Anti-dislodgement artificial chordae implant device and system

Abstract

The application provides an artificial chordae tendinae implant device and system. The implant device comprises a support assembly and a delivery assembly for delivering the support assembly. The support assembly comprises a support seat and a support head connected to the distal end of the support seat, and a leaflet accommodating space is formed between the support seat and the support head. The support seat comprises a support body, a first branch segment connected to the distal end of the support body, and a second branch segment connected to the distal end of the first branch segment. The support head comprises a support segment connected to the distal end of the second branch segment, and the distal end of the support segment extends towards the leaflet accommodating space in the direction of the second branch segment. The support body, the first branch segment, the second branch segment and the support segment jointly enclose the leaflet accommodating space. The support assembly has a contracted state and an expanded state. In the contracted state, the support assembly is accommodated in the delivery assembly. In the expanded state, the support assembly is unfolded, and the support assembly is used for supporting the leaflet.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to an anti-slip artificial tendon chordae implantation device and system. Background Technology

[0002] The mitral and tricuspid valves, among others, are one-way valves in the heart. Normal, healthy atrioventricular valves control the flow of blood from the atria to the ventricles, while preventing blood from flowing from the ventricles to the atria. For example, the mitral valve, located between the left atrium and left ventricle, controls the flow of blood from the left atrium to the left ventricle, while preventing blood from flowing from the left ventricle to the left atrium; the tricuspid valve, located between the right atrium and right ventricle, controls the flow of blood from the right atrium to the right ventricle, while preventing blood from flowing from the right ventricle to the right atrium.

[0003] The mitral valve consists of anterior and posterior leaflets, while the tricuspid valve consists of anterior, posterior, and septal leaflets. Normally, when the left or right ventricle contracts, the edges of any two adjacent leaflets of the mitral or tricuspid valve completely close, preventing blood from flowing from the ventricle to the atrium. If organic or functional changes occur in the leaflets or related structures, such as lesions or ruptures of the chordae tendineae, causing poor closure of adjacent leaflets of the mitral or tricuspid valve, the valve may not close completely when the left or right ventricle contracts. This leads to blood regurgitation from the ventricle to the atrium, causing a series of pathophysiological changes known as "mitral regurgitation" or "tricuspid regurgitation."

[0004] For mitral or tricuspid regurgitation caused by chordae tendineae lesions or ruptures, sutures can be implanted onto the valve leaflets as artificial chordae tendineae to provide tension and improve or treat the condition. Currently, most interventional devices for artificial chordae tendineae implantation first establish an extracorporeal-in vivo pathway via the transatrial septum or transapical approach, then clamp the prolapsed valve leaflets, and finally suture the sutures onto the leaflets to complete the implantation of the artificial chordae tendineae.

[0005] The prior art discloses a suturing device for implanting artificial tendineae for prolapsed leaflets, which includes an auxiliary device for assisting in clamping the leaflets. The auxiliary device specifically includes a rigid support head. Since the support head cannot be deformed, its size is limited by the inner diameter of the delivery device. The contact area between the support head and the leaflet is small, and the surface of the leaflet is very smooth, resulting in insufficient support force of the auxiliary device for the leaflet and easy slippage of the leaflet. Summary of the Invention

[0006] On one hand, this application provides an anti-slip artificial chordae tendineae implantation device, including a support component and a delivery component for delivering the support component. The support component includes a support seat and a support head connected to the distal end of the support seat, forming a leaflet receiving space between the support seat and the support head. The support seat includes a support body, a first branch segment connected to the distal end of the support body, and a second branch segment connected to the distal end of the first branch segment. The support head includes a support segment, the proximal end of which is connected to the distal end of the second branch segment, and the distal end of the support segment extends toward the leaflet receiving space from the second branch segment. The support body, the first branch segment, the second branch segment, and the support segment together enclose the leaflet receiving space. The support component has a contracted state and an expanded state; in the contracted state, the support component is housed within the delivery component; in the expanded state, the support component is deployed and used to support the leaflet.

[0007] On the other hand, this application provides an anti-slip artificial tendon chord implantation system, including an artificial tendon chord and the anti-slip artificial tendon chord implantation device as described above.

[0008] The anti-slip artificial chordae tendineae implantation device and system provided in this application includes a support component comprising a support base and a support head connected to the distal end of the support base. The support base includes a support body, a first branch segment connected to the distal end of the support body, and a second branch segment connected to the distal end of the first branch segment. The support head includes a support segment, the proximal end of which is connected to the distal end of the second branch segment, and the distal end of the support segment extends towards the leaflet receiving space from the second branch segment. Thus, the support body of the support base, the first and second branch segments, and the support segment of the support head together form a leaflet receiving space with a relatively large opening and space, facilitating leaflet entry. Furthermore, the support component has a contracted state and an expanded state. In the contracted state, the support component is housed within a delivery component for easy delivery; in the expanded state, the support component unfolds and supports the leaflet, increasing the support area for the leaflet and making it less prone to slippage. Attached Figure Description

[0009] To more clearly illustrate the technical solutions of the embodiments of this application, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are some embodiments of this application. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0010] Figure 1 This is a schematic diagram of the anti-slip artificial tendon chord implantation system provided in one embodiment of this application.

[0011] Figure 2 yes Figure 1A partial three-dimensional exploded view of the artificial tendon chord implantation system.

[0012] Figure 3 This is a three-dimensional structural diagram of the support component provided in an embodiment of this application in an expanded state.

[0013] Figure 4 yes Figure 3 A three-dimensional structural diagram of the supporting components in a contracted state.

[0014] Figure 5 yes Figure 4 A cross-sectional view of the supporting components housed within the outer sheath.

[0015] Figure 6 yes Figure 3 Side view of the supporting component.

[0016] Figure 7 yes Figure 3 Top view of the far end of the supporting component.

[0017] Figures 8 to 12 This is a schematic diagram illustrating the process of using the anti-slip artificial chordae tendineae implantation system provided in one embodiment of this application for transcatheter mitral valve chordae tendineae repair. Detailed Implementation

[0018] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of this application, and not all of them. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0019] Furthermore, the following descriptions of various embodiments are based on the accompanying illustrations and are used to illustrate specific embodiments that can be implemented in this application. Directional terms used in this application, such as "up," "down," "front," "back," "left," "right," "inner," "outer," and "side," are merely for reference to the accompanying illustrations. Therefore, the directional terms used are for better and clearer explanation and understanding of this application, and are not intended to indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this application.

[0020] It should be noted that, in order to more clearly describe the structure of the anti-slip artificial chordae tendineae implantation device and system provided in this application, the limiting terms "proximal" and "distal" used in the specification are conventional terms in the field of interventional medicine. Specifically, "distal" refers to the end away from the operator during the surgical procedure, and "proximal" refers to the end closer to the operator during the surgical procedure; the direction of the rotational axis of an object such as a cylinder or tube is defined as the axial direction; the circumferential direction is the direction around the axis of the object such as a cylinder or tube; and the radial direction is the direction along the diameter or radius.

[0021] It is worth noting that the term "end" appearing in terms such as "proximal end," "distal end," "one end," "the other end," "first end," "second end," "initial end," "end," "both ends," "head end," "upper end," and "lower end" is not limited to a head, end point, or end face, but also includes a portion extending axially and / or radially from the head, end point, or end face on the element to which the head, end point, or end face belongs. Unless otherwise defined, all technical and scientific terms used in this application have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The conventional terminology used in this application's specification is for the purpose of describing particular embodiments only and should not be construed as limiting this application.

[0022] Please see Figure 1 and Figure 2 This application provides an anti-slip artificial chordae tendineae implantation system 1, which includes an artificial chordae tendineae 2 and an anti-slip artificial chordae tendineae implantation device 3. The artificial chordae tendineae implantation device 3 is used to implant the artificial chordae tendineae 2 into the patient's body to replace the diseased or ruptured chordae tendineae in the patient's heart, thereby pulling the valve leaflets during ventricular systole to treat or reduce blood regurgitation (including but not limited to mitral regurgitation and tricuspid regurgitation).

[0023] Specifically, such as Figure 1 and Figure 2As shown, in this application, the artificial chordae tendineae implantation device 3 may include a support component 20, a delivery component 40, and a puncture component 60. The support component 20 includes a support seat 21 and a support head 23 connected to the distal end of the support seat 21. A leaflet receiving space 25 is formed between the support seat 21 and the support head 23. The support head 23 is used to support the leaflet entering the leaflet receiving space 25. The delivery component 40 includes an outer sheath 41, a middle sheath 43 movably inserted within the outer sheath 41, and an inner sheath 45 movably inserted within the middle sheath 43. The support component 20 is connected to the distal end of the inner sheath 45 via the proximal end of its support seat 21, thereby allowing the delivery component 20 to be delivered to the vicinity of the leaflet via the delivery component 40. The position of the support component 20 is adjusted via the inner sheath 45 to allow the leaflet to enter the leaflet receiving space 25. The puncture component 60 is movably inserted into the inner sheath 45. After the leaflet enters the leaflet receiving space 25, the distal end of the puncture component 60 can extend from the distal end of the inner sheath 45 to puncture the leaflet. The artificial chordae tendineae 2 is movably inserted into the puncture component 60. The distal end of the artificial chordae tendineae 2 can follow the puncture component 60 through the leaflet and detach from the puncture component 60 when the puncture component 60 is withdrawn, thereby implanting the distal end of the artificial chordae tendineae 2 onto the leaflet. The proximal end of the artificial chordae tendineae 2 can be fixed to the ventricular wall, papillary muscle, or apex of the heart to replace the natural chordae tendineae and maintain the tension between the leaflet and the ventricle or papillary muscle.

[0024] Please see Figure 3 In some embodiments, the support 21 includes a support body 211, a first branch segment 213 connected to the distal end of the support body 211, and a second branch segment 215 connected to the distal end of the first branch segment 213. The support head 23 includes a support section, the proximal end of which is connected to the distal end of the second branch segment 215, and the distal end of the support section extends toward the second branch segment 215 in a direction pointing toward the leaflet receiving space 25. Thus, the support body 211, the first branch segment 213, the second branch segment 215, and the support section together form the leaflet receiving space 25. It should be noted that, as Figure 3 As shown, the support 21 also has an axial inner cavity 217 that penetrates the opposite ends of the support body 211. The axial inner cavity 217 is connected to the leaflet receiving space 25 and the inner cavity of the inner sheath tube 45. The distal end of the puncture component 60 penetrates the leaflet receiving space 25 through the inner cavity of the inner sheath tube 45 and the axial inner cavity 217 of the support 21, thereby puncturing the leaflet in the leaflet receiving space 25.

[0025] Optionally, in Figure 3In the example, the first branch segment 213 is connected to the distal end of the support body 211 and located at one edge of the support body 211. The first branch segment 213 extends distally and in a direction away from the central axis of the support body 211. The second branch segment 215 extends approximately along the axial direction of the support body 211. The axial length of the first branch segment 213 (i.e., the length along the axial direction of the support body 211) is less than the axial length of the second branch segment 215 (i.e., the length along the axial direction of the support body 211). In this way, the support body 211, the first branch segment 213, the second branch segment 215, and the support segment can together form a leaflet accommodating space 25 with a relatively large opening and space, which is conducive to the entry of leaflets and can accommodate more leaflets. Of course, in other embodiments, the first branch segment 213 may not be located at the far edge of the supporting body 211, and / or the axial length of the first branch segment 213 may be greater than or equal to the axial length of the second branch segment 215. That is, the support 21 may be configured in other structural forms, and there are no limitations on this.

[0026] It is important to note that in this application, the supporting component 20 has both a contracted state and an expanded state. For details, please refer to [link / reference needed]. Figure 3 and Figure 4 In some embodiments, the support section of the support head 23 includes a pair of support portions 231, each support portion 231 being made of a shape memory material or an elastic material. The shape memory material includes, but is not limited to, stainless steel, nickel, titanium, or nickel-titanium alloys, while the elastic material includes, but is not limited to, rubber and silicone. The support portion 231 is preferably made of a shape memory metal material, which has high strength, thereby stably supporting the leaflet and allowing for smooth reception within the inner cavity of the outer sheath 41. Figure 4 As shown, when the outer side of at least one support portion 231 is compressed (e.g., by a manually applied compressive force), the pair of support portions 231 at least partially overlap, causing the support assembly 20 to be in a contracted state. Figure 3 As shown, when the outer side of any one of the support parts 231 is not under pressure, the pair of support parts 231 recover their deformation and unfold, so that the support assembly 20 is in an expanded state. The expanded support assembly 20 has a larger support area, which is beneficial for supporting the leaflets.

[0027] Please see Figure 5 In the contracted state, a pair of support portions 231 are retracted into the outer sheath 41 and maintain at least partial overlap under the compression of the outer sheath 41 wall. The support assembly 20 is housed within the outer sheath 41 of the delivery assembly 40, facilitating delivery to the vicinity of the valve leaflets within the patient's body. Figure 3As shown, in the extended state, after the pair of support portions 231 extend beyond the distal end of the outer sheath 41 under the push of the inner sheath 45, the squeezing effect of the outer sheath 41 wall on the pair of support portions 231 disappears, the support portions 231 recover their deformation, and the support assembly 20 unfolds to support the leaflets, increasing the support area for the leaflets and making it less likely for the leaflets to slip out, thereby facilitating the puncture assembly 60 to puncture the leaflets.

[0028] It is understood that, in order to facilitate the smooth insertion of the support assembly 20 into the outer sheath tube 41 and to reduce the diameter of the outer sheath tube 41, the size of the support seat 21 should not be too large. The axial length of the support seat 21 is in the range of 6 mm to 8 mm, and the maximum radial width of the support seat 21 is in the range of 4 mm to 6 mm.

[0029] Please see Figure 3 and Figure 6 In some embodiments, the supporting body 211 specifically includes a frustum 2112 and a guide segment 2114. The opposite ends of the guide segment 2114 are respectively connected to the distal end of the frustum 2112 and the proximal end of the first branch segment 213, the first branch segment 213 being connected to the distal edge of the guide segment 2114. Preferably, as shown... Figure 3 and Figure 6 As shown, the guide slide 2114 has an inclined structure, and the extension direction of the guide slide 2114 forms an angle α with the axial direction of the frustum 2112. That is, the surface of the guide slide 2114 facing the leaflet receiving space 25 is an inclined plane (not shown in the figure), and the axial inner cavity 217 through which the puncture assembly 60 passes passes through the inclined plane of the guide slide 2114. The surface of the first branch segment 213 facing the leaflet receiving space 25 is a first curved surface S1, and the surface of the second branch segment 215 facing the leaflet receiving space 25 is a second curved surface S2. The first curved surface S1 is smoothly connected between the inclined plane and the second curved surface S2. The inclined plane, the first curved surface S1, and the second curved surface S2 together form a slot, which connects the leaflet receiving space 25. Optionally, the depth of the slot ranges from 1 mm to 1.5 mm, the width of the slot (the dimension along the radial direction of the frustum 2112) ranges from 2.5 mm to 4 mm, and the length of the slot (the dimension along the axial direction of the frustum 2112) ranges from 2 mm to 3.5 mm.

[0030] Understandably, by providing a slot in the support 21 that connects to the leaflet receiving space 25, and by appropriately setting the size of the slot, when the leaflet enters the leaflet receiving space 25, the end of the leaflet can further enter the slot through the leaflet receiving space 25, allowing more leaflets to enter the support assembly 20. This prevents the leaflets from slipping out of the support assembly 20, which is beneficial for the puncture assembly 60 to perform puncture. Furthermore, the slot has an inclined plane facing the leaflet receiving space 25 and penetrated by the axial inner cavity 217. Compared to a horizontal plane, this inclined plane can provide greater resistance to the pulsating leaflets, which helps prevent the leaflets from slipping out of the leaflet receiving space 25, thereby improving puncture efficiency.

[0031] It should be noted that if the angle α between the inclined plane and the axial direction of the frustum 2112 (i.e., the axis of the support body 211) is too small, meaning the slope of the inclined plane is too large, the depth of the slot will increase and the width will decrease accordingly due to the limited size range of the support component 20. This may result in a very small area of ​​the leaflet falling into the support component 20. Conversely, if the angle α between the inclined plane and the axial direction of the frustum 2112 is too large, meaning the slope of the inclined plane is too small, the pulsating leaflet may slip out of the support component 20. Therefore, preferably, in some embodiments, the angle α between the inclined plane and the axial direction of the frustum 2112 is in the range of 25 degrees to 45 degrees.

[0032] More preferably, in some embodiments, the radius of curvature of the first curved surface S1 ranges from 3 mm to 9 mm. By setting the curved surface of the first branch segment 213 facing the leaflet receiving space 25 within a reasonable radius of curvature, it is beneficial to control the leaflet portion entering the slot within the support component 20 and prevent the leaflet from slipping out.

[0033] Furthermore, preferably, in some embodiments, the radius of curvature of the second curved surface ranges from 6 mm to 9 mm. By setting the curved surface of the second branch segment 215 facing the leaflet receiving space 25 within a reasonable radius of curvature, the support force on the leaflet can be improved, preventing the leaflet from slipping off, without increasing the overall width of the support assembly 20, which would affect its passability and bending ability.

[0034] like Figure 3As shown, in some embodiments, the diameter of the frustum 2112 is smaller than the radial dimension of the guide section 2114. Preferably, the radial dimension of the guide section 2114 gradually decreases from the distal end to the proximal end, and the junction of the guide section 2114 and the frustum 2112 is chamfered or rounded, forming a chamfered surface on the outer side of the guide section 2114. Thus, during the process of gradually retracting the support assembly 20 into the outer sheath 41, the support seat 21 slides against the distal end of the outer sheath 41 through the chamfered surface of the outer side of the guide section 2114, thereby gradually retracting into the outer sheath 41. That is, the chamfered guide section 2114 can serve a guiding function. It is understood that... Figure 3 In the example, the first branch segment 213 extends obliquely towards the distal end and away from the central axis of the supporting body 211. During the process of gradually retracting the supporting component 20 in the retracted state into the outer sheath tube 41, the obliquely extended first branch segment 213 can also play a guiding role, which will not be elaborated further.

[0035] Please refer to it again. Figure 3 and Figure 6 Optionally, in some embodiments, at least one of the first branch segment 213, the second branch segment 215, and the guide segment 2114 has a surface facing the leaflet receiving space 25 that is rounded at the edge to avoid snagging on the natural chordae tendineae or damaging the leaflets entering the leaflet receiving space 25. The rounding method includes, but is not limited to, chamfering or rounding.

[0036] like Figure 3 and Figure 6 As shown, in some embodiments, the support body 211 of the support 21 further includes a connecting tube 2116 connected to the proximal end of the frustum 2112, and the support 21 is connected to the inner sheath tube 45 through the connecting tube 2116. The inner cavity of the connecting tube 2116 communicates with the inner cavity of the inner sheath tube 45 and the axial inner cavity 217 of the support 21, so that the puncture assembly 60 can pass through.

[0037] Specifically, please refer to Figure 2 and Figure 5 In some embodiments, the connecting tube 2116 is coaxially arranged with the inner sheath tube 45 and fixedly connected by means of bonding, welding, or fusion. Optionally, the proximal end of the connecting tube 2116 can be partially inserted into the distal end of the inner sheath tube 45, or partially sleeved on the outside of the distal end of the inner sheath tube 45. Preferably, the proximal end of the connecting tube 2116 is inserted into the distal end of the inner sheath tube 45 to reduce the diameter of the connecting tube 2116. The connection depth between the connecting tube 2116 and the inner sheath tube 45 is between 4 mm and 6 mm, thereby ensuring that the support 21 and the inner sheath tube 45 have sufficient connection strength and stability, while not affecting the bending performance of the distal end of the inner sheath tube 45.

[0038] Preferably, in some embodiments, the outer diameter of the connecting pipe 2116 is smaller than the diameter of the frustum 2112, so that a step is formed at the connection between the connecting pipe 2116 and the frustum 2112. When the support 21 is connected to the inner sheath 45 through the connecting pipe 2116, the distal end of the inner sheath 45 abuts against the step, thereby playing a limiting role.

[0039] To ensure implantation safety, the support 21 can be made of biocompatible metal or polymer materials. Metal materials include, but are not limited to, nickel, titanium, nickel-titanium alloy, cobalt-chromium alloy or stainless steel. Polymer materials include, but are not limited to, one or more of PE (polyethylene), PET (polyethylene terephthalate), PTFE (polytetrafluoroethylene), PC (polycarbonate), preferably made of stainless steel with high hardness.

[0040] Please refer to it again. Figure 3 and Figure 7 In this application, at least one proximal end of a pair of support portions 231 is connected to a second branch segment 215 so that the support head 23 is connected to the support base 21, and the distal ends of the pair of support portions 231 extend symmetrically in different directions about the axis of the support body 211, so that the unfolded support head 23 has a large support area and a stable shape.

[0041] Specifically, Figure 3 and Figure 7 In the example, each support portion 231 is made of filaments by bending and heat setting. Each support portion 231 includes a first filament 2311 at a proximal end, a second filament 2312 at a distal end, and a third filament 2313 connecting the first filament 2311 and the second filament 2312.

[0042] Among them, such as Figure 3 and Figure 7 As shown, in some embodiments, both the first filament 2311 and the third filament 2313 are straight-extending filaments. The extension direction of the first filament 2311 is approximately parallel to the extension direction of the second branch segment 215, that is, the first filament 2311 extends approximately along the axial direction of the support body 211 of the support seat 21. The angle between the extension direction of the third filament 2313 and the extension direction of the first filament 2311 ranges from 110 degrees to 135 degrees, that is, the third filament 2313 is substantially parallel to the inclined plane of the guide slide segment 2114. This arrangement allows the support head 23 to better support the leaflets without slipping. Figure 7As shown, the second filament 2312 includes a first segment 2312a at its distal end and a second segment 2312b at its proximal end. The first segment 2312a is connected to the third filament 2313 and extends in a direction generally perpendicular to the third filament 2313. The second segment 2312b is connected to the end of the first segment 2312a away from the third filament 2313 and extends in a direction generally parallel to the third filament 2313. The second segments 2312b of the two second filaments 2312 corresponding to a pair of support portions 231 are opposite each other and located inside the support head 23.

[0043] Optionally, in some embodiments, the ends of the second sections 2312b of the second filaments 2312 of each pair of support portions 231 that are away from the third filament 2313 are connected together, in which case the pair of support portions 231 can be integrally made of the same filament; of course, the pair of support portions 231 can also be made of different filaments and then connected. In other embodiments, the ends of the second sections 2312b of the second filaments 2312 of each pair of support portions 231 that are away from the third filament 2313 can be relatively close but not connected integrally, that is, the pair of support portions 231 are made separately by different filaments, and the ends of the second sections 2312b of the second filaments 2312 of each support portion 231 that are away from the third filament 2313 can be connected to or not connected to the distal end of the second branch segment 215. In order to improve the structural strength of the support head 23 so that the support head 23 can stably support the leaflets, the pair of support portions 231 are preferably integrally made of the same filament.

[0044] Each support portion 231 can be made of metal wire or polymer wire with shape memory function or elasticity, preferably made of metal wire such as nickel, titanium, or nickel-titanium alloy. Furthermore, each support portion 231 can be made of a single strand of wire or multiple strands of wire wound together, and there is no limitation on this.

[0045] Optionally, Figure 3 and Figure 7 In the example, among the two first filaments 2311 corresponding to a pair of support portions 231, at least one of the proximal ends of the first filament 2311 is connected to the distal end of the second branch segment 215. Preferably, the proximal ends of both first filaments 2311 are connected to the distal ends of the second branch segment 215, which helps to improve the connection strength between the support head 23 and the support seat 21, thereby improving the support force of the support assembly 20 on the leaflets.

[0046] Optionally, Figure 3 and Figure 7In the example, among the two second filaments 2312 corresponding to a pair of support portions 231, at least one of the inner sides (i.e., the second segment 2312b) of the second filament 2312 is curved. Preferably, both second segments 2312b of the two second filaments 2312 are curved and symmetrical about the axis of the support body 211. By making the second segment 2312b of at least one second filament 2312 curved, the contact area between the support head 23 and the leaflet can be increased, which can play a role in preventing slippage and thus prevent the leaflet from slipping out of the support head 23 when puncturing the leaflet.

[0047] The curved structure of the second segment 2312b includes, but is not limited to, one or more S-shaped, C-shaped, V-shaped, or W-shaped curved structures formed by bending and concave. It should be noted that... Figure 3 and Figure 7 In the example, each second segment 2312b of the second filament 2312 is concave to form at least one S-shaped curve structure. It is understood that the more concave curve structures formed by the second segment 2312b, the better the anti-slip effect of the support head 23. However, the number of curve structures depends on the size of the filament used in the support part 231. Smaller filaments can be bent into more curve structures, but the support force of the support part 231 is relatively smaller. Taking all factors into consideration, the support part 231 is preferably made of nickel-titanium wire with a diameter of 0.65 mm, and the number of concave curve structures formed by the second segment 2312b is two.

[0048] To improve the anti-slip effect of the support head 23, the support section may also be provided with at least one anti-slip structure 235. The anti-slip structure 235 is formed by bending and concave folds in at least one support portion 231 and / or by increasing surface roughness and / or coating. The anti-slip structure 235 formed by bending and concave folds in the support portion 231 includes the curved structure on the aforementioned second section 2312b. Alternatively, at least one curved structure can be formed by bending and concave folds in one or more of the first section 2312a, the first filament 2311, and the third filament 2313 of the second filament 2311, thereby constituting at least one anti-slip structure 235. By increasing the surface roughness of any filament of at least one support portion 231 (e.g., adding grooves, protrusions, barbs), and / or by coating any filament of at least one support portion 231, the roughness of the support head 23 can be increased to improve friction, thereby enhancing the anti-slip effect.

[0049] Furthermore, Figure 3 and Figure 7In the example, after at least one second segment 2312b of the second filament 2312 is bent and concave into a curved structure, the second segment 2312b of the second filament 2312 forms at least one through hole 237. The position of the through hole 237 corresponds to the axial inner cavity 217 of the support 21 and extends to the inner cavity of the conveying assembly 40. That is, the through hole 237 connects to the axial inner cavity 217 of the support 21 and the inner cavity of the inner sheath 45. Specifically, in some embodiments, the end of the second segment 2312b of each second filament 2312 away from the third filament 2313 is bent and concave to form a C-shaped curved unit. The two C-shaped curved units corresponding to the second segments 2312b of the two second filaments 2312 face each other and surround to form a non-closed ring structure. The middle of the ring structure forms a through hole 237 corresponding to the axial inner cavity 217. Preferably, the through hole 237 is coaxially arranged with the axial inner cavity 217 and the inner cavity of the inner sheath tube 45. This ensures the concentricity of the puncture assembly 60 during puncture, prevents the puncture assembly 60 from swinging in a relatively large circumferential direction when puncturing the leaflet, and prevents the leaflet from slipping off the puncture assembly 60, which helps to improve the puncture success rate.

[0050] Please refer to it again. Figure 1 and Figure 2 In this application, the outer sheath 41, the middle sheath 43, and the inner sheath 45 are all hollow tubes of a certain length, and are sequentially nested together from the outside to the inside. The outer sheath 41 is used to construct the pathway from outside to inside the body, and the inner sheath 45 is used to connect the support 21 and accommodate the puncture assembly 60. Since the outer sheath 41 and the middle sheath 43 are typically used in conjunction with a guidewire to establish a channel from outside to inside the body, they are at least adjustable in their distal portions and can be pre-shaped to have a specific shape to meet specific interventional pathways. It should be noted that the outer sheath 41, the middle sheath 43, and the inner sheath 45 are typically multi-layered tubes, comprising, from the inside out, an inner membrane made of a polymer material such as PTFE, a middle layer of braided mesh made of a metal material such as nickel-titanium or stainless steel, and an outer membrane made of an elastomer material such as Pebax. The outer sheath 41, the middle sheath 43, and the inner sheath 45 can be sheaths as used in the prior art, which will not be elaborated upon here.

[0051] like Figure 1 and Figure 2 As shown, in this application, the puncture assembly 60 may include a puncture needle 61 and a push tube 63 movably inserted into the puncture needle 61. The puncture assembly 60 extends from the distal end of the inner sheath 45 and punctures the leaflet.

[0052] The puncture needle 61 is movably housed within the inner sheath 45 and is used to puncture the leaflets supported by the support assembly 20. The puncture needle 61 is a hollow tube with a sharp needle tip at its distal end. Understandably, if the needle tip angle is too small, its strength will be lower, and it may break when facing relatively tough or thick leaflets; conversely, if the needle tip angle is too large, the sharpness will be insufficient, increasing the puncture force required to puncture the leaflets and making it difficult to penetrate. Therefore, the needle tip angle of the puncture needle 61 is in the range of 25 degrees to 45 degrees, preferably 30 degrees.

[0053] Optionally, in some embodiments, the artificial tendon chord 2 is movably inserted into the inner cavity of the push tube 63 and, together with the push tube 63, is movably inserted into the inner cavity of the puncture needle tube 61. The distal end of the artificial tendon chord 2 extends from the distal end of the push tube 63 and can be movably connected to the distal end of the push tube 63 by means of interference fit, friction connection, knotting, or connecting washer 80. It should be noted that the minimum size of the knotted coil formed by the distal end of the artificial tendon chord 2 or the washer 80 connected to its distal end is larger than the inner diameter of the push tube 63. Thus, the artificial tendon chord 2 is movably inserted into the push tube 63, and its distal coil or washer 80 is housed in the distal inner cavity of the puncture needle tube 61. When the push tube 63 moves axially distally within the puncture needle tube 61, the distal end of the push tube 63 can push the suture coil or the pad 80 to move the artificial tendon chord 2 distally. However, when the push tube 63 retracts proximally with the puncture needle tube 61, it will not retract the artificial tendon chord 2, so that the artificial tendon chord 2 is implanted on the leaflet.

[0054] Preferably, such as Figure 1 and Figure 2 As shown, in some embodiments, a spacer 80 is connected to the distal end of the artificial chord 2. The spacer 80 is used to anchor to the leaflet, thereby dispersing the tension of the artificial chord 2 on the leaflet and preventing leaflet tearing. For example, Figure 1 As shown, there is an axial distance (e.g., 3 mm) between the gasket 80 and the tip of the puncture needle 61 to prevent the gasket 80 from protruding from the tip of the puncture needle 61 and obstructing the puncture needle 61 from puncturing the leaflet. The artificial tendon chord 2 can be connected to the gasket 80 by bonding or knotting, or a through hole can be provided in the gasket 80 for the artificial tendon chord 2 to pass through. The shape of the gasket 80 can be any reasonable shape, such as square, round, or elliptical, and is not limited thereto.

[0055] Optionally, in some embodiments, the minimum size of the shim 80 can be larger than the inner diameter of the puncture needle tube 61. The shim 80 is compressed and accommodated within the puncture needle tube 61, resulting in compressive contact and frictional connection between the shim 80 and the inner wall of the puncture needle tube 61. This helps to prevent axial slippage of the shim 80 within the puncture needle tube 61. However, after a certain pushing force is applied by the push tube 63, the shim 80 can be pushed out of the puncture needle tube 61. Of course, in other embodiments, the maximum size of the shim 80 can be smaller than the inner diameter of the puncture needle tube 61. The shim 80 is movably disposed within the inner cavity of the puncture needle tube 61. In this embodiment, the shim 80 can also be pushed out of the inner cavity of the puncture needle tube 61 by the push tube 63 and drive the artificial tendon chord 2 into the leaflet.

[0056] Among them, the puncture needle 61, the push tube 63 and the pad 80 are preferably made of medical metal materials such as nickel-titanium alloy.

[0057] The artificial tendon chord 2, as the implant, is flexible and can be bent arbitrarily without axial stretching. To ensure implantation safety, the artificial tendon chord 2 can be made of a biocompatible polymer material, preferably PTFE (polytetrafluoroethylene), e-PTFE (expanded polytetrafluoroethylene), PET (polyethylene terephthalate), or UHMWPE (ultra-high molecular weight polyethylene), but there are no restrictions on the specific materials used.

[0058] The following will combine Figure 5 , Figures 8 to 12 Taking transcatheter mitral valve chordae tendineae repair as an example, the usage process and working principle of the artificial chordae tendineae implantation system 1 of this application are explained. The surgical path is as follows: via femoral vein - aortic arch - aortic valve (AV) - left ventricle (LV) - mitral valve (MV) annulus - left atrium (LA).

[0059] First step, such as Figure 5 As shown, the components of the artificial tendon chord implantation system 1 are assembled. Specifically, the artificial tendon chord 2 and its connected pad 80 are completely inside the cavity of the puncture needle 61. The push tube 63 is movably sleeved between the artificial tendon chord 2 and the puncture needle 61, while the puncture needle 61 is completely inside the cavity of the inner sheath 45. The inner sheath 45 is movably inserted into the cavity of the middle sheath 43. The support component 20 in its contracted state is connected to the distal end of the inner sheath 45, and the opening direction of the leaflet receiving space 25 of the support component 20 is opposite to the bending direction of the middle sheath 43. At this time, the artificial tendon chord implantation system 1 is in its initial state.

[0060] The second step, as Figure 8As shown, under ultrasound / CT guidance, the femoral artery is punctured, and guided by a guidewire (not shown in the figure), the outer sheath 41 passes through the aortic arch to reach the position of the aortic valve near the left ventricle. The curvature of the distal end of the outer sheath 41 is adjusted so that the distal end of the outer sheath 41 is kept in the same plane as the cross-section of the valve leaflet. At this point, a channel from outside the body to inside the body is established through the outer sheath 41. Then, the middle sheath 43 (with the inner sheath 45 and support component 20 inserted) is inserted into the outer sheath 41, and gradually... Adjusting the angle of the distal end of the middle sheath 43 so that it extends from the distal end of the outer sheath 41 while bending the inner sheath 45 and the support component 20, causes the support component 20, which was originally in a contracted state, to unfold. Under real-time ultrasound / CT guidance, by bending the distal part of the middle sheath 43 to about 180°, the distal end of the middle sheath 43 is positioned below the mitral valve orifice. Pushing the inner sheath 45 causes the inner sheath 45 to carry the support component 20 into the left atrium, that is, above the valve orifice, close to the prolapsed valve leaflet.

[0061] The third step, as Figure 9 As shown, under ultrasound / CT guidance, while slightly controlling the bending of the middle sheath 43, the inner sheath 45 and the middle sheath 43 are slowly retracted, so that the support component 20 can grasp the mitral valve leaflet that has prolapsed and floated upward into the leaflet receiving space 25. At this time, through the cooperation between the support seat 21 and the support head 23, the prolapsed leaflet is controlled within the leaflet receiving space 25 of the support component 20.

[0062] Step four, as Figure 10 As shown, keeping the relative position of the support assembly 20 and the prolapsed leaflet unchanged, the puncture needle 61, housed inside the support assembly 20, is pushed out to puncture the leaflet. During this process, the expanded support head 23 can support the leaflet over a larger area, making it less likely for the leaflet to slip out.

[0063] Step 5, as Figure 11 As shown, after puncturing the leaflet, the push tube 63 inside the puncture needle 61 is gradually pushed distally until the push tube 63 completely pushes the pad 80 and the artificial tendon chord 2 connected to the pad 80 out of the puncture needle 61. At this time, the pad 80 and the artificial tendon chord 2 are implanted on the leaflet. Then, the push tube 63 is withdrawn into the puncture needle 61 and the puncture needle 61 is withdrawn into the support component 20. Then, the inner sheath 45 and the middle sheath 43 are withdrawn at the same time, and the bending shape of the middle sheath 43 is released until all components are withdrawn from the patient's body, and the pad 80 and the artificial tendon chord 2 remain in the patient's body.

[0064] Step 6, as follows Figure 12As shown, under ultrasound / CT guidance, the length of the artificial chordae tendineae 2 is adjusted according to the real-time degree of reflux. Excess artificial chordae tendineae 2 is trimmed, and the free end of the artificial chordae tendineae 2 is fixed to the posterior papillary muscle, ventricular wall, or apex of the heart by means of anchors, knotters, or manual knotting, thereby realizing the implantation of artificial chordae tendineae 2.

[0065] It is understood that the artificial chordae tendineae implantation system 1 of this application can also be applied to the following scenarios, for example, transcatheter interventional implantation of artificial chordae tendineae for mitral valve via the route of jugular vein-superior vena cava-right atrium-atrial septum-left atrium-mitral valve, and transatrial interventional implantation of artificial chordae tendineae for mitral valve via the route of left atrium-mitral valve. Other examples include transcatheter interventional implantation of artificial chordae tendineae for tricuspid valve via the route of femoral vein-inferior vena cava-right atrium-tricuspid valve, transcatheter interventional implantation of artificial chordae tendineae for tricuspid valve via the route of jugular vein-superior vena cava-right atrium-tricuspid valve, and transatrial interventional implantation of artificial chordae tendineae for tricuspid valve via the route of right atrium-tricuspid valve. Further details are omitted here.

[0066] In summary, the anti-slip artificial chordae tendineae implantation device 3 and implantation system 1 of this application can be used to implant artificial chordae tendineae 2 into the patient's body to replace the chordae tendineae that are diseased or broken in the patient's heart, thereby pulling the valve leaflets during ventricular systole to treat or alleviate valvular diseases such as mitral regurgitation and tricuspid regurgitation.

[0067] In the description of this specification, the references to terms such as "some embodiments," "illustrative embodiments," "examples," "specific examples," or "some examples," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of this application. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples.

[0068] Although embodiments of this application have been shown and described, those skilled in the art will understand that various changes, modifications, substitutions and variations can be made to these embodiments without departing from the principles and spirit of this application, the scope of which is defined by the claims and their equivalents.

Claims

1. A non-slip artificial tendon chord implantation device, characterized in that, include: A support assembly includes a support base and a support head connected to the distal end of the support base, wherein a leaflet receiving space is formed between the support base and the support head; A conveying assembly for conveying the supporting assembly; And puncture components for puncturing valve leaflets; in, The support includes a support body, a first branch segment connected to the distal end of the support body, and a second branch segment connected to the distal end of the first branch segment. The support head includes a support segment, the proximal end of which is connected to the distal end of the second branch segment, and the distal end of the support segment extends toward the second branch segment in the direction of the leaflet receiving space. When the puncture assembly punctures the leaflet, the supporting body and the supporting segment are located on the upper and lower sides of the leaflet, respectively, and the supporting body, the first branch segment, the second branch segment and the supporting segment together form the leaflet accommodating space. The support assembly has a retracted state and an expanded state; in the retracted state, the support assembly is housed within the conveying assembly; in the expanded state, the support assembly is deployed and used to support the leaflets. When the puncture assembly punctures the leaflet, the puncture assembly can penetrate the support section axially.

2. The anti-slip artificial tendon chord implantation device as described in claim 1, characterized in that, The axial length of the support ranges from 6 mm to 8 mm, and the maximum radial width of the support ranges from 4 mm to 6 mm.

3. The anti-slip artificial tendon chord implantation device as described in claim 1, characterized in that, The supporting body includes a frustum and a guide slide. The two ends of the guide slide are respectively connected to the far end of the frustum and the proximal end of the first branch segment. The extension direction of the guide slide has an angle with the axial direction of the frustum.

4. The anti-slip artificial tendon chord implantation device as described in claim 3, characterized in that, The surface of the guide section facing the leaflet receiving space is an inclined plane, the surface of the first branch section facing the leaflet receiving space is a first curved surface, and the surface of the second branch section facing the leaflet receiving space is a second curved surface. The first curved surface smoothly connects the inclined plane and the second curved surface, and the first curved surface, the inclined plane, and the second curved surface together form a slot.

5. The anti-slip artificial tendon chord implantation device as described in claim 4, characterized in that, The depth of the groove ranges from 1 mm to 1.5 mm; the width of the groove ranges from 2.5 mm to 4 mm; and the length of the groove ranges from 2 mm to 3.5 mm.

6. The anti-slip artificial tendon chord implantation device as described in claim 4, characterized in that, The angle between the inclined plane and the axis of the supporting body ranges from 25 degrees to 45 degrees; the radius of curvature of the second curved surface ranges from 6 mm to 9 mm; and the radius of curvature of the first curved surface ranges from 3 mm to 9 mm.

7. The anti-slip artificial tendon chord implantation device as described in claim 1, characterized in that, The first branch segment extends obliquely towards the distal end and away from the central axis of the support body, and the second branch segment extends along the axial direction of the support body. The axial length of the first branch segment is less than the axial length of the second branch segment.

8. The anti-slip artificial tendon chord implantation device as described in claim 1, characterized in that, The support segment includes a pair of support portions, at least one proximal end of the pair of support portions being connected to a second branch segment, and the distal ends of the pair of support portions extending symmetrically in different directions about the axis of the support body.

9. The anti-slip artificial tendon chord implantation device as described in claim 8, characterized in that, Each of the aforementioned support portions includes a first filament at a proximal end, a second filament at a distal end, and a third filament connecting the first and second filaments, wherein, At least one proximal end of the first filament is connected to the distal end of the second branch segment, and the extension direction of the first filament is parallel to the extension direction of the second branch segment. At least one of the inner sides of the second filament is a curved structure, and at least one of the inner sides forms at least one through hole, the through hole extending into the inner cavity of the conveying assembly; The angle between the extension direction of the third filament and the extension direction of the first filament is between 110 degrees and 135 degrees.

10. The anti-slip artificial tendon chord implantation device as described in claim 9, characterized in that, The distal end of each of the second filaments extends in a direction perpendicular to its corresponding third filament.

11. The anti-slip artificial tendon chord implantation device as described in claim 10, characterized in that, Each of the second filaments has a curved inner side, and the curved structures of the pair of support portions are symmetrical about the axis of the support body.

12. The anti-slip artificial tendon chord implantation device as described in claim 11, characterized in that, Each of the second filaments has an inner concave side that forms at least one S-shaped curve structure.

13. The anti-slip artificial tendon chord implantation device as described in claim 9, characterized in that, When the outer sides of the pair of support portions are compressed, the inner sides of the second filaments of the support portions at least partially overlap.

14. The anti-slip artificial tendon chord implantation device as described in claim 9, characterized in that, The support portion is made of shape memory material or elastic material.

15. The anti-slip artificial tendon chord implantation device as described in claim 8, characterized in that, The supporting section is provided with at least one anti-slip structure, which is formed by bending and folding the supporting part and / or by increasing the surface roughness and / or coating.

16. The anti-slip artificial tendon chord implantation device as described in claim 1, characterized in that, The delivery assembly includes an outer sheath, a middle sheath that is movably inserted within the outer sheath, and an inner sheath that is movably inserted within the middle sheath, wherein the support assembly is connected to the distal end of the inner sheath.

17. The anti-slip artificial tendon chord implantation device as described in claim 16, characterized in that, The puncture assembly is movably inserted into the inner sheath.

18. The anti-slip artificial tendon chord implantation device as described in claim 17, characterized in that, The puncture assembly includes a puncture needle and a push tube that is movably inserted inside the puncture needle. The puncture assembly extends from the distal end of the inner sheath and punctures the leaflet.

19. A non-slip artificial tendon chord implantation system, characterized in that, The device includes an artificial tendon chord and an anti-slip artificial tendon chord implantation device as described in any one of claims 1 to 18, wherein the artificial tendon chord is movably inserted in the puncture assembly, and the distal end of the artificial tendon chord follows the puncture assembly through the leaflet and disengages from the puncture assembly when the puncture assembly is withdrawn.

20. The anti-slip artificial tendon chord implantation system as described in claim 19, characterized in that, The distal end of the artificial tendon is connected to a pad, which is movably housed within the puncture assembly.

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