WO2021135913A1 - Valve suture device and valve suture system - Google Patents

Abstract

A valve suture device (100), which is used for implanting a suture into a heart valve, and comprises a clamping device (50), a conduit structure (30) and pins (71). The clamping device (50) is fixedly connected to a distal end of the conduit structure (30), the clamping device (50) comprises a distal chuck (53), a proximal chuck (51) and a chuck push rod (55), the distal chuck (53) is provided opposite to the proximal chuck (51), the chuck push rod (55) is fixedly connected to the distal chuck (53), and the chuck push rod (55) movably penetrates through the proximal chuck (51) and the conduit structure (30). The proximal chuck (51) is provided with a pin guiding passage (650) and a push rod guiding passage (660) which are independent of each other, and the conduit structure (30) is provided therein with a pin channel (331) and a push rod channel (351) which are independent of each other. A distal end of the pin channel (331) is in communication with the pin guiding passage (650), a distal end of the push rod channel (351) is in communication with the push rod guiding passage (660), the pins (71) movably penetrate through the pin channel (331) and the pin guiding passage (650), and the chuck push rod (55) movably penetrates through the push rod channel (351) and the push rod guiding passage (660). Both the chuck push rod (55) and the pins (71) can smoothly protrude from the proximal chuck (51). Further provided is a valve suture system (200) comprising the valve suture device (100).

Description

Valve suture device and valve suture system

This application claims the priority of a Chinese patent application filed with the State Intellectual Property Office of China, the application number is 201911409727.4, and the invention title is "Valve Suture Device and Valve Suture System" on December 31, 2019, the entire content of which is incorporated by reference In this application.

Technical field

The present invention relates to the technical field of medical devices, in particular to a valve suture device and a valve suture system.

Background technique

Heart valve disease is due to structural damage, fibrosis, adhesions, shortening, myxomatous degeneration, degenerative changes or congenital changes caused by inflammation of the heart valves (including valve leaflets, chordae (CT as shown in Figure 1) and papillary muscles) Abnormal function or structure of a single valve or multiple valves caused by developmental deformities, trauma, etc., resulting in valve stenosis and insufficiency.

Please refer to Figure 1. The left atrium (LA as shown in Figure 1) and the left ventricle (LV as shown in Figure 1) are separated by the mitral valve (MV as shown in Figure 1), and the right atrium (as shown in Figure 1) Show RA) and the right ventricle (RV shown in Figure 1) are separated by the tricuspid valve (TV shown in Figure 1). The tricuspid valve and the mitral valve allow blood to flow from the atrium into the ventricle only, not back flow. Mitral valve regurgitation or tricuspid valve regurgitation can cause ventricular blood to flow back to the atrium during systole, causing the atrial volume to expand and the pressure to increase, leading to increased ventricular load and easy heart failure.

Surgery is currently the mainstream method for the treatment of valvular heart disease. However, for some elderly patients, multiple comorbidities, or a history of thoracotomy, surgical operations have huge trauma and high mortality. At present, most of the valve repair devices for interventional treatment of mitral valve regurgitation and tricuspid valve regurgitation are in the research and development stage. Interventional treatment methods mainly include chordal repair or edge-to-edge repair by implanting sutures into the heart valve.

Please refer to Figures 2 and 3, an existing interventional heart valve repair instrument 100a for thoracic approach is punctured between the ribs and then the apex of the heart is punctured, and the entire instrument is advanced to the left ventricle and left atrium to implement the mitral valve Valve repair. Wherein, the pushing catheter 210a of the heart valve repair device 100a is hard, rigid, straight, and short in length, and is pierced in the pushing catheter 210a for puncturing the valve with a puncture needle (not shown) and puncture The chuck push rod 330a installed in the pushing catheter 210a for driving the proximal chuck 320a and the distal chuck 310a is also hard, rigid, straight, and short in length. Push the puncture needle contained in the proximal chuck 320a and the pushing catheter 210a to protrude from the corresponding opening on the proximal chuck 320a and puncture the valve, and then the puncture needle enters the distal chuck 310a and interacts with the distal chuck. The suture in 310a is fixed and connected, and then the puncture needle is withdrawn toward the proximal end to drive the suture through the valve, and then the suture is implanted on the valve. Later, the implanted suture can be used for chordal repair or edge-to-edge repair To repair the valve. During the use of this device, the pushing catheter 210a, the puncture needle, and the chuck push rod 330a are kept straight, and the proximal chuck 320a is provided with outlets (not shown) for the chuck push rod 330a and the puncture needle respectively. It is aligned with the chuck push rod 330a and the puncture needle correspondingly, so the chuck push rod 330a and the puncture needle are easy to align with the corresponding outlets on the proximal chuck.

The above-mentioned interventional heart valve repair device 100a is accessed through the thoracic cavity and needs to pierce the apex of the heart, so it still causes certain damage to the human body. If a more minimally invasive transvena cava interventional heart valve repair operation is used, the instrument needs to be passed through the curved blood vessel, then the delivery catheter must be a flexible flexible sheath, and the chuck push rod and puncture installed in the sheath Slender pieces such as needles also need to have a certain degree of flexibility to bend with the bending of the sheath, which will cause an obvious technical problem: the chuck push rod and the puncture needle will bend under the action of their own gravity, and The upper sheath is bent, the chuck push rod and the distal end of the puncture needle are difficult to align with the corresponding opening on the proximal chuck, which may hinder the relative opening and closing of the proximal chuck and the distal chuck, and cause the puncture needle to fail Extend the proximal chuck, thereby obstructing the clamping of the valve, puncturing the valve, and implanting the suture.

Summary of the invention

In order to solve the aforementioned problems, the present invention provides a valve suture device and a valve suture system.

In the first aspect, the present application discloses a valve suture device for implanting sutures into a heart valve, comprising a clamping device, a catheter structure and a needle, the clamping device is fixedly connected to the distal end of the catheter structure; The clamping device includes a distal chuck, a proximal chuck, and a chuck push rod. The distal chuck is arranged opposite to the proximal chuck, and the chuck push rod is opposite to the distal chuck. Fixed connection, the chuck push rod is movably installed in the proximal chuck and the catheter structure, and the chuck push rod is used to drive the distal chuck and the proximal chuck relatively apart Close; The proximal chuck is provided with mutually independent needle guide channels and push rod guide channels, the catheter structure is provided with mutually independent needle cavities and push rod cavities, the needle cavity The distal end of the channel is fixedly connected with the pin guide channel and communicates with each other, the distal end of the push rod cavity is fixedly connected with the push rod guide channel and communicates with each other, and the pin is movably penetrated in the In the pin cavity and the pin guide channel, the chuck push rod is movably arranged in the push rod cavity and the push rod guide channel.

In the second aspect, the present application also discloses a valve suture system, including the valve suture device and an adjustable bend sheath as described above, the adjustable bend sheath includes a sheath tube and a proximal end fixedly connected to the sheath tube The adjustable bend handle, the catheter structure is movably installed in the sheath and the adjustable bend handle.

The valve suture device and valve suture system provided by the present application are provided with a needle lumen and a push rod lumen independent of each other in the catheter structure, and the needle lumen and the needle guide provided on the proximal chuck The channels are fixedly connected and communicate with each other. The push rod lumen in the catheter structure and the push rod guide channel provided in the proximal chuck are fixedly connected and communicated with each other. The catheter structure enters the heart through a blood vessel approach, No matter how the catheter structure is bent: the chuck push rod can use the push rod cavity as a path to lead to the push rod guide channel, and smoothly pass through the push rod guide channel, thereby driving the proximal chuck and the distal end The chuck relatively opens and closes to clamp or loosen the valve; all the pins can use the pin cavity as a path to lead to the pin guide channel, and smoothly protrude from the distal port of the pin guide channel, and then Puncture the valve and implant sutures.

Description of the drawings

In order to explain the embodiments of the present invention or the technical solutions in the prior art more clearly, the following will briefly introduce the drawings that need to be used in the description of the embodiments or the prior art. Obviously, the drawings in the following description are only These are some embodiments of the present invention. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative work.

Figure 1 is a schematic diagram of the structure of the human heart.

Fig. 2 is a schematic diagram showing that the distal end chuck and the proximal end chuck of the heart valve repair instrument provided by the prior art do not clamp the valve.

Fig. 3 is a schematic diagram of the distal end chuck and the proximal end chuck of the heart valve repair instrument provided by the prior art clamping the valve.

4 is a schematic diagram of the three-dimensional structure of the valve suture system provided by the first embodiment of the application.

Fig. 5 is a schematic diagram of the three-dimensional structure of the valve suture device of the valve suture system shown in Fig. 4.

Fig. 6 is a three-dimensional assembly schematic diagram of the valve suture device shown in Fig. 5.

Fig. 7 is a schematic diagram of the bent state of the valve suture device shown in Fig. 5.

Fig. 8 is a schematic diagram of an application scenario of the valve suture device shown in Fig. 5.

Fig. 9 is a partial structural diagram of the valve suture device shown in Fig. 5.

Fig. 10 is a cross-sectional view of the valve suture device shown in Fig. 9 along E-E.

Fig. 11 is a perspective view of the catheter structure of the valve suture device shown in Fig. 5.

Fig. 12 is a schematic diagram of a perspective view of the valve suture device shown in Fig. 5 in an opened state.

Fig. 13 is a schematic view of another perspective view of the valve suture device shown in Fig. 5 in an opened state.

Fig. 14 is a schematic diagram of a perspective view of the valve suture device shown in Fig. 5 in a closed state.

Fig. 15 is a schematic view from another perspective of the valve suture device shown in Fig. 5 in a closed state.

Fig. 16 is a partial structural diagram of the valve suture device shown in Fig. 5.

Fig. 17 is a schematic diagram of the proximal chuck structure of the valve suture device shown in Fig. 5.

Fig. 18 is a cross-sectional view of the proximal chuck of the valve suture device shown in Fig. 5.

Fig. 19 is a cross-sectional view of the proximal collet holder of the valve suture device shown in Fig. 5.

Fig. 20 is a partial structural diagram of the clamping device of the valve suture device in an open state.

Fig. 21 is a partial structural diagram of the valve suture device shown in Fig. 5.

Fig. 22 is a partial structural diagram of the valve suture device shown in Fig. 5.

FIG. 23 is a schematic diagram of an application scenario of the valve suture system provided by the first embodiment of this application.

FIG. 24 is a schematic diagram of another application scenario of the valve suture system provided by the first embodiment of the application.

FIG. 25 is a schematic diagram of an application scenario of the valve suture system provided by the first embodiment of the application.

FIG. 26 is a cross-sectional view of the valve suture system provided by the second embodiment of the application along the radial cross-section of the catheter.

FIG. 27 is a cross-sectional view of the valve suture system provided by the third embodiment of the application along the radial cross-section of the catheter.

FIG. 28 is a schematic diagram of a part of the structure of the clamping device of the valve suture system provided by the fourth embodiment of the application.

FIG. 29 is a schematic diagram of a part of the structure of the valve suture system provided by the fourth embodiment of the application.

Detailed ways

The technical solutions in the embodiments of the present application will be described clearly and completely in conjunction with the accompanying drawings in the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all of them. Based on the implementation manners in this application, all other implementation manners obtained by those of ordinary skill in the art without creative work shall fall within the protection scope of this application.

In the technical field of interventional medical devices, the position close to the operator is usually defined as the proximal end, and the position away from the operator is defined as the distal end; the direction of the central axis of rotation of objects such as cylinders and tubes is defined as the direction of the central axis of rotation. The common direction is defined as the axial direction.

The first embodiment

Please refer to FIG. 4 in combination. FIG. 4 is a schematic diagram of the three-dimensional structure of the valve suture system provided by the first embodiment of this application.

The present application provides a valve suture system 200, which is used for the implantation of sutures (not shown) to repair the heart valve. The valve suture system 200 includes an adjustable bending sheath 300 and a valve suture device 100 partially penetrated in the adjustable bending sheath 300.

The adjustable bending sheath 300 includes a sheath 310 and a bending handle 320. The sheath 310 is fixedly connected to the distal end of the bending handle 320. The bending handle 320 is used to control the bending of the sheath 310 to adapt to the curved introduction path.

Please refer to FIGS. 5 and 6 together. FIG. 5 is a schematic diagram of the three-dimensional structure of the valve suture device of the valve suture system shown in FIG. 4. Fig. 6 is a three-dimensional assembly schematic diagram of the valve suture device shown in Fig. 5.

The valve suture device 100 includes an operating handle 10, a catheter structure 30, a clamping device 50, a needle assembly 70, a probe 80, and a guide wire 90 (as shown in FIG. 10). The catheter structure 30 is movably inserted in the sheath 310. The catheter structure 30 is fixedly connected between the clamping device 50 and the operating handle 10, and is used to deliver the clamping device 50 into the heart. The bending of the sheath 310 can drive the catheter structure 30 to bend . The clamping device 50 is used for accommodating sutures and clamping the valve. The needle assembly 70, the probe 80 and the guide wire 90 are movably installed in the clamping device 50, the catheter structure 30 and the operating handle 10. The pin assembly 70, the probe 80 and the guide wire 90 are all elongated pieces and are arranged at intervals. The insertion needle assembly 70 is used to puncture the valve distally and be fixedly connected with the suture, and then withdraw to the proximal end to draw the suture out of the valve to realize the implantation of the suture. The operating handle 10 is used to facilitate the operator to hold and manipulate the clamping device 50 and the needle assembly 70 to implant sutures into the heart valve. The probe 80 is used to detect whether the valve is effectively clamped by the clamping device 50. The effective clamping means that the clamping device 50 holds the valve stably, and the valve is not easily detached from the clamping device 50. The guide wire 90 can be bent and delivered to the lesion location, and is used to transport the clamping device 50 and the catheter structure 30 to the lesion location for guidance.

It can be understood that the pin assembly 70, the probe 80, the guide wire 90 and the control handle 10 can all be detached.

In this embodiment, the duct structure 30 is glued to the clamping device 50 and the operating handle 10. It can be understood that the glue connection between the duct structure 30 and the clamping device 50 is not restricted, and the glue connection between the duct structure 30 and the operating handle 10 is not restricted.

The operating handle 10 is provided with a chuck control part 11, a pin control part 13 and a probe control part 15. The chuck control member 11 is connected to the proximal end of the clamping device 50 for controlling the opening and closing of the clamping device 50. The pin control member 13 is fixedly connected to the proximal end of the pin assembly 70 for controlling the axial movement of the pin assembly 70 along the catheter structure 30. The probe control member 15 is fixedly connected to the proximal end of the probe 80 for controlling the axial movement of the probe 80 along the catheter structure 30. The guide wire 90 is pushed or retracted by the force applied by the operator.

The pin assembly 70 includes a pin 71 and a pin push rod 73 fixedly connected to the proximal end of the pin 71. The insertion needle 71 is movably installed in the catheter 31 and the clamping device 50 to puncture the valve distally and to be fixedly connected with the suture. The distal end of the pin push rod 73 is connected with the pin control member 13 for driving the pin 71 to move.

Please refer to FIGS. 9, 10 and 11 in combination. FIG. 9 is a partial structural diagram of the valve suture device shown in FIG. 5. Fig. 10 is a cross-sectional view of the valve suture device shown in Fig. 9 along E-E. Fig. 11 is a schematic diagram of the catheter structure of the valve suture device shown in Fig. 5.

The catheter structure 30 includes a catheter 31 and a needle single lumen tube 33 movably inserted inside the catheter 31, a guide wire single lumen tube 34, a push rod single lumen tube 35, and a probe single lumen tube 36. There are gaps between the inner wall of the catheter 31 and the needle single-lumen tube 33, the guide wire single-lumen tube 34, the push rod single-lumen tube 35, and the probe single-lumen tube 36 inside. In addition, the single-lumen needle tube 33, the single-lumen tube 34 of the guide wire, the single-lumen tube 35 of the push rod, and the single-lumen tube 36 of the probe are arranged at intervals and not fixedly connected to each other.

Please refer to FIGS. 7 and 8 together. FIG. 7 is a schematic diagram of the bending state of the valve suture device shown in FIG. 5. Fig. 8 is a schematic diagram of an application scenario of the valve suture device shown in Fig. 5.

The catheter 31 has a certain degree of flexibility, so that it can be bent to adapt to the tortuous intervention path in the blood vessel. It can be understood that correspondingly, the needle assembly 70, the probe 80 and the guide wire 90 (as shown in FIG. 10) inserted in the catheter 31 can also be bent.

It can be understood that the length of the duct 31 is not limited.

In this embodiment, the distance between the single-lumen needle tube 33, the single-lumen tube 34 of the guide wire, the single-lumen tube 35 of the push rod, and the single-lumen tube 36 of the probe ranges from 0.2 mm to 0.5 mm. When the lumen moves, it will not interfere with the adjacent single-lumen tubes. It can be understood that the distance range between the single-lumen needle tube 33, the single-lumen tube 34 of the guide wire, the single-lumen tube 35 of the push rod, and the single-lumen tube 36 of the probe is not limited.

The inner cavity of the single needle lumen tube 33 is a needle lumen 331, which is used to penetrate the needle assembly 70 and provide a guide for the needle assembly 70.

The inner cavity of the guidewire single-lumen tube 34 is a guidewire lumen 341 for piercing the guidewire 90 and providing guidance for the guidewire 90.

The inner cavity of the single-lumen tube 35 of the push rod is a push rod channel 351 for accommodating part of the clamping device 50 and providing guidance for opening and closing of the clamping device 50.

A probe cavity 361 is provided on the probe single-lumen tube 36 for piercing the probe 80 and providing guidance for the probe 80.

It is worth noting that if the single-lumen tubes (including the single-lumen needle tube, the single-lumen guide wire tube, the single-lumen tube of the push rod and the single-lumen probe tube) and the single-lumen tube and the catheter are fixedly connected, Because each single-lumen tube and the slender parts (such as the needle assembly, guide wire, chuck push rod and probe) in the catheter are distributed in different positions, diameters, or materials, each single-lumen tube is different from After a catheter is formed into a whole, the force that the whole is bent to the same angle in different directions (as shown in Figure 7) is different, that is, it is affected by anisotropy. Therefore, if the single-lumen tubes and between the single-lumen tubes and the catheter are fixedly connected, when the catheter is bent in a direction with greater bending resistance, there is a tendency to change in a direction with less bending resistance, for example, as shown in Figure 10. As shown, in the catheter 31, the resistance to bending along the connecting direction of the guide wire single-lumen tube 34 and the push rod single-lumen tube 35 (L1 as shown in FIG. 10) is greater than that along the connecting direction of the two-pin single-lumen tube 33 (L2 shown in Figure 10) bending resistance. Therefore, when the catheter 31 is bent along the connecting direction of the guide wire single-lumen tube 341 and the push rod single-lumen tube 35 (L1 shown in Figure 10), it is subject to anisotropy As a result, the catheter 31 tends to bend toward the connection direction of the two single-lumen tubes 33 (L2 as shown in FIG. 10), or directly wrinkles. In order to avoid this effect, in this embodiment, the single-lumen needle tube 33, the single-lumen guide wire tube 34, the single-lumen tube 35 of the push rod and the single-lumen tube 36 of the probe are among each other, as well as the single-lumen needle tube 33, There is a certain gap between the guide wire single lumen tube 34, the push rod single lumen tube 35, and the probe single lumen tube 36 and the inner wall of the catheter 31, so that when the catheter 31 is bent, the needle single lumen tube 33 and the guide wire The bending of the single-lumen tube 34, the single-lumen tube 35 of the push rod and the single-lumen probe tube 36 provides buffer space, the single-lumen tube 33 of the needle, the single-lumen tube 34 of the guide wire, the single-lumen tube 35 of the push rod and the single-lumen tube of the probe 36 is not easily affected by anisotropy, that is, the catheter 31 and the single-lumen tube 33 of the needle, the single-lumen tube 34 of the guide wire, the single-lumen tube 35 of the push rod, and the single-lumen tube 36 of the probe are close to isotropic.

In this embodiment, the numbers of the single-lumen needle tube 33, the single-lumen tube 34 of the guide wire, the single-lumen tube 35 of the push rod, and the single-lumen tube 36 of the probe are two, one, one, and two, respectively. The single-lumen tube 351 of the push rod is arranged close to the inner wall of the catheter 31, and the single-lumen tube 341 of the guide wire is arranged close to the inner wall of the catheter 31 and away from the single-lumen tube 351 of the push rod.

In this embodiment, compared to the single-lumen tube 35 of the push rod and the single-lumen tube 34 of the guide wire, the two-pin single-lumen tube 33 and the two-probe single-lumen tube 36 have smaller diameters. The push rod single-lumen tube 35 and the guide wire single-lumen tube 34 are spaced apart in the direction shown by L1 in FIG. 10, and the two pin single-lumen tubes 33 are spaced apart in the direction shown by L2 in FIG. 10, and the push rod single-lumen tube 35 is located Between the two probe single-lumen tubes 36, each probe single-lumen tube 36 is located between the push rod single-lumen tube 35 and one pin single-lumen tube 33, and L1 is approximately orthogonal to L2. In this way, in the first aspect, the single-lumen tubes are arranged compactly to increase the effective use of space in the catheter 31 as much as possible, reduce the outer diameter of the catheter 31, and make the catheter 31 flow more smoothly in the blood vessel. In the second aspect, the probe single-lumen tube 36 is located between the push rod single-lumen tube 35 and the needle single-lumen tube 33. When the clamping device 50 clamps the valve, its opening side faces the valve and passes through the probe single-lumen tube 36. Once the inner probe 80 detects the valve, it means that the valve covers the protruding hole of the needle 71 in the needle assembly 70, ensuring that the needle assembly 70 inserted in the needle single lumen tube 33 can smoothly puncture the valve. In the third aspect, the single-lumen needle tube 33 is set away from the single-lumen tube 35 of the push rod in the catheter 31, so that the needle assembly 70 inserted into the single-lumen tube 33 of the needle is inserted into the single-lumen tube 35 of the push rod. The distance between the chuck push rod 55 that controls the opening and closing of the clamping device 50 is as large as possible, and the single-lumen tube 33 and the single-lumen tube 35 of the push rod are prevented from crossing in the clamping device 50.

This embodiment only provides a preferred embodiment. It can be understood that the size and quantity of the single-lumen tube 33 for the needle, the single-lumen tube 34 for the guide wire, the single-lumen tube 35 for the push rod, and the single-lumen tube 36 for the probe are not limited. It can be understood that the arrangement of the single-lumen tube 33 for the insertion needle, the single-lumen tube 34 for the guide wire, the single-lumen tube 35 for the push rod, and the single-lumen tube 36 for the probe in the catheter 31 are not limited.

In this embodiment, the catheter 31 includes an inner layer, an intermediate layer, and an outer layer that are stacked and fixedly connected. The inner layer is made of polytetrafluoroethylene inner film, the middle layer is made of metal wire woven mesh, and the outer layer is made of thermoplastic material. The conduit 31 is made of thermoplastic molding with an outer layer covering the middle layer and an inner film.

In this embodiment, each single-lumen tube (ie, single-lumen tube 33 for inserting needle, single-lumen tube for guide wire 34, single-lumen tube for push rod 35 and single-lumen tube for probe 36) are selected from polyimide (PI for short). ). It can be understood that each single-lumen tube (ie, single-lumen tube for inserting needle 33, single-lumen tube for guide wire 34, single-lumen tube for push rod 35 and single-lumen tube for probe 36) can be, but not limited to, adopt biocompatible polymers. Materials such as polytetrafluoroethylene (PTFE), polyetheretherketone (PEEK), polyurethane (PU) or nylon elastomer (Pebax), etc.

Referring to FIG. 12, the clamping device 50 includes a proximal chuck 51, a distal chuck 53, a chuck push rod 55 and a guide rod 58, and the proximal chuck 51 is fixedly connected to the distal end of the catheter 31. The distal clamp 53 is used to accommodate sutures (not shown). One end of the chuck push rod 55 is connected to the chuck control member 11, the chuck push rod 55 is inserted through the push rod single-lumen tube 351, and the other end of the chuck push rod 55 is inserted through the proximal chuck 51. The guide rod 58 is fixedly connected to the distal chuck 53 and movably penetrates the proximal chuck 51. The proximal end of the guide rod 58 away from the distal chuck 53 and the distal end of the chuck push rod 55 away from the chuck control member 11 are fixed. Meet. The chuck push rod 55 is used to drive the guide rod 58 to make the distal chuck 53 and the proximal chuck 51 relatively open and close, so as to clamp or loosen the valve. The chuck push rod 55 and the guide rod 58 are both arranged along the axial direction of the distal chuck 53 and the proximal chuck 51.

It can be understood that the fixed connection between the chuck push rod 55 and the distal chuck 53 is not limited. For example, the distal end of the chuck push rod 55 may be, but not limited to, only be fixedly connected with the guide rod 58.

It can be understood that the clamping device 50 may also include a slider (not shown). The slider is movably accommodated in the proximal chuck 51 and slidably connected to the proximal chuck 51, and the guide rod 58 is fixedly connected to the distal chuck. 53 is slidably connected with the slider and with the proximal chuck 51, the chuck push rod 55 is fixedly connected with the slider, and the chuck push rod 55 is used to drive the slider to indirectly drive the guide rod 58 to push the distal chuck relative to Far away or close to the proximal chuck 51, the clamping device 50 can be opened and closed.

The proximal chuck 51 has a proximal clamping surface 517 on the side close to the distal chuck 53 (also shown in FIG. 17), and the distal chuck 53 has a distal clamping surface on the side close to the proximal chuck 51. 537. The proximal clamping surface 517 and the distal clamping surface 537 are disposed opposite to each other, and are used to contact the valve to clamp the valve when the valve is captured. Both the proximal clamping surface 517 and the distal clamping surface 537 are inclined surfaces that are arranged obliquely with respect to the axial direction of the proximal chuck 51, which is beneficial to increase the area for clamping the valve.

As shown in Figures 12 and 13, when the chuck push rod 55 drives the guide rod 58 to indirectly drive the distal chuck 53 to be relatively far away from the proximal chuck 51, the distal clamping surface 537 is also relatively far away from the proximal clamping surface 517. The clamping device 50 is in an open state, and can capture or release the valve.

As shown in Figures 14 and 15, the chuck push rod 55 drives the guide rod 58 to indirectly drive the distal chuck 53 to be relatively close to the proximal chuck 51, and the distal clamping surface 537 is also relatively close to the proximal clamping surface 517. The holding device 50 is in a closed state, and the holding device 50 can be folded or the valve can be clamped.

In this embodiment, the distal chuck 53 is approximately cylindrical. It can be understood that it is not limited that the distal chuck 53 is approximately cylindrical. The shape of the distal end clamping surface 537 and the proximal end clamping surface 517 is nearly circular, and the diameter of the distal end clamping surface 537 and the proximal end clamping surface 517 is 6mm-8mm, which is close to the size of the human vena cava vessel, which is beneficial to the largest Clamp the valve to the limit. It can be understood that the diameters of the distal end clamping surface 537 and the proximal end clamping surface 517 are not limited.

As shown in Figs. 16 and 17, Fig. 16 is a partial structural diagram of the valve suture device shown in Fig. 5, and Fig. 17 is a structural diagram of the proximal chuck of the valve suture device shown in Fig. 5.

The proximal chuck 51 is provided with a pin guide channel 650, a probe guide channel 670, a push rod guide channel 660 and a guide wire guide channel 63, a pin guide channel 650, a probe guide channel 670, a pusher The rod guide channel 660 and the guide wire guide channel 63 are arranged independently of each other. The pin 71 is movably inserted in the pin guide channel 650, the probe 80 is movably inserted in the probe guiding channel 670, the chuck push rod 55 is movably inserted in the push rod guiding channel 660, and the guide wire 90 The movable thread is arranged in the guide wire guide channel 63.

In this embodiment, the pin guide channel 650, the push rod guide channel 660, and the probe guide channel 670 are all inclined relative to the axial direction of the proximal chuck 51, and the proximal end of the pin guide channel 650, the push rod The proximal end of the rod guide channel 660 and the proximal end of the probe guide channel 670 are relatively converged relative to the axis of the proximal chuck 511, the distal end of the needle guide channel 650, the distal end of the push rod guide channel 660, the probe The needle guide channel 670 is relatively divergent with respect to the axis of the proximal chuck 51.

The pin guide channel 650 includes a pin end hole 65 and a pin sub-channel 651 that are connected to each other. The distal end opening of the pin end hole 65 is provided on the proximal clamping surface 517, and the pin end hole 65 is located in the pin sub-channel. At the distal end of 651, the pin assembly 70 is movably inserted through the pin end hole 65 and the pin sub-channel 651.

The probe guide channel 670 includes a probe end hole 67 and a probe sub-channel 671 that are connected to each other. The distal end of the probe end hole 67 is opened on the proximal clamping surface 517, and the probe end hole 67 is located in the probe sub-channel. At the distal end of 671, the probe 80 movably penetrates through the probe end hole 67 and the probe sub-channel 671.

The push rod guide channel 660 includes a push rod end hole 66 and a push rod sub-channel 661 connected to each other. The distal end opening of the push rod end hole 66 is opened on the proximal clamping surface 517, and the push rod end hole 66 is located in the push rod sub channel. At the distal end of 661, the chuck push rod 55 movably penetrates through the push rod end hole 66 and the push rod sub-channel 661.

In this embodiment, the distal opening of the guide wire guiding channel 63 is approximately located at the center of the proximal clamping surface 517, and the pin end hole 65, the probe end hole 67 and the push rod end hole 66 are surrounded by the guide wire Around the guide channel 63.

More specifically, the proximal chuck 51 includes a proximal chuck holder 511 and a proximal chuck body 513 that are fixedly connected, and the proximal chuck holder 511 is fixedly connected between the proximal chuck body 513 and the catheter 31. In this embodiment, the proximal collet holder 511 is glued to the catheter 31 (as shown in FIG. 15). It can be understood that the glue connection between the proximal collet holder 511 and the catheter 31 is not limited.

As shown in FIG. 18, in this embodiment, a buckle 5139 is provided at the proximal end of the proximal chuck body 513, a groove 5119 is provided at the distal end of the proximal chuck base 511, and the proximal chuck body 513 passes through the buckle. 5139 is engaged with the groove 5119 of the proximal chuck seat 511 in snapping connection. In this embodiment, the numbers of the buckles 5139 and the grooves 5119 are 3 respectively, and it is understood that the numbers of the buckles 5139 and the grooves 5119 are not limited to 3 respectively.

Please also refer to FIG. 19, the proximal chuck holder 511 includes a joint part 5112 and a seat body 5113 that are fixedly connected. The joint part 5112 is sleeved outside the catheter 31 and is fixedly connected to the catheter 31.

In this embodiment, the proximal chuck body 513 is approximately cylindrical and smoothly transitions with the distal chuck 53, and the diameter of the joint 5112 is close to the diameter of the catheter 31. The seat body 5113 is roughly in the shape of a truncated cone, and one end of the seat body 5113 adjacent to the joint 5112 has a diameter-reducing section, and the diameter-changing section is roughly a cone shape. The radial dimension of the variable diameter section gradually increases from the end connected to the joint 5112 toward the end connected to the proximal chuck body 513 (that is, from the proximal end to the distal end), so that the proximal chuck The radial dimension of 51 is gradually increased from the diameter of the proximal tube 31 to equal to the diameter of the distal chuck 53, and the seat body 5113 is smoothly connected between the joint 5112 and the proximal chuck body 513 as the proximal chuck body 513 and the transition between the duct 31. In this embodiment, the length of the truncated cone of the proximal chuck seat 511 is 10mm-22mm, and the taper can be in the range of 1:6 to 1:2. The tangent at each position on the outer wall of the proximal chuck seat 511 is consistent with the axial direction of the catheter 31. The angle between them does not exceed 45 degrees. In this way, the proximal chuck holder 511 adapts to the change in the outer diameter from the catheter 31 to the proximal chuck body 513. On the one hand, it makes the valve suture device 100 pass smoothly in the process of advancing or exiting in the blood vessel, avoiding the clamping device 50 Scraping the inner wall of the blood vessel, or allowing the valve suture device 100 to pass smoothly during the process of puncturing the atrial septum from the right atrium into or out of the left atrium. On the other hand, it prevents the proximal chuck 51 and the catheter 31 from forming a step and increasing thrombosis. possibility. It can be understood that the structure and shape of the proximal chuck 51 are not limited, and the angle range between the tangent at each position on the outer side wall of the proximal chuck seat 511 and the axial direction of the catheter 31 is not limited.

It can be understood that the seat body 5113 is not limited to be approximately a truncated cone shape, and the shape of the seat body 5113 can make the proximal chuck body 513 and the joint 5112 smoothly connect.

Please refer to FIG. 19 and FIG. 20 together. FIG. 20 is a partial structural diagram of the valve suture device shown in FIG. 5. In this embodiment, the joint part 5112 is a short tube body with a length of 2 mm-5 mm, and the joint part 5112 is provided with a plurality of openings 5118 (as shown in FIG. 15) along the circumferential direction, which are used to seep glue when the pipe 31 is glued and connected.

It can be understood that the length of the joint 5112 is not limited.

A baffle 5116 is provided at the distal end of the joint 5112 for abutting against the distal end of the catheter 31. A number of through holes 5117 are provided on the baffle 5116. The pin 71, the chuck push rod 55, the probe 80 and the guide wire 90 extend from the catheter 31 into the seat body 5113 through the corresponding through hole 5117.

A receiving space 5114 is provided inside the base 5113. The inner wall of the accommodating space 5114 is provided with a pin fitting groove 651B, a probe fitting groove 671B, and a push rod fitting groove 661B at intervals. The pin fitting groove 651B, the probe fitting groove 671B and the push rod fitting groove 661B are all opposite to the axis of the seat body 5113. Set to tilt. The proximal end of the pin fitting groove 651B, the proximal end of the probe fitting groove 671B, and the proximal end of the push rod fitting groove 661B are relatively gathered relative to the axis of the proximal chuck 511, the distal end of the pin fitting groove 651B and the probe fitting groove The distal end of the 671B and the distal end of the push rod fitting groove 661B diverge relative to the axis of the proximal chuck 511.

The proximal chuck main body 513 includes an embedded portion 5131 and a proximal clamping portion 5133. The proximal clamping portion 5133 is fixedly connected to the distal end of the embedded portion 5131. As shown in FIG. 17, the proximal clamping surface 517 is located at the distal end of the proximal clamping portion 5133. The diameter of the embedded portion 5131 gradually decreases in the direction toward the proximal end. The embedded portion 5131 is accommodated in the receiving space 5114 of the proximal chuck seat 511, and the embedded portion 5131 is closely fitted with the inner wall of the receiving space 5114.

The guide wire guiding channel 63 penetrates the embedded portion 5131 and the proximal clamping portion 5133 to provide guidance for the guide wire 90.

The pin end hole 65, the push rod end hole 66 and the probe end hole 67 (as shown in FIG. 17) are respectively provided on the proximal clamping portion 5133.

In this embodiment, the cross-sectional area of the embedded portion 5131 perpendicular to the axial direction of the proximal chuck 51 gradually increases from the proximal end to the distal end. The outer wall of the embedded part 5131 is provided with a pin guide groove 651A, a probe guide groove 671A, and a push rod guide groove 661A. The pin guide groove 651A communicates with the pin end hole 65, and the push rod guide groove 661A is connected to the The push rod end hole 66 is in communication, and the probe guide groove 671A is in communication with the probe end hole 67 (as shown in FIG. 17). The proximal end of the pin fitting groove 651A, the proximal end of the probe fitting groove 671A, and the proximal end of the push rod fitting groove 661A are relatively gathered relative to the axis of the proximal chuck 511, the distal end of the pin fitting groove 651A and the probe fitting groove The distal end of the 671A and the distal end of the push rod fitting groove 661A are relatively divergent with respect to the axis of the proximal chuck 511. It can be understood that the cross-sectional area of the embedded portion 5131 perpendicular to the axial direction of the proximal chuck 51 is not limited to gradually increase from the proximal end to the distal end.

The pin guide groove 651A and the pin mating groove 651B jointly form a pin sub-channel 651, the probe guide groove 671A and the probe mating groove 671B jointly form a probe sub-channel 671, and the push rod guide groove 661A is matched with the push rod The grooves 661B collectively form the probe sub-channel 671.

Please refer to Figure 21 and Figure 22 in combination. Figure 21 is a perspective view of the holding device of the valve suture in a closed state, and Figure 22 is another perspective view of the holding device of the valve suture in a closed state Figure.

The guide wire guide channel 63 communicates with the guide wire lumen 341 in the catheter 31, the needle guide channel 650 communicates with the needle lumen 331 in the catheter 31, and the push rod guide channel 660 communicates with the push rod cavity in the catheter 31. The channel 351 is in communication, and the probe guiding channel 670 is in communication with the probe lumen 361 in the catheter 31.

In this embodiment, the guide wire single lumen tube 34, the needle single lumen tube 33, the push rod single lumen tube 35, and the probe single lumen tube 36 in the catheter 31 respectively extend into the proximal chuck holder 511, and the guide wire The single-lumen tube 34 is fixedly connected to the embedded portion 5131, so that the guidewire lumen 341 communicates with the guidewire guide channel 63 in the proximal chuck 51; the single-lumen tube 33 is fixedly connected to the embedded portion 5131, so that the guidewire channel 341 communicates with the guidewire guide channel 63 in the proximal chuck 51; The needle lumen 331 communicates with the needle guide channel 650 in the proximal chuck 51; the push rod single lumen tube 35 is fixedly connected to the inlay part 5131, so that the push rod 351 and the push rod in the proximal chuck 51 The guide channel 660 is in communication; the probe single-lumen tube is fixedly connected to the embedded part 5131, so that the probe lumen 351 is in communication with the probe guide channel 670 in the proximal chuck 51.

It can be understood that the manner in which the guide wire lumen 341 is fixedly connected to the embedded portion 5131 is not limited, for example, a glue connection may be adopted but not limited to.

It can be understood that the manner in which the pin cavity 331 and the embedded portion 5131 are fixedly connected is not limited, for example, but not limited to a glued connection.

It can be understood that the manner in which the push rod cavity 351 is fixedly connected to the embedded portion 5131 is not limited, for example, but not limited to a glued connection.

It can be understood that the manner in which the probe cavity 361 and the embedded portion 5131 are fixedly connected is not limited. For example, a glued connection may be adopted but not limited to.

It can be understood that there is no limitation to the fixed connection between each cavity and the embedded portion 5131.

It can be understood that the pin guide channel 650, the probe guide channel 670, the push rod guide channel 660, and the guide wire guide channel 63 are provided on the proximal chuck body 513, or the pin guide channel 650 and the probe The guide channel 670 and the push rod guide channel 660 are provided on the proximal chuck main body 513 and the proximal chuck seat 511.

In this embodiment, from the proximal end to the distal direction, the guide wire lumen 341 communicates with the guide wire guide channel 63 for the guide wire 90 to move through; the needle lumen 331, the needle sub-channel 651 (by The pin guide groove 651A and the pin mating groove 651B are enclosed and formed) and the pin end hole 65 are connected in sequence for the pin assembly 70 to move through; the push rod cavity 351, the push rod sub-channel 661 (guided by the push rod The guide groove 661A and the push rod matching groove 661B are enclosed and formed) and the push rod end hole 66 are connected in sequence for the chuck push rod 55 to move through; the probe cavity 361, the probe sub-channel 671 (by the probe guide groove 671A and the probe matching groove 671B are surrounded and formed) and the probe end hole 67 are connected in sequence for the probe 80 to be movably penetrated.

In this way, on the one hand, no matter how the catheter 31 is bent, the guidewire 90 inserted in the guidewire lumen 341 can extend along the guidewire guide channel 63 in the proximal chuck 51, and can be aligned with the proximal clamp The guide wire guide channel 63 on the main body 513 can pass through the distal end of the guide wire guide channel 63. The pin assembly 70 inserted in the pin cavity 331 can extend along the pin guide channel 650 in the proximal chuck 51, and can be aligned with the pin end hole 65 on the proximal clamping body 513, It can pass through the distal end port of the pin end hole 65. The probe 80 inserted in the probe cavity 361 can extend along the probe guide channel 670 in the proximal chuck 51, and can be aligned with the probe end hole 67 on the proximal clamping body 513, so that Pass through the distal end of the probe end hole 67. The chuck push rod 55 inserted in the push rod cavity 351 can extend along the probe guide channel 670 in the proximal chuck 51, and pass through the distal port of the push rod end hole 66 to clamp the distal end. The head 53 is fixedly connected to control the opening and closing of the clamping device 50. On the other hand, since the size of the catheter 31 in the radial direction relative to the proximal chuck 51 is relatively small, the guide wire 90, the needle assembly 70, the probe 80, and the chuck push rod 55 are relatively small when housed in the catheter 31. The positions are compactly concentrated in the radial direction, while the relative positions of the guide wire 90, the pin assembly 70, the probe 80, and the chuck push rod 55 when passing through the proximal clamping surface 517 are relatively dispersed in the radial direction. In this embodiment, the guide wire lumen 341, the needle lumen 331, the probe lumen 361, and the push rod lumen 351 connecting the proximal clamping surface 517 and the catheter 31 are provided, and each lumen is arranged obliquely, When the guide wire 90, the pin assembly 70, the probe 80, and the chuck push rod 55 contained in the catheter 31 extend distally to the proximal clamping surface 517, the guide wire 90, the pin assembly 70, and the probe 80 and the chuck push rod 55 can not only extend in the axial direction of the proximal chuck 51, but also spread in the radial direction of the proximal chuck 51, so that the effective area of the proximal chuck 51 when clamping the valve can be increased , The pins, probes, and guide wires can be relatively arranged on the proximal chuck 51.

It can be understood that the obliquely sealed pin guide channel 650, the push rod guide channel 660, or the probe guide channel 670 are formed by the guide groove and the matching groove, for example, the pin guide channel 650, the push rod The guide channel 660 or the probe guide channel 670 can be, but not limited to, directly formed in the proximal chuck holder 511, that is, the proximal chuck holder 511 is no longer a hollow structure, but has multiple cavities inside. Structure.

Please refer to FIG. 16 again, the distal chuck 53 is provided with a guide wire guide channel 531, a pin end hole 533, and a probe end hole 535. The guide wire guiding channel 531 allows the guide wire 90 to be movably passed through. The pin end hole 533 is for the pin assembly 70 to be movably passed through. The probe end hole 535 is for the probe 80 to be movably penetrated.

The guide wire guide channel 531 communicates with the guide wire guide channel 63 on the proximal clamping portion 5133 and is arranged correspondingly in the axial direction. The pin end hole 533 communicates with the pin end hole 65 on the proximal clamping portion 5133 and is arranged correspondingly in the axial direction. The probe end hole 535 communicates with the probe end hole 67 on the proximal clamping portion 5133 and is arranged axially correspondingly.

In this embodiment, the suture (not shown) is accommodated in the pin end hole 533 of the distal chuck 53. It can be understood that the position of the suture is not limited. When the needle assembly 70 is punctured distally, it can be fixedly connected with the suture in the distal chuck 73.

As shown in FIG. 23, in an application scenario, the valve suture device 100 provided by the present application is used for tricuspid valve repair. First, the femoral vein (CFV as shown in FIG. 23) is opened and passed through the inferior vena cava (as shown in FIG. The IVC shown in 23) delivers the clamping device 50 to the right atrium (RA shown in FIG. 23) and the right ventricle (RV shown in FIG. 23) in sequence, and arrives at the tricuspid valve in situ.

As shown in Figure 24, after reaching the original position of the valve, the chuck push rod 55 (as shown in Figure 12) uses the push rod cavity 351 as a path to lead to the push rod guide channel 650, and smoothly guide the channel from the push rod 650 penetrates and drives the distal chuck 53 away from the proximal chuck 51, the distal chuck 55 and the proximal chuck 51 are relatively opened, the distal chuck 53, the proximal chuck 51 and the guide rod 58 (Figure 12) As shown) an opening is formed, and the opening is adjusted to face the edge of the valve and the valve part is accommodated in the opening. Then, the chuck push rod 55 withdraws toward the proximal end, the distal chuck 53 is driven by the chuck push rod 55 to approach the proximal chuck 51, the distal chuck 53 and the proximal chuck 51 are relatively closed and capture the valve .

The needle 71 uses the needle cavity 331 as a path to lead to the needle guide channel 670, and smoothly extends from the distal port of the needle guide channel 670, the needle 71 moves to the distal chuck 53 and punctures the valve And, it is fixedly connected with a suture (not shown in the figure) accommodated in the distal chuck 53. After that, the insert needle 71 is withdrawn toward the proximal end, and the suture is pulled out from the distal chuck 53 under the drive of the insert needle 71 and passed through the valve, so that the suture is implanted in the valve. Later, the sutures on each leaflet can be locked to achieve edge-to-edge repair.

As shown in FIG. 25, in another application scenario, the valve suture device 100 provided in the present application is used for mitral valve repair. First, the femoral vein (CFV as shown in FIG. 23) is opened, and the inferior vena cava is clamped. Hold the device 50 and deliver it to the right atrium (RA as shown in Figure 25), and then puncture the atrial septum (FO as shown in Figure 25), and then deliver them into the left atrium (LA as shown in Figure 25) and left ventricle (as shown in Figure 25). Shows LV), and finally reaches the original position of the mitral valve. The method of implanting the suture on the mitral valve of the valve suture device 100 is similar to the method of implanting the suture on the tricuspid valve, and will not be repeated here.

Another option that can be considered is to approach the superior jugular vena cava (SVC as shown in Figure 25) to the right atrium (RA as shown in Figure 25). Finally, the tricuspid valve is in situ or the mitral valve is in situ and the suture handle is operated to capture the valve, so that the suture can be implanted on the valve.

Second embodiment

Please refer to FIG. 26, which is a cross-sectional view of the valve suture system provided by the second embodiment of the application along the radial cross-section of the catheter.

The catheter structure 230 includes a catheter 231 and a multi-lumen tube 233 movably installed in the catheter 231. The catheter 231 and the multi-lumen tube 233 are both flexible pipes.

The multi-lumen tube 233 is provided with a needle cavity 2331 for movably passing through the needle assembly 70, and there is a gap between the needle assembly 70 and the inner wall of the needle cavity 2331. A push rod cavity 2351 is provided on the multi-lumen tube 233 for the chuck push rod 55 to move through. There is a gap between the chuck push rod 55 and the inner wall of the push rod cavity 2351. A probe cavity 2361 is provided on the multi-lumen tube 233 for the movable penetration of the probe 80, and there is a gap between the probe 80 and the inner wall of the probe cavity 2361. A guide wire channel 2371 is provided on the multi-lumen tube 233 for the movable guide wire 90 to pass through. There is a gap between the guide wire 90 and the inner wall of the guide wire channel 2371. In this embodiment, the needle cavities 2331, the push rod cavities 2351, the probe cavities 2361, and the guide wire cavities 2371 are all arranged at intervals.

In this embodiment, the multi-lumen tube 233 is fully enclosed, and the needle channel 2331, the push rod channel 2351, the probe channel 2361, and the guide wire channel 2371 are not provided on the peripheral wall of the multi-lumen tube 233. .

In this embodiment, the material of the multi-lumen tube 233 is uniform, and the difference in wall thickness is minimized, and the degree of anisotropy when the catheter structure 230 is bent is also small; and each channel in the multi-lumen tube 233 will not shake individually , The relative position of the probe 80, the pin assembly 70, the chuck push rod 55, and the guide wire 90 in the catheter is relatively fixed, so it will not form an S-shaped (twisted) channel, which is more conducive to the pin assembly 70 and the chuck. Pushing of the rod 55, the probe 80, and the guide wire 90. In this embodiment, the material of the multi-lumen tube 233 is polytetrafluoroethylene (PTFE for short). It is understood that the material of the multi-lumen tube 233 is not limited. For example, the material of the multi-lumen tube 233 can be, but not limited to, polyurethane. Resin (Polyurethane, PU for short) and other soft polymer materials.

In addition, compared with the first embodiment, the distal end of the multi-lumen tube 233 penetrates into the proximal chuck holder, and is fixedly connected to the baffle 5116 (as shown in FIG. 18) of the joint 5112.

It can be understood that the fixed connection manner of the multi-lumen tube 233 and the baffle 5116 is not limited. For example, it is possible but not limited to using glued connection and the like.

The third embodiment

Please refer to FIG. 27, which is a cross-sectional view of the valve suture system provided by the third embodiment of the application along the radial cross-section of the catheter.

The catheter structure 680 includes a catheter 681 and a multi-lumen tube 683 movably installed in the catheter 681. The catheter 681 and the multi-lumen tube 683 are both flexible pipes.

The multi-lumen tube 683 is provided with a needle cavity 6831, the needle assembly 70 movably penetrates the needle cavity 6831, and there is a gap between the needle assembly 70 and the inner wall of the needle cavity 6831.

A push rod cavity 6851 is provided on the peripheral wall of the multi-lumen tube 683, the chuck push rod 55 is movably installed in the push rod cavity 6851, and there is a gap between the chuck push rod 55 and the inner wall of the push rod cavity 6851.

A probe cavity 6861 is provided on the multi-lumen tube 683, the probe 80 is movably penetrated through the probe cavity 6861, and there is a gap between the probe 80 and the inner wall of the probe cavity 6861.

A guide wire lumen 6871 is provided on the peripheral wall of the multi-lumen tube 683, and the guide wire 90 movably passes through the guide wire lumen 6871, and there is a gap between the guide wire 90 and the inner wall of the guide wire lumen 6871.

In this embodiment, the needle cavities 6831, the push rod cavities 6851, the probe cavities 6861, and the guide wire cavities 6871 are all arranged at intervals.

In this embodiment, the multi-lumen tube 683 is semi-closed. Because the push rod channel 6851 and the guide wire channel 6871 are provided in the groove on the peripheral wall of the multi-lumen tube 683, the push rod channel 6851 and the guide wire lumen The channel 6871 is a half-wrapped type, and the chuck push rod 55 accommodated in the push rod channel 6851 is exposed between the catheter 681 and the multi-lumen tube 683. The guide wire 90 accommodated in the guide wire lumen 6871 is exposed between the catheter 681 and the multi-lumen tube 683. In this way, the push rod cavity 6851 can still provide guidance for the chuck push rod 55. The guidewire lumen 6871 can still provide guidance for the guidewire 90, and can reduce the cross-sectional area of the multi-lumen tube 683 and the wall thickness between the lumen. The wall thickness range of the multi-lumen tube 683 can be limited to 0.05mm~ 0.5mm, making the duct structure 680 more flexible, reducing the weight of the equipment and reducing the cost.

It can be understood that the wall thickness of the multi-lumen tube 683 is not limited.

In addition, compared with the first embodiment, the distal end of the multi-lumen tube 683 is fixedly connected to the baffle 5116 (as shown in FIG. 18) of the joint 5112. It can be understood that the fixed connection manner of the multi-lumen tube 233 and the baffle 5116 is not limited. For example, it is possible but not limited to using glued connection and the like.

It can be understood that the arrangement of the needle lumen 6831, the push rod lumen 6851, the probe lumen 6861, and the guide wire lumen 6871 on the multi-lumen tube 683 is not limited, for example, the needle lumen 6831, the push rod lumen The multi-lumen tube 683 of the channel 6851, the probe lumen 6861, and the guide wire lumen 6871 may all be provided on the peripheral wall of the multi-lumen tube 683.

It can be understood that the catheter structure 680 may be an integrated structure, for example, a plurality of mutually independent cavities are provided on the catheter structure 680.

Fourth embodiment

Please refer to FIG. 28 and FIG. 29 in combination. FIG. 28 is a partial structural diagram of a valve suture system clamping device provided by the fourth embodiment of the application, and FIG. 29 is a part of the valve suture system provided by the fourth embodiment of the application Schematic.

The guide wire guiding channel 91, the pin guiding channel 93, the probe guiding channel 94 and the push rod guiding channel 95 on the embedded portion 5139 are all arranged at intervals along the circumferential direction of the embedded portion 5139.

The difference between the fourth embodiment and the first embodiment is that the pin guide channel 93, the probe guide channel 94 and the push rod guide channel 95 are not arranged around the guide wire guide channel 91.

The above-disclosed are only the preferred embodiments of the present invention, which of course cannot be used to limit the scope of rights of the present invention. Therefore, equivalent changes made according to the claims of the present invention still fall within the scope of the present invention.

Claims (19)

1. A valve suture device for implanting sutures into a heart valve, which is characterized in that it comprises a clamping device, a catheter structure and a needle, the clamping device is fixedly connected to the distal end of the catheter structure; The clamping device includes a distal chuck, a proximal chuck and a chuck push rod, the distal chuck is arranged opposite to the proximal chuck, and the chuck push rod is fixedly connected to the distal chuck , The chuck push rod is movably installed in the proximal chuck and the catheter structure, and the chuck push rod is used to drive the distal chuck and the proximal chuck to relatively open and close; The proximal chuck is provided with a pin guide channel and a push rod guide channel that are independent of each other, and the catheter structure is provided with a pin cavity and a push rod cavity that are independent of each other. The distal end is fixedly connected with the pin guide channel and communicates with each other, the distal end of the push rod cavity is fixedly connected with the push rod guide channel and communicates with each other, and the pin is movably penetrated in the plug In the needle cavity and the needle guide channel, the chuck push rod is movably arranged in the push rod cavity and the push rod guide channel.
2. The valve suture device according to claim 1, wherein there is a gap between the insertion needle and the inner wall of the insertion needle lumen, and there is a gap between the push rod and the inner wall of the push rod lumen gap.
3. The valve suture device according to claim 2, wherein the catheter structure comprises a catheter and a single-lumen tube with a needle and a single-lumen tube inserted in the catheter, and the single-lumen tube of the needle The inner cavity is the insertion needle lumen, the inner cavity of the push rod single lumen tube is the push rod lumen; among the single needle lumen tube, the push rod single lumen tube, and the inner wall of the catheter There are gaps between each other;

   Alternatively, the catheter structure further includes a catheter and a multi-lumen tube movably installed in the catheter, and the multi-lumen tube is provided with the insertion needle cavity and the push rod cavity at intervals.
4. The valve suture device of claim 3, further comprising a probe, the proximal chuck is also provided with a probe guide channel, the probe guide channel and the pin guide The channel and the push rod guide channel are arranged at intervals; the catheter structure is provided with an independent probe lumen, and the probe lumen is arranged at intervals from the push rod lumen and the needle lumen, The distal end of the probe lumen and the probe guide channel are fixedly connected and communicated with each other; there is a gap between the probe and the inner wall of the probe lumen, and the probe movably penetrates the The probe cavity and the probe guide channel.
5. The valve suture device according to claim 4, wherein the catheter structure further comprises a probe single-lumen tube inserted in the catheter, and the inner cavity of the probe single-lumen tube is the probe In the needle lumen, there is a gap between the single-lumen tube of the probe, the single-lumen tube of the needle, the single-lumen tube of the push rod, and the inner wall of the catheter.
6. The valve suture device according to claim 4, wherein the multi-lumen tube is further provided with a probe lumen spaced apart from the needle lumen and the push rod lumen.
7. The valve suture device of claim 3, further comprising a guide wire, the proximal chuck is further provided with a guide wire guide channel, the guide wire guide channel and the needle guide The channel and the push rod guide channel are arranged at intervals, the catheter structure is provided with an independent guide wire lumen, and the guide wire lumen is arranged at intervals from the push rod lumen and the insert needle lumen, The distal end of the guide wire lumen and the guide wire guide channel are fixedly connected and communicated with each other; there is a gap between the guide wire and the inner wall of the guide wire lumen, and the guide wire movably passes through the The guide wire lumen and the guide wire guide channel.
8. The valve suture device of claim 7, wherein the catheter structure further comprises a guidewire single-lumen tube threaded into the catheter, and the inner cavity of the guidewire single-lumen tube is the guide wire In the wire lumen, there are gaps between the single-lumen tube of the guide wire, the single-lumen tube of the insertion needle, the single-lumen tube of the push rod, and the inner wall of the catheter.
9. 7. The valve suture device according to claim 7, wherein the multi-lumen tube is further provided with a guide wire lumen spaced apart from the needle lumen and the push rod lumen.
10. The valve suture device according to any one of claims 1-9, wherein the proximal chuck has a variable diameter section, and the radial dimension of the variable diameter section gradually increases from its proximal end to its distal end. Increase.
11. The valve suture device according to claim 10, wherein the diameter reducing section is in the shape of a cone.
12. The valve suture device according to claim 10, wherein the proximal chuck comprises a proximal chuck base and a proximal chuck body, and the proximal chuck base is fixedly connected to the proximal chuck Between the head body and the catheter structure, the variable diameter section is located on the proximal chuck seat; the pin guide channel and the push rod guide channel are provided on the proximal chuck body , Or the pin guide channel and the push rod guide channel are provided on the proximal chuck main body and the proximal chuck seat.
13. The valve suture device of claim 12, wherein the needle guide channel and the push rod guide channel are both inclined relative to the axial direction of the proximal chuck, and the needle guide The proximal end of the guide channel and the proximal end of the push rod guide channel are relatively converged with respect to the axis of the proximal chuck, and the distal end of the pin guide channel and the distal end of the push rod guide channel are opposite to each other The axis of the proximal chuck is relatively spread.
14. The valve suture device according to claim 12, wherein the proximal chuck holder has a receiving space, and the proximal chuck body includes an inlaid portion and a distal end fixedly connected to the inlaid portion The proximal clamping portion of the proximal clamping portion is provided with a pin end hole and a push rod end hole, the embedded portion is accommodated in the containing space and is fixedly connected to the inner wall of the containing space, so A pin guide groove and a push rod guide groove are provided on the embedded part, the pin guide groove and the inner wall of the containing space form a pin sub-channel, and the pin sub-channel and the pin end The hole is connected to form the pin guide channel, the push rod guide groove and the inner wall of the accommodating space form a push rod sub-channel, and the push rod sub-channel and the push rod end hole form the push rod guide引channel.
15. The valve suture device according to claim 14, wherein the inner wall of the containing space is provided with a pin fitting groove and a push rod fitting groove, and the pin fitting groove is formed by cooperating with the pin guide groove In the pin sub-channel, the push rod matching groove and the push rod guide groove cooperate to form the push rod sub-channel.
16. The valve suture device according to claim 14, wherein the proximal chuck seat comprises a joint part and a seat body that are fixedly connected, the containing space is provided inside the seat body, and the joint part The fixing sleeve is arranged on the distal end of the catheter structure, and the proximal end of the seat body forms the variable diameter section and is smoothly connected between the joint part and the proximal chuck body.
17. The valve suture device according to claim 14, wherein the cross-sectional area of the embedded part perpendicular to the axial direction of the proximal chuck gradually increases from the proximal end to the distal end.
18. The valve suture device of claim 1, wherein the valve suture device further comprises an operating handle, the operating handle is fixedly connected to the proximal end of the catheter structure, and a push rod is provided on the operating handle A control member and a pin control member, the proximal end of the chuck push rod is connected to the push rod control member, the proximal end of the pin is connected to a pin control member, and the pin control member movably passes through the Operation handle.
19. A valve suture system, characterized by comprising the valve suture device and an adjustable curved sheath according to any one of claims 1-18, wherein the adjustable curved sheath includes a sheath and is fixedly connected to the sheath The proximal end of the adjustable bend handle, the catheter structure is movably pierced in the sheath and the adjustable bend handle.

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