Locking devices, locking systems and implants
By designing the elastic locking piece of the locking device to cooperate with the shell, the problem of unstable length of the flexible slender piece during annuloplasty is solved, and the stability of the valve ring adjustment and the reduction of blood reflux are achieved.
Patent Information
- Application Number
- CN202311066632.3
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Filing Date
- 2023-08-22
- Publication Date
- 2025-09-19
- Estimated Expiration
- 2043-08-22
AI Technical Summary
The existing technology is difficult to effectively lock the length of the flexible slender member during annuloplasty, resulting in unstable adjustment of the valve ring and affecting the treatment effect of blood reflux.
A locking device is designed, including a shell and a winding assembly. The rotation of the winding assembly is restricted by the cooperation of an elastic locking piece and the shell. External force is used to release the locking piece from the shell restriction, thereby achieving the adjustability and locking of the flexible slender piece.
The stable locking of the length of the flexible slender member is achieved, which ensures the durability of the valve ring adjustment effect, reduces blood reflux, and adapts to the dynamic changes of the valve ring.
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Figure CN119499010B_ABST
Abstract
Description
Technical Field
[0001] The present application relates to the field of medical devices, and in particular to a locking device, a locking system and an implant. Background Art
[0002] Annular dilatation is one of the most common causes of mitral and tricuspid valve problems, often leading to mitral and tricuspid valve insufficiency and resulting in blood regurgitation. Annuloplasty is performed on dilated annuli to reduce the area of the mitral or tricuspid valve orifice by constricting the annulus. This allows the leaflets to close together during ventricular contraction, reducing or eliminating regurgitation.
[0003] In some annuloplasty applications, an annuloplasty structure is implanted on the valve annulus. The length of a flexible, elongated member (e.g., a tensioning wire or adjustment wire) of the annuloplasty structure is adjusted to reduce the annular circumference and treat regurgitation. After the length of the flexible, elongated member is adjusted, it is locked with a locking device to maintain the annular reduction effect. Summary of the Invention
[0004] An embodiment of the present application provides a locking device. The locking device includes a housing and a winding assembly at least partially housed in the housing. The winding assembly is capable of rotating relative to the housing. The winding assembly includes a winding member, a connecting member, and a locking member. The locking member is elastic. The locking member is arranged between the winding member and the connecting member. The winding member is fixedly connected to the connecting member. The locking member cooperates with the housing to limit the rotation of the winding assembly, and the locking member is configured to be able to break away from the restriction of the housing under the action of an external force.
[0005] The embodiment of the present application also provides a locking system. The locking system includes a conveying device and the above-mentioned locking device. The conveying device includes an outer tube, an inner tube movably installed in the outer tube, and a slender rod movably installed in the inner tube. The distal end of the outer tube is connected to the shell and is relatively fixed. The distal end of the inner tube is connected to the connecting member and is relatively fixed. The outer tube is configured to limit the rotation of the shell, the slender rod is configured to provide an external force to the locking member to release the locking member from the restriction of the shell, and the inner tube is configured to drive the winding assembly to rotate relative to the shell.
[0006] Embodiments of the present application also provide an implant. The implant comprises a flexible, elongated member, a plurality of anchors, and the aforementioned locking device. The flexible, elongated member connects the plurality of anchors and the locking device. Each anchor is configured to anchor to tissue. The flexible, elongated member is configured to adjust the spacing between the plurality of anchors. The locking device is configured to adjust the length of the flexible, elongated member and to lock the length of the flexible, elongated member.
[0007] In the locking device, locking system, and implant of the embodiments of the present application, when the elastic locking member cooperates with the housing to restrict the rotation of the winding assembly, the locking device is in a locked state; when the locking member is deformed by force and breaks away from the restriction of the housing, the locking device is in an unlocked state, at which time the winding assembly can be driven to rotate clockwise or counterclockwise. Therefore, after the flexible slender member is connected to the locking device, force is applied to release the locking member from the restriction of the housing, and the flexible slender member can be wound around the winding member by driving the winding assembly to rotate relative to the housing. When the flexible slender member is adjusted to an appropriate length, the locking member is restored to cooperate with the housing to restrict the rotation of the winding assembly relative to the housing, and the flexible slender member is now locked by the locking device. BRIEF DESCRIPTION OF THE DRAWINGS
[0008] In order to more clearly illustrate the technical solutions in the embodiments of this application or the background technology, the following describes the drawings required for the embodiments of this application. Obviously, the drawings described below are some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without inventive work.
[0009] Figure 1 This is a schematic diagram of the three-dimensional structure of a locking device according to one embodiment of the present application;
[0010] Figure 2 Schematic diagram of the structure of an implant (flexible elongated member is tightened) according to one embodiment of the present application;
[0011] Figure 3 is a schematic diagram of the three-dimensional structure of an anchor member according to one embodiment of the present application;
[0012] Figure 4 is a schematic diagram of the three-dimensional structure of an anchor member according to another embodiment of the present application;
[0013] Figure 5 yes Figure 3 The schematic diagram of the connection between the anchor member and the flexible elongated member is shown;
[0014] Figure 6 is a schematic structural diagram of an implant according to another embodiment of the present application (the flexible elongated member is tightened);
[0015] Figure 7 This is a schematic diagram of the connection between the flexible elongated member and the conveying member according to one embodiment of the present application;
[0016] Figure 8 yes Figure 1 A cross-sectional view of the locking device shown in a locked state;
[0017] Figure 9 yes Figure 1 A cross-sectional view of the locking device shown in an unlocked state;
[0018] Figure 10 yes Figure 1 Another cross-sectional view showing the locking device in an unlocked state;
[0019] Figure 11 yes Figure 1 A cross-sectional view of the locking device shown;
[0020] Figure 12 yes Figure 1 A schematic diagram of the locking device after the winding member is wound around the flexible elongated member;
[0021] Figure 13 yes Figure 1 An exploded schematic diagram of the locking device shown;
[0022] Figure 14 yes Figure 8 A schematic diagram of the three-dimensional structure of the winding assembly shown;
[0023] Figure 15 yes Figure 14 An exploded schematic diagram of the winding assembly shown;
[0024] Figure 16 yes Figure 15 A schematic diagram of the three-dimensional structure of the winding member shown;
[0025] Figure 17 yes Figure 16 A schematic diagram of a portion of the structure of the winding member shown;
[0026] Figure 18 yes Figure 13 A schematic diagram of the three-dimensional structure of the upper shell shown;
[0027] Figure 19 yes Figure 8 A cross-sectional view showing the locking end of the locking portion engaging with the locking groove of the housing;
[0028] Figure 20 is a front view of a locking device according to another embodiment of the present application;
[0029] Figure 21 yes Figure 20 A cross-sectional view of the locking device shown in a locked state;
[0030] Figure 22 yes Figure 20 A cross-sectional view of the locking device shown in an unlocked state;
[0031] Figure 23 yes Figure 21 An exploded schematic diagram of the winding assembly shown;
[0032] Figure 24 yes Figure 21 Another exploded schematic diagram of the winding assembly shown;
[0033] Figure 25 yes Figure 21 Another exploded schematic diagram of the winding assembly shown;
[0034] Figure 26 yes Figure 23 A schematic diagram of the three-dimensional structure of the winding member shown;
[0035] Figure 27 yes Figure 21 A cross-sectional view showing the locking end of the locking portion engaging with the locking groove of the housing;
[0036] Figure 28 is a cross-sectional view of a locking device according to another embodiment of the present application in a locked state;
[0037] Figure 29 yes Figure 28 A cross-sectional view of the locking device shown in an unlocked state;
[0038] Figure 30 yes Figure 28 An exploded schematic diagram of the winding assembly shown;
[0039] Figure 31 yes Figure 28 Another exploded schematic diagram of the winding assembly shown;
[0040] Figure 32 yes Figure 28 Another exploded schematic diagram of the winding assembly shown;
[0041] Figure 33 yes Figure 30 A schematic diagram of the three-dimensional structure of the winding member shown;
[0042] Figure 34 yes Figure 28 A cross-sectional view showing the locking end of the locking portion engaging with the locking groove of the housing;
[0043] Figure 35 is a front view of a locking system according to an embodiment of the present application;
[0044] Figure 36 yes Figure 35 Schematic diagram of the separation of the conveying device and the locking device shown;
[0045] Figure 37 yes Figure 35 a cross-sectional view of the locking system shown;
[0046] Figure 38 yes Figure 35An exploded schematic diagram of the conveying device shown;
[0047] Figures 39 to 41 A schematic diagram of a process of applying a locking device to mitral annuloplasty according to an embodiment of the present application. DETAILED DESCRIPTION
[0048] The following will be combined with the drawings in the embodiments of this application to clearly and completely describe the technical solutions in the embodiments of this application. Obviously, the embodiments described are only part of the embodiments of this application, not all of the embodiments. Based on the embodiments of this application, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of this application.
[0049] The limiting terms "proximal" and "distal" described in this application are commonly used terms in the field of interventional medicine. Specifically, "distal" refers to the end away from the operator during the surgical operation, and "proximal" refers to the end close to the operator during the surgical operation. Axial refers to the direction parallel to the line connecting the distal and proximal centers of the instrument or component, radial refers to the direction perpendicular to the axial direction, and circumferential refers to the direction around the axial direction. Unless otherwise defined, all technical and scientific terms used in this application have the same meaning as commonly understood by technicians in the technical field to which this application belongs. The common terms used in the specification of this application are only for the purpose of describing specific embodiments and are not to be understood as limitations on this application.
[0050] In the description of this application, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected" and "connected" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a direct connection, or an indirect connection through an intermediate medium, and it can be the internal connection of two elements or the interaction relationship between two elements.
[0051] The directional terms used in the embodiments of this application, such as "upper," "lower," "left," "right," "inner," and "outer," are merely references to the directions in the accompanying drawings. Therefore, the directional terms used are intended to better and more clearly illustrate and understand the embodiments of this application. They do not indicate or imply that the devices or components referred to must have a specific orientation, be constructed, or operate in a specific orientation. Therefore, they should not be construed as limiting the embodiments of this application. "Multiple" means at least two.
[0052] In the embodiments of this application, the terms "first," "second," and "third" are used for descriptive purposes only and should not be understood to indicate or imply relative importance or implicitly specify the number of the technical features indicated. Therefore, a feature specified as "first," "second," or "third" may explicitly or implicitly include one or more of the features.
[0053] In the embodiments of the present application, the character " / " generally indicates that the preceding and following related objects are in an "or" relationship. For those skilled in the art, the specific meanings of the above terms in the present application can be understood according to specific circumstances.
[0054] The disclosure herein provides many different implementations or examples for implementing various structures of the present application. It is understood that the specific implementations described herein are intended solely to illustrate the relevant application and are not intended to limit the application. It should also be noted that, for ease of description, only portions relevant to the application are shown in the accompanying drawings. The present application will be described in detail below with reference to the accompanying drawings and in conjunction with the implementations.
[0055] See also Figure 1 and Figure 2 , an embodiment of the present application provides a locking device 10. The locking device 10 can be provided in an implant 100 used for annuloplasty. The implant 100 includes a flexible elongated member 30, a plurality of anchors 50 and a locking device 10. The flexible elongated member 30 connects the plurality of anchors 50 and the locking device 10. Each anchor 50 is configured to anchor to tissue. The flexible elongated member 30 is configured to adjust the spacing between the plurality of anchors 50. The locking device 10 is configured to adjust the length of the flexible elongated member 30 and to lock the length of the flexible elongated member 30. The locking device 10 can also be applied to chordal repair, in which a flexible elongated member is used as an artificial chord connecting the valve leaflet to the papillary muscle / ventricular wall, and the locking device 10 adjusts the length of the flexible elongated member and locks the length of the flexible elongated member to adjust and fix the length of the artificial chord.
[0056] In the present application, the flexible elongated member 30 may be a linear object with flexibility, such as a thread, a filament, a rope, a strip, a belt, etc. The radial cross-sectional shape of the flexible elongated member 30 may be circular, oblate, rectangular, square or other shapes, etc., which is not limited in the present application. The flexible elongated member 30 may be made of a biocompatible metal material and / or polymer material, such as stainless steel 316L, tungsten, tantalum, nickel titanium, polyethylene, polyamide, polypropylene, polyurethane, etc. Exemplarily, the flexible elongated member 30 is a slender wire, which may be woven from a plurality of metal filaments. The flexible elongated member 30 has developability under a DSA (Digital subtraction angiography) device.
[0057] The following is a detailed description using the application of the locking device 10 in annuloplasty as an example.
[0058] During annuloplasty, after multiple anchors 50 connected by a flexible elongated member 30 are implanted in cardiac tissue, the locking device 10 adjusts the spacing between the multiple anchors 50 by tightening or loosening the flexible elongated member 30 (i.e., adjusting the length of the flexible elongated member 30), thereby adjusting the size of the physiological annulus. The locking device 10 can lock the length of the flexible elongated member 30 to maintain the adjusted annulus size. Tightening the flexible elongated member 30 by the locking device 10 can reduce the spacing between the multiple anchors 50, thereby reducing the patient's annulus size and reducing blood regurgitation. After the desired annulus reduction effect is achieved, the locking device 10 can lock the length of the flexible elongated member 30 to maintain the tension of the flexible elongated member 30, thereby maintaining the annular reduction effect. If the flexible elongated member 30 is overtightened (i.e., the spacing between the multiple anchors 50 is too small), the locking device 10 can loosen the flexible elongated member 30 to readjust the spacing between the multiple anchors 50 until the desired annular size adjustment is achieved.
[0059] It is understood that the multiple anchoring members 50 connected by the flexible elongated member 30 can be anchored to cardiac tissues such as the mitral valve annulus, the tricuspid valve annulus, the left ventricular wall or the right ventricular wall. When the implant 100 is implanted in the valve annulus, the valve annulus can be directly reduced by tightening the flexible elongated member 30. When the implant 100 is implanted in the ventricular wall below the valve annulus, such as the ventricular wall 0.5-2 cm below the valve annulus, the purpose of reducing the valve annulus can be achieved by tightening the flexible elongated member 30 to narrow the ventricle and reduce the volume of the ventricle. It should be noted that reducing the volume of the left ventricle can also treat ischemic heart failure. The implant 100 is specifically described below using the valve annulus as an example.
[0060] See also Figures 3 to 5 In some embodiments, the anchor 50 includes a tissue engaging element 52, a head 54, and a connecting structure 56. The head 54 is connected to the proximal end of the tissue engaging element 52. The connecting structure 56 can be rotatably mounted on the head 54 or the proximal portion of the tissue engaging element 52. The connecting structure 56 is provided with a connecting hole 560. The connecting hole 560 is configured to allow the flexible elongated member 30 to pass through. It can be understood that the anchor 50 is connected to the flexible elongated member 30 through the connecting hole 560 of the connecting structure 56. The distal end of the flexible elongated member 30 can be connected to the connecting structure 56 of the first anchor 50 anchored to the tissue, and the two cannot be separated and always remain connected. The flexible elongated member 30 can movably pass through the connecting holes 560 of the remaining anchors 50 anchored to the tissue, that is, the connecting structures 56 of the remaining anchors 50 can slide along the flexible elongated member 30.
[0061] In some examples, the connecting structure 56 includes a connecting element 562 and a connecting ring 564. The connecting element 562 is rotatably mounted on the head 54 of the anchor 50 or the proximal portion of the tissue-engaging element 52. The connecting ring 564 is movably connected to the connecting element 562 and defines a connecting hole 560. In other examples, the connecting structure 56 includes the connecting element 562, which includes an annular member 5622 and a protrusion 5624 fixed to the annular member 5622. The annular member 5622 is rotatably mounted on the head 54 of the anchor 50 or the proximal portion of the tissue-engaging element 52. The connecting hole 560 is defined in the protrusion 5624. In other examples, the connecting structure 56 may include only the connecting ring 564, which is rotatably mounted on the head 54 of the anchor 50 or the proximal portion of the tissue-engaging element 52 and defines the connecting hole 560.
[0062] See also Figure 5 In some embodiments, a fixing member 31 is provided at the distal end of the flexible elongated member 30. The fixing member 31 is located distal to the connection hole 560 of the first anchor 50. The fixing member 31 is coupled to the connection structure 56 to restrict proximal movement of the first anchor 50 relative to the flexible elongated member 30. Thus, the distal end of the flexible elongated member 30 is inseparable from the connection structure 56 of the first anchor 50. It will be appreciated that the flexible elongated member 30 is passed through the connection hole 560 of the first anchor 50, with the fixing member 31 at its distal end located distal to the connection hole 560. This prevents the fixing member 31 from being positioned proximal to the connection hole 560, increasing the distance between the first and second anchors 50 and causing uneven contraction of the annulus, thereby preventing structural changes in the leaflets in this area. The connection of the fixing member 31 to the connection structure 56 of the first anchor 50 restricts proximal movement of the first anchor 50 relative to the flexible elongated member 30, thereby preventing interference with surgical procedures.
[0063] Exemplarily, the connecting structure 56 includes a connecting element 562 and a connecting ring 564. The connecting element 562 can be rotatably mounted on the head 54 of the anchor 50. The fixing member 31 is a hollow cylindrical structure. The outer diameter of the fixing member 31 is larger than the inner diameter of the connecting ring 564 (i.e., the aperture of the connecting hole 560). The two free ends of the flexible elongated member 30 pass through the connecting ring 564 of the first anchor 50 from the proximal end to the distal end, and then pass through the fixing member 31, and the two free ends of the flexible elongated member 30 (i.e., the distal end of the flexible elongated member 30) are fixedly connected to the fixing member 31 by crimping. The fixing member 31 can be covered with a protective film 310, and the protective film 310 is connected to the connecting ring 564 by sutures, thereby connecting the fixing member 31 to the connecting structure 56 of the first anchor 50. The protective film 310 can be a biocompatible film, and the material can be selected from PET (Polyethylene terephthalate). In other examples, the fixing member 31 can be connected to the connecting structure 56 of the first anchor member 50 by welding or bonding. The flexible elongated member 30 can have only one free end fixedly connected to the fixing member 31. Furthermore, after the distal end of the flexible elongated member 30 is connected to the connecting structure 56 of the first anchor member 50, the flexible elongated member 30 and the connecting structure 56 of the first anchor member 50 can be inseparable and always maintained connected by knotting, wrapping, welding, or bonding.
[0064] The tissue-engaging element 52 is configured to anchor into tissue. The tissue-engaging element 52 has a distal tip 522 for easier tissue penetration. The head 54 is configured to connect to a drive device. In some examples, the tissue-engaging element 52 may be a spiral nail fixedly connected to the head 54. The anchor 50 is driven by the rotation of the drive device, causing the spiral nail to anchor into the tissue. The spiral nail can be made of stainless steel, titanium alloy, or cobalt alloy. In other examples, the tissue-engaging element 52 may be a plurality of pre-shaped nails fixedly connected to the head 54. The pre-shaped nails are made of shape-memory material (such as nickel-titanium-based shape-memory alloy, copper-based shape-memory alloy, iron-based shape-memory alloy, etc.) and are bent and heat-set. The anchor 50 is anchored into the tissue by the drive device. The pre-shaped nail is deformed by the delivery sheath, reducing its overall radial dimension to facilitate delivery. When the anchor 50 is released from the delivery sheath, the pre-shaped nail returns to its pre-set curved shape. When the pre-shaped nail is engaged with the tissue, it is in a curved shape that prevents the anchor 50 from falling off.
[0065] See also Figure 6In some embodiments, the implant 100 further includes at least one spacer 70. The spacer 70 is movably connected to the flexible elongated member 30. The spacer 70 is disposed between two adjacent anchoring members 50. It can be understood that the spacer 70 can prevent the flexible elongated member 30 from being over-tightened, resulting in the distance between the two adjacent anchoring members 50 being too short, thereby affecting the effect of reducing the valve ring. At the same time, the spacer 70 can act as a buffer, dispersing the tightening force on the anchoring member 50, and ensuring that the anchoring member 50 is implanted stably. Among them, the spacer 70 is a tubular member of a certain length, made of a biocompatible material. The spacer 70 can be wrapped with a coating to reduce the risk of heart tissue being damaged by the spacer 70 and to increase biocompatibility.
[0066] Optionally, a spacer 70 may be provided between any two adjacent anchors 50 among the plurality of anchors 50, i.e., the anchors 50 and the spacers 70 are staggered. Of course, a spacer 70 may also be provided between every two or more anchors 50, i.e., a spacer 70 may be provided between some adjacent anchors 50, while no spacer 70 may be provided between some adjacent anchors 50. This is not limited in the present application.
[0067] See also Figure 7 In some embodiments, the proximal end of the flexible elongated member 30 is connected to a conveying member 200. It will be understood that the distal end of the flexible elongated member 30 is connected to the first anchoring member 50. The flexible elongated member 30 and the conveying member 200 are transported into the patient's body along with the first anchoring member 50, and the proximal end of the conveying member 200 extends outside the patient's body. The anchoring member 50, the spacer 70, the locking device 10, etc. are transported to the flexible elongated member 30 via the conveying member 200. After the locking device 10 is stably connected to the flexible elongated member 30, the conveying member 200 is disconnected from the flexible elongated member 30 and withdrawn from the patient's body. In this way, the flexible elongated member 30 can be implanted at a suitable length, and there is no need to cut the flexible elongated member 30 in the body, which avoids the shedding of particles on the wire and makes the operation safer.
[0068] In the present application, the transport member 200 can be a flexible linear object, such as a thread, filament, rope, strip, or belt. The radial cross-section of the transport member 200 can be circular, oblate, rectangular, square, or other shapes, which are not limited in this application. The transport member 200 can be made of a biocompatible metal material and / or polymer material, such as 316L stainless steel, tungsten, tantalum, nickel titanium, polyethylene, polyamide, polypropylene, or polyurethane. Exemplarily, the transport member 200 is a slender wire, such as a polymer wire.
[0069] exist Figure 7In the example shown, the proximal end of the flexible elongated member 30 forms a U-shaped connection with the distal end of the transport member 200. This allows for easy separation of the transport member 200 from the flexible elongated member 30 by pulling the transport member 200 outside the body. In other embodiments, the transport member 200 can also be detachably connected to the flexible elongated member 30 via a threaded connection, a snap-fit connection, or other methods, which will not be described in detail.
[0070] exist Figure 5 In the example shown, the length of the flexible elongated member 30 is sufficiently long. When the flexible elongated member 30 is delivered into the patient's body along with the first anchor 50, the proximal end of the flexible elongated member 30 can extend outside the patient's body, facilitating the installation of the anchor 50, spacer 70, locking device 10, etc. After the locking device 10 is stably connected to the flexible elongated member 30, the excess portion of the flexible elongated member 30 can be trimmed with a wire cutter.
[0071] See also Figures 8 to 10 、 Figures 21 to 22 and Figures 28 to 29 In some embodiments, the locking device 10 includes a housing 12 and a winding assembly 14 at least partially housed in the housing 12. The winding assembly 14 is capable of rotating relative to the housing 12. The winding assembly 14 includes a winding member 142, a connecting member 144, and a locking member 146. The locking member 146 is elastic. The locking member 146 is disposed between the winding member 142 and the connecting member 144, and the winding member 142 is fixedly connected to the connecting member 144. The locking member 146 cooperates with the housing 12 to limit the rotation of the winding assembly 14, and the locking member 146 is configured to be able to break away from the restriction of the housing 12 under the action of an external force.
[0072] It can be understood that when the elastic locking member 146 cooperates with the housing 12 to restrict the rotation of the winding assembly 14, the locking device 10 is in a locked state; when the locking member 146 is deformed by force and breaks away from the restriction of the housing 12, the locking device 10 is in an unlocked state, at which time the winding assembly 14 can be driven to rotate clockwise or counterclockwise. Therefore, after the flexible elongated member 30 is connected to the locking device 10 (see Figure 11 ), applying force to disengage the locking member 146 from the restriction of the housing 12, the flexible elongated member 30 can be wound onto the winding member 142 by driving the winding assembly 14 to rotate relative to the housing 12 (see Figure 12 When the flexible elongated member 30 is adjusted to a suitable length, the locking member 146 is restored to cooperate with the housing 12 to restrict the winding assembly 14 from rotating relative to the housing 12 . At this time, the flexible elongated member 30 is locked by the locking device 10 .
[0073] The flexible elongated member 30 is wound around the winding member 142 at least twice, preferably at least three times. In this way, there is friction between the flexible elongated member 30 and the winding member 142, and there is also friction between the multiple turns of the flexible elongated member 30 wound around the winding member 142 due to overlap. The friction can offset the tension generated by the movement of the leaflets, ensuring that the flexible elongated member 30 is not pulled by the tension generated by the movement of the leaflets, and the locking device 10 is stably connected to the flexible elongated member 30. Generally, the flexible elongated member 30 is wound around the winding member 142 multiple times, and the friction between the flexible elongated member 30 that is wound multiple times is greater, the locking force of the locking device 10 on the flexible elongated member 30 is stronger, and the fatigue performance of the flexible elongated member 30 is better.
[0074] Please combine Figure 9 、 Figure 13 、 Figure 22 and Figure 29 In some embodiments, the housing 12 has a proximal opening 121. The connector 144 has a channel 1440 extending axially thereof. The channel 1440 extends through the proximal and distal surfaces of the connector 144. The channel 1440 is exposed to the proximal opening 121. The channel 1440 is configured to allow the elongated rod 26 to pass therethrough. The locking member 146 is released from the restraint of the housing 12 in response to a force applied thereto by the elongated rod 26.
[0075] It will be understood that the winding member 142 and the locking member 146 are entirely housed within the housing 12, and the connecting member 144 is at least partially housed within the housing 12. The channel 1440 of the connecting member 144 is exposed to the proximal opening 121 of the housing 12. Alternatively, the connecting member 144 may be entirely located within the housing 12, with the channel 1440 corresponding to the proximal opening 121, and the slender rod 26 first passing through the proximal opening 121 and then extending into the channel 1440. Alternatively, the connecting member 144 may be partially located within the housing 12 and partially extending from the proximal opening 121, with the slender rod 26 extending directly into the channel 1440. The slender rod 26 passes through the channel 1440 of the connecting member 144 and contacts the locking member 146 disposed between the winding member 142 and the connecting member 144. The slender rod 26 applies force to the locking member 146, causing the locking member 146 to deform and escape the restraints of the housing 12. At this point, the winding assembly 14 can rotate bidirectionally relative to the housing 12. When the locking device 10 needs to be locked, the slender rod 26 is removed, and the locking member 146 re-engages with the housing 12 due to its own elastic recovery shape (ie, returns to its natural state) to restrict the rotation of the winding assembly 14.
[0076] See also Figure 18 、 Figure 19 、 Figure 27 and Figure 34In some embodiments, the locking member 146 includes a resilient locking portion 1462. The locking portion 1462 is elongated and includes two opposing ends, at least one of which is a locking end 1462a. At least one locking groove 123 is defined within the housing 12 along its circumference. The locking end 1462a cooperates with one of the locking grooves 123 to restrict the rotation of the winding assembly 14. The locking portion 1462 is configured to allow the locking end 1462a to escape from the restriction of the locking groove 123 under the action of an external force.
[0077] It can be understood that when the locking portion 1462 is in a natural state, that is, the locking portion 1462 is not affected by external force, the locking end 1462a of the locking portion 1462 is located in one of the locking grooves 123. Since the locking end 1462a is against the surface of the locking groove 123, the locking end 1462a is restricted by the locking groove 123, and the winding assembly 14 cannot rotate relative to the shell 12. When the locking portion 1462 is deformed by external force and the locking end 1462a is disengaged from the locking groove 123, the winding assembly 14 can rotate relative to the shell 12. One locking groove 123, two locking grooves 123 or more locking grooves 123 can be provided along the circumference of the shell 12. Preferably, the locking portion 1462 is evenly provided with a plurality of locking grooves 123 along the circumference. The greater the number of locking grooves 123, the higher the adjustment accuracy of the length of the flexible slender member 30. Figure 19 、 Figure 27 and Figure 34 In the example, ten locking grooves 123 are provided along the circumference of the housing 12. In other examples, eight locking grooves 123, nine locking grooves 123, eleven locking grooves 123, or twelve locking grooves 123 may be provided along the circumference of the housing 12. The number of the locking grooves 123 is not specifically limited in this application.
[0078] The locking portion 1462 can be made of elastic material, such as shape memory alloy (nickel-titanium-based shape memory alloy Ni-TiSMA, copper-based shape memory alloy Cu SMA, iron-based shape memory alloy Fe SMA, etc.), stainless steel, etc. In one example, the locking portion 1462 is made of nickel-titanium alloy.
[0079] In some embodiments, the surface of the locking groove 123 includes a blocking surface 1232, a guide surface 1234, and a transition surface 1236 connecting the blocking surface 1232 and the guide surface 1234. The transition surface 1236 is arcuate. When the locking portion 1462 is in a neutral position, the locking end 1462a is located in one of the locking grooves 123, and the stop portion is substantially parallel to the blocking surface 1232. It will be appreciated that when the locking end 1462a of the stop portion is located in the locking groove 123 and remains stationary, the stop portion and the blocking surface 1232 of the locking groove 123 are substantially parallel, thereby preventing the winding assembly 14 from rotating relative to the housing 12. When the winding assembly 14 stops rotating, if the locking portion 1462 has not moved to a position substantially parallel to the blocking surface 1232, the locking portion 1462 will move along the guide surface 1234 to a position substantially parallel to the blocking surface 1232 due to its own elasticity (after the external force applied to the locking portion 1462 is removed, the locking portion 1462 tends to return to its natural state). In other embodiments, when the locking end 1462a of the stopper is located in the locking groove 123 and remains stationary, the locking portion 1462 and the blocking surface 1232 may intersect and form an angle.
[0080] See also Figure 11 In some embodiments, the housing 12 is provided with a first through hole 125. The winding member 142 is provided with a second through hole 1420. The first through hole 125 and the second through hole 1420 are configured to allow the flexible elongated member 30 to pass through. The winding assembly 14 is configured to rotate relative to the housing 12 to wind the flexible elongated member 30 onto the winding member 142 or to release the flexible elongated member 30 from the winding member 142. It can be understood that the flexible elongated member 30 moves through the first through hole 125 of the housing 12 and the second through hole 1420 of the winding member 142, so that the flexible elongated member 30 is connected to the locking device 10. The winding assembly 14 can be rotated forward relative to the housing 12 to wind the flexible elongated member 30 onto the winding member 142. The winding assembly 14 can be rotated backward relative to the housing 12 to release the flexible elongated member 30 from the winding member 142. In the present application, the rotation direction of the winding assembly 14 that winds the flexible elongated member 30 onto the winding member 142 is defined as forward rotation, and the rotation direction of the winding assembly 14 that unwinds the flexible elongated member 30 from the winding member 142 is defined as reverse rotation.
[0081] Exemplarily, the housing 12 is provided with first through-holes 125 on opposite sides, facilitating the flexible elongated member 30 to enter the housing 12 through the first through-hole 125 on one side, pass through the second through-hole 1420 of the winding assembly 142, and then exit through the first through-hole 125 on the other side. In one example, the two first through-holes 125 are symmetrically arranged about the central axis of the housing 12, with the central axes of the two first through-holes 125 and the central axes of the second through-hole 1420 coplanar. In this way, the winding assembly 14 can be rotated so that the central axis of the second through-hole 1420 is substantially colinear with the central axes of the two first through-holes 125, facilitating the flexible elongated member 30 to smoothly pass through the two first through-holes 125 and the second through-hole 1420. In other examples, the housing 12 may be provided with only one first through-hole 125.
[0082] See also Figure 1 and Figure 13 In some embodiments, the shell 12 includes an upper shell 122, a lower shell 124 and two annular members 126. The upper shell 122 is fixedly connected to the lower shell 124. The two annular members 126 are respectively fixedly arranged on opposite sides of the lower shell 124 to form two first through holes 125. Specifically, the upper shell 122 and the lower shell 124 can be fixedly connected by welding, bonding, threaded connection, etc. Mounting holes are provided on opposite sides of the lower shell 124, and the two annular members 126 are respectively fixedly installed in the mounting holes. The inner and outer sides of the annular member 126 are rounded to reduce damage to the flexible slender member 30.
[0083] See also Figures 14 to 16 、 Figures 23 to 26 and Figures 30 to 33 In some embodiments, the winding member 142 includes a bobbin 1422 and a fixing seat 1424 fixedly connected to the bobbin 1422. The connecting member 144 is fixedly connected to the fixing seat 1424. The fixing seat 1424 is provided with a receiving groove 1424a. The locking portion 1462 is received in the receiving groove 1424a. When the locking portion 1462 is in a natural state, the locking end 1462a extends out of the receiving groove 1424a and engages with one of the locking grooves 123 (see FIG. Figure 8 、 Figure 21 and Figure 28 When the locking portion 1462 is subjected to an external force, the locking portion 1462 is deformed so that the locking end 1462a retracts toward the receiving groove 1424a, and the locking end 1462a is free from the restriction of the locking groove 123 (see Figure 9 、 Figure 22 and Figure 29 ).
[0084] It will be understood that the second through hole 1420 of the winding member 142 is formed on the spool 1422, and the flexible elongated member 30 is wound onto the spool 1422 of the winding member 142. The fixing seat 1424 is fixedly connected to the connecting member 144, and together they define the movable space of the locking member 146. In the illustrated example, the spool 1422 is located at the distal end of the fixing seat 1424. Because the locking portion 1462 is elongated, when the locking portion 1462 is not subjected to external forces, the locking portion 1462 is substantially straight, and its locking end 1462a extends out of the receiving groove 1424a to engage with one of the locking grooves 123 of the housing 12. When the middle portion of the locking portion 1462 is subjected to external forces, the locking portion 1462 deforms and bends toward the distal end of the receiving groove 1424a, causing the locking end 1462a to retract radially along the receiving groove 1424a, freeing the locking end 1462a from the restraint of the locking groove 123.
[0085] See also Figure 10 、 Figure 15 and Figure 23 In some embodiments, the connector 144 includes a first connector 1442. The fixing seat 1424 is fixedly received in the inner cavity of the first connector 1442. The first connector 1442 is provided with an avoidance groove 1442a corresponding to the receiving groove 1424a. It can be understood that the locking portion 1462 is received in the receiving groove 1424a of the fixing seat 1424, and the fixing seat 1424 is fixedly received in the inner cavity of the first connector 1442, restricting the locking portion 1462 between the winding member 142 and the connector 144. The first connector 1442 is provided with an avoidance groove 1442a corresponding to the receiving groove 1424a to avoid affecting the locking end 1462a from extending out of the receiving groove 1424a.
[0086] Furthermore, the shell 12 is provided with a proximal opening 121. The connecting member 144 also includes a second connecting portion 1444 fixedly connected to the first connecting portion 1442. The second connecting portion 1444 extends from the proximal opening 121. It can be understood that the first connecting portion 1442 is accommodated in the shell 12, and the second connecting portion 1444 extends from the proximal opening 121. The connecting member 144 is provided with a channel 1440 extending along its axial direction. The channel 1440 passes through the proximal surface of the second connecting portion 1444 and the distal surface of the first connecting portion 1442, that is, a portion of the channel 1440 coincides with the inner cavity of the first connecting portion 1442. The second connecting portion 1444 of the connecting member 144 extends from the proximal opening 121 of the shell 12 to facilitate the entry of the slender rod 26 into the channel 1440. The slender rod 26 passes through the channel 1440 and applies force to the locking portion 1462 located in the accommodating groove 1424a, causing the locking portion 1462 to deform and bend toward the distal end of the accommodating groove 1424a to break away from the restriction of the locking groove 123. At this time, the winding assembly 14 can rotate in both directions relative to the shell 12.
[0087] See also Figure 16 、 Figure 17 、 Figure 26 and Figure 33 In some embodiments, the radial length of the receiving groove 1424a gradually decreases from the proximal end to the distal end, and the axial depth in the middle of the receiving groove 1424a is greater than the axial depth at the sides. It can be understood that the shape of the receiving groove 1424a restricts the distal axial movement of the two ends of the locking portion 1462, facilitating the application of force to the middle portion of the locking portion 1462, causing the locking portion 1462 to deform and bend toward the distal end of the receiving groove 1424a.
[0088] See also Figures 8 to 19 In some embodiments, the fixing seat 1424 further includes an axial hole 1424b communicating with the accommodating groove 1424a. The axial hole 1424b extends axially along the fixing seat 1424. The locking member 146 further includes a fixing shaft 1464 and a fixing pin 1466. The locking portion 1462 passes through the fixing shaft 1464 and is compressed by the fixing pin 1466. The fixing shaft 1464, the fixing pin 1466, and the locking portion 1462 are relatively fixed. The fixing shaft 1464 is movably accommodated in the axial hole 1424b. It will be understood that in this embodiment, the locking portion 1462 is naturally straight, with both opposing ends being free. The locking portion 1462 may be a straight elastic wire. The fixing shaft 1464 includes mounting holes along its radial direction. The locking portion 1462 passes through the mounting holes of the fixing shaft 1464 and is compressed by the fixing pin 1466. The fixing pin 1466 and the fixing shaft 1464 may be secured by welding or gluing. Locking portion 1462 is received in receiving groove 1424a, while fixed shaft 1464 is received in the receiving hole, allowing locking member 146 to move only axially. After passing through channel 1440 of connector 144, elongated rod 26 can contact fixed shaft 1464 of locking member 146. By applying force to fixed shaft 1464, external force is transmitted to locking portion 1462, causing locking portion 1462 to deform. In some examples, the central axis of axial hole 1424b substantially coincides with the central axis of winding member 142, allowing elongated rod 26 to accurately apply force to the central portion of locking portion 1462.
[0089] Furthermore, both opposing ends of the locking portion 1462 are locking ends 1462a. Multiple locking grooves 123 are provided within the housing 12 along its circumference. Each locking end 1462a cooperates with one of the locking grooves 123 to restrict the rotation of the winding assembly 14. It will be understood that when both opposing ends of the locking portion 1462 are locking ends 1462a, the number of locking grooves 123 provided within the housing 12 is even, thereby ensuring that when the winding assembly 14 stops rotating after rotating at any angle relative to the housing 12, both locking ends 1462a can enter their corresponding locking grooves 123.
[0090] In other embodiments, one of the two opposite ends of the locking portion 1462 is a locking end 1462a, and the other end is fixedly connected to the winding member 142 or the connecting member 144. In this way, the locking member 146 can omit the fixed shaft 1464 and the fixing pin 1466. The locking portion 1462 is straight in its natural state. The locking portion 1462 can be a linear elastic wire. One end of the locking portion 1462 is fixedly connected to the winding member 142 or the connecting member 144, which can prevent the locking portion 1462 from being offset relative to the winding member 142 and the connecting member 144 when assembling the winding assembly 14, thereby facilitating assembly. In this embodiment, a plurality of locking grooves 123 are provided in the shell 12 along its circumference. Since the locking portion 1462 is provided with a locking end 1462a, the locking grooves 123 provided in the shell 12 can be odd or even.
[0091] See also Figures 20 to 27 In some embodiments, the locking member 146 further includes a fixing portion 1468. One of the two opposite ends of the locking portion 1462 is a locking end 1462a, and the other end is fixedly connected to the fixing portion 1468. One of the fixing seat 1424 and the fixing portion 1468 is provided with a protrusion 1424c, and the other is provided with a matching groove 1468a adapted to the protrusion 1424c. The protrusion 1424c is received in the matching groove 1468a. It can be understood that the shapes of the protrusion 1424c and the matching groove 1468a are adapted, and the fixing seat 1424 of the winding member 142 and the fixing portion 1468 of the locking member 146 are matched and connected via the protrusion 1424c and the matching groove 1468a. When assembling the winding assembly 14, the locking member 146 is first connected to the fixing seat 1424, and then the connecting member 144 is fixedly connected to the winding member 142. After the winding assembly 14 is assembled, the axial movement of the locking member 146 is restricted when the locking portion 1462 is not subjected to external forces. In this embodiment, a plurality of locking grooves 123 are provided along the circumference of the housing 12. Since the locking portion 1462 has a locking end 1462a, the number of locking grooves 123 provided in the housing 12 can be odd or even.
[0092] In some examples, the fixing seat 1424 is provided with protrusions 1424c on both sides of the receiving groove 1424a, and the fixing portion 1468 is provided with corresponding mating grooves 1468a. In this example, the fixing portion 1468 and the locking portion 1462 can be made of the same elastic material. The fixing portion 1468 and the locking portion 1462 can be integrally formed, that is, the locking member 146 can be made of a single elastic wire through heat setting. In other examples, the fixing seat 1424 is provided with mating grooves 1468a on both sides of the receiving groove 1424a, and the fixing portion 1468 is provided with corresponding protrusions 1424c.
[0093] See also Figures 28 to 34In some embodiments, the locking member 146 further includes a fixing portion 1468. One of the two opposite ends of the locking portion 1462 is a locking end 1462a, and the other end is fixedly connected to the fixing portion 1468. The fixing seat 1424 is provided with a fixing groove 1424d adapted to the fixing portion 1468. The fixing portion 1468 is accommodated in the fixing groove 1424d. It can be understood that the shapes of the fixing portion 1468 and the fixing groove 1424d are adapted. In this embodiment, the fixing portion 1468 and the locking portion 1462 can be made of the same elastic material. The fixing portion 1468 and the locking portion 1462 can be formed as one piece, that is, the locking member 146 can be made of an elastic wire through heat setting. When assembling the winding assembly 14, first place the fixing portion 1468 and the locking portion 1462 of the locking member 146 in the fixing groove 1424d and the receiving groove 1424a of the fixing seat 1424, respectively, and then fix the connecting member 144 to the winding member 142. After the winding assembly 14 is assembled, when the locking portion 1462 is not subjected to external force, the axial movement of the locking member 146 is restricted. In this embodiment, a plurality of locking grooves 123 are provided along the circumference of the housing 12. Since the locking portion 1462 is provided with a locking end 1462a, the locking grooves 123 provided in the housing 12 can be odd or even.
[0094] In some embodiments, the fixing groove 1424d is provided on the outer peripheral wall of the fixing seat 1424. The fixing groove 1424d includes a first axial section 1424d1, a circumferential section 1424d2, and a second axial section 1424d3, which are sequentially connected. The second axial section 1424d3 is connected to the receiving groove 1424a. This can enhance the connection stability between the fixing portion 1468 and the fixing seat 1424.
[0095] See also Figures 35 to 37 , the embodiment of the present application further provides a locking system 300. The locking system 300 includes a delivery device 20 and a locking device 10 of any of the above embodiments. The delivery device 20 includes an outer tube 22, an inner tube 24 movably mounted in the outer tube 22, and a slender rod 26 movably mounted in the inner tube 24. The distal end of the outer tube 22 is connected to the housing 12 and is relatively fixed. The distal end of the inner tube 24 is connected to the connecting member 144 and is relatively fixed. The outer tube 22 is configured to limit the rotation of the housing 12, the slender rod 26 is configured to provide an external force to the locking member 146 to release the locking member 146 from the restriction of the housing 12, and the inner tube 24 is configured to drive the winding assembly 14 to rotate relative to the housing 12.
[0096] It will be appreciated that after the multiple anchors 50 connected by the flexible elongated member 30 are anchored to the annulus, the locking device 10 connected to the distal end of the delivery device 20 is connected to the flexible elongated member 30. The elongated rod 26 is then pushed distally to apply force to the locking member 146, causing it to deform and release from the restraints of the housing 12. The inner tube 24 is then rotated to drive the winding assembly 14 relative to the housing 12, winding the flexible elongated member 30 onto the winding member 142, tightening the flexible elongated member 30 and reducing the spacing between the multiple anchors 50, thereby reducing the size of the patient's annulus. After the desired annular reduction is achieved, the inner tube 24 is stopped, causing the winding assembly 14 to stop rotating. The elongated rod 26 is then withdrawn proximally, causing the locking member 146 to re-engage with the housing 12 due to its elastic recovery, thereby locking the flexible elongated member 30. During the rotation of the inner tube 24, the outer tube 22 remains stationary, thereby restricting the rotation of the housing 12.
[0097] In some embodiments, the housing 12 has a proximal opening 121. The connector 144 has a channel 1440 extending axially therefrom. Channel 1440 extends through the proximal and distal surfaces of the connector 144. The connector 144 includes a first connecting portion 1442 and a second connecting portion 1444 that are fixedly connected. The winding member 142 and the locking member 146 are integrally housed within the housing 12. The first connecting portion 1442 of the connector 144 is housed within the housing 12, while the second connecting portion 1444 extends from the proximal opening 121 of the housing 12 to facilitate connection with the inner tube 24 of the delivery device 20. Specifically, the distal end of the inner tube 24 is movably coupled to the second connecting portion 1444, and the inner tube 24 and the second connecting portion 1444 are relatively fixedly secured against rotation. In one example, the second connecting portion 1444 has at least one flat surface defined along the axial direction, and correspondingly, the distal end of the inner tube 24 has at least one flat surface defined thereon. The inner tube 24 and the second connecting portion 1444 are restricted from relative rotation by the flat surface. In another example, the inner tube 24 and the second connecting portion 1444 can limit relative rotation between the inner tube 24 and the second connecting portion 1444 through the cooperation between the protrusion 5624 and the sliding groove.
[0098] See also Figure 37 and Figure 38In some embodiments, the elongated rod 26 includes a main body section 262 and a force-applying section 264 connected to the main body section 262. The force-applying section 264 is configured to press the locking member 146 in the channel 1440 of the connecting member 144 to release the locking member 146 from the restriction of the housing 12. It can be understood that the elongated rod 26 passes through the channel 1440 of the connecting member 144 and contacts the locking member 146 disposed between the winding member 142 and the connecting member 144. The force-applying section 264 located in the channel 1440 presses the locking member 146 distally, causing the locking member 146 to deform and release from the restriction of the housing 12. At this time, the winding assembly 14 can rotate bidirectionally relative to the housing 12. When the locking device 10 needs to be locked, the elongated rod 26 is removed, and the locking member 146 re-engages with the housing 12 due to its own elastic recovery shape (i.e., returns to its natural state) to restrict the rotation of the winding assembly 14.
[0099] In some embodiments, at least the proximal portion of the channel 1440 of the connector 144 is internally threaded, and the force-applying section 264 is correspondingly externally threaded. A first annular projection 240 is provided within the lumen of the inner tube 24, and a second annular projection 260 is provided within the elongated rod 26. After the distal end of the inner tube 24 is connected to the connector 144 and the force-applying section 264 of the elongated rod 26 is threadedly connected to the channel 1440, the second annular projection 260 restricts proximal movement of the first annular projection 240. It will be appreciated that the threaded connection between the force-applying section 264 of the elongated rod 26 and the channel 1440 of the connector 144 allows the elongated rod 26 to move axially relative to the channel 1440 via a screw drive, while also ensuring a stable connection between the elongated rod 26 and the connector 144. The second annular projection 260 restricts proximal movement of the first annular projection 240, thereby maintaining the connection between the inner tube 24 and the connector 144.
[0100] It can be understood that since the slender rod 26 is threadedly connected to the connecting member 144 and the inner tube 24 is movably sleeved on the connecting member 144, when the winding assembly 14 is driven to rotate relative to the housing 12, the inner tube 24 and the slender rod 26 rotate synchronously, driving the winding assembly 14 to rotate. This can, on the one hand, prevent the threaded connection between the slender rod 26 and the connecting member 144 from being prematurely released when the ideal surgical effect is not achieved, ensure that the slender rod 26 continuously applies pressure to the locking member 146, so that the locking device 10 remains unlocked, and the inner tube 24 and the connecting member 144 are always sleeved, thereby stably driving the winding assembly 14 to rotate and wind the flexible slender member 30 onto the winding member 142, thereby improving the stability of the surgical operation; on the other hand, it can prevent the threaded connection between the connecting rod and the connecting member 144 from becoming increasingly tight and difficult to release, thereby improving the safety and reliability of the surgery.
[0101] See also Figure 36In some embodiments, the outer tube 22 includes an outer tube body 222 and a connecting claw 224 fixedly provided at the distal end of the outer tube body 222. The housing 12 is correspondingly provided with a connecting groove 127 adapted to the connecting claw 224. The outer tube 22 and the housing 12 are connected and relatively fixed to each other through the cooperation between the connecting claw 224 and the connecting groove 127. The number of the connecting claws 224 can be one or more, and the number of the connecting grooves 127 is the same as the number of the connecting claws 224. In one example, the number of the connecting claws 224 is two, and the two connecting claws 224 are fixedly connected to the distal end of the outer tube body 222 and arranged opposite to each other. Correspondingly, the housing 12 is provided with two connecting grooves 127.
[0102] See also Figure 2 and Figures 39 to 41 The working principle of the locking device 10 according to the embodiment of the present application will be described below using the locking device 10 as an example for mitral annuloplasty. The surgical path for mitral annuloplasty is: femoral vein - inferior vena cava - right atrium (RA) - atrial septum (AS) - left atrium (LA) - mitral valve annulus (MVA).
[0103] See also Figure 39 , sequentially from the anterior trigone of the mitral valve along the posterior annulus to the posterior trigone or vice versa, a sufficient number of anchors 50 are implanted in the mitral valve annulus. The distal end of the flexible elongated member 30 is connected to the first anchor 50, and the proximal end of the flexible elongated member 30 is U-shapedly connected to the distal end of the delivery member 200. The remaining anchors 50 are delivered to the flexible elongated member 30 by the delivery member 200 before implantation, thereby being movably connected to the flexible elongated member 30. Two adjacent anchors 50 are provided with a spacer 70, and the distance between the two adjacent anchors 50 is greater than the axial length of the spacer 70.
[0104] Please refer to the figure Figure 40 and Figure 41The locking device 10 is pre-connected to the distal end of the conveying device 20. First, the proximal end of the conveying member 200 is sequentially passed through the first through-hole 125, the second through-hole 1420 on one side of the locking device 10, and the second through-hole 1420 on the other side. The locking device 10 is then conveyed along the conveying member 200 to the flexible elongated member 30, where the locking device 10 is close to the last anchoring member 50. Then, the elongated rod 26 is rotated so that the elongated rod 26 moves distally through the screw drive, exerting a force on the locking portion 1462, causing the locking portion 1462 to deform and bend toward the distal end of the accommodating groove 1424a. The locking end 1462a retracts radially along the accommodating groove 1424a, freeing the locking end 1462a from the restriction of the locking groove 123 of the housing 12, and the winding assembly 14 can rotate bidirectionally relative to the housing 12. Next, fix the outer tube 22, rotate the inner tube 24 and the slender rod 26 clockwise to rotate the winding assembly 14 relative to the housing 12 and wind the flexible slender member 30 onto the winding member 142. After the flexible slender member 30 is wound around the winding member 142 at least twice, pull the transport member 200 out of the body. Observe the regurgitation of the mitral valve by ultrasound. If the amount of mitral valve regurgitation has not yet been reduced to the ideal state, continue to rotate the inner tube 24 and the slender rod 26 clockwise to further tighten the flexible slender member 30. If the flexible slender member 30 is over-tightened and causes mitral valve stenosis, rotate the inner tube 24 and the slender rod 26 counterclockwise to release part of the flexible slender member 30. During the operation, the clockwise and counterclockwise rotation (if necessary) of the winding assembly 14 is controlled until a good ring shrinking effect is achieved. Finally, the threaded connection between the elongated rod 26 and the connecting member 144 is released, and the locking portion 1462 resiliently recovers its shape and re-engages with the housing 12, thereby locking the flexible elongated member 30. The flexible elongated member 30 wound around the winding member 142 maintains a tight fit between the locking device 10 and the last anchoring member 50 due to friction.
[0105] It should be noted that, in the absence of conflict, the embodiments and features in the embodiments of this application can be combined with each other, and any combination of features in different embodiments is also within the scope of protection of this application. That is to say, the multiple embodiments described above can also be arbitrarily combined according to actual needs.
[0106] It should be noted that all the above drawings are for illustrative purposes only and do not represent the actual size of the product. Furthermore, the dimensional ratios between the components in the drawings are not intended to limit the actual product of the present application.
[0107] The above are only some of the embodiments and implementations of this application. The scope of protection of this application is not limited to them. Any changes or substitutions that can be easily conceived by a person skilled in the art within the technical scope disclosed in this application should be included in the scope of protection of this application. Therefore, the scope of protection of this application should be based on the scope of protection of the claims.
Claims
1. A locking device for an implant, characterized in that: include: case; and a winding assembly at least partially housed in the housing, the winding assembly being rotatable relative to the housing, the winding assembly comprising a winding member, a connecting member, and a locking member, the locking member being elastic and disposed between the winding member and the connecting member, the winding member being fixedly connected to the connecting member; wherein the locking member comprises an elastic locking portion, the locking portion is in the shape of an elongated strip and comprises two opposite ends, at least one of the two opposite ends being a locking end, and at least one locking groove is provided in the shell along its circumference; the winding member comprises a spool and a fixing seat fixedly connected to the spool, the connecting member is fixedly connected to the fixing seat, the fixing seat is provided with a receiving groove, the radial length of the receiving groove gradually decreases from the proximal end to the distal end, and the axial depth in the middle of the receiving groove is greater than the axial depth on both sides, and the locking portion is accommodated in the receiving groove; when the locking portion is in a natural state, the locking end extends out of the receiving groove and cooperates with one of the locking grooves to limit the rotation of the winding assembly; When the locking portion is subjected to an external force, the locking portion is deformed to cause the locking end to retract toward the accommodating groove, and the locking end is freed from the restriction of the locking groove.
2. The locking device according to claim 1, characterized in that The connecting member includes a first connecting portion, the fixing seat is fixedly accommodated in the inner cavity of the first connecting portion, and the first connecting portion is provided with an avoidance groove corresponding to the accommodating groove.
3. The locking device according to claim 2, characterized in that The shell is provided with a proximal opening, and the connecting member further includes a second connecting portion fixedly connected to the first connecting portion, and the second connecting portion extends from the proximal opening.
4. The locking device according to any one of claims 1 to 3, characterized in that: The fixing seat is also provided with an axial hole connected to the accommodating groove, and the axial hole extends along the axial direction of the fixing seat. The locking member also includes a fixing shaft and a fixing pin. The locking portion passes through the fixing shaft and is tightened by the fixing pin. The fixing shaft, the fixing pin and the locking portion are relatively fixed, and the fixing shaft can be movably accommodated in the axial hole.
5. The locking device according to claim 4, characterized in that: The two opposite ends are both locking ends. A plurality of locking grooves are provided in the shell along its circumference. Each locking end cooperates with one of the locking grooves to limit the rotation of the winding assembly.
6. The locking device according to any one of claims 1 to 3, characterized in that: The locking member also includes a fixing portion, one of the two opposite ends being the locking end, and the other end being fixedly connected to the fixing portion, one of the fixing seat and the fixing portion being provided with a protrusion, and the other being provided with a matching groove adapted to the protrusion, and the protrusion being accommodated in the matching groove.
7. The locking device according to any one of claims 1 to 3, characterized in that: The locking member also includes a fixing portion, one of the two opposite ends being the locking end, and the other end being fixedly connected to the fixing portion, the fixing seat being provided with a fixing groove adapted to the fixing portion, and the fixing portion being accommodated in the fixing groove.
8. The locking device according to claim 7, characterized in that The fixing groove is provided on the outer peripheral wall of the fixing seat, and the fixing groove includes a first axial section, a circumferential section, and a second axial section which are connected in sequence, and the second axial section is connected to the accommodating groove.
9. The locking device according to claim 1, characterized in that The surface of the locking groove includes a blocking surface, a guide surface, and a transition surface connecting the blocking surface and the guide surface, wherein the transition surface is arc-shaped; Wherein, when the locking portion is in a natural state, the locking end is located in one of the locking grooves, and the locking portion is substantially parallel to the blocking surface.
10. The locking device according to claim 1, wherein: The shell is provided with a first through hole, and the winding member is provided with a second through hole. The first through hole and the second through hole are configured to allow a flexible slender member to pass through. The winding assembly is configured to rotate relative to the shell to wind the flexible slender member onto the winding member or loosen the flexible slender member from the winding member.
11. The locking device according to claim 1, characterized in that The shell is provided with a proximal opening, and the connecting piece is provided with a channel extending along its axial direction, the channel passing through the proximal end surface and the distal end surface of the connecting piece, the channel being exposed at the proximal opening, and the channel being configured for a slender rod to pass through, the locking piece being released from the restriction of the shell in response to a force applied thereto by the slender rod.
12. A locking system, characterized in that: The invention comprises a conveying device and the locking device according to any one of claims 1 to 11, wherein the conveying device comprises an outer tube, an inner tube movably inserted into the outer tube, and an elongated rod movably inserted into the inner tube, wherein the distal end of the outer tube is connected to the housing and is relatively fixed, and the distal end of the inner tube is connected to the connecting member and is relatively fixed; The outer tube is configured to limit the rotation of the housing, the slender rod is configured to provide external force to the locking element to release the locking element from the restriction of the housing, and the inner tube is configured to drive the winding assembly to rotate relative to the housing.
13. The locking system according to claim 12, wherein: The connecting member is provided with a channel extending along its axial direction, and the channel passes through the proximal end surface and the distal end surface of the connecting member. The slender rod includes a main body section and a force-applying section connected to the main body section. The force-applying section is configured to press the locking member in the channel to release the locking member from the restriction of the shell.
14. The locking system according to claim 13, wherein: At least the proximal portion of the channel is provided with an internal thread, the force-applying section is correspondingly provided with an external thread, a first annular protrusion is provided in the inner cavity of the inner tube, and a second annular protrusion is provided on the slender rod; Wherein, after the distal end of the inner tube is connected to the connecting piece and the force-applying section of the slender rod is threadedly connected to the channel, the second annular protrusion restricts the first annular protrusion from moving toward the proximal end.
15. An implant, characterized in that It comprises a flexible slender member, a plurality of anchor members and a locking device according to any one of claims 1 to 11, wherein the flexible slender member connects the plurality of anchor members and the locking device, each of the anchor members is configured to be anchored to tissue, the flexible slender member is configured to adjust the spacing between the plurality of anchor members, and the locking device is configured to adjust the length of the flexible slender member and lock the length of the flexible slender member.
16. The implant according to claim 15, characterized in that The implant further includes at least one spacer, which is movably connected to the flexible elongated member and is disposed between two adjacent anchoring members.
17. The implant according to claim 15, characterized in that The anchor member includes a tissue engaging element, a head and a connecting structure, the head is connected to the proximal end of the tissue engaging element, the connecting structure can be rotatably mounted on the head or the proximal part of the tissue engaging element, the connecting structure is provided with a connecting hole, the connecting hole is configured for the flexible slender member to pass through, the distal end of the flexible slender member is provided with a fixing member, the fixing member is located on the distal side of the connecting hole of the first anchor member, the fixing member is connected to the connecting structure to limit the proximal movement of the first anchor member relative to the flexible slender member.
Citation Information
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