CN117618083A

CN117618083A - Puncture anchoring device

Info

Publication number: CN117618083A
Application number: CN202311614216.2A
Authority: CN
Inventors: 黄桥; 陈建; 李家杨
Original assignee: Hanxin Medical Technology Shenzhen Co ltd
Current assignee: Hanxin Medical Technology Shenzhen Co ltd
Priority date: 2023-11-29
Filing date: 2023-11-29
Publication date: 2024-03-01
Anticipated expiration: 2043-11-29

Abstract

The invention relates to a puncture anchoring device, which comprises a puncture needle, an anchoring piece, a needle sliding block, a push rod, a driving assembly and a rod sliding block. The anchor is connected with the suture and is movably positioned in the puncture needle. The needle slider is connected to the proximal end of the needle. The push rod is connected with the needle sliding block, and the far end of the push rod is movably arranged in the puncture needle. The rod sliding block is connected with the proximal end of the push rod, is adapted to push the needle sliding block to slide to the puncture position along with the distal end under the drive of the driving component, does not drive the needle sliding block any more, and continues to move to the limit position under the drive of the driving component; in the puncturing position, the needle completes puncturing and in the limit position, the plunger pushes the anchor out of the distal end of the needle. The device has a simple structure, drives the driving assembly, and can complete puncture and release of the anchoring piece and the suture at one time.

Description

Puncture anchoring device

Technical Field

The invention relates to the technical field of interventional medical instruments, in particular to a puncture anchoring device.

Background

The interventional therapy method is an emerging subject which integrates image diagnosis and clinical treatment. Under the guidance and monitoring of digital subtraction angiography machine, CT, ultrasonic and magnetic resonance imaging equipment, the special instrument is led into the lesion site of human body through natural duct or tiny wound of human body by using puncture needle, catheter and other interventional equipment to make minimally invasive treatment. The interventional therapy method does not need to open a knife, generally only needs local anesthesia rather than general anesthesia, thereby reducing the risk, having quick recovery, good effect, little interference to the body and protecting normal organs to the greatest extent.

Most of the interventional medical instruments in the market need to be used for puncturing human tissues and implanting the instruments in operation through two independent instruments, which means that the two instruments need to be used for puncturing and implanting the instruments respectively, the operation time is prolonged, and additional pain is brought to a patient by the two-time transvascular introduction instrument. In addition, some puncture instruments have complex structures and unstable puncture, and cannot be suitable for special pathological tissues in a human body, so that the success rate of the operation is low.

Disclosure of Invention

Aiming at the symptoms that the internal tissues need to be pierced and then sutured, the invention provides the piercing anchoring device which has simple structure and the functions of piercing and releasing the anchoring piece and the suture.

The puncture anchoring device provided by the technical scheme of the invention comprises a puncture needle, an anchoring piece, a needle sliding block, a push rod, a driving assembly and a rod sliding block. The anchor is connected with the suture and is movably positioned in the puncture needle. The needle slider is connected to the proximal end of the needle. The push rod is connected with the needle sliding block, and the far end of the push rod is movably arranged in the puncture needle. The rod sliding block is connected with the proximal end of the push rod, is adapted to push the needle sliding block to slide to the puncture position along with the distal end under the drive of the driving component, does not drive the needle sliding block any more, and continues to move to the limit position under the drive of the driving component; in the puncturing position, the needle completes puncturing and in the limit position, the plunger pushes the anchor out of the distal end of the needle.

With the puncture anchoring device, the puncture needle is started to complete the puncture action when the needle slider does not slide along with the rod slider, and the driving assembly drives the rod slider to slide to the limit position, so that the anchoring piece is pushed out of the puncture needle. The operation drive assembly can puncture tissues at one time, and then the anchor with the suture is conveyed to the outside of the far end of the tissues through the cavity of the puncture needle by utilizing the conveying channel formed in the tissues by the cavity of the puncture needle, so that the suture conveying is realized, the operation is convenient, two sets of conveying appliances are not needed, the success rate of the operation is improved, and the operation risk is reduced.

There are various ways in which the lever slider is driven by the drive assembly to merely push the needle slider to the puncturing position. As an example, in the puncture anchoring device according to an embodiment of the present invention, the rod slider and the needle slider cooperate with each other to form a stop, i.e., the needle slider and the rod slider are adapted to be engaged with each other when they are in contact with each other and disengaged from each other in real time when they are required to be separated. In this way, the needle slider can be slid distally with the rod slider to the puncture location by the stop.

For example, the stop may be a split of a portion of the outer surface of the two similar to a puzzle, or a connector may be used to connect the two in an active manner, but release the two at the puncture site.

In one embodiment of the invention, the puncture anchoring device is provided, wherein the needle slider comprises two mutually parallel guide rails, and the guide rails are provided with stop surfaces protruding out of a horizontal plane. The rod slider comprises two spring arms extending towards the far end in the same direction, and the far end surface of each spring arm abuts against the stop surface of the guide rail, so that the stop position is formed with the guide rail.

For another example, the puncture anchoring device may further include an elastic member compressed between the needle slider and the rod slider, the push rod penetrating the elastic member. In this way, the lever slider may be driven by the drive assembly to push the needle slider distally with it by compressing the resilient member. The elastic piece is a spring or a soft rubber block capable of recovering deformation.

The rod slide can be driven in a variety of ways, as long as it can be pushed to slide distally and can be pulled back to its original position after the instrument has been pushed out of the anchor.

As an example, in one embodiment of the present invention, a puncture anchoring device is provided wherein the drive assembly includes a pull member, a trigger, and a housing securing the pull member and the trigger. The needle slider and the lever slider are located within the housing, and the trigger is adapted to rotate to a limited angle relative to the housing under the constraint of the housing and return to an initial position. The trigger is connected to the rod slide via the pull member, thereby driving the rod slide. The rotation axis of the trigger is perpendicular to the axial direction of the housing, i.e. the trigger is rotatable between an initial position and the extreme angle relative to the proximal and distal ends of the housing.

The traction piece and the rod sliding block can be connected in a mode of mutual clamping through the matched grooves and the matched protrusions or in a threaded engagement mode, or the traction piece and the rod sliding block are connected through a third component. In the puncture anchoring device provided by the embodiment of the invention, the distal end of the connecting part is provided with a limiting through groove penetrating through two opposite side surfaces of the connecting part, and one part of the traction piece is positioned in the limiting through groove through a pressing clamp.

The determination of the puncture location in operative association with the puncture anchoring device may be accomplished by manipulation of the trigger such that the puncture needle, i.e., the needle, is passed through the tissue when the trigger is rotated to a predetermined angle. As regards the specific structural embodiment of the puncture location determination on the puncture anchoring device, the housing may further comprise, as an example, two upper slide rails and two lower slide rails opposite to the two upper slide rails. The two lower slide rails are positioned on the outer sides of the two guide rails. The lower slide rail is provided with a slope surface in the middle part of the lower slide rail, the rod slide block further comprises a slide piece which is connected with the far end of the spring arm and extends towards the radial direction, and the slide piece is adapted to not push the needle slide block when the two upper and lower slide rails slide to jump over the slope surface, so that the slope surface corresponds to the puncture position.

The rod slide block and the needle slide block can be arranged in parallel or parallel with each other, and can be partially accommodated in the needle slide block so as to reduce the volume of the whole puncture anchoring device. In the puncture anchoring device provided by the embodiment of the invention, the needle slider is provided with an assembling groove, the rod slider further comprises a connecting part which is positioned between the two elastic arms and is connected with the proximal ends of the two elastic arms, the connecting part and the elastic piece are positioned in the assembling groove, and the proximal end of the push rod is connected with the connecting part.

When part of the rod slide is accommodated in the needle slide, the movement path of the rod slide can be further realized by closing the assembly groove. For example, the puncture anchoring device provided by an embodiment of the invention further comprises a cover plate for closing the assembly groove, and the sliding piece is exposed from the cover plate and correspondingly positioned between the upper sliding rail and the lower sliding rail.

The material of the components can affect the accuracy of operation of the piercing anchoring device and the penetration force in the tissue. Compared with the high polymer material, the metal material can make the parts thinner on the premise of meeting the mechanical property, thereby further reducing the volume of the whole device, has higher mechanical strength, is more convenient to assemble and reduces the abrasion between the parts with assembly connection relation brought by operating the device for multiple times, has better applicability to different human tissues, and can smoothly puncture and release the anchoring piece and the suture line for partial special physiological tissues such as calcification, abnormal tissue thickening and the like. In the puncture anchoring device according to an embodiment of the present invention, the cap plate, the needle slider, and the rod slider are made of a metal material.

The connection between the piercing needle and the needle slider, and the connection between the push rod and the rod slider may be achieved in a variety of ways. For example, the first and second members may be directly fixed to each other by welding, bonding, or the like, may be screw-engaged, or may be connected to each other by a third member. As an example, in the puncture anchoring device according to an embodiment of the present invention, the rod slider further includes a rod connector, the connecting portion is provided with a groove on a surface thereof near the proximal end of the guide rail, the rod connector is embedded in the groove, and the proximal end of the push rod is fixed to the rod connector.

In another embodiment of the present invention, the puncture anchoring device further comprises a needle connector, the distal end of the needle slider is provided with a clamping groove, the needle connector is embedded in the clamping groove, and the proximal end of the puncture needle is fixed to the needle connector.

The anchors are used to pass the suture through the tissue and secure the suture to the distal side of the tissue to facilitate suturing. Typically, the anchor is configured within the needle, may be tubular, may be longer than the penetration opening formed by the needle, and may be made of an absorbable material or may be made of a self-expanding nitinol wire.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings required for the description of the embodiments will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments of the present invention, and other drawings may be obtained according to the structures shown in these drawings without inventive effort for a person skilled in the art.

Fig. 1 schematically shows a schematic structural view of a puncture anchoring device according to a first embodiment of the present invention;

FIG. 2 schematically illustrates an exploded view of the components of the puncture anchoring device provided in a first embodiment of the present invention;

FIG. 3 schematically illustrates an exploded view of the structure indicated by the dashed lines in FIG. 2;

FIG. 4 schematically illustrates an assembled view of the trigger, retractor and housing of the puncture anchoring device provided by the first embodiment of the present invention;

FIG. 5 is a front view of a rod sled of a puncture anchoring device provided in a first embodiment of the present invention;

FIG. 6 is a rear view of the lever slider of FIG. 5;

FIG. 7 schematically illustrates an assembled schematic view of a push rod with rod connector and needle sled of a puncture anchoring device provided in accordance with a first embodiment of the present invention;

FIG. 8 schematically illustrates a schematic view of the lancet and needle coupling of the puncture anchoring device provided by the first embodiment of the present invention;

fig. 9 schematically illustrates a perspective view of the assembled stem slider, needle slider, spring, puncture needle and push rod of the puncture anchoring device according to the first embodiment of the present invention;

FIG. 10 schematically illustrates a cross-sectional view of a first embodiment of the puncture anchoring device provided by the present invention with a rod sled moving the needle sled;

FIG. 11 schematically illustrates a top view of the first embodiment of the puncture anchoring device provided by the present invention with a rod sled moving the needle sled;

FIG. 12 is a schematic view schematically showing the assembly of the cap plate, needle slider, and trigger of the puncture anchoring device according to the first embodiment of the present invention;

FIG. 13 schematically illustrates an initial state of the anchor and plunger of the puncture anchoring device in the puncture needle according to the first embodiment of the present invention;

FIG. 14 is a schematic view showing the structure of three different anchors after they are pushed out of the needle to restore their natural state;

fig. 15 schematically illustrates a schematic view of a lancet ejection of the puncture anchoring device provided by the first embodiment of the present invention;

fig. 16 schematically illustrates a schematic view of the puncture anchoring device according to the first embodiment of the present invention, wherein the needle slider is no longer slid by the rod slider and only continues to slide along the upper and lower slide rails under the drive of the driving assembly;

FIG. 17 schematically illustrates a schematic view of the structure of the puncture anchoring device according to the first embodiment of the present invention, when the anchor is released;

FIG. 18 schematically illustrates a schematic view of a stapled tissue employing the piercing anchoring device provided by the first embodiment of the invention;

FIG. 19 schematically illustrates an assembled configuration of the puncture anchoring device except for a housing, provided by a second embodiment of the present invention;

FIG. 20 is an exploded view of the assembled structure of FIG. 19;

FIG. 21 schematically illustrates a front view of the lever slider illustrated in FIG. 19;

FIG. 22 schematically illustrates a rear view of the lever slider shown in FIG. 19;

FIG. 23 schematically illustrates a schematic view of the needle slider of FIG. 19;

FIG. 24 schematically illustrates a cross-sectional view of the assembled structure illustrated in FIG. 19;

fig. 25 schematically shows a top view of the structure shown in fig. 19.

Reference numerals illustrate:

puncture anchoring device: 100. 200; a housing 10; a puncture needle: 20. 220; an anchor: 30. 230, a step of; suture: 35; needle slider: 40. 240, a step of; push rod: 50. 250; and a driving assembly: 60. 260; rod slide: 70. 270; elastic piece: 80. 280; cover plate: 90. 290; and (3) an upper shell: 11; and (2) a lower shell: 12; first screens hole: 111; second screens hole: 121; limiting hole: 113; upper slide rail: 112; the following slide rail: 122, a step of; first horizontal sliding surface: 1221; a second horizontal sliding surface: 1222; slope surface: 1223; and (3) a trigger: 61. 261; pulling piece: 62; a handle: 611; and (2) rotating shaft: 612; a turntable: 613; and (3) connecting holes: 6131; limit protrusion: 6111; a rotating part: 622; pulling part: 621. Rod connector: 71; spring arm: 73. 273; sliding piece: 74; a connecting part: 72; spacing logical groove: 721. 2721; a first stop surface: 731; inclined abutment surface: 741; groove: 722, a method for manufacturing the same; guide groove: 723; needle connector: 41; distal end limit structure: 42; proximal end limit structure: 44; guide rail: 43. A second stop surface: 433. 2433; horizontal guide surface: 431; and (3) an assembly groove: 401. 2401; and (3) clamping holes: 901; elastic sheet: 2731; secondary isolation: 98; and (3) a joint: 95; through holes of the elastic piece: 281. Welding holes: 2701; welding column: 2402.

Detailed Description

The technical solutions of the puncture anchoring device according to 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 apparent that the described embodiments are only some embodiments of the present invention, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.

It should be noted that all the directional indicators in the embodiments of the present invention are merely used to explain the relative positional relationship, movement conditions, etc. between the components in a specific posture, and if the specific posture is changed, the directional indicators will be changed accordingly.

Furthermore, descriptions such as those referred to as "first," "second," and the like, are provided for descriptive purposes only and are not to be construed as indicating or implying a relative importance or implying an order of magnitude of the indicated technical features in the present disclosure. Thus, a feature defining "a first" or "a second" may explicitly or implicitly include at least one such feature. In the description of the present invention, the meaning of "plurality" means at least two, for example, two, three, etc., unless specifically defined otherwise.

In the present invention, unless specifically stated and limited otherwise, the terms "connected," "affixed," and the like are to be construed broadly, and for example, "affixed" may be a fixed connection, a removable connection, or an integral body; can be mechanically or electrically connected; either directly or indirectly, through intermediaries, or both, may be in communication with each other or in interaction with each other, unless expressly defined otherwise. The specific meaning of the above terms in the present invention can be understood by those of ordinary skill in the art according to the specific circumstances.

In addition, the technical solutions of the embodiments of the present invention may be combined with each other, but it is necessary to be based on the fact that those skilled in the art can implement the technical solutions, and when the technical solutions are contradictory or cannot be implemented, the combination of the technical solutions should be considered as not existing, and not falling within the scope of protection claimed by the present invention.

It should be noted that "distal end" and "proximal end" are used as terms of orientation, which are terms commonly used in the field of medical devices, where "distal end" refers to an end far from an operator during a surgical procedure, and "proximal end" refers to an end near to an operator during a surgical procedure. Axial, which refers to the direction parallel to the connecting line of the distal center and the proximal center of the medical instrument in the natural unfolding state; radial refers to a direction perpendicular to the axial direction.

Referring to fig. 1 to 3, a puncture anchoring device 100 according to a first embodiment of the present invention includes a housing 10, a puncture needle 20, an anchor 30 with suture as shown in fig. 3, a push rod 50, a driving assembly 60, a rod slider 70, a needle slider 40, an elastic member 80, and a cap plate 90.

The housing 10 includes an upper case 11 and a lower case 12 engaged with the upper case 11 and fixed to each other by self-tapping screws. The edge of the upper shell 11 matched with the lower shell 12 is provided with a semicircular first clamping hole 111, and correspondingly, the lower shell 12 is also provided with a semicircular second clamping hole 121. In the assembled state of the housing 10, the first and second detent holes 111 and 121 enclose each other to form a circular detent hole. The needle sled 40, the lever sled 70, the resilient member 80 and the cover plate 90 are located within the housing 10 such that the distal end of the needle 20 is telescopically disposed within the housing 10 relative to the housing 10 as shown in FIG. 1.

Referring to fig. 2 and 4, the upper case 11 has two upper rails 112 parallel to each other, and the lower case 12 has two lower rails 122 parallel to each other. Each upper rail 112 extends in the axial direction of the housing 10 and is opposite to a corresponding lower rail 122. As shown in fig. 2, the lower slide rail 122 is provided with a slope surface 1223 at the middle portion thereof, specifically with a first horizontal sliding surface 1221, a second horizontal sliding surface 1222, and a slope surface 1223 connecting the first horizontal sliding surface 1221 and the second horizontal sliding surface 1222 and located between the two horizontal sliding surfaces. Two lower slide rails 122 are located on opposite sides of the needle slider 40. It will be appreciated that since each set of upper and lower slide rails corresponds, the upper slide rail 112 is also located on opposite sides of the needle slide block 40.

The upper shell 11, the upper slide rail 112, the lower slide rail 122 and the lower shell 12 are all made of high polymer materials through high-temperature high-pressure injection molding. The upper rail 112 and the lower rail 122 are respectively connected to the upper case 11 and the lower case 12 by a suitable adhesive. In other embodiments of the present invention, the upper rail 112 may be fastened to the upper case 11 by a fastener, and the lower rail 122 may be fastened to the lower case 12 by a fastener.

Referring to fig. 1 and 12, the lancet 20 is tubular and has a cavity extending through its proximal and distal end surfaces. As shown in fig. 13, the anchor 30 is attached to the distal end of the suture 35 and is disposed within the lumen of the needle 20. The distal end of the push rod 50 is movably disposed in the cavity of the puncture needle 20, closer to the proximal side than the anchor 30, and can push the anchor 30 out of the puncture needle 20 by external force. The anchor 30 is made of a metal material, and may be circular in its natural state (i.e., free from external force), or may be a mesh structure formed by braiding nickel-titanium alloy wires having self-expansibility as shown in fig. 14. It will be appreciated that when the anchor 30 is of the aforementioned mesh structure, it will be compressed into a bundle of braided filaments within the needle 20 and will return to its natural shape after the needle 20 is pushed out.

Referring to fig. 2-4, the drive assembly 60 includes a trigger 61 and a pulling member 62. Specifically, as shown in FIG. 4, the trigger 61 includes a handle 611, two rotating shafts 612 located at the ends of the handle 611 and respectively connected to the ends of the handle 611, and a rotary plate 613 coaxially connected to the rotating shafts 612.

The opposite inner surface of the handle 611 is provided with a limit protrusion 6111, and the two limit protrusions 6111 are inserted into the limit hole 113 of the shell 10, so that the handle 611 is clamped with the shell 10, the rotation of the handle 611 is limited, and the false touch is prevented. The axis of the rotary shaft 612 is perpendicular to the axis of the housing 10.

The rotation shaft 612 rotatably penetrates through a circular clamping hole formed by encircling the first clamping hole 111 of the upper shell 11 and the second clamping hole 121 of the lower shell 12. The radial dimension of the turntable 613 is larger than the circular clamping hole and abuts against the inner wall of the housing 10. Thus, the shaft 612 is connected to the housing 10 through the two turntables 613, the shaft 612 is rotatable about its axis, i.e., in a direction perpendicular to the axis of the housing 10, by the handle 611, and the limit angle at which the handle 611 can rotate with respect to the housing 10 is restricted by the limit projection 6111 and the turntables 613 in cooperation with each other. The turntable 613 has a connection hole 6131.

As shown in fig. 2 and 4, the pulling member 62 is formed by bending a metal rod, and includes two rotating rods 622 as end portions and a pulling rod 621 connected to the two rotating rods 622. The pull 62 is generally pi-shaped. The rotating rod 622 is fixed in the connecting hole 6131 of the rotating disc 613, so that the pulling member 62 can rotate around the rotating shaft 612 along with the rotation of the rotating disc 613 under the driving of the handle 611, and the limit rotation angle is the same as the limit rotation angle of the handle 611.

Referring to fig. 5 to 7, the lever slider 70 includes a connection portion 72, two spring arms 73 provided at opposite sides of the connection portion 72 and extending in the same direction toward the distal end, a slider 74, and a lever connection member 71 as shown in fig. 7.

As shown in fig. 5, the connecting portion 72 has a block shape, and a stopper through groove 721 is provided at a proximal end portion thereof, and the stopper through groove 721 penetrates through two opposite side surfaces of the connecting portion 72. The pulling portion 621 of the pulling piece 62 shown in fig. 4 is caught in the stopper through groove 721. Thus, the pulling member 62 is connected to the lever slider 70, and the lever slider 70 can be driven by the pulling member 62 by rotating the handle 611.

As shown in fig. 6, the connecting portion 72 is provided with a groove 722 and a guide groove 723 on the back surface opposite to the surface where the stopper through groove 721 is located. The groove 722 communicates with the guide groove 723, and the guide groove 723 penetrates the proximal end face and the distal end face of the connecting portion 72. The rod connection 71 as shown in fig. 7 is snap-fitted to the recess 722. The rod connector 71 is fixedly coupled to the proximal end of the push rod 50, and the proximal end of the push rod 50 is positioned within the guide groove 723. The rod link 71 and the push rod 50 may be fixed to each other by bonding, crimping, welding, or the like.

The spring arms 73 have a thickness less than the thickness of the connecting portion 72, i.e., the horizontal surfaces of the spring arms 73 are not coplanar with the horizontal surfaces of the connecting portion 72, and are provided to facilitate placement of the connecting portion 72 within the needle slider 40, reducing the overall volume of the puncture anchoring device 100. The distal end of spring arm 73 has a first stop surface 731.

The slider 74 is fixed to the distal end portion of the spring arm 73, and extends out of the spring arm 73 in a direction perpendicular to the length direction of the spring arm 73, that is, in a radial direction. The two slides 74 cooperate with the two spring arms 73 and the connecting portion 72 to form a pi-like structure. The distal end of the slider 74 has an angled abutment surface 741 that can abut against the angled surface 1223 of the lower track 122 as shown in fig. 2. The slider 74 is adapted to slide along the upper rail 112 and the lower rail 122 as shown in fig. 2 under the drive of an external force.

The needle slider 40 comprises a needle connector 41 as shown in fig. 8, two mutually parallel guide rails 43, a distal detent structure 42 and a proximal detent structure 44. The needle connector 41 is connected to the proximal end of the needle 20. The needle connector 41 and the puncture needle 20 may be fixed to each other by bonding, crimping, welding, or the like.

The guide rail 43 has a horizontal guide surface 431 and a second stop surface 433 protruding from the horizontal guide surface 431. The first stop surface 731 and the second stop surface 433 cooperatively form a stop for the needle slider 40 and the lever slider 70. The two guide rails 43 and the proximal detent structure 44 cooperate to form an assembly slot 401.

Referring to fig. 8 and 9, the needle connector 41 is snapped by a distal detent structure 42. The push rod 50 is inserted into the puncture needle 20 after penetrating the elastic member 80, whereby the rod slider 70, the needle slider 40, the push rod 50 and the puncture needle 20 form a puncture combination, and both ends of the elastic member 80 can be compressed by the needle slider 40 and the rod slider 70.

Referring to fig. 8, 10 and 11, the assembly relationship of the needle slider 40 and the lever slider 70 may be: the connecting portion 72 of the lever slider 70 is movably located in the assembly groove 401 of the needle slider 40, and the elastic member 80 is compressed between the connecting portion 72 and the needle connecting member 41, so that the entire puncture anchoring device 100 is small in volume; the spring arm 73 of the rod slide 70 is positioned on the horizontal guide surface 431 of the guide rail 43 of the needle slide 40, and the distal end surface thereof abuts against the second stop surface 433 to form a stop; the slider 74 of the lever slider 70 extends out of the guide rail 43, and the pulling rod 621 of the pulling member 62 is pressed into the limit through groove of the connecting portion 72 of the lever slider 70.

To further constrain the motion trajectories of the rod sled 70, the elastic member 80, and the needle sled 40, the puncture anchoring device 100 provided in this embodiment further includes a cover plate 90 as shown in fig. 12. The cover plate 90 has a plurality of engagement holes 901. The engagement hole of the cover plate 90 engages with the proximal and distal limit structures 43 and 42 of the needle slider 40 as shown in fig. 8, thereby restraining the lever slider 70 and the elastic member 80 in the space enclosed by the cover plate 90 and the needle slider 40, restraining the needle slider 40 from moving in a predetermined manner, and the slider 74 of the lever slider 70 extends out of the cover plate 90 and is movable along the upper and lower slide rails 122. The cover plate 90, the needle slider 40 and the lever slider 70 are made of a polymer material.

The following describes the working mechanism and operation method of the puncture anchoring device according to the present embodiment, taking the puncture suturing of the foramen ovale (PFO) as an example.

First, turning the trigger 61 toward the distal end of the housing 10, as shown in fig. 15, the pulling member 62 connected to the trigger 61 will bring the connecting portion 72 of the lever slider into compression with the elastic member 80, and the distal end surface of the spring arm 73 of the lever slider 70 contacts the second stopper surface 433 of the needle slider 40 to form a stopper, so that the needle slider 40 will move together toward the distal end under the pushing of the lever slider 70.

Continuing to rotate the trigger 61, the spring arm 73 is elastically deformed, and referring to fig. 15 and 16, the sliding member 74 on the spring arm 73 moves distally along the first horizontal sliding surface 1221 of the lower sliding rail 122, and it will be understood that the upper sliding rail 112 and the lower sliding rail 122 cooperate to limit the movement track of the sliding member 74. Continuing to rotate the trigger 61 through a certain angle, the slider 74 slides until its inclined abutment surface 741 abuts the inclined surface 1223 of the lower slide rail 122. At this time, when the trigger 61 is rotated continuously, the spring arm 73 is bent by a certain angle, and the slider 74 is separated from the first horizontal sliding surface 1221 and the slope surface 1223, and jumps up the second horizontal sliding surface 1223 of the lower slide rail 122. At this point, the first stop surface 731 of the spring arm 73 of the lever slider 70 is free of the second stop surface 433 of the needle slider 40, i.e., the lever slider 70 will no longer move the needle slider 40 distally. Correspondingly, the position where the spring arm 73 of the lever slider 70 is disengaged from the needle slider 40 is defined as the "puncture position" in the present application. At this time, the distal end of the puncture needle 20 connected to the needle slider 40 is successfully penetrated through the secondary septum by the driving of the needle slider 70, and the anchor 30 is penetrated through the secondary septum with the puncture needle 20.

Continuing to rotate the trigger 61 distally, the link 72 with the pull member 62 overcomes the compressive force of the resilient member 80 and referring now to FIGS. 15-17, the slider 74 of the lever block will continue to slide along the second horizontal sliding surface 1222 of the lower track 122. It will be appreciated that the push rod 50 secured in the rod slide 70 will continue to move distally within the needle 20 until the trigger 61 is rotated to its extreme position by the limit of the upper housing 11, at which point the slide 74 of the rod slide is no longer slidable, and the corresponding push rod 50 will then successfully push the anchor 30 out of the needle 20 under the pushing of the rod slide.

After the anchor 30 is pushed out of the needle 20, as shown in FIG. 18, the suture 35 attached to the anchor 30 is also positioned distally of the secondary compartment 98 as the anchor 30 successfully passes through the secondary compartment 98. The trigger 61 is then reset. It will be appreciated that the needle 20, push rod 50 and rod sled 70, needle sled 40 will be reset to the initial position. The anchor 30 with suture 35 will remain on the distal side of secondary compartment 98 and the proximal end of suture 35 will remain on the proximal side of secondary compartment 98, thus completing the release of anchor 30.

The primary septum may then be puncture stitched. Thereafter, the proximal sides of the 2 anchored two sutures 35 are pulled taut to form a knot 95, i.e., the suturing of the foramen ovale is completed, as shown in fig. 18.

As described above, in the process of performing an operation by using the puncture anchoring device provided by the embodiment, only the trigger is required to be rotated, so that not only is the puncture of tissues completed, but also the anchoring piece with the suture is successfully released, and two operation actions are completed by one operation, so that the puncture anchoring device is convenient and quick, and has a simple and practical structure.

The puncture anchoring device 200 according to the second embodiment of the present invention has substantially the same structure as the device 100 described above, and includes a handle 261, a rotating shaft 2612, a pulling member 262, a lever slider 270, a needle slider 240, a puncture needle 220, an upper rail 212, a lower rail 222, an elastic member 280 and a cover plate 290, except that: the elastic member 280 is a soft rubber block capable of recovering deformation, and the materials adopted by part of the parts are different. For the same structure of the puncture anchoring device 200 as the device 100 described above, reference is made to the description related to the first embodiment, and the description thereof will not be repeated here.

Specifically, referring to fig. 19 to 25, the elastic member 280 has a through hole 281 penetrating the proximal end face and the distal end face thereof, and the proximal end of the push rod 250 is fixed in the through hole 281. The elastic member 280 may be made of silica gel or soft rubber such as rubber.

The cover 290, the needle slider 240, and the lever slider 270 are made of metal materials. In this way, the pulling piece 262 made of metal material can be more easily pressed into the limit through groove 2721 of the rod slide block 270 by utilizing the high elasticity of the metal material, and the stress is more stable.

The spring arm 273 of the lever slider 270 and the spring tab 2731 forming the distal end of the spring arm 273 are thinner than the corresponding components of the embodiment, and the spring tab 2731 contacts the second stop surface 2433 of the needle slider 240 during assembly to form a stop. Referring to fig. 21 and 22, on a surface of the lever slider 270 opposite to a surface provided with the stopper through groove 2721, the lever slider 270 has a welding hole 2701 extending axially along the connection portion 272. As shown in fig. 23, the needle slider 240 is provided with a welding post 2402 near its distal end.

When assembled, the trigger 261, the pulling member 262 and the lever slider 270 are assembled as described in the first embodiment, and then the elastic member 280 is fitted into the assembly groove 2401 of the needle slider 240. Finally, after the proximal end of the push rod 250 is fixed to the welding post 2402 of the needle slider 240 and passed through the through hole 281 of the elastic member 280 to be aligned with the welding hole 2701 of the rod slider 270, the push rod 250 is welded or bonded to the rod slider 270. After the push rod 250 is inserted into the puncture needle 220, it is welded or bonded to the welding post 2402 of the needle slider 240, and the elastic member 280 is compressed between the rod slider 270 and the needle slider 240. Finally, the rod slide 270 is limited between the needle slide 240 and the puncture cover 290, and the cover 290 is assembled with the needle slide 240 by bonding or welding.

In performing a surgical operation using the puncture anchoring device provided in the present embodiment, the trigger 261 is rotated distally, so that the trigger 261 is rotated distally again after the puncture needle 220 is withdrawn. In this process, the spring arm 273 of the lever slider 270 is a metal arm, and is always forced until it jumps over the second stop surface 2433 of the needle slider 240, so that the elastic piece at the distal end of the lever slider 270 continuously stores elastic potential energy. The elastic member 280 will slowly recover after being stressed, so that the soft rubber block between the rod slider 270 and the needle slider 240 can play a good role in buffering or accumulating the elastic potential energy in the process of storing the elastic potential energy by the elastic sheet, and the elastic sheet of the rod slider 270 can also better increase the elastic potential energy, and at the moment of jumping over the slope surface (not shown in the figure, see the slope surface 1223 shown in fig. 16), the elastic sheet can provide larger elastic potential energy, and the push rod 250 can be rapidly ejected or released, so that the release push rod 250 is more stable, and the success rate is also greatly improved.

Compared with the first embodiment, the welding post 2402 of the needle slider 240 is not used for fixing the puncture needle through the needle connecting piece 41, the push rod 250 in the rod slider 270 is directly connected with the connecting part 272, and is not mutually fixed through the rod connecting piece 271, so that errors generated by assembly of components are eliminated, the structure is simplified, the production efficiency is greatly improved, the thickness of the anchoring piece is increased in multiple punctures and releases, compared with the matching of the high polymer components, the metal abrasion generated by the matching movement of the metal components is less, and the movement precision of the instrument is higher.

In addition, the puncture performance of the puncture needle 220 is more stable, the puncture force of the puncture needle 220 can be greatly enhanced, and the puncture can be successfully performed in the face of special physiological structures such as tissue thickening, tissue lesion hardening and other special scenes. In addition, the push rod 250 of the rod slider 270 is more stable and powerful when being pushed out of the anchor 230 at the distal end, so that the puncture success rate of the device can be effectively improved, and the success rate of the operation can be indirectly improved.

The puncture anchoring device according to the present invention will be described in more detail with reference to the suture of the foramen ovale. It will be appreciated that the puncture anchoring device provided by the present invention is also applicable to other conditions requiring simultaneous puncture and suturing. Moreover, the foregoing description of the preferred embodiments of the invention is not intended to limit the scope of the invention, but rather, the equivalent structural changes made by the description of the invention and the accompanying drawings or the direct/indirect application in other related technical fields are included in the scope of the invention.

Claims

1. A puncture anchoring device, comprising:

a puncture needle;

an anchor coupled to the suture, the anchor being movably positioned within the needle;

a needle slider connected to the proximal end of the needle;

the push rod is connected with the needle sliding block, and the far end of the push rod is movably arranged in the puncture needle;

a drive assembly;

the rod sliding block is connected with the proximal end of the push rod, is adapted to push the needle sliding block to slide to the puncture position along the distal end under the drive of the driving component, does not drive the needle sliding block any more, and continues to move to the limit position under the drive of the driving component; in the puncturing position, the needle completes puncturing and in the limit position, the plunger pushes the anchor out of the distal end of the needle.

2. The puncture anchoring device of claim 1, wherein the rod slide cooperates with the needle slide to form a stop, the needle slide being adapted to slide distally with the rod slide to the puncture position via the stop.

3. The puncture anchoring device of claim 2, further comprising a resilient member through which the push rod passes, the resilient member being compressed between the needle slider and the rod slider.

4. A puncture anchoring device as recited in claim 3, further comprising a housing, said needle slide and said rod slide being located within said housing, said drive assembly comprising a pulling member and a trigger adapted to be rotatable to a limit angle relative to said housing under the constraint of said housing, said trigger being connected to said rod slide by said pulling member with its axis of rotation perpendicular to the axial direction of said housing.

5. The puncture anchoring device according to claim 4, wherein the needle slider has two guide rails parallel to each other, the guide rails having a stop surface protruding from a horizontal plane; the rod slider comprises two spring arms extending towards the far end in the same direction, and the far end face of each spring arm abuts against the stop surface to form the stop position with the guide rail.

6. The puncture anchoring device according to claim 5, wherein the housing comprises two upper slide rails and two lower slide rails opposite the two upper slide rails, the two lower slide rails being located outside the two slide rails, the lower slide rails having a ramp surface at a center thereof, the ramp surface corresponding to the puncture location, the lever slider further comprising a radially extending slider connected to the distal end of the spring arm, the slider being adapted to slide along the two upper and lower slide rails until the needle slider is no longer pushed when the slider is jumped over the ramp surface.

7. The puncture anchoring device according to claim 5, wherein the needle slider has an assembly groove, the rod slider further comprises a connecting portion located between and connected to the proximal ends of the two spring arms, the connecting portion and the elastic member are located in the assembly groove, and the proximal end of the push rod is connected to the connecting portion.

8. The puncture anchoring device according to claim 7, further comprising a cover plate closing the assembly slot, the slider being exposed from the cover plate.

9. The puncture anchoring device according to claim 7, wherein the rod slider further comprises a rod connecting member, the connecting portion being provided with a groove at a surface thereof near the proximal end of the guide rail, the rod connecting member being embedded in the groove, the proximal end of the push rod being fixed to the rod connecting member.

10. The puncture anchoring device according to claim 7, wherein the needle slider further comprises a needle connecting member, the needle slider being provided at a distal end thereof with a detent, the needle connecting member being fitted in the detent, a proximal end of the puncture needle being fixed to the needle connecting member.