CN116898506B

CN116898506B - Vascular stitching instrument

Info

Publication number: CN116898506B
Application number: CN202310856702.9A
Authority: CN
Inventors: 陆栋梁
Original assignee: Fengkaili Medical Instrument Shanghai Co ltd
Current assignee: Fengkaili Medical Instrument Shanghai Co ltd
Priority date: 2023-07-13
Filing date: 2023-07-13
Publication date: 2025-12-09
Anticipated expiration: 2043-07-13
Also published as: WO2025011653A1; CN116898506A

Abstract

This application relates to a vascular suture device, which includes an operating handle and at least two suture groups disposed at the distal end of the operating handle. Each suture group includes a first tube, a second tube mating with the first tube, and a suture needle located within the first tube. The operating handle is configured to drive the suture needle to extend from the first tube and then into the second tube, with the suture needle separating from the first tube. The suture groups are arranged side by side, and at least two planes intersect in the plane of the suture trajectory traversed by the suture needles of each suture group. The vascular suture device disclosed in this application can achieve rapid suturing of large-sized interventional openings in a single operation. The suturing process is simple, and the sutures in the suture area naturally cross after suturing, closing the large-sized interventional opening.

Description

Vascular stitching instrument

Technical Field

The application relates to the technical field of interventional instruments, in particular to a vascular suturing device.

Background

The interventional therapy is a therapy mode of guiding a specific instrument into a lesion part of a human body through a natural duct or a tiny wound of the human body by using a puncture needle, a catheter and other interventional instruments under the guidance and monitoring of an angiography machine, CT, ultrasonic, magnetic resonance and other imaging devices.

Taking intervention medical treatment of blood vessels as an example, after an intervention port is formed in the blood vessel, an intervention device is sent into the blood vessel through the intervention port and is sent to a focus for treatment, and after treatment is finished, the intervention device is retracted and the intervention port is sutured, so that the treatment can be finished with minimal damage.

The size of the access port and the selection of the access vessel are required to be selected according to the size of the access device, and when the size of the access device is large, the access vessel with a large diameter is required to be selected and the size of the access port is increased, but this increases the suturing difficulty of the access port.

Because the blood flow speed in large diameter interventional blood vessels is faster, suturing needs to be completed in a shorter time, and the large-size interventional port also needs to be sewn for a plurality of times and the suture lines are crossed, each suture needs to be intervened by using a guide wire, so that the whole suture process is complex, and the suture lines are crossed by manually adjusting different angles.

Accordingly, there is a need for improvement and advancement in the art.

Disclosure of Invention

In order to solve the problem of suturing the large-size access port, the application provides a vascular suturing device which can realize rapid suturing of the large-size access port in a single operation mode, the suturing process is simple, and the suturing lines of the suturing region naturally form an intersection after the suturing is completed so as to seal the large-size access port.

The above object of the present application is achieved by a first aspect of the present application, which provides a vascular stapler comprising an operation handle, and at least two suturing members disposed at a distal end of the operation handle, wherein each of the suturing members comprises a first tube, a second tube matching the first tube, and a suturing needle disposed in the first tube, wherein the operation handle is configured to drive the suturing needle to extend into the second tube after extending out of the first tube, and the suturing needle is separated from the first tube, wherein the suturing members of each of the suturing members are disposed side by side, and wherein at least two planes intersect each other in a plane along which the suturing needle of each of the suturing members passes.

Further, in the vascular suture device, the planes of the suture tracks through which the suture needles pass intersect and are collinear.

Further, in the vascular suturing device, the number of the suturing assemblies is two, and an included angle formed by planes of suturing tracks provided by the two suturing needles is 45-135 degrees.

Further, in the vascular suture device, the suture tracks provided by the two suture needles are perpendicular to each other.

Further, in the vascular suture device, the vascular suture device further comprises an anchor assembly, the anchor assembly comprises an anchor assembly tube body, deformation members and a driving member, each group of the suture assemblies are arranged in the anchor assembly tube body in a sliding mode side by side, the deformation members are located at the distal ends of the anchor assembly tube body, the deformation members comprise a contracted state and an expanded state, the deformation members do not protrude out of the anchor assembly tube body in the contracted state, the deformation members protrude out of the anchor assembly tube body to abut against the vascular wall in the expanded state, the distal ends of the driving members are connected with the deformation members, and the proximal ends of the driving members are connected with an operation handle or are free ends.

Further, in the vascular stapler, the deformable member includes a balloon, and the driving member includes a balloon catheter.

In the vascular suture device, the number of the deformation pieces and the number of the suture assemblies are two, wherein the included angle formed by the planes of suture tracks provided by the two suture needles ranges from 45 degrees to 135 degrees, the suture tracks provided by the two suture needles are divided into four areas, and the two deformation pieces are respectively positioned in two non-adjacent areas.

Further, the vascular suture device also comprises an introduction component, wherein the proximal end of the introduction component is connected with the distal end of the anchoring component tube body, a guide wire cavity is arranged in the introduction component, and the guide wire cavity is communicated with the anchoring component tube body.

Further, in the vascular suture device, the tube wall of the tube body of the anchoring assembly is provided with an avoidance hole, and the avoidance hole is used for allowing each suture needle to pass through.

Further, in the vascular suturing device, the suturing assembly further comprises a release tube arranged in the first tube body, the suturing needle is arranged in the release tube in a sliding mode, the pushing shaft is connected with the operating handle at the proximal end and is detachably connected with the suturing needle at the distal end, and the pushing shaft is configured to push the suturing needle out of the release tube and further drive the suturing needle to extend out of the release tube, bend and extend into the second tube body.

In the vascular stitching instrument provided by the application, the single stitching of the large-size access port on the blood vessel is realized by arranging at least two stitching assemblies, in the stitching process, the at least two stitching assemblies puncture the blood vessel walls at two sides of the access port at the same time, and an included angle exists between at least two stitching lines left after the puncture is completed, so that the intersection can be naturally formed at the access port. The operation steps in the sewing process are few, the sewing speed is high, and the large-size entrance can be rapidly sealed.

Drawings

The above and other features, advantages and aspects of embodiments of the present disclosure will become more apparent by reference to the following detailed description when taken in conjunction with the accompanying drawings. In the drawings, wherein like or similar reference numerals denote like or similar elements, in which:

FIG. 1 is a schematic perspective view of a vascular stapler according to the present application;

FIG. 2 is a schematic view of a portion of a dual-suture assembly vascular stapler according to the present application;

FIG. 3 is a schematic illustration of the function of a deformable member according to the present application into a blood vessel;

FIG. 4 is a schematic view of a suturing position for suturing an access port according to the present application, wherein four dots indicate the position of the suturing needle as it passes through the vessel wall;

FIG. 5 is a schematic view of a stitching track of a stitching assembly according to the present application, wherein the stitching track is shown in phantom;

FIG. 6 is a schematic view of a suturing assembly according to the present application;

fig. 7 is a schematic view of an anchor assembly according to the present application;

FIG. 8 is a schematic view of another deformable member according to the present application;

FIG. 9 is a schematic view of the deformation member shown in FIG. 8 in a deformed state;

FIG. 10 is a schematic cross-sectional view of an anchor assembly body provided by the present application;

FIG. 11 is a schematic view of yet another alternative form of deformation provided by the present application;

FIG. 12 is a schematic view of the deformation member shown in FIG. 11 in a deformed state;

FIG. 13 is a schematic view of an introduction assembly according to the present application;

FIG. 14 is a schematic view of a suture needle according to the present application passing through a deployment hole and undergoing a reduction;

FIG. 15 is a schematic view of a second tubular body with a first receiving structure thereon;

FIG. 16 is a schematic illustration of a receiver tube with a second receiver structure provided by the present application;

FIG. 17 is a schematic view of a suture thread passing through a wall of a vessel at an access port provided in accordance with the present application;

FIG. 18 is a schematic view of a suture after tying, provided by the application, and

In the figures, the same or corresponding reference numerals denote the same or corresponding parts, wherein reference numerals 1, operating handle, 2, anchor assembly, 21, anchor assembly tube, 22, deformation member, 23, driving member, 3, suturing assembly, 31, first tube, 32, second tube, 33, suturing needle, 34, receiving tube, 4, introduction assembly, 41, catheter, 42, guidewire lumen, 211, evasion hole, 35, release tube, 36, pushing shaft, 321, first receiving structure, 341, second receiving structure, 601, vessel, 602, access port, 603, guidewire channel, 604, suture channel, 605, first tube channel, 606, second tube channel, 607, balloon catheter channel, 608, calcified vessel (vessel wall), 609, suture.

Detailed Description

Embodiments of the present disclosure will be described in more detail below with reference to the accompanying drawings. While certain embodiments of the present disclosure are shown in the drawings, it should be understood that the present disclosure may be embodied in various forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete. It should be understood that the drawings and embodiments of the present disclosure are for illustration purposes only and are not intended to limit the scope of the present disclosure.

In describing embodiments of the present disclosure, the term "comprising" and its like should be taken to be open-ended, i.e., including, but not limited to. The term "based on" should be understood as "based at least in part on". The term "one embodiment" or "the embodiment" should be understood as "at least one embodiment". The terms "first," "second," and the like, may refer to different or the same object. Other explicit and implicit definitions are also possible below.

Furthermore, it should be noted that in the description of the embodiments of the present application, "in vivo" means inside the tissue organ of the patient and "in vitro" means outside the tissue organ of the patient, unless explicitly defined otherwise. Meanwhile, in the embodiment of the present application, "distal" means a direction away from a physician, and "proximal" means a direction close to the physician.

In some embodiments, referring to fig. 1, the application discloses a vascular suture device, which mainly comprises an operation handle 1, an anchor assembly 2 and a suture assembly 3, wherein the anchor assembly 2 is connected with the operation handle 1, and as shown in fig. 2, a deformation member 22 is arranged on the anchor assembly 2, and the section size of the deformation member 22 can be increased and decreased.

Further, referring to fig. 3, the deformable member 22 may be adapted to abut against the inner wall of the vessel at the access opening to provide a basis for a subsequent suturing operation. Because the deformation member 22 can provide the operator with basic position sensing when the deformation member 22 abuts against the inner wall of the blood vessel at the access port, the blood vessel walls at both sides of the access port can be tightened, and the suture assembly 3 can accurately pass through the blood vessel walls and suture the blood vessel walls at both sides of the access port.

Further, a passageway is provided within the anchor assembly, the passageway feeding the guidewire therethrough. Because a portion of the guidewire is positioned within the vessel and a portion is positioned outside the vessel after the interventional procedure is completed, the anchor assembly 2 needs to be guided using the guidewire while it is being advanced into the vessel.

Further, the guide wire positioned outside the blood vessel is first threaded into the passage in the anchor assembly 2, and then the operator continuously pushes the anchor assembly 2 to move toward the blood vessel, and during this process, the end of the anchor assembly 2 away from the operating handle 1 is extended into the blood vessel under the guide of the guide wire.

Further, as the deformation member 22 is advanced into the vessel through the access port to the target site, its volume may be increased. At this time, the operator pulls the operating handle 1 slightly proximally again, and the deforming member 22 abuts against the inner wall of the blood vessel at the access port.

In some embodiments, the number of the suturing members 3 is two or more, and two planes of suturing tracks of at least two suturing members 3 in the suturing members 3 intersect, as shown in fig. 4 and 5, a suturing track on a blood vessel and a suturing schematic diagram.

In some possible implementations, the suture track of each set of the above-described suture assemblies 3 passes through the operating handle 1.

In other exemplary embodiments, the number of stitching assemblies 3 is two, and the included angle formed by the planes of the stitching tracks provided by the two stitching assemblies 3 is in the range of 45 degrees to 135 degrees.

In some possible implementations, the planes of the stitching tracks provided by the two stitching assemblies 3 are perpendicular to each other, that is, the included angle formed by the planes of the stitching tracks provided by the two stitching assemblies 3 is in the range of 90 degrees.

In some embodiments, referring to fig. 2 and 6, the suturing assembly 3 is composed of a first tube 31, a second tube 32 and a suturing needle 33, both of which are located within the anchor assembly 2, the first tube 31 and the second tube 32. The number of the first pipe bodies 31 and the number of the second pipe bodies 32 are the same and are multiple, and one first pipe body 31 and one second pipe body 32 are correspondingly arranged to form a group.

In some possible implementations, the number of first tubes 31 and second tubes 32 is two, and the two first tubes 31 and second tubes 32 can form an "X" like suture at the access port, as shown in fig. 5.

It should be noted that in some embodiments, the number of first tubes 31 may be at least two, and the at least two first tubes 31 are disposed adjacently.

Further, a suture needle 33 is disposed in each first tube 31, and the suture needle 33 is connected to the operation handle 1, and can extend from the first tube 31 and extend into the second tube 32 under the driving of the operation handle 1. The operating handle 1 is also connected to the first tube 31 and the second tube 32, and is capable of driving the first tube 31 and the second tube 32 to extend and retract from the inside of the anchor assembly 2.

In some embodiments, referring to fig. 2 and 7, the anchor assembly 2 is composed of an anchor assembly tube 21, a deformation member 22, and a driving member 23, wherein the anchor assembly tube 21 is connected to the operating handle 1, the deformation member 22 is mounted on the anchor assembly tube 21, and the driving member 23 has a first end connected to the deformation member 22 and a second end connected to the operating handle 1 or is a free end. In this way, the operating handle 1 or the driving member 23 can force the cross-section of the deforming member 22 (in a plane perpendicular to the guide wire) to increase and decrease in size by the driving member 23. Before the deformation member 22 enters the blood vessel to the target position through the intervention opening, the deformation member 22 is accommodated in the anchor assembly tube 21, and the outer surface of the deformation member 22 does not protrude out of the anchor assembly tube 21. As the deformation member 22 is advanced through the access port into the vessel to the target site, its volume may be increased. At this time, the operator pulls the operating handle 1 slightly proximally again, and the deforming member 22 abuts against the inner wall of the blood vessel at the access port.

Further, at the distal end of the anchor assembly body 21, the deforming member 22 has two states, including a contracted state and an expanded state. In the contracted state, the deforming member 22 does not protrude from the anchor unit tube 21, and in the expanded state, the deforming member 22 protrudes from the anchor unit tube 21 and abuts against the vessel wall.

In some alternative embodiments, the deformation member 22 and the driving member 23 have the following structures:

In a first embodiment, referring to fig. 7, the deformation member 22 comprises a balloon, the driving member 23 comprises a balloon catheter with a valve, the balloon catheter is communicated with the space inside the balloon, gas or liquid (medical saline, contrast liquid, etc.) is injected into the balloon through the balloon catheter, the volume of the balloon is increased, the gas or liquid in the balloon is discharged, and the volume of the balloon is reduced. The volume of the saccule is adjusted to adapt to different blood vessel inner walls.

Further, the volume change of the balloon may result in a simultaneous change in the cross-sectional (perpendicular to the plane of the guidewire) dimensions of the balloon. The balloon catheter has a first end connected to the balloon and a second end extending from the operating handle 1 or the anchor assembly tube 21 near the operating handle 1 after passing through a passage in the anchor assembly tube 21.

Further, when the valve is opened, the second end of the balloon catheter is changed from the closed state to the open state, and at this time, liquid can be injected into the balloon through the pipeline or the liquid in the balloon can be removed.

Further, when the volume of the saccule is increased and the saccule is abutted against the inner wall of the blood vessel at the position to be sutured, a certain sealing effect can be achieved, the outflow quantity of blood in the blood vessel from the position to be sutured is reduced, and even the blood in the blood vessel cannot flow out from the intervention port.

In a second embodiment, referring to fig. 8, the deformation member 22 is composed of an expansion bracket, two sections of conduits and a section of traction wire, wherein the two sections of conduits are respectively fixed at two ends of the expansion bracket, the difference is that the first section of conduit is fixed on the outer wall of the anchor assembly tube 21, and a gap exists between the second section of conduit and the outer wall of the anchor assembly tube 21.

In some embodiments, as the second length of tubing is moved in a direction toward the first length of tubing, the tubing is deformed, and the diameter of the tubing increases, i.e., the diameter of the expanded stent increases, as shown in FIG. 9.

In some embodiments, the diameter of the expanded stent decreases as the second length of catheter is moved away from the first length of catheter.

In the first embodiment, the number of the deformation members 22 and the suture members 3 is two, and the two deformation members 22 and the two suture members 3 are alternately arranged around the axis of the anchor member tube 21, that is, one suture member 3 is disposed between the two deformation members 22, and one deformation member 22 is disposed between the two suture members 3.

In another embodiment, the number of the deformation members 22 and the number of the stitching members 3 are two, the stitching members 3 are divided into four areas by the provided stitching tracks, the two deformation members 22 are respectively located in two non-adjacent areas, for example, two first pipe bodies 31 and two second pipe bodies 32 exist at this time, the axes of the first pipe bodies 31 and the second pipe bodies 32 are perpendicular to the paper surface, and, for example, four intersecting areas can be divided after the axes of the two first pipe bodies 31 and the two second pipe bodies 32 are connected, that is, the two first pipe bodies 31 and the two second pipe bodies 32 are divided into four areas by the provided stitching tracks, at this time, one deformation member 22 is located in the left area of the paper surface adjacent to the two first pipe bodies 31, and the other deformation member 22 is located in the right area of the paper surface adjacent to the two second pipe bodies 32, that is, the two deformation members 22 are respectively located in two non-adjacent areas.

With the access opening as a reference, the two deformation members 22 are respectively used for fixing the vessel walls at two sides of the access opening, so that a better fixing effect can be obtained.

Further, the first end of the traction wire is connected with the second section of catheter, the second end passes through the channel in the anchoring assembly tube body 21 and then is connected with the operating handle 1, or the anchoring assembly tube body 21 stretches out near the operating handle 1, and when the traction wire is pulled by the operating handle 1 or directly pulled by the operating handle 1, the second section of catheter is driven to move towards the direction approaching or far away from the first section of catheter.

In some embodiments, the expansion stent in the second form of construction may be made of a memory alloy.

In a third embodiment, referring to fig. 11 and 12, the expansion stent in the second structure is replaced by a section of elastic catheter, grooves are uniformly distributed on the side wall of the catheter, the traction wire can deform the section of elastic catheter through the second section of catheter, the diameter of the catheter is increased, and when the force on the traction wire is eliminated, the length of the section of elastic catheter is recovered, and the diameter of the catheter is reduced.

In some embodiments, the expansion stent in the third form of construction may be cut using a molecular material or a blend of polymeric materials.

Further, referring to fig. 1, in some embodiments, an introducer assembly 4 is added, and the introducer assembly 4 is removably and fixedly connected, e.g., plugged, to the anchor assembly 2.

Further, referring to fig. 13, a guidewire lumen 42 is provided within the introducer assembly 4, the guidewire lumen 42 being in communication with the anchor assembly tube 21. The guidewire mentioned above would first enter the guidewire lumen 42 within the introducer assembly 4 and then pass through the guidewire lumen 42 into the anchor assembly tube 21.

Further, since the introduction unit 4 has elasticity, it moves along the guide wire and deforms after entering the blood vessel through the access port. As the length of the guide wire in contact with the introduction unit 4 increases, the anchor unit 2 positioned behind the introduction unit 4 can be smoothly introduced into the blood vessel through the introduction port.

Further, the introduction assembly 4 is constituted by a catheter 41, and a guidewire lumen 42 is located within the catheter 41.

Referring to fig. 2, in some embodiments, the anchor assembly tube 21 is provided with a relief hole 211 that mates with the first tube 31, the relief hole 211 being used to guide one end of the suture needle 33 into the second tube 32. The avoidance holes 211 can correct or guide the movement track of the stitching needles 33, so as to ensure that one end of each stitching needle 33 can extend into the corresponding second tube 32 during one stitching process.

Further, the suture needle 33 includes an elastically deformable member capable of returning to a curved shape. In the initial state, the suture needle 33 is received in the first tube 31 to be deformed under force, the suture needle 33 is reset to be in a bent shape after extending out of the first tube 31, passes through the avoiding hole, enters and is received in the second tube 32 to be deformed under force.

In the above process, the suture needle 33 is inserted from the blood vessel wall on one side of the access port, then is inserted from the blood vessel wall on the other side of the access port, and the end portion of the suture needle 33 is inserted into the second tube 32 corresponding to the insertion port when it is inserted from the blood vessel wall on the other side of the access port.

Further, the shape of the portion of the needle 33 located in the second tube 32 is changed again, the curvature is reduced, and the end of the needle 33 is pressed against the inner wall of the second tube 32.

In the above process, the suture needle 33 is removed from the blood vessel to be sutured, both ends of the suture thread carried by the suture needle 33 are located outside the blood vessel to be sutured and on both sides of the access port, respectively, and a part of the middle portion of the suture thread is located inside the blood vessel to be sutured.

Because the number of suture needles 33 is at least two, multiple sutures may be present at the access port on the vessel simultaneously during one operation, as shown in fig. 5.

The vascular stitching instrument provided in various embodiments of the present disclosure is mainly used for stitching a large-caliber vascular wound, and the current stitching manner of the large-caliber vascular wound is multiple stitching, which has the difficulty that a part of stitching instrument needs to be sent into the blood vessel in one complete stitching process, each stitching can lead to the shortening of the usable length of the vascular wound, that is, the former stitching position can be damaged by the latter stitching, and a secondary wound is generated on the vascular wound position.

And blood exudation in the suturing process can influence the vision of operators, and the suturing can be continued after the exuded blood is cleaned, which obviously prolongs the suturing time. Vascular displacement in multiple suturing also increases the difficulty of suturing.

It should be noted that, taking two sutures as an example, after the first suture is passed through the vessel wall on both sides of the access port, the suture cannot be bound. The second suture thread needs to be arranged, the angle of the second suture thread needs to be determined by the position of the first suture thread when the second suture thread is arranged, and the suture device has certain difficulty, blood flows out of the intervention opening when the suture device enters and exits the intervention opening for a plurality of times, the shape of the intervention opening also changes, and the practical situation needs to be repeatedly confirmed and operated by an operator for a plurality of times.

In some possible implementations, the second tube 32 is provided with a first receiving structure 321 for fixing the suture needle 33, referring to fig. 15, for example, a fixing hole, so that the suture needle 33 can be limited to the second tube 32 by a receiving structure 321. The primary purpose of the first receiving structure 321 is to increase the temporary connection strength of the suture needle 33 to the second tube 32, so as to avoid the suture needle 33 falling off the second tube 32 when the suture needle 33 moves with the second tube 32. Because the suture needle 33 is most likely pulled back into the blood vessel again in the event of a drop.

Further, when a portion of the suture needle 33 is introduced into the second tube 32, the end portion thereof is pressed against the inner wall of the second tube 32, and when the end portion of the suture needle 33 is moved to the first receiving structure 321, the end portion of the suture needle 33 is directly introduced into the first receiving structure 321, and at this time, the temporary connection strength of the suture needle 33 and the second tube 32 is increased.

Further, referring to fig. 6 and 16, a receiving tube 34 is added, the receiving tube 34 is disposed in the second tube 32 and connected to the operating handle 1, and the operating handle 1 is configured to drive the receiving tube 34 to extend and retract from the second tube 32.

Further, since the second tube 32 needs to act synchronously with the first tube 31, this means that the expansion range of the second tube 32 is limited, and there may be a problem that the suture needle 33 needs to be pulled for many times to be in place due to the insufficient pulling distance.

Further, after the receiving tube 34 is added, when the end of the suture needle 33 is extended into the receiving tube 34, the suture needle 33 can be completely or mostly pulled into the second tube body 32 through the receiving tube 34, at this time, after the anchor assembly 2 is pulled out of contact with the blood vessel, only the suture remains at the access port, at this time, the suture is manually knotted and the knotted portion is pushed to the blood vessel wall, so that the access port can be closed.

Further, referring to fig. 16, a second receiving structure 341 for fixing the suture needle 33 is added to the receiving tube 34, and the function of the second receiving structure 341 is the same as that of the first receiving structure 321, which is not described herein. The operating handle 1 can drive the pushing shaft 36 to push the suture needle 33 out of the release tube 35, and the suture needle 33 is bent and extended into the second tube body 32 after being extended out of the release tube 35.

Further, the push shaft 36 has a first end connected to the operating handle 1 and a second end detachably connected to the suture needle 33, such as a low-connection-strength glue, tight-fitting, or crimping.

In other embodiments, the suturing assembly may further comprise a release tube, a push shaft, the release tube may be located within the first tube, the suturing needle may be located within the release tube, the suturing needle may carry a suture, one end of the suture is connected to the suturing needle, and the other end is located between the first tube and the anchor assembly tube. Further, the suture needle can be an elastic deformation piece which can be reset to be in a bent shape, and the suture needle can be connected with the pushing shaft in a separable connection mode.

It should be noted that in still other embodiments, after the vascular stapler reaches the target site and the vessel is tensioned by the anchor assembly, the operator pushes the push shaft through the operating handle, at which time the push shaft will push the needle first out of the release tube, and during this process the needle will also extend out of the first tube. After the suture needle is extended from the inside of the release tube, the binding force applied to the part located outside of the release tube is removed, and the suture needle starts to bend.

Here, an example of a complete suturing procedure is shown for the access port in fig. 18.

Inserting one end of the guidewire into the catheter 41 and then pushing the vascular stapler until the deformation member 22 enters the blood vessel through the access port;

Withdrawing the guide wire and adjusting the positions of the operating handle 1 and the anchor assembly 2;

The volume of the deformation piece 22 is adjusted through the driving piece, so that the volume of the deformation piece 22 is increased;

Pulling the operating handle 1 slightly proximally to adjust the position so that the deforming member 22 abuts against the inner wall of the blood vessel;

Pushing each set of the first tube 31 and the second tube 32 out of the anchor assembly tube 21, wherein the first tube 31 and the second tube 32 are abutted against the outer wall of the blood vessel at the access port as much as possible;

The suture needle 33 is pushed out of the first tube body 31 through the push shaft 36, at the moment, the suture needle 33 positioned outside the first tube body 31 starts to bend, and the end part of the bent suture needle 33 passes through the avoidance hole 211 and then stretches into the receiving tube 34 at the second tube body 32;

pulling the receiving tube 34, the receiving tube 34 driving the suture needle 33 into the second tube 32;

Retracting the first tube 31 and the second tube 32 into the anchor assembly tube 21, with the suture passing through the vessel wall on either side of the access port, as shown in fig. 17;

shearing redundant sutures;

Draining the fluid from the deformable member 22 and removing the portion of the vascular stapler located within the blood vessel;

The ends of the suture are knotted pairwise and the knotted site is pushed to the vessel wall, the access port is closed, and the excess suture ends are trimmed again, as shown in fig. 18.

Further, in another embodiment, as shown in FIG. 10, a schematic cross-sectional view of an anchor assembly tube is shown. In this illustrated embodiment, the anchor assembly tube includes a guidewire channel 603 in a central position, a suture channel 604 disposed circumferentially about the central guidewire channel 603, a first tube channel 605, a second tube channel 606, and a balloon catheter channel 607. In particular, as shown in fig. 10, including two suture passages 604, the two suture passages 604 are symmetrically arranged with respect to the center point of the wire guide passage 603, on the basis of which a line is formed with the center point of the wire guide passage 603 and the center point of the two suture passages 604, then the two balloon catheter passages 607 are symmetrically arranged right and left with respect to the line, on the basis of which the line of the center points of the two suture passages 604 intersects the line of the center points of the two balloon catheter passages 607 at the center point of the wire guide passage 603, and the plane is divided into four areas, in which two first tube passages 605 and two second tube passages 606 are arranged, wherein, as shown in the figure, the two first tube passages 605 are in the upper half two planar areas, and the two second tube passages 606 are in the lower half two planar areas.

The foregoing description of the embodiments of the present disclosure has been presented for purposes of illustration and description, and is not intended to be exhaustive or limited to the embodiments disclosed. Many modifications and variations will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the various embodiments described. The terminology used herein was chosen in order to best explain the principles of the embodiments, the practical application, or the technical improvements in the marketplace, or to enable others of ordinary skill in the art to understand the embodiments disclosed herein.

The foregoing is merely an alternative embodiment of the present disclosure, and is not intended to limit the present disclosure, and various modifications and variations will be apparent to those skilled in the art. Any modifications, equivalent substitutions, improvements, etc. that fall within the spirit and principles of the present disclosure are intended to be included within the scope of the present disclosure.

Claims

1. A vascular suture device, characterized in that it comprises:

Operating handle; and

At least two suture assemblies are disposed at the distal end of the operating handle, wherein each set of suture assemblies includes a first tube, a second tube mating with the first tube, and a suture needle located within the first tube;

The operating handle is configured to drive the suture needle to extend from the first tube and into the second tube, and the suture needle is to separate from the first tube.

The suture components are arranged side by side, and at least two planes intersect in the plane of the suture trajectory traversed by the suture needles of each group of suture components.

The vascular suture device also includes an anchoring assembly, the tube of which has a clearance hole for each suture needle to pass through. The clearance hole is configured to guide one end of the suture needle into the second tube by correcting the movement trajectory of the suture needle.

2. The vascular suture device according to claim 1, wherein the planes along the suture trajectories of each of the suture needles intersect and are collinear.

3. The vascular suture device according to claim 1, wherein the number of suture components is two, and the included angle formed by the planes containing the suture tracks provided by the two suture needles is in the range of 45 degrees to 135 degrees.

4. The vascular suture device according to claim 3, wherein the planes containing the suture tracks provided by the two suture needles are perpendicular to each other.

5. The vascular suture device according to claim 1, wherein the anchoring assembly further comprises a deformable element and a driving element;

The anchoring component tube body, in which each group of stitching components is slidably disposed side by side;

The deformable element is located at the distal end of the anchoring assembly tube. The deformable element includes a contracted state and an expanded state. In the contracted state, the deformable element does not protrude from the anchoring assembly tube. In the expanded state, the deformable element protrudes from the anchoring assembly tube and abuts against the blood vessel wall.

The distal end of the drive component is connected to the deformable component, and the proximal end is connected to the operating handle or is a free end.

6. The vascular suture device according to claim 5, wherein the deforming element comprises a balloon, and the driving element comprises a balloon catheter.

7. The vascular suture device according to claim 5, characterized in that the number of the deformable element and the suture assembly are both two; wherein the included angle formed by the planes containing the suture tracks provided by the two suture needles ranges from 45 degrees to 135 degrees.

Furthermore, the suture tracks provided by the two suture needles divide the area into four regions, with the two deformable elements located in two non-adjacent regions respectively.

8. The vascular suture device according to claim 5, characterized in that it further comprises:

An inlet component is provided, the proximal end of which is connected to the distal end of the anchoring component tube. The inlet component has a guide wire cavity that is connected to the anchoring component tube.

9. The vascular suture device according to claim 1, wherein the suture assembly further comprises:

A release tube is provided inside the first tube body, and the suture needle is slidably disposed inside the release tube;

The push shaft is connected to the operating handle at its proximal end and can be detachably connected to the suture needle at its distal end.

The push shaft is configured to push the suture needle out of the release tube, thereby driving the suture needle to extend out of the release tube, bend, and insert into the second tube body.