CN112998772A

CN112998772A - Interventional defect stitching instrument

Info

Publication number: CN112998772A
Application number: CN201911334551.0A
Authority: CN
Inventors: 张庭超; 黄桥; 蒋权杰
Original assignee: Hangzhou Weiqiang Medical Technology Co Ltd
Current assignee: Hangzhou Endonom Medtech Co Ltd
Priority date: 2019-12-20
Filing date: 2019-12-20
Publication date: 2021-06-22
Anticipated expiration: 2039-12-20
Also published as: CN112998772B

Abstract

The invention provides an interventional defect stitching instrument which comprises a sheath tube, a stitching assembly arranged at the far end of the sheath tube and at least two puncture needles arranged in the sheath tube in a penetrating mode. The suture assembly comprises a main body piece fixedly connected with the sheath tube and a movable piece rotatably connected with the main body piece, and the two sides of the rotating axis line of the movable piece are respectively provided with at least one connecting cylinder connected with a suture. After the movable piece rotates in place relative to the main body piece, one connecting cylinder is correspondingly positioned on a moving path of the far end of one puncture needle, the at least two puncture needles are respectively butted with one corresponding connecting cylinder after puncturing tissues around the defect, and when the puncture needles move towards the near end, the connecting cylinders and the suture lines correspondingly connected with the puncture needles are driven to move towards the near end, so that the suture lines are implanted into the tissues around the defect, at least two suture points are formed through one-time intervention, the intervention frequency of instruments is reduced, and the operation time is shortened.

Description

Interventional defect stitching instrument

Technical Field

The invention relates to the field of medical instruments, in particular to an interventional defect stitching instrument which is mainly suitable for closing repair of patent foramen ovale and atrial septal defect of heart.

Background

Patent application discloses a foramen ovale blocking operation, which is an interventional treatment measure for congenital heart diseases applied earlier. In the conventional oval foramen closing operation, an umbrella-shaped metal closing device is generally used to clamp tissues around a defect, so that the defect part is closed. However, the occluder is a large foreign body, which not only has a risk of falling off, but also forms thrombus after being implanted into the blood vessel of the human body, and patients need to take anticoagulant drugs for at least half a year, even if the patient still has partial endothelialization, and thrombus continues to be generated. On the other hand, metal occluders remain in the patient for life, with a long-term risk of abrading surrounding tissue, causing complications such as cardiac perforation.

The defect closer assembly is used for replacing a foramen ovale blocking operation in a suturing mode, so that the risk caused by blocking defects by using a blocking device is avoided, however, the defect closer assembly can only implant one suture line at a time and form one suturing point, the defect closing repair can be completed after the suture line is implanted into tissues around the defects for multiple times and a plurality of suturing points are correspondingly formed, the instrument intervention times are more, and the operation time is longer.

Disclosure of Invention

In view of this, the present invention provides an interventional defect suturing device, which can implant at least two sutures to form at least two suture points in one intervention, thereby reducing the number of intervention of instruments and shortening the operation time.

In order to solve the technical problem, the invention provides an interventional defect stitching instrument, which comprises a sheath tube, a stitching assembly arranged at the far end of the sheath tube and at least two puncture needles arranged in the sheath tube in a penetrating way; the suture assembly comprises a main body piece fixedly connected with the sheath tube and a movable piece rotatably connected with the main body piece, and the two sides of the rotating axis of the movable piece are respectively provided with at least one connecting cylinder connected with a suture; the movable piece rotates relative to the main body piece until one connecting cylinder is correspondingly positioned on a moving path of the far end of the puncture needle; the at least two puncture needles are respectively butted with a corresponding connecting cylinder; when the puncture needle moves towards the near end, the connecting cylinder and the suture which are correspondingly connected with the puncture needle are driven to move towards the near end.

The invention provides an intervention type defect stitching instrument, wherein a stitching assembly comprises a main body piece and a moving piece which is rotatably connected with the main body piece, at least one connecting cylinder for connecting sutures is respectively arranged on the two sides of the rotating axis line of the moving piece, when the moving piece rotates to the right position relative to the main body piece, one connecting cylinder is correspondingly positioned on the moving path of the far end of one puncture needle, at least two puncture needles can be respectively butted with one corresponding connecting cylinder after puncturing tissues around defects, and when the puncture needle moves towards the near end, the connecting cylinder and the sutures correspondingly connected with the puncture needle are driven to move towards the near end, so that the sutures are implanted into the tissues around the defects, at least two sutures are implanted at one time, at least two stitching points are formed, the intervention times of instruments are reduced, and the operation time is shortened.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings needed to be used in the embodiments will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and it is obvious for those skilled in the art to obtain other drawings based on these drawings without creative efforts.

Fig. 1 is a schematic perspective view of an interventional defect stapler according to a first embodiment of the present invention.

FIG. 2 is a schematic view of the moveable member of the seaming element of FIG. 1 rotated into position relative to the body member.

Figure 3 is a schematic view of the moveable member of figure 2 in abutting engagement with the needle.

FIG. 4 is a schematic view of the interventional defect stapler of FIG. 2 with the sheath removed and the needle withdrawn.

Fig. 5 is a schematic cross-sectional view of the sheath of fig. 4.

Figure 6 is a perspective view of the suturing assembly of figure 1 in an initial state.

Fig. 7 is an enlarged schematic view of section VII in fig. 6.

Fig. 8 is a cross-sectional view of fig. 6.

FIG. 9 is a schematic view of the moveable member of FIG. 6 rotated into position relative to the body member.

Fig. 10 is an enlarged schematic view of the X portion in fig. 9.

Fig. 11 is a cross-sectional view of fig. 9.

Fig. 12 is a perspective view of the connector barrel of fig. 11.

FIG. 13 is a schematic view of the suturing assembly of FIG. 11 in association with a needle, suture and retractor.

Fig. 14 is an enlarged schematic view of the XIV portion of fig. 13.

Fig. 15 is a schematic view of the internal structure of the handle assembly of fig. 2 with the upper housing removed.

Fig. 16 is a perspective view of the base of fig. 15.

Fig. 17 is a cross-sectional view of the handle assembly of fig. 2.

Fig. 18 is an enlarged schematic view of the XVIII portion of fig. 17.

Fig. 19 is a perspective exploded view of the push rod lock of fig. 18.

Fig. 20 to 23 are schematic views illustrating a use process of the push rod lock of fig. 18.

Fig. 24 is a perspective exploded view of the bobbin of fig. 4.

Fig. 25 is a schematic view of the suture of fig. 4 attached to the connector barrel and spool.

Fig. 26a to 26g are schematic views illustrating a procedure for using the interventional defect stapler of fig. 1.

FIG. 27 is a schematic view of the suture attachment to the connector barrel and spacer of an interventional defect stapler according to a second embodiment of the invention.

Fig. 28 is a schematic view of the gasket of fig. 27 in a use state.

FIG. 29 is a schematic view of the attachment of the suture to the connector barrel of an interventional defect stapler according to a third embodiment of the invention.

FIG. 30 is a schematic view of the suture attachment to the connector barrel and spacer of an interventional defect stapler according to a fourth embodiment of the invention.

FIG. 31 is a schematic view of the connection of the first pushing rod, the second pushing rod and the sheath of the interventional defect stapler according to the fifth embodiment of the invention.

Detailed Description

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be obtained by a person skilled in the art without inventive effort based on the embodiments of the present invention, are within the scope of the present invention.

In the description of the present invention, it should be noted that the terms "upper", "lower", "left", "right", "inner", "outer", and the like indicate orientations or positional relationships based on those shown in the drawings, and are only for convenience of description and simplification of description, but do not indicate or imply that the referred device or element must have a specific orientation, be constructed in a specific orientation, and be operated, and thus, should not be construed as limiting the present invention. Furthermore, the terms "first," "second," "third," and the like are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.

In the description of the present invention, it should be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "connected," and the like are to be construed broadly and may be, for example, fixedly connected, detachably connected, or integrally connected; may be directly connected or indirectly connected through an intermediate. The specific meanings of the above terms in the present invention can be understood in specific cases to those skilled in the art.

In the description of the present invention, it should be noted that, in the field of interventional medical devices, the proximal end refers to the end closer to the operator, and the distal end refers to the end farther from the operator, and the above definition is only for convenience of description and should not be construed as limiting the present invention.

Referring to fig. 1 to 4, a first embodiment of the present invention provides an interventional defect stapler for implanting a suture to a tissue around a defect, the interventional defect stapler including a sheath 100, a suture assembly 200 disposed at a distal end of the sheath 100, and at least two puncture needles 300 disposed in the sheath 100. The suturing assembly 200 comprises a main body member 210 fixedly connected to the sheath 100 and a movable member 230 rotatably connected to the main body member 210, wherein the movable member 230 is provided with at least one connecting cylinder 500 connected with the suture 400 at two sides of a rotation axis thereof, respectively. After the movable member 230 rotates to a certain position relative to the main body member 210, a connecting cylinder 500 is correspondingly positioned on a moving path of the distal end of a puncture needle 300, and at least two puncture needles 300 are respectively butted with a corresponding connecting cylinder 500 after puncturing tissues (not shown) around the defect; when the puncture needle 300 moves towards the proximal end, the connecting cylinder 500 and the suture 400 which are correspondingly connected with the puncture needle are driven to move towards the proximal end, so that the suture 400 is implanted into tissues around the defect, at least two sutures 400 are implanted in one time, at least two suture points are formed, the intervention times of instruments are reduced, and the operation time is shortened.

As shown in fig. 4, a pulling member 600 is further disposed through the sheath 100, a distal end of the pulling member 600 is connected to the movable member 230, and the pulling member 600 moves along the axial direction of the sheath 100 to drive the movable member 230 to rotate relative to the main member 210.

In this embodiment, two puncture needles 300 are provided, and the movable element 230 is provided with a connecting cylinder 500 to which the suture 400 is connected at each of both sides of the rotational axis thereof. After the movable member 230 is rotated to a proper position relative to the main body member 210 by the traction member 600, the two puncture needles 300 are respectively abutted to a corresponding connecting cylinder 500 after puncturing the tissue around the defect, the two puncture needles 300 are withdrawn towards the proximal end to drive the connecting cylinder 500 and the suture 400 correspondingly connected with the two puncture needles 300 to be withdrawn, and the two sutures 400 can respectively penetrate through the tissue around the defect along the withdrawing paths of the corresponding two puncture needles 300, so that the two sutures 400 can be implanted in an interventional manner at one time to form two suturing points.

The main body 210 and the movable member 230 may be made of metal material such as stainless steel, ABS, PC, or the like. Preferably, in the present embodiment, the main body 210 and the movable member 230 are made of stainless steel.

It should be noted that the proximal end of the suture 400 and the proximal end of the traction element 600 are both inserted into the sheath 100 and extend to the outside of the patient.

Specifically, referring to fig. 5, the sheath tube 100 includes an outer tube (not shown), a reinforcing tube (not shown), and a plurality of inner tubes (not shown) passing through the reinforcing tube from outside to inside in sequence. The outer tube is made of materials with excellent biocompatibility and certain hardness, such as PEBAX and the like; the reinforcing pipe is preferably a metal woven net structure, has certain rigidity and can be bent in the axial direction, so that support is provided, the sheath pipe 100 is prevented from being twisted and deformed in the radial direction, and the bending of the sheath pipe 100 is not influenced; the inner pipe is a flexible pipe made of flexible materials such as PTFE and the like.

Wherein, the lumen of each inner tube forms a through channel for the puncture needle 300, the suture 400 and the traction piece 600 to pass through. In this embodiment, the sheath 100 includes two first cavities 110 for passing the puncture needle 300, two second cavities 120 for passing the suture 400, and one third cavity 130 for passing the traction element 600. That is, in the present embodiment, each puncture needle 300 is correspondingly inserted into one first cavity 110, and each suture 400 is correspondingly inserted into one second cavity 120, so as to avoid the mutual influence between two puncture needles 300 and two sutures 400 during the insertion process. Of course, in other embodiments, two needles 300 may share a single first lumen 110 and two sutures 100 may share a single second lumen 120.

Referring to fig. 1, 6-10, in the present embodiment, the main body 210 is substantially a round rod, and the main body 210 includes a tapered tip 211 at a distal end, a plug portion 212 at a proximal end, and a main body 213 disposed between the tapered tip 211 and the plug portion 212. The diameter of the mating part 212 is slightly smaller than the diameter of the body part 213. The insertion part 212 is inserted into the distal end of the sheath 100 and is fixedly connected to the distal end of the sheath 100 by any means such as heat fusion or welding. The main body 213 has a rectangular receiving cavity 214 at an end near the tapered end 211 for receiving the movable element 230, the length direction of the receiving cavity 214 is parallel to the axial direction of the main body 210, the width direction of the receiving cavity 214 is perpendicular to the axial direction of the main body 210, and the receiving cavity 214 penetrates through the main body 210 in the height direction, i.e., the direction perpendicular to the axial direction of the main body 210. Two side walls of the accommodating cavity 214 are respectively provided with a mounting hole for rotatably connecting the movable member 230.

Further, in the present embodiment, the main body 210 defines two first channels 215, two second channels 216 and a third channel 217. The two first channels 215 are respectively communicated with the two first cavities 110 of the sheath 100 for penetrating the two puncture needles 300; the two second channels 216 are respectively communicated with the two second cavities 120 of the sheath 100 for passing two sutures 400; the third channel 217 is connected to the third cavity 130 of the sheath 100 for passing the pulling member 600.

The second channel 216 and the third channel 217 extend along the axial direction of the main body 210 to communicate with the accommodating cavity 214.

Wherein, as shown in fig. 11, the two first channels 215 are symmetrical about the axis of the body member 210. Each first channel 215 includes a curved segment 2151 at the distal end, the curved segment 2151 is located at each location from the proximal end to the distal end and gradually moves away from the axial center line of the body member 210, and each first channel 215 is formed through the outer wall of the body member 210 at least at the distal end of the curved segment 2151 for the insertion needle 300 to extend out of or retract into the body member 210. In this embodiment, each first channel 215 penetrates through the outer wall of the main body 210 on the side away from the axial line of the main body 210, i.e., each first channel 215 is a slot opened on the main body 210 and having a curved distal portion.

In other embodiments, each first channel 215 can extend through the outer wall of the body member 210 at a portion of the curved segment 2151, or can extend through the outer wall of the body member 210 only at the distal end of the curved segment 2151, so long as the piercing needle 300 disposed in each first channel 215 can extend from the curved segment 2151 of the first channel 215 or be received in the body member 210.

The movable member 230 is disposed in the accommodating cavity 214 of the main body 210 and is rotatably connected to a sidewall of the accommodating cavity 214 through the rotating member 250, and the movable member 230 can rotate relative to the main body 210 with the rotating member 250 as an axis. Specifically, as shown in fig. 7 and 8, in the present embodiment, the movable member 230 includes a connection column 231 and two mounting blocks 232 located at two opposite sides of the connection column 231, and each mounting block 232 is connected to the connection column 231 through two connecting plates 233 arranged in parallel and at an interval. The connecting column 231 is axially provided with a through hole, and is rotatably connected between two opposite side walls of the accommodating cavity 214 through a rotating member 250 such as a rotating pin, and the rotating member 250 is inserted into the mounting holes on the two opposite side walls of the accommodating cavity 214 and the through hole of the connecting column 231, so that the moving member 250 can rotate relative to the main body member 210 by using the rotating member 250 as an axis.

Preferably, in this embodiment, a position-limiting member 270 is disposed at a position, close to the proximal end of the main body member 210, of a side opening of the receiving cavity 214, the position-limiting member 270 covers a part of the opening of the receiving cavity 214, and when the movable member 230 rotates relative to the main body member 210 to abut against the position-limiting member 270, the movable member 230 rotates to a full position, that is, the position-limiting member 270 stops the rotation of the movable member 230.

The limiting member 270 and the main body member 210 may be an integral structure or a non-integral structure. In this embodiment, the limiting member 270 and the main body member 210 are integrated.

The distal end surface of the retaining member 270 is perpendicular to the axial direction of the main body member 210 or inclined at a predetermined angle, so that the movable member 230 is perpendicular to the main body member 210 or inclined at a predetermined angle when rotating to a position relative to the main body member 210. In this embodiment, the distal end surface of the limiting member 270 is perpendicular to the axial direction of the main body member 210, and when the movable member 230 stops rotating under the stopping action of the limiting member 270, the movable member 230 is perpendicular to the main body member 210. As shown in FIG. 6, in the initial state, the moveable member 230 is completely received in the receiving cavity 214 and is parallel to the main member 210. As shown in fig. 9, in the present embodiment, when the movable member 230 rotates to a proper position relative to the main body member 210, the two mounting blocks 232 respectively located at the two opposite ends of the movable member 230 are located outside the accommodating cavity 214, and the movable member 230 is located at a position perpendicular to the axial direction of the main body member 210.

Further, referring to fig. 8, 11 and 12, two mounting blocks 232 at two opposite ends of the movable member 230 are respectively provided with a receiving hole 2321. In this embodiment, the receiving hole 2321 is a step-shaped through hole, and the receiving hole 2321 includes a small port and a large port that are disposed oppositely. As shown in fig. 11, in the present embodiment, when the movable member 230 rotates to a proper position relative to the main body member 210, the small end of the receiving hole 2321 faces the distal end of the main body member 210, the large end of the receiving hole 2321 faces the proximal end of the main body member 210, each receiving hole 2321 corresponds to an opening of the first channel 215, specifically, the axial line of each receiving hole 2321 is collinear with the axial line of the distal end of the curved section 2151, that is, the included angle between the axial line of each receiving hole 2321 and the axial direction of the main body member 210 is equal to the included angle between the axial line of the distal end of the curved section 2151 and the axial direction of the main body member 210.

Each receiving hole 2321 is installed with a connecting cylinder 500 therein, and the connecting cylinder 500 is movably inserted into the receiving hole 2321 through the large end of the receiving hole 2321. As shown in fig. 12, in the present embodiment, the connection cylinder 500 is a sleeve, the sleeve includes a cylinder 510, the cylinder 510 has a through hole penetrating through two end surfaces along an axial direction, the cylinder 510 has a plurality of openings 520 communicating with the through hole along a circumferential direction near an outer wall of the proximal end, an elastic reverse buckle 530 is disposed in each opening 520, the reverse buckle 530 includes a connection end and a free end opposite to the connection end, the connection end is connected to a proximal edge of the opening 520, and the free end extends to an inner cavity of the cylinder 510. In a natural state, the free end of the reverse 530 is inclined toward the inside of the through hole of the cylinder 510 with respect to the connection end.

Referring to fig. 13, each connector barrel 500 is connected with a suture 400, one end of the suture 400 is connected with the connector barrel 500 through the small port of the receiving hole 2321, and the other end of the suture 400 extends out of the patient through the second channel and the second cavity (not shown). The connection mode of the suture 400 and the connection cylinder 500 may be any connection mode such as riveting connection, glue bonding, etc., and in this embodiment, the suture 400 and the connection cylinder 500 are connected by riveting.

In this embodiment, two puncture needles 300 respectively disposed in two first cavities (not shown) are advanced towards the distal end, such that each puncture needle 300 extends from the curved portion 2151 of the first channel 215 out of the main body 210 to puncture the tissue around the defect to the sleeve (i.e. the connecting cylinder 500) abutting against the corresponding receiving hole 2321, and the needle tip of the puncture needle 300 is inserted into the sleeve, so as to realize the abutting of the puncture needle 300 and the connecting cylinder 500. It will be appreciated that the connector barrels 500 are movably received in the receiving openings 2321 such that withdrawing each of the puncture needles 300 simultaneously withdraws the connector barrels 500 coupled thereto, such that the suture 400 coupled to each of the connector barrels 500 is passed through the tissue surrounding the defect along the withdrawal path (i.e., the first channel 215 and the first lumen) of the corresponding puncture needle 300, and the suture 400 is implanted into the tissue surrounding the defect.

Specifically, referring to fig. 14, in the present embodiment, the puncture needle 300 includes a needle body 310 and a needle 320 connected to a distal end of the needle body 310, the needle 320 includes a tapered needle point and a connecting section connecting the needle point and the needle body 310, a diameter of the connecting section gradually decreases from the proximal end to the distal end, and the needle 320 forms an annular catching groove 330 at the connecting section. When the needle tip 320 of the needle 300 is inserted into the hub, the barbs 530 on the hub snap into the catching grooves 330 on the needle tip 320, causing the needle tip 320 of the needle 300 to snap into the hub, thereby moving the hub through the needle 300.

In other embodiments, a first magnetic element can be disposed in the sleeve, a second magnetic element can be disposed on the needle 320 of the puncture needle 300, and the needle 320 of the puncture needle 300 and the sleeve are connected by the first magnetic element and the second magnetic element. The first magnetic attraction piece and the second magnetic attraction piece can be two elements with magnetic attraction force, or one element with magnetic attraction force and the other metal element capable of being attracted magnetically.

In other embodiments, internal threads may be provided in the sleeve, external threads may be provided on the needle tip 320 of the introducer needle 300, and the needle tip 320 of the introducer needle 300 may be threadably engaged with the internal threads of the sleeve to provide docking of the introducer needle 300 with the connector 500.

It is understood that the connector 500 can be other than a sleeve, for example, the connector 500 is a cloth pre-installed in the receiving hole 2321, and the needle 320 of the puncture needle 300 is threaded on the cloth to realize the butt joint of the puncture needle 300 and the connector 500, which will not be described herein.

It should be noted that to facilitate the smooth extension of the needle 300 from the curved portion 2151 of the first channel 215 to the body member 210, the distal end of the curved portion 2151 preferably includes an acute angle of less than 15 degrees with respect to the axis of the body member 210, and the needle 300 may be pre-formed at the distal portion to form the same angle.

Referring to fig. 11 and 13 again, in the present embodiment, the pulling element 600 is provided as a single element for driving the movable element 230 to rotate relative to the main body element 210. Specifically, the distal end of the pulling element 600 passes through the gap between the two parallel connecting plates 233 which are spaced apart, and is wound around a part of the cylindrical surface of the connecting column 231, and is further connected to one end of a mounting block 232 close to the small end of the receiving hole 2321 by any one of crimping, bonding or welding; the proximal end of the pulling member 600 extends through the communicating third passageway 217 and third lumen (not shown) to the outside of the patient. When the pulling member 600 is controlled to move axially by the proximal end of the pulling member 600, the pulling member 600 can drive the movable member 230 to rotate relative to the main body member 210 about the rotating member 250.

In other embodiments, the two pulling members 600 may be provided, and the two pulling members 600 are respectively connected to the two mounting blocks 232 at the opposite ends of the movable member 230.

The traction member 600 is a wire or a tube made of a metal material or a polymer material, the metal material is selected from stainless steel, nickel titanium, cobalt-chromium alloy, and the like, and the polymer material is selected from at least one of PET, PTFE, or PP. Preferably, in this embodiment, the pulling element 600 is made of a nickel-titanium wire, and an operator can push the pulling element 600 towards the distal end to drive the movable element 230 to rotate to a position axially perpendicular to the main body element 210, or pull the pulling element 600 towards the proximal end to drive the movable element 230 to rotate reversely to a position axially parallel to the main body element 210.

It should be noted that the gap between the two spaced-apart webs 233 is also used for the distal end of the suture 400 to pass through for connection to the connector barrel 500, and the proximal end of the suture 400 extends out of the patient through the second channel and the second lumen (not shown).

Referring to fig. 1-4, 15 and 16, the interventional defect stapler further includes a handle assembly 700 disposed at the proximal end of the sheath 100, the handle assembly 700 being used to control the movement of the needle 300 and the retractor 600.

As shown in fig. 4, the handle assembly 700 includes an end cap 710, a lower shell 720 located at a distal end of the end cap 710, and an upper shell 730 for covering the lower shell 720, which are detachably connected by any means such as clamping, screwing, and the like, and together enclose to form an accommodation space. It can be understood that the end cap 710, the lower shell 720 and the upper shell 730 have corresponding openings for exposing other corresponding components of the handle assembly 700, which are not described herein.

As shown in fig. 15, the handle assembly 700 further includes a joint 740 and a base 750 disposed in the accommodating space, wherein the joint 740 is used for fixedly connecting the sheath 100 and the base 750. Specifically, in this embodiment, the joint 740 is funnel-shaped, and includes a large diameter section located at the proximal end, a small diameter section located at the distal end, and a transition section connecting the large diameter section and the small diameter section, and the diameter of the transition section gradually decreases from the proximal end to the distal end; the large diameter section of the joint 740 is axially provided with an internal threaded hole (not shown), and the transition section and the small diameter section of the joint 740 are axially provided with a through cavity (not shown) communicating with the internal threaded hole of the large diameter section, that is, two ends of the joint 740 are communicated. The sheath 100 is inserted into the distal end of the small diameter section of the joint 740, and preferably, the sheath 100 is fixedly connected to the joint 740 by heat fusion or adhesion. As shown in fig. 16, in this embodiment, the base 750 includes a cylindrical section 751 and a square column section 752 connected to a proximal end of the cylindrical section 751. The outer wall of the cylindrical section 751 is provided with external threads at the part close to the distal end for being screwed and fixed with the large-diameter section of the joint 740; the outer wall of the cylindrical section 751 is also symmetrically provided with a port 7511 and a threaded port 7512; the cylindrical section 751 is further provided with a plurality of through holes extending along the axial direction, and each through hole forms a through passage. A first placing cavity 7521 and a second placing cavity 7522 which are communicated with each other are arranged on the top surface of the square column section 752 at the position close to the far end, and a third placing cavity 7523 which extends along the axial direction is arranged on the near end surface of the square column section 752; the top surface of the square column 752 near the proximal end thereof is provided with two sets of positioning blocks 7524, a set of mounting holes 7525, and an opening 7526 communicating with the third receiving cavity 7523.

In this embodiment, the plurality of through holes axially formed in the cylindrical section 751 specifically include two first through holes for passing two puncture needles 300, two second through holes for passing two sutures 400, a third through hole for passing the pulling element 600, and an injection hole for introducing saline.

Wherein, the liquid injection hole is communicated with the interface 7511, and the interface 7511 is connected with a liquid injection pipe 760. When the sheath 100 and the base 750 are connected to the connector 740 having both ends through, the saline injected through the injection tube 760 may flow into each cavity of the sheath 100 to remove air in the cavity.

When the sheath 100 and the base 750 are connected to the connector 740 with two through ends, the first cavity 110 of the sheath 100, the first through hole of the cylindrical section 751 and the third installation cavity 7523 of the square column section 752 are correspondingly communicated for the puncture needle 300 to pass through; the second cavity 120 of the sheath tube 100, the second through hole of the cylindrical section 751 and the threaded interface 7512 of the cylindrical section 751 are correspondingly communicated for threading the suture 400; the third cavity 130 of the sheath tube 100 and the third through hole of the cylindrical section 751 are correspondingly communicated with the second placing cavity 7522 of the square column section 752 for passing through the traction element 600. In the present embodiment, the third through hole penetrates through the outer wall of the cylindrical section 751 to correspond to the second seating cavity 7522 of the square column section 752.

Referring again to fig. 4, 15 and 16, the handle assembly 700 further includes a driving member 770 for driving the pulling member 600 to move along the axial direction of the sheath 100. In this embodiment, the pulling member 600 is a pulling wire made of a nickel-titanium wire, and the driving member 770 is a knob, so that the pulling wire can be driven to move along the sheath 100 in a certain range by rotating the knob, so as to drive the movable member 230 to rotate relative to the main body member 210.

In this embodiment, the first accommodating cavity 7521 is a circular mounting groove provided with a gear mounting seat, a gear 771 is arranged in the mounting groove, a connecting column 7711 is convexly arranged at the top of the gear 771, and the knob is clamped on the connecting column 771 of the gear 771; the second placing cavity 7522 is two bar-shaped guiding chutes which are communicated with the first placing cavity 7521 and are symmetrical about the axis of the square column 752, each guiding chute extends along the axial direction of the square column 752, a rack 772 is arranged in the guiding chute close to the third through hole, and the proximal end of the traction wire is connected to the rack 772 after extending out of the third through hole of the cylindrical section 751. The rack 772 and the gear 771 are engaged with each other, when the knob is rotated, the gear 771 rotates along with the knob to drive the rack 772 to move, and the rack 772 drives the traction wire to move along the axial direction of the sheath 100, so as to drive the movable member 230 to rotate relative to the main body member 210. Specifically, in this embodiment, when the knob is rotated counterclockwise, the rack 772 slides towards the far end, and the pull wire slides towards the far end along the axial direction, so as to drive the movable member 230 to rotate relative to the main body member 210 until the movable member 230 stops at the stop member 270, and the movable member 230 is located at a position perpendicular to the axial direction of the main body member 210; turning the knob clockwise moves the rack 772 proximally, causing the pull wire to axially slide proximally, thereby causing the moveable member 230 to rotate in a reverse direction relative to the body member 210 to a position axially parallel to the body member 210.

In other embodiments, a rack 772 coupled to a pull wire can be disposed in the other guide channel of the second positioning chamber 7522, the distal end of the pull wire is also coupled to the movable member 230, and the movable member 230 is controlled by two pull wires.

In other embodiments, the strip-shaped guiding slot may extend along a direction forming a certain included angle with the axial direction of the square column section 752, as long as the gear 771 drives the rack 772 to move in the strip-shaped guiding slot, and the rack 772 can drive the pulling wire to move along the axial direction of the sheath tube 100 within a certain range.

In other embodiments, the square column 752 of the base 750 may not have the first positioning cavity 7521, the square column 752 only has the second positioning cavity 7522, a sliding block sliding along the axial direction of the square column 752 is disposed in the second positioning cavity 7522, the proximal end of the pull wire is connected to the sliding block, the driving member 770 is a sliding key connected to the sliding block, and the sliding key can drive the pull wire to move along the axial direction of the sheath tube 100 within a certain range, so as to drive the movable member 230 to rotate relative to the main body member 210. Obviously, in other embodiments, the driving member 770 may also have other structures, which are not described herein.

Referring to fig. 3, 4 and 17, in this embodiment, the handle assembly 700 further includes a first push rod 780 movably disposed in the third positioning chamber 7523, the first push rod 780 includes a push-pull plate 781 and a rod 783 protruding from a distal side of the push-pull plate 781, a distal end of the rod 783 is connected to the puncture needle 300, the puncture needle 300 is disposed in the base 750, the connector 740 and the sheath 100, and the first push rod 780 is axially slid in the third positioning chamber 7523 by the push-pull plate 781 to control the advancing and withdrawing of the puncture needle 300.

Specifically, as shown in fig. 17, the puncture needle 300 passes through the third installation cavity 7523 of the square column 752 of the base 750, the first through hole (not shown) of the cylindrical section 751 of the base 750, the through cavity of the connector 740, and the first cavity (not shown) of the sheath 100 from the proximal end to the distal end. As mentioned above, when the knob (i.e. the driving member 770) is rotated counterclockwise, the pull wire (i.e. the pulling member 600) drives the movable member 230 to rotate relative to the main body member 210 to a position axially perpendicular to the main body member 210, at this time, the first push rod 780 is pushed towards the distal end, the puncture needle 300 is pushed towards the distal end along with the first push rod 780, the puncture needle 300 extends out of the main body member 210 from the first channel 215 communicating with the first cavity and abuts against the connecting cylinders 500 (not shown) at the two ends of the movable member 230, as shown in fig. 3; after the puncture needle 300 is abutted with the corresponding connecting cylinder 500, the puncture needle 300 can be driven to retreat towards the proximal end by pulling the first push rod 780 towards the proximal end, and the connecting cylinder 500 is synchronously retreated along the puncture needle 300, so that the suture 400 connected with the connecting cylinder 500 moves towards the proximal end along the retreating path of the corresponding puncture needle 300.

Preferably, in this embodiment, the rod body 783 of the first push rod 780 is circumferentially provided with a plurality of guide grooves 7831 (shown in fig. 4) extending along the axial direction thereof, and a corresponding guide rail (not shown) is convexly provided in the third accommodating chamber 7523, so that under the cooperation of the guide rail and the guide groove 7831, the first push rod 780 is ensured not to rotate when moving axially in the third accommodating chamber 7523, thereby preventing the puncture needle 300 from being twisted and deformed due to the rotation of the first push rod 780.

Preferably, in this embodiment, the handle assembly 700 further includes a grip 785 at the proximal end thereof, and the grip 785 is engaged between the proximal ends of the lower and

upper shells

720 and 730. The handle 785 is formed with a through hole through which the first push rod 780 is inserted into the third receiving chamber 7523. The holding member 785 includes two support pieces located on two opposite sides of the through hole to assist an operator in pushing and pulling the first push rod 780, specifically, an index finger and a middle finger of the operator can be hooked to a gap between the two support pieces and the housing respectively, and the operator can push and pull the first push rod 780 with a thumb, so that the operator can control the first push rod 780 with one hand, and the other hand of the operator can perform other operations simultaneously, which is beneficial to improving the operation efficiency.

Further, referring to fig. 18 to 20, in order to prevent the puncture needle 300 from extending out of the main body 210 in advance due to the first push rod 780 being touched by mistake, in this embodiment, the handle assembly 700 further includes a push rod lock 790 disposed on the base 750, the push rod lock 790 is provided with a first locking portion, the first push rod 780 is provided with a second locking portion, and the first locking portion and the second locking portion cooperate to lock the first push rod 780 so as to prevent the first push rod 780 from moving in the axial direction.

Specifically, the push rod lock 790 comprises a lock housing 791, a lock cylinder 792 movably disposed in the lock housing 791, a hook needle 793 disposed at the bottom of the lock housing 791 and adapted to engage the lock cylinder 792, and a first elastic member 794 disposed in the lock housing 791 and located between the lock cylinder 792 and the base 750. In this embodiment, the lock case 791 is a box-shaped case with two open ends, a pair of stop blocks 7911 is disposed on two opposite inner walls of the top of the lock case 791, a pair of claws 7912 is convexly disposed on two opposite sides of the bottom of the lock case 791, a pair of first limit strips 7913 is convexly disposed on one inner wall of the lock case 791 between the two inner walls provided with the stop blocks 7911, and a fixing hole 7914 is further disposed at the bottom of the lock case 791; the lock core 792 comprises a generally blocky main body 7921, a cylindrical pressing part 7922 is convexly arranged at the top of the main body 7921, a pair of bosses 7923 arranged at intervals are convexly arranged at the bottom of the main body 7921, a pair of stopping sheets 7924 are convexly arranged on two opposite outer side surfaces of the main body 7921, a pair of second limiting strips 7925 is convexly arranged on one outer side surface of the main body 7921 between the two outer side surfaces provided with the stopping sheets 7924, and a locking part 7926 is convexly arranged between the pair of second limiting strips 7925 on the main body 7921; the crochet hook 793 is a U-shaped hook made of stainless steel, and includes a fixed end 7931 and a bent free end 7932, the bent free end 7932 can elastically deform in a direction of an external force and recover to deform when the external force is removed; the first elastic member 794 is any elastic member such as a spring, a bellows, or a leaf spring, and in this embodiment, the first elastic member 794 is a pair of springs.

As shown in fig. 20, in this embodiment, the locking block portion 7926 includes a first locking block and a second locking block disposed on a side of the first locking block away from the hook needle, the first locking block includes a first guiding and sliding inclined surface 7926a, a second guiding and sliding inclined surface 7926b, and a V-shaped groove 7926c located between the first guiding and sliding inclined surface 7926a and the second guiding and sliding inclined surface 7926b, and the second locking block includes a first stopping surface 7926d and a second stopping surface (not shown in the drawings) intersecting the first stopping surface 7926 d. The first guiding and sliding slope 7926a and the second guiding and sliding slope 7926b are slopes inclining from left to right of the center line of the free end 7932 of the crochet needle from bottom to top, the bottom ends of the two slopes intersect and the intersecting line is located at left of the center line of the free end 7932 of the crochet needle, and the top ends of the two slopes are respectively connected to two peaks of the V-shaped groove 7926 c. The V-shaped groove 7926c is located entirely on the right side of the center line of the free end 7932 of the latch needle, and two slopes of the V-shaped groove 7926c are symmetrical, that is, two peaks of the V-shaped groove 7926c are at the same level along the axial direction of the lock cylinder 792, a left peak of the V-shaped groove 7926c is located on the right side of the center line of the free end 7932 of the latch needle, and a plumb line where the bottom of the V-shaped groove 7626c is located is deviated from a plumb line where the latch needle 793 is fixedly connected with one end of the lock case 791 (i.e., the fixed end 7931 of the latch needle. The first stopping surface 7926d is a plumb surface parallel to the fixed end 7931 of the hook needle 793, and the lowest point of the first stopping surface 7926d in the axial direction of the lock cylinder 792 is at the same level with two peaks of the V-shaped groove 7926c, and corresponds to the groove bottom position of the V-shaped groove 7926 c. The second stop surface is a slope parallel to the slope of the left side of the V-groove 7626 c.

When the push rod lock 790 is installed, the lock core 792 is installed in the lock shell 791 from the bottom opening of the lock shell 791, so that the top surfaces of a pair of stopping pieces 7924 of the lock core 792 respectively abut against the bottom surfaces of a pair of stopping blocks 7911 of the lock shell 791, and a pair of second limiting strips 7925 of the lock core 792 are located between a pair of first limiting strips 7913 of the lock shell 791, preferably, in the embodiment, two outer side surfaces opposite to the pair of second limiting strips 7925 are in sliding contact with two inner side surfaces opposite to the pair of first limiting strips 7913; then, the fixed end 7931 of the hook needle 793 is inserted and fixed into the fixing hole 7914 at the bottom of the lock case 791, so that the free end 7932 is positioned between the pair of first limit strips 7913 of the lock case 791 and is positioned right below the locking block part 7926 of the lock core 792; then, a first elastic member 794 (i.e., a pair of springs) is installed in the lock case 791 from an opening at the bottom of the lock case 791, the pair of springs are respectively disposed at two opposite sides of a pair of protruding blocks 7923 spaced from the lock core 792, and the pair of springs respectively abut against the bottom surfaces of a pair of stopping pieces 7924 of the lock core 792, preferably, in this embodiment, a protruding column (not shown) is respectively disposed on the bottom surfaces of the pair of stopping pieces 7924, and each spring is sleeved on the protruding column of the corresponding stopping piece 7924; finally, a pair of claws 7912 of the lock housing 791 are snapped into a set of mounting holes 7525 (see fig. 16) of the square column section 752 of the base 750, the lock housing 792 is positioned between two sets of locating blocks 7524 of the square column section 752, thereby mounting the pusher lock 790 on the base 750, and a pair of springs are abutted between the lock core 792 and the square column section 752, wherein a pair of bosses 7923 of the lock core 792 is positioned over the openings 7526 of the square column section 752.

In this embodiment, the first locking portion of the push rod lock 790 is a pair of bosses 7923 protruding from the bottom of the lock cylinder 792, the second locking portion of the first push rod 780 is a groove 7832 opened on the top surface of the first push rod 780 near the distal end, when the bosses 7923 penetrate through the opening 7526 opened on the square column section 752 of the base and are inserted into the groove 7832, the first push rod 780 is locked, the first push rod 780 inserted in the third installation cavity 7523 cannot move in the axial direction, and the puncture needle 300 connected to the distal end of the first push rod 780 can be prevented from protruding out of the main body 210 in advance due to the accidental collision of the first push rod 780.

Specifically, referring to fig. 18, 20 to 23, when the pressing portion 7922 is pressed, the lock cylinder 792 moves downward to approach the first push rod 780, the first elastic member 794 begins to be compressed, the first guiding and sliding inclined surface 7926a abuts against the free end 7932 of the hook needle, the free end 7932 of the hook needle moves obliquely upward along the first guiding and sliding inclined surface 7926a relative to the lock block portion 7926, the free end 7932 of the hook needle is elastically deformed and deflected to the right side, when the lock cylinder 792 moves down until the first guiding and sliding inclined surface 7926a no longer abuts against the free end 7932 of the hook needle, the free end 7932 of the hook needle restores to be partially deformed and aligned from the right peak of the V-shaped groove 7926c, the free end 7932 of the hook needle is stopped by the first stopping surface 7926d, the pressing portion 7922 is released, the first elastic member 794 extends and pushes the lock cylinder 780 away from the first push rod 780, the free end 7932 of the hook needle moves downward relative to the lock block 7926 along the first stopping surface 7926d, so that the free end 7932 of the crochet hook is hooked in the groove bottom of the V-shaped groove 7926c, at this time, the first elastic member 794 is still in a compressed state, the free end 7932 of the crochet needle is not completely righted and in an elastically deformed state, the pair of bosses 7923 pass through the opening 7526 and are inserted into the groove 7832, and the first push rod 780 is locked against axial movement in the third seating chamber 7523; when the first push rod 780 needs to be unlocked, the pressing part 7922 is pressed again, the lock core 792 is made to approach the first push rod 780 again, the free end 7932 of the hook needle is separated from the V-shaped groove 7926c, the free end 7932 of the hook needle is completely deformed and separated from the V-shaped groove 7926c, and swings to the left side to exceed the left peak of the V-shaped groove 7926c under the stopping action of the second stopping surface, the pressing of the pressing part 7922 is released again, the first elastic member 794 extends and pushes the lock core 792 to be far away from the first push rod 780, the second guiding and sliding inclined surface 7926b abuts against the free end 7932 of the hook needle, the free end 7932 of the hook needle moves downwards obliquely relative to the lock block part 7926 along the second guiding and sliding inclined surface 7926b, the free end 7932 of the hook needle is elastically deformed and deflected towards the left side, and when the lock core 792 moves upwards under the pushing of the first elastic member 794 until the second guiding and sliding inclined surface 792 no longer abuts against the free end 7932 of the lock block 792, the free end 7932 returns to the original state, at this time, the pair of bosses 7923 move out of the grooves 7832, the first push rod 780 is unlocked, and the first push rod 780 is axially movable within the third seating chamber 7523.

In other embodiments, when the left peak of the V-shaped groove 7926c is located at the right side of the fixed end 7931 of the hook, the second locking block may not include a second stop surface, and when the pressing portion 7922 is pressed again to separate the free end 7932 of the hook from the V-shaped groove 7926c, the free end 7932 of the hook can be separated from the V-shaped groove 7926c under the action of self-elastic return.

It is understood that the locking block 7926 can be in other configurations, for example, in other embodiments, the two slopes of the V-groove 7926c are asymmetrical, in particular, the left slope of the V-groove 7926c extends to a greater height than the right slope in the axial direction of the lock cylinder 792, during locking of the first push rod 780, the free end 7932 of the hook needle is stopped at the left slope of the V-groove 7926c when it is back-pointed from the right peak of the V-groove 7926c, after releasing the pressing of the pressing portion 7922, the free end 7932 of the hook needle can move downwards along the left slope of the V-groove 7926c relative to the locking block 7926, so that the free end 7932 of the hook needle is hooked in the groove bottom of the V-groove 7926c, i.e., in other embodiments, the locking block 7926 may not include the second locking block with the first stopping surface 7926d, the locking block 7926 can also achieve locking of the first push rod 780, the corresponding unlocking process of this embodiment is similar to that described above, and will not be described in detail herein.

Referring to fig. 4, 24 and 25, the interventional defect stapler further includes at least one wire winder 800 for receiving the suture 400, the at least one wire winder 800 being disposed at one side of the handle assembly 700. Each of the wire winders 800 includes a wire winding case 810, a wire winding disc 820 disposed in the wire winding case 810, and a wire winding cover 830 for covering the wire winding case 810. Specifically, the winding shell 810 is a round box-shaped shell, the column 811 is convexly arranged in the inner cavity of the winding shell 81 along the axial direction, the outer wall of the winding shell 810 is provided with a connecting pipe 812 communicated with the inner cavity of the winding shell 810, and the connecting pipe 812 is axially provided with an internal threaded hole for being screwed and fixed with the threaded interface 7512 (see fig. 15 and 16) of the base; the axial section of the wire spool 820 is in an I shape, the wire spool 820 is provided with a through hole 821 for the upright post 811 to pass through along the axial direction, and the wire spool 820 is sleeved on the upright post 811 of the wire spool shell 810 and can rotate around the upright post 811; the winding cover 830 is a circular cover and detachably connected to the winding case 810 by any means such as fastening, screwing, and the like, in this embodiment, the winding cover 830 is fastened to the winding case 810, and the winding cover 830 and the winding case 810 are provided with corresponding fastening structures.

After the connection tube 812 is screwed with the screw interface 7512 of the base, the inner cavity of the winding case 810 is communicated with the through passage of the suture 400, and the proximal end of the suture 400 (i.e. the other end opposite to the end connected to the connection tube 500) can extend into the winding case 810 and be wound on the winding disc 820, so as to prevent the suture 400 from being too long and being entangled or knotted, and avoid confusion during the operation.

The proximal end of the suture 400 may be fixed to the spool 820 by riveting or adhesive bonding, or may be wound around the spool 820 without being fixed.

The axial length of the column 811 is long enough, one or more wire reels 820 can be sleeved on the column 811, and when a plurality of wire reels 820 are disposed in the wire casing 810, the plurality of wire reels 820 are sleeved on the column 811 in a string. In this embodiment, the spool 800 and the spool 810 are provided as one unit, and the two sutures 400 are wound around the same spool 820 and are accommodated in the same spool 800.

In other embodiments, the spools 820 may be provided in the same number as the sutures 400 in one spool 800, with each suture 400 being wound on one spool 820, i.e., different sutures 400 being wound on different spools 820 and received in the same spool 800.

It is understood that in other embodiments, the number of spools 800 may be the same as the number of sutures 400, a plurality of spools 800 may be threadably secured to the interface 7512 via a multi-way joint, one spool 820 may be provided for each spool 800, and each suture 400 may be wound on a spool 820 of one spool 800, i.e., different sutures 400 may be received in different spools 800.

As described above, the interventional defect suturing apparatus provided in this embodiment can form two suturing points through one intervention, specifically, please refer to fig. 26a to fig. 26g, and the following description will be given by taking a repair process of atrial septal defect of heart as an example to illustrate a use process of the interventional defect suturing apparatus provided in this embodiment, and mainly includes the following steps:

the first step is as follows: as shown in FIG. 26a, the distal end of the interventional defect stapler is advanced into the heart through an adjustable curved sheath 1000 and the body member 210 is passed through a defect in the atrial septum of the heart, such as the unclosed fossa ovalis.

The second step is that: as shown in fig. 26b, the driving member (not shown) drives the pulling member (not shown) to move toward the distal end along the axial direction of the sheath (not shown) so as to drive the movable member 230 to rotate to a proper position relative to the main body member 210, i.e., the movable member 230 is at a position perpendicular to the main body member 210. Specifically, the knob is rotated counterclockwise to drive the pull wire to move toward the far end along the axial direction, the pull wire drives the movable member 230 to rotate relative to the main body member 210 to stop at the position-limiting member (not shown), and the movable member 230 is perpendicular to the main body member 210.

The third step: as shown in FIG. 26c, the whole interventional defect stapler is withdrawn proximally, so that the two opposite ends of the movable member 230 respectively abut against the tissues 1a and 1b around the defect, and the first pushing rod (not shown) is pushed, so that the two puncture needles 300 connected to the distal end of the first pushing rod extend out of the main body member 210 and respectively puncture the tissues 1a and 1b around the defect, and each puncture needle 300 is abutted with the corresponding connecting cylinder 500. Wherein, the movable member 230 can support the tissues around the defect, which is beneficial for the puncture needle 300 to smoothly puncture the tissues 1a and 1b around the defect.

The fourth step: as shown in FIG. 26d, the first plunger (not shown) is withdrawn to withdraw the two needles 300 attached to the distal end of the first plunger, and each needle 300 simultaneously withdraws the hub 500 engaged therewith to move the suture 400 attached to the hub 500 through the tissues 1a and 1b surrounding the defect along the withdrawal path of the corresponding needle 300.

The fifth step: as shown in fig. 26e, the driving member (not shown) drives the pulling member (not shown) to move proximally along the axial direction of the sheath (not shown) so as to drive the movable member (not shown) to rotate relative to the main body member 210 to be accommodated in the accommodating cavity of the main body member 210, and the movable member is reset. Specifically, the knob is rotated clockwise to drive the pull wire to move toward the proximal end along the axial direction, so as to drive the movable member to rotate in the opposite direction relative to the main member 210 to a position parallel to the main member 210.

And a sixth step: as shown in FIG. 26f, the entire interventional defect stapler is withdrawn from the patient, and two sutures 400 are threaded through the tissues 1a and 1b, respectively, around the defect, with each suture 400 partially threaded through the tissue around the defect and partially folded back through the hole, with each suture 400 forming a suture point in the tissue around the defect, and with both ends of each suture 400 extending outside the patient. Wherein the spool 820 (not shown) is rotated by the suture 400 during withdrawal of the interventional defect stapler.

The seventh step: as shown in fig. 26g, the two ends of each suture 400 are cut off in vitro (one end is separated from the connecting cylinder, the other end is separated from the wire spool), and then the locking piece 2000 is fed to tie and lock the two implanted sutures 400, thereby completing the closed repair of the defect.

The invention provides an intervention type defect stitching instrument, wherein at least one connecting cylinder 500 for connecting a suture 400 is respectively arranged on two sides of a rotating axis line of a movable piece 230, when the movable piece 230 rotates to a certain position relative to a main body piece 210, each connecting cylinder 500 is positioned on a moving path of a far end of a puncture needle 300, at least two puncture needles 300 can be respectively butted with one connecting cylinder 500 after puncturing tissues around a defect, each puncture needle 300 is withdrawn to drive the connecting cylinder 500 butted with the puncture needle to be synchronously withdrawn, so that the suture 400 connected with each connecting cylinder 500 passes through the tissues around the defect along the withdrawing path of the corresponding puncture needle 300, thereby realizing the intervention of at least two sutures at one time, forming at least two suturing points, reducing the intervention times of instruments and shortening the operation time.

Referring to fig. 27 and 28 together, the structure of the interventional defect stapler according to the second embodiment of the present invention is similar to that of the interventional defect stapler according to the first embodiment, except that: in a second embodiment, the proximal end of each suture 400 (i.e., the end of the suture 400 opposite to the end connected to the connecting cylinder 500) is not connected to a spool (not shown) but is knotted, and further, a spacer 450 is provided at the proximal end of each suture 400, and after the interventional defect stapler is withdrawn, only one end of the suture 400 connected to the connecting cylinder 500 is cut off in vitro, and the other end of the suture 400 is finally pulled into the heart and sutured to the tissue around the defect by means of the spacer 450 and the knotting button, and the spacer 450 increases the contact area between the suture 400 and the tissue around the defect, so as to prevent the suture 400 from tearing the tissue around the defect.

Referring to fig. 29, a third embodiment of the present invention provides an interventional defect stapler having a structure similar to that of the interventional defect stapler of the first embodiment, except that: in the third embodiment, each mounting block 232 of the movable member 230 has two receiving holes (not shown) communicating with each other through a slot 2322, and a connecting cylinder 500 (i.e., a sleeve) is disposed in each receiving hole. In this embodiment, the two connecting tubes 500 of each mounting block 232 of the movable member 230 are connected to the same suture 400, the suture 400 is folded into a U shape, the folded section of the suture 400 is wound around the spool 820 (not shown) without being fixed, and after the insertion defect stapler is withdrawn, the folded section of the suture 400 can be pulled through the slot 2322 to the tissue in the heart contacting the periphery of the defect, thereby realizing that one suture 400 forms two suture points.

The intervention type defect stitching instrument provided by the embodiment can be implanted with two sutures 400 at a time to form four implantation points, and compared with a single-thread single stitching point, the intervention type defect stitching instrument not only improves the operation efficiency, but also disperses the stress of a plurality of stitching points and is safer.

It should be noted that the number of puncture needles and the number of through passages thereof are changed according to the number of the connecting tubes 500.

It is understood that in other embodiments, more connector barrels 500 may be provided at the mounting block 232 at each end of the moveable member 230 for implantation of more sutures 400 at a time, which will not be described in detail herein.

Referring to fig. 30, the structure of the interventional defect stapler according to the fourth embodiment of the present invention is similar to that of the interventional defect stapler according to the third embodiment, except that: in the fourth embodiment, a spacer 450 is threaded through each suture 400, the doubled-over section of the suture 400 is finally pulled into the heart and sewn on the tissue around the defect by means of the spacer 450, and the spacer 450 increases the contact area of the suture 400 and the tissue around the defect, so that the suture 400 can be prevented from tearing the tissue around the defect.

Wherein the spacer 450 may be a double hole spacer or two single hole spacers. Specifically, in this embodiment, the spacer 450 is a double-hole spacer, two ends of the doubled-over section of the suture 400 respectively pass through one through hole of the spacer 450, and the doubled-over section of the suture 400 is sutured on the tissue around the defect by means of the double-hole spacer. In other embodiments, spacer 450 comprises two single-hole spacers through which each end of the doubled-over portion of suture 400 is passed, and against which the doubled-over portion of suture 400 is sutured to the tissue surrounding the defect.

Where shim 450 may be pre-installed in slot 2322, pulling on suture 400 may move shim 450 out of slot 2322.

Referring to fig. 31, a fifth embodiment of the present invention provides an interventional defect stapler having a structure similar to that of the interventional defect stapler of the first embodiment, except that: in the fifth embodiment, the handle assembly 700 further includes a second push rod 900, the second push rod 900 is connected to the first push rod 780 by a second elastic member 950, the second push rod 900 is provided with a through hole (not shown), and the puncture needle 300 connected to the first push rod 780 passes through the through hole of the second push rod 900. The portion of the puncture needle 300 located at one side of the second push rod 900 far from the first push rod 780 is sleeved with a sheath 970, the sheath 970 is fixedly connected to the second push rod 900, and the sheath 970 and the puncture needle 300 are arranged in the same penetrating channel and can extend out of a main body component (not shown).

The first push rod 780 is pushed towards the distal end, so that the second push rod 900 connected to the first push rod 780 through the second elastic element 950, the puncture needle 300 connected to the first push rod 780, and the sheath 970 connected to the second push rod 900 are synchronously pushed towards the distal end along with the first push rod 780, the puncture needle 300 and the distal end of the sheath 970 are pushed out of the main body element (not shown) until the sheath 970 abuts against the periphery of the large port of the accommodating hole of the movable element (not shown), at this time, the first push rod 780 is continuously pushed, the sheath 970 and the second push rod 900 do not move any more due to the obstruction of the movable element, the second elastic element 950 starts to be compressed, and the puncture needle 300 is pushed out of the sheath 970 and enters the accommodating hole of the movable element to be abutted against the connecting cylinder.

The second elastic member 950 is any elastic element such as a spring, a bellows, or a spring plate, and in this embodiment, the second elastic member 950 is a pair of springs.

The sheath 970 is preferably a tube having a compliant and woven mesh structure.

In this embodiment, the puncture needle 300 is sleeved with a sheath 970, which can protect the puncture needle 300 and limit the path of the puncture needle 300 when being pushed, so as to guide the puncture needle 300 to be more accurately abutted to the connector on the movable member.

The foregoing is illustrative of embodiments of the present invention, and it should be noted that modifications and adaptations to those skilled in the art may be made without departing from the principles of the embodiments of the present invention and are intended to be within the scope of the present invention.

Claims

1. An interventional defect suturing device, characterized in that it comprises a sheath, a suturing assembly disposed at the distal end of the sheath, and at least two puncture needles pierced in the sheath; the suturing assembly includes The main body part fixedly connected to the sheath tube and the movable part rotatably connected to the main body part, the movable part is respectively provided with at least one connecting cylinder connected to the suture on both sides of the rotation axis line of the movable part;

The movable member rotates relative to the main body until one of the connecting cylinders is correspondingly located on the moving path of the distal end of a puncture needle; the at least two puncture needles are respectively connected to a corresponding connecting cylinder ; When the puncture needle moves to the proximal end, it drives the corresponding connecting cylinder and the suture to move to the proximal end.

2 . The interventional defect stapler according to claim 1 , wherein a traction member is pierced through the sheath tube, the distal end of the traction member is connected to the movable member, and the traction member extends along the sheath. 3 . Axial movement of the tube drives the movable member to rotate relative to the body member.

3 . The interventional defect stapler according to claim 1 , wherein at least two first passages are opened on the main body along the axial direction, and each of the first passages comprises a bend provided at the distal end thereof. 4 . The curved section is gradually away from the axis of the main body from the proximal end to the distal end, and each of the first passages penetrates through the outer wall of the main body at least at the distal end of the curved section, so as to provide The puncture needle protrudes or is received in the main body.

4. The interventional defect stapler of claim 3, wherein the movable member is rotated relative to the main body member until the axis of the connecting barrel is aligned with the axis of the distal end of the curved section .

5. The interventional defect stapler of claim 4, wherein the included angle between the axis of the distal end of the curved segment and the axis of the body member is less than 15 degrees.

6. The interventional defect stapler of claim 2, further comprising a handle assembly disposed at the proximal end of the sheath, the handle assembly comprising a driving member, and the proximal end of the pulling member is connected to the The driving member is used for driving the traction member to move along the axial direction of the sheath tube.

7. The interventional defect stapler according to claim 6, wherein the handle assembly further comprises a joint and a base, the joint is fixedly connected to the sheath and the base, and the base is inside A gear and a rack that mesh with each other are provided; the proximal end of the traction member is fixedly connected to the rack; the driving member is connected to the gear; the driving member is rotated, and the gear rotates with the driving member to rotate The rack and the traction member are driven to move in the axial direction.

8. The interventional defect stapler according to claim 7, wherein the handle assembly further comprises a first push rod slidably penetrated through the base in the axial direction, and the first push rod The distal end is fixedly connected to the puncture needle, the puncture needle is penetrated in the base, the joint and the sheath, and the axial movement of the first push rod can control the advancement and rearward movement of the puncture needle withdraw.

9 . The interventional defect stapler according to claim 8 , wherein the handle assembly further comprises a push rod lock disposed on the base, and a first locking portion is provided on the push rod lock, so that the A second locking portion is provided on the first push rod, and the first locking portion cooperates with the second locking portion to lock or unlock the first push rod.

10 . The interventional defect stapler according to claim 9 , wherein the push rod lock comprises a lock cylinder; the first locking portion is a boss protruding from the bottom of the lock cylinder, and the first locking portion is a boss. 11 . The second locking portion is a groove formed on the top surface of the first push rod; the boss is inserted into the groove to lock the first push rod, and the boss moves out of the groove to unlock the first push rod. A putter.

11. The interventional defect stapler according to claim 10, wherein the push rod lock further comprises a lock shell, a hook and an elastic member; the lock shell is fixedly connected to the base, and the lock cylinder The hook is movably arranged in the lock housing, one end of the hook is fixedly connected to the lock housing, and the opposite end of the hook is a free end; the elastic piece is arranged between the lock cylinder and the base ; A lock block part is arranged on the lock cylinder, and the free end of the hook is in a different position relative to the lock block part, so that the boss is inserted into or moved out of the groove.

12 . The interventional defect stapler according to claim 11 , wherein the locking block portion comprises a first locking block, and the first locking block comprises a first sliding guide inclined surface, a second sliding guide inclined surface and located on the a V-shaped groove between the first guide-sliding inclined surface and the second guide-sliding inclined surface;

In the initial state, the first and second sliding guide slopes are located above the free end of the crochet needle; when the lock cylinder is pressed, the elastic member is compressed, and the free end of the crochet needle moves along the first The sliding slope moves until the free end of the hook is hooked into the V-shaped groove from one side of the V-shaped groove, so that the boss is inserted into the groove; continue to press the lock cylinder, so the The free end of the crochet needle is separated from the V-shaped groove from the opposite side of the V-shaped groove; the lock cylinder is released, the elastic member is reset, and the free end of the crochet needle moves along the second sliding slope. to be separated from the locking block part, so that the boss moves out of the groove.

13. The interventional defect stapler according to claim 12, wherein the locking block portion further comprises a second locking block located above the V-shaped groove, the second locking block comprising a first stopper The first stop surface is used to stop the free end of the crochet needle, so that the free end of the crochet needle is hooked in the V-shaped groove.

14 . The interventional defect stapler according to claim 12 , wherein the vertical line where the bottom of the V-shaped groove is located deviates from the vertical line where one end of the crochet needle is fixedly connected to the lock shell. 15 .

15. The interventional defect stapler according to claim 8, wherein the handle assembly further comprises a second push rod, and an axial direction is provided between the second push rod and the first push rod The extending elastic piece, the second push rod is connected to the sheath with the same number as the puncture needles, each of the puncture needles movably passes through the second push rod and is respectively movably fitted to the corresponding puncture needle. inside the jacket.

16 . The interventional defect stapler according to claim 1 , wherein the main body part defines a accommodating cavity, the movable part is disposed in the accommodating cavity, and is rotatably connected to the accommodating cavity through a rotating part. 17 . the side wall of the accommodating cavity.

17 . The interventional defect stapler according to claim 16 , wherein a limiter is provided on one side of the accommodating cavity, the limiter covers part of the opening of the accommodating cavity, and the movable When the movable member rotates relative to the main body to abut the limiting member, the movable member rotates in place.

18. The interventional defect stapler according to claim 17, wherein the distal end surface of the limiting member is vertical or inclined with respect to the axial direction of the main body member.

19. The interventional defect stapler according to claim 6, wherein the handle assembly further comprises a wire winder, the wire winder communicates with the sheath, and a wire winder is arranged in the wire winder A reel, the portion of the suture remote from the connecting barrel is passed through the sheath and wound on the spool.

20. The interventional defect stapler of claim 1, wherein a spacer is sleeved on the suture.