Artificial chordae tendineae regulation device and artificial chordae tendineae regulation system

Abstract

The present invention discloses an artificial chordae tendineae regulation device and an artificial chordae tendineae regulation system. The artificial chordae tendineae regulation device includes a regulation main body member and a hook-shaped member. The regulation main body member is an elastic self-expanding member with a hollow interior, an open distal end, and a radial dimension at the distal end greater than that at the proximal end. The hook-shaped member includes at least one hook-shaped structure for hooking the artificial chordae tendineae. When the hook-shaped member hooks the artificial chordae tendineae, the hook-shaped structure of the hook-shaped member extends out of the distal end of the regulation main body member. After the hook-shaped member hooks the artificial chordae tendineae, the hook-shaped member is received in the regulation main body member and fixedly connected to the regulation main body member, and the hook-shaped member pulls a part of the artificial chordae tendineae into the regulation main body member, and the distal end of the regulation main body member abuts against the parts of the artificial chordae tendineae on both sides of the hook-shaped member. The artificial chordae tendineae regulation device and the artificial chordae tendineae regulation system of the present invention can perform real-time adaptive adjustment on the effective length of the artificial chordae tendineae.

Description

Technical Field

[0001] This application belongs to the technical field of medical devices. Specifically, it relates to an artificial chordae tendineae regulation device and an artificial chordae tendineae regulation system. Background Art

[0002] The mitral valve is a one-way "valve" between the left atrium ( Figure 1 , Figure 2 marked by LA in Figure 1 , Figure 2 ) and the left ventricle ( Figure 1 , Figure 2 marked by LV in

[0003] ), which can ensure that blood flows from the left atrium to the left ventricle. Mitral valve insufficiency is one of the most common heart valve diseases today. It is mainly caused by rheumatic heart disease, mitral valve myxomatous degeneration, cardiac ischemic disease, myocardial lesions, etc., resulting in lesions in the annulus fibrosus, valve leaflets, chordae tendineae (

[0004] such as Figure 1 marked by CT in Figure 2 ) and papillary muscles of the mitral valve structure, leading to incomplete closure of the valve leaflets of the mitral valve. When the left ventricle contracts, the impact of blood flow will cause the valve leaflets to prolapse into the left atrium, resulting in blood reflux. Summary of the Invention

[0005] The purpose of this application is to provide an artificial chordae tendineae regulation device and an artificial chordae tendineae regulation system, which can regulate the effective length of the artificial chordae tendineae in real time and adaptively, weaken or eliminate the recurrence of mitral valve or other heart valve regurgitation caused by the relaxation of the artificial chordae tendineae over time, and avoid repeated surgeries.

[0006] To achieve the above object, a first aspect of the present invention provides an artificial chordae tendineae regulation device, including a regulation main body member and a hook-shaped member;

[0007] The regulation main body member is an elastic self-expanding member with a hollow interior, an open distal end, and a radial dimension at the distal end greater than that at the proximal end;

[0008] The hook-shaped member includes at least one hook-shaped structure for hooking the artificial chordae tendineae;

[0009] When the hook-shaped member hooks the artificial chordae tendineae, the hook-shaped structure of the hook-shaped member extends out of the distal end of the regulation main body member;

[0010] After the hook-shaped member hooks the artificial chordae tendineae, the hook-shaped member is received in the regulation main body member and fixedly connected to the regulation main body member. The hook-shaped member pulls a part of the artificial chordae tendineae into the regulation main body member, and the distal end of the regulation main body member abuts against the parts of the artificial chordae tendineae on both sides of the hook-shaped member.

[0011] To achieve the above object, a second aspect of the present invention provides an artificial chordae tendineae regulation system, including: an adjustable bending sheath, a delivery device, and the artificial chordae tendineae regulation device as described above; the proximal end of the artificial chordae tendineae regulation device is detachably connected to the distal end of the delivery device, and both the artificial chordae tendineae regulation device and the delivery device are movably inserted into the adjustable bending sheath.

[0012] Compared with the prior art, the present invention has at least the following beneficial effects:

[0013] The artificial chordae tendineae regulation device and the artificial chordae tendineae regulation system of the present invention are provided with an elastically self-expanding regulation main body member and a hook-shaped member for hooking the chordae tendineae. During operation, first, the hook-shaped structure of the hook-shaped member is driven to extend out of the distal end of the regulation main body member, and the artificial chordae tendineae are hooked by using the hook-shaped structure. Then, the hook-shaped member is driven again so that it is received in the regulation main body member and fixedly connected to the regulation main body member. During this process, the redundant part of the artificial chordae tendineae will be pulled and retracted into the regulation main body member by the hook-shaped member, and the distal end of the regulation main body member will abut against the parts of the artificial chordae tendineae on both sides of the hook-shaped member, causing the artificial chordae tendineae to bend, thereby shortening the effective length of the artificial chordae tendineae. At this time, the regulation main body member will expand and deform outward in the radial direction where the artificial chordae tendineae are located under the tension of the artificial chordae tendineae; as time goes by, the elastic characteristics of the regulation main body member always tend to restore its initial shape, so that the regulation main body member can deform in real time and adaptively follow the change of the effective length of the artificial chordae tendineae caused by the change of the ventricular volume, prompting the length of the artificial chordae tendineae entering the regulation main body member to gradually increase to compensate for the change amount of the effective length of the artificial chordae tendineae and further shortening the effective length of the artificial chordae tendineae. That is, the technical solution of the present invention can perform real-time adaptive adjustment on the effective length of the artificial chordae tendineae to ensure that the artificial chordae tendineae are always in a tensioned state, weaken or eliminate the recurrence of regurgitation of the heart valve caused by the relaxation of the artificial chordae tendineae over time, and avoid repeated surgeries. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] The accompanying drawings here are incorporated into the specification and form a part of this specification, showing embodiments consistent with the present invention and used together with the specification to explain the principles of the present invention.

[0015] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the following will briefly introduce the drawings required for use in the description of the embodiments or the prior art. Obviously, for those of ordinary skill in the art, other drawings can also be obtained based on these drawings without creative efforts.

[0016] Figure 1 It is a schematic diagram of the artificial chordae tendineae being in a tensioned state at the initial stage of implantation.

[0017] Figure 2 It is a schematic diagram of the artificial chordae tendineae being in a relaxed state after being implanted for a period of time.

[0018] Figure 3 It is a cross-sectional view of the artificial chordae tendineae regulation device shown according to an exemplary embodiment of the present application.

[0019] Figure 4 It is Figure 3 A partial enlarged view of position A in

[0020] Figure 5 Schematic diagram of the artificial chordae tendineae regulating device of the present application after hooking the artificial chordae tendineae shown from one angle.

[0021] Figure 6 Cross-sectional view of the artificial chordae tendineae regulating device of the present application after hooking the artificial chordae tendineae shown from one angle.

[0022] Figure 7 Schematic diagram of the change of the regulating main body part when the artificial chordae tendineae regulating device of the present application adjusts the effective length of the artificial chordae tendineae.

[0023] Figure 8 For Figure 5 Schematic diagram of the structure of the regulating main body part in after removing the first coating.

[0024] Figure 9 Schematic diagram of the structure of the adapter in the artificial chordae tendineae regulating device of the present application.

[0025] Figure 10 Cross-sectional view of the artificial chordae tendineae regulating device of the present application after hooking the artificial chordae tendineae shown from another angle.

[0026] Figure 11 For Figure 10 Partial enlarged view of position B in .

[0027] Figure 12 Schematic diagram of the structure of the anchor plate of the anchor in the artificial chordae tendineae regulating device of the present application popping out.

[0028] Figure 13 For Figure 12 Schematic diagram of the structure of the anchor plate in being retracted.

[0029] Figure 14 Cross-sectional view of the artificial chordae tendineae regulating system shown according to an exemplary embodiment of the present application.

[0030] Figure 15 Cross-sectional view of the conveying device shown according to an exemplary embodiment of the present application.

[0031] Figure 16 For Figure 14 Schematic diagram of the structure of the regulating main body part in after extending from the distal end of the adjustable bending sheath.

[0032] Figure 17 Schematic diagram of the structure of the hook-shaped part of the artificial chordae tendineae regulating device shown according to another exemplary embodiment of the present application.

[0033] Figure 18 Schematic diagram of the artificial chordae tendineae regulating system of the present application entering the heart.

[0034] Among them, the reference numerals are explained as follows:

[0035] Artificial chordae tendineae regulation device 1000, regulation main body 1100, elastic net 1101, first coating 1103, hook-shaped member 1200, locking structure 1300, anchor 1310, anchor plate 1311, mating member 1320, clamping portion 1330, reinforcement member 1400, artificial chordae tendineae 2000, adjustable bending sheath 3000, delivery device 4000, first delivery member 4100, second delivery member 4200, intermediate tube 4300, connecting member 4400. Detailed implementation mode

[0036] To make the objectives, technical solutions and advantages of the embodiments of the present application clearer, the technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present application. Apparently, the described embodiments are some, but not all, of the embodiments of the present application. All other embodiments obtained by those of ordinary skill in the art based on the embodiments in the present application without creative efforts shall fall within the scope of protection of the present application.

[0037] It should be understood that the orientation or positional relationships indicated by "front", "rear", "upper", "lower", "left", "right", "longitudinal", "transverse", "vertical", "horizontal", "top", "bottom", "inner", "outer", "head", "tail", etc. are based on the orientation or positional relationships shown in the accompanying drawings, with a specific orientation structure and operation, and are only for the convenience of describing the technical solution, rather than indicating that the device or element referred to must have a specific orientation. Therefore, it should not be construed as a limitation to the present invention.

[0038] It should also be noted that unless otherwise clearly specified and limited, terms such as "installation", "connection", "connection", "fixation", "setting", etc. should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or integrated; it can be directly connected, or indirectly connected through an intermediate medium, and can be the internal communication of two elements or the interaction relationship between two elements. When an element is referred to as being "above" or "below" another element, the element can be "directly" or "indirectly" located above the other element, or there may also be one or more intermediate elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0039] In the description of the present invention, it still needs to be noted that the proximal end refers to the end of the instrument or component close to the operator, and the distal end refers to the end of the instrument or component far from the operator; the axial direction refers to the direction parallel to the center line connecting the distal end and the proximal end of the instrument or component, the radial direction refers to the direction perpendicular to the axial direction, and the circumferential direction refers to the direction surrounding the axial direction.

[0040] To solve the problem that the tightness state of the artificial chordae tendineae 2000 in the prior art cannot be adaptively adjusted according to the change of the left ventricular volume, as Figures 3 - 13 shown, a first aspect of the present invention discloses an artificial chordae tendineae regulation device 1000, including a regulation main body 1100 and a hook-shaped member 1200.

[0041] As Figure 3 , Figure 5 , Figure 6 and Figure 8 shown, the regulation main body 1100 is an elastic self-expanding member, which is hollow inside, its distal end is open, and the radial dimension of its distal end is larger than the radial dimension of its proximal end. Preferably, the radial dimension of the regulation main body 1100 gradually increases from its proximal end to its distal end. Specifically, the overall shape of the regulation main body 1100 can generally be in the shape of a bowl, a conical cylinder or a horn, and other shapes that meet the requirements of the regulation main body 1100 in this application. Therefore, the specific shape of the regulation main body 1100 is not limited in this application.

[0042] In a specific embodiment, as Figure 3 and Figure 5 shown, when the overall shape of the regulation main body 1100 is generally in the shape of a bowl, the generatrix of the regulation main body 1100 is an arc convex outward relative to the axis of the regulation main body 1100. After the generatrix rotates one week relative to the axis, a bowl shape can be roughly formed.

[0043] To ensure the elastic performance of the regulation main body 1100 itself, according to an embodiment of the present invention, as Figure 3 , Figure 5 and Figure 8 shown, the regulation main body 1100 at least includes an elastic net 1101 made of a shape memory material. Specifically, the elastic net can be woven or cut from a shape memory material. Exemplarily, an elastic net woven from nickel-titanium wires can be used, or a net structure cut from a nickel-titanium tube can also be used, or other shape memory materials, such as cobalt-chromium alloy, etc. In this embodiment, it is woven and shaped by nickel-titanium wires.

[0044] In addition, it should be noted that: the radial dimension range of the distal end of the adjustment main body 1100 is 2.5 mm - 5 mm. Preferably, the radial dimension of the distal end of the adjustment main body 1100 is set to 3 mm; the radial dimension range of the proximal end of the adjustment main body 1100 is 2 mm - 3 mm; the axial distance between the proximal end and the distal end of the adjustment main body 1100 is preferably 1.5 mm - 4 mm; among them, the wire diameter range of the nitinol wire used for braiding the elastic net is 0.1 mm - 0.3 mm, preferably 0.2 mm. If the wire diameter is too large or too small, it will affect the deformation degree of the elastic net under the action of the artificial tendon cord 2000 and the ability to restore the initial shape. The basis for the selection of the above dimensions is: the relaxation amount range of the artificial tendon cord 2000 after long-term implantation clinically is about 3 mm - 6 mm, and the force exerted by the artificial tendon cord 2000 on the adjustment main body 1100 should be small, between 1 N - 3 N. The elastic net 1101 woven according to the above dimension range can withstand a force value range of 1 N - 5 N, and under the action of the force within this value range, the elastic net 1101 has good deformation ability and resilience ability to restore to the initial shape.

[0045] The hook-shaped member 1200 includes at least one hook-shaped structure, and at least one hook-shaped structure can rotate 360° within the adjustment main body 1100 for hooking the artificial tendon cord 2000. Among them, in one embodiment of the present application, as Figure 3 , Figure 4 , Figure 10 , Figure 12 and Figure 13 shown, the number of hook-shaped structures is set to one; in order to more easily hook the artificial tendon cord 2000 and reduce the rotation of the hook-shaped member 1200 to save the time for hooking the artificial tendon cord 2000, in another embodiment of the present application, as Figure 17 shown, the number of hook-shaped structures can be set to two, and the two hook-shaped structures are symmetrically arranged; it can be understood that in other embodiments, the number of hook-shaped structures can also be set to more than two, such as three or four exemplarily, to improve the convenience of hooking the artificial tendon cord 2000. Specifically, the hook-shaped member 1200 is made of a rigid material with good biocompatibility, such as SUS316L, PEEK, etc., and the cross-sectional shape of the hook-shaped member 1200 can be a smooth cylindrical shape and other shapes convenient for hooking the artificial tendon cord 2000.

[0046] Refer to Figure 3 , Figure 5 , Figure 6 and Figure 10, when the hook-shaped member 1200 hooks the artificial chordae tendineae 2000, the hook-shaped structure of the hook-shaped member 1200 extends out of the distal end of the regulation main body member 1100; after the hook-shaped member 1200 hooks the artificial chordae tendineae 2000, the hook-shaped member 1200 is received in the regulation main body member 1100 and fixedly connected to the regulation main body member 1100. The hook-shaped member 1200 pulls a part of the artificial chordae tendineae 2000 into the regulation main body member 1100, and the distal end of the regulation main body member 1100 abuts against the parts of the artificial chordae tendineae 2000 on both sides of the hook-shaped member 1200.

[0047] In the above embodiment, as Figure 4 shown, the proximal end of the regulation main body member 1100 is open. Before the hook-shaped member 1200 hooks the artificial chordae tendineae 2000 and when the hook-shaped member 1200 hooks the artificial chordae tendineae 2000, the proximal end of the hook-shaped member 1200 movably penetrates through the proximal end of the regulation main body member 1100; after the hook-shaped member 1200 hooks the artificial chordae tendineae 2000, the proximal end of the hook-shaped member 1200 is fixedly connected to the proximal end of the regulation main body member 1100 to keep a part of the artificial chordae tendineae 2000 retracted into the regulation main body member 1100. By adopting the above operation, combined with Figure 5 , a part of the artificial chordae tendineae 2000 can be bent into a "U" shape or a "Ji" shape and received in the regulation main body member 1100, thereby effectively shortening the effective length of the artificial chordae tendineae 2000. And by adjusting the distance between the hook-shaped structure of the hook-shaped member 1200 and the proximal end of the regulation main body member 1100, the bending degree of the artificial chordae tendineae 2000 in the regulation main body member 1100 can be adjusted, so as to realize the initial adjustment of the effective length of the artificial chordae tendineae 2000, and make the initial effective length of the artificial chordae tendineae 2000 appropriate. It should be noted that the appropriate effective length of the artificial chordae tendineae 2000 should be the length required for the artificial chordae tendineae 2000 to pull the valve leaf so that the valve leaf can close normally.

[0048] The specific operation process is as follows: First, drive the hook-shaped structure of the hook-shaped member 1200 to extend out of the distal end of the regulation main body member 1100, and use the hook-shaped structure to hook the artificial chordae tendineae 2000. Then, drive the hook-shaped member 1200 again so that it is received in the regulation main body member 1100 and fixedly connected to the regulation main body member 1100. During this process, a part of the artificial chordae tendineae 2000 will be bent by the hook-shaped member 1200 and pulled into the regulation main body member 1100, and the distal end of the regulation main body member 1100 will abut against the parts of the artificial chordae tendineae 2000 on both sides of the hook-shaped member 1200. At this time, as Figure 7 shown, the regulation main body member 1100 will expand and deform outward in the radial direction where the artificial chordae tendineae 2000 is located under the tension of the artificial chordae tendineae 2000.

[0049] As time goes by, the volume of the ventricle gradually decreases, and the artificial chord tendineae 2000 has a tendency to gradually relax. The elastic characteristics of the regulation main body 1100 itself cause the regulation main body 1100 to gradually deform towards restoring its initial shape under the action of its own resilience force. During this process, the regulation main body 1100 can deform in real time and adaptively follow the change in the effective length of the artificial chord tendineae 2000 caused by the change in the ventricle volume, causing the length of the artificial chord tendineae 2000 entering the regulation main body 1100 to gradually increase to compensate for the change in the effective length of the artificial chord tendineae 2000 and further shortening the effective length of the artificial chord tendineae 2000. Specifically, in combination with Figure 7 The above adjustment process is explained as follows: When the regulation main body 1100 rebounds from the outward expansion position A1 to the position A2 under the action of its own elastic force, the arc length does not change, but the chord length between the hook-shaped member 1200 and the distal edge of the regulation main body 1100 increases from B1 to B2, that is, the length of the artificial chord tendineae 2000 accommodated in the regulation main body 1100 increases. In summary, the artificial chord tendineae regulation device 1000 of the present application can realize real-time adaptive adjustment of the effective length of the artificial chord tendineae 2000 according to the change in the left ventricle volume, so as to ensure that the artificial chord tendineae 2000 is always in a tension state, and the mitral valve can remain closed during ventricular systole, effectively avoiding the phenomenon of re-regurgitation after chord tendineae implantation.

[0050] In the above embodiment, as Figure 3 、 Figure 4 、 Figure 10 and Figure 11 shown, after the hook-shaped member 1200 hooks the artificial chord tendineae 2000, the proximal end of the regulation main body 1100 and the proximal end of the hook-shaped member 1200 are fixedly connected through the locking structure 1300. In this embodiment, the locking structure 1300 includes: a cooperating anchor member 1310 and a mating member 1320. As Figure 10 、 Figure 11 and Figure 12 shown, the anchor member 1310 includes a plurality of anchor plates 1311 fixedly connected to the proximal end of the hook-shaped member 1200 and turned outwards. Preferably, the plurality of anchor plates 1311 are arranged at intervals in the circumferential direction of the proximal end of the hook-shaped member 1200, and the plurality of anchor plates 1311 are in an outwards-turning state in the natural state after heat setting treatment. The mating member 1320 is sleeved outside the proximal end of the hook-shaped member 1200, and the distal end of the mating member 1320 is fixedly connected to the proximal end of the regulation main body 1100. As Figures 9 - 11 shown, the mating member 1320 is provided with a plurality of clamping portions 1330, and the anchor plates 1311 are cooperatively connected with the clamping portions 1330; preferably, the plurality of clamping portions 1330 are arranged at intervals in the circumferential direction of the mating member 1320; the clamping portions 1330 are clamping holes or clamping grooves.

[0051] Specifically, after the hook-shaped member 1200 hooks the artificial chord 2000, several anchor plates 1311 of the anchor 1310 will be inserted one by one into the card holes provided on the mating member 1320, so as to realize the stable fixed connection between the proximal end of the control main body 1100 and the proximal end of the hook-shaped member 1200, and further maintain the effective length of the artificial chord 2000 that has been initially adjusted as described above.

[0052] It should be understood that the locking structure 1300 here is only used as an example and is not a limitation to the present application. Other locking structures 1300 adopted by those of ordinary skill in the art based on the inspiration of the present application are all within the protection scope of the present application.

[0053] According to an embodiment of the present invention, in combination with Figure 3 , Figure 5 and Figure 8 , in order to avoid damage to the artificial chord 2000 caused by the control main body 1100, the distal part of the control main body 1100 is covered with a first covering 1103. Specifically, the first covering 1103 can be covered on the entire elastic net 1101, or in order to save costs, it is only necessary to cover the first covering 1103 on the distal end of the elastic net 1101 in contact with the artificial chord 2000. The first covering can be made of a flexible material with biocompatibility. In this embodiment, a polyester cloth is used.

[0054] The hook-shaped structure of the hook-shaped member 1200 can be covered with a second covering (not shown). Fabrics such as polyester cloth or a silicone film can be selected to form the second covering, so as to reduce the damage to the artificial chord 2000 caused by the hook-shaped structure under the long-term implanted state.

[0055] According to an embodiment of the present invention, as Figure 3 and Figure 4 shown, a reinforcing member 1400 is further provided between the proximal end of the control main body 1100 and the proximal end of the hook-shaped member 1200. Specifically, the reinforcing member 1400 is hollow inside for the proximal end of the hook-shaped member 1200 to pass through. During assembly, first, the proximal end of the control main body 1100 is welded to the distal end of the mating member 1320, and then the proximal end of the reinforcing member 1400 is inserted into the proximal end of the control main body 1100 and fixed by welding. The above design can, on the one hand, increase the connection stability of the control main body 1100, and on the other hand, enhance the anti-deformation ability of the proximal end of the control main body 1100;

[0056] Moreover, in this embodiment, the radial dimension of the distal end of the reinforcement member 1400 is further designed to be larger than that of the proximal end. After the hook-shaped member 1200 hooks the artificial tendon cord 2000, the end of the opening of the hook-shaped structure fits against the distal end of the reinforcement member 1400 or forms a small gap with the distal end of the reinforcement member 1400, wherein the above-mentioned gap is smaller than the diameter of the artificial tendon cord 2000, thereby effectively preventing the artificial tendon cord 2000 from slipping out of the hook-shaped structure.

[0057] As Figures 14 - 16 shown, in combination with Figure 3 、 Figure 4 and Figures 10 to 13 , the present invention also discloses an artificial tendon cord regulation system, including: an adjustable bending sheath 3000, a delivery device 4000, and the aforementioned artificial tendon cord regulation device 1000. The proximal end of the artificial tendon cord regulation device 1000 is detachably connected to the distal end of the delivery device 4000, and both the artificial tendon cord regulation device 1000 and the delivery device 4000 are movably inserted into the adjustable bending sheath 3000. Among them, the adjustable bending sheath 3000 is common in the prior art and usually includes a bending adjustment handle and a sheath tube that can be adjusted in bending. The angle of the distal section of the sheath tube can be adjusted through the bending adjustment handle, and no further elaboration will be made here.

[0058] Specifically, as Figure 14 shown, since the regulation main body member 1100 is an elastic self-expanding member, in the delivery state, the regulation main body member 1100 of the artificial tendon cord regulation device 1000 will be received in the inner cavity of the adjustable bending sheath 3000 and be in a retracted state. When in the implanted state, as Figure 16 shown, the delivery device 4000 will drive the regulation main body member 1100 to extend out of the distal end of the adjustable bending sheath 3000. At this time, the self-expanding member will rebound to the shaped state under the action of its own elastic force. Then, the delivery device 4000 drives the hook-shaped structure of the hook-shaped member 1200 to extend out of the distal end of the regulation main body member 1100 to hook the artificial tendon cord 2000; then, the delivery device 4000 drives the hook-shaped member 1200 again to receive it in the regulation main body member 1100. During this process, part of the artificial tendon cord 2000 will be bent by the hook-shaped member 1200 and pulled into the regulation main body member 1100, and the distal end of the regulation main body member 1100 will abut against the parts of the artificial tendon cord 2000 on both sides of the hook-shaped member 1200, thereby realizing the adjustment of the initial effective length of the artificial tendon cord 2000; next, the proximal end of the hook-shaped member 1200 can be locked with the regulation main body member 1100 through the locking structure 1300 to maintain the initial effective length of the artificial tendon cord 2000; finally, only the proximal end of the artificial tendon cord regulation device 1000 needs to be separated from the distal end of the delivery device 4000, and the delivery device 4000 is withdrawn, and as Figure 5The artificial chordae tendineae regulation device 1000 composed of a hook-shaped member 1200, a regulation main body member 1100, a mating member 1320, an anchor member 1310, and a reinforcement member 1400 as shown is placed in the ventricle to perform subsequent real-time adaptive regulation on the effective length of the artificial chordae tendineae 2000 to ensure that the artificial chordae tendineae 2000 is always in a tensioned state.

[0059] Specifically, as Figure 14 and Figure 15 shown, the delivery device 4000 includes: a first delivery member 4100 movably disposed within the adjustable bending sheath 3000 and a second delivery member 4200 movably disposed within the first delivery member 4100; the distal end of the first delivery member 4100 is detachably connected to the proximal end of the regulation main body member 1100, and the distal end of the second delivery member 4200 is detachably connected to the proximal end of the hook-shaped member 1200; the first delivery member 4100 is used to drive the regulation main body member to extend out of the distal end of the adjustable bending sheath 3000, and the second delivery member 4200 is used to drive the hook-shaped member 1200 to axially move relative to the regulation main body member and hook the artificial chordae tendineae 2000; after implantation, first separate the first delivery member 4100 from the mating member 1320, and then separate the second delivery member 4200 from the proximal end of the hook-shaped member 1200.

[0060] In this embodiment, both the first delivery member 4100 and the second delivery member 4200 are provided as hollow tubes, and the second delivery member 4200 in other embodiments can also be a rod; in addition, in this embodiment, as Figure 14 shown, the detachable connection method uses screw connection, and in other embodiments, it can also use snap fasteners, etc. Further, as Figure 15 shown, the first delivery member 4100 is detachably connected to the mating member 1320 through a connecting member 4400, wherein the proximal end of the connecting member 4400 is fixedly connected to the distal end of the first delivery member 4100, and the distal end of the connecting member 4400 is threadedly connected to the proximal end of the mating member 1320 to achieve the detachable connection between the first delivery member 4100 and the regulation main body member 1100.

[0061] According to an embodiment of the present invention, as Figure 12 , Figure 13 , Figure 14 and Figure 15 shown, an intermediate tube 4300 is movably sleeved between the first delivery member 4100 and the second delivery member 4200, and the intermediate tube 4300 is used to control the state of the hook-shaped member 1200 to change from a state of being axially movable relative to the regulation main body member 1100 to a state of being fixedly connected to the regulation main body member 1100. Specifically, as Figure 3 and Figure 13As shown, the anchor 1310 is movably installed in the middle tube 4300, and the middle tube 4300 first gathers and constrains the plurality of anchor plates 1311. In this state, the hook member 1200 can be driven by the second conveying member 4200 to perform axial movement relative to the regulating main body 1100 to hook the artificial tendon 2000; Figure 11 and Figure 12 As shown, when the hook-shaped member 1200 has hooked the artificial tendon 2000 and the hook-shaped member 1200 returns to its initial position relative to the regulating main body 1100, the intermediate tube 4300 is withdrawn toward the proximal end to release the restraint on the anchor plate 1311. At this time, a plurality of anchor plates 1311 will automatically unfold and pop into the card holes provided on the connecting member 1320 one by one, thereby achieving the fixed connection between the proximal end of the regulating main body 1100 and the proximal end of the hook-shaped member 1200, thereby achieving the maintenance of the initial effective length of the artificial tendon 2000 that has been adjusted as mentioned above.

[0062] Reference Figure 18 The following is an explanation of the use process of the artificial chord regulation system of the present application to regulate the artificial chords implanted in the mitral valve:

[0063] Step 1: After a small incision is made by puncturing the femoral artery, a puncture guide wire (not shown) is sent to the left ventricle LV via the femoral artery-abdominal aorta-thoracic aorta-aortic arch;

[0064] Step 2: The adjustable curved sheath 3000 is inserted along the puncture guide wire until the distal end of the adjustable curved sheath 3000 enters the left ventricle LV and reaches the vicinity of the artificial chordae tendineae 2000, and the puncture guide wire is withdrawn;

[0065] The third step is to withdraw the adjustable bending sheath 3000 toward the proximal end or push the first conveying member 4100, the second conveying member 4200 and the intermediate tube 4300 toward the distal end at the same time, so that the regulating body 1100 extends out of the distal end of the adjustable bending sheath 3000 and expands into a bowl shape;

[0066] Step 4: Push the second conveying member 4200 and the intermediate tube 4300 to the far end at the same time, so that the hook-shaped member 1200 extends out of the far end of the regulating main member 1100, and drive the second conveying member 4200 to make the hook-shaped member 1200 hook the artificial tendon 2000 and withdraw;

[0067] Step 5: The intermediate tube 4300 is withdrawn toward the proximal end, and a plurality of anchor pieces 1311 are ejected into the clamping holes of the fitting 1320 to achieve a fixed connection between the hook 1200 and the regulating main body 1100;

[0068] Step 6: Disconnect the first conveyor 4100 from the mating part 1320 and the second conveyor 4200 from the hook-shaped part 1200, and withdraw the first conveyor 4100, the intermediate tube 4300, and the second conveyor 4200 to complete the implantation of the artificial chordae tendineae regulating device 1000.

[0069] Subsequently, over time, as described above, the artificial chordae tendineae regulating device 1000 will adjust the effective length of the artificial chordae tendineae 2000 in real time and adaptively.

[0070] The above is only an example of regulating the artificial chordae tendineae implanted in the mitral valve. It can be understood that the artificial chordae tendineae regulating device and the artificial chordae tendineae regulating system of the present application can also regulate the artificial chordae tendineae implanted in the tricuspid valve.

[0071] The above are only specific embodiments of the present invention, enabling those skilled in the art to understand or implement the present invention. Various modifications to these embodiments will be obvious to those skilled in the art. The general principles defined herein can be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention will not be limited to these embodiments shown herein, but rather to the broadest scope consistent with the principles and novel features claimed herein.

Claims

1. An artificial chordae tendineae regulation device, characterized in that, It includes a regulating main body part and a hook-shaped part; The regulating main body part is an elastic self-expanding part with a hollow interior, an open distal end, and a radial dimension at the distal end greater than that at the proximal end; The hook-shaped part includes at least one hook-shaped structure for hooking an artificial chordae tendineae; When the hook-shaped part hooks the artificial chordae tendineae, the hook-shaped structure of the hook-shaped part extends out of the distal end of the regulating main body part; After the hook-shaped part hooks the artificial chordae tendineae, the hook-shaped part is received in the regulating main body part and fixedly connected to the regulating main body part. The hook-shaped part pulls a part of the artificial chordae tendineae into the regulating main body part, and the distal end of the regulating main body part abuts against the parts of the artificial chordae tendineae on both sides of the hook-shaped part.

2. The artificial chordae tendineae regulation device according to claim 1, wherein, The radial dimension of the regulating main body part gradually increases from its proximal end to its distal end.

3. The artificial chordae tendineae regulation device according to claim 2, wherein The overall shape of the regulating main body part generally presents a bowl shape, a conical tube shape or a trumpet shape.

4. The artificial chordae tendineae regulation device according to claim 2, characterized in that, The generatrix of the regulating main body part is an arc convex outward with respect to the axis of the regulating main body part.

5. The artificial chordae tendineae regulation device according to claim 1, characterized in that The regulating main body part is an elastic net made of a shape memory material.

6. The artificial chordae tendineae regulation device according to claim 5, characterized in that, The distal part of the regulating main body part is coated with a first coating.

7. The artificial chordae tendineae regulation device according to claim 1, wherein The hook-shaped structure is coated with a second coating.

8. The artificial chordae tendineae regulation device according to claim 1, wherein, The proximal end of the regulating main body part is open; before and when the hook-shaped part hooks the artificial chordae tendineae, the proximal end of the hook-shaped part movably passes through the proximal end of the regulating main body part; after the hook-shaped part hooks the artificial chordae tendineae, the proximal end of the hook-shaped part is fixedly connected to the proximal end of the regulating main body part.

9. The artificial chordae tendineae regulation device according to claim 8, wherein The proximal end of the regulating main body part and the proximal end of the hook-shaped part are fixedly connected through a locking structure.

10. The artificial chordae tendineae regulation device according to claim 9, characterized in that, The locking structure includes a cooperating anchor and a mating part; the anchor includes a plurality of anchor plates fixedly connected to the proximal end of the hook-shaped part and turned outwards; the mating part is sleeved outside the proximal end of the hook-shaped part, and the distal end of the mating part is fixedly connected to the proximal end of the regulating main body part; the mating part is provided with a plurality of clamping parts, and each anchor plate is cooperatively connected with one clamping part.

11. The artificial chordae tendineae regulation device according to claim 10, wherein, The plurality of anchor plates are arranged at intervals in the circumference of the proximal end of the hook-shaped part, and the plurality of clamping parts are arranged at intervals in the circumference of the mating part.

12. The artificial chordae tendineae regulation device according to claim 1, wherein, A reinforcing member is further provided between the proximal end of the regulating main body part and the proximal end of the hook-shaped part, and the reinforcing member is fixedly sleeved inside the proximal end of the regulating main body part.

13. The artificial chordae tendineae regulation device according to claim 2, characterized in that, The radial dimension range of the distal end of the regulating main body part is 2.5 mm - 5 mm, the radial dimension range of the proximal end of the regulating main body part is 2 mm - 3 mm, and the axial distance range between the proximal end and the distal end of the regulating main body part is 1.5 mm - 4 mm.

14. An artificial chordae tendineae regulation system, characterized in that, It includes: An adjustable bending sheath, a delivery device, and an artificial chordae tendineae regulating device according to any one of claims 1 - 13; The proximal end of the artificial chordae tendineae regulating device is detachably connected to the distal end of the delivery device, and both the artificial chordae tendineae regulating device and the delivery device are movably inserted into the adjustable bending sheath.

15. The artificial chordae tendineae regulation system according to claim 14, wherein The conveying device includes a first conveying member movably disposed within the adjustable bending sheath and a second conveying member movably disposed within the first conveying member; the distal end of the first conveying member is detachably connected to the proximal end of the regulating main body member of the artificial chordae tendineae regulating device; the distal end of the second conveying member is detachably connected to the proximal end of the hook-shaped member; The first conveying member is used to drive the regulating main body member to extend out of the distal end of the adjustable bending sheath, and the second conveying member is used to drive the hook-shaped member to axially move relative to the regulating main body member and hook the artificial chordae tendineae.

16. The artificial chordae tendineae regulation system according to claim 15, characterized in that, An intermediate tube is movably sleeved between the first conveying member and the second conveying member, and the intermediate tube is used to control the hook-shaped member to change from a state of being axially movable relative to the regulating main body member to a state of being fixedly connected to the regulating main body member.

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