A fixation device for a prosthetic heart valve

Abstract

The application relates to an auxiliary device of an artificial heart valve, in particular to a fixing device of an artificial heart valve; the application comprises an adjusting assembly which can rotate around a preset axis as a pivot and is used for adjusting the tightening force of a flexible tightening member of the artificial heart valve when rotating; and further comprises a locking assembly which is used for locking the adjusting assembly with a gear-shaped locking part when the adjusting assembly rotates to any angle, and locking the adjusting assembly. Compared with the prior art, the application realizes the control of the tightening force of the flexible tightening member by rotating and tightening the flexible tightening member through the adjusting assembly, greatly improves the convenience of use, realizes the instant locking of the adjusting assembly through the locking assembly, guarantees the accuracy of the tightening force of the flexible tightening member, and is more suitable for the high-precision requirement of the artificial heart valve surgery.

Description

Technical Field

[0001] This invention relates to an auxiliary device for an artificial heart valve, and more particularly to a device for fixing an artificial heart valve. Background Technology

[0002] Heart valves are vital structures that maintain the flow of blood pumped by the heart. Valvular diseases such as stenosis or insufficiency can lead to hemodynamic changes, causing a series of pathophysiological changes, and in severe cases, endangering life. With continuous advancements in technology, artificial heart valve replacement technology has become one of the main and most effective methods for treating heart valve diseases. This technique involves inserting an artificial heart valve into the body through a catheter, placing it at the site of the disease to achieve therapeutic treatment.

[0003] To ensure high efficacy after valve replacement, it's crucial to prevent paravalvular leakage and avoid excessive strain on cardiac tissues. This necessitates precise fixation of the valve stent within the heart, requiring a fixed structure to accurately define the artificial valve's position. For example, in mitral valve replacement, it's essential to prevent the valve from shifting into the atrium due to blood flow, which could lead to device failure. Currently, a common method involves attaching a tether to the artificial valve stent and extending it to the apex of the heart. The tether's tightness is then manually adjusted using imaging equipment to secure the valve. However, this method suffers from inconsistent tether tension, introducing errors. Furthermore, the subsequent external fixation is cumbersome, increasing surgical time and risks. Summary of the Invention

[0004] The purpose of this invention is to provide a fixation device for an artificial heart valve. This device can control the tightening force of the flexible fastener while adjusting the tightening force of the flexible fastener, thus ensuring the high precision required for the surgery.

[0005] To achieve the above objectives, embodiments of the present invention provide a fixation device for an artificial heart valve, comprising: an adjustment assembly rotatable about a preset axis, and used to adjust the tightening force of a flexible fastening member of the artificial heart valve during rotation. The adjustment assembly includes, along the preset axis, a rotating component and a gear-shaped locking component; the rotating component is connected to the flexible fastening member and is used to be wound around the flexible fastening member during rotation. A locking component is provided for engaging with a gear-shaped locking member to lock the adjusting component when it is rotated to any angle. Compared to existing technologies, the artificial heart valve fixation device of this invention includes an adjustment component and a locking component. The adjustment component consists of a rotating part and a gear-shaped locking part. By rotating the adjustment component around a preset axis, the flexible fastening element can be wound around the rotating part, achieving the purpose of tightening the flexible fastening element and adjusting its fastening force. Furthermore, when the adjustment component rotates to any angle, the locking component locks the adjustment component by engaging the gear-shaped locking part, thus maintaining a constant fastening force on the flexible fastening element. This invention achieves precise control of the fastening force and completes the locking through a mechanical structure, facilitating operation.

[0006] As a further improvement, the rotating component includes, along the predetermined axis, a connecting portion and a protrusion. The connecting part is connected to the flexible fastening member, and the protruding part is used to be wrapped by the flexible fastening member when rotating about a preset axis.

[0007] As a further improvement, the connecting part is detachably connected to the flexible fastening member.

[0008] As a further improvement, the connecting part is provided with a slot along the direction of the preset axis. The slot is used for the flexible fastening member to partially engage, so that the flexible fastening member is engaged with the connecting part.

[0009] As a further improvement, the connecting part, along the preset axis direction, includes: a snap-fit ​​side, a mounting side, and a side surface connecting the snap-fit ​​side and the mounting side; The card slot extends toward the side, so that the card slot has an opening exposed to the side; The flexible fastening member has: a snap-in portion that slides into the slot from the groove, and a snap-fit ​​portion connected to the snap-in portion; The snap-fit ​​part is used to snap into the snap-fit ​​side after the snap-fit ​​part slides into the snap-fit ​​slot; The protrusion is connected to the mounting side.

[0010] As a further improvement, the protrusion is coaxially connected to the gear-shaped locking component along the preset axis.

[0011] As a further improvement, the protrusion is detachably connected to the gear-shaped locking component.

[0012] Furthermore, the locking component is linearly movable relative to the gear-shaped locking member; The locking component is used to lock with the gear-shaped locking component when it moves toward the gear-shaped locking component to a first preset position; the locking component is also used to separate from the gear-shaped locking component when it moves away from the gear-shaped locking component to a second preset position.

[0013] Furthermore, the linear motion direction of the locking component is perpendicular to the preset axis, and the locking part includes: Rotating part; the rotating part is connected to the mounting side and is used to rotate synchronously when the protrusion rotates; Several snap-fit ​​parts are provided on the rotating part, and each snap-fit ​​part is also arranged sequentially on the rotating part around the preset axis. The locking component is used to engage with one of the engaging portions when it moves toward the gear-shaped locking member to the first preset position; the locking component is also used to disengage from one of the engaging portions when it moves away from the gear-shaped locking member to the second preset position.

[0014] To elaborate further, each of the aforementioned snap-fit ​​parts is a locking tooth or a locking groove.

[0015] Furthermore, when the snap-fit ​​portion is a locking tooth, each locking tooth has a guide tooth surface and a locking tooth surface; The guide tooth surface of any of the locking teeth is used to drive the locking assembly to move away from the gear-shaped locking member when the rotating part rotates in the forward direction, so that the locking assembly passes over the locking tooth; wherein, the forward rotation of the rotating part is clockwise rotation or counterclockwise rotation; The locking tooth surface of any of the locking teeth is used to engage with the locking component.

[0016] Furthermore, the guide tooth surface of each of the locking teeth has: a tooth root side connected to the rotating part and a tooth tip side disposed away from the tooth root side; Wherein, the guide tooth surface extends obliquely from the tooth root side to the tooth tip side, and the oblique direction of the guide tooth surface of each locking tooth is the same; or, the guide tooth surface extends curvedly from the tooth root side to the tooth tip side, and the curvature direction of the guide tooth surface of each locking tooth is the same. The locking tooth surface of each of the locking teeth has a locking bottom side connected to the rotating part; The locking tooth surface extends obliquely from the bottom of the locking surface to the top of the tooth surface.

[0017] Furthermore, when the snap-fit ​​portion is a locking groove, each locking groove has a guide wall surface and a locking wall surface; The guide wall of any of the locking grooves is used to drive the locking assembly to move away from the gear-shaped locking member when the rotating part rotates in the forward direction, so that the locking assembly passes over the locking groove; the forward rotation of the rotating part is either clockwise or counterclockwise. The locking wall of any of the locking slots is used to engage with the locking component.

[0018] Furthermore, the guide wall surface of each of the locking grooves has: a groove wall top side connected to the rotating part, and a groove wall bottom side disposed away from the groove wall top side; Wherein, the guide wall extends obliquely from the top side of the groove wall to the bottom side of the groove wall, and the oblique direction of the guide wall of each locking groove is the same; or, the guide wall extends curvedly from the top side of the groove wall to the bottom side of the groove wall, and the bending direction of the guide wall of each locking groove is the same. The locking wall surface of each of the locking grooves has a locking top side connected to the rotating part; The locking wall extends obliquely from the top side of the locking to the bottom side of the groove wall.

[0019] Furthermore, the fixing device also includes a housing for mounting the adjusting assembly and the locking assembly; The housing includes, along a predetermined axis, a front housing and a rear housing, forming a cavity together with the front housing and the rear housing. The front shell and the rear shell are detachably connected; The gear-shaped locking component is rotatably disposed within the cavity, and at least a portion of the rotating component is disposed outside the housing and coaxially connected to the gear-shaped locking component along the preset axis; the housing also has a slide for the locking component to move linearly relative to the gear-shaped locking component.

[0020] Furthermore, the rear housing includes a boss protruding towards the rotating portion of the locking member, the boss providing the slide rail. The locking assembly includes a locking pin and a resilient element, wherein the locking pin is used to engage with the engaging portion of the locking member, and wherein the resilient element is used to apply a force to the locking pin opposite to its direction of movement. The locking pin is slidably mounted within the slide rail, and the resilient element is sleeved around the outer periphery of the locking pin.

[0021] Furthermore, the locking pin includes a separation hole adapted to accommodate an external drive element that moves the locking pin.

[0022] Furthermore, the locking pin includes a limiting block, with one end of the elastic element abutting against the limiting block and the other end abutting against the inner wall of the rear shell.

[0023] Furthermore, the separation hole is located within the limiting block, or the separation hole is located on the side of the locking pin away from the locking component engagement portion.

[0024] Furthermore, the locking pin includes an arc-shaped end face for limiting the maximum circumferential rotation distance of the locking component's rotating part.

[0025] Furthermore, the housing is provided with a fixed end, which is connected to the flexible fastening element.

[0026] Compared with existing technologies, the advantages of this application are as follows: by adjusting the flexible fastening element through rotation and tightening, the tightening force of the flexible fastening element is controlled while greatly improving ease of use; and by using the locking component, the adjusting component can be locked instantly, ensuring the accuracy of the tightening force of the flexible fastening element, making it more suitable for the high precision requirements of artificial heart valve surgery. The artificial heart valve fixation device described herein is simple to operate; the flexible fastening element is simply knotted on the handle connecting shaft, and rotating the handle gradually tightens the flexible fastening element. Attached Figure Description

[0027] One or more embodiments are illustrated by way of example with corresponding pictures in the accompanying drawings. These illustrative descriptions do not constitute a limitation on the embodiments. Elements with the same reference numerals in the drawings represent similar elements. Unless otherwise stated, the figures in the drawings are not to be limited by scale. In the drawings, Figure 1 This is a schematic diagram of the overall appearance of the fixation device for the artificial heart valve of the present invention in Embodiment 1; Figure 2 An exploded view of the fixation device for an artificial heart valve provided in an embodiment of the present invention; Figure 3 Another exploded view of the artificial heart valve fixation device provided in an embodiment of the present invention; Figure 4 for Figure 1 A magnified view of the assembly of the card slot and the flexible fastener at point C; Figure 5 A schematic diagram of the assembly of the protrusion and the gear-shaped locking component in the fixation device for the artificial heart valve provided in an embodiment of the present invention; Figure 6 A schematic diagram from another angle showing the assembly of the protrusion and the gear-shaped locking component in the fixation device for the artificial heart valve provided in an embodiment of the present invention; Figure 7 for Figure 5 Enlarged schematic diagram of the assembly of the snap-fit ​​part and the rotating part at point B; Figure 8 A schematic diagram showing the specific locations of the blind holes and through holes provided in the rotating part according to an embodiment of the present invention; Figure 9 This is a schematic diagram showing the external appearance of the separation hole located inside the housing, as described in an embodiment of the present invention. Figure 10 for Figure 9 A schematic cross-sectional view of the internal assembly of the housing in a specific embodiment; Figure 11 This is a schematic cross-sectional view of the overall assembly of the separation hole located outside the housing, as described in an embodiment of the present invention. Figure 12 for Figure 11 A schematic cross-sectional view of the assembly of the elastic element, locking pin, and slide rail at point A. Figure 13 A schematic diagram of the locking assembly structure of the fixation device for an artificial heart valve provided in an embodiment of the present invention; Figure 14 This is a schematic diagram of a locking assembly provided in an embodiment of the present invention when the separation hole is located inside the housing; Figure 15 This is a cross-sectional view showing the positional relationship between the locking component and the rotating part of the locking member in an embodiment of the present invention; Figure 16 for Figure 15 Enlarged view of the positional relationship between the arc-shaped end face of the central locking pin and the guide tooth surface when they are in contact; Figure 17 This is a schematic diagram showing the connection relationship between the flexible fastening element and the housing described in this invention.

[0028] Figure label: 1. Adjustment components; 11. Rotating component; 12. Gear-shaped locking component; 111. Connecting part; 112. Protrusion; 113. Slot; 114. Engaging tooth; 121. Rotating part of locking component; 122. Snap-fit ​​part of locking component; 123. Through hole; 124. Blind hole; 1111, Snap-fit ​​side; 1112, Mounting side; 1113, Side view; 1221, Guide tooth surface; 1222, Locking tooth surface; 12211, Tooth root side; 12212, Tooth tip side; 12221, Locking bottom side; 2. Lock components; 21. Elastic element; 22. Locking pin; 23. Separation hole; 221. Limiting block; 222. Arc-shaped end face; 3. Shell; 31. Cavity; 32. Front shell; 33. Rear shell; 34. First tether hole; 35. Second tether hole; 36. Slide rail; 37. Boss; 331. Positioning shaft; 4. Flexible fastening components; 41. Insertion part; 42. Fastening part. Detailed Implementation

[0029] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the various embodiments of the present invention will be described in detail below with reference to the accompanying drawings. However, those skilled in the art will understand that many technical details have been presented in the various embodiments of the present invention to facilitate a better understanding of this application. However, the technical solutions claimed in this application can be implemented even without these technical details and various changes and modifications based on the following embodiments.

[0030] Embodiments of the present invention relate to a fixation device for an artificial heart valve, such as... Figure 1 As shown, the fixing device of this application includes: an adjustment component 1 and a locking component 2.

[0031] like Figure 2 and Figure 3 As shown, the adjustment component 1 is rotatable about a preset axis. The adjustment component 1 includes, along the preset axis, a rotating component 11 that is connected to the flexible fastening member 4 and is used to be wound around the flexible fastening member 4 during rotation; and a gear-shaped locking component 12 that is locked to the locking component 2.

[0032] It is clear from the above that, in practical applications, it is necessary to combine... Figure 2 and Figure 3 The rotating component 11 acts as the flexible fastening element 4, winding around the main body. During rotation, the main body is wound by the flexible fastening element 4, which gradually tightens during winding, thus adjusting the fastening force. At the same time, when the adjusting component 1 rotates to any angle, the gear-shaped locking component 12 can lock with the locking component 2 to lock the adjusting component 1.

[0033] Specifically, in this embodiment, such as Figure 2 and Figure 3 As shown, the rotating component 11 includes a connecting portion 111 and a protrusion 112 along a preset axis. In actual use, the flexible fastening member 4 is connected to the connecting portion 111, and during rotation, the flexible fastening member 4 rotates with the protrusion 112, and the number of winding turns continuously increases.

[0034] Furthermore, in this embodiment, as Figure 4 As shown, in order to facilitate the installation and disassembly of the flexible fastener 4 and the connecting part 111, the connecting part 111 and the flexible fastener 4 are detachably connected.

[0035] Specifically, in this embodiment, such as Figure 1 and Figure 4As shown, the connecting part 111 has a slot 113 along the direction of the preset axis. After the doctor inserts the four parts of the flexible fastening member into the slot 113, the connection with the connecting part 111 is completed.

[0036] In addition, it is worth mentioning that, such as Figure 1 and Figure 5 As shown, the connecting portion 111, along a predetermined axis, includes: a snap-fit ​​side 1111, a mounting side 1112, and a side surface 1113 connecting the snap-fit ​​side 1111 and the mounting side 1112. The snap-fit ​​groove 113 extends towards the side surface 1113, giving it an opening exposed on the side surface 1113. Simultaneously, the flexible fastening member 4 includes: a snap-in portion 41 that slides into the snap-fit ​​groove 113 from the opening, and a snap-fit ​​portion 42 connected to the snap-in portion 41. The snap-in portion 41 is the part of the flexible fastening member 4 that contacts the snap-fit ​​groove 113. The snap-fit ​​portion 42 is formed by self-tying the portion of the flexible fastening member 4 exposed outside the snap-fit ​​side 1111 at one end near the snap-fit ​​side 1111. The maximum diameter of the snap-in portion 41 is greater than the width of the snap-fit ​​groove 113, ensuring that the snap-fit ​​portion 41 can snap onto the snap-fit ​​side 1111.

[0037] During the engagement of the flexible fastener 4 and the connecting part 111, the user simply slides the insert part 41 into the slot 113 along the opening of the slot 113, and the engaging part 42 connected to the insert part 41 automatically engages with the outside of the slot 113, completing the engagement with the connecting part 111. The entire process is simple to operate, takes little time, and can quickly complete the assembly.

[0038] At the same time, in order to make the overall structure more compact, such as Figure 5 and Figure 6 As shown, the mounting side 1112 is used to connect the protrusion 112. In this way, the protrusion 112 is adjacent to the snap-fit ​​point between the flexible fastener 4 and the connecting part 111. During rotation, the flexible fastener 4 is directly wrapped around the protrusion 112, without producing a long suspended part, thus avoiding the problem of occupying too much space.

[0039] Furthermore, as a preferred embodiment, such as Figure 2 and Figure 3 As shown, the protrusion 112 can be a roller, and the flexible fastener 4 is wound around the axial side of the protrusion 112. Setting the protrusion 112 as a roller allows the flexible fastener 4 to be wound more evenly, and the tightening force is easier to control. Of course, in practical applications, the protrusion 112 can also be used as another shaft with a constant diameter to evenly adjust the tightening force; therefore, in this embodiment, the structure of the protrusion 112 is not specifically limited.

[0040] Furthermore, to achieve transmission between the rotating component 11 and the gear-shaped locking component 12, the protrusion 112 and the gear-shaped locking component 12 are coaxially connected along a predetermined axis. In this embodiment, as... Figure 2 and Figure 3 As shown, the protrusion 112 is detachably connected to the gear-shaped locking component 12. The detachable connection between the protrusion 112 and the gear-shaped locking component 12 is due to the fact that the protrusion 112, as the winding body of the flexible fastening component 4, is prone to tangling and knotting due to improper use or other reasons. The detachable connection allows for easier separation of the protrusion 112 and the gear-shaped locking component 12, thus simplifying the tangling and knotting problem of the flexible fastening component 4. Furthermore, if either component is damaged, the damaged part can be replaced, further reducing usage costs.

[0041] Specifically, such as Figure 2 and Figure 3 , Figure 8 As shown, the protrusion 112 is provided with a plurality of engaging teeth 114 arranged sequentially around a preset axis. The engaging teeth 114 are located on the side of the protrusion 112 away from the connecting part 111 and protrude outward from the outer surface of the protrusion 112. The locking component rotating part 121 is provided with a through hole 123 and a blind hole 124 along the preset axis. The through hole 123 passes through the locking component rotating part 121 along the preset axis, and the blind hole 124 is located on the side closer to the protrusion 112 and has the same shape as the engaging teeth 114, and is used to engage each engaging tooth 114. During assembly, the protrusion 112 passes through the through hole 123 along the preset axis and continues past the farthest end of the rotating part 121 of the locking component. At this time, the protrusion 112 is rotated. When each of the locking teeth 114 on the protrusion 112 coincides with the blind hole 124 in the preset axis direction, the protrusion 112 is retracted along the preset axis so that each of the locking teeth 114 engages with the blind hole 124. Considering that when adjusting the tightening force of the flexible fastening member 4, due to different ways of driving the adjustment component 1 to rotate, there may be a force in the same direction as the preset axis, the engaging structure of the locking teeth 114 with the through hole 123 and the blind hole 124 can prevent the rotating component 11 from separating from the gear-shaped locking component 12 during rotation.

[0042] As shown in the figure, to achieve locking of the locking component 2 relative to the gear-shaped locking member 12, the locking component 2 can move linearly relative to the gear-shaped locking member 12. In practical applications, when the locking component 2 moves towards the gear-shaped locking member 12 to a first preset position, the locking component 2 locks with the gear-shaped locking member 12. When the locking component 2 moves further away from the gear-shaped locking member 12 to a second preset position, the locking component 2 disengages from the gear-shaped locking member 12.

[0043] And, as Figure 5 and Figure 6 As shown, to maintain a good locking effect, the locking component 2 is configured to move linearly in a direction perpendicular to the preset axis. Simultaneously, the gear-shaped locking component 12 includes: a locking component rotating part 121 connected to the protrusion 112 and used to rotate synchronously when the protrusion 112 rotates; and a plurality of locking component engaging parts 122 sequentially arranged around the preset axis on the locking component rotating part 121. In use, the locking component 2 can engage and disengage with the locking component engaging parts 122 based on its position. When the locking component 2 moves towards the gear-shaped locking component 12 to the first preset position, the locking component 2 engages with one of the locking component engaging parts 122. When the locking component 2 moves away from the gear-shaped locking component 12 to the second preset position, it disengages from one of the locking component engaging parts 122. By locking the locking component 2 to several locking parts 122, when rotating, the component can be rotated to a rotation angle that matches the tightening force. The locking component 2 can be locked to the locking parts 122 at that location simply by controlling its position.

[0044] Specifically, such as Figure 7 As shown, the locking component engaging portion 122 is specifically shaped as a locking tooth, and the locking tooth has a guide tooth surface 1221 and a locking tooth surface 1222. The guide tooth surfaces 1221 have the same curvature direction. When the locking component rotating portion 121 rotates in the forward direction, the guide tooth surface 1221 drives the locking component 2 to move away from the gear-shaped locking component 12, so that the locking component 2 passes over the locking tooth. The locking tooth surface 1222 is used to engage with the locking component 2. In this embodiment, the locking component rotating portion 121 rotates in one direction, and is not limited to clockwise or counterclockwise rotation.

[0045] Furthermore, in this embodiment, the guide tooth surface 1221 is an arc surface, having a root side 12211 and a tip side 12212. The root side 12211 is connected to the rotating part 121 of the locking component, and the tip side 12212 is located away from the root side 12211. The root side 12211 extends and curves towards the tip side 12212 to form the guide tooth surface 1221.

[0046] As a preferred embodiment, the guide tooth surface 1221 can also be configured as an inclined surface, which can be formed by extending obliquely from the root side 12211 to the tip side 12212. Both shapes guide the locking component 2 so that the locking component 2 passes over the locking tooth, therefore the shape of the guide tooth surface 1221 is not specifically limited.

[0047] Furthermore, to achieve engagement between the locking tooth surface 1222 and the locking component 2, each locking tooth surface 1222 has: a locking bottom side 12221 connected to the rotating part 121 of the locking component; the locking tooth surface 1222 extends obliquely from the locking bottom side 12221 to the tooth tip side. When the locking component 2 passes the previous locking tooth, it falls into the angle between the locking tooth surface 1222 and the rotating part 121 of the locking component, and without continuing to rotate, the locking component 2 engages with the locking tooth.

[0048] As another preferred embodiment, the locking component engaging portion 122 can also be configured as a locking groove; each locking groove has a guide wall and a locking wall. The guide wall can be an inclined surface or an arc surface, guiding the locking component 2 over the guide wall and into the next locking groove. If rotation stops at this point, the locking component 2 falls into the angle between the locking wall and the rotating portion 121 of the locking component, and without further rotation, the locking component 2 engages with the locking groove.

[0049] As a preferred embodiment, in this case, such as Figure 13 and Figure 14 As shown, the contact surface between the locking component 2 and the gear-shaped locking component 12 is set as an arc surface, which contacts the guide tooth surface 1221 during the rotation of the adjusting component 1. This setting makes the contact between the guide tooth surface 1221 and the locking component 2 smoother when the adjusting component 1 rotates, and can reduce the wear of parts caused by friction between the guide tooth surface 1221 and the locking component 2.

[0050] Meanwhile, to facilitate the assembly of the overall device and protect the components from corrosion by contaminants and humid air, the fixing device also includes a housing 3 with a cavity 31.

[0051] Specifically, such as Figure 11 As shown, the gear-shaped locking component 12 is rotatably disposed inside the cavity 31, and the rotating component 11 is partially disposed outside the housing 3 and coaxially connected with the gear-shaped locking component 12 along the preset axis. The housing 3 is designed to prevent confidential components from being directly exposed to the outside air, reduce the corrosion of confidential components by external pollutants during storage or use, and extend the overall life of the fixing device and its accuracy during use.

[0052] like Figures 11 to 13As shown, it needs to be explained in detail that the housing 3 includes a boss 37, which is formed by a portion of the housing 3 protruding into the cavity 31. The boss 37 is provided with a slide 36. The slide 36 is used for linear movement of the locking assembly 2 relative to the gear-shaped locking member 12. At the same time, the locking assembly 2 includes: an elastic element 21 for generating a rebound force in the opposite direction relative to the direction of movement of the locking assembly 2; and a locking pin 22 for engaging with the locking member engaging portion 122; the locking pin 22 is slidably installed in the slide 36; the elastic element 21 is sleeved on the locking pin 22 and disposed in the slide 36.

[0053] In this embodiment, reference Figure 13 The locking pin 22 may include a limiting block 221 and a separating hole 23. The limiting block 221 provides support for the elastic element 21, and the separating hole 23 is adapted to accommodate a driving component with a diameter smaller than the separating hole 23, so as to drive the locking pin 22 to move. The separating hole 23 can be set at any position of the locking pin 22, as long as it is convenient for user operation. In one specific embodiment, the separating hole 23 is set on the side away from the locking component engagement portion 122. In one specific embodiment, the separating hole 23 is set in the limiting block 221. It should be particularly noted that, in order to further ensure that the locking component rotating portion 121 can only rotate in one direction, the locking pin 22 includes an arc-shaped end face 222 to prevent the gear-shaped locking component 12 from rotating in the opposite direction. Specifically, the end face of the locking pin 22 near the locking component engagement portion 122 has an arc-shaped structure. Figure 10 , Figure 11 , Figure 15 , Figure 16 As shown, when the locking pin 22 abuts against the locking component engaging portion 122, due to the presence of the arc-shaped end face 222, the locking component engaging portion 122 cannot rotate in the opposite direction to the winding fastener. It can only rotate until the locking component engaging portion 122 contacts the arc-shaped end face 222, thus minimizing the error of the fixation device for artificial valves. When rotating in the same direction as the winding fastener, the shape of the arc-shaped end face 222 can effectively reduce the friction generated when it contacts the locking component engaging portion 122, thereby reducing wear between parts.

[0054] In this embodiment, the elastic element 21 is a return spring. One end of the return spring abuts against the inner wall of the rear shell, and the other end abuts against the limiting block 221 of the locking pin 22. The spring force makes the locking pin 22 stably abut against the gear-shaped locking component 12. When the locking component 2 passes the guide tooth surface 1221, and at the same time the locking pin 22 moves away from the gear-shaped locking component 12, the elastic element 21 is compressed between the inner wall of the slide 36 and the locking pin 22. When the locking pin 22 passes the guide tooth surface 1221, the elastic element 21 applies a spring force to the limiting block 221, causing the locking component 2 to move towards the gear-shaped locking component 12, and finally engage with the locking tooth surface 1222.

[0055] like Figure 2 and Figure 3 As shown, in a preferred embodiment, the rear shell 33 of the housing 3 is detachably connected to the front shell 32 along a predetermined axis. The housing 32 and the rear shell 33 together form a cavity 31 for housing the gear-shaped locking component 12. The rotating component 11 is installed on the front shell 32, and the locking component 2 is installed on the rear shell 33. The detachable housing 3 allows for quicker replacement of components housed in the cavity 31 when they malfunction, and also facilitates easier maintenance and troubleshooting of simple problems.

[0056] Furthermore, to facilitate adjustments by the physician, such as Figures 11 to 13 As shown, the locking pin 22 has a separation hole 23 exposed on the housing 3. This structure is used to adjust the flexible fastening member 4 so that the fastening force is too large. A doctor can insert a sharp object with a diameter smaller than the separation hole 23 into the separation hole 23 and drive the locking component 2 to move away from the gear-shaped locking member 12 to the second preset position to separate from the locking tooth surface 1222, thereby reducing the fastening force.

[0057] As a preferred option, such as Figure 9 , Figure 10 , Figure 14 As shown, the separation hole 23 can be located in the part of the cavity 31 of the housing 3 where the locking pin 22 is located. In this case, a window is opened on the housing 3 to expose the separation hole 23 to the outside. The doctor can adjust the separation hole 23 through the window. Therefore, this embodiment does not limit the specific location of the separation hole 23.

[0058] In this embodiment, as Figure 12 As shown, as a preferred embodiment, the rear shell 33 is provided with a positioning shaft 331, and the protrusion 112 is provided with a shaft hole along the preset axis direction to cooperate with the positioning shaft 331. The two achieve fast and accurate positioning through the cooperation of the positioning shaft 331 and the shaft hole.

[0059] It should be noted that in this embodiment, the boss 37 is formed on the rear shell 33, therefore the locking component 2 is installed on the rear shell 33; however, when the boss 37 is formed on the front shell 32, the locking component 2 is installed on the front shell 32. Therefore, in this embodiment, the position of the boss 37 and the installation position of the locking component 2 relative to the shell 3 are not limited. Similarly, the positioning shaft 331 achieves the same effect when installed on the front shell 32 and the rear shell 33, and the positioning shaft 331 cooperates with the protrusion 112, so the installation position of the protrusion 112 is related to the installation position of the positioning shaft 331. Therefore, the installation position of the positioning shaft 331 and the installation position of the protrusion 112 are also not limited.

[0060] like Figure 17 As shown, in this embodiment, the flexible fastening element 4 is a tether. To fix the flexible fastening element 4, the housing 3 is provided with a fixing end, and the fixing end is provided with a first tether hole 34. The flexible fastening element 4 passes through the first tether hole 34 and is connected to the valve stent. In this embodiment, the first tether hole 34 is provided on the rear housing 33.

[0061] Preferably, such as Figure 9 , Figure 10 , Figure 17 As shown, the housing 3 is also provided with a second tether hole 35, which extends through the front housing 32 and the rear housing 33. The flexible fastening element 4 is passed through the second tether hole 35 and then fixed to the first tether hole 34. This design is because the flexible fastening element 4 is relatively soft and easily pulled unintentionally by external forces. Fixing it in other places may result in an excessively large area being occupied, and it is not convenient to manage the flexible fastening element 4 in a unified manner when adjusting it. This structure hides part of the flexible fastening element 4 inside the cavity 31, which can limit the degree of freedom of the flexible fastening element 4 when adjusting the fastening force, making the adjustment of the fastening force more balanced.

[0062] The usage method of this embodiment can be as follows: First, a physician leads out one end of the flexible fastener 4, which is connected to the heart valve stent, and passes it sequentially through the first tether hole 34 and the second tether hole 35. The portion of the flexible fastener 4 passing through the second tether hole 35 includes a locking portion 41.

[0063] Then, the locking portion 41 of the flexible fastening element 4 is inserted into the slot 113, and the portion of the flexible fastening element 4 exposed outside the locking side 1111 is self-tied and knotted to form a rope knot, ensuring that the maximum diameter of the knotted portion of the locking portion 42 is larger than the groove diameter of the slot 113, so as to ensure that the locking portion 42 will not move towards the heart valve during adjustment. If the length between the locking portion 42 and the end point of the flexible fastening element 4 is too long, this portion of the flexible fastening element 4 can also be wrapped around the slot 113 to prevent the flexible fastening element 4 from swaying outside the heart and affecting the surgical field of vision.

[0064] Finally, rotate the connecting part 111 so that the flexible fastening element 4 can begin to wrap around the protrusion 112 from any point. Since the locking part 42 is now engaged with the locking groove 113 on the locking side 1111, the end of the flexible fastening element 4 connected to the heart valve begins to tighten, increasing the tightening force. A physician uses imaging equipment to gradually rotate the connecting part 111, and stops rotating the connecting part 111 when the tightening force is adjusted to a suitable level.

[0065] It should be noted that if the rotation angle of the rotating connecting part 111 is too large, resulting in excessive tightening force of the flexible fastening element 4, the physician can insert tweezers or other pointed devices into the separation hole 23 and move the locking pin 22 away from the gear-shaped locking component 12 through the separation hole 23 to the second preset position to separate from the locking tooth surface 1222. At this time, the physician can rotate the connecting part 111 in the opposite direction to the rotation direction when the tightening force increases, so as to reduce the tightening force. After the adjustment is completed, the object inserted into the separation hole 23 is pulled out, and the locking pin 22 is re-engaged with the locking tooth surface 1222 under the action of the elastic element 21.

[0066] The core technical point of this invention is that the tightness of the flexible fastening member 4 is controlled by the unidirectional rotation of the gear-shaped locking member 12, i.e., the gear. It is not necessary to precisely limit the knotting position when knotting. In specific use, other knotting methods can also be selected as needed.

[0067] It will be apparent to those skilled in the art that this application is not limited to the details of the exemplary embodiments described above, and that this application can be implemented in other specific forms without departing from the spirit or essential characteristics of this application. Therefore, the embodiments should be considered illustrative and non-limiting in all respects, and the scope of this application is defined by the appended claims rather than the foregoing description. Thus, all variations falling within the meaning and scope of equivalents of the claims are intended to be included within this application. No reference numerals in the claims should be construed as limiting the scope of the claims.

Claims

1. A device for fixing an artificial heart valve, characterized in that, include: The adjustment component is rotatable about a preset axis and is used to adjust the tightening force of the flexible fastener of the artificial heart valve during rotation. The adjustment assembly includes, along the preset axis, a rotating component and a gear-shaped locking component. The rotating component is connected to the flexible fastening member and is used to be wound around the flexible fastening member during rotation. The rotating component includes, along the preset axis, a connecting portion and a protruding portion. The connecting portion is connected to the flexible fastening member, and the protruding portion is used to be wound around the flexible fastening member when rotating about the preset axis as a pivot. A locking component is provided for engaging with the gear-shaped locking member when the adjusting component is rotated to any angle, thereby locking the adjusting component. The locking component is linearly movable relative to the gear-shaped locking member, and the direction of linear movement is perpendicular to the preset axis. The gear-shaped locking component includes: a rotating part; the rotating part is connected to the protruding part and is used to rotate synchronously when the protruding part rotates; a plurality of locking parts are all disposed on the rotating part, and each locking part is also arranged sequentially around the preset axis. The locking assembly includes a locking pin and an elastic element, wherein the locking pin is used to engage with the locking part of the locking component, and wherein the elastic element is used to apply a force to the locking pin in the opposite direction of its movement; the locking pin is slidably mounted in a slide rail, and the elastic element is sleeved on the outer periphery of the locking pin; The locking pin includes an arc-shaped end face to prevent the gear-shaped locking component from rotating in the opposite direction.

2. The artificial heart valve fixation device as described in claim 1, characterized in that, The connecting part is detachably connected to the flexible fastener.

3. The artificial heart valve fixation device as described in claim 2, characterized in that, The connecting part has a slot along the preset axis, and the slot is used for the flexible fastening member to partially engage, so that the flexible fastening member is engaged with the connecting part.

4. The artificial heart valve fixation device as described in claim 3, characterized in that, The connecting portion, along the preset axis direction, includes: a snap-fit ​​side, a mounting side, and a side surface connecting the snap-fit ​​side and the mounting side; The card slot extends toward the side, so that the card slot has an opening exposed to the side; The flexible fastening member has: a snap-in portion that slides into the slot from the groove, and a snap-fit ​​portion connected to the snap-in portion; The snap-fit ​​part is used to snap into the snap-fit ​​side after the snap-fit ​​part slides into the snap-fit ​​slot; The protrusion is connected to the mounting side.

5. The artificial heart valve fixation device as described in claim 1, characterized in that, The protrusion and the gear-shaped locking component are coaxially connected along the preset axis.

6. The artificial heart valve fixation device as described in claim 1, characterized in that, The protrusion is detachably connected to the gear-shaped locking component.

7. The artificial heart valve fixation device as described in claim 1, characterized in that, The locking component is used to lock with the gear-shaped locking component and engage with one of the latching parts when it moves toward the gear-shaped locking component to a first preset position; the locking component is also used to separate from the gear-shaped locking component and disengage one of the latching parts when it moves away from the gear-shaped locking component to a second preset position.

8. The fixation device for an artificial heart valve as described in claim 1, characterized in that, Each of the aforementioned snap-fit ​​parts is a locking tooth or a locking groove.

9. The fixation device for an artificial heart valve as described in claim 8, characterized in that, When the snap-fit ​​part is a locking tooth, each locking tooth has a guide tooth surface and a locking tooth surface; The guide tooth surface of any of the locking teeth is used to drive the locking assembly to move away from the gear-shaped locking member when the rotating part rotates in the forward direction, so that the locking assembly passes over the locking tooth; wherein, the forward rotation of the rotating part is clockwise rotation or counterclockwise rotation; The locking tooth surface of any of the locking teeth is used to engage with the locking component.

10. The fixation device for an artificial heart valve as described in claim 9, characterized in that, The guide tooth surface of each of the locking teeth has: a tooth root side connected to the rotating part and a tooth tip side disposed away from the tooth root side; Wherein, the guide tooth surface extends obliquely from the tooth root side to the tooth tip side, and the oblique direction of the guide tooth surface of each locking tooth is the same; or, the guide tooth surface extends curvedly from the tooth root side to the tooth tip side, and the curvature direction of the guide tooth surface of each locking tooth is the same. The locking tooth surface of each of the locking teeth has a locking bottom side connected to the rotating part; The locking tooth surface extends obliquely from the bottom of the locking surface to the top of the tooth surface.

11. The fixation device for an artificial heart valve as described in claim 8, characterized in that, When the snap-fit ​​portion is a locking groove, each locking groove has a guide wall surface and a locking wall surface; The guide wall of any of the locking grooves is used to drive the locking assembly to move away from the gear-shaped locking member when the rotating part rotates in the forward direction, so that the locking assembly passes over the locking groove; the forward rotation of the rotating part is either clockwise or counterclockwise. The locking wall of any of the locking slots is used to engage with the locking component.

12. The fixation device for an artificial heart valve as described in claim 11, characterized in that, The guide wall surface of each of the locking grooves has: a groove wall top side connected to the rotating part, and a groove wall bottom side disposed away from the groove wall top side; Wherein, the guide wall extends obliquely from the top side of the groove wall to the bottom side of the groove wall, and the oblique direction of the guide wall of each locking groove is the same; or, the guide wall extends curvedly from the top side of the groove wall to the bottom side of the groove wall, and the bending direction of the guide wall of each locking groove is the same. The locking wall surface of each of the locking grooves has a locking top side connected to the rotating part; The locking wall extends obliquely from the top side of the locking to the bottom side of the groove wall.

13. The artificial heart valve fixation device as described in claim 6, characterized in that, The fixing device further includes a housing for mounting the adjusting component and the locking component; The housing includes, along a predetermined axis, a front housing and a rear housing, forming a cavity together with the front housing and the rear housing. The front shell and the rear shell are detachably connected; The gear-shaped locking component is rotatably disposed within the cavity, and at least a portion of the rotating component is disposed outside the housing and coaxially connected to the gear-shaped locking component along the preset axis; the housing also has a slide for the locking component to move linearly relative to the gear-shaped locking component.

14. The fixation device for an artificial heart valve as described in claim 13, characterized in that, The rear housing includes a boss that protrudes toward the rotating portion of the locking member, and the boss provides the slide rail.

15. The fixation device for an artificial heart valve as described in claim 13, characterized in that, The locking pin includes a separation hole adapted to accommodate an external drive element that moves the locking pin.

16. The fixation device for an artificial heart valve as described in claim 15, characterized in that, The locking pin includes a limiting block, and one end of the elastic element abuts against the limiting block, while the other end abuts against the inner wall of the rear shell.

17. The fixation device for an artificial heart valve as described in claim 16, characterized in that, The separation hole is located within the limiting block, or the separation hole is located on the side of the locking pin away from the locking component's engagement portion.

18. The fixation device for an artificial heart valve as described in claim 13, characterized in that, The housing has a fixed end, which is connected to the flexible fastening element.

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