adds a burden to the nursing work.

[0006] Mechanical compression is an improvement on traditional manual compression. Although it saves manpower, its incidence of hematoma is similar to that of manual compression. Most of the vascular puncture port occlusion devices or suturing devices already in use on the market are relatively complicated to operate and have a high failure rate. The design purpose of this type of medical device is mainly to reduce the physical compression time of medical staff. Therefore, this mechanical compression method does not actually reduce the postoperative bed rest time and the patient's pain, nor does it reduce the time for sheath removal after anticoagulation.

[0007] Summary of the Invention

[0008] According to various embodiments of the present application, the present application provides a blood vessel sealing assembly and a blood vessel sealing device.

[0009] The present application provides a blood vessel sealing assembly, comprising:

[0010] An outer sheath tube, wherein the outer sheath tube has an axially extending sheath tube inner cavity channel, the sheath tube inner cavity channel of the outer sheath tube axially comprises a main channel section and a distal channel section, and the channel inner cavity of the distal channel section is used to receive a hemostatic material; and

[0011] An inner catheter having an axially extending catheter lumen channel, the inner catheter being movably assembled in the sheath lumen channel of the outer sheath, the inner catheter and the outer sheath being configured to move relative to each other along the axial direction so that the distal end of the inner catheter pushes out the hemostatic material housed in the distal channel segment from the distal end of the outer sheath.

[0012] In one embodiment, the blood vessel closing component includes a hemostatic material, which is accommodated in the channel lumen of the distal channel segment, and the distal end of the inner catheter contacts the proximal end of the hemostatic material.

[0013] In one embodiment, the outer sheath is used to move in a proximal direction relative to the inner catheter in a stationary state, so that the distal end of the inner catheter pushes the hemostatic material contained in the distal channel section out of the distal end of the outer sheath.

[0014] In one embodiment, the blood vessel sealing assembly comprises:

[0015] an occluding element having a contracted state and an expanded state; and

[0016] A linkage device is connected to the blocking element and is used to control the blocking element to be in a contracted state or an expanded state at the distal end of the outer sheath.

[0017] In one embodiment, the linkage device includes:

[0018] An inner core tube, the inner core tube having an axially extending inner core tube cavity channel, the inner core tube being movably assembled in the inner tube cavity channel of the inner catheter; and

[0019] A driving wire is movably arranged in the core tube inner cavity channel of the inner core tube, and the driving wire is connected to the blocking element to control the switching of the blocking element between the contracted state and the expanded state.

[0020] In one embodiment, the distal end of the inner core tube extends beyond the distal end of the inner catheter, and the cavity gap between the inner core tube and the outer sheath tube is used to receive a hemostatic material;

[0021] The blocking element is an umbrella-shaped blocking element. The closed state of the umbrella-shaped blocking element is a contracted state, and the opened state of the umbrella-shaped blocking element is an expanded state. The driving wire is used to apply a force to the umbrella-shaped blocking element to cause it to open or close.

[0022] In one embodiment, the drive wire includes multiple unit wires, and the multiple unit wires are respectively connected to multiple positions around the umbrella-shaped blocking element. The movement of the multiple unit wires toward the proximal direction is used to apply a force to the umbrella-shaped blocking element to cause it to open, and the movement of the multiple unit wires toward the distal direction is used to apply a force to the umbrella-shaped blocking element to cause it to close.

[0023] The present application also provides a blood vessel closure device, comprising:

[0024] The vascular closure assembly; and

[0025] A control device is connected to at least one of the outer sheath tube and the inner catheter, and is used to control the inner catheter and the outer sheath tube to move relative to each other along the axial direction.

[0026] In one embodiment, the control device is fixedly connected to the proximal end of the inner catheter, and the control device is connected to the proximal end of the outer sheath tube for controlling the outer sheath tube to move relative to the inner catheter in a proximal direction.

[0027] In one embodiment, the control device includes a device base, a driving element and a transmission element. The device base is connected to the proximal end of the inner catheter, the transmission element is connected to the proximal end of the outer sheath, and the driving element is drivingly connected to the transmission element to drive the transmission element to move relative to the device base, thereby indirectly driving the outer sheath to move axially relative to the inner catheter.

[0028] In one embodiment, the driving element is a driving gear, which is rotatably assembled on the device base, and the transmission element is a transmission rack, which is axially movable and assembled on the device base, and the driving gear is driven and engaged with the transmission rack.

[0029] In one embodiment, the transmission gear includes a gear outer sleeve and a stopper inner plug, the stopper inner plug is assembled on the device base, the gear outer sleeve is rotatably assembled on the outside of the stopper inner plug, the gear outer sleeve is driven and engaged with the transmission rack, and at least one of the outer wall of the stopper inner plug and the inner wall of the gear outer sleeve is provided with a stopper structure for limiting the gear outer sleeve to rotate only in a single direction relative to the stopper inner plug.

[0030] The present application also provides a blood vessel closure device, comprising:

[0031] the vascular closure component;

[0032] a locking device, the locking device having a locked state and an unlocked state, the locking device being controllably connected to the linkage device and configured to control the blocking element to be in a locked state after being converted to an expanded state through the linkage device, or to control the blocking element to be in a contracted state when the blocking element is in an unlocked state; and

[0033] A control device is connected to the outer sheath and the inner catheter, and is used to drive the locking device to change from a locked state to an unlocked state during the process of controlling the outer sheath to move toward the proximal direction relative to the inner catheter.

[0034] In one embodiment, the control device includes a device base, a driving element and a transmission element, the device base is connected to the proximal end of the inner catheter, the transmission element is connected to the proximal end of the outer sheath, the driving element is assembled with the device base and is driven and connected to the transmission element, and is used to drive the transmission element to move relative to the device base, thereby indirectly driving the outer sheath to move axially relative to the inner catheter.

[0035] In one embodiment, the locking device includes a locking base, a locking element, and a locking element. The locking base is assembled on the device base, the locking base defines a locking cavity, the locking element is movably assembled on the locking base and is used to enter or exit the locking cavity, the locking element is assembled on the locking base, and the locking element is used to restrict the locking element from exiting the locking cavity of the locking base to present a locked state, or the locking element from exiting the locking cavity of the locking base to present an unlocked state.

[0036] The proximal end of the inner core tube is connected to the locking base, and the locking element is connected to the driving wire for driving the driving wire to move.

[0037] In one embodiment, the locking element is provided with a locking guide portion, wherein the locking guide portion has a locking guide surface, and the locking guide portion allows the locking element to enter the locking cavity along the locking guide surface.

[0038] In one embodiment, the locking element is provided with an unlocking guide portion, and the unlocking guide portion has an unlocking guide surface. The control device is driven to contact the unlocking guide surface to drive the locking element to release the movement restriction of the locking control element, and then drive the locking control device to change from a locked state to an unlocked state.

[0039] In one embodiment, the proximal end of the transmission element contacts the unlocking guide surface of the unlocking guide portion.

[0040] In one embodiment, a pushing element is provided at the proximal end of the transmission element, and the proximal end of the pushing element contacts the unlocking guide surface of the unlocking guide portion.

[0041] The details of one or more embodiments of the present application are set forth in the accompanying drawings and the description below, and other features, objects, and advantages of the present application will be apparent from the description, the drawings, and the claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0042] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the conventional technology, the following briefly introduces the drawings required for use in the embodiments or the conventional technology descriptions. Obviously, the drawings described below are merely embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on the disclosed drawings without any creative work.

[0043] FIG1 is a schematic structural diagram of a blood vessel sealing assembly provided in some embodiments of the present application.

[0044] FIG2 is a schematic structural diagram of a blood vessel sealing device provided in some embodiments of the present application.

[0045] FIG3 is a schematic diagram of a blood vessel sealing device in use according to some embodiments of the present application.

[0046] FIG4 is a schematic diagram of the structure of a control device provided in some embodiments of the present application.

[0047] FIG5 is a schematic structural diagram of a device substrate, a driving element, and a transmission element provided in some embodiments of the present application.

[0048] FIG6 is a schematic diagram of the transmission principle of the device substrate, driving element and transmission element provided in some embodiments of the present application.

[0049] FIG7 is a schematic structural diagram of a driving element provided in some embodiments of the present application.

[0050] FIG8 is a schematic structural diagram of a locking control device provided in some embodiments of the present application.

[0051] FIG9 is a schematic structural diagram of a locking base, a locking element, and a locking element provided in some embodiments of the present application.

[0052] FIG10 is a schematic diagram of an unlocked state of a locking control device provided in some embodiments of the present application.

[0053] FIG11 is a schematic diagram of a locked state of a locking control device provided in some embodiments of the present application.

[0054] FIG12 is a schematic diagram of the planar structure of a locking control device provided in some embodiments of the present application.

[0055] Reference numerals: A, hemostatic material; 1000, vascular closure assembly; 2000, control device; 3000, locking device; 1100, outer sheath; 1200, inner catheter; 1300, occluding element; 1400, inner core tube; 1500, driving wire; 1100a, sheath connector; 2100, device base; 2200, driving element; 2300, transmission element; 2200a, gear housing; 2200b, anti-rotation inner plug; 2200c, anti-rotation structure; 2400, transmission gear; 3100, locking base; 3200, locking element; 3300, locking element; 3100a, locking cavity; 3200a, locking guide; 3200a1, locking guide surface; 3200b, unlocking guide; 3200b1, unlocking guide surface; 3200c, pushing element. DETAILED DESCRIPTION

[0056] The following will be combined with the drawings in the embodiments of this application to clearly and completely describe the technical solutions in the embodiments of this application. Obviously, the embodiments described are only part of the embodiments of this application, not all of the embodiments. Based on the embodiments in this application, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of this application.

[0057] To more clearly describe the structure of vascular closure assembly 1000 and its associated device, the term "distal end" is defined herein to mean the end away from the operator during a surgical procedure, and the term "proximal end" is defined herein to mean the end closer to the operator during a surgical procedure. Unless otherwise defined, all technical and scientific terms used herein have the same meanings as commonly understood by those skilled in the art to which this application pertains. The terms used in this specification are for purposes of describing the embodiments only and are not intended to limit this application.

[0058] Referring to Figures 1 to 3, an embodiment of the present application provides a vascular closure component 1000, which includes an outer sheath 1100 and an inner catheter 1200. The outer sheath 1100 has an axially through-going sheath lumen channel. The sheath lumen channel of the outer sheath 1100 axially includes a main channel section and a distal channel section. The channel lumen of the distal channel section is used to accommodate a hemostatic material A. The inner catheter 1200 has an axially through-going catheter lumen channel. The inner catheter 1200 is movably assembled in the sheath lumen channel of the outer sheath 1100. The inner catheter 1200 and the outer sheath 1100 are used to move relative to each other along the axial direction, so that the distal end of the inner catheter 1200 pushes the hemostatic material A accommodated in the distal channel section out of the distal end of the outer sheath 1100.

[0059] As shown in FIG1 , the outer sheath 1100 can be divided into two sections along the axial direction. The section located near the distal end (the right section as shown in FIG1 ) corresponds to the distal channel section of the sheath lumen. Therefore, the section located near the proximal end (the left section as shown in FIG1 ) of the outer sheath 1100 corresponds to the main channel section of the sheath lumen. Thus, the hemostatic material A can be accommodated in the channel lumen of the distal channel section. The distal end of the inner catheter 1200 contacts or forms a gap with the proximal end of the hemostatic material A. The hemostatic material A can include a hemostatic blocking gel with hemostatic function, etc., so that after the vascular closure assembly 1000 is implanted at the target location, the relative movement between the inner catheter 1200 and the outer sheath 1100 along the axial direction can push the hemostatic material A out and apply it to the target location. As shown in FIG3 , the target location can be the subcutaneous tissue between the puncture site in the blood vessel wall and the skin surface. The release of the hemostatic material A to the target location can promote rapid blood coagulation, thereby achieving hemostasis at the puncture site.

[0060] The movement between the outer sheath 1100 and the inner catheter 1200 can be simultaneous movement, or the outer sheath 1100 is stationary and the inner catheter 1200 moves relative to the outer sheath 1100, or the inner catheter 1200 is stationary and the outer sheath 1100 moves relative to the inner catheter 1200. In one embodiment, the inner catheter 1200 can be controlled to be in a stationary state, for example, the inner catheter 1200 is fixed on a control device 2000 such as a control handle, and then the outer sheath 1100 is controlled to move in the proximal direction relative to the inner catheter 1200 in the stationary state, so that the distal end of the inner catheter 1200 pushes out the hemostatic material A contained in the distal channel segment from the distal end of the outer sheath 1100.

[0061] During this process, the retraction of the outer sheath 1100 can generate a force in the proximal direction, which can be used to cooperate with the synchronous control of other cooperating devices. For example, when the blood vessel closure component 1000 is equipped with a locking device 3000, the force generated by the retraction of the outer sheath 1100 can be used to unlock the locking device 3000, etc. The function of the locking device 3000 is described in detail later. Those skilled in the art can also use the synchronous force function brought about by the retraction of the outer sheath 1100 to form synchronous control cooperation with other devices, and there is no limitation on this.

[0062] Continuing with FIG1 , in one embodiment, a vascular closure assembly 1000 includes a sealing element 1300 having a contracted state and an expanded state. The contracted state of the sealing element 1300 facilitates implantation into a living body along with the vascular closure assembly 1000. When the hemostatic material A reaches the target location, the sealing element 1300 is able to enter the inner wall of the blood vessel. At this time, the sealing element 1300 is controlled to transition from the contracted state to the expanded state, allowing the sealing element 1300 to be used to seal the puncture in the blood vessel wall, reducing the amount of bleeding from the puncture, and implementing physical hemostasis. Utilizing the hemostatic material A to stop bleeding while controlling the amount of bleeding is a method that combines physical hemostasis with chemical hemostasis to improve the hemostatic effect.

[0063] The blocking element 1300 can adopt a variety of structures that can be flexibly converted between a contracted state and an expanded state according to needs, such as an airbag, a miniature folding umbrella, etc., and there is no limitation on this. Based on the different structural forms of the blocking element 1300, after the blocking element 1300 is implanted into the body of a living organism, the state conversion can be controlled by a corresponding linkage device. For example, the linkage device is connected to the blocking element 1300, and the linkage device is used to control the blocking element 1300 to be in a contracted state or an expanded state at the distal end of the sheath tube of the outer sheath tube 1100.

[0064] Continuing to refer to Figure 1, in one embodiment, when the blocking element 1300 adopts a structure such as a miniature folding umbrella that can achieve state conversion through structural transformation, the linkage device may include an inner core tube 1400 and a driving wire 1500. The inner core tube 1400 has an axially through-core tube lumen channel. The inner core tube 1400 is movably assembled in the catheter lumen channel of the inner catheter 1200. The driving wire 1500 is movably arranged in the core tube lumen channel of the inner core tube 1400. The driving wire 1500 is connected to the blocking element 1300, for example, the distal end of the wire of the driving wire 1500 is connected to the blocking element 1300.

[0065] After the vascular closure component 1000 is implanted into the body of a living organism, the occluding element 1300 can enter the inner wall of the blood vessel. At this time, the proximal end of the driving wire 1500 is still outside the body of the living organism. Therefore, the operator can use the driving wire 1500 to control the occluding element 1300 to switch between the contracted state and the expanded state, so that the occluding element 1300 is converted from the contracted state to the expanded state, and the puncture hole in the blood vessel wall is blocked by the occluding element 1300, thereby reducing the amount of bleeding from the puncture hole and implementing physical hemostasis.

[0066] In one embodiment, the distal end of the inner core tube 1400 extends beyond the distal end of the inner catheter 1200, and the cavity gap between the inner core tube 1400 and the outer sheath tube 1100 is used to accommodate the hemostatic material A. Since the outer sheath tube 1100, the inner catheter 1200 and the inner core tube 1400 are nested in sequence, the hemostatic material A can be assembled in the cavity gap between the inner core tube 1400 and the outer sheath tube 1100 by winding on the inner core tube 1400, and the distal end of the inner catheter 1200 is also in the cavity gap between the inner core tube 1400 and the outer sheath tube 1100, so that the inner catheter 1200 and the hemostatic material A are both in the cavity gap between the inner core tube 1400 and the outer sheath tube 1100, and the cavity gap is used as a guide track for the inner catheter 1200 to push the hemostatic material A, and the hemostatic material A is pushed out from the distal end of the sheath tube of the outer sheath tube 1100.

[0067] The driving wire 1500 transmits the force applied to the blocking element 1300, thereby causing the blocking element 1300 to undergo a change in its force state. The driving wire 1500 mainly has a force to retract in the proximal direction and a force to push in the distal direction in the core tube inner cavity channel of the inner core tube 1400. Among them, retracting in the proximal direction does not test the hardness of the driving wire 1500, while pushing in the distal direction needs to test the hardness of the driving wire 1500. Therefore, those skilled in the art can limit the corresponding hardness of the driving wire 1500 according to the force application requirements, so that the driving wire 1500 has the force to apply retraction and pushing, so as to meet the driving of the blocking element 1300. There is no limitation on this.

[0068] Taking the blocking element 1300 as an umbrella-shaped blocking element 1300 as an example, the structural principle of the umbrella-shaped blocking element 1300 is similar to that of a commonly used umbrella, which can be opened or closed. Therefore, the closing of the umbrella-shaped blocking element 1300 can be considered as a contracted state, and the opening of the umbrella-shaped blocking element 1300 can be considered as an expanded state. Referring to Figure 1, the umbrella tip of the umbrella-shaped blocking element 1300 is the center position of the umbrella of the umbrella-shaped blocking element 1300, and the umbrella tip can appear as the top of the cone when the umbrella-shaped blocking element 1300 is opened and presents a cone shape. The umbrella tail of the umbrella-shaped blocking element 1300 is the outer peripheral position of the umbrella of the umbrella-shaped blocking element 1300, and the umbrella tail can appear as the bottom of the cone when the umbrella-shaped blocking element 1300 is opened and presents a cone shape. The umbrella tip of the umbrella-shaped blocking element 1300 can face the proximal direction, and then the driving wire 1500 is connected to the umbrella tail of the umbrella-shaped blocking element 1300, with the umbrella tail facing the distal direction. After the blocking element 1300 enters the body of a living organism, it remains in a contracted state. When the driving wire 1500 is retracted and a force is applied to the umbrella-shaped blocking element 1300, it will be prompted to open to an expanded state, thereby blocking the puncture in the blood vessel wall.

[0069] In one embodiment, the drive wire 1500 may include multiple unit wires, which are respectively connected to multiple circumferential positions of the umbrella-shaped blocking element 1300. The movement of the multiple unit wires toward the proximal direction is used to apply a force to the umbrella-shaped blocking element 1300 to urge it to open, and the movement of the multiple unit wires toward the distal direction is used to apply a force to the umbrella-shaped blocking element 1300 to urge it to close. At this time, the multiple unit wires can jointly apply force at multiple circumferential positions of the umbrella-shaped blocking element 1300, so that the opening and closing of the umbrella-shaped blocking element 1300 are smoother.

[0070] 2 to 4 , the present application further provides a first vascular closure device, comprising a vascular closure assembly 1000 and a control device 2000. Since the structure, functional principles, and technical effects of the vascular closure assembly 1000 have been described in detail above, they will not be further elaborated here. Any technical details regarding the vascular closure assembly 1000 can be referred to the above description. The control device 2000 is connected to the outer sheath 1100 and inner catheter 1200 of the vascular closure assembly 1000. The control device 2000 is used to control the relative axial movement of the inner catheter 1200 and the outer sheath 1100 outside the body of a living person. In one embodiment, the control device 2000 is fixedly connected to the proximal end of the inner catheter 1200. The control device 2000 is connected to the proximal end of the outer sheath 1100, allowing the operator to control the proximal movement of the outer sheath 1100 relative to the inner catheter 1200, thereby generating a force exerted by the outer sheath 1100 in the proximal direction.

[0071] The control device 2000 can have a variety of structures. For example, in one embodiment, the control device 2000 includes a device base 2100, a driving element 2200 and a transmission element 2300. The device base 2100 is connected to the proximal end of the inner catheter 1200, the transmission element 2300 is connected to the proximal end of the outer sheath 1100, and the driving element 2200 is driven by the transmission element 2300 to drive the transmission element 2300 to move relative to the device base 2100, thereby indirectly driving the outer sheath 1100 to move axially relative to the inner catheter 1200.

[0072] The transmission element 2300 can be connected to the proximal end of the sheath tube of the outer sheath tube 1100 in a variety of ways. For example, the transmission element 2300 is directly connected to the proximal end of the sheath tube of the outer sheath tube 1100, or a sheath tube connector 1100a can be set between the transmission element 2300 and the proximal end of the sheath tube of the outer sheath tube 1100, and the sheath tube connector 1100a is indirectly driven and connected. Referring to Figure 3, the outer sheath tube 1100 is connected to the sheath tube connector 1100a by injection molding or other methods, and the transmission element 2300 is driven and connected to the sheath tube connector 1100a, so that the driving element 2200 drives the transmission element 2300 to move, and the transmission element 2300 drives the sheath tube connector 1100a to move, thereby indirectly driving the outer sheath tube 1100 to move by using the sheath tube connector 1100a. The device base 2100 can be a substrate, a base, a shell and other structures. For example, the device base 2100 includes a complete shell composed of at least two shells. The driving element 2200 and the transmission element 2300 are assembled in the shell and extend through corresponding through holes.

[0073] In one embodiment, the driving element 2200 is a driving gear that is rotatably mounted on the device base 2100. The transmission element 2300 is a transmission rack that is axially mounted on the device base 2100, and the driving gear and the transmission rack are driven and meshed. The driving gear can be directly driven and meshed with the transmission rack, or, as needed, one or more transmission gears 2400 can be added between the driving gear and the transmission rack to indirectly achieve driving meshing between the driving gear and the transmission rack.

[0074] In one embodiment, the driving element 2200 includes a gear outer sleeve 2200a and a stopper inner plug 2200b, and the stopper inner plug 2200b and the gear outer sleeve 2200a are both assembled on the device base 2100, wherein the gear outer sleeve 2200a is rotatably assembled on the outside of the stopper inner plug 2200b and can rotate relative to the stopper inner plug 2200b, and the gear outer sleeve 2200a is driven and engaged with the transmission rack, and at least one of the outer wall of the stopper inner plug 2200b and the inner wall of the gear outer sleeve 2200a is The latter is provided with a rotation-stop structure 2200c. For example, the rotation-stop structure 2200c is a one-way tooth constructed on the outer wall of the rotation-stop inner plug 2200b. The gear outer sleeve 2200a can be limited by the one-way tooth to move only in one direction. At the same time, the inner wall of the gear outer sleeve 2200a can also be provided with matching teeth or rough structures to enhance the rotation-limiting ability of the one-way tooth. There is no limitation on this. Therefore, the rotation-stop structure 2200c can limit the gear outer sleeve 2200a to rotate only in one direction relative to the rotation-stop inner plug 2200b.

[0075] Continuing with reference to Figures 2 to 4 and 8 , the present application further provides a second vascular closure device, comprising a vascular closure assembly 1000, a locking device 3000, and a control device 2000. The locking device 3000 has a locked state and an unlocked state. The locking device 3000 is controllably connected to a linkage device and is configured to control the occluding element 1300 to transition to an expanded state via the linkage device, thereby causing the locking device 3000 to transition to a locked state, or to control the occluding element 1300 to transition to a contracted state when the occluding element 1300 is in an unlocked state. The control device 2000 is connected to the outer sheath 1100 and the inner catheter 1200 and is configured to drive the locking device 3000 to transition from a locked state to an unlocked state while controlling the outer sheath 1100 to move proximally relative to the inner catheter 1200.

[0076] The second vascular closure device differs from the first in that the second vascular closure device includes a locking device 3000. As previously described, the withdrawal of the outer sheath 1100 generates a proximal force, which the locking device 3000 leverages to unlock the occluding element 1300. When the vascular closure assembly 1000 is implanted in a living body, the hemostatic material A reaches the target location, and the occluding element 1300 reaches the inner wall of the blood vessel. At this point, the control device 2000 controls the occluding element 1300 to transition from a contracted state to an expanded state, allowing it to seal the puncture in the blood vessel wall, reduce bleeding, and achieve physical hemostasis. At this point, the withdrawal of the drive wire 1500 causes the locking device 3000 to switch to a locked state.

[0077] The outer sheath 1100 is then withdrawn to push the hemostatic material A out of the distal end of the sheath and apply it to the puncture site in the blood vessel wall, thereby stopping bleeding while controlling the amount of bleeding. During this process, since the pushing out of the hemostatic material A is due to the axial proximal movement of the outer sheath 1100 relative to the inner catheter 1200 in a stationary state, the proximal withdrawal movement of the outer sheath 1100 exerts a proximal force on the locking device 3000. It should be noted that when the hemostatic material A is applied to the puncture site in the blood vessel wall, this force is precisely applied to the locking device 3000. Therefore, when the hemostatic material A is applied, the locking device 3000 is also synchronously triggered, allowing the locking device 3000 to switch from a locked state to an unlocked state, thereby releasing the lock on the blocking element 1300, allowing the blocking element 1300 to switch from an expanded state to a contracted state and be withdrawn from the living body.

[0078] Referring to Figures 5 to 7, in one embodiment, the control device 2000 includes a device base 2100, a driving element 2200 and a transmission element 2300. The device base 2100 is connected to the proximal end of the inner catheter 1200, and the transmission element 2300 is connected to the proximal end of the outer sheath 1100. The driving element 2200 is assembled with the device base 2100 and is driven and connected to the transmission element 2300, and is used to drive the transmission element 2300 to move relative to the device base 2100, thereby indirectly driving the outer sheath 1100 to move axially relative to the inner catheter 1200.

[0079] 8 to 12 , in one embodiment, the locking device 3000 includes a locking base 3100, a locking element 3200 and a locking element 3300. The locking base 3100 is assembled on the device base 2100. The locking base 3100 defines a locking cavity 3100a. The shape of the locking cavity 3100a can be adapted to accommodate the locking element 3300. The locking element 3300 is movably assembled on the locking base 3100, and the movement of the locking element 3300 can cause a part of the structure of the locking element 3300 to enter or leave the locking cavity 3100a. The locking element 3200 is assembled on the locking base 3100. The locking element 3200 can block the locking cavity 3100a by changing its position or shape. After a part of the structure of the element 3300 enters the locking cavity 3100a, it restricts the locking element 3300 from disengaging from the locking cavity 3100a of the locking base 3100, so that the locking device 3000 is in a locked state. Moreover, the locking element 3200 can also release the obstruction of the locking cavity 3100a by changing its position or shape, so that the locking element 3300 can continue to disengage from the locking cavity 3100a of the locking base 3100 through movement, thereby making the locking device 3000 in an unlocked state. The proximal end of the inner core tube 1400 is connected to the locking base 3100, and the locking element 3300 is connected to the drive wire 1500. For example, the locking element 3300 is connected to the proximal end of the wire of the drive wire 1500 to drive the drive wire 1500 to move.

[0080] Referring to Figures 10 and 11, in one embodiment, the locking element 3200 is provided with a locking guide portion 3200a, and the locking guide portion 3200a has a locking guide surface 3200a1. The locking guide portion 3200a can be in a state of blocking the locking cavity 3100a under no force. The locking element 3200 itself has an elastic deformation effect, allowing the locking element 3300 to enter the locking cavity 3100a along the locking guide surface 3200a1, and when the locking element 3300 enters the locking cavity 3100a along the locking guide surface 3200a1, the locking guide portion 3200a will return to the state of blocking the locking cavity 3100a, thereby limiting the locking element 3300 from leaving the locking cavity 3100a.

[0081] Continuing to refer to Figures 10 and 11, the locking guide surface 3200a1 can be presented as a gradually increasing inclined surface along the direction from the distal end to the proximal end, and part of the structure of the locking element 3300 can slide with the locking guide surface 3200a1. For example, the locking element 3300 has a protrusion as a structure that slides with the locking guide surface 3200a1. When the locking element 3300 retracts, it will pull the drive wire 1500 back to open the blocking element 1300. At this time, the locking element 3300 will also synchronously apply a force to the locking element 3200 to urge it to move downward to move out of the locking cavity 3100a. The locking element 3300 ends the sliding cooperation with the locking guide surface 3200a1 at the proximal end of the locking guide surface 3200a1, so that the protrusion enters the locking cavity 3100a, presenting a locked state, and keeping the blocking element 1300 in an expanded state.

[0082] The locking element 3200 is also provided with an unlocking guide portion 3200b, which has an unlocking guide surface 3200b1. The control device 2000 is driven to contact the unlocking guide surface 3200b1 to drive the locking element 3200 to release the movement restriction of the locking control element 3300, and then drive the locking control device 3000 to change from a locked state to an unlocked state. Continuing to refer to Figures 10 and 11, when the control device 2000 controls the outer sheath 1100 to retract, the action of the control device 2000 controlling the outer sheath 1100 to retract will apply a force in the proximal direction, and this force can be applied to the locking device 3000, for example, applied to the unlocking guide surface 3200b1 of the unlocking guide part 3200b, prompting the unlocking guide part 3200b to move downward, and then prompting the locking guide part 3200a to move downward to clear the locking cavity 3100a, so that the locking device 3000 is in an unlocked state, so that the protrusion of the locking element 3300 can be detached from the locking cavity 3100a, allowing the control blocking element 1300 to be converted from an expanded state to a contracted state and withdrawn from the body of the living organism. In one embodiment, the proximal end of the transmission element 2300 can directly contact and cooperate with the unlocking guide surface 3200b1 of the unlocking guide part 3200b, or a pushing element 3200c can be set at the proximal end of the transmission element 2300, or the proximal end of the pushing element 3200c can be indirectly contacted and cooperated with the unlocking guide surface 3200b1 of the unlocking guide part 3200b, and there is no limitation on this.

[0083] The technical features of the above-mentioned embodiments can be combined arbitrarily. In order to make the description concise, not all possible combinations of the technical features in the above-mentioned embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0084] The above-described embodiments merely represent several implementation methods of the present application, and although the descriptions thereof are relatively detailed, they should not be construed as limiting the scope of the patent application. It should be noted that a person of ordinary skill in the art may make various modifications and improvements without departing from the spirit of the present application, and such modifications and improvements fall within the scope of protection of the present application. Therefore, the scope of protection of the present patent application shall be determined by the appended claims.

Claims

1. A blood vessel sealing component, characterized in that: The vascular closure assembly comprises: An outer sheath tube, wherein the outer sheath tube has an axially penetrating sheath tube inner cavity channel, the sheath tube inner cavity channel of the outer sheath tube comprises a main channel section and a distal channel section along the axial direction, and the channel inner cavity of the distal channel section is used to receive a hemostatic material; and The inner catheter has an axially penetrating catheter lumen channel, the inner catheter is movably assembled in the sheath lumen channel of the outer sheath, and the inner catheter and the outer sheath are used for relative movement along the axial direction, so that the distal end of the inner catheter pushes out the hemostatic material contained in the distal channel segment from the distal end of the sheath of the outer sheath.

2. The blood vessel closing assembly according to claim 1, characterized in that: The blood vessel closing component includes a hemostatic material, which is accommodated in the channel lumen of the distal channel section, and the catheter distal end of the inner catheter contacts the material proximal end of the hemostatic material.

3. The blood vessel closure assembly according to claim 1, characterized in that: The outer sheath is used to move toward the proximal direction relative to the inner catheter in a static state, so that the distal end of the inner catheter pushes the hemostatic material received in the distal channel section out of the distal end of the outer sheath.

4. The blood vessel closure assembly according to claim 1, characterized in that: The vascular closure assembly comprises: an occluding element having a contracted state and an expanded state; and A linkage device is connected to the blocking element and is used to control the blocking element to be in a contracted state or an expanded state at the distal end of the outer sheath.

5. The blood vessel closing assembly according to claim 4, characterized in that: The linkage device comprises: An inner core tube, the inner core tube having an axially penetrating core tube lumen channel, the inner core tube being movably assembled in the catheter lumen channel of the inner catheter; and A driving wire is movably arranged in the core tube inner cavity channel of the inner core tube, and the driving wire is connected to the blocking element to control the switching of the blocking element between a contracted state and an expanded state.

6. The blood vessel closing assembly according to claim 5, characterized in that: The distal end of the inner core tube exceeds the distal end of the inner catheter, and the cavity gap between the inner core tube and the outer sheath tube is used to receive hemostatic material; The blocking element is an umbrella-shaped blocking element. The closing of the umbrella-shaped blocking element is a contracted state, and the opening of the umbrella-shaped blocking element is an expanded state. The driving wire is used to apply a force to the umbrella-shaped blocking element to cause it to open or close.

7. The blood vessel closing assembly according to claim 6, characterized in that: The drive wire includes multiple unit wires, which are respectively connected to multiple positions around the umbrella-shaped blocking element. The movement of the multiple unit wires toward the proximal direction is used to apply a force to the umbrella-shaped blocking element to cause it to open, and the movement of the multiple unit wires toward the distal direction is used to apply a force to the umbrella-shaped blocking element to cause it to close.

8. A blood vessel closing device, characterized in that: The vascular closure device comprises: The blood vessel closure assembly according to any one of claims 1 to 7; and A control device is connected to at least one of the outer sheath tube and the inner catheter, and is used to control the inner catheter and the outer sheath tube to move relative to each other along the axial direction.

9. The blood vessel closing device according to claim 8, characterized in that: The control device is fixedly connected to the proximal end of the inner catheter, and is connected to the proximal end of the outer sheath tube, and is used to control the outer sheath tube to move relative to the inner catheter toward the proximal direction.

10. The blood vessel closing device according to claim 9, characterized in that: The control device includes a device base, a driving element and a transmission element. The device base is connected to the proximal end of the inner catheter, the transmission element is connected to the proximal end of the outer sheath, and the driving element is drivingly connected to the transmission element for driving the transmission element to move relative to the device base, thereby indirectly driving the outer sheath to move axially relative to the inner catheter.

11. The blood vessel closing device according to claim 10, characterized in that: The driving element is a driving gear, which is rotatably mounted on the device base. The transmission element is a transmission rack, which is axially movable and mounted on the device base. The driving gear is drivingly meshed with the transmission rack.

12. The blood vessel closing device according to claim 11, characterized in that: The transmission gear includes a gear outer sleeve and a stopper inner plug, wherein the stopper inner plug is assembled on a device base, and the gear outer sleeve is rotatably assembled on the outside of the stopper inner plug, and the gear outer sleeve is driven and meshed with the transmission rack. At least one of the outer wall of the stopper inner plug and the inner wall of the gear outer sleeve is provided with a stopper structure for limiting the gear outer sleeve to rotate only in a single direction relative to the stopper inner plug.

13. A blood vessel closing device, characterized in that: The vascular closure device comprises: The blood vessel closure assembly according to any one of claims 5 to 7; A locking device, wherein the locking device has a locked state and an unlocked state, and the locking device is control-connected with the linkage device, and is used to control the blocking element to be in a locked state after being converted to an expanded state through the linkage device, or to control the blocking element to be converted to a contracted state when the blocking element is in an unlocked state; and A control device is connected to the outer sheath and the inner catheter, and is used to drive the locking device to change from a locked state to an unlocked state during the process of controlling the outer sheath to move toward the proximal direction relative to the inner catheter.

14. The blood vessel closing device according to claim 13, characterized in that: The control device includes a device base, a driving element and a transmission element. The device base is connected to the proximal end of the inner catheter, and the transmission element is connected to the proximal end of the outer sheath. The driving element is assembled with the device base and is drivingly connected to the transmission element, and is used to drive the transmission element to move relative to the device base, thereby indirectly driving the outer sheath to move axially relative to the inner catheter.

15. The blood vessel closing device according to claim 14, characterized in that: The locking device comprises a locking base, a locking element and a locking element, wherein the locking base is mounted on the device base, a locking cavity is provided on the locking base, the locking element is movably mounted on the locking base and is used to enter or leave the locking cavity, the locking element is mounted on the locking base, and the locking element is used to limit the locking element from leaving the locking cavity of the locking base to present a locked state, or the locking element from leaving the locking cavity of the locking base to present an unlocked state; The proximal end of the inner core tube is connected to the locking base, and the locking element is connected to the driving wire to drive the driving wire to move.

16. The blood vessel closing device according to claim 15, characterized in that: The locking element is provided with a locking guide portion, wherein the locking guide portion has a locking guide surface, and the locking guide portion allows the locking element to enter the locking cavity along the locking guide surface.

17. The blood vessel closing device according to claim 15, characterized in that: The locking element is provided with an unlocking guide portion, and the unlocking guide portion has an unlocking guide surface. The control device is driven to contact the unlocking guide surface to drive the locking element to release the movement restriction on the locking control element, and then drive the locking control device to change from a locked state to an unlocked state.

18. The blood vessel closing device according to claim 16, characterized in that: The proximal end of the transmission element contacts the unlocking guide surface of the unlocking guide portion.

19. The blood vessel closing device according to claim 16, characterized in that: A pushing element is arranged at the proximal end of the transmission element, and the proximal end of the pushing element contacts the unlocking guide surface of the unlocking guide portion.

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