CN117100457A

CN117100457A - Fixing device of artificial heart valve

Info

Publication number: CN117100457A
Application number: CN202210541068.5A
Authority: CN
Inventors: 吴明明; 冯彬; 陈大凯
Original assignee: Koka Nantong Lifesciences Co Ltd
Current assignee: Koka Nantong Lifesciences Co Ltd
Priority date: 2022-05-17
Filing date: 2022-05-17
Publication date: 2023-11-24

Abstract

The application relates to an auxiliary device of a prosthetic heart valve, in particular to a fixing device of the prosthetic heart valve; the application comprises the following steps: an adjustment assembly rotatable about a predetermined axis as a pivot axis and for adjusting a cinching force of a flexible cinching member of the prosthetic heart valve upon rotation; further comprises: and the locking component is used for locking with the gear-shaped locking component when the adjusting component rotates to any angle, and locking the adjusting component. Compared with the prior art, the flexible fastening piece is rotated and tightened through the adjusting component, so that the convenience in use is greatly improved while the fastening force of the flexible fastening piece is controlled; and the locking component can realize the instant locking of the adjusting component, thereby ensuring the fastening force accuracy of the flexible fastening piece and being more suitable for the high-accuracy requirement of the artificial heart valve operation.

Description

Fixing device of artificial heart valve

Technical Field

The application relates to an auxiliary device of a prosthetic heart valve, in particular to a fixing device of the prosthetic heart valve.

Background

Heart valves are important structures that maintain the flow of heart pump blood. Valve lesions such as stenosis or insufficiency lead to hemodynamic changes, causing a series of pathophysiological lesions, which are life threatening in severe cases. With the continued advancement of technology, prosthetic heart valve replacement technology has become one of the primary and most effective approaches in treating heart valve disease. The technology is used for inserting the artificial heart valve into a human body through a catheter, and placing the artificial heart valve at the focus position of the human body, so that the treatment of diseases is realized.

In order to ensure higher effectiveness after valve replacement, the valve is not required to be implanted to avoid paravalvular leakage, excessive pulling is not caused to tissues in the heart, and the fixing precision of the valve bracket in the heart is required to be high, so that a fixing structure is required to be set to accurately limit the position of the artificial valve. For example, in mitral valve replacement, it is necessary to ensure that the valve cannot be deflected into the atrium under the impact of blood flow after replacement, so that the apparatus is disabled, and at present, it is generally adopted to attach a tether to a prosthetic valve support, and draw the tether out of the apex of the heart, and manually adjust the tightness of the tether and fix the valve by means of an imaging device. However, the fastening force adjusted by the method is not constant, errors exist, and the fastening force is manually fixed in vitro after the fastening force is adjusted, so that the operation is troublesome, the operation time is increased, and the operation risk is increased.

Disclosure of Invention

It is an object of embodiments of the present application to provide a prosthetic heart valve fastening device that enables control of the fastening force of a flexible fastener while adjusting the fastening force, ensuring high accuracy certainty required for surgery.

To achieve the above object, embodiments of the present application provide a prosthetic heart valve fixation device including: an adjustment assembly rotatable about a predetermined axis and adapted to adjust the cinching force of the flexible cinching member of the prosthetic heart valve upon rotation. The adjusting assembly includes along the preset axis direction: a rotating member and a gear-like locking member, the rotating member being connected to the flexible tie and adapted to be wound by the flexible tie upon rotation;

the locking component is used for locking with the gear-shaped locking component when the adjusting component rotates to any angle, and locking the adjusting component;

embodiments of the present application are directed to a prosthetic heart valve fixation device that includes an adjustment assembly and a locking assembly, as opposed to the prior art; the adjusting component consists of a rotating component and a gear-shaped locking component; the flexible fastening member can be wound on the rotating component by rotating the adjusting component by taking the preset axis as a pivot shaft, so that the purposes of tightening the flexible fastening member and adjusting the fastening force of the flexible fastening member are achieved. In addition, when the adjustment assembly is rotated to any angle, the locking assembly achieves the effect of locking the adjustment assembly by locking the gear-like locking member, while the flexible fastener tightening force is maintained. The application achieves the accurate control of the fastening force, and the locking is completed through the mechanical structure, thereby facilitating the operation.

As a further improvement, the rotating member includes, in a preset axis direction: a connecting portion and a protruding portion;

wherein the connecting portion is connected with the flexible fastener, and the protruding portion is used for being wound by the flexible fastener when rotating around a preset axis as a pivot shaft.

As a further improvement, the connection portion is detachably connected with the flexible fastener.

As a further improvement, the connecting portion is provided with a clamping groove along the direction of the preset axis, and the clamping groove is used for clamping in a part of the flexible fastening piece so that the flexible fastening piece is clamped with the connecting portion.

As a further improvement, the connecting portion includes, in the preset axis direction: the device comprises a clamping side, a mounting side and a side surface for connecting the clamping side and the mounting side;

the clamping groove extends towards the side surface, so that the clamping groove is provided with a notch exposed to the side surface;

the flexible tie has: a clamping part sliding into the clamping groove from the notch and a clamping part connected with the clamping part;

the clamping part is used for being clamped with the clamping side after the clamping part slides into the clamping groove;

the protruding portion is connected with the mounting side.

As a further refinement, the projection is connected coaxially with the gear-like locking member along the predetermined axis.

As a further improvement, the projection is detachably connected with the gear-like locking member.

As a further feature, the locking assembly is linearly movable relative to the gear-like locking member;

the locking assembly is used for being locked with the gear-shaped locking component when moving to a first preset position in the direction of the gear-shaped locking component; the locking assembly is further configured to disengage from the gear-like locking member upon movement to the second predetermined position in a direction away from the gear-like locking member.

As a still further aspect, the linear movement direction of the locking assembly is perpendicular to the preset axis, and the locking portion includes:

a rotating part; the rotating part is connected with the mounting side and is used for synchronously rotating when the protruding part rotates;

the clamping parts are arranged on the rotating part, and each clamping part is further arranged on the rotating part in sequence around the direction of the preset axis;

the locking assembly is used for being clamped with one clamping part when moving to the first preset position in the direction of the gear-shaped locking part; the locking assembly is further used for being separated from one of the clamping parts when moving to the second preset position in a direction away from the gear-shaped locking part.

Further, each of the engaging portions is a locking tooth or a locking groove.

Further, when the engaging portion is a lock tooth, each of the lock teeth has a guide tooth surface and a lock tooth surface;

when the guiding tooth surface of any locking tooth is used for rotating the rotating part in the forward direction, the locking assembly is driven to move in the direction away from the gear-shaped locking part, so that the locking assembly passes over the locking tooth; wherein the rotation part rotates clockwise or anticlockwise;

the locking tooth surface of any of the locking teeth is configured to be engaged with the locking assembly.

Still further, the guide tooth face of each of the lock teeth has: a tooth root side connected to the rotating portion, and a tooth tip side provided away from the guide bottom side;

wherein the guide tooth surface is formed by obliquely extending from the tooth root side to the tooth tip side, and the oblique directions of the guide tooth surfaces of the locking teeth are the same; alternatively, the guide tooth surface is formed by bending and extending from the tooth root side to the tooth tip side, and the bending direction of the guide tooth surface of each locking tooth is the same;

the lock tooth surface of each lock tooth has: a locking bottom side connected with the rotating part;

the lock tooth surface is formed to extend obliquely from the lock bottom side to the tooth tip side.

Further, when the clamping part is a locking groove, each locking groove is provided with a guide wall surface and a locking wall surface;

when the guide wall surface of any locking groove is used for rotating the rotating part in the forward direction, the locking assembly is driven to move in the direction away from the gear-shaped locking component, so that the locking assembly passes over the locking groove; the rotation part rotates clockwise or anticlockwise;

the locking wall surface of any locking groove is used for being clamped with the locking assembly.

Further, the guide wall surface of each of the locking grooves has: the top side of the groove wall connected with the rotating part and the bottom side of the groove wall arranged far away from the guiding bottom side;

the guide wall surface is formed by obliquely extending from the top side of the groove wall to the bottom side of the groove wall, and the inclination directions of the guide wall surfaces of the locking grooves are the same; or the guide wall surface is formed by bending and extending from the top side of the groove wall to the side of the groove wall, and the bending direction of the guide tooth surface of each locking tooth is the same;

the locking surface of each locking groove has: a locking top side connected with the rotating part;

the locking groove surface is formed by obliquely extending from the locking top side to the groove wall bottom side.

Still further, the fixing device further includes: a housing for mounting the adjustment assembly and the locking assembly;

the housing includes along a predetermined axis: a front shell and a rear shell, wherein the front shell and the rear shell jointly enclose a cavity,

wherein the front shell and the rear shell are detachably connected;

the gear-shaped locking part is rotatably arranged in the cavity, and at least part of the rotating part is arranged outside the shell and is coaxially connected with the gear-shaped locking part along the preset axis; the housing also has a slide for linear movement of the locking assembly relative to the gear-like locking member.

Still further, the rear case includes a boss protruding toward the locking member rotating portion, the boss providing the slide. The locking assembly comprises a locking pin for engagement with the locking member engagement portion and a resilient element for applying a force to the locking pin opposite to the direction of movement thereof. The locking pin is slidably arranged in the slideway, and the elastic element is sleeved on the periphery of the locking pin.

Still further, the locking pin includes a release aperture adapted to receive an external driver that moves the locking pin.

Still further, the locking pin includes the stopper, elastic component one end butt stopper, one end butt the inner wall of backshell.

Still further, the separation hole is provided in the stopper, or the separation hole is provided at a side of the locking pin away from the locking member clamping portion.

Still further, the locking pin includes an arcuate end surface for limiting a maximum circumferential rotational distance of the locking member rotating member.

Still further, the housing is provided with a fixed end that is connected to the flexible fastener.

Compared with the prior art, the application has the beneficial effects that: the flexible fastening piece is rotated and tightened through the adjusting component, so that the convenience in use is greatly improved while the fastening force of the flexible fastening piece is controlled; and the locking component can realize the instant locking of the adjusting component, thereby ensuring the fastening force accuracy of the flexible fastening piece and being more suitable for the high-accuracy requirement of the artificial heart valve operation. The fixing device of the artificial heart valve is simple to operate, the flexible fastening piece is directly knotted on the handle connecting shaft, and the flexible fastening piece can be tensioned gradually by rotating the rotating handle.

Drawings

One or more embodiments are illustrated by way of example and not limitation in the figures of the accompanying drawings, in which like references indicate similar elements, and in which the figures of the drawings are not to be taken in a limiting sense, unless otherwise indicated. In the drawings of which there are shown,

FIG. 1 is a schematic overall view of an embodiment of a prosthetic heart valve fixation device according to the present application;

FIG. 2 is an exploded view of a prosthetic heart valve securing device according to an embodiment of the present application;

FIG. 3 is another angular exploded view of a prosthetic heart valve securing device according to an embodiment of the present disclosure;

FIG. 4 is an enlarged partial schematic view of the assembly of the clip groove with the flexible fastener at C of FIG. 1;

FIG. 5 is a schematic view illustrating the assembly of a protrusion and a gear-like locking member in a prosthetic heart valve fastening device according to an embodiment of the present application;

FIG. 6 is a schematic view illustrating another angle of assembly of the protrusion and the gear-like locking member in the prosthetic heart valve securing device according to an embodiment of the present application;

FIG. 7 is an enlarged view of the assembly of the clamping portion and the rotating portion at B in FIG. 5;

FIG. 8 is a schematic diagram of specific positions of blind holes and through holes of a rotating part according to an embodiment of the present application;

FIG. 9 is a schematic view showing the appearance of a separating hole positioned inside a housing according to an embodiment of the present application;

FIG. 10 is a schematic cross-sectional view of the interior assembly of the housing of the embodiment of FIG. 9;

FIG. 11 is a schematic view of an overall assembly cross-section of a separator hole on the outside of a housing according to an embodiment of the present application;

FIG. 12 is a schematic cross-sectional view of the assembly of the resilient member, locking pin and runner at A in FIG. 11;

FIG. 13 is a schematic view of a locking assembly of a prosthetic heart valve securing device according to an embodiment of the present application;

FIG. 14 is a schematic view of a locking assembly with a separation hole in the housing according to an embodiment of the present application;

FIG. 15 is a cross-sectional view of a locking assembly in relation to a rotational position of a locking member according to an embodiment of the present application;

FIG. 16 is an enlarged view of the arcuate end surface of the locking pin of FIG. 15 in contact with the pilot tooth surface;

FIG. 17 is a schematic view of the connection of the flexible fastener to the housing according to the present application.

Reference numerals:

1. an adjustment assembly;

11. a rotating member; 12. a gear-like locking member;

111. a connection part; 112. a protruding portion; 113. a clamping groove; 114. clamping teeth;

121. a locking member rotating section; 122. a locking member engagement portion; 123. a through hole; 124. a blind hole;

1111. a clamping side; 1112. a mounting side; 1113. a side surface;

1221. a guide tooth surface; 1222. locking the tooth surface; 12211. root side; 12212. tooth top side;

12221. locking the bottom side;

2. a locking assembly;

21. an elastic element; 22. a locking pin; 23. a separation hole;

221. a limiting block; 222. an arc end surface;

3. a housing;

31. a cavity; 32. a front shell; 33. a rear case; 34. a first rope tying hole, 35 and a second rope tying hole;

36. a slideway; 37. a boss; 331. positioning a shaft;

4. a flexible tie;

41. a clamping-in part; 42. and a fastening part.

Detailed Description

For the purpose of making the objects, technical solutions and advantages of the embodiments of the present application more apparent, the embodiments of the present application will be described in detail below with reference to the accompanying drawings. However, those of ordinary skill in the art will understand that in various embodiments of the present application, numerous technical details have been set forth in order to provide a better understanding of the present application. However, the claimed application may be practiced without these specific details and with various changes and modifications based on the following embodiments.

Embodiments of the present application relate to a prosthetic heart valve fixation device, as shown in fig. 1, comprising: an adjustment assembly 1 and a locking assembly 2.

As shown in fig. 2 and fig. 3, the adjusting assembly 1 is rotatable with a preset axis as a pivot, and the adjusting assembly 1 includes: a rotating member 11 connected to the flexible tie 4 and adapted to be wound by the flexible tie 4 when rotated; a gear-like locking member 12 in locking engagement with the locking assembly 2.

As can be seen from the above, in practical application, with reference to fig. 2 and 3, the rotating member 11 is used as a winding body of the flexible fastening member 4, and is wound by the flexible fastening member 4 during rotation, and the flexible fastening member 4 is gradually tightened during winding, thereby achieving the regulation of the fastening force. Meanwhile, when the adjusting assembly 1 rotates to any angle, the gear-shaped locking part 12 can be locked with the locking assembly 2 to complete locking of the adjusting assembly 1.

Specifically, in the present embodiment, as shown in fig. 2 and 3, the rotating member 11 includes, in a preset axis direction: a connection portion 111 and a projection portion 112. In actual use, the flexible tie 4 is connected to the connection portion 111, and when rotated, the flexible tie 4 rotates with the protrusion portion 112, and the number of windings increases.

In the present embodiment, as shown in fig. 4, the connection portion 111 is detachably connected to the flexible fastener 4 so that the flexible fastener 4 can be easily attached to and detached from the connection portion 111.

Specifically, in the present embodiment, as shown in fig. 1 and 4, the connecting portion 111 is provided with a locking groove 113 along a direction of a predetermined axis. After the user engages the flexible fastener 4 partially into the engagement groove 113, the engagement with the connection portion 111 is completed.

In addition, as shown in fig. 1 and 5, the connection portion 111 includes, along a predetermined axis direction: a clamping side 1111, a mounting side 1112, and a side 1113 connecting the clamping side 1111 and the mounting side 1112, wherein the clamping slot 113 extends in a direction of the side 1113 such that the clamping slot 113 has a slot opening exposed to the side 1113. Meanwhile, the flexible tie 4 has: the locking portion 41 slides into the locking groove 113 from the notch, and the locking portion 42 is connected to the locking portion 41, wherein the locking portion 41 is a portion of the flexible fastener 4 that contacts the locking groove 113. The locking portion 42 may be formed by knotting a portion of the end of the flexible fastener 4 adjacent to the locking side 1111, which is exposed to the outside of the locking side 1111, such that the maximum diameter of the locking portion 41 is larger than the width of the locking groove 113, thereby ensuring that the locking portion 41 can lock the locking side 1111.

In the process of clamping the flexible fastening member 4 and the connecting portion 111, the user only needs to slide the clamping portion 41 into the clamping groove 113 along the notch of the clamping groove 113 by a doctor, and the clamping portion 42 connected with the clamping portion 41 is automatically clamped outside the clamping groove 113, so that the clamping with the connecting portion 111 is completed. The whole process is simple to operate, the time consumption is short, and the assembly and combination can be completed quickly.

Meanwhile, in order to make the overall structure more compact, as shown in fig. 5 and 6, the mounting side 1112 is used to connect the protruding portion 112. In this way, the protruding portion 112 is adjacent to the fastening portion between the flexible fastening member 4 and the connecting portion 111, and when rotating, the flexible fastening member 4 is directly wound around the protruding portion 112, so that a longer portion of suspension is not generated, and the problem of overlarge occupied space is avoided.

Also, as shown in fig. 2 and 3, the projection 112 may be a roll shaft, and the flexible fastener 4 is wound around the axial side of the projection 112. The protrusion 112 is provided as a roll shaft, so that the flexible fastening member 4 can be wound more uniformly, and the fastening force can be adjusted more easily. Of course, in practical applications, the tightening force can be uniformly adjusted by the protruding portion 112 as another shaft body with a constant diameter, and therefore, in the present embodiment, the structure of the protruding portion 112 is not particularly limited.

And, to achieve the transmission of the rotating member 11 and the gear-like locking member 12, the protruding portion 112 is coaxially connected with the gear-like locking member 12 along a preset axis. In the present embodiment, as shown in fig. 2 and 3, the projection 112 is detachably connected with the gear-like locking member 12. Taking the bulge 112 and the gear-shaped locking part 12 into detachable connection, considering that the bulge 112 is taken as a winding main body of the flexible fastening piece 4, the problem of winding and knotting caused by improper use or other reasons is inevitably solved, and the detachable connection can relatively conveniently split the assembly of the bulge 112 and the gear-shaped locking part 12, so that the winding and knotting problem of the flexible fastening piece 4 is relatively simply solved; and if any part of the parts is damaged, the parts can be replaced by partially damaged parts, so that the use cost is further reduced.

Specifically, as shown in fig. 2, 3 and 8, the protruding portion 112 is provided with: the plurality of clamping teeth 114 are arranged on one side of the protruding part 112 far away from the connecting part 111, and protrude outwards from the outer surface of the protruding part 112; the locking member rotating portion 121 is provided with a through hole 123 and a blind hole 124 along a preset axis direction. The through hole 123 penetrates through the locking part rotating part 121 along a preset axis, and the blind hole 124 is located at one side close to the protruding part 112 and has the same shape as the arrangement of the clamping teeth 114, and is used for clamping each clamping tooth 114. During assembly, after the protruding portion 112 passes through the through hole 123 along the preset axis, the protruding portion 112 continues to pass over the far end of the locking member rotating portion 121, at this time, the protruding portion 112 is rotated, and when each of the locking teeth 114 on the protruding portion 112 coincides with the blind hole 124 in the preset axis direction, the protruding portion 112 is retracted again along the preset axis to lock each of the locking teeth 114 with the blind hole 124. In consideration of the fact that when the tightening force of the flexible tie 4 is adjusted, due to the different ways of driving the adjustment assembly 1 to rotate, the same force as the preset axis may occur, and the separation of the rotating member 11 from the gear-like locking member 12 during rotation can be avoided by the engagement structure of the engagement teeth 114 with the through hole 123 and the blind hole 124.

As shown, to achieve the locking of the locking assembly 2 relative to the gear-like locking member 12, the locking assembly 2 is linearly movable relative to said gear-like locking member 12. In practice, the locking assembly 2 is locked with the gear-like locking member 12 when the locking assembly 2 is moved in the direction of the gear-like locking member 12 to a first predetermined position. And when the locking assembly 2 is also moved to the second preset position in a direction away from the gear-like locking member 12, the locking assembly 2 is separated from the gear-like locking member 12.

And, as shown in fig. 5 and 6, in order to maintain a good locking effect, it is provided that the locking assembly 2 performs a linear motion in a direction perpendicular to the preset axis. Meanwhile, the gear-like locking member 12 includes: the locking member rotating parts 121 connected to the protruding parts 112 and adapted to rotate synchronously when the protruding parts 112 rotate are each provided with a plurality of locking member engaging parts 122 of the locking member rotating parts 121 in sequence around a direction of a preset axis. The locking assembly 2 can be locked to and separated from the locking member locking portion 122 by means of the position of the locking assembly 2 when in use, and when the locking assembly 2 moves to the first preset position in the direction of the gear-shaped locking member 12, the locking assembly 2 is locked to one of the locking member locking portions 122. When the locking assembly 2 moves to the second preset position in a direction away from the gear-like locking member 12, it is separated from one of the locking member engaging portions 122. By locking the locking assembly 2 with the locking member locking portions 122, the locking assembly is rotated to a rotation angle corresponding to the fastening force during rotation, and the locking assembly 2 can be locked with the locking member locking portions 122.

Specifically, as shown in fig. 7, the locking member engaging portion 122 is specifically shaped as a locking tooth, and the locking tooth has a guide tooth surface 1221, a locking tooth surface 1222. The bending direction of the guide tooth surface 1221 is the same, and when the guide tooth surface 1221 is used for normal rotation of the locking member rotating part 121, the locking assembly 2 is driven to move in a direction away from the gear-like locking member 12, so that the locking assembly 2 passes over the locking teeth. The locking tooth surface 1222 is for snap engagement with the locking assembly 2. The locking member rotating portion 121 indicated in the present embodiment is not limited to clockwise rotation or counterclockwise rotation.

Further, in the present embodiment, the leading tooth surface 1221 is a cambered surface, and the leading tooth surface 1221 has: a root side 12211 and a tip side 12212. Wherein the tooth root side 12211 is connected to the locking member rotating portion 121, the tooth tip side 12212 is distant from the tooth root side 12211, and the tooth root side 12211 to the tooth tip side 12212 is curved and extended to form a guide tooth surface 1221.

Preferably, the guide tooth flank 1221 can also be provided as a bevel, which can be formed by a sloping extension of the tooth root side 12211 to the tooth tip side 12212. Both shapes enable guiding the locking assembly 2 such that the locking assembly 2 passes over the locking tooth, and thus the shape of the guiding tooth face 1221 is not specifically limited.

Further, to complete the snap-fit with the lock assembly 2 by the lock tooth surfaces 1222, each lock tooth surface 1222 has: a lock bottom side 12221 connected to the lock member rotating portion 121; the lock tooth surface 1222 is formed by extending the lock bottom side 12221 obliquely to the tooth top side. When the lock assembly 2 passes the previous lock tooth, the lock assembly 2 falls into the included angle between the lock tooth surface 1222 and the lock member rotating part 121, and the lock assembly 2 is clamped with the lock tooth without further rotation.

As another preferable aspect, the locking member engaging portion 122 may also be provided as a locking groove; each locking groove is provided with a guide wall surface and a locking wall surface, wherein the guide wall surface can be an inclined surface or an arc surface, and the locking assembly 2 is guided to pass through the guide wall surface and enter the next locking groove. If the rotation is stopped at this time, the lock assembly 2 falls into the angle between the lock wall surface and the lock member rotating portion 121, and the lock assembly 2 and the lock groove are engaged without continuing the rotation.

As a preferred option, in the present embodiment, as shown in fig. 13 and 14, the contact surface of the locking assembly 2 with the gear-like locking member 12 is provided as an arc surface that contacts the guide tooth surface 1221 during rotation of the adjustment assembly 1. This arrangement allows smoother contact between the leading tooth surface 1221 and the locking assembly 2 when the adjustment assembly 1 is rotated, and reduces wear of the parts between the leading tooth surface 1221 and the locking assembly 2 due to friction.

Meanwhile, to facilitate the assembly of the whole device, the fixing device for protecting the parts from the corrosion of the pollutants and the humid air further comprises a housing 3 having a cavity 31.

Specifically, as shown in fig. 11, the gear-shaped locking component 12 is rotatably disposed in 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, so that the housing 3 is designed to avoid the direct exposure of the confidential components to the outside air, reduce the corrosion of the confidential components caused by external pollutants during storage or use, and prolong the service life of the whole fixing device and the precision thereof during use.

As shown in fig. 11 to 13, it should be noted in detail that the housing 3 includes a boss 37, the boss 37 is formed by projecting a portion of the housing 3 into the cavity 31, and 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-like locking member 12. Meanwhile, the locking assembly 2 includes: an elastic member 21 for generating an opposite direction resilience with respect to the moving direction of the locking assembly 2; and a lock pin 22 engaged with the lock member engaging portion 122; the locking pin 22 is slidably mounted within the slide 36; the elastic element 21 is sleeved on the locking pin 22 and is arranged on the slideway 36.

In this embodiment, referring to fig. 13, the locking pin 22 may include a stopper 221 and a separation hole 23, wherein the stopper 221 is used to provide support for the elastic element 21, and the separation hole 23 is adapted to receive a driving member having a smaller diameter than the separation hole 23 to move the locking pin 22. The separation hole 23 may be provided at any position of the locking pin 22 as long as it is convenient for the user to operate. In one embodiment, the separation hole 23 is provided on a side away from the locking member engaging portion 122. In one embodiment, a separation hole 23 is provided in the stopper 221. In particular, to further ensure that the locking member rotating portion 121 is rotatable in only one direction, the locking pin 22 includes an arcuate end surface 222 for preventing the gear-like locking member 12 from being rotated in the opposite direction. Specifically, the end surface of the lock pin 22 adjacent to the lock member engagement portion 122 has an arc-shaped structure. As shown in fig. 10, 11, 15, and 16, when the lock pin 22 abuts against the lock member engaging portion 122, the lock member engaging portion 122 cannot rotate in the opposite direction to the winding fastener until the lock member engaging portion 122 contacts the arc end surface 222 at most, and therefore, the error of the fixing device for the prosthetic valve is reduced as much as possible, and when the lock member engaging portion 122 rotates in the same direction as the winding fastener, the shape of the arc end surface 222 can effectively reduce the friction force generated when the lock member engaging portion 122 contacts, and the wear between the parts can be reduced.

In this embodiment, the elastic member 21 is a return spring, one end of which abuts against the inner wall of the rear case, and the other end abuts against the stopper 221 of the lock pin 22, and the elastic force of the spring makes the lock pin 22 stably abut against the gear-like lock member 12. When the lock assembly 2 passes over the guide tooth surface 1221 and the lock pin 22 moves away from the gear-like lock member 12, the elastic member 21 is compressed between the inner wall of the slide 36 and the lock pin 22, and when the lock pin 22 passes over the guide tooth surface 1221, the elastic member 21 applies elastic force to the stopper 221, so that the lock assembly 2 moves toward the gear-like lock member 12 and finally engages with the lock tooth surface 1222.

As shown in fig. 2 and 3, in the case 3, the rear case 33 is preferably detachably connected to the front case 32 along a direction of a predetermined axis. The housing 32 and the rear housing 33 together enclose a cavity 31 for receiving the gear-like locking member 12, the rotating member 11 is mounted to the front housing 32, and the locking assembly 2 is mounted to the rear housing 33. The detachable housing 3 can replace the components contained in the cavity 31 more quickly when the components fail, and can complete maintenance of the machine and treatment of simple problems more conveniently.

In addition, as shown in fig. 11 to 13, a separation hole 23 is formed in a portion of the locking pin 22 exposed to the housing 3 for facilitating adjustment by a user, and this structure is used to make the tightening force excessively large when adjusting the flexible tightening member 4, and the user inserts a sharp object having a smaller diameter than the separation hole 23 into the separation hole 23 by the user and drives the locking assembly 2 to move to a second preset position away from the gear-like locking member 12 to separate from the locking tooth surface 1222, thereby reducing the tightening force.

As a preferred solution, as shown in fig. 9, 10 and 14, the position of the separation hole 23 may be set at the portion of the locking pin 22 located in the cavity 31 of the housing 3, in which case a window is correspondingly formed on the housing 3 to expose the separation hole 23 to the outside, and the separation hole 23 can be adjusted by a doctor through the window, so that the specific position of the separation hole 23 is not limited in this embodiment.

In this embodiment, as shown in fig. 12, as a preferred scheme, a positioning shaft 331 is disposed on the rear housing 33, a shaft hole matched with the positioning shaft 331 is formed in the protruding portion 112 along the preset axis direction, and the positioning shaft 331 and the shaft hole are matched to achieve quick and accurate positioning.

Specifically, in the present embodiment, the boss 37 is formed at the rear case 33, and thus the lock assembly 2 is mounted to the rear case 33; however, when the boss 37 is formed at the front case 32, the locking assembly 2 is mounted to the front case 32. The boss 37 forming position and the mounting position of the lock assembly 2 with respect to the housing 3 are not limited in this embodiment. Similarly, the positioning shaft 331 is mounted to the front case 32 and the rear case 33 with the same effect, and the positioning shaft 331 is engaged with the protruding portion 112, so that the mounting position of the protruding portion 112 is related to the mounting position of the positioning shaft 331, and therefore the mounting position of the positioning shaft 331 and the mounting position of the protruding portion 112 are not limited as well.

In this embodiment, as shown in fig. 17, the flexible fastening member 4 is a tether, and for fixing the flexible fastening member 4, the housing 3 is provided with a fixing end, and the fixing end is provided with a first tether hole 34, and the flexible fastening member 4 passes through the first tether hole 34 and is connected to the valve support. In this embodiment, the first rope hole 34 is provided in the rear case 33.

Preferably, as shown in fig. 9, 10 and 17, the housing 3 is further provided with a second rope fastening hole 35, the second rope fastening hole 35 penetrates the front shell 32 and the rear shell 33, and the flexible fastening member 4 is fixed with the first rope fastening hole 34 after being transmitted from the second rope fastening hole 35, so the design is because the flexible fastening member 4 is relatively soft and easily pulled by the outside, the occupied area can be too large due to the fact that other places are fixed, and the flexible fastening member 4 is not convenient to uniformly manage when being assembled. The structure can limit the freedom degree of the flexible fastening piece 4 when the flexible fastening piece 4 is used for fastening force adjustment by hiding part of the flexible fastening piece 4 in the cavity 31, so that the fastening force adjustment is more balanced.

The application method of the embodiment can be as follows:

first, the physician draws one end of the flexible fastener 4 connected to the heart valve stent out and sequentially passes 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: the engaging portion 41.

Then, the clamping portion 41 of the flexible fastening member 4 is clamped into the clamping groove 113, and the portion of the flexible fastening member 4 exposed out of the clamping side 1111 is self-tied to form a knot, so that the maximum diameter of the knot portion of the clamping portion 42 is larger than the groove diameter of the clamping groove 113, and the clamping portion 42 can not move towards the direction approaching the heart valve during adjustment. If the length between the clamping portion 42 and the end point of the flexible fastening member 4 is too long, the flexible fastening member 4 can be wound around the clamping groove 113, so that the flexible fastening member 4 is prevented from shaking outside the heart, and the operation field is prevented from being affected.

Finally, the connecting portion 111 is rotated so that the flexible fastener 4 starts to be wound around the protruding portion 112 at an arbitrary point. Since the engaging portion 42 is engaged with the engaging groove 113 at this time on the engaging side 1111, at this time, the end of the flexible fastening member 4 to which the heart valve is connected starts to be tightened, and the fastening force increases. The physician rotates the connection part 111 step by means of the imaging device, and stops rotating the connection part 111 when the tightening force is adjusted to a proper level.

It should be noted that, when the rotation angle is too large at the time of rotating the connection portion 111, and the tightening force of the flexible fastener 4 is too tight, the user may insert the doctor into the separation hole 23 through forceps or other relatively sharp devices, and drive the locking pin 22 to move to the second preset position away from the gear-shaped locking member 12 through the separation hole 23 to be separated from the locking tooth surface 1222, at this time, the user may rotate the connection portion 111 in the rotation direction opposite to the connection portion 111 when the tightening force is increased, so that the tightening force is reduced, and pull out the object inserted into the separation hole 23 after the adjustment is completed, and the locking pin 22 is again clamped with the locking tooth surface 1222 under the action of the elastic element 21.

The key technical point of the application is that the tightness of the flexible fastening piece 4 is controlled by the unidirectional rotation of the gear-shaped locking part 12, namely the gear, the knotting position is not required to be precisely limited during knotting, and other knotting modes can be selected according to the needs in the specific use process.

It will be evident to those skilled in the art that the application is not limited to the details of the foregoing illustrative embodiments, and that the present application may be embodied in other specific forms without departing from the spirit or essential characteristics thereof. The present embodiments are, therefore, to be considered in all respects as illustrative and not restrictive, the scope of the application being indicated by the appended claims rather than by the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein. Any reference sign in a claim should not be construed as limiting the claim concerned.

Claims

1. A prosthetic heart valve fixation device, comprising:

an adjustment assembly rotatable about a predetermined axis as a pivot axis and for adjusting a cinching force of a flexible cinching member of the prosthetic heart valve upon rotation; the adjusting assembly includes along the preset axis direction: a rotating member and a gear-like locking member, the rotating member being connected to the flexible tie and adapted to be wound by the flexible tie upon rotation;

and the locking component is used for locking with the gear-shaped locking component when the adjusting component rotates to any angle, and locking the adjusting component.

2. The prosthetic heart valve fixation device of claim 1, wherein the rotational member comprises in the predetermined axial direction: a connecting portion and a protruding portion;

wherein the connection portion is connected with the flexible fastener, and the protrusion portion is used to be wound by the flexible fastener when rotating around a predetermined axis as a pivot axis.

3. The prosthetic heart valve securement device of claim 2, wherein the attachment portion is removably attached to the flexible fastener.

4. The prosthetic heart valve fastening device of claim 3, wherein the connector defines a slot along the predetermined axis for a portion of the flexible fastener to engage and retain the flexible fastener with the connector.

5. The prosthetic heart valve fixation device of claim 4, wherein the connection portion includes, in the predetermined axial direction: the device comprises a clamping side, a mounting side and a side surface for connecting the clamping side and the mounting side;

the clamping part is used for clamping with the clamping side after the clamping part slides into the clamping groove;

the protruding portion is connected with the mounting side.

6. The prosthetic heart valve fixation device of claim 2, wherein the projection is coaxially coupled with the gear-like locking member along the predetermined axis.

7. The prosthetic heart valve fixation device of claim 2,

the projection is detachably connected with the gear-like locking member.

8. The prosthetic heart valve fixation device of claim 1,

the locking assembly being linearly movable relative to the gear-like locking member;

wherein the locking assembly is locked with the gear-shaped locking component when moving to a first preset position in the direction of the gear-shaped locking component; the locking assembly is further configured to disengage from the gear-like locking member when moved to a second predetermined position in a direction away from the gear-like locking member.

9. The prosthetic heart valve fixation device of claim 8, wherein the linear motion of the locking assembly is perpendicular to the predetermined axis, the gear-like locking member comprising:

a rotating part; the rotating part is connected with the protruding part and is used for synchronously rotating when the protruding part rotates;

the clamping parts are arranged on the rotating part, and the clamping parts are sequentially arranged around the direction of the preset axis;

the locking assembly is used for being clamped with one clamping part when moving to the first preset position in the direction of the gear-shaped locking part; the locking assembly is further used for being separated from one of the clamping parts when moving to a second preset position in a direction away from the gear-shaped locking part.

10. The prosthetic heart valve fixation device of claim 9, wherein each of the clip portions is a locking tooth or a locking groove.

11. The prosthetic heart valve fixation device of claim 10, wherein when the clip is a locking tooth, each locking tooth has a leading tooth face, a locking tooth face;

12. The prosthetic heart valve fixation device of claim 11, wherein the leading tooth face of each of the locking teeth has: a tooth root side connected to the rotating portion, and a tooth tip side provided away from the guide bottom side;

13. The prosthetic heart valve fixation device of claim 10, wherein when the clip is a locking groove, each locking groove has a guide wall, a locking wall;

14. The prosthetic heart valve fixation device of claim 12, wherein the guide wall of each of the locking slots has: the top side of the groove wall connected with the rotating part and the bottom side of the groove wall arranged far away from the guiding bottom side;

15. The prosthetic heart valve fixation device of claim 6, wherein the fixation device further comprises: a housing for mounting the adjustment assembly and the locking assembly;

wherein the front shell and the rear shell are detachably connected;

16. The prosthetic heart valve fixation device of claim 15,

the rear shell comprises a boss protruding towards the locking part rotating part, and the boss is provided with the slideway;

the locking assembly comprises a locking pin and an elastic element, wherein the locking pin is used for being clamped with the clamping part of the locking component, and the elastic element is used for applying force opposite to the movement direction of the locking pin;

the locking pin is slidably arranged in the slideway, and the elastic element is sleeved on the periphery of the locking pin.

17. The unidirectional rotation locking device of claim 16, wherein the locking pin comprises a separation aperture adapted to receive an external drive that moves the locking pin.

18. The unidirectional rotation locking device of claim 17, wherein the locking pin comprises a stopper, and wherein the elastic element has one end abutting the stopper and one end abutting an inner wall of the rear housing.

19. The unidirectional rotation locking device of claim 18, wherein the separation hole is provided in the stopper or the separation hole is provided at a side of the locking pin away from the locking member engagement portion.

20. A unidirectional rotation locking apparatus as claimed in any one of claims 16 to 19, wherein said locking pin comprises an arcuate end surface for preventing reverse rotation of the gear-like locking member.

21. The prosthetic heart valve fixation device as claimed in claim 16,

the housing is provided with a fixed end which is connected with the flexible fastener.