CN212015867U - Minimally invasive artificial chordae tendineae adjusting system - Google Patents

Abstract

The utility model provides a minimally invasive artificial chordae adjusting system, which comprises a wire locking device, wherein the wire locking device comprises a sheath for hooking the artificial chordae, an ejector arranged in the sheath, and an adjusting piece arranged in the sheath and connected with the near end of the ejector; the adjusting piece drives the ejector piece to move towards the far end along the axial direction of the sheath, and the far end face of the ejector piece pushes the artificial chordae tendineae hooked by the sheath, so that the length of the artificial chordae tendineae contained in the sheath is increased. The utility model provides a wicresoft's formula artifical chordae tendineae governing system, after the sheath colludes artifical chordae tendineae, through the regulating part drive ejector member ejection artifical chordae tendineae, can increase the length of artifical chordae tendineae in the sheath to shorten the effective length of artifical chordae tendineae, whole in-process only needs once to arrest, convenient operation does not apply fixed pressure to artifical chordae tendineae moreover, is favorable to reducing or avoiding the chordae tendineae damage.

Description

Minimally invasive artificial chordae tendineae adjusting system

Technical Field

The utility model relates to the technical field of medical equipment, especially, relate to an artifical chordae tendineae governing system of wicresoft's formula.

Background

The heart is composed of four cavities, namely a left atrium, a left ventricle, a right atrium and a right ventricle, the left atrium and the right atrium and the left ventricle are separated by intervals and are not communicated with each other, and valves (atrioventricular valves) are arranged between the atria and the ventricles, so that blood can only flow into the ventricles from the atria and can not flow backwards.

The mitral valve is a one-way "valve" between the Left Atrium (LA) and the Left Ventricle (LV), which ensures blood flow from the left atrium to the left ventricle. A normal, healthy mitral valve has a plurality of Chordae Tendineae (CT). The valve leaves of the mitral valve are divided into an anterior leaf and a posterior leaf, when the left ventricle is in a diastole state, the two are in an opening state, and blood flows from the left atrium to the left ventricle; when the left ventricle is in a contraction state, the chordae tendineae are stretched to ensure that the valve leaflets are not flushed to the atrium side by blood flow, and the anterior and posterior leaflets are closed well, thereby ensuring that blood flows from the left ventricle to the aorta through the aortic valve (AV for short). If the chordae tendineae or papillary muscles are diseased, such as ruptured chordae tendineae, the mitral valve will not return to the closed state as it would in the normal state when the left ventricle is in the contracted state, and the momentum of the blood flow will further cause the leaflets to fall into the left atrium, causing blood backflow.

As shown in fig. 1, the lesion caused by the rupture of the chordae tendineae can be treated by implanting a suture X as an artificial chordae tendineae, either surgically or via a catheter intervention. After the artificial chordae tendineae are implanted, mitral regurgitation disappears, and after a period of time, the heart function gradually returns to normal, the heart volume gradually decreases, and the previously enlarged left ventricle due to regurgitation gradually returns to a shape close to the normal ventricle, i.e., the left ventricle decreases. However, as the left ventricle decreases, the implanted artificial chordae will be in a relaxed state, as shown in fig. 2, where the artificial chordae pull less tightly against the leaflets, and a condition of mild or severe regurgitation will occur in the mitral valve, where it is desirable to shorten the effective length of the relaxed artificial chordae to eliminate the condition.

Among the prior art, there is a technique of regulation and control chordae tendineae through the pipe, catches on artifical chordae tendineae through a hook, and two clamps of cooperation clip artifical chordae tendineae respectively in hook both sides, withdraw a section distance through the hook, and two clamps draw close each other and realize chordae tendineae regulation and control function, and this technique has following defect: 1. after the artificial chordae tendineae are hooked, the two clamps are still required to extend out to clamp the artificial chordae tendineae, and the chordae tendineae are caught for the second time; 2. two clips are required for the regulation and control of the chordae tendineae to fix and clamp the artificial chordae tendineae and apply larger pressure to the chordae tendineae, so that the chordae tendineae are prevented from slipping from the clips, the chordae tendineae are greatly damaged, and the long-term fatigue performance of the chordae tendineae is influenced.

SUMMERY OF THE UTILITY MODEL

Not enough to prior art, the utility model provides a wicresoft's artifical chordae tendineae governing system once catches and can adjust the chordae tendineae, does not exert fixed pressure moreover, can reduce or avoid the chordae tendineae damage.

In order to solve the technical problem, the utility model provides a minimally invasive artificial chordae tendineae adjusting system, which comprises a wire locking device, wherein the wire locking device comprises a sheath for hooking the artificial chordae tendineae, an ejector arranged in the sheath, and an adjusting piece arranged in the sheath and connected with the near end of the ejector; the adjusting piece drives the ejector piece to move towards the far end along the axial direction of the sheath, and the far end face of the ejector piece pushes the artificial chordae tendineae hooked by the sheath, so that the length of the artificial chordae tendineae contained in the sheath is increased.

The utility model provides a wicresoft's formula artificial chordae tendineae governing system after the sheath colludes the artificial chordae tendineae, pushes away the artificial chordae tendineae through regulating part drive ejector member, can increase the length of the artificial chordae tendineae in the sheath to shorten the effective length of artificial chordae tendineae, whole in-process only needs once to arrest, convenient operation does not apply fixed pressure to the artificial chordae tendineae moreover, is favorable to reducing or avoiding the chordae tendineae damage.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings needed to be used in the embodiments will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to these drawings without creative efforts.

Fig. 1 is a schematic view of the artificial chordae tendineae in a normal state.

Figure 2 is a schematic view of the artificial chordae in a relaxed state.

Fig. 3 is a schematic structural diagram of a minimally invasive artificial chordae tendineae adjustment system according to a first embodiment of the present invention.

Figure 4 is an axial cross-sectional view of the minimally invasive artificial chordae adjusting system of figure 3.

Fig. 5 is an axial sectional view of the wire locker of fig. 3.

Fig. 6 is a perspective view of the first housing of the sheath of fig. 5.

Fig. 7 is a schematic view of the proximal end face of the first housing of fig. 6.

Fig. 8 is a perspective view of the ejector in fig. 5.

Fig. 9 is an axial cross-sectional view of the ejector of fig. 8.

Fig. 10 is a perspective view of the adjusting member of fig. 5.

Fig. 11 is an axial cross-sectional view of the adjustment member of fig. 10.

Fig. 12 is a perspective view of the adjusting member and the ejector in fig. 10 after assembly.

Fig. 13 is a partial cross-sectional view of the controller of fig. 4 in an initial state.

Fig. 14 is a perspective view of the connector and the thread locker shown in fig. 3.

Fig. 15 is a partial cross-sectional view of the fitting and boot of fig. 3.

Fig. 16 is a partial cross-sectional view of the adjustable bend sheath of fig. 15.

Figures 17-22 are schematic illustrations of the use of the minimally invasive artificial chordae adjusting system of figure 3.

Fig. 23 is a schematic structural view of a handle assembly of a minimally invasive artificial chordae adjusting system according to a second embodiment of the invention.

Fig. 24 is an axial cross-sectional view of the front handle of fig. 23.

Fig. 25 is an axial cross-sectional view of the rear handle of fig. 23.

Fig. 26 is a schematic view of the articulating assembly of fig. 25.

Fig. 27 is an end view of the articulating assembly of fig. 26.

Fig. 28 is an exploded isometric view of the articulating assembly of fig. 26.

Detailed Description

The technical solutions in the embodiments of the present invention will be described clearly and completely with reference to the accompanying drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments in the present invention, all other embodiments obtained by a person skilled in the art without any creative effort belong to the protection scope of the present invention.

In the description of the present invention, it should be noted that the terms "upper", "lower", "inner", "outer", and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, and are only for convenience of description and simplification of description, but do not indicate or imply that the device or element referred to must have a specific orientation, be constructed in a specific orientation, and be operated, and thus should not be construed as limiting the present invention. Furthermore, the terms "first," "second," and the like are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.

In the description of the present invention, it is to be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "connected," and the like are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally connected; may be directly connected or indirectly connected through an intermediate. The specific meaning of the above terms in the present invention can be understood in specific cases to those skilled in the art.

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

Referring to fig. 3 and 4, the present invention provides a minimally invasive artificial chordae tendineae adjustment system 1000, including a wire locking device 100, wherein the wire locking device 100 is implantable in the heart of a patient for hooking and accommodating the artificial chordae tendineae and adjusting the effective length of the artificial chordae tendineae. Specifically, the wire locker 100 comprises a sheath 10 for hooking the artificial chordae tendineae, an ejector 20 arranged in the sheath 10, and an adjusting piece 30 arranged in the sheath 10 and connected with the proximal end of the ejector 20; the adjusting member 30 drives the ejector 20 to move distally along the axial direction of the sheath 10, and the distal end surface of the ejector 20 pushes the artificial chordae tendineae hooked by the sheath 10 to increase the length of the artificial chordae tendineae contained in the sheath 10, so as to shorten the effective length of the artificial chordae tendineae and improve the overall tension of the artificial chordae tendineae.

In order to ensure the implantation safety, the adjusting member 30, the ejector member 20 and the sheath 10 are preferably made of SUS316L stainless steel, and may be made of other materials with good biocompatibility and certain rigidity, such as PEEK, and the materials of the three parts may be different or the same.

The utility model discloses in, sheath 10 colludes behind the artifical chordae tendineae, through regulating part 30 drive ejector 20 ejector artificial chordae tendineae can increase the length of the artifical chordae tendineae in sheath 10 to shorten the effective length of artifical chordae tendineae, in whole accommodation process, only need once arrest, convenient operation does not apply fixed pressure to artifical chordae tendineae moreover, is favorable to reducing or avoiding the chordae tendineae damage.

Specifically, referring to fig. 5 to 7, the sheath 10 is cylindrical, the sheath 10 is hollow and has a first accommodating cavity 11 extending along an axial direction, and the pushing element 20 and the adjusting element 30 are accommodated in the first accommodating cavity 11 and located at a proximal end. The first accommodating cavity 11 penetrates at least the proximal end face of the sheath 10, so that the controller 200 can be detachably connected with the adjusting piece 30 from the proximal end of the sheath 10 to drive the adjusting piece 30 to rotate (see fig. 4). The outer wall of the distal end of the sheath 10 is provided with a first slot 12 penetrating to the first accommodating cavity 11 for hooking the artificial chordae tendineae. Preferably, in this embodiment, first fluting 12 is including the notch that is the loudspeaker form and the groove tripe that is oval-shaped, the notch with a bundle of oral area has between the groove tripe, loudspeaker form the notch is favorable to sheath 10 colludes fast and gets artifical chordae tendineae, and the artifical chordae tendineae that is got by colluding gets into oval-shaped behind the groove tripe, the bundle oral area can prevent that artifical chordae tendineae from following easily break away from out in the groove tripe. In this embodiment, a pair of guide grooves 13 extending in the axial direction of the sheath 10 is formed in the inner circumferential surface of the sheath 10, and the pair of guide grooves 13 is symmetrical with respect to the axis of the sheath 10. A ring-shaped protrusion 14 is further protruded from the inner circumferential surface of the proximal end of the sheath 10. The proximal end of the sheath 10 is provided with a first connection portion 15, the first connection portion 15 is used for being detachably connected with a joint 330 (see fig. 1) in an introducer 300, so that the circumferential position of the sheath 10 is limited by the joint 330; the first connecting portions 15 are at least two and are arranged at intervals along the circumferential direction of the sheath 10. In this embodiment, the first connecting portions 15 are 4 connecting grooves arranged at intervals along the circumferential direction of the sheath 10, and each connecting groove extends along the axial direction of the sheath 10, that is, the connecting grooves are slots.

In this embodiment, the sheath 10 includes a first shell and a second shell matching with the first shell, the first shell and the second shell are two semi-cylindrical shells with the same structure, the sheath 10 is formed after the first shell and the second shell match, and the first accommodating cavity 11 is formed between the first shell and the second shell.

Referring to fig. 5, 8 and 9, the pushing element 20 is a hollow substantially cylindrical body, the pushing element 20 includes a second accommodating cavity 22 extending along the axial direction, and the second accommodating cavity 22 at least penetrates through the proximal end surface of the pushing element 20, so that the adjusting element 30 can be accessed into the second accommodating cavity 22 from the proximal end of the pushing element 20. In this embodiment, the second accommodating cavity 22 penetrates through two opposite ends of the ejector 20, and the ejector 20 has a second slot 24 at a distal end, and the second slot 24 corresponds to a proximal end of the first slot 12. The second slot 24 corresponds to the proximal end of the first slot 12, that is, the contour line of the second slot 24 is the same as the contour line of the proximal end of the first slot 12, preferably, is circular arc, so that when the ejector 20 ejects the artificial chordae tendineae, the artificial chordae tendineae are accommodated in the concave second slot 24, and can play a role in limiting. The inner circumferential surface of the second receiving chamber 22 is provided with an internal thread (not shown) at least at the proximal end portion, and in this embodiment, the entire inner circumferential surface of the second receiving chamber 22 is provided with an internal thread. A pair of guide rods 26 extending along the axial direction of the ejector 20 are arranged on the upper and lower sides of the outer peripheral surface of the ejector 20, the pair of guide rods 26 are matched with the pair of guide grooves 13 of the sheath 10, and each guide rod 26 is in alignment with a corresponding guide groove 13 to limit the ejector 20 to move axially and not rotate in the sheath 10.

In other embodiments, the guide rods 26 of the ejector 20 and the guide grooves 13 of the sheath 10 may be correspondingly arranged in other numbers of 1 group, 3 groups, etc. to form at least one linear pair.

It will be understood that in other embodiments, the guide rod may be arranged protruding on the inner peripheral surface of the sheath 10, and the outer peripheral surface of the ejector 20 may be correspondingly provided with a guide groove, and may also be provided with at least one linear pair to limit the axial movement of the ejector 20 relative to the sheath 10.

Referring to fig. 5, 10-12, the adjusting element 30 is generally cylindrical and includes a main body portion 31 at a distal end and a rotating portion 33 at a proximal end. After the adjusting element 30 is connected to the second accommodating cavity 22 of the ejector element 20 from the proximal end of the ejector element 20, the main body 31 is accommodated in the second accommodating cavity 22, and the rotating part 33 is located outside the second accommodating cavity 22. The outer peripheral surface of the main body 31 is provided with an external thread (not shown) matching with the internal thread of the second accommodating cavity 22, and the main body 31 of the adjusting member 30 is screwed into the second accommodating cavity 22 of the ejector 20. The rotating portion 33 is provided with a ring-shaped groove 35, the ring-shaped groove 35 is engaged with the ring-shaped protrusion 14 on the inner circumferential surface of the sheath 10, and the ring-shaped groove 35 and the ring-shaped protrusion 14 form a rotating pair for limiting the adjusting member 30 to rotate around the axis relative to the sheath 10 but not to move in the axial direction.

In other embodiments, the annular groove 35 of the adjusting member 30 and the annular protrusion 14 of the sheath 10 may be correspondingly arranged in other numbers of 1 group, 3 groups, and the like, which are arranged at intervals along the axial direction, so as to form at least one rotation pair.

It will be appreciated that in other embodiments, the annular groove may be formed on the inner circumferential surface of the proximal end of the sheath 10, and the outer circumferential surface of the proximal end of the adjusting member 30 may be correspondingly provided with an annular protrusion, and may also constitute at least one rotation pair to limit the adjusting member 30 to rotate only around the axis relative to the sheath 10.

In this embodiment, the ejector 20 and the adjusting member 30 are a set of kit, the adjusting member 30 is inserted into the second accommodating cavity 22 of the ejector 20 from the proximal end of the ejector 20, and the adjusting member 30 is in threaded connection with the proximal end of the ejector 20. After the adjustment member 30 and the ejector member 20 are assembled, the assembly is placed in the first accommodating cavity 11 of the sheath 10, specifically, the guide rod 26 of the ejector member 20 is placed in the guide groove 13 of the sheath 10, the annular protrusion 14 of the sheath 10 is clamped in the annular groove 35 of the adjustment member 30, and then the first shell and the second shell of the sheath 10 are combined and fixedly connected through any one of laser welding, bonding, mechanical clamping and the like, so that the assembly of the wire locker 100 is completed.

As described above, in the present invention, the ejector 20 can only move axially relative to the sheath 10 under the limitation of the linear pair formed by the guide rod 26 and the guide groove 13; the adjusting member 30 can only rotate around the axis relative to the sheath 10, as defined by the rotation pair of the annular groove 35 and the annular protrusion 14, so that when the sheath 10 cannot rotate due to the limitation of the circumferential position by the joint 330, the adjusting member 30 rotates relative to the ejector 20, and the adjusting member 30 can push the ejector 20 to move distally along the axial direction of the sheath 10, that is, the rotation motion of the adjusting member 30 is converted into the axial motion of the ejector 20, so that the distal end of the ejector 20 pushes or moves away from the artificial chordae tendineae, thereby changing the length of the artificial chordae tendineae contained in the sheath 10 to adjust the effective length of the artificial chordae tendineae. In the whole adjusting process, the adjusting piece 30 is in threaded connection with the ejection piece 20, so that stepless adjustment and control of the whole adjusting process are realized. And when the external force drive is removed, the thread structure can realize the structure self-locking, and when the adjusting piece 30 or the ejecting piece 20 is not twisted by external force, the axial relative position between the adjusting piece 30 and the ejecting piece 20 cannot be changed, so that the real-time self-locking of the whole adjusting process is realized. In addition, the proximal end of the adjusting member 30 is connected to the sheath 10 and can only rotate relative to the sheath 10, and the ejector member 20 can only move back and forth in the axial direction relative to the sheath 10, after the length of the artificial chordae tendineae is adjusted, the artificial chordae tendineae are U-shaped and located between the sheath 10 and the ejector member 20, and the tension of the shortened artificial chordae tendineae has an axial reaction force on the ejector member 20, which is equivalent to applying an axial pressure to the thread fit, and thus the self-locking effect of the thread structure is enhanced. In addition, in the adjusting process, the patient can pause at any time, observe the reflux condition, then further adjust correspondingly, and when the adjustment is proper, the adjusting piece 30 can be reversely twisted, so that the ejector 20 is retracted in the proximal direction, and repentance operation is realized.

Further, referring to fig. 4, 11 and 13, the minimally invasive artificial chordae adjusting system 1000 further includes a controller 200, and a distal end of the controller 200 is detachably connected to the adjusting element 30.

Specifically, as shown in fig. 11, the rotating portion 33 has a recessed groove 32 formed in a proximal end surface thereof, the adjusting member 30 has a receiving cavity 34 extending in the axial direction from a bottom surface of the recessed groove 32, and the receiving cavity 34 penetrates at least a part of the body portion 31. In this embodiment, the receiving cavity 34 penetrates to the distal end of the main body 31, and the receiving cavity 34 and the sink 32 are correspondingly communicated to form a through passage. Further, the adjusting member 30 is provided with at least two locking grooves 36 from the inner wall of the sinking groove 32, and each locking groove 36 extends along the radial direction of the adjusting member 30. In this embodiment, the adjusting member 30 is provided with two slots 36 in an axial symmetry manner, each of the slots 36 extends to penetrate through the outer circumferential surface of the adjusting member 30 along the radial direction of the adjusting member 30, and the slots 36 are communicated with the annular groove 35.

Controller 200 includes that an adjusting tube 210 and movably wear to adorn in locking pole 250 in the adjusting tube 210, the distal end of adjusting tube 210 sets up two at least connection pieces 212, each the distal end of connection piece 212 sets up pothook 213, locking pole 250 is followed the axial of adjusting tube 210 is to the distal end removal to inserting accept chamber 34, locking pole 250 is followed the radial outside of adjusting tube 210 is supported and is pushed away each connection piece 212, so that pothook 213 outwards expands and the card is gone into in the draw-in groove 36 of regulating part 30, thereby the accessible rotates adjusting tube 210 is in order to drive regulating part 30 rotates.

Specifically, as shown in fig. 13, in this embodiment, a connector 214 is fixedly connected to a distal end of the adjusting tube 210, a pair of connecting pieces 212 made of an elastic material is symmetrically disposed at a distal end of the connector 214, a proximal end of each connecting piece 212 is fixedly connected to the connector 214, a distal end of each connecting piece 212 is a free end, each connecting piece 212 gradually approaches an axis of the adjusting tube 210 from the proximal end to the distal end, and in an initial state, the free ends of the pair of connecting pieces 212 are attached to each other. After the distal end of the locking rod 250 passes through the connecting pieces 212, the free ends of the pair of connecting pieces 212 are spread, the hooks 213 at the ends of the free ends penetrate into the two clamping grooves 36 of the adjusting piece 30 to form rigid connection, and then the locking rod 250 is pushed to the distal end until the distal end of the locking rod 250 penetrates into the accommodating cavity 34 of the adjusting piece 30, so that the assembly of the controller 200 and the wire locker 100 is completed, as shown in fig. 4.

The distal end of the locking rod 250 is tapered to facilitate spreading the attached pair of connecting pieces 212 when the locking rod is pushed and assembled to the distal end. The locking lever 250 may be a wire or rod such as a stainless steel wire, a nickel titanium wire, a copper wire, a braided steel cable, or the like. The connecting piece 212 is formed by shaping a metal sheet, preferably a metal sheet with a shape memory function, such as nickel-titanium alloy, cobalt-chromium alloy, and the like, and is subjected to laser cutting and then heat treatment in a shaping mold. The material of the connector 214 is preferably stainless steel, and a memory metal material or a polymer material can be selected. The adjusting pipe 210 may be a composite pipe made of multiple layers of materials, such as an outer film pebax, a braided stainless steel net in the middle, and a PTFE film as an inner film, or a metal pipe or a polymer material pipe, such as a nickel-titanium pipe, a PEEK pipe, and the like, having certain rigidity and flexibility.

The connector 212 and the adjusting tube 210 may be of an integral structure or a non-integral structure. Preferably, in this embodiment, the connector 212 and the adjusting tube 210 are integrated, which is beneficial to reducing the cost, saving the assembling time and improving the assembling precision.

Further, referring to fig. 3, 14 and 15, the minimally invasive artificial chordae tendineae adjustment system 1000 further includes a guiding device 300 for conveying the wire locker 100, where the guiding device 300 includes an adjustable curved sheath 310 and a connector 330 fixedly connected to a distal end of the adjustable curved sheath 310, a distal end of the connector 330 is provided with second connecting portions 335 corresponding to the first connecting portions 15 of the sheath 10, the number of the second connecting portions 335 is the same as the number of the first connecting portions 15, and the second connecting portions 335 are arranged at intervals along a circumferential direction of the connector 330.

Specifically, in this embodiment, the first connecting portion 15 is disposed at the proximal end of the sheath 10 and is provided with 4 connecting slots at intervals along the circumferential direction of the sheath 10, each connecting slot extends along the axial direction of the sheath 10, the second connecting portion 335 is a connecting rod matched with the connecting slot, the 4 connecting rods are disposed at the distal end of the joint 330 and are provided at intervals along the circumferential direction of the joint 330, and each connecting rod is correspondingly inserted into one connecting slot, so as to achieve the detachable connection between the joint 330 and the sheath 10, so as to define the circumferential position of the sheath 10 through the joint 330, so that the adjusting member 30 rotates relative to the sheath 10 while rotating relative to the ejector 20.

Wherein the connector 330 is a structural component with a connecting rod having an inner cavity, a proximal end of which is connected with the adjustable bending sheath 310, and a distal end of which is detachably connected with the sheath 10. The material of the joint 330 may be stainless steel, such as SUS304, or a polymer material with certain strength, such as PEEK, POM, ABS, etc.

As shown in fig. 16, the adjustable bending sheath 310 includes a sheath 311 and at least one set of bending adjusting components embedded in the sheath 311, the bending adjusting components include a pulling wire 312, a threading tube 313 and an anchoring ring 314, and preferably, a plurality of sets of bending adjusting components may be disposed on the adjustable bending sheath 310 to obtain a multi-angle bending adjusting function. It is understood that the structure of the adjustable bending sheath 310 is similar to that of the adjustable bending sheath in the prior art, and the detailed description is omitted here.

The controller 200 is movably inserted into the guiding device 300, and can extend into the sheath 10 from the inner cavity of the joint 330 to be detachably connected with the adjusting member 30.

Referring to fig. 17 to 22 together, the operation of the minimally invasive artificial chordae adjusting system 1000 according to the present embodiment will be described with reference to the accompanying drawings.

First, as shown in fig. 17, the instrument is introduced, preferably via the femoral artery-abdominal aorta-thoracic aorta-aortic orifice-left ventricle, and the thread locker 100 at the distal end of the minimally invasive artificial chordae regulating system 1000 is brought near the artificial chordae X by the guiding device 300. The sheath 10 is controlled to hook the artificial chordae tendineae X so that the artificial chordae tendineae X fall into the first slot 12 thereof.

Then, as shown in fig. 18, by rotating the proximal end of the adjusting tube 210, the connector 214 and the connecting piece 212 can be driven to rotate synchronously, and further the adjusting piece 30 connected with the connecting piece 212 is driven to rotate relative to the sheath 10, and further the ejector 20 is driven to move distally along the axial direction of the sheath 10, the portion of the artificial tendon X suspended in the first slot 12 of the sheath 10, which is in contact with the distal end of the ejector 20, is pushed by the ejector 20 to move distally, the artificial tendon X is bent into a U shape, and the length of the artificial tendon X contained in the sheath 10 is increased, so as to reduce the effective length of the artificial tendon X.

As shown in fig. 19 and 20, the mitral valve regurgitation status is observed according to medical imaging equipment such as ultrasound until the regurgitation disappears or reaches the slightest status, at this time, the rotation is stopped, and the locking thread is completed by the self-locking capability of the thread between the adjusting part 30 and the ejector part 20, so that the tendon can be regulated and controlled by the implant to realize self-locking fixation. The locking rod 250 is retracted to separate from the connecting sheet 212 at the far end of the adjusting tube 210, the connecting sheet 212 rebounds, the hook 213 at the tail end of the connecting sheet 212 separates from the adjusting piece 30, the adjusting tube 210 is continuously retracted, and the wire locker 100 can be completely separated from the controller 200.

Then, as shown in fig. 21, the adjustable bent sheath 310 of the guiding device 300 is retracted to drive the connector 330 to retract, and since the thread locker 100 is connected to the tendon X at this time and is subjected to a certain traction force, the connector 330 can be completely separated from the thread locker 100, thereby completing the releasing operation.

At this time, as shown in fig. 22, the effective length of the artificial chordae tendineae X is shortened reasonably, and the thread locker 100 is connected to the chordae tendineae X and left in the left ventricle.

In the whole adjusting process, the sheath 10 can perform adjusting operation by catching the artificial chordae tendineae X at one time, so that the operation is convenient and the time is saved; moreover, the sheath 10 and the ejector 20 do not apply fixed pressure to the artificial chordae tendineae X, and are movably matched with the artificial chordae tendineae X, so that chordae tendineae damage is reduced or avoided; in addition, by adopting the thread regulation and control mechanism, real-time stepless regulation and control can be carried out in a state of capturing the chordae tendineae at one time by observing the reflux condition in the repair process, repentance operation can be carried out if the regulation and control is excessive, or the operation of withdrawing the instrument is stopped, so that the safety is high.

Referring to fig. 23 to 28, the minimally invasive artificial chordae tendineae adjustment system according to the second embodiment of the present invention has a similar structure to the minimally invasive artificial chordae tendineae adjustment system 1000 of the first embodiment, except that: in the second embodiment, in the minimally invasive artificial chordae adjusting system, the adjustable bending sheath 310 of the guiding device 300 is a bidirectional adjusting pipe, and a handle assembly is added to make the operation of the instrument more convenient and faster. Specifically, the handle assembly includes a front handle 400, a rear handle 600, and a handle connector 500 connecting the front handle 400 and the rear handle 600. Wherein the front handle 400 is connected to the proximal end of the sheath 310 to drive the sheath 310 to move; the rear handle 600 is connected to the proximal ends of the locking rod 250 and the adjusting tube 210 to move the locking rod 250 and the adjusting tube 210.

Specifically, in this embodiment, in order to increase the adjustability of the wire locker 100 in the spatial position in the heart, the adjustable bending sheath 310 is made into a bidirectional bending adjusting tube, that is, the bending adjusting function can be realized in the three-dimensional direction of the control, specifically, a set of bending adjusting components is additionally arranged at different positions between the inner membrane and the outer membrane. The front handle 400 can adjust the position of the thread locking device 100 in the ventricle and the direction of the opening of the first slot 12 by controlling the movement of the adjustable bent sheath tube 310, so as to realize the hooking function and hook the chordae tendinae into the slot opening.

As shown in fig. 24, the front handle 400 includes a front handle case 470, a central fixing member 480 is disposed in the front handle case 470, and the central fixing member 480 is fixedly connected to the proximal end of the adjustable bending sheath 310, so that the adjustable bending sheath 310 can be moved by controlling the front handle 400. Specifically, in the front handle 400, a first bending adjustment knob 410 is disposed at the distal end of the front handle shell 470, a first bending adjustment fitting 420 is disposed in the front handle shell 470 and is in threaded connection with the first bending adjustment knob 410, and a first pull wire connector 430 is fixedly connected with the first bending adjustment fitting 420 and is fixedly connected with the pull wire 312; a second bending adjustment knob 450 is arranged at the proximal end of the front handle shell 470, a second bending adjustment fitting 460 is in threaded connection with the second bending adjustment knob 450, and a second pull wire connector 440 is fixedly connected with the second bending adjustment fitting 460 and fixedly connected with the pull wire 312 a; the first bending adjusting fitting piece 420 and the second bending adjusting fitting piece 460 are limited by the central fixing piece 480, can only move back and forth and cannot rotate, and the bending adjusting knob is rotated to drive the bending adjusting fitting piece to move towards the near end, so that the traction wire connector fixedly connected with the bending adjusting fitting piece is driven to move towards the near end, the traction wire is driven to move towards the near end, the far-end tube body of the bending adjustable sheath tube 310 is pulled to be bent, and the bending adjusting function is realized.

As shown in fig. 25, the front handle 400 and the rear handle 600 are connected by the handle connector 500, which includes a locking silicone 510, a locking knob 520, and a connecting rod 530, wherein the locking silicone 510 is disposed in an inner cavity of the central fixing member 480 of the front handle 400 for a sealing function. The locking knob 520 is in threaded connection with an inner cavity of the central fixing member 480 of the front handle 400, the connecting rod 530 is fixedly connected with the central fixing member 620 of the rear handle 600, and the front and rear handles are fixedly connected by twisting the locking knob 520.

As shown in fig. 25, the rear handle 600 includes a rear handle case 610, a rear handle central fixing member 620 fixedly connected to the rear handle case 610, an adjusting tube controller 630 fixedly connected to the proximal end of the adjusting tube 210, a knob 640 movably connected to the adjusting tube controller 630 in a staggered manner, and a locking lever controller 650, wherein the locking lever controller 650 is further fixedly connected to the proximal end of the locking lever 250. The adjusting pipe controller 630, the locking rod controller 650 and the knob 640 are assembled together from inside to outside.

Specifically, referring to fig. 26 to 28, a plurality of axially extending limiting grooves 710 are circumferentially formed on an outer circumferential surface of the adjusting tube controller 630, a plurality of axially extending detents 730 are circumferentially and convexly formed on inner circumferential surfaces of the locking rod controller 650 and the knob 640, and a detent groove 750 is formed between each two adjacent detents 730 of the locking rod controller 650. Each of the locking lever controllers 650 is inserted into one of the limiting grooves 710 of the adjustment tube controller 630, each of the locking knobs 640 is inserted into one of the limiting grooves 710 of the adjustment tube controller 630 after passing through one of the locking lever controllers 650, and each of the locking levers 730 of the knobs 640 is inserted into one of the limiting grooves 710 of the adjustment tube controller 630, and the locking levers 730 of the locking lever controllers 650 and the locking levers 730 of the knobs 640 are staggered at intervals. It can be seen that the knob 640, the locking lever controller 650 and the adjusting tube controller 630 are just staggered and connected in a staggered manner, that is, the knob 640 is outermost, the locking lever controller 650 is located between the knob 640 and the adjusting tube controller 630, and the three are radially matched in a clearance fit, so that the three can move axially relative to each other and are movably connected in a staggered manner. The knob 640 can be rotated to drive the locking rod controller 650 and the adjusting tube controller 630 to synchronously rotate, so as to drive the far-end locking wire, and the locking rod controller 650 can be retracted to drive the adjusting tube controller 630 to move backwards, so as to drive the far-end release.

As shown in fig. 26, the knob 640 does not restrict the axial movement of the adjusting tube controller 630, but only restricts the radial movement thereof, the locking rod controller 650 can move backward relative to the adjusting tube controller 630 by a distance (e.g., L) sufficient to drive the distal end of the locking rod 250 to disengage from the connecting piece 212, the adjusting tube controller 630 can be driven to rotate by twisting the knob 640, so that the adjusting tube 210 drives the adjusting piece 30 to rotate, the ejector 20 pushes the tendon to move distally, the distal end of the ejector 20 moves over the first slot 12 of the sheath 10, so as to achieve the wire locking function, observe whether the reflux condition needs to be further regulated or not according to the surgical condition, and if necessary, continue to move the ejector 20 distally in the lumen of the sheath 10, so as to achieve different degrees of regulation, if the operation is terminated by abandoning the control, the knob 640 can be turned reversely to drive the ejector 20 to move towards the proximal end of the sheath 10 until the ejector 20 is withdrawn to the proximal end of the sheath 10, at this time, the artificial chordae tendineae are in a free state in the first slot 12 of the sheath 10, and the artificial chordae tendineae can be separated from the sheath 10 by adjusting the position of the sheath 10, so that the operation can be terminated at any time.

Further, after the wire locking is completed, the locking lever controller 650 is retracted, and after the wire locking lever controller moves for the distance L, the distal end of the locking lever 250 is separated from the connecting piece 212, the hook 213 is reset, the locking lever controller 650 is retracted continuously, so as to drive the adjusting tube controller 630 to move backwards, and at this time, the distal end of the adjusting tube 210 is completely separated from the wire locking device 100.

The adjustable elbow 310 and the joint 330 are then completely disengaged from the cable locker 100 by the front handle 400, and the operation is complete.

It should be noted that, because the pull wire needs to bear a large pulling force during bending adjustment, the parts connected with the pull wire in the handle need to be made of metal materials to improve stability and strength, and other handle pieces can be made of polymer materials such as ABS and PC or metal materials such as stainless steel

In this embodiment, the distal end of the locking rod 250 can be driven to separate from the connecting piece 212 at the distal end of the adjusting tube 210 by controlling the locking rod controller 650 to move to the proximal end along the axial direction for different distances, so that the hook 213 resets, and further the adjusting tube 210 is separated from the adjusting piece 30, and further, the locking rod controller 650 can drive the adjusting tube 210 and the locking rod 250 to be completely separated from the locking device 100 by moving to the proximal end, thereby realizing further release, and being simple and fast to operate.

The above is an implementation manner of the embodiments of the present invention, and it should be noted that, for those skilled in the art, a plurality of improvements and decorations can be made without departing from the principles of the embodiments of the present invention, and these improvements and decorations are also considered as the protection scope of the present invention.

Claims (22)

1. The minimally invasive artificial chordae tendineae adjusting system is characterized by comprising a wire locking device, wherein the wire locking device comprises a sheath for hooking the artificial chordae tendineae, an ejector arranged in the sheath, and an adjusting piece arranged in the sheath and connected with the near end of the ejector; the adjusting piece drives the ejector piece to move towards the far end along the axial direction of the sheath, and the far end face of the ejector piece pushes the artificial chordae tendineae hooked by the sheath, so that the length of the artificial chordae tendineae contained in the sheath is increased.

2. The minimally invasive artificial chordae adjusting system of claim 1, wherein the adjustment member is threaded to the ejector proximal end, the adjustment member rotating relative to the ejector to urge the ejector to move distally in an axial direction of the sheath.

3. The minimally invasive artificial chordae adjusting system of claim 2, wherein a linear pair is provided between the sheath and the ejector, the linear pair limiting axial movement of the ejector relative to the sheath; a rotating pair is arranged between the sheath and the adjusting piece, and the rotating pair limits the adjusting piece to rotate around an axis relative to the sheath.

4. The minimally invasive artificial chordae adjusting system of claim 3, wherein the linear pair comprises at least one set of a guide rod and a guide groove extending along the axial direction of the sheath, the guide rod is protruded on the outer circumferential surface of the ejector, and the guide groove is opened on the inner circumferential surface of the sheath; or the guide rod is convexly arranged on the inner circumferential surface of the sheath, and the guide groove is arranged on the outer circumferential surface of the ejector.

5. The minimally invasive artificial chordae adjusting system of claim 3, wherein the revolute pair comprises at least one set of annular grooves and annular protrusions spaced apart along an axial direction of the sheath, the annular grooves being formed on an outer circumferential surface of the proximal end of the adjusting member, and the annular protrusions being formed on an inner circumferential surface of the proximal end of the sheath; or, the annular groove is arranged on the inner peripheral surface of the proximal end of the sheath, and the annular bulge is convexly arranged on the outer peripheral surface of the proximal end of the adjusting piece.

6. The minimally invasive artificial chordae adjusting system of claim 1, wherein the sheath is hollow and is provided with a first receiving cavity extending in an axial direction, the ejector and the adjuster being received in the first receiving cavity; the first containing cavity at least penetrates through the proximal end face of the sheath, and a first open slot penetrating to the first containing cavity is formed in the outer wall of the distal end of the sheath.

7. The minimally invasive artificial chordae adjusting system of claim 6, wherein the sheath comprises a first housing and a second housing juxtaposed with the first housing, the first housing and the second housing forming the first receiving cavity therebetween.

8. The minimally invasive artificial chordae adjusting system of claim 6, wherein the ejector is hollow and is provided with a second receiving cavity extending in an axial direction, the second receiving cavity extending through at least a proximal face of the ejector, the adjuster being accessible from the proximal end of the ejector into the second receiving cavity.

9. The minimally invasive artificial chordae adjusting system of claim 8, wherein the distal end of the ejector defines a second slot corresponding to the proximal end of the first slot.

10. The minimally invasive artificial chordae adjusting system of claim 8, wherein the adjuster comprises a body portion at a distal end and a rotating portion at a proximal end, the body portion being received within the second receiving cavity and the rotating portion being located outside the second receiving cavity.

11. The minimally invasive artificial chordae adjusting system of claim 10, wherein the rotating portion defines a countersink from a proximal face, and the adjusting element defines a receiving cavity extending axially from a bottom surface of the countersink, the receiving cavity extending through at least a portion of the body portion.

12. The minimally invasive artificial chordae adjusting system of claim 11, wherein the adjuster defines at least two slots from an inner wall of the sink, each slot extending radially of the adjuster.

13. The minimally invasive artificial chordae adjustment system of any one of claims 1 to 12, further comprising a controller, a distal end of the controller being removably connected to the adjuster.

14. The minimally invasive artificial chordae adjusting system of claim 13, wherein the controller comprises an adjusting tube, wherein the distal end of the adjusting tube is provided with at least two connecting tabs, and wherein the distal end of each connecting tab is provided with a hook; the connecting piece is made of elastic material; the clamping hook at the far end of the connecting sheet expands outwards and is clamped into the clamping groove of the adjusting piece.

15. The minimally invasive artificial chordae adjusting system of claim 14, wherein the controller further comprises a locking rod movably threaded in the adjusting tube, the locking rod moves along the axial direction of the adjusting tube to the far end to be inserted into the accommodating cavity, and the locking rod pushes each connecting piece outwards along the radial direction of the adjusting tube so that the hooks expand outwards and are clamped into the clamping grooves of the adjusting pieces.

16. The minimally invasive artificial chordae adjusting system of claim 15 further comprising an adjustable curved sheath having a joint at a distal end, the sheath having a first connection that is removably connected to the joint, the joint defining a circumferential position of the sheath such that the adjustment member rotates relative to the sheath while rotating relative to the ejector.

17. The minimally invasive artificial chordae adjusting system of claim 16, wherein the first connection portions are provided at a proximal end of the sheath, the first connection portions being at least two in number, the at least two first connection portions being spaced apart circumferentially of the sheath.

18. The minimally invasive artificial chordae adjusting system of claim 16, wherein the distal end of the joint is provided with a second number of connections corresponding to the number of first connections, the second number of connections being the same as the number of first connections, the second connections being spaced apart circumferentially of the joint.

19. The minimally invasive artificial chordae adjusting system of claim 16, further comprising a handle assembly comprising a front handle, a rear handle, and a handle connector connecting the front and rear handles; the front handle is connected with the near end of the adjustable bent sheath tube; the rear handle is connected with the locking rod and the near end of the adjusting tube.

20. The minimally invasive artificial chordae adjusting system of claim 19, wherein the rear handle comprises a tuning tube controller, a locking lever controller and a knob that fit together from inside to outside; the adjusting tube controller is fixedly connected with the near end of the adjusting tube, the locking rod controller is fixedly connected with the near end of the locking rod, and the locking rod controller and the knob are movably connected with the adjusting tube controller respectively.

21. The minimally invasive artificial chordae tendineae adjustment system of claim 20, wherein the outer circumferential surface of the adjustment tube controller is circumferentially provided with a plurality of axially extending limiting grooves, the inner circumferential surfaces of the lock rod controller and the knob are circumferentially provided with a plurality of axially extending detents, and the lock rod controller is provided with a detent groove between each two adjacent detents.

22. The minimally invasive artificial tendon adjustment system of claim 21 wherein each of the detents on the locking lever controller is inserted into a respective one of the limiting grooves on the adjustment tube controller, each of the detents on the knob is inserted into a respective one of the limiting grooves on the adjustment tube controller after passing through a respective one of the detent grooves on the locking lever controller, and the detents on the locking lever controller are spaced apart from and staggered with respect to the detents on the knob.

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