Implantable fixation device for engaging cardiac tissue including an improved locking mechanism

Abstract

The present invention discloses an implantable fixation device for engaging cardiac tissue including an improved locking mechanism, comprising: a first distal element, a second distal element, a first proximal element, a second proximal element and a locking mechanism, wherein the locking mechanism includes: a transmission column and a fixing clip, the transmission column includes a transmission column body, the transmission column body includes a plurality of clamping structures along its axial direction, the transmission column has a locked state and an unlocked state, in the locked state, the plurality of clamping structures on the transmission column body are frictionally engaged with the fixing clip, thereby restricting the movement of the transmission column; in the unlocked state, the transmission column is pushed by an external force, the transmission column moves relative to the fixing clip, thereby driving the first proximal element and the second proximal element to move. The improved locking mechanism of the fixation device enables medical staff to conveniently and quickly switch the fixation device between the locked state and the unlocked state, so that the fixation device can be locked in place.

Description

Technical Field

[0001] This application generally relates to the field of medical device technology, and more particularly to an implantable fixation device for engaging cardiac tissue that includes an improved locking mechanism. Background Art

[0002] Surgical repair of body tissues generally involves tissue approximation and fixation of the approximated tissues. In repairing a valve, tissue approximation includes enclosing the leaflets of the valve in a treatment device, which can then be held in place by fastening or fixing the leaflets. This method can be used to treat regurgitation, which most commonly occurs in the mitral valve.

[0003] Mitral regurgitation is characterized by the reverse flow of blood from the left ventricle through an incompetent mitral valve into the left atrium. During the normal cycle of cardiac contraction, the mitral valve acts as a check valve, preventing oxygenated blood from flowing back into the left atrium. In this way, oxygenated blood is pumped into the aorta through the aortic valve. Valve regurgitation significantly reduces the pumping efficiency of the heart, putting the patient at risk of severe progressive heart failure.

[0004] Mitral regurgitation can be caused by a variety of different mechanical defects in the mitral valve or the left ventricular wall. The leaflets, chordae tendineae connecting the leaflets to the papillary muscles, the papillary muscles, or the left ventricular wall may be damaged or incompetent. Typically, the valve annulus is damaged, dilated, or weakened, limiting the ability of the mitral valve to close properly in the face of high left ventricular pressure.

[0005] The most common treatments for mitral regurgitation are valve replacement or repair, including leaflet and annulus reconstruction, the latter generally referred to as valvuloplasty. A recent mitral repair technique is known as the "bow tie" or "edge-to-edge" technique, which relies on suturing adjacent segments of opposing leaflets together. While all of these techniques are very effective, they generally rely on open-heart surgery, typically opening the patient's chest through a sternotomy and then placing the patient on cardiopulmonary bypass. The need to open the chest and bypass the heart is traumatic and associated with high mortality and morbidity.

[0006] Therefore, there is a great need in the art to develop an implantable fixation device for engaging cardiac tissue that includes an improved locking mechanism, and the improved locking mechanism of the fixation device enables medical staff to conveniently and quickly switch the implantable fixation device between a locked state and an unlocked state, so that the fixation device can be locked in place and remain in the body as an implant. Summary of the Invention

[0007] The purpose of the present application is to provide an implantable fixation device for engaging cardiac tissue including an improved locking mechanism. The improved locking mechanism of the fixation device enables medical staff to conveniently and quickly switch the implantable fixation device between a locked state and an unlocked state, so that the fixation device can be locked in a fixed position and remain in the body as an implant.

[0008] The present invention provides an implantable fixation device for engaging cardiac tissue including an improved locking mechanism, comprising: a first distal element, a second distal element, a first proximal element, a second proximal element, and a locking mechanism, wherein the locking mechanism includes: a transmission column and a fixing clip;

[0009] The distal end of the first proximal element is connected to the first distal element, and the proximal end of the first proximal element is connected to the transmission column; the distal end of the second proximal element is connected to the second distal element, and the proximal end of the second proximal element is connected to the transmission column; the proximal ends of the first distal element and the second distal element are both connected to the fixing clip;

[0010] The cooperative movement of the transmission column and the fixing clip causes the first distal element and the second distal element to move between an open position and a closed position;

[0011] The transmission column includes a transmission column body, and the transmission column body includes a plurality of clamping structures along its axial direction. The transmission column includes a locked state and an unlocked state. In the locked state, the plurality of clamping structures of the transmission column body are frictionally engaged with the fixing clip, thereby restricting the movement of the transmission column, and further locking the first distal element and the second distal element at an appropriate position between the open position and the closed position; in the unlocked state, the transmission column is subjected to an external force, and the transmission column moves relative to the fixing clip, so that the transmission column drives the first proximal element and the second proximal element to move, and further drives the first distal element and the second distal element to move between the open position and the closed position.

[0012] In another preferred example, the first distal element and the second distal element are symmetrically arranged.

[0013] In another preferred example, the first proximal element and the second proximal element are symmetrically arranged.

[0014] In another preferred example, the first distal element and the second distal element are symmetrically arranged with the transmission column as the center axis.

[0015] In another preferred example, the first proximal element and the second proximal element are symmetrically arranged with the transmission column as the center axis.

[0016] In another preferred example, the drive column is made of a flexible material.

[0017] In another preferred example, the drive column is foldable.

[0018] In another preferred example, the fixing clip is a U-shaped clip.

[0019] In another preferred example, the shape of the cross-section of the plurality of latching structures is selected from the group consisting of: trapezoidal, square, cylindrical, or combinations thereof.

[0020] In another preferred example, the fixing clip always remains stationary.

[0021] In another preferred example, the drive column body is a flexible foldable ridge-shaped element.

[0022] In another preferred example, the drive column body is composed of a plurality of latching structures, and the plurality of latching structures are a plurality of successively arranged latching structures with trapezoidal cross-sections arranged along the axial direction of the drive column.

[0023] In another preferred example, the trapezoid of the latching structure with a trapezoidal cross-section is an isosceles trapezoid, and the height of each isosceles trapezoid remains unchanged or increases or decreases or alternately changes in the axial direction of the drive column from the distal end to the proximal end.

[0024] In another preferred example, the heights of the respective isosceles trapezoids are different, the lengths of the upper bases of the respective different isosceles trapezoids are approximately equal, and the lengths of the lower bases of the respective different isosceles trapezoids are approximately equal.

[0025] In another preferred example, the lower base of the isosceles trapezoid is arranged away from the first distal element and the second distal element.

[0026] In another preferred example, the drive column body is composed of a plurality of latching structures, and the plurality of latching structures are a plurality of successively arranged latching post structures arranged along the axial direction of the drive column. Each latching post structure includes an interconnected latching post and a connecting post. The cross-sectional diameter of the latching post is variable, the cross-sectional diameter of the connecting post is constant, and the maximum cross-sectional diameter of the latching post is greater than the cross-sectional diameter of the connecting post.

[0027] In another preferred example, the drive column body of the drive column is a cylindrical structure, and the plurality of latching structures are sleeved on the cylindrical structure, and the cross-sections of the plurality of latching structures are rectangular in shape, and the plurality of latching structures are spaced apart by a predetermined distance.

[0028] In another preferred example, the plurality of latching structures include a series of barb features.

[0029] In another preferred example, the barb features are inclined and angled.

[0030] In another preferred example, the shape and structure of the fixing clip match the shape and structure of the multiple positioning structures of the transmission column such that in the locked state, the fixing clip and the transmission column do not move; in the unlocked state, the transmission column can move relative to the axial direction of the transmission column.

[0031] In another preferred example, the implantable fixing device further includes a control rod for driving the transmission column to move relative to the fixing clip.

[0032] In another preferred example, a control rod connection part connected to the control rod is provided at the distal end of the transmission column body of the transmission column.

[0033] In another preferred example, the proximal end of the transmission column includes a transmission column seat, and the proximal end of the first proximal element is connected to the transmission column seat of the transmission column; the proximal end of the second proximal element is connected to the transmission column seat of the transmission column.

[0034] In another preferred example, the control rod is made of a rigid material or a flexible material.

[0035] In another preferred example, the control rod and the control rod connection part are threadedly connected.

[0036] In another preferred example, the control rod and the control rod connection part are connected by a hooking method.

[0037] In another preferred example, the implantable fixing device further includes a sheet-like component, and the sheet-like component includes a first sheet-like element and a second sheet-like element. The first sheet-like element is disposed on the first distal element, thereby forming a first tissue engagement surface between the first distal element and the first sheet-like element. The second sheet-like element is disposed on the second distal element, thereby forming a second tissue engagement surface between the second distal element and the second sheet-like element.

[0038] In another preferred example, the first sheet-like element and the second sheet-like element are two sheet-like components welded together with a predetermined structure.

[0039] It should be understood that within the scope of the present invention, the above technical features of the present invention and the technical features specifically described below (such as in the embodiments) can be combined with each other to form new or preferred technical solutions. Due to space limitations, they will not be repeated one by one here. Description of the Drawings

[0040] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the following will briefly introduce the drawings required for the description of the embodiments or the prior art. It should be understood that the drawings in the following description are only some embodiments of the present invention, and those of ordinary skill in the art can obtain other embodiments based on these drawings without creative efforts.

[0041] Figure 1 is a schematic structural diagram of the deployed state of an implantable fixation device for engaging heart tissue including an improved locking mechanism according to the first embodiment of the present application;

[0042] Figure 2 is a schematic structural diagram of the closed state of an implantable fixation device for engaging heart tissue including an improved locking mechanism according to the first embodiment of the present application;

[0043] Figure 3 is a schematic structural diagram of the locking mechanism of the fixation device according to the first embodiment of the present application;

[0044] Figure 4 shows a schematic diagram of a connection mode between the locking mechanism and the control rod according to the first embodiment of the present application;

[0045] Figures 5-6 is a schematic structural diagram of other deformations of the transmission column of the locking mechanism of the implantable fixation device according to the first embodiment of the present application;

[0046] Figure 7 is a schematic structural diagram of the transmission column of the locking mechanism of the implantable fixation device according to the second embodiment of the present application;

[0047] Figure 8 is a schematic structural diagram of the transmission column of the locking mechanism of the implantable fixation device according to the third embodiment of the present application.

[0048] In each of the drawings, the respective identifications are as follows:

[0049] 1a - First distal element

[0050] 1b - Second distal element

[0051] 2a - First proximal element

[0052] 2b - Second proximal element

[0053] 3 - Locking mechanism

[0054] 31 - Transmission column

[0055] 311 - Transmission column body

[0056] 300 - Card position structure

[0057] 3001 - Card positioning post

[0058] 3002 - Connecting post

[0059] 3111 - Control rod connecting part

[0060] 32 - Fixed clamp

[0061] 4 - Control rod

[0062] 10a - First sheet-like element

[0063] 10b - Second sheet-like element Detailed implementation mode

[0064] Through extensive and in-depth research, the present inventor has developed for the first time an implantable fixation device for joining heart tissue including an improved locking mechanism. The locking mechanism of the fixation device maintains the clamping angle of the fixation device at a desired position by increasing friction. The locking mechanism is simple, reliable and safe. The locking mechanism includes a friction-fit drive post and a fixed clamp, enabling the first distal element and the second distal element of the implantable fixation device to move between an open position and a closed position. The implantable fixation device can be used in a variety of therapeutic procedures, including endovascular, minimally invasive and open surgical procedures, and can be used in various anatomical regions, including the abdomen, chest, cardiovascular system, heart, intestine, stomach, urinary tract, bladder, lungs, and other organs, blood vessels and tissues. And the ingenious setting of the locking mechanism of the present application enables medical staff to conveniently lock and unlock the fixation device, so that the fixation device can be locked at a desired position. Because the present invention provides a frictional force to maintain the clamping angle at a desired position.

[0065] Terms

[0066] As used herein, "clip", "fixation device" and "implantable fixation device" are used interchangeably;

[0067] The terms "comprise", "comprising" or any other variant thereof are intended to cover non-exclusive inclusion, such that a process, method, article or apparatus that comprises a series of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such process, method, article or apparatus. Without further limitation, an element defined by the statement "comprising one" does not exclude the presence of additional identical elements in the process, method, article or apparatus that comprises the element. In the application documents of this patent, if it is mentioned that an act is performed according to a certain element, it means that the act is performed at least according to that element, including two cases: performing the act only according to that element and performing the act according to that element and other elements. Expressions such as "a plurality of", "multiple times", "multiple types", etc. include 2, 2 times, 2 types, and more than 2, more than 2 times, more than 2 types.

[0068] In the application documents of this patent, relational terms such as "first" and "second" are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations.

[0069] In the present invention, all directional indications (such as up, down, left, right, front, back, etc.) are only used to explain the relative positional relationship, movement conditions, etc. between components in a specific posture (as shown in the drawings). If the specific posture changes, the directional indications will change accordingly.

[0070] In the following description, many technical details are provided to help the reader better understand the present application. However, those of ordinary skill in the art can understand that the technical solutions claimed in the present application can be implemented even without these technical details and various changes and modifications based on the following embodiments.

[0071] Implantable fixation device (clip)

[0072] See Figure 1 and Figure 2 , the implantable fixation device of the present invention, an implantable fixation device for engaging heart tissue including an improved locking mechanism includes a pair of components, a pair of sheet-like components, a locking mechanism 3 and a control rod 4.

[0073] The pair of components includes two symmetrically arranged free ends, namely a first distal element 1a and a second distal element 1b, and a first proximal element 2a and a second proximal element 2b that are symmetrically arranged; the pair of sheet-like components includes a first sheet-like element 10a and a second sheet-like element 10b. The first sheet-like element 10a is disposed on the first distal element 1a, thereby forming a first tissue engagement surface between the first distal element 1a and the first sheet-like element 10a. The second sheet-like element 10b is disposed on the second distal element 1b, thereby forming a second tissue engagement surface between the second distal element 1b and the second sheet-like element 10b; the locking mechanism 3 includes a transmission column 31 and a fixing clip 32.

[0074] Through the cooperation of the transmission column 31 and the fixing clip 32, the movement of the transmission column 31 drives the movement of the first proximal element 2a and the second proximal element 2b. Thus, the movement of the first proximal element 2a and the second proximal element 2b enables the first distal element 1a and the second distal element 1b to move between an open position and a closed position. In the open position, the free ends (i.e., the first distal element 1a and the second distal element 1b) are spaced apart. In the closed position, the free ends (i.e., the first distal element 1a and the second distal element 1b) are close to each other and the engagement surfaces generally face each other. The pair of elements in the closed position is adapted to reduce retrograde blood flow through the engaged tissue.

[0075] Preferably, the first sheet-like element 10a and the second sheet-like element 10b are two sheet-like components welded together with a predetermined structure.

[0076] Preferably, the first distal element 1a and the second distal element 1b are symmetrically arranged with respect to the central axis of the transmission column 31.

[0077] Preferably, the first proximal element 2a and the second proximal element 2b are symmetrically arranged with respect to the central axis of the transmission column 31.

[0078] Locking mechanism

[0079] The locking mechanism includes a transmission column 31 and a fixing clip 32. The transmission column 31 is driven to move relative to the fixing clip 32 by a control rod 4. A control rod connection portion 3111 connected to the control rod 4 is provided at the distal end of the transmission column body 311 of the transmission column. Preferably, the control rod 4 is made of a rigid material or a flexible material.

[0080] The transmission column 31 is made of a flexible material. The transmission column 31 includes a transmission column body 311 and a transmission seat 312. The transmission seat 312 is provided at the proximal end of the transmission column 31. The proximal end of the first proximal element 2a is connected to the transmission seat 312; the proximal end of the second proximal element 2b is connected to the transmission seat 312.

[0081] The transmission column body 311 includes a plurality of clamping structures along its axial direction. The transmission column 31 has a locked state and an unlocked state. In the locked state, the plurality of clamping structures on the transmission column body 311 are in frictional engagement with the fixed clamp 31, thereby restricting the movement of the transmission column 31, and further locking the first distal element 1a and the second distal element 1b at an appropriate position between the open position and the closed position. In the unlocked state, the transmission column 31 is pushed by an external force, and the transmission column 31 moves relative to the fixed clamp 32, so that the transmission column 31 drives the first proximal element 2a and the second proximal element 2b to move, and further drives the first distal element 1a and the second distal element 1b to move between the open position and the closed position. Among them, the fixed clamp 32 always remains stationary, and the shape and structure of the fixed clamp 3 match the shape and structure of the plurality of clamping structures of the transmission column 31, so that in the locked state, the fixed clamp 3 and the transmission column 31 do not move. In the unlocked state, the transmission column 31 overcomes the interference friction of the fixed clamp on the transmission column 31, so that the transmission column 31 can move relative to the fixed clamp along the axial direction of the transmission column 31. Preferably, the shape of the plurality of clamping structures is selected from the following group: trapezoidal, square, cylindrical or a combination thereof. The plurality of clamping structures are used to increase the interference friction between the fixed clamp and the transmission column. In the unlocked state, the control rod controls the movement of the transmission column, thereby overcoming the interference friction between the fixed clamp and the transmission column.

[0082] Embodiment 1

[0083] Figures 1 to 4 An embodiment of the locking mechanism is shown, including a schematic structural diagram of the deployed state of the implantable fixation device and the closed state of the implantable fixation device. Figure 3 A schematic structural diagram of a cross-section of the locking mechanism of the fixation device according to the first embodiment of the present application is shown; the locking mechanism includes a transmission column 31 and a U-shaped clamp. Figure 4 A schematic diagram showing a connection method between the locking mechanism and the control rod according to the first embodiment of the present application; in Figures 5-6 A schematic structural diagram of other deformations of the transmission column of the locking mechanism of the implantable fixation device of the first embodiment is shown.

[0084] In Figure 1 it shows that the "clip" of the fixation device is in a partially open position, and in Figure 2 it shows an over-closed position. In this embodiment, the locking mechanism allows the user to lock the clip so that it cannot be opened or closed under the action of forces related to operation, advancement and deployment, and these forces come from normal systolic or diastolic hemodynamic pressure induction and tissue induction forces during the surgical implantation process or after implantation.

[0085] In this embodiment, the clip includes two link members (i.e., a first proximal element 2a and a second proximal element 2b) and two jaw members (a first distal element 1a and a second distal element 1b), which are hingedly connected to a central drive post 31, i.e., the "active bolt", and a static U-shaped clip member. The first distal element 1a and the second distal element 1b, and the first proximal element 2a and the second proximal element 2b can longitudinally translate along the drive post 31 to allow the user to adjust the opening angle of the clip through a control rod 4( Figure 4 ). This control rod 4 can be a rigid or flexible shaft that connects the drive post 31 to the control surface at the proximal end of the access catheter. In this embodiment, the control rod 4 and the control rod connection portion 3111 are connected by a hooking manner. In other embodiments, the control rod 4 and the control rod connection portion 3111 can be connected by a threaded manner.

[0086] When the control rod 4 is advanced distally, the drive post 31 moves distally relative to the U-shaped clip accordingly, thereby increasing the opening angle of the clip (opening action). When the control rod 4 is advanced proximally, the drive post 31 moves proximally relative to the U-shaped clip accordingly, thereby decreasing the opening angle of the clip (closing action).

[0087] In this embodiment, the drive post body 311 is composed of a plurality of latching structures 300, and the plurality of latching structures 300 are a plurality of structures arranged in sequence along the axial direction of the drive post and having a trapezoidal cross-section. The trapezoidal cross-section structure is an isosceles trapezoid, and the height of each isosceles trapezoid remains unchanged along the axial direction of the drive post from the distal end to the proximal end( Figure 4 ) and increases( Figure 5 ) or decreases( Figure 6 ) or changes alternately (not shown). The lower base (the longer base) of the isosceles trapezoid is arranged away from the first distal element (1a) and the second distal element (1b). Among them, in Figure 4 , each isosceles trapezoid is exactly the same. In Figure 5 and Figure 6 , the drive post includes a plurality of isosceles trapezoids with different heights, and the lengths of the upper bases of the different isosceles trapezoids are approximately equal, and the lengths of the lower bases of the different isosceles trapezoids are approximately equal. The function of the plurality of latching structures is to allow the user to close the angle of the clip arms by overcoming the interference fit friction of the U-shaped clip on the drive post 31. At the same time, by providing physical interference or increasing friction when the drive post 31 moves relative to the U-shaped clip during the opening action, the clip is locked in a partially closed or fully closed state. This helps to lock the clip at a fixed angle and prevent the clip from accidentally or incidentally opening during the operation or after implantation.

[0088] Embodiment 2

[0089] The difference from Embodiment 1 is that the locking mechanism (the drive post and the fixed clip) has a different structure.

[0090] Figure 7 The structural schematic diagram of the second embodiment of the transmission column structure of the locking mechanism of the implantable fixation device is shown;

[0091] In this embodiment, the transmission column body 311 is composed of a plurality of clamping structures 300. The plurality of clamping structures are a plurality of clamping column structures arranged in sequence along the axial direction of the transmission column 31. Each clamping column structure includes a clamping column 3001 and a connecting column 3002 that are connected. The cross-sectional diameter of the clamping column 3001 is variable, the cross-sectional diameter of the connecting column 3002 is constant, and the maximum cross-sectional diameter of the clamping column 3001 is greater than the cross-sectional diameter of the connecting column 3002.

[0092] Embodiment 3

[0093] The difference from Embodiment 1 is that the locking mechanism (transmission column and fixing clip) has a different structure.

[0094] Figure 8 The structural schematic diagram of the third embodiment of the transmission column structure of the locking mechanism of the implantable fixation device is shown;

[0095] The transmission column body 311 of the transmission column 31 includes a cylindrical structure and a plurality of clamping structures 300 sleeved on the cylindrical structure, and the cross-sections of the plurality of clamping structures are rectangular. The plurality of clamping structures are spaced apart by a predetermined distance, and the predetermined distance is in the range of 0.5 mm to 2.5 mm. In another embodiment, the predetermined distances between the respective clamping structures 300 are not equal.

[0096] In addition, in other embodiments, the plurality of clamping structures may be a series of barb features along the axial direction of the transmission column 31. The barb features cause the transmission column 31 to interact with the fixing clip 3, thereby generating frictional force, and further preventing the transmission column 31 from moving axially relative to the fixing clip 3 in a sliding manner, so that the opening angle of the clip increases or decreases. The friction features are inclined, angled or arranged in a manner that provides a higher locking force. Compared with the frictional force when closing to a smaller angle, it can prevent the clip from opening to a larger opening angle. The transmission column 31 in this embodiment is made of a flexible material such as rubber or plastic, and the material provides frictional force, where the frictional force is generated by the restoring force of the contracted barbs to expand the static part of the clip assembly to its uncontracted state.

[0097] In other embodiments, the transmission column body 311 is a flexible foldable ridge element (similar to a Christmas tree structure). In other words, the plurality of clamping structures of the transmission column body 311 are the plurality of ridge structures of the ridge element.

[0098] The main advantages of the present invention include:

[0099] (a) The fixing device of the present invention provides a way to increase the friction force to keep the clamping angle of the fixing device at the desired position. Compared with the prior art, the interference friction force between the fixing clip and the transmission column of the present invention helps to provide a higher locking force to prevent the further opening of the clamping angle.

[0100] (b) The fixing device of the present invention can be inserted into the mitral valve from a distal surgery or a vascular access point, and two valve leaflets can be joined and fixed together by using an endovascular or minimally invasive method. The fixing device of the present invention can be repositioned before fixation and optionally removed the feature of the fixing instrument to ensure the optimal placement position; the locking mechanism of the fixing device of the present invention allows the user to "lock" the fixing device at the desired position to fix the valve leaflets together, and the locking mechanism locks the fixing device in a single predetermined configuration or one of several predetermined configurations.

[0101] (c) The locking mechanism of the fixing device of the present invention allows locking at any position along the continuous points on the fixing device, so that the user can select the desired position to fix the valve leaflets during the operation; because the position required to fix the valve leaflets may vary due to changes in the thickness and quantity of the tissue captured by the fixing device, the presence or absence of diseases (such as calcification, hypertrophy), the age of the patient, and other factors that the user may not know before the operation. For example, if too much tissue is captured or joined by the fixing device, compared with capturing less tissue, the fixing device may not be able to close. Therefore, in some cases, the user can use the locking mechanism of the fixing device of the present invention for some special, unexpected positions, even if these positions are not determined to be used before the operation.

[0102] (d) The fixing device of the present invention is particularly suitable for those surgeries that require minimally invasive or endovascular access to the distal tissue position, where the instruments used must pass through a long, narrow and curved path to reach the treatment site; in addition, the fixing device of the present invention is suitable for repositioning or reversing at any site without disturbing or damaging the internal tissue and can be removed from the patient; and the device of the present invention can be locked in a fixed position and left in the body as an implant.

[0103] (e) The fixing device of the present invention is suitable for fixing tissue at the treatment site; typical tissue fixation applications include heart valve repair, septal defect repair, patent foramen ovale repair, vascular ligation and clamping, laceration repair and wound closure; that is, the fixing device of the present invention is used to repair internal tissues other than heart valves, and the present invention can also be used for open surgical operations.

[0104] (f) The fixing device of the present invention is used for various tissue contraction and repair surgeries, and is suitable for the repair of heart valves, especially the treatment of mitral regurgitation. According to the present invention, the mitral valve can be accessed either from the atrial side (antegrade approach) or from the ventricular side (retrograde approach), either through blood vessels or the heart wall. The fixing device of the present invention can join two or more valve leaflets by the "edge-to-edge" or "bow-tie" technique to reduce regurgitation without opening the chest, and can be performed intravascularly, that is, the instrument can enter the heart through a blood vessel far from the heart of the patient or in a minimally invasive manner; that is, there is no need for open surgery through the chest wall and heart wall as in the traditional method.

[0105] A large number of technical features are recorded in the description of this application, distributed in various technical solutions. If all possible combinations of technical features (i.e., technical solutions) of this application are listed, the description will be too long. To avoid this problem, each technical feature disclosed in the above-mentioned invention content of this application, each technical feature disclosed in the following embodiments and examples, and each technical feature disclosed in the drawings can be freely combined with each other to form various new technical solutions (these technical solutions are all considered to have been recorded in this specification), unless the combination of such technical features is technically infeasible. For example, in one example, features A + B + C are disclosed, and in another example, features A + B + D + E are disclosed, and features C and D are equivalent technical means that play the same role, and only one of them can be used technically and it is impossible to use both at the same time. Feature E can be combined with feature C technically. Then, the solution of A + B + C + D should not be considered to have been recorded because it is technically infeasible, and the solution of A + B + C + E should be considered to have been recorded.

[0106] All documents mentioned in this application are considered to be integrally included in the disclosure content of this application so that they can be used as a basis for modification when necessary. In addition, it should be understood that after reading the above-mentioned disclosure content of this application, those skilled in the art can make various changes or modifications to this application, and these equivalent forms also fall within the scope of protection required by this application.

Claims

1. An implantable fixation device for engaging heart tissue including an improved locking mechanism, characterized in that, Comprising: A first distal element (1a), a second distal element (1b), a first proximal element (2a), a second proximal element (2b), and a locking mechanism (3), wherein the locking mechanism (3) includes: a transmission column (31) and a fixing clip (32); The distal end of the first proximal element (2a) is connected to the first distal element (1a), and the proximal end of the first proximal element (2a) is connected to the transmission column (31); the distal end of the second proximal element (2b) is connected to the second distal element (1b), and the proximal end of the second proximal element (2b) is connected to the transmission column (31); the proximal ends of the first distal element (1a) and the second distal element (1b) are both connected to the fixing clip (32); The cooperative movement of the transmission column (31) and the fixing clip (32) causes the first distal element (1a) and the second distal element (1b) to move between an open position and a closed position; The transmission column (31) includes a transmission column body (311), and the transmission column body (311) includes a plurality of clamping structures along its axial direction. The transmission column (31) includes a locked state and an unlocked state. In the locked state, the plurality of clamping structures (300) of the transmission column body (311) are frictionally engaged with the fixing clip (32), so that the movement of the transmission column (31) is restricted by the interference friction force between the plurality of clamping structures (300) and the fixing clip (32), and further the first distal element (1a) and the second distal element (1b) are locked at an appropriate position between the open position and the closed position; in the unlocked state, the transmission column (31) is subjected to an external force, and the transmission column (31) moves relative to the fixing clip (32), so that the transmission column (31) drives the first proximal element (2a) and the second proximal element (2b) to move, and further drives the first distal element (1a) and the second distal element (1b) to move between the open position and the closed position.

2. The implantable fixation device according to claim 1, characterized in that, The first distal element and the second distal element are symmetrically arranged.

3. The implantable fixation device according to claim 1, characterized in that, The first proximal element and the second proximal element are symmetrically arranged.

4. The implantable fixation device according to claim 1, wherein, The first distal element and the second distal element are symmetrically arranged with respect to the axis of symmetry of the transmission column.

5. The implantable fixation device according to claim 1, characterized in that, The first proximal element and the second proximal element are symmetrically arranged with respect to the axis of symmetry of the transmission column.

6. The implantable fixation device according to claim 1, wherein, The transmission column is made of a flexible material.

7. The implantable fixation device according to claim 1, wherein The transmission column is foldable.

8. The implantable fixation device according to claim 1, characterized in that, The fixing clip (32) is a U-shaped clip.

9. The implantable fixation device according to claim 1, characterized in that, The shape of the cross-section of the plurality of clamping structures is selected from the following group: trapezoidal, square, cylindrical, or a combination thereof.

10. The implantable fixation device according to claim 1, wherein, The fixing clip always remains stationary.

11. The implantable fixation device according to claim 1, wherein, The transmission column body is a flexible and foldable ridge-shaped element.

12. The implantable fixation device according to claim 1, characterized in that, The transmission column body (311) is composed of a plurality of clamping structures (300), and the plurality of clamping structures (300) are a plurality of successively arranged clamping structures with a trapezoidal cross-section arranged along the axial direction of the transmission column.

13. The implantable fixation device according to claim 12, characterized in that, The trapezoid of the card slot structure with a trapezoidal cross-section is an isosceles trapezoid, and the height of each isosceles trapezoid remains unchanged or increases or decreases or changes alternately in sequence along the axial direction of the transmission column from the distal end to the proximal end.

14. The implantable fixation device according to claim 13, wherein The heights of the respective isosceles trapezoids are different, the lengths of the upper bases of the respective different isosceles trapezoids are approximately equal, and the lengths of the lower bases of the respective different isosceles trapezoids are approximately equal.

15. The implantable fixation device according to claim 13, wherein The lower base of the isosceles trapezoid is arranged away from the first distal element (1a) and the second distal element (1b).

16. The implantable fixation device according to claim 1, wherein, The transmission column body is composed of a plurality of card slot structures. The plurality of card slot structures are a plurality of card slot column structures arranged in sequence along the axial direction of the transmission column. Each card slot column structure includes a connected card slot column and a connecting column. The cross-sectional diameter of the card slot column is variable, the cross-sectional diameter of the connecting column is constant, and the maximum cross-sectional diameter of the card slot column is greater than the cross-sectional diameter of the connecting column.

17. The implantable fixation device according to claim 16, wherein The plurality of card slot structures include a series of barb features.

18. The implantable fixation device according to claim 17, wherein, The barb features are inclined and angled.

19. The implantable fixation device according to claim 16, wherein, The shape and structure of the fixing clip are matched with the shape and structure of the plurality of card slot structures of the transmission column so that in the locked state, the fixing clip and the transmission column do not move; in the unlocked state, the transmission column can move relative to the axial direction of the transmission column.

20. The implantable fixation device according to claim 1, wherein, The implantable fixing device further includes a control rod (4), and the control rod (4) is used to drive the transmission column (31) to move relative to the fixing clip (32).

21. The implantable fixation device according to claim 20, wherein, A control rod connection part (3111) connected to the control rod (4) is provided at the distal end of the transmission column body (311) of the transmission column.

22. The implantable fixation device according to claim 21, characterized in that, The proximal end of the transmission column includes a transmission column seat. The proximal end of the first proximal element is connected to the transmission column seat of the transmission column; the proximal end of the second proximal element is connected to the transmission column seat of the transmission column.

23. The implantable fixation device according to claim 22, wherein, The control rod is made of a rigid material or a flexible material.

24. The implantable fixation device according to claim 23, characterized in that, The control rod and the control rod connection part are threadedly connected.

25. The implantable fixation device according to claim 24, wherein, The control rod and the control rod connection part are connected by a hooking method.

26. The implantable fixation device according to any one of claims 1-25, characterized in that, The implantable fixing device further includes a sheet-like component. The sheet-like component includes a first sheet-like element (10a) and a second sheet-like element (10b). The first sheet-like element (10a) is arranged on the first distal element (1a), so as to form a first tissue joint surface between the first distal element (1a) and the first sheet-like element (10a). The second sheet-like element (10b) is arranged on the second distal element (1b), so as to form a second tissue joint surface between the second distal element (1b) and the second sheet-like element (10b).

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