CN115211915A - Interventional suturing device - Google Patents

Abstract

The invention discloses an interventional suturing device. The interventional suturing device includes a suturing assembly. The suturing assembly comprises a shell, a puncturing part contained in the shell and a driving part. The distal end of the housing has an opening. The puncture component comprises a needle handle and a puncture needle connected with the needle handle. The puncture needle is movably extended out of the opening and is provided with a cavity for the suture to pass through. The driving part is connected with the needle handle. The driving part drives the puncture part to rotate between an initial position and a preset position, and when the puncture part rotates to the preset position, the suture thread passes through the cavity and is pulled out of the cavity. The interventional suturing device provided by the embodiment of the invention avoids the problems that a suture line is easy to knot and is wound around a puncture needle in the puncture process, so that the operation is simpler and more convenient.

Description

Interventional suturing device

Technical Field

The invention relates to the technical field of medical instruments, in particular to an interventional suturing device.

Background

Mitral insufficiency is one of the most common annular tissue lesions today, and the main causes of mitral insufficiency are mitral annular dilation, chordae tendineae insufficiency, mitral valve mucus degeneration, leaflet prolapse, rheumatic annular tissue disease, and ischemic lesions.

Mitral insufficiency can be treated by adjusting the circumference of the annulus by pulling sutures after implanting them, which are usually done with suture devices. The existing suture device comprises a puncture needle with an arched bracket and a rack with a corresponding arched channel, wherein a suture line is preset at one end of the puncture needle, the puncture needle moves in the channel, and when a needle point enters from one end of the rack to the other end, the suture line is driven to penetrate through tissues for suture.

Disclosure of Invention

In order to solve the above technical problem or at least partially solve the above technical problem, the present invention provides an interventional suturing device comprising a suturing assembly comprising:

a housing having an opening at a distal end thereof;

the puncture component is accommodated in the shell and comprises a needle handle and a puncture needle connected with the needle handle, the puncture needle movably extends out of the opening, and the puncture needle is provided with a cavity for a suture to pass through;

a drive member connected to the needle handle;

the driving part drives the puncture part to rotate between an initial position and a preset position, and when the puncture part rotates to the preset position, the suture thread passes through the cavity and is pulled out of the cavity.

Compared with the prior art, the technical scheme provided by the embodiment of the invention has the following advantages:

in the interventional suturing device provided by the embodiment of the invention, the puncture component can be driven by the driving component to rotate from the initial position to the preset position so as to puncture the tissue to be sutured, then the suture thread passes through the cavity of the puncture needle and is pulled out of the cavity, and the driving component drives the puncture component to retreat from the preset position to the initial position so that the suture thread is sutured into the tissue to be sutured. The suture thread penetrates out of the cavity of the puncture needle after the tissue to be sutured is punctured, so that the problems that the suture thread is easy to tie and twine the puncture needle in the puncturing process are avoided, and the operation is simpler and more convenient.

Drawings

The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments consistent with the invention and together with the description, serve to explain the principles of the invention.

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the embodiments or the technical solutions in the prior art will be briefly described below, and it is obvious for those skilled in the art to obtain other drawings without inventive labor.

In the drawings:

FIG. 1 is a schematic structural diagram of an interventional suturing device provided in accordance with an embodiment of the present invention;

FIG. 2 is a schematic diagram of a portion of an interventional suturing device in accordance with an embodiment of the present invention;

fig. 3 and 4 are partial enlarged views at a in fig. 2;

FIGS. 5 and 6 are schematic structural views of a puncturing part provided in the embodiment of the present invention;

fig. 7 to 9 are schematic structural views of a puncture needle provided in accordance with an embodiment of the present invention;

FIG. 10 is a schematic structural view of a suturing assembly provided in accordance with an embodiment of the present invention;

FIG. 11 is a schematic structural diagram of a wire pulling assembly provided by an embodiment of the present invention;

FIG. 12 is a schematic structural diagram illustrating an embodiment of an interventional suturing device according to the present invention;

FIG. 13 is a cross-sectional view of one embodiment of a suturing assembly provided in accordance with an embodiment of the present invention;

FIG. 14 is another cross-sectional view of an embodiment of a suturing assembly in accordance with an embodiment of the present invention;

FIG. 15 is a schematic structural diagram of a driving member provided in an embodiment of the present invention;

FIGS. 16-20 are schematic views illustrating the operation of an interventional suturing device according to embodiments of the present invention;

FIGS. 21-25 are schematic views illustrating the operation of the interventional suturing device for suturing mitral valve annulus tissue according to an embodiment of the present invention;

fig. 26 is a schematic view of a knotting method of a suture according to an embodiment of the present invention.

Detailed Description

For a more clear understanding of the technical features, objects and effects of the present invention, embodiments of the present invention will now be described in detail with reference to the accompanying drawings. In the following description, it is to be understood that the orientations and positional relationships indicated by "front", "rear", "upper", "lower", "left", "right", "longitudinal", "lateral", "vertical", "horizontal", "top", "bottom", "inner", "outer", "leading", "trailing", and the like are configured and operated in specific orientations based on the orientations and positional relationships shown in the drawings, and are only for convenience of describing the present invention, and do not indicate that the device or element referred to must have a specific orientation, and thus, are not to be construed as limiting the present invention.

It should also be noted that, unless expressly specified or limited otherwise, the terms "mounted," "connected," "secured," "disposed," and the like are to be construed broadly and encompass, for example, both fixed and removable connections or integral units; can be mechanically or electrically connected; they may be directly connected or indirectly connected through intervening media, or may be connected through the interconnection of two elements or through the interaction of two elements. When an element is referred to as being "on" or "under" another element, it can be "directly" or "indirectly" on the other element or intervening elements may also be present. The terms "first", "second", "third", etc. are merely for convenience in describing the present technical solution, and cannot be understood to indicate or imply relative importance or to implicitly indicate the number of technical features indicated, so that a feature defined as "first", "second", "third", etc. may explicitly or implicitly comprise one or more of such features. The specific meanings of the above terms in the present invention can be understood by those skilled in the art according to specific situations.

In the following description, for purposes of explanation and not limitation, specific details are set forth, such as particular system structures, techniques, etc. in order to provide a thorough understanding of the embodiments of the invention. It will be apparent, however, to one skilled in the art that the present invention may be practiced in other embodiments that depart from these specific details. In other instances, detailed descriptions of well-known systems, devices, circuits, and methods are omitted so as not to obscure the description of the present invention with unnecessary detail.

In the description of the present invention, it should be noted that, in the field of interventional medical devices, the proximal end refers to the end closer to the operator, and the distal end refers to the end farther from the operator; axial refers to a direction parallel to the line connecting the center of the distal end and the center of the proximal end of the medical device. The foregoing definitions are for convenience only and are not to be construed as limiting the present invention.

Referring to fig. 1 to 26, an interventional suturing device 1 according to an embodiment of the present invention includes a suturing assembly 10, a tube assembly 20, a pull wire assembly 30 and a handle 40.

Referring to fig. 1-4, the suturing assembly 10 includes a housing 110, a puncture member 120 housed within the housing 10, and a drive member 130. The distal end of the housing 110 has an opening 110a. The puncture member 120 includes a needle shaft 121 and a puncture needle 122 connected to the needle shaft 121. The puncture needle 122 is movably protruded from the opening 110a, and the puncture needle 122 has a cavity 122a for passing the suture 3 therethrough. The drive member 130 is coupled to the needle shaft 121. The driving member 130 drives the puncture member 120 to rotate between the initial position and the preset position, and the suture thread 3 passes through the cavity 122a and is pulled out from the cavity 122a when the puncture member 120 rotates to the preset position.

In the interventional suturing device 1 provided by the embodiment of the invention, the puncture member 120 can be driven by the driving member 130 to rotate from the initial position to the preset position to puncture the tissue 5 to be sutured, then the suture thread 3 passes through the cavity 122a of the puncture needle 122 and is pulled out from the cavity 122a, and the driving member 130 drives the puncture member 120 to retreat from the preset position to the initial position, so that the suture thread 3 is sutured into the tissue 5 to be sutured. The suture 3 penetrates out of the cavity 122a of the puncture needle 122 after the tissue 5 to be sutured is punctured, so that the problems that the suture 3 is easy to knot and twine the puncture needle 122 in the puncturing process are avoided, and the operation is simpler and more convenient.

It will be appreciated that the drive member 130 drives the penetration member 120 to rotate between the initial position and the preset position. The initial position is a position where the piercing member 120 is entirely accommodated in the housing 110 (see fig. 16), and the preset position is a maximum position where the piercing needle 122 is passed out from the opening 110a of the housing 110, that is, a maximum position where the piercing needle 122 is passed into the tissue 5 to be sutured (see fig. 17). The driving part 130 drives the puncture part 120 to rotate from the initial position to the preset position, i.e., drives the puncture needle 122 to puncture the tissue 5 to be sutured. The driving part 130 drives the puncture part 120 to retract from the preset position to the initial position, i.e., to retract the puncture needle 122 into the housing 110.

Referring to fig. 5 to 9, the puncture member 120 includes a needle handle 121 and a puncture needle 122 connected to the needle handle 121. The puncture needle 122 includes a suspended needle tip 1221, a connecting end 1222 fixedly connected to the needle handle 121, and an arc-shaped needle body 1223 connected between the connecting end 1222 and the needle tip 1221. The curved needle body 1223 has a hollow cavity 122a, the connecting end 1222 has a wire inlet hole 122b communicating with the hollow cavity 122a, and the needle tip 1221 has a wire outlet hole 122c communicating with the hollow cavity 122 a. One end of the needle shaft 121 is provided with a receiving hole 121a for receiving the connecting end 1222 of the puncture needle 122, and the other end of the needle shaft 121 is provided with a connecting hole 121b for connecting with the driving member 130.

It can be understood that the needle body of the puncture needle 122 is arranged in an arc shape, so that the needle tip 1221 of the puncture needle 122 can form a vertical angle with the tissue 5 to be sutured, the resistance is minimum, and the operation is most convenient. The needle tip 1221 of the puncture needle 122, the arc-shaped needle body 1223, and the connecting end 1222 are integrally formed. The driving member 130 drives the needle handle 121 to rotate from the initial position, and the needle handle 121 drives the puncture needle 122 to rotate so that the needle tip 1221 punctures the tissue 5 to be sutured. The arc-shaped needle body 1223 is provided with a cavity 122a, the connecting end 1222 is provided with a thread inlet hole 122b communicated with the cavity 122a, and the needle tip 1221 is provided with a thread outlet hole 122c communicated with the cavity 122a, so that after the puncture needle 122 rotates to a preset position to puncture the tissue 5 to be sutured, the suture thread 3 can sequentially pass through the thread inlet hole 122b, the cavity 122a and the thread outlet hole 122c, and then the puncture needle 122 is retracted to an initial position to enable the suture thread 3 to be sutured into the tissue 5 to be sutured. Because the suture thread 3 passes through the cavity 122a of the puncture needle 122 to be sutured into the tissue 5 to be sutured after the puncture needle 122 punctures the tissue 5 to be sutured, the problems that the suture thread 3 is easy to knot and twines the puncture needle 122 in the puncturing process can be well avoided, and the suturing operation is simpler and more convenient.

Specifically, the puncture needle 122 may be configured to have a circular arc-shaped structure with a cavity 122a, the puncture needle 122 may perform a movement with a span of at least 8mm and a depth of at least 4mm, so as to facilitate the puncture of the tissue 5 to be sutured, and after the puncture needle 122 punctures the tissue 5 to be sutured, the puncture needle 122 may be retracted into the hollow inner cavity of the housing 10 along the puncture path, so that the suture thread 3 is left in the tissue 5 to be sutured. Correspondingly, the arc-shaped needle body 1223 is configured to be a circular arc-shaped structure with a radius of 4mm and a radian of 240 °. The cross-section of the arcuate needle body 1223 of the needle 122 can have various shapes. In one embodiment, the cross-section of the curved needle body 1223 is square, so that the stability of the curved needle body 1223 can be ensured when piercing the tissue 5 to be sutured. In another embodiment, the arcuate needle body 1223 is diamond shaped in cross-section to provide a greater penetration force to the needle 122. The puncture needle 122 may be made of a metal material, such as stainless steel, silver, nickel titanium, etc.

Referring to fig. 10, the housing 10 has a hollow inner cavity, and the distal end of the housing 10 is provided with an opening 110a communicating with the hollow inner cavity, and the puncture needle 122 is movably protruded or retracted from the opening 110a. The puncture needle 122 is retractably housed in the housing 10, and a certain gap is provided between the housed puncture needle 122 and the inner wall of the housing 10, so that the puncture needle 122 can freely rotate in the hollow inner cavity of the housing 10. The housing 10 may be made of High Density Polyethylene (HDPE), polyether Ether Ketone (PEEK), and other medical polymers, so as to facilitate processing, reduce weight, and facilitate transportation.

The proximal end of the housing 10 is provided with a coupling head 111, and the coupling head 111 is provided with a first guide hole 111a and a second guide hole 111b. When the piercing member 130 rotates to a predetermined position, the wire inlet hole 122b is abutted to the first guide hole 111a, and the wire outlet hole 122c is abutted to the second guide hole 111b. Thus, the suture 3 can pass through the first guide hole 111a into the thread-entering hole 122b, so that the suture 3 can sequentially enter the cavity 122a of the puncture needle 122 during the puncture, and pass out from the needle tip 1221 of the puncture needle 122 to pass out from the second guide hole 111b.

Referring to fig. 11, the interventional suturing device 1 includes a pulling wire assembly 30, the pulling wire assembly 30 includes a pulling member 310 and a noose 320 connected to a distal end of the pulling member 310, the pulling member 310 is movably disposed through the second guide hole 111b, and the noose 320 is extended out of a distal end of the second guide hole 111b. It will be appreciated that the noose 320 is pre-embedded at the distal end of the second guide hole 111b such that after the puncture needle 122 is rotated from the initial position to the predetermined position to pass through the tissue 5 to be sutured, the needle tip 1221 of the puncture needle 122 passes through the noose 320, and the suture 3 is caught by the pull wire assembly 30 and pulled out along the second guide hole 111b.

Referring to fig. 3, 4 and 12, the interventional suturing device 1 further includes a tube assembly 20 connected to the connector 111 of the housing 110. The tube body assembly 20 includes an inlet tube 210 and an outlet tube 211, the inlet tube 210 movably passes through the first guiding hole 111a, and the inlet tube 210 is coupled to the inlet hole 122b. The wire outlet pipe 211 is inserted into the second guiding hole 111b, and the wire outlet pipe 211 is abutted with the wire outlet hole 122c. Suture 3 can thus be passed through inlet bore 122b of needle 122 via inlet tube 210, into cavity 122a of needle 122, out through outlet bore 122c of needle 122, and into outlet tube 211.

Further, the pulling member 310 is movably disposed through the outlet tube 211, and the lasso 320 is capable of passing out of the distal end of the outlet tube 211. Thus, the noose 320 is pre-embedded at the distal end of the outlet tube 211, so that after the puncture needle 122 passes through the tissue 5 to be sutured, the needle tip 1221 of the puncture needle 122 passes through the noose 320, and the suture 3 is caught by the pull wire assembly 30 and pulled into the body assembly 20 along the outlet tube 211 to extend out of the body assembly 20.

It will be appreciated that the tube assembly 20 includes a guide tube having an inner lumen to receive the inlet tube 210 and the outlet tube 211. Specifically, the guiding tube may be provided with one inner cavity for accommodating the wire inlet tube 210 and the wire outlet tube 211, or a plurality of inner cavities for accommodating the wire inlet tube 211 and the wire outlet tube 210 respectively. For ease of machining, the housing 110 may be designed to be of equal radial dimension from the distal end to the proximal end. However, in order to reduce the size of the tube assembly 30, the housing 110 may be designed to gradually decrease in radial dimension from the distal end to the proximal end. Correspondingly, the first guide hole 111a is bent outwards along the radial direction to form an included angle, the second guide hole 111b is also bent outwards along the radial direction to form an included angle, the included angle formed by the incoming line pipe 210 is matched with the first guide hole 111a, and the included angle formed by the outgoing line pipe 211 is also matched with the second guide hole 111b. The commonly used suture 3 is a Polyethylene Terephthalate (PET) material, and since the PET material has a certain rigidity, when the suture 3 is pushed out from the inlet tube 210 having a certain angle or pushed into the outlet tube 211 having a certain angle, the suture 3 is easily bent, and thus the suture cannot be smoothly pushed out of the inlet tube 210 or pushed out of the outlet tube 211. In order to allow the suture 3 to be smoothly pushed out of the bobbin 211 or out of the bobbin 211, the first guide hole 111a and the second guide hole 111b are provided to be bent radially outward at an angle ranging from 120 ° to 180 °.

When the radial dimensions of the housing 110 from the distal end to the proximal end are equal, the first guide hole 111a and the second guide hole 111b are bent radially outward to form an angle of 180 °. When the radial dimension of the housing 110 gradually decreases from the distal end to the proximal end, the first guide hole 111a and the second guide hole 111b are bent radially outward at angles of 120 ° or more and less than 180 °. The distal end of the inlet pipe 211 has flexibility. Thus, the wire inlet pipe 211 with a flexible distal end is movably disposed in the first guide hole 111a, the shape of the distal end of the wire inlet pipe 211 can change along with the included angle of the first guide hole 111a, and the wire inlet pipe 211 can be pushed out from the first guide hole 111a to be communicated with the wire inlet hole 122b. The line outlet pipe 211 can be fixed to penetrate through the second guide hole 111b, and an included angle formed by the line outlet pipe 211 is matched with an included angle of the second guide hole 111b. Of course, the outlet pipe 211 is movably inserted into the second guiding hole 111b, and the distal end of the outlet pipe 211 has flexibility. In this way, the outlet tube 211 with a flexible distal end is movably inserted into the second guiding hole 111b, the shape of the distal end of the outlet tube 211 can change along with the included angle of the second guiding hole 111b, and the outlet tube 211 can be pushed out from the second guiding hole 111b to be communicated with the outlet hole 122c.

Further, in order to reduce the outer diameter of the tube assembly 30, the inlet tube 210 may not be provided, and the inlet hole 122b of the piercing member 120 directly communicates with the first guide hole 111 a. Since the suture 3 is made of PET material and the suture 3 has a certain rigidity, the suture 3 can be pushed into the first guide hole 111a and the thread-entering hole 122b so as to pass through the puncture needle 122 without hindrance. There is no gap between the thread inlet hole 122b and the first guide hole 111a to prevent blood or mucous membrane inside the tissue 5 to be sutured from wetting the suture thread 3. In addition, in order to facilitate pushing the suture 3, a nitinol wire may be connected to the proximal end of the suture 3, and the suture 3 is pushed out of the inlet tube 210 by pushing the nitinol wire.

Referring to fig. 13 to 15, the driving part 130 includes a rotation member 131 and a driving member 132, and the rotation member 131 includes a rotation wheel 1312 and a rotation shaft 1311. The rotation shaft 1311 passes through the rotation wheel 1312 and the needle shaft 121, and the driving member 132 is wound around the rotation wheel 1312 in the circumferential direction. It is understood that the shaft 1311 is fixedly connected to the rotating wheel 1312 and the needle handle 121, respectively, for example, by laser welding, so that the shaft 1311 and the rotating wheel 1312 cannot rotate relatively, and the shaft 1311 and the needle handle 121 cannot rotate relatively. In this way, the driving member 132 drives the rotating wheel 1312 to rotate the rotating shaft 1311, and the rotating shaft 1311 drives the puncturing part 120 to rotate together, so that the driving member 130 can control the rotation of the puncturing part 120 more accurately. The puncture needle 122 of the puncture part 120 can smoothly penetrate into the tissue 5 to be sutured to perform puncture suturing throughout the entire rotation. And after the puncture is finished, the puncture part 120 can be controlled to stably retreat by the driving piece 132, so that the damage to the tissue 5 to be sutured due to untimely transmission is avoided.

Specifically, the driving member 132 can be a cable, and the rotating wheel 1312 includes a wheel shaft and discs disposed at both ends of the wheel shaft, and the cable is wound around the wheel shaft and between the discs at both ends of the wheel shaft. Thus, the driving member 132 drives the rotating member 131 to rotate in a belt transmission manner, and the rotating wheel 1312 can be driven to rotate by pulling the steel cable, so that the transmission manner is stable in transmission and easy to control.

Referring to fig. 15, a friction enhancing member 1313 is further provided on the circumferential side of the rotating wheel 1312, and the driving member 132 is in contact connection with the friction enhancing member 1313. The friction enhancing component 1313 can increase the friction between the driving component 132 and the rotating wheel 1312, improve the smoothness of transmission, and prevent the rotating wheel 1312 from transmitting unstably under the pulling of the driving component 132, thereby causing the puncture needle 122 to damage the tissue 5 to be sutured. The friction enhancing members 1313 may be provided as a toothed structure that is provided to protrude at intervals along the circumferential side of the rotating wheel 1312.

In other embodiments, a stop ring (not shown) is disposed around the rotating wheel 1312, and the driving member 132 is disposed through the stop ring and wound around the rotating wheel 1312. Thus, the driving member 132 is wound around the rotating wheel 1312, and the retainer ring can be deformed to fix the driving member 132 on the rotating wheel 1312, so that pulling the driving member 132 can rotate the rotating wheel 1312. The driving member 132 is stably connected with the rotating wheel 1312, and the belt transmission effect is good. In another embodiment, the rotating wheel 1312 is radially opened with a shaft hole (not shown) penetrating through the rotating wheel 1312, and the driving member 132 is inserted into the shaft hole and wound around the rotating wheel 1312 in the circumferential direction. Specifically, the driving member 132 passes through the axial hole, then winds back along the circumference of the rotating wheel 1312, and passes through the axial hole again to form a ring that fits around the circumference of the rotating wheel 1312. Thus, the driving member 132 is fixed on the rotating wheel 132, and the rotating wheel 132 is rotated by pulling the driving member 132. The driving member 132 is stably connected with the rotating wheel 132, and the belt transmission effect is good.

Referring to fig. 10, the connector 111 at the proximal end of the housing 110 is in communication with the inner cavity of the housing 110, and the proximal end of the connector 111 is in communication with the guide tube of the tube assembly 20. The connector 111 is provided with a first pulling hole 111c and a second pulling hole 111d extending in the axial direction and penetrating into the lumen of the guide tube. The driving member 132 passes through the first pulling hole 111c from the distal end of the guide tube and then winds around the rotating wheel 1312 and extends in the opposite direction until passing through the second pulling hole 111d and extending into the guide tube. Both ends of the driving member 132 extend from the tube assembly 20 to the outside of the tube assembly 20, so that the driving member 132 can be remotely operated to pull the rotating member 131 to rotate in the forward or reverse direction. When the driving member 132 drives the rotating member 131 to rotate forward, the puncturing member 120 rotates and punctures the tissue 5 to be sutured, otherwise, the puncturing member 120 is retracted.

The end face of the opening 110a of the housing 10 is provided with an abutting portion 113, and the abutting portion 113 can enhance the friction force between the interventional suturing device 1 and the tissue 5 to be sutured, so as to avoid the relative sliding between the housing 10 and the tissue 5 to be sutured, ensure that the interventional suturing device 1 is stably kept on the tissue 5 to be sutured, and improve the puncture force of the puncture needle 122. In particular, the abutment 113 may be shaped as a toothed structure. It will be appreciated that the shape of the abutment 113 is not limited to a toothed configuration, but may be flared radially outwardly, or a barb or suction cup extending distally. Alternatively, a vacuum negative pressure device may be added to the abutting portion 113, as long as the frictional force between the interventional suturing device 1 and the tissue 5 to be sutured can be increased, and the suturing force of the puncture needle 122 can be increased.

The two opposite side walls of the housing 110 are opened with positioning holes 110c near the abutting portion 113, and the positioning holes 110c are used for connecting the rotation shaft 1311 of the driving member 130. The positioning holes 110c on the two opposite side walls of the housing 10 are respectively used for connecting two ends of the rotating shaft 1311. The rotation shaft 1311 is rotatably connected to the housing 110 through the two positioning holes 110c, and the rotation shaft 1311 is fixedly connected to the needle handle 121 of the puncturing part 120. Thus, when the puncture member 120 is rotated, the puncture needle 122 does not easily shake when it penetrates the tissue 5 to be sutured, and is not damaged.

The driving member 130 further includes two fixing members 133, and the two fixing members 133 are respectively sleeved at two ends of the rotation shaft 1311 and fixed in the positioning holes 110 c. The two fixing members 133 are respectively fixed in the two positioning holes 110c, and the fixing members 133 are provided with through holes to be rotatably connected with one end of the rotating shaft 1311. Thus, the rotating shaft 1311 can rotate around the fixing member 133 in the housing 10, and the rotating shaft 1311 does not loosen or fall off. Specifically, the fixing member 133 includes a boss 1332 provided on the outer side of the housing 110 and a protruding shaft 1331 engaged with the positioning hole 110 c. The through hole of the fixing member 133 penetrates the protruding shaft 1331 and the lug 1332, and the rotating shaft 1311 penetrates the through hole and is rotatably connected with the protruding shaft 1331. The protruding shaft 1331 of the fixing element 133 is fitted over the positioning hole 110c of the housing 110, the protruding shaft 1332 is just fit with the positioning hole 110c, the lug 1332 cannot pass through the positioning hole 110c, and the fixing element 133 and the housing 110 are welded and fixed. Thus, the rotation shaft 1311 can only rotate along the axis of the positioning hole 110c, and cannot move along the axial direction of the housing 110, so as to drive the puncturing part 120 to rotate in the housing 110 relative to the housing 110 by using the rotation shaft 1311 as a rotation shaft.

Referring to fig. 13, two opposite sidewalls of the housing 110 are respectively provided with at least one limiting hole, the limiting hole is located beside the positioning hole 110c, and a limiting member 115 is inserted into the limiting hole. When the puncturing part 130 rotates to a predetermined position, the stopper 115 abuts against the needle handle 121. In this way, the needle shaft 121 is stopped by the stopper 115, and the puncture depth of the puncture needle 122 is restricted. Thus, the limiting member 115 can improve the accuracy of puncturing by the puncture needle 122, and prevent the puncture needle 122 from damaging the tissue 5 to be sutured.

In practice, the position-limiting element 115 may be disposed substantially parallel to the rotation axis 1311. It is understood that the limiting member 115 and the rotation shaft 1311 are perpendicular to two opposite side walls of the housing 110. The spacing between the position-limiting element 115 and the rotation shaft 1311 is less than the length of the needle handle 121, so that the position-limiting element 115 can abut against the needle handle 121. When the abutment portion 113 abuts against the tissue 5 to be sutured, the puncture needle 122 is rotated by a certain angle along the rotation shaft 1311 to complete the puncture. When the needle handle 121 of the puncture needle 122 rotates to the preset position, the needle handle 121 abuts against the stopper 115, and the puncture needle 122 cannot rotate any further. The needle handle 121 is perpendicular to the wire inlet tube 210, the wire inlet hole 122b of the puncture needle 122 is opposite to the front surface of the first guide hole 111a, and then the wire inlet tube 210 can be pushed to enable the wire inlet hole 122b to be in butt communication with the wire inlet tube 210.

Specifically, when the puncturing part 120 is at the initial position, the stopper 115 is located on the extension line of the needle shaft 121. When the puncturing part 120 is located at the predetermined position, the limiting member 115 abuts against the needle handle 121. In this way, the stopper 115 can block the needle handle 121, thereby controlling the penetration depth of the puncture needle 122. In one embodiment, the position limiter 115 may be a pin.

Further, the housing 110 further comprises a spacer 114, the spacer 114 being arranged between the piercing member 130 and the driver 132. It will be appreciated that the spacer 114 serves to space the puncture member 120 from the drive member 132, preventing the suture 3 from wrapping around the drive member 132.

Referring to fig. 12, the interventional suturing device 1 further comprises an operating assembly including two sliding blocks 41, and the driving member 132 includes two driving ends 1321, wherein the two driving ends 1321 penetrate out of the tubular body assembly 20 and are connected with the two sliding blocks 41 in a one-to-one correspondence manner. Thus, by operating the two sliders 41 respectively, the driving member 132 can drive the rotating member 131 to rotate clockwise or counterclockwise, so as to drive the puncture needle 122 to rotate, thereby facilitating the operation. It can be appreciated that the proximal end of the tube assembly 20 is connected to a handle 40, and two sliders 41 are provided on the handle 40 for easy manipulation. The provision of the handle 40 also facilitates gripping of the interventional suturing device 1. In addition, the proximal end of the pulling member 131 can extend out of the tube body assembly 20 through the outlet tube 211, and an operating member connected to the proximal end of the pulling member 310 can be disposed on the handle 40, so as to facilitate the operation of the pulling member.

Referring to fig. 16 to 20, the operation process of the interventional suturing device 1 provided in the present embodiment is specifically as follows.

First, referring to fig. 16, the housing 110 is attached to the tissue 5 to be sutured, and the driving member 130 rotates along the direction D1 to drive the puncturing member 130 to rotate and puncture the tissue 5 to be sutured;

then, referring to fig. 17, the inlet tube 210 is pushed in the direction D2 into the entry hole 122b, and the suture 3 is pushed out of the inlet tube 210 into the arc-shaped needle body 1223 of the puncture needle 122 and out of the needle tip 1221. Referring to fig. 18, suture 3 is advanced in the direction D2 and then captured by pull wire assembly 30 preloaded in outlet tube 211, which pull wire assembly 30 pulls suture 3 proximally in the direction D3 from outlet tube 211;

next, referring to fig. 19, the wire feeding tube 210 is withdrawn into the first guiding hole 111a, and then the driving member 130 rotates in the direction D4, so as to rotate the puncturing member 120 back into the housing 110 of the interventional suturing device 1;

finally, with reference to fig. 20, the handle 40 is pulled out of the interventional suturing device 1 and the suture 3 is implanted on the tissue 5 to be sutured.

The interventional suturing device 1 of the embodiment of the invention can be used for mitral valve or tricuspid valve annuloplasty. The following describes the use of the interventional suturing device 1 according to the present invention, taking mitral valve annuloplasty as an example. Wherein the tissue 5 to be sutured is mitral valve annulus tissue 2. In the illustration, LA represents the left atrium and LV represents the left ventricle.

S1: referring to fig. 21, a guide device such as a guide wire (not shown) and an adjustable bending sheath, a pre-shaped sheath 4, etc. is used to establish a track from outside the patient's body to inside the patient's body, and then the distal end of the interventional suturing device 1 is passed through the atrial wall into the left atrium LA to reach the mitral valve annulus tissue 2;

s2: referring to fig. 22, the suture assembly 10 is fed along the sheath tube 4 into the left atrium LA, the suture assembly 10 is made to fit the mitral valve annulus tissue 2, then the puncturing member 120 is driven to puncture the mitral valve annulus tissue 2, then the wire inlet tube 210 is pushed again to make the wire inlet tube 210 and the wire inlet hole 122b of the puncturing needle 122 abut, the suture 3 is pushed through the puncturing needle 122 and caught by the noose 320 of the wire pulling assembly 30 to the outside of the body, then the wire inlet tube 210 is withdrawn into the first guiding hole 111a, finally the puncturing member 120 is withdrawn and the interventional suture device 1 is withdrawn, so that the suture 3 is implanted on the mitral valve annulus tissue 2.

S3: referring to fig. 23 to 25, in order to suture the plurality of sets of sutures 3 to the mitral valve annulus tissue 2 of the interventional suturing device 1, the mitral valve annulus tissue 2 is shaped by contracting the plurality of sets of sutures 3 to contract the mitral valve annulus tissue 2.

Referring to fig. 26, the mitral valve annulus tissue 2 is shaped by knotting two by two each set of sutures 3 in order to shape the mitral valve annulus tissue 2. In other embodiments, the mitral valve annulus tissue 2 can be shaped by knotting together sets of sutures 3; or the artificial annuloplasty ring is fed along each set of the sewing lines 3, and then each set of the sewing lines 3 is knotted two by two to fix the artificial annuloplasty ring to the mitral valve annulus tissue 2 so as to shape the mitral valve annulus tissue 2.

It is to be understood that the foregoing examples, while indicating the preferred embodiments of the invention, are given by way of illustration and description, and are not to be construed as limiting the scope of the invention; it should be noted that, for a person skilled in the art, the above technical features can be freely combined, and several changes and modifications can be made without departing from the concept of the present invention, which all belong to the protection scope of the present invention; therefore, all equivalent changes and modifications made within the scope of the claims of the present invention should be covered by the claims of the present invention.

Claims (16)

1. An interventional suturing device comprising a suturing assembly, the suturing assembly comprising:

a housing having an opening at a distal end thereof;

the puncture component is accommodated in the shell and comprises a needle handle and a puncture needle connected with the needle handle, the puncture needle movably extends out of the opening, and the puncture needle is provided with a cavity for a suture to pass through;

a drive member connected to the needle handle;

the driving part drives the puncture part to rotate between an initial position and a preset position, and when the puncture part rotates to the preset position, the suture thread passes through the cavity and is pulled out of the cavity.

2. The interventional suturing device of claim 1, wherein the puncture needle comprises a suspended needle tip, a connecting end fixedly connected to the needle handle, and an arc-shaped needle body connected between the connecting end and the needle tip, the arc-shaped needle body has the cavity, the connecting end is provided with a thread inlet hole communicated with the cavity, and the needle tip is provided with a thread outlet hole communicated with the cavity.

3. The interventional suturing device of claim 2, wherein the proximal end of the housing is provided with a connector, the connector is provided with a first guide hole, and the access hole is in butt joint with the first guide hole when the puncture member is rotated to the preset position.

4. The interventional suturing device of claim 3, further comprising a tube assembly, the tube assembly comprising a wire inlet tube movably disposed through the first guide hole, the wire inlet tube abutting the wire inlet hole.

5. The interventional suturing device of claim 4, wherein the first guide bore is curved radially outward to form an included angle in a range of 120 ° -180 °, and wherein the distal end of the inlet tube is flexible.

6. The interventional suturing device of claim 3, further comprising a pull wire assembly, wherein the connector further comprises a second guide hole, the second guide hole is abutted by the wire outlet hole when the puncturing member rotates to the preset position, the pull wire assembly comprises a pulling member and a noose connected to a distal end of the pulling member, the pulling member is movably disposed in the second guide hole, and the noose protrudes from a distal end of the second guide hole.

7. The interventional suturing device of claim 6, further comprising a tube assembly, wherein the tube assembly comprises a wire outlet tube, the wire outlet tube is disposed through the second guide hole, the wire outlet tube is in butt joint with the wire outlet hole, the pulling member is movably disposed through the wire outlet tube, and the lasso is threaded out from a distal end of the wire outlet tube.

8. The interventional suturing device of claim 7, wherein the second guide hole is angled radially outward, the angle ranging from 120 ° to 180 °, and the distal end of the outlet tube is flexible.

9. The interventional suturing device of any one of claims 1 to 8, wherein the drive component comprises a rotating member and a drive member, the rotating member comprising a rotating wheel and a rotating shaft, the rotating shaft extending through the rotating wheel and the needle handle, the drive member being coiled around a circumference of the rotating wheel.

10. The interventional suturing device of claim 9, wherein at least one limiting hole is formed in each of two opposite side walls of the housing, a limiting member is inserted into the limiting hole, and the limiting member abuts against the needle handle when the puncturing member is rotated to the predetermined position.

11. The interventional suturing device of claim 10, wherein the stop is substantially parallel to the rotational axis, and a spacing between the stop and the rotational axis is less than a length of the needle shaft.

12. The interventional suturing device of claim 9, wherein the end face of the opening is provided with an abutting portion, and two opposite side walls of the housing are provided with positioning holes near the abutting portion, and the positioning holes are used for connecting the rotating shaft.

13. The interventional suturing device of claim 12, wherein the driving member further comprises two fixing members respectively sleeved at two ends of the rotating shaft and fixed in the positioning holes.

14. The interventional suturing device of claim 9, wherein the rotating wheel is further provided with a friction enhancing member on a peripheral side thereof, and the driving member is in contact with the friction enhancing member.

15. The interventional suturing device of claim 9, wherein the rotating wheel is radially provided with an axial hole extending therethrough, and the driving member is inserted through the axial hole and wound around the rotating wheel in a circumferential direction thereof.

16. The interventional suturing device of claim 9, wherein the housing further comprises a spacer disposed between the puncture member and the drive member.

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