CN113116425A - Valve suture instrument - Google Patents

Abstract

The application discloses a valve suture instrument, which comprises a clamping device, a fixing piece and a puncture device, wherein the clamping device comprises a near-end chuck, a far-end chuck and a chuck push tube, the chuck push tube movably penetrates through the near-end chuck and is fixedly connected with the far-end chuck, and the chuck push tube drives the far-end chuck to move relative to the near-end chuck so as to clamp or release a valve; fixing part holding is used for the fixed connection suture in the distal end chuck, the pjncture needle of near-end chuck is worn to locate including the activity to the piercing depth device, the pjncture needle includes fixed syringe needle and the needle body that meets, the syringe needle includes fixed connection's pinpoint portion in proper order, transition portion and connecting portion, connecting portion meet with the needle body is fixed, pinpoint portion is used for the puncture valve and implants the suture with fixing part fixed connection in order to the valve, the external diameter of transition portion is crescent from the distal end to the near-end, the biggest external diameter of transition portion is the biggest external diameter on the syringe needle, the biggest external diameter of transition portion is greater than the biggest external diameter of pinpoint portion, the biggest external diameter of transition portion is.

Description

Valve suture instrument

Technical Field

The invention relates to the technical field of medical instruments, in particular to a valve suture instrument for a catheter intervention way.

Background

Heart valve disease is the stenosis and insufficiency of the orifice due to structural damage, fibrosis, adhesion, shortening, myxomatous degeneration, degenerative changes or abnormalities in the function or structure of a valve or valves caused by inflammation of the heart valve, including the leaflets, chordae tendineae (CT as shown in figure 1) and papillary muscles.

Referring to fig. 1, the left atrium (LA in fig. 1) and left ventricle (LV in fig. 1) are separated by the mitral valve (MV in fig. 1), and the right atrium (RA in fig. 1) and right ventricle (RV in fig. 1) are separated by the tricuspid valve (TV in fig. 1), which allows blood to flow only from the atrium to the ventricle but not back. Mitral regurgitation or tricuspid regurgitation can cause ventricular blood to flow back to atria during systole, which causes the atria to expand in volume and increase in pressure, which leads to increased load on the ventricles and is likely to cause heart failure.

Surgery is the mainstream method for treating valvular heart disease at present, but for some patients with advanced age, various complications or patients who have a history of open chest surgery, the surgery is very traumatic and has high death rate. At present, valve repair instruments for interventional therapy of mitral valve regurgitation and tricuspid valve regurgitation are in the research and development stage, and the interventional therapy mainly comprises the execution of chordae tendineae repair or edge-to-edge repair by implanting suture lines into heart valves.

Referring to fig. 2, a conventional heart valve repair device 100a is used to perform mitral valve repair by puncturing the apex of the heart after intercostal puncture, and advancing the entire device to the left ventricle and left atrium. After the puncture needle of the heart valve repair device 100a punctures the valve, the puncture needle still needs to be pushed forward to enlarge the puncture point of the valve until the maximum diameter of the puncture needle head abuts against the fixing piece of the connecting suture on the left atrium side. The puncture needle of the transapical instrument is rigid and straight, the pushing force is easy to transmit, and the puncture point is easy to enlarge.

If the heart valve repair is to be implemented through a more minimally invasive transcatheter intervention mode, the device needs to enter the atrium and the ventricle sequentially through the inferior vena cava or the superior vena cava, and the device needs to be adapted to the bending of a tortuous intervention path in the veins, so that the pushing force is exerted from the external end of the body to ensure that the puncture point of the valve leaflet is expanded to the outer diameter of the fixing piece more difficultly, and the corresponding valve puncture is more difficult.

Disclosure of Invention

In order to solve the problems, the invention provides a valve suture device which is used for implanting a suture in a catheter intervention mode and can enable a puncture needle to puncture a valve easily.

The application discloses a valve suture instrument, which is used for implanting a suture to a heart valve in a catheter intervention mode and comprises a clamping device, a fixing piece and a puncture device, wherein the clamping device comprises a near-end chuck, a far-end chuck and a chuck push tube, the far-end chuck is used for accommodating the suture, the chuck push tube is movably arranged on the near-end chuck in a penetrating mode and fixedly connected with the far-end chuck, and the chuck push tube drives the far-end chuck to move relative to the near-end chuck so as to clamp or loosen the valve; the fixing piece is contained in the far-end chuck and used for being fixedly connected with the suture, the puncture device comprises a puncture needle movably penetrating through the near-end chuck, the puncture needle comprises a needle head and a needle body which are fixedly connected, the needle head comprises a needle tip portion, a transition portion and a connecting portion, the needle tip portion, the transition portion and the connecting portion are fixedly connected, the needle tip portion is used for being fixedly connected with the fixing piece after puncturing the valve so as to implant the suture to the valve, the outer diameter of the transition portion gradually increases from the far end to the near end, the maximum outer diameter of the transition portion is the maximum outer diameter of the needle head, the maximum outer diameter of the transition portion is larger than the maximum outer diameter of the needle tip portion, and the maximum outer diameter of the transition portion is.

The application provides a valve suture system, because the biggest external diameter of the transition portion of pjncture needle is less than the external diameter of mounting for the biggest external diameter on the syringe needle and the biggest external diameter on the syringe needle, promotes the pjncture needle and makes during needle puncture valve, the puncture hole need not to expand the size of mounting external diameter, but expands to the external diameter size that is less than the mounting, to interveneeing the mode through the pipe, the range of puncture hole expansion is little, means that the thrust on the syringe needle that needs to transmit the pjncture needle is less to can reduce the puncture degree of difficulty, make the more easily puncture valve of pjncture needle.

Drawings

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 description of the embodiments or the prior art will be briefly described below, it is obvious that the drawings in the following description are only some embodiments of the present invention, and other drawings can be obtained by those skilled in the art without creative efforts.

Fig. 1 is a schematic diagram of a human heart structure.

Fig. 2 is a schematic view of an application scenario of a suture implantation system provided by the prior art.

Fig. 3 is a perspective assembly view of a valve suture apparatus provided in accordance with a first embodiment of the present application.

Fig. 4 is an enlarged schematic view of the structure of the distal end of the valve suture apparatus shown in fig. 3.

Fig. 5 is a cross-sectional view of the distal end of the valve suture apparatus shown in fig. 3.

FIG. 6 is a partial cross-sectional view of the clamping device of the valve suture apparatus shown in FIG. 3.

FIG. 7 is a perspective view of the puncture device of the valve suture apparatus shown in FIG. 3.

Fig. 8 is an enlarged schematic view of region ii shown in fig. 7.

FIG. 9 is a schematic view of the needle of the puncture device of the valve suture apparatus shown in FIG. 3.

FIG. 10 is a schematic view of a valve held by a valve suture apparatus as provided in the first embodiment of the present application.

FIG. 11 is a perspective view of a suture and a fastener assembly provided in accordance with a first embodiment of the present application.

Fig. 12 is a schematic application scenario diagram of the first embodiment of the present application.

Fig. 13 is an enlarged view of the partial application scene shown in fig. 12.

Fig. 14 is an enlarged schematic view of a partial application scene according to the first embodiment of the present application.

Fig. 15 is a schematic view of the first embodiment of the present application as it penetrates the valve.

Fig. 16 is a schematic view of a pullback puncture needle, anchor, and suture according to the first embodiment of the present application.

FIG. 17 is a schematic view of a needle and anchor arrangement of a valve suture apparatus according to a second embodiment of the present application.

FIG. 18 is a schematic view of the needle and needle assembly of a valve suture apparatus provided in accordance with a third embodiment of the present application.

FIG. 19 is a schematic view of the needle and anchor arrangement of a valve suture apparatus according to a third embodiment of the present application.

Detailed Description

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

In the field of interventional medical device technology, the position close to the operator is generally defined as proximal and the position away from the operator as distal; the direction of the central axis of rotation of an object such as a cylinder or a pipe is defined as the axial direction.

First embodiment

Referring to fig. 3-5 in combination, the present application provides a valve suture apparatus 100 for transcatheter implantation of sutures 200 into a heart valve for repair of the heart valve. The valve suture apparatus 100 includes an operating handle 10, a catheter 30, a clamping device 50, a puncture device 70, and an adjustable curved sheath 90. The catheter 30 is fixedly connected between the holding fixture 50 and the operating handle 10 for delivering the holding fixture 50 into the heart. The operating handle 10 is used for the operator to grasp and operate the holding device 50 and the puncturing device 70. The operating handle 10 is provided with a jaw control member 11 for controlling the opening and closing of the clamping device 50. The puncture device 70 is movably arranged in the clamping device 50, the catheter 30 and the operating handle 10 and is used for puncturing the valve to be fixedly connected with the suture thread 200 so as to implant the suture thread 200 into the heart. The clamping device 50 is used to clamp the valve.

The adjustable bending sheath 90 comprises a bending handle 91 and a sheath tube 93, and the proximal end of the sheath tube 93 is fixedly connected with the bending handle 91. The catheter 30 is movably inserted into the sheath tube 93 and the bending adjusting handle 91. The bending adjusting handle 91 is used for controlling the bending of the distal end of the sheath tube 93, and the catheter 30 inserted into the sheath tube 93 can be bent to adapt to the bending of the sheath tube 93. It will be appreciated that the length of the conduit 30 is not limited.

The clamping device 50 comprises a proximal end chuck 51, a distal end chuck 53 and a chuck push tube 55, the proximal end chuck 51 is fixedly connected with the distal end of the catheter 30, the proximal end chuck 51 is located between the distal end chuck 53 and the catheter 30, the chuck push tube 55 is movably inserted into the proximal end chuck 51 and is fixedly connected with the distal end chuck 53, the chuck push tube 55 is also movably inserted into the catheter 30 (as shown in fig. 3) and the operating handle 10 (as shown in fig. 3), and the proximal end of the chuck push tube 55 is connected with the chuck control member 11 (as shown in fig. 3) on the operating handle 10. The collet pushing tube 55 is used for driving the distal collet 53 to move under the driving of the collet control member 11, so as to control the opening and closing of the clamping device 50, thereby enabling the distal collet 53 and the proximal collet 51 to cooperate to clamp or release the valve. Distal cartridge 53 is also used to house suture 200. The puncture needle 71 of the puncture device 70 is partially movably disposed through the proximal cartridge 51.

Referring to fig. 6, a puncture channel 517 for accommodating the puncture needle 71 is disposed in the proximal collet 51, a second channel 532 for accommodating the fixing member 80 is disposed in the distal collet 53, and the second channel 532 and the puncture channel 517 are coaxially and communicatively disposed. Correspondingly, the fixing member 80 is accommodated in the second channel 532, and the fixing member 80 is substantially a circular tube. The second channel 532 is axially aligned with the puncture channel 517 to allow the puncture needle 71 to smoothly enter the distal collet 53 and to be fixedly coupled to the fixing member 80 when the puncture needle is punctured from the proximal collet 51 to the distal collet 53. It is understood that the second passageway 532 and the piercing passageway 517 may not be coaxially disposed, as long as the piercing device 70 is capable of being fixedly attached to the anchor 80. In this embodiment, a third channel 533 is further disposed at an end of the distal collet 53 away from the puncture channel 517, and the third channel 533 is disposed in communication with the second channel 532. The third channel 533 is for receiving the suture 200. The third channel 533 has an inner diameter smaller than the inner diameter of the second channel 532, thereby forming a stepped stop 539 at the junction of the third channel 533 and the second channel 532. The stop structure 539 abuts the distal end of the fastener 80 to prevent the fastener 80 from moving away from the proximal collet 51, thereby improving the stability of the puncture device 70 in puncturing the valve. It will be appreciated that the shape and configuration of the stop structure 539 is not limited, for example, the third channel 533 has the same bore diameter as the second channel 532, and the stop structure 539 is a protrusion disposed within the third channel 533.

Referring to fig. 7 in combination, fig. 7 is a perspective view of the puncture device of the valve suture apparatus shown in fig. 3.

The puncture device 70 includes a puncture needle 71, a puncture push rod 73 and a puncture handle 75, and the puncture push rod 73 is fixedly connected between the puncture needle 71 and the puncture handle 75. The introducer needle 71 is movably disposed through the catheter 30 (shown in FIG. 3) and the proximal cartridge 51. The puncture push rod 73 is movably arranged in the catheter 30 in a penetrating way. The puncture handle 75 is movably disposed through the operating handle 10 and protrudes from the operating handle 10 (as shown in fig. 3). The puncture handle 75 is used for driving the puncture push rod 73 to move, and the puncture needle 71 is driven by the puncture push rod 73 to puncture the valve from the proximal end to the distal end direction or withdraw from the valve from the distal end to the proximal end direction.

Referring to fig. 8, fig. 8 is an enlarged schematic view of the area ii shown in fig. 7.

The puncture needle 71 comprises a needle 711, a distal connector 713 and a needle 714, wherein the distal connector 713 is fixedly connected between the needle 711 and the needle 714. Needle body 714 is fixedly connected with one end of puncture push rod 73 far away from puncture handle 75. Needle 711 is used to puncture the valve and is fixedly attached to suture 200. Needle body 714 is removably insertable into catheter 30. In this embodiment, the needle body 714 is a bendable needle body, that is, the needle body 714 can be bent by force to adapt to a zigzag puncture path.

In this embodiment, the needle body 714 includes a bendable needle tube 7143 and a supporting inner core 7145 inserted into the bendable needle tube 7143. The bendable needle tubing 7143 can bend to accommodate the tortuous puncture path. In this embodiment, the supporting core 7145 is a nickel titanium wire. It is understood that the support core 7145 may not be limited to nickel titanium wire, but may be made of other materials having a shape memory function. It will be appreciated that the support core 7145 may also be other flexible materials, such as non-metallic materials. The supporting inner core 7145 can bend along with the bendable needle tube 7143, support is provided for the bendable needle tube 7143, the pushing force loss of the puncture push rod 73 to the bendable needle body 714 is reduced, axial force can be transmitted when the push rod puncture handle 75 is pushed forwards and withdrawn, and particularly when the puncture needle 71 is withdrawn, the bendable needle body 714 is protected from being stretched and deformed. The distal end of the support core 7145 exits the flexible needle cannula 7143 to be fixedly attached to the distal connector 713.

In this embodiment, the bendable needle tube 7143 is a spring tube. It can be understood that the bendable needle tube 7143 is not limited to be a spring tube, and the bendable needle tube 7143 can be bent.

In this embodiment, the distal link 713 is a hub and the needle 711 extends into the distal end of the distal link 713 near the proximal end of the distal link 713 and is fixedly attached.

In this embodiment, the length of the supporting inner core 7145 is greater than the length of the bendable needle tube 7143, and the distal end of the supporting inner core 7145 is fixedly arranged in the distal connector 713.

It will be appreciated that the support core 7145 is not limited to being fixedly disposed through the distal connector 713. For example, the support core 7145 and the distal connector 713 may be, but are not limited to, welded, threaded, etc.

It will be appreciated that a portion of the needle 711 adjacent the distal link 713 is not restricted to being fixedly disposed through the distal link 713. For example, the end of the needle 711 near the distal connector 713 may be coupled to the distal connector 713 by, but is not limited to, welding, threading, and the like.

It is understood that the distal connector 713 is not limited to a sleeve. For example, two blind holes are respectively formed at two ends of the distal end connecting member 713, and the two blind holes are not communicated with each other, so that the needle 711 and the supporting core 7145 are respectively and fixedly arranged in the blind holes from the two ends of the distal end connecting member 713.

In this embodiment, the distal link 713 is linear and rigid to reliably transmit the puncture force and to maintain stability when puncturing the valve, thereby improving the stability of the valve suture apparatus 100 when puncturing the valve. The rigidity of the element referred to in the present application means that the element is not easily deformed when the element penetrates a human body organ such as skin or a valve in a puncture operation, for example, the needle 711 does not deform when penetrating a valve.

In this embodiment, the connection between the support core 7145 and the distal connector 713 is a crimp connection. It will be appreciated that the connection between the support core 7145 and the distal connector 713 is not limited to crimping, for example, but is not limited to, a threaded connection, welding, or the like.

In this embodiment, the junction between the needle 711 and the distal end connector 713 is substantially equal to and smoothly connected to the outer diameter of the distal end connector 713, and the flexible needle tube 7143 and the distal end connector 713 are substantially equal to and smoothly connected to each other, thereby reducing the resistance of the puncture needle 71 during puncture.

In this embodiment, the material of the distal end connector 713 may be, but is not limited to, 304 stainless steel, 316 stainless steel, etc.

In this embodiment, the tip of the needle 711 needs to be sharp and wear resistant, and the tip of the needle 711 can be made of, but not limited to, stainless steel 304, stainless steel 316, or the like.

In the present embodiment, the needle 711 is subjected to a low temperature nitriding hardening treatment, thereby making the needle 711 have a greater hardness.

Referring to fig. 9, the needle 711 includes a needle tip portion 7112, a step portion 7113, a transition portion 7115, a fixing portion 7116, a connecting portion 7118 and a mounting portion 7119, which are fixedly connected in sequence.

The needle tip 7112 is used to puncture the valve, making the valve a puncture. The outer diameter of the needle tip 7112 gradually increases from the distal end of the needle tip 7112 to the proximal end of the needle tip 7112. In this embodiment, the needle tip 7112 is generally right circular cone shaped and the cone angle of the needle tip 7112 is less than 52 degrees to make the needle tip 7112 sharp enough to easily penetrate the valve. It is understood that the taper angle of the needle tip 7112 is not limited to less than 52 degrees and may be greater than or equal to 52 degrees; the shape of the needle tip 7112 is not limited, for example, the shape of the needle tip 7112 may be, but is not limited to, a beveled tip, a beveled cone, or the like.

The end of the needle tip 7112 near the step 7113 has the largest outer diameter of the needle tip 7112. The maximum outer diameter of the tip 7112 is greater than the outer diameter of the step 7113 such that the end of the tip 7112 adjacent to the step 7113 forms a step face 7111. Step face 7111 is configured to fixedly engage anchor 80 (shown in fig. 6) to prevent anchor 80 from disengaging needle 711 and failing to implant suture 200.

The transition section 7115 has an outer diameter that gradually increases from the distal end to the proximal end, and the maximum outer diameter of the transition section 7115 is the maximum outer diameter of the needle 711. The maximum outer diameter of the transition portion 7115 is greater than the maximum outer diameter of the needle tip portion 7112. The maximum outer diameter of the transition 7115 is indicated as D1 in fig. 9. The transition portion 7115 is used to enlarge the puncture hole (not shown) formed after the puncture through the needle tip portion 7112 to a size through which the fixing member 80 (shown in fig. 6) can easily pass. The mounting portion 7119 is fixedly coupled to the distal end connecting portion 713 (shown in fig. 8). In the present embodiment, the transition portion 7115 has a substantially truncated cone shape, and the taper angle of the transition portion 7115 ranges from 10 degrees to 22 degrees. The taper angle of the transition portion 7115 does not exceed 22 degrees so that the change in the outer diameter of the transition portion 7115 is relatively gradual, reducing the resistance to puncture of the valve. The taper angle of transition portion 7115 is not less than 10 degrees to avoid too little taper, resulting in a longer length of transition portion 7115, such that needle tip 7112 penetrates deeper along proximal collet 51 toward distal collet 53 during penetration. It will be appreciated that the transition portion 7115 is not limited to a truncated cone shape, and the maximum outer diameter of the transition portion 7115 is the maximum outer diameter of the needle 711.

The fixing portion 7116 includes a first sub-segment 7121, a second sub-segment 7123 and a third sub-segment 7125 which are sequentially and fixedly connected, the first sub-segment 7121 is fixedly connected between the second sub-segment 7123 and the transition portion 7115, and the third sub-segment 7125 is fixedly connected between the second sub-segment 7123 and the connecting portion 7118. In this embodiment, the first segment 7121 is a cylinder with an outer diameter equal to the maximum outer diameter D1; the second sub-section 7123 is fixedly connected between the first sub-section 7121 and the third sub-section 7125; the outer diameter of the second sub-section 7123 gradually decreases from the first sub-section 7121 toward the third sub-section 7125 (i.e., the distal end of the second sub-section 7123 is toward the proximal end) as a smooth transition between the first sub-section 7121 and the third sub-section 7125; the outer diameter of the third segment 7125 gradually increases from the end near the connecting portion 7118 to the second segment 7123 (i.e., the proximal end of the third segment 7125 is toward the distal end), so that the connecting portion 7118 and the second segment 7123 are connected in a smooth transition manner.

The connecting portion 7118 has an outer diameter less than the maximum outer diameter of the transition portion 7115. In the present embodiment, the connecting portion 7118 has a substantially cylindrical shape. It will be appreciated that the connecting portion 7118 is not limited to being cylindrical, as long as the maximum radial dimension of the connecting portion 7118 is no greater than the maximum outer diameter of the needle 711.

In this embodiment, the mounting portion 7119 is a cylinder with an outer diameter smaller than that of the connecting portion 7118, and the needle 711 is fixedly connected to the bendable needle body 714 by fixedly inserting the mounting portion 7119 through the distal end of the distal connecting member 713 (shown in fig. 8). It is understood that the installation portion 7119 is not limited to a cylinder, and may be, for example, but not limited to, a rectangular parallelepiped, etc. It is understood that the needle 711 is not limited to being fixedly disposed through the distal link 713 by the mounting portion 7119, for example, but not limited to, welding the needle 711 to the distal link 713, etc.

The maximum outer diameter of the needle tip portion 7112 and the maximum outer diameter of the connecting portion 7118 are smaller than the maximum outer diameter D1 of the needle 711. It will be appreciated that the maximum outer diameter D1 of the transition portion 7115 determines the maximum size of the puncture hole when the needle 71 penetrates the valve distally. The fixing portion 7116 is fixedly connected between the transition portion 7115 and the connecting portion 7118, the outer diameter of the fixing portion 7116 near the needle tip portion 7112 is D1, and the outer diameter of the fixing portion 7116 near the mounting portion 7119 is the outer diameter of the connecting portion 7118 and is smoothly connected with the connecting portion 7118.

It should be noted that fig. 9 is only an exemplary illustration of the segmented features of the needle 711, and it is understood that the transition portion 7115, the fixing portion 7116 and the connecting portion 7118 may be integrally formed.

It is understood that the specific shape of the fixing portion 7116 is not limited, and it suffices that the transition portion 7115 and the connecting portion 7118 are connected and the maximum outer diameter of the fixing portion 7116 is not greater than the maximum outer diameter. For example, the fixing portion 7116 may be a circular truncated cone, and the outer diameter of the fixing portion 7116 may gradually decrease from the transition portion 7115 toward the connecting portion 7118 (i.e., the distal end of the fixing portion 7116 is toward the proximal end).

It is understood that the structure of the fixing portion 7116 is not limited, for example, the fixing portion 7116 retains the first sub-segment 7121 and omits the second sub-segment 7123 and the third sub-segment 7125, the first sub-segment 7121 is fixedly connected between the transition portion 7115 and the connecting portion 7118, and the outer diameter of the first sub-segment 7121 is not greater than the maximum outer diameter D1 of the transition portion 7115, i.e., the maximum outer diameter of the fixing portion 7116 is not greater than the maximum outer diameter of the transition portion 7115.

It is understood that the step 7113, the fixing portion 7116 and the mounting portion 7119 may be omitted, and the connecting portion 7118 may be directly fixed and connected to the bendable needle tube 7143.

Referring to fig. 6 and 10, the fixing element 80 is received in the second channel 532 of the distal collet 53. The fixation element 80 includes a fixedly attached first end 81 and a second end 83, the first end 81 disposed adjacent the proximal cartridge 51, the first end 81 configured to form a fixed attachment with the needle tip 7112, and the second end 83 configured to fixedly attach to the suture 200. The fixture 80 is provided with a first passage 85 therein for allowing the needle tip 7112 to extend therethrough. The peripheral edge of the first end 81 is provided with a chamfer 89 for gradually enlarging the puncture point when the fixing member 80 is driven by the puncture needle 71 to withdraw proximally, although the puncture is conducted through a catheter, the withdrawing tension is easy to transmit compared with the pushing force, so that the process of enlarging the puncture point is easy to realize, and the fixing member 80 can easily pass through the valve. The fixing member 80 further includes a catch 87, the catch 87 is disposed on the inner wall of the first passage 85 and near the first end 81, and is used for engaging with the stepped surface 7111 after the needle tip 711 extends into the first passage 85, so as to improve the reliability of the connection between the fixing member 80 and the needle 711. It is understood that the latch 87 may be a movable latch or a latch with elastic deformation capability.

It will be appreciated that the manner in which second end 83 is fixedly attached to suture 200 is not limited, and for example, suture 200 may be threaded through second end 83 and second end 83 may be clamped with a pair of wire clamps, or, without limitation, a glued attachment or the like may be employed.

In this embodiment, the end surface of the first end 81 of the anchor 80 (i.e., the proximal end surface of the anchor 80) is spaced apart from the opening of the second channel 532 adjacent to the proximal collet 51 (i.e., the proximal end surface of the distal collet 53 or the distal collet 53 and the clamping surface of the valve), as indicated by d in fig. 10. In this embodiment, the separation distance d is 0.15mm, so that the needle tip portion 7112 is pushed against and pierces the valve (as indicated by V in fig. 10) before entering the fixing member 80, thereby preventing the valve from being pushed into the inner cavity of the fixing member 80 by the needle 711 before being pierced by the needle 711, and further improving the connection reliability between the fixing member 80 and the needle 711.

It will be appreciated that the distance d separating the end surface of the first end 81 of the retainer 80 from the opening of the second channel 532 adjacent the proximal clip 51 (i.e., the distal clip from the clamping surface of the valve) is preferably greater than or equal to 0.10 mm. For example, the separation distance d between the end surface of the first end 81 of the retainer 80 and the opening of the second channel 532 near the proximal collet 51 (i.e., the distal collet 53 and the clamping surface of the valve) may be, but is not limited to, 0.17mm, 0.20mm, 0.21mm, etc.

It will be appreciated that the snap-fit engagement of the needle 711 with the mount 80 is non-removable or removable. It will be appreciated that needle 711 is not limited to snap-fit engagement with mount 80.

As shown in fig. 10, the outer diameter of the fixing member 80 is denoted by D2, the inner diameter of the first channel 85 is denoted by D3, the difference between the outer diameter D2 of the fixing member 80 and the maximum outer diameter D1 of the transition portion 7115 is in the range of 0.1-0.2 mm, and in the present embodiment, the maximum outer diameter D1 of the transition portion 7115 is 0.10mm smaller than the outer diameter D2 of the fixing member 80. It will be appreciated that the range of difference between outer diameter D1 of mount 80 and outer diameter D2 of mount 80 is not limited.

In this embodiment, the maximum outer diameter D1 of the transition portion 7115 is larger than the inner diameter D3 of the first channel 85 of the fastener 80 such that when the step face 7111 of the puncture needle 7112 is snap-fit into engagement with the catch 87 of the fastener 80, the transition portion 7115 is stopped by the proximal face of the fastener 80 such that the transition portion 7115 has some radial clearance from the inner lumen of the fastener 80.

It will be appreciated that without limiting the configuration of needle 711 and without limiting the configuration or shape of anchor 80, the maximum outer diameter D1 of transition portion 7115 may be less than the maximum outer diameter D2 of anchor 80.

Referring to fig. 10 and 11, in the present embodiment, the suture 200 includes a first fixing end 201, a second fixing end 203 and a main body 205. The main body 205 is fixedly coupled between the first and second fixing ends 201 and 203. The first fixing end 201 and the second fixing end 203 are respectively fixedly connected with a fixing member 80. In this embodiment, suture 200 is housed within distal cartridge 53.

In this embodiment, the main body 205 is bent into a "U" shape, two ends of the bent main body are the first fixing end 201 and the second fixing end 203, and the rest is the main body 205.

In this embodiment, a gasket 209 is disposed on the suture 200, two through holes 2091 are disposed on the gasket 209 for the first fixing end 201 and the second fixing end 203 to pass through, and the gasket 209 is used to increase the contact area when the bending portion of the main body 205 contacts with the valve, so as to reduce the damage to the valve.

In this embodiment, the spacer 209 is provided with a curvature protruding toward the bent portion of the body 205 so that the spacer 209 can be more easily attached to the valve. It will be appreciated that the curvature of the spacer 209 is preferably such that it conforms to the valve to its maximum extent.

It is understood that the material of the gasket 209 is not limited, for example, the material of the gasket 209 may be, but not limited to, polyester fabric, Polytetrafluoroethylene (PTFE), polyester resin (PET), and the like. It will be appreciated that the shape of the spacer 209 is not limited. It is understood that the spacer 209 may be omitted.

In one application, as shown in fig. 12 and 13, the valve suture apparatus 100 provided herein is used for transcatheter tricuspid valve repair by first performing a femoral vein (CFV, shown in fig. 12) opening and delivering the clamping device 50 sequentially to the right atrium (RA, shown in fig. 12) and right ventricle (RV, shown in fig. 12) via the inferior vena cava (IVC, shown in fig. 12) to the tricuspid valve site.

After the distal collet 53 and the proximal collet 51 clamp the valve under the action of the collet control member 11, the puncture push rod 73 is driven by the puncture handle 75, and the puncture push rod 73 drives the puncture needle 71 to move, so that the puncture needle 71 punctures the valve and retracts.

When the needle 711 of the puncture needle 71 punctures the valve, the valve is not punctured as soon as the tip of the needle 711 contacts the valve. Due to the flexibility of the valve itself, the process of the needle 711 puncturing the valve and withdrawing can be understood as follows:

as shown in FIG. 14, first, needle 711 pushes the valve in the direction of distal collet 53 (V, FIG. 14), and the valve is pushed by needle 711 into distal collet 53, where the valve is supported in a generally tent-like manner and the valve is punctured to form a puncture (H, FIG. 14).

As shown in fig. 15, the needle 711 continues to puncture and push away the catch 87, as the needle 711 is gradually pushed distally, the puncture hole in the valve gradually expands along with the circular table surface of the transition portion 7115 to the size of the maximum outer diameter D1 of the transition portion 7115, and the stepped surface 7111 of the needle 711 is caught by the catch 87, so that the needle 711 and the fixing member 80 are fixedly connected. The penetration is in the direction from proximal collet 51 to distal collet 53.

As shown in fig. 16, suture 200 is withdrawn through the valve (V shown in fig. 16) with needle 711, and chamfer 89 of fastener 80 enlarges the puncture twice, gradually enlarging the outer diameter of the puncture from D1 to D2, and suture 200 is thus implanted on the valve. The retraction is in the direction from distal collet 53 to proximal collet 51. The sutures on each valve leaf can be subsequently locked and knotted, so that edge-to-edge repair is realized.

In the prior art, because the maximum outer diameter of the puncture needle is equal to or larger than the outer diameter of the fixing piece, the puncture hole formed after the puncture needle passes through the valve is finally enlarged to be larger than or equal to the outer diameter of the fixing piece, and the needed puncture force is larger. In the present embodiment, the puncture hole is finally enlarged twice to be equal to the outer diameter of the fixing member. The first enlargement of the puncture hole is to puncture the needle tip portion 7112 distally to form a puncture hole, so that the transition portion 7115 of the needle 711 passes through the puncture hole, and the outer diameter of the puncture hole is the maximum outer diameter D1 of the needle 711. The second enlargement of the puncture hole is that the needle 711 drives the fixing element 80 to puncture proximally, so that the fixing element 80 passes through the puncture hole, and the outer diameter of the puncture hole is enlarged from D1 to D2 of the fixing element 80. In this embodiment, the difference between the outer diameters D1 and D2 is small, and the chamfer 89 of the fastener 80 gradually enlarges the outer diameter of the puncture from D1 to D2 twice, making it easier for the fastener 80 to pass through the valve. Because of the flexibility of the valve, pulling force is applied to drive the needle 71 to retract, and in a curved catheter 30, the pulling force required to pull the needle 71 is more easily transmitted and the retraction is easier to achieve than pushing the needle in the prior art.

Second embodiment

Referring to fig. 17, the valve suture apparatus provided by the second embodiment is similar to the valve suture apparatus provided by the first embodiment in structure, and the needle head 611 includes a needle tip portion 6112, a step portion 6113, a transition portion 6115, a fixing portion 6116, a connecting portion 6118 and an installation portion 6119 which are fixedly connected in sequence, except that the fixing portion 6116 is substantially cylindrical, and the outer diameter of the connecting portion 6118 is the same as the maximum outer diameter (labeled as D1 in fig. 17) of the transition portion 6115.

Third embodiment

Referring to fig. 18, the valve suture apparatus provided in the third embodiment is similar to the valve suture apparatus provided in the second embodiment, except that the needle 811 provided in the third embodiment includes a needle tip portion 8112, a transition portion 8115 and a connecting portion 8119, which are fixedly connected in sequence, wherein the transition portion 8115 includes a first sub-portion 8121 and a second sub-portion 8123, the first sub-portion 8121 is fixedly connected between the second sub-portion 8123 and the needle tip portion 8112, the first sub-portion 8121 and the second sub-portion 8123 are both substantially in a circular truncated cone structure, a maximum outer diameter of the first sub-portion 8121 is smaller than a maximum outer diameter of the second sub-portion 8123, the second sub-portion 8123 has a maximum outer diameter of the needle 811 (indicated as D1 in fig. 18), and the outer diameters of the first sub-portion 8121 and the second sub-portion 8123 are both gradually decreased from a distal end to a proximal end; the maximum outer diameter of the connection portion 8119 is the same as the maximum outer diameter of the second sub-section 8123.

The needle 811 omits the step and the connection.

The distal end of the supporting inner core 8145 of the needle body 814 is fixedly arranged through the connecting part 8119, so that the needle body 814 is fixedly connected with the needle 811.

Referring to fig. 19 in combination, fig. 19 is a schematic view of a needle and a fixing element of a valve suture apparatus according to a third embodiment of the present application, wherein an axial direction of the needle 711 corresponds to an axial direction of a first channel of the fixing element 80.

While the invention has been described in connection with what is presently considered to be the most practical and preferred embodiment, it is to be understood that the invention is not to be limited to the disclosed embodiment, but on the contrary, is intended to cover various modifications and equivalent arrangements included within the spirit and scope of the appended claims.

Claims (15)

1. A valve suture apparatus is used for implanting a suture to a heart valve in a catheter intervention mode and is characterized by comprising a clamping device, a fixing piece and a puncture device, wherein the clamping device comprises a proximal chuck, a distal chuck and a chuck push tube, the distal chuck is used for accommodating the suture, the chuck push tube is movably arranged on the proximal chuck and fixedly connected with the distal chuck, and the chuck push tube drives the distal chuck to move relative to the proximal chuck so as to clamp or release the valve; the fixing piece is contained in the far-end chuck and used for being fixedly connected with the suture, the puncture device comprises a puncture needle movably penetrating through the near-end chuck, the puncture needle comprises a needle head and a needle body which are fixedly connected, the needle head comprises a needle tip portion, a transition portion and a connecting portion, the needle tip portion, the transition portion and the connecting portion are fixedly connected in sequence, the needle tip portion is used for puncturing a valve and is fixedly connected with the fixing piece so as to implant the suture to the valve, the outer diameter of the transition portion gradually increases from the far end to the near end, the maximum outer diameter of the transition portion is the maximum outer diameter of the needle head, the maximum outer diameter of the transition portion is larger than the maximum outer diameter of the needle tip portion, and the maximum outer diameter of the transition.

2. The valve suture apparatus of claim 1, wherein the difference between the maximum outer diameter of the transition portion and the outer diameter of the fixation member is in a range of 0.1mm to 0.2 mm.

3. The valve suture apparatus of claim 1, wherein the transition portion is frustoconical and has a taper angle in a range of 10 degrees to 22 degrees.

4. The valve suture apparatus of claim 1, wherein the needle tip portion is straight conical, the needle tip portion has a cone angle of less than 52 degrees, and an outer diameter of the needle tip portion increases from a distal end of the needle tip portion to a proximal end of the needle tip portion.

5. The valve suture apparatus of claim 4, wherein the needle further comprises a step secured between the needle tip portion and the transition portion, the step having an outer diameter less than a maximum outer diameter of the needle tip portion.

6. The valvular suture apparatus of claim 1, wherein the needle further comprises a fixation portion fixedly connected between the connecting portion and the transition portion, the fixation portion having a maximum outer diameter less than or equal to a maximum outer diameter of the transition portion, the fixation portion having a minimum outer diameter greater than or equal to an outer diameter of the connecting portion.

7. The valve suture apparatus of claim 1, wherein the needle further comprises a mounting portion secured between the needle body and the connecting portion.

8. The valve suture apparatus of claim 7, wherein the needle body is a bendable needle body, the needle body comprising a bendable needle tube and a support core disposed through the bendable needle tube, the support core fixedly connected to the proximal end of the mounting portion.

9. The valve suture apparatus of claim 8, wherein the bendable needle cannula is a spring tube.

10. The valve suture apparatus of claim 1, wherein the retainer defines a first channel, the first channel of the retainer having an inner diameter that is less than the maximum outer diameter of the needle.

11. The valvular suture apparatus of claim 10, wherein the retainer further comprises a catch disposed on an inner wall of the first channel, the catch configured to engage a proximal end surface of the needle tip portion proximate the transition portion after the needle tip portion has been inserted into the first channel.

12. The valve suture apparatus of claim 1, wherein the distal clip defines a second passageway, the fastener received in the second passageway, the second passageway extending through the proximal end face of the distal clip, the proximal end face of the fastener positioned within the second passageway and the proximal end face of the fastener spaced from the proximal end face of the distal clip.

13. The valve suture apparatus of claim 12, wherein the separation distance is greater than or equal to 0.1 mm.

14. The valve suture apparatus of claim 12, wherein a stop is disposed within the second channel, the distal end of the securing member abutting the stop.

15. The valve suture apparatus of claim 1, wherein an outer periphery of the proximal end of the retainer is chamfered.

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