Multi-directional adjustable mitral valve replacement valve support

Abstract

The invention relates to the technical field of medical instruments, in particular to a multidirectional adjustable mitral valve replacement valve stent which comprises an outer stent, an inner stent, an anchoring portion, an adjusting portion and a plurality of adjusting ropes, one end of each adjusting rope is connected with a stent body, the other end of each adjusting rope is connected with the anchoring portion, the anchoring portion is used for being fixed to the apex cordis, and the adjusting portion is connected with the anchoring portion. The adjusting part can be used for adjusting the length of at least one adjusting rope. The valve perivalvular leakage adjusting device has the advantages that local perivalvular leakage of a valve can be effectively and accurately adjusted, the position with the perivalvular leakage can be adjusted through the adjusting rope in the same direction in the operation, and the perivalvular leakage is thoroughly eliminated.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a multi-directional adjustable mitral valve replacement stent. Background Technology

[0002] With the increasing aging of the global population, the incidence of valvular heart disease is also rising year by year. Mitral valve disease, as one of the most common valvular heart diseases, has an ever-increasing demand for treatment.

[0003] Mitral regurgitation (Mitral Re1 type, "saddle-shaped" annulus, dynamic systolic annular area change >20%, adjacent to coronary arteries and conduction bundles) poses significant challenges to device design. The development of minimally invasive techniques such as transcatheter mitral valve replacement (TMVR) has provided new options for mitral valve replacement. While these minimally invasive procedures offer advantages such as less trauma and faster recovery, they still retain some significant drawbacks and challenges.

[0004] Currently, commonly used products in transcatheter mitral valve replacement (TMVR), such as Tendyne, use a cord at the apex of the heart for traction and fixation. However, Tendyne uses a single cord for fixation. When paravalvular leakage occurs during the procedure, only the single cord can be tightened, making it impossible to precisely adjust the direction of the leakage. This results in a larger implanted valve size and greater dilation of the original valve annulus, thus increasing the risk of outflow tract obstruction. Summary of the Invention

[0005] The purpose of this invention is to provide a multidirectional adjustable mitral valve replacement stent, which aims to solve the problems in the prior art and has the functions of completely eliminating paravalvular leakage, reducing the risk of outflow tract obstruction, and increasing the range of indications.

[0006] This invention is achieved through the following technical solution: A mitral valve replacement stent that can be multidirectionally adjustable by adjusting the length of different adjustment ropes includes a stent body, an anchoring part, an adjustment part, and multiple adjustment ropes; one end of the adjustment rope is connected to the stent body, and the other end is connected to the anchoring part; the anchoring part is used to fix it at the apex of the heart. The adjusting part is connected to the anchoring part, and the adjusting part can be used to adjust the length of at least one of the adjusting ropes.

[0007] Preferably, the adjustment part includes an adjustment chamber, a spring, and a locking member. The adjustment chamber has a through hole for the adjustment rope to extend into. The spring is disposed inside the adjustment chamber, and the side wall of the adjustment chamber has a groove. The locking member is adapted to the groove. The spring is used to push the locking member and compress the adjustment rope that extends between the locking member and the inner wall of the adjustment chamber.

[0008] Preferably, the sloping groove is configured such that the distance between the locking element and the inner wall of the adjusting chamber is less than the cross-sectional diameter of the adjusting rope.

[0009] Preferably, the anchoring part includes a core fixing member, which is connected to the adjustment chamber, and the adjustment rope passes through the adjustment chamber and is connected to the core fixing member.

[0010] Preferably, the apical fixation member is configured to be connected with a plurality of said adjustment chambers, each adjustment chamber corresponding to each adjustment rope.

[0011] Preferably, it also includes a bundle tube, which is connected to the regulating chamber and is used to gather multiple regulating ropes into the regulating chamber.

[0012] Preferably, the bundle tube is constructed as an integral part of the regulating chamber.

[0013] Preferably, the support body includes an outer support and an inner support that are adapted to each other, and both the outer support and the inner support are provided with connection holes for connecting to the adjustment rope.

[0014] Preferably, the outer support includes a first support layer, a second support layer, and a plurality of third support layers extending radially in sequence. One end of the first support layer is provided with a connecting hole, and the other end is connected to the second support layer. The third support layers are connected to the second support layer.

[0015] Preferably, the first support layer, the second support layer, and the third support layer are all internally constructed with inserts.

[0016] Preferably, the inner support is constructed as a multi-layered, wave-shaped support layer connected sequentially along the axial direction.

[0017] Preferably, both the inner and outer supports have connecting beams at their bottoms, and the connecting beams have connecting holes.

[0018] Compared with the prior art, the present invention has the following advantages and beneficial effects: The technical solution of this invention provides a multi-directional adjustable mitral valve replacement stent. By setting an adjustment part, the length of each adjustment rope can be individually adjusted, which can realize the deflection adjustment of the valve at multiple angles. This is beneficial for precise adjustment and control of paravalvular leakage, and can achieve better fit and anchorage with the lesion site. Attached Figure Description

[0019] The accompanying drawings, which are included to provide a further understanding of embodiments of the invention and form part of this application, do not constitute a limitation thereof. In the drawings: Figure 1 A schematic diagram of a multidirectional adjustable mitral valve replacement stent provided in an embodiment of the present invention; Figure 2A schematic diagram of another multidirectional adjustable mitral valve replacement stent provided in an embodiment of the present invention; Figure 3 This is a schematic diagram of the internal structure of the regulating chamber provided in an embodiment of the present invention; Figure 4 A schematic diagram (front view) showing the connection between the adjusting part and the anchoring part provided in an embodiment of the present invention. Figure 5 This is a schematic diagram illustrating the individual adjustment of the adjustment rope in a multi-directional adjustable mitral valve replacement stent provided in an embodiment of the present invention.

[0020] Figure 6 This is a schematic diagram of the structure of the external support provided in an embodiment of the present invention.

[0021] Figure 7 This is a schematic diagram of the internal support structure provided in an embodiment of the present invention; Figure 8 This is a schematic diagram illustrating the principle of the protrusion and groove of the locking component in an embodiment of the present invention.

[0022] The attached diagram shows the markings and corresponding component names: 100-Support body, 110-Outer support, 111-First support layer, 1111-First support unit, 112-Second support layer, 1121-Second support unit, 113-Third support layer, 120-Inner support, 200-Anchoring part, 210-Center tip fixing part, 300-Adjusting part, 310-Adjusting chamber, 311-Through hole, 312-Inclined groove, 313-Groove, 320-Spring, 330-Locking part, 331-Protrusion, 400-Adjusting rope, 500-Bulk tube, 600-Connecting hole, 700-Insertion part, 800-Connecting beam. Detailed Implementation

[0023] To make the objectives, technical solutions, and advantages of the present invention clearer, the present invention will be further described in detail below with reference to the embodiments and accompanying drawings. The illustrative embodiments and descriptions of the present invention are only used to explain the present invention and are not intended to limit the present invention.

[0024] In the following description, numerous specific details are set forth in order to provide a thorough understanding of the invention. However, it will be apparent to those skilled in the art that these specific details are not necessary to practice the invention. In other instances, well-known structures, circuits, materials, or methods have not been specifically described in order to avoid obscuring the invention.

[0025] Throughout this specification, references to "an embodiment," "an example," or "an example" mean that a particular feature, structure, or characteristic described in connection with that embodiment or example is included in at least one embodiment of the invention. Therefore, the phrases "an embodiment," "an example," "an example," or "an example" appearing in various places throughout the specification do not necessarily refer to the same embodiment or example. Furthermore, specific features, structures, or characteristics can be combined in one or more embodiments or examples in any suitable combination and / or sub-combination. Moreover, those skilled in the art will understand that the illustrations provided herein are for illustrative purposes and are not necessarily drawn to scale. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0026] In the description of this invention, the terms "front", "rear", "left", "right", "up", "down", "vertical", "horizontal", "high", "low", "inner", and "outer" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this invention and simplifying the description, and do not 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 limiting the scope of protection of this invention.

[0027] Example like Figure 1 As shown in the figure, an embodiment of the present invention provides a multidirectional adjustable mitral valve replacement stent, the stent body 100 including an outer stent 110 and an inner stent 120; as Figure 6 As shown, one end of the outer bracket 110 extends radially, and the other end extends axially and is provided with a connecting hole 600. Internal support 120, such as Figure 1 and Figure 2 As shown, the inner support 120 can be adapted to be connected to the center of the outer support 110, and the lower end of the inner support 120 is also provided with a connection hole 600. When the inner support 120 and the outer support 110 are connected together, the connection holes 600 of the two overlap. Anchoring part 200, such as Figure 1 and Figure 6 As shown, the anchoring part 200 includes an apical fixation member 210. The apical fixation member 210 is connected to the outer stent 110 and the inner stent 120 via an adjusting rope 400. The apical fixation member 210 is surgically fixed at the apex of the patient's heart. Then, the adjusting rope 400 is inserted into the patient's left ventricle and connected to the outer stent 110 and the inner stent 120.

[0028] The adjusting rope 400 can be made of a variety of materials, such as polymer materials, metal wire materials, biomaterials, and biodegradable materials.

[0029] Adjustment unit 300, such as Figure 3 and Figure 4 As shown, the adjustment unit 300 includes an adjustment chamber 310, a spring 320, and a locking member 330. The adjustment chamber 310 has a through hole 311 for the adjustment rope 400 to extend into. The through hole 311 is located at one end of the adjustment chamber 310 along the axial direction, and the other end of the adjustment chamber 310 is connected to the core fixing member 210. The spring 320 is disposed inside the adjustment chamber 310. As shown, one end of the spring 320 is connected to the inner wall of the adjustment chamber 310 with the through hole 311. In this embodiment, one end of the spring 320 is fixedly connected to the inner wall of the adjustment chamber 310, and the outer end of the spring 320 is... The diameter is slightly smaller than the inner wall diameter of the adjustment chamber 310, and the adjustment rope 400, which passes through the through hole 311, can also pass through the center of the spring 320; in addition, the side wall of the adjustment chamber 310 is constructed with inclined grooves 312. In this embodiment, two symmetrical inclined grooves 312 are constructed on the side wall of the adjustment chamber 310. The inclined grooves 312 are through grooves, and the locking member 330 is a pin. The pin is adapted to the inclined groove 312 and can slide in the inclined groove 312. Both ends of the pin slightly extend out of the inclined groove 312 and are outside the adjustment chamber 310, which facilitates the application of force to the pin during surgery; it should be noted that, Figure 6 As shown, the spring 320 is normally in a state close to its limit compression within the adjusting chamber 310. When the upper end of the spring 320 is at the lower end of the stroke of the inclined groove 312, the spring 320 is in a state of limit compression. When it is necessary to adjust the length of the adjusting rope 400, the pin is pressed and slids downward from the upper end of the stroke of the inclined groove 312 to compress the spring 320. The adjusting rope 400 located between the inner wall of the adjusting chamber 310 and the pin is loosened. After the adjustment is completed, the spring 320 returns to its original position, pushing the pin to slide in the inclined groove 312 to the upper end of the stroke of the inclined groove 312, so that the pin presses the adjusting rope 400 tightly to prevent the adjusting rope 400 from becoming loose.

[0030] It should be noted that a spring with a high elastic coefficient should be selected for spring 320 to provide sufficient clamping force to the adjusting rope 400.

[0031] It should be noted that in some other embodiments, in order to prevent the adjusting rope 400 from loosening, the inner wall of the adjusting chamber 310 may be constructed with some protrusions 331 to increase the friction force, thereby increasing the contact area between the adjusting rope 400 and the inner wall of the adjusting chamber 310, thereby increasing the friction force and achieving the effect of preventing loosening.

[0032] Furthermore, in some other embodiments, such as Figure 8As shown, in order to prevent the adjusting rope 400 from loosening, a protrusion 331 can be provided on the surface of the portion of the locking member 330 located inside the adjusting chamber 310. At the same time, a groove 313 adapted to the protrusion 331 is constructed on the inner wall of the adjusting chamber 310 at the position corresponding to the upper end of the stroke of the inclined groove 312, so that the adjusting rope 400 is embedded between the protrusion 331 and the groove 313, thereby achieving the anti-loosening effect.

[0033] Furthermore, in order to facilitate determining the specific location of the protrusion 331 during the operation, a mark can be set on the part of the locking member 330 that extends out of the inclined groove 312, so that the specific location of the protrusion 331 in the adjustment chamber 310 can be easily determined. Thus, by rotating the locking member 330, the protrusion 331 and the groove 313 can be quickly matched to tighten the adjustment rope 400.

[0034] It should be noted that the distance between the upper end edge of the inclined groove 312 and the inner wall of the adjusting chamber 310 is less than the cross-sectional diameter of the adjusting rope 400. When the locking member 330 is moved, the adjusting rope 400 can pass through the gap between the locking member 330 and the inner wall of the adjusting chamber 310, and then connect with the core fixing member 210.

[0035] Preferred, combined Figure 1 , Figure 3 and Figure 4 As shown, in this embodiment, the apical fixation member 210 is connected to three adjustment chambers 310. Correspondingly, three connection holes 600 are provided on the outer support 110 and the inner support 120. Each connection hole 600 and adjustment chamber 310 corresponds to an adjustment rope 400, so that the length of the three adjustment ropes 400 can be adjusted individually or adjusted multiple times to achieve a uniform change in the length of the three adjustment ropes 400.

[0036] Preferably, it also includes a bundle tube 500, such as Figure 2 As shown, the bundle tube 500 is a cylindrical tube with a diameter that is the same as the outer diameter of the adjustment chamber 310. The lower end of the bundle tube 500 is connected to the adjustment chamber 310. The bundle tube 500 can restrain multiple adjustment ropes 400. At the same time, the multiple adjustment ropes 400 that are bundled can be inserted into the adjustment chamber 310 simultaneously to achieve uniform length adjustment. In addition, the bundle tube 500 can reduce the volume occupied by the adjustment ropes 400 in the heart and reduce the risk of thrombosis.

[0037] Furthermore, the bundle tube 500 can be integrally formed with the adjustment chamber 310, and the structure of the adjustment chamber 310 can be integrated with the bundle tube 500. Then, a sloping groove 312 is constructed on the bottom outer wall of the bundle tube 500, and a locking member 330 is installed in the sloping groove 312. A spring 320 is installed on the inner wall of the bundle tube 500, and the bundle tube 500 can be directly connected to the apex fixing member 210.

[0038] like Figure 6 As shown, in this embodiment, the outer support 110 includes a first support layer 111, a second support layer 112, and three third support layers 113 (a total of three third support layers 113 in this embodiment). The upper end of the first support layer 111 is connected to the second support layer 112, and the lower end is constructed with three V-shaped connecting beams 800. Then, the connecting beams 800 are constructed with connecting holes 600, and the number of connecting holes 600 is three. The three third support layers 113 extend radially in sequence, and the lowermost third support layer 113 is connected to the second support layer 112.

[0039] Among them, such as Figure 6 As shown, the first support layer 111 includes several annularly arranged first support units 1111, which can uniformly transmit the load along multiple directions of the first support unit 1111, reducing the risk of local deformation; and an inserter 700 is constructed in the middle of the first support unit 1111. The inserter 700 is located here, which can ensure that the first support unit 1111 maintains good structural integrity when inserting into the valve.

[0040] Preferred, such as Figure 6 As shown, the second support layer 112 includes several second support units 1121 arranged in a ring and connected in sequence. The ring arrangement design enables the load to be uniformly transmitted along multiple directions of the second support unit 1121, reducing the risk of local deformation.

[0041] Preferably, the second support unit 1121 also has an insert 700. The insert 700 can bend outward from the inside of the second support unit 1121 and can be inserted into the original valve annulus when the valve stent reaches the lesion site, so as to achieve a better anchoring effect.

[0042] Preferred, such as Figure 6 As shown, the third support layer 113 is constructed as a ring-shaped wave-shaped support layer. During the beating of the atrium, the periodic structural design of the wave-shaped structure layer can effectively dissipate kinetic energy and ensure the structural stability of the external stent 110. The third support layer 113 is constructed with an insert 700. When the third support layer 113 is attached to the valve annulus, it inserts into the valve and achieves a good anchoring effect. The insert 700 is constructed at the "trough" position of the wave-shaped support layer and can bend out from the wave-shaped structure. At the same time, the structures on both sides of the insert 700 remain symmetrical to ensure that the insert 700 can stably perform the insertion function.

[0043] Preferred, such as Figure 7 As shown, the stent 120 is constructed as a multi-layered wave-shaped support layer connected sequentially along the axial direction. During the beating of the atrium, the wave-shaped periodic structure design can effectively dissipate kinetic energy and ensure the structural stability of the stent 120.

[0044] Preferably, the bottom of the inner support 120 has a connecting beam 800, the two ends of which are connected to the "trough" positions of the wave-shaped support layer and span several "wave"-shaped structures; the bottom of the connecting beam 800 has a connecting hole 600.

[0045] The above embodiments of the present invention focus on describing the differences between the various embodiments. As long as the different optimization features between the various embodiments are not contradictory, they can be combined to form a better embodiment. For the sake of brevity, they will not be described in detail here.

[0046] The specific embodiments described above further illustrate the purpose, technical solution, and beneficial effects of the present invention. It should be understood that the above description is only a specific embodiment of the present invention and is not intended to limit the scope of protection of the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. A multi-directional adjustable mitral valve replacement stent, characterized in that, include: The support body (100), anchoring part (200), adjusting part (300), and multiple adjusting ropes (400); One end of the adjusting rope (400) is connected to the support body (100), and the other end is connected to the anchoring part (200); The anchoring part (200) is used to fix it at the apex of the heart; The adjusting part (300) is connected to the anchoring part (200), and the adjusting part (300) can be used to adjust the length of at least one of the adjusting ropes (400).

2. The multidirectional adjustable mitral valve replacement stent according to claim 1, characterized in that, The adjustment part (300) includes an adjustment chamber (310), a spring (320), and a locking member (330). The adjustment chamber (310) is configured with a through hole (311) for the adjustment rope (400) to extend into. The spring (320) is disposed in the adjustment chamber (310), and the side wall of the adjustment chamber (310) is configured with a groove (312). The locking member (330) is adapted to the groove (312). The spring (320) is used to push the locking member (330) and compress the adjustment rope (400) that extends between the locking member (330) and the inner wall of the adjustment chamber (310).

3. The multidirectional adjustable mitral valve replacement stent according to claim 2, characterized in that, The sloping groove (312) is configured such that the distance between the locking member (330) and the inner wall of the adjusting chamber (310) is less than the cross-sectional diameter of the adjusting rope (400).

4. The multidirectional adjustable mitral valve replacement stent according to claim 2, characterized in that, The anchoring part (200) includes a apex fixing member (210), which is connected to the adjustment chamber (310), and the adjustment rope (400) passes through the adjustment chamber (310) and is connected to the apex fixing member (210).

5. The multidirectional adjustable mitral valve replacement stent according to claim 4, characterized in that, The apical fixation member (210) is configured to be connected with a plurality of the adjustment chambers (310), each adjustment chamber (310) corresponding to each adjustment rope (400).

6. The multidirectional adjustable mitral valve replacement stent according to claim 2, characterized in that, It also includes a bundle tube (500) connected to the regulating chamber (310) for gathering multiple regulating ropes (400) into the regulating chamber (310).

7. The multidirectional adjustable mitral valve replacement stent according to claim 6, characterized in that, The bundle tube (500) is constructed to be integrally formed with the regulating chamber (310).

8. The multidirectional adjustable mitral valve replacement stent according to claim 1, characterized in that, The support body (100) includes an outer support (110) and an inner support (120) that are adapted to each other, and both the outer support (110) and the inner support (120) are provided with a connection hole (600) for connecting to the adjustment rope (400).

9. The multidirectional adjustable mitral valve replacement stent according to claim 8, characterized in that, The outer support (110) includes a first support layer (111), a second support layer (112), and a plurality of third support layers (113) extending radially in sequence. One end of the first support layer (111) is provided with the connection hole (600), and the other end is connected to the second support layer (112). The third support layer (113) is connected to the second support layer (112).

10. The multidirectional adjustable mitral valve replacement stent according to claim 9, characterized in that, The first support layer (111), the second support layer (112), and the third support layer (113) are all equipped with inserts (700).

11. The multidirectional adjustable mitral valve replacement stent according to claim 8, characterized in that, The inner support (120) is constructed as a multi-layered wave-shaped support layer connected sequentially along the axial direction.

12. The multidirectional adjustable mitral valve replacement stent according to claim 8, characterized in that, Both the inner support (120) and the outer support (110) have connecting beams (800) at their bottoms, and the connecting beams (800) have connecting holes (600).

Images