CN113274168A - Implantable fixation device for engaging cardiac tissue including improved locking mechanism - Google Patents

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 comprises: the transmission column comprises a transmission column body, the transmission column body comprises a plurality of clamping structures along the axial direction of the transmission column body, the transmission column comprises a locking state and an unlocking state, and in the locking state, the plurality of clamping structures on the transmission column body are in friction combination with the fixing clamp, so that the movement of the transmission column is limited; under the unlocking state, the transmission column is pushed by external force, the transmission column moves relative to the fixing clamp, so that the transmission column drives the first near-end element and the second near-end element to move, and the improved locking mechanism of the fixing device enables medical staff to conveniently and rapidly freely switch the fixing device between the locking state and the unlocking state, so that the fixing device can be locked at a proper position.

Description

Implantable fixation device for engaging cardiac tissue including improved locking mechanism

Technical Field

The present application relates generally to the field of medical devices, and more particularly to an implantable fixation device that engages cardiac tissue including an improved locking mechanism.

Background

Surgical repair of body tissues typically involves tissue fixation in tissue coalescence and coalescence. In repairing a valve, tissue apposition involves wrapping the leaflets of the valve in a treatment device, which can then be held by fastening or securing the leaflets. This method can be used to treat regurgitation that most commonly occurs in the mitral valve.

Mitral regurgitation is characterized by the retrograde flow from the left ventricle through the dysfunctional mitral valve into the left atrium. During the normal period of systole, the mitral valve acts as a check valve, preventing the flow of oxygenated blood back into the left atrium. Thus, oxygenated blood is pumped through the aortic valve and into the aorta. Valve regurgitation can significantly reduce the pumping efficiency of the heart, exposing the patient to the risk of severe progressive heart failure.

Mitral regurgitation can be caused by a number of different mechanical defects of the mitral valve or the left ventricular wall. The leaflets, the chordae connecting the leaflets and papillary muscles, the papillary muscles or the left ventricular wall may be damaged or dysfunctional. Often, the valve annulus is damaged, dilated or weakened, thereby limiting the ability of the mitral valve to close properly in the face of high left ventricular pressure.

The most common treatment for mitral regurgitation is valve replacement or repair, including leaflet and annulus reconstruction, the latter commonly referred to as annuloplasty. One recent mitral valve 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 typically rely on open heart surgery, usually by opening the patient's chest cavity through a sternotomy and then circulating the patient extracorporeally. The need to open the chest and bypass at the same time is traumatic and associated with high mortality and morbidity.

Accordingly, there is a great need in the art to develop an implantable fixation device that engages cardiac tissue that includes an improved locking mechanism that allows medical personnel to easily and quickly freely switch the implantable fixation device between a locked state and an unlocked state so that the fixation device can be locked in place and left as an implant or in the body.

Disclosure of Invention

It is an object of the present application to provide an implantable fixture for engaging cardiac tissue that includes an improved locking mechanism that allows medical personnel to easily and quickly freely switch the implantable fixture between a locked state and an unlocked state so that the fixture can be locked in a fixed position and left as an implant or in the body.

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 comprises: a transmission column and a fixing clamp;

the distal end of the first proximal element is connected with the first distal element, and the proximal end of the first proximal element is connected with the transmission column; the distal end of the second proximal element is connected with the second distal element, and the proximal end of the second proximal element is connected with the transmission column; the proximal end of the first distal element and the proximal end of the second distal element are both connected to the retaining clip;

the cooperative movement of the drive post and the retaining clip moves the first and second distal elements between an open position and a closed position;

the drive post comprises a drive post body including a plurality of detent structures along an axial direction thereof, the drive post including a locked state and an unlocked state, in the locked state, the plurality of detent structures of the drive post body frictionally engaging the retaining clip to thereby limit movement of the drive post such that the first and second distal elements are locked in position between the open and closed positions; in the unlocking state, the transmission column is subjected to external force, the transmission column moves relative to the fixing clamp, and therefore the transmission column drives the first near-end element and the second near-end element to move, and further drives the first far-end element and the second far-end element to move between the opening position and the closing position.

In another preferred embodiment, the first distal element and the second distal element are symmetrically arranged.

In another preferred embodiment, the first proximal element and the second proximal element are symmetrically arranged.

In another preferred embodiment, the first distal member and the second distal member are symmetrically disposed about the transmission post as a central axis.

In another preferred example, the first proximal element and the second proximal element are symmetrically arranged with the transmission column as a central axis.

In another preferred embodiment, the drive column is made of a flexible material.

In another preferred embodiment, the drive column is collapsible.

In another preferred embodiment, the fixing clip is a type clip.

In another preferred embodiment, the cross-section of the plurality of detent structures has a shape selected from the group consisting of: trapezoidal, square, cylindrical, or combinations thereof.

In another preferred embodiment, the retaining clip is held stationary at all times.

In another preferred example, the transmission column body is a ridge element which can be flexibly folded.

In another preferred embodiment, the transmission column body is composed of a plurality of clamping structures, and the clamping structures are a plurality of clamping structures which are arranged in sequence along the axial direction of the transmission column and have trapezoidal cross sections.

In another preferred embodiment, the trapezoid of the blocking structure with the trapezoid cross section is an isosceles trapezoid, and the height of each isosceles trapezoid is constant or sequentially increased or decreased or alternatively changed from the far end to the near end along the axial direction of the transmission post.

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

In another preferred embodiment, the lower base of the isosceles trapezoid is located away from the first and second distal elements.

In another preferred embodiment, the drive post body comprises a plurality of screens structures, a plurality of screens structures are for following a plurality of screens post structures of arranging in proper order that the axial direction of drive post set up, and every screens post structure is including a screens post and a spliced pole that meet, the cross section diameter of screens post is the change, the cross section diameter of spliced pole is unchangeable, the biggest cross section diameter of screens post is greater than the diameter of the cross section of spliced pole.

In another preferred embodiment, the driving post body of the driving post is a cylindrical structure, the plurality of clamping structures are sleeved on the cylindrical structure, the cross section of each clamping structure is rectangular, and the plurality of clamping structures are spaced at a predetermined distance.

In another preferred embodiment, the plurality of detent structures comprise a series of barb features.

In another preferred embodiment, the barb features are angled.

In another preferred embodiment, the shape and structure of the retaining clip cooperate with the shape and structure of the plurality of detent structures of the drive post such that in the locked state, the retaining clip does not move with the drive post; in the unlocked state, the drive post is movable relative to an axial direction along the drive post.

In another preferred embodiment, the implantable fixation device further comprises a control rod for driving the transmission post to move relative to the fixation clamp.

In another preferred example, the distal end of the drive column body of the drive column is provided with a control rod connecting part connected with the control rod.

In another preferred embodiment, the proximal end of the drive post comprises a drive post holder, and the proximal end of the first proximal element is connected with the drive post holder of the drive post; the proximal end of the second proximal element is connected with the drive column seat of the drive column.

In another preferred embodiment, the control rod is made of a rigid material or a flexible material.

In another preferred example, the control rod and the control rod connecting part are connected by screw threads.

In another preferred example, the control rod and the control rod connecting part are connected by hooking.

In another preferred embodiment, the implantable fixation device further comprises a sheet-like component comprising a first sheet-like element disposed on the first distal element so as to form a first tissue engagement surface between the first distal element and the first sheet-like element, and a second sheet-like element disposed on the second distal element so as to form a second tissue engagement surface between the second distal element and the second sheet-like element.

In another preferred embodiment, the first sheet element and the second sheet element are two sheet parts welded together with a predetermined configuration.

It is to be understood that within the scope of the present invention, the above-described features of the present invention and those specifically described below (e.g., in the examples) may be combined with each other to form new or preferred embodiments. Not to be reiterated herein, but to the extent of space.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below. It is to be understood that the drawings in the following description are merely exemplary embodiments of the invention and that one skilled in the art may, without any inventive step, derive other embodiments from these drawings.

FIG. 1 is a structural schematic diagram of a deployed state of an implantable fixation device engaging cardiac tissue including an improved locking mechanism according to a first embodiment of the present application;

FIG. 2 is a schematic structural view of a closed state of an implantable fixation device engaging cardiac tissue including a modified locking mechanism according to a first embodiment of the present application;

FIG. 3 is a schematic structural view of a locking mechanism of a fixation device according to a first embodiment of the present application;

FIG. 4 shows a schematic view of one manner of connecting the locking mechanism to the control lever according to the first embodiment of the present application;

FIGS. 5-6 are schematic structural views of other variations of the drive post of the locking mechanism of the implantable fixation device according to the first embodiment of the present application;

FIG. 7 is a schematic view of a drive post configuration of a locking mechanism of an implantable fixation device according to a second embodiment of the present application;

fig. 8 is a schematic view of a drive post configuration of a locking mechanism of an implantable fixation device according to a third embodiment of the present application.

In the drawings, the designations are as follows:

1 a-first distal element

1 b-second distal element

2 a-first proximal element

2 b-second proximal element

3-locking mechanism

31-drive column

311-drive column body

300-clamping structure

3001 clamping column

3002 connecting column

3111 control lever connection

32-fixation clamp

4-control lever

10 a-first sheet-like element

10 b-second sheet-like element

Detailed Description

The present inventors, through extensive and intensive studies, have for the first time developed an implantable fixation device for engaging cardiac tissue that includes an improved locking mechanism that maintains the clamping angle of the fixation device in a desired position by increasing friction, that is simple, reliable and safe, that includes a friction fit drive post and a fixation clamp such that the first and second distal elements of the implantable fixation device move between an open position and a closed position; the implantable fixation device can be used in a variety of therapeutic procedures including intravascular, minimally invasive, and open surgical procedures, and in a variety of anatomical regions including the abdomen, chest, cardiovascular system, heart, intestinal tract, stomach, urinary tract, bladder, lung, and other organs, vessels, and tissues; and the ingenious setting of the locking mechanism of the application enables medical staff to conveniently lock and unlock the fixing device, so that the fixing device can be locked at a required position. Since the invention provides a friction force to keep the clamping angle in the desired position.

Term(s) for

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

the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Without further limitation, the use of the verb "comprise a" to define an element does not exclude the presence of another, same element in a process, method, article, or apparatus that comprises the element. In the present patent application, if it is mentioned that a certain action is executed according to a certain element, it means that the action is executed according to at least the element, and two cases are included: performing the action based only on the element, and performing the action based on the element and other elements. The expression of a plurality of, a plurality of and the like includes 2, 2 and more than 2, more than 2 and more than 2.

In the present patent application, relational terms such as first and second, and the like may be used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions.

In the present invention, all the directional indications (such as up, down, left, right, front, rear, etc.) are used only to explain the relative positional relationship between the respective members, the motion situation, etc. in a certain posture (as shown in the drawing), and if the certain posture is changed, the directional indication is changed accordingly.

In the following description, numerous technical details are set forth in order to provide a better understanding of the present application. However, it will be understood by those skilled in the art that the technical solutions claimed in the present application may be implemented without these technical details and with various changes and modifications based on the following embodiments.

Implantable fixation device (clip)

Referring to fig. 1 and 2, the implantable fixation device of the present invention, an implantable fixation device that engages cardiac tissue including an improved locking mechanism, includes a pair of members, a pair of blade members, a locking mechanism 3, and a control rod 4.

The pair of parts comprises two free ends, namely a first distal element 1a and a second distal element 1b, which are symmetrically arranged, and a first proximal element 2a and a second proximal element 2b, which are symmetrically arranged; the pair of sheet members comprises a first sheet member 10a, a second sheet member 10b, the first sheet member 10a being disposed on the first distal member 1a so as to form a first tissue engaging surface between the first distal member 1a and the first sheet member 10a, the second sheet member 10b being disposed on the second distal member 1b so as to form a second tissue engaging surface between the second distal member 1b and the second sheet member 10 b; the locking mechanism 3 comprises a drive post 31 and a retaining clip 32.

By cooperation of the transmission column 31 and the fixing clip 32, the movement of the transmission column 31 brings the first and second proximal elements 2a, 2b into motion, so that the movement of the first and second proximal elements 2a, 2b allows the first and second distal elements 1a, 1b to move between an open position, in which the free ends (i.e. the first and second distal elements 1a, 1b are spaced apart, and a closed position, in which the free ends (i.e. the first and second distal elements 1a, 1b are close to each other and the engagement surfaces substantially face each other, wherein the pair of elements in the closed position is adapted to reduce retrograde blood flow through the engaged tissue.

Preferably, the first sheet element 10a and the second sheet element 10b are two sheet parts welded together with a predetermined configuration.

Preferably, the first distal element 1a and the second distal element 1b are arranged symmetrically about the central axis of the drive column 31.

Preferably, the first proximal element 2a and the second proximal element 2b are arranged symmetrically about the central axis of the drive column 31.

Locking mechanism

The locking mechanism comprises a transmission column 31 and a fixing clamp 32. The control rod 4 drives the transmission column 31 to move relative to the fixing clamp 32. The distal end of the drive column body 311 of the drive column is provided with a control rod connection portion 3111 for connection with the control rod 4. Preferably, the control rod 4 is made of a rigid material or a flexible material.

The transmission column 31 is made of a flexible material, the transmission column 31 comprises a transmission column body 311 and a transmission seat 312, the transmission column seat 312 is arranged at the proximal end of the transmission column 31, and the proximal end of the first proximal element 2a is connected with the transmission column seat 312; the proximal end of the second proximal element 2b is connected to the drive column base 312.

The drive post body 311 comprises a plurality of detent structures along its axial direction, and the drive post 31 comprises a locked state in which the detent structures on the drive post body 311 frictionally engage the retaining clip 31 to thereby limit movement of the drive post 31 and thereby lock the first and second distal members 1a, 1b in position between the open and closed positions; in the unlocked state, the transmission column 31 is pushed by 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. Wherein the fixing clip 32 is kept still all the time, and the shape and structure of the fixing clip 3 are matched with the shape and structure of a plurality of clamping structures of the transmission column 31, so that the fixing clip 3 and the transmission column 31 do not move in a locking state; in the unlocked state, the drive stud 31 overcomes the interference friction of the retaining clip on the drive stud 31, so that the drive stud 31 can move relative to the retaining clip in the axial direction of the drive stud 31. Preferably, the shape of the plurality of detent structures is selected from the group consisting of: trapezoidal, square, cylindrical, or combinations thereof. The clamping structures are used for increasing interference friction between the fixing clamp and the transmission column, and the control rod controls the transmission column to move in an unlocking state, so that the interference friction between the fixing clamp and the transmission column is overcome.

Example 1

One embodiment of a locking mechanism is shown in fig. 1-4, including a schematic structural view of an implantable fixation device in a deployed state and an implantable fixation device in a closed state. FIG. 3 shows a schematic structural diagram of a cross-section of a locking mechanism of a fixation device according to a first embodiment of the present application; wherein the locking mechanism comprises a drive post 31 and a clevis. FIG. 4 shows a schematic view of one manner of connecting the locking mechanism to the control lever according to the first embodiment of the present application; further variations of the drive post of the locking mechanism of the implantable fixation device of the first embodiment are shown in fig. 5-6.

The fixation device "clip" is shown in a partially open position in fig. 1, and an over-closed position in fig. 2. In this embodiment, the locking mechanism allows the user to lock the clip from opening or closing under forces associated with manipulation, advancement and deployment from normal systolic or diastolic hemodynamic pressure-induced and tissue-induced forces during surgical implantation or after implantation.

In this embodiment, the clip comprises 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) hingedly connected to a central drive post 31, i.e. a "live bolt", and a static clevis member, the first distal element 1a and the second distal element 1b, the first proximal element 2a and the second proximal element 2b being longitudinally translatable along the drive post 31 to allow a user to adjust the opening angle of the clip by means of a control lever 4 (fig. 4), which control lever 4 may be a rigid or flexible shaft connecting the drive post 31 to a control surface at the proximal end of the access catheter. In this embodiment, the lever 4 and the lever connection portion 3111 are coupled by hooking, and in other embodiments, the lever 4 and the lever connection portion 3111 are coupled by screwing.

When the control rod 4 is advanced distally, the drive column 31 correspondingly moves distally relative to the clevis, thereby increasing the opening angle of the clip by the opening action. As the control rod 4 is advanced proximally, the drive post 31 correspondingly moves proximally relative to the clevis, thereby reducing the clip opening angle from a closing motion.

In this embodiment, the driving post body 311 is composed of a plurality of detent structures 300, and the detent structures 300 are a plurality of structures with trapezoidal cross sections arranged in sequence along the axial direction of the driving post. The cross section is in a trapezoidal structure, and the height of each isosceles trapezoid is kept constant (fig. 4) from the far end to the near end along the axial direction of the transmission post, and is sequentially increased (fig. 5) or decreased (fig. 6) or alternatively changed (not shown). The lower base (longer base) of the isosceles trapezium is arranged away from the first distal element (1a) and the second distal element (1 b). Wherein each isosceles trapezoid is identical in fig. 4. In fig. 5 and 6, the driving post includes a plurality of isosceles trapezoids having different heights, wherein 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 detent structures is to allow the user to close the angle of the clamping arms by overcoming the interference friction of the clevis against drive post 31. While locking the clamp in a partially closed or fully closed condition by providing physical interference or increased friction as the drive post 31 moves relative to the clevis during the opening action. This helps lock the clip at a fixed angle and prevents accidental or accidental opening of the clip during surgery or after implantation.

Example 2

The difference from embodiment 1 is that the locking mechanism (drive post and retaining clip) has a different structure.

FIG. 7 is a schematic diagram illustrating a second embodiment of a drive post structure of a locking mechanism of an implantable fixation device;

in this embodiment, drive post body 311 comprises a plurality of screens structures 300, and a plurality of screens structures are a plurality of screens post structures that arrange in proper order that set up along the axial direction of drive post 31, and each screens post structure is including a screens post 3001 and a spliced pole 3002 that meet, and the cross section diameter of screens post 3001 is variable, and the cross section diameter of spliced pole 3002 is unchangeable, and the biggest cross section diameter of screens post 3001 is greater than the diameter of the cross section of spliced pole 3002.

Example 3

The difference from embodiment 1 is that the locking mechanism (drive post and retaining clip) has a different structure.

FIG. 8 is a schematic structural diagram illustrating a third embodiment of a drive post structure of a locking mechanism of an implantable fixation device;

the driving post body 311 of the driving post 31 includes a cylindrical structure and a plurality of position-locking structures 300, which are arranged on the cylindrical structure, and the cross section of the position-locking structures is rectangular, and the position-locking structures are separated by a predetermined distance, which is in the range of 0.5mm to 2.5 mm. In another embodiment, the predetermined distances between the detent structures 300 are not equal.

Additionally, in other embodiments, the plurality of detent structures may be a series of barb features on drive post 31 along its axial direction that allow drive post 31 to interact with retaining clip 3 to create friction that resists movement of drive post 31 relative to retaining clip 3 in a sliding manner along the axial direction to increase or decrease the clip opening angle. The friction feature is sloped, angled or provided in a manner that provides a higher locking force, preventing the clip from opening to a greater opening angle than a friction force that closes to a lesser angle. The drive post 31 in this embodiment is constructed of a flexible material, such as rubber or plastic, that provides a frictional force due to the restoring force of the contracting barbs on the static portion of the clip assembly expanding to its uncontracted state.

In other embodiments, the driving post body 311 is a ridge-shaped element (similar to a christmas tree structure) that can be flexibly folded, in other words, the plurality of locking structures of the driving post body 311 are a plurality of ridge-shaped structures of the ridge-shaped element.

The main advantages of the invention include:

(a) the present invention provides an increased friction force to hold the clamp angle of the fixture in a desired position, and the interference friction between the clamp and drive post of the present invention helps provide a higher locking force to prevent further opening of the clamp angle as compared to the prior art;

(b) the use of the fixation device of the present invention allows access to the mitral valve from a distal surgical or vascular access point, and the two leaflets can be joined and secured together using endovascular or minimally invasive methods, the fixation device of the present invention can reposition and optionally remove features of the fixation instrument prior to fixation to ensure optimal placement; the locking mechanism of the fixation device of the present invention allows a user to "lock" the fixation device in a desired position to secure the leaflets together, the locking mechanism locking the fixation device in a single predetermined configuration or one of several predetermined configurations;

(c) the locking mechanism of the fixation device of the present invention allows locking at any location along a continuum of points on the fixation device so that a user can select a desired location to secure the leaflets during a procedure; because the location required to secure the leaflets may vary due to variations in the thickness and amount of tissue captured by the fixation device, the presence or absence of disease (e.g., calcification, hypertrophy), the age of the patient, and other factors that may not be known to the user prior to surgery, for example, if too much tissue is captured or engaged by the fixation device, the fixation device may not close as compared to capturing less tissue, and therefore, in some cases, users may use the fixation device of the present invention to use the locking mechanism of the fixation device in certain specific, unintended locations even if those locations are not decided to be used prior to surgery;

(d) the fixation device of the present invention is particularly useful in procedures requiring minimally invasive or endovascular access to a distal tissue site, where the instruments used must travel a long, narrow and tortuous path to reach the treatment site; furthermore, the fixation device of the present invention is adapted to be repositionable or reversible and removable from the patient at any location without disturbing or damaging internal tissue; and the device of the present invention can be locked in a fixed position and left as an implant in or on the body;

(e) the fixation device of the present invention is adapted to fix tissue at a treatment site; typical tissue fixation applications include heart valve repair, septal defect repair, patent foramen ovale repair, vessel ligation and clamping, laceration repair, and wound closure; that is, the fixation device of the present invention is used to repair body tissues other than heart valves, and the present invention may also be used in open surgery;

(f) the fixation device of the present invention is useful in a variety of tissue apposition and repair procedures, suitable for the repair of heart valves, particularly the treatment of mitral regurgitation, and according to the present invention, the mitral valve is accessed either from the atrial side (antegrade approach) or the ventricular side (retrograde approach), or is threaded through a blood vessel or heart wall, the fixation device of the present invention enables two or more leaflets to coapt via "edge-to-edge" or "bowtie" techniques to reduce regurgitation without opening the chest, and can be performed intravascularly, i.e., the instrument can be accessed into the heart via a blood vessel remote from the patient's heart or in a minimally invasive manner; i.e. without the need for open surgery through the chest and heart walls as in conventional methods.

The present specification describes a number of technical features distributed throughout the various technical aspects, and if all possible combinations of technical features (i.e. technical aspects) of the present specification are listed, the description is made excessively long. In order to avoid this problem, the respective technical features disclosed in the above summary of the invention of the present application, the respective technical features disclosed in the following embodiments and examples, and the respective technical features disclosed in the drawings may be freely combined with each other to constitute various new technical solutions (which are considered to have been described in the present specification) unless such a combination of the technical features is technically infeasible. For example, in one example, the feature a + B + C is disclosed, in another example, the feature a + B + D + E is disclosed, and the features C and D are equivalent technical means for the same purpose, and technically only one feature is used, but not simultaneously employed, and the feature E can be technically combined with the feature C, then the solution of a + B + C + D should not be considered as being described because the technology is not feasible, and the solution of a + B + C + E should be considered as being described.

All documents mentioned in this application are to be considered as being incorporated in their entirety into the disclosure of this application so as to be subject to modification as necessary. Further, it is understood that various changes or modifications may be made to the present application by those skilled in the art after reading the above disclosure of the present application, and such equivalents are also within the scope of the present application as claimed.

Claims (10)

1. An implantable fixation device that engages cardiac tissue including an improved locking mechanism, 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) comprises: a transmission column (31) and a fixing clamp (32);

the distal end of the first proximal element (2a) is connected with the first distal element (1a), and the proximal end of the first proximal element (2a) is connected with the transmission column (31); the distal end of the second proximal element (2b) is connected with the second distal element (1b), and the proximal end of the second proximal element (2b) is connected with the transmission column (31); the proximal end of the first distal element (1a) and the proximal end of the second distal element (1b) are connected with the fixing clip (32);

the co-operating movement of the transmission column (31) and the retaining 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 drive post (31) comprises a drive post body (311), the drive post body (311) comprising a plurality of detent structures along its axial direction, the drive post (31) comprising a locked state in which the plurality of detent structures (300) of the drive post body (311) frictionally engage the retaining clip (32) to thereby restrict movement of the drive post (31) and thereby cause the first and second distal elements (1a, 1b) to be locked in position between the open and closed positions; in the unlocking state, the transmission column (31) is subjected to external force, the transmission column (31) moves relative to the fixing clamp (32), and therefore the transmission column (31) drives the first near-end element (2a) and the second near-end element (2b) to move, and further drives the first far-end element (1a) and the second far-end element (1b) to move between the opening position and the closing position.

2. The implantable fixation device of claim 1, wherein the fixation clip (32) is a U-shaped clip.

3. The implantable fixation device of claim 1, wherein a cross-section of said plurality of detent structures has a shape selected from the group consisting of: trapezoidal, square, cylindrical, or combinations thereof.

4. The implantable fixation device of claim 1, wherein said drive post body (311) is comprised of a plurality of detent structures (300), said plurality of detent structures (300) being a plurality of detent structures arranged in series along an axial direction of said drive post, said detent structures having a trapezoidal cross-section.

5. The implantable fixation device of claim 4, wherein said trapezoidal shape of said detent structure having a trapezoidal cross-section is an isosceles trapezoid, and the height of each isosceles trapezoid is constant or sequentially increased or decreased or alternatively changed from the distal end to the proximal end along the axial direction of said drive post.

6. The implantable fixation device according to claim 4, wherein the lower base of said isosceles trapezoid is located away from said first and second distal elements (1a, 1 b).

7. The implantable fixation device of claim 1, wherein said drive post body is comprised of a plurality of detent structures, said detent structures being a plurality of detent post structures arranged in sequence along an axial direction of said drive post, each detent post structure comprising a detent post and a connecting post connected together, said detent post having a varying cross-sectional diameter, said connecting post having a constant cross-sectional diameter, said detent post having a maximum cross-sectional diameter greater than the cross-sectional diameter of said connecting post.

8. The implantable fixation device according to claim 1, further comprising a control rod (4), said control rod (4) being adapted to drive said transmission column (31) in a movement relative to said fixation clamp (32).

9. The implantable fixation device according to claim 8, wherein a distal end of the transmission post body (311) of the transmission post is provided with a control rod connection (3111) to which the control rod (4) is connected.

10. The implantable fixation device according to any one of claims 1-9, further comprising a sheet-like component comprising a first sheet-like element (10a) and a second sheet-like element (10b), said first sheet-like element (10a) being arranged on said first distal element (1a) so as to form a first tissue engagement surface between said first distal element (1a) and said first sheet-like element (10a), and said second sheet-like element (10b) being arranged on said second distal element (1b) so as to form a second tissue engagement surface between said second distal element (1b) and said second sheet-like element (10 b).

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