CN113116424A - Transcatheter valve suture instrument and puncture needle thereof - Google Patents

Abstract

The application provides a puncture needle and a valve suture instrument, which are used for implanting suture to a heart valve. The valve suture instrument comprises a clamping device and a puncture device, wherein the clamping device is used for accommodating the suture, the puncture device comprises a puncture needle, the puncture needle comprises a needle head and a bendable needle body fixedly connected with the needle head, the needle head and the bendable needle body movably penetrate through the clamping device, and the needle head is used for puncturing the valve and is connected with the suture. The valve suture apparatus provided by the application comprises the puncture needle with the bendable needle body, so that the curved interventional path in the human blood vessel can be adapted, and the valve suture apparatus can be suitable for a treatment mode through a catheter.

Description

Transcatheter valve suture instrument and puncture needle thereof

Technical Field

The invention relates to the technical field of medical instruments, in particular to a valve suture instrument through a catheter and a puncture needle thereof.

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), 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. Wherein, the puncture needle in the prosthetic device 100a is a rigid straight needle body.

If a more minimally invasive transcatheter intervention is desired to perform heart valve repair, the device must be advanced sequentially into the atrium and ventricle through the inferior or superior vena cava, and the device must accommodate the tortuous access path in the vein. It is apparent that the prior art dirty valve repair device 100a shown in fig. 2 is not suitable for transcatheter valve repair.

Disclosure of Invention

In order to solve the aforementioned problems, the present invention provides a valve suture apparatus and a puncture needle thereof, which can be suitably used for transcatheter intervention type heart valve repair.

In a first aspect, the application discloses a puncture needle, be applied to implant suture to heart valve, the puncture needle includes needle head portion and fixed connection the bendable needle body of needle head portion, needle head portion is used for puncturing the valve.

In one embodiment, the bendable needle body comprises a bendable needle tube and a supporting inner core arranged in the bendable needle tube in a penetrating mode, and the supporting inner core is fixedly connected with the needle head portion.

In one embodiment, the bendable needle cannula is a spring tube.

In one embodiment, a blind hole is formed in one side, close to the bendable needle body, of the needle head, and the far end of the supporting inner core is fixedly connected to the blind hole.

In one embodiment, the bendable needle tube comprises a tube body and a plurality of slot units repeatedly arranged on the tube wall of the tube body along the axial direction, each slot unit comprises N slots which are mutually spaced along the axial direction and penetrate through the tube wall of the tube body, N is a positive integer greater than or equal to 3, each slot extends along the circumferential direction of the tube body, and two adjacent slots are mutually staggered along the circumferential direction of the tube body; the part of the tube body corresponding to each slot enables the tube body to have flexibility so as to realize bending of the bendable needle tube; the pipe body is rigid corresponding to the position between every two adjacent slots.

In one embodiment, each of the slots is an arc-shaped slot, the arc length of each of the slots in each of the slot units is equal, and all the slots of each of the slot units surround the tube body at least one turn in the circumferential direction.

In one embodiment, in each slot unit, two adjacent slots are relatively rotated by 360/N degrees.

In one embodiment, each of the slots has a central angle in a range of 200 to 240 degrees.

In a second aspect, the present application further discloses a valve suture apparatus for implanting a suture to a heart valve, which is characterized by comprising a holding device and a puncturing device, wherein the holding device is used for accommodating the suture, the puncturing device comprises the puncturing needle as described above, the needle head and the bendable needle body are movably arranged through the holding device, and the needle head is used for puncturing the valve and connecting the suture.

In one embodiment, the puncture device further comprises a distal connector fixedly connected between the needle head and the bendable needle body.

In one embodiment, the distal connector is integrally formed with the tip segment, or the distal connector and the tip segment are separate pieces.

In one embodiment, the puncture device further comprises a puncture push rod, and the puncture push rod is fixedly connected with one end of the bendable needle body, which is far away from the needle head portion, and is used for driving the bendable needle body and the needle head portion to move.

In an embodiment, the puncture device further comprises a puncture handle, and the puncture handle is fixedly connected to one end of the puncture push rod, which is far away from the bendable needle body, and is used for controlling the puncture push rod to drive the bendable needle body and the needle head to move.

In an embodiment, the puncture device further comprises a proximal connector, and the proximal connector is fixedly connected between the puncture push rod and the bendable needle body.

In an embodiment, the clamping device includes a proximal end chuck, a distal end chuck and a chuck push tube, the chuck push tube is movably disposed in the proximal end chuck and is fixedly connected to the distal end chuck, the chuck push tube is configured to drive the distal end chuck to move relative to the proximal end chuck to control opening and closing of the clamping device, the needle head and the bendable needle body are movably disposed in the proximal end chuck, and the distal end chuck is configured to accommodate the suture.

In an embodiment, the needle-free type endoscope further comprises a catheter, wherein the catheter is fixedly connected with the near-end chuck, the bendable needle body is movably arranged in the catheter in a penetrating mode, the chuck push tube is movably arranged in the catheter in a penetrating mode, and the chuck push tube and the bendable needle body are arranged at intervals.

In an embodiment, the medical device further comprises an operating handle, the operating handle is fixedly connected with one end, away from the proximal end chuck, of the catheter, a chuck control piece is arranged on the operating handle, and the chuck control piece is connected with one end, away from the distal end chuck, of the chuck push tube and is used for controlling the chuck push tube to drive the distal end chuck to move.

In one embodiment, the tip segment distal end is a rigid straight needle tip; the needle tip is provided with a step for connecting with the suture.

In one embodiment, the device further comprises an adjustable bent sheath, and the catheter is movably arranged in the adjustable bent sheath.

The application provides a valve suture apparatus and a puncture needle thereof, which can adapt to the curved interventional path in the human blood vessel due to the puncture needle with the bendable needle body, thereby being applicable to the treatment mode through the catheter.

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 structural view 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 a perspective assembly view of the valve suture apparatus shown in fig. 3 with the bendable sheath removed.

FIG. 5 is an exploded perspective view of the valve suture apparatus shown in FIG. 3 with the bendable sheath removed.

Fig. 6 is an enlarged partial schematic view of the region of the valve suture apparatus I shown in fig. 4.

FIG. 7 is a schematic structural view of the cartridge device of the valve suture apparatus shown in FIG. 3.

Fig. 8 is a cross-sectional view of the chuck assembly shown in fig. 7.

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

FIG. 10 is an enlarged, fragmentary view of the area of the valve suture apparatus II shown in FIG. 5.

FIG. 11 is a cross-sectional view of the lancing device of FIG. 10 in secured connection with a suture.

Fig. 12 is a perspective view of a suture provided in accordance with a first embodiment of the present application.

Fig. 13 is a schematic view of the puncture device and the suture.

FIG. 14 is a schematic view of the assembled puncture device and suture.

FIG. 15 is a partial cross-sectional view of the collet device of the valve suture apparatus shown in FIG. 3.

Fig. 16 is a schematic view of an application scenario of the valve suture apparatus provided in the first embodiment of the present application.

Fig. 17 is an enlarged view of the portion of the heart of fig. 16.

Fig. 18 is a schematic view of an application scenario of a partial structure of the valve suture apparatus shown in fig. 3.

Fig. 19 is a schematic view of yet another application scenario of the valve suture apparatus provided herein.

Fig. 20 is a schematic structural view of a puncture device according to a second embodiment of the present application.

Fig. 21 is a schematic structural view of a puncture device according to a third embodiment of the present application.

Fig. 22 is a partial structural view of the puncture device shown in fig. 21.

Fig. 23 is a partial structural view of the puncture device shown in fig. 21.

FIG. 24 is a perspective view of the puncturing device shown in FIG. 21, wherein each slot unit of the bendable needle cannula includes three slots.

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, a position close to the operator is generally defined as proximal and a 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.

Referring to fig. 3 to 5 in combination, fig. 3 is a schematic perspective assembly view of a valve suture apparatus according to a first embodiment of the present application, fig. 4 is a schematic perspective assembly view of the valve suture apparatus shown in fig. 3 with an adjustable curved sheath removed, and fig. 5 is a schematic perspective exploded view of the valve suture apparatus shown in fig. 3 with the adjustable curved sheath removed.

The present application provides a valve suture apparatus 100 for implanting a suture 200 (shown in fig. 8) into a heart to repair a 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 sheath tube 93 and the bending adjusting handle 91 are movably sleeved outside the catheter 30, and the distal end of the catheter 30 extends out of the distal end of the sheath tube 93. The bending adjusting handle 91 is used for controlling the bending of the sheath 93. The catheter 30 inserted into the sheath tube 93 can be bent in accordance with the bending of the sheath tube 93. It will be appreciated that the length of the conduit 30 is not limited.

Referring to fig. 6 and 7 in combination, fig. 6 is an enlarged view of a portion of the region of the valve suture apparatus I shown in fig. 4. FIG. 7 is a schematic structural view of the cartridge device of the valve suture apparatus shown in FIG. 3.

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 (shown in FIG. 8). The puncture device 70 is partially movably disposed through the proximal cartridge 51.

Referring to fig. 9, fig. 9 is a schematic structural view of the puncture device of the valve suture apparatus shown in fig. 3. The puncture device 70 includes a puncture needle 71 and a puncture push rod 73 fixedly connected to a proximal end of the puncture needle 71. As shown in FIG. 8, the needle 71 is movably disposed through the proximal cartridge 51 and the catheter 30. A puncture push rod 73 is movably disposed through the catheter 30. The puncture push rod 73 is used for driving the puncture needle 71 to move. The puncture needle 71 is used to puncture the valve and is attached to the suture 200.

Referring to fig. 10 and 11 in combination, fig. 10 is an enlarged view of a portion of the region of the valve suture apparatus ii shown in fig. 5. FIG. 11 is a cross-sectional view of the lancing device of FIG. 10 in secured connection with a suture.

The puncture needle 71 comprises a needle head 711, a distal end connector 713 and a bendable needle body 714, wherein the distal end connector 713 is fixedly connected between the needle head 711 and the bendable needle body 714. Needle section 711 is used to puncture the valve and is fixedly attached to suture 200. The bendable needle body 714 is movably arranged in the catheter 30. Bendable needle body 714 is bendable under the influence of bending of catheter 30 to accommodate a tortuous puncture path during catheter interventional treatment procedures.

In this embodiment, the bendable needle body 714 includes a bendable needle tube 7143 and a supporting inner core 7145 disposed inside 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 appreciated that the bendable needle tube 7143 is not limited to a spring tube, as long as the bendable needle tube 7143 can be bent.

In this embodiment, the tip section 711 includes a needle tip 7112 and a protrusion 7113 fixedly connected thereto. The protrusion 7113 is fixedly connected to the distal connector 713.

In this embodiment, the distal link 713 has a through hole 717, and the protrusion 7113 penetrates through the distal end of the through hole 717 and is fixedly connected to the distal link 713. The length of the supporting inner core 7145 is larger than that of the bendable needle tube 7143, and the distal end of the supporting inner core 7145 is exposed out of the distal end of the bendable needle tube 7143 and fixedly arranged in the through hole 717 of the distal end connecting piece 713.

It is to be understood that the distal link 713 is not limited to the through hole 717. For example, the distal link 713 may include, but is not limited to, blind holes at each end of the distal link 713, such that the protrusion 7113 and the supporting core 7145 are fixedly inserted into the blind holes at each end of the distal link 713.

In this embodiment, the end of the needle section 711 remote from the supporting plunger 7145 (i.e., the needle tip 7112) is linear, and the needle section 711 is rigid, which facilitates the reliable transmission of the piercing force for the needle section 711 to facilitate the piercing of the valve and to make the needle section 711 more stable. Note that, 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 portion 711 does not deform when penetrating a valve.

In this embodiment, the projection 7113 is a segment of a cylinder. It is understood that the protrusion 7113 is not limited to be a cylinder, and it is preferable that the protrusion 7113 is disposed through the distal end connector 713 and is fixedly connected thereto, for example, the receiving space 717 can be, but is not limited to, a rectangular parallelepiped, and the protrusion 7113 can be, but is not limited to, a rectangular parallelepiped for matching with the receiving space 717.

In this embodiment, the distal link 713 is linear and rigid to provide a reliable piercing force and remain stable when piercing the valve.

In this embodiment, the support core 7145 is crimped with the distal connector 713. It will be appreciated that the support core 7145 is not limited to crimping with the distal connector 713, for example, but not limited to, a threaded connection, welding, etc.

The puncture needle 71 further comprises a proximal connecting member 716, as shown in fig. 9, the proximal connecting member 716 is fixedly connected between the puncture push rod 73 and the bendable needle body 714, and the support inner core 7145 is fixedly arranged at the distal end of the proximal connecting member 716. In this embodiment, the supporting core 7145 is crimped with the proximal connector 716. It will be appreciated that the support core 7145 is not limited to crimping with the proximal connector 716, for example, but not limited to, welding, threaded connection, etc.

In this embodiment, the distal end of the supporting inner core 7145 is fixedly connected to the distal end connector 713, the proximal end of the supporting inner core 7145 is fixedly connected to the proximal end connector 716, the bendable needle tube 7143 is sleeved outside the supporting inner core 7145, and the two ends of the supporting inner core 7145 are respectively abutted to the distal end connector 713 and the proximal end connector 716, i.e., the distal end connector 713 and the proximal end connector 716 respectively press the bendable needle tube 7143 at the two ends of the bendable needle tube 7143, so that the bendable needle tube 7143 is limited and fixed.

In this embodiment, the junction of the needle head 711 and the distal connector 713 is substantially equal to and smoothly connected with the outer diameter of the distal connector 713, and the bendable needle tube 7143, the distal connector 713 and the proximal connector 716 are substantially equal to and smoothly connected with each other, so as to reduce the resistance of the puncture needle 71 during puncturing.

In this embodiment, the distal face of the supporting core 7145 is aligned with the proximal face of the projection 7113. It will be appreciated that the distal face of the supporting core 7145 is not limited to being aligned with the proximal face of the projection 7113.

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 distal end of needle tip 7112 is tapered to facilitate reduction of the puncture point and damage to the valve. The tip 7112 may be, but is not limited to, 420 stainless steel, 304 stainless steel that has been heat treated or cryonitrided, or 316 stainless steel, which may be advantageous in making the tip 7112 sharp and wear resistant. A step 7115 is also provided on the tip section 711 for snap-fit secure attachment to the suture 200.

Referring again to fig. 5, the puncturing device 70 further includes a puncturing handle 75. The puncture push rod 73 is fixedly connected to a puncture handle 75, and the puncture handle 75 is inserted into the operation handle 10 and exposed from the proximal end of the operation handle 10. The puncture handle 75 is used for driving the puncture push rod 73 to move. The puncture push rod 73 is located between the puncture handle 75 and the puncture needle 71. The operator can control the penetration and withdrawal of the puncture device 70 by the puncture handle 75.

It will be appreciated that the manner in which the piercing push rod 73 is fixedly attached to the piercing handle 75 is not limited, and for example, but not limited to, a snap-fit connection, a reverse-fit connection, a threaded connection, etc. may be employed.

Because the transcatheter approach is used for interventional treatment, the valve suture device 100 needs to be inserted into the heart through a blood vessel (such as a vein) and the chuck device 50 is sent to the vicinity of the heart valve, the interventional path is tortuous, and the puncture needle 71 of the application is provided with the bendable needle body 714, so that the puncture needle 71 can be bent along the interventional path, and the transcatheter approach can be used for treatment. Compared with the transapical puncture method in the prior art, the transcatheter method has the advantages that only an incision is needed to be made on a blood vessel (such as a femoral vein or a jugular vein) near the surface of the body, and the implantation of a suture is implemented at the position of a mitral valve or a tricuspid valve in the heart by the intervention of a blood vessel (such as a superior vena cava or an inferior vena cava) of a human body, so that the injury to the human body is smaller, the minimally invasive effect is realized, and the operation risk can be reduced.

Referring to fig. 12, fig. 12 is a perspective view of a suture according to a first embodiment of the present application.

In this embodiment, the suture 200 includes a first fixed end 201, a second fixed end 203, a main body 205, and a fixing member 280. 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 to a fixing member 280. Mount 280 is adapted to be fixedly coupled to tip segment 711. In this embodiment, suture 200 is received in distal collet 53 (as shown in fig. 8), and mount 280 is axially aligned with tip segment 711 to ensure that tip segment 711 can engage mount 280 when penetrating distal collet 53.

In this embodiment, the fixing member 280 is a hollow pipe structure. It is understood that, without limiting the structure of the fixing member 280 to a hollow tube, the fixing member 280 can be fixedly connected to the needle head 711.

In this embodiment, the suture is bent into a "U" shape, the two ends after bending 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.

Referring to fig. 13 and 14, fig. 13 is a schematic structural view of the puncture device and the suture, and fig. 14 is a schematic structural view of the puncture device and the suture assembled together.

The fixing member 280 includes a third end 281 and a fourth end 283 which are fixedly connected, the third end 281 is arranged near one side of the needle head part 711, and the third end 281 is arranged between the needle head part 711 and the fourth end 283. The third end 281 is used for fixedly connecting with the needle head part 711. The fourth end 283 fixedly attaches to the first fixed end 201 or the second fixed end 203 of the suture 200.

In this embodiment, as shown in fig. 11, third end 281 is provided with a snap 2812, and third end 281 is snap-fitted into abutment with step 7115 of tip segment 711 by snap 2812. Fig. 12 shows a state where the third end 281 is engaged with the needle head 711.

It will be appreciated that third end 281 is non-removable or removable from snap-fit engagement with tip segment 711.

It is to be understood that the manner of attachment of tip segment 711 to mount 280 is not limited, and for example, but not limited to, a glued attachment or the like may be employed.

Referring to fig. 15, fig. 15 is a partial cross-sectional view of the clip device of the valve suture apparatus shown in fig. 3.

In this embodiment, a lumen 512 is provided in the proximal chuck 51 for the puncture needle 71 to movably penetrate through, and is used to provide a guiding function for the puncture needle 71, so that the puncture needle 71 does not shake in the lumen 512, and the size of the inner cavity 512 of the proximal chuck 51 is matched with the size of the distal connector 713, so as to ensure that the puncture needle 71 moves linearly and smoothly in the inner cavity 512. An inner lumen 532 is provided within distal collet 53 coaxial with lumen 512 for receiving fastener 280. With lumen 512 coaxial with lumen 532, the passage of tip segment 711 from proximal collet 51 into distal collet 53 is unobstructed and can be inserted into fixture 280 and snap-fit into engagement with fixture 280.

It can be understood that lumen 512 is not limited to be linear, lumen 532 is linear, lumen 512 is not limited to be coaxial with lumen 532, and it is sufficient that needle head 711 in lumen 512 can smoothly enter lumen 532 and connect with fastener 280.

In this embodiment, lumen 512 is an axial hole or slot formed by removing a portion of the material of proximal collet 51.

Stop feature 535 is also included in distal collet 53 to limit movement of mount 280 away from proximal collet 51. In this embodiment, a passageway 533 is provided in the distal collet 53 in communication with the lumen 532, the lumen 532 and the passageway 533 having different internal diameters, thereby forming a stepped stop 535 at the junction of the lumen 532 and the passageway 533. The stop 535 is configured to abut an end of the fastener 280 away from the proximal collet 51, thereby preventing the fastener 280 from moving away from the proximal collet 51.

A lumen (not shown) through which the puncture handle 75 is inserted is provided in the operation handle 10. The catheter 30 is provided with a lumen (not shown) through which the puncture rod 73 and the puncture needle 71 are movably inserted, and the lumen is tight and smooth and free from blockage. In the present embodiment, the lumen in catheter 30 is a plastic tube inserted into catheter 30, and polyimide is selected as the material. Because polyimide has good biocompatibility, hardness and smoothness. It is to be understood that the lumen material is not limited to plastic tubing.

Before the puncture device 70 punctures the valve, i.e. before the puncture state, the puncture needle 71 is located at the proximal cartridge 51. When the puncture device 70 needs to puncture the valve, the collet pushing tube 55 applies a force to the distal collet 53 under the action of the collet control member 11, so that the distal collet 53 and the proximal collet 51 cooperate with each other to clamp the valve (not shown). The proximal collet 51 and the valve form a clamping surface (i.e., a side of the proximal collet 51 close to the distal collet 53), the needle portion 711 is still located in the proximal collet 51, and a distance d between one end of the needle portion 711 away from the bendable needle body 714 (i.e., the needle tip 7112) and the clamping surface is in a range of 1-2 mm. Before the puncture state, the needle head 711, the distal end connector 713 and the bendable needle body 71 are located in the proximal collet 51.

It is understood that the distance d between the needle tip 7112 and the clamping surface is not limited to 1 to 2 mm.

Referring to fig. 16 and 17, in one application scenario, when the valve suture apparatus 100 provided herein is used to implant a suture 200 at the tricuspid valve, the femoral vein (CFV, fig. 16) is first opened and the clamping device 50 is delivered sequentially to the right atrium (RA, fig. 16) and right ventricle (RV, fig. 16) via the inferior vena cava (IVC, fig. 16) to the tricuspid valve site.

Referring to fig. 18, after the operator controls the clip control member 11 to make the distal clip 53 and the proximal clip 51 cooperate to clamp the valve, the operator controls the puncture handle 75 (shown in fig. 3) to move the puncture push rod 73 (shown in fig. 8). The puncture needle 71 punctures the valve (shown in fig. 18V) from the proximal cartridge 51 to the distal end by the puncture push rod 73 and is connected to the fixing member 280 provided at the distal cartridge 53. Thereafter, the operator controls the puncture handle 75 to retract the puncture push rod 73 and the puncture device 70 proximally, and the fixing member 280 with the main body 205 is also retracted proximally by the puncture device 70 and passes through the valve, thereby completing the implantation of the suture 200. After the suture is implanted on each valve leaflet, the suture on each valve leaflet can be locked through the intervention of the locking device, so that the edge-to-edge repair is realized.

In one application scenario, the valve suture device 50 can also perform jugular vein opening by implanting sutures 200 through the catheter route onto the tricuspid valve, sequentially into the right atrium (RA as shown in fig. 17) and right ventricle (RV as shown in fig. 17) through the superior vena cava (SVC as shown in fig. 17) to the tricuspid valve site.

Referring to fig. 19, in one application, the valve suture apparatus 100 of the present application is used to implant a suture 200 on a mitral valve by first opening the femoral vein (CFV, fig. 16), delivering the clamping device 50 via the inferior vena cava (IVC, fig. 16) to the right atrium (RA, fig. 16), and then puncturing the interatrial septum (FO, fig. 19), sequentially into the left atrium (LA, fig. 19) and left ventricle (LV, fig. 19), to reach the mitral valve location.

In one application scenario, the valve suture device 50 is used to implant a suture 200 on a mitral valve via a catheter approach, and may also be used to perform a jugular vein opening, sequentially into the right atrium (RA as shown in FIG. 17) and right ventricle (RV as shown in FIG. 17) via the superior vena cava (SVC as shown in FIG. 17), to pierce the interatrial septum (FO as shown in FIG. 19), and sequentially into the left atrium (LA as shown in FIG. 19) and left ventricle (LV as shown in FIG. 19) to the mitral valve site.

The manner in which suture 200 is implanted in the mitral valve by valve suture apparatus 100 is similar to the manner in which suture 200 is implanted in the tricuspid valve and will not be described in detail herein.

Second embodiment

Referring to fig. 20, fig. 20 is a schematic structural view of a puncturing device according to a second embodiment of the present application.

The puncture needle body 91 comprises a needle head 911, a distal end connector 913 and a bendable needle body 914 which are fixedly connected. The distal end connector 913 is fixedly connected between the needle portion 911 and the bendable needle body 914.

The second embodiment differs from the first embodiment in that a tip segment 911 is provided integrally with a distal end connector 913. The proximal end of the distal attachment member 913 is provided with a blind hole 9139.

More specifically, the bendable needle body 914 comprises a bendable needle tube 9143 and a supporting inner core 9145, and the supporting inner core 9145 is fixedly arranged on the bendable needle tube 9143 in a penetrating manner. In this embodiment, the supporting inner core 9145 is longer than the bendable needle tube 9143, and the supporting inner core 9145 is exposed from the distal end of the bendable needle tube 9143 and fixedly disposed through the blind hole 9139.

Third embodiment

Referring to fig. 21 and 22 in combination, fig. 21 is a schematic structural view of a puncturing device according to a third embodiment of the present application, fig. 22 is a schematic structural view of a portion of the puncturing device shown in fig. 21, and fig. 23 is a schematic structural view of a portion of the puncturing device shown in fig. 21.

The third embodiment is different from the first embodiment in that the bendable needle tube 310 includes a tube body 311 and a plurality of slot units 312 repeatedly arranged in an axial direction on a tube wall of the tube body 311. The distal end of the bendable needle cannula 310 is integrally formed with the distal connector 320 and the proximal end of the bendable needle cannula 310 is integrally formed with the proximal connector 330.

Each slot unit 312 includes N slots 3121 axially spaced apart from each other and penetrating the tube wall of the tube body 311, and each slot 3121 extends in a circumferential direction of the tube body 311. The adjacent two slots 3121 are offset from each other in the circumferential direction of the tube body 311, that is, in each slot unit 312, the adjacent two slots 3121 rotate around the circumferential direction by a certain rotation angle, and the adjacent two slots 3121 rotate by 360/N degrees relatively.

It can be understood that N is a positive integer greater than or equal to 3, and different values of N allow the bending direction and degree of the pipe body 311 to be different, and the larger the value of N is, the more the bending direction of the pipe body 311 can be, and the more the overall flexibility of the pipe body 311 will be obvious.

In this embodiment, N is 4, that is, each slot unit 312 includes 4 slots 3121 axially spaced from each other and penetrating through the tube wall of the tube body 311, and two adjacent slots 3121 are relatively rotated by 90 degrees.

It is understood that the value of N is not limited to 4, for example, as shown in fig. 24, N is 3, that is, each slot unit 312 includes 3 slots 3121 axially spaced apart from each other and penetrating through the tube wall of the tube body 311, and the relative rotation angle between two adjacent slots 841 is 120 degrees.

It is to be understood that the angle of relative rotation between the adjacent two slots 3121 is not limited, and the range of the rotation angle between the adjacent two slots 3121 around the circumferential direction is preferably 72 degrees to 108 degrees.

Each slot 3121 extends along the circumference of the tube 311 an arc length greater than or equal to 1/2 the circumference of the tube 311 and less than or equal to 2/3 the circumference of the tube 311; the arc length of each slot 3121 extending along the circumferential direction of the tube body 311 is greater than or equal to 1/2 of the circumference of the tube body 311, which can ensure that the arc length of the slot 3121 is not too short, and can ensure that the tube body 311 has better flexibility; the arc length of each slot 3121 extending along the circumferential direction of the tube 311 is less than or equal to 2/3 of the circumference of the tube 311, which ensures that the arc length of the slot 3121 is not too long and that the tube 311 has good rigidity. The sum of the arc lengths of all the slots 3121 of each slot unit 312 is greater than or equal to the circumference of the pipe body 311, i.e., it is satisfied that the arc lengths of all the slots 3121 of each slot unit 312 surround at least one turn in the circumferential direction of the pipe body 311. The slots 3121 in each slot unit 312 of the tube body 311 provide the tube body 311 with flexible properties, and the solid area of the wall of the tube body 311 between each adjacent two of the first slots 3121 provides the tube body 311 with rigid properties, thereby providing the tube body 311 with both rigidity and flexibility. In the present embodiment, the arc length of each slot 3121 is equal within each slot unit 312. As shown in fig. 22, each slot 3121 is an arc-shaped slot, and the corresponding central angle of the slot 3121 is 220 degrees.

It is to be understood that the arc length of each slot 3121 within each slot unit 312 is not limited to being equal, and the arc length of the slots 3121 may not be equal. It is to be understood that the central angle corresponding to the slot 3121 is not limited, and the central angle corresponding to each slot 3121 is preferably in a range of 200 degrees to 240 degrees. It is understood that the shape of the slot 3121 is not limited.

In the present embodiment, the distance between every two adjacent slots 3121 is substantially 0.25mm in the axial direction. It is understood that the interval between every two adjacent slots 3121 in the axial direction is not limited.

In this embodiment, the tube body 311 is made of a nitinol tube, and the slots 3121 are cut into the tube body 311 by a laser cutting apparatus. It is understood that the tube 311 may be made of, but not limited to, stainless steel, nitinol, cobalt chrome, etc.

In this way, the portion of the tube 311 corresponding to each slot 3121 makes the tube 311 flexible to achieve bending of the bendable needle tube 310, and the portion of the tube 311 corresponding to the portion between each two adjacent slots 3121 has rigidity to effectively transmit the puncturing force during puncturing.

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 (19)

1. The utility model provides a puncture needle, is applied to the valve suture apparatus of implanting the suture to heart valve, its characterized in that, puncture needle includes needle head portion and fixed connection the bendable needle body of needle head portion, needle head portion is used for puncturing the valve.

2. The puncture needle according to claim 1, wherein the bendable needle body comprises a bendable needle tube and a supporting plunger inserted into the bendable needle tube, and the supporting plunger is fixedly connected with the needle head.

3. A puncture needle according to claim 2, wherein the bendable needle tube is a spring tube.

4. The puncture needle according to claim 2, wherein a blind hole is formed at a side of the needle head portion adjacent to the bendable needle body, and a distal end of the support plunger is fixedly connected to the blind hole.

5. The puncture needle according to claim 2, wherein the bendable needle tube comprises a tube body and a plurality of slit units repeatedly arranged in an axial direction on a tube wall of the tube body, each of the slit units comprises N slits axially spaced from each other and penetrating the tube wall of the tube body, N is a positive integer of 3 or more, each of the slits extends in a circumferential direction of the tube body, and adjacent two of the slits are offset from each other in the circumferential direction of the tube body.

6. The needle of claim 5 wherein each of said slots is an arcuate slot, all of said slots in each of said slot units having equal arcuate lengths, all of said slots of each of said slot units surrounding at least one circumferential turn of said tube.

7. The puncture needle according to claim 6, wherein in each of the slot units, the adjacent two slots are relatively rotated by 360/N degrees.

8. A puncture needle according to claim 5, wherein each of said slots has a central angle in the range of 200 to 240 degrees.

9. A valve suture apparatus for implanting a suture to a heart valve, comprising a holding device for accommodating the suture and a puncture device comprising the puncture needle of any one of claims 1 to 8, wherein the needle head and the bendable needle body are movably disposed through the holding device, and the needle head is used for puncturing the valve and connecting the suture.

10. The valve suture apparatus of claim 9, wherein the puncture device further comprises a distal connector fixedly connected between the needle portion and the bendable needle body.

11. The valve suture apparatus of claim 10, wherein the distal connector is integrally formed with the needle portion or the distal connector and the needle portion are separate pieces.

12. The valve suture apparatus of claim 9, wherein the puncture device further comprises a puncture push rod fixedly connected to an end of the bendable needle body away from the needle head portion for driving the bendable needle body and the needle head portion to move.

13. The valve suture apparatus of claim 12, wherein the puncture device further comprises a puncture handle fixedly connected to an end of the puncture push rod away from the bendable needle body for controlling the puncture push rod to drive the bendable needle body and the needle head to move.

14. The valve suture apparatus of claim 12, wherein the puncture device further comprises a proximal connector fixedly connected between the puncture push rod and the bendable needle body.

15. The valve suture apparatus of claim 9, wherein the clamping device comprises a proximal clamp, a distal clamp, and a clamp pushing tube movably disposed in the proximal clamp and fixedly connected to the distal clamp, wherein the clamp pushing tube is configured to move the distal clamp relative to the proximal clamp to control the opening and closing of the clamping device, wherein the needle portion and the bendable needle body are movably disposed in the proximal clamp, and the distal clamp is configured to receive the suture.

16. The valve suture apparatus of claim 15, further comprising a catheter fixedly coupled to the proximal clip, the bendable needle movably disposed within the catheter, the clip push tube spaced from the bendable needle.

17. The valve suture apparatus of claim 16, further comprising an operating handle fixedly coupled to an end of the catheter distal to the proximal collet, wherein a collet control member is disposed on the operating handle and coupled to an end of the collet pusher tube distal to the distal collet for controlling the movement of the collet pusher tube with the distal collet.

18. The valve suture apparatus of claim 16, further comprising an adjustable bend sheath, the catheter movably disposed within the adjustable bend sheath.

19. The valve suture apparatus of claim 9, wherein the tip segment distal end is a rigid straight needle tip; the needle tip is provided with a step for connecting with the suture.

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