Blood vessel sealing device

Abstract

A blood vessel sealer includes: a temporary occlusion module including an expandable mechanism; a sealant located at a proximal end of the expandable mechanism; the pipe fitting system comprises a first pipe fitting, the first pipe fitting is connected with the expandable mechanism and comprises an enabling unit, and the enabling unit is used for controlling expansion and contraction of the expandable mechanism; the second pipe fitting is arranged on the outer layer of the first pipe fitting in a sleeving manner and is used for supporting and positioning the sealant; the third pipe fitting is arranged on the outer layer of the second pipe fitting in a sleeving mode and used for containing and protecting the sealant; the segmented withdrawing mechanism is used for controlling the relative movement of the pipe fitting system and the expandable mechanism in stages, so that in the first stage, the expandable mechanism retracts to be in contact with or relatively close to the second pipe fitting, and meanwhile, the second pipe fitting keeps supporting and positioning of the sealant; and in the second stage, the second pipe fitting and the expandable mechanism synchronously withdraw towards the near end until the expandable mechanism is at least partially separated from the sealant. The sealing agent is prevented from being brought out in the withdrawing process of the instrument, and the blocking effectiveness is not affected.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of medical devices, and more particularly to a vascular closure device. BACKGROUND

[0002] After a vascular puncture is made, a catheter or other device can be advanced through the introducer sheath and over a guidewire to a location for performing a medical procedure. After the procedure is complete, the device and introducer sheath can be removed, leaving a puncture extending between the skin and the vessel wall. To seal the puncture, external pressure can be applied to the overlying tissue, for example manually and / or using sandbags, until hemostasis occurs.

[0003] After a diagnostic or therapeutic procedure requiring access to the vasculature is completed, the vascular puncture hole can be closed by various schemes. However, many of these closure procedures can be time consuming, expensive, and uncomfortable for the patient, requiring the patient to remain immobile for long periods of time in the operating room, catheter lab, or holding area. Also, some of these closure methods can increase the risk of hematoma from pre-hemostatic bleeding.

[0004] Since there is a great risk that the temporary occlusion will move due to friction of the temporary occlusion when withdrawing, affecting the effect of the occlusion, it is important to be able to do so without the risk of displacement of the implant when withdrawing the instrument for various types of temporary occlusions. The product Mynx Control (reference US8029533B2, US8721680B2) on the market, which is composed of a thin-walled balloon, can effectively control the risk of displacement by retracting the temporary occlusion into the support tube that originally supports the implant when the withdrawal operation is performed, but this implementation has obvious size limitations for the temporary occlusion, which limits the expansion of its application. The thin-walled balloon similar to the Mynx Control product has obvious disadvantages, such as the need for the operator to inflate and deflate the balloon to achieve this purpose, the need to use a syringe to draw liquid, control the opening and closing of two-way operations, etc., making the instrument operation inconvenient. Therefore, it is meaningful to explore a better implementation of the temporary occlusion. However, other technical routes, such as the Vascade series, which are made of metal braids, still have a larger size in the compressed state, and similar to the Mynx Control design, the operation of retracting the temporary occlusion into the tube cannot be achieved. Therefore, it is necessary to break through the size limitations of the temporary occlusion in the existing technology through a better way, while effectively avoiding the risk of displacement, and also adapting to more implementation ways of the temporary occlusion.

[0005] The outer diameter of the inflatable mechanism is usually large, and in the process of withdrawing, it is easy to bring the sealant together. However, the ideal release effect is to release the sealant to the position as close to the blood vessel opening as possible, rather than being withdrawn together or even brought out and exposed to the outside of the skin. SUMMARY

[0006] The present application aims to provide a labor-saving, simple and reliable vascular occluder which can safely and securely withdraw the temporary occlusion of various types or sizes of vascular occluder with the support of the sealant based on the above problems.

[0007] To achieve this purpose, the present application provides a vascular occluder comprising: a temporary occlusion module comprising an inflatable mechanism; a sealant located at the proximal end of the inflatable mechanism; a tube system comprising: a first tube connected to the inflatable mechanism and comprising an enabling unit for controlling the inflation and contraction of the inflatable mechanism; a second tube sleeved on the outer layer of the first tube for supporting and fixing the sealant; a third tube sleeved on the outer layer of the second tube for accommodating and protecting the sealant; a segmented withdrawal mechanism for controlling the relative movement of the tube system and the inflatable mechanism in stages, so that: in the first stage, the inflatable mechanism is withdrawn to contact or relatively close to the second tube, while the second tube remains in a supporting position for the sealant; in the second stage, the second tube and the inflatable mechanism are withdrawn synchronously to the proximal end until the inflatable mechanism is at least partially separated from the sealant.

[0008] The reason for the need to set up two stages instead of directly withdrawing the whole vascular occluder is that the outer diameter of the inflatable mechanism is usually large, and it is easy to bring the sealant back during the withdrawal process. However, the ideal release effect is to release the sealant as close as possible to the opening of the blood vessel, rather than being withdrawn together or even exposed to the outside of the skin. Therefore, by designing two stages of movement, only the inflatable mechanism is withdrawn in the first stage, and the second tube maintains the supporting function of the sealant during the withdrawal process. Thus, although the inflatable mechanism is withdrawn, the sealant will not be withdrawn. When the inflatable mechanism is partially or completely withdrawn to the proximal end of the sealant, i.e. in the second stage, the remaining part is synchronously withdrawn, so as to leave the sealant, thus achieving the purpose of hemostatic occlusion.

[0009] Among them, the segmented withdrawal mechanism comprises: a first movement mechanism for controlling the relative movement between the first tube and the second tube to achieve the first stage withdrawal; a second movement mechanism for controlling the relative movement between the relatively static whole composed of the first tube, the second tube and the inflatable mechanism and the third tube to achieve the second stage withdrawal.

[0010] The first movement mechanism comprises: a withdrawal lever connected to the first tube for driving the first tube to move proximally; a positioning tube movement slider connected to the second tube for keeping the second tube stationary to support the sealant during the first stage withdrawal.

[0011] The second motion mechanism includes: a retraction lever connected to the first tube, used to drive the second tube to move synchronously to the proximal end with the expandable mechanism; and a main tube motion slider connected to the first tube, used to coordinate the movement of the second tube to achieve synchronous retraction.

[0012] The inner diameter of the third fitting is larger than the outer diameter of the second fitting, while providing sufficient space for the expandable mechanism to retract.

[0013] The segmented retraction mechanism allows for two-stage retraction operations with a single hand. The inflatable mechanism is a larger, non-balloon-type structure suitable for occlusion of larger blood vessels. The first and second stages of the retraction mechanism can be sequentially executed by simple operation of a single handle element such as a lever, button, knob, roller, pull rod, or joystick.

[0014] The beneficial effect of this invention is that it provides a vascular sealing device that employs a multi-stroke anti-reverse retraction mechanism during device withdrawal, a process consisting of at least two strokes. This multi-stage retraction solves the problem that some temporary occlusions with larger dimensions are difficult to retract into the central catheter during device withdrawal. Especially when the temporary occlusion size is large, it also increases the risk of sealant being carried out during device withdrawal. This invention avoids the sealant being carried out during device withdrawal, thus preventing it from affecting the effectiveness of the occlusion.

[0015] To make the above-mentioned objects, features and advantages of the present invention more apparent and understandable, preferred embodiments are described below in detail with reference to the accompanying drawings. Attached Figure Description

[0016] To more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0017] Figure 1 This is an overview diagram of the equipment, showing its constituent modules; Figure 2 It is a structural cross-sectional view of the temporary sealing module, tubular module, and sealant; Figure 3 This is an example diagram of a protective tube in a tubular module; Figure 4 This is a schematic diagram of the insertion of a vascular sheath during device use; Figure 5 This is a diagram showing the relative relationship between the temporary occlusion module, the tubular module, and the vascular sheath when the device is inserted into the vascular sheath during use; Figure 6This diagram shows the relative relationship between the sheath connector and the vascular sheath when the device is inserted. Figure 7 This is a schematic diagram of a sheath connector fitting with a large-sized vascular sheath; Figure 8 This is a schematic diagram of another type of sheath connector used with a medium-sized vascular sheath; Figure 9 This is a schematic diagram of another type of sheath connector used with a small-sized vascular sheath; Figure 10 This is a schematic diagram of a common vascular sheath; Figure 11 This is a schematic diagram of the expandable mechanism in an expanded state; Figure 12 This is a detailed view of the expandable mechanism in its expanded state; Figure 13 This is a schematic diagram of the internal structure of the temporary sealing actuator when the expandable mechanism is in the contracted state. Figure 14 This is a schematic diagram of the internal structure of the temporary sealing actuator when the expandable mechanism is in the expanded state. Figure 15 It is a planar schematic diagram of the interlocking features of the inner and outer shells and the retraction interlocking features when the expandable mechanism is in the expanded state; Figure 16 It is a three-dimensional schematic diagram of the interlocking features of the inner and outer shells and the retraction interlocking features when the expandable mechanism is in the expanded state. Figure 17 This is a detailed view of the upper inner shell; Figure 18 This is a detailed view of the lower inner shell; Figure 19 This is a schematic diagram of the bleeding indicator structure; Figure 20 This is a schematic diagram of the bleeding indicator structure; Figure 21 This is a schematic diagram of the bleeding indicator structure; Figure 22 This is a schematic diagram of the pull-to-unlock structure; Figure 23 This is a schematic diagram of the pull-to-unlock mechanism during unlocking; Figure 24 This is a schematic diagram of the position locking structure; Figure 25 This is a schematic diagram of a linear motion mechanism; Figure 26 This is a schematic diagram of the damping structure in the sliding groove of a linear motion mechanism; Figure 27 This is a schematic diagram of the two contact surfaces during the pullback process; Figure 28 This is a schematic diagram of the slider position during the retraction process; Figure 29 This is a schematic diagram of the slider position during the retraction process; Figure 30 This is a schematic diagram of the slider position during the retraction process; Figure 31 This is a schematic diagram of the slider position during the retraction process.

[0018] Figure 32 This is a detailed diagram of the hooks and maze blocks.

[0019] Figure 33 This is a detailed diagram illustrating the movement of the hook's movable end within the maze groove.

[0020] Figure 34 It is the operating surface when operating the instrument with one hand.

[0021] Figure 35 It refers to the initial position of the instrument brake and its relative position to the inner shell module.

[0022] Figure 36 It refers to the stop position of the instrument brake and its relative position to the inner shell module. Detailed Implementation

[0023] This invention relates to a vascular closure device, comprising a retraction structure suitable for various types of temporary closures, especially relatively large temporary closures. This retraction structure involves a reciprocating movement between the temporary closure and the tubing. With the sealant supported, the temporary closure, originally located further away from the sealant, is retracted to a position closer to the proximal end than the sealant, ensuring that the temporary closure does not carry the sealant out during device withdrawal. In existing solutions, because the temporary closure uses a thin-walled balloon, it can be easily retracted into the center of the tubing. This invention, however, provides a more applicable and innovative method for larger temporary closures.

[0024] To achieve this segmented retraction in this invention, two parts are required. First, different motion mechanisms are needed to control the tubing related to the sealant, and these mechanisms can achieve segmented changes in the controlled object's operation during retraction. In this invention, the temporary plug is connected to a tubing containing an enabling unit (which could be a traction wire, etc.), surrounded by another tubing layer that supports the sealant and fixes its position. Outside this tubing layer is another protective layer, with the sealant positioned between the positioning and protective tubing layers. After the sealant is released, the temporary plug at a more distal end needs to retract through the released collagen to a position closer to the sealant. During this process, the supporting and positioning tubing maintains the sealant's positioning. Therefore, this invention employs a segmented retraction positioning method based on this structure, retracting larger, non-balloon-type temporary plugs into the tubing while keeping the sealant relatively fixed.

[0025] In this invention, the retraction process is divided into two steps. The first step is to retract the temporary sealant until it is in contact with or relatively close to the tubing. During this process, the tubing supports the sealant, preventing potential sealant displacement during retraction. This risk often increases with larger temporary sealants. In the first step, the anti-reverse function of the tubing supporting and positioning the sealant is completed. The second step involves the tubing, which previously provided support, moving proximally along with the expandable mechanism, allowing both parts to retract smoothly and synchronously into the outermost, larger tubing of the catheter section. The outer tubing has a larger allowance for the inner diameter, providing sufficient space. At the end of the latter half of the travel, the expandable mechanism has detached from the sealant, and the instrument can be safely withdrawn from the body. This allows the operator to complete the retraction of the larger expandable mechanism, avoiding the risk of the operator pulling the sealant and expandable mechanism out of the channel when withdrawing the instrument.

[0026] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of them. The components of the embodiments of the present invention described and shown in the accompanying drawings can generally be arranged and designed in various different configurations. Therefore, the following detailed description of the embodiments of the present invention provided in the accompanying drawings is not intended to limit the scope of the claimed invention, but merely to illustrate selected embodiments of the invention. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without inventive effort are within the scope of protection of the present invention.

[0027] Figure 1An exemplary embodiment of the device is shown. The vascular closure device 1 typically includes a tubular module 2, a temporary occlusion module 3, a handle module 4, a sealant 5, and a sheath connector 6.

[0028] In the initial state, the temporary sealing module 3 is located at or near the distal end of the tubular module 2, and the sealant 5 is located at or near the proximal end of the expandable mechanism 31 of the temporary sealing module 3. The sealant 5 can be wholly or partially contained within the tubular module 2. The proximal end of the tubular module 2 extends into the interior of the handle module 4 and connects with its components. The distal end of the handle module 4 connects to the sheath connector 6.

[0029] Figure 2 This diagram illustrates a typical installation method for the tubular module 2, the temporary sealing module 3, and the sealant 5. The tubular module 2 consists of a protective tube 21, a positioning tube 22, and a main tube 23; the temporary sealing module 3 consists of an expandable mechanism 31 and an enabling unit 32. The sealant 5 is a biochemical agent that expands in volume or adheres to human tissue upon contact with blood. The main tube 23 can partially extend into the expandable mechanism 31. The enabling unit 32 is connected to the distal end of the expandable mechanism 31 and is deployed inside the main tube 23. The expansion and contraction of the expandable mechanism 31 can be achieved by applying tension to the enabling unit 32. The sealant 5 is located at or near the proximal end of the expandable mechanism 31 and is situated on the outer layer of the main tube. The distal end of the positioning tube 22 is located at or near the proximal end of the sealant 5 and is also situated on the outer layer of the main tube. The protective tube 21 is situated on the outer layer of the positioning tube 22 and completely or partially encloses the sealant 5.

[0030] Optional, such as Figure 3 As shown, the protective tube 21 may include a blood inlet 211 and a bleeding outlet 212. The blood inlet 211 is located near the distal end of the protective tube 21 but near the proximal end relative to the sealant 5. The bleeding outlet 212 is located near the proximal end of the protective tube 21. The proximal end of the protective tube 21 is connected to the relevant internal parts of the handle module 4.

[0031] When using the equipment, such as Figure 4 As shown, the temporary occlusion module 3 of the instrument, along with the sealant 5 and the tubular module 2, are first inserted into the vascular sheath 7. The vascular sheath 7 should be left in the patient's body after the preoperative procedure, and the surgeon is preparing to occlude the vascular puncture site. The vascular sheath 7 typically includes a vascular sheath body 71, a vascular sheath valve body 72, and vascular sheath side branches 73. The distance between the vascular sheath 7 and the sheath connector 6 can be adjusted appropriately, such as... Figure 6 As shown, the proximal end of the vascular sheath valve body 72 is brought close to or abutted against the sheath connector 61, ensuring that the groove of the sheath connector 62 can cover and wrap around the vascular sheath body 71.

[0032] The sheath connector 6 is initially in the open state. After the vascular sealing device 1 is partially inserted into the vascular sheath 7 as described above, the sheath connection buckle 62 engages with the sheath connection seat 61, thus closing the connection. Figure 7 , Figure 8 , Figure 9 As shown, (a) is the open state and (b) is the closed state. In the closed state, the two have a certain locking force and are not easily disengaged. The specially designed groove of the sheath connector 62 can, during subsequent operations, lock the steps of the sheath body 71 and the sheath valve body 72 of various vascular sheaths even if the vascular sheath 7 moves slightly distally relative to the vascular sealer 1. When used correctly (i.e., when the sheath connector 62 locks the steps of the sheath body 71 and the sheath valve body 72), such as... Figure 5 , Figure 6 As shown, the temporary occlusion module 3, sealant 5, and distal portion of tubular module 2 (including at least the blood inlet 211) of vascular sealer 1 should be completely exposed at the distal end of vascular sheath 7, and vascular sheath collateral 73 should be unobstructed and able to perform its original function.

[0033] Figure 10 This shows a variety of vascular sheaths available on the market. Figure 7 An embodiment of a flip-top snap-on sheath connector design for fastening large-size vascular sheaths is shown. Figure 8 An embodiment of a clip-on sheath connector design for fastening a medium-sized vascular sheath is shown. Figure 9 An embodiment of another flip-top snap-on sheath connector design for fastening small-sized vascular sheaths is shown.

[0034] Go to Figure 11 , Figure 12 When the operator presses the switch button 411, the expandable mechanism 31 of the temporary sealing module 3 can be changed to an expanded state. Figure 13 , Figure 14 The text details how the temporary blocking actuation mechanism 422 within the inner shell 42 of the handle module 4 drives the enabling unit 32 to cause the expandable mechanism 31 to expand. (For example...) Figure 13 As shown, the expandable mechanism 31 is in its initial contracted state at this time. The temporary sealing actuation mechanism 422 consists of a lower inner shell 4221 and an upper inner shell 4222 (not shown, see also) Figure 17 It consists of maze block 4223, pressure plate 4224, hook 4225, reset spring 4226, and enable unit connector 4227.

[0035] The enabling unit 32 is guided by the guide groove 4222a of the upper inner shell 4222 and the guide groove 4221a of the lower inner shell 4221, such as Figure 17As shown, it is then connected to the enable unit connector 4227. Optionally, in this part of the enable unit 32, the main guide tube 23 may also completely or partially cover the enable unit 32, passing together through the guide groove 4222a of the upper inner shell 4222 and the guide groove 4221a of the lower inner shell 4221. The enable unit connector 4227 is installed in the labyrinth block 4223, and the two are relatively stationary. The labyrinth block 4223 has the feature of forming a contact pair with the switch button 411. When the switch button 411 is pressed, it can drive the labyrinth block 4223 to slide in the labyrinth block slide mechanism 4221b of the lower inner shell 4221 along a certain limited trajectory and limit position range, thereby pulling the enable unit connector 4227 and the enable unit 32 to run a distance, such as Figure 14 As shown, this causes the expandable mechanism 31 to be in an expanded state. Further combined with... Figure 13 , Figure 14 , Figure 32 As can be seen, the restrained end 4225a of the hook 4225 can rotate within the corresponding mounting hole of the lower inner shell 4221, while maintaining a certain degree of freedom to tilt / lift. Its other movable end 4225b is located in the labyrinth groove 4223a of the labyrinth block 4223, which is also a type of sliding mechanism. The presence of the labyrinth groove 4223a further restricts the relative range of motion and the breakpoint of motion between the hook 4225 and the labyrinth block 4223. The pressure plate 4224 is installed in the upper inner shell 4222. When the upper inner shell 4222 and the lower inner shell 4221 are correctly installed, the pressure plate 4224 can press down on the hook 4225 at any time, or when the hook 4225 slightly lifts up along the labyrinth groove, ensuring that its movable end 4225b maintains good contact with the labyrinth groove 4223a at all times. The maze groove 4223a of the maze block 4223 has a special design, utilizing a structure similar to a wedge, ramp, and step difference to increase the "elastic potential energy" or "gravitational potential energy" of objects moving relative to it. Upon reaching the target position, this potential energy is released, creating a directional movement effect. This ensures that during relative movement with the hook 4225, the movable end 4225b of the hook 4225 can only move unidirectionally along a specific trajectory and cannot move in the opposite direction. In this embodiment, the hook 4225 can only perform a clockwise-like movement. Figure 13 , Figure 14As shown, when the switch button 411 is pressed, the hook 4225 moves along the labyrinth groove 4223a to a specially designed wedge / V-shaped locking feature 4223b, where it locks into place, keeping the expandable mechanism 31 in an expanded state. Pressing the switch button 411 again allows the hook 4225 to return to its original position along the labyrinth groove, returning the expandable mechanism 31 to a contracted state. The return spring 4226 is installed in the lower inner shell 4221 and contacts the corresponding feature of the labyrinth block 4223, providing a force to assist the labyrinth block 4223 in returning to its original position, and thus assisting the expandable mechanism 31 in returning to its contracted state. In some embodiments where the expandable mechanism 31 can contract autonomously, the return spring 4226 may be omitted or a smaller stiffness coefficient may be used.

[0036] Figure 32 , Figure 33 The "locking and resetting" mechanism of the typical control expandable mechanism 31 for expansion and contraction is explained in more detail. This mechanism mainly consists of a hook 4225 and a maze block 4223. The hook 4225 has a constrained end 4225a and a movable end 4225b. The constrained end 4225a is restricted within a clearance-fitted hole, allowing the hook 4225 to rotate around the constrained end. Simultaneously, due to the clearance fit, the movable end 4225b of the hook has a certain degree of freedom to lift and fall. The feature of the maze block 4223 that mainly cooperates with the hook 4225 is called the maze groove 4223a. Its characteristic is that it has typical ramp and step features, with each ramp feature followed by a step feature. This step feature prevents the movable end 4225b of the hook from returning to its original path, thus becoming a movement breakpoint. Combined with the restrictive features around the perimeter of the maze groove 4223a, it together limits the range of motion, ensuring that the movable end 4225b can only move along a predetermined path. Figure 32 In the maze 4223a, there are four sets of ramps and steps (hereinafter referred to as ramps 1-4 and steps 1-4 for ease of description). In addition, the maze block 4223 also has a locking feature 4223b that can lock and maintain the relative position of the hook 4225 and the maze block 4223.

[0037] Figure 33 The movement of the movable end 4225b of the hook 4225 in the labyrinth groove 4223a was demonstrated step by step.

[0038] P1 demonstrates the active end 4225b in its initial position (corresponding to the expandable mechanism 31 being in its initial retracted state). P2 demonstrates that the active end 4225b is passing through the ramp 1 feature of the maze groove 4223a (corresponding to the state where the switch button 411 is being pressed by an external force and the expandable mechanism 31 is being opened by an external force). P3 demonstrates that the active end 4225b passes through the step 1 feature (corresponding to the switch button 411 being fully pressed by external force and the expandable mechanism 31 being in an expanded state opened by external force). P4 demonstrates that the active end 4225b passes through the ramp 2 and step 2 features and moves to the locking feature 4223b. At this time, the hook 4225 and the maze block 4223 are locked together (the corresponding switch button 411 is in the pressed state without external force and the expandable mechanism 31 is in the expanded state without external force). P5 demonstrates that the active end 4225b passes through the features of ramp 3 and step 3 (corresponding to the switch button 411 being fully pressed down by external force again, and the expandable mechanism 31 being in an expanded state that is opened by external force again). P6 demonstrates that the active end 4225b is passing through the ramp 4 feature, and will then return to the P1 demonstration state by passing through the step 4 feature (corresponding to the switch button 411 popping up and the expandable mechanism 31 returning to the contracted state). It should be noted here that in this embodiment, the switch button 411 is fully pressed down by external force (corresponding to...) Figure 33 P3 and P5 in the middle) and the switch button 411 are kept pressed in the locking feature 4223b (corresponding to Figure 33 Compared to P4 in the diagram, the relative positions of the maze block 4223 and the hook 4225 do indeed show some changes and differences, but in both states, the expandable mechanism 31 is in an expanded state. This is because the enabling unit 32 has a certain degree of elasticity. During the process where the maze block 4223 drives the enabling unit connector 4227, and subsequently the enabling unit 32, causing the expandable mechanism 31 to expand, even if the expandable mechanism 31 has reached its expanded state, it can still excessively pull the enabling unit 32 to a certain extent. Alternatively, the enabling unit 32 can also use a mechanism that limits the upper limit of the force, such as a coil spring. The torque fluctuation of the coil spring is very small and can be considered essentially constant. With the lever arm also essentially constant, the force pulling out the coil spring can also be considered constant. The enabling unit 32 connects to or integrates a coil spring. When the rated driving torque of the coil spring is not reached, the expandable mechanism 31 can expand normally. When excessively pulled, the coil spring is stretched, maintaining the rated force while absorbing the displacement caused by excessive pulling.

[0039] Again Figure 13 , Figure 14 As shown, the switch button 411's switch button shaft 411c is located at the right end of the diagram. It is connected to the base plate 417 of the housing 41 and has a degree of freedom of rotation. The contact pair between the switch button 411 and the labyrinth block 4223 is in the middle position, and the user-pressed interface is located at the left end of the diagram. This design utilizes the lever principle, which can significantly reduce the force required for the user to press the switch button 411 to expand the expandable mechanism 31.

[0040] Go to Figure 15 , Figure 16 A locking mechanism exists between the switch button 411 and the lower inner shell 4221, comprising several interlocking features. When the switch button 411 is pressed and the expandable mechanism 31 expands, the male interlocking feature 411a of the switch button 411 disengages from the first limiting groove of the female interlocking feature 4221c of the lower inner shell 4221. The switch button 411 belongs to the outer shell 41, while the lower inner shell 4221 belongs to the inner shell 42, thereby unlocking the relative displacement freedom between the outer shell 41 and the inner shell 42. In this embodiment, the inner shell 42 can move a certain distance relative to the outer shell 41 for a tension indication function (described in detail below). After moving a predetermined distance, and when the switch button 411 needs to be used to close the temporary sealing module 3 to retract the expandable mechanism 31, the inner and outer shell interlocking female feature 4221c of the lower inner shell 4221 has a second limiting groove that can accommodate the inner and outer shell interlocking male feature 411a of the switch button 411 to enter, so that the outer shell 41 and the inner shell 42 become relatively stationary again.

[0041] Still quoting Figure 15 , Figure 16 There is another locking mechanism between the switch button 411 and the retraction lever 413, which includes some interlocking features. When the switch button 411 is pressed and the expandable mechanism 31 is in the expanded state, the interlocking feature 411b of the switch button 411 on the retraction lever will insert into the proximal end of the retraction lever 413 (left side of the figure), thereby blocking the rotation path of the retraction lever 413 and preventing the user from accidentally using the retraction lever 413 when the expandable mechanism 31 is in the expanded state, thus achieving the function of retraction interlock. The switch button 411 and the retraction lever 413 both belong to the housing 41, and their pivots are both fixed on the base plate 417. Therefore, their pivots are in a relatively stationary state. Even in the state where the housing 41 and the inner housing 42 can be displaced relative to each other as described above, these two can still achieve the function of retraction interlock. The retraction interlocking function is discontinued when the switch button 411 is pressed again and the expandable mechanism 31 returns to the retracted state.

[0042] Figure 19 , 20 21 describes that in some embodiments, the bleeding indicator 424 is mainly composed of a blood inlet 211, a bleeding outlet 212, an outlet blood vessel 4241, an outlet blood vessel moving groove 4242, and an outlet blood vessel display port 414.

[0043] The outflow vessel 4241 is connected to the bleeding port 212 and passes through the outflow vessel movement groove 4242 and the outflow vessel display port 414. The inflow port 211 is located at the distal end of the protective tube 21. When the inflow port 211 is located inside the blood vessel, under the pressure inside the blood vessel, the blood enters through the inflow port 211, flows through the cavity between the protective tube 21 and the positioning tube 22, flows out from the bleeding port 212, and enters the outflow vessel 4241. The outflow vessel passes through the outflow vessel movement groove 4242 located on the inner shell 42, and the blood flows out of the instrument shell through the outflow vessel display port 414 on the outer shell 41. When the operator or assistant can see the blood flowing out from the outflow vessel display port 414, it can be confirmed that the inflow port 211 is located at the distal end of the protective tube 21; conversely, if the operator or assistant cannot see the blood flowing out from the outflow vessel display port 414, it is impossible to confirm that the inflow port 211 is located at the distal end of the protective tube 21, thereby achieving the purpose of confirming the position of the inflow port 211 in the body.

[0044] In the exemplary embodiment shown, the outflow vessel 4241 can move in the outflow vessel moving groove 4242 and the outflow vessel display port 414 when the instrument is in use, and remain in a state of extending out of the outer shell 41. This is because in this embodiment, when the instrument is in use, the inner shell 42 will slide relative to the outer shell 41 to a certain extent. At this time, this design will ensure that the bleeding indicator is normally visible and plays an indicative role.

[0045] In some embodiments, the blood vessel will be drawn out from the blood vessel moving groove 4242 and the blood vessel display port 414 by the movement of the protective tube moving slider 4213 on the inner shell 41, and then retracted into the outer shell 41.

[0046] In addition, the optional bleeding indication is configured to be in the form of no outflowing vessel, with bleeding directly from the bleeding point 212.

[0047] Figure 22 In an exemplary embodiment, a pull-unlock mechanism, which belongs to the category of locking mechanisms, is described. The pull-unlock mechanism consists of a release stop 4231, a lever guide groove 4232, a release lever guide block 4122, and a release lever blocking block 4121.

[0048] In the exemplary embodiment shown, the mechanism uses a release stop 4231 on the inner shell 42 to restrict the degree of freedom of the release lever 412 by blocking the release lever blocking block 4121, thus playing a locking role. When the instrument is operated to the appropriate position, the release lever blocking block 4121 will disengage from the restriction of the release stop 4231. At this time, operating the release lever 412 allows the lever guide groove 4232 to gradually restrict the degree of freedom of the release lever guide block 4122. When the release lever guide block 4122 reaches the final position, it plays a role in restricting the relative sliding between the outer shell 41 and the inner shell 42.

[0049] See attached Figure 22In the initial stage, the release lever blocking block 4121 located on the release lever 412 is blocked by the release stop block 4231, and the release lever 412 cannot be actuated in the current state. The release lever guide block 4122 located on the release lever 412 is located in the lever guide groove 4232 in the initial stage, and at this time the lever guide groove 4232 does not constrain the release lever guide block 4122.

[0050] See attached Figure 23 When the device is operated normally and the mechanism is unlocked, the release lever blocking block 4121 located on the release lever 412 is removed from the blocking range of the release stop block 4231. In the current state, the release lever 412 can be actuated. The release lever guide block 4122 located on the release lever 412 is located in the lever guide groove 4232. At this time, the lever guide groove 4232 still does not constrain the release lever guide block 4122.

[0051] See attached Figure 24 When the actuator release lever 412 is operated normally, the release lever blocking block 4121 located on the release lever 412 has completely disengaged from the blocking range of the release stop block 4231, and the release lever guide block 4122 located on the release lever 412 is located in the lever guide groove 4232. At this time, the lever guide groove 4232 constrains the release lever guide block 4122, and this constraint has a constraining effect on the relative displacement of the outer shell 41 and the inner shell 42 through the constraint structure 4233.

[0052] Figure 25 Figures (a) and (b) show the structure of the linear motion mechanism 421, which consists of a left inner shell 4211, a right inner shell 4212, a protective tube motion slider 4213, a positioning tube motion slider 4214, and a main tube motion slider 4215.

[0053] In an exemplary embodiment, the protective tube 21 is connected to the protective tube movement slider 4213, the positioning tube 22 is connected to the positioning tube movement slider 4214, the main tube 23 is connected to the main tube movement slider 4215, and the left inner shell 4211 and the right inner shell 4212 are spliced ​​together.

[0054] See Figure 26 In (a) and (b), the protective tube moving slider 4213 is coupled to the left inner shell 4211 and the right inner shell 4212 through the left inner shell release sliding groove 4211a and the right inner shell release sliding groove 4212a, and can slide along the stroke of the sliding groove. Furthermore, the damping portions of the left inner shell sliding groove 4211c and the right inner shell sliding groove 4212c provide limiting or damping during sliding. The protective tube moving slider 4213 is coupled to the release lever 412 and can be driven by the release lever to perform linear motion.

[0055] The positioning tube movement slider 4214 and the main control tube movement slider 4215 are coupled to each other through the left inner shell retraction sliding groove 4211a and the right inner shell retraction sliding groove 4212a, and can slide along the stroke of the sliding groove. Furthermore, portions of the damping 4211c of the left inner shell sliding groove and the damping 4212c of the right inner shell sliding groove provide limiting or damping during sliding. The main control tube movement slider 4215 is coupled to the retraction lever 413 and can be driven by the retraction lever 413 to perform linear motion.

[0056] In the exemplary embodiment, when the actuator release lever 412 is operated, the protective tube movement slider 4213 will move in conjunction with it, and the protective tube 21 will be retracted to the proximal end in sync until the sealant 5 is fully exposed, thus achieving a fully released state. This operation can be performed with one hand.

[0057] In another embodiment, the protective tube 21 can be released by directly driving the protective tube to move the slider 4213.

[0058] In an exemplary embodiment, the positioning tube 22 is located on the outer layer of the main tube 23, and the two can slide relative to each other.

[0059] like Figure 27 The positioning tube moving slider 4214 and the main tube moving slider 4215 are respectively located in the position shown in the figure in the initial state. The left inner shell sliding groove damper 4211c and the right inner shell sliding groove damper 4212c provide limiting or damping.

[0060] like Figures 28-31 As shown, the positioning tube movement slider 4214 and the main tube movement slider 4215 have protruding portions that can cooperate with the left inner shell retraction sliding groove 4211a and the right inner shell retraction sliding groove 4212a. During sliding, the positioning tube movement slider 4214 and the main tube movement slider 4215 can slide under the restriction of the left inner shell retraction sliding groove 4211a and the right inner shell retraction sliding groove 4212a. This drives the movement of the positioning tube 22 and the main tube 23.

[0061] In an exemplary embodiment, in the initial state, such as Figure 27 As shown, at this time, the contact surface 4214a of the positioning tube moving slider 4214 and the contact surface 4215a of the main tube moving slider 4215 are a certain distance apart, allowing relative sliding between the positioning tube moving slider 4214 and the main tube moving slider 4215. The retraction lever 413 is in its initial, inactive state. Figure 28 As shown, when the actuator retracts lever 413, the distance between the contact surface 4214a of the positioning tube and the contact surface 4215a of the main tube gradually decreases until they just touch, as... Figure 29This is the first half of the stroke; at this point, the expansion mechanism 31 can contact or be relatively close to the positioning tube 22. For example... Figure 30 As shown, when the retraction lever 413 continues to move proximally, the positioning tube movement slider 4214 will push the main control tube movement slider 4215 to move proximally together until the end position is reached, as... Figure 31 As shown, the positioning tube moving slider 4214 and the main moving slider 4215 are finally located at the near end of the sliding groove, which is the second half of the stroke.

[0062] During the first half of the stroke, the anti-reverse function of the positioning tube 22 is completed, and the temporary sealing has been withdrawn with the sealant providing support. During the second half of the stroke, the positioning tube 22 and the expandable mechanism 31 are relatively stationary. They move together relative to the inner shell 41 towards the proximal end, allowing the positioning tube 22 and the expandable mechanism 31 to withdraw synchronously. Sufficient space is provided for the expandable mechanism 31 to withdraw within the protective tube 21. By the end of the second half of the stroke, the expandable mechanism 31 has at least partially separated from the sealant 5. Therefore, withdrawing the expandable mechanism 31 will not bring the sealant out with it. Thus, the sealant 5 can remain in the target position without shifting as the device 1 is withdrawn, and the vascular sealer 1 can be safely withdrawn from the human body.

[0063] It can be recognized that although the segmented retraction mechanism divides the retraction movement into two stages, which are realized by the first and second motion mechanisms respectively, the aforementioned ingenious design allows the actions of the two actuators to be completed by the same actuator. The surgeon only needs to operate one lever, that is, from the user experience perspective, simply moving the lever from one end to the other to complete the retraction of the expandable mechanism 31. Moreover, this step can be operated with one hand, which simplifies the operation and ensures that the position of the sealant 5 is not affected when the expandable mechanism 31 is retracted to its side. This ensures that the expandable mechanism 31 can at least partially detach from the sealant 5 and retract into the protective tube, avoiding the risk that the surgeon may press on the wound when withdrawing the vascular sealer 1 and bring the sealant 5 and the expandable mechanism 31 out of the channel together.

[0064] It should be noted that although the term "lever" is used to describe the brake of the segmented retraction mechanism for ease of understanding, those skilled in the art can quickly understand that the brake can be designed as a button, knob, roller, lever, joystick, or other common handle interaction element to achieve the same objective. Since such interaction design is obvious, it will not be described in detail here.

[0065] See Figure 34 In an exemplary embodiment, as a complex instrument handle containing multiple actuators, the actuators can be arranged on the operating surface (1) 43 and the operating surface (2) 44, the operating surface (1) 43 and the operating surface (2) 44 are adjacent surfaces and the angle between them is 0° to 180°.

[0066] See Figure 35 and Figure 36 The switch button 411, release lever 412, and retraction lever 413 are respectively arranged on the operating surface (1) 43 and the operating surface (2) 44. The relevant motion mechanism of the switch button 411 is located in the upper inner shell 4222 and the lower inner shell 4221 (see Figure 16 In the structure, the relevant motion mechanisms of the release lever 412 and the retraction lever 413 are located within the left inner shell 4211 and the right inner shell 4212, and are connected via the left inner shell 4211, the right inner shell 4212, the upper inner shell 4222, and the lower inner shell 4221 (see...). Figure 16 The direction of the actuators changes, adjusting the arrangement of the actuator switch button 411, release lever 412, and retraction lever 413. This exemplary embodiment allows the operator to easily operate the instrument with one hand, performing operations such as temporary occlusion deployment, sealant release, and temporary occlusion retraction.

[0067] In some embodiments, to improve the tactile feel, the handle is held by the right hand, and the sealant release and retraction interactions are preferably operated by the right thumb, while the expandable mechanism interaction is preferably operated by the right index finger. Because the length and optimal force application of the thumb differ significantly from that of the index finger, the interactions preferably configured for operation by the right index finger and those configured for operation by the right thumb are distributed on two different planes on the handle housing, with the included angle between the two planes between 75-120°. In some embodiments, the expandable mechanism interaction has greater resistance or damping, allowing it to be operated simultaneously by the right index and middle fingers, such as by setting it as a button with a larger operable area.

[0068] During the procedure, the operator holds the vascular sealing device 1 in their right hand, inserts the temporary occlusion module 3, along with the sealant 5 and the tubular module 2, into the vascular sheath 7, and pushes the device 1 distally until the vascular sheath valve body 72 reaches the sheath connector 6. The operator then operates the sheath connection buckle 62 to secure the vascular sheath 7 to the sheath connector seat 61. The operator holds the handle module 4 in their right hand and operates the switch button 411 with their right index finger to inflate the expandable mechanism 31. Holding the handle module 4 in their right hand, the operator moves the entire device proximally. The operator can visually inspect the outflow vessel display port 414 and / or the tension indicator window 415. When the expandable mechanism 31 reaches the vessel wall and the outflow vessel display port 414 and / or the tension indicator window 415 confirm that the temporary occlusion module 3 has successfully sealed the vascular puncture site, the operator operates the release lever 412 with their right thumb to complete the deployment of the sealant 5. The operator then operates the switch button 411 again with their right index finger to retract the expandable mechanism 31. Next, use your right thumb to operate the retraction lever 413 to retract the temporary occlusion module 3. Finally, use your right hand to hold the vascular sealing device 1 and withdraw the entire device to complete the sealing process.

[0069] Although embodiments of the present invention have been disclosed above, they are not limited to the applications listed in the specification and embodiments. It can be applied to various fields suitable for the present invention. Other modifications can be readily implemented by those skilled in the art. Therefore, without departing from the general concept defined by the claims and their equivalents, the present invention is not limited to the specific details and illustrations shown and described herein.

Claims

1. A vascular sealing device, characterized in that, include: A temporary sealing module, the temporary sealing module comprising an expandable mechanism; Sealant, located near the proximal end of the expandable mechanism; Piping system, the piping system comprising: The first pipe is connected to the expandable mechanism and includes an enabling unit for controlling the expansion and contraction of the expandable mechanism; The second fitting is sleeved on the outer layer of the first fitting and is used to support and position the sealant. The third fitting is fitted over the second fitting and is used to contain and protect the sealant. The segmented retraction mechanism is used to control the relative movement between the pipe system and the expandable mechanism in stages, such that: In the first stage, the expandable mechanism retracts to contact or be relatively close to the second tube, while the second tube maintains its supporting position for the sealant. In the second stage, the second fitting and the expandable mechanism are retracted to the proximal end in sync until the expandable mechanism is at least partially detached from the sealant.

2. A vascular sealing device as described in claim 1, characterized in that... The segmented withdrawal mechanism includes: The first motion mechanism is used to control the relative movement between the first pipe fitting and the second pipe fitting in order to achieve the first stage of retraction; The second motion mechanism is used to control the relative movement between the first pipe and the third pipe as a whole when the first pipe and the second pipe are relatively stationary, so as to realize the second stage of retraction.

3. A vascular sealing device as described in claim 2, characterized in that... The first motion mechanism includes: A retraction lever, connected to the first tube, is used to drive the first tube to move towards the proximal end; The positioning tube movement slider, connected to the second tube, is used to keep the second tube stationary during the first stage of retraction to support the sealant.

4. A vascular sealing device as described in claim 2, characterized in that... The second motion mechanism includes: A retractable lever, connected to the first tube, is used to drive the second tube to move synchronously to the proximal end with the expandable mechanism; The main tube movement slider is connected to the first tube and is used to coordinate the movement of the second tube to achieve synchronous retraction.

5. A vascular sealing device as described in claim 1, characterized in that... The inner diameter of the third pipe is larger than the outer diameter of the second pipe to provide sufficient space for the retraction of the expandable mechanism.

6. A vascular sealing device as described in claim 1, characterized in that... The segmented retraction mechanism can complete two-stage retraction actions by operating with one hand.

7. A vascular sealing device as described in claim 1, characterized in that... The aforementioned expandable mechanism is a large-sized, non-balloon structure, suitable for occlusion of large blood vessels.

8. A vascular sealing device as described in claim 1, characterized in that... The segmented retraction mechanism can complete the first and second stages of action sequentially by simply operating a single handle interaction element such as a lever, button, knob, scroll wheel, pull rod, or joystick.

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