CN116965866A

CN116965866A - Biological tissue suturing device, single needle tissue closing instrument and operation method thereof

Info

Publication number: CN116965866A
Application number: CN202310928757.6A
Authority: CN
Inventors: 林育坤; 周祥; 程智广
Original assignee: Shenzhen Chuangke Medical Technology Co ltd
Current assignee: Shenzhen Chuangke Medical Technology Co ltd
Priority date: 2023-07-26
Filing date: 2023-07-26
Publication date: 2023-10-31

Abstract

The invention provides a biological tissue suture device, a single needle tissue closure instrument and an operation method thereof, wherein the biological tissue suture device comprises a base, a needle seat and a suture needle, the suture needle is arranged in an arc shape, one end of the suture needle is provided with a needle point, and one end of the suture needle far away from the needle point is used for being connected with a suture thread; the upper surface of the needle seat is provided with an accommodating space matched with the outer contour of the suture needle and is used for accommodating the suture needle and providing a movement track for the suture needle; the needle seat is arranged on the base and can rotate relative to the base so as to enable the needle seat to be in a closed state or an unfolding state. The invention can realize the closure of objects to be closed (such as vascular wounds) with various sizes, and can realize the multiple needle penetration actions through one intervention, thereby achieving better closing effect.

Description

Biological tissue suturing device, single needle tissue closing instrument and operation method thereof

Technical Field

The invention relates to the technical field of medical instruments, in particular to a biological tissue suturing device, a single needle tissue closing instrument and an operation method thereof.

Background

For more than half a century, how to quickly and safely stop bleeding at the puncture site by using the Seldinger technique has remained a clinical challenge. For a long time, the manual compression hemostasis method is the only choice for the operator. The method requires that an operator continuously applies near blood flow blocking pressure to a blood vessel puncture point for 10-20 min and strictly brakes for 6-24 h; the hemostatic effect is exact, and the hemostatic effect is still the gold standard for stopping bleeding at the puncture point until now. However, the artificial compression hemostasis method has the defects of hematoma formation, discomfort of patients, vagal nerve reflex, time occupation of medical staff and the like, and along with the development of vascular interventional therapy, thicker catheter sheaths and anticoagulants are often required, and the compression time required for hemostasis is longer, so that the problem is more remarkable. In order to reduce the compression and braking time, improve the comfort level of patients and liberate the hands of medical staff, people continuously explore new hemostatic methods, materials and devices, and vascular closers assist in closing vascular puncture points and achieve the aim of hemostasis. Over the years, the vascular occlusive device hemostasis method has gradually become a conventional method for puncture point treatment after vascular interventional procedures. In modern surgery, how to close the blood vessel to stop bleeding with high efficiency is always one of the difficulties facing the surgeon, and rapid hemostasis is also always a bottleneck restricting the development of the surgery. Many conventional medical devices for hemostasis of arterial puncture sites, percutaneous vascular puncture and hemostasis of vascular anastomosis have advantages but have respective limitations in terms of universality. A vessel closer is currently on the market and basically corresponds to a corresponding vessel closing type, and a plurality of instruments can be used in a conventional one-field operation. The cumbersome operation of frequent replacement of the device undoubtedly increases the workload of the physician, so that there is an urgent need to develop a highly versatile vascular closure device to better achieve vascular closure in any range.

Based on this, the prior art provides a vascular closure device for suturing a vascular puncture site. The vascular closure device can be used for suturing a wider range of vascular wound sizes, providing better hemostatic effect. However, the vascular closure device in the prior art still has some defects in practical application:

1. when the existing vascular closure apparatus is used for suturing a blood vessel, a single suture line is used for suturing around a vascular wound, and the hemostatic effect is often poor;

2. in the prior art, when suturing vascular puncture openings with different sizes, a plurality of vascular closure devices or vascular closure devices are often needed to be used;

3. the existing vascular closure devices in the market are still used for suturing by a straight needle, and the use effect and the application range of the vascular closure devices are limited;

4. the existing circular needle suturing technology cannot realize suturing in a narrow tissue space such as a vascular wound due to the limited size of a mechanical structure.

It should be noted that the information disclosed in this background section is only for enhancement of understanding of the general background of the invention and should not be taken as an acknowledgement or any form of suggestion that this information forms the prior art already known to a person skilled in the art.

Disclosure of Invention

The present invention aims to provide a biological tissue suturing device, a single needle tissue closing instrument and an operation method thereof, which can solve one or more of the above technical problems.

In order to achieve the above object, the present invention provides a biological tissue suturing device comprising a base, a needle seat and a suturing needle,

the suture needle is arranged in an arc shape, one end of the suture needle is provided with a needle point, and one end of the suture needle, which is far away from the needle point, is used for being connected with a suture thread;

the upper surface of the needle seat is provided with an accommodating space matched with the outer contour of the suture needle and is used for accommodating the suture needle and providing a movement track for the suture needle;

the needle seat is arranged on the base and can rotate relative to the base so as to enable the needle seat to be in a closed state or an unfolding state.

Optionally, the base includes the horizontal mounting plate, the axial length of needle file is less than or equal to the length of horizontal mounting plate, the proximal end of horizontal mounting plate is equipped with first mounting hole, the proximal end of the bottom of needle file is equipped with the pivot, the position of pivot with first mounting hole looks adaptation, both rotate and connect.

Optionally, the proximal end of the horizontal mounting plate is further provided with a first positioning boss, the bottom of the first positioning boss and the top of the first mounting hole are located at the same horizontal position, and the axial length of the first positioning boss is greater than the diameter of the first mounting hole, so that the first positioning boss axially exceeds the first mounting hole.

Optionally, the horizontal mounting plate has a first side and a second side opposite to each other in a horizontal direction, the first mounting hole is located on the first side, and the first positioning boss is located on the second side; and the first mounting hole has a first distance from the edge of the first side of the horizontal mounting plate.

Optionally, a second positioning boss is disposed between the rotating shaft and the edge of the first side of the needle seat at the bottom of the needle seat, and the second positioning boss is adapted to the first space.

Optionally, when the needle stand is in a closed state, the first positioning boss and the second positioning boss are positioned at two sides of the rotating shaft in the horizontal direction; and when the needle seat is in the unfolding state, the second positioning boss rotates to abut against the first positioning boss.

Optionally, the upper surface of needle file is provided with bulge and first recess, first recess by bulge surrounds and forms, the shape of bulge's interior profile with the outline phase-match of sewing needle, the sewing needle is located in the initial state first recess, and with bulge's interior profile offsets.

Optionally, the top end of the protruding part is provided with an eave part protruding inwards along the circumference of the protruding part, and the inner outline of the protruding part and the eave part jointly define the movement track of the suture needle.

Optionally, a connection hole is provided at the proximal end of the outer side surface of the protruding portion, for allowing the distal end of the operating rod to be hinged to the needle seat.

Optionally, the biological tissue suturing device further comprises a driving shaft, a second mounting hole is formed in the center of the needle seat in the horizontal direction and is biased to the first side, and the driving shaft is rotatably connected with the second mounting hole.

Optionally, the drive shaft includes coaxial first axis body and second axis body that sets up, the diameter of first axis body is greater than the second axis body, the diameter of second axis body with the aperture looks adaptation of second mounting hole, first axis body is located the below of second mounting hole, the second axis body is located the top of second mounting hole.

Optionally, the biological tissue suturing device further comprises a poking piece, wherein the poking piece is located in the first groove, one end of the poking piece is fixedly connected with the second shaft body, and the other end of the poking piece abuts against the suturing needle; a first clamping groove matched with the poking piece is formed in one end, close to the needle point, of the suture needle, and a second clamping groove matched with the poking piece is formed in one end, far away from the needle point, of the suture needle;

the biological tissue suturing device further comprises a control wire, the distal end of the control wire comprises a sleeving part, and the sleeving part is fixedly connected with the first shaft body so as to drive the first shaft body to rotate.

Optionally, the base includes a first proximal end plate at a proximal end, and the height of the horizontal mounting plate is less than the height of the first proximal end plate; the distal end of the first proximal end plate is provided with a second groove, the second groove and the first groove are positioned at the same height, the outline of the second groove is arc-shaped, a part of a movement track of the suture needle is formed, and the circle center of the arc-shaped is positioned at the first side; when the needle seat is in the unfolding state, the circle center of the second groove coincides with the circle center of the first groove.

Optionally, the second side of the first proximal end plate is provided with a first through groove and a second through hole along an axial direction, the first through groove is used for accommodating and supporting the control rod, and the second through hole is used for allowing the control wire to pass through.

Optionally, the base further comprises a first distal end plate at a distal end, the hub being located between the first distal end plate and the first proximal end plate; the biological tissue suturing device further comprises a seat cover which is covered with the base, wherein the seat cover comprises a top plate, a second proximal end plate and a second distal end plate, the top plate is arranged opposite to the horizontal mounting plate, the second proximal end plate is connected with the first proximal end plate, and the second distal end plate is connected with the first distal end plate.

Optionally, the suturing device further includes a seat cover covering the base, the seat cover including a top plate disposed opposite the horizontal mounting plate, a second proximal end plate connected to the first proximal end plate, and a second distal end plate connected to the first distal end plate.

To achieve the above object, the present invention also provides a single needle tissue closing device comprising the above-described biological tissue suturing apparatus.

To achieve the above object, the present invention also provides a method of operating a single needle tissue closure device, applied to the single needle tissue closure device described above, the method of operating comprising:

pushing the single needle tissue closing instrument with the needle seat in a closed state towards the direction of approaching the object to be closed until the biological tissue suturing device penetrates the object to be closed and reaches the target cavity at the distal end of the object to be closed;

unfolding the needle seat;

according to a preset suturing strategy, controlling the needle seat to sequentially lean against each target suturing point position of the object to be closed, and driving the suturing needle to pass through peripheral tissues of the target suturing point positions along the movement track along with the suturing thread after the needle seat leans against each target suturing point position until the suturing needle returns to the initial position so as to complete suturing of the target suturing point positions, wherein at least two suturing point positions are positioned on different sides of the object to be closed;

After the suturing of all the target suture points is completed, closing the needle seat, withdrawing the single needle tissue closing instrument, and knotting and locking the suture line so as to retract and pull the two sides of the object to be closed.

Optionally, the driving the suture needle to pass through the peripheral tissue of the target suture point along the movement track, until the suture needle returns to the initial position, so as to complete the suturing of the target suture point, including:

pulling a first control part of the control wire to drive a driving shaft to drive a poking piece clamped with a second clamping groove of the suture needle to push the suture needle to penetrate into peripheral tissues of the target suture point along the movement track along the suture thread until the first clamping groove of the suture needle penetrates out of the peripheral tissues and enters into a second groove;

the second control part of the control wire is pulled to drive the driving shaft to drive the poking plate to retract from the second clamping groove until the poking plate is clamped with the first clamping groove;

and pulling the first control part to drive the driving shaft to drive the poking piece clamped with the first clamping groove to push the suture needle to drive the suture thread to pass through the peripheral tissue of the target suture point along the movement track until the suture needle returns to the initial position of the suture needle, so that the suture of the target suture point is completed.

Compared with the prior art, the biological tissue suturing device, the single needle tissue closing instrument and the operation method thereof provided by the invention have the following advantages:

the biological tissue suturing device comprises a base, a needle seat and a suturing needle, wherein the suturing needle is arranged in an arc shape, a needle point is arranged at one end of the suturing needle, and one end, far away from the needle point, of the suturing needle is connected with a suturing thread; the upper surface of the needle seat is provided with an accommodating space matched with the outer contour of the suture needle and is used for accommodating the suture needle and providing a movement track for the suture needle; the needle seat is arranged on the base and can rotate relative to the base so as to enable the needle seat to be in a closed state or an unfolding state. Because the needle seat has two states of unfolding and closing, the biological tissue suturing device provided by the invention can realize the closing of objects to be closed (such as vascular wounds) with various sizes, and can suture the objects to be closed (such as vascular wounds) in a narrow space, and meanwhile, the suturing range of the suturing needle can be effectively increased in a needle seat unfolding mode, so that the closing requirement of objects to be closed (such as vascular wounds) with a larger range can be met. In addition, the needle seat can provide a movement track for the suture needle, so that the suture needle can stably move along the movement track, and the suture effect is improved. In addition, the biological tissue suturing device provided by the invention can realize multiple needle threading actions through one intervention, so that a better closing effect can be achieved, and particularly, a better hemostatic effect can be achieved when a vascular wound is closed. In addition, the present invention can achieve closure of various sizes of objects to be closed (e.g., vascular wounds) by suturing the objects to be closed (e.g., vascular wounds) using an arc-shaped suture needle.

Because the single needle tissue closing device and the operation method thereof provided by the invention belong to the same inventive concept as the biological tissue suturing device provided by the invention, the single needle tissue closing device and the operation method thereof provided by the invention have at least all advantages of the biological tissue suturing device provided by the invention, and the detailed description can be referred to above, and the detailed description is omitted.

Drawings

Fig. 1 is a schematic view of a needle holder in a biological tissue suturing device according to an embodiment of the present invention in a closed state;

fig. 2 is a schematic view showing a structure of a needle holder in an unfolded state in a biological tissue suturing device according to an embodiment of the present invention;

FIG. 3 is a schematic perspective view of a base of a biological tissue suturing device according to an embodiment of the present invention;

fig. 4 is a schematic perspective view showing a back view of a needle holder in a biological tissue suturing device according to an embodiment of the present invention;

fig. 5 is a schematic perspective view of a needle holder in a biological tissue suturing device according to an embodiment of the present invention;

FIG. 6 is an exploded view of the biological tissue suturing device of FIG. 1;

FIG. 7 is a schematic view showing a lever driving a needle holder to rotate in a biological tissue suturing device according to an embodiment of the present invention;

Fig. 8 is a schematic view of a needle holder in a biological tissue suturing device according to an embodiment of the present invention in an unfolded state under the drive of a control rod;

FIG. 9 is a schematic view of a biological tissue suturing device according to an embodiment of the present invention in which a needle holder, a dial and a suturing needle are engaged with each other;

FIG. 10 is a schematic view showing a driving shaft driven by a control wire in a biological tissue suturing device according to an embodiment of the present invention;

FIG. 11 is a schematic view showing the reverse rotation of the drive shaft driven by the control wire in the biological tissue suturing device according to the embodiment of the present invention;

FIG. 12 is a schematic view of the overall structure of a single needle tissue closure device according to an embodiment of the present invention;

fig. 13 is a schematic view showing a partial structure of a needle holder in an unfolded state in a single needle tissue closing device according to an embodiment of the present invention;

FIG. 14 is a schematic view of a single needle tissue closure device according to an embodiment of the present invention in which a paddle begins to rotate a needle;

FIG. 15 is a schematic view of a single needle tissue closure device according to an embodiment of the present invention in which a paddle pushes a needle into a second recess;

FIG. 16 is a diagram illustrating the connection between a seat cover and a base in a single needle tissue closure device according to one embodiment of the present invention;

FIG. 17 is a cross-sectional view of a guide tube according to an embodiment of the present invention;

FIG. 18 is a diagram illustrating a connection relationship between a guide tube and a first transition joint according to an embodiment of the present invention;

FIG. 19 is a flow chart of a method of operation of a single needle tissue closure device according to one embodiment of the present invention;

FIG. 20a is a schematic view of a single needle tissue closure device according to the present invention prior to initiating suturing of a side of a subject to be closed;

FIG. 20b is a schematic view of a single needle tissue closure device according to the present invention with a suture thread penetrating the tissue surrounding the object to be closed;

FIG. 20c is a schematic view of a single needle tissue closure device according to the present invention with a suture needle penetrating the peripheral tissue of the object to be closed;

FIG. 20d is a schematic view of a single needle tissue closure device according to the present invention prior to initiating suturing of another side of a subject to be closed;

FIG. 20e is a schematic view of a single needle tissue closure device according to the present invention with a suture thread passing through the tissue surrounding the other side of the object to be closed;

FIG. 20f is a schematic illustration of a single needle tissue closure device according to the present invention withdrawn from an object to be closed;

FIG. 20g is a graph of the suturing effect of the single needle tissue closure device provided by the present invention.

Wherein, the reference numerals are as follows:

a base-110; a second groove-111; guiding fillets-1111; a second eave portion-1112; a first mounting hole-112; a first positioning boss-113; a horizontal mounting plate-101; a first distal endplate-102; a first proximal endplate-103; a first through slot-114; a second through hole-115;

a needle stand-120; a first groove-121; a first eave portion-1211; a spindle-122; a second positioning boss-123; third groove-124; a connection hole-125; a second mounting hole-126; a projection-127; a first eave portion-1271;

suture needle-130; a needle tip-131; a first card slot-132; a second clamping groove-133;

a lever-141; a main joystick-1411; a split joystick-1412; a lever joint-142; a second through hole-1421;

a drive shaft-151; first shaft-1511; a second shaft-1512; a paddle-152; a clamping part-1521; control wire-153; a first manipulation section-1531; a second manipulation section-1532; socket-1533;

suture-160;

a seat cover-170; a top plate-171; a second distal endplate-172; a second proximal endplate-173;

guide tube-200; a guidewire lumen-201; a guidewire port-202; a first pipe segment-210; an outer tube-211; an inner tube-212; a second pipe segment-220; a third pipe segment-230;

sheath-300; a first transition joint-400;

A second transition joint-500; a first via-510;

a handle-600;

an object to be closed-710; target cavity lane-720; peripheral tissue-730.

Detailed Description

The biological tissue suturing device, the single needle tissue closure device and the method of operation thereof according to the present invention are described in further detail below with reference to the accompanying drawings and detailed description. The advantages and features of the present invention will become more apparent from the following description. It should be noted that the drawings are in a very simplified form and are all to a non-precise scale, merely for the purpose of facilitating and clearly aiding in the description of embodiments of the invention. For a better understanding of the invention with objects, features and advantages, refer to the drawings. It should be understood that the structures, proportions, sizes, etc. shown in the drawings are shown only in connection with the present disclosure for the understanding and reading of the present disclosure, and are not intended to limit the scope of the invention, which is defined by the appended claims, and any structural modifications, proportional changes, or dimensional adjustments, which may be made by the present disclosure, should fall within the scope of the present disclosure under the same or similar circumstances as the effects and objectives attained by the present invention. Specific design features of the invention disclosed herein, including for example, specific dimensions, orientations, positions, and configurations, will be determined in part by the specific intended application and use environment. In the embodiments described below, the same reference numerals are used in common between the drawings to denote the same parts or parts having the same functions, and the repetitive description thereof may be omitted. In this specification, like reference numerals and letters are used to designate like items, and thus once an item is defined in one drawing, no further discussion thereof is necessary in subsequent drawings. Additionally, if a method described herein comprises a series of steps, and the order of the steps presented herein is not necessarily the only order in which the steps may be performed, and some of the described steps may be omitted and/or some other steps not described herein may be added to the method.

It is noted that relational terms such as first and second, and the like are used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. Moreover, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Without further limitation, an element defined by the phrase "comprising one … …" does not exclude the presence of other like elements in a process, method, article, or apparatus that comprises the element. The singular forms "a," "an," and "the" include plural referents, the term "or" is generally used in the sense of comprising "and/or" and the term "several" is generally used in the sense of comprising "at least one," the term "at least two" is generally used in the sense of comprising "two or more," and the term "first," "second," "third," are for descriptive purposes only and are not to be construed as indicating or implying any relative importance or number of features indicated.

In the description of the present invention, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "axial", "radial", "circumferential", etc. indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings are merely for convenience in describing the present invention and to simplify the description, and do not indicate or imply that the device or element being referred to must have a specific orientation, be configured and operated in a specific orientation, and therefore should not be construed as limiting the present invention. The terms "mounted," "connected," and "secured" are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally formed; can be mechanically or electrically connected; can be directly connected or indirectly connected through an intermediate medium, and can be communicated with the inside of two elements or the interaction relationship of the two elements. In the present invention, unless expressly stated or limited otherwise, a first feature "above" or "below" a second feature may include both the first and second features being in direct contact, as well as the first and second features not being in direct contact but being in contact with each other through additional features therebetween. Moreover, a first feature being "above," "over" and "on" a second feature includes the first feature being directly above and obliquely above the second feature, or simply indicating that the first feature is higher in level than the second feature. The first feature being "under", "below" and "beneath" the second feature includes the first feature being directly under and obliquely below the second feature, or simply means that the first feature is less level than the second feature.

The core idea of the present invention is to provide a biological tissue suturing device, a single needle tissue closing instrument and a method for operating the same, which solves one or more of the following technical problems: when the existing vascular closure apparatus is used for suturing a blood vessel, a single suture line is used for suturing around a vascular wound, and the hemostatic effect is often poor; in the prior art, when suturing vascular puncture openings with different sizes, a plurality of vascular closure devices or vascular closure devices are often needed to be used; the existing vascular closure apparatus is still used for suturing by a straight needle, and one or more of the technical problems of limited use effect and application range and the like are solved. It should be noted that, as those skilled in the art will appreciate, the term "proximal" herein refers to an end proximal to an operator, and the term "distal" refers to an end distal from the operator. It should be noted that, although the vascular wound is described herein as an object to be closed, the present invention may also be implemented to close objects other than vascular wound, as will be understood by those skilled in the art, and the present invention is not limited thereto.

In the present specification, the direction from the proximal end to the distal end is defined as the axial direction of the biological tissue suturing device, and the direction perpendicular to the axial direction is the horizontal direction, with the left hand side of the operator being "left" and the right hand side of the operator being "right", with the operator standing angle.

In order to achieve the above-mentioned idea, referring to fig. 1 and 2, the present invention provides a biological tissue suturing device, which includes a base 110, a needle stand 120 and a suturing needle 130, wherein the suturing needle 130 is arc-shaped, one end of the suturing needle 130 is provided with a needle point 131, and one end of the suturing needle 130 far from the needle point 131 is used for being connected with a suturing thread 160; the upper surface of the needle holder 120 has an accommodating space matched with the outer contour of the suture needle for accommodating the suture needle and providing a moving track for the suture needle; the needle holder 120 is provided on the base 110 and is rotatable with respect to the base 110 to place the needle holder 120 in a closed state or an expanded state.

When the needle holder 120 is in the closed state, the biological tissue suturing device can smoothly pass through a narrow space of the object 710 to be closed (e.g., a vascular wound of fig. 20 a); after the biological tissue suturing device penetrates the object to be closed 710, the needle stand 120 is driven to rotate relative to the base 110 to enable the object to be closed to be in an unfolding state, and the needle stand 120 provides a movement track for the suturing needle 130, so that the suturing needle 130 can stably move along the movement track to suture the object to be closed. After suturing one needle, the suturing needle 130 is withdrawn to allow for a second suturing of the object 710 to be closed. Therefore, the biological tissue suturing device provided by the invention can realize multiple needle penetration actions at the object to be closed through one intervention, can reduce secondary injury caused by needle penetration for small-size objects to be closed such as vascular wounds, and has better hemostatic effect.

Alternatively, the base 110 may be made of PP (polypropylene), ABS (acrylonitrile butadiene styrene), stainless steel, or other polymer materials or metal materials having a certain hardness and strength. The needle 130 may be made of a metal material having a high rigidity and hardness such as stainless steel, and may be increased in hardness by heat treatment or surface plating so that the movement of the needle 130 is more stable and reliable and is easier to pass through the tissue around the object 710 to be closed (e.g., a vascular wound). By providing one end of the needle 130 as a pointed end (i.e., providing the needle tip 131), the resistance of the needle 130 when passing through the tissue 730 (see fig. 20 a) surrounding the object 710 to be closed (e.g., a vascular wound) can be reduced. The end of the needle 130 distal from the needle tip 131 may be attached to the suture 160 by adhesive, pressure fit or other attachment means. Further, the material of the suture 160 may be PP (polypropylene) or nylon. The needle mount 120 may be made of PP (polypropylene), ABS (acrylonitrile butadiene styrene), stainless steel, or other high polymer materials or metal materials having a certain hardness and strength.

With continued reference to fig. 3, the base 110 includes a horizontal mounting plate 101, and a first mounting hole 112 is formed at a proximal end of the horizontal mounting plate 101; the needle stand 120 is arranged on the horizontal mounting plate 101, and the axial length of the needle stand is smaller than or equal to the length of the horizontal mounting plate; the proximal end of the bottom of the needle seat is provided with a rotating shaft 122, the position of the rotating shaft 122 is matched with the first mounting hole 112, and the rotating shaft and the first mounting hole are rotatably connected. Thus, this arrangement may further facilitate the rotation of the hub 120 relative to the base 110, either in a closed or an extended position.

Specifically, the hub 120 is rotatable relative to the horizontal mounting plate 101, in an expanded state when at least a portion of the hub 120 is located outside the horizontal mounting plate 101, and in a closed state when the hub 120 is located entirely within the horizontal mounting plate 101. It should be noted that, as understood by those skilled in the art, at least a portion of the area of the hub 120 is located outside the horizontal mounting plate 101, which means that at least a portion of the area of the hub 120 extends beyond the horizontal mounting plate 101 in the horizontal direction; the needle stand 120 is entirely located in the horizontal mounting plate 101, which means that the edge of the needle stand 120 does not exceed the horizontal mounting plate 101 in the horizontal direction.

With continued reference to fig. 3, the proximal end of the horizontal mounting plate 101 is further provided with a first positioning boss 113, wherein the bottom of the first positioning boss 113 and the top of the first mounting hole 112 are located at the same horizontal position, and the axial length of the first positioning boss 113 is greater than the diameter of the first mounting hole 112, so that the first positioning boss 113 axially exceeds the first mounting hole 113. Therefore, the first positioning boss 113 can play a limiting role, so that the needle seat 120 can smoothly rotate and be in an unfolding state. It should be noted that, as those skilled in the art will appreciate, the present invention does not limit the rotation direction of the needle holder 120, and the needle holder 120 may be rotated from the closed state to the open state by rotating rightward, or may be rotated from the closed state to the open state by rotating leftward.

With continued reference to fig. 3, the horizontal mounting plate 101 has a first side and a second side opposite to each other in a horizontal direction, the first mounting hole 112 is located on the first side, and the first positioning boss 113 is located on the second side; and, the first mounting hole 112 has a first distance from the edge of the first side of the horizontal mounting plate 101. Thus, this arrangement can ensure that the first positioning boss 113 not only plays a limiting role, but also can ensure that the normal rotation of the needle holder 120 is not hindered when the needle holder 120 is not fully deployed.

Those skilled in the art will appreciate that in one embodiment, first positioning boss 113 is in relation to first mounting hole 112 as shown in fig. 4, when hub 120 is rotated counterclockwise from the closed position. In another embodiment (not shown), the relationship of first positioning boss 113 and first mounting hole 112 is interchanged in the direction of the line where the two are located, at which time first positioning boss 113 and first mounting hole 112 are interchanged in position, at which time the deployment of hub 120 is rotated clockwise from the closed state. Thus, the present description encompasses two radial embodiments.

With continued reference to fig. 4, a second positioning boss 123 is disposed between the rotating shaft 122 and the edge of the first side of the needle holder at the bottom of the needle holder, and the second positioning boss 123 is adapted to the first space. Therefore, by providing the second positioning boss 123, a limiting function can be further performed, so that the needle holder 120 can smoothly rotate to the unfolded state.

Further, in the closed state of the needle holder 120, the first positioning boss 113 and the second positioning boss 123 are located at two sides of the rotating shaft 122 in the horizontal direction; in the unfolded state of the needle holder 120, the second positioning boss 123 rotates to abut against the first positioning boss 113. Therefore, the arrangement can limit the limit position reached by the expansion of the needle seat 120, so as to ensure that the needle seat 120 can smoothly rotate to the expansion state; and it is ensured that the needle holder 120 can be smoothly reversely rotated to the initial position to be in the closed state, thereby further ensuring the stability and reliability of the suture needle 130 during the movement.

With continued reference to fig. 5, the upper surface of the needle holder is provided with a protrusion 127 and a first groove 121, the first groove 121 is surrounded by the protrusion 127, the shape of the inner contour of the protrusion 127 matches with the outer contour of the suture needle 130, and the suture needle 130 is located in the first groove 121 in the initial state and abuts against the inner contour of the protrusion 127. This arrangement ensures that the hub 120 can be rotated 90 ° to ensure that the hub 120 can be deployed to a maximum angle to ensure that the same size suture needle 130 can have a greater suture depth.

Specifically, the curvature of the suture needle 130 is consistent with the curvature of the inner contour of the first groove 121, and may be set correspondingly according to the curvature of the suture needle 130, which is not limited in the present invention, for example, pi 2 to pi, or more.

With continued reference to fig. 5, the top end of the protruding portion 127 has a first eave 1271 protruding inward along its circumferential direction. Thus, it is ensured that the movement of the suture needle 130 on the needle holder 120 does not deviate from the movement track formed by the first groove 121, thereby making the movement of the suture needle 130 more stable and reliable. In an exemplary embodiment, the outer contours of both sides of the protrusion 127 are arranged in an arc shape. This arrangement effectively ensures that the hub 120 can be rotated smoothly.

With continued reference to fig. 2 and 3, the base 110 includes a first proximal end plate 103 at a proximal end, and the horizontal mounting plate 101 has a height less than the height of the first proximal end plate 103; the distal end of the first proximal end plate 103 is provided with a second groove 111, the second groove 111 and the first groove 121 are at the same height, the outline of the second groove 111 is arc-shaped, and forms a part of the movement track of the suture needle 130, and the center of the arc is located at the first side; when the needle holder 120 is in the unfolded state, the center of the second groove 111 coincides with the center of the first groove 121. Therefore, the second groove 111 and the first groove 121 provide a movement track for the suture needle 130, so that the trackless movement range of the suture needle 130 can be effectively reduced, and the stability and reliability of the suture needle 130 in the movement process can be further improved, so that the suture effect of the biological tissue suture device is further improved, and a better tissue closing effect is achieved.

Preferably, the curvature corresponding to the movement track formed by the first groove 121 and the second groove 111 is greater than or equal to 3ρ2, so that the trackless movement range of the suture needle 130 can be reduced to less than or equal to 90 °, thereby further improving the stability and reliability of the suture needle 130 during movement.

With continued reference to fig. 3, in an exemplary embodiment, the groove bottom of the second groove 111 on the side for communicating with the first groove 121 is disposed obliquely downward to form a guiding fillet 1111. Thus, by providing the guide rounded corner 1111 at the opening section of the second groove 111 (i.e., the side for communicating with the first groove 121), the guide function can be performed when the suture needle 130 enters the second groove 111, so as to further improve the stability and reliability of the suture needle 130 during the movement.

With continued reference to fig. 3, further, the top of the first proximal end plate 103 is provided with an inwardly protruding second eave portion 1112 along the circumferential direction thereof, that is, the top of the second groove 111 is provided with an inwardly protruding second eave portion 1112 along the circumferential direction thereof. Therefore, by the second eave 1112, the movement of the suture needle 130 on the base 110 can be ensured not to deviate from the movement track formed by the second groove 111, so that the movement of the suture needle 130 is more stable and reliable.

With continued reference to fig. 7 and 8, as shown in fig. 7 and 8, a proximal end of the outer side surface of the protruding portion 127 is provided with a connecting hole 125 for the distal end of the lever 141 to be hinged to the hub 120. By pushing the lever 141 toward the distal end, the needle holder 120 and the shaft 122 may be driven to rotate in the forward direction, so as to drive the needle holder 120 to rotate to the unfolded state. Similarly, by proximally withdrawing the lever 141, the hub 120 and the shaft 122 may be rotated in opposite directions to rotate the hub 120 to the closed position.

With continued reference to fig. 6, in an exemplary embodiment, the lever 141 includes a main lever 1411 and a sub-lever 1412 connected to each other, the distal end of the sub-lever 1412 is connected to the corresponding hub 120, and the biological tissue suturing device further includes a lever joint 142 for connecting different sub-levers 1412 to the same main lever 1411 through the same lever joint 142, so that one main lever 1411 can control the different sub-levers 1412 to drive the hub 120 connected thereto to rotate, thereby reducing the number of parts and facilitating the operation. As will be appreciated by those skilled in the art, in another embodiment, there are two sets of hubs 120 and base 110, where there are two sub-levers 1412 connected to one hub 120, respectively, and the two sub-levers 1412 are controlled to drive the two hubs 120 to rotate simultaneously by controlling one main lever 1411.

Specifically, the main lever 1411 and the sub-levers 1412 may be made of metal materials with high mechanical properties, such as stainless steel, nickel titanium, etc., and the lever joint 142 may be made of polymer materials or metal materials with high connectivity, such as stainless steel, PP (polypropylene), ABS (acrylonitrile butadiene styrene copolymer), etc.

With continued reference to fig. 4, a third groove 124 is further provided at the bottom of the needle holder 120 near one end of the base 110 (specifically near one end of the horizontal mounting plate 101), and the third groove 124 is disposed around the rotating shaft 122 and the second positioning boss 123. In the assembled state, the third groove 124 is configured to provide an accommodating space for the first positioning boss 113, so as to ensure that the needle holder 120 can smoothly rotate under the driving of the operating rod 141.

With continued reference to fig. 1, 2, 5, 6 and 9, the biological tissue suturing device further includes a driving shaft 151, a second mounting hole 126 is provided at the center of the needle holder 120 in the horizontal direction and biased to the first side, and the driving shaft 151 is rotatably connected with the second mounting hole 126. By providing the driving shaft 151, the suture needle 130 can be driven to carry the suture thread 160 to perform a suture motion. Specifically, the driving shaft 151 may be made of PP (polypropylene), ABS (acrylonitrile butadiene styrene), stainless steel, or other polymer materials or metal materials having a certain hardness and strength.

With continued reference to fig. 6, the driving shaft 151 includes a first shaft body 1511 and a second shaft body 1512 that are coaxially disposed, the diameter of the first shaft body 1511 is larger than that of the second shaft body 1512, the diameter of the second shaft body 1512 is adapted to the aperture of the second mounting hole 126, the first shaft body 1511 is located below the second mounting hole 126, and the second shaft body 1512 is located above the second mounting hole 126. Therefore, the driving shaft 151 can be more conveniently connected to the needle seat 120 in a rotating way, and the driving shaft 151 can be effectively prevented from being separated from the needle seat 120, so that the stability of the biological tissue suturing device provided by the invention in the use process is further improved.

With continued reference to fig. 6 and 9, the biological tissue suturing device further includes a pulling piece 152, wherein the pulling piece 152 is located in the first groove 121, one end of the pulling piece 152 is fixedly connected with the second shaft 1512, and the other end of the pulling piece abuts against the suturing needle 130; the end of the suture needle 130 near the needle tip 131 is provided with a first clamping groove 132 matched with the poking piece 152, and the end of the suture needle 130 far away from the needle tip 131 is provided with a second clamping groove 133 matched with the poking piece 152. Therefore, the driving shaft 151 can be driven to rotate around its own axis by the control wire 153, so as to drive the pulling piece 152 to rotate around the driving shaft 151, and the rotating pulling piece 152 drives the suture needle 130 clamped with the pulling piece 152 to rotate. In addition, by respectively providing the first clamping groove 132 and the second clamping groove 133 at two ends of the suture needle 130, the dial 152 may be selectively clamped with one of the first clamping groove 132 and the second clamping groove 133 according to specific use requirements, so as to ensure that the suture needle 130 can smoothly complete a full-circle (i.e. 360 °) rotation movement.

With continued reference to fig. 6, the biological tissue suturing device further includes a control wire 153, wherein a distal end of the control wire 153 includes a sleeve joint portion 1533, and the sleeve joint portion 1533 is fixedly connected with the first shaft 1511, so as to drive the first shaft 1511 to rotate, and further drive the second shaft 1512 to rotate together with the pulling plate 152.

Specifically, referring to fig. 10-11, the driving shaft 151 is driven to rotate around its own axis by the control wire 153, and since the second shaft body 1512 of the driving shaft 151 is not connected to the paddle 152, the first shaft body 1511 is connected to the socket portion 1533 of the control wire 153, so that the control wire 153 drives the first shaft body 1511 to rotate, the second shaft body 1512 further drives the paddle 152 to rotate around the driving shaft 151, and the rotating paddle 152 drives the suture needle 130 engaged with the second shaft body 151to rotate. In addition, by respectively providing the first clamping groove 132 and the second clamping groove 133 at two ends of the suture needle 130, the dial 152 may be selectively clamped with one of the first clamping groove 132 and the second clamping groove 133 according to specific use requirements, so as to ensure that the suture needle 130 can smoothly complete a full-circle (i.e. 360 °) rotation movement. Specifically, one of the points on the socket 1533 may be fixedly connected to the driving shaft 151 by bonding or welding.

Specifically, when suturing begins, the needle holder 120 is located in the target channel (for example, in a blood vessel), the suturing needle 130 is completely located in the first groove 121, the paddle 152 is clamped with the second clamping groove 133, the driving shaft 151 is driven by the control wire 153 to drive the paddle 152 to rotate forward, the rotating paddle 152 pushes the suturing needle 130 to rotate through the peripheral tissue 730 on one side of the object to be closed 710 (for example, a blood vessel wound) with the suturing thread 160, at this time, the needle tip 131 of the suturing needle 130 and the first clamping groove 132 completely enter the second groove 111, and then the driving shaft 151 is driven by the control wire 153 to drive the paddle 152 to rotate reversely, so as to retract the paddle 152 until the paddle 152 is clamped with the first clamping groove 132; then, the driving shaft 151 is driven to drive the pulling piece 152 to rotate forward by the control wire 153, the rotating pulling piece 152 pushes the suture needle 130 to drive the suture thread 160 to completely penetrate through the peripheral tissue 730 on one side of the object 710 (for example, a vascular wound) to be closed, so as to enter a target channel (for example, a blood vessel), thereby completing the suturing of a suturing point, and after the suturing of a suturing point is completed, the driving shaft 151 is driven to drive the pulling piece 152 to rotate reversely by the control wire 153 again, so as to retract the pulling piece 152 until the pulling piece 152 is clamped with the second clamping groove 133, so as to prepare for the suturing of the next suturing point. It can be seen that, through the mutually engaged pulling piece 152 and the second slot 133, the suture needle 130 can be driven to complete the first-stage rotation motion (to drive the suture thread 160 to penetrate into the peripheral tissue 730 on one side of the object to be closed 710 (e.g. a vascular wound)), and through the mutually engaged pulling piece 152 and the second slot 133, the suture needle 130 can be driven to complete the second-stage rotation motion (to drive the suture thread 160 to completely penetrate out of the peripheral tissue 730 on one side of the object to be closed 710 (e.g. a vascular wound)). It should be noted that the needle holder 120 is always in the unfolded state during the suturing movement of the suturing needle 130, as will be understood by those skilled in the art.

In an exemplary embodiment, the center of rotation of the paddle 152 is offset from the center of rotation of the needle 130. Thus, by eccentrically setting the rotation center of the dial 152 and the rotation center of the suture needle 130, the rotation diameter of the suture needle 130 can be increased to increase the movement range of the suture needle 130, thereby increasing the suture range of the suture needle 130.

With continued reference to fig. 2, in an exemplary embodiment, as shown in fig. 2, an end of the pulling piece 152 away from the driving shaft 151 is bent toward the position of the suture needle 130, so as to form a clamping portion 1521 that is matched with the first clamping groove 132 and the second clamping groove 133. Thus, the setting may facilitate the engaging of the pulling piece 152 with the first engaging groove 132 or the second engaging groove 133. Meanwhile, because the rotation center of the pulling piece 152 and the rotation center of the suture needle 130 are eccentrically arranged, the distance between the pulling piece 152 and the first clamping groove 132 or the second clamping groove 133 is different when the pulling piece 152 rotates at different angles, and therefore, by bending one end of the pulling piece 152 away from the driving shaft 151 towards the position of the suture needle 130 to form the clamping part 1521, the pulling piece 152 can be ensured to have a certain elastic restoring capability, so that the pulling piece 152 can be ensured to be clamped with the first clamping groove 132 or the second clamping groove 133 under the condition of each rotation angle.

Further, the pulling piece 152 may be made of nickel titanium, cobalt chrome alloy, stainless steel, or other materials with better elasticity. Therefore, the setting may further ensure that the pulling piece 152 has a certain elastic restoring capability, so as to ensure that when the rotation center of the pulling piece 152 and the rotation center of the suture needle 130 are set in a deviated manner, the pulling piece 152 can be clamped with the first clamping groove 132 or the second clamping groove 133 under the condition of each rotation angle.

In an exemplary embodiment, the side wall of the first clamping groove 132 near the side of the second clamping groove 133 is disposed at a downward inclination, and the side wall of the second clamping groove 133 far from the side of the first clamping groove 132 is disposed at a downward inclination. Therefore, the setting not only can be more convenient for withdrawing the pulling piece 152 from the first clamping groove 132 or the second clamping groove 133, but also can be more convenient for clamping the pulling piece 152 into the first clamping groove 132 or the second clamping groove 133.

With continued reference to fig. 3 and 6, the second side of the first proximal end plate 103 is provided with a first through slot 114 and a second through hole 115 along the axial direction, which are away from the second groove 111 and are located on a side of the first positioning boss 113 away from the first positioning hole 112, the first through slot 114 is used for accommodating and supporting a control rod, and the second through hole 115 is used for allowing the control wire 153 to pass through. Therefore, by providing the first through slot 114, it is not only ensured that the distal end of the lever 141 can pass through the proximal end of the base 110 (specifically, the first proximal end plate 103) to be connected with the needle holder 120, but also the lever 141 is limited, so as to ensure that the lever 141 can smoothly drive the needle holder 120 to rotate. In addition, by providing the first penetration groove 114 in a groove type structure, not only can it be ensured that the distal end of the lever 141 smoothly passes through the proximal end of the base 110 to be hinged with the hub 120, but also the thickness of the first proximal end plate 103 can be reduced compared to a through-hole type structure, so that the size of the cross section (cross section perpendicular to the axial direction) of the biological tissue suturing device 100 can be reduced. Through the arrangement of the second through hole 115, the distal end of the control wire 153 can pass through the proximal end of the base 110 to be connected with the driving shaft 151, and the control wire 153 can play a limiting role, so that the control wire 153 can smoothly drive the driving shaft 151 to drive the shifting piece 152 to rotate. In addition, by providing the second through hole 115 with a through hole structure, it is possible to facilitate the second through hole 115 on the side of the first proximal end plate 103 near the horizontal mounting plate 101, so that it is more convenient to fixedly connect the manipulation wire 153 penetrating out of the second through hole 115 to one end (i.e., the first shaft body 1511) of the driving shaft 151 near the horizontal mounting plate 101.

With continued reference to fig. 10 and 11, fig. 10 is a schematic diagram illustrating a driving shaft 151 driven to rotate by a control wire 153 in a biological tissue suturing device according to an embodiment of the present invention; fig. 11 is a schematic diagram illustrating a driving shaft 151 driven to rotate reversely by a control wire 153 in a biological tissue suturing device according to an embodiment of the present invention. As shown in fig. 10 and 11, in an exemplary embodiment, the manipulation wire 153 includes a first manipulation portion 1531 and a second manipulation portion 1532, and a distal end of the first manipulation portion 1531 is connected with a distal end of the second manipulation portion 1532 to form a socket portion 1533 for being socket-connected on an outer circumference of the driving shaft 151. Thus, the driving shaft 151 can be controlled to rotate the paddle 152 in different directions by the first control portion 1531 and the second control portion 1532. Specifically, as shown in fig. 10 and 11, by pulling the first manipulation unit 1531, the driving shaft 151 may be driven to rotate the pulling plate 152 forward, so as to drive the suture needle 130 to insert or insert the suture thread 160 into or out of the peripheral tissue 730 of the object 710 to be closed (e.g. a vascular wound); by pulling the second control portion 1532, the driving shaft 151 may be driven to drive the pulling piece 152 to rotate reversely, so as to drive the pulling piece 152 to withdraw from the first clamping groove 132 or the second clamping groove 133. Specifically, one of the points on the socket 1533 may be fixedly connected to the driving shaft 151 by bonding or welding.

Preferably, the first manipulation part 1531 and the second manipulation part 1532 are formed by folding the same wire, which are two ends of the same manipulation wire, and the middle parts of the two are sleeved on the driving shaft 151, thereby forming the sleeved part 1533. This arrangement can ensure the strength of the manipulation wire 153, and can eliminate the step of connecting the first manipulation unit 1531 and the second manipulation unit 1532. Specifically, the cross section of the metal wire can be rectangular, circular or other shapes, and the metal wire can be made of metal materials such as stainless steel or nickel titanium. Further, the manipulation wire 153 may be wound around the driving shaft 151 two or more times to increase the steerable angular range of the driving shaft 151, thereby increasing the steerable angular range of the paddle 152.

With continued reference to fig. 1, the base 110 further includes a first distal end plate 102 at a distal end, and the hub 120 is positioned between the first distal end plate 102 and the first proximal end plate 103. As shown in fig. 16, the biological tissue suturing device further includes a seat cover 170 covering the base 110, the seat cover 170 including a top plate 171 disposed opposite the horizontal mounting plate 101, a second proximal end plate 173 connected to the first proximal end plate 103, and a second distal end plate 172 connected to the first distal end plate 102. Thus, by providing the cap 170 to cover the base 110, the biological tissue suturing device 100 may have a smooth outer contour with the needle hub 120 maintained in a closed state to further facilitate pushing the biological tissue suturing device 100 to the distal end of the subject 710 (e.g., a vascular wound) to be closed.

Based on the same inventive concept, the present invention further provides a single needle tissue closing apparatus, please refer to fig. 12 to 15, wherein fig. 12 is a schematic diagram of an overall structure of the single needle tissue closing apparatus according to an embodiment of the present invention; fig. 13 is a schematic view showing a partial structure of a needle holder 120 in an unfolded state in a single needle tissue closing device according to an embodiment of the present invention; FIG. 14 is a schematic view of a single needle tissue closure device according to an embodiment of the present invention in which a paddle 152 begins to push the needle 130 to rotate; fig. 15 is a schematic view illustrating a structure in which a pulling piece 152 in a single needle tissue closing device according to an embodiment of the present invention pushes a suture needle 130 into a second groove 111. As shown in fig. 12 to 15, the single needle tissue closing instrument provided by the present invention includes the above-described biological tissue suturing device 100. Because the single-needle tissue closing apparatus provided by the present invention includes the biological tissue suturing device 100 described above, the single-needle tissue closing apparatus provided by the present invention can implement closing of objects 710 to be closed (e.g., vascular wounds) with various sizes, and the single-needle tissue closing apparatus provided by the present invention not only can suture objects 710 to be closed (e.g., vascular wounds) in a small space, but also can effectively increase the suturing range of the suturing needle 130 by means of unfolding the needle stand 120, so as to meet the closing requirement of objects 710 to be closed (e.g., vascular wounds) with a larger range. In addition, the single needle tissue closing instrument provided by the invention can realize multiple needle penetration actions through one intervention, so that a better closing effect can be achieved, and particularly, a better hemostatic effect can be achieved when a vascular wound is closed. It should be noted that the needle hub 120 is in a closed state until the biological tissue suturing device 100 is advanced to the distal end of the object 710 to be closed (e.g., a vascular wound), as will be appreciated by those skilled in the art.

With continued reference to fig. 12-15, as shown in fig. 12-15, the single needle tissue closure device provided by the present invention further comprises a guide tube 200, wherein the proximal end of the guide tube 200 is connected to the distal end of the biological tissue suturing device 100. Thus, by providing the guide tube 200 at the distal end, a guiding function may be performed to facilitate better pushing of the biological tissue suturing device 100 through the guide tube 200 to the distal end of the object 710 to be closed (e.g., a vascular wound).

Further, the single needle tissue closing device provided by the present invention further comprises a sheath 300, wherein the sheath 300 is connected to the proximal end of the biological tissue suturing device 100. Since the sheath 300 has a certain axial strength and torsion strength, the pushability and pushability of the single needle tissue closure device can be ensured. Please continue to refer to fig. 17, which is a cross-sectional view of a guide tube 200 according to an embodiment of the present invention. In an exemplary embodiment, as shown in fig. 17, the guide tube 200 has a guide wire lumen 201 penetrating a distal end surface thereof in an axial direction thereof, and one side of a proximal end of the guide tube 200 is provided with a guide wire hole 202 communicating with the guide wire lumen 201. Thus, by providing the guide tube 200 with a guidewire lumen 201 extending through its distal end surface, the guide tube 200 may be guided through an object 710 to be closed (e.g., a vascular wound) into a target passageway (e.g., a blood vessel) by facilitating passage through a guidewire (a wire for guiding a surgical instrument to be pushed during an interventional procedure) disposed within the guidewire lumen 201. Meanwhile, by providing the guide wire hole 202 communicating with the guide wire lumen 201 at the side of the guide tube 200, not only can the guide wire be withdrawn from the patient through the guide wire hole 202 after the guide tube 200 is guided into the target channel (e.g., blood vessel) by the guide wire, but also the opening and closing movement of the needle holder 120 can be prevented from being affected by the guide wire passing through the biological tissue suturing device 100, and the overall size of the single needle tissue closing instrument can be advantageously reduced, in particular, the size of the biological tissue suturing device 100 and the guide tube 200 can be reduced.

Specifically, the dimensions of the guidewire lumen 201 and the guidewire aperture 202 satisfy the following conditions: a guidewire of 0.035 to 0.038 inches in diameter is allowed through.

With continued reference to fig. 12 and 17, as shown in fig. 12 and 17, in an exemplary embodiment, the guide tube 200 includes a first tube segment 210, a second tube segment 220 and a third tube segment 230 sequentially connected in a distal-to-proximal direction thereof, the outer diameter of the first tube segment 210 gradually decreases in a proximal-to-distal direction thereof, the outer diameter of the second tube segment 220 remains unchanged in a proximal-to-distal direction thereof, the third tube segment 230 is bent so that the guide tube 200 is disposed at an angle to the biological tissue suturing device 100, the guide wire lumen 201 extends through both axial ends of the first tube segment 210, and the guide wire hole 202 is provided in the second tube segment 220 and extends through the distal end of the second tube segment 220. Thus, by providing the guide tube 200 as a catheter with a gradual change in size, with a large outer diameter at the proximal end and a small outer diameter at the distal end, the guide tube 200 can be made to have a smaller distal-most cross-sectional size/diameter, thereby making it easier to initially access the target tissue or lumen.

With continued reference to fig. 17, as shown in fig. 17, in an exemplary embodiment, the first pipe section 210 includes an outer pipe 211 and an inner pipe 212 coaxially disposed, the outer pipe 211 is sleeved on the outer portion of the inner pipe 212, and the guide wire cavity 201 penetrates through two axial ends of the inner pipe 212. Therefore, the arrangement ensures that the hardness of the distal end of the guide tube 200 is relatively low (soft), so that the distal end of the guide tube 200 has better compliance, and the guide tube 200 can be easily biased when touching the tissue/blood vessel corner to adjust the pushing direction, so that the single-needle tissue closing device provided by the invention can be pushed in a curved, complex or large-corner target channel more easily.

Specifically, the outer tube 211 and the inner tube 212 may be sleeved by hot melt, adhesive, injection molding, or other connection means. The outer tube 211 may be made of polymer materials such as PP (polypropylene), PEBAX (block polyether amide), PTFE (polytetrafluoroethylene), etc. The inner tube 212 may be made of polymer materials such as PP (polypropylene), PE (polyethylene), TPU (thermoplastic polyurethane elastomer), etc.

Preferably, the inner wall of the inner tube 212 has a certain smoothness to enable the guidewire to smoothly pass within the guidewire lumen 201.

In an exemplary embodiment, the first pipe segment 210 further includes a reinforcing layer (not shown) disposed between the outer pipe 211 and the inner pipe 212. Thus, by providing an additional layer between the outer tube 211 and the inner tube 212, the strength of the first tube section 210 may be increased, thereby enhancing the overall mechanical properties of the guide tube 200. In particular, the reinforcement layer includes, but is not limited to, a metal mesh braid or a metal cut tube, or the like.

With continued reference to fig. 17, in an exemplary embodiment, the portions of the second tube segment 220 other than the guidewire port 202 are solid, and the third tube segment 230 is solid along its proximal to distal ends, as shown in fig. 17. Thus, this arrangement ensures a high stiffness of the proximal end of the guide tube 200, thereby ensuring a certain axial stiffness and circumferential stiffness of the guide tube 200 to increase the pushing and twisting performance of the guide tube 200.

In an exemplary embodiment, the outer surface of the guide tube 200 is coated with a hydrophilic coating (not shown). Thus, by applying a hydrophilic coating to the outer surface of the guide tube 200, the guide tube 200 may be made smoother when passing through the object 710 to be closed (e.g., a vascular wound) and into a target passageway (e.g., a blood vessel). Specifically, the hydrophilic coating may be applied only to the outer surface of the first pipe section 210, or may be applied to the outer surface of the entire section of the guide pipe 200, which is not limited in the present invention.

With continued reference to fig. 13 and fig. 18, fig. 18 is a diagram illustrating a connection relationship between the guide tube 200 and the first transition joint 400 according to an embodiment of the present invention. As shown in fig. 13 and 18, in an exemplary embodiment, the single needle tissue closing apparatus further includes a first transition joint 400 provided between the guide tube 200 and the biological tissue suturing device 100, and a second transition joint 500 provided between the biological tissue suturing device 100 and the sheath 300, the first transition joint 400 having an outer diameter gradually increasing in a distal-to-proximal direction thereof, and the second transition joint 500 having an outer diameter gradually decreasing in a distal-to-proximal direction thereof. Since the dimension of the cross section (cross section perpendicular to the axial direction) of the biological tissue suturing device 100 is different from the dimension of the cross section (cross section perpendicular to the axial direction) of the proximal end of the guide tube 200, by providing the first transition joint 400 having a gradually changed dimension with a small distal outer diameter and a large proximal outer diameter between the guide tube 200 and the biological tissue suturing device 100, the biological tissue suturing device 100 and the guide tube 200 can be smoothly transited to reduce the tissue passing resistance caused by the dimensional change. Similarly, since the dimension of the cross section (the cross section perpendicular to the axial direction) of the biological tissue suturing device 100 is different from the dimension of the cross section (the cross section perpendicular to the axial direction) of the distal end of the sheath 300, by providing the second transition joint 500 having a gradually changed dimension with a larger distal end and a smaller proximal end between the sheath 300 and the biological tissue suturing device 100, the biological tissue suturing device 100 and the sheath 300 can be smoothly transited to reduce the tissue passing resistance caused by the dimensional change.

Specifically, the first transition joint 400 may be fixedly connected to the biological tissue suturing device 100 and the guide tube 200 by bonding, welding, hot melting, crimping, or other connection means. The second transition joint 500 may also be fixedly coupled to the biological tissue suturing device 100 and the sheath 300 by bonding, welding, hot melt, crimping, or other means of attachment. The first transition joint 400 and the second transition joint 500 may be made of a relatively soft polymer material such as PE (polyethylene), HDPE (high density polyethylene), or silicone.

With continued reference to fig. 1 and 6, in an exemplary embodiment, the second transition joint 500 is provided with a plurality of first through holes 510 extending through both axial ends thereof. Thus, by providing a plurality of the first through holes 510, the manipulation rod 141, the manipulation wire 153, and the second transition joint 500 may be conveniently passed through different first through holes 510 to extend into the sheath 300.

Further, as shown in fig. 6, the lever connector 142 is provided with a plurality of second through holes 1421 penetrating both axial ends thereof. Thus, the steering wire 153 of the biological tissue suturing device 100 is passed through the steering rod joint 142 via the second through hole 1421 to extend into the sheath 300.

In an exemplary embodiment, the sheath 300 has a first lumen (not shown) for threading the suture 160, a second lumen (not shown) for threading the lever 141, and a third lumen (not shown) for threading the steering wire 153. Specifically, at least a portion of the suture 160 is disposed through the first lumen, at least a portion of the lever 141 is disposed through the second lumen, and at least a portion of the control wire 153 is disposed through the third lumen. Therefore, the arrangement can avoid the mutual interference among the suture line 160, the control rod 141 and the control wire, so as to further ensure the stability of the single-needle tissue closing instrument provided by the invention in the use process.

With continued reference to fig. 12, in an exemplary embodiment, as shown in fig. 12, the single needle tissue closing apparatus further includes a handle 600 connected to the proximal end of the sheath 300, wherein a first driving button (not shown) for controlling the lever 141 to drive the needle holder 120 to rotate relative to the base 110 and a second driving button (not shown) for controlling the control wire 153 to drive the suturing needle 130 to perform suturing motion along the motion track are provided on the handle 600. Thus, by providing the first driving button and the second driving button on the handle 600, it is possible to more facilitate the operator's operation.

The invention also provides an operation method of the single needle tissue closing device, which is applied to the single needle tissue closing device. Fig. 19 is a flowchart illustrating an operation method of the single needle tissue closing device according to an embodiment of the present invention. As shown in fig. 19, the operation method of the single needle tissue closing apparatus provided by the invention comprises the following steps:

step S110, pushing the single needle tissue closing device with the needle holder 120 in the closed state toward the direction approaching the object to be closed 710 until the biological tissue suturing device 100 penetrates the object to be closed 710 and reaches into the target cavity 720 (see fig. 20 a) located at the distal end of the object to be closed 710;

step S120, unfolding the needle seat 120;

step S130, according to a preset suturing strategy, controlling the needle stand 120 to sequentially abut against each target suture point of the object to be closed 710, and driving the suturing needle 130 to pass through the peripheral tissue 730 of the target suture point along the movement track with the suturing thread 160 for each target suture point after the needle stand 120 abuts against the target suture point until the suturing needle 130 returns to the initial position, so as to complete suturing of the target suture point, wherein at least two suture points are located on different sides of the object to be closed 710;

Step S140, closing the needle stand 120 after the suturing of all the target suture points is completed;

step S150, withdraw the single needle tissue closing device, and tie and lock the suture 160 to retract and pull the two sides of the object to be closed 710.

Therefore, the operation method of the single needle tissue closing apparatus provided by the invention can realize the closing of objects 710 (such as vascular wounds) to be closed with various sizes, the invention can suture the objects 710 (such as vascular wounds) to be closed in a narrow space, and simultaneously the suture range of the suture needle 130 can be effectively increased by the way of unfolding the needle seat 120, so that the closing requirement of the objects 710 (such as vascular wounds) to be closed with a larger range can be met. In addition, the operation method of the single needle tissue closing instrument provided by the invention can realize multiple needle threading actions through one intervention, so that a better closing effect can be achieved, and particularly, a better hemostatic effect can be achieved when a vascular wound is closed.

It should be noted that, as will be understood by those skilled in the art, the number of the target suture points of the object to be closed 710 may be set according to practical situations (for example, the actual size of the object to be closed 710), which is not limited in the present invention, but the condition that at least one target suture point is set on each side of the object to be closed 710 is required to be satisfied. It should be further noted that, as those skilled in the art can understand, the stitching of each target stitching point on the same side may be performed first, and then the stitching of each target stitching point on the other side may be performed, or the stitching of each target stitching point on both sides may be performed alternately: after the stitching of a certain target stitching point on one side is completed, stitching of a certain target stitching point on the other side is performed, and so on, until the stitching of all target stitching points on both sides of the object 710 to be closed is completed. In addition, it should be noted that, as those skilled in the art can understand, after the knotting is completed, the knotted knot can be locked by using the knot pusher, and then cut after the locking.

Specifically, the stitching strategy includes the number of target stitching points, the positions of the target stitching points, and the stitching order of the target stitching points. Further, the single needle tissue closure device may be moved by rotation and/or translation to enable the hub 120 of the single needle tissue closure device to abut different target suture points.

In an exemplary embodiment, the pushing of the single needle tissue closing device with the needle hub 120 in the closed state toward the direction approaching the object to be closed 710 until the biological tissue suturing device 100 penetrates the object to be closed 710 and reaches the target cavity 720 at the distal end of the object to be closed 710, includes:

threading a guide wire into the guide tube 200, pushing the single needle tissue closing device with the needle stand 120 in a closed state towards the direction approaching to the object to be closed 710 through the guide wire, and withdrawing the guide wire from the guide tube 200 after the guide tube 200 penetrates into the object to be closed 710 and enters the target cavity 720;

pushing the single needle tissue closing instrument continues until the biological tissue suturing device 100 penetrates the object 710 to be closed and reaches within the target lumen 720 at the distal end of the object 710 to be closed.

Specifically, a guide wire may be inserted into the guide wire lumen 201 of the guide tube 200, the distal end of the guide wire is inserted out of the distal end of the guide tube 200, a single needle tissue closing device is pushed through the guide wire along a path which is preset in the body and leads to the object to be closed 710 (for example, a vascular wound), after the guide tube 200 enters the target lumen 720 (for example, a vascular wound), the guide wire is withdrawn before the guide wire hole 202 on the guide tube 200 enters the body, and then the single needle tissue closing device is continuously pushed until the biological tissue suturing device 100 reaches the target lumen 720 (for example, a vascular wound) at the distal end of the object to be closed 710 (for example, a vascular wound), and a distance is continuously pushed after reaching the target lumen 720 (for example, a vascular wound) to be closed.

In an exemplary embodiment, the driving the suture needle 130 with the suture thread 160 along the moving track through the peripheral tissue 730 of the target suture site until the suture needle 130 returns to its initial position to complete the suturing of the target suture site, comprising:

pulling the first manipulation portion 1531 of the manipulation wire 153 to drive the driving shaft 151 to drive the pulling piece 152 engaged with the second clamping groove 133 of the suture needle 130 to push the suture needle 130 to penetrate into the peripheral tissue 730 of the target suture point along the movement track with the suture thread 160 until the first clamping groove 132 of the suture needle 130 penetrates out of the peripheral tissue 730 and enters the second groove 111;

The second operation portion 1532 of the operation wire 153 is pulled to drive the driving shaft 151 to drive the pulling piece 152 to retract from the second clamping groove 133 until the pulling piece 152 is clamped with the first clamping groove 132;

the first manipulation portion 1531 is pulled to drive the driving shaft 151 to drive the pulling piece 152 engaged with the first clamping groove 132 to push the suture needle 130 to drive the suture thread 160 to pass through the peripheral tissue 730 of the target suture point along the moving track until the suture needle 130 returns to the initial position, so as to complete the suturing of the target suture point.

Specifically, please refer to fig. 20a to 20g, wherein fig. 20a is a schematic diagram of a single needle tissue closing apparatus provided by the present invention before starting suturing one side of an object 710 to be closed; FIG. 20b is a schematic view of a single needle tissue closure device according to the present invention, wherein the suture needle 130 is inserted into the peripheral tissue 730 on one side of the object to be closed 710 with the suture thread 160; FIG. 20c is a schematic view of a single needle tissue closing device according to the present invention, wherein the suture needle 130 is passed through the peripheral tissue 730 on one side of the object to be closed 710 with the suture thread 160; FIG. 20d is a schematic view of a single needle tissue closure device according to the present invention prior to initiating suturing of another side of a subject 710 to be closed; FIG. 20e is a schematic illustration of a single needle tissue closure device according to the present invention wherein the needle 130 carries the suture 160 through the peripheral tissue 730 on the other side of the object 710 to be closed; FIG. 20f is a schematic illustration of a single needle tissue closure device according to the present invention withdrawn from an object 710 to be closed; FIG. 20g is a graph of the suturing effect of the single needle tissue closure device provided by the present invention. As shown in fig. 20a to 20g, the deployed needle holder 120 of the single needle tissue closing apparatus may be first abutted against a target suture site on one side of the object 710 to be closed, then the suture needle 130 is driven to penetrate the peripheral tissue 730 on the side with the suture thread 160, and then the suture needle 130 is driven to penetrate the peripheral tissue 730 on the side with the suture thread 160, so as to complete the suturing of one of the target suture sites on the side. The single needle tissue closing instrument is then rotated 180 ° and moved to bring the hub 120 into abutment with a target suture site on the other side of the object to be closed 710, and the suture needle 130 is then driven to penetrate and penetrate the peripheral tissue 730 on that side with the suture thread 160, thereby completing the suturing of one of the target suture sites on that side. After suturing of all target suture sites is completed, the biological tissue suturing device 100 is withdrawn from the object to be closed 710 (e.g., a vascular wound), and then the suture 160 is pulled and knotted, locked, and cut, so that both sides of the object to be closed 710 (e.g., a vascular wound) can be pulled and retracted, thereby closing both sides of the object to be closed 710 (e.g., a vascular wound).

It should be noted that in the description of the present specification, descriptions of terms "one embodiment," "some embodiments," "examples," "specific examples," or "some examples," etc., mean that a particular feature, structure, material, or characteristic described in connection with the embodiment or example is included in at least one embodiment or example of the present invention. In this specification, schematic representations of the above terms are not necessarily directed to the same embodiment or example. Furthermore, the particular features, structures, materials, or characteristics described may be combined in any suitable manner in any one or more embodiments or examples. Furthermore, the various embodiments or examples described in this specification and the features of the various embodiments or examples may be combined and combined by those skilled in the art without contradiction.

It should be further noted that the above description is only for the preferred embodiments of the present invention, and is not intended to limit the scope of the present invention, and any changes and modifications made by those skilled in the art based on the above disclosure shall fall within the scope of the present invention. It will be apparent to those skilled in the art that various modifications and variations can be made to the present invention without departing from the spirit or scope of the invention. Thus, the present invention is intended to include such modifications and alterations insofar as they come within the scope of the invention or the equivalents thereof.

Claims

1. A biological tissue suturing device is characterized by comprising a base, a needle seat and a suturing needle,

2. The biological tissue suturing device of claim 1, wherein the base comprises a horizontal mounting plate, the axial length of the hub is less than or equal to the length of the horizontal mounting plate, a first mounting hole is formed in the proximal end of the horizontal mounting plate, a rotating shaft is arranged in the proximal end of the bottom of the hub, the position of the rotating shaft is matched with that of the first mounting hole, and the rotating shaft and the first mounting hole are in rotary connection.

3. The biological tissue suturing device of claim 2, wherein the proximal end of the horizontal mounting plate is further provided with a first positioning boss, the bottom of the first positioning boss being positioned at the same horizontal location as the top of the first mounting hole, the axial length of the first positioning boss being greater than the diameter of the first mounting hole, thereby causing the first positioning boss to axially extend beyond the first mounting hole.

4. The biological tissue suturing device of claim 3, wherein the horizontal mounting plate has first and second opposite sides in a horizontal direction, the first mounting aperture being located on the first side and the first positioning boss being located on the second side; and the first mounting hole has a first distance from the edge of the first side of the horizontal mounting plate.

5. The biological tissue suturing device of claim 4, wherein a second locating boss is disposed between the shaft and an edge of the first side of the hub at the bottom of the hub, the second locating boss being adapted to the first spacing.

6. The biological tissue suturing device of claim 5, wherein the first and second positioning bosses are located on either side of the shaft in a horizontal direction when the hub is in a closed state; and when the needle seat is in the unfolding state, the second positioning boss rotates to abut against the first positioning boss.

7. The biological tissue suturing device of claim 6, wherein the upper surface of the hub is provided with a projection and a first recess surrounded by the projection, the inner contour of the projection being shaped to match the outer contour of the suturing needle, the suturing needle being initially positioned within the first recess and abutting against the inner contour of the projection.

8. The biological tissue suturing device of claim 7, wherein the top end of the boss has an eave portion protruding inwardly along its circumference, the inner contour of the boss and the eave portion together defining a path of movement of the suturing needle.

9. The biological tissue suturing device of claim 7, wherein the proximal end of the outer side of the boss is provided with a connecting aperture for articulating the distal end of the lever with the hub.

10. The biological tissue suturing device of claim 7, further comprising a drive shaft, wherein the hub is centrally disposed in the horizontal direction and is offset to the first side with a second mounting hole, and wherein the drive shaft is rotatably coupled to the second mounting hole.

11. The biological tissue suturing device of claim 10, wherein the drive shaft comprises a first shaft body and a second shaft body coaxially disposed, the first shaft body having a diameter greater than the second shaft body, the second shaft body having a diameter that matches the bore diameter of the second mounting bore, the first shaft body being positioned below the second mounting bore, the second shaft body being positioned above the second mounting bore.

12. The biological tissue suturing device of claim 11, further comprising a paddle positioned within the first recess, one end of the paddle being fixedly connected to the second shaft and the other end of the paddle abutting the suturing needle; a first clamping groove matched with the poking piece is formed in one end, close to the needle point, of the suture needle, and a second clamping groove matched with the poking piece is formed in one end, far away from the needle point, of the suture needle;

13. The biological tissue suturing device of claim 7, wherein the base includes a first proximal end plate at a proximal end, the horizontal mounting plate having a height less than a height of the first proximal end plate; the distal end of the first proximal end plate is provided with a second groove, the second groove and the first groove are positioned at the same height, the outline of the second groove is arc-shaped, a part of a movement track of the suture needle is formed, and the circle center of the arc-shaped is positioned at the first side; when the needle seat is in the unfolding state, the circle center of the second groove coincides with the circle center of the first groove.

14. The biological tissue suturing device of claim 13, wherein the second side of the first proximal end plate is axially provided with a first through slot for receiving and supporting a steering rod and a second through hole for passing a steering wire therethrough, both distal from the second recess.

15. The biological tissue suturing device of claim 13, wherein the base further comprises a first distal end plate at a distal end, the hub being positioned between the first distal end plate and the first proximal end plate; the biological tissue suturing device further comprises a seat cover which is covered with the base, wherein the seat cover comprises a top plate, a second proximal end plate and a second distal end plate, the top plate is arranged opposite to the horizontal mounting plate, the second proximal end plate is connected with the first proximal end plate, and the second distal end plate is connected with the first distal end plate.

16. A single needle tissue closure device comprising the biological tissue suturing device of any one of claims 1-15.

17. A method of operation of a single needle tissue closure device as claimed in any one of claims 1 to 10, the method of operation comprising:

unfolding the needle seat;

18. The method of operating a single needle tissue closure device according to claim 17, wherein said driving said needle with said suture thread along said trajectory through surrounding tissue of said target suture site until said needle returns to its original position to complete suturing of said target suture site, comprises: